Health Evidence Review Commission’s

Value-based Benefits Subcommittee

March 8, 2012

Meridian Park Hospital Community Health Education Center, Room 117B&C 19300 SW 65th Avenue, Tualatin, OR 97062

AGENDA VALUE-BASED BENEFITS SUBCOMMITTEE March 8, 2012 9:00am - 1:00pm Meridian Park Hospital Community Health Education Center, Room 117B&C 19300 SW 65th Avenue, Tualatin, OR 97062

A working lunch will be served at approximately 12:00 PM All times are approximate

I. Call to Order, Roll Call, Approval of Highlights – Lisa 9:00 AM Dodson

II. Staff report –Ariel Smits, Cat Livingston, Darren Coffman 9:10 AM

III. Straightforward - Ariel Smits 9:25 AM A. Straightforward table—February, 2012 B. Straightforward table—March, 2012 C. Laryngoplasty

IV. ICD 10 – Cat Livingston and Ariel Smits 9:45 AM A. Family medicine B. Nephrology C. Vascular surgery D. Gastroenterology E. Urology F. Allergy G. Heart transplant H. Pediatric surgery

V. Previous Discussion Items – Ariel Smits 11:15 AM a. Vascular bone grafts for avascular necrosis of the hip (pending surgeon availability) b. Continuous glucose monitoring c. Gender identity disorder

VI. New Discussion Items - Ariel Smits 12:00 PM a. HPV vaccination for males b. Lichen sclerosus c. Re-ranking the esophagitis line d. Tympanostomy tubes for chronic otitis media and hearing loss guideline

VII. Public Comment 12:55 PM

VIII. Adjournment – Lisa Dodson 1:00 PM

Section 1

Minutes

Value-based Benefits Subcommittee Recommendations Summary For Presentation to: Health Evidence Review Commission on February 9, 2012

For specific coding recommendations and guideline wording, please see the text of the 2/9/12 VbBS highlights.

CODE MOVEMENT . Coverage for botulinum toxin injection for blepharospasm and torticullis was added to a covered line with a coding specification. . The code for unspecified types of concussion was added to a covered line and left on an uncovered line, with coverage to be determined by residual symptoms being present

ITEMS CONSIDERED BUT NO CHANGES MADE . Coverage of vascularized bone grafting as a treatment for avascular necrosis of the hip was discussed and will be further discussed at a future meeting date dependent on the availability of hip surgeon(s) familiar with the procedure . Coverage for continuous glucose monitoring for diabetes was discussed and will be further addressed at the March, 2012 VBBS meeting

GUIDELINE CHANGES . None

CHANGES FOR THE OCTOBER 1, 2013 PRIORITIZED LIST AS PART OF THE ICD- 10 CONVERSION PROCESS . Specialty group recommendations review: Cardiothoracic Surgery, Neonatology, Pediatrics, Rheumatology . Multiple lines were renamed . Several lines were deleted . Several lines were merged . Guidelines were modified as shown in Appendix A . New line “Feeding Problems in the Newborn” was created and ranked at approximately line 21 . Line 447 SARCOIDISIS was rescored to about line 380 . Line 560 RAYNAUD’S was rescored to about line 525

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 1 MEETING HIGHLIGHTS

VALUE-BASED BENEFITS SUBCOMMITTEE Portland State Office Building February 9, 2012 9:00 AM – 1:00 PM

Members Present: Lisa Dodson, MD, chair; Kevin Olson, MD; James Tyack, DMD; Chris Kirk, MD; Mark Gibson; Irene Croswell RPh

Staff Present: Darren Coffman; Ariel Smits, MD, MPH; Cat Livingston, MD, MPH; Dorothy Allen; Dave Lenar

Also Attending: Wally Shaffer, MD and Denise Taray, DMAP; Ellen Pinney,OHA; Michael Adkins; Kristine Andrews; Ann Neilson, Amgen; Anne Marie Licos, William LaVia and Paul Nielsen, MedImmune; Jennifer Stoll, Allergan; Bill Struyk, Johnson and Johnson.

The meeting was called to order at 9:15 AM. Roll call was done. Introductions of subcommittee members followed. Smits reviewed the goals of the subcommittee, which include reviewing placement of procedures and diagnoses on the Prioritized List, review of new medical procedures (with the Health Technology Assessment Subcommittee), review of the ICD-10 conversion process for the Prioritized List, and discussion of value- based benefits packages based on the Prioritized List for potential use within the Exchange. A vote was then held for a chair and vice chair. Lisa Dodson, MD was elected unanimously as Chair and Kevin Olson, MD was elected unanimously as Vice Chair.

Smits gave a staff report, which included a discussion on what additional members, if any, the subcommittee felt would be appropriate. Suggestions included someone with expertise in addictions, complementary and alternative medicine, and health plan/insurance design. The full HERC will discuss the process for nominating and deciding on additional subcommittee membership.

Smits then brought up an outstanding issue for discussion. The Health Services Commission was asked to discuss coverage of hormone treatment for transgendered individuals. Currently, the diagnosis of gender identity disorder is on the same line as conditions such as pedophilia and bestiality. This diagnosis is inappropriate for such a placement. If this diagnosis is moved to a new line, then the question before the subcommittee will be what procedures and treatments should be included on this new line and where should it be ranked. HERC staff have been working with various advocacy groups in Oregon to develop this topic. However, these groups have not indicated that they are ready to bring testimony yet. If the subcommittee is to have time to adequately examine this issue and make changes which can be included as part of the biennial review for the October 1, 2013 Prioritized List, then the group needs to start discussing this topic. The decision was to place this item on the March, 2012 agenda, and notify the advocacy groups to allow them to participate if they desire.

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 2

Topic: Vascular bone grafts for avascular necrosis of the hip

Discussion: Smits reviewed a summary document outlining the use of vascularized bone grafting for the treatment of avascular necrosis (AVN) of the hip, the evidence of effectiveness for this treatment, and staff recommendations for coverage.

Testimony was heard from Mr. Michael Adkins, who also provided written materials for the subcommittee. He testified about his frustrations trying to obtain this procedure for his AVN. He argued that the procedure is effective, cost- effective, and should be covered for both early stage and late stage avascular necrosis of the hip.

Discussion started with the question about whether AVN progressed when not treated, or whether some patients treated with vascularized bone grafting may have not progressed in their disease due to the natural history of the disease. Livingston found a review in the Journal of Bone and Joint Surgery which found that the rate of progression is 59%.

Olson expressed that the presented literature constituted a low level of evidence. He explained how the Health Services Commission had added bone marrow transplant for the treatment of breast cancer based on similarly promising, but low level evidence. Once final data from randomized controlled studies was available it was shown that the treatment was of more harm than good and it was taken back off of the list. Olson stated that he would like an expert to come before the VBBS to give testimony and answer committee members’ questions. He would like specific information on which patients could best benefit from this type of surgery, and what qualifications should the surgeon have who performs this surgery (extra training, etc.).

The group expressed interest in having more information on the outcomes of this surgery in various patient groups. The group felt that a guideline may be needed if coverage of this condition is added, which would specify which patients are candidates, and any restrictions on provider type.

Actions: 1) HERC staff will find an orthopedic expert in the treatment of avascular necrosis of the hip to provide testimony and answer subcommittee questions regarding vascularized bone grafting as a treatment option. 2) HERC staff will place this topic on a future VBBS agenda, the date to be determined by expert availability 3) Staff and subcommittee members will review additional literature provided by Mr. Adkins prior to this future meeting

Topic: Botox for blepharospasm and dystonia

Discussion: Smits reviewed a summary document regarding the use of Botox for treatment of belpharospasm and dystonia. Submitted testimony from the manufacturer clarified which CPT codes are utilized for this treatment. Coffman pointed out that the proposed guideline should actually be a coding specification.

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 3

Action: 1) Add 64612-4 [Chemodenervation of muscle(s); extremity(s) and/or trunk muscle(s)] to line 388 DYSTONIA (UNCONTROLLABLE); LARYNGEAL SPASM AND STENOSIS 2) Add the following coding specification to line 388: a. Chemodenervation with botulinum toxin injection (CPT 64612-64614) is included on this line only for treatment of blepharospasm (ICD-9 333.81), spasmodic torticollis (ICD-9 333.83), and other fragments of torsion dystonia (ICD-9 333.89).

Topic: Continuous glucose monitoring in diabetes

Discussion: Smits introduced a summary document with suggested changes to the coverage of continuous glucose monitoring for patients with diabetes. Shaffer noted that DMAP currently has administrative rules that do not allow payment for the monitoring system. Therefore, despite having the procedure CPT code on the Prioritized List, there is currently no coverage for this type of monitoring through OHP.

There was discussion about which patients should be eligible for this type of therapy (type 2 diabetics who are insulin dependent or only type 1 diabetics), and what harms this therapy might have. Pollack raised a question about relative cost of standard monitoring vs continuous glucose monitoring. Staff indicated that standard monitoring costs $4-$10 a day based on usual cost for test strips, while continuous monitoring systems cost $1000-$1300 for the monitor and about $35 for a probe that is replaced every 3 days.

Gibson raised concern about whether this technology should be covered for 3 days as a diagnostic strategy, or covered long term. Smits indicated that other major insurers typically cover for 3 days only. Gibson also raised concerns about the proposed guideline not containing enough specifics. The group felt that the guideline needed more information about the type of diabetic eligible, the length of therapy, what constituted hypoglycemia and whether the hypoglycemia needed therapy by a second person to qualify, and whether the patient should have previously been shown to be compliant with traditional glucose testing. Gibson pointed out that the MED project has recently reviewed this topic and that this review should be considered by the Subcommittee. Shaffer noted that the MED review conclusion was that there was insufficient evidence for use in type 1 diabetes. The group also felt that national guidelines such as CMS guidelines should be sought.

The group decided to have HERC staff find additional information about this topic and bring back to the March, 2012 VBBS meeting

Action: 1) HERC staff will obtain the MED review on this topic, CMS guidelines, and any other additional high quality information 2) This topic will be readdressed at the March, 2012 VBBS meeting.

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 4

Topic: Concussion NOS

Discussion: Smits introduced a summary document with suggested changes to the placement of the ICD-9 code for concussion NOS. There was no discussion.

Actions: 1) Add 850.9 (Concussion, unspecified) to line 101 HEAD INJURY: HEMATOMA/EDEMA WITH PERSISTENT SYMPTOMS, COMPOUND/DEPRESSED FRACTURES OF SKULL 2) Keep 850.9 on line 641 HEAD INJURY: HEMATOMA/EDEMA WITH NO PERSISTENT SYMPTOMS

Topic: ICD-10 review--Cardiothoracic Surgery

Discussion: Livingston introduced a summary document with suggested changes to the cardiothoracic surgery lines on the Prioritized List based on ICD- 10 review. All recommendations were accepted except for a request to switch the Rheumatic Multiple Valvular Disease line with the Aortic Valvular Disease Line. There was a discussion about the process of ranking and that switching lines without adherence to the ranking methodology was not appropriate. A brief discussion occurred about combining separate valvular disease lines but the decision was made to keep them separate.

Actions: 1) DELETE Line 63 FLAIL CHEST. Codes go to open and closed rib fracture lines. 2) DELETE Line 309 PAPILLARY MUSCLE RUPTURE 3) Delete GUIDELINE NOTE 13, MINIMALLY INVASIVE CORONARY ARTERY BYPASS SURGERY 4) Modify GUIDELINE NOTE 18, VENTRICULAR ASSIST DEVICES as shown in Appendix A 5) Rename lines: a. Line 109 CARDIOMYOPATHY, HYPERTROPHIC MUSCLE b. Line 153 PNEUMOTHORAX AND HEMOTHORAX PLEURAL EFFUSION TUBE THORACOSTOMY/THORACOTOMY Treatment: SURGICAL THERAPY, MEDICAL THERAPY c. Line 192 RHEUMATIC MULTIPLE VALVULAR DISEASE d. Line 237 Treatment: AORTIC VALVE REPLACEMENT, VALVULOPLASTY, MEDICAL THERAPY MEDICAL AND SURGICAL THERAPY e. Line 307 Treatment: SURGICAL TREATMENT MEDICAL AND SURGICAL THERAPY f. Line 385 ANEURYSM DISEASES OF PULMONARY ARTERY

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 5

Topic: ICD-10 review--Neonatology

Discussion: Livingston introduced a summary document with suggested changes to the neonatology lines on the Prioritized List based on ICD-10 review. There was some discussion of ankyloglossia and the clarification that the diagnosis code for this condition is below the funded region, and so treatment of tongue tie would pair below the funded region. The comorbidity rule may be used if true feeding problems are present. All recommendations were accepted.

The new line: Feeding Problems in Newborn was ranked as follows: Category: 6 (not intrinsic, diagnosis made after delivery) Impact on healthy life years: 10 Impact on suffering: 5 Population effects: 0 Vulnerability of population affected: 2 Tertiary prevention: 5 Effectiveness: 5 Cost: 2 Score: 4400 Approximately Line: 21

Actions: 1) New line for Feeding Problems in the Newborn was created and ranked at approximately line 21 2) Lines 28 and 29 were merged; the new line was titled INTRACRANIAL HEMORRHAGES; CEREBRAL CONVULSIONS, DEPRESSION, COMA, AND OTHER ABNORMAL CERERAL SIGNS OF THE NEWBORN 3) A coding specification was added to Line 112 – “E80.4 is included on this line for neonates only.” 4) Guideline Note 48 was modified as shown in Appendix A. 5) Line 14 was renamed OTHER RESPIRATORY CONDITIONS OF FETUS AND NEWBORN 6) Line 674 was renamed EDEMA AND OTHER CONDITIONS INVOLVING THE INTEGUMENTSKIN OF THE FETUS AND NEWBORN

Topic: ICD-10 review--Pediatrics

Discussion: Smits introduced a summary document with suggested changes to the pediatric lines on the Prioritized List based on ICD-10 review. The major proposal was to move all viral pneumonias currently on line 644 to line 330. The group debated whether RSV pneumonia should be distinguished from other viral pneumonias. There was some concern whether patients with mild viral pneumonia should receive care, as other viral illnesses are not covered. The group felt that a viral infection severe enough to cause pneumonia should at least have office visit coverage.

Actions: 1) Rename line 330 PNEUMONIA DUE TO RESPIRATORY SYNCYTIAL VIRUS IN PERSONS UNDER AGE 3 VIRAL PNEUMONIA

Value-based Benefits Committee meeting Feb 9, 2012 Page 6

2) Move all ICD-10 codes for viral pneumonias from line 664 to line 330 3) Rename line 644 OTHER VIRAL INFECTIONS, EXCLUDING PNEUMONIA DUE TO RESPIRATORY SYNCYTIAL VIRUS IN PERSONS UNDER AGE 3

Topic: ICD-10 review--Rheumatology

Discussion: Livingston introduced a summary document with suggested changes to the rheumatology lines on the Prioritized List based on ICD-10 review. Recommendations made by the ICD 10 Rheumatology group were adopted with the additional following scoring decisions:

CALCIUM PYROPHOSPHATE DEPOSITION DISEASE (CPPD) AND HYDROXYAPETITE DEPOSITION DISEASE Category: 7 Impact on healthy life years: 3 Pain and suffering: 2 Population effects: 0 Tertiary prevention: 0 Vulnerable population: 0 Effectiveness: 3 Need for treatment: 50% Net cost: 3 Score: 150 Approximate Line: 525

PANNICULUTIS Category: 7 Impact on healthy life years: 1 Impact on pain and suffering: 2 Population effects: 0 Vulnerable population: 0 Tertiary prevention – can cause ulceration, treatment may be able to prevent ulceration: 1 Effectiveness of therapy - 25%: 2 Net cost: 3 Need for treatment: 75% Score: 120 Approximate Line: 545

SARCOIDOSIS Category: 6 Impact on healthy life years: 3 Impact on pain and suffering: 2 Population effects: 0 Vulnerable population: 1 Tertiary prevention: 3 Effectiveness of therapy: 4 Net cost: unchanged Need for treatment: 50% Score: 720 Approximate Line: 380

Value-based Benefits Committee meeting Feb 9, 2012 Page 7

RAYNAUDS Category: 7 Impact on healthy life years: 2 Impact on pain and suffering: 2 Population effects: 0 Vulnerable population: 0 Tertiary prevention: 1 Effectiveness of therapy: 3 Net cost: 4 Need for treatment: 50% Score: 150 Approximate Line: 525

Actions: 1) A new line was created: “CALCIUM PYROPHOSPHATE DEPOSITION DISEASE (CPPD) AND HYDROXYAPETITE DEPOSITION DISEASE” and ranked at approximately line 525 2) A new line was created “PANNICULITIS” and ranked at apprixmately line 545 3) Line 439 SICCA SYNDROME; POLYMYALGIA RHEUMATICA was deleted and all diagnoses moved to other lines 4) Line 357 was renamed SYSTEMIC SCLEROSIS; SJOGREN’S SYNDROME 5) Several lines were rescored as above 6) Line 447 SARCOIDISIS was rescored to about line 380 7) Line 560 RAYNAUD’S was rescored to about line 525 8) Line 140 was renamed WEGENER’S GRANULOMATOSIS GRANULOMATOSIS WITH POLYANGIITIS 9) Line 326 was renamed GOUT AND CRYSTAL ARTHROPATHIES 10) Line 117 was renamed GIANT CELL ARTERITIS, POLYMYALGIA RHEUMATICA, AND KAWASAKI DISEASE THROMBOANGIITIS OBLITERANS

Topic: ICD-10 Review—Family Medicine

Discussion: Tabled to the March, 2012 VBBS subcommittee meeting.

Topic: ICD-10 Review--Nephrology

Discussion: Tabled to the March, 2012 VBBS subcommittee meeting.

Topic: Straightforward Issues

Discussion: Tabled to the March, 2012 VBBS subcommittee meeting.

Topic: Larynoplasty

Discussion: Tabled to the March, 2012 VBBS subcommittee meeting.

Value-based Benefits Committee meeting Feb 9, 2012 Page 8

Public Comment

Public testimony was heard from Kristine Andrews regarding coverage of home births. She provided verbal and written testimony about her family’s experience with a birth center delivery that resulted in a poor outcome. She requested that the VBBS subcommittee consider limitations on home birth to low risk births as defined by the Dutch model, and to certain types of providers.

Written testimony was also received on the morning of the meeting from Dr. Stella Dantos. The subcommittee decided to hold off on hearing this testimony, and consider it in the context of a more indepth discussion of this topic.

