benefits must be available for healthcare services ... · 21 – when used for noninvasive prenatal...

Department of Origin: Integrated Healthcare Services

Approved by: Chief Medical Officer

Date Approved: 12/30/14

Department(s) Affected: Coding, Claims, Customer Service, Integrated

Healthcare Services

Effective Date:

12/30/14

Medical Policy Document:

Prenatal Testing Replaces Effective Policy Dated:

06/25/14

Reference #: MP/P011

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PRODUCT APPLICATION:

PreferredOne Community Health Plan (PCHP)

PreferredOne Administrative Services, Inc. (PAS) ERISA

PreferredOne Administrative Services, Inc. (PAS) Non-ERISA

PreferredOne Insurance Company (PIC) Group

PreferredOne Insurance Company (PIC) Individual

Please refer to the member’s benefit document for specific information. To the extent there is any

inconsistency between this policy and the terms of the member’s benefit plan or certificate of coverage, the

terms of the member’s benefit plan document will govern.

Benefits must be available for healthcare services. Healthcare services must be ordered by a physician,

physician assistant, or nurse practitioner. Healthcare services must be medically necessary, applicable

conservative treatments must have been tried, and the most cost-effective alternative must be requested for

coverage consideration.

This policy applies to PAS members only when the employer group has elected to provide benefits for the

service/procedure/device. Check benefits in SPD/COC. If benefits are not specifically addressed in the SPD/COC,

verify with the appropriate account manager the availability of benefits.

PURPOSE: The intent of this policy is to provide coverage guidelines for prenatal testing.

POLICY: Prenatal testing during pregnancy is covered when the test results will influence the course or care of the member’s

pregnancy and the testing is considered medically necessary.

GUIDELINES:

I. Routine prenatal screening lab tests – any of the following: A-O

A. Blood Type (ABO)/ D Type (RH)/Antibody Screen

B. Chlamydia

C. Cystic Fibrosis (CF) carrier testing (standard CF transmembrane regulator [CFTR] mutation panel -CPT

81220)

D. Glucose/ Glucose Tolerance Test (GTT)

E. Gonorrhea

F. Group B Streptococcus

G. Hemoglobin/Hematocrit/MCV

H. Hepatitis B (HBsAG)

I. HIV

J. Pap Test

K. PPD

L. VDRL

M. Rubella Titer

N. Urinalysis/Urine Culture

O. Varicella Titer





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II. Fetal aneuploidy screening – any of the following: A- G

A. First trimester NT testing alone for multiple gestations; or

B. First trimester NT measurements results combined with the results of first trimester blood tests that include

PAPP-A plus hCG ; or

C. Integrated, sequential, or contingent screening: First-trimester triple screen (NT, PAPP-A, and hCG) plus

second-trimester quad screen; or

D. Second-trimester quad screen: MSAFP, estriol, Inhibin A, and hCG; or

E. Serum integrated screening schemes for pregnancies where NT measurement is not available or cannot be

obtained: First-trimester (PAPP-A, and hCG*) plus second-trimester quad screen.

F. Noninvasive Prenatal Testing for Fetal Aneuploidy (NIPT) screening (such as, but not limited to, Harmony,

MaterniT21Plus, or verifi), – must have a singleton pregnancy and one of: 1-5

1. The mother is 35 years of age or older at time of delivery; or

2. Fetal ultrasonographic findings indicate an increased risk of aneuploidy; or

3. History of prior pregnancy with a trisomy; or

4. Positive test results for aneuploidy, including first trimester, sequential, or integrated screen, or a quad

screen; or

5. Parental balanced translocation with increased risk of fetal trisomy 13 or trisomy 21.

G. Invasive prenatal testing by chorionic villus sampling (CVS), genetic amniocentesis, and percutaneous

umbilical blood sampling (PUBS) (cordocentesis) for diagnosis of fetal chromosomal abnormalities.

III. Ultrasonography for routine screening of normal pregnancy: A, and not B or C

A. Fetal ultrasound with detailed anatomic examination is medically necessary to evaluate the fetus for

amniotic band syndrome (also known as amniotic constriction band syndrome), or if there are known or

suspected fetal anatomic abnormalities, including anatomic abnormalities due to genetic conditions.

