New York

Yes, Medicaid reimburses for genetic testing when performed by a NYS Medicaid enrolled laboratory with a permit in Genetic Testing.

Amir Bassiri
Medicaid Director, Deputy Commissioner
New York Department of Health
Empire State Plaza, Corning Tower, Room 1466
Albany, NY 12237
Phone: (518) 474-3018

https://medicaiddirectors.org/wp-content/uploads/2023/06/Public_DirectorsList_June2023-1.pdf

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. DNA based testing defined under State licensure as investigational for a certain disease is not reimbursable. Codes 81400 through 81408, 81479 and 84999 are not reimbursable for non-genetic applications such as microbial detection or quantification or testing for acquired changes in genetic material (e.g., T or B cell markers, immunoglobulin heavy or light chainrearrangements associated with malignancy).

DNA based testing defined under State licensure as investigational for a certain disease is not reimbursable.

Newborn screening is mandated in New York State (NYS) Public Health Law §2500-a and §2500-f. In 2022, the statute was amended to add glucose-6-phosphate dehydrogenase (G6PD) deficiency to the list of newborn screening conditions in NYS. G6PD deficiency was not added to the panel of conditions screened by the Newborn Screening Program through testing of dried blood spots; instead, the law, effective June 20, 2022, requires newborns be given a diagnostic test for G6PD deficiency if they:

1. present with hemolytic anemia; or
2. present with hemolytic jaundice; or
3. present with early onset increasing neonatal jaundice persisting beyond the first week of life (bilirubin level greater than the 40th percentile for age in hours); or
4. are admitted to the hospital for jaundice following discharge; or
5. have a familial, racial, or ethnic risk of G6PD deficiency (African, Asian, Mediterranean, or Middle Eastern ancestry).

Newborns and infants, who meet any one of the above criteria, must be tested for G6PD deficiency using a quantitative test.

There is currently no license requirement. Passing bill S6021/A278 would establish genetic counseling as a licensed profession in New York State. The following link explains the bill in more detail.

https://nysgeneticstaskforce.org/licensure/

Genetic counseling is required for some genetic testing.

New York Insurance Law §4322

Enteral Formula Coverage Criteria

1. Members who are fed via nasogastric, gastrostomy or jejunostomy tube.
2. Members with inborn metabolic disorders.
3. Children up to 21 years of age, who require liquid oral nutritional therapy when there is a documented diagnostic condition where caloric and dietary nutrients from food cannot be absorbed or metabolized.
4. Adults with a diagnosis of HIV infection, AIDS, or HIV-related illness, or other disease or condition, who are oral-fed, and who…
   1. require supplemental nutrition, demonstrate documented compliance with an appropriate medical and nutritional plan of care, and have a body mass index (BMI) under 18.5 as defined by the Centers for Disease
      Control, up to 1,000 calories per day; or
   2. require supplemental nutrition, demonstrate documented compliance with an appropriate medical and nutritional plan of care, have a body mass index (BMI) under 22 as defined by the Centers for Disease
      Control, and a documented, unintentional weight loss of 5 percent or more within the previous 6-month period, up to 1,000 calories per day; or
   3. require total oral nutritional support, have a permanent structural limitation that prevents the chewing of food, and placement of a feeding tube is medically contraindicated.

Prior authorization is required.

https://www.emedny.org/info/phase2/paper.aspx

https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.emedny.org%2FProviderManuals%2FLaboratory%2FPDFS%2FLaboratory_Fee_Schedule.xls&wdOrigin=BROWSELINK

Yes

Testing for a BRCA1 or BRCA2 mutation may be appropriate in individuals with the following risk factors:

A personal history of:

1. Breast cancer (includes invasive and ductal carcinoma in situ):
   1. Diagnosed at age 45 or younger;
   2.  Diagnosed at age 50 or younger with 1 or more close relatives* with a diagnosis of breast cancer, pancreatic cancer, or aggressive prostate cancer;
   3. Diagnosed at age 50 or younger and unknown or limited family history;
   4. Two or more primary tumors of the breast (includes bilateral tumors or two or more clearly separate ipsilateral primary tumors occurring either synchronously or asynchronously) when first breast cancer was diagnosed at age 50 or younger;
   5.  Diagnosed at age 60 or younger with triple-negative breast cancer;
   6. Diagnosed at any age with 1 or more close relatives* with breast cancer at age 50 or younger;
   7. Diagnosed at any age with 1 or more close relatives* with invasive ovarian cancer;
   8.  Diagnosed at any age with 1 or more close male relatives with breast cancer at any age;
   9. Diagnosed at any age with 2 or more close relatives* with breast cancer at any age;
   10. Diagnosed at any age with 2 or more close relatives* with pancreatic and/or aggressive prostate cancer; OR
   11. Diagnosed at any age and of an ethnicity associated with higher mutation frequency (e.g., Ashkenazi Jewish), no additional family history may be required.
2. Breast cancer in a male at any age.
3. Invasive ovarian cancer at any age.
4. Aggressive prostate cancer at any age with 1 or more close relatives* who have been diagnosed with breast (=50 years of age), ovarian, pancreatic or aggressive prostate cancer.
5. Pancreatic cancer at any age with 1 or more close relatives* who have been diagnosed with breast (=50 years of age), ovarian, or pancreatic cancer. For individuals of Ashkenazi Jewish ancestry who have pancreatic cancer, no additional relative is needed for testing.

OR

A maternal or paternal family history of**:

1. First or second-degree relative meeting any of the above criteria;
2. Third-degree relative with breast and/or invasive ovarian cancer with 2 or more close relatives* with breast cancer (at least one with breast cancer at age 50 or younger) and/or invasive ovarian cancer;
3. Confirmed BRCA1 or BRCA2 mutation in a close relative.*

** In individuals without a personal history of breast or ovarian cancer and with family history only, clinical judgment should be used when determining if the individual has a reasonable likelihood of a mutation. Limitations of test result interpretation should be discussed with the individual prior to testing, as part of the informed consent and genetic counseling processes.

BRCA1 and BRCA2 mutation testing in conjunction with BRCA Large Rearrangement Test (BART) must be billed using CPT code 81162 effective 4/01/2016.

BRCA Large Rearrangement Test (BART) – BART tests for large rearrangement mutations in BRCA genes. 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 (represented by CPT 81164). 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. When performing tests for BRCA1 and BRCA2 plus BART, CPT Code 81162 must be billed.

Coverage is available.

Coverage is available.

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 outlined below.

Revised Bethesda Guidelines for testing colorectal tumors for microsatellite instability (Adapted from National Comprehensive Cancer Network Guidelines [NCCN], 2015)

1. Colorectal cancer diagnosed in a patient less than 50 years old.
2. Presence of synchronous, metachronous colorectal, or other Lynch Syndrome-associated* tumors, regardless of age.
3. Colorectal cancer with microsatellite instability-high histology** diagnosed in a patient who is less than 60 years old.
4. Colorectal cancer diagnosed in a patient with one or more first-degree¹ relatives with a Lynch Syndrome-associated tumor, with one of the cancers being diagnosed under 50 years of age.
5. Colorectal cancer diagnosed in a patient with two or more first or second-degree² relatives with Lynch Syndrome-associated tumors, regardless of age.
6. Lynch Syndrome-associated cancers include: colorectal, endometrial, gastric, ovarian, pancreatic, ureter and renal pelvis, biliary tract, brain (usually glioblastoma as seen in Turcot syndrome), sebaceous gland adenomas and kertatocanthomas in Muir-Torre syndrome, or carcinoma of the small bowel.
   **Changes in two or more of the National Cancer Institute-recommended panels of microsatellite markers including: presence of tumor infiltrating lymphocytes, Crohn’s-like lymphocytic reaction, mucinous/signet-ring differentiation, or medullary growth pattern.

Amsterdam Criteria II(Adapted from National Comprehensive Cancer Network Guidelines [NCCN], 2015)

At least three relatives with a Lynch-syndrome associated cancer (colorectal, endometrial, small bowel, ureter or renal pelvis); all of the following criteria should be present:

1. One relative should be a first-degree1 relative of the other two;
2. At least two successive generations should be affected;
3. At least one person should be affected before age 50;
4.  In the case of colorectal cancer, Familial Adenomatous Polyposis should be excluded;
5. The tumor should be verified whenever possible.

Coverage is available.