The subcommittee decided to add this topic to a future agenda, to allow more time and consideration. HERC staff will research this topic, and place it on a future agenda.

Issues for next meeting:

1) Vascular bone grafts for avascular necrosis of the hip 2) Continuous glucose monitoring in diabetes 3) Ranking of esophagitis line 4) Tympanostomy tubes for chronic otitis media and hearing loss guideline 5) Creation and ranking of new line for gender identity disorder 6) ICD-10 review for Family Medicine, Nephrology, Vascular Surgery, and other categories

Next meeting:

March 8, 2012 at Meridian Park Hospital Rm 117B&C in Tualatin, OR

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 9

Attachment A Guideline Changes as Part of the ICD-10 Review Note: these take effect October 1, 2013

Guideline modifications

GUIDELINE NOTE 18, VENTRICULAR ASSIST DEVICES Lines 108,279 Ventricular assist devices are covered only in the following circumstances: 1. as a bridge to cardiac transplant; 2. as treatment for pulmonary hypertension when pulmonary hypertension is the only contraindication to cardiac transplant and the anticipated outcome is cardiac transplant; or, 3. as a bridge to recovery.

Ventricular assist devices are not covered for destination therapy. Ventricular assist devices are covered for cardiomyopathy only when the intention is bridge to cardiac transplant. Implantable VADs are covered for indications 1 and 2. Temporary or short term VADs are covered for indications 1 and 3.

GUIDELINE NOTE 48, FRENULECTOMY/FRENULOTOMY Line 373 Frenulectomy/frenulotomy (D7960) is included on this line for the following situations: 1. In the presence of ankyloglossia 2.1. When deemed to cause gingival recession 3. 2. When deemed to cause movement of the gingival margin when frenum is placed under tension. 4.3. Maxillary labial frenulectomy not covered until age 12 and above

Value-based Benefits Subcommittee minutes, Feb 9, 2012 Page 10

Section 3

Straightforward Items

Straightforward Issues—February, 2012

Straightforward Issues—February, 2012 Code Code Description Line(s) Involved Issue Recommendation(s) 33406 Replacement, aortic valve, with 237 DISEASES AND DMAP is requesting that 33406 Add 33406 to line 237 cardiopulmonary bypass; with DISORDERS OF AORTIC VALVE be added to line 237 to pair with allograft valve (freehand) 424.1 (aortic valve disorders). 33406 is currently on lines 76, 90, 116, 192, 195, 308, 354. 22305 Closed treatment of vertebral 507 CLOSED DMAP is requesting that 22305 Add 22305 and 22310 to process fracture(s) DISLOCATIONS/FRACTURES OF be added to line 507 to pair with line 507. 22310 Closed treatment of vertebral NON-CERVICAL VERTEBRAL 805.2 (Closed fracture of dorsal COLUMN WITHOUT SPINAL process fracture(s), without CORD INJURY [thoracic] vertebra without manipulation, requiring and mention of spinal cord injury) including casting or bracing and 805.4 (Closed fracture of lumbar vertebra without mention of spinal cord injury). 22305 and 22310 are currently on line 158 CERVICAL VERTEBRAL DISLOCATIONS/ FRACTURES, OPEN OR CLOSED; OTHER VERTEBRAL DISLOCATIONS/FRACTURES, OPEN; SPINAL CORD INJURIES WITH OR WITHOUT EVIDENCE OF VERTEBRAL INJURY. 63045 Laminectomy, facetectomy and 271 CHRONIC OSTEOMYELITIS DMAP is requesting that 63046 Add 63045-63048 to line foraminotomy (unilateral or be added to line 271 to pair with 271 bilateral with decompression of 730.28 (Unspecified spinal cord, cauda equina and/or osteomyelitis, other specified nerve root[s], [eg, spinal or lateral sites). 63046 is currently on recess stenosis]), single vertebral lines 84, 158, 400, 434, as are segment; cervical similar codes 63045,63047, and 63046 Thoracic 63048. 63047 Lumbar 63048 Each additional segment, cervical, thoracic, or lumbar

1 Straightforward Issues—February, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 27075 Radical resection of tumor; wing 208 CANCER OF BONES DMAP is requesting that 27075 Add 27075-27078 to line of ilium, 1 pubic or ischial ramus be added to line 208 to pair with 208. or symphysis pubis 170.6 (Malignant neoplasm of 27076 Radical resection of tumor; ilium, pelvic bones, sacrum, and including acetabulum, both pubic coccyx). 27075 is currently on rami, or ischium and acetabulum lines 207,243,271,549. Similar 27077 Radical resection of tumor; codes 27076-27078 are also innominate bone, total missing from line 208. 27078 Radical resection of tumor; ischial tuberosity and greater trochanter of femur

11620 Excision, malignant lesion 275 CANCER OF PENIS AND DMAP is requesting that 11620 Add 11620-11626 to including margins, scalp, neck, OTHER MALE GENITAL ORGANS be added to line 208 to pair with lines 275 and 311 hands, feet, genitalia; excised 311 CANCER OF VAGINA, 184.4 (Malignant neoplasm of diameter 0.5 cm or less VULVA AND OTHER FEMALE vulva, unspecified). 11620 and GENITAL ORGANS 11621 0.6 to 1.0 cm similar codes are currently on 11622 1.1 to 2.0 cm lines 243,257,292,622. 11623 is 11623 2.1 to 3.0 cm on lines 197,243,257,275, 292, 11624 3.1 to 4.0 cm 622. 11626 Over 4.0 cm

38542 Dissection, deep jugular node(s) 221 NON-HODGKIN'S DMAP is requesting that 38542 Delete 38542 from LYMPHOMAS be added to line 221 to pair with Diagnostic Procedure 200.71 (Large cell lymphoma, File lymph nodes of head, face, and neck). 38542 is currently on Add 38542 to line 221. lines 278,339,427,597,598 and the Diagnostic Procedure File.

2 Straightforward Issues—February, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 66020 Injection, anterior chamber of eye 413 CENTRAL SEROUS DMAP is requesting that 66020 Add 66020 to line 413 (separate procedure); air or liquid RETINOPATHY be added to line 413 to pair with 360.34 (Hypotony of eye; Flat anterior chamber). 66020 is currently on line 344. Per eMedicine, injection of air or viscoelastic is standard of care for treatment of this condition. 403.91 Hypertensive chronic kidney 66 END STAGE RENAL DMAP is requesting that 90961 Remove 403.91 from disease, unspecified, with chronic DISEASE (End-stage renal disease (ESRD) line 366 kidney disease stage V or end related services monthly, for stage renal disease patients 20 years of age and Add 403.91 to line 66 older; with 2-3 face-to-face physician visits per month) be Keep 403.91 on 110 added to line 366 to pair with 403.91. 90951-90970 (ESRD related services) are currently only on line 65. 403.91 is currently on line 366. HERC staff identified that 403.91 is more appropriate for line 65. Also on line 110 (renal transplant). 382.9 Unspecified otitis media 502 CHRONIC OTITIS MEDIA DMAP is requesting that 382.9 Add 382.9 to line 502 be added to line 502 (and kept on line 418, ACUTE OTITIS MEDIA) Keep 382.9 on line 418 to pair with 42830 (Adenoidectomy, primary; younger than age 12). 382.9 includes both “acute otitis media, NOS” and “chronic otitis media, NOS.”

3 Straightforward Issues—February, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 27884 Amputation, leg, through tibia and 308 COMPLICATIONS OF A DMAP Hearings Division Add 27884 and 27886 to fibula; secondary closure or scar PROCEDURE ALWAYS requested review of pairing line 448 revision REQUIRING TREATMENT 997.60 (Unspecified 448 COMPLICATIONS OF A 27886 Amputation, leg, through tibia and PROCEDURE USUALLY complication of amputation Add 27886 to line 308 fibula; re-amputation REQUIRING TREATMENT stump) with 27884. 27884 currently appears on lines 146,190,208,250,308,346. The 997.6x family of amputation stump complications only appear on line 448. On review, 27886 was found to be missing from both line 448 and line 308.

17340 Cryotherapy for acne 292 CANCER OF SKIN, Inappropriate CPT code noted Remove 17340 from lines EXCLUDING MALIGNANT during ICD-10 review of this 292, 524, 534, 618, 642, MELANOMA line. Further review finds this and 652 524 ECTROPION, TRICHIASIS OF EYELID, BENIGN code on a series of inappropriate NEOPLASM OF EYELID lines. This code will remain on CIRCUMSCRIBED 534 lines 530 TOXIC ERYTHEMA, ACNE SCLERODERMA ROSACEA, DISCOUID LUPUS 618 CORNS AND and 545 CYSTIC ACNE. CALLUSES 642 VIRAL WARTS EXCLUDING VENEREAL WARTS 652 SEBORRHEIC KERATOSIS, DYSCHROMIA, AND VASCULAR DISORDERS, SCAR CONDITIONS, AND FIBROSIS OF SKIN

4 Straightforward Issues—February, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 273.4 Alpha-1-antitrypsin deficiency 254 DEFICIENCIES OF HERC staff discovered that Remove 273.4 from line CIRCULATING ENZYMES 273.4 is currently located on line 479 (ALPHA 1-ANTITRYPSIN DEFICIENCY); CYSTIC 479. This code has previously FIBROSIS; EMPHYSEMA always been located on the lung Add 273.4 to lines 254 Treatment: HEART-LUNG AND LUNG TRANSPLANT and liver transplant lines. and 255 255 ACUTE AND SUBACUTE Medical therapy for this NECROSIS OF LIVER; condition would be coded SPECIFIED INBORN ERRORS OF METABOLISM (EG. MAPLE COPD or cirrhosis. There was SYRUP URINE DISEASE, no reason found for the current TYROSINEMIA) Treatment: LIVER TRANSPLANT placement of this code, although 479 DISORDERS OF PLASMA it may have resulted from a new PROTEIN METABOLISM ICD-9 code assigned to this condition.

77301 Intensity modulated radiotherapy 197 CANCER OF BREAST DMAP is requesting that 77301 Add 77301 to line 197 plan, including dose-volume be added to line 197 to pair with histograms for target and critical 174.2 (Malignant neoplasm of structure partial tolerance female breast upper-inner specifications quadrant). 77301 currently appears on lines 102,124,136, 137,140,144,162,166,165,207 and 17 other lines. 197 has all other radiation therapy codes.

5 Straightforward Issues—February, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 626.8 Disorders of menstruation and 446 MENSTRUAL BLEEDING DMAP requested that 626.8 be Add 626.9 to line 446 other abnormal bleeding from DISORDERS removed from its current line, female genital tract 403 IMPERFORATE HYMEN; ABNORMALITIES OF VAGINAL SEPTUM, and added to line 446. However, 626.8 includes “retained menstruation” as a subdiagnosis; therefore it is appropriate to keep on line 403. Other subdiagnoses include “dysfunctional or functional uterine hemorrhage NOS,” which is appropriate for line 446.

6 Straightforward Issues—March, 2012

Straightforward Issues—March, 2012 Code Code Description Line(s) Involved Issue Recommendation(s) 60521 Thymectomy, partial or total; 276 CANCER OF Dr. Kirk (OHP Medical Add 60521 and 60522 to sternal split or transthoracic ENDOCRINE SYSTEM, Director) requested that lines 276 and 402 EXCLUDING THYROID; approach, without radical CARCINOID SYNDROME thymectomy codes be paired mediastinal dissection line 402 BENIGN NEOPLASM with the benign and malignant 60522 Thymectomy, partial or total; OF RESPIRATORY AND neoplasm of thymus diagnoses. sternal split or transthoracic INTRATHORACIC ORGANS Currently 164.0 (Malignant approach, with radical mediastinal neoplasm of thymus) appears on dissection line 276 and 212.6 Benign neoplasm of thymus) appears on line 402. 60521 and 60522 currently only appear on line 150 MYASTHENIA GRAVIS. One thymectomy code (60520) appears on all three lines.

20605 Arthrocentesis, aspiration and/or 378 ATHEROSCLEROSIS, HERC staff found this Delete 20605 from line injection; intermediate joint or PERIPHERAL inappropriate CPT code on line 378 bursa (eg, temporomandibular, 378 during ICD-10 materials acromioclavicular, wrist, elbow or review. ankle, olecranon bursa)

29305 Application of hip spica cast; 1 leg 336 CONGENITAL DMAP is requesting that 29305 Add 29305 and 29325 to 29325 Application of hip spica cast; 1 DISLOCATION OF HIP; and 29325 be added to line 336 line 336 and one-half spica or both legs COXA VARA AND VALGA to pair with 754.30 (Congenital dislocation of hip, unilateral). Currently these CPT codes both appear on lines 89, 143, 189, 297, 382. Casting is a standard treatment for this condition.

1 Straightforward Issues—March, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 31603 Tracheostomy, emergency 14 OTHER RESPIRATORY DMAP is requesting that 31603 Add 31603 to line 14 procedure; transtracheal CONDITIONS OF FETUS be added to line 14 to pair with AND NEWBORN 769 (Respiratory distress syndrome in newborn). 31603 is currently on multiple lines. 44125 Enterectomy, resection of small 84 DEEP ABSCESSES, DMAP is requesting that 44125 Add 44125 to line 84 intestine; with enterostomy INCLUDING APPENDICITIS be added to line 84 to pair with AND PERIORBITAL ABSCESS; INTESTINAL 777.6 (Perinatal intestinal PERFORATION perforation). 44125 is currently on lines 48,97,111,163,229. Other enterectomy codes are on line 84 (44120, 44121). 43249 Upper gastrointestinal endoscopy 71 CONGENITAL DMAP is requesting that 43249 Add 43249 to lines 71 including esophagus, stomach, and ANOMALIES OF UPPER be added to line 71 to pair with and 126 ALIMENTARY TRACT, either the duodenum and/or EXCLUDING TONGUE 750.3 (Tracheoesophageal jejunum as appropriate; with 126 FOREIGN BODY IN fistula, esophageal atresia and balloon dilation of esophagus PHARYNX, LARYNX, stenosis) and to line 126 to pair TRACHEA, BRONCHUS with 935.1 (Foreign body in AND ESOPHAGUS esophagus). 43249 is currently on lines 229, 339, 409, 421, 423, 622, 667. Most upper endoscopy codes on located on line 71. Currently, only 43247 (EGD with removal of foreign body) is on line 126. 50546 Laparoscopy, surgical; 54 CONGENITAL DMAP is requesting that 50546 Add 50546 to line 54 nephrectomy, including partial HYDRONEPHROSIS be added to line 54 to pair with ureterectomy 753.21 (Congenital obstruction of ureteropelvic junction). Currently, 50546 is located on lines 54,84,96,228,287,538.

2 Straightforward Issues—March, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 50650 Ureterectomy, with bladder cuff 96 CONGENITAL DMAP is requesting that 50650 Add 50650 to line 96 ANOMALIES OF URINARY be added to line 96 to pair with SYSTEM 753.4 (Other specified anomalies of ureter). 50650 is currently on lines 228,287,323.

28150 Phalangectomy, toe, each toe 250 PERIPHERAL DMAP is requesting that 28150 Add 29150 to line 250 VASCULAR DISEASE, LIMB be added to line 250 to pair with THREATENING INFECTIONS, AND 785.4 (Gangrene) and to line Do not add 29150 to line VASCULAR 410 to pair with 707.15 (Ulcer 410 COMPLICATIONS of other part of foot). 28150 is 410 CHRONIC ULCER OF currently on lines 297,565. SKIN Other foot amputation codes are on line 250. No foot amputation codes are located on line 410.

77301 Intensity modulated radiotherapy 275 CANCER OF PENIS DMAP is requesting that 77301 Add 77301 and 77470 to plan, including dose-volume AND OTHER MALE and 77470 be added to line 275 line 275 histograms for target and critical GENITAL ORGANS to pair with 187.4 (Malignant structure partial tolerance neoplasm of penis, part specifications unspecified). Line 275 includes 77470 Special treatment procedure (eg, radiation therapy. 77301 and total body irradiation, hemibody 77470 are on multiple lines. radiation, per oral, endocavitary or intraoperative cone irradiation)

3 Straightforward Issues—March, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 44799 Unlisted procedure, intestine 111 CONGENITAL DMAP is requesting that 44799 Remove 44799 from line ANOMALIES OF DIGESTIVE pair with 569.62 (Mechanical 111 SYSTEM AND ABDOMINAL WALL EXCLUDING complication of colostomy and NECROSIS; CHRONIC enterostomy). 569.62 is on line Advise DMAP to add INTESTINAL PSEUDO- 448 COMPLICATIONS OF A 44799 to Ancillary List. OBSTRUCTION PROCEDURE USUALLY REQUIRING TREATMENT. 44799 is currently on line 111. Per DMAP, documentation with this case indicated that the procedure was done for changing a j-tube due to leaking. DMAP is requesting that this code be added to the Ancillary List, which allows manual review which is where such unlisted procedures normally are placed.

37609 Ligation or biopsy, temporal artery 117 GIANT CELL From Dr. Kirk: “446.5 Temporal Add 37609 to line 117. ARTERITIS, KAWASAKI Arteritis does not pair with DISEASE, THROMBOANGIITIS 37609 Biopsy of Temporal Remove 37609 from the OBLITERANS Arteritis.” 37609 is currently on Diagnostic Procedures the Diagnostic Procedures List, List. and lines 346 OTHER ANEURYSM OF PERIPHERAL ARTERY, 378 ATHEROSCLEROSIS, PERIPHERAL. 446.5 (Giant cell arteritis, including temporal arteritis) is currently on line 117.

4 Straightforward Issues—March, 2012

Code Code Description Line(s) Involved Issue Recommendation(s) 33211 Insertion or replacement of 308 COMPLICATIONS DMAP is requesting that 33212, Add 33211-33212, temporary transvenous dual OF A PROCEDURE 33214-33215 be added to line 33214-33215, 33218- chamber pacing electrodes ALWAYS REQUIRING 308 to pair with 996.01 33219 to line 308 TREATMENT 33212 Insertion of pacemaker pulse [Mechanical complication due to generator only; with existing cardiac pacemaker (electrode)]. single lead HERC staff identified 33211, 33214 Upgrade of implanted pacemaker 33218 and 33219 as also system, conversion of single missing from this line and chamber system to dual chamber appropriate for inclusion. 33206- system (includes removal of 33210 and 33213 are currently previously placed pulse generator, on line 308. testing of existing lead, insertion of new lead, insertion of new pulse generator) 33215 Repositioning of previously implanted transvenous pacemaker or pacing cardioverter-defibrillator (right atrial or right ventricular) electrode 33218 Repair of single transvenous electrode, permanent pacemaker or pacing cardioverter-defibrillator 33219 Repair of single transvenous electrode, permanent pacemaker or pacing cardioverter-defibrillator

5 Laryngoplasty

Question: where on the Prioritized List should various ICD-9 codes for laryngeal problems and CPT codes for laryngoplasty procedures be located?