B. Two-dimensional (2D) ultrasounds, if done solely to determine the fetal sex, or to provide parents with a

view and photograph of the fetus, are not considered medically necessary.

C. Three-dimensional (3D) or four-dimensional (4D) ultrasonography are non-covered - these technologies are

not considered medically necessary.

IV. Antepartum fetal surveillance - non-stress tests (NST), contraction stress tests (CST), biophysical profile (BPP),

modified BPP, and umbilical artery Doppler velocimetry, whether in-office or in-hospital, are medically

necessary in accordance with the American Congress of Obstetricians and Gynecologists (ACOG) Clinical

Guideline on Antepartum Fetal Surveillance.





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DEFINITIONS: Amniocentesis:

Surgical insertion of a hollow needle through the wall of the abdomen and into the uterus of a pregnant female to get

a sample of the amniotic fluid (fluid that surrounds the fetus). The amniotic fluid is then examined to detect genetic

and biochemical disorders, blood disorders, and fetal lung maturity.

Aneuploidy:

A term used to describe a chromosome problem, such as Down syndrome, that is caused by an extra or missing

chromosome.

Chorionic Villus Sampling (CVS):

Procedure in which a small sample of cells is removed from the placenta where it joins the uterus. The cells are used

to test for chromosome abnormalities such as Down syndrome in the fetus.

Estriol:

An estrogenic hormone occurring in urine during pregnancy.

Four Dimensional:

Specified by or exhibiting four dimensions, such as the three spatial dimensions and single temporal dimension of

relative theory.

Human Chorionic Gonadotropin (hCG): A hormone that is normally produced first by the cells that make up the

placenta, then later by the placenta during pregnancy. Its primary function is to support the pregnancy by

encouraging the production of progesterone.

Inhibin-A:

A protein hormone secreted by the corpus luteum and the placenta, present in maternal serum during pregnancy.

Maternal Serum Alpha Fetoprotein (MSAFP or AFP):

A fetal blood protein present abnormally in adults with some forms of cancer (as of liver) and normally in the

amniotic fluid of pregnant women but with very low levels tending to be associated with Down syndrome in the

fetus and very high levels with neural tube defects (as in spina bifida) in which the tube remains open.

Nuchal translucency (NT):

The measurement of fluid in the nuchal region in the back of the neck. Measurements larger than in the normal

range are associated most often with Down Syndrome or Trisomy 21.

Pregnancy-Associated Plasma Protein-A (PAPP-A):

A protein found in maternal blood during pregnancy. Levels of this hormone may indicate chromosomal

abnormalities in the developing fetus.

Quad Screen:

A maternal blood screen that looks for MSAFP, hCG, estriol, and Inhibin-A. Performed between the 16th and 18th

week of pregnancy.

Three Dimensional:

Having or seeming to have, the dimension of depth as well as width and height.





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Triple Screen:

Also known as triple test, multiple marker, or MSAFP Plus. A maternal blood screen that looks for MSAFP, hCG,

and estriol. Performed between the 15th and 20th week of pregnancy although results obtained in the 16th -18th

week are said to be the most accurate.

Ultrasonography:

Uses sound waves rather than radiation (X-ray) for visualization. An ultrasound during pregnancy is performed with

an ultrasound probe on the abdomen or in the vagina. With ultrasonic imaging, the intrauterine contents can be

evaluated to check the placement and development of the fetus.





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FOR INTERNAL USE ONLY

COVERAGE:

Prior Authorization: Yes, for CPT 81420 Fetal chromosomal aneuploidy (eg trisomy 21, monosomy x) genomic

sequence panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13,18, and

21 – when used for Noninvasive Prenatal Testing for Fetal Aneuploidy (NIPT) screening only

Coverage is subject to the member’s contract benefits.

RELATED CRITERIA/POLICIES:

Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria

Medical Policy: MP/C009 Coverage Determination Guidelines

Medical Policy: MP/G001 Genetic Testing for Heritable Conditions

Medical Policy: MP/L001 Laboratory Tests

REFERENCES:

1. 2013 NCQA Standards and Guidelines for the Accreditation of Health Plans

- QI 9 Clinical Practice Guidelines

- QI 8 Disease Management

2. American Congress of Obstetricians and Gynecologists (ACOG). Invasive prenatal testing for aneuploidy.

Washington (DC): American Congress of Obstetricians and Gynecologists (ACOG); 2007 Dec. 9 p. (ACOG

practice bulletin; no. 88).