The prognostic breast cancer assays eligible for reimbursement are Oncotype DX®, EndoPredict® and Prosigna®. Coverage of the Oncotype DX® test for Breast Cancer was added in 2015. Oncotype DX®, EndoPredict®, and Prosigna® prognostic gene expression tests assist practitioners in making determinations regarding the effective and appropriate use of chemotherapy in female or male patients with malignant neoplasms of the breast, when all of the following criteria* are met:

1. When the test results 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); and
2. The tumor is estrogen receptor positive (ER+), progesterone receptor positive (PR+), or both; and
3. Human epidermal growth factor receptor 2 (HER2) negative; and
4. Tumor is T1 or T2; and
5. Node-negative or 1-3 positive nodes.

CYP2D6 – Testing for CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) gene analysis, common variants should be billed using CPT code 81226. NYS Medicaid considers
genotyping, once in a lifetime, for CYP2D6 polymorphisms medically necessary to determine drug therapy for the following:

1. Patients diagnosed with Huntington’s disease requiring doses of Xenazine® (tetrabenzine) greater than 50 mg per day.
2. 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.

CYP2D9 – Testing for CYP2D9 (cytochrome P450, family 2, subfamily C, polypeptide 9) gene analysis, common variants (e.g., *2,*3,*5,*6) should be billed using CPT code 81227. NYS Medicaid considers genotyping, once in a lifetime, for CYP2D9 medically necessary to determine eligibility for MAYZENT® (siponimod) drug therapy.

DMD – Testing of the DMD (dystrophin) (e.g., Duchene/Becker muscular dystrophy) gene should be billed using CPT code 81161. NYS Medicaid considers testing, once in a lifetime, medically necessary to determine eligibility for Exondys 51® (eteplirsen) drug therapy.

BCR/ABL1 – Testing for BCR/ABL1 (t(9;22)) translocation analysis should be billed using CPT code 81170. NYS Medicaid considers BCR/ABL1 testing medically necessary to determine drug therapy for the following:

1. 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:
   1. have an inadequate initial response to tyrosine kinase inhibitor (TKI) therapy
   2. exhibit a loss of response (defined as a hematologic or cytogenetic relapse)
   3. 1-log increase in BCR-ABL1 transcript levels and loss of major molecular response (MMR)
   4. have disease progression to accelerated or blast phase

PDGFRA – Testing for platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) gene analysis should be billed using CPT code 81314. 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).

EGFR – Testing for neuroblastoma RAS viral [v-ras] oncogene homolog gene analysis should be billed using CPT code 81311. 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.

HIV genotypic/phenotypic drug resistance testing and phenotypic prediction using genotypic comparison to known databases is a covered service when clinically indicated. Medicaid will reimburse each test (87900, 87901, 87903, 87904, 87906) up to a maximum of three times in a 365- day period across all providers. NYS Medicaid will reimburse for any combination of 87901 and 87903 up to a maximum of four times in a 365-day period across all providers. Code 87903 reimburses $675.29 for resistance determinations of up to 10 antiviral drugs. Code 87904 should be billed in addition to 87903 to claim reimbursement for additional drug resistance determinations, using one unit for each (1) additional drug.

Medicaid fee-for-service (FFS) covers 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.

Reminders:

1. Genetic counseling is covered by Medicaid and should be provided to pregnant members prior to non-invasive prenatal testing to weigh benefits versus risks. Genetic counseling must also be provided to those who test positive for a fetal chromosomal abnormality.
2. Prenatal testing of a fetus by amniocentesis or chorionic villus sampling will continue to be covered:
   1.  subsequent to a positive or high-risk score on a NIPS test; or
   2. subsequent to an inconclusive test result in a high-risk pregnancy.
3. Diagnostic testing (e.g., cytogenetic analysis or molecular genetic testing) for suspected aneuploidies continues to be covered if medically necessary.
4. Cell-free fetal DNA testing should not be offered to members who are pregnant with three or more fetuses because it has not been sufficiently evaluated in these groups.
5. Micro-deletion testing, in conjunction with non-invasive trisomy testing, is not reimbursable.

