Dive Brief:

• House lawmakers have introduced a bipartisan bill that would require Medicare to temporarily cover breakthrough medical devices for four years while the Centers for Medicare and Medicaid Services would be required to make a permanent coverage determination.
• The bill’s goal is to provide Medicare beneficiaries with faster access to Food and Drug Administration-approved breakthrough devices by removing “unnecessary barriers” that prevent seniors from accessing the most innovative and cutting-edge treatments, U.S. Rep. Brad Wenstrup, R-Ohio, a co-sponsor of the bill, said in a statement.
• The bill would also provide temporary coverage for some breakthrough devices, such as digital therapeutics, that did not exist or were not considered when Medicare was first created.

Dive Insight:

The FDA can give breakthrough designation to new medical devices if there are no approved alternative treatments for a life-threatening or debilitating conditions, or if the technology offers significant advantages over alternatives.

The Medicare coverage determination process can take up to three years, delaying seniors’ access to potentially life-changing new diagnostic and treatment options, bill co-sponsor Suzan DelBene, D-Wash., said in a statement.

Called the “Ensuring Patient Access to Critical Breakthrough Products Act,” the new legislation aims to expedite the coverage determination process for devices.

"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," DelBene said.

CMS proposed a similar policy under the Trump Administration, called the Medicare Coverage for Innovative Technologies (MCIT) final rule, but reversed course in November of 2021 after meeting strong opposition from some healthcare groups over safety concerns.

The rule, supported by the medtech industry, would have granted expedited Medicare coverage for up to four years for certain FDA-designated breakthrough devices once they received market authorization. In announcing the agency’s decision to rescind the rule, the CMS said it had concerns that provisions in the rule may not have been sufficient to protect Medicare patients.

DelBene pointed to a novel treatment from ReCor Medical for high blood pressure that received breakthrough designation. “If this treatment was covered by Medicare faster, it could help seniors live longer lives and experience fewer cardiovascular issues,” the lawmaker said.

“In order for companies to invest in new medical technologies they need a clear path to both FDA-approval and reimbursement. Increasingly, the time and uncertainty associated with securing reimbursement has become the major barrier for young companies looking to invest in groundbreaking medical technologies,” Marc Cummings, CEO of Life Science Washington, a Seattle-based trade group, said in a press release.

Cummings said the proposed legislation would provide companies the certainty they need to invest in new technologies to diagnose and treat diseases that don’t currently have effective therapies. It would also ensure doctors and patients can access the new technologies as soon as they are FDA approved, the CEO said.