3. American Congress of Obstetricians and Gynecologists (ACOG). Antepartum Fetal Surveillance. Washington,

(DC): American Congress of Obstetricians and Gynecologists (ACOG); 2009 p. (ACOG practice bulletin: no.

9)

4. American Academy of Pediatrics Website. Prenatal screening and diagnosis for pediatricians. Available at:

http://www.aap.org. Accessed March 29, 2011.

5. American Congress of Obstetricians and Gynecologists Website. Practice bulletin: Screening for fetal

chromosomal abnormalities. 2007. Available at: http://www.acog.org. Accessed March 29, 2011.

6. California Technology Assessment Forum Website. First-trimester ultrasound nuchal translucency screening for

fetal aneuploidy. Available at: http://www.ctaf.org. Accessed March 29, 2011.

7. Centers for Disease Control and Prevention Website. Birth defects: Down syndrome. Available at:

http://www.cdc.gov. Accessed March 29, 2011.

8. ECRI Institute. Evidence report. First-trimester combined screening for chromosomal abnormalities. March

2008.

9. Fender L, Twining P. Imaging in obstetrics and infertility. In: Grainger and Allison’s Diagnostic Radiology. 5th

ed. Orlando, FL;Churchill Livingstone:2008.

10. Hayes, Winifred S. Directory Report. First-trimester prenatal screening using nuchal translucency combined

with maternal PAPP-A and free β-hCG levels. February 23, 2009.

11. Hayes, Winifred S. Directory Report. Three-dimensional and four-dimensional ultrasound for high-risk

pregnancies and routine screening. November 17, 2009.

12. Institute for Clinical Systems Improvement (ICSI) Website. Health care guideline: routine prenatal care.

Available at: http://www.icsi.org. Accessed March 29, 2011.

13. Canick JA, et al. UpToDate. First trimester and integrated screening for Down syndrome and trisomy 18. 2013.

Retrieved from http://www.uptodate.com/contents/first-trimester-combined-test-and-integrated-tests-for-





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screening-for-down-syndrome-and-trisomy-

18?source=search_result&search=first+trimester&selectedTitle=2%7E150

14. Simpson LL. UpToDate. First trimester cystic hygroma and enlarged nuchal translucency. 2012. Retrieved from http://www.uptodate.com/contents/first-trimester-cystic-hygroma-and-increased-nuchal-

translucency?topicKey=OBGYN%2F435&elapsedTimeMs=5&source=search_result&searchTerm=first+trimes

ter+cystic+hygroma&selectedTitle=1%7E150&view=print&displayedView=full

15. Hochberg L, Stone J. UpToDate. Prenatal screening and diagnosis of neural tube defects. 2012. Retrieved from

http://www.uptodate.com/contents/prenatal-screening-and-diagnosis-of-neural-tube-

defects?source=search_result&search=prenatal+screening+and+diagnosis+of&selectedTitle=2%7E150

16. Sfakianaki AK. Copel J. UpToDate. Routine prenatal ultrasonography as a screening tool. 2012. Retrieved from

http://www.uptodate.com/contents/routine-prenatal-ultrasonography-as-a-screening-

tool?source=search_result&search=routine+prenatal+ultrasonography&selectedTitle=1%7E150

17. Lockwood CJ, Magriples U. UpToDate. Initial prenatal assessment and patient education. 2013. Retrieved from

http://www.uptodate.com/contents/initial-prenatal-assessment-and-patient-

education?topicKey=OBGYN%2F446&elapsedTimeMs=7&source=search_result&searchTerm=The+initial+pr

enatal+assessment+and+routine+prenatal+care&selectedTitle=1%7E150&view=print&displayedView=full

18. UpToDate®. Ultrasound examination in obstetrics and gynecology. May 2010.

19. Aetna Clinical Policy Bulletin: Noninvasive Down Screening. Number 0282 Accessed 06/13/2011.

20. Aetna Clinical Policy Bulletin: Serum Marker Screening for Down Syndrome. Number 0464 Accessed

06/13/2011.

