Medicare Part B - Noridian Lcds

MMEEDDIICCAARREE

NATIONAL & LOCAL COVERAGE DETERMINATIONS REFERENCE MANUAL

CMS NCDs October 2012 Medicare Part B - Noridian LCDs

Easy Policy Access – Click “Bookmark Tab” on left side of page…. Click on Individual LCD/NCD

Quick Reference: Lab Testing Covered Under NCD or LCD (South Dakota Part B November 2011)

NCD (Black) or LCD (Blue) Name Common Name or Abbrev. CPT Code CPT Descriptor Alpha-fetoprotein AFP 82105 Alpha-fetoprotein; serum Blood Counts Blood smear exam 85007 Blood count; blood smear, microscopic examination with manual differential WBC count Blood Counts Blood smear exam 85008 Blood count; blood smear, microscopic examination without manual differential WBC count Blood Counts CBC (without diff) 85027 Blood count, complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet ) Blood Counts CBC with diff 85025 Blood count, complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count Blood Counts Hematocrit/ HCT 85014 Blood count, hematocrit (Hct) Blood Counts Hemoglobing/ HGB 85018 Blood count, Hemoglobin Blood Counts Manual cell counts 85032 Blood count; manual cell count (erythrocyte, leukocyte, or platelet) each Blood Counts Platelet 85049 Blood count; platelet, automated Blood Counts Spun microhematocrit 85013 Blood count, Spun microhematocrit Blood Counts WBC 85048 Blood count, leukocyte (WBC), automated Blood Counts WBC differential 85004 Blood count, automated differential white blood cell (WBC) count BNP BNP 83880 Natiuretic Peptide CA 125 Tumor Antigen CA 125 86304 Immunoassay for tumor antigen, quantitative, CA 125 CA 15-3 & CA 27.29 Tumor Antigens CA 15-3 & CA 27.29 86300 Immunoassay for tumor antigen, quantitative; CA 15-3 CA 27.29 CA 19-9 Tumor Antigen CA 19-9 86301 Immunoassay for tumor antigen, quantitative; CA 19-9 Carcinoembryonic Antigen CEA 82378 Carcinoembryonic antigen (CEA) Collagen Crosslinks Collagen crosslinks 82523 Collagen cross links, any method Cytogenetics Testing - LDC Cytogenetics / Chromosome Multiple 88272/88273/88274/88275 – Cytogentics multiple 3-300; 88280 Chromosome karyotyping; studies 88283 Chromosome banding; 88285 Chromosome count additional; 88289 Chromosome study additional; 88291 Cyto/molecular report; 88299 Cytogenetic study Digoxin Digoxin 80162 Digoxin (Therapeutic Drug Assay) Fecal Occult Blood Occult Blood 82272 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, single specimen (eg, from digital rectal exam) Fecal Occult Blood Occult Blood G0394 Blood occult test (e.g., guaiac), feces, for single determination for colorectal neoplasm (e.g., patient provided 3 cards or 1 triple card for consecutive collection) Gamma Glutamyl Transferase GGT 82977 Glutamyltransferase, gamma (GGT) Genetic Testing - LCD Molecular Testing Multiple Types – Multiple 83890 Molecular diag isolation/extraction; 83891 Molecular diag isolation/extraction of purify. Examples : Factor V Leiden, Nuc. Acid; 83892 Molecular diag enzymatic digestion; 83893 Molecular diag DOT/BLOT Hemachromatosis, Factor 2, production; 83894 Molecular diag separation by gel electrophoresis; 83898 Molecular diag Prothrom Nuc, PCR Methods amplification; 83904 Molecular diag mutation identification; 83912 Molecular diag interp and report Glucose Testing Glucose 82947 Glucose; quantitative, blood (except reagent strip) Glucose Testing Glucose Home Device 82962 Glucose, blood by glucose monitoring device(s) FDA specifically for home use. Glucose Testing Glucose POC 82948 Glucose; blood, reagent strip Glycated Hemoglobin/ Glycated Protein Glycated Protein 82985 Glycated protein Glycated Hemoglobin/ Glycated Protein Hemoglobin A1c / Hgb A1c 83036 Hemoglobin; glycated Hepatitis Panel/Acute Hepatitis Panel Hepatitis Panel 80074 Acute Hepatitis Panel NCD (Black) or LCD (Blue) Name Common Name or Abbrev. CPT Code CPT Descriptor HIV Testing Diagnosis HIV 1 86701 Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1 HIV Testing Diagnosis HIV 1 87390 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-1 HIV Testing Diagnosis HIV 1& 2 / HIV 86703 Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1 and HIV-2, single assay HIV Testing Diagnosis HIV 2 86702 Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-2 HIV Testing Diagnosis HIV 2 87391 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-2 HIV Testing Diagnosis HIV by PCR 87534 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe HIV Testing Diagnosis HIV Western Blot 86689 Qualitative or semiquantitative immunoassays performed by multiple step methods; HTLV or HIV antibody, confirmatory test (for example, Western Blot) HIV Testing Prognosis/Monitoring HIV viral load or quantification 87536 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification HIV Testing Prognosis/Monitoring HIV viral load/ HIV quantification 87539 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification Human Chorionic Gonadotropin HCG, Quantitative 84702 Gonadotropin, chorionic (hCG); quantitative Iron Studies Ferritin 82728 Ferritin Iron Studies Iron 83540 Iron Iron Studies Iron Binding Capacity / IBC 83550 Iron Binding capacity Iron Studies Transferrin 84466 Transferrin Lipid Testing Cholesterol 82465 Cholesterol, serum or whole blood, total Lipid Testing HDL Cholesterol 83718 Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol) Lipid Testing LDL Cholesterol Direct 83721 Lipoprotein, direct measurement, LDL cholesterol Lipid Testing Lipid Panel 80061 Lipid panel Lipid Testing Lipoprotein electrophoresis 83700 Lipoprotein, blood; electrophoretic separation and quantitation Lipid Testing Lipoprotein High Resolution 83701 Lipoprotein blood; high resol. fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (eg, electrophoresis, ultracentrifugation) Lipid Testing Lipoprotein subclasses 83704 Lipoprotein blood; quant. of lipoprotein particle #s & lipoprotein particles subclasses Lipid Testing Triglycerides 84478 Triglycerides Partial Thromboplastin Time PTT / APTT 85730 Thromboplastin time, partial (PTT); plasma or whole blood Prostate Specific Antigen PSA 84153 Prostate Specific Antigen (PSA), total Prothrombin Time Protime / PT 85610 Prothrombin Time Thyroid Testing T3 Uptake/ THBR 84479 Thyroid hormone (T3 or T4) uptake or thyroid hormone binding ratio (THBR) Thyroid Testing T4 84436 Thyroxine (T4); total Thyroid Testing T4, Free 84439 Thyroxine (T4); free Thyroid Testing TSH 84443 Thyroid stimulating hormone (TSH) Urine Culture, Bacterial Kirby Bauer Sensitivity 87184 Susceptibility studies, antimicrobial agent; disk method, per plate (12 or< agents). Urine Culture, Bacterial MIC 87186 Susceptibility studies, antimicrobial agent; microdilution or agar dilution (minimum inhibitory concentration (MIC) or breakpoint), each multi-antimicrobial, per plate. Urine Culture, Bacterial Urine Colony Count 87086 Culture, bacterial; quantitative, colony count, urine. Urine Culture, Bacterial Urine Culture / C&S 87088 Culture, bacterial; with isolation & presumptive identification of each isolates, urine. Vitamin D Vitamin D 25 82306 Vitamin D; 25 Hydroxy Vitamin D Vitamin D 1,25 82652 Vitamin D; 1,25 Dihydroxy

QUICK REFERENCE INFORMATION:

R Preventive Services

Official CMS Information for Medicare Fee-For-Service Providers

This educational tool provides information on Medicare preventive services. Information provided includes Healthcare Common Procedure Coding System (HCPCS)/Current Procedural Terminology (CPT) codes; International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis codes; coverage requirements; frequency requirements; and beneficiary liability for each Medicare preventive service.

SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS

Initial Preventive All Medicare beneficiaries whose first G0402: Physical Once in a lifetime G0402 – IPPE Part B coverage began on or after 01/01/05 • Copayment/coinsurance waived Examination (IPPE) G0403 – EKG for IPPE No specific diagnosis code Must furnish no later than Important – The screening EKG is an • Deductible waived Also known as G0404 – EKG tracing for IPPE Contact the local Medicare 12 months after the effective optional service that may be G0403, G0404, and G0405: the “Welcome G0405 – EKG interpret & report Contractor for guidance date of the first Medicare performed as a result of a to Medicare for IPPE Part B coverage • Copayment/coinsurance applies referral from an IPPE Preventive Visit” • Deductible applies

All Medicare beneficiaries who are no No specific diagnosis code longer within 12 months after the effective Annual Wellness G0438 – Initial visit • Once in a lifetime for G0438 • Copayment/coinsurance waived date of their first Medicare Part B coverage Visit (AWV) G0439 – Subsequent visit Contact the local Medicare • Annually for G0439 • Deductible waived Contractor for guidance period and who have not received an IPPE or AWV within the past 12 months Medicare beneficiaries with certain risk factors for AAA Ultrasound No specific diagnosis code Screening for G0389 – Ultrasound exam AAA Important – Eligible beneficiaries must • Copayment/coinsurance waived Contact the local Medicare Once in a lifetime Abdominal Aortic screening receive a referral for an • Deductible waived Contractor for guidance Aneurysm (AAA) ultrasound screening for AAA as a result of an IPPE 80061 – Lipid panel Cardiovascular Report one or more of the All Medicare beneficiaries without 82465 – Cholesterol • Copayment/coinsurance waived Screening following codes: apparent signs or symptoms of Every 5 years 83718 – Lipoprotein • Deductible waived Blood Tests cardiovascular disease 84478 – Triglycerides V81.0, V81.1, V81.2 82947 – Glucose; quantitative, • Two screening tests per year blood (except reagent strip) Medicare beneficiaries with certain risk for beneficiaries diagnosed 82950 – Glucose; post-glucose factors for diabetes or diagnosed with with pre-diabetes Diabetes • Copayment/coinsurance waived dose (includes glucose) V77.1 pre-diabetes • One screening per year if Screening Tests • Deductible waived 82951 – Glucose; tolerance test Beneficiaries previously diagnosed with previously tested, but not (GTT), 3 specimens diabetes are not eligible for this benefit diagnosed with pre-diabetes, (includes glucose) or if never tested • Up to 10 hours of initial Medicare beneficiaries diagnosed G0108 – DSMT, individual, per training within a continuous Diabetes No specific diagnosis code with diabetes 30 minutes 12-month period • Copayment/coinsurance applies Self-Management G0109 – DSMT, group (2 or more), Contact the local Medicare Physician or qualified non-physician • Subsequent years: Up to • Deductible applies Training (DSMT) Contractor for guidance practitioner treating the beneficiary’s per 30 minutes 2 hours of follow-up training diabetes must order DSMT each year after the initial year

ICN 006559 May 2012 CPT only copyright 2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS\DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 1 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS

97802 ;– initial MNT assessment, individual, each 15 minutes 97803 – MNT; re-assessment, individual, each 15 minutes 97804 – MNT; group (2 or more), Certain Medicare beneficiaries diagnosed each 30 minutes with diabetes, renal disease, or who have No specific diagnosis code • First year: 3 hours of Medical Nutrition G0270 – MNT reassessment and received a kidney transplant within the last • Copayment/coinsurance waived one-on-one counseling Therapy (MNT) subsequent intervention(s) Contact the local Medicare 3 years • Deductible waived Contractor for guidance • Subsequent years: 2 hours for change in diagnosis, A registered dietitian or nutrition individual, each professional must provide the services 15 minutes G0271 – MNT reassessment and subsequent intervention(s) for change in diagnosis, group (2 or more), each 30 minutes

G0123, G0124, G0141, G0143, G0144, G0145, G0147, G0148 – Screening cytopathology, cervical or vaginal • Annually if at high risk Report one of the for developing cervical P3000 – Screening Pap smear following codes: or vaginal cancer, or by technician under childbearing age with • Copayment/coinsurance waived Screening Pap Tests Low Risk – V72.31, V76.2, All female Medicare beneficiaries physician supervision abnormal Pap test within • Deductible waived V76.47, V76.49 P3001 – Screening Pap smear past 3 years requiring interpretation High Risk – V15.89 • Every 24 months for all by physician other women Q0091 – Screening Pap smear; obtaining, preparing and conveyance to lab

• Annually if at high risk Report one of the for developing cervical or vaginal cancer, or G0101 – Cervical or vaginal cancer following codes: Screening Pelvic childbearing age with • Copayment/coinsurance waived screening; pelvic and Low Risk – V72.31, V76.2, All female Medicare beneficiaries Examinations abnormal Pap test within • Deductible waived clinical breast examination V76.47, V76.49 past 3 years High Risk – V15.89 • Every 24 months for all other women

77052 – Computer-aided detection; screening mammography Report one of the • Aged 35 through 39: Screening 77057 – Screening mammography, All female Medicare beneficiaries aged 35 • Copayment/coinsurance waived following codes: One baseline Mammography bilateral and older • Deductible waived • Aged 40 and older: Annually G0202 – Screening mammography, V76.11 or V76.12 digital

76977 – Ultrasound bone density measurement and interpretation; peripheral site(s), any method 77078 – Computed tomography, bone mineral density study, 1 or more sites; Certain Medicare beneficiaries that fall into axial skeleton at least one of the following categories: 77079 – Computed tomography, • Women determined by their physician bone mineral density or qualified non-physician practitioner to study, 1 or more sites; be estrogen deficient and at clinical risk appendicular skeleton for osteoporosis; (peripheral) (e.g., radius, No specific diagnosis code Every 24 months Bone Mass • Individuals with vertebral abnormalities; • Copayment/coinsurance waived wrist, heel) Measurements Contact the local Medicare • Individuals receiving (or expecting to More frequently if • Deductible waived 77080 – Dual-energy X-ray Contractor for guidance receive) glucocorticoid therapy for more medically necessary absorptiometry (DXA), than 3 months; bone density study, 1 or • Individuals with primary more sites; axial skeleton hyperparathyroidism; or 77081 – DXA, bone density • Individuals being monitored to assess study, 1 or more sites; response to FDA-approved osteoporosis appendicular skeleton drug therapy 77083 – Radiographic absorptiometry (e.g., photodensitometry, radiogrammetry), 1 or more sites G0130 – Single energy X-ray study

G0104 – Flexible Sigmoidoscopy G0104, G0105, G0121, G0328, G0105 – Colonoscopy (high risk) and 82270: G0106 – Barium Enema • Copayment/coinsurance waived (alternative to G0104) • FOBT every year • Deductible waived G0120 – Barium Enema • Flexible Sigmoidoscopy G0106 and G0120: (alternative to G0105) All Medicare beneficiaries aged 50 and once every 4 years, or G0121 – Colonoscopy older who are: 120 months after a previous • Copayment/coinsurance applies • Deductible waived (not high risk) • At normal risk of developing colorectal Screening Colonoscopy for G0328 – Fecal Occult Blood Test cancer; or people not at high risk No deductible for all surgical (FOBT), immunoassay, No specific diagnosis code • At high risk of developing • Screening Colonoscopy procedures (CPT code range of Colorectal Cancer 1-3 simultaneous colorectal cancer every 10 years (every 10000 to 69999) furnished on Screening 82270 – FOBT (blood, occult, Contact the local Medicare 24 months for high risk), or the same date and in the same by peroxidase activity Contractor for guidance High risk for developing colorectal cancer is 48 months after a previous encounter as a Colonoscopy, (e.g., guaiac), qualitative; defined in 42 CFR 410.37(a)(3) Flexible Sigmoidoscopy Flexible Sigmoidoscopy, or feces, consecutive Refer to http://www.gpo.gov/fdsys/pkg/CFR- • Barium Enema (as an Barium Enema that were collected specimens with 2011-title42-vol2/pdf/CFR-2011-title42-vol2- alternative to a covered initiated as colorectal cancer single determination, sec410-37.pdf on the Internet Flexible Sigmoidoscopy) screening services for colorectal neoplasm every 48 months, and every Modifier -PT should be appended screening (i.e., patient 24 months for high risk to at least one CPT code in the was provided 3 cards surgical range of 10000 to 69999 or single triple card for on a claim for services furnished in consecutive collection) this scenario

G0102: • Copayment/coinsurance applies G0102 – Digital Rectal Exam (DRE) All male Medicare beneficiaries aged 50 Prostate Cancer Annually for • Deductible applies G0103 – Prostate Specific Antigen V76.44 and older (coverage begins the day after Screening covered beneficiaries Test (PSA) 50th birthday) G0103: • Copayment/coinsurance waived • Deductible waived

G0117 – By an optometrist or ophthalmologist Medicare beneficiaries with diabetes Glaucoma G0118 – Under the direct mellitus, family history of glaucoma, Annually for • Copayment/coinsurance applies V80.1 Screening supervision of African-Americans aged 50 and older, or covered beneficiaries • Deductible applies an optometrist or Hispanic-Americans aged 65 and older ophthalmologist

90654, 90655, 90656, 90657, 90660, 90662, Q2034 (effective Report one of the for dates of service on or after Once per influenza season Seasonal Influenza following codes: 07/01/12, and claims processed • Copayment/coinsurance waived Virus Vaccine and V04.81 – Influenza All Medicare beneficiaries Medicare may provide on or after 10/01/12), Q2035, • Deductible waived Administration additional flu shots if Q2036, Q2037, Q2038, Q2039 – V06.6 – Pneumococcus medically necessary Influenza Virus Vaccine and Influenza G0008 – Administration

Once in a lifetime 90669, 90670 – Pneumococcal Report one of the Pneumococcal Conjugate Vaccine following codes: Medicare may provide • Copayment/coinsurance waived Vaccine and 90732 – Pneumococcal V03.82 – Pneumococcus All Medicare beneficiaries additional vaccinations based on risk and provided that at • Deductible waived Administration Polysaccharide Vaccine V06.6 – Pneumococcus G0009 – Administration least 5 years have passed and Influenza since receipt of a previous dose

90740 – Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (3 dose schedule) 90743 – Hepatitis B vaccine, adolescent dosage Certain Medicare beneficiaries at (2 dose schedule) intermediate or high risk for contracting Hepatitis B (HBV) 90744 – Hepatitis B vaccine, hepatitis B • Copayment/coinsurance waived Vaccine and pediatric/adolescent V05.3 Scheduled dosages required • Deductible waived Administration dosage (3 dose schedule) Medicare beneficiaries that are currently 90746 – Hepatitis B vaccine, positive for antibodies for hepatitis B are adult dosage not eligible for this benefit 90747 – Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (4 dose schedule) G0010 – Administration

G0436 – Smoking and tobacco cessation counseling Outpatient and hospitalized beneficiaries visit for the asymptomatic who use tobacco, regardless of whether Two cessation attempts per Counseling patient; intermediate, they have signs or symptoms of tobacco- year; each attempt includes a to Prevent greater than 3 minutes, Report one of the following related disease; who are competent and maximum of four intermediate • Copayment/coinsurance waived Tobacco Use for up to 10 minutes codes: 305.1 or V15.82 alert at the time that counseling is provided; or intensive sessions, up • Deductible waived Asymptomatic G0437 – Smoking and tobacco and whose counseling is furnished by to eight sessions in a Beneficiaries cessation counseling a qualified physician or other Medicare- 12-month period visit for the asymptomatic recognized practitioner patient; intensive, greater than 10 minutes

Beneficiaries who are at increased risk for G0432 – Infectious agent Annually for beneficiaries at HIV infection or pregnant antibody detection by increased risk enzyme immunoassay Increased risk for HIV infection is defined Report one of the following Three times per pregnancy for (EIA) technique in Publication 100-03, Sections 190.14 Human codes: beneficiaries who are pregnant: G0433 – Infectious agent antibody (diagnostic) and 210.7 (screening) Immunodeficiency V73.89 – Primary • First, when a woman is • Copayment/coinsurance waived detection by enzyme- Refer to http://www.cms.gov/Regulations- Virus (HIV) V22.0, V22.1, V69.8, or diagnosed with pregnancy; • Deductible waived linked immunosorbent and-Guidance/Guidance/Manuals/ Screening V23.9 – Secondary, as • Second, during the third assay (ELISA) technique Downloads/ncd103c1_Part3.pdf and http:// appropriate trimester; and G0435 – Infectious agent antibody www.cms.gov/Regulations-and-Guidance/ • Third, at labor, if ordered by detection by rapid Guidance/Manuals/Downloads/ncd103c1_ the woman’s clinician antibody test Part4.pdf on the CMS website

• Men aged 45 through 79 and women aged 55 through 79: Encouraging aspirin use for the primary prevention of cardiovascular disease when the Intensive Behavioral benefits outweigh the risks Therapy (IBT) for G0446 – Intensive behavioral • Adults aged 18 and older: Screening Cardiovascular for high blood pressure therapy to reduce No specific diagnosis code Disease cardiovascular disease • Adults with hyperlipidemia, Annually for covered • Copayment/coinsurance waived Contact the local Medicare This is a new risk, individual, face-to- hypertension, advancing age, and other beneficiaries • Deductible waived Contractor for guidance benefit beginning face, bi-annual, known risk factors for cardiovascular- for dates of service 15 minutes and diet-related chronic disease: on or after 11/08/11 Intensive behavioral counseling to promote a healthy diet Must be furnished by a qualified primary care physician or other primary care practitioner in a primary care setting

Screening and All Medicare beneficiaries are eligible for Behavioral alcohol screening Counseling Medicare beneficiaries who misuse Interventions in G0442 – Annual alcohol misuse screening, 15 minutes alcohol, but whose levels or patterns of Primary Care to No specific diagnosis code • Annually for G0442 G0443 – Brief face-to-face alcohol consumption do not meet criteria • Copayment/coinsurance waived Reduce Alcohol • Four times per year behavioral counseling Contact the local Medicare for alcohol dependence, are eligible for • Deductible waived Misuse for G0443 for alcohol misuse, Contractor for guidance counseling if they are competent and alert This is a new 15 minutes at the time that counseling is provided and benefit beginning counseling is furnished by qualified primary for dates of service care physicians or other primary care on or after 10/14/11 practitioners in a primary care setting

5 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS

All Medicare beneficiaries Screening for Depression Must be furnished by a qualified primary No specific diagnosis code care physician or other primary care This is a new G0444 – Annual depression • Copayment/coinsurance waived Contact the local Medicare practitioner in a primary care setting that Annually benefit beginning screening, 15 minutes • Deductible waived Contractor for guidance has staff-assisted depression care supports for dates of service in place to assure accurate diagnosis, on or after 10/14/11 effective treatment, and follow-up

For screening for chlamydia, gonorrhea, and syphilis in women at increased risk • One annual occurrence of who are not pregnant report screening for chlamydia, V74.5 and V69.8 gonorrhea, and syphilis in For screening for syphilis in women at increased risk men at increased risk report who are not pregnant 86631, 86632, 87110, 87270, V74.5 and V69.8 • One annual occurrence of 87320, 87490, 87491, 87810 – For screening for chlamydia screening for syphilis in men Chlamydia and gonorrhea in pregnant at increased risk • Up to two occurrences per 87590, 87591, 87850 – Gonorrhea women at increased risk for Sexually active adolescents and adults at STIs report: pregnancy of screening for Sexually 87800 – Combined chlamydia and increased risk for STIs: HIBC consisting chlamydia and gonorrhea in Transmitted gonorrhea testing • V74.5 and V69.8, and of individual, 20 to 30 minute, face-to-face pregnant women who are at • V22.0, V22.1, or V23.9 counseling sessions, if referred for this Infections (STIs) 86592, 86593, 86780 – Syphilis increased risk for STIs and Screening and High For screening for syphilis service by a primary care provider and continued increased risk for 87340, 87341 – Hepatitis B Intensity Behavioral in pregnant women report provided by a Medicare eligible primary the second screening (hepatitis B surface antigen) • Copayment/coinsurance waived Counseling (HIBC) V74.5 and V22.0, V22.1, care provider in a primary care setting • One occurrence per • Deductible waived to Prevent STIs G0445 – High intensity behavioral or V23.9 Increased risk for STIs is defined in pregnancy of screening This is a new counseling to prevent For screening for syphilis Publication 100-03, Section 210.10 for syphilis in pregnant sexually transmitted benefit beginning in pregnant women at Refer to http://www.cms.gov/Regulations- women; up to two additional infection; face-to-face, for dates of service increased risk for STIs report: and-Guidance/Guidance/Transmittals/ occurrences per pregnancy individual, includes: if at continued increased risk on or after 11/08/11 • V74.5 and V69.8, and Downloads/R141NCD.pdf on the education, skills training for STIs • V22.0, V22.1, or V23.9 CMS website and guidance on how to • One occurrence per change sexual behavior; For screening for pregnancy of screening performed semi-annually, hepatitis B in pregnant for hepatitis B in pregnant 30 minutes women report V73.89 and women; one additional V22.0, V22.1, or V23.9 occurrence per pregnancy For screening for if at continued increased risk hepatitis B in pregnant for STIs women at increased risk for • Up to two HIBC counseling STIs report: sessions annually • V73.89 and V69.8, and • V22.0, V22.1, or V23.9

• One visit every week for the first month; • One visit every other week for months 2 – 6; and • One visit every month for months 7 – 12 At the 6-month visit, a reassessment of obesity and a Intensive Behavioral Medicare beneficiaries with obesity determination of the amount of Therapy (IBT) 2 (BMI ≥ 30 kg/m ) who are competent and weight loss must be performed for Obesity G0447 – Face-to-face behavioral Report one of the following alert at the time that counseling is provided • Copayment/coinsurance waived counseling for obesity, codes: V85.30 – V85.39, and whose counseling is furnished by a To be eligible for additional This is a new face-to-face visits occurring • Deductible waived 15 minutes V85.41 – V85.45 qualified primary care physician or other benefit beginning once a month for an additional for dates of service primary care practitioner in a primary care setting 6 months, beneficiaries must on or after 11/29/11 have lost at least 3kg For beneficiaries who do not achieve a weight loss of at least 3kg during the first 6 months, a reassessment of their readiness to change and BMI is appropriate after an additional 6-month period

Frequently Asked Questions developing a sustained partnership with patients, and practicing in the context of family and community. We do not consider Ambulatory Surgical Centers (ASCs), emergency departments, hospices, Why is CMS adding new preventive services as Medicare benefits? independent diagnostic testing facilities, inpatient hospital settings, Inpatient Rehabilitation Facilities (IRFs), and Skilled Nursing Facilities (SNFs) to be primary care settings under this definition. Under Section 4105 of the Affordable Care Act, CMS may add coverage of “additional preventive services” through the National Coverage Determination (NCD) process if the service meets all of the following criteria. They must be: 1) reasonable and necessary for the prevention or early detection of How do I determine the last date a beneficiary received a preventive service, illness or disability, 2) recommended with a grade of A or B by the United States Preventive Services so that I know the beneficiary is eligible to receive the next service and the Task Force (USPSTF), and 3) appropriate for individuals entitled to benefits under Part A or enrolled service will not be denied due to frequency edits? under Part B of the Medicare Program. For more information on USPSTF recommendations, visit http://www.uspreventiveservicestaskforce.org/recommendations.htm on the Internet. Watch for Your options for accessing eligibility information depend on the Medicare Administrative Contractor announcements of additional new preventive benefits and educational materials at http://www.cms.gov/ (MAC) jurisdiction in which your practice or facility is located. For example, MACs who have Internet Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/PreventiveServices.html on portals provide the information through the eligibility screens of the portals. You may also be able to the CMS website, or refer to http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- access the information through the HIPAA Eligibility Transaction System (HETS), as well as HETS User MLN/MLNProducts/Downloads/MLNProducts_listserv.pdf to sign up to receive news of new Medicare Interface, through the provider call center Interactive Voice Responses (IVRs). CMS suggests that Learning Network® (MLN) products by e-mail. For the latest information on Medicare preventive providers check with their MAC to see what options are available to check eligibility. services, visit http://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/News_and_Announcements. html on the CMS website. My patients do not follow up on routine preventive care. How can I help them remember when they are due for their next preventive service? Some services must be performed in a primary care setting. What is that? Medicare.gov provides a “Preventive Screening Checklist” that you can give to your patients. They can A primary care setting is one in which there is provision of integrated, accessible health care services use the checklist to track their preventive services. For the checklist, visit http://www.medicare.gov/ by clinicians who are accountable for addressing a large majority of personal health care needs, navigation/manage-your-health/preventive-services/preventive-service-checklist.aspx on the Internet.

7 Resources

RESOURCE WEBSITE

Medicare Preventive Services General Information http://www.cms.gov/Medicare/Prevention/PrevntionGenInfo

The MLN Educational Web Guides MLN Guided Pathways to Medicare Resources help providers gain knowledge on resources and products related to Medicare and the CMS website. For more information about preventive services, refer to the “Coverage of Preventive Services” section in the “MLN Guided Pathways to Medicare Resources – Basic Curriculum for Health Care Professionals, MLN Guided Pathways to Medicare Resources Suppliers, and Providers” booklet at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/ Downloads/Guided_Pathways_Basic_Booklet.pdf on the CMS website. For all other “Guided Pathways” resources, visit http://www.cms.gov/Outreach-and-Education/Medicare- Learning-Network-MLN/MLNEdWebGuide/Guided_Pathways.html on the CMS website.

http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/ Preventive Services MLN Page PreventiveServices.html

http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ “Publications for Your Medicare Beneficiaries” BenePubFS-ICN905183.pdf

Official CMS Information for Medicare Fee-For-Service Providers

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Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report October 2012

Clinical Diagnostic Laboratory Services

Health & Human Services Department Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 CMS Email Point of Contact: [email protected] TDD 410.786.0727

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Table of Contents

NCD Manual Changes ...... ii Table of Contents ...... xxiii Introduction ...... 1 Non-covered ICD-9-CM Codes for All NCD Edits ...... 4 Reasons for Denial for All NCD Edits ...... 6 Coding Guidelines for All NCD Edits ...... 7 Additional Coding Guidelines ...... 8 190.12 - Urine Culture, Bacterial ...... 12 190.13 - Human Immunodeficiency Virus (HIV)Testing (Prognosis Including Monitoring) 18 190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis) ...... 20 190.15 - Blood Counts ...... 28 190.16 - Partial Thromboplastin Time (PTT) ...... 39 190.17 - Prothrombin Time (PT) ...... 50 190.18 - Serum Iron Studies ...... 65 190.19 - Collagen Crosslinks, Any Method ...... 77 190.20 - Blood Glucose Testing ...... 80 190.21 - Glycated Hemoglobin/Glycated Protein ...... 87 190.22 - Thyroid Testing ...... 91 190.23 - Lipids Testing ...... 99 190.24 - Digoxin Therapeutic Drug Assay ...... 106 190.25 - Alpha-fetoprotein ...... 111 190.26 - Carcinoembryonic Antigen ...... 114 190.27 - Human Chorionic Gonadotropin ...... 117 190.28 - Tumor Antigen by Immunoassay CA 125 ...... 119 190.29 - Tumor Antigen by Immunoassay CA 15-3/CA 27.29 ...... 121 190.30 - Tumor Antigen by Immunoassay CA 19-9 ...... 123 190.31 - Prostate Specific Antigen ...... 125 190.32 - Gamma Glutamyl Transferase ...... 128 190.33 - Hepatitis Panel/Acute Hepatitis Panel ...... 140 190.34 - Fecal Occult Blood Test ...... 144

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Introduction

Background Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA), Public Law 105-33, mandated the use of a negotiated rulemaking committee to develop national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B by January 1, 1999. This provision requires that these national coverage policies be designed to promote program integrity and national uniformity and simplify administrative requirements with respect to clinical diagnostic laboratory services in connection with the following: Beneficiary information required to be submitted with each claim or order for laboratory services; The medical condition for which a laboratory test is reasonable and necessary (within the meaning of section 1862(a)(1)(A) of the Social Security Act); The appropriate use of procedure codes in billing for a laboratory test, including the unbundling of laboratory services; The medical documentation that is required by a Medicare contractor at the time a claim is submitted for a laboratory test (in accordance with section 1833(e) of the Act); Record keeping requirements in addition to any information required to be submitted with a claim, including physicians’ obligations regarding these requirements; Procedures for filing claims and for providing remittances by electronic media; and Limitations on frequency of coverage for the same services performed on the same individual. On March 10, 2000, a proposed rule was published in the Federal Register (65 FR 13082) that set forth uniform national coverage and administrative policies for clinical diagnostic laboratory services. These proposed policies reflected the consensus of the Negotiated Rulemaking Committee. The final rule, published in the Federal Register on November 23, 2001 (66 FR 58788), addresses the public comments received on the proposed rule. The final rule established the national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B. It promotes Medicare program integrity and national uniformity, and simplifies administrative requirements for clinical diagnostic services. There are 23 national coverage determinations included in the final rule listed below:  Culture, Bacterial, Urine  Human Immunodeficiency Virus Testing (Prognosis including monitoring)  Human Immunodeficiency Virus Testing (Diagnosis)  Blood Counts  Partial Thromboplastin Time  Prothrombin Time  Serum Iron Studies  Collagen Crosslinks, Any Method  Blood Glucose Testing  Glycated Hemoglobin/Glycated Protein  Thyroid Testing  Lipids  Digoxin Therapeutic Drug Assay  Alpha-fetoprotein

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 Carcinoembryonic Antigen  Human Chorionic Gonadotropin  Tumor Antigen by Immunoassay - CA125  Tumor Antigen by Immunoassay CA 15-3/CA 27.29  Tumor Antigen by Immunoassay CA 19-9  Prostate Specific Antigen  Gamma Glutamyl Transferase  Hepatitis Panel/Acute Hepatitis Panel  Fecal Occult Blood What Is a National Coverage Policy? Part B of title XVIII of the Social Security Act (the Act) provides for Supplementary Medical Insurance (SMI) for certain Medicare beneficiaries, specifying what health care items or services will be covered by the Medicare Part B program. Diagnostic laboratory tests are generally covered under Part B, unless excluded from coverage by the Act. Services that are excluded from coverage include routine physical examinations and services that are not reasonable and necessary for the diagnosis or treatment of an illness or injury. CMS interprets these provisions to prohibit coverage of screening services, including laboratory tests furnished in the absence of signs, symptoms, or personal history of disease or injury, except as explicitly authorized by statute. A test may be considered medically appropriate, but nonetheless be excluded from Medicare coverage by statute. A national coverage policy for diagnostic laboratory test(s) is a document stating CMS’s policy with respect to the circumstances under which the test(s) will be considered reasonable and necessary, and not screening, for Medicare purposes. Such a policy applies nationwide. A national coverage policy is neither a practice parameter nor a statement of the accepted standard of medical practice. Words such as ‘‘may be indicated’’ or ‘‘may be considered medically necessary’’ are used for this reason. Where a policy gives a general description and then lists examples (following words like ‘‘for example’’ or ‘‘including’’), the list of examples is not meant to be all-inclusive but to provide some guidance. What Is the Effect of a National Coverage Policy? A national coverage policy to which this introduction applies is a National Coverage Decision (NCD) under section 1862(a) (1) of the Social Security Act. Regulations on National Coverage Decisions are codified at 42 CFR 405.732(b)–(d). A Medicare contractor may not develop a local policy that conflicts with a national coverage policy. What Is the Format for These National Coverage Policies? Below are the headings for national coverage policies, developed by the Negotiated Rulemaking Committee on Clinical Diagnostic Laboratory Tests. Other Names/Abbreviations This section identifies other names for the policy. It reflects more colloquial terminology. Description This section includes a description of the test(s) addressed by the policy and provides a general description of the appropriate uses of the test(s).

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HCPCS Codes The descriptor(s) used in this section is (are) the Current Procedural Terminology (CPT) or other CMS Common Procedure Coding System (HCPCS). The CPT is developed and copyrighted by the American Medical Association (AMA). If a descriptor does not accurately or fully describe the test, a more complete description may be included elsewhere in the policy, such as in the Indications section. ICD–9–CM Codes Covered by Medicare Program This section includes covered codes—those where there is a presumption of medical necessity, but the claim is subject to review to determine whether the test was in fact reasonable and necessary. The diagnosis codes are from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD–9–CM). Where the policy takes an ‘‘exclusionary’’ approach, as described below, this section states: ‘‘Any ICD–9–CM code not listed in either of the ICD–9–CM code sections below.’’ Indications This section lists detailed clinical indications for Medicare coverage of the test(s). Limitations This section lists any national frequency expectations, as well as other limitations on Medicare coverage of the specific test(s) addressed in the policy—for example, if it would be unnecessary to perform a particular test with a particular combination of diagnoses. ICD–9–CM Codes That Do Not Support Medical Necessity This section lists/describes generally non-covered codes for which there are only limited exceptions. However, additional documentation could support a determination of medical necessity in certain circumstances. Subject to section 1879 of the Social Security Act (the Act), 42 CFR 411, subpart K, section 7330 of the Medicare Carriers Manual section 3440–3446.9 of the Medicare Fiscal Intermediary Manual and any applicable rulings, it would be appropriate for the ordering physician or the laboratory to obtain an advance beneficiary notice from the beneficiary. Where the policy takes an ‘‘inclusionary’’ approach, as described below, this section states: ‘‘Any ICD–9–CM code not listed in either of the ICD–9–CM sections above.’’ Other Comments This section may contain other relevant comments that are not addressed in the sections above. Documentation Requirements This section refers to documentation requirements for clinical diagnostic laboratory tests at 42 CFR 410.32(d) and includes any specific documentation requirements related to the test(s) addressed in the policy. Sources of Information Relevant sources of information used in developing the policy are listed in this section.

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Non-covered ICD-9-CM Codes for All NCD Edits

This section lists codes that are never covered. If a code from this section is given as the reason for the test, the test may be billed to the Medicare beneficiary without billing Medicare first because the service is not covered by statute, in most instances because it is performed for screening purposes and is not within an exception. The beneficiary, however, does have a right to have the claim submitted to Medicare, upon request.

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 798.0 - 798.9 Sudden death, cause unknown V15.85 Personal history of contact with and (suspected) exposure to potentially hazardous body fluids V16.1 Family history of malignant neoplasm, trachea, bronchus, and lung V16.2 Family history of malignant neoplasm, other respiratory and intrathoracic organs V16.40 Family history of malignant neoplasm, genital organs V16.50 Family history of malignant neoplasm, urinary organs V16.51 Family history of malignant neoplasm, kidney V16.52 Family history of malignant neoplasm, bladder V16.59 Family history of malignant neoplasm, other V16.6 Family history of malignant neoplasm, leukemia V16.7 Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms V16.8 Family history of malignant neoplasm, other specified malignant neoplasm V16.9 Family history of malignant neoplasm, unspecified malignant neoplasm V17.0-V17.3 Family history of certain chronic disabling diseases V17.41 Family history of sudden cardiac death (SCD) V17.49 Family history of other cardiovascular diseases V17.5 - V17.89 Family history of asthma; other chronic respiratory conditions arthritis; other musculoskeletal diseases V18.0 Family history of diabetes mellitus V18.11 Family history of multiple endocrine neoplasia (MEN) syndrome V18.19 Family history of other endocrine and metabolic diseases V18.2-V18.4, V18.51,V18.59, Family history of anemia; other blood disorders; mental retardation; V18.61, V18.69, V18.7-V18.9 colonic polyps; other digestive disorders; polycystic kidney; other kidney diseases; other genitourinary diseases; infectious and parasitic diseases; genetic disease carrier V19.0-V19.8 Family history of other conditions V20.0 - V20.2 Health supervision of infant or child V20.31 Health supervision for newborn under 8 days old

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Code Description V20.32 Health supervision for newborn 8 to 28 days old V28.0 - V28.9 Encounter for antenatal screening of mother V50.0 - V50.9 Elective surgery for purposes other than remedying health states V53.2 Hearing aid V60.0-V60.6 Lack of housing; inadequate housing; lack of material resources; person living alone; no other household person avle to render care; holiday relief care; and person living in residential institution V60.81 Foster care (status) V60.89 Other specified housing or economic circumstances V60.9 Unspecified housing or economic circumstances V62.0 Unemployment V62.1 Adverse effects of work environment V65.0 Healthy persons accompanying sick persons V65.11 Pediatric pre-birth visit for expectant parent(s) V65.19 Other person consulting on behalf of another person V68.0 - V68.9 Encounters for administrative purposes V70.0 - V70.9 General medical examinations V73.0-V73.6 Special screening examinations for viral and chlamydia diseases V73.81 Special screening examinations for Human papillomavirus (HPV) V73.88-V73.89 Other specified chlamydial and viral diseases V73.98-V73.99 Unspecified chlamydial and viral disease V74.0 - V74.9 Special screening examinations for bacterial and spirochetal diseases V75.0 - V75.9 Special screening examination for other infectious diseases V76.0 Special screening for malignant neoplasms, respiratory organs V76.3 Special screening for malignant neoplasms, bladder V76.42-V76.43, V76.45- Special screening for malignant neoplasms,(sites other than breast, V76.47, V76.49, V76.50, cervix, and rectum) V76.52, V76.81, V76.89,V76.9 V77.0 Special screening for endocrine, nutrition, metabolic, and immunity disorders V77.2-V77.99 Special screening for endocrine, nutrition, metabolic, and immunity disorders V78.0-V78.9 Special screening for disorders of blood and blood-forming organs V79.0-V79.9 Special screening for mental disorders V80.01 Special screening for traumatic brain injury V80.09 Special screening for other neurological conditions V80.1-V80.3 Special screening for glaucoma and other eye conditions; ear diseases V81.3-V81.6 Special screening for cardiovascular, respiratory, and genitourinary diseases V82.0-V82.6, V82.71,V82.79, Special screening for other conditions V82.81, V82.89, V82.9

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Reasons for Denial for All NCD Edits

NOTE: This section has not been negotiated by the Negotiated Rulemaking Committee. It includes CMS’s interpretation of its longstanding policies and is included for informational purposes.

 Tests for screening purposes that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicitly authorized by statute. These include exams required by insurance companies, business establishments, government agencies, or other third parties.  Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statute.  Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial.  A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim.  If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.  Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary.  Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate for the testing performed will result in denial of claims.

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Coding Guidelines for All NCD Edits

1. Any claim for a clinical diagnostic laboratory service must be submitted with an ICD-9- CM diagnosis code. Codes that describe symptoms and signs, as opposed to diagnosis, should be provided for reporting purposes when a diagnosis has not been established by the physician. (Based on Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 43). 2. Screening is the testing for disease or disease precursors so that early detection and treatment can be provided for those who test positive for the disease. Screening tests are performed when no specific sign, symptom, or diagnosis is present and the patient has not been exposed to a disease. The testing of a person to rule out or to confirm a suspected diagnosis because the patient has a sign and/or symptom is a diagnostic test, not a screening. In these cases, the sign or symptom should be used to explain the reason for the test. When the reason for performing a test is because the patient has had contact with, or exposure to, a communicable disease, the appropriate code from category V01, Contact with or exposure to communicable diseases, should be assigned, not a screening code, but the test may still be considered screening and not covered by Medicare. For screening tests, the appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1996, pages 50 and 52). 3. A three-digit code is to be used only if it is not further subdivided. Where fourth-digit and/or fifth-digit sub-classifications are provided, they must be assigned. A code is invalid if it has not been coded to the full number of digits required for that code. (From Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44). 4. Diagnoses documented as “probable,” “suspected,” “questionable,” “rule-out,” or “working diagnosis” should not be coded as though they exist. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as signs, symptoms, abnormal test results, exposure to communicable disease or other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 45). 5. When a non-specific ICD-9 code is submitted, the underlying sign, symptom, or condition must be related to the indications for the test.

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Additional Coding Guidelines

190.12 – Urine Culture, Bacterial 1. Specific coding guidelines: a. Use CPT 87086 Culture, bacterial, urine; quantitative, colony count where a urine culture colony count is performed to determine the approximate number of bacteria present per milliliter of urine. The number of units of service is determined by the number of specimens. b. Use CPT 87088 where a commercial kit uses manufacturer defined media for isolation, presumptive identification, and quantitation of morphotypes present. The number of units of service is determined by the number of specimens. c. Use CPT 87088 where identification of morphotypes recovered by quantitative culture or commercial kits and deemed to represent significant bacteriuria requires the use of additional testing, for example, biochemical test procedures on colonies. Identification based solely on visual observation of the primary media is usually not adequate to justify use of this code. The number of units of service is determined by the number of isolates. d. Use CPT 87184 or 87186 where susceptibility testing of isolates deemed to be significant is performed concurrently with identification. The number of units of service is determined by the number of isolates. These codes are not exclusively used for urine cultures but are appropriate for isolates from other sources as well. e. Appropriate combinations are as follows: CPT 87086, 1 per specimen with 87088, 1 per isolate and 87184 or 87186 where appropriate. f. Culture for other specific organism groups not ordinarily recovered by media used for aerobic urine culture may require use of additional CPT codes (for example, anaerobes from suprapubic samples). g. Identification of isolates by non-routine, nonbiochemical methods may be coded appropriately (for example, immunologic identification of streptococci, nucleic acid techniques for identification of N. gonorrhoeae). h. While infrequently used, sensitivity studies by methods other than CPT 87184 or 87186 are appropriate. CPT 87181, agar dilution method, each antibiotic or CPT 87188, macrotube dilution method, each antibiotic may be used. The number of units of service is the number of antibiotics multiplied by the number of unique isolates. 2. ICD-9-CM code 780.02, 780.9 or 799.3 should be used only in the situation of an elderly patient, immunocompromised patient or patient with neurologic disorder who presents without typical manifestations of a urinary tract infection but who presents with one of the following signs or symptoms, not otherwise explained by another co-existing condition: increasing debility; declining functional status; acute mental changes; changes in awareness; or hypothermia. 3. In cases of post renal-transplant urine culture used to detect clinically significant occult infection in patients on long term immunosuppressive therapy, use code V58.69.

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190.13 – Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring) 1. Specific coding guidelines: a. Temporary code G0100 has been superseded by code 87536 effective January 1, 1998. b. CPT codes for quantification should not be used simultaneously with other nucleic acid detection codes for HIV-1 (that is, 87534, 87535) or HIV-2 (that is, 87537, 87538). 2. Codes 647.60-647.64 should only be used for HIV infections complicating pregnancy. 190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis) 1. Specific coding guidelines: a. CPT 86701 or 86703 is performed initially. CPT 86702 is performed when 86701 is negative and clinical suspicion of HIV-2 exists. b. CPT 86689 is performed only on samples repeatedly positive by 86701, 86702, or 86703. c. CPT 87534 or 87535 is used to detect HIV-1 RNA where indicated. CPT 87537 or 87538 is used to detect HIV-2 RNA where indicated. 190.16 – Partial Thromboplastin Time (PTT) 1. When patients are being converted from heparin therapy to warfarin therapy, use code V58.61 to document the medical necessity of the PTT. 2. When coding for Disseminated Intravascular Coagulation (DIC), use 286.6 or code for the signs and symptoms clinically indicating DIC. 3. If a specific condition is known and is the reason for a pre-operative test, submit the clinical text description or ICD-9-CM code describing the condition with the order/referral. If a specific condition or disease is not known, and the pre-operative test is for pre-operative clearance only, assign code V72.84. 4. Assign codes 289.8 – other specified disease of blood and blood-forming organs only when a specific disease exists and is indexed to 289.8, (for example, myelofibrosis). Do not assign code 289.8 to report a patient on long term use of anticoagulant therapy (for example, to report a PTT value or re-check need for medication adjustment.) Assign code V58.61 to referrals for PTT checks or re-checks. (Reference AHA’s Coding Clinic, March-April, pg 12 – 1987, 2nd quarter pg 8 – 1989) 190.17 – Prothrombin Time (PT) 1. If a specific condition is known and is the reason for a pre-operative test, submit the text description or ICD-9-CM code describing the condition with the order/referral. If a specific condition or disease is not known, and the pre-operative test is for pre- operative clearance only, assign code V72.84. 2. Assign codes 289.8 – other specified disease of blood and blood-forming organs only when a specific disease exists and is indexed to 289.8 (for example, myelofibrosis). Do not assign code 289.8 to report a patient on long term use of anticoagulant therapy (e.g. to report a PT value or re-check need for medication adjustment.) Assign code

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V58.61 to referrals for PT checks or re-checks. (Reference AHA’s Coding Clinic, March-April, pg 12 – 1987, 2nd quarter pg 8 – 1989) 190.19 – Collagen Crosslinks, Any Method 1. When the indication for the test is long-term administration of glucocorticosteroids, use ICD-9-CM code V58.69. 190.20 – Blood Glucose Testing 1. A diagnostic statement of impaired glucose tolerance must be evaluated in the context of the documentation in the medical record in order to assign the most accurate ICD-9- CM code. An abnormally elevated fasting blood glucose level in the absence of the diagnosis of diabetes is classified to Code 790.6 - other abnormal blood chemistry. If the provider bases the diagnostic statement of impaired glucose tolerance” on an abnormal glucose tolerance test, the condition is classified to 790.2 -- normal glucose tolerance test. Both conditions are considered indications for ordering glycated hemoglobin or glycated protein testing in the absence of the diagnosis of diabetes mellitus. 2. When a patient is under treatment for a condition for which the tests in this policy are applicable, the ICD-9-CM code that best describes the condition is most frequently listed as the reason for the test. 3. When laboratory testing is done solely to monitor response to medication, the most accurate ICD-9-CM code to describe the reason for the test would be V58.69 -- long term use of medication. 4. Periodic follow-up for encounters for laboratory testing for a patient with a prior history of a disease, who is no longer under treatment for the condition, would be coded with an appropriate code from the V67 category -- follow-up examination. 5. According to ICD-9-CM coding conventions, codes that appear in italics in the Alphabetic and/or Tabular columns of ICD-9-CM are considered manifestation codes that require the underlying condition to be coded and sequenced ahead of the manifestation. For example, the diagnostic statement, “thyrotoxic exophthalmos (376.21),” which appears in italics in the tabular listing, requires that the thyroid disorder (242.0-242.9) is coded and sequenced ahead of thyrotoxic exophthalmos. Therefore, a diagnostic statement that is listed as a manifestation in ICD-9-CM must be expanded to include the underlying disease in order to accurately code the condition. 190.21 – Glycated Hemoglobin/Glycated Protein 1. A diagnostic statement of impaired glucose tolerance must be evaluated in the context of the documentation in the medical record in order to assign the most accurate ICD-9- CM code. An abnormally elevated fasting blood glucose level in the absence of the diagnosis of diabetes is classified to Code 790.6 - other abnormal blood chemistry. If the provider bases the diagnostic statement of impaired glucose tolerance” on an abnormal glucose tolerance test, the condition is classified to 790.2 -- normal glucose tolerance test. Both conditions are considered indications for ordering glycated hemoglobin or glycated protein testing in the absence of the diagnosis of diabetes mellitus.

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190.22 – Thyroid Testing 1. When a patient is under treatment for a condition for which the tests in this policy are applicable, the ICD-9-CM code that best describes the condition is most frequently listed as the reason for the test. 2. When laboratory testing is done solely to monitor response to medication, the most accurate ICD-9-CM code to describe the reason for the test would be V58.69 - long term use of medication. 3. Periodic follow-up for encounters for laboratory testing for a patient with a prior history of a disease, who is no longer under treatment for the condition, would be coded with an appropriate code from the V67 category -- follow-up examination. 4. According to ICD-9-CM coding conventions, codes that appear in italics in the Alphabetic and/or Tabular columns of ICD-9-CM are considered manifestation codes that require the underlying condition to be coded and sequenced ahead of the manifestation. For example, the diagnostic statement “thyrotoxic exophthalmos (376.21),” which appears in italics in the tabular listing, requires that the thyroid disorder (242.0-242.9) is coded and sequenced ahead of thyrotoxic exophthalmos. Therefore, a diagnostic statement that is listed as a manifestation in ICD-9-CM must be expanded to include the underlying disease in order to accurately code the condition. 5. Use code 728.9 to report muscle weakness as the indication for the test. Other diagnoses included in 728.9 do not support medical necessity. 6. Use code 194.8 (Malignant neoplasm of other endocrine glands and related structures, other) to report multiple endocrine neoplasia syndromes (MEN-1 and MEN-2). Other diagnoses included in 194.8 do not support medical necessity. 190.26 – Carcinoembryonic Antigen 1. To show elevated CEA, use ICD-9-CM 790.99 (Other nonspecific findings on examination of blood) only if a more specific diagnosis has not been made. If a more specific diagnosis has been made, use the code for that diagnosis. 190.31 – Prostate Specific Antigen 1. To show elevated PSA, use ICD-9-CM code 790.93 (Elevated prostate specific antigen). If a more specific diagnosis code has been made, use the code for that diagnosis.

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190.12 - Urine Culture, Bacterial

Previously Listed as Edit 1 Other Names/Abbreviations Urine culture Description A bacterial urine culture is a laboratory procedure performed on a urine specimen to establish the probable etiology of a presumed urinary tract infection. It is common practice to do a urinalysis prior to a urine culture. A urine culture may also be used as part of the evaluation and management of another related condition. The procedure includes aerobic agar-based isolation of bacteria or other cultivable organisms present, and quantitation of types present based on morphologic criteria. Isolates deemed significant may be subjected to additional identification and susceptibility procedures as requested by the ordering physician. The physician’s request may be through clearly documented and communicated laboratory protocols. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 87086 Culture, bacterial; quantitative, colony count, urine. 87088 Culture, bacterial; with isolation and presumptive identification of each isolates, urine. 87184 Susceptibility studies, antimicrobial agent; disk method, per plate (12 Listed in manual only or fewer agents). 87186 Susceptibility studies, antimicrobial agent; microdilution or agar Listed in manual only dilution (minimum inhibitory concentration (MIC) or breakpoint), each multi-antimicrobial, per plate. ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 003.1 Salmonella septicemia 038.0, 038.10-038.11, 038.12, 038.19, 038.2, 038.3, 038.40-038.44, 038.49, 038.8, 038.9 Septicemia 276.2 Acidosis 276.4 Metabolic acidosis/alkalosis 286.6 Defibrination syndrome/disseminated intravascular coagulation 288.00 Neutropenia, unspecified 288.01 Congenital neutropenia

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Code Description 288.02 Cyclic neutropenia 288.03 Drug induced neutropenia 288.04 Neutropenia due to infection 288.09 Other neutropenia 288.8 Other specified disease of white blood cells including leukemoid reaction/leukocytosis 306.53 Psychogenic dysuria 306.59 Other psychogenic genitourinary malfunction 518.82 Other pulmonary insufficiency, not elsewhere classified 570 Acute and subacute necrosis of liver 580.0-580.9 Acute glomerulonephritis 583.0-583.9 Nephritis and Nephropathy, not specified as acute or chronic 585.6 End stage renal disease 590.00-590.9 Infections of kidney/pyelonephritis acute and chronic 592.0-592.9 Calculus of kidney and ureter 593.0-593.9 Other disorders of kidney & ureter (cyst, stricture, obstruction, reflux) 594.0-594.9 Calculus of lower urinary tract 595.0-595.9 Cystitis 597.0 Urethritis, not sexually transmitted and urethral syndrome 597.80-597.89 Other urethritis 598.00-598.01 Urethral stricture due to infection 599.0 Urinary tract infection, site not specified 599.70 Hematuria, unspecified 599.71 Gross hematuria 599.72 Microscopic hematuria 600.00-600.91 Hyperplasia of prostate 601.0-601.9 Inflammatory diseases of prostate 602.0-602.9 Other disorders of prostate (calculus, congestion, atrophy, etc.) 604.0-604.99 Orchitis and epididymitis 608.0 - 608.1, 608.20-608.24, Other disorders of male genital organs (seminal vesiculitis, 608.3-608.9 spermatocele, etc.) 614.0-614.9 Inflammatory disease of ovary, fallopian tube, pelvic cellular tissue, and peritoneum 615.0-615.9 Inflammatory disease of uterus, except cervix 616.0 Cervicitis and endocervicitis 616.10-616.11 Vaginitis and vulvovaginitis 616.2–616.4, 616.50, 616.51, Other inflammatory conditions of cervix, vagina and vulva 616.81, 616.89, 616.9 619.0-619.9 Fistula involving female genital tract 625.6 Stress incontinence, female 639.0 Genital tract and pelvic infection complicating abortion, ectopic or molar pregnancies

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Code Description 639.5 Shock complicating abortion, ectopic or molar pregnancies 646.60-646.64 Infections of genitourinary tract in pregnancy 670.00 Major puerperal infection, unspecified, unspecified as to episode of care or not applicable 670.02 Major puerperal infection, unspecified, delivered, with mention of postpartum complication 670.04 Major puerperal infection, unspecified, postpartum condition or complication 670.10 Puerperal endometritis, unspecified as to episode of care or not applicable 670.12 Puerperal endometritis, delivered, with mention of postpartum complication 670.14 Puerperal endometritis, postpartum condition or complication 670.20 Puerperal sepsis, unspecified as to episode of care or not applicable 670.22 Puerperal sepsis, delivered, with mention of postpartum complication 670.24 Puerperal sepsis, postpartum condition or complication 670.30 Puerperal septic thrombophlebitis, unspecified as to episode of care or not applicable 670.32 Puerperal septic thrombophlebitis, delivered, with mention of postpartum complication 670.34 Puerperal septic thrombophlebitis, postpartum condition or complication 670.80 Other major puerperal infection, unspecified as to episode of care or not applicable 670.82 Other major puerperal infection, delivered, with mention of postpartum complication 670.84 Other major puerperal infection, postpartum condition or complication 672.00-672.04 Pyrexia of unknown origin during the puerperium 724.5 Backache, unspecified 771.81 Septicemia (sepsis) of newborn 771.82 Urinary tract infection of newborn 771.83 Bacteremia of newborn 780.02 General symptoms, transient alteration of awareness 780.60 Fever, unspecified 780.61 Fever presenting with conditions classified elsewhere 780.62 Postprocedural fever 780.63 Postvaccination fever 780.64 Chills (without fever) 780.65 Hypothermia not associated with low environmental temperature 780.66 Febrile nonhemolytic transfusion reaction 780.79 Other malaise and fatigue 780.93 Memory loss 780.94 Early satiety

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Code Description 780.96 Generalized pain 780.97 Altered mental status 780.99 Other general symptoms 785.0 Tachycardia, unspecified 785.50-785.59 Shock without mention of trauma 788.0-788.63, 788.64, Symptoms involving urinary system (renal colic, dysuria, retention of urine, 788.65, 788.69, 788.7-788.8 incontinence of urine, frequency, polyuria, nocturia, oliguria, anuria, other abnormality of urination, urethral discharge, extravasation of urine.) 788.91 Functional urinary incontinence 788.99 Other symptoms involving urinary system 789.00-789.09 Abdominal pain 789.60-789.69 Abdominal tenderness 789.7 Colic 790.7 Bacteremia 791.0-791.9 Nonspecific findings on examination of urine (proteinuria, chyluria, hemoglobinuria, myoglobinuria, biliuria, glycosuria, acetonuria, other cells & casts in urine, other nonspecific findings on urine examination) 799.3 Debility, unspecified (only for declining functional status) 939.0 Foreign body in genitourinary tract, bladder and urethra 939.3 Foreign body in genitourinary tract, penis V44.50-V44.6 Artificial cystostomy or other artificial opening of urinary tract status V55.5-V55.6 Attention to cystostomy or other artificial opening of urinary tract V58.69 Long-term (current) use of other medications Indications 1. A patient’s urinalysis is abnormal suggesting urinary tract infection, for example, abnormal microscopic (hematuria, pyuria, bacteriuria); abnormal biochemical urinalysis (positive leukocyte esterase, nitrite, protein, blood); a Gram’s stain positive for microorganisms; positive bacteriuria screen by a non-culture technique; or other significant abnormality of a urinalysis. While it is not essential to evaluate a urine specimen by one of these methods before a urine culture is performed, certain clinical presentations with highly suggestive signs and symptoms may lend themselves to an antecedent urinalysis procedure where follow-up culture depends upon an initial positive or abnormal test result. 2. A patient has clinical signs and symptoms indicative of a possible urinary tract infection (UTI). Acute lower UTI may present with urgency, frequency, nocturia, dysuria, discharge or incontinence. These findings may also be noted in upper UTI with additional systemic symptoms (for example, fever, chills, lethargy); or pain in the costovertebral, abdominal, or pelvic areas. Signs and symptoms may overlap considerably with other inflammatory conditions of the genitourinary tract (for example, prostatitis, urethritis, vaginitis, or cervicitis). Elderly or immunocompromised patients, or patients with neurologic disorders may present atypically (for example, general debility, acute mental status changes, declining functional status).

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3. The patient is being evaluated for suspected urosepsis, fever of unknown origin, or other systemic manifestations of infection but without a known source. Signs and symptoms used to define sepsis have been well established. 4. A test-of cure is generally not indicated in an uncomplicated infection. However, it may be indicated if the patient is being evaluated for response to therapy and there is a complicating co-existing urinary abnormality including structural or functional abnormalities, calculi, foreign bodies, or ureteral/renal stents or there is clinical or laboratory evidence of failure to respond as described in Indications 1 and 2. 5. In surgical procedures involving major manipulations of the genitourinary tract, preoperative examination to detect occult infection may be indicated in selected cases (for example, prior to renal transplantation, manipulation or removal of kidney stones, or transurethral surgery of the bladder or prostate). 6. Urine culture may be indicated to detect occult infection in renal transplant recipients on immunosuppressive therapy. Limitations 1. CPT 87086 may be used one time per encounter. 2. Colony count restrictions on coverage of CPT 87088 do not apply as they may be highly variable according to syndrome or other clinical circumstances (for example, antecedent therapy, collection time, and degree of hydration). 3. CPT 87088, 87184, and 87186 may be used multiple times in association with or independent of 87086, as urinary tract infections may be polymicrobial. 4. Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be medically appropriate but is considered screening and therefore not covered by Medicare. The U.S. Preventive Services Task Force has concluded that screening for asymptomatic bacteriuria outside of the narrow indication for pregnant women is generally not indicated. There are insufficient data to recommend screening in ambulatory elderly patients including those with diabetes. Testing may be clinically indicated on other grounds including likelihood of recurrence or potential adverse effects of antibiotics, but is considered screening in the absence of clinical or laboratory evidence of infection. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Documentation Requirements Appropriate HCPCS/CPT code(s) must be used as described. Sources of Information Bone, RC, RA Bal, FB Cerra, & ACCP/SCCM Consensus Conference Committee.1992. Definitions for sepsis & organ failure & guidelines for the use of innovative therapies in sepsis. Chest 101:1644-1655. Clarridge, JE, JR Johnson, and MT Pezzlo. 1998 (in press). Cumitech 2B: Laboratory Diagnosis of Urinary Tract Infections. AS Weissfeld (coor. ed.); ASM Press, Washington, DC. Kunin, CM. 1994. Urinary tract infections in females. Clin. Infect. Dis. 18:1-12.

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Sodeman, TM. 1995. A practical strategy for diagnosis of urinary tract infections. Clin. Lab. Med. 15:235-250. Stamm WE, and TM Hooton. 1993. Management of urinary tract infections in adults. N. Engl. J. Med. 329:1328-1334. United States Preventive Services Task Force (1996). Guidelines for screening for asymptomatic bacteriuria. Lachs MS, Nachamkin I, Edelstein PH et al. 1992. Spectrum bias in the evaluation of diagnostic tests: lessons from the rapid dipstick test for urinary tract infection. Ann. Int. Med. 117:135-140.

