Obstetric Ultrasound (Including 3D, 4D, Standard, Limited, Comprehensive, Targeted and Follow-Up) Hs-002

OBSTETRIC ULTRASOUND (INCLUDING 3D, 4D, STANDARD, LIMITED, COMPREHENSIVE, TARGETED AND FOLLOW-UP) HS-002

Care1st Health Plan Arizona, Inc.

Easy Choice Health Plan Obstetric Ultrasound (including 3D, 4D, Standard, Limited, Harmony Health Plan of Illinois Comprehensive, Targeted and Missouri Care Follow-Up) ‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona Policy Number: HS-002 OneCare (Care1st Health Plan Arizona, Inc.)

Staywell of Florida Original Effective Date: 3/1/2007

WellCare (Arkansas, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi, Nebraska, New Jersey, Revised Date(s): 3/13/2008; 6/4/2009; New York, South Carolina, Tennessee, Texas) 6/18/2010; 8/12/2011; 5/3/2012; 8/9/2013; WellCare Prescription Insurance 8/7/2014; 8/6/2015; 11/3/2016; 10/5/2017

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

DISCLAIMER

The Clinical Coverage Guideline (CCG) is intended to supplement certain standard WellCare benefit plans and aid in administering benefits. Federal and state law, contract language, etc. take precedence over the CCG (e.g., Centers for Medicare and Medicaid Services [CMS] National Coverage Determinations [NCDs], Local Coverage Determinations [LCDs] or other published documents). The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this CCG. Additionally, CCGs relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. Providers are responsible for the treatment and recommendations provided to the member. The application of the CCG is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. All links are current at time of approval by the Medical Policy Committee (MPC) and are subject to change prior to the annual review date. Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com. All guidelines can be found at this site as well but selecting the Provider tab, then “Tools” and “Clinical Guidelines”.

BACKGROUND

Sixty to seventy percent of pregnant women in the United States receive an ultrasound examination during their pregnancy. The American College of Obstetricians and Gynecologists (ACOG) recommends that in low-risk pregnancies use of ultrasound generally be reserved for answering specific medical questions, rather than as a routine offering to all women. However, many health care providers recommend that one ultrasound examination, usually done between 16 and 20 weeks of pregnancy, be included as a routine part of prenatal care. The use of ultrasonography to test for potential fetal abnormalities, confirm the site of pregnancy within the uterus, and Clinical Coverage Guideline page 1

Original Effective Date: 3/1/2007 - Revised: 3/13/2008, 6/4/2009, 6/18/2010, 8/12/2011, 5/3/2012, 8/9/2013, 8/7/2014, 8/6/2015, 11/3/2016, 10/5/2017 OBSTETRIC ULTRASOUND (INCLUDING 3D, 4D, STANDARD, LIMITED, COMPREHENSIVE, TARGETED AND FOLLOW-UP) HS-002

determine gestational age is considered the standard of care.1,2

Types of Examinations. ACOG uses the terms “standard”, “limited”, and “specialized” to describe various types of ultrasound examinations performed during the second or third trimesters. Although the standard and limited examinations are defined by their components, the specialized examination is defined by the indications for the exam, that is, the circumstances that suggest a more thorough ultrasound exam is needed.1

3D and 4D Ultrasound. Three-dimensional (3D) ultrasound (US) is used to create both a surface image of the fetus in utero and cross-sectional images from any angle; images of extra-fetal and maternal structures can be created in a similar manner. In constructing the 3D US image, the software automatically records and stores the image as part of the process. The stored virtual 3D US image can be rotated for different surface views and cross sections from angles not available with two-dimensional (2D) US. This has potential use in detecting and diagnosing abnormalities in maternal and extra-fetal structures as well as in the developing fetus. Four-dimensional (4D) US, or real-time 3D US, can create many images per second, so that fetal motion can be observed in three dimensions. While use of 3D US and 4D US has been commercialized to create non-diagnostic “keepsake” images, the value of these detailed images for informing parental decision making and pregnancy and postpartum management is currently under investigation.3

