Bipartisan bill looks to have Medicare cover breakthrough medical devices:  Lawmakers said the legislation would offer Medicare beneficiaries access to breakthrough medical devices

A new bipartisan bill, the “Ensuring Patient Access to Critical Breakthrough Products Act”, has been introduced by lawmakers looking to require Medicare to cover new breakthrough medical devices for four (4) years.

Introduced by Representatives Suzan DelBene, D-Wash., and Brad Wenstrup, R-Ohio, the lawmakers said the legislation would provide Medicare beneficiaries with faster access to safe, effective breakthrough medical devices.


Currently, new medical devices that provide more effective treatment or diagnosis of life-threatening diseases, have no approved alternatives, or offer significant advantages over existing options.  They can now receive breakthrough designation by the Food and Drug Administration (FDA).  Unfortunately, lawmakers said, breakthrough devices are not always covered by Medicare, even after they are approved.  The Medicare coverage determination process can take up to three (3) years, which the House members said can delay seniors’ access to new diagnostic and treatment options.

For example, ReCor Medical recently developed a novel treatment for high blood pressure, a condition experienced by three (3) out of four (4) U.S. seniors.  Hypertension is estimated to cost the healthcare system about $50 billion per year.  This treatment, the representatives said, has been shown to decrease blood pressure in two (2) out of every three (3) patients in clinical trials, and it was given breakthrough designation.  “If this treatment was covered by Medicare faster, it could help seniors live longer lives and experience fewer cardiovascular issues,” they said.

What the legislation is meant to do is ensure that FDA-designated breakthrough products are covered by Medicare for four (4) years.  During this period, the Centers for Medicare and Medicaid Services (CMS) would be required to make a permanent coverage determination.  The bill also provides temporary coverage for certain breakthrough devices that did not exist or were not considered when Medicare was first created, like digital therapeutics.


In late 2021, CMS rescinded a final rule that would have granted expedited Medicare coverage for certain breakthrough devices.  The decision to rescind the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule was due to concerns that its provisions were insufficient to protect Medicare patients.  It gave expedited Medicare coverage for up to four (4) years for certain FDA-designated breakthrough devices once they received or cleared market authorization.  CMS said at the time that the kinds of clinical studies needed for FDA market authorization might not consider the differences in clinical profiles, complexities of medical conditions or associated treatments of the diverse population of Medicare patients.


“Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives,” said DelBene.  “Guaranteeing Medicare coverage of breakthrough medical devices would encourage future innovation and investment in next-generation medical technologies while improving the quality of life for millions of seniors.  We can’t let the coverage approval process be a barrier to life-saving treatments or care.”

“Seniors should be able to access the most innovative care and breakthrough devices as soon as we know these are deemed safe and effective by the FDA,” said Wenstrup.  “They should not have to wait years for a Medicare coverage decision on life-saving treatments.  With this legislation, millions of seniors could live longer, healthier lives, and companies that develop these innovative treatments would be supported in their investment in medical technologies and devices.”

REFERENCE:  HealthCare Finance; 28 MAR 2023; Jeff Lagasse