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190.13 - Human Immunodeficiency Virus (HIV)Testing (Prognosis Including Monitoring)

Previously Listed as Edit 2 Other Names/Abbreviations HIV-1 or HIV-2 quantification or viral load Description HIV quantification is achieved through the use of a number of different assays which measure the amount of circulating viral RNA. Assays vary both in methods used to detect viral RNA as well as in ability to detect viral levels at lower limits. However, all employ some type of nucleic acid amplification technique to enhance sensitivity, and results are expressed as the HIV copy number. Quantification assays of HIV plasma RNA are used prognostically to assess relative risk for disease progression and predict time to death, as well as to assess efficacy of anti-retroviral therapies over time. HIV quantification is often performed together with CD4+ T cell counts which provide information on extent of HIV induced immune system damage already incurred. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 87536 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification 87539 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 042 Human immunodeficiency virus [HIV] disease 079.53 Human immunodeficiency virus, type 2 [HIV-2] 647.60-647.64 Other viral diseases complicating pregnancy (including HIV-I and II) 795.71 Nonspecific serologic evidence of human immunodeficiency virus [HIV V08 Asymptomatic human immunodeficiency virus [HIV] infection status

Indications 1. A plasma HIV RNA baseline level may be medically necessary in any patient with confirmed HIV infection.

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2. Regular periodic measurement of plasma HIV RNA levels may be medically necessary to determine risk for disease progression in an HIV-infected individual and to determine when to initiate anti-retroviral treatment regimens. 3. In clinical situations where risk of HIV infection is significant and initiation of therapy is anticipated, a baseline HIV quantification may be performed. These situations include: a. Persistence of borderline or equivocal serologic reactivity in an at-risk individual. b. Signs and symptoms of acute retroviral syndrome characterized by fever, malaise, lymphadenopathy and rash in an at-risk individual. Limitations 1. Viral quantification may be appropriate for prognostic use including baseline determination, periodic monitoring, and monitoring of response to therapy. Use as a diagnostic test method is not indicated. 2. Measurement of plasma HIV RNA levels should be performed at the time of establishment of an HIV infection diagnosis. For an accurate baseline, 2 specimens in a 2-week period are appropriate. 3. For prognosis including anti-retroviral therapy monitoring, regular, periodic measurements are appropriate. The frequency of viral load testing should be consistent with the most current Centers for Disease Control and Prevention guidelines for use of anti-retroviral agents in adults and adolescents or pediatrics. 4. Because differences in absolute HIV copy number are known to occur using different assays, plasma HIV RNA levels should be measured by the same analytical method. A change in assay method may necessitate re-establishment of a baseline. 5. Nucleic acid quantification techniques are representative of rapidly emerging & evolving new technologies. Users advised to remain current on FDA-approval status. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Other Comments Assessment of CD4+ T cell numbers is frequently performed in conjunction with viral load determination. When used in concert, the accuracy with which the risk for disease progression and death can be predicted is enhanced. Sources of Information CDC.1998. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. MMWR 47 (RR-5). CDC.1998. Guidelines for use of antiretroviral agents in pediatric HIV infection. MMWR47 RR-4. CDC.1998. Public Health Service Task Force recommendations for the use of anti-retroviral drugs in pregnant women infected with HIV-1 for maternal health and for reducing perinatal HIV- 1 transmission in the United States. MMWR 47 (RR-2). Carpenter, C.C., M.A. Fischi, S.M. Hammer, et . al. 1998. Antiretroviral therapy for HIV infection in 1998. Updated recommendations of international AIDS society-USA panel. A.M.A. 280:78-86. Saag, M.S., M. Holodniy, D.R. Kuritzkes, et al. 1996. HIV viral load markers in clinical practice. Nature Medicine 2(6): 625-629.

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190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis)

Previously Listed as Edit 3 Other Names/Abbreviations HIV, HIV-1, HIV-2, HIV1/2, HTLV III, Human T-cell lymphotropic virus, AIDS, Acquired immune deficiency syndrome Description Diagnosis of Human Immunodeficiency Virus (HIV) infection is primarily made through the use of serologic assays. These assays take one of two forms: antibody detection assays and specific HIV antigen (p24) procedures. The antibody assays are usually enzyme immunoassays (EIA) which are used to confirm exposure of an individual’s immune system to specific viral antigens. These assays may be formatted to detect HIV-1, HIV-2, or HIV-1 and 2 simultaneously and to detect both IgM and IgG. When the initial EIA test is repeatedly positive or indeterminate, an alternative test is used to confirm the specificity of the antibodies to individual viral components. The most commonly used method is the Western Blot. The HIV-1 core antigen (p24) test detects circulating viral antigen which may be found prior to the development of antibodies and may also be present in later stages of illness in the form of recurrent or persistent antigenemia. Its prognostic utility in HIV infection has been diminished as a result of development of sensitive viral RNA assays, and its primary use today is as a routine screening tool in potential blood donors. In several unique situations, serologic testing alone may not reliably establish an HIV infection. This may occur because the antibody response (particularly the IgG response detected by Western Blot) has not yet developed (that is, acute retroviral syndrome), or is persistently equivocal because of inherent viral antigen variability. It is also an issue in perinatal HIV infection due to transplacental passage of maternal HIV antibody. In these situations, laboratory evidence of HIV in blood by culture, antigen assays, or proviral DNA or viral RNA assays, is required to establish a definitive determination of HIV infection. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 86689 Qualitative or semiquantitative immunoassays performed by multiple step methods; HTLV or HIV antibody, confirmatory test (for example, Western Blot) 86701 Antibody; HIV-1 86702 Antibody; HIV-2 86703 Antibody; HIV-1 and HIV-2, single assay 87390 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-1 87391 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-2

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Code Description 87534 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique 87535 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, amplified probe technique 87537 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, direct probe technique 87538 Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, amplified probe technique ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 003.1 Salmonella septicemia 007.2 Coccidiosis (Isoporiasis) 007.4 Cryptosporidiosis 007.8 Other specified protozoal intestinal diseases 010.00-010.96 Primary tuberculous infection 011.00-011.96 Pulmonary tuberculosis 012.00-012.86 Other respiratory tuberculosis 013.00-013.96 Tuberculosis of meninges--+ and central nervous system 014.00-014.86 Tuberculosis of intestines, peritoneum and mesenteric glands 015.00-015.96 Tuberculosis of bones and joints 016.00-016.96 Tuberculosis of genitourinary system 017.00-017.96 Tuberculosis of other organs 018.00-018.96 Miliary tuberculosis 027.0 Listeriosis 031.0-031.9 Diseases due to other mycobacteria 038.2 Pneumococcal septicemia 038.43 Septicemia (Pseudomonas) 039.0-039.9 Actinomycotic infections (includes Nocardia) 041.7 Pseudomonas infection 042 HIV disease (Acute retroviral syndrome, AIDS-related complex) 046.3 Progressive multifocal leukoencephalopathy 049.0-049.9 Other non-arthropod-borne viral diseases of central nervous system 052.0-052.1, 052.2, 052.7- Chickenpox (with complication) 052.8 053.0, 053.10-053.13,053.14, Herpes zoster 053.19-053.22, 053.29, 053.71,053.79, 053.8, 053.9

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Code Description 054.0, 054.10-054.13, Herpes simplex 054.19, 054.2, 054.3, 054.40-054.44, 054.49, 054.5, 054.6, 054.7-054.73, 054.74, 054.79, 054.8, 054.9 055.0-055.8 Measles (with complication) 070.20-070.23 Viral hepatitis B with hepatic coma 070.30-070.33 Viral hepatitis B without mention of hepatic coma 070.41 Acute hepatitis C with hepatic coma 070.42 Hepatitis delta without mention of active hepatitis B disease with hepatic coma 070.44 Chronic hepatitis C with hepatic coma 070.49 Other specified viral hepatitis with hepatic coma 070.51 Acute hepatitis C without mention of hepatic coma 070.52 Hepatitis delta without mention of active hepatitis B disease without hepatic coma 070.54 Chronic hepatitis C without hepatic coma 070.59 Other specified viral hepatitis without hepatic coma 070.6 Unspecified viral hepatitis with hepatic coma 070.70 Unspecified viral hepatitis C without hepatic coma 070.71 Unspecified viral hepatitis C with hepatic coma 070.9 Unspecified viral hepatitis without hepatic coma 078.0 Molluscum contagiosum 078.10 – 078.19 Viral warts 078.3 Cat-scratch disease 078.5 Cytomegaloviral disease 078.88 Other specified diseases due to Chlamydiae 079.50 Retrovirus unspecified 079.51 HTLV-I 079.52 HTLV-II 079.53 Human immunodeficiency virus, type 2 079.59 Other specified Retrovirus 079.83 Parvovirus B19 079.88 Other specified chlamydial infection 079.98 Unspecified chlamydial infection 085.0-085.9 Leishmaniasis 088.0 Bartonellosis 090.0-090.9 Congenital syphilis 091.0-091.9 Early syphilis symptomatic 092.0-092.9 Early syphilis, latent 093.0-093.9 Cardiovascular syphilis 094.0-094.9 Neurosyphilis

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Code Description 095.0-095.9 Other forms of late syphilis, with symptoms 096 Late syphilis, latent 097.0-097.9 Other and unspecified syphilis 098.0-098.89 Gonococcal infections 099.0 Chancroid 099.1 Lymphogranuloma venereum 099.2 Granuloma inguinale 099.3 Reiter’s disease 099.40-099.49 Other nongonococcal urethritis 099.50-099.59 Other venereal diseases due to Chlamydia trachomatis 099.8 Other specified venereal diseases 099.9 Venereal disease, unspecified 110.1 Dermatophytosis of nail 111.0 Pityriasis versicolor 112.0-112.9 Candidiasis 114.0-114.9 Coccidioidomycosis 115.00-115.99 Histoplasmosis 116.0-116.2 Blastomycotic infection 117.3 Aspergillosis 117.5 Cryptococcosis 118 Opportunistic mycoses 127.2 Strongyloidiasis 130.0-130.9 Toxoplasmosis 131.01 Trichomonal vulvovaginitis 132.2 Phthirus pubis 133.0 Scabies 136.21 Specific infection due to acanthamoeba 136.29 Other specific infections by free-living amebae 136.3 Pneumocystosis 136.8 Other specified infectious and parasitic disease (i.e.: microsporidiosis) 176.0-176.9 Kaposi’s sarcoma 180.0-180.9 Malignant neoplasm of cervix uteri 200.20-200.28 Burkitt’s tumor or lymphoma 200.80-200.88 Lymphosarcoma, other named variants 201.00-201.98 Hodgkin’s disease 263.0 Malnutrition of moderate degree 263.1 Malnutrition of mild degree 263.9 Unspecified protein-calorie malnutrition 280.0-280.9 Iron deficiency anemias 285.9 Anemia, unspecified 287.30-287.39 Primary thrombocytopenia

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Code Description 288.00 Neutropenia, unspecified 288.01 Congenital neutropenia 288.02 Cyclic neutropenia 288.03 Drug induced neutropenia 288.04 Neutropenia due to infection 288.09 Other neutropenia 288.4 Hemophagocytic syndromes 288.50 Leukocytopenia, unspecified 288.51 Lymphocytopenia 288.59 Other decreased white blood cell count 288.60 Leukocytosis, unspecified 288.61 Lymphocytosis (symptomatic) 288.62 Leukemoid reaction 288.63 Monocytosis (symptomatic) 288.64 Plasmacytosis 288.65 Basophilia 288.66 Bandemia 288.69 Other elevated white blood cell count 288.8 Other specified disease of white blood cells 289.53 Neutropenic splenomegaly 294.8 Other persistent mental disorders due to conditions classified elsewhere 310.1 Personality change due to conditions classified elsewhere 322.2 Chronic meningitis 331.19 Other frontotemporal dementia 331.83 Mild cognitive impairment, so stated 336.9 Unspecified disease of spinal cord 348.30 Encephalopathy unspecified 348.39 Other encephalopathy 354.0-354.9 Mononeuritis of upper limbs and mononeuritis multiplex 356.8 Other specified idiopathic peripheral neuropathy 363.20 Chorioretinitis, unspecified 425.4 Other primary cardiomyopathies 473.0-473.9 Chronic sinusitis 481-482.41 Pneumococcal pneumonia and other bacterial pneumonia 482.42 Methicillin resistant pneumonia due to Staphylococcus aureus 482.49-482.9 Other pneumonia due to Staphylococcus, specified and unspecified 484.1 Pneumonia in cytomegalic inclusion disease 486 Pneumonia, organism unspecified 512.81 Primary spontaneous pneumothorax 512.82 Secondary spontaneous pneumothorax

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Code Description 512.83 Chronic pneumothorax 516.8 Other specified alveolar and parietoalveolar pneumonopathies 528.2 Oral aphthae 528.6 Leukoplakia of oral mucosa 530.20-530.21 Ulcer of esophagus 530.85 Barrett’s esophagus 583.9 Nephropathy with unspecified pathological lesion in kidney 588.81 Secondary hyperparathyroidism (of renal origin) 588.89 Other specified disorders resulting from impaired renal function 647.60-647.64 Other viral diseases complicating pregnancy (use for HIV I and II) 682.0-682.9 Other cellulitis and abscess 690.10-690.18 Seborrheic dermatitis 696.1 Other psoriasis 698.3 Lichenification and lichen simplex chronicus 704.8 Other specified diseases of hair and hair follicles 706.0-706.9 Diseases of sebaceous glands 780.60 Fever, unspecified 780.61 Fever presenting with conditions classified elsewhere 780.62 Postprocedural fever 780.63 Postvaccination fever 780.64 Chills (without fever) 780.65 Hypothermia not associated with low environmental temperature 780.66 Febrile nonhemolytic transfusion reaction 780.79 Other malaise and fatigue 783.21 Abnormal loss of weight 783.40 Lack of expected normal physiological development 785.6 Enlargement of lymph nodes 786.00 Respiratory abnormality, unspecified 786.05 Shortness of breath 786.2 Cough 786.30 Hemoptysis, unspecified 786.31 Acute idiopathic pulmonary hemorrhage in infants (AIPHI) 786.39 Other hemoptysis 786.4 Abnormal sputum 787.91 Diarrhea 795.71 Nonspecific serologic evidence of human immunodeficiency virus 799.4 Wasting disease V01.71 Contact or exposure to varicella V01.79 Contact or exposure to other viral diseases V71.5 Rape

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Indications Diagnostic testing to establish HIV infection may be indicated when there is a strong clinical suspicion supported by one or more of the following clinical findings: 1. The patient has a documented, otherwise unexplained, AIDS-defining or AIDS- associated opportunistic infection. 2. The patient has another documented sexually transmitted disease which identifies significant risk of exposure to HIV and the potential for an early or subclinical infection. 3. The patient has documented acute or chronic hepatitis B or C infection that identifies a significant risk of exposure to HIV and the potential for an early or subclinical infection. 4. The patient has a documented AIDS-defining or AIDS-associated neoplasm. 5. The patient has a documented AIDS-associated neurologic disorder or otherwise unexplained dementia. 6. The patient has another documented AIDS-defining clinical condition, or a history of other severe, recurrent, or persistent conditions which suggest an underlying immune deficiency (for example, cutaneous or mucosal disorders). 7. The patient has otherwise unexplained generalized signs and symptoms suggestive of a chronic process with an underlying immune deficiency (for example, fever, weight loss, malaise, fatigue, chronic diarrhea, failure to thrive, chronic cough, hemoptysis, shortness of breath, or lymphadenopathy). 8. The patient has otherwise unexplained laboratory evidence of a chronic disease process with an underlying immune deficiency (for example, anemia, leukopenia, pancytopenia, lymphopenia, or low CD4+ lymphocyte count). 9. The patient has signs and symptoms of acute retroviral syndrome with fever, malaise, lymphadenopathy, and skin rash. 10. The patient has documented exposure to blood or body fluids known to be capable of transmitting HIV (for example, needlesticks and other significant blood exposures) and antiviral therapy is initiated or anticipated to be initiated. 11. The patient is undergoing treatment for rape. (HIV testing is part of the rape treatment protocol.) Limitations 1. HIV antibody testing in the United States is usually performed using HIV-1 or HIV-½ combination tests. HIV-2 testing is indicated if clinical circumstances suggest HIV-2 is likely (that is compatible clinical findings and HIV-1 test negative). HIV-2 testing may be indicated in areas of the country where there is greater prevalence of HIV-2 infections. 2. The Western Blot test should be performed only after documentation that the initial EIA tests are repeatedly positive or equivocal on a single sample. 3. The HIV antigen tests currently have no defined diagnostic usage. 4. Direct viral RNA detection may be performed in those situations where serologic testing does not establish a diagnosis but strong clinical suspicion persists (for example, acute retroviral syndrome, nonspecific serologic evidence of HIV, or perinatal HIV infection). 5. If initial serologic tests confirm an HIV infection, repeat testing is not indicated.

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6. If initial serologic tests are HIV EIA negative and there is no indication for confirmation of infection by viral RNA detection, the interval prior to retesting is 3-6 months. 7. Testing for evidence of HIV infection using serologic methods may be medically appropriate in situations where there is a risk of exposure to HIV. However, in the absence of a documented AIDS defining or HIV-associated disease, an HIV-associated sign or symptom, or documented exposure to a known HIV-infected source, the testing is considered by Medicare to be screening and thus is not covered by Medicare (for example, history of multiple blood component transfusions, exposure to blood or body fluids not resulting in consideration of therapy, history of transplant, history of illicit drug use, multiple sexual partners, same-sex encounters, prostitution, or contact with prostitutes). 8. The CPT Editorial Panel has issued a number of codes for infectious agent detection by direct antigen or nucleic acid probe techniques that have not yet been developed or are only being used on an investigational basis. Laboratory providers are advised to remain current on FDA-approval status for these tests. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Documentation Requirements Appropriate HCPCS/CPT code (s) must be used as described. Sources of Information CDC, 1993. Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 41 (No. RR17). CDC, 1994. Revised classification system for human immunodeficiency virus infection in children less than 13 years of age. CDC, 1998. Guidelines for treatment of sexually transmitted diseases. MMWR 47 (RR1):11-17. Piatak, M., M.S. Saag, L.C. Yang, et al. 1993. High levels of HIV-1 in plasma during all stages of infection determined by competitive PCR. Science 259:1749-1754. Rhame, R.S. 1994. Acquired immunodeficiency syndrome, p. 628-652. In Infectious Diseases; P.D. Hoeprich, M.C. Jordan, and A.R. Ronald (J.B. Lippincott Co., Philadelphia). Vasudevachari, M.D., R.T. Davey, Jr., J.A. Metcalf, and H.C. Lane. 1997. Principles and procedures of human immunodeficiency virus serodiagnosis. In Manual of Clinical Laboratory Immunology (Fifth ed.); N.R. Rose, E.C. de Macario, J.D. Folds, H.C. Lane, and R.M. Nakamura (ASM Press, Washington, DC).

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190.15 - Blood Counts

Previously Listed as Edit 4 Other Names/Abbreviations CBC Description Blood counts are used to evaluate and diagnose diseases relating to abnormalities of the blood or bone marrow. These include primary disorders such as anemia, leukemia, polycythemia, thrombocytosis and thrombocytopenia. Many other conditions secondarily affect the blood or bone marrow, including reaction to inflammation and infections, coagulopathies, neoplasms and exposure to toxic substances. Many treatments and therapies affect the blood or bone marrow, and blood counts may be used to monitor treatment effects. The complete blood count (CBC) includes a hemogram and differential white blood count (WBC). The hemogram includes enumeration of red blood cells, white blood cells, and platelets, as well as the determination of hemoglobin, hematocrit, and indices. The symptoms of hematological disorders are often nonspecific, and are commonly encountered in patients who may or may not prove to have a disorder of the blood or bone marrow. Furthermore, many medical conditions that are not primarily due to abnormalities of blood or bone marrow may have hematological manifestations that result from the disease or its treatment. As a result, the CBC is one of the most commonly indicated laboratory tests. In patients with possible hematological abnormalities, it may be necessary to determine the hemoglobin and hematocrit, to calculate the red cell indices, and to measure the concentration of white blood cells and platelets. These measurements are usually performed on a multichannel analyzer that measures all of the parameters on every sample. Therefore, laboratory assessments routinely include these measurements. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 85004 Blood count, automated differential white blood cell (WBC) count 85007 Blood count; blood smear, microscopic examination with manual differential WBC count 85008 Blood count; blood smear, microscopic examination without manual differential WBC count 85013 Blood count, Spun microhematocrit 85014 Blood count, hematocrit (Hct) 85018 Blood count, Hemoglobin 85025 Blood count, complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count 85027 Blood count, complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) 85032 Blood count; manual cell count (erythrocyte, leukocyte, platelet) each 85048 Blood count, leukocyte (WBC), automated

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Code Description 85049 Blood count; platelet, automated

ICD-9-CM Codes Covered by Medicare Program Any ICD-9-CM code not listed in either the non-covered section or the medical necessity section. Indications Indications for a CBC or hemogram include red cell, platelet, and white cell disorders. Examples of these indications are enumerated individually below. 1. Indications for a CBC generally include the evaluation of bone marrow dysfunction as a result of neoplasms, therapeutic agents, exposure to toxic substances, or pregnancy. The CBC is also useful in assessing peripheral destruction of blood cells, suspected bone marrow failure or bone marrow infiltrate, suspected myeloproliferative, myelodysplastic, or lymphoproliferative processes, and immune disorders. 2. Indications for hemogram or CBC related to red cell (RBC) parameters of the hemogram include signs, symptoms, test results, illness, or disease that can be associated with anemia or other red blood cell disorder (e.g., pallor, weakness, fatigue, weight loss, bleeding, acute injury associated with blood loss or suspected blood loss, abnormal menstrual bleeding, hematuria, hematemesis, hematochezia, positive fecal occult blood test, malnutrition, vitamin deficiency, malabsorption, neuropathy, known malignancy, presence of acute or chronic disease that may have associated anemia, coagulation or hemostatic disorders, postural dizziness, syncope, abdominal pain, change in bowel habits, chronic marrow hypoplasia or decreased RBC production, tachycardia, systolic heart murmur, congestive heart failure, dyspnea, angina, nailbed deformities, growth retardation, jaundice, hepatomegaly, splenomegaly, lymphadenopathy, ulcers on the lower extremities). 3. Indications for hemogram or CBC related to red cell (RBC) parameters of the hemogram include signs, symptoms, test results, illness, or disease that can be associated with polycythemia (for example, fever, chills, ruddy skin, conjunctival redness, cough, wheezing, cyanosis, clubbing of the fingers, orthopnea, heart murmur, headache, vague cognitive changes including memory changes, sleep apnea, weakness, pruritus, dizziness, excessive sweating, visual symptoms, weight loss, massive obesity, gastrointestinal bleeding, paresthesias, dyspnea, joint symptoms, epigastric distress, pain and erythema of the fingers or toes, venous or arterial thrombosis, thromboembolism, myocardial infarction, stroke, transient ischemic attacks, congenital heart disease, chronic obstructive pulmonary disease, increased erythropoietin production associated with neoplastic, renal or hepatic disorders, androgen or diuretic use, splenomegaly, hepatomegaly, diastolic hypertension.) 4. Specific indications for CBC with differential count related to the WBC include signs, symptoms, test results, illness, or disease associated with leukemia, infections or inflammatory processes, suspected bone marrow failure or bone marrow infiltrate, suspected myeloproliferative, myelodysplastic or lymphoproliferative disorder, use of drugs that may cause leukopenia, and immune disorders (e.g., fever, chills, sweats, shock, fatigue, malaise, tachycardia, tachypnea, heart murmur, seizures, alterations of

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consciousness, meningismus, pain such as headache, abdominal pain, arthralgia, odynophagia, or dysuria, redness or swelling of skin, soft tissue bone, or joint, ulcers of the skin or mucous membranes, gangrene, mucous membrane discharge, bleeding, thrombosis, respiratory failure, pulmonary infiltrate, jaundice, diarrhea, vomiting, hepatomegaly, splenomegaly, lymphadenopathy, opportunistic infection, such as oral candidiasis.) 5. Specific indications for CBC related to the platelet count include signs, symptoms, test results, illness, or disease associated with increased or decreased platelet production and destruction, or platelet dysfunction (e.g., gastrointestinal bleeding, genitourinary tract bleeding, bilateral epistaxis, thrombosis, ecchymosis, purpura, jaundice, petechiae, fever, heparin therapy, suspected DIC, shock, pre-eclampsia, neonate with maternal ITP, massive transfusion, recent platelet transfusion, cardiopulmonary bypass, hemolytic uremic syndrome, renal diseases, lymphadenopathy, hepatomegaly, splenomegaly, hypersplenism, neurologic abnormalities, viral or other infection, myeloproliferative, myelodysplastic, or lymphoproliferative disorder, thrombosis, exposure to toxic agents, excessive alcohol ingestion, autoimmune disorder (SLE, RA). 6. Indications for hemogram or CBC related to red cell (RBC) parameters of the hemogram include, in addition to those already listed, thalassemia, suspected hemoglobinopathy, lead poisoning, arsenic poisoning, and spherocytosis. 7. Specific indications for CBC with differential count related to the WBC include, in addition to those already listed, storage diseases; mucopolysaccharidoses, and use of drugs that cause leukocytosis such as G-CSF or CM-CSF. 8. Specific indications for CBC related to platelet count include, in addition to those already listed, May-Hegglin syndrome and Wiskott-Aldrich syndrome. Limitations 1. Testing of patients who are asymptomatic, or who do not have a condition that could be expected to result in a hematological abnormality, is screening and is not a covered service. 2. In some circumstances it may be appropriate to perform only a hemoglobin or hematocrit to assess the oxygen carrying capacity of the blood. When the ordering provider requests only a hemoglobin or hematocrit, the remaining components of the CBC are not covered. 3. When a blood count is performed for an end-stage renal disease (ESRD) patient, and is billed outside the ESRD rate, documentation of the medical necessity for the blood count must be submitted with the claim. 4. In some patients presenting with certain signs, symptoms or diseases, a single CBC may be appropriate. Repeat testing may not be indicated unless abnormal results are found, or unless there is a change in clinical condition. If repeat testing is performed, a more descriptive diagnosis code (e.g., anemia) should be reported to support medical necessity. However, repeat testing may be indicated where results are normal in patients with conditions where there is a continued risk for the development of hematologic abnormality.

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ICD-9-CM Codes That Do Not Support Medical Necessity

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 078.10 – 078.19 Viral warts 210.0-210.9 Benign neoplasm of lip, oral cavity, and pharynx 214.0 Lipoma, skin and subcutaneous tissue of face 216.0-216.9 Benign neoplasm of skin 217 Benign neoplasm of breast 222.0-222.9 Benign neoplasm of male genital organs 224.0 Benign neoplasm of eyeball, except conjunctiva, cornea, retina, and choroid 230.0 Carcinoma in situ of lip, oral cavity and pharynx 232.0-232.9 Carcinoma in situ of skin 300.00-300.09 Neurotic disorders 301.0-301.9 Personality disorders 302.0-302.9 Sexual and gender identity disorders 307.0 Stuttering 307.20-307.23 Tics 307.3 Stereotypic movement disorder 307.80-307.89 Pain disorders related to psychological factors 312.00-312.9 Disturbance of conduct, not elsewhere classified 313.0-313.9 Disturbance of emotions specific to childhood and adolescence 314.00-314.9 Hyperkinetic syndrome of childhood 338.0 Central pain syndrome 338.11 Acute pain due to trauma 338.12 Acute post-thoracotomy pain 338.18 Other acute postoperative pain 338.19 Other acute pain 338.21 Chronic pain due to trauma 338.22 Chronic post-thoracotomy pain 338.28 Other chronic postoperative pain 338.29 Other chronic pain 338.4 Chronic pain syndrome 363.30-363.35 Chorioretinal scars 363.40-363.43 Choroidal degeneration 363.50-363.57 Hereditary choroidal dystrophies 363.70-363.9 Choroidal detachment 366.00-366.9 Cataract 367.0-367.9 Disorders of refraction and accommodation 371.00-371.9 Corneal opacity and other disorders of cornea 373.00-373.9 Inflammation of eyelids

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Code Description 375.00-375.9 Disorders of lacrimal system

376.21-376.22 Endocrine exophthalmos 376.40-376.47 Deformity of orbit 376.50-376.52 Enophthalmos 376.6 Retained (old) foreign body following penetrating wound of orbit 376.81-376.82 Orbital cysts; myopathy of extraocular muscles 376.89 Other orbital disorders 376.9 Unspecified disorder of orbit 377.10-377.16 Optic atrophy 377.21-377.24 Other disorders of optic disc 384.20-384.25 Perforation of tympanic membrane 384.81-384.82 Other specified disorders of tympanic membrane 385.00-385.9 Other disorders of middle ear and mastoid 387.0-387.9 Otosclerosis 388.00-388.32 Degenerative and vascular disorders of ear; noise effects on inner ear; sudden hearing loss, unspecified; and tinnitus 388.40-388.45 Other abnormal auditory perception 388.5 Disorders of acoustic nerve 389.00-389.06, 389.08 Conductive hearing loss 389.10-389.18 Sensorineural hearing loss 389.20-389.22 Mixed hearing loss 389.7 Deaf, non-speaking, not elsewhere classifiable 389.8, 389.9 Hearing loss 440.0-440.1 Atherosclerosis of aorta and renal artery 443.81-443.9 Other and unspecified peripheral vascular disease 448.1 Capillary nevus, non neoplastic 457.0 Postmastectomy lymphedema syndrome 470 Deviated nasal septum 471.0-471.9 Nasal polyps 478.0 Hypertrophy of nasal turbinates 478.11 Nasal mucositis (ulcerative) 478.19 Other disease of nasal cavity and sinuses 478.4 Polyp of vocal cord or larynx 520.0-520.9 Disorders of tooth development and eruption 521.00-521.15, 521.20- Diseases of hard tissues of teeth 521.25, 521.30-521.35, 521.40-521.42,521.49, 521.5- 521.7, 521.81, 521.89, 521.9 524.00-524.9 Dentofacial anomalies, including malocclusion

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Code Description 525.0, 525.10-525.13, Other diseases and conditions of teeth and supporting structures 525.19, 525.20-525.26, 525.3, 525.40-525.44, 525.50-525.54, 525.60- 525.67, 525.69 525.71 Osseointegration failure of dental implant 525.72 Post-osseointegration biological failure of dental implant 525.73 Post-osseointegration mechanic failure of dental implant 525.8 Other specified disorders of the teeth and supporting structures 525.9 Unspecified disorder of the teeth and supporting structures 526.0-526.3 Diseases of the jaws 526.61 Perforation of root canal space 526.62 Endodontic overfill 526.63 Endodontic underfill 526.69 Other periradicular pathology associated with previous endodontic treatment 527.6-527.9 Diseases of salivary glands 575.6 Cholesterolosis of gallbladder 600.00-600.91 Hyperplasia of prostate 603.0 Encysted hydrocele 603.8 Other specified types of hydrocele 603.9 Hydrocele, unspecified 605 Redundant prepuce and phimosis 606.0-606.1 Infertility, male azoospermia and oligospermia 608.1 Spermatocele 608.20 Torsion of testis, unspecified 608.21 Extravaginal torsion of spermatic cord 608.22 Intravaginal torsion of spermatic cord 608.23 Torsion of appendix testis 608.24 Torsion of appendix epididymis 608.3 Atrophy of testis 610.0-610.9 Benign mammary dysplasia 611.1-611.6 Other disorders of breast 611.9 Unspecified breast disorder 616.2 Cyst of Bartholin’s gland 618.00-618.05, 618.09, Genital prolapse 618.1-618.7, 618.81-618.83, 618.84, 618.89, 618.9 620.0-620.3 Noninflammatory disorders of ovary, fallopian tube, & broad ligament 621.6-621.7 Malposition or chronic inversion of uterus 627.2-627.9 Menopausal and post menopausal disorders 628.0-628.9 Infertility, female

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Code Description 676.00-676.94 Other disorders of breast associated with childbirth and disorders of lactation 691.0-691.8 Atopic dermatitis and related disorders 692.0-692.9 Contact dermatitis and other eczema 700 Corns and callosities 701.0-701.9 Other hypertrophic and atrophic conditions of skin 702.0-702.8 Other dermatoses 703.9 Unspecified disease of nail 706.0-706.9 Diseases of sebaceous glands 709.00-709.4 Other disorders of skin and subcutaneous tissue 715.00-715.98 Osteoarthrosis 716.00-716.99 Other and unspecified arthropathies 718.00- 718.99 Other derangement of joint 726.0-726.91 Peripheral enthesopathies and allied syndromes 727.00-727.9 Other disorders of synovium, tendon, and bursa 728.10-728.85 Disorders of muscle ligament and fascia 732.0-732.9 Osteochondropathies 733.00-733.09 Osteoporosis 734 Flat foot 735.0-735.9 Acquired deformities of toe 736.00-736.9 Other acquired deformities of limb 737.0-737.9 Curvature of spine 738.0-738.9 Other acquired deformity 739.0-739.9 Nonallopathic lesions, not elsewhere classified 799.81 Decreased libido 830.0-832.19 Dislocation of jaw, shoulder, and elbow 832.2 Nursemaid's elbow 833.00-833.19 Dislocation of wrist 834.00-834.12 Dislocation of finger 835.00-835.13 Dislocation of hip 836.0-836.69 Dislocation of knee 837.0-837.1 Dislocation of ankle 838.00-838.19 Dislocation of foot 839.00-839.9 Other, multiple and ill-defined dislocations 840.0-848.9 Sprains and strains of joints and adjacent muscles 905.0-909.9 Late effects of musculoskeletal and connective tissue injuries 910.0-919.9 Superficial injuries 930.0-932 Foreign body on external eye, in ear, in nose 955.0-957.9 Injury to peripheral nerve V03.0-V06.9 Need for prophylactic vaccination

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Code Description V11.0-V11.3 Personal history of mental disorder; schizophrenia, affective disorders, neurosis, and alcoholism V11.4 Personal history of combat and operational stress reaction V11.8-V11.9 Personal history of other and unspecified mental disorders V14.0-V14.8 Personal history of allergy to medicinal agents V16.0 Family history of malignant neoplasm, gastrointestinal tract V16.3 Family history of malignant neoplasm, breast V21.0-V21.9 Constitutional states in development V25.01-V25.04, V25.09 Encounter for contraceptive management; general counseling and advice V25.11 Encounter for insertion of intrauterine contraceptive device V25.12 Encounter for removal of intrauterine contraceptive device V25.13 Encounter for removal and reinsertion of intrauterine contraceptive device V25.2-V25.3, V25.40-V25.43, Encounter for sterilization; menstrual extraction; surveillance of V25.49, V25.5, V25.8, V25.9 previously prescribed contraceptive methods; and insertion of implantable subdermal contraceptive; other specified and unspecified contraceptive management V26.0-V26.39 Procreative management V26.41 Other procreative counseling and advice using natural family planning V26.42 Encounter for fertility preservation counseling V26.49 Other procreative management, counseling and advice V26.51 Tubal ligation status V26.52 Vascectomy status V26.81 Encounter for assisted reproductive fertility procedure cycle V26.82 Encounter for fertility preservation procedure V26.89-V26.9 Other specified and unspecified procreative management V40.0-V40.9 Mental and behavioral problems V41.0-V41.9 Problems with special senses and other special functions V43.0-V43.1 Organ or tissue replaced by other means, eye globe or lens V44.0-V44.9 Artificial opening status V45.00-V45.02, V45.09 Other post surgical states V45.11 Renal dialysis status V45.12 Non-compliance with renal dialysis V45.2-V45.4, V45.51, V45.52, Other post surgical states V45.59, V45.61, V45.69, V45.71-V45.79, V45.81- V45.85, V45.86, V45.89 V48.0-V48.9 Problems with head, neck, and trunk V49.0 - V49.85 Other conditions influencing health status V49.86 Do not resuscitate status V49.87 Physical restraints status

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Code Description V49.89 - V49.9 Other specified and unspecified conditions influencing health status V51.0 Encounter for breast reconstruction following mastectomy V51.8 Other aftercare involving the use of plastic surgery V52.0-V52.9 Fitting and adjustment of prosthetic device and implant V53.01-V53.09 Fitting and adjustment of devices related to nervous system & special senses V53.1 Fitting and adjustment of spectacles and contact lenses V53.31-V53.39 Fitting and adjustment of cardiac device V53.4 Fitting and adjustment of orthodontic devices V53.50 Fitting and adjustment of intestinal appliance and device V53.51 Fitting and adjustment of gastric lap band V53.59 Fitting and adjustment of other gastrointestinal appliance and device V53.6 Fitting and adjustment of urinary devices V53.7 Fitting and adjustment of orthopedic devices V53.8 Fitting and adjustment of wheelchair V53.90-V53.99 Fitting and adjustment of other and unspecified device V54.01-V54.9 Other orthopedic aftercare V55.0-V55.9 Attention to artificial openings V57.0-V57.2 Care involving use of rehabilitation procedures V57.3 Care involving speech-language therapy V57.4-V57.9 Orthoptic training, other specified, and unspecified rehabilitation procedure V58.5 Orthodontics V59.01-V59.9 Donors V61.01 Family disruption due to family member on military deployment V61.02 Family disruption due to return of family member from military deployment V61.03 Family disruption due to divorce or legal separation V61.04 Family disruption due to parent-child estrangement V61.05 Family disruption due to child in welfare custody V61.06 Family disruption due to child in foster care or in care of non-parental family member V61.07 Family disruption due to death of family member V61.08 Family disruption due to other extended absence of family member V61.09 Other family disruption V61.10 Counseling for marital and partner problems, unspecified V61.11 Counseling for victim of spousal and partner abuse V61.12 Counseling for perpetrator of spousal and partner abuse V61.20 Counseling for parent-child problem V61.21 Counseling for victim of child abuse V61.22 Counseling for perpetrator of parental child abuse

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Code Description V61.23 Counseling for parent-biological child problem V61.24 Counseling for parent-adopted child problem V61.25 Counseling for parent (guardian)-foster child problem V61.29 Other parent-child problems V61.3 Problems with aged parents or in-laws V61.41 Alcoholism in family V61.42 Substance abuse in family V61.49, V61.5-V61.9 Other specified and unspecified family problems V62.21 Personal current military deployment status V62.22 Personal history of return from military deployment V62.29 Other occupational circumstances or maladjustment V62.3-V62.84 Educational circumstances; other psychological or physical stress, not elsewhere classified; suicidal ideation V62.85 Homicidal ideation V62.89-V62.9 Other psychological or physical stress, not elsewhere classified; and unspecified psychosocial circumstances V65.2 Person feigning illness V65.3 Dietary surveillance and counseling V65.40-V65.49 Other counseling, not elsewhere classified V65.5 Person with feared complaint in whom no diagnosis was made V65.8 Other reasons for seeking consultation V65.9 Unspecified reason for consultation V66.0-V66.9 Convalescence and palliative care V67.3 Follow-up examination following psychotherapy V67.4 Follow-up examination following treatment of healed fracture V69.3 Problems related to lifestyle, gambling and betting V71.01 - V71.09 Observation and evaluation for suspected conditions not found, mental V72.0 Examination of eyes and vision V72.11 - V72.12; V72.19 Encounter for hearing conservation and treatment; other examination of ears and hearing V72.2 Dental examination V72.40, V72.41, V72.42 Pregnancy examination or test; pregnancy unconfirmed; negative result; positive result. V72.5 Radiological examination, not elsewhere classified V72.60 Laboratory examination, unspecified V72.61 Antibody response examination V72.62 Laboratory examination ordered as part of a routine general medical examination V72.63 Pre-procedural laboratory examination V72.69 Other laboratory examination V72.7 Diagnostic skin and sensitization tests V72.9 Unspecified examination

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Code Description V76.10-V76.19 Special screening for malignant neoplasms, breast V76.2 Special screening for malignant neoplasms, cervix V76.44 Special screening for malignant neoplasms, other sites, prostate V76.51 Special screening for malignant neoplasms, Intestine, colon V77.1 Special screening for diabetes mellitus V81.0-V81.2 Special screening for cardiovascular diseases

Documentation Required Appropriate HCPCS/CPT code (s) must be used as described. Sources of Information Wintrobe’s Clinical Hematology, G. Richard Lee et al editors, Lea & Febiger, 9th edition, Philadelphia PA 1993. Hematology, Clinical and Laboratory Practice, R. Bick et al editors, Mosby-Year Book, Inc., St. Louis, Missouri, 1993. “The Polycythemias”, V.C. Broudy, Medicine, Chapter 5.V. Scientific American, NY, NY 1996. Laboratory Test Handbook, D.S. Jacobs et al, Lexi-Comp Inc, 4th edition, Cleveland OH 1996. Cancer: Principles & Practice of Oncology, DeVita, et al., 5th ed., Phil: Lippincott-Raven, 1997. Cecil Textbook of Medicine, Bennett, et al., 20th edition, Philadelphia: W.B. Saunders, 1996. Williams Hematology, Beutler, et al., 5th edition, New York: McGraw-Hill, 1995.

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190.16 - Partial Thromboplastin Time (PTT)

Previously Listed as Edit 5 Other Names/Abbreviations PTT Description Basic plasma coagulation function is readily assessed with a few simple laboratory tests: The Partial Thromboplastin Time (PTT), Prothrombin Time (PT), Thrombin Time (TT), or a quantitative fibrinogen determination. The PTT test is an in vitro laboratory test used to assess the intrinsic coagulation pathway and monitor heparin therapy. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 85730 Thromboplastin time, partial (PTT); plasma or whole blood ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 002.0-002.9 Typhoid and paratyphoid 003.0-003.9 Other Salmonella infections 038.9 Unspecified Septicemia 042 Human immunodeficiency virus (HIV) disease 060.0-060.9 Yellow fever 065.0-065.9 Arthropod borne hemorrhagic fever 070.0-070.9 Viral hepatitis 075 Infectious mononucleosis 078.6 Hemorrhagic nephrosonephritis 078.7 Arenaviral hemorrhagic fever 120.0 Schistosomiasis haematobium 121.1 Clonorchiasis 121.3 Fascioliasis 124 Trichinosis 135 Sarcoidosis 155.0-155.2 Malignant neoplasm of liver and intrahepatic bile ducts 197.7 Malignant neoplasm of liver, specified as secondary 238.4 Polycythemia vera 238.71 Essential thrombocythemia 238.72 Low grade myelodysplastic syndrome lesions

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Code Description 238.73 High grade myelodysplastic syndrome lesions 238.74 Myelodysplastic syndrome with 5q deletion 238.75 Myelodysplastic syndrome, unspecified 238.76 Myelofibrosis with myeloid metaplasia 238.77 Post-transplant lymphoproliferative disorder (PTLD) 238.79 Other lymphatic and hematopoietic tissues 239.9 Neoplasm of unspecified nature, site unspecified 246.3 Hemorrhage and infarction of thyroid 249.40 Secondary diabetes mellitus with renal manifestations, not stated as uncontrolled 249.41 Secondary diabetes mellitus with renal manifestations, uncontrolled 250.40-250.43 Diabetic with renal manifestations 269.0 Deficiency of Vitamin K 273.0-273.3, 273.8-273.9 Disorders of plasma protein metabolism 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 275.1 Disorders of copper metabolism 275.2 Disorders of magnesium metabolism 275.3 Disorders of phosphorus metabolism 275.40-275.49 Disorders of calcium metabolism 275.5 Hungry bone syndrome 275.8-275.9 Other specified disorders of mineral metabolism, and unspecified disorder of mineral metabolism 277.1 Disorders of porphyrin metabolism 277.30 Amyloidosis, unspecified 277.31 Familial Mediterranean fever 277.39 Other amyloidosis 285.1 Acute posthemorrhagic anemia 286.0 Congenital factor VIII disorder - Hemophilia A 286.1 Congenital factor IX disorder - Hemophilia B 286.2-286.3 Other congenital factor deficiencies 286.4 von Willebrand’s disease 286.52 Acquired hemophilia 286.53 Antiphospholipid antibody with hemorrhagic disorder 286.59 Other hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors 286.6 Defibrination syndrome 286.7 Acquired coagulation factor deficiency 286.9 Other and unspecified coagulation defects

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Code Description 287.0-287.39 Allergic purpura; qualitative platelet defects; other non- thrombocytopenic purpuras; primary thrombocytopenia 287.41 Posttransfusion purpura 287.49 Other secondary thrombocytopenia 287.5-287.9 Thrombocytopenia, unspecified; other specified and unspecified hemorrhagic conditions 289.0 Polycythemia, secondary 289.81 Primary hypercoagulable state 325 Phlebitis and thrombophlebitis of intracranial venous sinuses 360.43 Hemophthalmos, except current injury 362.30-362.37 Retinal vascular occlusion 362.43 Hemorrhagic detachment of retinal pigment epithelium 362.81 Retinal hemorrhage 363.61-363.63 Choroidal hemorrhage 363.72 Choroidal detachment 368.9 Unspecified Visual Disturbances 372.72 Conjunctive hemorrhage 374.81 Hemorrhage of eyelid 376.32 Orbital hemorrhage 377.42 Hemorrhage in optic nerve sheaths 379.23 Vitreous hemorrhage 380.31 Hematoma of auricle or pinna 403.01, 403.11, 403.91 Hypertensive chronic kidney disease, with chronic kidney disease stage V or end stage renal disease 404.02, 404.12, 404.92 Hypertensive heart and chronic kidney disease, without heart failure and with chronic kidney disease stage V or end stage renal disease 410.00-410.92 Acute myocardial infarction 423.0 Hemopericardium 427.31 Atrial fibrillation 427.9 Cardiac dysrhythmias, unspecified 428.0 Congestive heart failure, unspecified 429.79 Mural thrombus 430-432.9 Cerebral hemorrhage 433.00-433.91 Occlusion and stenosis of precerebral arteries 434.00-434.91 Occlusion of cerebral arteries 435.9 Focal neurologic deficit 444.01, 444.09, 444.1-444.9 Arterial embolism and thrombosis 446.6 Thrombotic microangiopathy 447.2 Rupture of artery 448.0 Hereditary Hemorrhagic telangiectasia 451.0-451.9 Phlebitis and thrombophlebitis

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Code Description 453.0 Budd-Chiari syndrome 453.1 Thrombophlebitis migrans 453.2 Embolism and thrombosis of inferior vena cava 453.3 Embolism and thrombosis of renal vein 453.40 Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.41 Acute venous embolism and thrombosis of deep vessels of proximal lower extremity 453.42 Acute venous embolism and thrombosis of deep vessels of distal lower extremity 453.50 Chronic venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.51 Chronic venous embolism and thrombosis of deep vessels of proximal lower extremity 453.52 Chronic venous embolism and thrombosis of deep vessels of distal lower extremity 453.6 Venous embolism and thrombosis of superficial vessels of lower extremity 453.71 Chronic venous embolism and thrombosis of superficial veins of upper extremity 453.72 Chronic venous embolism and thrombosis of deep veins of upper extremity 453.73 Chronic venous embolism and thrombosis of upper extremity, unspecified 453.74 Chronic venous embolism and thrombosis of axillary veins 453.75 Chronic venous embolism and thrombosis of subclavian veins 453.76 Chronic venous embolism and thrombosis of internal jugular veins 453.77 Chronic venous embolism and thrombosis of other thoracic veins 453.79 Chronic venous embolism and thrombosis of other specified veins 453.81 Acute venous embolism and thrombosis of superficial veins of upper extremity 453.82 Acute venous embolism and thrombosis of deep veins of upper extremity Acute venous embolism and thrombosis of upper extremity, 453.83 unspecified 453.84 Acute venous embolism and thrombosis of axillary veins 453.85 Acute venous embolism and thrombosis of subclavian veins 453.86 Acute venous embolism and thrombosis of internal jugular veins 453.87 Acute venous embolism and thrombosis of other thoracic veins 453.89 Acute venous embolism and thrombosis of other specified veins 453.9 Other venous embolism and thrombosis of unspecified site 456.0 Esophageal varices with bleeding 456.1 Esophageal varices without bleeding 456.8 Varices of other sites

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Code Description 459.89 Ecchymosis 530.7 Gastroesophageal laceration – hemorrhage syndrome 530.82 Esophageal hemorrhage 531.00-535.61 Gastric-Duodenal ulcer disease 535.70 Eosinophilic gastritis, without mention of obstruction 535.71 Eosinophilic gastritis, with obstruction 537.83 Angiodysplasia of stomach and duodenum with hemorrhage 537.84 Dieulafoy lesion (hemorrhagic) of stomach and duodenum 556.0-557.9 Hemorrhagic bowel disease 562.02-562.03 Diverticulosis of small intestine with hemorrhage 562.12 Diverticulosis of colon with hemorrhage 562.13 Diverticulitis of colon with hemorrhage 568.81 Hemoperitoneum (nontraumatic) 569.3 Hemorrhage of rectum and anus 570 Acute and subacute necrosis of liver 571.0-571.9 Chronic liver disease and cirrhosis 572.0 Abscess of liver 572.1 Portal pyemia 572.2 Hepatic encephalopathy 572.3 Portal hypertension 572.4 Hepatorenal syndrome 572.8 Other sequelae of chronic liver disease 573.0-573.9 Other disorders of liver 576.0-576.9 Biliary tract disorders 577.0 Acute pancreatitis 578.0-578.9 Gastrointestinal Hemorrhage 579.0-579.9 Malabsorption 581.0-581.9 Nephrotic Syndrome 583.9 Nephritis, with unspecified pathological lesion in kidney 584.5 Acute kidney failure with lesion of tubular necrosis 584.6 Acute kidney failure with lesion of renal cortical necrosis 584.7 Acute kidney failure with lesion of renal medullary (papillary) necrosis 584.8 Acute kidney failure with other specified pathological lesion in kidney 584.9 Acute kidney failure, unspecified 585.4-585.9 Chronic kidney disease 586 Renal failure 593.81-593.89 Other disorders of kidney and ureter, with hemorrhage 596.7 Hemorrhage into bladder wall 596.81 Infection of cystostomy 596.82 Mechanical complication of cystostomy 596.83 Other complication of cystostomy

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Code Description 596.89 Other specified disorders of bladder 599.70 Hematuria, unspecified 599.71 Gross hematuria 599.72 Microscopic hematuria 607.82 Penile hemorrhage 608.83 Vascular disorders of male genital organs 611.89 Other specified disorders of breast including hematoma 620.7 Hemorrhage of broad ligament 621.4 Hematometra 622.8 Other specified disorders of cervix, with hemorrhage 623.6 Vaginal hematoma 623.8 Other specified diseases of the vagina, with hemorrhage 624.5 Hematoma of vulva 626.6 Metrorrhagia 626.7 Postcoital bleeding 627.0 Premenopausal bleeding 627.1 Postmenopausal bleeding 629.0 Hematocele female not elsewhere classified 632 Missed abortion 634.00-634.92 Spontaneous abortion 635.10-635.12 Legally induced abortion, complicated by delayed or excessive hemorrhage 636.10-636.12 Illegally induced abortion, complicated by delayed or excessive hemorrhage 637.10-637.12 Abortion unspecified, complicated by delayed or excessive hemorrhage 638.1 Failed attempt abortion, complicated by delayed or excessive hemorrhage 639.1 Delayed or excessive hemorrhage following abortion and ectopic and molar pregnancies 639.6 Complications following abortion and ectopic and molar pregnancies, embolism 640.00-640.93 Hemorrhage in early pregnancy 641.00-641.93 Antepartum hemorrhage 642.00-642.94 Hypertension complicating pregnancy, childbirth, and the puerperium 646.70-646.73 Liver disorders in pregnancy 649.30 Coagulation defects complicating pregnancy, childbirth, or the puerperium, unspecified as to episode of care or not applicable 649.31 Coagulation defects complicating pregnancy, childbirth, or the puerperium, delivered, with or without mention of antepartum condition 649.32 Coagulation defects complicating pregnancy, childbirth, or the puerperium, delivered, with mention of postpartum complication

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Code Description 649.33 Coagulation defects complicating pregnancy, childbirth, or the puerperium, antepartum condition or complication 649.34 Coagulation defects complicating pregnancy, childbirth, or the puerperium, postpartum condition or complication 649.50 Spotting complicating pregnancy, unspecified as to episode of care or not applicable 649.51 Spotting complicating pregnancy, delivered, with or without mention of antepartum condition 649.53 Spotting complicating pregnancy, antepartum condition or complication 656.00-656.03 Fetal maternal hemorrhage 658.40-658.43 Infection of amniotic cavity 666.00-666.34 Postpartum hemorrhage 671.20-671.54 Phlebitis in pregnancy 673.00-673.84 Obstetrical pulmonary embolus 674.30-674.34 Other complications of surgical wounds, with hemorrhage 710.0 Systemic Lupus erythematosus 713.2 Arthropathy associated with hematologic disorders (note: may not be used without indicating associated condition first) 713.6 Arthropathy associated with Henoch Schonlein (note: may not be used without indicating associated condition first) 719.10-719.19 Hemarthrosis 729.5 Pain in limb 729.81 Swelling of limb 733.10-733.19 Pathologic fracture associated with fat embolism 762.1 Other forms of placental separation with hemorrhage (affecting newborn code – do not assign to mother’s record) 764.90-764.99 Fetal intrauterine growth retardation 767.0, 767.11 Subdural and cerebral hemorrhage 767.8 Other specified birth trauma, with hemorrhage 770.3 Fetal and newborn pulmonary hemorrhage 772.0 Fetal blood loss affecting newborn 772.10-772.14 Fetal and neonatal intraventricular hemorrhage 772.2 Fetal and neonatal subarachnoid hemorrhage 772.3 Fetal and neonatal umbilical hemorrhage after birth 772.4 Fetal and neonatal gastrointestinal hemorrhage 772.5 Fetal and neonatal adrenal hemorrhage 772.6 Fetal and neonatal cutaneous hemorrhage 772.8 Fetal and neonatal other specified hemorrhage of fetus or newborn 772.9 Fetal and neonatal unspecified hemorrhage of newborn 774.0-774.7 Other perinatal jaundice 776.0 Hemorrhagic disease of the newborn 776.1 Transient neonatal thrombocytopenia

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Code Description 776.2 Disseminated intravascular coagulation in newborn 776.3 Other transient neonatal disorders of coagulation 776.4 Polycythemia neonatorum 776.5 Congenital anemia 776.6 Anemia of prematurity 776.7 Transient neonatal neutropenia 776.8 Other specified transient hematological disorders 776.9 Unspecified hematological disorder specific to newborn 780.2 Syncope 782.4 Jaundice, unspecified, not of newborn 782.7 Spontaneous ecchymoses Petechiae 784.7 Epistaxis 784.8 Hemorrhage from throat 785.4 Gangrene 785.50 Shock 786.05 Shortness of breath 786.30 Hemoptysis, unspecified 786.31 Acute idiopathic pulmonary hemorrhage in infants (AIPHI) 786.39 Other hemoptysis 786.50 Chest pain, unspecified 786.59 Chest pain 789.00-789.09 Abdominal pain 789.7 Colic 790.92 Abnormal coagulation profile 800.00-800.99 Fracture of vault of skull 801.00-801.99 Fracture of base of skull 802.20-802.9 Fracture of face bones 803.00-803.99 Other fracture, skull 804.00-804.99 Multiple fractures, skull 805.00- 806.9 Fracture, vertebral column 807.00-807.09 Fracture of rib(s), closed 807.10-807.19 Fracture of rib(s), open 808.8-808.9 Fracture of pelvis 809.0-809.1 Fracture of trunk 810.00-810.13 Fracture of clavicle 811.00-811.19 Fracture of scapula 812.00-812.59 Fracture of humerus 813.10-813.18 Fracture of radius and ulna, upper end, open 813.30-813.33 Fracture of radius and ulna, shaft, open 813.50-813.54 Fracture of radius and ulna, lower end, open 813.90-813.93 Fracture of radius and ulna, unspecified part, open

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Code Description 819.0-819.1 Multiple fractures 820.00–821.39 Femur 823.00-823.92 Tibia and fibula 827.0–829.1 Other multiple lower limb 852.00–853.19 Subarachnoid subdural, and extradural hemorrhage, following injury, Other and specified intracranial hemorrhage following injury 860.0-860.5 Traumatic pneumothorax and hemothorax 861.00-861.32 Injury to heart and lung 862.0-862.9 Injury to other and unspecified intrathoracic organs 863.0-863.99 Injury to gastrointestinal tract 864.00-864.19 Injury to liver 865.00-865.19 Injury to spleen 866.00-866.13 Injury to kidney 867.0-867.9 Injury to pelvic organs 868.00-868.19 Injury to other intra-abdominal organs 869.0-869.1 Internal injury to unspecified or ill defined organs 900.00-900.9 Injury to blood vessels of head and neck 901.0-901.9 Injury to blood vessels of the thorax 902.0-902.9 Injury to blood vessels of the abdomen and pelvis 903.00-903.9 Injury to blood vessels of upper extremity 904.0-904.9 Injury to blood vessels of lower extremity and unspecified sites 920-924.9 Contusion with intact skin surface 925.1-929.9 Crushing injury 958.2 Secondary and recurrent hemorrhage 959.9 Injury, unspecified site 964.2 Poisoning by anticoagulants 964.5 Poisoning by anticoagulant antagonists 964.7 Poisoning by natural blood and blood products 980.0 Toxic effects of alcohol 989.5 Snake venom 995.20 Unspecified adverse effect of unspecified drug, medicinal and biological substance 995.21 Arthus phenomenon 995.24 Failed moderate sedation during procedure 995.27 Other drug allergy 995.29 Unspecified adverse effect of other drug, medicinal and biological substance 996.70-996.79 Other complications of internal prosthetic device 997.02 Iatrogenic cerebrovascular infarction or hemorrhage 998.11 Hemorrhage or hematoma complicating a procedure 998.12 Hematoma complicating a procedure

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Code Description 999.2 Other vascular complications of medical care V12.3 Personal history of diseases of blood and blood forming organs V58.2 Admission for Transfusion of blood products V58.61 Long term (current use) of anticoagulants V58.83 Encounter for therapeutic drug monitoring

Indications 1. The PTT is most commonly used to quantitate the effect of therapeutic unfractionated heparin and to regulate its dosing. Except during transitions between heparin and warfarin therapy, in general both the PTT and PT are not necessary together to assess the effect of anticoagulation therapy. PT and PTT must be justified separately. 2. A PTT may be used to assess patients with signs or symptoms of hemorrhage or thrombosis. For example:  Abnormal bleeding, hemorrhage or hematoma petechiae or other signs of thrombocytopenia that could be due to Disseminated Intravascular Coagulation  Swollen extremity with or without prior trauma 3. A PTT may be useful in evaluating patients who have a history of a condition known to be associated with the risk of hemorrhage or thrombosis that is related to the intrinsic coagulation pathway. Such abnormalities may be genetic or acquired. For example:  Dysfibrinogenemia  Afibrinogenemia (complete)  Acute or chronic liver dysfunction or failure, including Wilson’s disease  Hemophilia  Liver disease and failure  Infectious processes  Bleeding disorders  Disseminated intravascular coagulation  Lupus erythematosus or other conditions associated with circulating inhibitors, e.g., factor VIII Inhibitor, lupus-like anticoagulant  Sepsis  Von Willebrand’s disease  Arterial and venous thrombosis, including the evaluation of hypercoagulable states  Clinical conditions associated with nephrosis or renal failure  Other acquired and congenital coagulopathies as well as thrombotic states 4. A PTT may be used to assess the risk of thrombosis or hemorrhage in patients who are going to have a medical intervention known to be associated with increased risk of bleeding or thrombosis. An example is as follows: evaluation prior to invasive

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procedures or operations of patients with personal or family history of bleeding or who are on heparin therapy Limitations 1. The PTT is not useful in monitoring the effects of warfarin on a patient’s coagulation routinely. However, a PTT may be ordered on a patient being treated with warfarin as heparin therapy is being discontinued. A PTT may also be indicated when the PT is markedly prolonged due to warfarin toxicity. 2. The need to repeat this test is determined by changes in the underlying medical condition and/or the dosing of heparin. 3. Testing prior to any medical intervention associated with a risk of bleeding and thrombosis (other than thrombolytic therapy) will generally be considered medically necessary only where there are signs or symptoms of a bleeding or thrombotic abnormality or a personal history of bleeding, thrombosis or a condition associated with a coagulopathy. Hospital/clinic-specific policies, protocols, etc., in and of themselves, cannot alone justify coverage. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM sections above. Sources of Information CMD Clinical Laboratory Workgroup 1999 CPT Physicians’ Current Procedural Terminology, American Medical Association Blue Book of Diagnostic Tests; PL Liu; Saunders Wintrobe’s Clinical Hematology; 9th Ed, 1993, Lea and Febiger Harrison’s Principles of Internal Medicine, 14th Ed., McGraw Hill, 1997. Disorders of Hemostasis, Ratnoff, Oscar D. & Forbes, Charles D., W.B. Saunders Co., 1996 Hemostasis and Thrombosis: Basic Principles and Clinical Practice. Colman, et al editors, J.B. Lippincott, 3rd Edition, 1994, pp 896-898and 1045-1046. “College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy,” Arch Pathol Lab Med, Vol 122, Sep 1998, P 782-798. Lupus Anticoagulants/Antiphospholipid-protein Antibodies: The Great Imposters, Triplett DA, Lupus 1996:5:431

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190.17 - Prothrombin Time (PT)

Previously Listed as Edit 6 Other Names/Abbreviations PT Description Basic plasma coagulation function is readily assessed with a few simple laboratory tests: the Partial Thromboplastin Time (PTT), Prothrombin Time (PT), Thrombin Time (TT), or a quantitative fibrinogen determination. The PT test is one in-vitro laboratory test used to assess coagulation. While the PTT assesses the intrinsic limb of the coagulation system, the PT assesses the extrinsic or tissue factor dependent pathway. Both tests also evaluate the common coagulation pathway involving all the reactions that occur after the activation of factor X. Extrinsic pathway factors are produced in the liver and their production is dependent on adequate vitamin K activity. Deficiencies of factors may be related to decreased production or increased consumption of coagulation factors. The PT/INR is most commonly used to measure the effect of warfarin and regulate its dosing. Warfarin blocks the effect of vitamin K on hepatic production of extrinsic pathway factors. A PT is expressed in seconds and/or as an international normalized ratio (INR). The INR is the PT ratio that would result if the WHO reference thromboplastin was used in performing the test. Current medical information does not clarify the role of laboratory PT testing in patients who are self monitoring. Therefore, the indications for testing apply regardless of whether or not the patient is also PT self-testing. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 85610 Prothrombin Time ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 002.0-002.9 Typhoid and paratyphoid 003.0-003.9 Other Salmonella infections 038.9 Unspecified Septicemia 042 Human Immunodeficiency virus (HIV) disease 060.0-060.9 Yellow fever 065.0-065.9 Arthropod-borne hemorrhagic fever 070.0-070.9 Viral hepatitis 075 Infectious mononucleosis 078.6 Hemorrhagic nephrosonephritis

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Code Description 078.7 Arenaviral hemorrhagic fever 084.8 Blackwater fever 120.0 Schistosomiasis 121.1 Clonorchiasis 121.3 Fascioliasis 124 Trichinosis 134.2 Hirudiniasis 135 Sarcoidosis 152.0-152.9 Malignant neoplasm of small intestine, including duodenum 155.0-155.2 Malignant neoplasm of liver and intrahepatic bile ducts 156.0-156.9 Malignant neoplasm of gallbladder and extrahepatic bile ducts 157.0-157.9 Malignant neoplasm of pancreas 188.0-189.9 Malignant neoplasm of bladder, kidney, and other and unspecified urinary organs 197.7 Secondary malignant neoplasm, liver 198.0 Secondary malignant neoplasm, kidney 198.1 Secondary malignant neoplasm, other urinary organs 200.00-200.28 Lymphosarcoma and reticulosarcoma; Burkitt’s tumor or lymphoma 200.30-200.38 Marginal zone lymphoma 200.40-200.48 Mantle cell lymphoma 200.50-200.58 Primary central nervous system lymphoma 200.60-200.68 Anaplastic large cell lymphoma 200.70-200.78 Large cell lymphoma 200.80-200.88 Malignant tumors of lymphatic tissue; other named variants 202.00-202.68 Other malignant neoplasms of lymphoid and histiocytic tissue 202.70-202.78 Peripheral T-cell lymphoma 202.80-202.98 Other lymphomas; other and unspecified malignant neoplasms of lymphoid and histiocytic tissue 209.20-209.27, 209.29 Malignant carcinoid tumors of other and unspecified sites 209.70 Secondary neuroendocrine tumor, unspecified site 209.71 Secondary neuroendocrine tumor of distant lymph nodes 209.72 Secondary neuroendocrine tumor of liver 209.73 Secondary neuroendocrine tumor of bone 209.74 Secondary neuroendocrine tumor of peritoneum 209.75 Secondary Merkel cell carcinoma 209.79 Secondary neuroendocrine tumor of other sites 223.0-223.9 Benign neoplasm of kidney and other urinary organs 238.4 Polycythemia vera 238.5 Histocytic and mast cells – neoplasm of uncertain behavior 238.6 Plasma cells – neoplasm of uncertain behavior 238.71 Essential thrombocythemia 238.72 Low grade myelodysplastic syndrome lesions

