Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support.
The Centers for Medicare and Medicaid Services (CMS) issued a 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. Late Friday, CMS came out with a final rule delaying that coverage again until Dec. 15, 2021.
The medtech industry and members of Congress had been pressuring CMS to enact the final rule. But physicians’ organizations and the insurance industry pushed back, citing safety and efficacy concerns for devices not thoroughly tested. The American Medical Association also raised concern about the lack of opportunity for stakeholder review and input about these coverage decisions and about allowing private payor coverage policy to determine whether an item is “reasonable and necessary” for purposes of Medicare coverage.
The further delay caused dismay in the medtech industry, including the Medical Device Manufacturers Association (MDMA).
“MDMA is disappointed that CMS decided to continue to delay the implementation of the MCIT final rule. This is a targeted policy that has strong bipartisan support in Congress, and it would be a boost for the treatment and care of our nation’s seniors, as well as for innovation,” association president & CEO Mark Leahey said in a statement. “MDMA will continue to work with CMS and policymakers to quickly and efficiently implement the MCIT program, and to help ensure that Medicare beneficiaries get timely access to new medical procedures and therapies.”
“While it’s certainly disappointing that a Medicare policy to help suffering seniors was delayed, we look forward to continuing to make the case that breakthrough medical technologies deemed safe and effective by the FDA should be quickly covered by Medicare,” said AdvaMed president & CEO Scott Whitaker. “We remain hopeful that CMS will work with us to achieve this important goal of improving Medicare beneficiaries’ access to lifesaving treatments.”
CMS officials said in January that they believe four years of Medicare coverage will encourage manufacturers to voluntarily develop evidence to show these treatments improve the health of Medicare patients. When MCIT coverage sunsets, manufacturers will have all current coverage options available such as a national coverage determination (NCD), one or more local coverage determinations (LCD), and claim-by-claim decisions.