Question source: DMAP

Issue: DMAP requested a review of whether 31588 Laryngoplasty, not otherwise specified (eg, for burns, reconstruction after partial laryngectomy) should pair with 748.3 Other anomalies of larynx, trachea, and bronchus. As HERC staff reviewed this question, the placement of various laryngeal diagnoses and laryngoplasty procedures was found to not be appropriate.

Current List placement: 478.5 (Abscess or cellulitis of vocal cords) is on line 214 SUPERFICIAL ABSCESSES AND CELLULITIS 478.71 (Cellulitis of larynx) is on line 214 SUPERFICIAL ABSCESSES AND CELLULITIS 478.74 (Stenosis of larynx) is on line 388 DYSTONIA (UNCONTROLLABLE); LARYNGEAL SPASM AND STENOSIS 478.79 (Other diseases of larynx, which includes abscess, necrosis, and obstruction of larynx) is on line 214 SUPERFICIAL ABSCESSES AND CELLULITIS 748.2 (Web of larynx) is currently on line 14 OTHER RESPIRATORY CONDITIONS OF FETUS AND NEWBORN. 748.3 (Other anomalies of larynx, trachea, and bronchus [includes agenesis of larynx, atresia of larynx, congenital stenosis of larynx]) is currently on line 49 CONGENITAL AIRWAY OBSTRUCTION WITH OR WITHOUT CLEFT PALATE. Note: this is the name of this line on the April 1, 2012 list, which differs from the name appearing on the January 1, 2012 list [CLEFT PALATE WITH AIRWAY OBSTRUCTION]

31580 (Laryngoplasty, for laryngeal web) is on 214 SUPERFICIAL ABSCESSES AND CELLULITIS 31582 (Laryngoplasty, for laryngeal stenosis) is on 388 DYSTONIA (UNCONTROLLABLE); LARYNGEAL SPASM AND STENOSIS and 543 PARALYSIS OF VOCAL CORDS OR LARYNX 31584 (Laryngoplasty, with open reduction of fracture) is on line 91 DEEP OPEN WOUND OF NECK, INCLUDING LARYNX; FRACTURE OF LARYNX OR TRACHEA, OPEN 31587 (Laryngoplasty, cricoid split) is on 214 SUPERFICIAL ABSCESSES AND CELLULITIS 31588 (Laryngoplasty, NOS [eg for burns, reconstruction after partial laryngectomy]) is on 214 SUPERFICIAL ABSCESSES AND CELLULITIS

Recommendations: 1) Add 31580 to line 14 to pair with 748.2 a. Remove 31580 from line 214 2) Add 31582, 31587, and 31588 to line 49 to pair with 748.3

Section 4

ICD-10-CM Overview of Recommendations for Converting Lines to ICD-10-CM Family Medicine

Specialty consultants: Dr. Brett White; Dr. Safina Koreishi

CREATE NEW LINES None

COMBINE MULTIPLE LINES None

DELETE LINES None

RESCORE LINES None

GUIDELINES None

RENAME LINES None

CODE PLACEMENT FOR DISCUSSION None

Page 1 Overview of Recommendations for Converting Lines to ICD-10-CM Nephrology

Specialty consultants: Dr. Richard Parker

CREATE NEW LINES None

COMBINE MULTIPLE LINES None

DELETE LINES 352 ACUTE GLOMERULONEPHRITIS AND OTHER ACUTE RENAL FAILURE, move all acute kidney injury codes to line 138 as renamed below and all chronic kidney disease codes to line 366 as renamed below. [Note: when lines 138 and 352 were proposed for merging, the new line scored out to place at 138]

RESCORE LINES None

GUIDELINES None

RENAME LINES Line 138 ACUTE GLOMERULONEPHRITIS: WITH LESION OF RAPIDLY PROGRESSIVE GLOMERULONEPHRITIS ACUTE KIDNEY INJURY Line 366 NEPHROTIC SYNDROME AND OTHER RENAL DISORDERS CHRONIC KIDNEY DISEASE

CODE PLACEMENT Move all codes that do not specify end stage renal disease from line 66 to line 366 and rename line 366 as above

Page 1 Overview of Recommendations for Converting Lines to ICD-10-CM Vascular Surgery

Specialty consultants: Eric Kirker, MD

CREATE NEW LINES: None

COMBINE MULTIPLE LINES None

DELETE LINES Delete 350 ARTERIAL ANEURYSM OF NECK 1) All ICD-10 codes on line 350 also appear on line 349 NON-DISSECTING ANEURYSM WITHOUT RUPTURE and will remain there. 2) Move all CPT codes from 350 to 349.

RESCORE LINES None

GUIDELINES None

RENAME LINES 1) Rename 250 PERIPHERAL VASCULAR DISEASE, LIMB THREATENING LIMB THREATENING VASCULAR DISEASE, INFECTIONS, AND VASCULAR COMPLICATIONS 2) Rename 378 ATHEROSCLEROSIS, PERIPHERAL NON-LIMB THREATENING PERIPHERAL VASCULAR DISEASE

CODE PLACEMENT 1) Place all peripheral vascular disease diagnoses with rest pain, ulcer, gangrene or other limb threatening conditions on upper vascular disease line (line 250) a. Currently, some diagnoses appear on line 378 b. Place all interventions (amputation, endarterectomy, revascularization, etc.) on upper line. i. Add to line 250: 34101-34203 (embolectomy), 35081 (repair of aneurysm), 35256 (repair of blood vessel with vein graft, lower extremity), 35450-35476 (balloon angioplasty), 35510-35671 (bypass graft), 35685, 35686, 35701-35761 (exploration of artery), 35879, 35881,36002, 37184-37186 (thrombectomy), 37201-37209 (stenting), 37220-37235 (revascularlization) c. Currently only amputations and limited endarterectomy CPT codes on 250 2) Place all non-limb threatening vascular disease diagnoses on lower vascular disease line (line 378) a. Place all interventions except amputation (endarterectomy, revascularization, etc.) on lower line i. Add to line 378: 24900-24931 (amputation, arm), 24935, 24940, 25900- 25909 (amputation, forearm), 25915, 25920-25931 (hand amputation),

Page 1 Overview of Recommendations for Converting Lines to ICD-10-CM 26910, 26951-2, 27025, 27290, 27295, 27590-27598 (amputation, thigh), 27880-27889 (amputation, leg), 28800-28825 (amputation, foot) b. Currently does not have amputation CPT codes 3) Remove all non-major blood vessels (vessels of the foot) from line 86 INJURY TO MAJOR BLOOD VESSELS OF EXTREMITIES as these vessels only require suture/ligation, not repair. Add these ICD-9 codes to line 216 DEEP OPEN WOUND, WITH OR WITHOUT TENDON OR NERVE INVOLVEMENT a. S95.001A-S95.999A (laceration, specified or unspecified injury of the dorsal artery, plantar artery, dorsal vein, other specified artery of the ankle or foot, or unspecified artery of ankle or foot). Podiatry has reviewed this recommendation and concurs b. Do not move vessels of the hand and finger, per hand surgery input

Page 2 Overview of Recommendations for Converting Lines to ICD-10-CM

Gastroenterology

Specialty consultants: Dr. James Regan

CREATE NEW LINES None

COMBINE MULTIPLE LINES Merge line 224 ESOPHAGEAL VARICES with line 62 ULCERS, GASTRITIS, DUODENITIS, AND GI HEMORRHAGE 1) Add all CPT codes on line 224 that do not appear on line 62 to line 62 2) Esophageal varices are a common cause of GI hemorrhage and should not be treated differently 3) There are only 4 ICD-10 diagnoses on line 224 (all esophageal varices diagnoses)

DELETE LINES None

RESCORE LINES None

GUIDELINES No changes

RENAME LINES Rename line 163, ACUTE VASCULAR INSUFFICIENCY OF INTESTINE 1) Move several diagnoses from line 35 dealing with intestinal vascular insufficiency to line 163 (K55.1-.9)

CODE PLACEMENT 1) Move I84.6 (Gastric varices) from Excluded List to line 62 ULCERS, GASTRITIS, DUODENITIS, AND GI HEMORRHAGE 2) Move K57.11, K57.31, K57.51, K57.91 (Diverticulosis of small and/or large intestine with bleeding) to line 62 ULCERS, GASTRITIS, DUODENITIS, AND GI HEMORRHAGE from line 191 DIVERTICULITIS OF COLON 3) Move Z80.0 (Family history of malignant neoplasm of digestive organs) from the Excluded File to line 173 ANAL, RECTAL AND COLONIC POLYPS to allow for additional screening procedures, etc.

Page 1 Urology ICD-10 Recommendations

Specialty consultants: Dr. Douglas Ackerman; Dr. John Barry; Dr. MJ Kaempf

CREATE NEW LINES None

COMBINE MULTIPLE LINES None

DELETE LINES 1) Delete line 294 RUPTURE OF BLADDER, NONTRAUMATIC and place only ICD-10 code (N32.89 Other specified disorders of bladder) on line 690 GENITOURINARY CONDITIONS WITH NO OR MINIMALLY EFFECTIVE TREATMENTS OR NO TREATMENT NECESSARY. Move all CPT codes from line 294 to line 690. 2) Delete line 353 VESICULAR FISTULA and move the 2 ICD-10 codes (N32.1 Vesicointestinal fistula and N32.2 Vesical fistula, not elsewhere classified) to line 245 URINARY FISTULA. Move all CPT codes from line 353 to line 245.

RESCORE LINES 1) Line 538 Condition: BENIGN NEOPLASM OF KIDNEY AND OTHER URINARY ORGANS Treatment: MEDICAL AND SURGICAL TREATMENT a. recommend moving line close to 228 (kidney cancer) b. scoring puts this line around 570 c. Add the following guideline:

GUIDELINE NOTE XXX TREATMENT OF BENIGN NEOPLASM OF URINARY ORGANS Line 538 Treatment of benign urinary system tumors is covered with evidence of bleeding or urinary obstruction. Treatment of 1) oncocytoma which is >5 cm in size or symptomatic and 2) angiomyolipoma (AML) which is >5cm in women of child bearing age or in symptomatic men or women is covered.

2) Line 570: Condition: SUBLINGUAL, SCROTAL, AND PELVIC VARICES Treatment: VENOUS INJECTION, VASCULAR SURGERY a. Recommend: swap with 579 CHRONIC PROSTATITIS, OTHER DISORDERS OF PROSTATE

GUIDELINES GUIDELINE NOTE XXX OBSTRUCTIVE AND REFLEX UROPATHY Line 30 ICD-10 N13.9 (Obstructive and reflux uropathy unspecified) appears on this line for pediatric populations only

RENAME LINES 1) Change treatment description of line 30 to VESICOURETERAL REFLUX Treatment: MEDICAL THERAPY, REIMPLANTATION SURGERY

2) Line 96 CONGENITAL ANOMALIES OF GENITOURINARY SYSTEM

Page 1 Urology ICD-10 Recommendations

CODE PLACEMENT 1) Line 96 CONGENITAL ANOMALIES OF GENITOURINARY SYSTEM: many diagnoses moved to line 690 GENITOURINARY CONDITIONS WITH NO OR MINIMALLY EFFECTIVE TREATMENTS OR NO TREATMENT NECESSARY, as there is no therapy available. These diagnoses include many congenital anomalies such as absence, aplasia, or hypoplasia of genitourinary organs 2) N43.3 (Hydrocele, unspecified) appears on line 567 HYDROCELE; should also appear on line 175 COMPLICATED HERNIAS (OTHER THAN DIAPHRAGMATIC HERNIA); UNCOMPLICATED INGUINAL HERNIA IN CHILDREN AGE 18 AND UNDER; PERSISTENT HYDROCELE for children only. See guideline already applied to line 175 below. a. GUIDELINE NOTE 63, HYDROCELE REPAIR Line 175 Excision of hydrocele is only covered for children with hydroceles which persist after 18 months of age.

Page 2 Allergy Recommendations for Converting Lines to ICD-10-CM

Specialty consultants: Joe Hassett, Kevin Parks

CONCEPTUAL ISSUES Argument that allergy involves secondary prevention. If a child has atopic dermatitis, and identify allergic components, then can prevent development worsening symptoms or disease complications. Secondary prevention versus diagnostic element.

CREATE NEW LINES

1) Hereditary angioedema - Currently hereditary angioedema and angioedema are on the same line 343. Hereditary angioedema is much more serious than angioneurotic edema and having them on the same line does not make sense. Angioneurotic edema is similar to urticaria and should be prioritized similarly. Hereditary angioedema can be life threatening.

D84.1 Defects in the complement system, should be removed from all other lines Code Line Condition Treatment D84.1 67 METABOLIC DISORDERS INCLUDING MEDICAL HYPERLIPIDEMIA THERAPY D84.1 254 DEFICIENCIES OF CIRCULATING ENZYMES HEART-LUNG (ALPHA 1-ANTITRYPSIN DEFICIENCY); CYSTIC AND LUNG FIBROSIS; EMPHYSEMA TRANSPLANT D84.1 255 ACUTE AND SUBACUTE NECROSIS OF LIVER; LIVER SPECIFIED INBORN ERRORS OF METABOLISM TRANSPLANT (EG. MAPLE SYRUP URINE DISEASE, TYROSINEMIA) D84.1 338 DISORDERS INVOLVING THE IMMUNE SYSTEM MEDICAL THERAPY D84.1 343 HEREDITARY ANGIOEDEMA; ANGIONEUROTIC MEDICAL EDEMA THERAPY

a. Ranking recommendations for hereditary angioedema Category 6 Impact on healthy life years – puberty, 10-20% death rate Vulnerable populations 0 Population effects 0 Impact on healthy life years 8 Impact on pain/suffering 3 – comorbidity of depression, 40% including children have depression Tertiary prevention – 0 no disease modifying approach at present

Page 1 Allergy Recommendations for Converting Lines to ICD-10-CM Effectiveness of treatment – 4, especially for biologics. Data is pretty good for benefit I 75% or above. Androgens cause a lot of side effects (<25%, only men) Need for medical service 1 Net cost 1 (biologics can be >100,000 easily and will skew results) Score is 1760 which is Line 166

b. Angioedema – large spectrum in severity Category 7 Impact on healthy life years 3 Vulnerable populations 0 Population effects 0 Impact on pain/suffering 1 Tertiary prevention 0 Effectiveness of treatment 4 Need for medical service 1 20% moderate, 2% severe 50% need for medical service Net cost 4 – office visit, otc meds +/- prednisone Score 160, Line 520

2. Allergic bronchopulmonary aspergillosis – this is an allergic issue, not an opportunistic infection issue. Can prevent bronchiectasis if treated, long term prednisone. B44.81 Allergic 354 COCCIDIOIDOMYCOSIS, HISTOPLASMOSIS, bronchopulmonary BLASTOMYCOTIC INFECTION, OPPORTUNISTIC aspergillosis AND OTHER MYCOSES

Category 7 Impact on healthy life years 4 Pain and suffering 2 Vulnerable 0 Contagion 0 Tertiary prevention 2 Effectiveness of treatment 4 Need for service 1 Net cost 3 Score 640, Line 390 Feels like it should be higher than hyphema, acute sinusitis. This requires hours of diagnostic and therapeutic effort.

RESCORE LINES

a. Line 594 DERMATITIS DUE TO SUBSTANCES TAKEN INTERNALLY – if progresses in severity, could be life threatening. Argument, that cannot see people referred at point in care where options are much more limited. Costs go up dramatically because of delayed care. People are going to be overlooked.

Page 2 Allergy Recommendations for Converting Lines to ICD-10-CM . Some codes may be more appropriate on line 225 TOXIC EPIDERMAL NECROLYSIS AND STAPHYLOCOCCAL SCALDED SKIN SYNDROME; STEVENS-JOHNSON SYNDROME; ERYTHEMA MULTIFORME MAJOR; ECZEMA HERPETICUM

GUIDELINES

No changes

RENAME LINES

None

CODE PLACEMENT

L27.0 Generalized skin eruption due to drugs and medicaments taken internally recommended to be moved from unfunded line 594 DERMATITIS DUE TO SUBSTANCES TAKEN INTERNALLY to a funded line 448 COMPLICATIONS OF A PROCEDURE USUALLY REQUIRING TREATMENT Rational: this can be life threatening

Z01.82 Encounter for allergy DMAP Ancillary Codes Exclude – although uncomfortable with this, shouldn’t family testing File history be adequate?

Page 3 Cardiac Transplant ICD 10 Recommendations

Cardiac Transplant Recommendations for ICD 10 Conversion

Specialty consultants: Dr. Howard Song, Cardiac Transplant

GUIDELINES

1) There is currently an issue with combined heart lung kidney transplants. Often in the gray area (renal dysfunction that is not quite failure), UNOS has GFR <45 ml/min is a contraindication to a heart transplant. Multiple sites around country are interested in the gray area, there is not yet data to demonstrate outcomes for combined heart/kidney outside of UNOS recommendations.

 Make no change to guideline GUIDELINE NOTE 70, HEART-KIDNEY TRANSPLANTS Line 279 Patients under consideration for heart/kidney transplant must qualify for each individual type of transplant under current DMAP administrative rules and transplant center criteria with the exception of any exclusions due to heart and/or kidney disease

2) Add coding specification to line 279: Heart-kidney transplant is only covered when there is Stage V or VI renal disease and there is a qualifying cardiac indication.