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Code Description 238.73 High grade myelodysplastic syndrome lesions 238.74 Myelodysplastic syndrome with 5q deletion 238.75 Myelodysplastic syndrome, unspecified 238.76 Myelofibrosis with myeloid metaplasia 238.77 Post-transplant lymphoproliferative disorder (PTLD) 238.79 Other lymphatic and hematopoietic tissues 239.4 Neoplasm of unspecified nature, bladder 239.5 Neoplasm of unspecified nature, other genitourinary organs 239.9 Neoplasm of unspecified nature, site unspecified 246.3 Hemorrhage and infarction of thyroid 249.40 Secondary diabetes mellitus with renal manifestations, not stated as uncontrolled 249.41 Secondary diabetes mellitus with renal manifestations, uncontrolled 250.40-250.43 Diabetic with renal manifestations 263.0-263.9 Other and unspecified protein/calorie malnutrition 269.0 Deficiency of Vitamin K 269.2 Unspecified vitamin deficiency 273.0-273.3, 273.8-273.9 Disorders of plasma protein metabolism 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 277.1 Disorders of porphyrin metabolism 277.30 Amyloidosis, unspecified 277.31 Familial Mediterranean fever 277.39 Other amyloidosis 280.0 Iron deficiency anemia, secondary to blood loss - chronic 280.9 Iron deficiency anemia, unspecified 281.0 Pernicious anemia 281.1 Other vitamin B12 deficiency anemia, NEC 281.9 Unspecified deficiency anemia, NOS 285.0 Sideroblastic anemia 285.1 Acute posthemorrhagic anemia 286.0-286.9 Coagulation defects 287.0-287.39 Allergic purpura; qualitative platelet defects; other non- thrombocytopenic purpuras; primary thrombocytopenia 287.41 Posttransfusion purpura 287.49 Other secondary thrombocytopenia 287.5-287.9 Thrombocytopenia, unspecified; other specified and unspecified hemorrhagic conditions 289.81 Primary hypercoagulable state

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Code Description 290.40-290.43 Vascular dementia 325 Phlebitis and thrombophlebitis of intracranial venous sinuses 342.90-342.92 Hemiplegia NOS 360.43 Hemophthalmos, except current injury 362.18 Retinal vasculitis 362.30-362.37 Retinal vascular occlusion 362.43 Hemorrhagic detachment of retinal pigment epithelium 362.81 Retinal hemorrhage 363.61-363.72 Choroidal hemorrhage and rupture, detachment 368.9 Unspecified visual disturbances 372.72 Conjunctival hemorrhage 374.81 Hemorrhage of eyelid 376.32 Orbital hemorrhage 377.42 Hemorrhage in optic nerve sheaths 377.53 Disorders of optic chiasm associated with vascular disorders 377.62 Disorders of visual pathways associated with vascular disorders 377.72 Disorders of visual cortex associated with vascular disorders 379.23 Vitreous hemorrhage 380.31 Hematoma of auricle or pinna 386.2 Vertigo of central origin 386.50 Labyrinthine dysfunction, unspecified 394.0-394.9 Diseases of the mitral valve 395.0 Rheumatic aortic stenosis 395.2 Rheumatic aortic stenosis with insufficiency 396.0-396.9 Diseases of mitral and aortic valves 397.0-397.9 Diseases of other endocardial structures 398.0-398.99 Other rheumatic heart disease 403.01, 403.11, 403.91 Hypertensive chronic kidney disease, with chronic kidney disease stage V or end stage renal disease 404.02, 404.12, 404.92 Hypertensive heart and chronic kidney disease, without heart failure and with chronic kidney disease stage V or end stage renal disease 410.00-410.92 Acute myocardial infarction 411.1 Intermediate coronary syndrome 411.81 Coronary occlusion without myocardial infarction 411.89 Other acute and subacute forms of ischemic heart disease 413.0-413.9 Angina pectoris 414.00-414.07 Coronary atherosclerosis 414.3 Coronary atherosclerosis due to lipid rich plaque 414.4 Coronary atherosclerosis due to calcified coronary lesion 414.8 Other specified forms of chronic ischemic heart disease 414.9 Chronic ischemic heart disease, unspecified

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Code Description 415.0 – 415.19 Acute pulmonary heart disease 416.9 Chronic pulmonary heart disease, unspecified 423.0 Hemopericardium 424.0 Mitral valve disorders 424.1 Aortic valve disorder 424.90 Endocarditis, valve unspecified, unspecified cause 425.0, 425.11, 425.18, Cardiomyopathy 425.2-425.9 427.0-427.9 Cardiac dysrhythmias 428.0-428.9 Heart failure 429.0-429.4 Ill-defined descriptions and complications of heart disease 429.79 Other sequelae of myocardial infarction, not elsewhere classified 430 Subarachnoid hemorrhage 431 Intracerebral hemorrhage 432.0-432.9 Other and unspecified intracranial hemorrhage 433.00-433.91 Occlusion and stenosis of precerebral arteries 434.00-434.91 Occlusion of cerebral arteries 435.0-435.9 Transient cerebral ischemia 436 Acute, but ill-defined cerebrovascular disease 437.0 Cerebral atherosclerosis 437.1 Other generalized ischemic cerebrovascular disease 437.6 Nonpyogenic thrombosis of intracranial venous sinus 440.0-440.32 Atherosclerosis of aorta; of other arteries; of bypass grafts 440.4 Chronic total occlusion of artery of the extremities 440.8-440.9 Atherosclerosis of other specified arteries; generalized and unspecified atherosclerosis 441.0-441.9 Aortic aneurysm and dissection 443.0-443.9 Other peripheral vascular disease 444.01, 444.09, 444.1-444.9 Arterial embolism and thrombosis 447.1 Stricture of artery 447.2 Rupture of artery 447.6 Arteritis, unspecified 448.0 Hereditary hemorrhagic telangiectasia 448.9 Other and unspecified capillary diseases 451.0-451.9 Phlebitis and thrombophlebitis 452 Portal vein thrombosis 453.0 Budd-Chiari syndrome 453.1 Thrombophlebitis migrans 453.2 Embolism and thrombosis of inferior vena cava 453.3 Embolism and thrombosis of renal vein

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Code Description 453.40 Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.41 Acute venous embolism and thrombosis of deep vessels of proximal lower extremity 453.42 Acute venous embolism and thrombosis of deep vessels of distal lower extremity 453.50 Chronic venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.51 Chronic venous embolism and thrombosis of deep vessels of proximal lower extremity 453.52 Chronic venous embolism and thrombosis of deep vessels of distal lower extremity 453.6 Venous embolism and thrombosis of superficial vessels of lower extremity 453.71 Chronic venous embolism and thrombosis of superficial veins of upper extremity 453.72 Chronic venous embolism and thrombosis of deep veins of upper extremity 453.73 Chronic venous embolism and thrombosis of upper extremity, unspecified 453.74 Chronic venous embolism and thrombosis of axillary veins 453.75 Chronic venous embolism and thrombosis of subclavian veins 453.76 Chronic venous embolism and thrombosis of internal jugular veins 453.77 Chronic venous embolism and thrombosis of other thoracic veins 453.79 Chronic venous embolism and thrombosis of other specified veins 453.81 Acute venous embolism and thrombosis of superficial veins of upper extremity 453.82 Acute venous embolism and thrombosis of deep veins of upper extremity Acute venous embolism and thrombosis of upper extremity, 453.83 unspecified 453.84 Acute venous embolism and thrombosis of axillary veins 453.85 Acute venous embolism and thrombosis of subclavian veins 453.86 Acute venous embolism and thrombosis of internal jugular veins 453.87 Acute venous embolism and thrombosis of other thoracic veins 453.89 Acute venous embolism and thrombosis of other specified veins 453.9 Other venous embolism and thrombosis of unspecified site 455.2 Internal hemorrhoids with other complication 455.5 External hemorrhoids with other complication 455.8 Unspecified hemorrhoids with other complication 456.0-456.1 Esophageal varices 456.8 Varices of other sites 459.0 Hemorrhage, unspecified 459.10-459.19 Postphlebetic syndrome

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Code Description 459.2 Compression of vein 459.81 Venous (peripheral) insufficiency, unspecified 459.89 Other, other specified disorders of circulatory system 511.81 Malignant pleural effusion 511.89 Other specified forms of effusion, except tuberculosis 514 Pulmonary congestion and hypostasis 530.7 Gastroesophageal laceration - hemorrhage syndrome 530.82 Esophageal hemorrhage 530.86 Infection of esophagostomy 530.87 Mechanical complication of esophagostomy 531.00-535.61 Gastric ulcer, duodenal ulcer, peptic ulcer, gastrojejunal ulcer, gastritis and duodenitis 535.70 Eosinophilic gastritis, without mention of obstruction 535.71 Eosinophilic gastritis, with obstruction 555.0-555.9 Regional enteritis 556.0-556.9 Ulcerative colitis 557.0-557.9 Vascular insufficiency of intestine 562.02-562.03 Diverticulosis of small intestine with hemorrhage 562.10 Diverticulosis of colon w/o hemorrhage 562.11 Diverticulitis of colon w/o hemorrhage 562.12 Diverticulosis of colon with hemorrhage 562.13 Diverticulitis of colon with hemorrhage 568.81 Hemoperitoneum (nontraumatic) 569.3 Hemorrhage of rectum and anus 571.0-571.9 Chronic liver disease and cirrhosis 572.2 Hepatic encephalopathy 572.4 Hepatorenal syndrome 572.8 Other sequelae of chronic liver disease 573.1-573.9 Hepatitis in viral diseases, other and unspecified disorder of liver 576.0-576.9 Other disorders of Biliary tract 577.0 Acute pancreatitis 578.0-578.9 Gastrointestinal hemorrhage 579.0-579.9 Intestinal Malabsorption 581.0-581.9 Nephrotic Syndrome 583.9 Nephritis, with unspecified pathological lesion in kidney 584.5 Acute kidney failure with lesion of tubular necrosis 584.6 Acute kidney failure with lesion of renal cortical necrosis 584.7 Acute kidney failure with lesion of renal medullary (papillary) necrosis 584.8 Acute kidney failure with other specified pathological lesion in kidney 584.9 Acute kidney failure, unspecified

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Code Description 585.4-585.9 Chronic kidney disease 586 Renal failure, unspecified 593.81-593.89 Other specified disorders of kidney and ureter 596.7 Hemorrhage into bladder wall 596.81 Infection of cystostomy 596.82 Mechanical complication of cystostomy 596.83 Other complication of cystostomy 596.89 Other specified disorders of bladder 599.70 Hematuria, unspecified 599.71 Gross hematuria 599.72 Microscopic hematuria 607.82 Vascular disorders of penis 608.83 Vascular disorders of male genital organs 611.89 Other specified disorders of breast including hematoma 620.7 Hematoma of broad ligament 621.4 Hematometra 622.8 Other specified noninflammatory disorders of cervix 623.6 Vaginal hematoma 623.8 Other specified noninflammatory disorders of the vagina 624.5 Hematoma of vulva 626.2-626.9 Abnormal bleeding from female genital tract 627.0 Premenopausal menorrhagia 627.1 Postmenopausal bleeding 629.0 Hematocele female, not classified elsewhere 632 Missed abortion 634.10-634.12 Spontaneous abortion, complicated by excessive hemorrhage 635.10-635.12 Legally induced abortion, complicated by delayed or excessive hemorrhage 636.10-636.12 Illegally induced abortion, complicated by delayed or excessive hemorrhage 637.10-637.12 Abortion unspecified, complicated by delayed or excessive hemorrhage 638.1 Failed attempted abortion, complicated by delayed or excessive hemorrhage 639.1 Delayed or excessive hemorrhage following abortion and ectopic and molar pregnancies 639.6 Complications following abortion and ectopic and molar pregnancies with embolism 640.00-640.93 Hemorrhage in early pregnancy 641.00-641.93 Antepartum hemorrhage, abruptio placentae, and placenta previa 642.00-642.94 Hypertension complicating pregnancy, childbirth, and the puerperium 646.70-646.73 Liver disorders in pregnancy

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Code Description 649.30 Coagulation defects complicating pregnancy, childbirth, or the puerperium, unspecified as to episode of care or not applicable 649.31 Coagulation defects complicating pregnancy, childbirth, or the puerperium, delivered, with or without mention of antepartum condition 649.32 Coagulation defects complicating pregnancy, childbirth, or the puerperium, delivered, with mention of postpartum complication 649.33 Coagulation defects complicating pregnancy, childbirth, or the puerperium, antepartum condition or complication 649.34 Coagulation defects complicating pregnancy, childbirth, or the puerperium, postpartum condition or complication 649.50 Spotting complicating pregnancy, unspecified as to episode of care or not applicable 649.51 Spotting complicating pregnancy, delivered, with or without mention of antepartum condition 649.53 Spotting complicating pregnancy, antepartum condition or complication 656.00-656.03 Fetal maternal hemorrhage 658.40-658.43 Infection of amniotic cavity 666.00-666.34 Postpartum hemorrhage 671.20-671.94 Venous complications in pregnancy and the puerperium except legs, vulva and perineum 673.00-673.84 Obstetrical pulmonary embolism 674.30-674.34 Other complications of obstetrical surgical wounds 713.2 Arthropathy associated with hematological disorders 713.6 Arthropathy associated with hypersensitivity reaction 719.15 Hemarthrosis pelvic region and thigh 719.16 Lower leg 719.19 Multiple sites 729.5 Pain in limb 729.81 Swelling of limb 733.10 Pathologic fracture, unspecified site 746.00-746.9 Other Congenital anomalies of heart 762.1 Other forms of placental separation and hemorrhage 767.0, 767.11 Birth trauma, subdural and cerebral hemorrhage and injury to scalp 767.8 Other specified birth trauma 770.3 Pulmonary hemorrhage 772.0 Fetal blood loss affecting newborn 772.10-772.14 Fetal and neonatal intraventricular hemorrhage 772.2 Fetal and neonatal subarachnoid hemorrhage 772.3 Fetal and neonatal umbilical hemorrhage after birth 772.4 Fetal and neonatal gastrointestinal hemorrhage 772.5 Fetal and neonatal adrenal hemorrhage 772.6 Fetal and neonatal cutaneous hemorrhage 772.8 Fetal and neonatal other specified hemorrhage of fetus or newborn

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Code Description 772.9 Fetal and neonatal unspecified hemorrhage of newborn 774.6 Unspecified fetal and neonatal jaundice 776.0 Hemorrhagic disease of the newborn 776.1 Transient neonatal thrombocytopenia 776.2 Disseminated intravascular coagulation in newborn 776.3 Other transient neonatal disorders of coagulation 776.4 Polycythemia neonatorum 776.5 Congenital anemia 776.6 Anemia of prematurity 776.7 Transient neonatal neutropenia 776.8 Other specified transient hematological disorders 776.9 Unspecified hematological disorder specific to newborn 780.2 Syncope and collapse 782.3 Edema 782.4 Jaundice, unspecified, not of newborn 782.7 Spontaneous ecchymosis 784.7 Epistaxis 784.8 Hemorrhage from throat 785.4 Gangrene 785.50 Shock without mention of trauma 786.05 Shortness of breath 786.30 Hemoptysis, unspecified 786.31 Acute idiopathic pulmonary hemorrhage in infants (AIPHI) 786.39 Other hemoptysis 786.50 Chest pain, unspecified 786.51 Precordial pain 786.59 Chest pain, other 789.00-789.09 Abdominal pain 789.1 Hepatomegaly 789.51 Malignant ascites 789.59 Other ascites 789.7 Colic 790.92 Abnormal coagulation profile 790.94 Euthyroid sick syndrome 791.2 Hemoglobinuria 794.8 Abnormal Liver Function Study 800.00-800.99 Fracture of vault of skull 801.00-801.99 Fracture of base of skull 802.20-802.9 Fracture of face bones 803.00-803.99 Other and unqualified skull fractures 804.00-804.99 Multiple fractures involving skull or face with other bones

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Code Description 805.00-806.9 Fracture, vertebral column 807.00-807.09 Fractures of rib(s), closed 807.10-807.19 Fracture of rib(s), open 808.8-808.9 Unspecified fracture of pelvis 809.0-809.1 Ill-defined fractures of bones of trunk 810.00-810.13 Fracture of clavicle 811.00-811.19 Fracture of scapula 812.00-812.59 Fracture of humerus 813.10-813.18 Fracture of radius and ulna, upper end, open 813.30-813.33 Shaft, open 813.50-813.54 Lower end, open 813.90-813.93 Fracture unspecified part, open 819.0-819.1 Multiple fractures involving both upper limbs, closed and open 820.00-821.39 Fracture of neck of femur 823.00-823.92 Fracture of tibia and fibula 827.0-829.1 Other multiple lower limb 852.00-853.19 Subarachnoid subdural, and extradural hemorrhage, following injury, Other and specified intracranial hemorrhage following injury 860.0-860.5 Traumatic pneumothorax and hemothorax 861.00-861.32 Injury to heart and lung 862.0-862.9 Injury to other and unspecified intrathoracic organs 863.0-863.90 Injury to gastrointestinal tract 863.91-863.95, 863.99 Adding to Injury to gastrointestinal tract 864.00-864.19 Injury to liver 865.00-865.19 Injury to spleen 866.00-866.13 Injury to kidney 867.0-867.9 Injury to pelvic organs 868.00-868.19 Injury to other intra-abdominal organs 869.0-869.1 Internal injury to unspecified or ill defined organs 900.00-900.9 Injury to blood vessels of head and neck 901.0-901.9 Injury to blood vessels of the thorax 902.0-902.9 Injury to blood vessels of the abdomen and pelvis 903.00-903.9 Injury to blood vessels of upper extremity 904.0-904.9 Injury to blood vessels of lower extremity and unspecified sites 920-924.9 Contusion with intact skin surface 925.1-929.9 Crushing injury 958.2 Secondary and recurrent hemorrhage 959.9 Injury, unspecified site 964.0-964.9 Poisoning by agents primarily affecting blood constituents 980.0-980.9 Toxic effect of alcohol 981 Toxic effect of petroleum products

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Code Description 982.0-982.8 Toxic effects of solvents other than petroleum-based 987.0-987.9 Toxic effect of other gases, fumes or vapors 989.0-989.9 Toxic effect of other substances chiefly non-medicinal as to source 995.20 Unspecified adverse effect of unspecified drug, medicinal and biological substance 995.21 Arthus phenomenon 995.24 Failed moderate sedation during procedure 995.27 Other drug allergy 995.29 Unspecified adverse effect of other drug, medicinal & biological substance 996.82 Complication of transplanted liver 997.02 Iatrogenic cerebrovascular infarction or hemorrhage 997.41 Retained cholelithiasis following cholecystectomy 997.49 Other digestive system complications 998.11-998.12 Hemorrhage or hematoma complicating a procedure 999.2 Other vascular complications 999.80 Transfusion reaction, unspecified 999.83 Hemolytic transfusion reaction, incompatibility unspecified 999.84 Acute hemolytic transfusion reaction, incompatibility unspecified 999.85 Delayed hemolytic transfusion reaction, incompatibility unspecified 999.89 Other transfusion reaction V08 Asymptomatic HIV infection V12.1 History of nutritional deficiency V12.3 Personal history of diseases of blood and blood-forming organs V12.50-V12.55, V12.59 Personal history of transient ischemic attack, cerebral infarction, or pulmonary embolism without residual deficits V15.1 Personal history of surgery to heart and great vessels V15.21 Personal history of undergoing in utero procedure during pregnancy V15.22 Personal history of undergoing in utero procedure while a fetus V15.29 Surgery to other organs V42.0 Kidney replaced by transplant V42.1 Heart replaced by transplant V42.2 Heart valve replaced by transplant V42.6 Lung replaced by transplant V42.7 Liver replaced by transplant V42.81-V42.89 Other specified organ or tissue replaced by transplant V43.21-V43.22 Heart replaced by other means V43.3 Heart valve replaced by other means V43.4 Blood vessel replaced by other means V58.2 Transfusion of blood products V58.61 Long-term (current) use of anticoagulants V58.83 Encounter for therapeutic drug monitoring

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Indications 1. A PT may be used to assess patients taking warfarin. The PT is generally not useful in monitoring patients receiving heparin who are not taking warfarin. 2. A PT may be used to assess patients with signs or symptoms of abnormal bleeding or thrombosis. For example:  Swollen extremity with or without prior trauma  Unexplained bruising  Abnormal bleeding, hemorrhage or hematoma  Petechiae or other signs of thrombocytopenia that could be due to Disseminated Intravascular Coagulation 3. A PT may be useful in evaluating patients who have a history of a condition known to be associated with the risk of bleeding or thrombosis that is related to the extrinsic coagulation pathway. Such abnormalities may be genetic or acquired. For example:  Dysfibrinogenemia  Afibrinogenemia (complete)  Acute or chronic liver dysfunction or failure, including Wilson’s disease and Hemochromatosis  Disseminated intravascular coagulation (DIC)  Congenital and acquired deficiencies of factors II, V, VII, X  Vitamin K deficiency  Lupus erythematosus  Hypercoagulable state  Paraproteinemia  Lymphoma  Amyloidosis  Acute and chronic leukemias  Plasma cell dyscrasia  HIV infection  Malignant neoplasms  Hemorrhagic fever  Salicylate poisoning  Obstructive jaundice  Intestinal fistula  Malabsorption syndrome  Colitis  Chronic diarrhea  Presence of peripheral venous or arterial thrombosis or pulmonary emboli or myocardial infarction

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 Patients with bleeding or clotting tendencies  Organ transplantation  Presence of circulating coagulation inhibitors 4. A PT may be used to assess the risk of hemorrhage or thrombosis in patients who are going to have a medical intervention known to be associated with increased risk of bleeding or thrombosis. For example:  Evaluation prior to invasive procedures or operations of patients with personal history of bleeding or a condition associated with coagulopathy.  Prior to the use of thrombolytic medication Limitations 1. When an ESRD patient is tested for PT, testing more frequently than weekly requires documentation of medical necessity, e.g., other than chronic renal failure or renal failure unspecified. 2. The need to repeat this test is determined by changes in the underlying medical condition and/or the dosing of warfarin. In a patient on stable warfarin therapy, it is ordinarily not necessary to repeat testing more than every two to three weeks. When testing is performed to evaluate a patient with signs or symptoms of abnormal bleeding or thrombosis and the initial test result is normal, it is ordinarily not necessary to repeat testing unless there is a change in the patient’s medical status. 3. Since the INR is a calculation, it will not be paid in addition to the PT when expressed in seconds, and is considered part of the conventional PT test. 4. Testing prior to any medical intervention associated with a risk of bleeding and thrombosis (other than thrombolytic therapy) will generally be considered medically necessary only where there are signs or symptoms of a bleeding or thrombotic abnormality or a personal history of bleeding, thrombosis or a condition associated with a coagulopathy. Hospital/clinic-specific policies, protocols, etc., in and of themselves, cannot alone justify coverage. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information CMD Clinical Laboratory Workgroup 1999 CPT Physicians’ Current Procedural Terminology, American Medical Association Wintrobe’s Clinical Hematology 9th Ed. Lea and Febinger Harrison’s Principles of Internal Medicine, McGraw Hill, 14th Ed., 1997. Diagnostic Tests Handbook, Springhouse Corporation, 1987. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. Colman, et al editors, J.B. Lippincott, 3rd Edition, 1994, pp 896-898 and 1045-1046. Disorders of Hemostasis, Ratnoff, Oscar D. and Forbes, Charles D., W.B. Saunders Co. 1996. Merck Manual of Diagnosis and Therapy, 16th Edition (should be replaced w/17th Edition 1999.)

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“Performance of the Coumatrak System at a Large Anticoagulation Clinic”. Coagulation and Transfusion Medicine. January 1995. p. 98-102. “Monitoring Oral Anticoagulation Therapy with Point-of-Care Devices. Correlation and Caveats”. Clinical Chemistry: No. 9, 1997, p1785-1786. “College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy”. Arch.Pathol.Lab.Med. Vol.122. September 1998. p. 768-780. “A Structured Teaching and Self-management Program for Patients Receiving Oral Anti- coagulation”. JAMA; 1999; 281: 145-150.

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190.18 - Serum Iron Studies

Previously Listed as Edit 7 Description Serum iron studies are useful in the evaluation of disorders of iron metabolism, particularly iron deficiency and iron excess. Iron studies are best performed when the patient is fasting in the morning and has abstained from medications that may influence iron balance. Iron deficiency is the most common cause of anemia. In young children on a milk diet, iron deficiency is often secondary to dietary deficiency. In adults, iron deficiency is usually the result of blood loss and is only occasionally secondary to dietary deficiency or malabsorption. Following major surgery the patient may have iron deficient erythropoietin for months or years if adequate iron replacement has not been given. High doses of supplemental iron may cause the serum iron to be elevated. Serum iron may also be altered in acute and chronic inflammatory and neoplastic conditions.

Total Iron Binding Capacity (TIBC) is an indirect measure of transferring, a protein that binds and transports iron. TIBC quantifies transferring by the amount of iron that it can bind. TIBC and transferring are elevated in iron deficiency, and with oral contraceptive use, and during pregnancy. TIBC and transferring may be decreased in malabsorption syndromes or in those affected with chronic diseases. The percent saturation represents the ratio of iron to the TIBC.

Assays for ferreting are also useful in assessing iron balance. Low concentrations are associated with iron deficiency and are highly specific. High concentrations are found in hemosiderosis (iron overload without associated tissue injury) and hemochromatosis (iron overload with associated tissue injury). In these conditions the iron is elevated, the TIBC and transferrin are within the reference range or low, and the percent saturation is elevated. Serum ferritin can be useful for both initiating and monitoring treatment for iron overload.

Transferrin and ferritin belong to a group of serum proteins known as acute phase reactants, and are increased in response to stressful or inflammatory conditions and also can occur with infection and tissue injury due to surgery, trauma or necrosis. Ferritin and iron/TIBC (or transferrin) are affected by acute and chronic inflammatory conditions, and in patients with these disorders, tests of iron status may be difficult to interpret.

HCPCS Codes (Alphanumeric, CPT AMA) Code Description 82728 Ferritin 83540 Iron 83550 Iron Binding capacity 84466 Transferrin

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ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 002.0-002.9 Typhoid and paratyphoid fevers 003.0-003.9 Other salmonella infections 006.0-006.9 Amebiasis 007.0-007.9 Other protozoal intestinal diseases 008.00 Intestinal infections due to Escherichia coli [E. coli], unspecified 008.01 Intestinal infections due to enteropathogenic E. coli 008.02 Intestinal infections due to enterotoxigenic E. coli 008.03 Intestinal infections due to enteroinvasive E. coli 008.04 Intestinal infections due to enterohemorrhagic E. coli 008.09 Intestinal infections due to other intestinal E. coli organisms 008.1 Intestinal infections due to Arizona group of paracolon bacilli 008.2 Intestinal infections due to Aerobacter aerogenes 008.3 Intestinal infections due to Proteus (mirabilis) (morganii) 008.41 Intestinal infections due to Staphylococcus 008.42 Intestinal infections due to Pseudomonas 008.43 Intestinal infections due to Campylobacter 008.44 Intestinal infections due to Yersinia enterocolitis 008.45 Intestinal infections due to Clostridium difficile 008.46 Intestinal infections due to other anaerobes 008.47 Intestinal infections due to other gram-negative bacteria 008.49 Intestinal infections due to other bacteria 008.5 Bacterial enteritis, unspecified 008.61 Enteritis due to Rotavirus 008.62 Enteritis due to Adenovirus 008.63 Enteritis due to Norwalk virus 008.64 Enteritis due to other small round viruses (SRVs) 008.65 Enteritis due to Calicivirus 008.66 Enteritis due to Astrovirus 008.67 Enteritis due to Enterovirus, not elsewhere classified 008.69 Other viral enteritis 008.8 Intestinal infections due to other organisms, not elsewhere classified 009.0-009.3 Ill-defined intestinal infections 011.50-011.56 Tuberculous bronchiectasis 014.00-014.86 Tuberculosis of intestines, peritoneum, and mesenteric glands 015.00-015.96 Tuberculosis of bones and joints 016.00-016.06 Tuberculosis of kidney

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Code Description 016.10-016.16 Tuberculosis of bladder 016.20-016.26 Tuberculosis of ureter 016.30-016.36 Tuberculosis of other urinary organs 042 Human Immunodeficiency virus (HIV) disease 070.0-070.9 Viral hepatitis 140.0-149.9 Malignant neoplasm of lip oral cavity and pharynx 150.0-159.9 Malignant neoplasm of digestive organs and peritoneum 160.0-165.9 Malignant neoplasm of respiratory and intrathoracic organs 170.0-176.9 Malignant neoplasm of bone, connective tissue, skin and breast 179-189.9 Malignant neoplasm of genitourinary organs 190.0-199.1 Malignant neoplasm of other and unspecified sites 199.2 Malignant neoplasm associated with transplanted organ 200.00-200.28 Lymphosarcoma and reticulosarcoma; Burkitt’s tumor or lymphoma 200.30-200.38 Marginal zone lymphoma 200.40-200.48 Mantle cell lymphoma 200.50-200.58 Primary central nervous system lymphoma 200.60-200.68 Anaplastic large cell lymphoma 200.70-200.78 Large cell lymphoma 200.80-200.88 Malignant tumors of lymphatic tissue; other named variants 201.00-201.98 Hodgkin’s disease 202.00-202.68 Other malignant neoplasms of lymphoid and histiocytic tissue 202.70-202.78 Peripheral T-cell lymphoma 202.80-202.98 Other lymphomas; other and unspecified malignant neoplasms of lymphoid and histiocytic tissue 203.00-203.01 Multiple myeloma, without mention of having achieved remission and in remission 203.02 Multiple myeloma, in relapse 203.10-203.11 Plasma cell leukemia, without mention of having achieved remission and in remission 203.12 Plasma cell leukemia, in relapse 203.80-203.81 Other immunoproliferative neoplasms, without mention of having achieved remission and in remission 203.82 Other immunoproliferative neoplasms, in relapse 204.00-204.01 Acute lymphoid leukemia, without mention of having achieved remission and in remission 204.02 Acute lymphoid leukemia, in relapse 204.10-204.11 Chronic lymphoid leukemia, without mention of having achieved remission and in remission 204.12 Chronic lymphoid leukemia, in relapse 204.20-204.21 Subacute lymphoid leukemia, without mention of having achieved remission and in remission 204.22 Subacute lymphoid leukemia, in relapse

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Code Description 204.80-204.81 Other lymphoid leukemia, without mention of having achieved remission and in remission 204.82 Other lymphoid leukemia, in relapse 204.90-204.91 Unspecified lymphoid leukemia, without mention of having achieved remission and in remission 204.92 Unspecified lymphoid leukemia, in relapse 205.00-205.01 Acute myeloid leukemia, without mention of having achieved remission and in remission 205.02 Acute myeloid leukemia, In relapse 205.10-205.11 Chronic myeloid leukemia, without mention of having achieved remission and in remission 205.12 Chronic myeloid leukemia, in relapse 205.20-205.21 Subacute myeloid leukemia, without mention of having achieved remission and in remission 205.22 Subacute myeloid leukemia, in relapse 205.30-205.31 Myeloid sarcoma, without mention of having achieved remission and in remission 205.32 Myeloid sarcoma, in relapse 205.80-205.81 Other myeloid leukemia, without mention of having achieved remission and in remission 205.82 Other myeloid leukemia, in relapse 205.90-205.91 Unspecified myeloid leukemia, without mention of having achieved remission and in remission 205.92 Unspecified myeloid leukemia, in relapse 206.00-206.01 Acute monocytic leukemia, without mention of having achieved remission and in remission 206.02 Acute monocytic leukemia, in relapse 206.10-206.11 Chronic monocytic leukemia, without mention of having achieved remission and in remission 206.12 Chronic monocytic leukemia, in relapse 206.20-206.21 Subacute monocytic leukemia, without mention of having achieved remission and in remission 206.22 Subacute monocytic leukemia, in relapse 206.80-206.81 Other monocytic leukemia, without mention of having achieved remission and in remission 206.82 Other monocytic leukemia, in relapse 206.90-206.91 Unspecified monocytic leukemia, without mention of having achieved remission and in remission 206.92 Unspecified monocytic leukemia, in relapse 207.00-207.01 Acute erythremia and erythroleukemia, without mention of having achieved remission and in remission 207.02 Acute erythremia and erythroleukemia, in relapse

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Code Description 207.10-207.11 Chronic erythremia, without mention of having achieved remission and in remission 207.12 Chronic erythremia, in relapse 207.20-207.21 Megakaryocytic leukemia, without mention of having achieved remission and in remission 207.22 Megakaryocytic leukemia, in relapse 207.80-207.81 Other specified leukemia, without mention of having achieved remission and in remission 207.82 Other specified leukemia, in relapse 208.00-208.01 Acute leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.02 Acute leukemia of unspecified cell type, in relapse 208.10-208.11 Chronic leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.12 Chronic leukemia of unspecified cell type, in relapse 208.20-208.21 Subacute leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.22 Subacute leukemia of unspecified cell type, In relapse 208.80-208.81 Other leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.82 Other leukemia of unspecified cell type, in relapse 208.90-208.91 Unspecified leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.92 Unspecified leukemia of unspecified cell type, in relapse 209.00-209.03 Malignant carcinoid tumors of the small intestine 209.10-209.17 Malignant carcinoid tumors of the appendix, large intestine and rectum 209.20-209.27, 209.29 Malignant carcinoid tumors of other and unspecified sites 209.30 Malignant poorly differentiated neuroendocrine tumor, any site 209.31 Merkel cell carcinoma of the face 209.32 Merkel cell carcinoma of the scalp and neck 209.33 Merkel cell carcinoma of the upper limb 209.34 Merkel cell carcinoma of the lower limb 209.35 Merkel cell carcinoma of the trunk 209.36 Merkel cell carcinoma of other sites 209.40-209.43 Benign carcinoid tumors of the small intestine 209.50-209.57 Benign carcinoid tumors of the appendix, large intestine and rectum 209.60-209.67, 209.69 Benign carcinoid tumor of other and unspecified sites 209.70 Secondary neuroendocrine tumor, unspecified site 209.71 Secondary neuroendocrine tumor of distant lymph nodes 209.72 Secondary neuroendocrine tumor of liver 209.73 Secondary neuroendocrine tumor of bone

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Code Description 209.74 Secondary neuroendocrine tumor of peritoneum 209.75 Secondary Merkel cell carcinoma 209.79 Secondary neuroendocrine tumor of other sites 210.0-229.9 Benign neoplasms 230.0-233.2 Carcinoma in situ (various) 233.30 Carcinoma in situ, unspecified female genital organ 233.31 Carcinoma in situ, vagina 233.32 Carcinoma in situ, vulva 233.39 Carcinoma in situ, other female genital organ 233.4-234.9 Carcinoma in situ (various) 235.0-235.9 Neoplasms of uncertain behavior of digestive and respiratory systems 236.0-236.99 Neoplasms of uncertain behavior of genitourinary organs 237.0-237.72 Neoplasms of uncertain behavior of endocrine glands and nervous system 237.73 Schwannomatosis 237.79 Other neurofibromatosis 237.9 Other and uncertain parts of the nervous system 238.0-238.6 Neoplasms of uncertain behavior of other and unspecified sites and tissues 238.71-238.76 Neoplasms of other lymphatic and hematopoietic tissues 238.77 Post-transplant lymphoproliferative disorder (PTLD) 238.79, 238.8, 238.9 Neoplasms of uncertain behavior 239.0-239.7 Neoplasms of unspecified nature 239.81 Neoplasms of unspecified nature, retina and choroid 239.89 Neoplasms of unspecified nature, other specified sites 239.9 Neoplasms of unspecified nature, site unspecified 249.00-249.01 Secondary diabetes mellitus without mention of complication 249.10-249.11 Secondary diabetes mellitus with ketoacidosis 249.20-249.21 Secondary diabetes mellitus with hyperosmolarity 249.30-249.31 Secondary diabetes mellitus with other coma 249.40-249.41 Secondary diabetes mellitus with renal manifestations 249.50-249.51 Secondary diabetes mellitus with ophthalmic manifestations 249.60-249.61 Secondary diabetes mellitus with neurological manifestations 249.70-249.71 Secondary diabetes mellitus with peripheral circulatory disorders 249.80-249.81 Secondary diabetes mellitus with other specified manifestations 249.90-249.91 Secondary diabetes mellitus with unspecified complication 250.00-250.93 Diabetes mellitus 253.2 Panhypopituitarism 253.7 Iatrogenic pituitary disorders 253.8 Other disorders of the pituitary and other syndromes of diencephalohypophysial origin

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Code Description 256.31-256.39 Other ovarian failure 257.2 Other testicular hypofunction 260 Kwashiorkor 261 Nutritional marasmus 262 Other severe protein-calorie malnutrition 263.0-263.9 Other and unspecified protein-calorie malnutrition 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 277.1 Disorders of porphyrin metabolism 280.0-280.9 Iron deficiency anemias 281.0-281.9 Other deficiency anemias 282.40-282.49 Thalassemias 282.60-282.63 Sickle-cell diseases 282.64 Sickle-cell/Hgb C disease with crisis 282.68 Other sickle-cell disease without crisis 282.69 Other sickle-cell disease with crisis 285.0 Sideroblastic anemia (includes hemochromatosis with refractory anemia) 285.1 Acute post-hemorrhagic anemia 285.3 Antineoplastic chemotherapy induced anemia 285.21 Anemia in chronic kidney disease 285.22 Anemia in neoplastic disease 285.29 Anemia of other chronic disease 285.9 Anemia, unspecified 286.0-286.9 Coagulation defects (congenital factor disorders) 287.0-287.39 Allergic purpura; qualitative platelet defects; other non- thrombocytopenic purpuras; primary thrombocytopenia 287.41 Posttransfusion purpura 287.49 Other secondary thrombocytopenia 287.5-287.9 Thrombocytopenia, unspecified; other specified and unspecified hemorrhagic conditions 289.52 Splenic sequestration 306.4 Physiological malfunction arising from mental factors, gastrointestinal 307.1 Anorexia nervosa 307.50-307.59 Other and unspecified disorders of eating 403.01 Hypertensive chronic kidney disease, malignant, with chronic kidney disease stage V or end stage renal 403.11 Hypertensive chronic kidney disease, benign, with chronic kidney disease stage V or end stage renal disease

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Code Description 403.91 Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage V or end stage renal disease 404.02 Hypertensive heart & chronic kidney disease, malignant, without heart failure & with chronic kidney disease stage V or end stage renal disease 404.03 Hypertensive heart & chronic kidney disease, malignant, with heart failure & with chronic kidney disease stage Or end stage renal disease 404.12 Hypertensive heart & chronic kidney disease, benign, without heart failure & with chronic kidney disease stage Or end stage renal disease 404.13 Hypertensive heart and chronic kidney disease, benign, with heart failure & chronic kidney disease stage V or end stage renal disease 404.92 Hypertensive heart and chronic kidney disease, unspecified, without heart failure & with chronic kidney disease stage V or end stage renal disease 404.93 Hypertensive heart and chronic kidney disease, unspecified, with heart failure and chronic kidney disease stage V or end stage renal disease 425.4 Other primary cardiomyopathies 425.5 Alcoholic cardiomyopathy 425.7 Nutritional and metabolic cardiomyopathy 425.8 Cardiomyopathy in other diseases classified elsewhere 425.9 Secondary cardiomyopathy, unspecified 426.0-426.81, 426.89, 426.9 Conduction disorders 427.0-427.9 Cardiac dysrhythmias 428.0-428.9 Heart failure 530.7 Gastroesophageal laceration-hemorrhage syndrome 530.82 Esophageal hemorrhage 531.00-531.91 Gastric ulcer 532.00-532.91 Duodenal ulcer 533.00-533.91 Peptic ulcer, site unspecified 534.00-534.91 Gastrojejunal ulcer 535.00-535.61 Gastritis and duodenitis 535.70 Eosinophilic gastritis, without mention of obstruction 535.71 Eosinophilic gastritis, with obstruction 536.0-536.9 Disorders of function of stomach 537.83 Angiodysplasia of stomach and duodenum with hemorrhage 537.84 Dieulafoy lesion (hemorrhagic) of stomach and duodenum 555.0-555.9 Regional enteritis 556.0-556.9 Ulcerative colitis 557.0 Acute vascular insufficiency of intestine 557.1 Chronic vascular insufficiency of intestine 562.02 Diverticulosis of small intestine with hemorrhage 562.03 Diverticulitis of small intestine with hemorrhage 562.12 Diverticulosis of colon with hemorrhage

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Code Description 562.13 Diverticulitis of colon with hemorrhage 569.3 Hemorrhage of rectum and anus 569.85 Angiodysplasia of intestine with hemorrhage 569.86 Dieulafoy lesion (hemorrhagic) of intestine 569.87 Vomiting of fecal matter 570 Acute and subacute necrosis of liver 571.0-571.9 Chronic liver disease and cirrhosis 572.0 Abscess of liver 572.1 Portal pyemia 572.2 Hepatic encephalopathy 572.3 Portal hypertension 572.4 Hepatorenal syndrome 572.8 Other sequelae of chronic liver disease 573.0-573.9 Other disorders of liver 578.0-578.9 Gastrointestinal hemorrhage 579.0-579.3 Intestinal malabsorption 579.8-579.9 Other specified and unspecified intestinal malabsorption 581.0-581.9 Nephrotic syndrome 585.4-585.9 Chronic kidney disease 586 Renal failure, unspecified 608.3 Atrophy of testis 626.0-626.9 Disorders of menstruation and other abnormal bleeding from female genital tract 627.0 Premenopausal menorrhagia 627.1 Postmenopausal bleeding 648.20-648.24 Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium: Anemia 698.0-698.9 Pruritus and related conditions 704.00-704.09 Alopecia 709.00-709.09 Dyschromia 713.0 Arthropathy associated with other endocrine and metabolic disorders 716.40-716.99 Other and unspecified arthropathies 719.40-719.49 Pain in joint 773.2 Hemolytic disease due to other and unspecified isoimmunization 773.3 Hydrops fetalis due to isoimmunization 773.4 Kernicterus due to isoimmunization 773.5 Late anemia due to isoimmunization 783.9 Other symptoms concerning nutrition, metabolism and development 790.01-790.09 Abnormality of red blood cells 790.4 Nonspecific elevation of levels of transaminase or lactic acid dehydrogenase [LDH]

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Code Description 790.5 Other nonspecific abnormal serum enzyme levels 790.6 Other abnormal blood chemistry 799.4 Cachexia 964.0 Poisoning by agents primarily affecting blood constituents, iron compounds 984.0-984.9 Toxic effect of lead and its compounds (including fumes) 996.85 Complications of transplanted organ, bone marrow 999.80 Transfusion reaction, unspecified 999.83 Hemolytic transfusion reaction, incompatibility unspecified 999.84 Acute hemolytic transfusion reaction, incompatibility unspecified 999.85 Delayed hemolytic transfusion reaction, incompatibility unspecified 999.89 Other transfusion reaction V08 Asymptomatic HIV infection V12.1 Personal history of nutritional deficiency V12.3 Personal history of diseases of blood and blood forming organs V15.1 Personal history of surgery to heart and great vessels V15.21 Personal history of undergoing in utero procedure during pregnancy V15.22 Personal history of undergoing in utero procedure while a fetus V15.29 Surgery to other organs V43.21-V43.22 Heart replaced by other means V43.3 Heart valve replaced by other means V43.4 Blood vessel replaced by other means V43.60 Unspecified joint replaced by other means V56.0 Extracorporeal dialysis V56.8 Other dialysis Indications 1. Ferritin, iron and either iron binding capacity or transferrin are useful in the differential diagnosis of iron deficiency, anemia, and for iron overload conditions. a. The following presentations are examples that may support the use of these studies for evaluating iron deficiency:  Certain abnormal blood count values (i.e., decreased Mean Corpuscular Volume (MCV), decreased hemoglobin/hematocrit when the MCV is low or normal, or increased Red cell Distribution Width (RDW) and low or normal MCV)  Abnormal appetite (pica)  Acute or chronic gastrointestinal blood loss  Hematuria  Menorrhagia  Malabsorption  Status post-gastrectomy  Status post-gastrojejunostomy

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 Malnutrition  Preoperative autologous blood collection(s)  Malignant, chronic inflammatory and infectious conditions associated with anemia which may present in a similar manner to iron deficiency anemia  Following a significant surgical procedure where blood loss had occurred and had not been repaired with adequate iron replacement. b. The following presentations are examples that may support the use of these studies for evaluating iron overload:  Chronic Hepatitis  Diabetes  Hyperpigmentation of skin  Arthropathy  Cirrhosis  Hypogonadism  Hypopituitarism  Impaired porphyrin metabolism  Heart failure  Multiple transfusions  Sideroblastic anemia  Thalassemia major  Cardiomyopathy, cardiac dysrhythmias and conduction disturbances 2. Follow-up testing may be appropriate to monitor response to therapy, e.g., oral or parenteral iron, ascorbic acid, and erythropoietin. 3. Iron studies may be appropriate in patients after treatment for other nutritional deficiency anemias, such as folate and vitamin B12, because iron deficiency may not be revealed until such a nutritional deficiency is treated. 4. Serum ferritin may be appropriate for monitoring iron status in patients with chronic renal disease with or without dialysis. 5. Serum iron may also be indicated for evaluation of toxic effects of iron and other metals (e.g., nickel, cadmium, aluminum, and lead) whether due to accidental, intentional exposure or metabolic causes. Limitations 1. Iron studies should be used to diagnose and manage iron deficiency or iron overload states. These tests are not to be used solely to assess acute phase reactants where disease management will be unchanged. For example, infections and malignancies are associated with elevations in acute phase reactants such as ferritin, and decreases in serum iron concentration, but iron studies would only be medically necessary if results of iron studies might alter the management of the primary diagnosis or might warrant direct treatment of an iron disorder or condition.

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2. If a normal serum ferritin level is documented, repeat testing would not ordinarily be medically necessary unless there is a change in the patient’s condition, and ferritin assessment is needed for the ongoing management of the patient. For example, a patient presents with new onset insulin-dependent diabetes mellitus and has a serum ferritin level performed for the suspicion of hemochromatosis. If the ferritin level is normal, the repeat ferritin for diabetes mellitus would not be medically necessary. 3. When an End Stage Renal Disease (ESRD) patient is tested for ferritin, testing more frequently than every three months requires documentation of medical necessity (e.g., other than chronic renal failure or renal failure, unspecified). 4. It is ordinarily not necessary to measure both transferrin and TIBC at the same time because TIBC is an indirect measure of transferrin. When transferrin is ordered as part of the nutritional assessment for evaluating malnutrition, it is not necessary to order other iron studies unless iron deficiency or iron overload is suspected as well. 5. It is not ordinarily necessary to measure either iron/TIBC (or transferrin) and ferritin in initial patient testing. If clinically indicated after evaluation of the initial iron studies, it may be appropriate to perform additional iron studies either on the initial specimen or on a subsequently obtained specimen. After a diagnosis of iron deficiency or iron overload is established, either iron/TIBC (or transferrin) or ferritin may be medically necessary for monitoring, but not both. 6. It would not ordinarily be considered medically necessary to do a ferritin as a preoperative test except in the presence of anemia or recent autologous blood collections prior to the surgery. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information CDC. Recommendations to prevent and control iron deficiency in the United States. MMWR 1998; 47(RR-3):1-29. Powell LW, George DK, McDonnell SM, Kowdley KV. Diagnosis of hemochromatosis. Ann.Intern.Med. 1998;129:925-931. Spiekerman AM. Proteins used in nutritional assessment. Clin.Lab.Med. 1993;13:353-369. Wallach JB. Handbook of Interpretation of Diagnostic Tests. Lippincott-Raven Publishers (Philadelphia) 1998, pp. 170-180. Van Walraven C, Goel V, Chan B. Effect of Population-Based Interventions on Laboratory Utilization. JAMA. 1998; 280:2028-2033. Guyatt GH, Patterson C, Ali M, Singer J, Levine M, Turpie I, Meyer R. Diagnosis of Iron- Deficiency Anemia in the Elderly. AmJMed. 1990; 88:205-209. Burns ER, Goldberg SN, Lawrence C, Wenz B. AJCP. 1990; 3: 240-245. Burns ER, et al. Brief Clinical Observations. AmJMed. 1991; 90:653-654. Yang Q, et al. Hemochromatosis-associated Mortality in the United States from 1979 to 1992: An Analysis of Multiple-Cause Mortality Data. AnIntMed.1998;129:946-953.

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190.19 - Collagen Crosslinks, Any Method

Previously Listed as Edit 8 Description Collagen crosslinks, part of the matrix of bone upon which bone mineral is deposited, are biochemical markers the excretion of which provides a quantitative measurement of bone resorption. Elevated levels of urinary collagen crosslinks indicate elevated bone resorption. Elevated bone resorption contributes to age-related and postmenopausal loss of bone leading to osteoporosis and increased risk of fracture. The collagen crosslinks assay can be performed by immunoassay or by high performance liquid chromatography (HPLC). Collagen crosslink immunoassays measure the pyridinoline crosslinks and associated telopeptides in urine. Bone is constantly undergoing a metabolic process called turnover or remodeling. This includes a degradation process, bone resorption, mediated by the action of osteoclasts, and a building process, bone formation, mediated by the action of osteoblasts. Remodeling is required for the maintenance and overall health of bone and is tightly coupled; that is, resorption and formation must be in balance. In abnormal states of bone remodeling, when resorption exceeds formation, it results in a net loss of bone. The measurement of specific, bone-derived resorption products provides analytical data about the rate of bone resorption. Osteoporosis is a condition characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine, and wrist. The term primary osteoporosis is applied where the causal factor in the disease is menopause or aging. The term secondary osteoporosis is applied where the causal factor is something other than menopause or aging, such as long-term administration of glucocorticosteroids, endocrine-related disorders (other than loss of estrogen due to menopause), and certain bone diseases such as cancer of the bone. With respect to quantifying bone resorption, collagen crosslink tests can provide adjunct diagnostic information in concert with bone mass measurements. Bone mass measurements and biochemical markers may have complementary roles to play in assessing effectiveness of osteoporosis treatment. Proper management of osteoporosis patients, who are on long-term therapeutic regimens, may include laboratory testing of biochemical markers of bone turnover, such as collagen crosslinks, that provide a profile of bone turnover responses within weeks of therapy. Changes in collagen crosslinks are determined following commencement of antiresorptive therapy. These can be measured over a shorter time interval when compared to bone mass density. If bone resorption is not elevated, repeat testing is not medically necessary. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82523 Collagen cross links, any method ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

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Code Description 242.00-242.91 Thyrotoxicosis 245.2 Chronic lymphocytic thyroiditis (only if thyrotoxic) 246.9 Unspecified disorder of thyroid 252.00-252.02, 252.08 Hyperparathyroidism 256.2 Postablative ovarian failure 256.31-256.39 Other ovarian failure 256.8 Other ovarian dysfunction 256.9 Unspecified ovarian dysfunction 268.9 Unspecified vitamin D deficiency 269.3 Mineral deficiency, not elsewhere classified 627.0 Premenopausal menorrhagia 627.1 Postmenopausal bleeding 627.2 Symptomatic menopausal or female climacteric state 627.4 Symptomatic states associated with artificial menopause 627.8 Other specified menopausal and postmenopausal disorders 627.9 Unspecified menopausal & postmenopausal disorder 731.0 Osteitis deformans w/o mention of bone tumor (Paget’s bone disease) 733.00-733.09 Osteoporosis 733.10-733.19 Pathological fracture 733.90 Disorder of bone and cartilage, unspecified 805.8 Fracture of vertebral column without mention of spiral cord injury, unspecified, closed V58.65 Long-term (current) use of steroids V58.69 Long-term (current) use of other medications Indications Generally speaking, collagen crosslink testing is useful mostly in “fast losers” of bone. The age when these bone markers can help direct therapy is often pre-Medicare. By the time a fast loser of bone reaches age 65, she will most likely have been stabilized by appropriate therapy or have lost so much bone mass that further testing is useless. Coverage for bone marker assays may be established, however, for younger Medicare beneficiaries and for those men and women who might become fast losers because of some other therapy such as glucocorticoids. Safeguards should be incorporated to prevent excessive use of tests in patients for whom they have no clinical relevance. Collagen crosslinks testing is used to:  Identify individuals with elevated bone resorption, who have osteoporosis in whom response to treatment is being monitored.  Predict response (as assessed by bone mass measurements) to FDA approved antiresorptive therapy in postmenopausal women.  Assess response to treatment of patients with osteoporosis, Paget’s disease of the bone, or risk for osteoporosis where treatment may include FDA approved antiresorptive agents, anti- estrogens or selective estrogen receptor moderators.

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Limitations Because of significant specimen to specimen collagen crosslink physiologic variability (15-20%), current recommendations for appropriate utilization include: one or two base-line assays from specified urine collections on separate days; followed by a repeat assay about 3 months after starting anti-resorptive therapy; followed by a repeat assay in 12 months after the 3-month assay; and thereafter not more than annually, unless there is a change in therapy in which circumstance an additional test may be indicated 3 months after the initiation of new therapy. Some collagen crosslink assays may not be appropriate for use in some disorders, according to FDA labeling restrictions. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Arnaud CD. Osteoporosis: Using ‘bone markers’ for diagnosis and monitoring. Geriatrics 1996; 51:24-30. Chesnut CH, III, Bell NH, Clark G, et al. Hormone replacement therapy in postmenopausal women: urinary N-telopeptide of type I collagen monitors therapeutic effect and predicts response of bone mineral density. Am. J. Med. 1997;102:29-37. Garnero P, Delmas PD. Clinical usefulness of markers of bone remodelling in osteoporosis. In: Meunier PJ. (ed).Osteoporosis: diagnosis and management. London: Martin Dunitz Ltd 1998:79-101. Garnero P, Shih WJ, Gineyts E, et al. Comparison of new biochemical markers of bone turnover in late postmenopausal osteoporotic women in response to alendronate treatment. J. Clin. Endocrinol. Metab.1994;79:1693-700. Harper KD, Weber TJ. Secondary osteoporosis - Diagnostic considerations. Endocrinol. Metab.Clin. North Am. 1998;27:325-48. Hesley RP, Shepard KA, Jenkins DK, Riggs BL. Monitoring estrogen replacement therapy and identifying rapid bone losers with an immunoassay for deoxypyridinoline. Osteoporos.Int. 1998;8:159-64. Melton LJ, III, Khosla S, Atkinson EJ, et al. Relationship of bone turnover to bone density and fractures. J.Bone Miner.Res.1997;12:1083-91. Millard PS. Prevention of osteoporosis: making sense of the published evidence. In: Rosen CJ (ed). Osteoporosis: diagnostic & therapeutic principles. Totowa: Humana Press. 1996:275-85. Rosen CJ. Biochemical markers of bone turnover. In: Rosen CJ(ed). Osteoporosis: diagnostic and therapeutic principles. Totowa: Humana Press Inc. 1996:129-41. Schneider DL, Barrett-Connor EL. Urinary N-Telopeptide levels discriminate normal, osteopenic, and osteoporotic bone mineral density. Arch. Intern. Med. 1997;157:1241-5.

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190.20 - Blood Glucose Testing

Previously Listed as Edit 9 Description This policy is intended to apply to blood samples used to determine glucose levels. Blood glucose determination may be done using whole blood, serum or plasma. It may be sampled by capillary puncture, as in the fingerstick method, or by vein puncture or arterial sampling. The method for assay may be by color comparison of an indicator stick, by meter assay of whole blood or a filtrate of whole blood, using a device approved for home monitoring, or by using a laboratory assay system using serum or plasma. The convenience of the meter or stick color method allows a patient to have access to blood glucose values in less than a minute or so and has become a standard of care for control of blood glucose, even in the inpatient setting. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82947 Glucose; quantitative, blood (except reagent strip) 82948 Glucose; blood, reagent strip 82962 Glucose, blood by glucose monitoring device cleared by FDA for home use. ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 011.00-011.96 Tuberculosis 038.0, 038.10-038.19, 038.2, Septicemia 038.3, 038.40-038.49, 038.8, 038.9 112.1 Recurrent vaginal candidiasis 112.3 Interdigital candidiasis 118 Opportunistic mycoses 157.4 Malignant neoplasm of Islets of Langerhans 158.0 Malignant neoplasm of retroperitoneum 211.7 Benign neoplasm of Islets of Langerhans 242.00-242.91 Thyrotoxicosis 249.00-249.01 Secondary diabetes mellitus without mention of complication 249.10-249.11 Secondary diabetes mellitus with ketoacidosis 249.20-249.21 Secondary diabetes mellitus with hyperosmolarity 249.30-249.31 Secondary diabetes mellitus with other coma 249.40-249.41 Secondary diabetes mellitus with renal manifestations 249.50-249.51 Secondary diabetes mellitus with ophthalmic manifestations 249.60-249.61 Secondary diabetes mellitus with neurological manifestations

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Code Description 249.70-249.71 Secondary diabetes mellitus with peripheral circulatory disorders 249.80-249.81 Secondary diabetes mellitus with other specified manifestations 249.90-249.91 Secondary diabetes mellitus with unspecified complication 250.00-250.93 Diabetes mellitus 251.0-251.9 Disorders of pancreatic internal secretion 253.0-253.9 Disorders of the pituitary gland 255.0 Cushing syndrome 263.0-263.9 Malnutrition 271.0-271.9 Disorders of carbohydrate transport and metabolism 272.0-272.4 Disorders of lipoid metabolism 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 276.0 Hyperosmolality and/or hypernatremia 276.1 Hyposmolality and/or hyponatremia 276.2 Acidosis 276.3 Alkalosis 276.4 Mixed acid-base balance disorder 276.50-276.52 Volume depletion 276.61 Transfusion associated circulatory overload 276.69 Other fluid overload 276.7 Hyperpotassemia 276.8 Hypopotassemia 276.9 Electrolyte and fluid disorders not elsewhere classified 278.3 Hypercarotinemia 293.0 Delirium due to conditions classified elsewhere 294.9 Unspecified persistent mental disorders due to conditions classified elsewhere 298.9 Unspecified psychosis 300.9 Unspecified nonpsychotic mental disorder 310.1 Personality change due to conditions classified elsewhere 331.83 Mild cognitive impairment, so stated 337.9 Autonomic nervous system neuropathy 345.10-345.11 Generalized convulsive epilepsy 348.31 Metabolic encephalopathy 355.9 Neuropathy, not otherwise specified 356.9 Unspecified hereditary and idiopathic peripheral neuropathy 357.9 Unspecified inflammatory and toxic neuropathy 362.10 Background retinopathy 362.18 Retinal vasculitis

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Code Description 362.29 Nondiabetic proliferative retinopathy 362.50-362.57 Degeneration of macular posterior pole 362.60-362.66 Peripheral retinal degeneration 362.81-362.89 Other retinal disorders 362.9 Unspecified retinal disorders 365.04 Borderline glaucoma, ocular hypertension 365.32 Corticosteroid-induced glaucoma residual 366.00-366.09 Presenile cataract 366.10-366.19 Senile cataract 367.1 Acute myopia 368.8 Other specified visual disturbance 373.00 Blepharitis 377.24 Pseudopapilledema 377.9 Unspecified disorder of optic nerve and visual pathways 378.50-378.55 Paralytic strabismus 379.45 Argyll-Robertson pupils 410.00-410.92 Acute myocardial infarctions 414.00-414.06 Coronary atherosclerosis, of unspecified type of vessel, native or graft and of native coronary artery of transplanted heart 414.07 Coronary atherosclerosis, of bypass graft (artery) (vein) of transplanted heart 414.10-414.12 Coronary atherosclerosis, aneurysm of heart (wall), aneurysm of coronary vessels, and dissection of coronary artery 414.19 Coronary atherosclerosis, other aneurysm of heart 414.3 Coronary atherosclerosis due to lipid rich plaque 414.4 Coronary atherosclerosis due to calcified coronary lesion 425.9 Secondary cardiomyopathy, unspecified 440.23 Arteriosclerosis of extremities with ulceration 440.24 Arteriosclerosis of extremities with gangrene 440.9 Arteriosclerosis, not otherwise specified 458.0 Postural hypotension 462 Acute pharyngitis 466.0 Acute bronchitis 480.0-480.3, 480.8, 480.9 Viral pneumonia 481 Pneumococcal pneumonia 482.0-482.2, 482.30-482.32, 482.39, 482.40-482.42, 482.49, 482.81-482.84, 482.89, 482.9 Other bacterial pneumonia 483.0-483.1, 483.8 Pneumonia due to other specified organism 484.1, 484.3, 484.5-484.8 Pneumonia in infectious diseases classified elsewhere 485 Bronchopneumonia, organism unspecified

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Code Description 486 Pneumonia, organism unspecified 490 Recurrent bronchitis, not specified as acute or chronic 491.0-491.9 Chronic bronchitis 527.7 Disturbance of salivary secretion (drymouth) 528.00 Stomatitis and mucositis, unspecified 528.09 Other stomatitis and mucositis (ulcerative) 535.50-535.51 Gastritis 536.8 Dyspepsia 571.8 Other chronic nonalcoholic liver disease 572.0 Abscess of liver 572.1 Portal pyemia 572.2 Hepatic encephalopathy 572.3 Portal hypertension 572.4 Hepatorenal syndrome 572.8 Other sequelae of chronic liver disease 574.50-574.51 Choledocholithiasis 575.0-575.12 Cholecystitis 576.1 Cholangitis 577.0 Acute pancreatitis 574.50-574.51 Choledocholithiasis 577.1 Chronic pancreatitis 577.8 Pancreatic multiple calculi 590.00-590.9 Infections of the kidney 595.9 Recurrent cystitis 596.4 Bladder atony 596.53 Bladder paresis 599.0 Urinary tract infection, recurrent 607.84 Impotence of organic origin 608.89 Other disorders male genital organs 616.10 Vulvovaginitis 626.0 Amenorrhea 626.4 Irregular menses 628.9 Infertility - female 648.00 Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, unspecified as to episode of care or not applicable 648.03 Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, antipartum condition or complication 648.04 Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, postpartum condition or complication 648.80 Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, unspecified as to episode of care or not applicable

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Code Description 648.83 Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, antepartum condition or complication 648.84 Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, postpartum condition or complication 649.20 Bariatric surgery status complicating pregnancy, childbirth, or the puerperium, unspecified as to episode of care or not applicable 649.21 Bariatric surgery status complicating pregnancy, childbirth, or the puerperium, delivered, with or without mention of antepartum condition 649.22 Bariatric surgery status complicating pregnancy, childbirth, or the puerperium, delivered, with mention of postpartum complication 649.23 Bariatric surgery status complicating pregnancy, childbirth, or the puerperium, antepartum condition or complication 649.24 Bariatric surgery status complicating pregnancy, childbirth, or the puerperium, postpartum condition or complication 656.60-656.63 Fetal problems affecting management of mother large for-date of fetus 657.00-657.03 Polyhydramnios 680.0-680.9 Carbuncle and furuncle 686.00-686.9 Infections of skin and subcutaneous tissue 698.0 Pruritus ani 698.1 Pruritus of genital organs 704.1 Hirsutism 705.0 Anhidrosis 707.00-707.25, 707.8, 707.9 Chronic ulcer of skin 709.3 Degenerative skin disorders 729.1 Myalgia 730.07 Acute osteomyelitis of ankle and foot 730.17 Chronic osteomyelitis of ankle and foot 730.27 Unspecified osteomyelitis of ankle and foot 780.01 Coma 780.02 Transient alteration of awareness 780.09 Alteration of consciousness, other 780.2 Syncope and collapse 780.31 Febrile convulsions (simple), unspecified 780.32 Complex febrile convulsions 780.33 Post traumatic seizures 780.39 Seizures, not otherwise specified 780.4 Dizziness and giddiness 780.71 Malaise and fatigue 780.72 Functional quadriplegia 780.79 Other malaise and fatigue 780.8 Generalized hyperhidrosis 781.0 Abnormal involuntary movements

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Code Description 782.0 Loss of vibratory sensation 783.1 Abnormal weight gain 783.21 Abnormal loss of weight 783.5 Polydipsia 783.6 Polyphagia 785.0 Tachycardia 785.4 Gangrene 786.01 Hyperventilation 786.09 Dyspnea 786.50 Chest pain, unspecified 787.60 Full incontinence of feces 787.61 Incomplete defecation 787.62 Fecal smearing 787.63 Fecal urgency 787.91 Diarrhea 788.41-788.43 Frequency of urination and polyuria 789.1 Hepatomegaly 790.21-790.29 Abnormal glucose tolerance test 790.6 Other abnormal blood chemistry (hyperglycemia) 791.0 Proteinuria 791.5 Glycosuria 796.1 Abnormal reflex 799.4 Cachexia V23.0-V23.3, V23.41-V23.49, V23.5, V23.7, V23.81- V23.87, V23.89, V23.9 Supervision of high-risk pregnancy V58.63-V58.65 Long-term (current) drug use V58.67 Long-term (current) use of insulin V58.69 Long term current use of other medication V67.2 Follow-up examination, following chemotherapy V67.51 Follow-up examination with high-risk medication not elsewhere classified V77.1 Covered for procedure Special screening for endocrine, nutrition, metabolic, & immunity code 82947 only disorders Indications Blood glucose values are often necessary for the management of patients with diabetes mellitus, where hyperglycemia and hypoglycemia are often present. They are also critical in the determination of control of blood glucose levels in patient with impaired fasting glucose (FPG 110-125 mg/dL), patient with insulin resistance syndrome and/or carbohydrate intolerance (excessive rise in glucose following ingestion of glucose/glucose sources of food), in patient with a hypoglycemia disorder such as nesidioblastosis or insulinoma, and in patients with a catabolic or malnutrition state. In addition to conditions listed, glucose testing may be medically necessary

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This is CMS Logo. in patients with tuberculosis, unexplained chronic or recurrent infections, alcoholism, coronary artery disease (especially in women), or unexplained skin conditions (i.e.: pruritis, skin infections, ulceration and gangrene without cause). Many medical conditions may be a consequence of a sustained elevated or depressed glucose level, including comas, seizures or epilepsy, confusion, abnormal hunger, abnormal weight loss or gain, and loss of sensation. Evaluation of glucose may be indicated in patients on medications known to affect carbohydrate metabolism. Effective January 1, 2005, the Medicare law expanded coverage to diabetic screening services. Some forms of blood glucose testing covered under this NCD may be covered for screening purposes subject to specified frequencies. See 42 CFR410.18, sec. 90 ch.18 Claims Processing Manual for screening benefit description. Limitations Frequent home blood glucose testing by diabetic patients should be encouraged. In stable, non- hospitalized patients unable or unwilling to do home monitoring, it may necessary to measure quantitative blood glucose up to 4 times a year. Depending upon patient’s age, type of diabetes, complications, degree of control, and other co-morbid conditions, more frequent testing than 4 times a year may be reasonable and necessary. In patients presenting nonspecific signs, symptoms, or diseases not normally associated with disturbances in glucose metabolism, a single blood glucose test may be medically necessary. Repeat testing may not be indicated unless abnormal results are found or there is a change in clinical condition. If repeat testing is performed, a diagnosis code (e.g., diabetes) should be reported to support medical necessity. However, repeat testing may be indicated where results are normal in patients with conditions of a continuing risk of glucose metabolism abnormality (e.g., monitoring glucocorticoid therapy). ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Documentation Requirements The ordering physician must include evidence in the patient’s clinical record that an evaluation of history and physical preceded the ordering of glucose testing and that manifestations of abnormal glucose levels were present to warrant the testing. Sources of Information AACE Guidelines for Management of Diabetes Mellitus, Endocrine Practice (1995)1:149-157. Bower, Bruce F. & Robert E. Moore, Endocrine Function and Carbohydrates. Clinical Laboratory Medicine, K. D. McClatchy, Baltimore/Williams & Wilkins, 1994. pp 321-323. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Diabetes Care, Volume 20, Number 7, July 1997, pages 1183 et seq. Roberts, H. J., Difficulté Diagnoses. W. B. Saunders Co., pp 69-70.

