Recently, we covered what genetic testing is and why you may be interested in getting this type of testing. If you want, or need, to get genetic testing, it’s also helpful to know much it will cost. Without health insurance coverage, some people may find this type of diagnostic or exploratory testing to be prohibitively expensive.

Some health insurance plans can cover types of genetic testing, but not all. Specifically, Medicare has recently made changes that allow seniors to have certain types of genetic testing in specific circumstances. So, how does Medicare cover genetic testing, and when are those circumstances?

Next Generation Sequencing (NGS)

In 2017, the Centers for Medicare & Medicaid Services (CMS) proposed a national coverage determination for a new type of genetic testing that looks for specific biomarkers in Medicare beneficiaries with cancer. Known as Next Generation Sequencing (NGS) in vitro diagnostic (IVD) testing, this procedure can analyze over 300 genes and at least two genomic signatures to look for genetic mutations in certain cells. If you have cancer, doctors can use the results of this test to predict your reaction to certain drugs and possible future treatments.

NGS can analyze over 300 genes and at least two genomic signatures to look for genetic mutations in certain cells.

The national coverage determination for next generation sequencing will be implemented on April 8, 2019. This type of testing will generally be treated as a clinical laboratory diagnostic test. At this point, Medicare can only offer possible coverage of genetic tests that have been authorized by Congress. Generally, Medicare does not cover genetic tests performed without symptoms, complaints, or a personal history with the disease. In this case, a family history doesn’t count as a personal history.

Requirements for NGS Genetic Testing Medicare Coverage

In order for Medicare to cover your prospective NGS test, there are several requirements that beneficiary, physician, and test must fill. First and foremost, a treating physician must order the test and a specially certified laboratory must perform it. According to the determination, beneficiaries must also:

  • Either have recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer
  • Either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician
  • Decide to seek further cancer treatment (e.g., therapeutic chemotherapy)

The diagnostic test must also have:

  • Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic
  • An FDA-approved or FDA-cleared indication for use in that patient’s cancer
  • Results provided to the treating physician for management of the patient using a report template to specify treatment options

The coverage determination notes that this list isn’t an exhaustive list of all benefit categories and coverage requirements for this service. For example, Medicare offers some coverage of genetic testing for beneficiaries with Lynch syndrome, a condition that increases your risk of certain cancers, under certain circumstances. Medicare guidelines also have a list of requirements for genetic testing for the BRCA1 or BRCA2 gene mutations, which are linked to breast cancer, under certain circumstances.

BRCA1 and BRCA2 Genetic Testing Medicare Coverage

Medicare should help cover BRCA1 or BRCA2 genetic testing if the following circumstances are met:

  • You have a personal history of breast cancer and meet one or more of the following requirements:
    • You have had a diagnosis before the age of 45 (family history not required).
    • You have had a diagnosis before the age of 50 or two breast primaries, and you have at least one close blood relative who’s also received a breast cancer diagnosis before turning 50 or an ovarian, fallopian tube, or primary peritoneal cancer diagnosis.
    • You have had two breast primaries at first breast cancer diagnosis before you turn 50.
    • You have had a breast cancer diagnosis at any age and have at least two close blood relatives with a breast, ovarian, fallopian tube, or primary peritoneal cancer diagnosis.
    • You have a close male blood relative with breast cancer.
    • You have a personal history of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
    • You’re of an ethnicity connected with a higher mutation frequency, like Ashkenazi Jewish and others.
    • You have a close blood relative who knows they have the BRCA1 or BRCA2 gene mutation.
  • You have a personal history of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • You’re a male with a personal history of male breast cancer.

Medicare Administrative Contractors (MACs)

The NGS coverage determination also leaves room for other genetic tests utilizing NGS for beneficiaries with cancer to be covered by Medicare. Medicare leaves these decisions to the jurisdiction of Medicare Administrative Contractors (MACs), who are private health care insurers that have been given a geographic area to process Original Medicare or Durable Medical Equipment claims for Medicare Fee-For-Service beneficiaries. In order for an MAC to approve the coverage, the test and patient must at least meet the following requirements:

  • The test is done at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
  • The test is ordered by your doctor.
  • You meet the same requirements for a patient listed for the NGS test in the national coverage determination.

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There are other rare conditions that can be met to allow you to qualify for certain Medicare genetic testing coverage, mostly dealing with certain cancers. If you have a Medicare Advantage or Part D plan, or have more in depth or specific questions about your Medicare coverage in relation to genetic screenings, it may be worth speaking with a licensed Medicare agent.