21. Aetna Clinical Policy Bulleting: Ultrasound for Pregnancy. Number 0199 Accessed 06/13/2011.

22. Aetna Clinical Policy Bulletin: Fetal Echocardiogram. Number 0106. Accessed 07/01/2011.

23. Aetna Clinical Policy Bulletin: Invasive Prenatal Diagnosis of Genetic Diseases. Number 0358. Accessed

07/01/2011.

24. Messerlin GM, Canick JA. UpToDate. Overview of prenatal screening and diagnosis of Down syndrome. 2013.

Retrieved from http://www.uptodate.com/contents/overview-of-prenatal-screening-and-diagnosis-of-down-

syndrome?source=search_result&search=down+syndrome&selectedTitle=3%7E150

25. Wolfberg A, Bianchi DW. UpToDate. Prenatal diagnosis using cell-free fetal nucleic acids in maternal blood.

2013. Retrieved from http://www.uptodate.com/contents/prenatal-diagnosis-using-cell-free-fetal-nucleic-acids-

in-maternal-blood?source=search_result&search=prenatal+diagnosis+using+cell-free&selectedTitle=1%7E150

26. Walsh J. California Technology Assessment Forum. Fetal Aneuploidy Detection by Maternal Plasma DNA

Sequencing. June 20, 2012.

27. American Congress of Obstetricians and Gynecologists (ACOG). ACOG Committee on Genetics. ACOG

committee opinion. Number 486. Update on Carrier Screening for Cystic Fibrosis. ObstetGynecol.

2011;117:1028-31.

28. Wenstrom KD. UpToDate. Cystic Fibrosis: Prenatal genetic screening. Mar 2014. Retrieved from

http://www.uptodate.com/contents/cystic-fibrosis-prenatal-genetic-

screening?source=search_result&search=cystic+fibrosis%3A+prenatal&selectedTitle=1%7E150.

29. Gregg AR, et al. ACMG statement on noninvasive prenatal screening for fetal aneuploidy. The Noninvasive

Prenatal Screening Work Group of the American College of Medical Genetics and Genomics. GenetMed;2013

advance online publication.


committee opinion. Number 545. Noninvasive Prenatal Testing for Fetal Aneuploidy. Obstet Gynecol.

2012;120(6):1532-34.


committee opinion. Number 442. Prenatal and preconceptional carrier screening for genetic diseases in

individual of Eastern European Jewish descent. Obstet Gynecol. 2009;114(4):950-3.

http://www.uptodate.com/contents/initial-prenatal-assessment-and-patient-education?topicKey=OBGYN%2F446&elapsedTimeMs=7&source=search_result&searchTerm=The+initial+prenatal+assessment+and+routine+prenatal+care&selectedTitle=1%7E150&view=print&displayedView=full



http://www.uptodate.com/contents/prenatal-diagnosis-using-cell-free-fetal-nucleic-acids-in-maternal-blood?source=search_result&search=prenatal+diagnosis+using+cell-free&selectedTitle=1%7E150

http://www.uptodate.com/contents/prenatal-diagnosis-using-cell-free-fetal-nucleic-acids-in-maternal-blood?source=search_result&search=prenatal+diagnosis+using+cell-free&selectedTitle=1%7E150





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32. Watson MS, Cutting GR, Desnick RJ, et al. Cystic fibrosis population carrier screening: 2004 revision of

American College of Medical Genetics mutation panel. 2004 Genet Med 6:5:387-391

33. National Library of Medicine (NLM). Genetics Home Reference. Published January 7, 2013. Available at:

http://ghr.nlm.nih.gov/ghr/glossary. Accessed on April 23, 2013.

DOCUMENT HISTORY:

Created Date: 3/29/11

Reviewed Date: 03/16/12, 03/15/13, 10/30/14

Revised Date: 03/29/13, 10/30/13, 06/25/14

http://ghr.nlm.nih.gov/ghr/glossary

PreferredOne Community Health Plan (“PCHP”) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.

PCHP:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Community Health PlanPO Box 59052Minneapolis, MN 55459-0052Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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PreferredOne Insurance Company (“PIC”) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.

PIC:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Insurance CompanyPO Box 59212Minneapolis, MN 55459-0212Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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benefits must be available for healthcare services ... · 21 – when used for noninvasive prenatal...

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