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190.21 - Glycated Hemoglobin/Glycated Protein

Previously Listed as Edit 10 Description The management of diabetes mellitus requires regular determinations of blood glucose levels. Glycated hemoglobin/protein levels are used to assess long-term glucose control in diabetes. Alternative names for these tests include glycated or glycosylated hemoglobin or Hgb, hemoglobin glycated or glycosylated protein, and fructosamine.

Glycated hemoglobin (equivalent to hemoglobin A1) refers to total glycosylated hemoglobin present in erythrocytes, usually determined by affinity or ion-exchange chromatographic methodology. Hemoglobin A1c refers to the major component of hemoglobin A1, usually determined by ion-exchange affinity chromatography, immunoassay or agar gel electrophoresis. Fructosamine or glycated protein refers to glycosylated protein present in a serum or plasma sample. Glycated protein refers to measurement of the component of the specific protein that is glycated usually by colorimetric method or affinity chromatography.

Glycated hemoglobin in whole blood assesses glycemic control over a period of 4-8 weeks and appears to be the more appropriate test for monitoring a patient who is capable of maintaining long-term, stable control. Measurement may be medically necessary every 3 months to determine whether a patient’s metabolic control has been on average within the target range. More frequent assessments, every 1-2 months, may be appropriate in the patient whose diabetes regimen has been altered to improve control or in whom evidence is present that intercurrent events may have altered a previously satisfactory level of control (for example, post- major surgery or as a result of glucocorticoid therapy). Glycated protein in serum/plasma assesses glycemic control over a period of 1-2 weeks. It may be reasonable and necessary to monitor glycated protein monthly in pregnant diabetic women. Glycated hemoglobin/protein test results may be low, indicating significant, persistent hypoglycemia, in nesidioblastosis or insulinoma, conditions which are accompanied by inappropriate hyperinsulinemia. A below normal test value is helpful in establishing the patient’s hypoglycemic state in those conditions.

HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82985 Glycated protein 83036 Hemoglobin; glycated

ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

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Code Description 211.7 Benign neoplasm of islets of Langerhans 249.00-249.01 Secondary diabetes mellitus without mention of complication 249.10-249.11 Secondary diabetes mellitus with ketoacidosis 249.20-249.21 Secondary diabetes mellitus with hyperosmolarity 249.30-249.31 Secondary diabetes mellitus with other coma 249.40-249.41 Secondary diabetes mellitus with renal manifestations 249.50-249.51 Secondary diabetes mellitus with ophthalmic manifestations 249.60-249.61 Secondary diabetes mellitus with neurological manifestations 249.70-249.71 Secondary diabetes mellitus with peripheral circulatory disorders 249.80-249.81 Secondary diabetes mellitus with other specified manifestations 249.90-249.91 Secondary diabetes mellitus with unspecified complication 250.00-250.93 Diabetes mellitus & various related codes 251.0 Hypoglycemic coma 251.1 Other specified hypoglycemia 251.2 Hypoglycemia unspecified 251.3 Post-surgical hypoinsulinemia 251.4 Abnormality of secretion of glucagon 251.8 Other specified disorders of pancreatic internal secretion 251.9 Unspecified disorder of pancreatic internal secretion 258.0-258.9 Polyglandular dysfunction and related disorders 271.4 Renal glycosuria 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 577.1 Chronic pancreatitis 579.3 Other and unspecified postsurgical nonabsorption 648.00 Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, unspecified as to episode of care or not applicable 648.03 Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, antepartum condition or complication 648.04 Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, postpartum condition or complication 648.80 Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, unspecified as to episode of care or not applicable 648.83 Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, antepartum condition or complication 648.84 Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, postpartum condition or complication 790.21-790.29 Abnormal glucose tolerance test 790.6 Other abnormal blood chemistry (hyperglycemia) 962.3 Poisoning by insulin and antidiabetic agents

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Code Description V12.21 Personal history of gestational diabetes V12.29 Personal history of other endocrine, metabolic, and immunity disorders V58.67 Long-term (current) use of insulin V58.69 Long-term use of other medication Indications Glycated hemoglobin/protein testing is accepted as medically necessary for management and control of diabetes and to assess hyperglycemia, a history of hyperglycemia or dangerous hypoglycemia. Glycated protein testing may be used in place of glycated hemoglobin in the management of diabetic patients, and is useful in patients with abnormalities of erythrocytes such as hemolytic anemia or hemoglobinopathies. Limitations It is not reasonable and necessary to perform glycated hemoglobin tests more often than every three months on a controlled diabetic patient to determine if the patient’s metabolic control has been on average within the target range. It is not reasonable and necessary for these tests to be performed more frequently than once a month for diabetic pregnant women. Testing for uncontrolled type one or two diabetes mellitus may require testing more than four times a year. The above Description Section provides the clinical basis for those situations in which testing more frequently than four times per annum is indicated, and medical necessity documentation must support such testing in excess of the above guidelines. Many analytical methods of glycated hemoglobin show interference from elevated levels of fetal hemoglobin or by variant hemoglobin molecules. When the glycated hemoglobin assay is initially performed in these patients, the laboratory may inform the ordering physician of a possible analytical interference. Alternative testing, including glycated protein, for example, fructosamine, may be indicated for monitoring the degree of glycemic control. It is therefore conceivable that a patient will have both a glycated hemoglobin and glycated protein ordered on the same day. This should be limited to the initial assay of glycated hemoglobin, with subsequent exclusive use of glycated protein. These tests are not considered to be medically necessary for the diagnosis of diabetes. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Bower, Bruce F. and Robert Moore, Endocrine Function and Carbohydrates. Clinical Laboratory Medicine, Kenneth D. McClatchy, editor. Baltimore/Williams & Wilkins, 1994. pp. 321-323. Tests of Glycemia in Diabetes. Diabetes Care. 1/98, 21:Supp. 1:S69-S71.American Association of Clinical Endocrinologists Guidelines for Management of Diabetes Mellitus Dons, Robert F, Endocrine & Metabolic Testing Manual, 3rd Edition. Expert Committee on Glycated Hgb. Diabetes Care, 11/84, 7:6:602-606. Evaluation of Glycated Hgb in Diabetes, Diabetes. 7/91 30:613-617. Foster, Daniel W., Diabetes Mellitus, Harrison’s Principles of Internal Medicine. 13th ed., Kurt J. Isselbacher et al. Editors, New York/McGraw-Hill, 1994, pg. 1990. Management of Diabetes in Older Patients. Practical Therapeutics. 1991, Drugs 41:4:548-565. Koch, D. D, Fructosamine: How Useful Is It? Laboratory Medicine, V. 21, N. 8, August 1990, pp. 497-503.

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Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Diabetes Care, Volume 20, Number 7, July 1997, pp. 1183 et seq. Sacks, David B., Carbohydrates. In Tietz Textbook of Clinical Chemistry, 2nd Ed., Carl A. Burtis and Edward R. Ashwood, editors. Philadelphia, W.B. Saunders Co., 1994. pp. 980-988. Tests of Glycemia in Diabetes, American Diabetes Association, Diabetes Care, Volume 20, Supplement I, January 1997, pp. 518-520.

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190.22 - Thyroid Testing

Previously Listed as Edit 11 Description Thyroid function studies are used to delineate the presence or absence of hormonal abnormalities of the thyroid and pituitary glands. These abnormalities may be either primary or secondary and often but not always accompany clinically defined signs and symptoms indicative of thyroid dysfunction. Laboratory evaluation of thyroid function has become more scientifically defined. Tests can be done with increased specificity, thereby reducing the number of tests needed to diagnose and follow treatment of most thyroid disease. Measurements of serum sensitive thyroid-stimulating hormone (TSH) levels, complemented by determination of thyroid hormone levels [free thyroxine (fT-4) or total thyroxine (T4) with Triiodothyronine (T3) uptake] are used for diagnosis and follow-up of patients with thyroid disorders. Additional tests may be necessary to evaluate certain complex diagnostic problems or on hospitalized patients, where many circumstances can skew tests results. When a test for total thyroxine (total T4 or T4 radioimmunoassay) or T3 uptake is performed, calculation of the free thyroxine index (FTI) is useful to correct for abnormal results for either total T4 or T3 uptake due to protein binding effects. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 84436 Thyroxine; total 84439 Thyroxine; free 84443 Thyroid stimulating hormone (TSH) 84479 Thyroid hormone (T3 or T4) uptake or thyroid hormone binding ratio (THBR) ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 017.50-017.56 Tuberculosis of the thyroid gland 183.0 Malignant neoplasm of ovary 193 Malignant neoplasm of thyroid gland 194.8 Malignant neoplasm of other endocrine glands and related structures 198.89 Secondary malignant neoplasm of the thyroid 220 Benign neoplasm of ovary 226 Benign neoplasm of thyroid gland 227.3 Benign neoplasm of pituitary gland and craniopharyngeal duct 234.8 Carcinoma in situ of other and unspecified sites

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Code Description 237.4 Neoplasm of uncertain behavior of other and unspecified endocrine glands 239.7 Neoplasm of unspecified nature, thyroid gland 240.0-240.9 Goiter specified and unspecified 241.0-241.9 Nontoxic nodular goiter 242.00-242.91 Thyrotoxicosis with or without goiter 243 Congenital hypothyroidism 244.0-244.9 Acquired hypothyroidism 245.0-245.9 Thyroiditis 246.0-246.9 Other disorders of thyroid 249.00-249.01 Secondary diabetes mellitus without mention of complication 249.10-249.11 Secondary diabetes mellitus with ketoacidosis 249.20-249.21 Secondary diabetes mellitus with hyperosmolarity 249.30-249.31 Secondary diabetes mellitus with other coma 249.40-249.41 Secondary diabetes mellitus with renal manifestations 249.50-249.51 Secondary diabetes mellitus with ophthalmic manifestations 249.60-249.61 Secondary diabetes mellitus with neurological manifestations 249.70-249.71 Secondary diabetes mellitus with peripheral circulatory disorders 249.80-249.81 Secondary diabetes mellitus with other specified manifestations 249.90-249.91 Secondary diabetes mellitus with unspecified complication 250.00-250.93 Diabetes mellitus 252.1 Hypoparathyroidism 253.1 Other and unspecified anterior pituitary hyper function 253.2 Panhypopituitarism 253.3 Pituitary dwarfism 253.4 Other anterior pituitary disorders 253.7 Iatrogenic pituitary disorders 255.2 Adrenogenital disorders 255.41 Glucocorticoid deficiency 255.42 Mineralocorticoid deficiency 256.31-256.39 Ovarian failure 257.2 Testicular hypofunction 258.0 – 258.9 Polyglandular dysfunction and related disorders 262 Malnutrition, severe 263.0-263.9 Malnutrition, other and unspecified 266.0 Ariboflavinosis 272.0 Pure hypercholesterolemia 272.2 Mixed hyperlipidemia 272.4 Other and unspecified hyperlipidemia 275.40-275.49 Calcium disorders 275.5 Hungry bone syndrome

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Code Description 276.0 Hyposmolality and/or hypernatremia 276.1 Hyposmolality and/or hyponatremia 278.3 Hypercarotenemia 279.41 Autoimmune lymphoproliferative syndrome 279.49 Autoimmune disease, not elsewhere classified 281.0 Pernicious anemia 281.9 Unspecified deficiency anemia 283.0 Autoimmune hemolytic anemia 285.9 Anemia, unspecified 290.0 Senile dementia, uncomplicated 290.10-290.13 Presenile dementia 290.20-290.21 Senile dementia with delusional or depressive features 290.3 Senile dementia with delirium 293.0-293.1 Delirium 293.81-293.89 Other specified transient mental disorders due to conditions classified elsewhere 294.8 Other persistent mental disorders due to conditions classified elsewhere 296.00-296.99 Episodic mood disorders 297.0 Paranoid state, simple 297.1 Delusional disorder 297.9 Unspecified paranoid state 298.3 Acute paranoid reaction 300.00-300.09 Anxiety states 307.9 Other and unspecified special symptoms or syndromes NEC 310.1 Personality change due to conditions classified elsewhere 311 Depressive disorder, NEC 327.00 Organic insomnia, unspecified 327.01 Insomnia due to medical condition classified elsewhere 327.09 Other organic insomnia 327.29 Other organic sleep apnea 327.52 Sleep related leg cramps 327.8 Other Organic sleep disorders 331.0, 331.11, 331.19, 331.2 Alzheimer’s, pick’s disease, Senile degeneration of brain 331.83 Mild cognitive impairment, so stated 333.1 Essential and other specified forms of tremor 333.99 Other extrapyramidal diseases and abnormal movement disorders 354.0 Carpal Tunnel syndrome 356.9 Idiopathic peripheral neuropathy, unspecified polyneuropathy 358.1 Myasthenic syndromes in diseases classified elsewhere 359.5 Myopathy in endocrine diseases classified elsewhere

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Code Description 359.9 Myopathy, unspecified 368.2 Diplopia 372.71 Conjunctival hyperemia 372.73 Conjunctival edema 374.41 Lid retraction or lag 374.82 Eyelid edema 376.21 Thyrotoxic exophthalmos 376.22 Exophthalmic ophthalmoplegia 376.30-376.31 Exophthalmic conditions, unspecified and constant 376.33-376.34 Orbital edema or congestion, intermittent exophthalmos 378.50-378.55 Paralytic strabismus 401.0-401.9 Essential hypertension 403.00-403.91 Hypertensive chronic kidney disease 404.00-404.93 Hypertensive heart and chronic kidney disease 423.9 Unspecified disease of pericardium 425.7 Nutritional and metabolic cardiomyopathy 427.0 Paroxysmal supraventricular tachycardia 427.2 Paroxysmal tachycardia, unspecified 427.31 Atrial fibrillation 427.89 Other specified cardiac dysrhythmia 427.9 Cardiac dysrhythmia, unspecified 428.0 Congestive heart failure, unspecified 428.1 Left heart failure 429.3 Cardiomegaly 511.9 Unspecified pleural effusion 518.81 Acute respiratory failure 529.8 Other specified conditions of the tongue 560.1 Paralytic ileus 564.00-564.09 Constipation 564.7 Megacolon, other than Hirschsprung’s 568.82 Peritoneal effusion (chronic) 625.3 Dysmenorrhea 626.0-626.2 Disorders of menstruation 626.4 Irregular menstrual cycle Other current conditions in mother, classifiable elsewhere, but 648.10-648.14 complicating pregnancy, childbirth, or puerperium, thyroid dysfunction 676.20-676.24 Engorgement of breast associated w/ childbirth & disorders of lactation 698.9 Unspecified pruritic disorder 701.1 Keratoderma, acquired (dry skin) 703.8 Other specified diseases of nail (Brittle nails) 704.00-704.09 Alopecia

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Code Description 709.01 Vitiligo 710.0-710.9 Diffuse disease of connective tissue 728.2 Muscle wasting 728.87 Muscle weakness (generalized) 728.9 Unspecified disorder of muscle, ligament, and fascia 729.1 Myalgia and myositis, unspecified 729.82 Musculoskeletal cramp 730.30-730.39 Periostitis without osteomyelitis 733.02 Idiopathic osteoporosis 733.09 Osteoporosis, drug induced 750.15 Macroglossia, congenital 759.2 Anomaly of other endocrine glands 780.01 Coma 780.02 Transient alteration of awareness 780.09 Alteration of consciousness, other 780.50 Insomnia 780.51 Insomnia with sleep apnea, unspecified 780.52 Insomnia, unspecified 780.60 Fever, unspecified 780.61 Fever presenting with conditions classified elsewhere 780.62 Postprocedural fever 780.63 Postvaccination fever 780.64 Chills (without fever) 780.65 Hypothermia not associated with low environmental temperature 780.66 Febrile nonhemolytic transfusion reaction 780.71 Chronic fatigue syndrome 780.72 Functional quadriplegia 780.79 Other malaise and fatigue 780.8 Generalized hyperhidrosis 780.93 Memory loss 780.94 Early satiety 780.96 Generalized pain 780.97 Altered mental status 780.99 Other general symptoms 781.0 Abnormal involuntary movements 781.3 Lack of coordination, ataxia 782.0 Disturbance of skin sensation 782.3 Localized edema 782.8 Changes in skin texture 782.9 Other symptoms involving skin and integumentary tissues 783.0 Anorexia

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Code Description 783.1 Abnormal weight gain 783.21 Abnormal loss of weight 783.6 Polyphagia 784.1 Throat pain 784.42 Dysphonia 784.43 Hypernasality 784.44 Hyponasality 784.49 Other voice and resonance disorders 784.51 Dysarthria 784.59 Other speech disturbance 785.0 Tachycardia, unspecified 785.1 Palpitations 785.9 Other symptoms involving cardiovascular system 786.09 Other symptoms involving respiratory system 786.1 Stridor 787.20 Dysphagia, unspecified 787.21 Dysphagia, oral phase 787.22 Dysphagia, oropharyngeal phase 787.23 Dysphagia, pharyngeal phase 787.24 Dysphagia, pharyngo-esophageal phase 787.29 Other dysphagia 787.91-787.99 Other symptoms involving digestive system 789.51 Malignant Ascites 789.59 Other Ascites Other nonspecific (abnormal) findings on radiological and other 793.99 examination of body structure 794.5 Thyroid, abnormal scan or uptake 796.1 Other nonspecific abnormal findings, abnormal reflex 799.21 Nervousness 799.22 Irritability 799.23 Impulsiveness 799.24 Emotional lability 799.25 Demoralization and apathy 799.29 Other signs and symptoms involving emotional state 990 Effects of radiation, unspecified V10.87 Personal history of malignant neoplasm of the thyroid V10.88 Personal history of malignant neoplasm of other endocrine gland V10.91 Personal history of malignant neuroendocrine tumor V12.21 Personal history of gestational diabetes V12.29 Personal history of other endocrine, metabolic, and immunity disorders V58.69 Long term (current) use of other medications

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Code Description V67.00-V67.9 Follow-up examination Indications Thyroid function tests are used to define hyper function, euthyroidism, or hypofunction of thyroid disease. Thyroid testing may be reasonable and necessary to:  Distinguish between primary and secondary hypothyroidism  Confirm or rule out primary hypothyroidism  Monitor thyroid hormone levels (for example, patients with goiter, thyroid nodules, or thyroid cancer)  Monitor drug therapy in patients with primary hypothyroidism  Confirm or rule out primary hyperthyroidism  Monitor therapy in patients with hyperthyroidism Thyroid function testing may be medically necessary in patients with disease or neoplasm of the thyroid and other endocrine glands. Thyroid function testing may also be medically necessary in patients with metabolic disorders; malnutrition; hyperlipidemia; certain types of anemia; psychosis and non-psychotic personality disorders; unexplained depression; ophthalmologic disorders; various cardiac arrhythmias; disorders of menstruation; skin conditions; myalgias; and a wide array of signs and symptoms, including alterations in consciousness; malaise; hypothermia; symptoms of the nervous and musculoskeletal system; skin and integumentary system; nutrition and metabolism; cardiovascular; and gastrointestinal system. It may be medically necessary to do follow-up thyroid testing in patients with a history of malignant neoplasm of the endocrine system and in patients on long-term thyroid drug therapy. Limitations Testing may be covered up to two times a year in clinically stable patients; more frequent testing may be reasonable and necessary for patients whose thyroid therapy has been altered or in whom symptoms or signs of hyperthyroidism or hypothyroidism are noted. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Documentation Requirements When these tests are billed at a greater frequency than the norm (two per year), the ordering physician’s documentation must support the medical necessity of this frequency. Sources of Information AACE Clinical Practice Guidelines for the Diagnosis and Management of Thyroid Nodules, Endocrine Practice (1996) 2:1, pp. 78-84. AACE Clinical Practice Guidelines for Evaluation and Treatment of Hyperthyroidism and Hypothyroidism, Endocrine Practice (1995) 1:1, pp. 54-62. AACE Clinical Practice Guidelines for Management of Thyroid Carcinoma, Endocrine Practice (1997) 3:1, pp. 60-71. Cooper DS. Treatment of thyrotoxicosis. In Braverman LE, Utiger RD, eds. Werner and Ingbar’s The Thyroid: A Fundamental and Clinical Text. 6th ed. Philadelphia, Pa: JB Lippincott Co; 1991:887-916.

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Endocrinology. DeGroot LJ, et. al. Eds. 3rd ed. Philadelphia, Pa: W.B.Saunders Co.; 1995. Endocrinology and Metabolism. Felig, P, Baxter, JD, Frohman, LA, eds.3rd ed. McGraw-Hill, Inc.: 1995. Franklyn JA. The Management of Hyperthyroidism. N Engl J Med. 1994; 330(24):1731-1738. Glenn GC and the Laboratory Testing Strategy Task Force of the College of American Pathologists. Practice parameter on laboratory panel testing for screening and case finding in asymptomatic adults. Arch Pathol LabMed. 1996:120:929-43. Larsen PR, Ingbar SH. The Thyroid Gland. In: Wilson JD, Foster DW, eds. Williams Textbook of Endocrinology. 9th ed. Philadelphia, Pa: WB Saunders Co; 1992:357-487. The Merck Manual, 16th Edition, pp. 1072-1081.

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190.23 - Lipids Testing

Previously Listed as Edit 12 Description Lipoproteins are a class of heterogeneous particles of varying sizes and densities containing lipid and protein. These lipoproteins include cholesterol esters and free cholesterol, triglycerides, phospholipids and A, C, and E apoproteins. Total cholesterol comprises all the cholesterol found in various lipoproteins. Factors that affect blood cholesterol levels include age, sex, body weight, diet, alcohol and tobacco use, exercise, genetic factors, family history, medications, menopausal status, the use of hormone replacement therapy, and chronic disorders such as hypothyroidism, obstructive liver disease, pancreatic disease (including diabetes), and kidney disease. In many individuals, an elevated blood cholesterol level constitutes an increased risk of developing coronary artery disease. Blood levels of total cholesterol and various fractions of cholesterol, especially low density lipoprotein cholesterol (LDL -C) and high density lipoprotein cholesterol (HDL-C) are useful in assessing and monitoring treatment for that risk in patients with cardiovascular and related diseases. Blood levels of the above cholesterol components including triglyceride have been separated into desirable, borderline and high-risk categories by the National Heart, Lung, and Blood Institute in their report in 1993. These categories form a useful basis for evaluation and treatment of patients with hyperlipidemia. Therapy to reduce these risk parameters includes diet, exercise and medication, and fat weight loss, which is particularly powerful when combined with diet and exercise. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 80061 Lipid panel 82465 Cholesterol, serum or whole blood, total 83700 Lipoprotein, blood; electrophoretic separation and quantitation 83701 Lipoprotein blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (e.g., electrophoresis, ultracentrifugation) 83704 Lipoprotein, blood; quantitation of lipoprotein particle numbers and lipoprotein particle subclasses 83718 Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol) 83721 Lipoprotein, direct measurement, LDL cholesterol 84478 Triglycerides

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ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 242.00-245.9 Disorders of the thyroid gland with hormonal dysfunction 249.00-249.01 Secondary diabetes mellitus without mention of complication 249.10-249.11 Secondary diabetes mellitus with ketoacidosis 249.20-249.21 Secondary diabetes mellitus with hyperosmolarity 249.30-249.31 Secondary diabetes mellitus with other coma 249.40-249.41 Secondary diabetes mellitus with renal manifestations 249.50-249.51 Secondary diabetes mellitus with ophthalmic manifestations 249.60-249.61 Secondary diabetes mellitus with neurological manifestations 249.70-249.71 Secondary diabetes mellitus with peripheral circulatory disorders 249.80-249.81 Secondary diabetes mellitus with other specified manifestations 249.90-249.91 Secondary diabetes mellitus with unspecified complication 250.00-250.93 Diabetes mellitus 255.0 Cushing’s syndrome 260 Kwashiorkor 261 Nutritional marasmus 262 Other severe, protein-calorie malnutrition 263.0 Malnutrition of moderate degree 263.1 Malnutrition of mild degree 263.8 Other protein-calorie malnutrition 263.9 Unspecified protein-calorie malnutrition 270.0 Disturbances of amino-acid transport 271.1 Galactosemia 272.0 Pure hypercholesterolemia 272.1 Hypertriglyceridemia 272.2 Mixed hyperlipidemia (tuberous xanthoma) 272.3 Hyperchylomicronemia 272.4 Other and unspecified hyperlipidemia (unspecified xanthoma) 272.5 Lipoprotein deficiencies 272.6 Lipodystrophy 272.7 Lipidoses 272.8 Other disorders of lipoid metabolism 272.9 Unspecified disorders of lipoid metabolism 277.30 Amyloidosis, unspecified 277.31 Familial Mediterranean fever 277.39 Other amyloidosis 278.00 Obesity

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Code Description 278.01 Morbid obesity 278.02 Overweight 278.03 Obesity hypoventilation syndrome 303.90-303.92 Alcoholism 362.10-362.16 Other background retinopathy and retinal vascular change 362.30-362.34 Retinal vascular occlusion 362.82 Retinal exudates and deposits 371.41 Senile corneal changes 374.51 Xanthelasma 379.22 Crystalline deposits in vitreous 388.00 Degenerative & vascular disorder of ear, unspecified 388.02 Transient ischemic deafness 401.0, 401.1, 401.9 Essential hypertension 402.00-402.91 Hypertensive heart disease 403.00-403.91 Hypertensive chronic kidney disease 404.00-404.93 Hypertensive heart and chronic kidney disease 405.01-405.99 Secondary hypertension 410.00-410.92 Acute myocardial infarction 411.0-411.1 Other acute & subacute forms of ischemic heart disease 411.81 Coronary occlusion without myocardial infarction 411.89 Other acute and subacute ischemic heart disease 412 Old myocardial infarction 413.0-413.1 Angina pectoris 413.9 Other and unspecified angina pectoris 414.00-414.03 Coronary atherosclerosis 414.04 Coronary atherosclerosis, of artery bypass graft 414.05 Coronary atherosclerosis, of unspecified graft 414.06 Coronary atherosclerosis, of coronary artery of transplanted heart 414.07 Coronary atherosclerosis, of bypass graft (artery) (vein) of transplanted heart 414.10 Aneurysm of heart (wall) 414.11 Coronary vessel aneurysm 414.12 Dissection of coronary artery 414.19 Other aneurysm of heart 414.3 Coronary atherosclerosis due to lipid rich plaque 414.4 Coronary atherosclerosis due to calcified coronary lesion 414.8 Other specified forms of chronic ischemic heart disease 414.9 Chronic ischemic heart disease, unspecified 428.0-428.9 Heart failure 429.2 Heart disease, unspecified 429.9 Heart disease NOS

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Code Description 431 Intracerebral hemorrhage 433.00-433.91 Occlusion & stenosis of precerebral arteries 434.00-434.91 Occlusion of cerebral arteries 435.0-435.9 Transient cerebral ischemia 437.0 Cerebral atherosclerosis 437.1 Other generalized ischemic cerebrovascular disease 437.5 Moyamoya disease 438.0, 438.10-438.14, 438.19, 438.20-438.22, 438.30-438.32, 438.40- 438.42, 438.50-438.53, 438.6, 438.7, 438.81-438.85, 438.89, 438.9 Late effects of cerebrovascular disease 440.0-440.32 Atherosclerosis of aorta; of other arteries; of bypass grafts 440.4 Chronic total occlusion of the artery of the extremities 440.8-440.9 Atherosclerosis of other specified arteries; generalized and unspecified atherosclerosis 441.00-441.9 Aortic aneurysms and dissection 442.0 Upper extremity aneurysm 442.1 Renal artery aneurysm 442.2 Iliac artery aneurysm 444.01, 444.09, 444.1-444.9 Arterial embolism and thrombosis 557.1 Chronic vascular insufficiency of intestine 571.8 Other chronic non-alcoholic liver disease 571.9 Unspecified chronic liver disease without mention of alcohol 573.5 Hepatopulmonary syndrome 573.8 Other specified disorders of liver 573.9 Unspecified disorders of liver 577.0-577.9 Pancreatic disease 579.3 Other & unspecified postsurgical nonabsorption 579.8 Other specified intestinal malabsorption 581.0-581.9 Nephrotic syndrome 584.5 Acute kidney failure with lesion of tubular necrosis 585.4-585.9 Chronic kidney disease 588.0 Renal osteodystrophy 588.1 Nephrogenic diabetes insipidus 588.81 Secondary hyperparathyroidism (of renal origin) 588.89 Other specified disorders resulting from impaired renal function 588.9 Unspecified disorder resulting from impaired renal function 607.84 Impotence of organic origin, penis disorder 646.70-646.71 Liver disorders in pregnancy

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Code Description 646.73 Liver and biliary tract disorders in pregnancy, antepartum condition or complication 648.10-648.14 Thyroid dysfunction in pregnancy and the puerperium 696.0 Psoriatic arthropathy 696.1 Other psoriasis 751.61 Biliary atresia 764.10-764.19 “Light for dates” with signs of fetal malnutrition 786.50 Chest pain, unspecified 786.51 Precordial pain 786.59 Chest pain, other 789.1 Hepatomegaly 790.4 Abnormal transaminase 790.5 Abnormal alkaline phosphatase 790.6 Other abnormal blood chemistry 793.4 Nonspecific (abnormal) findings on radiological and other examination of gastrointestinal tract 987.9 Toxic effect of unspecified gas or vapor 996.81 Complication of transplanted organ, kidney V42.0 Transplanted organ, kidney V42.7 Organ replacement by transplant, liver V58.63-V58.64 Long-term (current) drug use V58.69 Long term (current) use of other medications V81.0-V81.2 Covered only for Special screening for cardiovascular, respiratory, and genitourinary procedure codes 80061, diseases 82465, 83718 & 84478.

Indications The medical community recognizes lipid testing as appropriate for evaluating atherosclerotic cardiovascular disease. Conditions in which lipid testing may be indicated include:  Assessment of patients with atherosclerotic cardiovascular disease  Evaluation of primary dyslipidemia  Any form of atherosclerotic disease, or any disease leading to the formation of atherosclerotic disease  Diagnostic evaluation of diseases associated with altered lipid metabolism, such as: nephrotic syndrome, pancreatitis, hepatic disease, and hypo and hyperthyroidism  Secondary dyslipidemia, including diabetes mellitus, disorders of gastrointestinal absorption, chronic renal failure  Signs or symptoms of dyslipidemias, such as skin lesions  As follow-up to the initial screen for coronary heart disease (total cholesterol + HDL cholesterol) when total cholesterol is determined to be high (>240 mg/dL), or borderline-

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high (200-240 mg/dL) plus two or more coronary heart disease risk factors, or an HDL cholesterol <35 mg/dL. To monitor the progress of patients on anti-lipid dietary management and pharmacologic therapy for the treatment of elevated blood lipid disorders, total cholesterol, HDL cholesterol and LDL cholesterol may be used. Triglycerides may be obtained if this lipid fraction is also elevated or if the patient is put on drugs (for example, thiazide diuretics, beta blockers, estrogens, glucocorticoids, and tamoxifen) which may raise the triglyceride level. When monitoring long-term anti-lipid dietary or pharmacologic therapy and when following patients with borderline high total or LDL cholesterol levels, it may be reasonable to perform the lipid panel annually. A lipid panel at a yearly interval will usually be adequate while measurement of the serum total cholesterol or a measured LDL should suffice for interim visits if the patient does not have hypertriglyceridemia. Any one component of the panel or a measured LDL may be reasonable and necessary up to six times the first year for monitoring dietary or pharmacologic therapy. More frequent total cholesterol HDL cholesterol, LDL cholesterol and triglyceride testing may be indicated for marked elevations or for changes to anti-lipid therapy due to inadequate initial patient response to dietary or pharmacologic therapy. The LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved. Electrophoretic or other quantitation of lipoproteins may be indicated if the patient has a primary disorder of lipoid metabolism. Effective January 1, 2005, the Medicare law expanded coverage to cardiovascular screening services. Several of the procedures included in this NCD may be covered for screening purposes subject to specified frequencies. See 42 CFR 410.17 and section 100, chapter 18, of the Claims Processing Manual, for a full description of this benefit. Limitations Lipid panel and hepatic panel testing may be used for patients with severe psoriasis which has not responded to conventional therapy and for which the retinoid etretinate has been prescribed and who have developed hyperlipidemia or hepatic toxicity. Specific examples include erythrodermia and generalized pustular type and psoriasis associated with arthritis. Routine screening and prophylactic testing for lipid disorder are not covered by Medicare. While lipid screening may be medically appropriate, Medicare by statute does not pay for it. Lipid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc. Once a diagnosis is established, one or several specific tests are usually adequate for monitoring the course of the disease. Less specific diagnoses (for example, other chest pain) alone do not support medical necessity of these tests. When monitoring long-term anti-lipid dietary or pharmacologic therapy and when following patients with borderline high total or LDL cholesterol levels, it is reasonable to perform the lipid panel annually. A lipid panel at a yearly interval will usually be adequate while measurement of the serum total cholesterol or a measured LDL should suffice for interim visits if the patient does not have hypertriglyceridemia. Any one component of the panel or a measured LDL may be medically necessary up to six times the first year for monitoring dietary or pharmacologic therapy. More frequent total cholesterol HDL cholesterol, LDL cholesterol and triglyceride testing may be indicated for

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This is CMS Logo. marked elevations or for changes to anti-lipid therapy due to inadequate initial patient response to dietary or pharmacologic therapy. The LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved. If no dietary or pharmacological therapy is advised, monitoring is not necessary. When evaluating non-specific chronic abnormalities of the liver (for example, elevations of transaminase, alkaline phosphatase, abnormal imaging studies, etc.), a lipid panel would generally not be indicated more than twice per year. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information American Diabetes Association. Management of Dyslipidemia in Adults with Diabetes. J. Florida M.A. 1998, 85:2 30-34. Jialal, I. Evolving lipoprotein risk factors: lipoprotein (a) and oxidizing low-density lipoprotein. Clin Chem 1998; 44:8(B) 1827-1832. McMorrow, ME, Malarkey, L. Laboratory and Diagnostic Tests: A Pocket Guide. W.B. Saunders Company. 206-207. U.S. Department of Health and Human Services. National Cholesterol Education Program. Recommendations for Improving Cholesterol Measurement. NIH Publication 90-2964. February 1990. National Institutes of Health. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. NIH Publication 93-3095. September 1993. Bierman EL. Atherosclerosis and other forms of arteriosclerosis. Harrison’s Principles of Internal Medicine. Eds. Isselbacher KJ, Braunwald E, Wilson JD, et al. McGraw-Hill. New York. 1994; 2058-2069. Brown MS and Goldstein JL. The hyperlipoproteinemias and other disorders of lipid metabolism. Harrison’s Principles of Internal Medicine. Eds. Isselbacher KJ, Braunwald E, Wilson JD, et al. McGraw-Hill. New York. 1994; 1106-1116.

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190.24 - Digoxin Therapeutic Drug Assay

Previously Listed as Edit 13 Description A digoxin therapeutic drug assay is useful for diagnosis and prevention of digoxin toxicity, and/or prevention for under dosage of digoxin. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 80162 Digoxin (Therapeutic Drug Assay) ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 242.00-242.91 Thyrotoxicosis with or without goiter 243 Congenital hypothyroidism 244.0-244.9 Acquired hypothyroidism 245.0-245.9 Thyroiditis 275.2 Disorders of magnesium metabolism 275.40-275.49 Disorders of calcium metabolism 275.5 Hungry bone syndrome 276.0 Hyperosmolality 276.1 Hyposmolality 276.2 Acidosis 276.3 Alkalosis 276.4 Mixed acid-base balance disorder 276.50-276.52 Volume depletion 276.61 Transfusion associated circulatory overload 276.69 Other fluid overload 276.7 Hyperpotassemia 276.8 Hypopotassemia 276.9 Electrolyte and fluid disorders not elsewhere classified 293.0 Delirium due to conditions classified elsewhere 293.1 Subacute delirium 307.47 Other dysfunctions of sleep stages or arousal from sleep 339.3 Drug induced headache, not elsewhere classified 368.16 Psychophysical visual disturbances 368.8 Other specified visual disturbances

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Code Description 368.9 Unspecified visual disturbances 397.9 Rheumatic diseases of endocardium 398.0 Rheumatic Myocarditis 398.91 Rheumatic Heart Failure 402.01 Hypertensive heart disease, malignant with heart failure 402.11 Hypertensive heart disease, benign with heart failure 402.91 Hypertensive heart disease, unspecified with heart failure 403.00-403.91 Hypertensive chronic kidney disease 404.00-404.93 Hypertensive heart and chronic kidney disease 410.00-410.92 Acute myocardial infarction 411.0-411.89 Other acute & subacute forms of ischemic heart disease 413.0-413.9 Angina pectoris 414.4 Coronary atherosclerosis due to calcified coronary lesion 422.0-422.99 Acute myocarditis 425.0, 425.11, 425.18, 425.2- Cardiomyopathy 425.9 426.0-426.9 Conduction disorders 427.0-427.9 Cardiac dysrhythmias 428.0-428.9 Heart failure 429.2 Cardiovascular disease, unspecified 429.4 Heart Disturbances Postcardiac Surgery 429.5 Rupture chordae tendineae 429.6 Rupture papillary muscle 429.71 Acquired cardiac septal defect 444.01 Saddle embolus of abdominal aorta 444.09 Other arterial embolism and thrombosis of abdominal aorta 514 Pulmonary congestion & hypostasis 573.5 Hepatopulmonary syndrome 579.9 Unspecified Intestinal malabsorption 584.5 Acute kidney failure with lesion of tubular necrosis 584.6 Acute kidney failure with lesion of renal cortical necrosis 584.7 Acute kidney failure with lesion of renal medullary (papillary) necrosis 584.8 Acute kidney failure with other specified pathological lesion in kidney 584.9 Acute kidney failure, unspecified 585.1-585.9 Chronic kidney disease 586 Renal Failure, unspecified 587 Renal sclerosis, unspecified 588.0 Renal osteodystrophy 588.1 Nephrogenic Diabetes Insipidus 588.81 Secondary hyperparathyroidism (of renal origin)

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Code Description 588.89 Other specified disorders resulting from impaired renal function 588.9 Unspecified disorder resulting from impaired renal function 780.01 Coma 780.02 Transient alteration of awareness 780.09 Other ill-defined general symptoms (drowsiness, semicoma, somnolence, stupor, unconsciousness) 780.1 Hallucinations 780.2 Syncope and collapse 780.4 Dizziness and giddiness 780.71 Malaise and fatigue 780.72 Functional quadriplegia 780.79 Other malaise and fatigue 783.0 Anorexia 784.0 Headache 787.01-787.03 Nausea & vomiting 787.04 Bilious emesis 787.91 Diarrhea 794.31 Abnormal electrocardiogram 799.21 Nervousness 799.22 Irritability 799.23 Impulsiveness 799.24 Emotional lability 799.25 Demoralization and apathy 799.29 Other signs and symptoms involving emotional state 972.0 Poisoning by cardiac rhythm regulators 972.1 Poisoning by cardiotonic glycosides & drugs of similar action 995.20 Unspecified adverse effect of unspecified drug, medicinal and biological substance 995.21 Arthus phenomenon 995.24 Failed moderate sedation during procedure 995.27 Other drug allergy 995.29 Unspecified adverse effect of other drug, medicinal & biological substance *E942.1 Adverse effect of cardiotonic glycosides and drugs of similar action V58.69 Encounter long term - medication use (not elsewhere classified) *Code may not be reported as a stand-alone or first-listed code on the claim Indications Digoxin levels may be performed to monitor drug levels of individuals receiving digoxin therapy because the margin of safety between side effects and toxicity is narrow or because the blood level may not be high enough to achieve the desired clinical effect.

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Clinical indications may include individuals on digoxin:  With symptoms, signs or electrocardiogram (ECG) suggestive of digoxin toxicity  Taking medications that influence absorption, bioavailability, distribution, and/or elimination of digoxin  With impaired renal, hepatic, gastrointestinal, or thyroid function  With pH and/or electrolyte abnormalities  With unstable cardiovascular status, including myocarditis  Requiring monitoring of patient compliance Clinical indications may include individuals:  Suspected of accidental or intended overdose  Who have an acceptable cardiac diagnosis (as listed) and for whom an accurate history of use of digoxin is unobtainable The value of obtaining regular serum digoxin levels is uncertain, but it may be reasonable to check levels once yearly after a steady state is achieved. In addition, it may be reasonable to check the level if:  Heart failure status worsens  Renal function deteriorates  Additional medications are added that could affect the digoxin level  Signs or symptoms of toxicity develop Steady state will be reached in approximately 1 week in patients with normal renal function, although 2-3 weeks may be needed in patients with renal impairment. After changes in dosages or the addition of a medication that could affect the digoxin level, it is reasonable to check the digoxin level one week after the change or addition. Based on the clinical situation, in cases of digoxin toxicity, testing may need to be done more than once a week. Digoxin is indicated for the treatment of patients with heart failure due to systolic dysfunction and for reduction of the ventricular response in patients with atrial fibrillation or flutter. Digoxin may also be indicated to treat other supraventricular arrhythmias, particularly with heart failure. Limitations This test is not appropriate for patients on digitoxin or treated with digoxin FAB (fragment antigen binding) antibody. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Doherty JE. Digitalis serum levels: clinical use. Ann Intern Med 1971 May; 74(5):787-789. Duhme DW, Greenblatt DJ, Koch-Weser J. Reduction of digoxin toxicity associated with measurement of serum levels. A report from the Boston Collaborative Drug Surveillance Program. Ann Intern Med 1974 Apr; 80(4):516-519 Goldman RH, Use of Serum Digoxin Levels in Clinical Practice. JAMA 1974, Jul 15, 229(3).

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Howanitz PJ, Steindel SJ. Digoxin therapeutic drug monitoring practices. A College of American Pathologists Q-Probes study of 666 institutions and 18,679 toxic levels. Arch Pathol Lab Med 1993 Jul; 117(7):684-690. Marcus FI. Pharmacokinetic interactions between digoxin and other drugs. J Am Coll Cardiol 1985 May; 5(5 Suppl A):82A-90A. Rodin SM, Johnson BF. Pharmacokinetic interactions with digoxin. Clin Pharmaco-kinet 1988 Oct; 15(4):227-244. Smith TW, Butler VP Jr, Haber E. Determination of therapeutic and toxic serum digoxin concentrations by radioimmunoassay. N Engl J Med 1969 Nov 27; 281(22):1212-1216. Smith TW, Haber E. Digoxin intoxication: the relationship of clinical presentation to serum digoxin concentration. J Clin Invest 1970, Dec; 49 (12):2377-2386. Valdes R. Jr, Jortani SA, Gheorghiade M. Standards of laboratory practice: cardiac drug monitoring. National Academy of Clinical Biochemistry. Clin Chem 1998 May; 44(5): 1096-1109. Konstam M, Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of Patients with Left- Ventricular Systolic Dysfunction. Clinical Practice Guideline No.11. AHCPR Pub. No. 94-0612. Rockville, MD: Agency for Health Care Policy & Research, Public Health Service, U.S. Dept. of Health and Human Services. June 1994.

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190.25 - Alpha-fetoprotein

Previously Listed as Edit 14 Other Names/Abbreviations AFP Description Alpha-fetoprotein (AFP) is a polysaccharide found in some carcinomas. It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82105 Alpha-fetoprotein; serum ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 070.22-070.23 Chronic viral hepatitis B with hepatic coma, with or without mention of hepatitis delta 070.32-070.33 Chronic viral hepatitis B without mention of hepatic coma, with or without mention of hepatitis delta 070.44 Chronic hepatitis C with hepatic coma 070.54 Chronic hepatitis C without mention of hepatic coma 095.3 Syphilis of liver 121.1 Clonorchiasis 121.3 Fascioliasis 155.0-155.2 Malignant neoplasm of the liver and intrahepatic bile ducts 164.2-164.9 Malignant neoplasm of the mediastinum 183.0 Malignant neoplasm, ovary 186.0 Malignant neoplasm of undescended testis 186.9 Malignant neoplasm, other and unspecific testis 197.1 Secondary malignant neoplasm of mediastinum 197.7 Secondary malignant neoplasm of liver 198.6 Secondary malignant neoplasm of ovary 198.82 Secondary malignant neoplasm, genital organs 209.20-209.27, 209.29 Malignant carcinoid tumors of other and unspecified sites 209.70 Secondary neuroendocrine tumor, unspecified site

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Code Description 209.71 Secondary neuroendocrine tumor of distant lymph nodes 209.72 Secondary neuroendocrine tumor of liver 209.73 Secondary neuroendocrine tumor of bone 209.74 Secondary neuroendocrine tumor of peritoneum 209.75 Secondary Merkel cell carcinoma 209.79 Secondary neuroendocrine tumor of other sites 211.5 Benign neoplasm of liver and biliary passages 235.3 Neoplasm of uncertain behavior of liver and biliary passages 272.2 Mixed hyperlipidemia 273.4 Alpha-1-antitrypsin deficiency 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 275.1 Disorder of copper metabolism 277.00 Cystic Fibrosis without mention of meconium ileus 277.03 Cystic fibrosis with gastrointestinal manifestations 277.6 Other deficiencies of circulating enzymes 285.0 Sideroblastic Anemia 338.3 Neoplasm related pain (acute) (chronic) 414.4 Coronary atherosclerosis due to calcified coronary lesion 444.01 Saddle embolus of abdominal aorta 444.09 Other arterial embolism and thrombosis of abdominal aorta 571.2 Alcoholic cirrhosis of liver 571.40 Chronic hepatitis, unspecified 571.41 Chronic persistent hepatitis 571.42 Autoimmune hepatitis 571.49 Other chronic hepatitis 571.5 Cirrhosis of liver without mention of alcohol 573.5 Hepatopulmonary syndrome 608.89 Other specified disorders of male genital organs 793.11 Solitary pulmonary nodule 793.19 Other nonspecific abnormal finding of lung field 793.2 Non-specific (abnormal) findings on radiological and other examination of other intrathoracic organs 793.3 Non-specific (abnormal) findings on radiological and other examination of biliary tract 793.6 Non-specific (abnormal) findings on radiological and other examination of abdominal area, including retroperitoneum 795.89 Other abnormal tumor markers V10.07 Personal history of malignant neoplasm, liver

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Code Description V10.43 Personal history of malignant neoplasm, ovary V10.47 Personal history of malignant neoplasm, testis V86.0 Estrogen receptor positive status [ER+] V86.1 Estrogen receptor negative status [ER-]

Indications AFP is useful for the diagnosis of hepatocellular carcinoma in high-risk patients (such as alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1-antitrypsin deficiency) and in separating patients with benign hepatocellular neoplasms or metastases from those with hepatocellular carcinoma and, as a non-specific tumor associated antigen, serves in marking germ cell neoplasms of the testis, ovary, retro peritoneum, and mediastinum. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Tatsuta M. Yamamura H. Iishi H. Kasugai H. Okuda S.Value of serum alpha-fetoprotein and ferritin in the diagnosis of hepatocellular carcinoma. Oncology. 43(5):306-10, 1986.

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190.26 - Carcinoembryonic Antigen

Previously Listed as Edit 15 Other Names/Abbreviations CEA Description Carcinoembryonic antigen (CEA) is a protein polysaccharide found in some carcinomas. It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82378 Carcinoembryonic antigen (CEA) ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 150.0-150.9 Malignant neoplasm of the esophagus 151.0-151.9 Malignant neoplasm of stomach 152.0-154.8 Malignant neoplasm of small intestine, including duodenum, rectum, rectosigmoid junction and anus 157.0-157.9 Primary malignancy of pancreas 159.0 Malignant neoplasm of intestinal tract, part unspecified 162.0-162.9 Malignant neoplasm of trachea, bronchus, lung 174.0-174.9 Malignant neoplasm of female breast 175.0-175.9 Malignant neoplasm of male breast 183.0 Malignant neoplasm of ovary 197.0 Secondary malignant neoplasm of neoplasm of lung 197.4 Secondary malignant neoplasm of small intestine 197.5 Secondary malignant neoplasm of large intestine and rectum 209.00-209.03 Malignant carcinoid tumors of the small intestine 209.10-209.17 Malignant carcinoid tumors of the appendix, large intestine and rectum 209.20-209.27, 209.29 Malignant carcinoid tumors of other and unspecified sites 209.70 Secondary neuroendocrine tumor, unspecified site 209.71 Secondary neuroendocrine tumor of distant lymph nodes 209.72 Secondary neuroendocrine tumor of liver 209.73 Secondary neuroendocrine tumor of bone 209.74 Secondary neuroendocrine tumor of peritoneum

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Code Description 209.75 Secondary Merkel cell carcinoma 209.79 Secondary neuroendocrine tumor of other sites 230.3 Carcinoma in situ of colon 230.4 Carcinoma in situ of rectum 230.7 Carcinoma in situ of other/unspecified parts of intestine 230.9 Carcinoma in situ other and unspecified digestive organs 235.2 Neoplasm of uncertain behavior of stomach, intestines, rectum 338.3 Neoplasm related pain (acute) (chronic) 790.99 Other nonspecific findings on examination of blood 795.81 Elevated carcinoembryonic antigen [CEA] 795.89 Other abnormal tumor markers V10.00 Personal history of malignant neoplasm of gastro-intestinal tract, unspecified V10.05 Personal history of malignant neoplasm, large intestine V10.06 Personal history of malignant neoplasm, rectum, rectosigmoid junction, anus V10.11 Personal history of malignant neoplasm, bronchus, and lung V10.3 Personal history of malignant neoplasm, breast V10.43 Personal history of malignant neoplasm, ovary V67.2 Follow-up examination following chemotherapy

Indications CEA may be medically necessary for follow-up of patients with colorectal carcinoma. It would however only be medically necessary at treatment decision-making points. In some clinical situations (e.g. adenocarcinoma of the lung, small cell carcinoma of the lung, and some gastrointestinal carcinomas) when a more specific marker is not expressed by the tumor, CEA may be a medically necessary alternative marker for monitoring. Preoperative CEA may also be helpful in determining the post-operative adequacy of surgical resection and subsequent medical management. In general, a single tumor marker will suffice in following patients with colorectal carcinoma or other malignancies that express such tumor markers. In following patients who have had treatment for colorectal carcinoma, ASCO guideline suggests that if resection of liver metastasis would be indicated, it is recommended that postoperative CEA testing be performed every two to three months in patients with initial stage II or stage III disease for at least two years after diagnosis. For patients with metastatic solid tumors which express CEA, CEA may be measured at the start of the treatment and with subsequent treatment cycles to assess the tumor’s response to therapy. Limitations Serum CEA determinations are generally not indicated more frequently than once per chemotherapy treatment cycle for patients with metastatic solid tumors which express CEA or every two months post-surgical treatment for patients who have had colorectal carcinoma.

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However, it may be proper to order the test more frequently in certain situations, for example, when there has been a significant change from prior CEA level or a significant change in patient status which could reflect disease progression or recurrence. Testing with a diagnosis of an in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Journal Clinical Oncol: 14(10:2843-2877), 1996 Vauthey JN. Dudrick PS. Lind DS. Copeland EM 3rd. Management of recurrent colorectal cancer: another look at carcinoembryonic antigen detected recurrence [see comments]. [Review] Digestive Diseases. 14(1):5©13, 1996 Jan-Feb. Germ J. The prognostic importance of tumor markers in adenocarcinoma of the gastrointestinal tract. [Review] [38 refs] Current Opinion in Oncology. 9(4):380-7, 1997 Jul. Bergama chi R. Arnaud JP. Routine compared with nonscheduled follow-up of patients with “curative” surgery for colorectal cancer. Annals of Surgical Oncology. 3(5):464-9, 1996 Sep. Kim YH. Ajani JA. Ota DM. Lynch P. Roth JA. Value of serial carcinoembryonic antigen levels in patients with respectable adenocarcinoma of the esophagus and stomach Cancer. 75(2):451©6, 1995 Jan 15.

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190.27 - Human Chorionic Gonadotropin

Previously Listed as Edit 16 Other Names/Abbreviations hCG Description Human Chorionic Gonadotropin (hCG) is useful for monitoring and diagnosis of germ cell neoplasms of the ovary, testis, mediastinum, retroperitoneum, and central nervous system. In addition, hCG is useful for monitoring pregnant patients with vaginal bleeding, hypertension and/or suspected fetal loss. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 84702 Gonadotropin, chorionic (hCG); quantitative ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 158.0 Malignant neoplasm of retroperitoneum 158.8 Malignant neoplasm of specified parts of peritoneum 164.2 Malignant neoplasm of anterior mediastinum 164.3 Malignant neoplasm of posterior mediastinum Malignant neoplasm, other (includes malignant neoplasm of contiguous overlapping sites of thymus, heart, and mediastinum 164.8 whose point of origin cannot be determined 164.9 Malignant neoplasm of mediastinum, part specified 181 Malignant neoplasm of placenta 183.0 Malignant neoplasm of ovary 183.8 Other specified sites of uterine adnexa 186.0 Malignant neoplasm of undescended testis 186.9 Malignant neoplasm of other and unspecified testis 194.4 Malignant neoplasm of pineal gland 197.1 Secondary malignant neoplasm of mediastinum 197.6 Secondary malignant neoplasm of retroperitoneum and peritoneum 198.6 Secondary malignant neoplasm of ovary 198.82 Secondary malignant neoplasm of other genital organs 236.1 Neoplasm of uncertain behavior, placenta 338.3 Neoplasm related pain (acute) (chronic)

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Code Description 623.8 Vaginal bleeding 625.9 Pelvic pain 630 Hydatidiform mole 631.0 Inappropriate change in quantitative human chorionic gonadotropin (hCG) in early pregnancy 631.8 Other abnormal products of conception 632 Missed abortion 633.90-633.91 Unspecified ectopic pregnancy 634.00-634.02 Spontaneous abortion, complicated by genital tract and pelvic infection 640.00-640.03 Threatened abortion 642.30-642.34 Transient hypertension of pregnancy 642.40-642.74 Pre-eclampsia or eclampsia 642.90-642.94 Unspecified hypertension complicating pregnancy, childbirth, or the puerperium 795.89 Other abnormal tumor markers V10.09 Personal history of malignant neoplasm, other gastrointestinal sites V10.29 Personal history of malignant neoplasm of other respiratory and intrathoracic organs V10.43 Personal history of malignant neoplasm, ovary V10.47 Personal history of malignant neoplasm, testis V22.0-V22.1 Normal pregnancy

Limitations It is not reasonable and necessary to perform hCG testing more than once per month for diagnostic purposes. It may be performed as needed for monitoring of patient progress and treatment. Qualitative hCG assays are not appropriate for medically managing patients with known or suspected germ cell neoplasms. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information O’Callaghan A. Mead GM. Testicular carcinoma. [Review] [23 Refs] Postgraduate Medical Journal. 73(862):4816, 1997 Aug. Sawamura Y. Current diagnosis and treatment of central nervous system germ cell tumors. [Review] [47 Refs] Current Opinion in Neurology. 9(6):41923, 1996 Dec. Wilkins M. Horwich A. Diagnosis and treatment of urological malignancy: The testes. [Review] [23 Refs] British Journal of Hospital Medicine. 55(4): 199203, 1996. Feb 21, Mar 5.

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190.28 - Tumor Antigen by Immunoassay CA 125

Previously Listed as Edit 17 Description Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers. When elevated, serum concentration of these markers may reflect tumor size and grade. This policy specifically addresses tumor antigen CA 125. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 86304 Immunoassay for tumor antigen, quantitative, CA 125 ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 158.8 Malignant neoplasm, specified parts of peritoneum 158.9 Malignant neoplasm, peritoneum, unspecified 180.0 Malignant neoplasm, endocervix 182.0 Malignant neoplasm of corpus uteri, except isthmus 183.0 Malignant neoplasm,ovary 183.2 Malignant neoplasm, fallopian tube 183.8 Malignant neoplasm, other specified sites of uterine adnexa 184.8 Malignant neoplasm, other specified sites of female genital organs 198.6 Secondary malignant neoplasm, ovary 198.82 Secondary malignancy of genital organs 236.0-236.3 Neoplasm of uncertain behavior of female genital organs 338.3 Neoplasm related pain (acute) (chronic) 789.39 Abdominal or pelvic swelling, mass or lump of other specified site 795.82 Elevated cancer antigen 125 [CA 125] 795.89 Other abnormal tumor markers V10.41 Personal history of malignant neoplasm, cervix uteri V10.42 Personal history of malignant neoplasm, other parts of the uterus V10.43-V10.44 Personal history of malignant neoplasm of female genital organs

Indications CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube,

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This is CMS Logo. endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma or primary peritoneal carcinoma. A CA 125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of postoperative monitoring. Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient’s CA 125 half-life, which has significant prognostic implications. The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance CA 125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient’s response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle. Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient’s response to treatment with subsequent treatment cycles. The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single “tumor marker” will suffice in following a patient with one of these malignancies. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Documentation Requirements Indicated if service request for CA125 is requested more frequently than stipulated. Sources of Information Clinical Pancreatic Guideline for the Use of Tumor Markers in Breast and Colorectal Cancer, American Society of Clinical Oncology. J Clin Oncol 14:2843-2877, 1996. Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR Radioimmunoassay for Early Detection of Breast Cancer Recurrence in Patients with Stage II and Stage III Disease. J Clin Oncol 1977, 15(6):2322-2328.

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190.29 - Tumor Antigen by Immunoassay CA 15-3/CA 27.29

Previously Listed as Edit 18 Description Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers. When elevated, serum concentration of markers may reflect tumor size & grade. This policy specifically addresses the following tumor antigens: CA 15-3 and CA 27.29 HCPCS Codes (Alphanumeric, CPT AMA) Code Description 86300 Immunoassay for tumor antigen, quantitative; CA 15-3 (27.29) ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 174.0-174.9 Breast, primary (female) - malignant neoplasm of female breast 175.0-175.9 Breast, primary (male) - malignant neoplasm of male breast 198.2 Secondary malignant neoplasm (skin of breast) 198.81 Secondary malignant neoplasm (breast) 338.3 Neoplasm related pain (acute) (chronic) 795.89 Other abnormal tumor markers V10.3 Personal history of malignant neoplasm, breast Indications Multiple tumor markers are available for monitoring the response of certain malignancies to therapy and assessing whether a residual tumor exists post-surgical therapy. CA 15-3 is often medically necessary to aid in the management of patients with breast cancer. Serial testing must be used in conjunction with other clinical methods for monitoring breast cancer. For monitoring, if medically necessary, use consistently either CA 15-3 or CA 27.29, not both. CA 27.29 is equivalent to CA 15-3 in its usage in management of patients with breast cancer. Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient’s response to treatment with subsequent treatment cycles. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections.

