Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation.
Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that the Centers for Medicare and Medicaid Services (CMS) has delayed implementing with a final rule.
CMS issued that final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately upon taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register to review questions of fact, law and policy the rules may raise. CMS officials decided that coverage of breakthrough devices warranted further review.
The MCIT rule was supposed to take effect on March 12, but CMS delayed it by another 60 days to give the public more opportunities to comment. In May, CMS came out with a final rule delaying that coverage again until Dec. 15, 2021.
The Medical Device Manufacturers Association lauded the bill’s introduction.
“MDMA thanks Congresswomen DelBene and Walorski and all of the original cosponsors for their bipartisan leadership to introduce the ‘Ensuring Patient Access to Critical Breakthrough Products Act,’” said MDMA president & CEO Mark Leahey in a news release. “This is a commonsense solution to address the increasing time between FDA market authorization and CMS coverage of innovative medical technologies. This alarming ‘valley of death’ punishes patients and physicians who are desperately seeking cures and therapies for their unmet medical needs.”
The trade group continues to encourage CMS to implement MCIT, according to Leahey. “MDMA continues to work closely with Congress, CMS and other stakeholders to enact targeted and reasonable improvements to the reimbursement pathways to help ensure that patients are able to benefit from America’s medical technology innovations,” he said.