Three-dimensional (3D) ultrasound (US) is achieved by stacking together multiple 2D US images or cross sections in the manner of tomography. Computer software converts these multiple 2D US images into a virtual 3D US volume. The pixels of the 2D US image (the smallest piece of digital information) are transformed into voxels of the 3D US image. The 2D US images can be acquired by moving the probe or scanner perpendicular to the 2D US planes or in a fanlike pattern, methods typically used for trans-abdominal (TA) images, or by rotation, used for transvaginal (TV) images.3

The appropriate scanner motion can be motorized, or can be done freehand, with a positional marker that synchronizes the 2D US planes. Entirely freehand acquisition can also be done, but this method is not precise enough for carrying out measurements. A single scan of the complete volume can take a few seconds for highest spatial resolution, but the latest instruments can carry out 20 or more scans per second for 4D US motion studies. A cine-loop capability allows repeated viewing of real-time motion. The virtual volume is recorded and stored in a computer. The information can be transferred to hard disks or transported electronically to distant locations. Although the volume is acquired in a matter of seconds, it is available for manipulation and study at length.1

Standard Examination. A standard exam is performed during the second or third trimester of pregnancy. ACOG states that fetal anatomy can be assessed adequately after approximately 16-20 weeks of gestation. A more detailed fetal anatomic examination may be necessary if an abnormality or suspected abnormality is found on the standard examination. If a trans-abdominal examination is not definitive or conclusive, a transvaginal examination is indicated.1

Limited Examination. In most cases, a limited examination is appropriate only when the patient has had a prior complete examination. A limited examination is performed when a specific question requires investigation. The request for limited ultrasound must be accompanied by a specific reason that documents medical necessity (i.e. no fetal movement felt by patient; vaginal bleeding episode; questionable breech or presentation other than cephalic on pelvic exam, guidance for amniocentesis or CVS by abdominal or vaginal route).

Specialized Examination (Detailed or Targeted Anatomic Examination). ACOG stated that a detailed or targeted anatomic examination may be necessary when an anomaly is suspected on the basis of history, biochemical abnormalities or clinical evaluation, or suspicious results from either the limited or standard ultrasound examination.1

The Society for Maternal-Fetal Medicine (SMFM) stated that a fetal ultrasound with detailed anatomic examination is not necessary as a routine scan for all pregnancies; the scan is necessary for a known or suspected fetal anatomic or genetic abnormality. The SMFM stated that the performance of this scan is expected to be rare outside of referral practices with special expertise in the identification of, and counseling about, fetal abnormalities.4

Clinical Coverage Guideline page 2

SMFM has also determined that no more than one fetal ultrasound with detailed anatomic examination is necessary per pregnancy, per practice, when medically necessary.4 Once this detailed fetal anatomical exam is done, a second one should not be performed unless there are extenuating circumstances with a new diagnosis. The SMFM has stated that it is appropriate to repeat the detailed fetal anatomical ultrasound examination when a patient is seen by another maternal-fetal medicine specialist practice for a second opinion on a fetal anomaly, or if the patient is referred to a tertiary center in anticipation of delivering an anomalous fetus at a hospital with specialized neonatal capabilities.

A focused ultrasound assessment is sufficient for follow-up to provide a reexamination of a specific organ or system known or suspected to be abnormal, or when doing a focused assessment of fetal size by measuring the bi-parietal diameter, abdominal circumference, femur length, or other appropriate measurements. An ultrasound without detailed anatomic examination is appropriate for a fetal maternal evaluation of the number of fetuses, amniotic/chorionic sacs, survey of intracranial, spinal and abdominal anatomy, evaluation of a 4-chamber heart view, assessment of the umbilical cord insertion site, assessment of amniotic fluid volume, and evaluation of maternal adnexa when visible and appropriate.4

Other specialized examinations include fetal Doppler, biophysical profile, fetal echocardiography, or additional biometric studies. For example, a fetal Doppler examination would be appropriate if Intrauterine Growth Restriction (IUGR) is diagnosed. Specialized examinations are performed by an operator with experience and expertise in such ultrasonography who determines the components of the examination on a case-by-case basis.1

Position Statements. ACOG states that ultrasonography is an accurate method of determining gestational age, fetal number, viability and placental location. In addition, ACOG endorses the “prudent use” of ultrasonography and discouraging its non-medical use.1

POSITION STATEMENT

Applicable To: Medicaid – Georgia, Hawaii Medicare – California (Easy Choice), Hawaii

NOTE: For all other lines of business, please refer to the current contracted vendor for Radiology requests.

