The Biden administration intends to release its version of a rule on expedited Medicare coverage for breakthrough medical technology next October, according to the Health and Human Services Department's regulatory agenda.
The rule might differ from the Trump administration's version of the policy by requiring more evidence collection on how effective a device is for Medicare beneficiaries, and it may give the Centers for Medicare and Medicaid Services more say in the coverage determination process, said Tom Bulleit, a partner at Ropes & Gray.
CMS repealed a rule last month that would have allowed Medicare to immediately cover medical devices designated as "breakthrough technology" by the Food and Drug Administration for four years after they received market authorization.
CMS officials said when repealing the rule that they planned to revisit ways to improve access to breakthrough technologies, through rulemaking or existing pathways. Including a proposed rule on the topic on the regulatory agenda indicates CMS decided a new rule is necessary to bolster Medicare access to these technologies.
The notice of a proposed rule is a welcome addition to next year's regulatory plan, said Susan Feigin Harris, a partner at Morgan Lewis.
"If you think about all of the kinds of innovation we can pursue, there can be dramatic changes that propel us forward," Harris said. "I looked at it and went great, you know, these are the continuation of what we need."
The rule, which never actually went into effect, was finalized in the last days of the Trump administration. Medical device manufacturers applauded the policy, but many provider and beneficiary advocacy associations worried the rule would have led to coverage of devices without evidence they could properly serve the needs of Medicare beneficiaries.
Bulleit believes CMS will probably take these comments into consideration. CMS seemed to feel the previous policy removed the agency from the coverage determination process, since approval would be automatic, Bulleit said. He could see the future proposal try to address that. The new rule might require breakthrough devices to have evidence they're effective for Medicare beneficiaries before approval or require additional data to be collected post-approval.
"That seems to me to be a reasonable approach, they can always withdraw the coverage if the data shows bad things that could let it go forward, if it shows good things," he said.
The Association of American Medical Colleges also hopes to see additional protections for Medicare beneficiaries in the Biden administration's version of the policy, said Ivy Baer, senior director and regulatory counsel for AAMC.
There's been a groundswell of support for an expedited coverage pathway for breakthrough technology since CMS repealed the rule. A bipartisan group of lawmakers sent the agency a letter last month urging CMS to put out a replacement policy quickly.
But CMS predicts the new proposed rule won't come out until next October. That's not too surprising, given how long the regulatory process can take, Harris said. Still, the timeline also may be due to competing priorities, Bulleit said.
"It does kind of surprise me that they made all this progress, and they're saying really it's going to be another year before we get back to this," Bulleit said. "But I guess what that suggests is, you know, the progress we made wasn't close enough to what CMS wants to see."
Baer said she's gotten no indication at this point that CMS intends to include a provision codifying a definition of what items or services are considered "reasonable and necessary" for diagnosis or treatment under Medicare, another component of the repealed Trump administration rule.