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Sources of Information Clinical Pancreatic Guideline for the Use of Tumor Markers in Breast and Colorectal Cancer, American Society of Clinical Oncology. J Clin Oncol 14:2843-2877, 1996. Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR Radioimmunoassay for Early Detection of Breast Cancer Recurrence in Patients with Stage II & Stage III Disease. J Clin Oncol 1977, 15(6):2322-2328. Bone GG, von Mensdorff-Pouilly S, Kenemans P, van Kamp GJ, et al. Clinical and Technical Evaluation of ACS BR Serum Assay of MUC-1 Gene Derived Glycoprotein in Breast Cancer, and Compared with CA15-3 Assays. Clin Chem 1997, 43(4):585-593.

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190.30 - Tumor Antigen by Immunoassay CA 19-9

Previously Listed as Edit 19 Description Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers. When elevated, serum concentration of these markers may reflect tumor size and grade. This policy specifically addresses the following tumor antigen: CA19-9. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 86301 Immunoassay for tumor antigen, quantitative; CA 19-9 ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 155.1 Malignant neoplasm, intrahepatic bile ducts 156.0 Malignant neoplasm of the gallbladder 156.1 Malignant neoplasm, extrahepatic bile ducts 156.2 Malignant neoplasm of the Ampulla of Vater 156.8 Malignant neoplasm, other specified sites of gallbladder and extrahepatic bile ducts 156.9 Malignant neoplasm, unspecified part of biliary tract 157.0-157.9 Malignant neoplasm, pancreas 197.8 Secondary malignant neoplasm, other digestive organs and spleen 235.3 Neoplasm of uncertain behavior, liver and biliary passages 235.5 Neoplasm of uncertain behavior, other & unspecified digestive organs 338.3 Neoplasm related pain (acute) (chronic) 795.89 Other abnormal tumor markers V10.09 Other personal history of cancer

Indications Multiple tumor markers are available for monitoring the response of certain malignancies to therapy and assessing whether residual tumor exists post-surgical therapy. Levels are useful in following the course of patients with established diagnosis of pancreatic and biliary ductal carcinoma. The test is not indicated for diagnosing these two diseases.

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Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient’s response to treatment with subsequent treatment cycles. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Clinical Pancreatic Guideline for the Use of Tumor Markers in Breast and Colorectal Cancer, American Society of Clinical Oncology. J Clin Oncol 14:2843-2877, 1996. Richter JM, Christensen MR, Rustgi AK, and Silverstein MD. The Clinical Utility of the CA19-9 Radioimmunoassay for the Diagnosis of Pancreatic Cancer Presenting as Pain or Weight Loss: A Cost Effective Analysis. Arch Intern Med 1989, 149:2292-2297. Safi F, SchlosseW, Falkenreck S, et. al. Prognostic Value of CA 19-9 Serum Course in Pancreatic Cancer. Hepaetogastroenterology 1998 Jan-Feb; 45(19):253-9.

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190.31 - Prostate Specific Antigen

Previously Listed as Edit 20 Other Names/Abbreviations Total PSA Description Prostate Specific Antigen (PSA), a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post-operative phase of prostate cancer. Three to 6 months after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent disease. Six months following introduction of antiandrogen therapy, PSA is reported of distinguishing patients with favorable response from those in whom limited response is anticipated. PSA when used in conjunction with other prostate cancer tests, such as digital rectal examination, may assist in the decision-making process for diagnosing prostate cancer. PSA also, serves as a marker in following the progress of most prostate tumors once a diagnosis has been established. This test is also an aid in the management of prostate cancer patients and in detecting metastatic or persistent disease in patients following treatment. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 84153 Prostate Specific Antigen (PSA), total ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 185 Malignant neoplasm of prostate 188.5 Malignant neoplasm of bladder neck 196.5 Secondary malignant neoplasm, lymph nodes of inguinal region & lower limb 196.6 Secondary malignant neoplasm, intrapelvic lymph nodes 196.8 Secondary malignant neoplasm, lymph nodes of multiple sites 198.5 Secondary malignant neoplasm, bone and bone marrow 198.82 Secondary malignant neoplasm, genital organs 233.4 Carcinoma in situ, prostate 236.5 Neoplasm of uncertain behavior of prostate 239.5 Neoplasm of unspecified nature, other genitourinary organs 596.0 Bladder neck obstruction 599.60, 599.69 Urinary obstruction 599.70 Hematuria, unspecified 599.71 Gross hematuria

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Code Description 599.72 Microscopic hematuria 600.00 Hypertrophy (benign) of prostate without urinary obstruction and other lower urinary tract (LUTS) 600.01 Hypertrophy (benign) of prostate with urinary obstruction and other lower urinary tract symptoms (LUTS) 600.10 Nodular prostate without urinary obstruction 600.11 Nodular prostate with urinary obstruction 600.21 Benign localized hyperplasia of prostate with urinary obstruction and other lower urinary tract symptoms (LUTS) 601.9 Unspecified prostatitis 602.9 Unspecified disorder of prostate 788.20 Retention of urine, unspecified 788.21 Incomplete bladder emptying 788.30 Urinary incontinence, unspecified 788.41 Urinary frequency 788.43 Nocturia 788.62 Slowing of urinary stream 788.63 Urgency of urination 788.64 Urinary hesitancy 788.65 Straining on urination 790.93 Elevated prostate specific antigen (PSA) 793.6 Non-specific (abnormal) findings on radiological and other examination of abdominal area, including retroperitoneum 793.7 Non-specific (abnormal) findings on radiological and other examination of musculoskeletal system 794.9 Bone scan evidence of malignancy V10.46 Personal history of malignant neoplasm; prostate

Indications PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs & symptoms (e.g., hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia & incontinence) as well as with patients with palpably abnormal prostate glands on physician exam, and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder. PSA is also a marker used to follow the progress of prostate cancer once a diagnosis has been established, such as detecting metastatic or persistent disease in patients who may require additional treatment. PSA testing may also be useful in the differential diagnosis of men presenting with as yet undiagnosed disseminated metastatic disease. Limitations Generally, for patients with lower urinary tract signs or symptoms, the test is performed only once per year unless there is a change in the patient’s medical condition.

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Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Laboratory Test Handbook, 3rd edition, pp.338-340. Cooner WH, Mosley BR, Rutherford CL, et al. Prostate Cancer Detection in a Clinical Urological Practice by Ultrasonography, Digital Rectal Examination and Prostate Specific Antigen. J.Urol.1990; 143: 1146-1154.

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190.32 - Gamma Glutamyl Transferase

Previously Listed as Edit 21 Other Names/Abbreviations GGT Description Gamma glutamyl transferase (GGT) is an intracellular enzyme that appears in blood following leakage from cells. Renal tubules, liver, and pancreas contain high amounts, although the measurement of GGT in serum is almost always used for assessment of Hepatobiliary function. Unlike other enzymes which are found in heart, skeletal muscle, and intestinal mucosa as well as liver, the appearance of an elevated level of GGT in serum is almost always the result of liver disease or injury. It is specifically useful to differentiate elevated alkaline phosphatase levels when the source of the alkaline phosphatase increase (bone, liver, or placenta) is unclear. The combination of high alkaline phosphatase and a normal GGT does not, however, rule out liver disease completely. As well as being a very specific marker of Hepatobiliary function, GGT is also a very sensitive marker for hepatocellular damage. Abnormal concentrations typically appear before elevations of other liver enzymes or biliuria are evident. Obstruction of the biliary tract, viral infection (e.g., hepatitis, mononucleosis), metastatic cancer, exposure to hepatotoxins (e.g., organic solvents, drugs, alcohol), and use of drugs that induce microsomal enzymes in the liver (e.g., cimetidine, barbiturates, phenytoin, and carbamazepine) all can cause a moderate to marked increase in GGT serum concentration. In addition, some drugs can cause or exacerbate liver dysfunction (e.g., atorvastatin, troglitazone, and others as noted in FDA Contraindications and Warnings.) GGT is useful for diagnosis of liver disease or injury, exclusion of hepatobiliary involvement related to other diseases, and patient management during the resolution of existing disease or following injury. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82977 Glutamyl transferase, gamma (GGT) ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 003.1 Salmonella septicemia 006.0-006.9 Amebiasis 014.00-014.86 Tuberculosis of intestines, peritoneum, and mesenteric glands 017.90-017.96 Tuberculosis of other specified organs 018.90-018.96 Miliary tuberculosis, unspecified

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Code Description 020.0-020.9 Plague 022.3 Anthrax septicemia 027.0 Listeriosis 027.1 Erysipelothrix infection 030.1 Tuberculoid leprosy [Type T] 032.83 Diphtheritic peritonitis 036.1 Meningococcal encephalitis 036.2 Meningococcemia 038.0, 038.10-038.19, 038.2, Septicemia 038.3, 038.40-038.49, 038.8, 038.9 038.12 Methicillin resistant Staphylococcus aureus septicemia 039.2 Actinomycotic infections, abdominal 040.0 Gas gangrene 042 Human immunodeficiency virus (HIV) disease 054.0 Eczema herpeticum 054.5 Herpetic septicemia 060.0-060.1 Yellow fever 070.0-070.9 Viral hepatitis 072.71 Mumps hepatitis 073.0 Ornithosis, with pneumonia 074.8 Other specified diseases due to Coxsackie virus 075 Infectious mononucleosis 078.5 Cytomegaloviral disease 079.99 Unspecified viral infection 082.0-082.9 Tick-borne rickettsioses, stet 084.9 Other pernicious complications of malaria 086.1 Chagas disease with organ involvement other than heart 088.81 Lyme disease 091.62 Secondary syphilitic hepatitis 095.3 Syphilis of liver 100.0 Leptospirosis icterohemorrhagica 112.5 Candidiasis, disseminated 115.00 Infection by Histoplasma capsulatum without mention of manifestation 120.9 Schistosomiasis, unspecified 121.1 Clonorchiasis 121.3 Fascioliasis 122.0 Echinococcus granulosus infection of liver 122.5 Echinococcus multilocularis infection of liver 122.8 Echinococcosis, unspecified, of liver 122.9 Echinococcus, other and unspecified

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Code Description 130.5 Hepatitis due to toxoplasmosis 135 Sarcoidosis 150.0-159.9 Malignant neoplasm of digestive organs and peritoneum 160.0-165.9 Malignant neoplasm of respiratory and intrathoracic organs 170.0-176.9 Malignant neoplasm of bone, connective tissue, skin, and breast 179-189.9 Malignant neoplasm of genitourinary organs 200.00-200.28 Lymphosarcoma and reticulosarcoma; Burkitt’s tumor or lymphoma 200.30-200.38 Marginal zone lymphoma 200.40-200.48 Mantle cell lymphoma 200.50-200.58 Primary central nervous system lymphoma 200.60-200.68 Anaplastic large cell lymphoma 200.70-200.78 Large cell lymphoma 200.80-200.88 Malignant tumors of lymphatic tissue; other named variants 201.00-201.98 Hodgkin’s disease 202.00-202.68 Other malignant neoplasms of lymphoid and histiocytic tissue 202.70-202.78 Peripheral T-cell lymphoma 202.80-202.98 Other lymphomas; other and unspecified malignant neoplasms of lymphoid and histiocytic tissue 203.00-203.01 Multiple myeloma, without mention of having achieved remission and in remission 203.02 Multiple myeloma, in relapse 203.10-203.11 Plasma cell leukemia, without mention of having achieved remission and in remission 203.12 Plasma cell leukemia, in relapse 203.80-203.81 Other immunoproliferative neoplasms, without mention of having achieved remission and in remission 203.82 Other immunoproliferative neoplasms, in relapse 204.00-204.01 Acute lymphoid leukemia, without mention of having achieved remission and in remission 204.02 Acute lymphoid leukemia, in relapse 204.10-204.11 Chronic lymphoid leukemia, without mention of having achieved remission and in remission 204.12 Chronic lymphoid leukemia, in relapse 204.20-204.21 Subacute lymphoid leukemia, without mention of having achieved remission and in remission 204.22 Subacute lymphoid leukemia, in relapse 204.80-204.81 Other lymphoid leukemia, without mention of having achieved remission and in remission 204.82 Other lymphoid leukemia, in relapse 204.90-204.91 Unspecified lymphoid leukemia, without mention of having achieved remission and in remission 204.92 Unspecified lymphoid leukemia, in relapse

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Code Description 205.00-205.01 Acute myeloid leukemia, without mention of having achieved remission and in remission 205.02 Acute myeloid leukemia, In relapse 205.10-205.11 Chronic myeloid leukemia, without mention of having achieved remission and in remission 205.12 Chronic myeloid leukemia, in relapse 205.20-205.21 Subacute myeloid leukemia, without mention of having achieved remission and in remission 205.22 Subacute myeloid leukemia, in relapse 205.30-205.31 Myeloid sarcoma, without mention of having achieved remission and in remission 205.32 Myeloid sarcoma, in relapse 205.80-205.81 Other myeloid leukemia, without mention of having achieved remission and in remission 205.82 Other myeloid leukemia, in relapse 205.90-205.91 Unspecified myeloid leukemia, without mention of having achieved remission and in remission 205.92 Unspecified myeloid leukemia, in relapse 206.00-206.01 Acute monocytic leukemia, without mention of having achieved remission and in remission 206.02 Acute monocytic leukemia, in relapse 206.10-206.11 Chronic monocytic leukemia, without mention of having achieved remission and in remission 206.12 Chronic monocytic leukemia, in relapse 206.20-206.21 Subacute monocytic leukemia, without mention of having achieved remission and in remission 206.22 Subacute monocytic leukemia, in relapse 206.80-206.81 Other monocytic leukemia, without mention of having achieved remission and in remission 206.82 Other monocytic leukemia, in relapse 206.90-206.91 Unspecified monocytic leukemia, without mention of having achieved remission and in remission 206.92 Unspecified monocytic leukemia, in relapse 207.00-207.01 Acute erythremia and erythroleukemia, without mention of having achieved remission and in remission 207.02 Acute erythremia and erythroleukemia, in relapse 207.10-207.11 Chronic erythremia, without mention of having achieved remission and in remission 207.12 Chronic erythremia, in relapse 207.20-207.21 Megakaryocytic leukemia, without mention of having achieved remission and in remission 207.22 Megakaryocytic leukemia, in relapse

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Code Description 207.80-207.81 Other specified leukemia, without mention of having achieved remission and in remission 207.82 Other specified leukemia, in relapse 208.00-208.01 Acute leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.02 Acute leukemia of unspecified cell type, in relapse 208.10-208.11 Chronic leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.12 Chronic leukemia of unspecified cell type, in relapse 208.20-208.21 Subacute leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.22 Subacute leukemia of unspecified cell type, in relapse 208.80-208.81 Other leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.82 Other leukemia of unspecified cell type, in relapse 208.90-208.91 Unspecified leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.92 Unspecified leukemia of unspecified cell type, in relapse 209.20-209.27, 209.29 Malignant carcinoid tumors of other and unspecified sites 209.70 Secondary neuroendocrine tumor, unspecified site 209.71 Secondary neuroendocrine tumor of distant lymph nodes 209.72 Secondary neuroendocrine tumor of liver 209.73 Secondary neuroendocrine tumor of bone 209.74 Secondary neuroendocrine tumor of peritoneum 209.75 Secondary Merkel cell carcinoma 209.79 Secondary neuroendocrine tumor of other sites 211.5 Benign neoplasm of liver and biliary passages 211.6 Benign neoplasm of pancreas, except islets of Langerhans 211.7 Benign neoplasm of islets of Langerhans 228.04 Hemangioma of intra-abdominal structures 230.7 Carcinoma in situ of other and unspecified parts of intestine 230.8 Carcinoma in situ of liver and biliary system 230.9 Carcinoma in situ other and unspecified digestive organs 235.0-235.9 Neoplasms of uncertain behavior of digestive and respiratory systems 236.0-236.99 Neoplasms of uncertain behavior of genitourinary organs 237.0-237.72 Neoplasms of uncertain behavior of endocrine glands and nervous system 237.73 Schwannomatosis 237.79 Other neurofibromatosis 237.9 Other and uncertain parts of the nervous system 238.0-238.6 Neoplasms of uncertain behavior of other and unspecified sites and tissues

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Code Description 238.71-238.76 Neoplasms of other lymphatic and hematopoietic tissues 238.77 Post-transplant lymphoproliferative disorder (PTLD) 238.79 Other lymphatic and hematopoietic tissues 238.8 Other specified sites 238.9 Site unspecified 239.0 Neoplasm of unspecified nature of digestive system 250.00-250.93 Diabetes mellitus 252.00-252.02, 252.08 Hyperparathyroidism 263.1 Malnutrition of mild degree 263.9 Unspecified protein-calorie malnutrition 268.0 Rickets, active 268.2 Osteomalacia, unspecified 269.0 Deficiency of vitamin K 270.2 Other disturbances of aromatic amino acid metabolism 270.9 Unspecified disorder of amino acid metabolism 271.0 Glycogenosis 272.0 Pure hypercholesterolemia 272.1 Pure hypertriglyceridemia 272.2 Mixed hyperlipidemia 272.4 Other and unspecified hyperlipidemia 272.7 Lipidoses 272.9 Unspecified disorder of lipoid metabolism 273.4 Alpha-1-antitrypsin deficiency 275.01 Hereditary hemochromatosis 275.02 Hemochromatosis due to repeated red blood cell transfusions 275.03 Other hemochromatosis 275.09 Other disorders of iron metabolism 275.1 Disorders of copper metabolism 275.2 Disorders of magnesium metabolism 275.3 Disorders of phosphorus metabolism 275.40-275.49 Disorders of calcium metabolism 275.5 Hungry bone syndrome 277.1 Disorders of porphyrin metabolism 277.30 Amyloidosis, unspecified 277.31 Familial Mediterranean fever 277.39 Other amyloidosis 277.4 Disorders of biliuria excretion 277.6 Other deficiencies of circulating enzymes 282.60-282.69 Sickle cell disease 286.6 Defibrination syndrome 286.7 Acquired coagulation factor deficiency

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Code Description 289.4 Hypersplenism 289.52 Splenic sequestration 291.0-291.9 Alcoholic psychoses 303.00-303.03 Acute alcoholic intoxication 303.90-303.93 Other and unspecified alcohol dependence 304.00-304.93 Drug dependence 305.00-305.93 Non-dependent abuse of drugs 357.5 Alcoholic polyneuropathy 359.21 Myotonic muscular dystrophy 359.22 Myotonia congenita 359.23 Myotonic chondrodystrophy 359.24 Drug induced myotonia 359.29 Other specified myotonic disorder 452 Portal vein thrombosis 456.0-456.21 Esophageal varices 453.0 Budd-Chiari syndrome 453.1 Thrombophlebitis migrans 453.2 Embolism and thrombosis of inferior vena cava 453.3 Embolism and thrombosis of renal vein 453.40 Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.41 Acute venous embolism and thrombosis of deep vessels of proximal lower extremity 453.42 Acute venous embolism and thrombosis of deep vessels of distal lower extremity 453.50 Chronic venous embolism and thrombosis of unspecified deep vessels of lower extremity 453.51 Chronic venous embolism and thrombosis of deep vessels of proximal lower extremity 453.52 Chronic venous embolism and thrombosis of deep vessels of distal lower extremity 453.6 Venous embolism and thrombosis of superficial vessels of lower extremity 453.71 Chronic venous embolism and thrombosis of superficial veins of upper extremity 453.72 Chronic venous embolism and thrombosis of deep veins of upper extremity 453.73 Chronic venous embolism and thrombosis of upper extremity, unspecified 453.74 Chronic venous embolism and thrombosis of axillary veins 453.75 Chronic venous embolism and thrombosis of subclavian veins 453.76 Chronic venous embolism and thrombosis of internal jugular veins 453.77 Chronic venous embolism and thrombosis of other thoracic veins

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Code Description 453.79 Chronic venous embolism and thrombosis of other specified veins 453.81 Acute venous embolism and thrombosis of superficial veins of upper extremity 453.82 Acute venous embolism and thrombosis of deep veins of upper extremity Acute venous embolism and thrombosis of upper extremity, 453.83 unspecified 453.84 Acute venous embolism and thrombosis of axillary veins 453.85 Acute venous embolism and thrombosis of subclavian veins 453.86 Acute venous embolism and thrombosis of internal jugular veins 453.87 Acute venous embolism and thrombosis of other thoracic veins 453.89 Acute venous embolism and thrombosis of other specified veins 453.9 Other venous embolism and thrombosis of unspecified site 456.0-456.21 Esophageal varices 555.0-555.9 Regional enteritis 556.0-556.9 Ulcerative colitis 557.0 Acute vascular insufficiency of intestine 558.1-558.3, 558.41-558.42, Other and unspecified noninfectious gastroenteritis and colitis 558.9 560.0-560.2 Intestinal obstruction: intussusceptions, paralytic ileus, volvulus 560.30 Impaction of intestine, unspecified 560.31 Gallstone ileus 560.32 Fecal impaction 560.39 Other impaction of intestine 560.81-560.89, 560.9 Other and unspecified intestinal obstruction 562.01 Diverticulitis of small intestine (without mention of hemorrhage) 562.03 Diverticulitis of small intestine with hemorrhage 562.11 Diverticulitis of colon (without mention of hemorrhage) 562.13 Diverticulitis of colon with hemorrhage 567.0-567.29, 567.38-567.9 Peritonitis 569.83 Perforation of intestine 569.87 Vomiting of fecal matter 570 Acute and subacute necrosis of liver 571.0-571.9 Chronic liver disease and cirrhosis 572.0 Abscess of liver 572.1 Portal pyemia 572.2 Hepatic encephalopathy 572.3 Portal hypertension 572.4 Hepatorenal syndrome 572.8 Other sequelae of chronic liver disease 573.0-573.9 Other disorders of liver 574.00-574.91 Cholelithiasis

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Code Description 575.0-575.9 Other disorders of gallbladder 576.0-576.9 Other disorders of biliary tract 581.0-581.9 Nephrotic syndrome 582.0-582.9 Chronic glomerulonephritis 583.0-583.9 Nephritis and nephropathy not specified as acute or chronic 584.5 Acute kidney failure with lesion of tubular necrosis 584.6 Acute kidney failure with lesion of renal cortical necrosis 584.7 Acute kidney failure with lesion of renal medullary (papillary) necrosis 584.8 Acute kidney failure with other specified pathological lesion in kidney 584.9 Acute kidney failure, unspecified 585.6 End stage renal disease 586 Renal failure, unspecified 587 Renal sclerosis, unspecified 588.0-588.9 Disorders resulting from impaired renal function 590.00-590.9 Infections of kidney 642.50-642.54 Severe pre-eclampsia 646.70, 646.71, 646.73 Liver disorders in pregnancy 782.4 Jaundice, unspecified, not of newborn 789.1 Hepatomegaly 790.4 Nonspecific elevation of levels of transaminase or lactic acid dehydrogenase 790.5 Other nonspecific abnormal serum enzyme levels 960.0-960.9 Poisoning by antibiotics 961.0-961.9 Poisoning by other anti-infectives 962.0-962.9 Poisoning by hormones and synthetic substitutes 963.0-963.5, 963.8, 963.9 Poisoning by primarily systemic agents 964.0-964.9 Poisoning by agents primarily affecting blood constituents 965.00-965.02, 965.09, 965.1, 965.4-965.5, 965.61, 965.69, 965.7-965.9 Poisoning by analgesics, antipyretics, and antirheumatics 966.0-966.4 Poisoning by anticonvulsants and anti-parkinsonism drugs 967.0-967.6, 967.8, 967.9 Poisoning by sedatives and hypnotics 968.0-968.7, 968.9 Poisoning by other CNS depressants and anesthetics 969.00 Poisoning by antidepressant, unspecified 969.01 Poisoning by monoamine oxidase inhibitors 969.02 Poisoning by selective serotonin & norepinephrine reuptake inhibitors 969.03 Poisoning by selective serotonin reuptake inhibitors 969.04 Poisoning by tetracyclic antidepressants 969.05 Poisoning by tricyclic antidepressants 969.09 Poisoning by other antidepressants 969.1-969.5, 969.6 Poisoning by tranquilizers and psychodysleptics (hallucinogens)

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Code Description 969.70 Poisoning by psychostimulant, unspecified 969.71 Poisoning by caffeine 969.72 Poisoning by amphetamines 969.73 Poisoning by methylphenidate 969.79 Poisoning by other psychostimulants 969.8, 969.9 Poisoning by other specified and unspecified psychotropic agents 970.0-970.1 Poisoning by analeptics and opiate antagonists 970.81 Poisoning by cocaine 970.89 Poisoning by other central nervous system stimulants 970.9 Poisoning by unspecified central nervous system stimulants 971.0-971.3, 971.9 Poisoning by drugs primarily affecting the autonomic nervous system 972.0-972.9 Poisoning by agents primarily affecting the cardiovascular system 973.0-973.6, 973.8, 973.9 Poisoning by agents primarily affecting the GI system 974.0-974.7 Poisoning by water, mineral, and uric acid metabolism drugs 975.0-975.8 Poisoning by agents primarily acting on the smooth and skeletal muscles and respiratory system 976.0-976.9 Poisoning by agents primarily affecting skin and mucous membrane, ophthalmological, otorhinolaryngological, and dental drugs 977.0-977.4, 977.8, 977.9 Poisoning by other and unspecified drugs, and medicinal substances 978.0-978.6, 978.8, 978.9 Poisoning by bacterial vaccines 979.0-979.7 Poisoning by other vaccines and biological sustances 979.9 Poisoning by drugs, medicinal, and biological substances 980.0-989.89 Toxic effects of substances chiefly nonmedicinal as to source V42.7 Organ replaced by transplant, liver V58.61-V58.64, V58.69 Long-term (current) drug use V67.1 Follow-up examination, radiotherapy V67.2 Follow-up examination, chemotherapy V67.51 Follow-up examination after completed treatment with high-risk medications, not elsewhere classified Indications 1. To provide information about known or suspected hepatobiliary disease, for example: a. Following chronic alcohol or drug ingestion b. Following exposure to hepatotoxins c. When using medication known to have a potential for causing liver toxicity (e.g., following the drug manufacturer’s recommendations) d. Following infection (e.g., viral hepatitis and other specific infections such as amebiasis, tuberculosis, psittacosis, and similar infections) 2. To assess liver injury/function following diagnosis of primary or secondary malignant neoplasms

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3. To assess liver injury/function in a wide variety of disorders and diseases known to cause liver involvement (e.g., diabetes mellitus, malnutrition, disorders of iron and mineral metabolism, sarcoidosis, amyloidosis, lupus, and hypertension) 4. To assess liver function related to gastrointestinal disease 5. To assess liver function related to pancreatic disease 6. To assess liver function in patients subsequent to liver transplantation 7. To differentiate between the different sources of elevated alkaline phosphatase activity Limitations When used to assess liver dysfunction secondary to existing non-hepatobiliary disease with no change in signs, symptoms, or treatment, it is generally not necessary to repeat a GGT determination after a normal result has been obtained unless new indications are present. If the GGT is the only “liver” enzyme abnormally high, it is generally not necessary to pursue further evaluation for liver disease for this specific indication. When used to determine if other abnormal enzyme tests reflect liver abnormality rather than other tissue, it generally is not necessary to repeat a GGT more than one time per week. Because of the extreme sensitivity of GGT as a marker for cytochrome oxidase induction or cell membrane permeability, it is generally not useful in monitoring patients with known liver disease. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Ockner, R.K., “Clinical approach to liver disease,” in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 808-809. Ockner, R.K., “Laboratory tests in liver disease,” in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 814-817. Gornall, A.G., and Goldberg, D.M., “Hepatobiliary Disorders,” in Gornall, A.G. (ed.), Applied Biochemistry of Clinical Disorders (2nd ed.), 1986, J.B. Lippincott, pp. 211-246. Scharschmidt, B.F., “Parasitic, bacterial, fungal, and granulomatous liver disease,” in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 834-838. Pincus, M.R.,& Schaffner, J.A., “Assessment of liver function,” Henry, J.B. (ed.), Clinical Diagnosis & Management by Laboratory Methods (19th ed.), 1996, WB Saunders, pp. 253-267. Bordley, D.R., Nattinger, A.B., et al., “Gastrointestinal, Hepatobiliary, and Pancreatic Problems,” in Panzer, R.J., Black, E.R., and Griner, P.F. (eds.), Diagnostic Strategies for Common Medical Problems, 1991, American College of Physicians, pp. 94-185. Tietz, N.W. (ed.), Clinical Guide to Laboratory Tests (3rd ed.), 1995, pp. 286-287. Zakim, D., and Boyer, T.D., Hepatology (2nd ed.), 1990, W.B. Saunders. Dufour, D.R., Clinical Use of Laboratory Data: A Practical Guide, 1998, Williams & Wilkins, pp. 142-155. Harrison’s Principles of Internal Medicine (14th ed.), 1998, McGraw Hill

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Wallach, J., Interpretation of Diagnostic Tests, 1996, Little Brown and Co. Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, Springhouse Corporation. Sleisenger and Fordtrans’s Gastrointestinal and Liver Disease (6th ed.), 1997, W.B. Saunders.

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190.33 - Hepatitis Panel/Acute Hepatitis Panel

Previously Listed as Edit 22 Description This panel consists of the following tests:  Hepatitis A antibody (HAAb), IgM antibody;  Hepatitis B core antibody (HBcAb), IgM antibody;  Hepatitis B surface antigen (HBsAg) and;  Hepatitis C antibody.

Hepatitis is an inflammation of the liver resulting from viruses, drugs, toxins, and other etiologies. Viral hepatitis can be due to one of at least five different viruses, designated hepatitis A, B, C, and E. Most cases are caused by hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV).

HAV is the most common cause of hepatitis in children and adolescents in the United States. Prior exposure is indicated by a positive IgG anti-HAV. Acute HAV is diagnosed by IgM anti- HAV, which typically appears within four weeks of exposure, and which disappears within three months of its appearance. IgG anti-HAV is similar in the timing of its appearance, but it persists indefinitely. Its detection indicates prior effective immunization or recovery from infection. Although HAV is spread most commonly by fecal-oral exposure, standard immune globulin may be effective as a prophylaxis.

HBV produces three separate antigens (surface, core, and e (envelope) antigens) when it infects the liver, although only hepatitis B surface antigen (HBsAg) is included as part of this panel. Following exposure, the body normally responds by producing antibodies to each of these antigens; one of which is included in this panel: hepatitis B surface antibody (HBsAb)-IgM antibody. HBsAg is the earlier marker, appearing in serum four to eight weeks after exposure, and typically disappearing within six months after its appearance. If HBsAg remains detectable for greater than six months, this indicates chronic HBV infection. HBcAb, in the form of both IgG and IgM antibodies, are next to appear in serum, typically becoming detectable two to three months following exposure. The IgM antibody gradually declines or disappears entirely one to two years following exposure, but the IgG usually remains detectable for life. Because HBsAg is present for a relatively short period and usually displays a low titer, a negative result does not exclude an HBV diagnosis. HBcAb, on the other hand, rises to a much higher titer and remains elevated for a longer period of time, but a positive result is not diagnostic of acute disease, since it may be the result of a prior infection. The last marker to appear in the course of a typical infection is HBsAb, which appears in serum four to six months following exposure to infected blood or body fluids; in the U.S., sexual transmission accounts for 30% to 60% of new cases of HBV infection. The diagnosis of acute HBV infection is best established by documentation of positive IgM antibody against the core antigen (HBcAb-IgM) and by identification of a positive hepatitis B surface antigen (HBsAg). The diagnosis of chronic HBV infection is established primarily by

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This is CMS Logo. identifying a positive hepatitis B surface antigen (HBsAg) and demonstrating positive IgG antibody directed against the core antigen (HBcAb-IgG). Additional tests such as hepatitis B e antigen (HBeAg) and hepatitis B e antibody (HBeAb), the envelope antigen and antibody, are not included in the hepatitis panel, but may be of importance in assessing the infectivity of patients with HBV. Following completion of a HBV vaccination series, HBsAb alone may be used monthly for up to six months, or until a positive result is obtained, to verify an adequate antibody response. HCV is the most common cause of post-transfusion hepatitis; overall HCV is responsible for 15% to 20% of all cases of acute hepatitis, and is the most common cause of chronic liver disease. The test most commonly used to identify HCV measures HCV antibodies, which appear in blood two to four months after infection. False positive HCV results can occur. For example, a patient with a recent yeast infection may produce a false positive anti-HCV result. For this reason, at present positive results usually are confirmed by a more specific technique. Like HBV, HCV is spread exclusively through exposure to infected blood or body fluids. This panel of tests is used for differential diagnosis in a patient with symptoms of liver disease or injury. When the time of exposure or the stage of the disease is not known, a patient with continued symptoms of liver disease despite a completely negative hepatitis panel may need a repeat panel approximately two weeks to two months later to exclude the possibility of hepatitis. Once a diagnosis is established, specific tests can be used to monitor the course of the disease. HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 80074 Acute Hepatitis Panel ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 070.0-070.9 Viral hepatitis 456.0-456.21 Esophageal varices with or without mention of bleeding 570 Acute and subacute necrosis of liver 571.5 Cirrhosis of liver without mention of alcohol 572.0 Abscess of liver 572.1 Portal pyemia 572.2 Hepatic encephalopathy 572.3 Portal hypertension 572.4 Hepatorenal syndrome 572.8 Other sequelae of chronic liver disease 573.3 Hepatitis, unspecified 573.5 Hepatopulmonary syndrome 780.31 Febrile convulsions (simple), unspecified 780.32 Complex febrile convulsions

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Code Description 780.33 Post traumatic seizures 780.71 Chronic fatigue syndrome 780.72 Functional quadriplegia 780.79 Other malaise and fatigue 782.4 Jaundice, unspecified, not of newborn 783.0-783.6 Symptoms concerning nutrition, metabolism, and development 787.01-787.03 Nausea and vomiting 787.04 Bilious emesis 789.00-789.09 Abdominal pain 789.1 Hepatomegaly 789.61 Localized abdominal tenderness (RUQ) 789.7 Colic 790.4 Nonspecific elevation of levels of transaminase or lactic acid dehydrogenase (LDH) 794.8 Nonspecific abnormal results of function studies, liver 996.82 Complications of transplanted organ, liver V72.85 Liver transplant recipient evaluation Indications 1. To detect viral hepatitis infection when there are abnormal liver function test results, with or without signs or symptoms of hepatitis. 2. Prior to and subsequent to liver transplantation. Limitations After a hepatitis diagnosis is established, only individual tests are needed. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Ockner, R.K., “Approaches to the diagnosis of jaundice,” in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 817-818. Ockner, R.K., “Acute viral hepatitis,” in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 818-826. Ockner, R.K., “Chronic hepatitis,” in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 830-834. Arvan, D.A., “Acute viral hepatitis,” in Panzer, R.J., Black, E.R., & Griner, P.F. (eds.), Diagnostic Strategies for Common Medical Problems, 1991, American College of Physicians, pp. 141-151. Goldberg, D.M., “Diagnostic Enzymology,” in Gornall, A.G. (ed.), Applied Biochemistry of Clinical Disorders (2nd ed.), 1986, J.B. Lippincott, pp. 33-51. Pincus, M.R.,& Schaffner, J.A., “Assessment of liver function,” in Henry J.B.(ed.), Clinical Diagnosis & Management by Laboratory Methods (19th ed.), 1996, W.B. Saunders, pp 253-267. Tietz, N.W. (ed.), Clinical Guide to Laboratory Tests (3rd ed.), 1995, pp. 320-327. Zakim, D., and Boyer, T.D., Hepatology (2nd ed.), 1990, W.B. Saunders.

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Harrison’s Principles of Internal Medicine (14th ed.), 1998, McGraw Hill. Wallach, J., Interpretation of Diagnostic Tests, 1996, Little Brown and Co. Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, Springhouse Corporation. Sleisenger and Fordtrans’s Gastrointestinal and Liver Disease (6th ed.), 1997, W.B. Saunders.

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190.34 - Fecal Occult Blood Test

Previously Listed as Edit 23 Description The Fecal Occult Blood Test (FOBT) detects the presence of trace amounts of blood in stool. The procedure is performed by testing one or several small samples of one, two or three different stool specimens. This test may be performed with or without evidence of iron deficiency anemia, which may be related to gastrointestinal blood loss. The range of causes for blood loss include inflammatory causes, including acid-peptic disease, non-steroidal anti-inflammatory drug use, hiatal hernia, Crohn’s disease, ulcerative colitis, gastroenteritis, and colon ulcers. It is also seen with infectious causes, including hookworm, strongyloides, ascariasis, tuberculosis, and enteroamebiasis. Vascular causes include angiodysplasia, hemangiomas, varices, blue rubber bleb nevus syndrome, and watermelon stomach. Tumors and neoplastic causes include lymphoma, leiomyosarcoma, lipomas, adenocarcinoma and primary and secondary metastases to the GI tract. Drugs such as nonsteroidal anti-inflammatory drugs also cause bleeding. There are extra gastrointestinal causes such as hemoptysis, epistaxis, and oropharyngeal bleeding. Artifactual causes include hematuria, and menstrual bleeding. In addition, there may be other causes such as coagulopathies, gastrostomy tubes or other appliances, factitial causes, and long distance running. Three basic types of fecal hemoglobin assays exist, each directed at a different component of the hemoglobin molecule. 1. Immunoassays recognize antigenic sites on the globin portion and are least affected by diet or proximal gut bleeding, but the antigen may be destroyed by fecal flora. 2. The heme-porphyrin assay measures heme-derived porphyrin and is least influenced by enterocolic metabolism or fecal storage. This assay does not discriminate dietary from endogenous heme. The capacity to detect proximal gut bleeding reduces its specificity for colorectal cancer screening but makes it more useful for evaluating overall GI bleeding in case finding for iron deficiency anemia. 3. The guaiac-based test is the most widely used. It requires the peroxidase activity of an intact heme moiety to be reactive. Positivity rates fall with storage. Fecal hydration such as adding a drop of water increases the test reactivity but also increases false positivity. Of these three tests, the guaiac-based test is the most sensitive for detecting lower bowel bleeding. Because of this sensitivity, it is advisable, when it is used for screening, to defer the guaiac-based test if other studies of the colon are performed prior to the test. Similarly, this test’s sensitivity may result in a false positive if the patient has recently ingested meat. Both of these cautions are appropriate when the test is used for screening, but when appropriate indications are present, the test should be done despite its limitations.

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HCPCS Codes (Alphanumeric, CPT AMA)

Code Description 82272 Blood, occult, by peroxidase activity (e.g., guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening ICD-9-CM Codes Covered by Medicare Program

The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo

Code Description 003.0 Salmonella gastroenteritis 003.1 Salmonella septicemia 004.0-004.9 Shigellosis 005.0-005.4, 005.81, 005.89, 005.9 Other food poisoning (bacterial) 006.0-006.9 Amebiasis 007.0-007.9 Other protozoal intestinal diseases 008.41-008.49 Intestinal infections due to other specified bacteria 009.0-009.3 Ill-defined intestinal infections 014.00-014.86 Tuberculosis of intestines, peritoneum, and mesenteric glands 040.2 Whipple’s disease 095.2 Syphilitic peritonitis 095.3 Syphilis of liver 098.0 Gonococcal infection, acute, lower genitourinary tract 098.7 Gonococcal Infection anus and rectum 098.84 Gonococcal endocaritis 123.0-123.9 Other cestode infection 124 Trichinosis 127.0-127.9 Other intestinal helminthiases 139.8 Late effects of other and unspecified infectious and parasitic diseases 150.0-157.9 Malignant neoplasm of digestive organisms 159.0-159.9 Malignant neoplasm of other and ill-defined sites within the digestive organs and peritoneum 176.3 Kaposi’s sarcoma, gastrointestinal sites 197.4-197.5 Secondary malignant neoplasm of intestines 197.8 Secondary malignant neoplasm of other digestive organs & spleen 199.0 Disseminated malignant neoplasm 204.00-204.01 Acute lymphoid leukemia, without mention of having achieved remission and in remission 204.02 Acute lymphoid leukemia, in relapse

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Code Description 204.10-204.11 Chronic lymphoid leukemia, without mention of having achieved remission and in remission 204.12 Chronic lymphoid leukemia, in relapse 204.20-204.21 Subacute lymphoid leukemia, without mention of having achieved remission and in remission 204.22 Subacute lymphoid leukemia, in relapse 204.80-204.81 Other lymphoid leukemia, without mention of having achieved remission and in remission 204.82 Other lymphoid leukemia, in relapse 204.90-204.91 Unspecified lymphoid leukemia, without mention of having achieved remission and in remission 204.92 Unspecified lymphoid leukemia, in relapse 205.00-205.01 Acute myeloid leukemia, without mention of having achieved remission and in remission 205.02 Acute myeloid leukemia, in relapse 205.10-205.11 Chronic myeloid leukemia, without mention of having achieved remission and in remission 205.12 Chronic myeloid leukemia, in relapse 205.20-205.21 Subacute myeloid leukemia, without mention of having achieved remission and in remission 205.22 Subacute myeloid leukemia, in relapse 205.30-205.31 Myeloid sarcoma, without mention of having achieved remission and in remission 205.32 Myeloid sarcoma, in relapse 205.80-205.81 Other myeloid leukemia, without mention of having achieved remission and in remission 205.82 Other myeloid leukemia, in relapse 205.90-205.91 Unspecified myeloid leukemia, without mention of having achieved remission and in remission 205.92 Unspecified myeloid leukemia, in relapse 206.00-206.01 Acute monocytic leukemia, without mention of having achieved remission and in remission 206.02 Acute monocytic leukemia, in relapse 206.10-206.11 Chronic monocytic leukemia, without mention of having achieved remission and in remission 206.12 Chronic monocytic leukemia, in relapse 206.20-206.21 Subacute monocytic leukemia, without mention of having achieved remission and in remission 206.22 Subacute monocytic leukemia, in relapse 206.80-206.81 Other monocytic leukemia, without mention of having achieved remission and in remission 206.82 Other monocytic leukemia, in relapse 206.90-206.91 Unspecified monocytic leukemia, without mention of having achieved remission and in remission

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Code Description 206.92 Unspecified monocytic leukemia, in relapse 207.00-207.01 Acute erythremia and erythroleukemia, without mention of having achieved remission and in remission 207.02 Acute erythremia and erythroleukemia, in relapse 207.10-207.11 Chronic erythremia, without mention of having achieved remission and in remission 207.12 Chronic erythremia, in relapse 207.20-207.21 Megakaryocytic leukemia, without mention of having achieved remission and in remission 207.22 Megakaryocytic leukemia, in relapse 207.80-207.81 Other specified leukemia, without mention of having achieved remission and in remission 207.82 Other specified leukemia, in relapse 208.00-208.01 Acute leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.02 Acute leukemia of unspecified cell type, in relapse 208.10-208.11 Chronic leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.12 Chronic leukemia of unspecified cell type, in relapse 208.20-208.21 Subacute leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.22 Subacute leukemia of unspecified cell type, in relapse 208.80-208.81 Other leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.82 Other leukemia of unspecified cell type, in relapse 208.90-208.91 Unspecified leukemia of unspecified cell type, without mention of having achieved remission and in remission 208.92 Unspecified leukemia of unspecified cell type, in relapse 209.00-209.03 Malignant carcinoid tumors of the small intestine 209.10-209.17 Malignant carcinoid tumors of the appendix, large intestine & rectum 209.40-209.43 Benign carcinoid tumors of the small intestine 209.50-209.57 Benign carcinoid tumors of the appendix, large intestine and rectum 209.70 Secondary neuroendocrine tumor, unspecified site 209.71 Secondary neuroendocrine tumor of distant lymph nodes 209.72 Secondary neuroendocrine tumor of liver 209.73 Secondary neuroendocrine tumor of bone 209.74 Secondary neuroendocrine tumor of peritoneum 209.75 Secondary Merkel cell carcinoma 209.79 Secondary neuroendocrine tumor of other sites 211.0-211.9 Benign neoplasm of other parts of digestive system 228.04 Hemangioma of intra-abdominal structures 230.2-230.9 Carcinoma in situ of digestive organs

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Code Description 235.2 Neoplasm of uncertain behavior of stomach, intestines, and rectum 235.5 Neoplasm of uncertain behavior of other & unspecified digestive organs 239.0 Neoplasm of unspecified nature, digestive system 280.0-280.9 Iron deficiency anemias 284.2 Myelophthisis 285.0-285.29 Siderblastic anemia and anemia of other chronic disease 285.3 Antineoplastic chemotherapy induced anemia 285.8-285.9 Other and unspecified anemias 286.0-286.9 Coagulation defects 287.0-287.39 Allergic purpura; qualitative platelet defects; other non- thrombocytopenic purpuras; primary thrombocytopenia 287.41 Posttransfusion purpura 287.49 Other secondary thrombocytopenia 287.5-287.9 Thrombocytopenia, unspecified; other specified and unspecified hemorrhagic conditions 338.3 Neoplasm related pain (acute) (chronic) 448.0 Hereditary hemorrhagic telangiectasia 455.0-455.8 Hemorrhoids 456.0-456.21 Esophageal varices with or without mention of bleeding 530.10-530.21, 530.3-530.7, 530.81-530.89, 530.9 Diseases of the esophagus Gastric ulcer; duodenal ulcer; peptic ulcer, site unspecified; 531.00-535.61 gastrojejunal ulcer; and gastritis and duodenitis 535.70 Eosinophilic gastritis, without mention of obstruction 535.71 Eosinophilic gastritis, with obstruction 536.2 Persistent vomiting Dyspepsia and other specified and unspecified functional disorders 536.8-536.9 of stomach 537.0-537.4 Other disorders of stomach and duodenum 537.82-537.83 Angiodysplasia of stomach and duodenum 537.84 Dieulafoy lesion (hemorrhagic) of stomach and duodenum 537.89 Other specified disorders of stomach and duodenum 555.0-558.3 Non-infectious enteritis and colitis 558.41 Eosinophilic gastroenteritis 558.42 Eosinophilic colitis 558.9 Non-infectious enteritis and colitis 560.0-560.2 Intestinal obstruction: intussusceptions, paralytic ileus, volvulus 560.30 Impaction of intestine, unspecified 560.31 Gallstone ileus 560.32 Fecal impaction 560.39 Other impaction of intestine

NCD 190.34 *October 12 Changes – Red

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Code Description 562.10-562.13 Diverticulosis/diverticulitis of colon 564.00-564.9 Functional digestive disorders, not elsewhere classified 565.0-565.1 Anal fissure and fistula 569.0 Anal and rectal polyp 569.1 Rectal prolapse 569.3 Hemorrhage of rectum and anus 569.41 - 569.44, 569.49 Other specified disorders of rectum and anus 569.82-569.83 Ulceration and perforation of intestine 569.84-569.85 Angiodysplasia of intestine with or without mention of hemorrhage 569.86 Dieulafoy lesion (hemorrhagic) of intestine 569.87 Vomiting of fecal matter 571.0 - 571.9 Chronic liver disease and cirrhosis 577.0-577.9 Diseases of the pancreas 578.0-578.9 Gastrointestinal hemorrhage 579.0 Celiac disease 579.8 Other specified intestinal malabsorption 596.1 Intestinovesical fistula 617.5 Endometriosis of intestine 780.71 Chronic fatigue syndrome 780.72 Functional quadriplegia 780.79 Other malaise and fatigue 783.0 Anorexia 783.21 Abnormal loss of weight 787.01-787.03 Nausea and vomiting 787.04 Bilious emesis 787.1 Heartburn 787.20 Dysphagia, unspecified 787.21 Dysphagia, oral phase 787.22 Dysphagia, oropharyngeal phase 787.23 Dysphagia, pharyngeal phase 787.24 Dysphagia, pharyngo-esophageal phase 787.29 Other dysphagia 787.7 Abnormal feces 787.91 Diarrhea 787.99 Other symptoms involving digestive system 789.00-789.09 Abdominal pain 789.30-789.39 Abdominal or pelvic swelling, mass, or lump 789.40-789.49 Abdominal rigidity 789.51 Malignant ascites 789.59 Other ascites 789.60-789.69 Abdominal tenderness

NCD 190.34 *October 12 Changes – Red

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Code Description 789.7 Colic 790.92 Abnormal coagulation profile 792.1 Nonspecific abnormal findings in stool contents 793.6 Nonspecific (abnormal) findings on radiological and other examination, abdominal area, including retroperitoneum 794.8 Nonspecific abnormal results of function studies, liver 863.0-863.90 Injury to gastrointestinal tract 863.91-863.95, 863.99 Injury to gastrointestinal tract 864.00-864.09 Injury to liver without mention of open wound into cavity 864.11-864.19 Injury to liver with open wound into cavity 866.00-866.03 Injury to kidney without mention of open wound into cavity 866.10-866.13 Injury to kidney with open wound into cavity 902.0 -902.9 Injury to blood vessels of abdomen and pelvis 926.11-926.19 Crushing injury of trunk, other specified sites 926.8 Crushing injury of trunk, multiple sites 926.9 Crushing injury of trunk, unspecified site 964.2 Poisoning by agents primarily affecting blood constituents, anticoagulants 995.20 Unspecified adverse effect of unspecified drug, medicinal and biological substance 995.24 Failed moderate sedation during procedure V10.00-V10.09 Personal history of malignant neoplasm, gastrointestinal tract V12.00 Personal history of unspecified infectious and parasitic disease V12.72 Personal history of colonic polyps V58.61 Long term (current) use of anticoagulants V58.63-V58.65 Long-term (current) drug use V58.66 Long-term (current) use of aspirin V58.69 Long term (current) use of other medications V67.51 Following treatment w/ high risk medication, not elsewhere specified

Indications 1. To evaluate known or suspected alimentary tract conditions that might cause bleeding into the intestinal tract. 2. To evaluate unexpected anemia. 3. To evaluate abnormal signs, symptoms, or complaints that might be associated with loss of blood. 4. To evaluate patient complaints of black or red-tinged stools. Limitations 1. The FOBT is reported once for the testing of up to three separate specimens (comprising either one or two tests per specimen).

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2. In patients who are taking non-steroidal anti-inflammatory drugs and have a history of gastrointestinal bleeding but no other signs, symptoms, or complaints associated with gastrointestinal blood loss, testing for occult blood may generally be appropriate no more than once every three months. When testing is done for the purpose of screening for colorectal cancer in the absence of signs, symptoms, conditions, or complaints associated with gastrointestinal blood loss, report the HCPCS code for colorectal cancer screening; fecal-occult blood test, 1-3 simultaneous determinations should be used. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Sources of Information Ahlquist, D.A., “Approach to the patient with occult gastrointestinal bleeding,” in Tadatake, Y. (ed.), Textbook of Gastroenterology (2nd ed.), 1995, J.B. Lippincott, pp. 699-717. Tietz, N.W. (ed.), Clinical guide to Laboratory Tests (3rd ed.), 1995, pp.452-454. Schleisenger, M.H., Wall, S.D., et al., “Part X. Gastrointestinal Diseases” in Wyngaarden, J.B., & Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp. 656-807. Harrison’s Principles of Internal Medicine (14th ed.), 1998, McGraw Hill. Wallach, J., Interpretation of Diagnostic Tests, 1996, Little Brown and Co. Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, Springhouse Corporation. Sleisenger and Fordtrans’s Gastrointestinal and Liver Disease (6th ed.), 1997, W.B. Saunders.

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Printed on 10/16/2012. Page 1 of 11 Local Coverage Determination (LCD) for B-type Natriuretic Peptide (BNP) Testing (L31568)

Contractor Information Contractor Name Contractor Number Contractor Type Noridian Administrative Services, LLC opens in 03402 MAC - Part B new window Back to Top

LCD Information Document Information LCD ID Number L31568 Primary Geographic Jurisdiction opens in new window South Dakota LCD Title B-type Natriuretic Peptide (BNP) Testing Oversight Region Region X Contractor's Determination Number B2010. 02 R1 Original Determination Effective Date AMA CPT/ADA CDT Copyright Statement For services performed on or after 07/25/2011 CPT only copyright 2002-2012 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Original Determination Ending Date Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or Revision Effective Date indirectly practice medicine or dispense medical services. The AMA For services performed on or after 02/27/2012 assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Revision Ending Date Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

CMS National Coverage Policy Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1862(a)(7) excludes routine physical examinations (screening).

Printed on 10/16/2012. Page 2 of 11

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR Sections 410.32(a) & 410.32(a)(3) require that clinical laboratory services be ordered and used promptly by the physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who is treating the beneficiary.

42CFR411.15 excludes from coverage examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury with specific legislative enactments as the only exceptions.

Indications and Limitations of Coverage and/or Medical Necessity Abstract:

B-type natriuretic peptide (BNP) is a cardiac neurohormone produced mainly in the left ventricle. It is secreted in response to ventricular volume expansion and pressure overload, conditions often present in congestive heart failure (CHF). Used in conjunction with other clinical information, measurement of BNP levels (either total or N-terminal) is useful in rapidly establishing or excluding the diagnosis of CHF in patients with acute dyspnea. Also, BNP levels determined in the first few days after an acute coronary syndrome or event may be useful in the prediction of longer-term cardiovascular risk.

Indications:

BNP measurements may be considered reasonable and necessary when used in combination with other medical data such as medical history, physical examination, laboratory studies, chest x-ray, and electrocardiography in the following two clinical situations.

• Acute exacerbation of dyspnea in patients with known or suspected pulmonary or other non-cardiac causes of dyspnea to rule out CHF. Plasma BNP levels are significantly increased in patients with CHF presenting with acute dyspnea compared to patients presenting with acute dyspnea due to other causes.

• Acute exacerbation of dyspnea in patients known to suffer from both chronic obstructive pulmonary disease (COPD) and CHF. The BNP level may assist the physician distinguish between an exacerbation of COPD and decompensated CHF. Plasma BNP levels are significantly increased in patients with CHF with or without concurrent lung disease compared with patients who have primary lung disease.

Limitations:

BNP measurements must be assessed in conjunction with standard diagnostic tests, medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not been established yet. Moreover, certain conditions such as (and not limited to) ischemia, infarction and renal insufficiency, advanced age, female gender may cause elevation of circulating BNP; obesity, upstream heart failure and other conditions lower the BNP level. These conditions confound the interpretation of BNP levels to varying extents.

Printed on 10/16/2012. Page 3 of 11 The efficacy and/or utility of plasma BNP level as a monitor of the degree of CHF or the efficiency of CHF treatment has not been established. Treatment guided by BNP has not been shown to be superior to symptom-guided treatment in either clinical or quality of life outcomes. Therefore, BNP measurements for monitoring and management of CHF are non-covered.

The efficacy but not the utility of BNP as a risk stratification tool (to assess risk of death, myocardial infarction or congestive heart failure) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation and unstable angina) has been established. However, the assessment of BNP level has not been shown to alter patient management. The BNP is not sufficiently sensitive to either preclude or necessitate any other evaluation or treatment in this group of patients.

Screening examinations are statutorily non-covered.

Coding Information Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes 83880 NATRIURETIC PEPTIDE

ICD-9 Codes that Support Medical Necessity It is the responsibility of the provider to code to the highest level specified in the ICD-9-CM (e.g., to the fourth or fifth digit). The correct use of an ICD-9-CM code listed below does not assure coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. 402.01 MALIGNANT HYPERTENSIVE HEART DISEASE WITH HEART FAILURE 402.11 BENIGN HYPERTENSIVE HEART DISEASE WITH HEART FAILURE 402.91 UNSPECIFIED HYPERTENSIVE HEART DISEASE WITH HEART FAILURE HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I 404.01 THROUGH STAGE IV, OR UNSPECIFIED Printed on 10/16/2012. Page 4 of 11 404.03 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I 404.11 THROUGH STAGE IV, OR UNSPECIFIED HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END 404.13 STAGE RENAL DISEASE HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE 404.91 I THROUGH STAGE IV, OR UNSPECIFIED HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR 404.93 END STAGE RENAL DISEASE 410.62 TRUE POSTERIOR WALL INFARCTION SUBSEQUENT EPISODE OF CARE 410.72 SUBENDOCARDIAL INFARCTION SUBSEQUENT EPISODE OF CARE 410.82 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES SUBSEQUENT EPISODE OF CARE 410.92 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE 423.2 CONSTRICTIVE PERICARDITIS 425.4 OTHER PRIMARY CARDIOMYOPATHIES 428.0 CONGESTIVE HEART FAILURE UNSPECIFIED 428.1 LEFT HEART FAILURE 428.20 UNSPECIFIED SYSTOLIC HEART FAILURE 428.21 ACUTE SYSTOLIC HEART FAILURE 428.22 CHRONIC SYSTOLIC HEART FAILURE 428.23 ACUTE ON CHRONIC SYSTOLIC HEART FAILURE 428.30 UNSPECIFIED DIASTOLIC HEART FAILURE 428.31 ACUTE DIASTOLIC HEART FAILURE 428.32 CHRONIC DIASTOLIC HEART FAILURE 428.33 ACUTE ON CHRONIC DIASTOLIC HEART FAILURE 428.40 UNSPECIFIED COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.41 ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.42 CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.43 ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 428.9 HEART FAILURE UNSPECIFIED 491.21 OBSTRUCTIVE CHRONIC BRONCHITIS WITH (ACUTE) EXACERBATION 491.22 OBSTRUCTIVE CHRONIC BRONCHITIS WITH ACUTE BRONCHITIS 493.22 CHRONIC OBSTRUCTIVE ASTHMA WITH (ACUTE) EXACERBATION 493.92 ASTHMA UNSPECIFIED WITH (ACUTE) EXACERBATION 519.11 ACUTE BRONCHOSPASM 786.00 RESPIRATORY ABNORMALITY UNSPECIFIED 786.02 ORTHOPNEA 786.05 SHORTNESS OF BREATH 786.06 TACHYPNEA 786.07 WHEEZING 786.09 RESPIRATORY ABNORMALITY OTHER

Diagnoses that Support Medical Necessity Not Applicable Printed on 10/16/2012. Page 5 of 11 ICD-9 Codes that DO NOT Support Medical Necessity Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity Not Applicable Back to Top

General Information Documentations Requirements The patient's medical record must contain documentation that fully supports the medical necessity for services. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and literature that supports the request. At a minimum two (2) Phase II studies (human feasibility studies suggesting efficacy, pilots) or one (1) Phase III study (primary evidence of safety and efficacy, pivotal) must be submitted for the Medical Director’s review.

Appendices Not Applicable

Utilization Guidelines

Sources of Information and Basis for Decision Selected list

Bassan R, Tura BR, Maisel AS. B-type Natriuretic peptide: A strong predictor or early and late mortality in patients with acute chest pain without ST- segment elevation in the emergency department. Coron Artery Disease. 2009; 20:143-149.

Berger R, Moertl D, Sieglinde P, et al. N-Terminal pro-B-type natriuretic peptide-guided intensive management in addition to multidisciplinary care in chronic heart failure: A 3-arm, prospective, randomized pilot study. J Am Coll Cardiol. 2010;55(7):645-653.

Bibbin-Domingo K, Ansari M, Schiller N, Massie B, Whooley M. Is B-type natriuretic peptide a useful screening test for systolic dysfunction in patients with coronary disease? Data from the Heart and Soul Study. Am J Med. 2004;116(8):561-563.

Cowie M, Jourdain P, Maisel A, et al. Clinical applications of B-type natriuretic peptide (BNP) testing. European Heart Journal. 2003;24:1710-1718. http://www.westershopsitals.nhs.uk/WHC/archive/evidence/05%20hf/BNP%20clinical%20appicatoins-EHJ%202003.pdf. Accessed April 5, 2005.

Daniels LB, Maisel AS. Natriuretic peptides. J AM Coll Cardiol. 2007;50:2357-2368.

Dao Q, Krishnaswamy P, Kazanegra R, et al. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J AM Coll Cardiol. 2001;37(2):379-385.

Printed on 10/16/2012. Page 6 of 11 de Lemos J, Morrow D, Bentley J, et al. The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. N Engl J Med. 2001;345(14):1014-1021.

Fonarow GC, Peacock WF, Horwich TB, et al. Usefulness of B-type natriuretic peptide and cardiac troponin to predict in-hospital mortality from ADHERE. Am J Cardiol. 2008;101:231-237.

Garbowski M, Filipiak K, Karpinski G, et al. Serum B-type natriuretic peptide levels on admission predict not only short-term death but also angiographic success of procedure in patients with acute ST-elevation myocardial infarction treated with primary angioplasty. Am Heart J 2004; 148;655-62.

Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). http://www.acc.org/clinical/guidelines/failure/index.pdf. Accessed: October 7, 2005.

Ioannidis JPA, Panagiotou OA. Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses. JAMA 2011;305(21):2200-2210.

Kuster G, Tanner H, Printzen G, Suter T, Mohacsi P, Hess O. B-type natriuretic peptide for diagnosis and treatment of congestive heart failure. Swiss Med Wkly. 2003;133:623-628. http://www.smw.ch/pdf200x/2002/43/smw-10081.pdf. Accessed April 5, 2005.

Latini R, Masson S, Wong M, et. al. Incremental prognostic value of changes in B-type natriuretic peptide in heart failure. American Journal of Medicine, 2006;119(1):70e24-70.

Le Jemtel TH, Padeletti M, Jelic S. Diagnostic and therapeutic challenges in patients with coexistent chronic obstructive pulmonary disease and chronic heart failure. J AM Coll Cardiol. 2007; 49 (2): 171–180.

Logeart D, Thabut G, Jopurdain P et al. Predischarge B-type Natriuretic peptide assay for identifying patients at high risk of re-admission after decompensated heart failure. J Am Coll Cardiol. 2004;43(4):635-641.

Lubien E, DeMaria A, Krishnaswamy P, et al. Utility of B-natriuretic peptide in detecting diastolic dysfunction: comparison with Doppler velocity recordings. Circulation. 2002;105(5):595-601.

Maisel A. Natriuretic peptide-guided therapy for heart failure: Ready for “battle” or too “scarred” by the challenges of trial design? J Am Coll Cardiol. 2010;55(1):61-64.

Maisel A, Clopton P, Krishnaswamy P, et al. Impact of age, race, and sex on the ability of B-type natriuretic peptide to aid in the emergency diagnosis of heart failure: results from the Breathing Not Properly (BNP) multinational study. Am Heart J. 2004;147(6):1078-1084.

Maisel A, Hollander J, Guss D, McCullough P, et al. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT). A multicenter study of B-type natriuretic peptide levels, emergency department decision making, and outcomes in patients presenting with shortness of breath. J Am Coll Cardiol. 2004;44(6):1328-1333.

Maisel A, Krishnaswamy P, Nowak R, et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002;347(3):161-167.

Printed on 10/16/2012. Page 7 of 11 Mak G, DeMaria A, Clopton P, Maisel A. Utility of B-natriuretic peptide in the evaluation of left ventricular diastolic function: comparison with tissue Doppler imaging recordings. Am Heart J. 2004;148(5):895-902.

McCullough P, Nowak R, McCord J, et al. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002;106(4):416-422.

McMurray JJV. Systolic heart failure. N Engl J Med. 2010;362(3):228-238.

Morrison L, Harrison A, Krishnaswamy P, Kazanegra R, Clopton P, Maisel A. Utility of a rapid B-natriuretic peptide assay in differentiating congestive heart failure from lung disease in patients presenting with dyspnea. J Am Coll Cardiol. 2002;39(2):202-209.

Mueller C, Scholer A, Laul-Kilian K et al. Use of B-type Natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 350(7)647-654.

O’Connor CM, Gattis Strough W, Gallup DS, Hasselblad V, Gheorghaiade M. Demographic, clinical characteristics, and outcomes of patients hospitalized for decompensated heart failure: observations from the IMPACT-HF registry. J Card Fail. 2005;11(3):200-2005.

Packer M. Should B-type Natriuretic peptide be measured routinely to guide the diagnosis and management of chronic heart failure? Circulation. 2003;108:2950-2953.

Pfisterer M, Buser P, Rickli H, et al. BNP-guided vs. symptom-guided heart failure therapy: the Trial of Intensified vs Standard Medical Therapy in elderly patients with congestive heart failure (TIME-CHF) randomized trial. JAMA. 2009 Jan 28;301(4):383-92.