Use of three-dimensional and four-dimensional ultrasound techniques are considered NOT medically necessary for all indications.

The following types of obstetric ultrasound are considered medically necessary for the following indications:

A. CPT 76801 Limited OB Ultrasound (< 14 weeks gestation) 76802+ each additional gestation 76805 Standard Ultrasound (> 14 weeks gestation) 76810+ each additional gestation

Note: Generally performed one time during current pregnancy

Indications 1. To confirm the presence of an intrauterine pregnancy vs. ectopic pregnancy 2. To define the cause of vaginal bleeding 3. To evaluate pelvic pain 4. To estimate gestational age 5. To diagnose or evaluate multiple gestations 6. To confirm cardiac activity after failed attempt with portable Doppler 7. As an adjunct to chronic villous sampling (CVS) 8. To evaluate suspected hydatidiform mole

Clinical Coverage Guideline page 3

B. CPT 76811 Comprehensive/Targeted OB Ultrasound (> 14 weeks gestation) 76812+ each additional gestation

Note: Generally performed one time during current pregnancy unless there is documentation justifying a repeat procedure Note: Will be covered if performed by a registered diagnostic medical sonographer (RDMS) under direct supervision by a physician with specialized training or experience in the subject including a perinatologist and a pediatric cardiologist

Indications 1. Suspected fetal anomaly or documented marker for aneuploidy during a standard examination (76805) 2. IUGR (EFW < 10%tile growth), elevated maternal serum AFP, abnormal first trimester screen or multiple marker screen (MMS) 3. Polyhydramnios (AFI) > 24 cm or a single pocket of fluid at least 8 cm in depth 4. 2-vessel umbilical cord detected at standard OB ultrasound 5. Fetal cardiac arrhythmias 6. Significant exposure to drugs or chemicals which are known or suspected teratogens in the first trimester 7. Exposure to radiation >5 rads in the first trimester 8. Finding of pyelectasis on standard OB ultrasound 9. Abnormal fetal karyotype 10. Advanced maternal age (age 35 and above at time of delivery) 11. Multiple gestation 12. Other specified viral, infectious and parasitic diseases complicating pregnancy 13. Congenital cardiovascular disorders complicating pregnancy 14. Hereditary disease in family FIRST DEGREE PARENT possibly affecting fetus 15. Rh isoimmunization and/or isoimmunization from other and unspecified blood-group incompatibility 16. Diabetes mellitus 17. Unspecified obstetrical trauma 18. Oligohydramnios (AFI < 5cm or the absence of a fluid pocket 2 cm in depth)

C. CPT 76815 Limited OB Ultrasound (> 14 weeks gestation) 76816 Follow-Up OB Ultrasound (> 14 weeks gestation)

Indications for a Limited OB Ultrasound 1. No fetal movement or decreased fetal movement > 24 weeks gestation 2. Vaginal bleeding 3. Verifying fetal presentation in patient who is in labor outside of the hospital or >35 weeks gestation 4. Pelvic pain in pregnancy 5. Assessment of amniotic fluid volume in cases of oligohydramnios (AFI < 5cm or the absence of a fluid pocket 2 cm in depth) and polyhydramnios (AFI) > 24 cm or a single pocket of fluid at least 8 cm in depth 6. Placental localization in cases of suspected previa 7. Evaluation of certain placental abnormalities (abruption) 8. Follow-up of growth of uterine fibroids (submucosal/intramural interfering with intrauterine growth) 9. Patients with uncertain dates

Indications for a follow-up OB ultrasound 1. Serial growth assessment in cases of documented IUGR (frequency no less than every 3 weeks) 2. Size/dates discrepancy (small for gestational age fetus, large for gestational age fetus) 3. Follow-up of detected fetal structural abnormalities 4. Follow-up by a MFM of poorly visualized fetal anatomic structures from a previous standard or targeted ultrasound examination 5. Multiple gestation 6. Maternal medical condition associated with risk of poor fetal growth with size dates discordance (hypertension, chronic renal disease, connective tissue disorder, diabetes mellitus (uncontrolled pregestational or gestational), antiphospholipid antibody syndrome, inflammatory bowel disease, severe malnutrition, hyperthyroidism) Clinical Coverage Guideline page 4