RENAME LINES 279 CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, TRANSPOSITION OF GREAT VESSELS, HYPOPLASTIC LEFT HEART SYNDROME

To CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, MALIGNANT ARRHYTHMIAS, AND COMPLEX CONGENITAL HEART DISEASE TRANSPOSITION OF GREAT VESSELS, HYPOPLASTIC LEFT HEART SYNDROME

CODE PLACEMENT Lines 254, 256 and 279 The common final pathway that indicates need for heart transplant is CHF, malignant arrhythmia, intractable angina or myocarditis. Every other condition penultimate causative disease, and therefore does not need to be on the transplant line. These penultimate disease codes were removed from this line. Example: I27.89 Other specified pulmonary heart diseases = Eisenmenger’s syndrome Currently on line 108 Heart Failure add to to Line 256 RESPIRATORY FAILURE DUE TO PRIMARY PULMONARY

Page 1 Cardiac Transplant ICD 10 Recommendations

HYPERTENSION, PRIMARY PULMONARY FIBROSIS, LYMPHANGIOLEIOMYOMATOSIS, EISENMENGER'S DISEASE Delete other cardiac defects, as would not transplant unless have Eisenmenger’s syndrome

Remove the following codes from 256: Q20.0 Common arterial trunk 139,256 Q21.0 Ventricular septal defect 74,256 Q21.1 Atrial septal defect 129,256 Q25.0 Patent ductus arteriosus 85,256(D) Q26.2 Total anomalous pulmonary venous connection 141,256(A)

Add to line 279 – malignant arrhythmias can be indication for transplant I47.2 Ventricular tachycardia I49.01 Ventricular fibrillation I49.02 Ventricular flutter

Add Stage 5 and Stage 6 kidney disease to line 279. Code Description N18.5 Chronic kidney disease, stage 5 N18.6 End stage renal disease

Page 2 Lines attached to Issue: 262 Organ Transplants - Heart and Lung

Line Condition Treatment

254 DEFICIENCIES OF CIRCULATING ENZYMES (ALPHA 1- HEART-LUNG AND LUNG TRANSPLANT ANTITRYPSIN DEFICIENCY); CYSTIC FIBROSIS; EMPHYSEMA

256 RESPIRATORY FAILURE DUE TO PRIMARY HEART-LUNG AND LUNG TRANSPLANTS PULMONARY HYPERTENSION, PRIMARY PULMONARY FIBROSIS, LYMPHANGIOLEIOMYOMATOSIS, EISENMENGER'S DISEASE

279 CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, CARDIAC TRANSPLANT; HEART/KIDNEY TRANSPLANT TRANSPOSITION OF GREAT VESSELS, HYPOPLASTIC LEFT HEART SYNDROME

Wednesday, January 25, 2012 Page 1 of 1 Overview of Recommendations for Converting Lines to ICD-10-CM Pediatric Surgery

Specialty consultants: Barry Newman, MD

CREATE NEW LINES 1) Line XXX FOREIGN BODY IN GASTROINTESTINAL TRACT Treatment: Medical therapy ICD-10: T18.2xxA, T18.3xxA, T18.4xxA, T18.5xxA, T18.8xxA, T18.9xxA CPT: 43247, 44363, 44383, 44390, 45307, 45332, 45378, 45379, 45915, 46608, 98966- 98969, 99051, 99060, 99070, 99078, 99201-99217, 99241-99245, 99341-99366, 99441- 99444

ICD-10 codes from this line are to be separated out from line 48 CONGENITAL ANOMALIES OF DIGESTIVE SYSTEM AND ABDOMINAL WALL EXCLUDING NECROSIS; CHRONIC INTESTINAL PSEUDO-OBSTRUCTION. These codes all represent foreign bodies in various parts of the GI tract. Many of the conditions to be moved don’t need any treatment, or need endoscopy only. Many are just observed to ensure passage. These conditions are normally not life threatening (unlike obstruction). If obstructed, can use obstruction code (or other complications can be coded as that complication).

CPT codes: 43247 (upper endoscopy with foreign body removal), 44363 (small intestinal endoscopy with foreign body removal), 44383 (ileoscopy through stoma), 44390 (colonoscopy with removal of foreign body), 45307 (proctosigmoidoscopy, rigid, with removal of foreign body), 45332 (Sigmoidoscopy, flexible, with removal of foreign body), 45378 (colonscopy, diagnostic), 45379 (colonoscopy, with removal of foreign body), 45915 (removal of fecal impaction or foreign body, under anesthesia), 46608 (anoscopy, with removal of foreign body), 98966-98969, 99051, 99060, 99070, 99078, 99201-99217, 99241-99245, 99341-99366, 99441-99444 (medical visit codes, ER codes)

Ranking recommendations for Foreign Body in GI Tract Category 7 Impact on healthy life years – 4 Vulnerable populations 0 Population effects 0 Impact on healthy life years 5 Impact on pain/suffering 1 Tertiary prevention – 0 Effectiveness of treatment – 5 Need for medical service 0.2 Net cost 3 Score is 240 which is in the low 400’s

2) Line XXX Condition: OTHER CONGENITAL ANOMALIES OF MUSCULOSKELETAL SYSTEM Treatment: MEDICAL AND SURGICAL TREATMENT ICD-10: Q79.0-Q79.59 CPT: 39503, 39545, 49600-49611, 51500, 98966- 98969,99051,99060,99070,99078,99201-99360,99366,99374,99375,99379-99444,99468- 99480,99605-99607

Move all Q79 codes from line 111 (congenital diaphragmatic hernia, other congenital malformations of the diagphragm, exomphalos, gastroschisis, prune belly syndrome, congenital hernia of bladder, congenital malformations of the abdominal wall). These conditions are substantial problems with high risk of fatality if untreated.

Page 1 Overview of Recommendations for Converting Lines to ICD-10-CM CPT—39503 (Repair, neonatal diaphragmatic hernia, with or without chest tube insertion and with or without creation of ventral hernia), 39545 (Imbrication of diaphragm for eventration, transthoracic or transabdominal, paralytic or nonparalytic), 49600-49611 (repair of omphalocele), 51500 (Excision of urachal cyst or sinus, with or without umbilical hernia repair), medical, ER, ICU, hospital codes

Ranking recommendations for OTHER CONGENITAL ANOMALIES OF MUSCULOSKELETAL SYSTEM Category 6 Impact on healthy life years –10 Vulnerable populations 0 Population effects 0 Impact on healthy life years 5 Impact on pain/suffering 5 Tertiary prevention – 5 Effectiveness of treatment – 4 Need for medical service 1 Net cost 0 Scored around line 40.

3) Create a new line various non-congenital neonatal conditions and ask neonatology where this should go. These conditions include P78.2 (Neonatal hematemesis and melena due to swallowed maternal blood), P78.3 (Noninfective neonatal diarrhea), P78.82 (Peptic ulcer of newborn), P78.83 (Newborn esophageal reflux), P78.89 (Other specified perinatal digestive system disorders) and P78.9 (Perinatal digestive system disorder, unspecified). These diagnoses are currently on line 111 CONGENITAL ANOMALIES OF DIGESTIVE SYSTEM AND ABDOMINAL WALL EXCLUDING NECROSIS; CHRONIC INTESTINAL PSEUDO-OBSTRUCTION.

Line XXX Condition: PERINATAL GASTROINTESTINAL CONDITIONS Treatment: Medical therapy ICD-10: P78.2, P78.3, P78.82, P78.83, P78.89, P78.9 CPT: TBD Ranking: TBD

COMBINE MULTIPLE LINES 1) Combine line 204 CONGENITAL CYSTIC LUNG - MILD AND MODERATE, line 301 HYPOPLASIA AND DYSPLASIA OF LUNG, and line 677 CONGENITAL CYSTIC LUNG - SEVERE. Rename “Congenital lung anomalies”. There used to be no treatment for severe congenital cystic lung; now it is treated line the moderate type. Include all CPT codes from both lines. Leave at line 204. See new line below.

Line 204 Condition: CONGENITAL LUNG ANOMALIES Treatment: MEDICAL AND SURGICAL TREATMENT ICD-10: J98.4, Q33.0, Q33.2, Q33.3, Q33.4, Q33.6 CPT: 31601,31603,31820,31825, 32140,32141,32480- 32488,32500,32501,32662,32800,98966-98969,99051,99060,99070,99078,99201- 99360,99366,99374,99375,99379-99444,99468-99480,99605-99607 HCPCS: G0406-G0408,G0425-G0427,S0270-S0274

Page 2 Overview of Recommendations for Converting Lines to ICD-10-CM RESCORE LINES 1) Consider rescoring line 40 SPINA BIFIDA—consult neurosurgery. Thinks the outcomes are poor and should be much lower line. No recommendations made as to how to rescore

GUIDELINES None

RENAME LINES Rename Line 444 INCONTINENCE OF FECES; FECAL IMPACTION

CODE PLACEMENT 1) Move K56.41 (Fecal impaction) from line 48 INTUSSCEPTION, VOLVULUS, INTESTINAL OBSTRUCTION, AND FOREIGN BODY IN STOMACH, INTESTINES, COLON, AND RECTUM to line 444 and rename line 444 INCONTINENCE OF FECES; FECAL IMPACTION as noted above 2) Meconium diagnoses (P24) deleted from line 111 CONGENITAL ANOMALIES OF DIGESTIVE SYSTEM AND ABDOMINAL WALL EXCLUDING NECROSIS; CHRONIC INTESTINAL PSEUDO-OBSTRUCTION and left on other lines (not a congenital issue)

Page 3 Lines attached to Issue: 91 ICD-10 review Pediatric Surgery

Line Condition Treatment

40 SPINA BIFIDA SURGICAL TREATMENT

48 INTUSSCEPTION, VOLVULUS, INTESTINAL MEDICAL AND SURGICAL TREATMENT OBSTRUCTION, AND FOREIGN BODY IN STOMACH, INTESTINES, COLON, AND RECTUM

71 CONGENITAL ANOMALIES OF UPPER ALIMENTARY MEDICAL AND SURGICAL TREATMENT TRACT, EXCLUDING TONGUE

97 NECROTIZING ENTEROCOLITIS IN FETUS OR MEDICAL AND SURGICAL TREATMENT NEWBORN

111 CONGENITAL ANOMALIES OF DIGESTIVE SYSTEM MEDICAL AND SURGICAL TREATMENT AND ABDOMINAL WALL EXCLUDING NECROSIS; CHRONIC INTESTINAL PSEUDO-OBSTRUCTION

204 CONGENITAL CYSTIC LUNG - MILD AND LUNG RESECTION, MEDICAL THERAPY MODERATE

247 HYPOPLASTIC LEFT HEART SYNDROME REPAIR

449 ADRENOGENITAL DISORDERS MEDICAL AND SURGICAL TREATMENT

677 CONGENITAL CYSTIC LUNG - SEVERE LUNG RESECTION

Monday, January 30, 2012 Page 1 of 1 Section 5

Previously Discussed Items

Continuous Glucose Monitoring in Diabetes

Question: Should continuous glucose monitoring be covered for type 1 and/or type 2 diabetic patients?

Question source: DMAP

Issue: Currently continuous glucose monitoring via subcutaneous sensors (CPT 95250-1) is a covered service for type 1 diabetes on line 10 TYPE I DIABETES MELLITUS. This type of monitoring is not included on line 33 TYPE II DIABETES MELLITUS. DMAP requested that this service be reviewed for 1) inclusion on line 33, 2) possible addition of a guideline for restriction on use for one or both lines. Of note: DMAP has indicated that while these CPT codes are on line 10 on the List, current administrative rules prevents payment for these services.

This issue was discussed at the February, 2012 VBBS meeting. At that time, VBBS members requested that HERC staff find additional information on this topic available through the MED project, CMS, or other highly trusted sources.

Current List information: On line 10 TYPE I DIABETES MELLITUS: 95250 Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording 95251 Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording

Evidence review 1) See Appendix A for previously presented evidence review from February, 2012 2) MED review 2010 a. Reviewed evidence for frequency of blood glucose testing. Did not specifically examine continuous blood glucose monitoring (CGM) i. No studies address the frequency of self monitoring of blood glucose (SMBG) for type 1 diabetes except as a component of an intensive program to improve glycemic control ii. No studies were found that addressed the frequency of self monitoring of blood glucose for type 2 diabetes on clinical outcomes. SMBG decreased Hba1c by a non-clinically significant amount iii. Harms of frequent monitoring 1. Seven RCTs suggested the frequency of mild to moderate hypoglycemia may be increased with frequent SMBG, but results were inconsistent. One good quality cost-utility study found quality of life decreased slightly with intensive SMBG compared to standard care. iv. Two good quality cost-effectiveness studies found that SMBG was not cost effective compared to standard care. In one study, SMBG (about nine times per week) compared to no SMBG had an incremental cost per life-year

Continuous Glucose Monitoring in Diabetes Page 1 Continuous Glucose Monitoring in Diabetes

gained was approximately US$92,301 and cost per quality adjusted life-year gained was US$107,331 (or approximately $1 million dollars over ten years). Overall quality of the evidence: high 3) Washington TECH review 2011 – contained a section comparing CGM to SMBG a. Overall strength of evidence for efficacy of CGM was low b. Differences in HgA1c values not significantly different between CGM and SMBG c. No significant differences in the effects of CGM versus SMBG alone on episodes of hypoglycemia based on 2 RCTs d. No differences were found in any quality of life measures between CGM and SMBG e. Based on a subanalysis of the JDRF 2008 trial, consistent use of CGM ≥ 6 days per week for 6 months was associated with lower mean A1c values compared with baseline. f. In another JDRF extension study of those initially randomized to SMBG who switched to CGM after the trial, no consistent pattern for improvement in A1C of ≥ 0.5% or achieving A1C <7% was seen at 6 months in those 8-12 years old. Prior to CGM use, severe hypoglycemia occurred in 26.4 per 100 person years compared with 13.0 per 100 person-years after 6 months of CGM use (p-value not stated). g. Safety issues related to CGM or SMBG device design and implementation are described as safe use is a function of both design and implementation. The overall strength of evidence is moderate based on the number and quality of studies. No major adverse events were reported 4) AHRQ review a. Protocol only has been published 5) CMS Tech report 2007 a. It is unclear whether CGM provides additional benefit to traditional SMBG 6) CMS coverage a. Current CMS coverage guidelines indicate that test strips, home monitors that use test strips, and insulin pumps are covered supplies. Continuous glucose monitoring devices are not listed as covered supplies. They are listed as a non- covered service in one document.

Summary: 1) No evidence of improvement in blood glucose levels for type 2 diabetics 2) Limited evidence for use in type 1 diabetics. At a minimum, continuous glucose monitoring should only in used in limited circumstances

Recommendations: 1) Do not add continuous glucose monitoring to line 33 TYPE II DIABETES MELLITUS 2) Remove continuous glucose monitoring from line 10 TYPE I DIABETES MELLITUS a. Remove 95250-1 from line 10 b. Evidence of benefit very small compared to typical care

Continuous Glucose Monitoring in Diabetes Page 2 Continuous Glucose Monitoring in Diabetes

Appendix A

Evidence Review for February 2012 VBBS meeting 1) Cochrane a. Currently under review for both type 1 and type 2 diabetes, no reviews published to date 2) NICE 2004 (with subsequent updates) recommendations on the management of type 1 diabetes a. Children and young people with type 1 diabetes who have persistent problems with hypoglycaemia unawareness or repeated hypoglycaemia or hyperglycaemia should be offered continuous glucose monitoring systems (Level B recommendation) b. Continuous glucose monitoring systems have a role in the assessment of glucose profiles in adults [with type 1 diabetes] with consistent glucose control problems on insulin therapy, notably: i. repeated hyper- or hypoglycaemia at the same time of day ii. hypoglycaemia unawareness, unresponsive to conventional insulin dose adjustment. iii. (Level B recommendation) c. Continuous glucose monitoring not mentioned in the NICE recommendations for management of type 2 diabetes 3) SIGN 2010 recommendations on the management of diabetes (evidence reviewed for continuous glucose monitoring was all in type 1 diabetics) a. Systems using continuous monitoring of glucose by means of subcutaneous sensors which measure interstitial glucose levels have been developed. These systems are generally only considered for use by patients who experience particular difficulties in maintaining normal glucose levels or who have been transferred to continuous subcutaneous insulin infusion therapy b. The evidence on the value of CGM in people with type 1 diabetes is conflicting. c. CGM may be a useful adjuvant to conventional self monitoring in selected adults with type 1 diabetes as an aid to improve glycaemic control, however further research is required to identify the groups of patients who will gain most benefit. d. CGM should not be used routinely in people with diabetes e. There is limited evidence that continuous glucose monitoring may be of benefit to women during pregnancy. Use of continuous glucose monitoring compared to conventional monitoring was associated with an improvement in birth weight and macrosomia in one study of women with type 1 and type 2 diabetes but not in another randomised control trial in women with gestational diabetes. f. Continuous glucose monitoring may be considered in women with type 1 and type 2 diabetes (Level B recommendation) 4) Other studies a. Golicki 2008 i. Systematic review of continuous glucose monitoring system (CGMS) in children with type 1 diabetes ii. N=5 trials with 131 children

Continuous Glucose Monitoring in Diabetes Page 3 Continuous Glucose Monitoring in Diabetes

iii. Combined data from all trials showed that the CGMS did not significantly reduce HbA1c levels compared with control groups. The pooled weighted mean difference was −0.02% (95% CI −0.29 to 0.25) iv. Conclusions/interpretation The Continuous Glucose Monitoring System is not better than self-monitoring of blood glucose with regard to improvement of metabolic control among type 1 diabetic children b. Cooke 2009 i. MITRE study—RCT to determine whether continuous glucose monitoring systems improved HbA1c for insulin treated adults with diabetes compared to standard care ii. N=404 adults taking at least two daily insulin injections and with two consecutive HbA1c values >7.5% iii. 18 month study iv. Neither an intention-to-treat nor per-protocol analysis showed improvement in HbA1c in the device groups compared with standard care. v. Conclusions The additional information provided by these devices did not result in improvements inHbA1c in this population. 5) Other policies a. Cigna 2011 i. CIGNA covers a minimally invasive, continuous glucose monitoring system (CGMS) as medically necessary for ANY of the following: 1. up to three days (72 hours) under the core medical benefits of the plan for the management of difficult to control insulin-treated diabetes mellitus (e.g., hypo- or hyperglycemic episodes unresponsive to adjustments in therapy, asymptomatic nocturnal hypoglycemia) for up to six separate sessions in any given 12- month period 2. long-term use in a type 1 diabetic age 25 years or older 3. long-term use in a type 1 diabetic age 24 years or younger with recurrent, severe hypoglycemic events (i.e., blood glucose < 50 mg/dL) despite appropriate modifications in insulin therapy and compliance with frequent self monitoring of blood glucose (i.e., at least four times daily) 4. long-term use in a type 2 diabetic with recurrent, severe hypoglycemic events (i.e., blood glucose < 50mg/dL) despite appropriate modifications in insulin therapy, and compliance with frequent self monitoring of blood glucose (i.e., at least four times daily) and EITHER of the following: a. fasting C-peptide level ≤ 110% of the lower limit of normal of the laboratory’s measurement method AND a concurrently obtained fasting glucose ≤ 225 mg/dL b. renal insufficiency with a creatinine clearance (actual or calculated from age, gender, weight and serum creatinine) ≤ 50 ml/minute AND a fasting C-peptide level ≤ 200% of

Continuous Glucose Monitoring in Diabetes Page 4 Continuous Glucose Monitoring in Diabetes

the lower limit of normal of the laboratory’s measurement method b. Aetna 2011 i. Aetna considers the short-term (up to 72 hours) diagnostic use of continuous glucose monitoring devices medically necessary for persons with diabetes who have either of the following problems in controlling blood glucose level, unresponsive to conventional insulin dose adjustment: 1. Hypoglycemia unawareness; or 2. Repeated hypoglycemia and hyperglycemia at the same time each day. ii. For short-term (up to 72 hours) diagnostic use, no more than two continuous glucose monitoring periods are considered medically necessary within a 12-month period. iii. Aetna considers the long-term (greater than 72 hours) therapeutic use of continuous glucose monitoring devices medically necessary as an adjunct to fingerstick testing of blood glucose in adults age 25 years and older with type 1 diabetes, and for younger persons with type 1 diabetes who have had recurrent episodes of severe hypoglycemia (defined as hypoglycemia (blood glucose less than 50 mg/dL) with unawareness that required assistance from another person to administer oral carbohydrate, glucagon, or other resuscitative actions) despite appropriate modifications in insulin regimen and compliance with frequent self-monitoring (at least 4 fingersticks/day). Long-term use of continuous glucose monitoring devices is considered experimental and investigational for all other indications.