Philbin EF, Rocco TA, Lindenmuth NV, Ulrich K, Jenkins PL. Clinical outcomes in heart failure: report from a community hospital-based registry. Am J Med. 1999;107:549-555.

Ray P, Le Manach Y, Riou B. Houle T. Statistical evaluation of a biomarker. Anesthesiology. 2010; 112:1023-1040.

Troughton RW, Frampton AM. Biomarker-Guided Treatment of Heart Failure. JAMA. 2010; 56 (25):2101-2103.

Solinas L, Raucci R, Terrazzino S et al. Prevalence, clinical characteristics, resource utilization and outcome of patients with acute chest pain in the emergency department. A multicenter, prospective, observational study in north-eastern Italy. Ital Heart J. 2003;4(5):318-324.

Wieczorek S, Wu A, Christenson R, et al. A rapid B-type natriuretic peptide assay accurately diagnoses left ventricular dysfunction and heart failure: a multicenter evaluation. Am Heart J. 2002;144(5):834-839.

Wu A, Omland T, Duc P, et al. The effect of diabetes on B-type natriuretic peptide concentrations in patients with acute dyspnea: an analysis from the Breathing Not Properly (BNP) Multinational Study. http://care.diabetesjournals.org/cgi/content/full/27/10/2398. Accessed April 7, 2005.

Young J, Supplement Ed and Roundtable Moderator. Testing for B-type natriuretic peptide in the diagnosis and assessment of heart failure: what are the nuances? Cleve Clin J Med. 2004;71(Supplement 5):S1-S17. http://www.ccjm.org/toc/BNP.htm. Accessed April 5, 2005. Advisory Committee Meeting Notes This LCD was originally discussed at the July 8,2010 Part A Open Door Coverage Meeting and presented at the January 18, 2011 Open Public Meeting and the following Part B Carrier Advisory Committee Meetings:

Arizona February 8, 2011 Montana March 3, 2011 Printed on 10/16/2012. Page 8 of 11 North Dakota February 15, 2011 South Dakota February 17, 2011 Utah February 10, 2011 Wyoming February 10, 2011

Response to Part A Provider Recommendations from the July Part A Open Door Coverage meeting draft LCD:

Comment: We received one written request to expand the Indications list to include risk stratification among patients with acute coronary artery syndrome (ACS). Response: This indication will not be added to the list of reimbursable conditions. Evidence of the usefulness of BNP in this condition is not straightforward. The most recent (2010) systematic review concluded the literature did not establish the utility of the test in predicting either MI or rehospitalization following ACS. Moreover, even if the evidence were clear, there is no evidence the clinical lab test results alter patient management as is required for Medicare reimbursement [42CFR410.32(a)]. Patients who present with ACS receive maximal tolerated therapy regardless of the test results, both medical and surgical. The BNP test is insufficiently sensitive to preclude any therapy. It is also inadequate to direct therapy to either a medical or surgical path: "The therapeutic benefits that can be derived from BNP and NT-proBNP assessment in ACS are not clear with respect to invasive versus conservative management" -McCullogh et al 2010; and most patients undergo surgical interventions, regardless of BNP results.

Comment: Noridian received two written requests to expand the indications list to include monitoring the course of heart failure therapy. Response: This indication will not be added to the list of reimbursable conditions. All recent literature indicates that symptom-guided therapy is equal or superior to BNP-guided therapy, both in overall clinical outcomes and quality of life. (In part, this finding may be related to the absence of any proven effective treatment for heart failure with preserved ejection fraction, which is common in older patients; hence, treatment is necessarily focused most productively on the reduction of symptoms.)

Comment: One practitioner requested the addition of "suspected" pulmonary disease to the first indication, differentiation of known or "suspected" pulmonary disease from heart failure. Response: The recommendation is accepted. The cause of the dyspnea does not need to be known. However, the physician must have documented sufficient information to indicate a reason for the suspicion of pulmonary or other non-cardiac cause of the dyspnea.

Comment: We received requests for the addition of codes: swelling of limb, edema, fluid retention Response: The codes will not be added. The codes are sufficiently non-specific to allow indications not intended by the LCD.

NAS Response to Provider Recommendation (for comment period ending 05/11/2011):

Comment: We received a lengthy, thoughtful request for coverage of BNP in the role of risk stratification for Acute Coronary Syndrome, including references to literature purported to support that request. Response: We have reviewed this information before. No cardiologist we queried would withhold any diagnostic or therapeutic intervention in any group of cardiac patients based on BNP findings. In addition, none of them altered management based on the test. It appears to us that the test, at best, is used to add strength to a practitioner’s conclusions re patient status. Many of the MDs we spoke with believe the test is entirely superfluous. Thus, we have not added this requested coverage.

Comment: One final comment repeated the recommendation that BNP-guided therapy be covered, due to the assertion that “…more data has become available…” supporting BNP-guided therapy. Response: NAS has reviewed all the pertinent literature, including that supplied in this comment. The data simply do not support the assertion that BNP-guided therapy is clearly superior to symptom-guided treatment. NAS does not accept this recommendation. (Please see references.)

Comment: One comment recommended addition of a list of several ICD-9 diagnosis codes.

Printed on 10/16/2012. Page 9 of 11 Response: Upon review, NAS believes that the current list of covered diagnosis codes is appropriate and that addition of those recommended by the commenter are not supported by the weight of evidence. NAS will not add further ICD-9 codes at this time.

Start Date of Comment Period 01/18/2011

End Date of Comment Period 05/15/2011

Start Date of Notice Period 06/09/2011

Revision History Number R1

Revision History Explanation 03/31/2011 - The MCD did not publically display the address for submission of comments to this draft LCD. Therefore, NAS is extending the formal Comment Period from 04/20/11 to 05/15/2011 and published a notification to this effect on noridianmedicare.com as well.

Comments may be submitted to: Noridian Administrative Services, LLC Attn: Part B Contractor Medical Director(s) PO BOX 6740 Fargo ND 58108-6740 [email protected]

J3 CB2010.02 06/01/2011 - released to final

B2010. 02 R1 02/01/2012-The”Contractors Determination Number” changed due to the consolidation of LCD for JF implementation. Idaho MAC B (Contract #02202) was added to this LCD.

02/27/2012: The following states and contractor numbers were added to the LCD: Alaska MAC B (Contract #02102); Oregon MAC B (Contract #02302); and Washington MAC B (Contract #02402).

Reason for Change Other

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Printed on 10/16/2012. Page 10 of 11 All Versions Updated on 03/24/2012 with effective dates 02/27/2012 - N/A Updated on 03/23/2012 with effective dates 02/01/2012 - 02/26/2012 Updated on 06/02/2011 with effective dates 07/25/2011 - 01/31/2012 Read the LCD Disclaimer opens in new window Back to Top

Printed on 10/16/2012. Page 11 of 11 Local Coverage Determination (LCD) for Cytogenetic Studies (L24295)

Contractor Information Contractor Name Contractor Number Contractor Type Noridian Administrative Services, 03402 MAC - Part B LLC opens in new window Back to Top

LCD Information Document Information LCD ID Number L24295

LCD Title Primary Geographic Jurisdiction opens in new window Cytogenetic Studies South Dakota

Contractor's Determination Number Oversight Region B2006.24 R12 Region X

AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2012 American Medical Original Determination Effective Date Association. All Rights Reserved. CPT is a registered For services performed on or after 12/01/2006 trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee Original Determination Ending Date schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or Revision Effective Date indirectly practice medicine or dispense medical For services performed on or after 02/27/2012 services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Revision Ending Date Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

CMS National Coverage Policy Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim, which lacks the necessary information to process the claim.

Medicare National Coverage Determinations (NCD) Manual, 100-3, Section 190.3

Indications and Limitations of Coverage and/or Medical Necessity Cytogenetics is the study of chromosomes by light or fluorescent microscopy. Cytogenetic testing is used to study an individual's chromosome makeup. The term karyotyping refers to the arrangement of nucleus chromosomes in order from the largest to the smallest to analyze their number and structure. Cytogenetic testing involves the determination of chromosome number and structure; variations in either can produce numerous physical abnormalities. With cytogenetic testing, the total chromosome count is determined first, followed by the sex chromosome complement and then by any abnormalities. A normal karyotype of chromosomes consists of a pattern of 22 pairs of autosomal chromosomes and a pair of sex chromosomes: XY for the male and XX for the female. A plus (+) or minus (-) sign indicates, respectively, a gain or loss of chromosomal material.

Printed on 10/16/2012. Page 1 of 20

Specimens for cytogenetic analysis can be obtained for routine analysis from the peripheral blood, in which case T lymphocytes are examined; from amniotic fluid for culture of amniocytes; from trophoblastic cells from the chorionic villus; from bone marrow; from solid tumors, and from cultured fibroblasts, usually obtained from a skin biopsy. Enough cells must be examined so that the chance of missing a cytogenetically distinct cell line (a situation of mosaicism) is statistically low. For most clinical indications, 20 mitoses are examined and counted under direct microscopic visualization, and two are photographed or digitalized and karyotypes are prepared. Observation of aberrations usually prompts more extended scrutiny, and in many cases, further analysis of the original culture.

Per Medicare National Coverage Determinations (NCD) Manual, 100-3, Section 190.3:

"Medicare covers these tests when they are reasonable and necessary for the diagnosis or treatment of the following conditions: ● Genetic disorders (e.g., mongolism) in a fetus; (See the Medicare Benefit Policy Chapter 15, "Covered Medical and Other Health Services," 20.1) ● Failure of sexual development; or ● Chronic myelogenous leukemia. ● Acute leukemias, lymphoid (FAB L1-L3), myeloid (FAB M0-M7) and unclassified; or ● Myelodysplasia." (End of Quote)

The above quotation obligates the carrier to cover the listed diagnoses but does not limit coverage to that list. Further, genetic disorders and failure of sexual development involve chromosomal abnormalities that are stable over time, and, accordingly, payment for cytogenetic studies for these abnormalities will be allowed once per lifetime. This is in contrast to the malignancies, where repeated cytogenetic studies may be appropriate. At the present time, it should be noted that, even in cases of genetic disorders, the general policy limitation is for once per lifetime testing. When clinically-relevant technological advances (such as with FISH testing), are available, and repeat testing is believed to be medically reasonable and necessary, such claims must be billed using an additional ICD-9-CM code. (See the section titled ICD-9-CM Codes that Support Medical Necessity and attached Coding Guidelines for additional information.)

"Urovysion", a proprietary test for recurrent bladder cancer identification and monitoring, utilizes multiple probes, which are applied simultaneously, for dates of service on and after 01/01/2011, is correctly identified by two new CPT codes included in this LCD.

NAS finds little evidence in the literature that consistent chromosomal abnormalities in the conditions of polycythemia vera, agnogenic myeloid metaplasia, idiopathic thrombocythemia and multiple myeloma are known, or that their identification is likely to affect patient care; consequently, these are considered to be payable diagnoses only when the medical record contains clear, unequivocal documentation that this testing is medically reasonable and necessary for the individual case under consideration.

Concerning the testing of HER-2/neu antibodies, Noridian believes that current literature amply supports the notion that HER-2/neu tests on histological sections of breast cancers may, in the appropriate clinical settings, provide useful prognostic information and therapeutic indications for treating metastatic disease with anti-HER- 2/neu antibodies. For this or any other medically necessary use of in situ hybridization (FISH) testing, for dates of service on or after January 1, 2005, quantitative or semi-quantitative in situ hybridization (tissue or cellular) performed by computer-assisted technology should be reported as CPT code 88367 when performed by a physician (limited to M.D./D.O.). Beginning January 1, 2005, quantitative or semi-quantitative in situ hybridization (tissue or cellular) performed by manual methods should be reported as CPT code 88368 when performed by a physician (limited to M.D./D.O.). Do not report CPT code 88365 with CPT codes 88367 or 88368 for the same probe. Only one unit of service may be reported for CPT code 88365, 88367 or 88368 for each reportable probe. These codes include both a professional component and a technical component.

When a test for HER-2/neu protein over expression is performed using an immunocytochemistry technique, the test should be billed as 88342, immunocytochemistry. Thus, other CPT codes listed in the CPT/HCPCS Codes section of this policy should not be used when billing for HER-2/neu antibodies.

Since there is no current provider category for PhD Geneticists, notwithstanding the certainty that such providers are capable of demonstrating superb training and expertise, Medicare Contractors do not have the authority to create a provider category to allow payment for their services. We encourage these providers to continue discussion with CMS in this regard.

Printed on 10/16/2012. Page 2 of 20 NAS recognizes that Cytogenetic Testing is an emerging technology with rapidly expanding indications and will accept recommendations to reconsider the list of covered diagnoses. However, these requests for reconsideration must be submitted as a formal reconsideration (See www.noridianmedicare.com for the reconsideration process.) and must be accompanied by complete copies of relevant peer-reviewed literature that support the recommendation.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.

Coding Information Bill Type Codes:

Revenue Codes:

99999 Not Applicable

CPT/HCPCS Codes Short descriptions only are listed. Please consult the current CPT book for complete descriptions. 88120 Cytp urne 3-5 probes ea spec 88121 Cytp urine 3-5 probes cmptr 88230 Tissue culture lymphocyte 88233 Tissue culture skin/biopsy 88235 Tissue culture placenta 88237 Tissue culture bone marrow 88239 Tissue culture tumor 88240 Cell cryopreserve/storage 88241 Frozen cell preparation 88245 Chromosome analysis 20-25 88248 Chromosome analysis 50-100 88249 Chromosome analysis 100 88261 Chromosome analysis 5 88262 Chromosome analysis 15-20 88263 Chromosome analysis 45 88264 Chromosome analysis 20-25 88267 Chromosome analys placenta 88269 Chromosome analys amniotic 88271 Cytogenetics dna probe 88272 Cytogenetics 3-5 88273 Cytogenetics 10-30 88274 Cytogenetics 25-99 88275 Cytogenetics 100-300 88280 Chromosome karyotype study Printed on 10/16/2012. Page 3 of 20 88283 Chromosome banding study 88285 Chromosome count additional 88289 Chromosome study additional 88291 Cyto/molecular report 88299 Cytogenetic study

ICD-9 Codes that Support Medical Necessity Note: Diagnosis codes are based on the current ICD-9-CM codes that are effective at the time of LCD publication. Any updates to ICD-9-CM codes will be reviewed by NAS, and coverage should not be presumed until the results of such review have been published/posted.

These are the only covered ICD-9-CM codes that support medical necessity:

171.9* MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED 188.0 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER 188.1 MALIGNANT NEOPLASM OF DOME OF URINARY BLADDER 188.2 MALIGNANT NEOPLASM OF LATERAL WALL OF URINARY BLADDER 188.3 MALIGNANT NEOPLASM OF ANTERIOR WALL OF URINARY BLADDER 188.4 MALIGNANT NEOPLASM OF POSTERIOR WALL OF URINARY BLADDER 188.5 MALIGNANT NEOPLASM OF BLADDER NECK 188.6 MALIGNANT NEOPLASM OF URETERIC ORIFICE 188.7 MALIGNANT NEOPLASM OF URACHUS 188.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BLADDER 189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS 200.00 RETICULOSARCOMA UNSPECIFIED SITE 200.01 RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 200.02 RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES 200.03 RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 200.04 RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 200.05 RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 200.06 RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES 200.07 RETICULOSARCOMA INVOLVING SPLEEN 200.08 RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 200.10 LYMPHOSARCOMA UNSPECIFIED SITE 200.11 LYMPHOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 200.12 LYMPHOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES 200.13 LYMPHOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 200.14 LYMPHOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 200.15 LYMPHOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 200.16 LYMPHOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES 200.17 LYMPHOSARCOMA INVOLVING SPLEEN 200.18 LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 200.20 BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE 200.21 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 200.22 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES 200.23 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 200.24 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 200.25 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 200.26 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES 200.27 BURKITT'S TUMOR OR LYMPHOMA INVOLVING SPLEEN 200.28 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 200.80 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES 200.81 OF HEAD FACE AND NECK OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRATHORACIC 200.82 LYMPH NODES OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRA- 200.83 ABDOMINAL LYMPH NODES OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES 200.84 OF AXILLA AND UPPER LIMB

Printed on 10/16/2012. Page 4 of 20 200.85 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRAPELVIC 200.86 LYMPH NODES 200.87 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING SPLEEN OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES 200.88 OF MULTIPLE SITES 201.00 HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE 201.01 HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.02 HODGKIN'S PARAGRANULOMA INVOLVING INTRATHORACIC LYMPH NODES 201.03 HODGKIN'S PARAGRANULOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 201.04 HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 201.05 HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 201.06 HODGKIN'S PARAGRANULOMA INVOLVING INTRAPELVIC LYMPH NODES 201.07 HODGKIN'S PARAGRANULOMA INVOLVING SPLEEN 201.08 HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.10 HODGKIN'S GRANULOMA UNSPECIFIED SITE 201.11 HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.12 HODGKIN'S GRANULOMA INVOLVING INTRATHORACIC LYMPH NODES 201.13 HODGKIN'S GRANULOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 201.14 HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 201.15 HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 201.16 HODGKIN'S GRANULOMA INVOLVING INTRAPELVIC LYMPH NODES 201.17 HODGKIN'S GRANULOMA INVOLVING SPLEEN 201.18 HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.20 HODGKIN'S SARCOMA UNSPECIFIED SITE 201.21 HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.22 HODGKIN'S SARCOMA INVOLVING INTRATHORACIC LYMPH NODES 201.23 HODGKIN'S SARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 201.24 HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 201.25 HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 201.26 HODGKIN'S SARCOMA INVOLVING INTRAPELVIC LYMPH NODES 201.27 HODGKIN'S SARCOMA INVOLVING SPLEEN 201.28 HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.40 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF 201.41 HEAD FACE AND NECK HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING INTRATHORACIC 201.42 LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING INTRA-ABDOMINAL 201.43 LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF 201.44 AXILLA AND UPPER LIMB HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF 201.45 INGUINAL REGION AND LOWER LIMB HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING INTRAPELVIC LYMPH 201.46 NODES 201.47 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING SPLEEN HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF 201.48 MULTIPLE SITES 201.50 HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE 201.51 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.52 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING INTRATHORACIC LYMPH NODES 201.53 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING INTRA-ABDOMINAL LYMPH NODES 201.54 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF INGUINAL REGION AND 201.55 LOWER LIMB 201.56 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING INTRAPELVIC LYMPH NODES 201.57 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING SPLEEN 201.58 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF MULTIPLE SITES 201.60 HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE Printed on 10/16/2012. Page 5 of 20 201.61 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.62 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING INTRATHORACIC LYMPH NODES 201.63 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING INTRA-ABDOMINAL LYMPH NODES 201.64 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF INGUINAL REGION AND 201.65 LOWER LIMB 201.66 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING INTRAPELVIC LYMPH NODES 201.67 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING SPLEEN 201.68 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF MULTIPLE SITES 201.70 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE 201.71 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.72 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING INTRATHORACIC LYMPH NODES 201.73 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING INTRA-ABDOMINAL LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF AXILLA AND UPPER 201.74 LIMB HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF INGUINAL REGION AND 201.75 LOWER LIMB 201.76 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING INTRAPELVIC LYMPH NODES 201.77 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING SPLEEN 201.78 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF MULTIPLE SITES 201.90 HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE 201.91 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF HEAD FACE AND NECK 201.92 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING INTRATHORACIC LYMPH NODES 201.93 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING INTRA-ABDOMINAL LYMPH NODES 201.94 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER 201.95 LIMB 201.96 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING INTRAPELVIC LYMPH NODES 201.97 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING SPLEEN 201.98 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.00 NODULAR LYMPHOMA UNSPECIFIED SITE 202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES 202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES 202.07 NODULAR LYMPHOMA INVOLVING SPLEEN 202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE 202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK 202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES 202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES 202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES 202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN 202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.90 UNSPECIFIED SITE OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.91 INVOLVING LYMPH NODES OF HEAD FACE AND NECK OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.92 INVOLVING INTRATHORACIC LYMPH NODES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.93 INVOLVING INTRA-ABDOMINAL LYMPH NODES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.94 INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.95 INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 202.96 Printed on 10/16/2012. Page 6 of 20 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRAPELVIC LYMPH NODES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.97 INVOLVING SPLEEN OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE 202.98 INVOLVING LYMPH NODES OF MULTIPLE SITES 203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 203.01 MULTIPLE MYELOMA IN REMISSION 203.02 MULTIPLE MYELOMA, IN RELAPSE 203.10 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 203.11 PLASMA CELL LEUKEMIA IN REMISSION 203.12 PLASMA CELL LEUKEMIA, IN RELAPSE 203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.01 LYMPHOID LEUKEMIA ACUTE IN REMISSION 204.02 ACUTE LYMPHOID LEUKEMIA, IN RELAPSE 204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 204.22 SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE 204.80 OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.81 OTHER LYMPHOID LEUKEMIA IN REMISSION 204.82 OTHER LYMPHOID LEUKEMIA, IN RELAPSE 205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.01 MYELOID LEUKEMIA ACUTE IN REMISSION 205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE 205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.11 MYELOID LEUKEMIA CHRONIC IN REMISSION 205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE 205.20 SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.21 MYELOID LEUKEMIA SUBACUTE IN REMISSION 205.22 SUBACUTE MYELOID LEUKEMIA, IN RELAPSE 205.30 MYELOID SARCOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.31 MYELOID SARCOMA IN REMISSION 205.32 MYELOID SARCOMA, IN RELAPSE 205.80 OTHER MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.81 OTHER MYELOID LEUKEMIA IN REMISSION 205.82 OTHER MYELOID LEUKEMIA, IN RELAPSE 205.90 UNSPECIFIED MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.91 UNSPECIFIED MYELOID LEUKEMIA IN REMISSION 206.00 ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.01 MONOCYTIC LEUKEMIA ACUTE IN REMISSION 206.02 ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 206.82 OTHER MONOCYTIC LEUKEMIA, IN RELAPSE 206.90 UNSPECIFIED MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.91 UNSPECIFIED MONOCYTIC LEUKEMIA IN REMISSION 207.20 MEGAKARYOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 207.21 MEGAKARYOCYTIC LEUKEMIA IN REMISSION 207.22 MEGAKARYOCYTIC LEUKEMIA, IN RELAPSE 207.82 OTHER SPECIFIED LEUKEMIA, IN RELAPSE 208.00 ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 208.01 LEUKEMIA OF UNSPECIFIED CELL TYPE ACUTE IN REMISSION 208.02 ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 225.2 BENIGN NEOPLASM OF CEREBRAL MENINGES 238.4 POLYCYTHEMIA VERA 238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS 238.71 ESSENTIAL THROMBOCYTHEMIA 238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED Printed on 10/16/2012. Page 7 of 20 238.77 POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 259.0 DELAY IN SEXUAL DEVELOPMENT AND PUBERTY NOT ELSEWHERE CLASSIFIED 273.1 MONOCLONAL PARAPROTEINEMIA 273.3 MACROGLOBULINEMIA 284.01 CONSTITUTIONAL RED BLOOD CELL APLASIA 284.09 OTHER CONSTITUTIONAL APLASTIC ANEMIA 284.19 OTHER PANCYTOPENIA 284.2 MYELOPHTHISIS 284.81 RED CELL APLASIA (ACQUIRED) (ADULT) (WITH THYMOMA) 284.89 OTHER SPECIFIED APLASTIC ANEMIAS 284.9 APLASTIC ANEMIA UNSPECIFIED 285.0 SIDEROBLASTIC ANEMIA 285.1 ACUTE POSTHEMORRHAGIC ANEMIA 285.21 ANEMIA IN CHRONIC KIDNEY DISEASE 285.22 ANEMIA IN NEOPLASTIC DISEASE 285.29 ANEMIA OF OTHER CHRONIC DISEASE 285.8 OTHER SPECIFIED ANEMIAS 285.9 ANEMIA UNSPECIFIED 287.30 PRIMARY THROMBOCYTOPENIA,UNSPECIFIED 287.31 IMMUNE THROMBOCYTOPENIC PURPURA 287.32 EVANS’ SYNDROME 287.33 CONGENITAL AND HEREDITARY THROMBOCYTOPENIC PURPURA 287.39 OTHER PRIMARY THROMBOCYTOPENIA 287.41 POSTTRANSFUSION PURPURA 287.49 OTHER SECONDARY THROMBOCYTOPENIA 288.01* CONGENITAL NEUTROPENIA 288.02 CYCLIC NEUTROPENIA 288.1 FUNCTIONAL DISORDERS OF POLYMORPHONUCLEAR NEUTROPHILS 288.2 GENETIC ANOMALIES OF LEUKOCYTES 288.3 EOSINOPHILIA 288.4 HEMOPHAGOCYTIC SYNDROMES 288.61 LYMPHOCYTOSIS (SYMPTOMATIC) 288.63 MONOCYTOSIS (SYMPTOMATIC) 288.64 PLASMACYTOSIS 288.65 BASOPHILIA 288.8 OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS 289.6 FAMILIAL POLYCYTHEMIA 289.7 METHEMOGLOBINEMIA 289.81 PRIMARY HYPERCOAGULABLE STATE 289.82 SECONDARY HYPERCOAGULABLE STATE 289.83 MYELOFIBROSIS 289.89 OTHER SPECIFIED DISEASES OF BLOOD AND BLOOD-FORMING ORGANS 334.8 OTHER SPINOCEREBELLAR DISEASES 388.5 DISORDERS OF ACOUSTIC NERVE 389.10 SENSORINEURAL HEARING LOSS UNSPECIFIED 629.9 UNSPECIFIED DISORDER OF FEMALE GENITAL ORGANS 630 HYDATIDIFORM MOLE INAPPROPRIATE CHANGE IN QUANTITATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) IN EARLY 631.0 PREGNANCY 632 MISSED ABORTION 646.33 RECURRENT PREGNANCY LOSS, ANTEPARTUM CONDITION OR COMPLICATION CENTRAL NERVOUS SYSTEM MALFORMATION IN FETUS UNSPECIFIED AS TO EPISODE OF CARE IN 655.00 PREGNANCY 655.01 CENTRAL NERVOUS SYSTEM MALFORMATION IN FETUS WITH DELIVERY 655.03 CENTRAL NERVOUS SYSTEM MALFORMATION IN FETUS ANTEPARTUM CHROMOSOMAL ABNORMALITY IN FETUS AFFECTING MANAGEMENT OF MOTHER UNSPECIFIED AS TO 655.10 EPISODE OF CARE IN PREGNANCY 655.11 CHROMOSOMAL ABNORMALITY IN FETUS AFFECTING MANAGEMENT OF MOTHER WITH DELIVERY 655.13 CHROMOSOMAL ABNORMALITY IN FETUS AFFECTING MANAGEMENT OF MOTHER ANTEPARTUM Printed on 10/16/2012. Page 8 of 20 655.20 HEREDITARY DISEASE IN FAMILY POSSIBLY AFFECTING FETUS AFFECTING MANAGEMENT OF MOTHER UNSPECIFIED AS TO EPISODE OF CARE IN PREGNANCY HEREDITARY DISEASE IN FAMILY POSSIBLY AFFECTING FETUS AFFECTING MANAGEMENT OF MOTHER 655.21 WITH DELIVERY HEREDITARY DISEASE IN FAMILY POSSIBLY AFFECTING FETUS AFFECTING MANAGEMENT OF MOTHER 655.23 ANTEPARTUM CONDITION OR COMPLICATION 656.40 INTRAUTERINE DEATH AFFECTING MANAGEMENT OF MOTHER UNSPECIFIED AS TO EPISODE OF CARE 656.41 INTRAUTERINE DEATH AFFECTING MANAGEMENT OF MOTHER DELIVERED 656.43 INTRAUTERINE DEATH AFFECTING MANAGEMENT OF MOTHER ANTEPARTUM 656.50 POOR FETAL GROWTH AFFECTING MANAGEMENT OF MOTHER UNSPECIFIED AS TO EPISODE OF CARE 656.51 POOR FETAL GROWTH AFFECTING MANAGEMENT OF MOTHER DELIVERED POOR FETAL GROWTH AFFECTING MANAGEMENT OF MOTHER ANTEPARTUM CONDITION OR 656.53 COMPLICATION EXCESSIVE FETAL GROWTH AFFECTING MANAGEMENT OF MOTHER UNSPECIFIED AS TO EPISODE OF 656.60 CARE 656.61 EXCESSIVE FETAL GROWTH AFFECTING MANAGEMENT OF MOTHER DELIVERED 656.63 EXCESSIVE FETAL GROWTH AFFECTING MANAGEMENT OF MOTHER ANTEPARTUM 657.00 POLYHYDRAMNIOS UNSPECIFIED AS TO EPISODE OF CARE 657.01 POLYHYDRAMNIOS WITH DELIVERY 657.03 POLYHYDRAMNIOS ANTEPARTUM COMPLICATION 658.00 OLIGOHYDRAMNIOS UNSPECIFIED AS TO EPISODE OF CARE 658.01 OLIGOHYDRAMNIOS DELIVERED 658.03 OLIGOHYDRAMNIOS ANTEPARTUM 659.50 ELDERLY PRIMIGRAVIDA UNSPECIFIED AS TO EPISODE OF CARE 659.51 ELDERLY PRIMIGRAVIDA DELIVERED 659.53 ELDERLY PRIMIGRAVIDA ANTEPARTUM 659.60 OTHER ADVANCED MATERNAL AGE UNSPECIFIED AS TO EPISODE OF CARE OR NOT APPLICABLE 659.61 OTHER ADVANCED MATERNAL AGE DELIVERED WITH OR WITHOUT ANTEPARTUM CONDITION 659.63 OTHER ADVANCED MATERNAL AGE ANTEPARTUM CONDITION OR COMPLICATION 740.0 ANENCEPHALUS 740.1 CRANIORACHISCHISIS 740.2 INIENCEPHALY 742.0 ENCEPHALOCELE 742.1 MICROCEPHALUS 742.2 CONGENITAL REDUCTION DEFORMITIES OF BRAIN 742.3 CONGENITAL HYDROCEPHALUS 742.4 OTHER SPECIFIED CONGENITAL ANOMALIES OF BRAIN 742.51 DIASTEMATOMYELIA 742.53 HYDROMYELIA 742.59 OTHER SPECIFIED CONGENITAL ANOMALIES OF SPINAL CORD 742.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF NERVOUS SYSTEM 743.00 CLINICAL ANOPHTHALMOS UNSPECIFIED 743.03 CYSTIC EYEBALL CONGENITAL 743.06 CRYPTOPHTHALMOS 743.10 MICROPHTHALMOS UNSPECIFIED 743.11 SIMPLE MICROPHTHALMOS 743.12 MICROPHTHALMOS ASSOCIATED WITH OTHER ANOMALIES OF EYE AND ADNEXA 743.20 BUPHTHALMOS UNSPECIFIED 743.21 SIMPLE BUPHTHALMOS 743.22 BUPHTHALMOS ASSOCIATED WITH OTHER OCULAR ANOMALIES 743.30 CONGENITAL CATARACT UNSPECIFIED 743.31 CONGENITAL CAPSULAR AND SUBCAPSULAR CATARACT 743.32 CONGENITAL CORTICAL AND ZONULAR CATARACT 743.33 CONGENITAL NUCLEAR CATARACT 743.34 CONGENITAL TOTAL AND SUBTOTAL CATARACT 743.35 CONGENITAL APHAKIA 743.36 CONGENITAL ANOMALIES OF LENS SHAPE 743.37 CONGENITAL ECTOPIC LENS 743.39 OTHER CONGENITAL CATARACT AND LENS ANOMALIES 743.41 CONGENITAL ANOMALIES OF CORNEAL SIZE AND SHAPE Printed on 10/16/2012. Page 9 of 20 743.42 CONGENITAL CORNEAL OPACITIES INTERFERING WITH VISION 743.43 OTHER CONGENITAL CORNEAL OPACITIES SPECIFIED CONGENITAL ANOMALIES OF ANTERIOR CHAMBER CHAMBER ANGLE AND RELATED 743.44 STRUCTURES 743.45 ANIRIDIA 743.46 OTHER SPECIFIED CONGENITAL ANOMALIES OF IRIS AND CILIARY BODY 743.47 SPECIFIED CONGENITAL ANOMALIES OF SCLERA 743.48 MULTIPLE AND COMBINED CONGENITAL ANOMALIES OF ANTERIOR SEGMENT 743.49 OTHER CONGENITAL ANOMALIES OF ANTERIOR SEGMENT 743.51 VITREOUS ANOMALIES CONGENITAL 743.52 FUNDUS COLOBOMA 743.53 CHORIORETINAL DEGENERATION CONGENITAL 743.54 CONGENITAL FOLDS AND CYSTS OF POSTERIOR SEGMENT 743.55 CONGENITAL MACULAR CHANGES 743.56 OTHER RETINAL CHANGES CONGENITAL 743.57 SPECIFIED CONGENITAL ANOMALIES OF OPTIC DISC 743.58 VASCULAR ANOMALIES CONGENITAL 743.59 OTHER CONGENITAL ANOMALIES OF POSTERIOR SEGMENT 743.61 CONGENITAL PTOSIS OF EYELID 743.62 CONGENITAL DEFORMITIES OF EYELIDS 743.63 OTHER SPECIFIED CONGENITAL ANOMALIES OF EYELID 743.64 SPECIFIED CONGENITAL ANOMALIES OF LACRIMAL GLAND 743.65 SPECIFIED CONGENITAL ANOMALIES OF LACRIMAL PASSAGES 743.66 SPECIFIED CONGENITAL ANOMALIES OF ORBIT 743.69 OTHER CONGENITAL ANOMALIES OF EYELIDS LACRIMAL SYSTEM AND ORBIT 743.8 OTHER SPECIFIED ANOMALIES OF EYE CONGENITAL 743.9 UNSPECIFIED ANOMALY OF EYE CONGENITAL 744.00 UNSPECIFIED CONGENITAL ANOMALY OF EAR WITH IMPAIRMENT OF HEARING 744.01 CONGENITAL ABSENCE OF EXTERNAL EAR 744.02 OTHER CONGENITAL ANOMALIES OF EXTERNAL EAR WITH IMPAIRMENT OF HEARING 744.03 CONGENITAL ANOMALY OF MIDDLE EAR EXCEPT OSSICLES 744.04 CONGENITAL ANOMALIES OF EAR OSSICLES 744.05 CONGENITAL ANOMALIES OF INNER EAR 744.09 OTHER CONGENITAL ANOMALIES OF EAR CAUSING IMPAIRMENT OF HEARING 744.1 ACCESSORY AURICLE 744.21 ABSENCE OF EAR LOBE CONGENITAL 744.22 MACROTIA 744.23 MICROTIA 744.24 SPECIFIED CONGENITAL ANOMALIES OF EUSTACHIAN TUBE 744.29 OTHER CONGENITAL ANOMALIES OF EAR 744.3 UNSPECIFIED CONGENITAL ANOMALY OF EAR 744.41 BRANCHIAL CLEFT SINUS OR FISTULA 744.42 BRANCHIAL CLEFT CYST 744.43 CERVICAL AURICLE 744.46 PREAURICULAR SINUS OR FISTULA 744.47 PREAURICULAR CYST 744.49 OTHER BRANCHIAL CLEFT CYST OR FISTULA; PREAURICULAR SINUS 744.5 WEBBING OF NECK 744.81 MACROCHEILIA 744.82 MICROCHEILIA 744.83 MACROSTOMIA 744.84 MICROSTOMIA 744.89 OTHER SPECIFIED CONGENITAL ANOMALIES OF FACE AND NECK 744.9 UNSPECIFIED CONGENITAL ANOMALIES OF FACE AND NECK 745.0 COMMON TRUNCUS 745.10 COMPLETE TRANSPOSITION OF GREAT VESSELS 745.11 DOUBLE OUTLET RIGHT VENTRICLE 745.12 CORRECTED TRANSPOSITION OF GREAT VESSELS 745.19 OTHER TRANSPOSITION OF GREAT VESSELS 745.2 TETRALOGY OF FALLOT Printed on 10/16/2012. Page 10 of 20 745.3 COMMON VENTRICLE 745.4 VENTRICULAR SEPTAL DEFECT 745.5 OSTIUM SECUNDUM TYPE ATRIAL SEPTAL DEFECT 745.60 ENDOCARDIAL CUSHION DEFECT UNSPECIFIED TYPE 745.61 OSTIUM PRIMUM DEFECT 745.69 OTHER ENDOCARDIAL CUSHION DEFECTS 745.7 COR BILOCULARE 745.8 OTHER BULBUS CORDIS ANOMALIES AND ANOMALIES OF CARDIAC SEPTAL CLOSURE 745.9 UNSPECIFIED DEFECT OF SEPTAL CLOSURE 746.00 CONGENITAL PULMONARY VALVE ANOMALY UNSPECIFIED 746.01 ATRESIA OF PULMONARY VALVE CONGENITAL 746.02 STENOSIS OF PULMONARY VALVE CONGENITAL 746.09 OTHER CONGENITAL ANOMALIES OF PULMONARY VALVE 746.1 TRICUSPID ATRESIA AND STENOSIS CONGENITAL 746.2 EBSTEIN'S ANOMALY 746.3 CONGENITAL STENOSIS OF AORTIC VALVE 746.4 CONGENITAL INSUFFICIENCY OF AORTIC VALVE 746.5 CONGENITAL MITRAL STENOSIS 746.6 CONGENITAL MITRAL INSUFFICIENCY 746.7 HYPOPLASTIC LEFT HEART SYNDROME 746.81 SUBAORTIC STENOSIS CONGENITAL 746.82 COR TRIATRIATUM 746.83 INFUNDIBULAR PULMONIC STENOSIS CONGENITAL 746.84 CONGENITAL OBSTRUCTIVE ANOMALIES OF HEART NOT ELSEWHERE CLASSIFIED 746.85 CORONARY ARTERY ANOMALY CONGENITAL 746.86 CONGENITAL HEART BLOCK 746.87 MALPOSITION OF HEART AND CARDIAC APEX 746.89 OTHER SPECIFIED CONGENITAL ANOMALIES OF HEART 746.9 UNSPECIFIED CONGENITAL ANOMALY OF HEART 747.0 PATENT DUCTUS ARTERIOSUS 747.10 COARCTATION OF AORTA (PREDUCTAL) (POSTDUCTAL) 747.11 INTERRUPTION OF AORTIC ARCH 747.20 CONGENITAL ANOMALY OF AORTA UNSPECIFIED 747.21 CONGENITAL ANOMALIES OF AORTIC ARCH 747.22 CONGENITAL ATRESIA AND STENOSIS OF AORTA 747.29 OTHER CONGENITAL ANOMALIES OF AORTA 747.31 PULMONARY ARTERY COARCTATION AND ATRESIA 747.32 PULMONARY ARTERIOVENOUS MALFORMATION 747.39 OTHER ANOMALIES OF PULMONARY ARTERY AND PULMONARY CIRCULATION 747.40 CONGENITAL ANOMALY OF GREAT VEINS UNSPECIFIED 747.41 TOTAL ANOMALOUS PULMONARY VENOUS CONNECTION 747.42 PARTIAL ANOMALOUS PULMONARY VENOUS CONNECTION 747.49 OTHER ANOMALIES OF GREAT VEINS 747.5 ABSENCE OR HYPOPLASIA OF UMBILICAL ARTERY 747.60 ANOMALY OF THE PERIPHERAL VASCULAR SYSTEM UNSPECIFIED SITE 747.61 GASTROINTESTINAL VESSEL ANOMALY 747.62 RENAL VESSEL ANOMALY 747.63 UPPER LIMB VESSEL ANOMALY 747.64 LOWER LIMB VESSEL ANOMALY 747.69 ANOMALIES OF OTHER SPECIFIED SITES OF PERIPHERAL VASCULAR SYSTEM 747.81 CONGENITAL ANOMALIES OF CEREBROVASCULAR SYSTEM 747.82 SPINAL VESSEL ANOLMALY 747.83 PERSISTENT FETAL CIRCULATION 747.89 OTHER SPECIFIED CONGENITAL ANOMALIES OF CIRCULATORY SYSTEM 747.9 UNSPECIFIED CONGENITAL ANOMALY OF CIRCULATORY SYSTEM 748.0 CHOANAL ATRESIA 748.1 OTHER CONGENITAL ANOMALIES OF NOSE 748.2 WEB OF LARYNX 748.3 OTHER CONGENITAL ANOMALIES OF LARYNX TRACHEA AND BRONCHUS

Printed on 10/16/2012. Page 11 of 20 748.4 CONGENITAL CYSTIC LUNG 748.5 CONGENITAL AGENESIS HYPOPLASIA AND DYSPLASIA OF LUNG 748.60 CONGENITAL ANOMALY OF LUNG UNSPECIFIED 748.61 CONGENITAL BRONCHIECTASIS 748.69 OTHER CONGENITAL ANOMALIES OF LUNG 748.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF RESPIRATORY SYSTEM 748.9 UNSPECIFIED CONGENITAL ANOMALY OF RESPIRATORY SYSTEM 749.00 CLEFT PALATE UNSPECIFIED 749.01 CLEFT PALATE UNILATERAL COMPLETE 749.02 CLEFT PALATE UNILATERAL INCOMPLETE 749.03 CLEFT PALATE BILATERAL COMPLETE 749.04 CLEFT PALATE BILATERAL INCOMPLETE 749.10 CLEFT LIP UNSPECIFIED 749.11 CLEFT LIP UNILATERAL COMPLETE 749.12 CLEFT LIP UNILATERAL INCOMPLETE 749.13 CLEFT LIP BILATERAL COMPLETE 749.14 CLEFT LIP BILATERAL INCOMPLETE 749.20 CLEFT PALATE WITH CLEFT LIP UNSPECIFIED 749.21 CLEFT PALATE WITH CLEFT LIP UNILATERAL COMPLETE 749.22 CLEFT PALATE WITH CLEFT LIP UNILATERAL INCOMPLETE 749.23 CLEFT PALATE WITH CLEFT LIP BILATERAL COMPLETE 749.24 CLEFT PALATE WITH CLEFT LIP BILATERAL INCOMPLETE 749.25 OTHER COMBINATIONS OF CLEFT PALATE WITH CLEFT LIP 750.0 TONGUE TIE 750.10 CONGENITAL ANOMALY OF TONGUE UNSPECIFIED 750.11 AGLOSSIA 750.12 CONGENITAL ADHESIONS OF TONGUE 750.13 CONGENITAL FISSURE OF TONGUE 750.15 MACROGLOSSIA 750.16 MICROGLOSSIA 750.19 OTHER CONGENITAL ANOMALIES OF TONGUE 750.21 CONGENITAL ABSENCE OF SALIVARY GLAND 750.22 ACCESSORY SALIVARY GLAND 750.23 CONGENITAL ATRESIA SALIVARY DUCT 750.24 CONGENITAL FISTULA OF SALIVARY GLAND 750.25 CONGENITAL FISTULA OF LIP 750.26 OTHER SPECIFIED CONGENITAL ANOMALIES OF MOUTH 750.27 CONGENITAL DIVERTICULUM OF PHARYNX 750.29 OTHER SPECIFIED CONGENITAL ANOMALIES OF PHARYNX 750.3 CONGENITAL TRACHEOESOPHAGEAL FISTULA ESOPHAGEAL ATRESIA AND STENOSIS 750.4 OTHER SPECIFIED CONGENITAL ANOMALIES OF ESOPHAGUS 750.5 CONGENITAL HYPERTROPHIC PYLORIC STENOSIS 750.6 CONGENITAL HIATUS HERNIA 750.7 OTHER SPECIFIED CONGENITAL ANOMALIES OF STOMACH 750.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF UPPER ALIMENTARY TRACT 750.9 UNSPECIFIED CONGENITAL ANOMALY OF UPPER ALIMENTARY TRACT 751.0 MECKEL'S DIVERTICULUM 751.1 CONGENITAL ATRESIA AND STENOSIS OF SMALL INTESTINE 751.2 CONGENITAL ATRESIA AND STENOSIS OF LARGE INTESTINE RECTUM AND ANAL CANAL 751.3 HIRSCHSPRUNG'S DISEASE AND OTHER CONGENITAL FUNCTIONAL DISORDERS OF COLON 751.4 CONGENITAL ANOMALIES OF INTESTINAL FIXATION 751.5 OTHER CONGENITAL ANOMALIES OF INTESTINE 751.60 UNSPECIFIED CONGENITAL ANOMALY OF GALLBLADDER BILE DUCTS AND LIVER 751.61 BILIARY ATRESIA CONGENITAL 751.62 CONGENITAL CYSTIC DISEASE OF LIVER 751.69 OTHER CONGENITAL ANOMALIES OF GALLBLADDER BILE DUCTS AND LIVER 751.7 CONGENITAL ANOMALIES OF PANCREAS 751.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF DIGESTIVE SYSTEM 751.9 UNSPECIFIED CONGENITAL ANOMALY OF DIGESTIVE SYSTEM

Printed on 10/16/2012. Page 12 of 20 752.0 CONGENITAL ANOMALIES OF OVARIES 752.10 UNSPECIFIED CONGENITAL ANOMALY OF FALLOPIAN TUBES AND BROAD LIGAMENTS 752.11 EMBRYONIC CYST OF FALLOPIAN TUBES AND BROAD LIGAMENTS 752.19 OTHER CONGENITAL ANOMALIES OF FALLOPIAN TUBES AND BROAD LIGAMENTS 752.2 DOUBLING OF UTERUS 752.31 AGENESIS OF UTERUS 752.32 HYPOPLASIA OF UTERUS 752.33 UNICORNUATE UTERUS 752.34 BICORNUATE UTERUS 752.35 SEPTATE UTERUS 752.36 ARCUATE UTERUS 752.39 OTHER ANOMALIES OF UTERUS 752.40 UNSPECIFIED CONGENITAL ANOMALY OF CERVIX VAGINA AND EXTERNAL FEMALE GENITALIA 752.41 EMBRYONIC CYST OF CERVIX VAGINA AND EXTERNAL FEMALE GENITALIA 752.42 IMPERFORATE HYMEN 752.43 CERVICAL AGENESIS 752.44 VAGINAL DUPLICATION 752.45 VAGINAL AGENESIS 752.46 TRANSVERSE VAGINAL SEPTUM 752.47 LONGITUDINAL VAGINAL SEPTUM 752.49 OTHER CONGENITAL ANOMALIES OF CERVIX VAGINA AND EXTERNAL FEMALE GENITALIA 752.51 UNDESCENDED TESTIS 752.52 RETRACTILE TESTIS 752.61 HYPOSPADIAS 752.62 EPISPADIAS 752.63 CONGENITAL CHORDEE 752.64 MICROPENIS 752.65 HIDDEN PENIS 752.69 OTHER PENILE ANOMALIES 752.7 INDETERMINATE SEX AND PSEUDOHERMAPHRODITISM 752.81 SCROTAL TRANSPOSITION 752.89 OTHER SPECIFIED ANOMALIES OF GENITAL ORGANS 752.9 UNSPECIFIED CONGENITAL ANOMALY OF GENITAL ORGANS 753.0 RENAL AGENESIS AND DYSGENESIS 753.10 CYSTIC KIDNEY DISEASE UNSPECIFIED 753.11 CONGENITAL SINGLE RENAL CYST 753.12 POLYCYSTIC KIDNEY UNSPECIFIED TYPE 753.13 POLYCYSTIC KIDNEY AUTOSOMAL DOMINANT 753.14 POLYCYSTIC KIDNEY AUTOSOMAL RECESSIVE 753.15 RENAL DYSPLASIA 753.16 MEDULLARY CYSTIC KIDNEY 753.17 MEDULLARY SPONGE KIDNEY 753.19 OTHER SPECIFIED CYSTIC KIDNEY DISEASE 753.20 UNSPECIFIED OBSTRUCTIVE DEFECT OF RENAL PELVIS AND URETER 753.21 CONGENITAL OBSTRUCTION OF URETEROPELVIC JUNCTION 753.22 CONGENITAL OBSTRUCTION OF URETEROVESICAL JUNCTION 753.23 CONGENITAL URETEROCELE 753.29 OTHER OBSTRUCTIVE DEFECT OF RENAL PELVIS AND URETER 753.3 OTHER SPECIFIED ANOMALIES OF KIDNEY 753.4 OTHER SPECIFIED ANOMALIES OF URETER 753.5 EXSTROPHY OF URINARY BLADDER 753.6 CONGENITAL ATRESIA AND STENOSIS OF URETHRA AND BLADDER NECK 753.7 CONGENITAL ANOMALIES OF URACHUS 753.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF BLADDER AND URETHRA 753.9 UNSPECIFIED CONGENITAL ANOMALY OF URINARY SYSTEM 754.0 CONGENITAL MUSCULOSKELETAL DEFORMITIES OF SKULL FACE AND JAW 754.1 CONGENITAL MUSCULOSKELETAL DEFORMITIES OF STERNOCLEIDOMASTOID MUSCLE 754.2 CONGENITAL MUSCULOSKELETAL DEFORMITIES OF SPINE 754.30 CONGENITAL DISLOCATION OF HIP UNILATERAL

Printed on 10/16/2012. Page 13 of 20 754.31 CONGENITAL DISLOCATION OF HIP BILATERAL 754.32 CONGENITAL SUBLUXATION OF HIP UNILATERAL 754.33 CONGENITAL SUBLUXATION OF HIP BILATERAL 754.35 CONGENITAL DISLOCATION OF ONE HIP WITH SUBLUXATION OF OTHER HIP 754.40 GENU RECURVATUM 754.41 CONGENITAL DISLOCATION OF KNEE (WITH GENU RECURVATUM) 754.42 CONGENITAL BOWING OF FEMUR 754.43 CONGENITAL BOWING OF TIBIA AND FIBULA 754.44 CONGENITAL BOWING OF UNSPECIFIED LONG BONES OF LEG 754.50 CONGENITAL TALIPES VARUS 754.51 CONGENITAL TALIPES EQUINOVARUS 754.52 CONGENITAL METATARSUS PRIMUS VARUS 754.53 CONGENITAL METATARSUS VARUS 754.59 OTHER CONGENITAL VARUS DEFORMITIES OF FEET 754.60 CONGENITAL TALIPES VALGUS 754.61 CONGENITAL PES PLANUS 754.62 TALIPES CALCANEOVALGUS 754.69 OTHER CONGENITAL VALGUS DEFORMITIES OF FEET 754.70 TALIPES UNSPECIFIED 754.71 TALIPES CAVUS 754.79 OTHER CONGENITAL DEFORMITIES OF FEET 754.81 PECTUS EXCAVATUM 754.82 PECTUS CARINATUM 754.89 OTHER SPECIFIED NONTERATOGENIC ANOMALIES 755.00 POLYDACTYLY UNSPECIFIED DIGITS 755.01 POLYDACTYLY OF FINGERS 755.02 POLYDACTYLY OF TOES 755.10 SYNDACTYLY OF MULTIPLE AND UNSPECIFIED SITES 755.11 SYNDACTYLY OF FINGERS WITHOUT FUSION OF BONE 755.12 SYNDACTYLY OF FINGERS WITH FUSION OF BONE 755.13 SYNDACTYLY OF TOES WITHOUT FUSION OF BONE 755.14 SYNDACTYLY OF TOES WITH FUSION OF BONE 755.20 UNSPECIFIED REDUCTION DEFORMITY OF UPPER LIMB CONGENITAL 755.21 TRANSVERSE DEFICIENCY OF UPPER LIMB 755.22 LONGITUDINAL DEFICIENCY OF UPPER LIMB NOT ELSEWHERE CLASSIFIED LONGITUDINAL DEFICIENCY COMBINED INVOLVING HUMERUS RADIUS AND ULNA (COMPLETE OR 755.23 INCOMPLETE) LONGITUDINAL DEFICIENCY HUMERAL COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL 755.24 DEFICIENCIES INCOMPLETE) LONGITUDINAL DEFICIENCY RADIOULNAR COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL 755.25 DEFICIENCIES INCOMPLETE) LONGITUDINAL DEFICIENCY RADIAL COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL 755.26 DEFICIENCIES INCOMPLETE) LONGITUDINAL DEFICIENCY ULNAR COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL DEFICIENCIES 755.27 INCOMPLETE) LONGITUDINAL DEFICIENCY CARPALS OR METACARPALS COMPLETE OR PARTIAL (WITH OR WITHOUT 755.28 INCOMPLETE PHALANGEAL DEFICIENCY) 755.29 LONGITUDINAL DEFICIENCY PHALANGES COMPLETE OR PARTIAL 755.30 UNSPECIFIED REDUCTION DEFORMITY OF LOWER LIMB CONGENITAL 755.31 TRANSVERSE DEFICIENCY OF LOWER LIMB 755.32 LONGITUDINAL DEFICIENCY OF LOWER LIMB NOT ELSEWHERE CLASSIFIED LONGITUDINAL DEFICIENCY COMBINED INVOLVING FEMUR TIBIA AND FIBULA (COMPLETE OR 755.33 INCOMPLETE) LONGITUDINAL DEFICIENCY FEMORAL COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL 755.34 DEFICIENCIES INCOMPLETE) LONGITUDINAL DEFICIENCY TIBIOFIBULAR COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL 755.35 DEFICIENCIES INCOMPLETE) LONGITUDINAL DEFICIENCY TIBIA COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL DEFICIENCIES 755.36 INCOMPLETE) LONGITUDINAL DEFICIENCY FIBULAR COMPLETE OR PARTIAL (WITH OR WITHOUT DISTAL 755.37 DEFICIENCIES INCOMPLETE) Printed on 10/16/2012. Page 14 of 20 755.38 LONGITUDINAL DEFICIENCY TARSALS OR METATARSALS COMPLETE OR PARTIAL (WITH OR WITHOUT INCOMPLETE PHALANGEAL DEFICIENCY) 755.39 LONGITUDINAL DEFICIENCY PHALANGES COMPLETE OR PARTIAL 755.4 CONGENITAL REDUCTION DEFORMITIES UNSPECIFIED LIMB 755.50 UNSPECIFIED ANOMALY OF UPPER LIMB CONGENITAL 755.51 CONGENITAL DEFORMITY OF CLAVICLE 755.52 CONGENITAL ELEVATION OF SCAPULA 755.53 RADIOULNAR SYNOSTOSIS 755.54 MADELUNG'S DEFORMITY 755.55 ACROCEPHALOSYNDACTYLY 755.56 ACCESSORY CARPAL BONES 755.57 MACRODACTYLIA (FINGERS) 755.58 CLEFT HAND CONGENITAL 755.59 OTHER CONGENITAL ANOMALIES OF UPPER LIMB INCLUDING SHOULDER GIRDLE 755.60 UNSPECIFIED CONGENITAL ANOMALY OF LOWER LIMB 755.61 COXA VALGA CONGENITAL 755.62 COXA VARA CONGENITAL 755.63 OTHER CONGENITAL DEFORMITY OF HIP (JOINT) 755.64 CONGENITAL DEFORMITY OF KNEE (JOINT) 755.65 MACRODACTYLIA OF TOES 755.66 OTHER CONGENITAL ANOMALIES OF TOES 755.67 CONGENITAL ANOMALIES OF FOOT NOT ELSEWHERE CLASSIFIED 755.69 OTHER CONGENITAL ANOMALIES OF LOWER LIMB INCLUDING PELVIC GIRDLE 755.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF UNSPECIFIED LIMB 755.9 UNSPECIFIED CONGENITAL ANOMALY OF UNSPECIFIED LIMB 756.0 CONGENITAL ANOMALIES OF SKULL AND FACE BONES 756.10 CONGENITAL ANOMALY OF SPINE UNSPECIFIED 756.11 CONGENITAL SPONDYLOLYSIS LUMBOSACRAL REGION 756.12 SPONDYLOLISTHESIS CONGENITAL 756.13 ABSENCE OF VERTEBRA CONGENITAL 756.14 HEMIVERTEBRA 756.15 FUSION OF SPINE (VERTEBRA) CONGENITAL 756.16 KLIPPEL-FEIL SYNDROME 756.17 SPINA BIFIDA OCCULTA 756.19 OTHER CONGENITAL ANOMALIES OF SPINE 756.2 CERVICAL RIB 756.3 OTHER CONGENITAL ANOMALIES OF RIBS AND STERNUM 756.4 CHONDRODYSTROPHY 756.50 CONGENITAL OSTEODYSTROPHY UNSPECIFIED 756.51 OSTEOGENESIS IMPERFECTA 756.52 OSTEOPETROSIS 756.53 OSTEOPOIKILOSIS 756.54 POLYOSTOTIC FIBROUS DYSPLASIA OF BONE 756.55 CHONDROECTODERMAL DYSPLASIA 756.56 MULTIPLE EPIPHYSEAL DYSPLASIA 756.59 OTHER CONGENITAL OSTEODYSTROPHIES 756.6 CONGENITAL ANOMALIES OF DIAPHRAGM 756.70 ANOMALY OF ABDOMINAL WALL UNSPECIFIED 756.71 PRUNE BELLY SYNDROME 756.72 OMPHALOCELE 756.73 GASTROSCHISIS 756.81 CONGENITAL ABSENCE OF MUSCLE AND TENDON 756.82 ACCESSORY MUSCLE 756.83 EHLERS-DANLOS SYNDROME 756.89 OTHER SPECIFIED CONGENITAL ANOMALIES OF MUSCLE TENDON FASCIA AND CONNECTIVE TISSUE 757.0 HEREDITARY EDEMA OF LEGS 757.1 ICHTHYOSIS CONGENITA 757.2 DERMATOGLYPHIC ANOMALIES 757.31 CONGENITAL ECTODERMAL DYSPLASIA 757.32 VASCULAR HAMARTOMAS Printed on 10/16/2012. Page 15 of 20 757.33 CONGENITAL PIGMENTARY ANOMALIES OF SKIN 757.39 OTHER SPECIFIED CONGENITAL ANOMALIES OF SKIN 758.0 DOWN'S SYNDROME 758.1 PATAU'S SYNDROME 758.2 EDWARDS' SYNDROME 758.31 CRI-DU-CHAT SYNDROME 758.32 VELO-CARDIO-FACIAL SYNDROME 758.33 OTHER MICRODELETIONS 758.39 OTHER AUTOSOMAL DELETIONS 758.4 BALANCED AUTOSOMAL TRANSLOCATION IN NORMAL INDIVIDUAL 758.5 OTHER CONDITIONS DUE TO AUTOSOMAL ANOMALIES 758.6 GONADAL DYSGENESIS 758.7 KLINEFELTER'S SYNDROME 758.81 OTHER CONDITIONS DUE TO SEX CHROMOSOME ANOMALIES 758.89 OTHER CONDITIONS DUE TO CHROMOSOME ANOMALIES 758.9 CONDITIONS DUE TO ANOMALY OF UNSPECIFIED CHROMOSOME 759.83 FRAGILE X SYNDROME 783.22 UNDERWEIGHT 783.40 UNSPECIFIED LACK OF NORMAL PHYSIOLOGICAL DEVELOPMENT 783.41 FAILURE TO THRIVE 783.42 DELAYED MILESTONES 783.43 SHORT STATURE 796.5 ABNORMAL FINDING ON ANTENATAL SCREENING 796.6 NONSPECIFIC ABNORMAL FINDINGS ON NEONATAL SCREENING V13.61 PERSONAL HISTORY OF (CORRECTED) HYPOSPADIAS PERSONAL HISTORY OF OTHER (CORRECTED) CONGENITAL MALFORMATIONS OF GENITOURINARY V13.62 SYSTEM V13.63 PERSONAL HISTORY OF (CORRECTED) CONGENITAL MALFORMATIONS OF NERVOUS SYSTEM V13.64 PERSONAL HISTORY OF (CORRECTED) CONGENITAL MALFORMATIONS OF EYE, EAR, FACE AND NECK PERSONAL HISTORY OF (CORRECTED) CONGENITAL MALFORMATIONS OF HEART AND CIRCULATORY V13.65 SYSTEM V13.66 PERSONAL HISTORY OF (CORRECTED) CONGENITAL MALFORMATIONS OF RESPIRATORY SYSTEM V13.67 PERSONAL HISTORY OF (CORRECTED) CONGENITAL MALFORMATIONS OF DIGESTIVE SYSTEM PERSONAL HISTORY OF (CORRECTED) CONGENITAL MALFORMATIONS OF INTEGUMENT, LIMBS, AND V13.68 MUSCULOSKELETAL SYSTEMS V13.69 PERSONAL HISTORY OF OTHER (CORRECTED) CONGENITAL MALFORMATIONS V18.4 FAMILY HISTORY OF INTELLECTUAL DISABILITIES V19.5 FAMILY HISTORY OF CONGENITAL ANOMALIES V49.89* OTHER SPECIFIED CONDITIONS INFLUENCING HEALTH STATUS **171.9 Medical record must contain documentation of either: alveolar soft part sarcoma, alveolar rhabdomyosarcoma, clear cell sarcoma, desmoplastic small sound cell tumor, Ewing sarcoma, myxoid liposarcoma, low grade fibromyxoid sarcoma, extra skeletal myxoid chondrosarcoma, inflammatory myofibroblastic tumor or synovial sarcoma in order to use these diagnosis codes

*288.01 Limited to infantile genetic agranulocytosis only

*V49.89 To be used only when repeat testing is believed to be medically reasonable and necessary

Diagnoses that Support Medical Necessity All ICD-9-CM codes listed in this policy under ICD-9-CM Codes that Support Medical Necessity above. ICD-9 Codes that DO NOT Support Medical Necessity All ICD-9-CM codes not listed in this policy under ICD-9-CM Codes that Support Medical Necessity above.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity All ICD-9-CM codes not listed in this policy under ICD-9-CM Codes that Support Medical Necessity above. Back to Top

Printed on 10/16/2012. Page 16 of 20 General Information Documentations Requirements Medical record documentation maintained by the ordering/referring physician must indicate the medical necessity for performing the test. Additionally, a copy of the results should be maintained in the medical records. For billing for testing which is limited to "once per lifetime" under the terms of this LCD, see #4 in attached Coding Guidelines. Documentation that these tests meet standards of medical reasonableness and necessity must be maintained in the patient's medical record and must be made available to Medicare upon request.

If the provider of the service is other than the ordering/referring physician, that provider must maintain hard copy or electronic documentation of the test results and interpretation, along with copies of the ordering/referring physician's order for the studies. The ordering physician must state the clinical indication/medical necessity for the study in their order for the test.

Copies of the medical records must be made available upon Medicare request.

The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.

Appendices

Utilization Guidelines CPT codes will be limited to once per lifetime. When clinically-relevant technological advances (such as with FISH testing), are available, and repeat testing is believed to be medically reasonable and necessary, such claims must be billed using the instructions included in #4 of attached Coding Guidelines.

Sources of Information and Basis for Decision ● Eugene Braunwald, et al, eds, Harrisons Principle of Internal Medicine, (16th ed). New York: McGraw-Hill, 2005 ● Jacobs, D., Demott, W., Grady, H., Horvat, R., Huestis, D., and Kasten, B. (2002). Laboratory Test Handbook. Hudson: Lexi-Comp, Inc. ● CPT Assistant, Volume 9, Issue 10, October 1999, pgs. 2, 3. ● DeVita VT, et al, eds, Cancer Principles and Practice of Oncology, 5th ed, Philadelphia, Lippincott-Raven, 1997 ● Medical consultants ● NAS Carrier Advisory Committee members Advisory Committee Meeting Notes Notice of this DRAFT medical policy was made available to providers and the public in the following states:

Arizona, Montana, North Dakota, South Dakota, Utah and Wyoming.

This policy does not reflect the sole opinion of the contractor or the Contractor Medical Director(s). Although the final decision rests with the contractor, this policy was developed in cooperation with the Carrier Advisory Committee(s), which include representatives of various medical specialty societies.