CODING

Covered CPT®* Codes 76801 Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, first trimester (<14 weeks 0 days), transabdominal approach; single or first gestation 76802+ Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, first trimester (<14 weeks 0 days), transabdominal approach; each additional gestation +(List separately in addition to code for primary procedure) 76805 Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, after first trimester (> or = 14 weeks 0 days), transabdominal approach; single or first gestation 76810+ Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, after first trimester (> or = 14 weeks 0 days), transabdominal approach; each additional gestation +(List separately in addition to code for primary procedure) 76811 Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation plus detailed fetal anatomic examination, transabdominal approach; single or first gestation 76812+ Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation plus detailed fetal anatomic examination, transabdominal approach; each additional gestation +(List separately in addition to code for primary procedure) 76815 Ultrasound, pregnant uterus, real time with image documentation, limited (e.g., fetal heart beat, placental location, fetal position and/or qualitative amniotic fluid volume), one or more fetuses 76816 Ultrasound, pregnant uterus, real time with image documentation, follow-up (e.g., re-evaluation of fetal size by measuring standard growth parameters and amniotic fluid volume, re-evaluation of organ system(s) suspected or confirmed to be abnormal on a previous scan), transabdominal approach, per fetus 76817 Ultrasound, pregnant uterus, real time with image documentation, transvaginal

HCPCS Codes - No applicable codes.

Covered ICD-10-PCS Code BY49ZZZ - B94GZZZ Imaging, Fetus/Obstetrical, Ultrasonography

ICD-10-CM Diagnosis Codes O09.10 – O09.13 Supervision of pregnancy with history of ectopic or molar pregnancy O09.511 – O09-523 Supervision of elderly primagravida and multigravida O10.011 - O10.013 Pre-existing essential hypertension complicating pregnancy O10.111 - O10.113 Pre-existing hypertensive heart disease complicating pregnancy, O10.211 - O10.213 Pre-existing hypertensive chronic kidney disease complicating pregnancy O10.311 - O10.313 Pre-existing hypertensive heart & chronic kidney disease complicating pregnancy, O10.411 - O10.413 Pre-existing secondary hypertension complicating pregnancy O10.911 - O10.913 Unspecified Pre-existing hypertension complicating pregnancy O11.1 - O11.3 Pre-existing hypertension with pre-eclampsia O20.8 Other hemorrhage in early pregnancy O20.9 Hemorrhage in early pregnancy, unspecified O24.011 - O24.93 Diabetes mellitus in pregnancy O25.11 – O25.13 Malnutrition in pregnancy O28.3 Abnormal ultrasonic finding on antenatal screening of mother O28.4 Abnormal radiological finding on antenatal screening of mother O28.5 Abnormal chromosomal and genetic finding on antenatal screening of mother O28.8 Other abnormal findings on antenatal screening of mother O30.001 - O30.293 Multiple gestation O31.11x0 – O31.11x2 Continuing pregnancy after spontaneous abortion of one fetus or more O31.12x0 – O31.12x2 Continuing pregnancy after spontaneous abortion of one fetus or more O31.13x0 – O31.13x2 Continuing pregnancy after spontaneous abortion of one fetus or more O31.21x0 – O31.21.x2 Continuing pregnancy after intrauterine death of one fetus or more, first trimester Clinical Coverage Guideline page 5

