Does Medicare cover genetic testing?

When does Medicare cover genetic testing?

Medicare Part B covers medically necessary diagnostic laboratory tests when your health care provider orders them. CMS says clinical laboratory diagnostic tests can include tests that predict the risk associated with one or more genetic variations, and next generation sequencing (NGS) is one technique that can measure genetic variations as a lab test.

CMS's national coverage determination for NGS applies only to diagnostic lab tests using NGS for acquired (somatic) and inherited (germline) cancer. Local Medicare Administrative Contractors may decide coverage of NGS tests for RNA sequencing and protein analysis.

What are Medicare's rules for NGS testing of an existing cancer?

For acquired (somatic) cancer, Medicare covers an NGS diagnostic lab test nationally when it's done in a CLIA-certified laboratory, ordered by your treating physician, and all of these requirements are met:

• You have recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer.
• You haven't been tested before with the same NGS test for the same cancer genetic content.
• You've decided to seek further cancer treatment (like therapeutic chemotherapy).
• The test has Food and Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic, and an FDA-approved or -cleared indication for use in your cancer.
• The results go to your treating physician for managing your care, using a report template that specifies treatment options.

When does Medicare cover inherited cancer gene testing?

For inherited (germline) cancer, Medicare covers an NGS diagnostic lab test nationally when it's done in a CLIA-certified laboratory, ordered by your treating physician, and all of these requirements are met:

• You have ovarian or breast cancer.
• You have a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer.
• You have a risk factor for germline (inherited) breast or ovarian cancer.
• You haven't been tested before with the same germline NGS test for the same germline genetic content.
• The test has FDA approval or clearance, and the results go to your treating physician for managing your care, using a report template that specifies treatment options.

What if my genetic test isn't covered under the national rule?

Local Medicare Administrative Contractors (MACs) may decide coverage in some cases. For acquired cancer, a MAC may cover an NGS test for a patient with advanced cancer who meets the same patient conditions, when the test is done in a CLIA-certified lab and ordered by a treating physician. For inherited cancer, a MAC may cover an NGS test for a patient with any cancer diagnosis who has a clinical indication for germline testing of hereditary cancers, has a risk factor for germline cancer and hasn't had the same germline test before, when the test is done in a CLIA-certified lab, ordered by a treating physician, and the results go to the treating physician.

CMS's rule also says NGS testing for acquired cancer is non-covered if the cancer patient doesn't meet the national coverage criteria. HHS's Office of Inspector General warns that if Medicare denies the claim for a genetic test, you could be responsible for the entire cost of the test, which could be thousands of dollars.

What do I pay for a covered genetic test?

You usually pay nothing for Medicare-covered diagnostic laboratory tests. The "Medicare & You" handbook says you generally pay nothing for lab tests when you get them from a laboratory, pharmacy, doctor or hospital that accepts assignment. Medicare Advantage plans must cover all medically necessary services that Original Medicare covers, and some offer extra benefits; rules and costs vary by plan, and you may need approval (prior authorization) from your plan first.

How do I avoid a genetic testing scam?

Genetic testing fraud occurs when Medicare is billed for a test or screening that wasn't medically necessary or wasn't ordered by your treating physician. Scammers offer "free" screenings or cheek swabs to get Medicare information for identity theft or fraudulent billing, through telemarketing calls, booths at public events, health fairs and door-to-door visits. HHS's Office of Inspector General advises:

• If a genetic testing kit is mailed to you, don't accept it unless your physician ordered it. Refuse the delivery or return it to the sender, and keep a record of the sender's name and the date you returned it.
• Be suspicious of anyone who offers you "free" genetic testing and then asks for your Medicare number.
• Have a physician you know and trust assess your condition and approve any request for genetic testing.
• If anyone other than your physician's office asks for your Medicare information, don't give it.
• If you suspect fraud, contact the HHS OIG Hotline, or call 1-800-MEDICARE. See how to spot a Medicare scam.