Continuous Glucose Monitoring in Diabetes Page 5

MEDICAID EVIDENCE-BASED DECISIONS PROJECT (MED)

Rapid Review

Self-monitoring of Blood Glucose for Type 1 and Type 2 Diabetes

September 2010

This report was written by the Center for Evidence-based Policy at Oregon Health & Science University (the Center). The Center is a policy resource and is not providing any legal or business advice. This Report is intended for the benefit of the Medicaid Evidence-based Decisions Project participant organizations and their constituent decision-making bodies. This report is not a Policy Statement of the Center for Evidence-based Policy.

Center for Evidence-based Policy Oregon Health & Science University 3455 SW US Veterans Hospital Road, Mailstop SN-4N, Portland, OR 97239-2941 503.494.2182 Fax 503.494.3807 http://www.ohsu.edu/ohsuedu/research/policycenter/med/index.cfm

Executive Summary

Background Diabetes mellitus (DM) is a serious chronic disease with significant morbidity, mortality, and cost. According to the Centers for Disease Control and Prevention, over 23 million (7.6% of the population) Americans have diagnosed (17.9 million) or undiagnosed (5.7 million) diabetes mellitus (DM). Of the 17.9 million people with diagnosed diabetes, 2.2 million (14.5%) use insulin only, 10.3 million (57.6%) use oral medications only, 2.6 million (14.5%) use both, and 2.8 million (15.6%) do not take diabetes medications. An estimated $174 billion in health care costs are either directly or indirectly related to DM, and 16% of total Medicaid expenses are for individuals with DM. Supplies for self- monitoring of blood glucose (SMBG) are an important portion of this expense. Moreover, in one Canadian province, for example, non-insulin diabetics accounted for approximately 60% of the CAN$109 million public dollars spent on glucose test strips, and glucose test strips are among the top five classes in terms of total expenditures - exceeding expenditures for all oral diabetes medications.

SMBG is used to guide the day-to-day management of blood glucose through appropriate changes in diet, exercise, and/or medications to improve overall glycemic control and clinical outcomes. However, there is controversy about the benefits and frequency of SMBG particularly for diabetics who do not use insulin. We therefore reviewed the evidence about the impact of frequent (once or more a day) versus less frequent (or not at all) SMBG guided by the following key questions.

Key Questions 1. Does frequent self-monitoring (once or more a day) of blood glucose (SMBG) compared to less frequent (less than once a day or not at all) improve clinical outcomes and glycemic control in patients with Type 1 and 2 diabetes? 2. Are there subgroups of patients that are more likely to benefit from frequent SMBG? 3. What are the harms associated with frequent SMBG? 4. What are the costs of frequent SMBG compared to less frequent SMBG?

Methods The MED core sources were searched for systematic reviews and technology assessments published between January 2000 and July 2010 using the terms diabetes or self-monitoring of blood glucose. A Medline search was conducted to identify RCTs that have been published after the last search dates for the systematic review used in the report (April 2009 to July 2010). We also searched for guidelines published after January 2009, since several good quality RCTs assessing SMBG for Type 2 diabetes were published in 2007 and 2008. The quality of the evidence and guidelines were assessed using checklists adapted from the Scottish Intercollegiate Guidelines Network (SIGN) and Appraisal of Guidelines Research & Evaluation (AGREE), respectively. A summary judgment of overall quality of evidence (high, moderate, or low) was assigned to each outcome using a modified version of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. One systematic review

1

WA Health Technology Assessment - HTA

WASHINGTON STATE HEALTH CARE AUTHORITY

Glucose Monitoring: Self‐monitoring in individuals with insulin dependent diabetes, 18 years of age or under

Date: January 14, 2011

Health Technology Assessment Program 676 Woodland Square Loop SE P.O. Box 42712 Olympia, WA 98504-2712 WA Health Technology Assessment - HTA

http://www.hta.hca.wa.gov

Glucose Monitoring: Self-monitoring in individuals with insulin dependent diabetes, 18 years of age or under

Provided by:

Spectrum Research, Inc.

Prepared by:

Andrea C. Skelly, PhD, MPH Jeannette M. Schenk Kisser, PhD, MS Jennifer A. Mayfield, MD, MPH Carin M. Olson, MD, MS Erika D. Ecker, BS

With assistance from: Ellen Van Alstyne, MS Nora B. Henrikson, PhD, MPH

January 14, 2011

WA HTA: Glucose Monitoring Final Report (1-14-2011) Page 2 of 152 WA Health Technology Assessment - HTA

Executive Summary Introduction Self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) are two techniques that persons with diabetes use at home help them maintain blood glucose within a safe range. Intensive treatment with tight control of blood glucose has become the standard of care for diabetes. Such intensive treatment requires monitoring as part of that regimen: by knowing the blood sugar level the patient or caregiver can adjust diet, exercise, and insulin appropriately. SMBG has become a standard practice recommendation for patients with type 1 diabetes. Children and teenagers under the age of 18 with diabetes are most likely to have type 1 diabetes and have the most to gain from maintaining good glucose control yet present some of the greatest challenges in achieving and maintaining good control. As they will probably have many years at risk, children and adolescents with diabetes are at high risk for microvascular complications related to poor glucose control.

This technical review will assess the value of SMBG and CGM for persons under the age of 18 who have diabetes and use insulin. Most persons in this age group with diabetes and that require insulin have type 1 diabetes. The primary focus is on evaluation of self-monitoring methods used to assess glucose levels at home (versus data used exclusively by providers in a clinical setting) for daily decision making regarding self-care, based on the context and key questions provided below by the Washington State Health Technology Assessment Program.

Self-monitoring of blood glucose (SMBG), sometimes called intermittent monitoring, using meters which analyze small amounts of capillary blood on reagent-coated test stripes, provides immediate documentation of glycemic status. This allows one to implement strategies to address and avoid out of range glucose values. It provides only a snapshot of the blood glucose level and thus, cannot provide information on whether there is a trend toward higher or lower levels.

Minimally-invasive devices which measure interstitial fluid glucose concentration via sensors which have been inserted subcutaneously have become more widely available. These devices take samples very 1-20 minutes over the time that the device is worn. Such continuous glucose monitors (CGM) may download data to an insulin pump and/or are stored in a receiver device. CGMs may guide real-time adjustment of food and insulin. Frequent readings may assist patients in seeing if there is a trend toward increasing or decreasing glucose levels so that they can act accordingly. They may aid in identifying times of consistent hyperglycemia or increased risk of hypoglycemia. Some may sound an alarm based on specific targets values and rate of change of interstitial glucose which may facilitate initiation of the appropriate action(s) to avoid hyper- or hypoglycemic events. In those with hypoglycemia unawareness, CGM and appropriate setting of alarm thresholds may be of particular benefit. CGM may not be used alone for treatment decisions and confirmatory SMBG be done.

WA HTA: Glucose Monitoring Final Report (1-14-2011) Page 8 of 152

Gender Identity Disorder/Gender Dysphoria

Question: Where should gender identity disorder be located on the Prioritized List?

Question Source: HERC staff; Office of Multicultural Health; OHA; Transactive Advocacy Group; Basic Rights Oregon

Issue: Gender identity disorder is co-located on a line with several inappropriate diagnoses, such as pedophilia. During the 2012 Biennial Review of the Prioritized List, this line should be separated into two lines, and the new lines reprioritized. If the new line is split and all current CPT codes are kept on both lines, then the treatments included would be psychotherapy and medical treatments. Medical treatments would include hormone therapy. Surgical therapy, such as sex reassignment surgery, is not currently a treatment option on line 513 and is excluded based on DMAP administrative rule.

Basic Rights Oregon has submitted a request that treatments for gender identification disorder include psychotherapy and puberty suppressing hormone therapy for gender-questioning children only. This advocacy group feels that coverage of psychotherapy would be significant as a letter from a DMV approved therapist is required to change one’s gender designation on your driver’s license. Additional treatments (hormone therapy for adolescents and adults, surgical options) may be addressed at a future time.

Note: Gender identity disorder is being renamed “gender dysphoria” in the new DSM-5 manual.

Current List Placement Gender identification disorder is currently on Line 513. Treatments on this line include medical treatments and psychotherapy.

Line: 513 Condition: GENDER IDENTIFICATION DISORDER, PARAPHILIAS AND OTHER PSYCHOSEXUAL DISORDERS Treatment: MEDICAL/PSYCHOTHERAPY ICD-9: 302.0-302.4,302.50,302.6,302.85,302.9 CPT: 90804-90815,90846-90857,90882,90887,96101,98966-98969,99051,99060,99201-99215,99241- 99245,99366,99441-99444,99605-99607 HCPCS: G0176,G0177,G0425-G0427,H0004,H0023,H0032,H0034,H0035,H2010,H2011,H2014, H2027, H2032,H2033,S0270-S0274,S9484,T1016

ICD-9 codes on line 513 ICD-9 Code description code 302.0 Ego-dystonic sexual orientation 302.1 Zoophilia 302.2 Pedophilia 302.3 Transvetic fetishism 302.4 Exhibitionism 302.50 Trans-sexualism with unspecified sexual history 302.6 Gender identity disorder in children 302.85 Gender identify disorder in adolescents or adults 302.9 Unspecified psychosexual disorder

Gender Identity Disorder/Gender Dysphoria Page 1

Gender Identity Disorder/Gender Dysphoria

Current Ranking Pop Vulnera Tertiary Effectiv NeedFor NetCos Line Score Category HLY Suffering Effects blePop Prev eness Services t 513 160 7 2 4 1 0 1 1 1 2

HSC Staff Recommendations 1) Divide Line 513 into two separate lines

Line: XXX Condition: GENDER IDENTIFICATION DISORDER DYSPHORIA Treatment: MEDICAL/PSYCHOTHERAPY ICD-9: 302.6,302.85 CPT: 90804-90815,90846-90857,90882,90887,96101,98966-98969,99051,99060,99201-99215,99241- 99245,99366,99441-99444,99605-99607 HCPCS: G0176,G0177,G0425-G0427,H0004,H0023,H0032,H0034,H0035,H2010,H2011,H2014, H2027, H2032,H2033,S0270-S0274,S9484,T1016

Line: WWW Condition: PARAPHILIAS AND OTHER PSYCHOSEXUAL DISORDERS Treatment: MEDICAL/PSYCHOTHERAPY ICD-9: 302.0-302.5, 302.9 CPT: 90804-90815,90846-90857,90882,90887,96101,98966-98969,99051,99060,99201-99215,99241- 99245,99366,99441-99444,99605-99607 HCPCS: G0176,G0177,G0425-G0427,H0004,H0023,H0032,H0034,H0035,H2010,H2011,H2014, H2027, H2032,H2033,S0270-S0274,S9484,T1016

2) Rerank the two newly created lines (see previous ranking above) a. The vulnerable population score in particular should be increased for the new gender dysphoria line 3) Add histrelin (Supprelin) insertion (GnRH analog used to suppress puberty) CPT (11981- 11983) codes to new gender dysphoria line and alter existing guideline to include this line a. Treatment added for precocious puberty in October 2011 b. CPT code and guideline will appear on the April 1, 2012 List 4) Adopt the guideline below for the Gender Dysphoria line a. Address other treatments and procedures to include on the gender identity disorder line (i.e. transgender surgery, hormone therapy for adults and adolescents) at a future meeting if requested by advocacy groups

GUIDELINE XXX GENDER DYSPHORIA Line XXX Hormone treatment is included on this line only for use in delaying the onset of puberty and/or continued pubertal development for gender questioning children and adolescents (age 17 and younger).

Gender Identity Disorder/Gender Dysphoria Page 2

Gender Identity Disorder/Gender Dysphoria

GUIDELINE NOTE XXX IMPLANTABLE GNRH ANALOG THERAPY Line 193,XXX Use of drug delivery implant therapy for GnRH analogue therapy (such as histrelin) (CPT 11981-11983) is covered only after injectable depot medications (such as Lupron) have been tried or are contraindicated.

Gender Identity Disorder/Gender Dysphoria Page 3

Section 6

New Discussion Items

HPV Vaccination for Males

Question: should coverage for HPV vaccination be added for males?

Question source: DMAP

Issue: ACIP has recommended HPV vaccination for males since 2009. They recently re-issued recommendations in December, 2011 advising that males aged 9-21 be vaccinated, and that males 22-26 may be vaccinated with HPV4 vaccine only (not HPV 2). Currently, the Prioritized List only includes HPV vaccination for females aged 9-26 with either HPV2 or HPV4 vaccine. The Prevention Tables need to be updated to reflect current ACIP recommendations. The HPV vaccination CPT code is currently on lines 3 and 4 (Prevention lines). DMAP has received multiple complaints about the lack of coverage. The HSC had a policy to follow ACIP recommendations for vaccination issues.

Note: the current Prevention Tables include recommendation for vaccination only through age 18. The Vaccines for Children (VFC) program covers vaccination only for this age group.

Recommendation: 1) Make the changes noted below in the Prevention Tables a. Add coverage for males age 9-18 b. Consider adding coverage for males and females age 19-26

Birth to 10 Years (Cont’d) ______Interventions for the General Population (Cont’d) ______IMMUNIZATIONS Diphtheria-tetanus-acellular pertussis (DTaP) Inactivated poliovirus (OPV) Measles-mumps-rubella (MMR) H. influenzae type b (Hib) conjugate Hepatitis B Varicella Pneumococal Hepatitis A Influenza Rotavirus Human papillomavirus (HPV)1 CHEMOPROPHYLAXIS Ocular prophylaxis (birth) ______1HPV2 and HPV4 for women females aged 9 to 18. Discussion with provider regarding HPV4 for males aged 9 through 18

HPV Vaccination for Males Page 1 HPV Vaccination for Males

Ages 11-24 Years (Cont’d) ______Interventions for the General Population (Cont’d) ______IMMUNIZATIONS TDaP (11-16 yr) Hepatitis B1 MMR (11-12 yr)2 Varicella (11-12 yr)3 Rubella4 (females >12 yr) Influenza5 Polio6 Human papillomavirus (HPV)7 Meningococcal (11-12 yr) 8 CHEMOPROPHYLAXIS Multivitamin with folic acid (females planning/ capable of pregnancy) ______1If not previously immunized: current visit, 1 and 6 mo later. 2If no previous second dose of MMR. 3If susceptible to chickenpox. 4Serologic testing, documented vaccination history, and routine vaccination against rubella (preferably with MMR) are equally acceptable alternatives.

5Yearly (6 mo through 18 yrs). 6If not previously immunized. 7HPV2 and HPV4 for women females aged 9 to 18. Discussion with provider regarding HPV4 for males aged 9 through 18. 8 Children 13 through 18 if not previously vaccinated.

HPV Vaccination for Males Page 2 Morbidity and Mortality Weekly Report Weekly / Vol. 60 / No. 50 December 23, 2011

Transmission of Hepatitis C Virus Through Transplanted Organs and Tissue — Kentucky and Massachusetts, 2011

On September 29, 2011, the United Network for Organ Policies of the Organ Procurement and Transplantation Network Sharing notified CDC of two patients who tested positive for (OPTN), the oversight entity for solid organs in the United States, hepatitis C virus (HCV) infection approximately 6 months require testing for HCV by antibody only, whereas the Food and after receiving kidney transplants from a deceased donor. Drug Administration (FDA), which regulates human cells, tis- Before transplantation, the donor had tested negative for HCV sues, and cellular and tissue-based products, requires screening antibody by the organ procurement organization. Tissue also of donated tissue for HCV by both antibody and NAT (1). The was procured from the donor for possible transplantation. The donor’s HCV antibody tested negative on both organ and tissue tissue bank performed an HCV antibody test on the donor’s donor screening, but misreading of the reaction wells on testing serum specimen that was negative and nucleic acid testing led to an incorrectly reported negative HCV NAT result. Once (NAT) that was positive, but misread as negative. Retesting this error was identified, repeat NAT was performed at the tissue of the donor specimen during the investigation confirmed bank and confirmed that the donor was HCV-positive at the time the NAT results as positive. Donated tissue included 43 of donation. During the donor’s final hospital stay in March, he musculoskeletal grafts and one cardiopulmonary patch, which received six units of blood products. Pretransfusion serum from were distributed to health-care facilities in several states. An the donor was not available for analysis. Testing of posttransfusion investigation was initiated to 1) identify potential sources of stored serum at CDC on October 28 confirmed by NAT that the donor’s infection, 2) document the mode of transmission the donor was HCV-positive with genotype 1a and a viral load to the organ recipients, and 3) ensure timely notification of >69,000,000 IU/mL. Blood traceback investigation of the six of the implanting surgeons and testing of tissue recipients. associated blood donors to the infected donor is ongoing, and all Implantation of infected HCV tissue occurred after recognition remaining units from these donations have been quarantined. of new HCV infection in the organ transplant recipients, high- lighting the need for rapid communication between transplant Organ Transplant Investigation centers, organ procurement organizations, tissue banks, and In March 2011, three organs (two kidneys and the liver) public health authorities regarding suspected transplantation from the donor were transplanted into three recipients at a transmission events. local hospital in Kentucky (Figure). Both kidney recipients had Donor Investigation The donor, a middle-aged man in Kentucky, sustained a INSIDE traumatic brain injury in March 2011 in an all-terrain vehicu- lar incident and died 2 days later. His medical history was 1701 Food Safety Epidemiology Capacity in State Health significant for schizophrenia, substance abuse, and a 5-month Departments — United States, 2010 incarceration approximately 10 years before his death. The 1705 Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males — Advisory donor had no known history of intravenous drug use or other Committee on Immunization Practices (ACIP), 2011 hepatitis risk factors, according to his father at the time of organ 1709 Use of Hepatitis B Vaccination for Adults with procurement; however, further investigation revealed that the Diabetes Mellitus: Recommendations of the Advisory donor’s father had limited contact with his son during the Committee on Immunization Practices (ACIP) year before his death and was unfamiliar with recent personal 1712 QuickStats habits or behaviors.