O31.22x0 – O31.22x2 Continuing pregnancy after intrauterine death of one fetus or more, second trimester O31.23x0 - O31.23.2 Continuing pregnancy after intrauterine death of one fetus or more, third trimester O32.0XX0 - O33.9 Maternal care for malpresentation of fetus O34.01 - O34.93 Maternal care for abnormality of pelvic organs O35.0XX0 - O35.9XX9 Maternal care for known or suspected fetal abnormality and damage O36.0110 - O36.93X9 Maternal care for other fetal problems O40.1XX0 - O40.3XX9 Polyhydramnios O41.01X0 - O41.03X9 Oligohydramnios O44.00 - O44.03 Complete placenta previa NOS or without hemorrhage O44.10 - O44.13 Placenta previa with hemorrhage Complete placenta previa with hemorrhage O45.001 - O45.93 Premature separation of placenta [abruption placentae] O46.001 - O46.93 Antepartum Hemorrhage, not elsewhere classified O68 Labor and delivery complicated by abnormality of fetal acid-base balance O69.89x0 Labor and delivery complicated by other cord complications, not applicable or unspecified O71.89 Other specified obstetric trauma O76 Abnormality in fetal heart rate and rhythm complicating labor and delivery O98.411 - O98.413 Viral hepatitis complicating pregnancy O98.511 - O98.513 Other viral diseases complicating pregnancy O98.611 - O98.613 Protozoal diseases complicating pregnancy O98.711 – O98.713 Human immunodeficiency virus (HIV) disease complicating pregnancy O98.811 – O98.813 Other maternal infectious and parasitic diseases complicating pregnancy O99.281 – O99.283 Endocrine, nutritional and metabolic diseases complicating pregnancy O99.321 - O99.323 Drug use complicating pregnancy O99.411 - O99.413 Disease of circulatory system complicating pregnancy O99.511 – O99.513 Diseases of the respiratory system complicating pregnancy O99.611 – O99.613 Disease of the digestive system complicating pregnancy O99.711 – O99.713 Disease of the skin and subcutaneous tissue complicating pregnancy O99.810 Abnormal glucose complicating pregnancy O99.820 Streptococcus B carrier state complicating pregnancy O98.830 Other infection carrier state complicating pregnancy O9A.111 – O9A.113 Malignant neoplasm complicating pregnancy O9A.211 - O9A.213 Injury, poisoning and certain other consequences of external causes complicating pregnancy O9A.311- O9A.313 Physical abuse complicating pregnancy O9A.411 – O9A.413 Sexual abuse complicating pregnancy O9A.511 – O9A.513 Psychological abuse complicating pregnancy R93.5 Abnormal findings on diagnostic imaging of other abdominal regions, including retroperitoneum R90.89 Other abnormal findings on diagnostic imaging of central nervous system R89.8 Other abnormal findings in specimens from other organs, systems, and tissues R93.8 Abnormal findings on diagnostic imaging of other specified body structures Z36 Encounter for antenatal screening of mother

Coding information is provided for informational purposes only. The inclusion or omission of a CPT, HCPCS, or ICD-10 code does not imply member coverage or provider reimbursement. Consult the member's benefits that are in place at time of service to determine coverage (or non- coverage) as well as applicable federal / state laws.

REFERENCES

1. American College of Obstetricians and Gynecologists. ACOG practice bulletin: ultrasonography in pregnancy (no. 101). Obstetrics and Gynecology. 2009; 113(2 Pt 1): 451-461. 2. American College of Obstetricians and Gynecologists. Prenatal diagnosis of fetal chromosomal abnormalities (no. 77). Obstetrics and Gynecology. 2001; 97(5 Pt 1): suppl 1-12. 3. National coverage determination for ultrasound diagnostic procedures (220.5). Centers for Medicare and Medicaid Services Web site. Published May 22, 2007). http://www.cms.hhs.gov/mcd/search.asp. Accessed September 18, 2017. 4. Coding committee: white paper on ultrasound code 76811. Society for Maternal-Fetal Medicine Web site. http://www.smfm.org. Published Clinical Coverage Guideline page 6

May 2004. Accessed September 18, 2017.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

10/5/2017  Approved by MPC. No changes. 11/3/2016  Approved by MPC. Updated language regarding frequency. 8/6/2015  Approved by MPC. Updated coding and applicable markets. 8/7/2014  Approved by MPC. No changes. 8/9/2013  Reinstated for markets where CareCore is not a vendor. Renamed to include 3D and 4D Ultrasound (HS-109). 5/3/2012  Retired by MPC; covered by CareCore criteria. 12/1/2011  New template design approved by MPC. 8/12/2011  Approved by MPC. No changes.

Clinical Coverage Guideline page 7

Original Effective Date: 3/1/2007 - Revised: 3/13/2008, 6/4/2009, 6/18/2010, 8/12/2011, 5/3/2012, 8/9/2013, 8/7/2014, 8/6/2015, 11/3/2016, 10/5/2017