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

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1 Easy Choice Health Plan, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Inc. Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc. WellCare Health Insurance of Illinois, Inc. WellCare Health Plans of New Jersey, Inc. WellCare Health Insurance of Arizona, Inc. WellCare of Florida, Inc. WellCare of Connecticut, Inc. WellCare of Georgia, Inc. WellCare of Kentucky, Inc. WellCare of Louisiana, Inc. WellCare of New York, Inc. WellCare of Ohio, Inc. WellCare of South Carolina, Inc. WellCare of Texas, Inc. WellCare Prescription Insurance, Inc. Windsor Health Plan Windsor Rx Medicare Prescription Drug Plan Obstetric Ultrasound (including 3D, 4D, Standard, Limited, Comprehensive, Targeted and Follow-Up) Applies to AZ, HI, MO, NJ and SC only. Policy Number: Original Effective Date: 3/1/2007 Revised Date(s): 3/13/2008; 6/4/2009; 6/18/2010; 8/12/2011; 5/3/2012; 8/9/2013; 8/7/2014 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.

2 DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. 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 Clinical Coverage Guideline. When a conflict exists between the two documents, the Member s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. 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. Note: The lines of business (LOB) are subject to change without notice; consult for list of current LOBs. 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 1,2 determine gestational age is considered the standard of care. 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 1 that suggest a more thorough ultrasound exam is needed. 3D and 4D Ultrasound Three-dimensional (3D) ultrasound (US) is used to create both a surface image of the fetus in utero and crosssectional 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 3 under investigation. 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 3 transvaginal (TV) images. 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. 1 Although the volume is acquired in a matter of seconds, it is available for manipulation and study at length. Clinical Coverage Guideline page 2

3 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 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 1 or standard ultrasound examination. 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 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 adenexa 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- Clinical Coverage Guideline page 3

4 medical use. 1 POSITION STATEMENT Applicable To: Medicaid Florida, Georgia, Hawaii, Kentucky Medicare Easy Choice Health Plan, Florida, Georgia, Hawaii, Kentucky* For markets noted below, please refer to Care Core National Radiology / Imaging criteria (program effective August 2014) available at Medicaid Illinois, Missouri, New Jersey, New York, South Carolina Medicare - Arizona, Connecticut, Illinois, Louisiana, Missouri, New Jersey, New York, Ohio, Texas, Windsor * Kentucky pending state approval; CCG to be used until Care Core is effective in late 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 Limited OB Ultrasound (< 14 weeks gestation) each additional gestation CPT Standard Ultrasound (> 14 weeks gestation) 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 B. CPT Comprehensive/Targeted OB Ultrasound (> 14 weeks gestation) 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 Clinical Coverage Guideline page 4

5 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 Limited OB Ultrasound (> 14 weeks gestation) 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 evey 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, sever malnutrition, hyperthyroidism) CODING Covered CPT * Codes Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, first trimester (<14 weeks 0 days), transabdominal approach; single or first gestation 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) Clinical Coverage Guideline page 5

