Kentucky

Yes

Lisa Lee, Commissioner, Department for Medicaid Services
(502)-564-4321

http://www.kymmis.com/kymmis/provider%20relations/PriorAuthorizationForms.aspx

https://chfs.ky.gov/agencies/dms/Pages/feesrates.aspx

Coverage is available.

Genetic testing for BRCA1 and BRCA2 for individuals with a personal history of a BRCA-Related Cancer is proven and medically necessary in the following situations:

• A known BRCA1/BRCA2 mutation in a Close Blood Relative; or
• At least one first- or second-degree relative with a BRCA-Related Cancer; or
• Ashkenazi Jewish ancestry; or
• An unknown or Limited Family History;
• A BRCA 1/2 pathogenic mutation detected in tumor tissue; or
• A personal history of pancreatic cancer; or
• Men with a personal history of Breast Cancer; or
• Men with a personal history of metastatic prostate cancer; or
• Women with a personal history of Ovarian Cancer; or
• Women with a personal history of Breast Cancer in any of the following situations:
  • Metastatic Breast Cancer; or
  • Breast Cancer diagnosed at age 45 or younger; or
  • An additional Breast Cancer primary (prior diagnosis or bilateral cancer); or
  • Triple-Negative Breast Cancer diagnosed at age 60 or younger
• Individual has a Tyrer-Cuzick, BRCAPro or Penn11 Score of 2.5% or greater for a BRCA1/2 pathogenic variant.

Genetic testing for BRCA1 and BRCA2 for individuals without a personal history of a related cancer is proven and medically necessary in the following situations:

• A known BRCA1/BRCA2 mutation in a Close Blood Relative; or
• At least one first- or second-degree relative with a BRCA-Related Cancer; or
• Ashkenazi Jewish ancestry and at least one Close Blood Relative with a BRCA-Related Cancer; or
• Individual has a Tyrer-Cuzick, BRCAPro or Penn11 Score of 5% or greater for a BRCA1/2 pathogenic variant

Genetic testing for BRCA1 and/or BRCA2 is unproven and not medically necessary for all other indications including:

• Screening for cancer risk for individuals not listed in the proven indications above; or
• Risk assessment of other cancers; or
• Confirmation of direct to consumer genetic testing without meeting any of the proven indications above.

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals with a personal history of cancer is proven and medically necessary if all of the following criteria are met:

• The suspected hereditary cancer syndromes can be diagnosed by testing of two or more genes included in the specific hereditary cancer panel; AND
• A personal history of at least two different cancers (e.g., Breast and Ovarian); or
• A personal history of BRCA-related cancer diagnosed at age 40 or younger; or
• A personal history of BRCA-related cancer and at least one Close Blood Relative with a cancer associated with Lynch Syndrome; or
• At least one Close Blood Relative diagnosed with a BRCA-Related Cancer at age 40 or younger; or
• At least three Close Blood Relatives, on the same side of the family, diagnosed with any cancer; or
• A personal history of cancer associated with Lynch Syndrome; or
• A personal history of cancer where tumor testing results demonstrate that the cancer was MSI-high or had immunohistochemical staining showing the absence of one or more mismatch repair proteins (MLH1, MSH2, MSH6 or PMS2); or
• A personal history of colorectal polyposis with at least 10 adenomatous polyps, at least 2 hamartomatous polyps or at least 5 serrated polyps/lesions proximal to the rectum; or
• The individual has a PREMM5, MMRpro or MMRpredict Score of 2.5% or greater for having a Lynch syndrome gene mutation.

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals without a personal history of cancer is proven and medically necessary if all of the following criteria are met:

• The suspected hereditary cancer syndromes can be diagnosed by testing of two or more genes included in the specific hereditary cancer Panel; AND
• At least one first- or second-degree relative diagnosed with a BRCA-Related Cancer at age 40 or younger; or
• At least three Close Blood Relatives, on the same side of the family, diagnosed with any cancer; or
• At least one first-degree relative with a cancer associated with Lynch Syndrome; or
• At least one first- or second-degree relative with a cancer associated with Lynch Syndrome diagnosed at age 50 or younger; or
• At least one first- or second-degree relative with at least two cancers associated with Lynch Syndrome; or
• Two or more first- or second-degree relatives with a cancer associated with Lynch Syndrome; or
• At least one first- or second-degree relative with a clinical diagnosis of Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis, Juvenile Polyposis Syndrome or Peutz-Jeghers Syndrome; or
• The individual has a PREMM5, MMRpro or MMRpredict Score of 5% or greater for having a Lynch syndrome gene mutation.

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals diagnosed with cancer at age 18 or younger is proven and medically necessary. Multi-Gene hereditary cancer Panels are unproven and not medically necessary for all other indications.

Yes

Molecular profiling using Chromosomal Microarray analysis (e.g., Oncoscan, Reveal SNP-Oncology, CGH or SNP array) is proven and medically necessary for individuals with acute leukemia. Use of a Next Generation Sequencing profile test to assess minimal residual disease (e.g., ClonoSeq) is proven and medically necessary when the following criteria are met:

• Individual has acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) and testing is being performed within 3 months of completing a course of therapy and there is no clinical evidence of disease; or
• Individual has multiple myeloma and testing is being performed within three months of an allogenic or autologous bone marrow transplant; and there is no clinical evidence of disease

All other multigene, gene expression or microarray molecular profiling for hematological malignancies is unproven and not medically necessary due to insufficient evidence of efficacy. This includes, but is not limited to the following:

• Assessment of minimal residual disease by Next Generation Sequencing for acute myeloid leukemia Use of multi-gene Next Generation Sequencing gene panels for predicting prognosis.

Multigene molecular profiling of metastatic non-small cell lung cancer is proven and medically necessary when all of the following criteria are met:

1. The panel selected has no more than 50 genes; and
2. No prior molecular profiling has been performed on the same tumor.

Implementing temporary coverage of noninvasive prenatal testing (NIPT) for fetal aneuploidy

Preimplantation Genetic Testing (PGT) for Monogenic/single gene defects (PGT-M) or inherited structural chromosome rearrangements (PGT-SR) is proven and medically necessary using polymerase chain reaction (PCR), next generation sequencing (e.g., Chromosomal Rearrangements), or chromosomal microarray for the following:

• The embryo is at increased risk of a recognized inherited disorder with both of the following:
• The increased risk of a recognized inherited disorder is due to one of the following:
  • The parents are carriers of an autosomal recessive disease
  • At least one parent is a carrier of an autosomal dominant, sex-linked, or mitochondrial condition  At least one parent is a carrier of a balanced structural chromosome rearrangement
  • The medical condition being prevented must result in Significant Health Problems or Severe Disability and be caused by a single gene (PGT-M) or structural changes of a parents’ chromosome (PGT-SR)
  • Human leukocyte antigen (HLA) typing on an embryo in order for the future child to provide bone marrow or blood to treat an affected sibling

The Metabolic Foods and Formulas Program was established to assist patients with inborn errors of metabolism who have:

• No insurance;
• Insurance that has been denied; or
• Exhausted their insurance benefits.

• Preimplantation screening
  • https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/ky/preimplantation-genetic-testing-ky-cs.pdf
• Chromosome microarray testing
  • https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/ky/chromosome-microarray-test-nononcology-ky-cs.pdf
• PGT
  • https://chfs.ky.gov/agencies/dph/dmch/cfhib/Pages/kymffp.aspx
• BRCA/Lynch/Hereditary Cancer Coverage
  • https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/ky/genetic-testing-hereditary-cancer-ky-cs.pd