U.S. Department of Health and Human Services Centers for Disease Control and Prevention Lichen Sclerosus

Question: should lichen sclerosus be a covered condition?

Question source: Doug Luther, OHP Medical Director for FamilyCare; Lara Williams, MD Everywoman's Health; OB/Gyn ICD-10 workgroup

Issue: Lichen sclerosus is a disease of unknown cause that results in white patches on the skin, which may cause scarring on and around genital skin. It can lead to vulvar cancer in about 10% of cases. It can also lead to complications such as labial fusion.

Currently, lichen sclerosus is on line below the current funding line. The ICD-9 code (701.0) for this diagnosis is a generic code “Circumscribed scleroderma.” ICD-10 has a specific code for lichen sclerosus (L90.0). Currently, 701.0 is on line 534 CIRCUMSCRIBED SCLERODERMA. The ICD-10 OB/Gyn workgroup identified this diagnosis as requiring movement to the covered region of the list. They suggested adding this code to line 460 DYSTROPHY OF VULVA to allow for periodic visits for treatment of complications, such as labial fusion, dysparunia, pain, etc. as well as to monitor for cancerous changes. This issue was independently raised by Drs. Luther and Williams.

From Dr. Williams: Was just reading some of the diagnosis codes where diagnosis will be covered but subsequent visits will not. The one that concerned me the most is 701.0 which is lichen sclerosis. This diagnosis can lead to squamous cell cancer in 10% of cases and not being followed by an OB/GYN can be a problem. Most experts in Vulvar dermatology recommend follow up q 6 months- not something that a primary care provider would have sufficient expertise to follow and make sure more problems are developing (cancer, fusion of labia, etc).

From Dr. Luther: Obviously, if the diagnosis is below the line then as she points out, plans generally would not be authorizing ongoing services for that diagnosis, leading to the potential issue of missed diagnosis. Notwithstanding that an exception could be made, once the diagnosis is made, and it’s below the line, plans typically will not authorize ongoing consultation.

Current evidence based reviews (see Cochrane review of treatments 2011) find that various topical medications are efficacious in the treatment of lichen sclerosus.

Recommendations: 1) Add 701.0 to line 460 DYSTROPHY OF VULVA; keep on line 534 CIRCUMSCRIBED SCLERODERMA 2) Add the following coding specification to line 460 a. “ICD-9 701.0 is included on this line only for the diagnosis of lichen sclerosus.” .

Lichen Sclerosus Page 1

GERD Re-Ranking Summary

Question: Should gastroesophageal reflux disease (GERD) be re-prioritized lower on the List?

Question Source: Lyle Jackson, Medical Directors meeting; ICD 10 General Surgery group

Issue: Dr. Jackson raised the issue that now that excellent treatments for GERD are now available over the counter, and the only key necessary intervention is an esophagogastroduodenoscopy (EGD) to screen for precancerous conditions in those with troublesome dysphagia.

Dysphagia is located in two places: 1) Line 78 NEUROLOGICAL DYSFUNCTION IN BREATHING, EATING, SWALLOWING, BOWEL, OR BLADDER CONTROL CAUSED BY CHRONIC CONDITIONS 2) DIAGNOSTIC FILE

Current List Status

Line: 423 Condition: ESOPHAGITIS (See Guideline Notes 1,64,65,76) Treatment: MEDICAL THERAPY ICD-9: 530.1-530.2,530.6,530.81-530.83,530.85,530.89-530.9 CPT: 43248,43249,43256,96150-96154,98966- 98969,99051,99060,99070,99078,99201-99360,99366,99374,99375,99379- 99444,99468-99480,99605-99607 HCPCS: G0406-G0408,G0425-G0427,S0270-S0274

Current Ranking: Vulnerable Populations

Tertiary Prevention Healthy Life Years Population Effects Need for Services Pain & Suffering Effectiveness

Category Net Cost

Score

Line Condition Treatment 423 ESOPHAGITIS MEDICAL THERAPY 448 7 4 2 0 0 2 4 0.7 2

Impact on Healthy Life Years Gisbert, 2009 1) Study involving 12,815 patients who presented to their PCP for GERD related reasons, in 6 European countries 2) 2678 were interviewed (randomly selected) 3) Used a reflux disease questionnaire (score range 0–5, where high score = worse status) 4) Results a) Heartburn dimension scores ranged from 0.8 (Sweden) to 1.2 (UK) b) Mean regurgitation dimension scores ranged from 1.0 (Norway) to 1.4 (Germany) c) Mean overall GIS scores (range 1–4, where low score = worse status) ranged from 3.3 (Germany) to 3.5 (Spain). d) Sleep disturbance was common in all countries in terms of both frequency and intensity. GERD Re-Ranking Summary

Effectiveness of Treatment Pinxteren, 2010 1. Cochrane systematic review 2. Compared empiric treatment with proton pum p inhibitoris (PPIs), histamine2-receptor antagonists (H2RA), and prokinetics to those with endoscopically negative reflux disease. 3. 32 trials, 9738 participants a. 15 empiric treatment b. 13 in endoscopically-negative reflux disease group c. 4 trials included both 4. Empiric treatment for GERD a. RR of heartburn remission i. PPI 0.37 (95% CI 0.32 to 0.44) ii. H2RA 0.77 (95% CI 0.60 to 0.99) i. Prokinetics 0.86 (95% CI 0.73 to 1.01) 5. Treatment for endoscopically negative reflux a. RR of heartburn remission i. PPI 0.73 (95% CI 0.67 to 0.78) ii. H2RA 0.84 (95% CI 0.74 to 0.95) iii. PPI v. prokinetic 0.72 (95% CI 0.56 to 0.92)

6. PPIs are more effective than H2RA and prokinetics in both empirical and in those with endoscopically negative reflux disease.

Evidence Based Guidelines NICE, 2004 1. Guideline reviews appropriate interventions for dyspepsia 2. Key interventions for GORD A. Interventions for gastro-oesophageal reflux disease (GORD) (1) Offer patients who have GORD a full-dose PPI for 1 or 2 months. (2) If symptoms recur following initial treatment, offer a PPI at the lowest dose possible to control symptoms, with a limited number of repeat prescriptions.

3. Referral for endoscopy

a. Review medications for possible causes of dyspepsia (for example, calcium antagonists, nitrates, theophyllines, bisphosphonates, corticosteroids and non- steroidal anti-inflammatory drugs [NSAIDs]). In patients requiring referral, suspend NSAID use. b. Urgent specialist referral for endoscopic investigation[1] is indicated for patients of any age with dyspepsia when presenting with any of the following: chronic gastrointestinal bleeding, progressive unintentional weight loss, progressive difficulty swallowing, persistent vomiting, iron deficiency anaemia, epigastric mass or suspicious barium meal. c. Routine endoscopic investigation of patients of any age, presenting with dyspepsia and without alarm signs, is not necessary. However, in patients aged 55 years and older with unexplained[2] and persistent[2] recent-onset dyspepsia alone, an urgent referral for endoscopy should be made. GERD Re-Ranking Summary

4. Interventions for uninvestigated dyspepsia

a. Initial therapeutic strategies for dyspepsia are empirical treatment with a proton pump inhibitor (PPI) or testing for and treating H. pylori. There is currently insufficient evidence to guide which should be offered first. A 2-week washout period following PPI use is necessary before testing for H. pylori with a breath test or a stool antigen test.

Professional Guidelines American Gastroenterological Association, Medical Position Statement, 2008 Grade A or B evidence for treatment I. Weight loss should be advised for overweight or obese II. Elevate the head of the bed for selected patients. Lifestyle modification sincluding avoiding late meals and specific foods I. Antisecretory drugs for the treatment of patients with esophageal GERD syndromes (healing esophagitis and symptomatic relief). In these uses, proton pump inhibitors (PPIs) are more effective than histamine2 receptor antagonists (H2RAs), which are more effective than placebo. II. Twice-daily PPI therapy for patients with an esophageal syndrome with an inadequate symptom response to once-daily PPI therapy. III. A short course or as-needed use of antisecretory drugs in patients with a symptomatic esophageal syndrome without esophagitis when symptom control is the primary objective. For a short course of therapy, PPIs are more effective than H2RAs, which are more effective than placebo.

Grade D: recommend against, fair evidence that it is ineffective or harms outweigh benefits I. Routine endoscopy in subjects with erosive or nonerosive reflux disease to assess for disease progression.

Grade B: recommended with fair evidence that it improves important outcomes I. Endoscopy with biopsy for patients with an esophageal GERD syndrome with troublesome dysphagia. Biopsies should target any areas of suspected metaplasia, dysplasia, or in the absence of any visual abnormalities, normal mucosa (at least 5 samples to evaluate for eosinophilic esophagitis).

Grade Insufficient: no recommendation, insufficient evidence to recommend for or against I. Routine upper endoscopy in the setting of chronic GERD symptoms to diminish the risk of death from esophageal cancer. II. Endoscopic screening for Barrett’s esophagus and dysplasia in adults 50 years or older with _5–10 years of heartburn to reduce mortality from esophageal adenocarcinoma.

GERD Re-Ranking Summary

Summary The GERD line may be ranked overly positively on effectiveness and impact on healthy life years. The effectiveness of PPI which is first line treatment, is 73% in those empirically treated, and around 27% in those with endoscopically negative symptoms. Effectiveness ranking is possibly more appropriate at a level 3.

Regarding the potential effects of moving GERD to the non-funded region, there is insufficient evidence to support endoscopy for screening resulting in reduction of death from esophageal adenocarcinoma, nor for those with chronic GERD symptoms. There is evidence to support doing diagnostic endoscopy for those with dysphagia. This would continue to be covered. Guidelines on upper endoscopy for GERD is also one of the future topics to be developed through the Evidence-based Guidelines Subcommittee

HSC Staff Recommendations 1. Consider reranking line 423

Some options

Vulnerable Populations

Tertiary Prevention Healthy Life Years Population Effects Need for Services Pain & Suffering Effectiveness

Category Net Cost

Score

Line Condition Treatment 423 ESOPHAGITIS MEDICAL THERAPY 448 7 4 2 0 0 2 4 0.7 2

Option 1: Change Healthy Life Years to 3 and effectiveness to 3 and Need for Services to 0.3 Results in a score of 126 Approximate New Line: 540

Health and Quality of Life Outcomes BioMed Central

Research Open Access Impact of gastroesophageal reflux disease on patients' daily lives: a European observational study in the primary care setting Javier P Gisbert*1, Alun Cooper2, Dimitrios Karagiannis3, Jan Hatlebakk4, Lars Agréus5, Helmut Jablonowski6 and Javier Zapardiel7

Address: 1Department of Gastroenterology, Hospital Universitario de la Princesa, Madrid, Spain, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain, 2Bridge Medical Centre, Crawley, West Sussex, UK, 3Department of Gastroenterology, Athens Medical Center, Athens, Greece, 4Institute of Medicine, Haukeland University Hospital, Bergen, Norway, 5Center for Family and Community Medicine, Karolinska Institutet, Huddinge/Stockholm, Sweden, 6Klinikum Salzgitter GmbH, Salzgitter, Germany and 7AstraZeneca, Madrid, Spain Email: Javier P Gisbert* - [email protected]; Alun Cooper - [email protected]; Dimitrios Karagiannis - [email protected]; Jan Hatlebakk - [email protected]; Lars Agréus - [email protected]; Helmut Jablonowski - [email protected]; Javier Zapardiel - [email protected] * Corresponding author

Published: 2 July 2009 Received: 1 April 2009 Accepted: 2 July 2009 Health and Quality of Life Outcomes 2009, 7:60 doi:10.1186/1477-7525-7-60 This article is available from: http://www.hqlo.com/content/7/1/60 © 2009 Gisbert et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract Background: The impact of gastroesophageal reflux disease (GERD) on the daily lives of patients managed in primary care is not well known. We report the burden of GERD in a large population of patients managed in primary care, in terms of symptoms and impact on patients' daily lives. Methods: RANGE (Retrospective ANalysis of GERD) was an observational study that was conducted at 134 primary care sites across six European countries. All adult subjects who had consulted their primary care physician (PCP) during a 4-month identification period were screened retrospectively and those consulting at least once for GERD-related reasons were identified. From this population, a random sample of patients was selected to enter the study and attended a follow- up appointment, during which the Reflux Disease Questionnaire (RDQ), the GERD Impact Scale (GIS) and an extra-esophageal symptoms questionnaire were self-administered. Based on medical records, data were collected on demographics, history of GERD, its diagnostic work-up and therapy. Results: Over the 4-month identification period, 373,610 subjects consulted their PCP and 12,815 (3.4%) did so for GERD-related reasons. From 2678 patients interviewed (approximately 75% of whom reported taking medication for GERD symptoms), symptom recurrence following a period of remission was the most common reason for consultation (35%). At the follow-up visit, with regard to RDQ items (score range 0–5, where high score = worse status), mean Heartburn dimension scores ranged from 0.8 (Sweden) to 1.2 (UK) and mean Regurgitation dimension scores ranged from 1.0 (Norway) to 1.4 (Germany). Mean overall GIS scores (range 1–4, where low score = worse status) ranged from 3.3 (Germany) to 3.5 (Spain). With regard to extra-esophageal symptoms, sleep disturbance was common in all countries in terms of both frequency and intensity. Conclusion: In this large European observational study, GERD was associated with a substantial impact on the daily lives of affected individuals managed in the primary care setting.

Page 1 of 8 (page number not for citation purposes) Short-term treatment with proton pump inhibitors, H2- receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease (Review)

van Pinxteren B, Sigterman KE, Bonis P, Lau J, Numans ME

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 11 http://www.thecochranelibrary.com

Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Short-term treatment with proton pump inhibitors, H2- receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease

Bart van Pinxteren1, Kirsten E Sigterman1, Peter Bonis2, Joseph Lau2, Mattijs E Numans1

1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands. 2New England Medical Centre/Tufts Evidence-based Practice Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Centre, Boston, MA, USA

Contact address: Mattijs E Numans, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, Utrecht, 3508 GA, Netherlands. [email protected].

Editorial group: Cochrane Upper Gastrointestinal and Pancreatic Diseases Group. Publication status and date: Edited (no change to conclusions), published in Issue 11, 2010. Review content assessed as up-to-date: 4 October 2009.

Citation: van Pinxteren B, Sigterman KE, Bonis P, Lau J, Numans ME. Short-term treatment with proton pump inhibitors, H2- receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease. Cochrane Database of Systematic Reviews 2010, Issue 11. Art. No.: CD002095. DOI: 10.1002/14651858.CD002095.pub4.

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background Approximately 25% of adults regularly experience heartburn, a symptom of gastro-oesophageal reflux disease (GORD). Most patients are treated empirically (without specific diagnostic evaluation e.g. endoscopy. Among patients who have an upper endoscopy, findings range from a normal appearance, mild erythema to severe oesophagitis with stricture formation. Patients without visible damage to the oesophagus have endoscopy negative reflux disease (ENRD). The pathogenesis of ENRD, and its response to treatment may differ from GORD with oesophagitis. Objectives Summarise, quantify and compare the efficacy of short-term use of proton pump inhibitors (PPI), H2-receptor antagonists (H2RA) and prokinetics in adults with GORD, treated empirically and in those with endoscopy negative reflux disease (ENRD). Search methods We searched MEDLINE (January 1966 to November 2008), EMBASE (January 1988 to November 2008), and EBMR in November 2008. Selection criteria Randomised controlled trials reporting symptomatic outcome after short-term treatment for GORD using proton pump inhibitors, H2-receptor antagonists or prokinetic agents. Participants had to be either from an empirical treatment group (no endoscopy used in treatment allocation) or from an endoscopy negative reflux disease group (no signs of erosive oesophagitis). Data collection and analysis Two authors independently assessed trial quality and extracted data.

Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results Thirty-two trials (9738 participants) were included: fifteen in the empirical treatment group, thirteen in the ENRD group and four in both. In empirical treatment of GORD the relative risk (RR) for heartburn remission (the primary efficacy variable) in placebo- controlled trials for PPI was 0.37 (two trials, 95% confidence interval (CI) 0.32 to 0.44), for H2RAs 0.77 (two trials, 95% CI 0.60 to 0.99) and for prokinetics 0.86 (one trial, 95% CI 0.73 to 1.01). In a direct comparison PPIs were more effective than H2RAs (seven trials, RR 0.66, 95% CI 0.60 to 0.73) and prokinetics (two trials, RR 0.53, 95% CI 0.32 to 0.87). In treatment of ENRD, the RR for heartburn remission for PPI versus placebo was 0.73 (eight trials, 95% CI 0.67 to 0.78) and for H2RA versus placebo was 0.84 (two trials, 95% CI 0.74 to 0.95). The RR for PPI versus H2RA was 0.78 (three trials, 95% CI 0.62 to 0.97) and for PPI versus prokinetic 0.72 (one trial, 95% CI 0.56 to 0.92). Authors’ conclusions PPIs are more effective than H2RAs in relieving heartburn in patients with GORD who are treated empirically and in those with ENRD, although the magnitude of benefit is greater for those treated empirically.