Medicaid covers genetic counseling when provided by a certified or credentialed genetic counselor. A written order is required. Genetic counseling services may be provided in a practitioner’s office or in an Article 28 hospital outpatient department (OPD) or diagnostic and treatment center (D&TC) or via telemedicine. Reimbursement will be made to physicians, nurse practitioners, licensed midwives and Article 28 clinics who employ or contract with genetic counselors. Genetic counselors must be certified by the American Board of Genetic Counseling (ABGC), the American Board of Medical Genetics (ABMG) or be an advanced practice nurse in genetics (APNG), who is credentialed by the Genetic Nursing Credentialing Commission (GNCC).

Effective September 1, 2014 Medicaid fee-for-service (FFS) will begin covering prenatal carrier testing for fragile X syndrome when one or more of the following criteria is met:
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; The mother has elevated Follicle Stimulating Hormone (FSH) levels before age 40 or premature ovarian failure with no known cause; or The mother or a 1st or 2nd degree* female relative of either parent is a confirmed carrier.

Effective October 1, 2014 Medicaid fee-for-service (FFS) will begin covering 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.

Coverage is available for the following cytogenetic CPT codes:
88245 Chromosome analysis for breakage syndromes; baseline Sister Chromatid Exchange (SCE), 20-25 cells
88248 baseline breakage, score 50-100 cells, count 20 cells, 2 karyotypes (e.g., for ataxia telangiectasia, Fanconi anemia, fragile X)
88249 score 100 cells, clastogen stress (e.g., diepoxybutane, mitomycin C, ionizing radiation, UV radiation)
88262 Chromosome analysis; count 15-20 cells, 2 karyotypes, with banding
88263 count 45 cells for mosaicism, 2 karyotypes, with banding
88267 Chromosome analysis, amniotic fluid or chorionic villus, count 15 cells, 1 karyotype, with banding
88269 Chromosome analysis, in situ for amniotic fluid cells, count cells from 6-12 colonies, 1 karyotype, with banding
88271 Molecular cytogenetics; DNA probe, each (e.g., FISH)
88272 chromosomal in situ hybridization, analyze 3-5 cells (e.g., for derivatives and markers)
88273 chromosomal in situ hybridization, analyze 10-30 cells (e.g., for microdeletions)
88274 interphase in situ hybridization, analyze 25-99 cells
88275 interphase in situ hybridization, analyze 100-300 cells
88280 Chromosome analysis; additional karyotypes, each study (Use in addition to code 88267, 88269)
88285 additional cells counted, each study (Use in addition to code 88269)
88291 Cytogenetics and molecular cytogenetics, interpretation, and report

Note: Cytogenetic studies procedure codes 88245, 88267 and 88269 must be billed in combination with procedure code 88280 to report a 2-karyotype chromosome analysis as described in the quality control standards for cytogenetic licensure.

Close relative is defined as a first, second or third-degree blood relative on the same side of the family (either maternal or paternal).

First-degree relatives: parents, siblings, children;
Second-degree relatives: grandparents, aunts and uncles, nieces and nephews, grandchildren, half- siblings;
Third-degree relatives: great-grandparents, great-aunts and great-uncles, great-grandchildren, and first cousins.

https://www.emedny.org/ProviderManuals/Laboratory/PDFS/Laboratory-Policy_Section.pdf

https://www.health.ny.gov/health_care/medicaid/program/update/2014/2014-08.htm#exp

https://www.health.ny.gov/health_care/medicaid/program/update/2014/2014-09.htm#exp

https://www.health.ny.gov/health_care/medicaid/program/update/2022/docs/mu_no4_apr22.pdf

https://www.health.ny.gov/health_care/medicaid/program/update/2014/2014-10.htm#nys

https://www.health.ny.gov/health_care/medicaid/program/update/2015/2015-10.htm#fam

https://www.emedny.org/ProviderManuals/Laboratory/PDFS/Laboratory_Procedure_Codes.pdf

https://www.health.ny.gov/health_care/medicaid/program/update/2019/2019-07.htm#breastcancer

https://www.health.ny.gov/health_care/medicaid/program/update/2015/2015-10.htm#cov

https://www.health.ny.gov/community/infants_children/child_health/medical.htm

https://www.emedny.org/ProviderManuals/DME/PDFS/DME_Policy_Section-2004-1.pdf

https://www.emedny.org/training/PDF/Enteral_Formula_Prior_Authorization.pdf

https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/state-laws-medical-foods-tab.pdf