Does Medicare Cover Genetic Testing?

Medicare covers genetic testing in limited situations only, and only when ordered by your doctor.

Most genetic testing services covered by Medicare are related to conditions such as cancer.

Direct-to-consumer DNA test kits, such as 23andMe, aren’t covered by Medicare.

Medicare first began covering laboratory diagnostic tests using next generation sequencing (NGS) in 2018. Only Medicare beneficiaries with advanced cancer that met specific criteria qualified for coverage.

Next generation sequencing is a test that analyzes a patient’s genetic makeup in order to pursue more targeted treatments and medications.

According to the U.S. Center for Medicare & Medicaid Services, NGS testing provides the most comprehensive genetic analysis of a patient’s cancer because it can detect multiple types of genetic alterations at the same time.

These tests are meant to help patients and their oncologists make more informed treatment decisions.

The NGS test, also known as a multigene panel, can help identify beneficiaries who qualify for clinical trials.

Clinical laboratory tests are covered under Medicare Part B. You usually pay nothing for Medicare-approved clinical diagnostic laboratory services.

Two years later in 2020, CMS expanded coverage for Next Generation Sequencing tests to people with any stage of female breast or ovarian cancer to determine if they have hereditary-associated mutations.

For example, several types of breast cancer exist, and some types are inherited. Genetic testing can help determine whether a patient has an inherited cancer and identify more tailored treatment options.

Unlike CMS’ earlier determination, Medicare beneficiaries with breast and ovarian cancer who meet the criteria no longer need to be in the advanced stages of cancer to undergo genetic testing.

According to the national coverage determination, diagnostic tests using NGS must be ordered by a treating physician and analyzed in a certified lab.

The test must also be approved or have clearance from the U.S. Food and Drug Administration, and test results must be provided to the treating physician in a report that specifies treatment options.

People with other cancers may still qualify for Medicare coverage of NGS testing.

Businesses that process Medicare claims in specific regions — called Medicare Administrative Contractors — can decide on a case-by-case basis whether to cover NGS tests for any cancer at any stage.

If your genetic testing isn’t covered by Medicare but you still want the test, you can choose to pay for it out-of-pocket.

Your doctor may be able to tell you about financial assistance programs you qualify for based on your condition.

Since 2014, Medicare Part B has covered Cologuard, a genetic test used to screen for colorectal cancer.

Cologuard tests fecal DNA in a stool sample to detect signs — called molecular markers or biomarkers — of altered DNA shed into the stool from colon cancer or small growths in the colon, called polyps.

Cologuard is the only genetic screening preventative test — i.e., a test to detect indicators of potential disease as opposed to the presence of a disease — Medicare covers.

Medicare covers Cologuard once every three years for beneficiaries between ages 50 and 85 who have no symptoms of colorectal cancer and are at an average risk for developing it.

Just like other Medicare-covered preventive services, Part B pays 100 percent of the approved amount for Cologuard for those who qualify.

Since 1998, Medicare has covered cytogenetic studies in specific situations.

Cytogenetics involves testing samples of tissue, blood or bone marrow in a lab to identify changes in chromosomes.

Medicare covers these tests when they are necessary for the diagnosis or treatment of certain kinds of leukemia and rare blood cancers.

Cytogenetic studies may also be covered when they are used to diagnose or treat genetic disorders in a fetus or failure of sexual development.

Genetic testing in the health care industry is rapidly evolving. Medicare rules and decisions regarding this technology are likely to change over time.

In August 2020, CMS issued a local coverage determination on pharmacogenomics testing, including single gene, multi-gene panels and combinatorial tests.

Pharmacogenomics is the study of how genes affect the body’s response to certain medicines.

CMS considers these tests reasonable medical decision-making tools once a clinician has narrowed down treatment possibilities to specific medications and those medications have been deemed more or less effective for a patient based on his or her genetic makeup.

For example, Professional PGx Express is a pharmacogenetics test that gives doctors information for up to 24 genes in order to help them make prescribing decisions for mental health medications with less trial and error.

Local coverage determinations aren’t sweeping national policies. Rather, they provide flexibility and guidance to Medicare Administrative Contractors, who ultimately decide how to interpret CMS determinations on a regional basis.

Cases of scammers offering free genetic testing services to Medicare beneficiaries has been on the rise in recent years.

According to the U.S. Administration for Community Living, unscrupulous people will often target Medicare enrollees via telemarketing calls, booths at public events and door-to-door visits offering free genetic tests.

They often claim that the testing is covered by Medicare and free of charge to the beneficiary.

Authorities say don’t fall for it — or you could be left paying the bill.

“If a company bills Medicare for genetic testing, and Medicare denies the claim, the beneficiary could be responsible for the entire cost of the test — which often totals around $10,000,” Rebecca Kinney, acting director of the Office of Healthcare Information and Counseling, wrote in a government news release.

In September 2019, the Justice Department took down a massive fraud scheme involving genetic cancer testing. Thirty-five people were charged for unlawfully billing Medicare more than $2.1 billion.

The DOJ said recruiters or marketers often approached seniors at health fairs or during door-to-door visits. They would obtain the beneficiary’s Medicare information for identity theft or fraudulent billing purposes.

The recruiter would then get a doctor to sign off on the genetic test so it could be processed by a lab.

The doctors received a kickback in exchange for ordering the test. After the lab was reimbursed for the test by Medicare, the lab shared proceeds of that payment with the recruiter.

If you believe you were contacted by a scammer, or if you have any concerns about billing errors or possible fraud, contact your local Senior Medicare Patrol.

The program, funded by the U.S. Administration for Community Living, helps Medicare enrollees protect themselves from Medicare fraud, errors and abuse.