New York

Yes

Brett Friedman
State Medicaid Director, Deputy Commissioner
(518)-474-3018

The molecular pathology codes (81400 through 81408, 81479 and 84999) are reimbursable for DNA based genetic testing not specifically listed in the fee schedule. All molecular pathology codes (81200 through 81408 and 81479) may be performed as:

1. A family study of up to six individuals to determine the genetic carrier/disease status of an individual patient or a fetus as part of a comprehensive program of genetic counseling and where indicated by familial medical history or adjunctive prenatal testing; OR
2. An individual study by diagnostic deletion analysis of a patient affected by a genetic disorder.

NYS Medicaid covers genetic counseling when provided by a certified or credentialed genetic counselor. Genetic counseling services may be provided in a practitioner’s office or in an Article 28 hospital outpatient department, or free-standing diagnostic and treatment center.
In order for the service to be reimbursed, NYS Medicaid requires that the genetic counselor be:

1. Certified by the American Board of Genetic Counseling; or
2. Certified by the American Board of Medical Genetics; or
3. An Advanced Practice Nurse in Genetics who is credentialed by the Genetic Nursing Credentialing Commission.

NYS Medicaid also covers genetic counseling when provided by a physician.

To increase patient access to genetic counseling services in areas of the State without qualified genetic counselors, NYS will reimburse for genetic counseling provided via telemedicine.

Senate Bill S2287A “Hannah’s Law” requires insurance companies who cover prescription drugs to include coverage for the cost of external formulas whether administered orally or via feeding tube.

Senate Bill S2287A “Hannah’s Law” requires insurance companies who cover prescription drugs to include coverage for the cost of external formulas whether administered orally or via feeding tube.

https://www.emedny.org/ProviderManuals/Physician/index.aspx

https://www.emedny.org/ProviderManuals/Laboratory/PDFS/Laboratory_Fee_Schedule.xls

Coverage is available.

Testing for mutations in the BRCA1 and BRCA2 genes of individuals at high risk for hereditary breast and ovarian cancer (HBOC) is covered.

If a Medicaid enrollee previously had testing for BRCA1 and BRCA2 genes with negative test results, and BART testing was not performed, the enrollee may have BART only testing. The addition of BART testing must be considered medically necessary. For a Medicaid enrollee where BRCA1 and BRCA2 testing is being ordered for the first time, BART is performed as a reflex test if the BRCA1 and BRCA2 test results are negative.

Some familial variant genes are covered.

Reimbursement is available for initial screening of the MLH1 and MSH2 genes when medical criteria are met. Reimbursement for testing of the MSH6 gene is available only following a negative test result in the MLH1 and MSH2 genes. Similarly, testing of the PMS2 gene is only covered following a negative test result in the MLH1, MSH2 and MSH6 genes. Syndrome testing for known familial variants.
Genetic testing for Lynch Syndrome mutations will be covered when one or more of the following criteria are met:

1. Individuals diagnosed with colorectal cancer (CRC) under age 70.
2. Individuals age 70 or older who meet the Bethesda criteria outlined below as applicable.
3. Women who were diagnosed with endometrial cancer at less than 50 years of age.
4. Individuals who meet the Amsterdam II criteria.

NYS Medicaid considers genotyping, once in a lifetime, for CYP2D6 polymorphisms medically necessary to determine drug therapy for the following:

• Patients diagnosed with Huntington’s disease requiring doses of Xenazine® (tetrabenzine) greater than 50 mg per day.
• Patients diagnosed with Gaucher disease type 1 requiring Cerdelga® (eliglustat).

At this time, pharmacogenetic testing of CYP2D6 for any purpose other than those specified above is not reimbursable.

NYS Medicaid considers BCR/ABL1 testing medically necessary to determine drug therapy for the following:

• Patients diagnosed with chronic myelogenous leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) that have been prescribed Gleevec® (imatinib), Sprycel® (dasatinib), Tasigna® (nilotinib), Bosulif® (bosutinib) or Iclusig® (ponatinib) and one or more of the following:
  • Have an inadequate initial response to tyrosine kinase inhibitor (TKI) therapy
  • Exhibit a loss of response (defined as a hematologic or cytogenetic relapse)
  • 1-log increase in BCR-ABL1 transcript levels and loss of major molecular response (MMR)
  • Have disease progression to accelerated or blast phase

NYS Medicaid considers PDGFRA testing medically necessary, once in a lifetime, when used to determine drug therapy for the treatment of chronic myeloid leukemia such as Imatinib (Gleevec).