PLAIN LANGUAGE SUMMARY Short-term treatment with medications for heartburn symptoms. Patients with only mild or intermittent heartburn may have adequate relief with lifestyle modifications and antacids, although other options are available. The two most commonly used drugs for treatment of heartburn are H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). These drugs act by suppressing the discharge of acid from the stomach. This review found that in the short term PPIs relieve heartburn better than H2RAs in patients who are treated without specific diagnostic testing and, although the difference is smaller, in patients with GORD who have a normal upper endoscopy too. In summary, proton pump inhibitor drugs appear to be more effective than H2-receptor antagonists for relieving heartburn, the cardinal feature of “gastro-oesophageal reflux disease” (GORD).

Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. National Institute for Clinical Excellence

Issue date: August 2004 Quick reference guide

Dyspepsia – management of dyspepsia in adults in primary care

In June 2005 the recommendations on referral for endoscopy in the NICE guideline on dyspepsia were amended in line with the recommendation in the NICE Clinical Guideline on referral for suspected cancer (NICE Clinical Guideline no. 27: Referral guidelines for suspected cancer. June 2005. See www.nice.org.uk/CG027). This quick reference guide has been amended to take account of the changes in the NICE guideline (see pages 2, 3, 5, 6 and 13). For ease of reference, the original text in this document has been struck through and the revised text has been set in italics below it.

Clinical Guideline 17 Developed by the Newcastle Guideline Development and Research Unit Key priorities for implementation

Referral for endoscopy use is necessary before testing for H. pylori with a breath test or a stool antigen test. ● Review medications for possible causes of dyspepsia (for example, calcium antagonists, Interventions for gastro-oesophageal reflux nitrates, theophyllines, bisphosphonates, disease (GORD) corticosteroids and non-steroidal anti- ● Offer patients who have GORD a full-dose PPI inflammatory drugs [NSAIDs]). In patients for 1 or 2 months.

requiring referral, suspend NSAID use. ● If symptoms recur following initial ● Urgent specialist referral for endoscopic treatment, offer a PPI at the lowest dose investigation* is indicated for patients of any possible to control symptoms, with a limited age with dyspepsia when presenting with number of repeat prescriptions. any of the following: chronic gastrointestinal Interventions for peptic ulcer disease bleeding, progressive unintentional weight ● Offer H. pylori eradication therapy to H. loss, progressive difficulty swallowing, pylori-positive patients who have peptic ulcer persistent vomiting, iron deficiency anaemia, disease. epigastric mass or suspicious barium meal. ● For patients using NSAIDs with diagnosed ● Routine endoscopic investigation of patients peptic ulcer, stop the use of NSAIDs where of any age, presenting with dyspepsia and possible. Offer full-dose PPI or H2RA therapy without alarm signs, is not necessary. for 2 months to these patients and if H. pylori However, for patients over 55, consider is present, subsequently offer eradication endoscopy when symptoms persist despite therapy. Helicobacter pylori (H. pylori) testing and Interventions for non-ulcer dyspepsia acid suppression therapy, and when patients ● Management of endoscopically determined have one or more of the following: previous non-ulcer dyspepsia involves initial treatment gastric ulcer or surgery, continuing need for for H. pylori if present, followed by NSAID treatment or raised risk of gastric symptomatic management and periodic cancer or anxiety about cancer. monitoring. ● Routine endoscopic investigation of patients ● Re-testing after eradication should not be of any age, presenting with dyspepsia and offered routinely, although the information without alarm signs, is not necessary. it provides may be valued by individual However, in patients aged 55 years and older patients. with unexplained** and persistent** recent- Reviewing patient care onset dyspepsia alone, an urgent referral for ● Offer patients requiring long-term endoscopy should be made. management of symptoms for dyspepsia an Interventions for uninvestigated dyspepsia annual review of their condition, ● Initial therapeutic strategies for dyspepsia encouraging them to try stepping down or are empirical treatment with a proton pump stopping treatment. inhibitor (PPI) or testing for and treating H. ● A return to self-treatment with antacid pylori. There is currently insufficient evidence and/or alginate therapy (either prescribed or to guide which should be offered first. A 2- purchased over-the-counter and taken as week washout period following PPI required) may be appropriate.

2 NICE guideline: quick reference guide – dyspepsia 6 Reviewing patient care

Recommendations ● Offer patients requiring long-term management of dyspepsia symptoms an annual review of their condition, encouraging them to try stepping down or stopping treatment*. ● A return to self-treatment with antacid and/or alginate therapy (either prescribed or purchased over-the-counter and taken as-required) may be appropriate. ● Offer simple lifestyle advice, including healthy eating, weight reduction and smoking cessation. ● Advise patients to avoid known precipitants they associate with their dyspepsia where possible. These include smoking, alcohol, coffee, chocolate, fatty foods and being overweight. Raising the head of the bed and having a main meal well before going to bed may help some people. ● Routine endoscopic investigation of patients of any age presenting with dyspepsia and without alarm signs is not necessary. However, for patients over 55, consider endoscopy when symptoms persist despite H. pylori testing and acid suppression therapy and when patients have one or more of the following: previous gastric ulcer or surgery, continuing need for NSAID treatment, or raised risk of gastric cancer or anxiety about cancer. ● Routine endoscopic investigation of patients of any age, presenting with dyspepsia and without alarm signs, is not necessary. However, in patients aged 55 years and older with unexplained** and persistent** recent-onset dyspepsia alone, an urgent referral for endoscopy should be made. * Unless there is an underlying condition or comedication requiring continuing treatment. ** In the referral guidelines for suspected cancer (NICE Clinical Guideline no. 27), ‘unexplained’ is defined as ‘a symptom(s) and/or sign(s) that has not led to a diagnosis being made by the primary care professional after initial assessment of the history, examination and primary care investigations (if any)’. In the context of this recommendation, the primary care professional should confirm that the dyspepsia is new rather than a recurrent episode and exclude common precipitants of dyspepsia such as ingestion of NSAIDs. ‘Persistent’ as used in the recommendations in the referral guidelines refers to the continuation of specified symptoms and/or signs beyond a period that would normally be associated with self-limiting problems. The precise period will vary depending on the severity of symptoms and associated features, as assessed by the healthcare professional. In many cases, the upper limit the professional will permit symptoms and/or signs to persist before initiating referral will be 4–6 weeks.

NICE guideline: quick reference guide – dyspepsia 13 GASTROENTEROLOGY 2008;135:1383–1391

AGA INSTITUTE

American Gastroenterological Association Medical Position Statement on the Management of Gastroesophageal Reflux Disease

The American Gastroenterological Association (AGA) Institute Medical Position Panel consisted of the authors of the technical review, a community-based gastroenterologist (Stephen W. Hiltz, MD, MBA, AGAF), an insurance provider representative (Edgar Black, MD, Medical Director, Policy Resources Technology Evaluation Center, BlueCross BlueShield Association), a general surgeon (Irvin M. Modlin, MD), a patient advocate (Gregory Lane), a primary care physician (Steve P. Johnson, MD), a gastroenterologist with expertise in health services research (Philip S. Schoenfeld, MD), the Chair of the AGA Institute Clinical Practice and Quality Management Committee (John Allen, MD, MBA, AGAF), and the Chair of the AGA Institute Practice Management and Economics Committee and the AGA Institute CPT Advisor (Joel V. Brill, MD, AGAF).

n the development of this medical position statement, 12 Montreal consensus defined GERD as “a condition which Ibroad questions pertinent to diagnostic and management develops when the reflux of stomach contents causes trou- strategies for patients with gastroesophageal reflux disease blesome symptoms and/or complications.” Symptoms are (GERD) were developed by interaction among the authors of “troublesome” if they adversely affect an individual’s well- the technical review,1 representatives from the American Gas- being. Esophageal GERD syndromes are categorized as troenterological Association (AGA) Institute Council, and the those that are symptom based and those that are defined by AGA Institute Clinical Practice and Quality Management tissue injury, while the extraesophageal syndromes are clas- Committee. The questions were designed to encapsulate the sified as of established or proposed association with GERD, major management issues encountered in patients with GERD acknowledging that while the evidence on hand is sufficient in current clinical practice. The issue of management of Bar- to link these syndromes to reflux, it is insufficient to estab- rett’s esophagus was intentionally excluded, because this will lish causation. be the focus of a subsequent medical position statement. For A distinguishing feature of the Montreal definition is each question, a comprehensive literature search was con- that it does not use the term “nonerosive reflux disease” but ducted, pertinent evidence reviewed, and the quality of relevant rather subdivides esophageal syndromes into symptomatic data evaluated. The details of development methodology, lit- syndromes and syndromes with esophageal injury. Hence, erature search methodology, and literature search yield associ- functional heartburn does not fit the Montreal definition of ated with each of the questions are available on the AGA GERD, whereas it is included under the umbrella of non- Institute Web site as a separate document.2 The resultant erosive reflux disease. The distinction between GERD and conclusions were based on the best available evidence or, in the episodic heartburn in the Montreal definition is in the word absence of quality evidence, expert opinion. The strength of “troublesome.” In the absence of esophageal injury, heart- these conclusions was weighed using US Preventive Services burn symptoms of insufficient frequency or severity to be Task Force (USPSTF) grades. Of note, none of the formulated perceived as troublesome by the patient (after assurance of practice recommendations were judged to be sufficiently un- their benign nature) do not meet the Montreal definition of equivocal to be proposed as performance measures for gauging a symptomatic esophageal GERD syndrome. quality of care. 2. What Is the Efficacy of Lifestyle Modifications for GERD? Which Elements Diagnosis and Initial Therapy Should Be Recommended and in Which 1. What Is an Operational Definition of Circumstances? GERD? What Is the Distinction Between GERD and Episodic Heartburn? Grade B: recommended with fair evidence that it There can be no criterion standard definition of improves important outcomes GERD because the threshold distinction between physio- logic reflux and reflux disease is ultimately arbitrary. Hence, I. Weight loss should be advised for overweight or obese these questions can only be answered by opinion (USPSTF patients with esophageal GERD syndromes. AGA INSTITUTE grade not applicable). Fortuitously, a recent consensus in defining GERD (the Montreal consensus) emanated from a panel of world experts. The Montreal definition was © 2008 by the AGA Institute adopted in the technical review as a suitable framework 0016-5085/08/$34.00 upon which to build management recommendations. The doi:10.1053/j.gastro.2008.08.045 Prioritization Methodology

Rank Order of Health Care Categories

1) Maternity & Newborn Care (100) - Obstetrical care for pregnancy. Prenatal care; delivery services; postpartum care; newborn care for conditions intrinsic to the pregnancy.

2) Primary Prevention and Secondary Prevention (95) - Effective preventive services used prior to the presence of disease and screenings for the detection of diseases at an early stage. Immunizations; fluoride treatment in children; mammograms; pap smears; blood pressure screening; well child visits; routine dental exams.

3) Chronic Disease Management (75) - Predominant role of treatment in the presence of an established disease is to prevent an exacerbation or a secondary illness. Medical therapy for diabetes mellitus, asthma, and hypertension. Medical/psychotherapy for schizophrenia.

4) Reproductive Services (70) - Excludes maternity and infertility services. Contraceptive management; vasectomy; tubal occlusion; tubal ligation.

5) Comfort Care (65) - Palliative therapy for conditions in which death is imminent. Hospice care; pain management.

6) Fatal Conditions, Where Treatment is Aimed at Disease Modification or Cure (40) - Appendectomy for appendicitis; medical & surgical treatment for treatable cancers; dialysis for end-stage renal disease; medical therapy for stroke; medical/psychotherapy for single episode major depression.

7) Nonfatal Conditions, Where Treatment is Aimed at Disease Modification or Cure (20) - Treatment of closed fractures; medical/psychotherapy for obsessive-compulsive disorders; medical therapy for chronic sinusitis.

8) Self-limiting conditions (5) - Treatment expedites recovery for conditions that will resolve on their own whether treated or not. Medical therapy for diaper rash, acute conjunctivitis and acute pharyngitis.

9) Inconsequential care (1) - Services that have little or no impact on health status due to the nature of the condition or the ineffectiveness of the treatment. Repair fingertip avulsion that does not include fingernail; medical therapy for gallstones without cholecystitis, medical therapy for viral warts.

Impact Healthy Life Years + Impact on Suffering Need for + Population Effects X Effectiveness X Service + Vulnerable of Population Affected + Tertiary Prevention (categories 6 & 7 only)

1 Prioritization Methodology

Population and Individual Impact Measures

Impact on Health Life Years - to what degree will the condition impact the health of the individual if left untreated, considering the median age of onset (i.e., does the condition affect mainly children, where the impacts could potentially be experienced over a person’s entire lifespan)? Range of 0 (no impact) to 10 (high impact).

Impact on Suffering - to what degree does the condition result in pain and suffering? Effect on family members (e.g. dealing with a loved one with Alzheimer’s disease or needing to care for a person with a life-long disability) should also be factored in here. Range of 0 (no impact) to 5 (high impact).

Population Effects - the degree to which individuals other than the person with the illness will be affected. Examples include public health concerns due the spread of untreated tuberculosis or public safety concerns resulting from untreated severe mental illness. Range of 0 (no effects) to 5 (widespread effects).

Vulnerability of Population Affected - to what degree does the condition affect vulnerable populations such as those of certain racial/ethnic decent or those afflicted by certain debilitating illnesses such as HIV disease or alcohol & drug dependence? Range of 0 (no vulnerability) to 5 (high vulnerability).

Tertiary Prevention - in considering the ranking of services within new categories 6 and 7, to what degree does early treatment prevent complications of the disease (not including death)? Range of 0 (doesn’t prevent complications) to 5 (prevents severe complications).

Effectiveness - to what degree does the treatment achieve its intended purpose? Range of 0 (no effectiveness) to 5 (high effectiveness).

Need for Medical Services - the percentage of time in which medical services would be required after the diagnosis has been established. Percentage from 0 (services never required) to 1 (services always required).

Net Cost - the cost of treatment for the typical case (including lifetime costs associated with chronic diseases) minus the expected costs if treatment is not provided -- including costs incurred through safety net providers (e.g., emergency departments) for urgent or emergent care related to the injury/illness or resulting complications. Range of 0 (high net cost) to 5 (cost saving).

2 DRAFT Scoring Criteria for the HSC Individual and Population Health Impact Measures

Impact on Healthy Life Years 0 – No impact on health 1 – Nonfatal with a marginal impact on health 2 – Nonfatal with a modest impact on health 3 – Nonfatal with a low probability of a significant residual effect or a high probability of a residual effect with a moderate impact on health 4 – Nonfatal with low probability (<20%) of significant disability or at least a moderate probability of a significant residual effect 5 – Nonfatal, but at least moderate (>20%) probability of significant disability (e.g., blindness); Low fatality with onset in elderly 6 – Moderately fatal with onset in elderly; low fatality with onset in middle age 7 – Highly fatal with onset in elderly; moderately fatal with onset in middle age; low fatality with onset in young adulthood 8 – Highly fatal with onset in middle aged; moderately fatal with onset in young adulthood; low fatality with onset in childhood/newborn 9 – Highly fatal with onset in young adulthood; moderately fatal with onset in childhood/newborn 10 – Highly fatal with onset in childhood/newborn

Impact on Pain and Suffering 0 – No impact on pain or suffering 1 – Intermittent pain of moderate level or frequent pain of low level and/or low level of suffering of the individual, immediate family or caregiver 2 – Frequent pain of moderate level or constant pain of low level and/or modest level of suffering of the individual, immediate family or caregiver 3 – Intermittent pain of high level or constant pain of moderate level and/or moderate level of suffering of the individual, immediate family or caregiver 4 – Frequent pain of high level and/or high level of suffering of the individual, immediate family or caregiver 5 – Constant pain of high level and/or extreme suffering of the individual, immediate family or caregiver

Population Effects 0 – No impact on population health 1 – Nontreatment would result in limited spread of a significant nonfatal disease or have a low impact on population safety (e.g. due to the nontreatment of a mental health condition) 2 – Nontreatment would result in a moderate spread of a significant nonfatal disease or have a modest impact on population safety 3 – Nontreatment would result in a limited spread of a potentially fatal disease or a wide spread of a significant nonfatal disease or have a moderate impact on population safety 4 – Nontreatment would result in a moderate spread of a potentially fatal disease or have a high impact on population safety 5 – Nontreatment would result in a wide spread of a potentially fatal disease or have a very high impact on population safety Impact on Vulnerable Populations 0 – No impact on vulnerable populations 1 – Somewhat disproportionate impact of a condition with a moderate impact on health on one or more vulnerable populations (does not include men, women, children or pregnant women considered as separate populations or low-income individuals, since methodology is only being applied to Medicaid population at this point) 2 – Moderately disproportionate impact of a condition with a moderate impact on health on one or more vulnerable populations 3– Somewhat disproportionate impact of a condition with a significant impact on health on one or more vulnerable populations 4 – Moderately disproportionate impact of a condition with a significant impact on health on one or more vulnerable populations 5 – Highly disproportionate impact of a condition with a significant impact on health on one or more vulnerable populations

Tertiary Prevention 0 – No tertiary prevention provided by treatment and early treatment does not prevent progression of the disease 1 – Treatment will prevent of moderate complication and/or early treatment may prevent progression of the disease resulting in a moderate impact on health 2 – Low to modest likelihood that treatment will prevent a significant complication or prevent progression of the disease resulting in significant impact on health 3 –Moderate to high likelihood that treatment will prevent a significant complication or prevent progression of the disease resulting in significant impact on health 4 – Low to modest likelihood that treatment will prevent severely debilitating complication and/or early treatment with prevent progression of disease leading to severe disability or death 5 – Moderately to high likelihood that treatment will prevent severely debilitating complication and/or early treatment with prevent progression of disease leading to severe disability or death

Effectiveness 0 – No demonstrated effectiveness (<5%) or causes harm 1 - Achieves desired result in 5-25% of cases 2 - Achieves desired result in 25-50% of cases 3 – Achieves desired result in 60-75% of cases 4 – Achieves desired result in 75-95% of cases 5 – Achieves desired result in 95+% of cases

Net Cost 0 – Very high cost (>$100,000) 1 – High cost ($20,000-$100,000) 2 – Moderate cost ($5,000-$20,000) or higher cost somewhat offset by cost of treatment alternative 3 – Modest cost ($1,000-$5,000) or higher cost significantly offset by cost of treatment alternative 4 – Low cost (<$1,000) or higher cost nearly offset by cost of treatment alternative 5 – Cost savings Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary

Question: How should tympanostomy tubes for hearing loss in chronic otitis media be addressed, given the noncoverage of this service on line 502?