6 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 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) Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation plus detailed fetal anatomic examination, transabdominal approach; single or first gestation 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) 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 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 HCPCS Codes - No applicable codes ICD-9-CM Procedure Code Diagnostic Ultrasound of gravid uterus Draft 2013 ICD-10-PCS Codes BY49ZZZ - B94GZZZ Imaging, Fetus/Obstetrical, Ultrasonography Covered ICD-9-CM Diagnosis Codes Other specified hemorrhage in early pregnancy; antepartum condition or complication Unspecified hemorrhage in early pregnancy; antepartum condition or complication Placenta Previa without hemorrhage; antepartum condition or complication Placenta Previa with hemorrhage; antepartum condition or complication Placental Abruption; antepartum condition or complication Hemorrhage associated with coagulation defects; antepartum condition or complication Hemorrhage associated with trauma or uterine leiomyoma; antepartum condition or complication Benign Essential Hypertension; antepartum condition or complication Hypertension secondary to renal disease; antepartum condition or complication Other Pre-existing Hypertension; antepartum condition or complication Pre-Eclampsia or eclampsia superimposed on Pre-existing Hypertension; antepartum condition or complication Other viral diseases complicating pregnancy, antepartum condition or complication Other specified infectious and parasitic diseases complicating pregnancy, antepartum condition or complication Diabetes mellitus complicating pregnancy, antepartum condition or complication Drug dependence complicating pregnancy, antepartum condition or complication Congenital cardiovascular disorders complicating pregnancy, antepartum condition or complication Gestational Diabetes; abnormal glucose tolerance; antepartum condition or complication Other Current Conditions; antepartum condition or complication Twin pregnancy, antepartum condition or complication Triplet pregnancy, antepartum condition or complication Quadruplet pregnancy, antepartum condition or complication Twin pregnancy with fetal loss and retention of one fetus, antepartum condition or complication Triplet pregnancy with fetal loss and retention of one or more fetus(es), antepartum condition or complication Quadruplet pregnancy with fetal retention of one or more fetus(es), antepartum condition or complication Unstable lie; malposition and malpresentation of the fetus Breech presentation without mention of version converted to cephalic presentation Breech Presentation, unspecified Transverse or oblique presentation; malposition and malpresentation of the fetus Face or brow presentation; malposition and malpresentation of the fetus High head at term; malposition and malpresentation of the fetus Clinical Coverage Guideline page 6

7 Multiple gestations with malpresentation of one fetus or more Prolapsed arm malposition or malpresentation of the fetus Compound presentation or other specified malposition or malpresentation Hydrocephalic fetus causing disproportion; antepartum condition or complication Other fetal abnormality causing disproportion; antepartum condition or complication Congenital abnormalities of uterus; antepartum condition or complication Tumors of body of uterus; antepartum condition or complication Retroverted and incarcerated gravid uterus; antepartum condition or complication Other abnormalities in shape or position of gravid uterus and neighboring structures; antepartum condition or complication Central nervous system malformation in fetus; antepartum condition or complication Chromosomal abnormality in fetus; antepartum condition or complication Hereditary disease in family possibly affecting fetus; antepartum condition or complication Suspected damage to fetus from viral disease in the mother; antepartum condition or complication Suspected damage to fetus from other disease in the mother; antepartum condition or complication Suspected damage to fetus from drugs; antepartum condition or complication Suspected damage to fetus from radiation; antepartum condition or complication Decreased fetal movements Other known or suspected fetal abnormality, not elsewhere classified; antepartum condition or complication Unspecified known or suspected fetal abnormality affecting management of mother, antepartum condition or complication Rhesus isoimmunization complicating pregnancy, antepartum condition or complication Isoimmunization from other and unspecified blood-group incompatibility; antepartum condition or complication Poor fetal growth complicating pregnancy, antepartum condition or complication Excessive fetal growth complicating pregnancy; antepartum condition or complication Polyhydramnios complicating pregnancy, antepartum condition or complication Oligohydramnios complicating pregnancy, antepartum condition or complication Elderly primigravida; 1 st pregnancy in a woman who will be 34 years of age or older at expected date of delivery; antepartum condition or complication Elderly multigravida; 2 nd or more pregnancy in a woman who will be 34 years of age or older at expected date of delivery; antepartum condition or complication Abnormality in fetal heart rate or rhythm; antepartum condition or complication Other umbilical cord complications; antepartum condition or complication Other specified obstetrical trauma; antepartum condition or complication Nonspecific abnormal findings on radiological and other examinations of abdominal area, including retroperitoneum Other nonspecific abnormal findings on radiological and other examinations of body structure Abnormal Karyotype in fetus V23.1 Pregnancy with history of trophoblastic disease; hydatidiform mole V28.3 Encounter for routine screening for malformation of fetus ultrasound NOS V28.4 Screening for Fetal Growth Retardation (IUGR) using ultrasound V28.81 Encounter for fetal anatomic survey V28.9 Antenatal screening for abnormalities Draft ICD-10-CM Diagnosis Codes O09.10 O09.13 Supervision of pregnancy with history of ectopic or molar pregnancy O20.8 Other hemorrhage in early pregnancy O20.9 Hemorrhage in early pregnancy, unspecified O O Pre-exsisting diabetes mellitus, Type 1, in pregnancy O O Pre-exsisting diabetes mellitus, Type 2, in pregnancy O O Unspecified pre-existing diabetes mellitus in pregnancy O O Gestational diabetes mellitus in pregnancy O O Other pre-exsisting diabetes mellitus in pregnancy O O Unspecified 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 Clinical Coverage Guideline page 7

