Does Medicare Cover Genetic Testing?
Medicare generally covers genetic testing only when it is ordered by your doctor to diagnose or treat cancer. One preventative genetic test that screens for colorectal cancer is also covered. You will owe little, if anything, for these tests so long as you meet eligibility criteria.
Understanding Medicare’s Coverage of Generic Testing
Medicare covers genetic testing in limited situations only, and only when ordered by your doctor.
Direct-to-consumer DNA test kits, such as 23andMe, aren’t covered by Medicare.
Next Generation Sequencing Tests for Cancer Patients
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.
- Recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer
- Not been previously tested using NGS for the same cancer and genetic content
- Decided to seek further cancer treatment, such as chemotherapy
Clinical laboratory tests are covered under Medicare Part B. You usually pay nothing for Medicare-approved clinical diagnostic laboratory services.
Medicare Expands Next Generation Sequencing in 2020
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.
- Ovarian or breast cancer
- A clinical indication for hereditary breast or ovarian cancer
- A high-risk factor for inherited breast or ovarian cancer
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.
Medicare Coverage of Cologuard, A Genetic Screening Test
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.
Pharmacogenomics and Other Genetic Tests
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.
Pharmacogenomics Testing Coverage
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.
Beware of Medicare Genetic Testing Scams
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.
19 Cited Research Articles
- United Healthcare. (2021, March 16). Genetic Testing. Retrieved from https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/genetic-testing.pdf
- Genomind. (2021, January 26). Genomind Receives Medicare Coverage for Pharmacogenetics Test. Retrieved from https://www.genomeweb.com/business-news/genomind-receives-medicare-coverage-pharmacogenetics-test#.YIqg031Kgo8
- Riggs, E., Morrill-Cornelius, S. and Alexander, C. (2020, November 25). Demystifying Medicare Genetic Testing Policies. Retrieved from https://informeddna.com/demystifying-medicare-genetic-testing-policies/
- Centers for Medicare & Medicaid Services. (2020, August 3). Local Coverage Determination (LCD): MolDX: Pharmacogenomics Testing (L38294). Retrieved from https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38294&ver=16&SearchType=Advanced&CoverageSelection=Local&ArticleType=BC%7CSAD%7CRTC%7CReg&PolicyType=Both&s=All&KeyWord=Pharmacogenomics&KeyWordLookUp=Title&KeyWordSearchType=Exact&kq=true&bc=EAAAABAAAAAA
- Taylor, A. (2020, March 13). Medicare Coverage for Next-Generation Sequencing Tests. Retrieved from https://www.cancertodaymag.org/Pages/cancer-talk/Medicare-Coverage-for-Next-Generation-Sequencing-Tests.aspx
- Centers for Medicare & Medicaid Services. (2020, January 27). CMS Expands Coverage of Next Generation Sequencing as a Diagnostic Tool for Patients with Breast and Ovarian Cancer. Retrieved from https://www.cms.gov/newsroom/press-releases/cms-expands-coverage-next-generation-sequencing-diagnostic-tool-patients-breast-and-ovarian-cancer
- Inserro, A. and Caffrey, M. (2020, January 27). Medicare Patients With Breast, Ovarian, Other Cancers. Retrieved from https://www.ajmc.com/view/cms-agrees-to-cover-ngs-for-medicare-patients-with-breast-ovarian-other-cancers
- Waddill, K. (2020, January 27). CMS: Medicare Will Cover Genetic Diagnostics For Certain Cancers. Retrieved from https://healthpayerintelligence.com/news/cms-medicare-will-cover-genetic-diagnostics-for-certain-cancers
- Landi, H. (2019, September 30). DOJ arrests 35 in $2.1B Medicare scam targeting seniors for fraudulent genetic testing. Retrieved from https://www.fiercehealthcare.com/payer/doj-arrests-35-2-1b-medicare-scam-targeting-seniors-for-fraudulent-genetic-testing
- Kinney, R. (2019, September 27). Beware of a Growing Medicare Scam: “Free Genetic Testing.” Retrieved from https://acl.gov/news-and-events/acl-blog/beware-growing-medicare-scam-free-genetic-testing
- Klug, M. (2019, May). Genetic Tests and Medicare: Coverage and Oversight. Retrieved from https://www.smpresource.org/Handler.ashx?Item_ID=E3BA48E4-57F1-458B-B3D1-7F22FD13FF58
- Jones, B. (2018, April 26). Paying for Tumor Testing. Retrieved from https://www.cancertodaymag.org/Pages/cancer-talk/Paying-for-Tumor-Testing.aspx
- UCSF Cancer Genetics and Prevention Program. (2017, February). Medicare Insurance Coverage for Genetics. Retrieved from https://kintalk.org/medicare/
- Centers for Medicare & Medicaid Services. (n.d.). Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R). Retrieved from https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=296
- Centers for Medicare & Medicaid Services. (n.d.). National Coverage Determination (NCD) for Cytogenetic Studies (190.3). Retrieved from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=198&ncdver=1&bc=AAAAEAAAAAAA
- Jacques, L. B. (n.d.). Medicare Coverage of Genomic Testing. Retrieved from https://www.genome.gov/sites/default/files/genome-old/pages/About/OD/ReportsPublications/June2008_JacquesHoL.pdf
- Medicare.gov. (n.d.). Clinical laboratory tests. Retrieved from https://www.medicare.gov/coverage/clinical-laboratory-tests
- Medicare.gov. (n.d.). Local Coverage Determination. Retrieved from https://www.medicare.gov/claims-appeals/local-coverage-determinations-lcd-challenge
- National Cancer Institute. (n.d.). Cytogenetics. Retrieved from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/cytogenetics