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Advancing Access to Precision Medicine Act - A Bipartisan Bill

On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R. 5062)(“Bill”) to “provide a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care, and for other purposes.” (Bill, page 1).  The National Academy of Medicine’s report on its study is due within 3 years from the date of enactment.

Improving Access to Precision Medicine

The Bill directs the Department of Health and Human Services to enter into an agreement with the National Academy of Medicine to recommend how the federal government can support the use of genetic and genomic testing to allow for better delivery of precision medicine, including:

“(A) encouraging the expansion of health insurance coverage of genetic and genomic testing, including diagnostic, predictive, and pre-symptomatic testing, and whole genome sequencing;

(B) supporting the collection of evidence for the clinical utility and appropriate use of genetic and genomic tests;

(C) improving access to genetic counselors, pathologists, and other relevant professionals, including strengthening related workforce education and training efforts;…”

Bill, page 2.

The Bill also requires a report on how coverage provisions in the Medicare and Medicaid programs may restrain the use of genetic testing to improve outcomes for beneficiaries including especially individuals suffering from rare or orphan diseases and individuals in special populations, such as infants, children and the critically ill. The report should include recommendations on how the Centers from Medicare & Medicaid Services can make better determinations to support the use of precision medicine. Bill, pages 2 and 3.

State Option to Provide Whole Genome Sequencing for Certain Children

The Bill allows states to apply for “an exception to the federal medical assistance percentage” to provide qualified children on Medicaid (e.g., those suspected of suffering from a genetic disease) with access to whole genome sequencing. (See February 15, 2018 Swalwell press release.) As a first step, states may apply for a grant to assist them in developing a plan to implement clinical access. Bill, page 6.

Another Step Forward

The Bill, if passed by Congress and signed into law by the President, will further advance the purpose of the 21st Century Cures Act, which authorized funding and allocated resources to advance personalized medicine. The Bill is supported by the Personalized Medicine Coalition, the EveryLife Foundation for Rare Diseases, Biocom, the Advanced Medical Technology Association, and the American Association for Cancer Research. (See February 15, 2018 Swalwell press release).

© 2020 Foley & Lardner LLPNational Law Review, Volume VIII, Number 63


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,...