Question source: DMAP, Medical Directors, and community providers seeking to clarify impact of 13 line reduction

Issue: DMAP, staff and Medical Directors have received a number of questions from community providers about the impact of the new noncoverage of Line 502 Chronic Otitis Media. Previously, tympanostomy tubes were covered for OHP patients on line 502 with the diagnosis of chronic otitis media and the limitations in guideline note 51. This is no longer a covered line. Tympanostomy tubes are also specified to be covered on line 383. This line is not associated with a guideline clarifying when tympanostomy tubes are covered or not. The net effect of the 13 line reduction, with this issue, is that it is unlikely any reduction in coverage of tympanostomy tubes would occur, and the cost savings associated with the line reduction would not materialize. Currently, for conductive hearing loss, there are no limitations at all for tympanostomy tubes, leaving coverage broader than it was before if hearing loss codes are used. Line 502 ranked so low (and the reason that chronic otitis media is one of those lines that is no longer covered in the budget shortfall environment) is because there is only short term benefit for hearing loss with TM tubes, any advantage of having the procedure dissipates by 12 months, and there is not evidence that tubes have an effect on speech, language, or cognitive development.

January 1, 2012 Prioritized List Status

CPT Code 69436 Tympanostomy (requiring insertion of ventilating tube), general anesthesia

Line: 383 Condition: HEARING LOSS - AGE 5 OR UNDER (See Coding Specification Below) (See Guideline Notes 64,65,76) Treatment: MEDICAL THERAPY INCLUDING HEARING AIDS ICD-9: 388.00,388.02-388.2,388.4-388.5,388.8,389,V53.2 CPT: 69424-69436,69714,69715,92590-92595,92597,98966-98969,99051,99060,99070,99078,99201- 99360,99366, 99374,99375,99379-99444,99468-99480,99605-99607 HCPCS: G0406-G0408,G0425-G0427,S0270-S0274

CPT Code 69436 is included on this line only as treatment for conductive hearing loss (389.0,389.2).

Line: 418 Condition: ACUTE OTITIS MEDIA (See Guideline Notes 29,64,65,76) Treatment: MEDICAL AND SURGICAL TREATMENT ICD-9: 381.0,381.51,381.8-381.9,382.0,382.4-382.9,384.0,993.0 CPT: 69210,69420-69436,98966-98969,99051,99060,99070,99078,99201- 99360,99366,99374,99375,99379-99444, 99468-99480,99605-99607 HCPCS: G0406-G0408,G0425-G0427,S0270-S0274 Line: 502 Condition: CHRONIC OTITIS MEDIA (See Guideline Notes 51,64,65,76) Treatment: PE TUBES/ADENOIDECTOMY/TYMPANOPLASTY, MEDICAL THERAPY ICD-9: 380.5,381.1-381.8,382.1-382.3,383.1-383.2,383.30-383.31,383.9,384.2-384.9 CPT: 42830-42836,69210-69222,69310,69400-69511,69601- 69650,69700,69801,69802,69905,69910,69979,92562- 92565,92571-92577,92590,92591,98966-98969,99051,99060,99070,99078,99201- 99360,99366,99374,99375,

Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary Page 1 Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary

99379-99444,99468-99480,99605-99607 HCPCS: G0406-G0408,G0425-G0427,S0270-S0274 Line: 590 Condition: CONDUCTIVE HEARING LOSS Treatment: AUDIANT BONE CONDUCTORS ICD-9: 389.0,389.2 CPT: 69710,69711,92562-92565,92571-92577,92590,92591

GUIDELINE NOTE 29, TYMPANOSTOMY TUBES IN ACUTE OTITIS MEDIA Line 418 Tympanostomy tubes (69436) are only included on this line as treatment for 1) recurrent acute otitis media (three or more episodes in six months or four or more episodes in one year) that fail appropriate medical management, 2) for patients who fail medical treatment secondary to multiple drug allergies or who fail two or more consecutive courses of antibiotics, or 3) complicating conditions (immunocompromised host, meningitis by lumbar puncture, acute mastoiditis, sigmoid sinus/jugular vein thrombosis by CT/MRI/MRA, cranial nerve paralysis, sudden onset dizziness/vertigo, need for middle ear culture, labyrinthitis, or brain abscess). Patients with craniofacial anomalies, Down’s syndrome, cleft palate, and patients with speech and language delay may be considered for tympanostomy with their first episode of acute otitis media.

GUIDELINE NOTE 51, CHRONIC OTITIS MEDIA WITH EFFUSION Line 502 Antibiotic and other medication therapy are not indicated for children with chronic otitis media with effusion (OME). Children with chronic OME present for 3 months or longer or with language delay, learning problems, or significant hearing loss at any time should have hearing testing. Children with chronic OME who are not at risk should be reexamined at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected.

For the child who has had chronic OME and who has a hearing deficiency in the better- hearing ear of 25 dB or greater, myringotomy with tube insertion recommended after a total of 4 to 6 months of effusion with a documented hearing deficit.

Adenoidectomy is an appropriate surgical treatment for chronic OME in children over 3 years with their second set of tubes. First time tubes are not an indication for an adenoidectomy.

MED Report, 2010 1) Evidence review evaluating the benefits and harms, indications, and therapies offered prior to pressure equalization tubes (or tympanostomy tubes, or Grommet tubes) in children under 5 years of age 2) Conclusions: a. Pressure equalization tubes decrease the duration of middle ear effusion (consistent evidence) b. PETs provide short-term (three to six month) improvements in hearing but this advantage dissipates by 12 months c. There are not consistent benefits in speech, or language from the use of PET tubes 3) Subgroups who may benefit more:

Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary Page 2 Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary

a. Children with baseline language or other developmental delays and hearing loss may benefit from earlier PET placement b. children with poor baseline hearing (ie >25 dB) c. children in daycare. d. 4) Cost: PET tubes are associated with higher cost for follow up (in addition to the procedure) 5) Complications: otorrhea, and otosclerosis (clinical significance uncertain)

Cochrane, 2010 1) Systematic review of randomized controlled trials 2) N= 10 trials with 1728 participants 3) Some randomized children, other trials randomized ears 4) Results: studies randomizing children a. At 3 months, mean hearing level was 12 dB better (95% CI 10 to 14 dB) in those treated with grommets as compared to the controls (based on 1 study) b. At 6-9 months, metanalysis of 3 studies found a benefit of 4 dB (95% CI 2 to 6 dB) c. At 12-18 months, no differences in mean hearing levels were found. 5) Results: studies randomizing ears (N= 230) a. At 4-6 months mean hearing level was 10 dB better in the grommet ear (95% CI 5 to 16 dB) b. At 7 to 12 months hearing level was 6 dB (95% CI 2 to 10 dB) better in the grommet ear c. At 18 to 24 months was 5 dB (95% CI 3 to 8 dB) better in the grommet ear 6) Clinical impact: No effect was found on language or speech development or for behaviour, cognitive or quality of life outcomes. 7) Adverse effects: a. 1/3 of ears receiving grommets had tympanosclerosis was seen in about a third of ears that received grommets b. Otorrhoea was common in infants, but in older children (three to seven years) occurred in < 2% of grommet ears over two years of follow up 8) Authors conclusions: “In children with OME the effect of grommets on hearing, as measured by standard tests, appears small and diminishes after six to nine months by which time natural resolution also leads to improved hearing in the non-surgically treated children. No effect was found on other child outcomes but data on these were sparse. No study has been performed in children with established speech, language, learning or developmental problems so no conclusions can be made regarding treatment of such children.” National Guidelines NICE, 2008 1) Children who will benefit from surgical intervention Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) should be considered for surgical intervention. • Once a decision has been taken to offer surgical intervention for OME in children, insertion of ventilation tubes is recommended. Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms.

Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary Page 3 Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary

• Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention where surgery is contraindicated or not acceptable.

Summary Tympanostomy tubes for chronic otitis media with effusions now fall below the funding region at Line 502. Because of a lack of guideline on Line 383, this condition-treatment could inadvertently now be covered if the diagnosis used is for hearing loss (without any type of guideline i.e. a 1 dB hearing loss would qualify) on Line 383. Guidance is necessary to clarify when it is appropriate for tympanostomy tubes with hearing loss.

The evidence still demonstrates no effectiveness of myringotomy tubes on learning, cognitive function, speech or quality of life. This (and the fact that there are few other treatments) contributes to the relatively low prioritization of OME. There is no good data on children with established speech and language impairment. HSC Staff Recommendation 1) Clarify intent (for Medical Directors and DMAP purposes) that until changes go into effect on October 1, 2012, the HERC intent is for Guideline Note 51, to provide parameters for tympanostomy tubes applying to 383. 2) For October 1, 2012 Prioritized List, consider adopting the following option: Option 1: Line 383 a. Remove CPT code 69436 b. Remove coding specification “CPT Code 69436 is included on this line only as treatment for conductive hearing loss (389.0,389.2)”

Option 2 (consider limiting coverage to those who may clearly have a greater chance of benefit, although based on limited evidence) a. Leave tympanostomy code on Line 383 b. Change coding specification to: “CPT code 69436 is included on this line only as a treatment in those with all of the following: i. documented speech or language delay ii. chronic otitis media with effusion persistent after a total of 4 to 6 months iii. hearing deficiency in the better-hearing ear of 25 dB or greater

Otitis Media, Hearing Loss, and Tympanostomy Tubes Issue Summary Page 4

MEDICAID EVIDENCE-BASED DECISIONS PROJECT (MED)

Rapid Review

Pressure Equalization Tubes in Children

July 28, 2010

This report was written by Rachel Effros, MD. MPH on behalf of the Center for Evidence-based Policy (the Center). at Oregon Health & Science University The Center is a policy resource and is not providing any legal or business advice. This Report is intended for the benefit of the Medicaid Evidence-based Decisions Project participant organizations and their constituent decision-making bodies. This report is not a Policy Statement of the Center for Evidence-based Policy.

Center for Evidence-based Policy Oregon Health & Science University 3455 SW US Veterans Hospital Road, Mailstop SN-4N, Portland, OR 97239-2941 503.494.2182 Fax 503.494.3807 http://www.ohsu.edu/ohsuedu/research/policycenter/med/index.cfm

Executive Summary

Otitis media is one of the most frequent infections in children and is a leading cause of both visits to the physician and use of antibiotics in this population. The direct costs of otitis media are estimated at $3-5 billion per year in the US. Recurrent infections or chronic fluid in the middle ear can cause hearing deficits, and there is concern that in a rapidly developing child, this could lead to language and other developmental problems.

Pressure equalization tubes (PET) are small plastic or metal tubes that are surgically inserted into the tympanic membrane to allow for drainage of the fluid from the middle ear with the goal of improved hearing. The hope is that if hearing is improved, then language and other developments can be optimized. One of the challenges of determining which children require PET placement is that not all middle ear disease is associated with hearing loss and even the presence of a mild to moderate hearing loss from a middle ear effusion does not necessarily translate into later speech or language delays in children. Further, the high rates of spontaneous resolution of both acute otitis media and middle ear effusions, and the fact that most PET only remain in the ear drum for 6-12 months, may lessen the potential benefit of PET insertion.

Methods We conducted a comprehensive search of the MED core sources for systematic reviews (SRs), technology assessments (TAs), and randomized controlled trials (RCTs) published between January 1, 1999 through March 19, 2010. We reviewed the reference lists of included articles, and conducted an expert librarian search of MEDLINE for the same date range. We also included relevant practice guidelines. Studies were assessed for quality and the overall strength of the evidence was rated for each key outcome.

Findings

Key Questions #1: What are the benefits and harms of PE tubes among children under five years of age? There is limited evidence in a small number of children with recurrent illness that PETs reduce the frequency of acute otitis media (AOM). There is more conclusive and consistent evidence that PETs decrease the duration of middle ear effusion over the first year. In addition, PETs provide short-term (three to six month) improvements in hearing but this advantage dissipates by 12 months. Overall, there does not seem to be consistent benefits in language and development as a result of PET placement for OME. The most common complication of PET appears to be otorrhea, which can result in increased use of oral or topical antibiotics. Tympanosclerosis and retraction pockets of the TM are also complications of PET, but their clinical significance remains uncertain. Limited evidence suggests that children with PET sustain higher costs in follow-up in addition to the costs of the procedure itself without consistent, measurable benefits in language and development.

1

Quick reference guide

Issue date: February 2008 Surgical management of otitis media with effusion in children

NICE clinical guideline 60 Developed by the National Collaborating Centre for Women’s and Children’s Health Surgical management of OME in children Key priorities for implementation

Key priorities for implementation

Diagnosis of OME G Formal assessment of a child with suspected OME should include: – clinical history taking, focusing on: poor listening skills; indistinct speech or delayed language development; inattention and behaviour problems; hearing fluctuation; recurrent ear infections or upper respiratory tract infections; balance problems and clumsiness; poor educational progress – clinical examination, focusing on: otoscopy; general upper respiratory health; general developmental status – hearing testing, which should be carried out by trained staff using tests suitable for the developmental stage of the child, and calibrated equipment – tympanometry.

Children who will benefit from surgical intervention G Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) should be considered for surgical intervention.

Surgical interventions G Once a decision has been taken to offer surgical intervention for OME in children, insertion of ventilation tubes is recommended. Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms.

Non-surgical interventions G The following treatments are not recommended for the management of OME: antibiotics; topical or systemic antihistamines; topical or systemic decongestants; topical or systemic steroids; homeopathy; cranial osteopathy; acupuncture; dietary modification, including probiotics; immunostimulants; massage. G Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention where surgery is contraindicated or not acceptable.

Management of OME in children with Down’s syndrome G Hearing aids should normally be offered to children with Down’s syndrome and OME with hearing loss.

Management of OME in children with cleft palate G Insertion of ventilation tubes at primary closure of the cleft palate should be performed only after careful otological and audiological assessment. G Insertion of ventilation tubes should be offered as an alternative to hearing aids in children with cleft palate who have OME and persistent hearing loss.

4 NICE clinical guideline 60 Quick reference guide Grommets (ventilation tubes) for recurrent acute otitis media in children (Review)

McDonald S, Langton Hewer CD, Nunez DA

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 6 http://www.thecochranelibrary.com

Grommets (ventilation tubes) for recurrent acute otitis media in children (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Grommets (ventilation tubes) for recurrent acute otitis media in children

Stephen McDonald1, Claire D Langton Hewer1, Desmond A Nunez2

1ENT Department, St Michael’s Hospital, University Hospitals Bristol NHS Trust, Bristol, UK. 2Academic Department of Otolaryn- gology, Southmead Hospital, Bristol, UK

Contact address: Stephen McDonald, ENT Department, St Michael’s Hospital, University Hospitals Bristol NHS Trust, Southwell Street, Bristol, BS2 8EG, UK. [email protected]. [email protected].

Editorial group: Cochrane Ear, Nose and Throat Disorders Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 6, 2011. Review content assessed as up-to-date: 10 January 2011.

Citation: McDonald S, Langton Hewer CD, Nunez DA. Grommets (ventilation tubes) for recurrent acute otitis media in children. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004741. DOI: 10.1002/14651858.CD004741.pub2.

Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

Background

This is an update of a Cochrane Review first published in The Cochrane Library in Issue 4, 2008.

Acute suppurative otitis media is one of the most common infectious diseases in childhood. Recurrent acute otitis media is defined for the purposes of this review as either three or more acute infections of the middle ear cleft in a six-month period, or at least four episodes in a year. Strategies for managing the condition include the assessment and modification of risk factors where possible, repeated courses of antibiotics for each new infection, antibiotic prophylaxis and the insertion of ventilation tubes (grommets).

Objectives

To establish whether grommet insertion reduces the frequency of episodes of recurrent acute otitis media and the proportion of children with symptoms of ear disease.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 11 January 2011.

Selection criteria

Randomised controlled trials comparing grommet insertion versus control (antibiotics/other treatments/no treatment) for recurrent acute otitis media in children aged from 0 to 16 years.

Data collection and analysis

Two authors independently selected studies; three authors independently assessed study quality and extracted data. We synthesised data descriptively.

Grommets (ventilation tubes) for recurrent acute otitis media in children (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results Two studies involving 148 children were included in the review. One of these studies, involving 95 children, showed that grommet insertion leads to a mean reduction of 1.5 episodes of acute otitis media in the first six months after treatment. This study also showed a significant increase in the proportion of children with no episodes of acute otitis media (P < 0.001) in the grommet group. The other included study also found a higher proportion of patients in the grommet group had no episodes of acute otitis media in the six months after intervention, but the difference did not reach statistical significance (P = 0.16). Authors’ conclusions Grommets have a significant role in maintaining a ’disease-free’ state in the first six months after insertion. Further research is required to investigate the effect beyond six months. Clinicians should consider the possible adverse effects of grommet insertion before surgery is undertaken.

PLAIN LANGUAGE SUMMARY Grommets (ventilation tubes) for recurrent acute otitis media in children Acute otitis media is a common disease of childhood, involving inflammation of the space behind the eardrum (the middle ear cleft). Episodes typically involve a fever and a build up of pus that stretches the eardrum causing severe pain. The drum may then rupture, relieving the pain, and a discharge of pus enters the ear canal. A small proportion of children suffer with recurrent acute otitis media, which is defined as either three or more acute infections of the middle ear cleft in a six-month period, or at least four episodes in a year. One of the strategies used to treat this condition is the insertion of a miniature plastic ventilation tube (or grommet) into the eardrum, which prevents the painful accumulation of pus in the middle ear. This review aims to assess the evidence for the effectiveness of this treatment in reducing recurrent acute otitis media. We searched for scientific studies which compared treating children with recurrent acute otitis media with either grommets or a non- surgical treatment such as antibiotics (or no treatment). In these studies, children with grommets in place were considered to have suffered an episode of acute otitis media if they had a discharge of pus from the ear. Two suitable studies were found to be suitable for further analysis. The combined results from these two studies suggested that more children treated with grommets are rendered symptom-free in the six months following surgery compared to those who receive other treatments or no treatment. One of the two included studies, involving 95 children, showed that grommets reduce the number of episodes of acute otitis media in the first six months after surgery, by an average of 1.5 episodes per child. When considering the size of this effect, it is important to bear in mind that the studies were not perfect in their design and execution. To be confident in these findings further high-quality research is required.

Grommets (ventilation tubes) for recurrent acute otitis media in children (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.