Michigan

Kate Massey
Director of Michigan Medicaid
richardsd@michigan.gov, (517)-582-4145

Medicaid reimburses medically necessary genetic testing when one of the following apply:

1. The test is necessary to establish a molecular diagnosis when a definitive diagnosis remains uncertain and a genetic diagnosis is suspected, and the results will directly impact the treatment or management of the disease.
2. A definitive diagnosis has been made through conventional diagnostic testing and the test is necessary to guide treatment or management of the disease, including selection of specific medication and/or medication dose to ensure efficacy and safety.

Genetic testing is considered a covered benefit when it is medically necessary to establish a molecular diagnosis and treatment of a genetic disease and all of the following are met:

1. The testing must be ordered by a licensed physician (MD or DO), physician assistant, or advanced practice registered nurse (i.e., nurse practitioner, certified nurse midwife) who is an enrolled provider.
2. The beneficiary has documented clinical features symptomatic of a condition or disease, or is at risk of inheriting the disease based upon personal history, family history, documentation of a genetic mutation and/or ethnic background.
3. A physical examination, history, pedigree analysis, and completion of conventional diagnostic testing must be completed prior to testing.
4. If applicable, the testing method is an FDA-approved method for the identification of a specific genetically-linked inheritable disease as evidenced by the following measures:
   1. The genotypes to be detected by a genetic test must be shown, by scientifically valid methods, to be associated with the occurrence of the disease;
      The analytical and clinical validity of the test must be established.
   2. The observations must be independently replicated and subject to peer review; and
   3. The clinical testing laboratory must be an enrolled provider who is properly certified by CLIA.

Whenever possible, Michigan Medicaid follows Medicare guidelines. Medicare does not cover a genetic test for a clinically affected individual for purposes of medical research, family planning, disease risk assessment of other family members or when the treatment and surveillance of the beneficiary will not be affected, or in any other circumstance that does not directly affect the diagnosis or treatment of the beneficiary

Genetic testing is not considered a covered benefit for:

1. Criteria other than those outlined above.
2. Testing to confirm a diagnosis or disorder that can be diagnosed by conventional diagnostic methods.
3. Testing for conditions or purposes where the test results would not directly influence the management or treatment of the disease or condition (e.g., a disease without known treatment).
4. Testing for informational purposes or management of a beneficiary’s family member.
5. Confirmatory testing for validation of laboratory results.
6. Screening for investigational or research purposes.
7. Minors under the age of 18 for adult onset conditions that have no preventative or therapeutic treatments.
8. Testing that has not been performed in a CLIA-certified laboratory.
9. The sole purpose of family planning counseling and infertility services.
10. Testing attributable to standing laboratory orders. Testing must be ordered for a specific beneficiary and the medical record and/or order must clearly document the medical necessity of the specific diagnostic test to be performed.

Providers must follow state law regarding informed consent for predictive genetic testing. This includes any statutory requirements for pre- or post-testing genetic counseling. There must be made available, upon request, documentation of pre-testing informed consent provided before testing. This documentation must include the limitations of the test, possible outcomes, and methods for communicating and maintaining confidentiality of results.

Section 1202 of Act 246

Section 1202 of Act 246

Authorization is required for most genetic and molecular laboratory tests. Refer to the Community Health Automated Medicaid Processing System (CHAMPS) Code Rate and Reference tool for authorization necessity. Authorization requests must be submitted to Medicaid within 30 days of the date of service using the Genetic and Molecular Laboratory Test Authorization Request form (MSA-2081). Specimen processing should not be completed until after the authorization request has been approved.

Coverage is available.

Medicaid reimburses medically necessary genetic testing when one of the following apply:

1. The test is necessary to establish a molecular diagnosis when a definitive diagnosis remains uncertain and a genetic diagnosis is suspected, and the results will directly impact the treatment or management of the disease.
2. A definitive diagnosis has been made through conventional diagnostic testing and the test is necessary to guide treatment or management of the disease, including selection of specific medication and/or medication dose to ensure efficacy and safety.

Genetic testing is considered a covered benefit when it is medically necessary to establish a molecular diagnosis and treatment of a genetic disease and all of the following are met:

1. The testing must be ordered by a licensed physician (MD or DO), physician assistant, or advanced practice registered nurse (i.e., nurse practitioner, certified nurse midwife) who is an enrolled provider.
2. The beneficiary has documented clinical features symptomatic of a condition or disease, or is at risk of inheriting the disease based upon personal history, family history, documentation of a genetic mutation and/or ethnic background.
3. A physical examination, history, pedigree analysis, and completion of conventional diagnostic testing must be completed prior to testing.
4. If applicable, the testing method is an FDA-approved method for the identification of a specific genetically-linked inheritable disease as evidenced by the following measures:
   1. The genotypes to be detected by a genetic test must be shown, by scientifically valid methods, to be associated with the occurrence of the disease;
      The analytical and clinical validity of the test must be established.
   2. The observations must be independently replicated and subject to peer review; and
   3. The clinical testing laboratory must be an enrolled provider who is properly certified by CLIA.

Coverage is available.

Coverage is available.

Fatty acid oxidation disorders, including:

• Carnitine uptake defect (CUD)
• Medium-chain acyl-CoA dehydrogenase deficiency (MCAD)
• Long-chain L-3-hydroxyacyl-CoA dehydrogenase deficiency (LCHAD)
• Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD)
• Trifunctional protein deficiency (TFP)

Public Health Genomics Program – provides assessment, policy development, and assurance related to newborn screening, birth defects, genetic disorders, and the use of genomics in public health programs https://www.michigan.gov/mdhhs/0,5885,7-339-73971_4911_4916_47257—,00.html

• Medicaid Provider Manual Laboratory Section 5.5 Genetic Testing
  • https://www.michigan.gov/mdhhs/0,5885,7-339-71551_2945_5100-87572–,00.html
• Medicaid Provider Manual Medical Supplier 2.13.A Enteral Nutrition
  • https://www.mdch.state.mi.us/dch-medicaid/manuals/MedicaidProviderManual.pdf