8 O28.5 Abnormal chromosomal and genetic finding on antenatal screening of mother O28.8 Other abnormal findings on antenatal screening of mother O O44.03 Placenta previa specified as without hemorrhage O O44.13 Placenta previa with hemorrhage O O45.93 Premature separation of placenta [abruption placentae] O O46.93 Antepartum Hemorrhage, not elsewhere classified O O Pre-existing essential hypertension complicating pregnancy O O Pre-existing hypertensive heart disease complicating pregnancy, O O Pre-existing hypertensive chronic kidney disease complicating pregnancy O O Pre-existing hypertensive heart & chronic kidney disease complicating pregnancy, O O Pre-existing secondary hypertension complicating pregnancy O O Pre-existing hypertension complicating pregnancy O O11.3 Pre-existing hypertension with pre-eclampsia O O24.93 Diabetes mellitus in pregnancy O O 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 O31.22x0 O31.22x2 Continuing pregnancy after intrauterine death of one fetus or more, second trimester O31.23x0 - O Continuing pregnancy after intrauterine death of one fetus or more, third trimester O32.0XX0 - O33.9 Maternal care for malpresentation of fetus O O34.93 Maternal care for abnormality of pelvic organs O35.0XX0 - O35.9XX9 Maternal care for known or suspected fetal abnormality and damage O O36.93X9 Maternal care for other fetal problems O40.1XX0 - O40.3XX9 Polyhydramnios O41.01X0 - O41.03X9 Oligohydramnios O69.89x0 Labor and delivery complicated by other cord complications O O09.13 Supervision of pregnancy with history of ectopic or molar pregnancy O O Supervision of elderly primigravida O O Supervision of elderly multigravida O71.89 Other specified obstetric trauma O76 Abnormality in fetal heart rate and rhythm complicating labor and delivery O O Viral hepatitis complicating pregnancy O O Other viral diseases complicating pregnancy O O Protozoal diseases complicating pregnancy O O Human immunodeficiency virus (HIV) disease complicating pregnancy O O Other maternal infectious and parasitic diseases complicating pregnancy O Other infection carrier state complicating pregnancy O O Endobrine, nutritional and metabolic diseases complicating pregnancy O O Drug use complicating pregnancy O O Disease of circulatory system complicating pregnancy O O Diseases of the respiratory system complicating pregnancy O O Disease of the digestive system complicating pregnancy O O Disease of the skin and subcutaneous tissue complicating pregnancy O Streptococcus B carrier state complicating pregnancy O Abnormal glucose complicating pregnancy O9A.111 O9A.113 Malignant neoplasm complicating pregnancy O9A 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 specified body structures 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 *Current Procedural Terminology (CPT) 2014 American Medical Association: Chicago, IL. Clinical Coverage Guideline page 8

9 REFERENCES 1. American College of Obstetricians and Gynecologists. ACOG practice bulletin: ultrasonography in pregnancy (no. 101). Obstetrics and Gynecology. 2009; 113(2 Pt 1): American College of Obstetricians and Gynecologists. Prenatal diagnosis of fetal chromosomal abnormalities (no. 77). Obstetrics and Gynecology. 2001; 97(5 Pt 1): suppl National coverage determination for ultrasound diagnostic procedures (220.5). Centers for Medicare and Medicaid Services Web site. Published May 22, 2007). Accessed July 31, Coding committee: white paper on ultrasound code Society for Maternal-Fetal Medicine Web site. Published May Accessed July 31, MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS Date Action 8/7/2014 8/9/2013 5/3/ /1/2011 8/12/2011 Approved by MPC. Reinstated for markets where CareCore is not a vendor. Renamed to include 3D and 4D Ultrasound (HS-109). Retired by MPC; covered by CareCore criteria. New template design approved by MPC. Approved by MPC. No changes. Clinical Coverage Guideline page 9