The Section titled "Does the 'CPT 30% Rule' apply?" needs clarification. This rule comes from the AMA (American Medical Association), the organization that holds the copyrights for all CPT codes. The rule states that if, in a given section (e.g., surgery) or subsection (e.g., surgery, integumentary) of the CPT Manual, more than 30% of the codes are listed in the LCD, then the short descriptors must be used rather than the long descriptors found in the CPT Manual.

This policy is subject to the reasonable and necessary guidelines and the limitation of liability provision.

This medical policy consolidates and replaces all previous policies and publications on this subject by NAS and its predecessors for Medicare Part B.

Printed on 10/16/2012. Page 17 of 20

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period

Revision History Number R12

Revision History Explanation J3 CB2006.24 The LCD for Cytogenetic Studies was in place in four of the J3 states. The policy was reviewed and updated.

09/03/2007 - This policy was updated by the ICD-9 2007-2008 Annual Update.

J3 CB2006.24 R1 2008 ICD-9-CM Updates – diagnosis code 284.8 requires a 5th digit, therefore, diagnosis code 284.89 has been added to the policy, effective 10/1/2007.

J3 CB2006.24 R2 CPT coding changes under Indications and Limitations of Coverage and/or Medical Necessity were made regarding in situ hybridization (FISH) testing to be consistent with NCCI manual language.

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

J3 CB2006.24 R3 Based on the 2008-2009 Annual Updates, the following diagnosis codes were added with an effective date of October 01, 2008: 203.02, 203.12, 203.82, 204.02, 204.12, 204.22, 204.82, 205.02, 205.12, 205.22, 205.32, 205.82, 206.02, 206.82, 207.22, 207.82,208.02, 238.77

J3 CB2006.24 R4 ICD-9-CM code 284.81 was added effective 06/01/2009.

J3 CB2006.24 R5

ICD-9-CM 2009-2010 Annual Updates - the following diagnosis codes 756.72 and 756.73 were added with an effective date of 10/01/2009.

Removed 756.79 because this code has been replaced in the LCD with the two new diagnoses codes (756.72 and 756.73) that specifically describe the diseases that were previously described by this non-specific code. The effective date of this code removal is 10/01/2009.

J3 CB2006.24 R6 ICD-9-CM codes 204.10, 238.72, 238.73 and 238.79 were added to the LCD with an effective date of 04/01/2010.

J3 CB2006.24 R7 ICD-9-CM code 238.75 was added to the LCD with an effective date of 08/15/2010.

09/06/2010 - This policy was updated by the ICD-9 2010-2011 Annual Update.

J3 CB2006.24 R8 Based on the ICD-9 CM 2010 Annual Update, the following codes were added to the policy with an effective date of October 01, 2010: 752.31, 752.32, 752.33, 752.34, 752.35, 752.36, 752.39, 752.43, 752.44, 752.45, 752.46, 752.47, V13.62, V13.63, V13.64, V13.65, V13.66, V13.67 and V13.68.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 88230 descriptor was changed in Group 1 88233 descriptor was changed in Group 1 88235 descriptor was changed in Group 1 88237 descriptor was changed in Group 1 88239 descriptor was changed in Group 1 Printed on 10/16/2012. Page 18 of 20 88245 descriptor was changed in Group 1 88248 descriptor was changed in Group 1 88249 descriptor was changed in Group 1 88261 descriptor was changed in Group 1 88262 descriptor was changed in Group 1 88263 descriptor was changed in Group 1 88264 descriptor was changed in Group 1 88267 descriptor was changed in Group 1 88269 descriptor was changed in Group 1 88271 descriptor was changed in Group 1 88272 descriptor was changed in Group 1 88273 descriptor was changed in Group 1 88274 descriptor was changed in Group 1 88275 descriptor was changed in Group 1 88285 descriptor was changed in Group 1 88289 descriptor was changed in Group 1

J3 CB2006.24 R9 This LCD was updated with CPT/HCPCS 2011 changes. Effective for dates of service on/after 01/01/2011: CPT codes 88120 and 88121 were added to the LCD. ICD-9-CM codes 238.6, 238.71, 273.1 and 288.61 were added to the listing of payable diagnoses.

J3 CB2006.24 R10 The following ICD-9-CM codes were added effective for dates of service on or after 01/01/2011: 188.0 – 188.8.

Effective 06/15/2011 , the following language was added to the Documentation Requirements section of the LCD: When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and literature that supports the request. At a minimum two (2) Phase II studies (human feasibility studies suggesting efficacy, pilots) or one (1) Phase III study (primary evidence of safety and efficacy, pivotal) must be submitted for the Medical Director’s review.

J3 CB2006.24 R11 ICD-9-CM codes 284.1, 631 and 747.3 are truncated and replaced with 284.19, 631.0, 747.31, 747.32, 747.39 effective 10/01/2011.

B2006.24 R12 02/01/2012-The”Contractors Determination Number” changed due to the consolidation of LCD for JF implementation. Idaho MAC B (Contract #02202) was added to this LCD.

02/27/2012: The following states and contractor numbers were added to the LCD: Alaska MAC B (Contract #02102); Oregon MAC B (Contract #02302); and Washington MAC B (Contract #02402).

Reason for Change Other

Related Documents This LCD has no Related Documents.

LCD Attachments Coding Guidelines-B2006.24 R12 opens in new window (PDF - 5 KB )

All Versions Updated on 03/24/2012 with effective dates 02/27/2012 - N/A Updated on 03/23/2012 with effective dates 02/01/2012 - 02/26/2012 Updated on 09/06/2011 with effective dates 10/01/2011 - 01/31/2012 Updated on 04/19/2011 with effective dates 06/15/2011 - 09/30/2011 Updated on 02/24/2011 with effective dates 01/01/2011 - 06/14/2011 Updated on 01/06/2011 with effective dates 01/01/2011 - N/A Updated on 12/08/2010 with effective dates 01/01/2011 - N/A Updated on 11/21/2010 with effective dates 10/01/2010 - 12/31/2010 Printed on 10/16/2012. Page 19 of 20 Updated on 09/21/2010 with effective dates 10/01/2010 - N/A Some older versions have been archived. Please visit the MCD Archive Site opens in new window to retrieve them. Read the LCD Disclaimer opens in new window Back to Top

Printed on 10/16/2012. Page 20 of 20 Local Coverage Determination (LCD) for Genetic Testing (L24308)

Contractor Information Contractor Name Contractor Number Contractor Type Noridian Administrative Services, 03402 MAC - Part B LLC opens in new window Back to Top

LCD Information Document Information LCD ID Number L24308

LCD Title Primary Geographic Jurisdiction opens in new window Genetic Testing South Dakota

Contractor's Determination Number Oversight Region B2006.31 R14 Region X

AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2012 American Medical Original Determination Effective Date Association. All Rights Reserved. CPT is a registered For services performed on or after 12/01/2006 trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee Original Determination Ending Date schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or Revision Effective Date indirectly practice medicine or dispense medical For services performed on or after 10/01/2012 services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Revision Ending Date Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

CMS National Coverage Policy Social Security Act:

Title XVIII of the Social Security Act, section 1862 (a) (1) (A). this section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

Medicare Program Integrity Manual, Chapter 3, Section 3.4.1.2.B governs development of lab claims for additional documentation.

Medicare Claims Processing Manual, Chapter 16, Section 40.7 governs the right of the beneficiary to require a lab to file a claim for a lab test that the lab believes Medicare will not cover.

Medicare Claims Processing Manual, Chapter 16, Section 120.1 governs diagnosis information submitted by the ordering physician to the performing laboratory. The instruction states: Tests that are performed in the absence of signs, symptoms, complaints, personal history of disease, or injury are not covered except when there is a statutory provision that explicitly covers tests for screening as described.

Printed on 10/16/2012. Page 1 of 20 "The final rule clarifies that effective February 21, 2002, the use of the term “screening” or “screen” in CPT code descriptor does not necessarily describe a test performed in the absence of signs and symptoms of illness, disease or condition. Contractors do not deny a service based solely on the presence of the term “screening” or “screen” in the descriptor.

If a person is tested to rule out or to confirm a suspected diagnosis because the patient has a sign and/or symptoms, this is considered a diagnostic test, not a screening test. Contractors have discretionary authority to make reasonable and necessary scope of benefit determinations."

Indications and Limitations of Coverage and/or Medical Necessity Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis and treatment of illness or injury...". Furthermore, it has been longstanding CMS policy that "tests that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered unless explicitly authorized by statute". Screening services, such as pre-symptomatic genetic tests and services, are those used to detect an undiagnosed disease or disease predisposition, and as such are not a Medicare benefit and not covered by Medicare. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk for and/or of a condition unless the risk assessment clearly and directly effects the management of the patient. However, Medicare does cover a broad range of legislatively mandated preventive services to prevent disease, detect disease early when it is most treatable and curable, and manage disease so that complications can be avoided. These services can be found on the CMS website at http://www.cms.gov/PrevntionGenInfo/. Any preventive services and tests not listed on the CMS Preventive Services webpage are considered non-covered screening (preventive) tests or services which are not a benefit of the Medicare program.

Hereditary Breast and Ovarian Cancer

Families can be suspected of having hereditary breast or ovarian cancer based on occurrence at an early age, in multiple generations, often bilaterally, and in a pattern suggesting an autosomal dominant pattern of inheritance. The susceptibility may be transmitted through the maternal or paternal side of the family.

Germ-line alterations in two genes, BRCA1 and BRCA2, are associated with an increased risk of breast and ovarian cancer. Alterations in BRCA1 and BRCA2 explain many, but not all, of inherited forms of breast and ovarian cancer. With the identification of BRCA1 and BRCA2, it is now possible to test for abnormalities in the genes to provide information on the future risk of cancer and to make important treatment decisions in affected individuals. Approximately five- to ten-percent of all breast cancers, and a similarly small percentage of ovarian cancers, are attributed to dominantly inherited susceptibility.

Families at high risk of harboring a BRCA1 or BRCA2 mutation are those in which the incidence of breast or ovarian cancer suggests an autosomal dominant inheritance (i.e., about half the family members are affected). Men rarely develop breast cancer and, thus, there may not be an affected first-degree relative, and the size of the family may not permit analysis of possible autosomal dominant inheritance.

In patients with breast or ovarian cancer who are from high-risk families without a known BRCA1 or BRCA2 gene, the entirety of both genes must be analyzed to identify possible mutations. In those families with a known BRCA1 or BRCA2 gene mutation, only a single mutation site sequence is required. In the case of individuals with Ashkenazi Jewish ancestry, testing for 3 mutations common in this population may be warranted even after a single mutation has been identified in their family member.

The clinical information preceding this statement notwithstanding, testing of unaffected family members or other individuals is considered by Medicare to be screening and is not payable under the Medicare program.

Hereditary Colorectal and Endometrial Cancer Syndromes

Lynch Syndrome (previously denoted in this policy as Hereditary Non-Polyposis Colorectal Cancer (HNPCC) syndrome), is an autosomal dominant syndrome that accounts for about 3-5% of colorectal cancer cases. HNPCC syndrome mutations occur in the following genes: hMLH1, hMSH2, hMSH6, PMS2 and EPCAM. Colorectal cancers associated with Lynch syndrome occur at a younger age (average age of onset between 44-61 years of age) compared with the more common colorectal cancers typically found during the seventh decade of life. Other Lynch syndrome-associated cancers include endometrial, ovarian, gastric, pancreas , ureter and renal pelvis, biliary tract, brain (usually glioblastoma, and small intestine cancers, as well as sebaceous gland adenomas/carcinomas and keratoacanthomas (AKs). Female carriers of a specific Lynchgene mutation have up to a 71% risk of endometrial cancer and 12% risk of ovarian cancer, in addition to the other Lynch syndrome cancer risks. Furthermore, gynecologic cancers may precede colorectal cancer in as many as 50% of female gene mutation carriers.

Printed on 10/16/2012. Page 2 of 20

Inherited mutations in MLH1 and MSH2 account for the majority (~70%) of mutations detected with MSH6 and PMS2 found in the remainder of mutation positive cases. MSH6 mutations are responsible for approximately 15% of Lynch syndrome cases. Recent reports confirm that PMS2 mutations are a significant contributor to Lynch syndrome. Estimates of the proportion of Lynch syndrome cases due to PMS2 vary and are as high as 15%.

Familial Adenomatous Polyposis (FAP) is an autosomal dominant syndrome caused by a germ-line mutation of the APC gene. Characteristically, affected patients develop multiple adenomas diffusely throughout the colon beginning in their teens. Colorectal cancer is inevitable in patients with FAP if colectomy is not performed. The average age at symptomatic diagnosis ranges from 34 to 45 years of age. However, the average age of colonic adenoma appearance is 16 years and of cancer diagnosis is 39 years. The FAP gene mutation occurs in approximately 1/10,000 - 1/30,000 live births in the United States, affects both sexes equally, and accounts for up to 1% of colorectal cancers.

MYH-associated polyposis (MAP) is an autosomal recessive syndrome linked to germ-line mutations of the MYH gene. The full clinical picture of MYH-associated polyposis (MAP) is incompletely understood at this time. Current evidence suggests it is associated with about 0.4-1.0% of colorectal cancers.

General Coverage Rules

Although there are still many unanswered questions regarding optimal clinical management of patients with inherited cancer-predisposing gene mutations, there is increasing data documenting benefits from increased surveillance, prophylactic surgery, hormonal manipulation, and changes in chemotherapy. Individuals who are carriers of a mutation, even if they have already been diagnosed and treated for a primary cancer, can be provided with additional information regarding their risk for further disease development and possible treatment and surveillance options.

For the above syndromes, those individuals who are determined not to be carriers may be prevented from undergoing unnecessary prophylactic surgery such as total versus partial colectomy, mastectomy, hysterectomy, and oophorectomy. Frequency of surveillance procedures (mammography, colonoscopy, etc.) may be affected depending on the presence or absence of a mutation.

1. Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof.

2. Predictive or pre-symptomatic genetic tests and services, in the absence of past or present illness in the beneficiary, are not covered under national Medicare rules. For example, Medicare does not cover genetic tests based on family history alone.

3. A covered genetic test must be used to manage a patient. Medicare does not cover a genetic test for a clinically affected individual for purposes of family planning, disease risk assessment of other family members, when the treatment and surveillance of the beneficiary will not be affected, or in any other circumstance that does not directly affect the diagnosis or treatment of the beneficiary.

4. The results of the genetic test must potentially affect at least one of the management options considered by the referring physician in accordance with accepted standards of medical care (e.g. surgery, the extent of surgery, a change in surveillance, hormonal manipulation, or a change from standard therapeutic or adjuvant chemotherapy).

5. Pre-test genetic counseling must be provided by a qualified and appropriately trained practitioner.

6. An informed consent form signed by the patient prior to testing which includes a statement that he/she agree to post-test counseling is required. This consent form must be available on request by Medicare.

7. Genetic analysis must be provided through a laboratory which meets the American Society of Clinical Oncology (ASCO) recommended requirements:

• The lab must meet appropriate Clinical Laboratory Improvement Amendment (CLIA) 1988 regulations;

Printed on 10/16/2012. Page 3 of 20 • Successful participation in the American College of Medical Genetics (ACMG)/College of American Pathologists (CAP) inspection and survey program; • appropriate state licensing; and • credentialing of laboratory directors and staff by the American Board of Medical Genetics (ABMG).

Hereditary Breast and Ovarian Cancer Syndromes

BRCA1 and BRCA2 genetic testing is covered only for the following individuals: For the purpose of this policy, only genetic relations are relevant (i.e. "blood relatives"). Non-genetic relations, such as through marriage or adoption are not relevant to coverage. A close relative means a first degree (parents, full siblings, offspring), second degree (grandparents, grandchildren, aunts, uncles, nephews, nieces, half-siblings), or third degree (great-grandparents, great-aunts, great-uncles, first cousins) relatives.) Also, for this policy, invasive and ductal carcinoma in situ (DCIS) breast cancers should be included. Comprehensive genetic testing of BRCA1 and BRCA2 includes full sequencing and detection of large genomic rearrangements

If the individual is of Ashkenazi Jewish descent, test the three common mutations first. Then if negative, consider comprehensive("Reflex") testing based on assessment of individual and family history as if the individual is of non -Ashkenazi Jewish descent.

1. Personal history of breast cancer + one or more of the following:

• Diagnosed age ≤45 y, with or without family history • Diagnosed age ≤50 y or two breast primaries, with ≥1 close blood relative(s) with breast cancer ≤50 y and/or ≥1 close blood relative(s) with epithelial ovarian/fallopian tube/primary peritoneal cancer • Two breast primaries when first breast cancer diagnosis occurred prior to age 50 • Diagnosed age <60 y with a triple negative breast cancer (ER-, PR-, HER2-) • Diagnosed age <50 y with a limited family history, defined as fewer than 2 first- or second-degree female relatives or female relatives surviving beyond 45 years in either lineage • Diagnosed at any age, with ≥2 close blood relatives with breast and/or epithelial ovarian/fallopian tube/primary peritoneal cancer, at any age • Close male blood relative with breast cancer • Personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer • If of certain ethnicity associated with higher mutation frequency, (eg, Ashkenazi Jewish) no additional family history required • a close relative with a known BRCA1 or BRCA2 gene mutation

2. Personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer.

3. Personal history of male breast cancer.

Hereditary Colorectal Cancer Syndromes hMLH1, hMSH2, hMSH6 and PMS2 gene tests are covered to diagnose Lynch syndrome. hMLH1, hMSH2 and hMSH6 gene testing must be negative before a test for the less common PMS2 gene mutations is considered reasonable and necessary. The tests are covered for a beneficiary who has or has had colorectal or endometrial cancer and meets one of the following criteria:

1. Amsterdam II Criteria for Lynch syndrome genetic testing

At least two close relatives of the affected beneficiary must have or have had a cancer associated with Lynch syndrome; and all of the following criteria must be present:

• One must be a first-degree relative of the other two; • At least two successive generations must be affected; • At least one of the relatives or the beneficiary with cancer associated with hereditary non-polyposis colorectal cancer should be diagnosed before the age 50 years; • Familial adenomatous polyposis (FAP) should be excluded in the colorectal cancer case(s) (if any); • Histologic diagnosis of tumors should be verified whenever possible.

2. Revised Bethesda guidelines • Colorectal cancer diagnosed in a beneficiary at less than 50 years of age • Presence of synchronous or metachronous Lynch syndrome-associated cancers*, regardless of age • Colorectal cancer with the MSI-H histology diagnosed in a beneficiary who is less than 60 years of age • Colorectal cancer with one or more first-degree relatives with a Lynch syndrome-associated cancer*, with one of the cancers being diagnosed under age 50 years Printed on 10/16/2012. Page 4 of 20 • Colorectal cancer with two or more first- or second-degree relatives with Lynch syndrome-associated cancers*, regardless of age

* Lynch syndrome-associated cancers include endometrial, ovarian, gastric, pancreas, ureter and renal pelvis, biliary tract, brain (usually glioblastoma), and small intestine cancers, as well as sebaceous gland adenomas/carcinomas and keratoacanthomas.

3. Has a blood relative with a known Lynch syndrome related gene mutation

4. Endometrial cancer diagnosed in a beneficiary at less than 50 years of age

5. If any of the Bethesda guidelines are met, microsatellite instability (MSI) and/or immunohistochemistry (IHC) testing on the colon cancer tissue may be clinically appropriate. If the tumor is MSI positive or mutation of one of the mismatch repair genes is indicated by failure of IHC staining, then genetic testing should be undertaken. Further unnecessary testing can often be avoided by performance of IHC prior to any MSI testing. NAS leaves to the provider’s judgment and the individual clinical situation in determining the order of performance of any of these two test protocols. This does not apply to MSI or IHC testing of non-GI primary tumors since the sensitivity and specificity of MSI/IHC testing in these tumors is poorly documented at this time.

APC and MYH gene testing for Familial Adenomatous Polyposis (FAP), Attenuated FAP (AFAP), or MYH- associated polyposis (MAP) is covered for the following individuals;

• A beneficiary with ≥ 20 cumulative colorectal adenomas over a lifetime. • Testing for APC gene mutations should precede testing for the less common MYH mutation.

HLA-B*5701 Testing

The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is a working group of the Office of AIDS Research Advisory Council (OARAC). The Panel recommends HLA-B*5701 testing prior to initiating abacavir therapy to reduce the risk of hypersensitivity reaction. HLA-B*5701-positive patients should not be prescribed abacavir, and the positive status should be recorded as an abacavir allergy in the patient’s medical record (All). Based on this recommendation, NAS has added this testing to the list of covered Genetic Tests under this LCD.

Therapy-Directing testing

NAS has determined that sufficient literature support now exists to allow coverage for KRAS testing. Its coverage is limited to use in patients with metastatic colorectal cancer for whom either cetuximab (Erbitux) or panitumumab (Vectibix) therapy is contemplated as being appropriate. Although there remain some unanswered questions concerning the role of “personalized medicine,” it appears that there is sufficient sensitivity and specificity in the K-RAS testing to allow the decision to be made that use of either of the two drugs noted above would be inappropriate if the KRAS mutation is identified. For further billing information, see Coding Guidelines via the link noted below.

In addition, NAS has determined that JAK2 testing is appropriate in patients with signs or symptoms suggesting an underlying chronic myeloproliferative disorder, including increased red-cell mass, increased platelets, unexplained persistent peripheral cytopenia to cytosis, unexplained peripheral or hepatic vein thrombosis (Budd-Chiari Syndrome) or bone marrow examination showing features of a chronic myeloproliferative disorder. Documentation must also indicate that the provider anticipates that the test result is likely to be of use in management of the condition.

The BCR/ABL fusion gene is the classic mutation seen in Chronic Myelogenous Leukemia (CML) and is also seen in Acute Lymphocytic Leukemia (ALL) and certain other hematologic diseases. Major factors influencing providers’ consideration of testing for this gene include some that are too non-specific to support coverage under this LCD. NAS does, however, consider some to support the BCR/ABL fusion gene testing and those are listed in the payable ICD-9 code section below.

Noridian is aware that there remain numerous potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care.

Printed on 10/16/2012. Page 5 of 20 Noridian has decided that no additional “personalized medicine” or “therapy-directing” testing will be included under the coverage purview of this LCD. Instead, providers are reminded that Noridian will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable FDA approval and labeling (if such exists) and appropriate standards of medical reasonableness and necessity. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. Providers are also reminded that all such claims will be subject to post pay review. It is our hope that subsequent developments in this field will lead to Contractors’ ability to monitor development and ascertain coverage and payment criteria to the extent that LCD coverage can be appropriately and timely extended. The rapidity and non-standardized development of the current reality in this field mitigates against being able to do so at the present time.

As noted in each major section above providers are once again reminded: The clinical information preceding this statement notwithstanding, testing of unaffected family members or other individuals is considered by Medicare to be screening and is not payable under the Medicare program.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis and treatment of illness or injury...". Furthermore, it has been longstanding CMS policy that "tests that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered unless explicitly authorized by statute". Screening services, such as pre-symptomatic genetic tests and services, are those used to detect an undiagnosed disease or disease predisposition, and as such are not a Medicare benefit and not covered by Medicare. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk for and/or of a condition unless the risk assessment clearly and directly effects the management of the patient. However, Medicare does cover a broad range of legislatively mandated preventive services to prevent disease, detect disease early when it is most treatable and curable, and manage disease so that complications can be avoided. These services can be found on the CMS website at http://www.cms.gov/PrevntionGenInfo/. Any preventive services and tests not listed on the CMS Preventive Services webpage are considered non-covered screening (preventive) tests or services which are not a benefit of the Medicare program.

Hereditary Breast and Ovarian Cancer

In patients with breast or ovarian cancer who are from high-risk families without a known BRCA1 or BRCA2 gene, the entire gene must be sequenced to identify possible mutations. In those families with a known BRCA1 or BRCA2 gene mutation, only a single mutation site sequence is required. In the case of individuals with Ashkenazi Jewish ancestry, testing for 3 mutations common in this population may be warranted even after a single mutation has been identified in their family member.

Hereditary Colorectal and Endometrial Cancer Syndromes

Printed on 10/16/2012. Page 6 of 20 Lynch Syndrome (previously denoted in this policy as Hereditary Non-Polyposis Colorectal Cancer (HNPCC) syndrome), is an autosomal dominant syndrome that accounts for about 3-5% of colorectal cancer cases. HNPCC syndrome mutations occur in the following genes: hMLH1, hMSH2, hMSH6, PMS2 and EPCAM. Colorectal cancers associated with Lynch syndrome occur at a younger age (average age of onset between 44-61 years of age) compared with the more common colorectal cancers typically found during the seventh decade of life. Other Lynch syndrome-associated cancers include endometrial, ovarian, gastric, pancreas , ureter and renal pelvis, biliary tract, brain (usually glioblastoma, and small intestine cancers, as well as sebaceous gland adenomas/carcinomas and keratoacanthomas (AKs). Female carriers of a specific Lynchgene mutation have up to a 71% risk of endometrial cancer and 12% risk of ovarian cancer, in addition to the other Lynch syndrome cancer risks. Furthermore, gynecologic cancers may precede colorectal cancer in as many as 50% of female gene mutation carriers.

General Coverage Rules

Printed on 10/16/2012. Page 7 of 20

5. Pre-test genetic counseling must be provided by a qualified and appropriately trained practitioner.

7. Genetic analysis must be provided through a laboratory which meets the American Society of Clinical Oncology (ASCO) recommended requirements:

• The lab must meet appropriate Clinical Laboratory Improvement Amendment (CLIA) 1988 regulations; • Successful participation in the American College of Medical Genetics (ACMG)/College of American Pathologists (CAP) inspection and survey program; • appropriate state licensing; and • credentialing of laboratory directors and staff by the American Board of Medical Genetics (ABMG).

Hereditary Breast and Ovarian Cancer Syndromes

BRCA1 and BRCA2 genetic testing is covered only for the following individuals: For the purpose of this policy, only genetic relations are relevant (i.e. "blood relatives"). Non-genetic relations, such as through marriage or adoption are not relevant to coverage. A close relative means a first degree (parents, full siblings, offspring), second degree (grandparents, grandchildren, aunts, uncles, nephews, nieces, half-siblings), or third degree (great-grandparents, great-aunts, great-uncles, first cousins) relatives.) Also, for this policy, invasive and ductal carcinoma in situ (DCIS) breast cancers should be included. If the individual is of Ashkenazi Jewish descent, test the three common mutations first. Then if negative, consider full sequence ("Reflex") testing based on assessment of individual and family history as if the individual is of non-Ashkenazi Jewish descent.

1. Personal history of breast cancer + one or more of the following:

• Diagnosed age ≤45 y, with or without family history • Diagnosed age ≤50 y or two breast primaries, with ≥1 close blood relative(s) with breast cancer ≤50 y and/or ≥1 close blood relative(s) with epithelial ovarian/fallopian tube/primary peritoneal cancer • Two breast primaries when first breast cancer diagnosis occurred prior to age 50 • Diagnosed age <60 y with a triple negative breast cancer (ER-, PR-, HER2-) • Diagnosed age <50 y with a limited family history, defined as fewer than 2 first-or second-degree female relatives or female relatives surviving beyond 45 years in either lineage •Diagnosed at any age, with ≥2 close blood relatives with breast and/or epithelial ovarian/fallopian tube/primary peritoneal cancer, at any age • Close male blood relative with breast cancer • Personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer • If of certain ethnicity associated with higher mutation frequency, (eg, Ashkenazi Jewish,) no additional family history required • a close relative with a known BRCA1 or BRCA2 gene mutation

2. Personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer.

3. Personal history of male breast cancer.

1. Amsterdam II Criteria for Lynch syndrome genetic testing

At least two close relatives of the affected beneficiary must have or have had a cancer associated with Lynch syndrome; and all of the following criteria must be present:

2. Revised Bethesda guidelines • Colorectal cancer diagnosed in a beneficiary at less than 50 years of age • Presence of synchronous or metachronous Lynch syndrome-associated cancers*, regardless of age • Colorectal cancer with the MSI-H histology diagnosed in a beneficiary who is less than 60 years of age • Colorectal cancer with one or more first-degree relatives with a Lynch syndrome-associated cancer*, with one of the cancers being diagnosed under age 50 years • Colorectal cancer with two or more first- or second-degree relatives with Lynch syndrome-associated cancers*, regardless of age

3. Has a blood relative with a known Lynch syndrome related gene mutation

4. Endometrial cancer diagnosed in a beneficiary at less than 50 years of age

APC and MYH gene testing for Familial Adenomatous Polyposis (FAP), Attenuated FAP (AFAP), or MYH- associated polyposis (MAP) is covered for the following individuals;

• A beneficiary with ≥ 20 cumulative colorectal adenomas over a lifetime. • Testing for APC gene mutations should precede testing for the less common MYH mutation.

HLA-B*5701 Testing

Therapy-Directing testing

Printed on 10/16/2012. Page 9 of 20 Noridian is aware that there remain numerous potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care.

Noridian has decided that no additional “personalized medicine” or “therapy-directing” testing will be included under the coverage purview of this LCD. Instead, providers are reminded that Noridian will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable FDA approval and labeling (if such exists) and appropriate standards of medical reasonableness and necessity. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. Providers are also reminded that all such claims will be subject to post pay review. It is our hope that subsequent developments in this field will lead to Contractors’ ability to monitor development and ascertain coverage and payment criteria to the extent that LCD coverage can be appropriately and timely extended. The rapidity and non-standardized development of the current reality in this field mitigates against being able to do so at the present time.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.

Coding Information Bill Type Codes:

Revenue Codes:

99999 Not Applicable

CPT/HCPCS Codes MOLECULAR DIAGNOSTICS; MOLECULAR ISOLATION OR EXTRACTION, EACH NUCLEIC ACID TYPE (IE, 83890 DNA OR RNA) MOLECULAR DIAGNOSTICS; ISOLATION OR EXTRACTION OF HIGHLY PURIFIED NUCLEIC ACID, EACH 83891 NUCLEIC ACID TYPE (IE, DNA OR RNA) 83892 MOLECULAR DIAGNOSTICS; ENZYMATIC DIGESTION, EACH ENZYME TREATMENT 83893 MOLECULAR DIAGNOSTICS; DOT/SLOT BLOT PRODUCTION, EACH NUCLEIC ACID PREPARATION MOLECULAR DIAGNOSTICS; SEPARATION BY GEL ELECTROPHORESIS (EG, AGAROSE, 83894 POLYACRYLAMIDE), EACH NUCLEIC ACID PREPARATION 83896 MOLECULAR DIAGNOSTICS; NUCLEIC ACID PROBE, EACH 83898 MOLECULAR DIAGNOSTICS; AMPLIFICATION, TARGET, EACH NUCLEIC ACID SEQUENCE 83900 MOLECULAR DIAGNOSTICS; AMPLIFICATION, TARGET, MULTIPLEX, FIRST 2 NUCLEIC ACID SEQUENCES 83904 Printed on 10/16/2012. Page 10 of 20 MOLECULAR DIAGNOSTICS; MUTATION IDENTIFICATION BY SEQUENCING, SINGLE SEGMENT, EACH SEGMENT MOLECULAR DIAGNOSTICS; SEPARATION AND IDENTIFICATION BY HIGH RESOLUTION TECHNIQUE (EG, 83909 CAPILLARY ELECTROPHORESIS), EACH NUCLEIC ACID PREPARATION 83912 MOLECULAR DIAGNOSTICS; INTERPRETATION AND REPORT EXAMINATION AND SELECTION OF RETRIEVED ARCHIVAL (IE, PREVIOUSLY DIAGNOSED) TISSUE(S) FOR 88363 MOLECULAR ANALYSIS (EG, KRAS MUTATIONAL ANALYSIS) 88386 ARRAY-BASED EVALUATION OF MULTIPLE MOLECULAR PROBES; 251 THROUGH 500 PROBES

These are the only covered ICD-9-CM codes that support medical necessity:

The following Diagnosis codes meet criteria for BRCA1 and BRCA2 gene mutation testing: 158.0 MALIGNANT NEOPLASM OF RETROPERITONEUM 158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM 174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST 174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST 174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST 174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST 174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST 174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST 174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST 174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST 174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE 175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST 175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST 183.0 MALIGNANT NEOPLASM OF OVARY 183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE 233.0 CARCINOMA IN SITU OF BREAST V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST V10.43 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OVARY

The following diagnosis codes meet criteria for hereditary colorectal cancer (HNPCC) and Familial Adenomatous Polyposis (FAP) testing including APC, MYH, and HNPCC syndromes, including endometrial cancer, as well as for KRAS testing, within the limitations noted above: 153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE 153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON 153.2 MALIGNANT NEOPLASM OF DESCENDING COLON 153.3 MALIGNANT NEOPLASM OF SIGMOID COLON 153.4 MALIGNANT NEOPLASM OF CECUM 153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS 153.6 MALIGNANT NEOPLASM OF ASCENDING COLON 153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE 153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE 153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION 154.1 MALIGNANT NEOPLASM OF RECTUM 154.2 MALIGNANT NEOPLASM OF ANAL CANAL 154.3 MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE 154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS 171.9 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED 179 MALIGNANT NEOPLASM OF UTERUS-PART UNS 182.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF UTERUS 183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE 197.5 SECONDARY MALIGNANT NEOPLASM OF LARGE INTESTINE AND RECTUM 203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

Printed on 10/16/2012. Page 11 of 20 203.01 MULTIPLE MYELOMA IN REMISSION 203.02 MULTIPLE MYELOMA, IN RELAPSE 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 238.4 POLYCYTHEMIA VERA 238.71 ESSENTIAL THROMBOCYTHEMIA 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED 238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 286.3 CONGENITAL DEFICIENCY OF OTHER CLOTTING FACTORS 289.81 PRIMARY HYPERCOAGULABLE STATE 753.13 POLYCYSTIC KIDNEY AUTOSOMAL DOMINANT 753.14 POLYCYSTIC KIDNEY AUTOSOMAL RECESSIVE 756.51 OSTEOGENESIS IMPERFECTA 756.83 EHLERS-DANLOS SYNDROME 757.1 ICHTHYOSIS CONGENITA 759.83 FRAGILE X SYNDROME V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.42 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OTHER PARTS OF UTERUS V12.72* PERSONAL HISTORY OF COLONIC POLYPS V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT *V12.72 should be used to denote any of the polyposis conditions as described under Indications and Limitations above.

The following diagnosis codes meet coverage criteria for JAK2 testing: 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 238.4 POLYCYTHEMIA VERA 238.71 ESSENTIAL THROMBOCYTHEMIA 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED 238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 287.5 THROMBOCYTOPENIA UNSPECIFIED 288.50 LEUKOCYTOPENIA, UNSPECIFIED 288.51 LYMPHOCYTOPENIA 288.59 OTHER DECREASED WHITE BLOOD CELL COUNT 288.61 LYMPHOCYTOSIS (SYMPTOMATIC) 288.69 OTHER ELEVATED WHITE BLOOD CELL COUNT 288.8 OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS 453.0 BUDD-CHIARI SYNDROME 789.2 SPLENOMEGALY

The following diagnosis codes meet coverage criteria as indications for molecular testing of lymphoma, so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD: 200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES 200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK 200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES 200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB 200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.47 MANTLE CELL LYMPHOMA, SPLEEN 200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES Printed on 10/16/2012. Page 12 of 20 200.70 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES 200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK 200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES 200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB 200.75 LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 200.76 LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.77 LARGE CELL LYMPHOMA, SPLEEN 200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 202.00 NODULAR LYMPHOMA UNSPECIFIED SITE 202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES 202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES 202.07 NODULAR LYMPHOMA INVOLVING SPLEEN 202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

The following diagnosis codes meet coverage criteria as indications for testing for BCR/ABL fusion gene so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD:

288.61 LYMPHOCYTOSIS (SYMPTOMATIC) 288.69 OTHER ELEVATED WHITE BLOOD CELL COUNT 288.8 OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS 789.2 SPLENOMEGALY

The following diagnosis codes meet coverage criteria as indications for HLA-B*5701 testing prior to initiating abacavir therapy in patients with either Human Immunodeficiency Virus (HIV) disease or Asymptomatic Human Immunodeficiency virus (HIV) infection. 042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE V08 ASYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION STATUS

Diagnoses that Support Medical Necessity All ICD-9-CM codes listed above under ICD-9-CM Codes that Support Medical Necessity above. ICD-9 Codes that DO NOT Support Medical Necessity All ICD-9-CM codes not listed above under ICD-9-CM Codes that Support Medical Necessity above.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity All ICD-9-CM codes not listed above under ICD-9-CM Codes that Support Medical Necessity above. Back to Top

General Information Documentations Requirements The documentation is not required at the time of the initial claim, but may be requested for post-payment review. Documentation must be adequate to verify that coverage guidelines listed above have been met.

The documentation, which must be made available upon request from the laboratory or billing provider, must include personal and family history information consistent with this policy, and a signed informed consent indicating that the patient was informed of the following issues and information:

• cancer risks associated with each possible test result • likelihood of carrying a gene mutation given the patient's personal and family history (e.g. pedigree analysis) • implication for family members

Printed on 10/16/2012. Page 13 of 20 • potential adverse effects, benefits, and limitations of testing • relevant management options such as surveillance, prophylactic surgery, and medical preventive or therapeutic measures if available and risks associated with them.

For these tests, the billing provider must provide to the laboratory copies of the signed informed consent documentation.

The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition (ICD-9-CM code) that warrants the test.

The documentation must be made available from the billing provider (i.e. the laboratory) upon request by the contractor.

Before furnishing a beneficiary a test which the physician or laboratory believes is excluded from coverage as not reasonable and necessary (rather than excluded from coverage as part of a routine test), the physician or laboratory must obtain a signed Advanced Beneficiary Notice (ABN) from the beneficiary (or representative) that the physician or laboratory has informed him/her of the non-coverage of the test and that there will be a charge for the test. (Medicare Claims Processing Manual, Chapter 16, Section 40.7 - Billing for Noncovered Clinical Laboratory Tests)

When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and any pertinent peer-reviewed literature that supports the request. At a minimum, literature such as two (2) Phase II studies (human studies of efficacy, pivotal) or one (1) Phase III study (evidence of safety and efficacy, pivotal) must be submitted for the Medical Director’s review.

Appendices

Utilization Guidelines Genetic testing is considered a screening test for unaffected patients. Medicare does not cover screening tests. Predictive and pre-symptomatic genetic tests and services are not covered under this policy.

Statute does not permit genetic counselors to directly bill Medicare.

A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage.

Sources of Information and Basis for Decision 1. Screening for the Lynch Syndrome (HNPCC), The New England Journal of Medicine, Vol. 352, No. 18, May 5, 2005.

2. Prophylactic Surgery to Reduce the Risk of Gynecologic Cancers in the Lynch Syndrome, The New England Journal of Medicine, Vol. 354, No. 3, January 19, 2006.

3. Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility. U.S. Preventive Services Task Force, Sept. 2005.

4. Technology Assessment, Genetic Tests for Cancer; Agency for Healthcare Research and Quality (AHRQ), January 9, 2006.

Printed on 10/16/2012. Page 14 of 20 5. National Comprehensive Cancer Network (NCCN),"Genetic/Familial High-Risk Assessment: Breast and Ovarian", Clinical Practice Guidelines in Oncology, Vol. 1, 2011.

6. Screening Services Reminder; Noridian Medicare B News, Issue 218, March 3, 2005.

7. Prophylactic Oophorectomy in Carriers of BRCA1 or BRCA2 Mutations; The New England Journal of Medicine, Vol. 346, No. 21, May 23, 2002.

8. NAS Carrier Advisory Committee Members

9. NCCN Guidelines™ , Colon Cancer Screening v2.2011, available at www.nccn.org.

10. National Comprehensive Cancer Network Practice Guidelines in Oncology, Genetic/Familial High Risk Assessment – Breast and Ovarian, v.1. 2012. Accessed May 4, 2012 at www.nccn.org.

11. Judkins T, et al. Clinical significance of large rearrangements in BRCA1 and BRCA2. Cancer. 2012 Apr 27. doi: 10.1002/cncr.27556. [Epub ahead of print]

12. Palma MD, et al. The relative contribution of point mutations and genomic rearrangements in BRCA1 and BRCA2 in high-risk breast cancer families. Cancer Res. 2008 Sep 1;68(17):7006-14.

13. Smith, LD et al. (2011). Contribution of large genomic BRCA1 alterations to early-onset breast cancer selected for family history and tumour morphology: a report from The Breast Cancer Family Registry. Breast Cancer Res 2011 Jan 31;13(1):R14.

14. Staaf J, et al. Detection and precise mapping of germline rearrangements in BRCA1, BRCA2, MSH2, and MLH1 using zoom-in array comparative genomic hybridization (aCGH). Hum Mutat. 2008 Apr;29(4):555-64.

15. Rouleau E, et al. High-resolution oligonucleotide array-CGH applied to the detection and characterization of large rearrangements in the hereditary breast cancer gene BRCA1. Clin Genet. 2007 Sep;72(3):199-207.

16. Tayeh MK, et al. Targeted comparative genomic hybridization array for the detection of single- and multiexon gene deletions and duplications. Genet Med. 2009 Apr;11(4):232-40.

17. BRACAnalysis® Technical Specifications, Myriad Genetic Laboratories, Inc. Updated: April 2012. http://www.myriad.com/lib/technical-specifications/BRACAnalysis-Technial-Specifications.pdf Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or the Contractor Medical Director(s). Although the final decision rests with the contractor, this policy was developed in cooperation with the Carrier Advisory Committee(s), which include representatives of various medical specialty societies.

This policy is subject to the reasonable and necessary guidelines and the limitation of liability provision.

This medical policy consolidates and replaces all previous policies and publications on this subject by NAS and its predecessors for Medicare Part B.

NAS’ Response to Provider Recommendations:

1. Several requests were received for the addition of diagnoses for which we received no literature suggesting that therapy would be affected by Genetic Testing results.

NAS has declined to add these conditions where there is no evidence that results of testing will affect therapy.

2. NAS received comments that Part A and Part B do not have identical LCDs on this subject.

NAS strives to have consistent Part A and B policies to the extent possible, given that there are systemic differences between Parts A&B.

Printed on 10/16/2012. Page 15 of 20

3. One commenter noted that the CPT codes used for molecular testing are also used for infectious disease molecular testing, remarking that steps that are in common to both genetic and infectious disease testing must be adequately dealt with

NAS has taken those concerns into account and believes that edits put in place to adjudicate these claims will not cause inappropriate denials.

4. Numerous requests were made for payment for testing that appears to be screening, by definition, including a request for “…coverage to include any gene with cancer predisposition.” One request was also made to include “…among qualifying diagnoses having a family member with a positive gene test of non-cancer related diagnoses directly caused by the gene change (such as macrocephaly for PTEN or CHRPE for FAP, etc.”

NAS reminds the provider community that screening test, other than those expressly provided for by Congressional action, are not payable by Medicare.

Also, it is always a good idea to not use abbreviations or acronyms without defining them.

5. One request was received requesting that we “…consider sebaceous neoplasm as an HNPCC-associated cancer because we have patients with Muir-Torre syndrome who are not able to get the appropriate genetic testing because of Medicare’s (sic) exclusion of sebaceous neoplasms.

NAS must remind all providers requesting new coverage that you must include relevant literature supporting your request. None was received concerning this provider request, so we have no rationale for adding it.

6. One request was received (which contained numerous supportive articles) requesting that NAS add multiple myeloma to the list of covered conditions for genetic testing.

NAS has added the appropriate diagnosis codes: 203.00 Multiple myeloma without mention of remission 203.01 Multiple myeloma in remission

7. NAS received several requests for the coverage of several conditions, on the assumption that the testing would be for diagnostic and therapeutic purposes, not screening.

286.3 Congenital deficiency of other clotting factors 289.81 Primary hypercoagulable state 753.13 Polycystic kidney, autosomal dominant 753.14 Polycystic kidney, autosomal recessive 756.51 Osteogenesis imperfecta 756.83 Ehlers-Danlos syndrome 757.1 Ichthyosis congenita 759.83 Fragile X syndrome

NAS has reviewed these conditions and has decided to add coverage for the above conditions so long as they are used for diagnostic and therapeutic purposes, not screening.

8. NAS received a number of thoughtful and largely correct recommendations concerning coverage criteria related to the “Amsterdam II” criteria, coverage of MSI/IHC testing and NAS’ previous requirement for MLH1 and MSH2 testing to precede MSH6 testing in order for there to be coverage for the MSH6 testing.

NAS agrees and has accepted these recommendations and has revised this LCD accordingly.

9. We have received requests for coverage of JAK2 testing, along with a growing body of supportive literature.

NAS has adopted the position that JAK2 will be covered, under the conditions set out in the Indications and Limitations section, as noted above. We continue to review submitted literature on other examples of this emergin genetic testing field and will consider adding coverage of new disease -specific tests if and as literature support warrants.

10. We received a request to add HLA-B*5701 testing prior to instituting treatment with Abacavir and abacavir- containing regimens in HIV positive patients.

Printed on 10/16/2012. Page 16 of 20 Based on compelling literature and the recommendation of The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is a working group of the Office of AIDS Research Advisory Council (OARAC), NAS agrees and has added this coverage.

Noridian received a request for change in the LCD to accommodate the following Compendium provision:

As of May 2012, the NCCN has updated their guidelines on Hereditary Breast and Ovarian Cancer syndrome testing, which now state that for patients meeting the testing criteria, “the NCCN guidelines panel emphasizes the need for comprehensive testing, which encompasses full BRCA1/2 sequencing and detection of large genomic rearrangements.”

Noridian agrees that it is appropriate to make the changes allowing for detection of large genomic arrangements. We have therefore added CPT 88386-TC and modified language in the Indications and Limitations section on BRCA testing to allow coverage of this additional testing in appropriate situations.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period

Revision History Number R14

Revision History Explanation J3 CB2006.31 The LCD for Genetic Testing was in Utah only. However, the original Utah policy included some codes as payable, which on closer consideration represented screening tests. These screening tests have been removed. The policy was reviewed in it other aspects and updated.

J3 CB2006.31 R1 This is the first revision to this LCD. It has been brought to NAS’ attention that due to a clerical error, an early draft version of this LCD was inadvertently posted as final. This revision corrects that error and brings the LCD into compliance with National CMS coverage. It also incorporates provider comments received and NAS’ responses to those comments.

11/10/2007 - The description for CPT/HCPCS code 83898 was changed in group 1

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

J3 CB2006.31 R2 2008-2009 ICD-9-CM updates were applied. Diagnosis code 203.02 has been added to Group 2 with an effective date of October 1, 2008.

11/09/2008 - The description for CPT/HCPCS code 83890 was changed in group 1 11/09/2008 - The description for CPT/HCPCS code 83891 was changed in group 1 11/09/2008 - The description for CPT/HCPCS code 83892 was changed in group 1 11/09/2008 - The description for CPT/HCPCS code 83893 was changed in group 1 11/09/2008 - The description for CPT/HCPCS code 83894 was changed in group 1

J3 CB2006.31 R3 CPT code 83909 was added to the LCD effective 06/01/2009. Coverage of KRAS testing is added effective 06/01/2009. Amsterdam II criteria was expanded.

J3 CB2006.31 R4 Revisions made to "Hereditary Colorectal Cancer Syndromes" in section "Indications and Limitations of Coverage and/or Medical Necessity". Changed "three" to "two" in third paragraph under "Hereditary Colorectal Cancer Syndromes".

Paragraph three in section "Utilization Guidelines" is revised. The revision is listed below.

Printed on 10/16/2012. Page 17 of 20 "A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria."

J3 CB2006.31 R5 The following ICD-9-CM 171.9, 204.00, 204.10, 205.00, 205.10, 238.4, 238.71, 238.75, 238.76, V42.82 meet criteria coverage to the hereditary colorectal cancer (HNPCC) and Familial Adenomatous Polyposis (FAP) testing including APC, MYH, and HNPCC syndromes, including endometrial cancer, as well as KRAS testing and were added to the LCD with an effective of 10/15/2009.

ICD-9-CM 238.79 and 453.0 meet coverage criteria for JAK2 testing and were added with an effective of 10/15/2009.

Revisions were also made to the following sections of the LCD: “Indications and Limitations of Coverage and/or Medical Necessity” under “Hereditary Breast and Ovarian Cancer Syndromes”,and under "Therapy-Directing testing" and to the "Advisory Committee Meeting Notes" with an effective date of 10/15/2009.

J3 CB2006.31 R6 The following revisions were made to: “1. Personal history of breast cancer+ one or more of the following” in the “Indications and Limitations of Coverage and/or Medical Necessity”.

Expanded ICD9-CM diagnosis codes 204.00, 204.10, 205.00, 205.10, 238.4, 238.71, 238.75, 238.76 from HNPCC, FAP and KRAS coverage section to also apply to JAK2 Testing.

Additional information added to paragraph 3 in “Utilization and Guidelines”.

J3 CB2006.31 R7

Added ICD-9-CM 158.0 and 158.8 to the BRCA1 and BRACA2 gene mutation testing with an effective date 1/1/2010.

Revised "Hereditary Breast and Ovarian Cancer Syndromes" numbers 2 and 3 under the section “Indications and Limitations of Coverage and/or Medical Necessity”.

J3 CB2006.31 R8 ICD-9-CM codes 204.11 and 204.12 were added as payable for JAK2 testing effective for dates of service on or after April 1, 2010.

Group 4 for molecular testing of lymphoma was added with the following ICD-9-CM codes effective for dates of service on or after April 1, 2010: 200.40-200.48, 200.70-200.78, 202.00-202.08.

05/17/2010 - the following link in the Indications and Limitations of Coverage section was updated to: http://new.cms.gov/PrevntionGenInfo/

J3 CB2006.31 R9 This LCD was updated with CPT/HCPCS 2011 changes. Effective for dates of service on/after 01/01/2011: CPT code 88363 was added.

Indications and Limitations of Coverage and/or Medical Necessity was updated adding a section for BCR/ABL fusion gene.

The following ICD-9-CM codes were added for JAK2 testing: 287.5, 288.50, 288.51, 288.59, 288.61, 288.69, 288.8, 789.2

The following ICD-9-CM codes were added for testing for BCR/ABL fusion gene: 288.61, 288.69, 288.8, 789.2.

Printed on 10/16/2012. Page 18 of 20

J3 CB2006.31 R10 Effective 6/15/2011, the LCD is revised consistent with recent updates to the NCCN Guidelines and the Bethesda and Amsterdam genetic testing criteria. “Hereditary Non-Polyposis Colorectal Cancer (HNPCC) syndrome” was replaced with the more currently acceptable description “Lynch Syndrome” wherever appropriate in the LCD. ICD- 9-CM code 183.2 is added as payable to Group 1 diagnosis codes.

J3 CB2006.31 R11 Effective 09/15/2011, the following diagnosis codes 042,V08 and CPT codes 83896, and 83900 were added to the LCD. HLA-B*5701 Testing for coverage is added to the "Indications and Limitations of Coverage and/or Medical Necessity". In addition, in the "Advisory Committee Meeting Notes" section of the LCD, #10 was added to the NAS Response to Provider Recommendations.

B2006.31 R12 02/01/2012-The”Contractors Determination Number” changed due to the consolidation of LCD for JF implementation. Idaho MAC B (Contract #02202) was added to this LCD.

02/27/12: The following states and contracts were added to this LCD: Oregon MAC B (Contract # 02302); Washington MAC B (Contract # 02402); and Alaska MAC B (Contract # 02102).

B2006.31 R13 LCD is updated due to a Reconsideraton request. The update was delayed due to the JF transition to add the following to “Personal history of breast cancer + one or more of the following”:

• Diagnosed age < 60 y with a triple negative breast cancer (ER-, PR-, HER2-) • Diagnosed age <50 y with a limited family history, defined as fewer than 2 first- or second-degree female relatives or female relatives surviving beyond 45 years in either lineage

In addition, “If of certain ethnicity associated with higher mutation frequency, (eg, found populations of Ashkenazi Jewish, Icelandic, Swedish, Hungarian or other) no additional family history required” is revised to “If no certain ethnicity associated with higher mutation frequency, (eg, Ashkenzai Jewish) no additional family history required”. These updates will be effective April 23, 2012.

B2006.31 R14 Effective 10/01/2012, NAS incorporated changes allowing for detection of large genomic arrangements. We have therefore added CPT 88386 and modified language in the Indications and Limitations section on BRCA testing to allow coverage of this additional testing in appropriate situations.

Reason for Change Coverage Change (actual change in medical parameters) HCPCS Addition/Deletion

Related Documents This LCD has no Related Documents.

LCD Attachments Genetic Testing B2006.31 R14 opens in new window (PDF - 20 KB )

All Versions Updated on 08/31/2012 with effective dates 10/01/2012 - N/A Updated on 03/24/2012 with effective dates 04/23/2012 - 09/30/2012 Updated on 03/24/2012 with effective dates 04/23/2012 - N/A

Printed on 10/16/2012. Page 19 of 20 Updated on 03/24/2012 with effective dates 04/23/2012 - N/A Updated on 03/23/2012 with effective dates 02/27/2012 - 04/22/2012 Updated on 03/23/2012 with effective dates 02/01/2012 - 02/26/2012 Updated on 08/11/2011 with effective dates 09/15/2011 - 01/31/2012 Updated on 05/09/2011 with effective dates 06/15/2011 - 09/14/2011 Updated on 04/19/2011 with effective dates 06/15/2011 - N/A Updated on 02/24/2011 with effective dates 01/01/2011 - 06/14/2011 Updated on 12/09/2010 with effective dates 01/01/2011 - N/A Updated on 11/21/2010 with effective dates 04/01/2010 - 12/31/2010 Updated on 05/18/2010 with effective dates 04/01/2010 - N/A Updated on 02/25/2010 with effective dates 04/01/2010 - N/A Updated on 02/25/2010 with effective dates 04/01/2010 - N/A Some older versions have been archived. Please visit the MCD Archive Site opens in new window to retrieve them. Read the LCD Disclaimer opens in new window Back to Top

Printed on 10/16/2012. Page 20 of 20 Local Coverage Determination (LCD) for Non-Covered Services (L24473)

Contractor Information Contractor Name Contractor Number Contractor Type Noridian Administrative Services, 03402 MAC - Part B LLC opens in new window Back to Top

LCD Information Document Information LCD ID Number L24473

LCD Title Primary Geographic Jurisdiction opens in new window Non-Covered Services South Dakota

Contractor's Determination Number Oversight Region B2006.99 R13 Region X

AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2012 American Medical Original Determination Effective Date Association. All Rights Reserved. CPT is a registered For services performed on or after 11/01/2007 trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee Original Determination Ending Date schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or Revision Effective Date indirectly practice medicine or dispense medical For services performed on or after 02/27/2012 services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Revision Ending Date Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

CMS National Coverage Policy Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act, section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Medicare Claims Processing Manual (CMS Pub. 100-04), Chapter 23, Section 30 A

Medicare Program Integrity Manual

Medicare National Coverage Determination Manual

Indications and Limitations of Coverage and/or Medical Necessity

Printed on 10/16/2012. Page 1 of 17 Medicare does not cover items and services that are not reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member. Section 1862 (a) (1) of the Social Security Act is the basis for denying payment for types of care, or specific items, services, or procedures that are not excluded by any other statutory clause and meet all technical requirements for coverage but are determined to be any of the following:

● Not generally accepted in the medical community as safe and effective in the setting and for the condition for which it is used. ● Not proven to be safe and effective based on peer review or scientific literature. ● Experimental. ● Not medically necessary in the particular case. ● Furnished at a level, duration or frequency that is not medically appropriate. ● Not furnished in accordance with accepted standards of medical practice.

Or,

● Not furnished in a setting (such as inpatient care at a hospital or SNF, outpatient care through a hospital or physicians office or home care) appropriate to the patients medical needs and condition.

To be considered medically necessary, items and services must have been established as safe and effective. That is, the items and services must be:

● Consistent with the symptoms or diagnosis of the illness or injury under treatment. ● Necessary and consistent with generally accepted professional medical standards (e.g., not experimental or investigational). ● Not furnished primarily for the convenience of the patient, the attending physician or other physician or supplier. ● Furnished at the most appropriate level that can be provided safely and effectively to the patient.

A service or procedure on the national non-coverage list may be non-covered for a variety of reasons. It may be non-covered based on a specific exclusion contained in the Medicare law (for example, acupuncture) it may be viewed as not yet proven safe and effective and, therefore, not medically reasonable and necessary; or it may be a procedure that is always considered cosmetic in nature and is denied on that basis. The precise basis for a national decision to non-cover a procedure may be found in the references cited in this policy. These national non -covered services are listed in this LCD for informational purposes only.

A service or procedure on the local list is always denied on the basis that NAS does not believe it is ever medically reasonable and necessary. The NAS list of LCD exclusions contains procedures that, for example, are:

● Experimental. ● Not proven safe and effective.

Or,

● Not approved by the FDA.

Medical devices that are not approved for marketing by the Food and Drug Administration (FDA) are considered investigational by Medicare and are not considered reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve functioning of a malformed body member. Program payment, therefore, may not be made for medical procedures and services performed using devices that have not been approved for marketing by the FDA or for those not included in an FDA-approved investigational (IDE) trial.

If a test, treatment or procedure is neither specifically covered nor excluded in Medicare law or guidelines, carriers must make a coverage determination that is based upon the general acceptance of the test, treatment or procedure by the professional medical community as an effective and proven treatment for the condition for which it is being used. Medicare will make payment only when a service is accepted as effective and proven. Some tests or services are obsolete and have been replaced by more advanced procedures. The tests or procedures may be paid only if the physician who performs them satisfactorily justifies the medical need for the procedure(s).

Printed on 10/16/2012. Page 2 of 17 “When processing a claim, carriers continue to determine if a service is reasonable and necessary to treat illness or injury. If a service is not reasonable and necessary to treat illness or injury for any reason (including lack of safety and efficacy because it is an experimental procedure, etc.), carriers consider the service noncovered notwithstanding the presence of a payment amount for the service in the Medicare fee schedule. The presence of a payment amount in the MPFS and the Medicare physician fee schedule database (MPFSDB) does not imply that CMS has determined that the service may be covered by Medicare. The nature of the status indicator in the database does not control coverage except where the status is N for noncovered.” [Medicare Claims Processing Manual (CMS Pub. 100-04, Chapter 23, Section 30 A)]

It is important to note that the fact that a new service or procedure has been issued a CPT code or is FDA approved for a specific indication does not, in itself, make the procedure medically reasonable and necessary. NAS evaluates new services, procedures, drugs or technology and considers national and local policies before these new services may be considered Medicare covered services.

This LCD contains listings of numerous non-covered services which have no specific CPT code. Adding difficulty to correct coding for such services is the fact that there are many where two or more specific unlisted codes could arguably be used to designate the service. Initial preparation of the LCD to cover every possible code use – and more importantly, maintenance of the LCD as code changes occur – is difficult if not impossible.

Therefore, providers must bear in mind that any service that is described in any NAS LCD as “non-covered” will remain non-covered no matter which CPT code is selected for billing. Since many of the unlisted codes, however, are also correctly used for billing of covered services, it is likely that prepay denial edits cannot be implemented into the claims processing computer system. Because of this, clearly non-covered services can in some instances be paid. Providers are reminded that these paid services will be subject to recoupment by NAS, as well as other review contractors, including the Recovery Audit Contractors (RACs).

If you disagree with some aspects of a final LCD, you have the option of submitting a formal reconsideration to NAS Medicare Part B. See www.noridianmedicare.com for the reconsideration process. This reconsideration must be accompanied by complete copies of relevant peer-reviewed literature that support the recommendation. Abstracts are not sufficient for this purpose. Keep in mind that no change will be made that will put the LCD in conflict with CMS regulations.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.

Coding Information Bill Type Codes:

Revenue Codes:

99999 Not Applicable

CPT/HCPCS Codes NAS Non-Coverage Determinations:

Printed on 10/16/2012. Page 3 of 17 Note: These lists of non-covered services are not all-inclusive:

Services that are not covered due to being investigational/experimental, not proven effective or are not reasonable and necessary:

To bill the patient for procedures and services that are not covered for these reasons will generally require an Advance Beneficiary Notice (ABN) to be obtained before the service is rendered.

Note: The following therapies and tests have been determined to be non-covered by NAS since the implementation date of the currently effective NAS LCD Non-Covered Services. These codes will be added to the existing list of non-covered services for this LCD on the next effective date.

All new Category III Codes, unless instructed otherwise by CMS, will be added to the non-coverage list as they are released, since these codes have been created to track new, unproven therapies and tests. If providers believe that any of the Category III codes have been proven safe and effective, those providers may request their removal from this list through the NAS LCD Reconsideration Process.

Group 1 - Not Proven Effective, Not Medically Reasonable and Necessary

Note: The following services, as described below and billed with any CPT and or HCPCS code, are considered not proven effective or not medically reasonable and necessary and will be denied as such:

Claims for these services will always be reviewed when they are billed with an unlisted procedure code.

