Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support.
The Centers for Medicare and Medicaid Services (CMS) issued a final rule in January granting coverage for breakthrough devices the same day as their FDA approvals. The rule was supposed to take effect March 12, but CMS has postponed the Medicare Coverage of Innovative Technology (MCIT) final rule by 60 days to give the public more opportunities to comment, the agency said in a Federal Register notice.
Immediately upon taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register so it could review questions of fact, law and policy the rules may raise. CMS officials decided that further review was warranted.
The pause is mystifying to officials of the medtech trade group AdvaMed, according to its president and CEO. Scott Whitaker told Medical Design & Outsourcing that the final rule, which has broad bipartisan support, has been the subject of plenty of deliberation within and outside the government.
“It feels like a long and deliberate process, which again underscores why some of us are a little confused that at the last minute they would suggest that it wasn’t moving forward,” Whitaker said. “We are all trying to better understand it and we are all speculating a little bit.
“It may be one of two things,” he added. “There is some sense that the agency just wasn’t ready to implement it, whether they weren’t able to get the work done in time, or because there are open policy questions that they needed further answer to. We’re hopeful that that is the reason. There are some that suggest that the underlying policy is something that the new administration might not be supportive of. I’m not sure why that would be… We’re trying to square those two things as best we can and we’re hopeful that once they dig into this rule — the new administration — they’ll realize the value it provides for innovation and for patients who are impacted by it.”
If the Biden administration does not support the underlying concept of the proposed rule, the medtech industry is willing to talk about it, according to Whitaker.
“I’m not sure from a policy perspective who’d be opposed to speeding up the process for Medicare beneficiaries to get access to these breakthrough products,” he said. “Not a large number have been cleared and it’s not a simple definition that’s wide open to interpretation. It’s very clear from statute to regulation. There shouldn’t be a lot of ambiguity, that and it underscores why we’re a little bit concerned and confused.”
Mark Leahey, president and CEO of the Medical Device Manufacturers Association, told MDO that MDMA is sure the rule will go into effect.
“While we are disappointed in the delay of the MCIT program, we remain confident that it will be enacted due to the strong ongoing support of physician and patient groups, as well as the bipartisan support in Congress,” Leahey said in an email. “MDMA will continue to work with CMS to advance the MCIT program, and to help ensure that patients get timely access to medical technology innovation.”
If the proposed rule goes into effect without changes on May 15, 2021, the coverage would last for four years, during which CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.
CMS officials said in a news release 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.
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