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HHS and Medicare Asked to Expand Coverage for Genetic Tests

Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic testing. In a March 7, 2017 letter to Secretary Price of HHS and Dr. Crosson, Chairman of Medicare, the congressmen seek a resolution to an important issue challenging precision medicine – who will pay for genetic tests that are necessary to develop and deliver personalized health care?

Referencing the 21st Century Cures, the Precision Medicine Initiative, and Cancer Moonshot, the congressmen ask the federal government’s support of personalized medicine by extending insurance coverage under Medicare and Medicaid to genetic testing. The congressman argue that enhanced coverage would benefit the patients and would expand the pool of data that could be used to further validate genetic markers, genetic tests, and their interpretation.

With these goals in mind, HHS in coordination with the National Academy of Medicine were asked to conduct a study to:

  • Examine how genetic testing can improve preventative medicine and support precision medicine initiatives;
  • Analyze how the use of genetic testing can reduce health care expenditures; and
  • Make recommendations to the federal government on how it can:
  • Encourage the expansion of health insurance coverage of genetic testing for diagnostic and preventative medicine;
  • Support the development of evidence for the clinical utility of genetic tests; and
  • Strengthen the support of genetic testing, e.g., training of genetic counselors.

The congressmen also ask that Medicare initiate a study to:

  • Review how the current Medicare and Medicaid coverage determination may restrain the use of genetic tests;
  • Develop recommendations on how the Centers for Medicare and Medicaid Services can cover clinical precision medicine; and
  • Analyze how the use of genetic testing can reduce federal health care expenditures.

Implementation of the congressmen’s suggestions would be a good first step toward resolving questions of whether precision medicine can reduce health care costs in the short and long term. In addition, implementation would further support investment in the underlying technology and science. The response to the congressman’s requests will certainly signal where precision medicine stands in the new administration’s agenda.

© 2019 Foley & Lardner LLP


About this Author

Antoinette F. Konski, Intellectual Property Attorney, Foley Lardner Law Firm

Antoinette F. Konski is a partner and intellectual property lawyer with Foley & Lardner LLP. Ms. Konski works with life science clients, creating and optimizing value in intellectual property portfolios encompassing technologies that include personalized medicine, regenerative and stem cell biology, antibodies, immunology, gene therapy, nanotechnology, diagnostics, small molecules and drug delivery. She represents public and private companies and universities. Ms. Konski currently serves as the firm’s Silicon Valley IP office chairperson, vice chair of the Chemical,...