• Accu-Splina • Bile duct extracorporeal wave lithotripsy • Bladder check, NMP22® Test • Breast ductoscopy • Bronchoscopy with valve placement • BSGI, Breast Scintography • Carbon monoxide, expired gas analysis [eg. ETCO/hemolysis breath test] • Circular boot treatment • Clinical drug interaction testing • Coblation debridement of tendon and/or fascia • Cocaine test for Horner’s Syndrome • Confocal microendoscopy • Cryoablation of lung mass or tumor • Cryopreservation, ovarian reproductive tissue, oocytes • CT fusion • Destruction of macular drusen, photocoagulation • Electrical impedance breast scan • Endoluminal treatment for Gastroesophageal Reflux Disease (GERD) • Endoscopic lysis of epidural adhesions with direct visualization using mechanical means or solution injection [eg, normal saline] • Flicker Fusion • Food scratch test • Gel platelet application • Head shaking test • Heidelberg Gastric Analysis Test • Hydrotherapy treatments (also known as hydromassage & hydrobed modality) • Hypertonic sinus irrigation • Inert gas rebreathing for cardiac output measurement; during rest • Inert gas rebreathing for cardiac output measurement; during exercise • Laparoscopic radiofrequency ablation of lung lesion • Laser myringectomy • Laser treatment or low light laser therapy: of rotator cuff tendonitis, to stimulate circulation, for pain and inflammation, for low level laser treatment including, but not limited to trigger points, knees, hips and other joints • Lipoprotein, direct measurement, intermediate density lipoproteins [IDL][remnant lipoprotein] • Low back vertebtral decompression • Lung spectroscopy • Mammary duct(s) catheter lavage • Medialization thyroplasty • Microvas Treatments for all indications other than those allowed by NCD • Microdose therapy for arthritis or fibromyalgia Printed on 10/16/2012. Page 4 of 17 • Microwave phased array thermotherapy for destruction/reduction of malignant breast tumor • M.O.S.T. protocol (Mental office-based stress test) • Neuroform® Stent placement for ischemic disease • Neurometrix® nerve conduction testing • Qcare • Palate implant procedure (Pillar System) • Percutaneous neuromodulation therapy • PFL CO monitor • Phonophoresis • Platelet plasma mixed with laminate, protein bone growth stimulator • Platelet rich plasma injection for osteoarthrosis • Prolonged extracorporeal percutaneous transseptal ventricular assist device • Pulsed magnetic neuromodulation incontinence treatment • Pulsed radiofrequency treatment • Reconstruction of iliac bone or crest • Rhinophototherapy, intranasal application of ultraviolet and visible light • Saccades eye test or Saccadic eye test • Secca® procedure • Sonorex treatment • Speculoscopy, including sampling • Splint mouth guard or night guard • Sublingual antigen drops • Therabite appliance dispensed due to trismus • Therapy using Superluminous Diodes • Transoral fundoplasty • Transmyocardial transcatheter closure of ventricular septal defect, with implant, including cardiopulmonary bypass if performed. • Urinalysis infectious agent detection, semi quantitative analysis of volatile compounds • Vagal nerve stimulation for depression • von Willebrand Propetide Ag

27412 AUTOLOGOUS CHONDROCYTE IMPLANTATION, KNEE 27415 OSTEOCHONDRAL ALLOGRAFT, KNEE, OPEN OSTEOCHONDRAL AUTOGRAFT(S), KNEE, OPEN (EG, MOSAICPLASTY) (INCLUDES HARVESTING OF 27416 AUTOGRAFT[S]) 28446 OPEN OSTEOCHONDRAL AUTOGRAFT, TALUS (INCLUDES OBTAINING GRAFT[S]) ARTHROSCOPY, KNEE, SURGICAL; OSTEOCHONDRAL AUTOGRAFT(S) (EG, MOSAICPLASTY) (INCLUDES 29866 HARVESTING OF THE AUTOGRAFT[S]) 29867 ARTHROSCOPY, KNEE, SURGICAL; OSTEOCHONDRAL ALLOGRAFT (EG, MOSAICPLASTY) ARTHROSCOPY, KNEE, SURGICAL; MENISCAL TRANSPLANTATION (INCLUDES ARTHROTOMY FOR 29868 MENISCAL INSERTION), MEDIAL OR LATERAL TRANSCATHETER PLACEMENT OF WIRELESS PHYSIOLOGIC SENSOR IN ANEURYSMAL SAC DURING ENDOVASCULAR REPAIR, INCLUDING RADIOLOGICAL SUPERVISION AND INTERPRETATION, INSTRUMENT 34806 CALIBRATION, AND COLLECTION OF PRESSURE DATA (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) UPPER GASTROINTESTINAL ENDOSCOPY INCLUDING ESOPHAGUS, STOMACH, AND EITHER THE DUODENUM AND/OR JEJUNUM AS APPROPRIATE; WITH DELIVERY OF THERMAL ENERGY TO THE MUSCLE 43257 OF LOWER ESOPHAGEAL SPHINCTER AND/OR GASTRIC CARDIA, FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE 46707 REPAIR OF ANORECTAL FISTULA WITH PLUG (EG, PORCINE SMALL INTESTINE SUBMUCOSA [SIS]) 82172 APOLIPOPROTEIN, EACH 83987 PH; EXHALED BREATH CONDENSATE 84145 PROCALCITONIN (PCT) 89240 UNLISTED MISCELLANEOUS PATHOLOGY TEST THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (TMS) TREATMENT; INITIAL, 90867 INCLUDING CORTICAL MAPPING, MOTOR THRESHOLD DETERMINATION, DELIVERY AND MANAGEMENT THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (TMS) TREATMENT; SUBSEQUENT 90868 DELIVERY AND MANAGEMENT, PER SESSION 91132 ELECTROGASTROGRAPHY, DIAGNOSTIC, TRANSCUTANEOUS; 91133 ELECTROGASTROGRAPHY, DIAGNOSTIC, TRANSCUTANEOUS; WITH PROVOCATIVE TESTING NONINVASIVE PHYSIOLOGIC STUDY OF IMPLANTED WIRELESS PRESSURE SENSOR IN ANEURYSMAL SAC 93982 FOLLOWING ENDOVASCULAR REPAIR, COMPLETE STUDY INCLUDING RECORDING, ANALYSIS OF PRESSURE AND WAVEFORM TRACINGS, INTERPRETATION AND REPORT 95800 Printed on 10/16/2012. Page 5 of 17 SLEEP STUDY, UNATTENDED, SIMULTANEOUS RECORDING; HEART RATE, OXYGEN SATURATION, RESPIRATORY ANALYSIS (EG, BY AIRFLOW OR PERIPHERAL ARTERIAL TONE), AND SLEEP TIME SLEEP STUDY, UNATTENDED, SIMULTANEOUS RECORDING; MINIMUM OF HEART RATE, OXYGEN 95801 SATURATION, AND RESPIRATORY ANALYSIS (EG, BY AIRFLOW OR PERIPHERAL ARTERIAL TONE) 97026 APPLICATION OF A MODALITY TO 1 OR MORE AREAS; INFRARED 97033 APPLICATION OF A MODALITY TO 1 OR MORE AREAS; IONTOPHORESIS, EACH 15 MINUTES J2010 INJECTION, LINCOMYCIN HCL, UP TO 300 MG J7330 AUTOLOGOUS CULTURED CHONDROCYTES, IMPLANT EXTRACORPOREAL SHOCK WAVE INVOLVING MUSCULOSKELETAL SYSTEM, NOT OTHERWISE SPECIFIED, 0019T LOW ENERGY 0030T ANTIPROTHROMBIN (PHOSPHOLIPID COFACTOR) ANTIBODY, EACH IG CLASS PLACEMENT OF A SUBCONJUNCTIVAL RETINAL PROSTHESIS RECEIVER AND PULSE GENERATOR, AND 0100T IMPLANTATION OF INTRA-OCULAR RETINAL ELECTRODE ARRAY, WITH VITRECTOMY EXTRACORPOREAL SHOCK WAVE INVOLVING MUSCULOSKELETAL SYSTEM, NOT OTHERWISE SPECIFIED, 0101T HIGH ENERGY EXTRACORPOREAL SHOCK WAVE, HIGH ENERGY, PERFORMED BY A PHYSICIAN, REQUIRING ANESTHESIA 0102T OTHER THAN LOCAL, INVOLVING LATERAL HUMERAL EPICONDYLE 0103T HOLOTRANSCOBALAMIN, QUANTITATIVE 0111T LONG-CHAIN (C20-22) OMEGA-3 FATTY ACIDS IN RED BLOOD CELL (RBC) MEMBRANES 0123T FISTULIZATION OF SCLERA FOR GLAUCOMA, THROUGH CILIARY BODY CONJUNCTIVAL INCISION WITH POSTERIOR EXTRASCLERAL PLACEMENT OF PHARMACOLOGICAL AGENT 0124T (DOES NOT INCLUDE SUPPLY OF MEDICATION) COMMON CAROTID INTIMA-MEDIA THICKNESS (IMT) STUDY FOR EVALUATION OF ATHEROSCLEROTIC 0126T BURDEN OR CORONARY HEART DISEASE RISK FACTOR ASSESSMENT COMPUTER-AIDED DETECTION, INCLUDING COMPUTER ALGORITHM ANALYSIS OF MRI IMAGE DATA FOR LESION DETECTION/CHARACTERIZATION, PHARMACOKINETIC ANALYSIS, WITH FURTHER PHYSICIAN 0159T REVIEW FOR INTERPRETATION, BREAST MRI (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) STEREOTACTIC PLACEMENT OF INFUSION CATHETER(S) IN THE BRAIN FOR DELIVERY OF THERAPEUTIC 0169T AGENT(S), INCLUDING COMPUTERIZED STEREOTACTIC PLANNING AND BURR HOLE(S) MONITORING OF INTRAOCULAR PRESSURE DURING VITRECTOMY SURGERY (LIST SEPARATELY IN 0173T ADDITION TO CODE FOR PRIMARY PROCEDURE) COMPUTER-AIDED DETECTION (CAD) (COMPUTER ALGORITHM ANALYSIS OF DIGITAL IMAGE DATA FOR LESION DETECTION) WITH FURTHER PHYSICIAN REVIEW FOR INTERPRETATION AND REPORT, WITH OR 0174T WITHOUT DIGITIZATION OF FILM RADIOGRAPHIC IMAGES, CHEST RADIOGRAPH(S), PERFORMED CONCURRENT WITH PRIMARY INTERPRETATION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) COMPUTER-AIDED DETECTION (CAD) (COMPUTER ALGORITHM ANALYSIS OF DIGITAL IMAGE DATA FOR LESION DETECTION) WITH FURTHER PHYSICIAN REVIEW FOR INTERPRETATION AND REPORT, WITH OR 0175T WITHOUT DIGITIZATION OF FILM RADIOGRAPHIC IMAGES, CHEST RADIOGRAPH(S), PERFORMED REMOTE FROM PRIMARY INTERPRETATION SUPRACHOROIDAL DELIVERY OF PHARMACOLOGIC AGENT (DOES NOT INCLUDE SUPPLY OF 0186T MEDICATION) PLACEMENT OF INTRAOCULAR RADIATION SOURCE APPLICATOR (LIST SEPARATELY IN ADDITION TO 0190T PRIMARY PROCEDURE) INSERTION OF ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICE, WITHOUT EXTRAOCULAR RESERVOIR; 0191T INTERNAL APPROACH, INTO THE TRABECULAR MESHWORK ARTHRODESIS, PRE-SACRAL INTERBODY TECHNIQUE, INCLUDING INSTRUMENTATION, IMAGING (WHEN 0195T PERFORMED), AND DISCECTOMY TO PREPARE INTERSPACE, LUMBAR; SINGLE INTERSPACE ARTHRODESIS, PRE-SACRAL INTERBODY TECHNIQUE, INCLUDING INSTRUMENTATION, IMAGING (WHEN 0196T PERFORMED), AND DISCECTOMY TO PREPARE INTERSPACE, LUMBAR; EACH ADDITIONAL INTERSPACE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) MEASUREMENT OF OCULAR BLOOD FLOW BY REPETITIVE INTRAOCULAR PRESSURE SAMPLING, WITH 0198T INTERPRETATION AND REPORT PERCUTANEOUS SACRAL AUGMENTATION (SACROPLASTY), UNILATERAL INJECTION(S), INCLUDING THE 0200T USE OF A BALLOON OR MECHANICAL DEVICE, WHEN USED, 1 OR MORE NEEDLES PERCUTANEOUS SACRAL AUGMENTATION (SACROPLASTY), BILATERAL INJECTIONS, INCLUDING THE USE 0201T OF A BALLOON OR MECHANICAL DEVICE, WHEN USED, 2 OR MORE NEEDLES POSTERIOR VERTEBRAL JOINT(S) ARTHROPLASTY (EG, FACET JOINT[S] REPLACEMENT), INCLUDING 0202T FACETECTOMY, LAMINECTOMY, FORAMINOTOMY, AND VERTEBRAL COLUMN FIXATION, INJECTION OF BONE CEMENT, WHEN PERFORMED, INCLUDING FLUOROSCOPY, SINGLE LEVEL, LUMBAR SPINE 0205T

Printed on 10/16/2012. Page 6 of 17 INTRAVASCULAR CATHETER-BASED CORONARY VESSEL OR GRAFT SPECTROSCOPY (EG, INFRARED) DURING DIAGNOSTIC EVALUATION AND/OR THERAPEUTIC INTERVENTION INCLUDING IMAGING SUPERVISION, INTERPRETATION, AND REPORT, EACH VESSEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) ALGORITHMIC ANALYSIS, REMOTE, OF ELECTROCARDIOGRAPHIC-DERIVED DATA WITH COMPUTER 0206T PROBABILITY ASSESSMENT, INCLUDING REPORT EVACUATION OF MEIBOMIAN GLANDS, AUTOMATED, USING HEAT AND INTERMITTENT PRESSURE, 0207T UNILATERAL SKIN ADVANCED GLYCATION ENDPRODUCTS (AGE) MEASUREMENT BY MULTI-WAVELENGTH 0233T FLUORESCENT SPECTROSCOPY Group 2 - Components of Another Service, Never Separately Billable to the Contractor or the Patient

• Allergy - AG prep • Anesthesia IV start or intubation • Angiojet thrombectomy any artery or vein • Application of mitomycin • Cast mold • Cellvizio® pCLE System • Coronary sinus venography • Embolic protection device • Eye retractor advancement • Gliasite balloon placement • Implantation/placement of antibiotic beads • Implantation of Doppler device • Intrapericardial defibrillator coil • Intraoperative blood flow measurement • On Q pain pump placement and/or management • Pentacam • PICC removal (when billed by same provider) • Pin fixation • Pope earwick • Potential acuity meter • Preferential hyperacuity perimeter • Pump catheter placement • Pupillography or measure of alertness by pupillometry • Resection/ligation of atrial appendage • Schirmer test (ophthalmic mucous membrane test) • Stat fee • Stryker pain pump insertion • Suture removal (when billed by same provider) • Symphony system for procedure • Two week home auto CPAP titration study • Ultrasound guidance for fiducial marker placement • Via modem transmission telemedicine • Visiometer testing ELECTRONIC ANALYSIS OF IMPLANTED NEUROSTIMULATOR PULSE GENERATOR SYSTEM (EG, RATE, PULSE AMPLITUDE AND DURATION, CONFIGURATION OF WAVE FORM, BATTERY STATUS, ELECTRODE 95980 SELECTABILITY, OUTPUT MODULATION, CYCLING, IMPEDANCE AND PATIENT MEASUREMENTS) GASTRIC NEUROSTIMULATOR PULSE GENERATOR/TRANSMITTER; INTRAOPERATIVE, WITH PROGRAMMING MULTIVARIATE ANALYSIS OF PATIENT-SPECIFIC FINDINGS WITH QUANTIFIABLE COMPUTER 0185T PROBABILITY ASSESSMENT, INCLUDING REPORT 0208T PURE TONE AUDIOMETRY (THRESHOLD), AUTOMATED; AIR ONLY 0209T PURE TONE AUDIOMETRY (THRESHOLD), AUTOMATED; AIR AND BONE 0210T SPEECH AUDIOMETRY THRESHOLD, AUTOMATED; 0211T SPEECH AUDIOMETRY THRESHOLD, AUTOMATED; WITH SPEECH RECOGNITION COMPREHENSIVE AUDIOMETRY THRESHOLD EVALUATION AND SPEECH RECOGNITION (0209T, 0211T 0212T COMBINED), AUTOMATED PLACEMENT OF A POSTERIOR INTRAFACET IMPLANT(S), UNILATERAL OR BILATERAL, INCLUDING 0219T IMAGING AND PLACEMENT OF BONE GRAFT(S) OR SYNTHETIC DEVICE(S), SINGLE LEVEL; CERVICAL PLACEMENT OF A POSTERIOR INTRAFACET IMPLANT(S), UNILATERAL OR BILATERAL, INCLUDING 0220T IMAGING AND PLACEMENT OF BONE GRAFT(S) OR SYNTHETIC DEVICE(S), SINGLE LEVEL; THORACIC PLACEMENT OF A POSTERIOR INTRAFACET IMPLANT(S), UNILATERAL OR BILATERAL, INCLUDING 0221T IMAGING AND PLACEMENT OF BONE GRAFT(S) OR SYNTHETIC DEVICE(S), SINGLE LEVEL; LUMBAR EACH ADDITIONAL VERTEBRAL SEGMENT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY 0222T PROCEDURE)

Printed on 10/16/2012. Page 7 of 17 0223T ACOUSTIC CARDIOGRAPHY, INCLUDING AUTOMATED ANALYSIS OF COMBINED ACOUSTIC AND ELECTRICAL INTERVALS; SINGLE, WITH INTERPRETATION AND REPORT ACOUSTIC CARDIOGRAPHY, INCLUDING AUTOMATED ANALYSIS OF COMBINED ACOUSTIC AND ELECTRICAL INTERVALS; MULTIPLE, INCLUDING SERIAL TRENDED ANALYSIS AND LIMITED 0224T REPROGRAMMING OF DEVICE PARAMETER, AV OR VV DELAYS ONLY, WITH INTERPRETATION AND REPORT ACOUSTIC CARDIOGRAPHY, INCLUDING AUTOMATED ANALYSIS OF COMBINED ACOUSTIC AND 0225T ELECTRICAL INTERVALS; MULTIPLE, INCLUDING SERIAL TRENDED ANALYSIS AND LIMITED REPROGRAMMING OF DEVICE PARAMETER, AV AND VV DELAYS, WITH INTERPRETATION AND REPORT Group 3 – Statutorily Non-covered Service, the Patient is Liable for Payment

• Astigmatic keratotomy • CO2 laser resurfacing of lip • INTIMA-MEDIA Thickness (IMT) Scan • Laparoscopic implantation, replacement, revision, or removal of gastric stimulation electrodes, lesser curvature • Leukocytes, stool • Occlusal orthotic appliance • Open implantation, replacement, revision, or removal of gastric stimulation electrodes, lesser curvature • Orthomolecular medicine • Validated, statistically reliable, randomized, controlled, single- patient clinical investigation of FDA approved chronic care drugs, provided by a pharmacist, interpretation and report to the prescribing health care professional

MEDICATION THERAPY MANAGEMENT SERVICE(S) PROVIDED BY A PHARMACIST, INDIVIDUAL, FACE-TO- 99605 FACE WITH PATIENT, WITH ASSESSMENT AND INTERVENTION IF PROVIDED; INITIAL 15 MINUTES, NEW PATIENT MEDICATION THERAPY MANAGEMENT SERVICE(S) PROVIDED BY A PHARMACIST, INDIVIDUAL, FACE-TO- 99606 FACE WITH PATIENT, WITH ASSESSMENT AND INTERVENTION IF PROVIDED; INITIAL 15 MINUTES, ESTABLISHED PATIENT MEDICATION THERAPY MANAGEMENT SERVICE(S) PROVIDED BY A PHARMACIST, INDIVIDUAL, FACE-TO- 99607 FACE WITH PATIENT, WITH ASSESSMENT AND INTERVENTION IF PROVIDED; EACH ADDITIONAL 15 MINUTES (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY SERVICE)

ICD-9 Codes that Support Medical Necessity

XX000 Not Applicable

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information Documentations Requirements The medical record must be made available to Medicare upon request.

Printed on 10/16/2012. Page 8 of 17 When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and literature that supports the request. At a minimum two (2) Phase II studies (human feasibility studies suggesting efficacy, pilots) or one (1) Phase III study (primary evidence of safety and efficacy, pivotal) must be submitted for the Medical Director’s review.

Appendices

Utilization Guidelines

Sources of Information and Basis for Decision Policies from other states:

First Coast Services Option policy

TrailBlazer Health Enterprises, LLC policy

NAS Carrier Advisory Committee Members Advisory Committee Meeting Notes This medical policy was presented at the Medicare Part B Open Public Meeting held on September 14, 2010. It was again discussed at the following Carrier Advisory Committee meetings on the following dates:

Arizona 10/19/2010 Montana 10/07/2010 North Dakota 10/12/2010 South Dakota 10/14/2010 Utah 10/21/2010 Wyoming 10/21/2010

The Section titled "Does the ‘CPT 30% Rule' apply?" needs clarification. This rule comes from the AMA (American Medical Association), the organization that holds the copyrights for all CPT codes. The rule states that if, in a given section (e.g., surgery) or subsection (e.g., surgery, integumentary) of the CPT Manual, more than 30% of the codes are listed in the LCD, then the short descriptors must be used rather than the long descriptors found in the CPT Manual.

This policy is subject to the reasonable and necessary guidelines and the limitation of liability provision.

This medical policy consolidates and replaces all previous policies and publications on this subject by NAS and its predecessors for Medicare Part B.

NAS' Response to Provider Recommendations (for comment period ending 10/31/2006):

1. 0027T Endoscopic adhesiolysis now enjoys an RCT that clearly favors its coverage. See attached article. It is a more aggressive form of adhesiolysis that we already cover 62264.

The literature supplied had been reviewed by Noridian Administrative Services (NAS) as part of the consideration for noncoverage. No new literature has been supplied.

2. L8680; 95974, 95975 Neurostimulation codes – in one section states that the non-coverage refers to use in vagal nerve stimulation, but not in the other section.

The above listed codes in will be denied when used for Vagal Nerve Stimulation for Depression under this Non-covered Services LCD.

3. NAS should clarify the language of L8680 for general use: per electrode means per programmable contact. Thus a lead array with 8 contacts would be billed as L8680 x 8. This new code was brought about because of the various lead arrays currently available containing differing numbers of contacts per array: 2, 4,8,16. These codes are used for spinal cord stimulators, deep brain, cranial nerve and peripheral neurostimulators.

This draft policy addresses only non-covered services. This request is not in the prevue of this LCD.

Printed on 10/16/2012. Page 9 of 17

4. 99148-99150 Moderate sedation services, provided by a physician other than the health care professional performing the diagnostic or therapeutic service that the sedation supports…....

NAS will remove the codes 99148-99150 from the Non-covered Services policy and add them to the next revision of the NAS Monitored Anesthesia Care LCD.

5. Group 3 — Other Reasons (Benefit Category Determinations, Statutory Exclusions, other Reasons)" by its title indicates that you want this policy to list statutory exclusions which are always considered non-covered. If this policy is going to be referenced by both providers and administrative staff, language changes would be helpful.

The three categories describe the conditions under which a denial may be made. As with all lists a category “other” is often required to group several disparate conditions. In Group 3 and “e.g.” will be inserted into the parenthetical descriptor.

6. Code 96999 is a dermatology code and would not be used in conjunction with a test of eye movements like saccades. Is there a typographical error in listing the procedure code or is the incorrect explanation attached to the procedure code?

NAS has many examples of “coding to get paid” rather than correct coding. This is one example NAS has to deny.

7. On page 8, 0099T Implantation of intrastromal corneal ring segments is identified as part of group 1, investigational, not proven effective or experimental. While use of this procedure has been largely for refractive and thus not medically necessary conditions, there is one notable exception. The FDA has approved use of these implantable devices for use in cases of the medical condition Keratoconus, and other conditions where corneal thinning causes ectasia.

NAS agrees with the comment that 0099T is appropriate for use with keratoconus. Thus, 0099T will be removed from the non-covered policy. However, 0099T will continue to be not covered for refractive surgery which is not a Medicare benefit.

8. I recommend that Medicare does approve this implant therapy. I am the spouse of a treatment resistant depressive (TRD) who has been in a deep depression for the last three years. VNS Therapy offers the most hope we have yet had.

This comment is testimonial in nature. No further scientific literature has been submitted in support of this procedure payment, other than that provided by the manufacturer upon which the denial decision was made.

9. The Pentacam is an evolutionary advance in anterior-segment diagnostic imaging of the eye.. Indeed it is relatively new compared to historical technologies in this area.

NAS will not pay 92499 in addition to a Medicare covered procedure for using a Pentacam to perform that procedure. NAS will continue to pay those Medicare covered procedure codes per fee schedule.

10. NAS has published that Intima-Media Scans (IMT) are considered screening and not covered as 93799. There is a new code 0126T.

NAS considers IMT Scans not covered. 93799 also will be added.

NAS' Response to Provider Recommendations (for comment period ending 04/13/2007):

1. There were a number of requests to remove the Descement’s Stripping Automated Endothelial Keratoplasty (DSAEK) from the non-covered list.

Noridian Administrative Services (NAS) has reviewed the literature and comments supplied. NAS has determined that the DSAEK procedure would meet medical necessity requirements for Medicare coverage.

2. There were many comments requesting coverage for radiofrequency microremodeling treatment for stress urinary incontinence (RENESSA).

Printed on 10/16/2012. Page 10 of 17 NAS has reviewed the comments and literature supplied on this procedure. It is the opinion of NAS that radiofrequency microremodeling treatment for stress urinary incontinence (RENESSA) is not reasonable and necessary for coverage outside of a Medicare approved clinical trial. Radiofrequency microremodeling treatment for stress urinary incontinence will remain non-covered.

NOTE: The NAS Medical Directors have determined coverage is now appropriate for this procedure effective 01/01/2009. Please see Revision History at the bottom of this LCD.

3. There were comments dealing with description and grammatical issues.

NAS did not accept these as changes.

4. There was a comment on the ABN information supplied in the LCD.

NAS has chosen to leave the information as published.

Comment Period Ending 08/31/2009:

Many individuals and several medical specialty societies requested NAS to remove the facet block codes from the final LCD. A number of our practitioners supported their requests with outcomes data on their patients.

After careful review of the outcomes submitted to us, we requested and analyzed the block-related practices of those providers. We extended the comment period for the Non-Covered Services LCD draft for two months. Assisted by the specialty societies, we identified additional studies and attempted to link specific techniques and practices to outcomes.

While the current literature (30,000 studies in 30 years) is inadequate to establish the efficacy of lumbar blockade in the treatment of LBP, the literature does appear to support our providers' positive patient outcomes for some techniques and related practices in carefully selected patient populations - but to a limited extent. NAS removed the codes from the draft Non-Coverage LCD.

NAS' Response to Provider Recommendations (for comment period ending 12/15/2010):

1. One specialty society commented that they were unaware of the meaning of two items listed in the Non- Covered Services LCD, "drug interaction testing" and "scratch testing." They also requested explanatory language be added to distinguish the NAS non-coverage language from medically necessary services appropriately coded for “percutaneous or skin prick testing as described by CPT Code 95004.

NAS agrees that the terms are nebulous in their applicability to any specific testing protocol, but such claims are commonly submitted on claims. For that reason, they will be maintained in the LCD. To their second point, NAS does not believe the requested additional language is necessary and will not currently add it.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/14/2011

Revision History Number R13

Revision History Explanation J3 CB2006.99 This is the original LCD for Non-Covered Services, LCD # L24625.

J3 CB2006.99 R1 This is the first revision to this LCD and also replaces LCD # L24625, incorporating changes where needed. Comments from providers and NAS responses to those comments are also included.

11/10/2007 - The description for CPT/HCPCS code 0068T was changed in group 1 11/10/2007 - The description for CPT/HCPCS code 0069T was changed in group 1 11/10/2007 - The description for CPT/HCPCS code 0070T was changed in group 1 11/10/2007 - The description for CPT/HCPCS code 0087T was changed in group 1 Printed on 10/16/2012. Page 11 of 17 11/10/2007 - The description for CPT/HCPCS code 0175T was changed in group 1 11/10/2007 - The description for CPT/HCPCS code 29866 was changed in group 1 11/10/2007 - CPT/HCPCS code 0153T was deleted from group 1 11/10/2007 - CPT/HCPCS code 0154T was deleted from group 1 11/10/2007 - CPT/HCPCS code 0065T was deleted from group 3 11/10/2007 - CPT/HCPCS code 0074T was deleted from group 3 11/10/2007 - CPT/HCPCS code 0115T was deleted from group 3 11/10/2007 - CPT/HCPCS code 0116T was deleted from group 3 11/10/2007 - CPT/HCPCS code 0117T was deleted from group 3

J3 CB2006.99 R2 Based on 2008 CPT/HCPCS updates, the following codes were deleted and replaced, or new codes were added, and therefore, this LCD has been updated:

Group 1 - Investigational, Not Proven Effective, or Experimental 0153T was deleted and replaced with 34806 0154T was deleted and replaced with 93982 27416 - New CPT code 28446 - new CPT code

Group 3 - Other Reasons (e.g. - Benefit Category Determinations, Statutory Exclusions, other Reasons) 0065T was deleted and replaced with 99174 0074T was deleted and replaced with 99444 0115T was deleted and replaced with 99605 0116T was deleted and replaced with 99606 0117T was deleted and replaced with 99607

In addition CPT code 0064T was removed from the Non-Covered Services LCD. This code is addressed in the NAS LCD for Allergy Testing.

J3 CB2006.99 R3 Due to a clerical error, CPT code 0159T was included both in Group 1 and Group 3. The correct group is Group 1 and denial would be Not proven effective unless a valid ABN has been obtained. Code 0159T has been deleted from Group 3. This change is effective for dates of service on or after 11/01/2007.

J3 CB2006.99 R4 During a routine review of this LCD, it was discovered that due to a clerical error the following paragraph under the heading Indications and Limitations of Coverage and/or Medical Necessity was missing some pertinent information. A corrected paragraph is listed below (Note: This paragraph in its entirety was included in the DRAFT LCD.):

Also, the following two paragraphs under the heading CPT/HCPCS Codes were missing from the final LCD The added paragraphs are listed below. (Note: These paragraphs in their entirety were included in the DRAFT LCD.):

Above corrections/additions have been incorporated into the body of the LCD, effective for dates of service on or after 11/01/2007.

J3 CB2006.99 R5 0048T is removed from this policy, effective 11/24/2008. 0089T is deleted and removed from this LCD effective 01/01/09.

Printed on 10/16/2012. Page 12 of 17

The description for CPT/HCPCS codes 0124T, 0174T and 34806 was changed in group 1 effective 01/01/09.

2009 CPT/HCPCS codes 0185T, 0186T, 0190T, 0191T, 0192T, 0193T, 0194T, 0195T, 0196T, 0197T, and 0198T were added to this LCD to Group 1 with an effective date of 01/01/09.

The CPT/HCPCS listed below were deleted and replaced with the following codes effective 01/01/2009.

0026T was deleted from group 1 and replaced with 84999 0027T was deleted from group 1 and replaced with 64999 0029T was deleted from group 1 and replaced with 58999 0031T was deleted from group 1 and replaced with 58999 0032T was deleted from group 1 and replaced with 53899 0041T was deleted from group 1 and replaced with 81099 0043T was deleted from group 1 and replaced with 84999 0046T was deleted from group 1 and replaced with 19499 0047T was deleted from group 1 and replaced with 19499 0049T was deleted from group 1 and replaced with 33999 0058T was deleted from group 1 and replaced with 89240 0059T was deleted from group 1 and replaced with 89240 0060T was deleted from group 1 and replaced with 76499 0061T was deleted from group 1 and replaced with 19499 0162T was deleted from group 3 and replaced with 95980 and moved to group 2

J3 CB2006.99 R6 0193T is removed from this policy, effective 01/01/2009.

J3 CB2006.99 R7 HCPCS codes 0176T, 0177T, 0192T, 0197T were removed from the LCD effective for dates of service on or after 04/24/09.

CMS issued Change Request 6366, dated March 12, 2009, indicating that HCPCS code 0085T is nationally non- covered, effective for dates of service on or after December 08, 2008. Therefore, 0085T is removed from this LCD.

J3 CB2006.99 R8

11/15/2009 - CPT/HCPCS code 0068T was deleted from group 1 and replaced with 93799 11/15/2009 - CPT/HCPCS code 0069T was deleted from group 1 and replaced with 93799 11/15/2009 - CPT/HCPCS code 0070T was deleted from group 1 and replaced with 93799 11/15/2009 - CPT/HCPCS code 0077T was deleted from group 1 11/15/2009 - CPT/HCPCS code 0084T was deleted from group 1 11/15/2009 - CPT/HCPCS code 0086T was deleted from group 1 and replaced with 93799 11/15/2009 - CPT/HCPCS code 0087T was deleted from group 1 and replaced with 89398 11/15/2009 - CPT/HCPCS code 0170T was deleted from group 1 and replaced with 46707 11/15/2009 - CPT/HCPCS code 0194T was deleted from group 1 and replaced with 84145

The following CPT/HCPCS codes were added with an effective date of 1/1/2010: 46707, 84145, 0199T, 0200T, 0201T, 0202T, 0203T, 0204T, 0205T, 0206T, 0207T, 0208T, 0209T, 0210T, 0211T, 0212T, 0219T, 0220T, 0221T, 0222T

J3 CB2006.99 R9 The following changes are effective 09/04/2010:

Groups 1 and 2 were combined to form one group titled, “Not Proven Effective, Not Medically Reasonable and Necessary”.

The following CPT codes were added to Group 1: 29867, 29868, 43257, 83701, 83704, 97026, 97033.

The title of Group 2 was changed to: Components of Another Service, Never Separately Billable to the Contractor or the Patient.

The title of Group 3 was changed to: Statutorily Non-covered Service, the Patient is Liable for Payment

Printed on 10/16/2012. Page 13 of 17

Miscellaneous CPT codes were removed and only descriptions of services remain.

99174 and 99444 were removed as they have an “N” status in the MPFSDB.

0156T and 0158T are removed from the LCD.

DL24473 Winter 2010 CAC meeting proposed changes:

The following services were added to Group 1: • Balloon sinuplasty • Bile duct extracorporeal wave lithotripsy • Bladder check, NMP22® Test • BSGI, Breast Scintography • Coblation debridement of tendon and/or fascia • Cryoablation of lung mass or tumor • CT fusion • Flicker Fusion • Heidelberg Gastric Analysis Test • Laparoscopic radiofrequency ablation of lung lesion • Laser myringectomy • Lung spectroscopy • Microdose therapy for arthritis or fibromyalgia • Neuroform® Stent placement • Neurometrix® nerve conduction testing • Palate implant procedure (Pillar™ System) • Percutaneous neuromodulation therapy • Platelet rich plasma injection for osteoarthrosis • Secca® procedure • Transoral fundoplasty • von Willebrand Propetide Ag 0233T

The following services were added to Group 2: • Cellvizio® pCLE System

The following services were added to Group 3: 0223T, 0224T, 0225T

The following services were moved to different groupings: 0185T was moved from Group 1 to Group 2 0126T was moved from Group 3 to Group 1 95980 was moved from Group 1 to Group 2.

NOTE: The four T codes added to this draft (0233T, 0223T, 0224T, and 0225T) will be added to Groups 1 and 3 CPT codes when the LCD finalizes. For this draft, they are added to the Group narrative section since these codes will not be loaded for use into the Medicare Coverage Database until some time in November.

Printed on 10/16/2012. Page 14 of 17 0220T descriptor was changed in Group 1 0221T descriptor was changed in Group 1 0222T descriptor was changed in Group 1 29866 descriptor was changed in Group 1 29867 descriptor was changed in Group 1 29868 descriptor was changed in Group 1 83701 descriptor was changed in Group 1 83704 descriptor was changed in Group 1 99605 descriptor was changed in Group 3 99606 descriptor was changed in Group 3 99607 descriptor was changed in Group 3

11/21/2010 - The following CPT/HCPCS codes were deleted: 0017T was deleted from Group 1 0104T was deleted from Group 1 0105T was deleted from Group 1 0140T was deleted from Group 1 0160T was deleted from Group 1 0161T was deleted from Group 1 0203T was deleted from Group 1 0204T was deleted from Group 1 0130T was deleted from Group 3

J3 CB2006.99 R10: This revision to the active LCD occurred while a draft of this LCD was out for comment period.

The following CPT/HCPCS codes were moved from Group 1 to Group 2: 0208T, 0209T, 0210T, 0211T, 0212T, 0219T, 0220T, 0221T, 0222T.

The following CPT/HCPCS codes were deleted and replaced in Group 1: 0140T with 83987 (since the replacement code is a miscellaneous code only the description remains), 0160T with 90867, 0161T with 90868, 0203T with 95800, 0204T with 95801.

The following CPT codes were deleted but their code descriptions remain in the same existing grouping when billed with a miscellaneous code: 0017T, 0104T, 0105T, 0130T.

The following CPT codes were deleted since they are governed by NCD: 83701, 83704.

CPT code 0199T is removed effective 01/01/2010.

J3 CB2006.99 R11 The following services were added to Group 1: • Bile duct extracorporeal wave lithotripsy • Bladder check, NMP22® Test • BSGI, Breast Scintography • Coblation debridement of tendon and/or fascia • Cryoablation of lung mass or tumor • CT fusion • Flicker Fusion • Heidelberg Gastric Analysis Test • Laparoscopic radiofrequency ablation of lung lesion • Laser myringectomy • Lung spectroscopy • Microdose therapy for arthritis or fibromyalgia • Neuroform® Stent placement for ischemic disease • Neurometrix® nerve conduction testing • Palate implant procedure (Pillar™ System) • Percutaneous neuromodulation therapy • Platelet rich plasma injection for osteoarthrosis • Secca® procedure • Transoral fundoplasty • von Willebrand Propetide Ag and 0233T.

Printed on 10/16/2012. Page 15 of 17 The following services were added to Group 2: • Cellvizio® pCLE System, 95980, 0223T, 0224T, 0225T.

The following services were moved to different groupings: 0185T was moved from Group 1 to Group 2 0126T was moved from Group 3 to Group 1 95980 was moved from Group 1 to Group 2. 0223T, 0224T, 0225T were moved from Group 3 to Group 2.

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 90867 descriptor was changed in Group 1 90868 descriptor was changed in Group 1 0222T descriptor was changed in Group 2

J3 CB2006.99 R12

11/21/2011 - The following CPT/HCPCS codes were deleted: 0166T was deleted from Group 1 0167T was deleted from Group 1 0168T was deleted from Group 1 0155T was deleted from Group 3 0157T was deleted from Group 3

01667T is replaced with description(TRANSMYOCARDIAL TRANSCATHETER CLOSURE OF VENTRICULAR SEPTAL DEFECT, WITH IMPLANT, INCLUDING CARDIOPULMONARY BYPASS IF PERFORMED).

0167T is replaced with description(TRANSMYOCARDIAL TRANSCATHETER CLOSURE OF VENTRICULAR SEPTAL DEFECT, WITH IMPLANT, INCLUDING CARDIOPULMONARY BYPASS IF PERFORMED).

0168T is replaced with description (RHINOPHOTOTHERAPY, INTRANASAL APPLICATION OF ULTRAVIOLET AND VISIBLE LIGHT).

Above descriptions will be added to Group 1 with an effective date of 01/01/2012.

0155T is replaced with description (laparoscopic implantation, replacement, revision, or removal of gastric stimulation electrodes, lesser curvature.

0157T is replaced with description (open implantation, replacement, revision, or removal of gastric stimulation electrodes, lesser curvature).

Above descriptions will be added to Group 3 with an effective date of 01/01/2012.

B2006.99 R13 02/01/2012-This revision is due to the consolidation of LCDs for JF implementation. Idaho MAC B (Contract #02202) was added to this LCD.

02/27/2012: The following states and contractor numbers were added to the LCD: Alaska MAC B (Contract #02102); Oregon MAC B (Contract #02302); and Washington MAC B (Contract #02402).

Reason for Change Other

Related Documents This LCD has no Related Documents.

Printed on 10/16/2012. Page 16 of 17

LCD Attachments There are no attachments for this LCD.

All Versions Updated on 03/24/2012 with effective dates 02/27/2012 - N/A Updated on 03/23/2012 with effective dates 02/01/2012 - 02/26/2012 Updated on 12/04/2011 with effective dates 01/01/2012 - 01/31/2012 Updated on 04/19/2011 with effective dates 06/15/2011 - 12/31/2011 Updated on 02/24/2011 with effective dates 03/01/2011 - 06/14/2011 Updated on 01/06/2011 with effective dates 03/01/2011 - N/A Updated on 12/14/2010 with effective dates 01/01/2011 - 02/28/2011 Updated on 07/15/2010 with effective dates 09/04/2010 - 12/31/2010 Updated on 07/15/2010 with effective dates 09/04/2010 - N/A Some older versions have been archived. Please visit the MCD Archive Site opens in new window to retrieve them. Read the LCD Disclaimer opens in new window Back to Top

Printed on 10/16/2012. Page 17 of 17 Local Coverage Determination (LCD) for Vitamin D Assay Testing (L32132)

Contractor Information Contractor Name Contractor Number Contractor Type Noridian Administrative Services, 03402 MAC - Part B LLC opens in new window Back to Top

LCD Information Document Information LCD ID Number L32132

LCD Title Primary Geographic Jurisdiction opens in new window Vitamin D Assay Testing South Dakota

Contractor's Determination Number Oversight Region B2011.01 R1 Region X

AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2012 American Medical Original Determination Effective Date Association. All Rights Reserved. CPT is a registered For services performed on or after 11/14/2011 trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee Original Determination Ending Date schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or Revision Effective Date indirectly practice medicine or dispense medical For services performed on or after 02/27/2012 services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Revision Ending Date Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

CMS National Coverage Policy Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

42CFR410.32(a) requires a clinical diagnostic test be ordered by the physician who is treating the patient for a specific medical problem and uses the results in the management of the beneficiary’s specific problem.

MBPM Internet Only Manual(IOM 100-02), chap. 6, §20.4.3 applies 42CFR410.32 to hospitals.

Indications and Limitations of Coverage and/or Medical Necessity

Printed on 10/16/2012. Page 1 of 10 Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/dl. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay.

Indications:

Measurement of 25-OH Vitamin D, CPT 82306, level is indicated for patients with:

• chronic kidney disease stage III or greater

• cirrhosis

• hypocalcemia

• hypercalcemia

• hypercalciuria

• hypervitaminosis D

• parathyroid disorders

• malabsorption states

• obstructive jaundice

• osteomalacia

• osteoporosis if i. T score on DEXA scan <-2.5 or ii. History of fragility fractures or iii. FRAX > 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or iv. FRAX > 3% (any fracture) with T-score <-1.5 or v. Initiating bisphosphanate therapy (Vit D level should be determined and managed as necessary before bisphosphonate is initiated)

• osteosclerosis/petrosis

• rickets

• vitamin D deficiency on replacement therapy related to a condition listed above; to monitor the efficacy of treatment.

Measurement of 1, 25-OH Vitamin D, CPT 82652, level is indicated for patients with:

• unexplained hypercalcemia (suspected granulomatous disease or lymphoma)

• unexplained hypercalciuria (suspected granulomatous disease or lymphoma)

• suspected genetic childhood rickets

Printed on 10/16/2012. Page 2 of 10

• suspected tumor-induced osteomalacia

• nephrolithiasis or hypercalciuria

Limitations:

Testing may not be used for routine or other screening.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1,25 dihydroxy vitamin D deficiency exists; mostly, in those with renal disease. Documentation must justify the test(s) chosen for a particular disease entity. Various component sources of 25-OH vitamin D, such as stored D or diet-derived D, should not be billed separately.

Once a beneficiary has been shown to be vitamin D deficient, further testing may be medically necessary only to ensure adequate replacement has been accomplished. If Vitamin D level is between 20 and 50 ng/dl and patient is clinically stable, repeat testing is often unnecessary; if performed, documentation most clearly indicate the necessity of the test. If level <20 ng/dl or > 60 ng/dl, a subsequent level(s) may be reimbursed until the level is within the normal range.

Coding Information Bill Type Codes:

999x Not Applicable

Revenue Codes:

CPT/HCPCS Codes Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural Teminology (CPT) codes. 82306 VITAMIN D; 25 HYDROXY, INCLUDES FRACTION(S), IF PERFORMED 82652 VITAMIN D; 1, 25 DIHYDROXY, INCLUDES FRACTION(S), IF PERFORMED

ICD-9 Codes that Support Medical Necessity The following ICD-9 CM codes support the medical necessity of CPT code 82306 252.00 HYPERPARATHYROIDISM, UNSPECIFIED 252.01 PRIMARY HYPERPARATHYROIDISM 252.02 SECONDARY HYPERPARATHYROIDISM, NON-RENAL 252.08 OTHER HYPERPARATHYROIDISM 252.1 HYPOPARATHYROIDISM 261 NUTRITIONAL MARASMUS Printed on 10/16/2012. Page 3 of 10 262 OTHER SEVERE PROTEIN-CALORIE MALNUTRITION 268.0 RICKETS ACTIVE 268.2 OSTEOMALACIA UNSPECIFIED 268.9* UNSPECIFIED VITAMIN D DEFICIENCY 275.3 DISORDERS OF PHOSPHORUS METABOLISM 275.40* UNSPECIFIED DISORDER OF CALCIUM METABOLISM 275.41 HYPOCALCEMIA 275.42 HYPERCALCEMIA 278.4 HYPERVITAMINOSIS D 571.9 UNSPECIFIED CHRONIC LIVER DISEASE WITHOUT ALCOHOL 579.0 CELIAC DISEASE 579.1 TROPICAL SPRUE 579.2 BLIND LOOP SYNDROME 579.3 OTHER AND UNSPECIFIED POSTSURGICAL NONABSORPTION 579.4 PANCREATIC STEATORRHEA 579.8 OTHER SPECIFIED INTESTINAL MALABSORPTION 579.9 UNSPECIFIED INTESTINAL MALABSORPTION 585.3 CHRONIC KIDNEY DISEASE, STAGE III (MODERATE) 585.4 CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE) 585.5 CHRONIC KIDNEY DISEASE, STAGE V 585.6 END STAGE RENAL DISEASE 588.81 SECONDARY HYPERPARATHYROIDISM (OF RENAL ORIGIN) 733.00 OSTEOPOROSIS UNSPECIFIED 733.01 SENILE OSTEOPOROSIS 733.02 IDIOPATHIC OSTEOPOROSIS 733.09 OTHER OSTEOPOROSIS 733.90 DISORDER OF BONE AND CARTILAGE UNSPECIFIED 756.52 OSTEOPETROSIS 268.9* If more than one LCD-listed condition contributes to Vit. D deficiency in a given patient and/or is improved by Vit. D administration, coders should use: ICD-9-CM 268.9 UNSPECIFIED VITAMIN D DEFICIENCY.This code should not be used for any other indication.

275.40* Use only for HYPERCALCIURIA

The following ICD-9-CM codes support the medical necessity of CPT code 82652 268.0 RICKETS ACTIVE 268.2* OSTEOMALACIA UNSPECIFIED 275.40* UNSPECIFIED DISORDER OF CALCIUM METABOLISM 275.42* HYPERCALCEMIA 592.0 CALCULUS OF KIDNEY 592.1 CALCULUS OF URETER 592.9 URINARY CALCULUS UNSPECIFIED 268.2* Use only for tumor-induced osteomalacia 275.40* Use only for unexplained hypercalciuria 275.42* Use only for unexplained hypocalcemia

Diagnoses that Support Medical Necessity All ICD-9-CM codes listed under ICD-9-CM Codes that Support Medical Necessity above.

ICD-9 Codes that DO NOT Support Medical Necessity All ICD-9-CM codes not listed under ICD-9-CM Codes that Support Medical Necessity above.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

Printed on 10/16/2012. Page 4 of 10 Back to Top

General Information Documentations Requirements Documentation must clearly indicate the necessity for the test(s), any and all repeat testing and frequency of testing.

The medical record must be made available to Medicare upon request.

Appendices N/A

Utilization Guidelines

Sources of Information and Basis for Decision IOM (Institute of Medicine). Dietary Reference Intake for Calcium and Vitamin D.2011. Washington D.C.: the National Academies Press

American Medical Association (AMA). Council on Science and Public Health "Appropriate Supplementation of Vitamin D," CSAPH Report 4-A-09.

Autier P, Gandini S. Vitamin D Supplementation and Total Mortality. A Meta-analysis of Randomized Controlled Trials. Arch Intern Med. 2007;167(16);1730-1737.

Bischoff-Ferrari HA, Dawson-Hughs B, Willett W, et al. Effect of vitamin D on falls a meta-analysis. JAMA April 2004;291:16:1999-2006. www.jama.com. Accessed 03/04/2009.

Bischoff-Ferrari HA, Dietrich T, Orav EJ, Dawson-Hughes B. Positive association between 25-Hydroxy vitamin D levels and bone mineral density: a population-based study of younger and older adults. The American Journal of Medicine. 2004;116:634-639.

Bischoff-Ferrari HA, Willett W, Wong J, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation, a meta-analysis of randomized controlled trials. JAMA. May 2005;293:18:2257-2264. www.jama.com. Accessed 03/04/2009.

Bodnar LM, Simhan HN, Powers RW, Frank MP, Cooperstein E, Roberts JM. High prevalence of vitamin D insufficiency in black and white pregnant women residing in the northern United States and their neonates. J Nutr. 2007;137:447-452. http://jn.nutrition.org. Accessed 02/10/2009.

Cannell JJ. Autism and Vitamin D. Med Hypothese. 2008;70:4:750-759. http://www.ncbi.nlm.nih.gov/pubmed/17920208. Accessed 02/10/2009.

Cannell JJ, Hollis BW, Zasloff M, Heaney RP. Diagnosis and treatment of vitamin D deficiency. Expert Opin Pharmacother. 2008;9:1-12.

Chapuy M, Arlot M, Duboeuf F, et al. vitamin D3 and calcium to prevent hip fractures in elderly women. The New England Journal of Medicine. December 1992;327:23:1637-1641.

Chronic Kidney Disease 2006: A Guide to Select NKF-KDOQI Guidelines and Recommendations. Printed on 10/16/2012. Page 5 of 10

Woolcott CG, Wilkens LR, Nomura AM et al. Plasma 25-hydroxyvitamin D levels and the risk of colorectal cancer: the multiethnic cohort study. Cancer Epidemiol Biomarkers Prev 2010; 19(1):130-134.

Vitamin D and Calcium Systematic Review of Health Outcomes. Structured Abstract. Agency for Healthcare Research and Quality. Rockville, MD. http://www.ahrq.gov/clinic/tp/vitadcaltp.htm

MacLean C, Alexander A, Carter J et al. Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis Executive Summary. No.12 (Prepared by Southern California/RAND Evidence-based Practice Center under Contract with the Agency for Healthcare Research and Quality. December 2007.

Vitamin D Evidence-based Monograph. The Natural Standard Research Collaboration. (Last updated June 1, 2010.) http://naturalstandard.com; and http://www.mayoclinic.com/health/vitamin-d

Bjelakovic, Goran, Gluud et al. Vitamin D supplementation for prevention of mortality in adults. (Protocol) Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No,: CD007470. DOI:10.1002/14651858.CD007470. [Last review 2010; no changes to last published edit 03 May 2009.]

Giovannucci E, Liu Y, Hollis BW, Rimm EB. 25-Hydroxyvitamin D and Risk of Myocardial Infarction in Men; A Prospective Study. Arch Intern Med.2008:168(11):1174-1180.

Wagner CL, Greer FR, and the Section on Breastfeeding and Committee on Nutrition. Prevention of Rickets and Vitamin D Deficiency in Infants, Children, and Adolescents. [published correction appears in Pediatrics 2009;123;197.]. Pediatrics 2008;122;1142-1152.

Lafferty, FW. Differential diagnosis of hypercalcemia. J Bone Miner Res 1991; 6 Suppl 2:S51.

Silverberg S, Bilezikian. Primary Hyperparathyroidism. In: Primer on Metabolic Bone Diseases and Disorders of Mineral Metabolism. 7th ed., 2008:7:302-306.

Horwitz M, Hodak S, Stewart A. Non-Parathyroid Hypercalcemia. In: Primer on Metabolic Bone Diseases and Disorders of Mineral Metabolism. 7th ed., 2008:7:307-312.

Am. J. Med. 107(6):561-567(1999), "The effects of vitamin D insufficiency in patients with primary hyperparathyroidism", Silverberg, S.J., et.al.

Schilling, T, Pecherstorfer, M, Blind, E, et al. Parathyroid hormone-related protein (PTH-rP) does not regulate serum 1,25-dihydroxyvitamin D levels in hypercalcemia of malignancy. J Clin Endocrinol Metab 1993; 76:801.

Jacobus, CH, Holick, MF, Shao, Q, et al. Hypervitaminosis D associated with drinking milk. N Engl J Med 1992; 326:1173.

Goltzman, D, Cole, DEC. Hypoparathyroidism. In Primer on the Metabolic Bone Diseases and Disorders of Bone Metabolism, American Society of Bone and Mineral Research 2006; 6:216.

Bernstein, CN, Leslie, WD, Leboff, MS. AGA technical review on osteoporosis in gastrointestinal diseases. Gastroenterology 2003; 124:795.

Johnson, JM, Maher, JW, Demaria, EJ, et al. The Long-term Effects of Gastric Bypass on Vitamin D Metabolism. Ann Surg 2006; 243:701.

American Gastroenterological Association medical position statement: guidelines on osteoporosis in gastrointestinal diseases. Gastroenterology 2003; 124:791.

Hahn, TJ. Drug-induced disorders of vitamin D and mineral metabolism. Clin Endocrinol Metab 1980; 9:107.

Sotaniemi, EA, Hakkarainen, HK, Puranen, JA, Lahti, RO. Radiologic bone changes and hypocalcemia with anticonvulsant therapy in epilepsy. Ann Intern Med 1972; 77:389.

Välimäki, MJ, Tiihonen, M, Laitinen, K, et al. Bone mineral density measured by dual-energy X-ray absorptiometry and novel markers of bone formation and resorption in patients on antiepileptic drugs. J Bone Miner Res 1994; 9:631.

Printed on 10/16/2012. Page 6 of 10

Compston, JE. Hepatic osteodystrophy: Vitamin D metabolism in patients with liver disease. Gut1986; 27:1073.

Holick, MF. Vitamin D deficiency. N Engl J Med 2007; 357:266.

Am. J. Kidney Dis.50(1):59-68(2007) "Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD", Al Aly, Z, et. al.

Bone, (2008), "Serum 25-hydroxyvitamin D as an independent determinant of 1-84 PTH and bone mineral density in non-diabetic predialysis CKD patients", Tomida, K., et. al.

Ceglia L. Vitamin D and skeletal muscle tissue and function. Mol Aspects Med. 2008 Dec;29(6):407-14. Epub 2008 Aug 8. Review.

Ward KA, Das G, Berry JL, Roberts SA, Rawer R, Adams JE, Mughal Z. Vitamin D status and muscle function in post-menarchal adolescent girls. J Clin Endocrinol Metab. 2009 Feb;94(2):559-63. Epub 2008 Nov 25.

Gordon PL, Sakkas GK, Doyle JW, Shubert T, Johansen KL. Relationship between vitamin D and muscle size and strength in patients on hemodialysis. J Ren Nutr. 2007 Nov;17(6):397-407. PubMed PMID: 17971312.

Hollick MF High Prevalence of Vitamin D Inadequacy and Implications for Health Mayo Clin Proc. 2006;81(3):353- 373.

Buischoff-Ferrari, HA et al Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes Am J Clin Nutr (2006) 84:18.

Ybarra J, Sánchez-Hernández J, Pérez A. Hypovitaminosis D and morbid obesity. Nurs Clin North Am. 2007 Mar;42(1):19-27, v. Review.

Goldner WS, Stoner JA, Thompson J, Taylor K, Larson L, Erickson J, McBride C. Prevalence of vitamin D insufficiency and deficiency in morbidly obese patients: a comparison with non-obese controls. Obes Surg. 2008 Feb;18(2):145-50.

Sánchez-Hernández J, Ybarra J, Gich I, De Leiva A, Rius X, Rodríguez-Espinosa J, Pérez A. Effects of bariatric surgery on vitamin D status and secondary hyperparathyroidism: a prospective study. Obes Surg. 2005 Nov- Dec;15(10):1389-95.

Lee JH, O’Keefe JH, Bell D et al. Vitamin D deficiency. JACC. 2008; 52(24):1949-56.

Lapp JL. Vitamin D: bone health and beyond. Am J Lifestyle Med. 2009;3:386-93.

Binkley N, Krueger D, Gemar D, Drezner MK. Correlation among 25-hydroxy-vitamin D assays. J Clin Endocrinol Metab. 2008; 93:1804–1808

Bolland MJ, Bacon CJ, Horne AM et al. Vitamin D Insufficiency and Health. Am J Clin Nutr 2010; 91:82-89.

Other Contractor(s)' Policies Advisory Committee Meeting Notes This draft LCD was presented at the Part A Open Door Coverage Meeting held on October 21, 2010.

This medical policy was presented at the Medicare Part B Open Public Meeting held on June 28, 2011. It was again discussed at the following Carrier Advisory Committee meetings on the following dates:

Arizona 07/12/2011 Montana 07/07/2011 North Dakota 07/19/2011 South Dakota 07/21/2011 Utah 07/14/2011 Wyoming 07/14/2011

Response to Part A Provider Recommendations from the October 21, 2010 Part A Open Door Coverage meeting draft LCD:

Printed on 10/16/2012. Page 7 of 10 Comment: Providers produced literature demonstrating the dearth of evidence of the utility of Vitamin D supplementation in patients with bone loss associated with long-term steroid or anti-convulsant intake.

Response: Noridian agrees with the providers’ conclusions and eliminates this coverage category.

Comment: Several commenters requested the addition of screening codes to allow for Vitamin D screening in the Medicare population.

Response: Neither Noridian nor CMS has authority to allow coverage of screening examinations. The Medicare law (Social Security Act 1862) prohibits payment for screening examinations. Congress must write specific emending legislation to allow payment for screening examinations, and such has been done for all currently covered screening, such as mammography, colonography.

Comment: Several commenters submitted literature indicating widespread prevalence of Vitamin D “deficiency” among Medicare beneficiaries and requested coverage for periodic patient examinations despite the absence of symptoms.

Response: Noridian will not add this coverage due to insufficient and questionable evidence of deficiency and benefits of treatment compounded by the absence of a reasonable understanding of the appropriate management of any deficiency in the face of known risks of supplementation. Since there is no consensus on the definition of normal and abnormal value ranges for Vitamin D, in general, but particularly among the poorly studied Medicare population; no standard across laboratories for either the assay or result reporting; and no evidence that supplementation beyond recommended daily doses is beneficial: coverage is denied. Noridian’s conclusions are supported by the November 2010 analysis of the Institute of Medicine Dietary Reference Intakes committee, a study undertaken on behalf of the USDA, DOD, FDA, HHS and NIH.

Comment: Several commenters submitted supportive literature and requested coverage for Vit. D testing in a variety of medical conditions, which may be worsened by Vit. D deficiency. These conditions include: cancer (both generally and specifically), heart disease, autoimmune disorders, especially Multiple Sclerosis, glucose homeostasis, prevention of tuberculosis, Parkinson’s Disease, and overall mortality.

Response: Coverage for testing in these conditions will not be added. Vitamin D receptor sequences have been found in over 1000 genes and the literature on Vit. D has expanded exponentially over the past few years. However, all submitted and otherwise reviewed studies have produced preliminary or suggestive results requiring further study. The best randomized clinical trials are inconsistent. All reviewed systematic reviews on the other hand, including recent AHRQ and Cochrane analyses, conclude that evidence - at best - is intriguing but not conclusive for any of the conditions. This conclusion is supported by the November 2010 analysis of the Institute of Medicine Dietary Reference Intakes committee, a study undertaken on behalf of the USDA, DOD, FDA, HHS and NIH.

Comment: One commenter requested coverage of hypovitaminosis D in the absence of symptoms or signs of disease. Another commenter requested use of condition, hypovitaminosis D, only for patients under treatment for a covered condition whose last level was low.

Response: Coverage will not be added. There is no consensus on the definition of this condition, hypovitaminosis D, or the necessity of treatment except in specific conditions as listed in this LCD. Given the lack of consensus on the normal range for Vit. D levels, especially in the Medicare population, the emerging evidence of risks of supplementation and the recommendations of Dietary Reference Intakes report against other than routine daily intake (except in the disorders listed in our LCD), there is ample reason not to add this condition.

In the case of patients on Vit. D supplementation with a need for treatment and monitoring, the underlying condition (which management is affected by Vit. D) should be coded. If more than one LCD-listed condition contributes to Vit. D deficiency in a given patient and/or is improved by Vit. D administration, coders should use: ICD-9-CM 268.9 UNSPECIFIED VITAMIN D DEFICIENCY.

Note: In this LCD, the range of “normal”, for the purposes of repeat testing, was established by a consensus of Noridian providers, all experts in the fields and based on the best literature evidence currently available.

Comment: Two commenters requested the addition of Hypervitaminosis D.

Response: Noridian will add this condition. There is evidence in the literature that levels above 60 are harmful in some populations and emerging evidence of potential harm at levels lower than 60.

Printed on 10/16/2012. Page 8 of 10 Comment: One of the commenters requesting addition of hypervitaminosis D also requested addition of several other codes related to liver and kidney disease; malnutrition states; malaise and fatigue, myalgia and Myositis; and obesity.

Response: Severe nutritional disorders require vitamin supplementation at higher than usual levels for repletion and Noridian will add codes for both marasmus and severe protein-calorie malnutrition. The draft LCD already includes codes that specify degrees of renal disease below which one would not expect to see Vit. D abnormalities and no additional codes will be listed. The level of evidence for addition of codes for hepatic osteodystrophy, proximal myopathy, muscle strength, weight gain and obesity is C and does not support addition of the conditions to the LCD. Noridian will add a code for chronic non-alcoholic liver disease. The addition of any of the diagnoses listed here or other diagnoses depends on the submission of literature supporting the utility of Vit. D supplementation above the daily recommended levels of the Reference Dietary Intakes.

Comment: One commenter objected to the restrictions of once a year testing and one test per day.

Response: Noridian agrees and will remove the language from the LCD. Coverage for any test will be based solely on the documentation of medical necessity.

NAS Response to Provider Recommendation (for comment period ending 09/12/2011):

Comment: Two providers requested the addition of antiepileptic and glucocorticoid drug administration as an indication for Vitamin D testing.

Response: The indications will not be added. The level of evidence supporting the indication (either drug class) is C. The literature neither establishes an association between supra-normal Vit. D supplementation and any positive clinical outcome nor the consequent value of serum testing in these patients. The literature suggests that the development of osteoporosis in the setting of antiepileptic therapy is multifactorial and that supplementation with 1000 IU/day Vit. D may be useful. Similarly, routine supplementation with 400-800 IU Vit. D is recommended for those patients receiving glucocorticoids. (See Institute of Medicine (IOM), Dietary intake recommendations, 2011.) There is high-level evidence that administration of greater than usual doses of Vit. D in elderly women is harmful.

From the IOM Dietary intake Recommendations, 2011:

”Special Consideration

Medications. Glucocorticoids are well known for their anti-inflammatory properties. One of the most undesirable side effects of glucocorticoid therapy is severe osteopenia. One of the mechanisms by which glucocorticoids induce osteopenia is by inhibiting vitamin D-dependent intestinal calcium absorption (Lukert and Raisz, 1990). Therefore, patients on glucocorticoid therapy may require additional vitamin D in order to maintain their serum 25(OH)D levels in the mid-normal range (25 to 45 ng/ml [62.5 to 112.5 nmol/liter]).

Medications to control seizures, such as phenobarbital and dilantin, can alter the metabolism and the circulating half-life of vitamin D (Favus and Christakos, 1996). Holick (1995) recommended that patients on at least two antiseizure medications who are institutionalized, and therefore not obtaining most of their vitamin D requirement from exposure to sunlight, increase their vitamin D intake to approximately 25 µg (1,000 IU)/day to maintain their serum 25(OH)D levels within the mid-normal range of 25 to 45 ng/ml (62.5 to 112.5 nmol/liter). This should prevent the osteomalacia and vitamin D deficiency associated with antiseizure medications.”

Note: During the first comment period on this LCD (Noridian Part A draft), several providers argued against our inclusion of the indications requested above and submitted literature supporting their position. Noridian agreed and removed antiepileptic and glucocorticoid drug administration as indications from the LCD. Current review of the literature supports that position.

Comment: One commenter suggested that daily recommended doses for Vit D had increased, especially for those with osteoporosis. He requested coverage of at least quarterly Vit. D testing for monitoring of these patients’ Vit. D levels.

Response: Osteoporosis may be covered under the specific conditions outlined in the LCD. Recommendations for treatment are not addressed in this LCD. However, the LCD references cite routine supplementation for all adults over 50 with 400 – 1000IU daily. If there is reason to suspect an inadequate response to routine supplementation, it may be reasonable to obtain Vit. D level. Documentation must clearly identify the reason for the test and any testing frequency.

Printed on 10/16/2012. Page 9 of 10 This policy does not reflect the sole opinion of the contractor or the Contractor Medical Director(s). Although the final decision rests with the contractor, this policy was developed in cooperation with the Carrier Advisory Committee(s), which include representatives of various medical specialty societies.

This policy is subject to the reasonable and necessary guidelines and the limitation of liability provision.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 11/14/2011

Revision History Number R1

Revision History Explanation J3 CB2011.01 - Two comments and responses will be added to the final copy in the Advisory Committee Meeting Notes under "NAS Response to Provider Recommendation (for comment period ending 09/12/2011)."

09/22/2011 - this draft LCD is being released to final.

B2011.01 R1 02/01/2012-The”Contractors Determination Number” changed due to the consolidation of LCD for JF implementation. Idaho MAC B (Contract #02202) was added to this LCD.

02/27/2012: The following states and contractor numbers were added to the LCD: Alaska MAC B (Contract #02102); Oregon MAC B (Contract #02302); and Washington MAC B (Contract #02402).

Reason for Change Other

Related Documents This LCD has no Related Documents.

LCD Attachments There are no attachments for this LCD.

All Versions Updated on 03/24/2012 with effective dates 02/27/2012 - N/A Updated on 03/23/2012 with effective dates 02/01/2012 - 02/26/2012 Updated on 09/23/2011 with effective dates 11/14/2011 - 01/31/2012 Read the LCD Disclaimer opens in new window Back to Top

Printed on 10/16/2012. Page 10 of 10