NYS Medicaid considers EGFR testing medically necessary, once in a lifetime, when used to determine effective drug therapy for medications such as cebtuximab (Erbitux) that treat certain cancers (e.g., lung, colorectal, head and neck) thought to be associated with this genetic mutation.

Medicaid fee-for-service (FFS) and Medicaid Managed Care (MMC) cover non-invasive prenatal trisomy screening using cell-free fetal DNA for high-risk singleton pregnancies when one or more of the following criteria is met:

1. Either parent has a family history of an aneuploidy in a 1st* or 2nd** degree relative;
2. The pregnant woman is of advanced maternal age (defined by the American College of Obstetricians and Gynecologists as 35 years or older at the time of delivery);
3. Standard serum screening or fetal ultrasonographic findings indicate an increased risk of an aneuploidy;
4. Parent(s) have a history of a previous pregnancy with a trisomy; and/or
5. Either parent is known to have a Robertsonian translocation.

Medicaid Managed Care (MMC) and Family Health Plus (FHPlus) will cover prenatal carrier testing for fragile X syndrome when one or more of the following criteria is met:

1. There is a personal or family history of fragile X tremor/ataxia syndrome, autism spectrum disorder or unexplained mental retardation in a 1st, 2nd or 3rd degree* relative of either parent;
2. The mother has elevated Follicle Stimulating Hormone (FSH) levels before age 40 or premature ovarian failure with no known cause; or
3. The mother or a 1st or 2nd degree* female relative of either parent is a confirmed carrier.”

Medicaid Managed Care (MMC) and Family Health Plus (FHPlus) will cover prenatal carrier testing for spinal muscular atrophy (SMA), once in a lifetime, when one or more of the following criteria is met:

1. There is a personal or family history of SMA or other muscular dystrophy of unknown type in a 1st* or 2nd** degree relative of either parent;
2. The father is a known carrier

Carrier screening for SMA of the male partner of a pregnancy will be covered if the pregnant female is found to be a carrier.

The New York State Medicaid program will provide reimbursement for the Oncotype DX® test for Breast Cancer when all of the following criteria are met:

1. Tumor is Stage 1 or Stage 2; AND
2. Node-negative (non-metastatic), or micrometastatic disease (<2mm nodal involvement); AND
3. Estrogen receptor positive (ER+), alone, or in combination with progesterone receptor positive (PR+); AND
4. Human epidermal growth factor receptor 2 (HER2) negative; AND
5. Tumor size is equal to or greater than 0.6 cm; AND
6. The tumor is unilateral and non-fixed; AND
7. Test is ordered within 6 months of diagnosis; AND
8. When the test result will aid the patient and practitioner in making the decision regarding chemotherapy (i.e., when chemotherapy is a therapeutic option and is not precluded due to any other factor).

Genetic Counseling via Telemedicine:
To increase patient access to genetic counseling services in areas of the State without qualified genetic counselors, NYS will reimburse for genetic counseling provided via telemedicine

• DME Manual Procedure Codes
  • https://www.emedny.org/ProviderManuals/DME/index.aspx
• New York State Medicaid Coverage of Testing for Lynch Syndrome Changes in Personal/Familial History Criteria for Medicaid Breast Cancer (BRCA) Genetic Testing –
  • https://www.health.ny.gov/health_care/medicaid/program/update/2015/2015-10.htm
• New York State Medicaid Coverage of Genetic Counseling
  • https://www.health.ny.gov/health_care/medicaid/program/update/2015/2015-07.htm#gc
• Provider Manual Laboratory Procedure Codes
  • https://www.emedny.org/ProviderManuals/Laboratory/index.aspx
• Metabolic Legislation
  • https://www.nysenate.gov/legislation/bills/2013/s2287