The Centers for Medicare and Medicaid Services finalized its decision Friday to repeal a rule that would have created an expedited Medicare coverage pathway for medical devices considered "breakthrough technology."
The rule, originally finalized in the last days of the Trump administration, would have allowed Medicare to cover devices deemed "breakthrough" by the Food and Drug Administration for four years once they received market authorization. Medicare beneficiaries can currently get breakthrough devices covered through other methods, like a national coverage determination, but this would have sped the process.
The Biden CMS — and many medical associations and beneficiary advocates — worried the rule as written would've led to coverage of devices without evidence they could properly serve the needs of Medicare beneficiaries.
Medical device manufacturers are upset with CMS' decision to toss out the policy but want to keep working with the agency to advance access to health technology for Medicare beneficiaries.
"While MDMA is disappointed over the ongoing delays to policies that are designed to improve patient access to American innovations, we remain focused on working with CMS to help realize their stated goal of enhancing access to new medical technologies," Medical Device Manufacturers Association president and CEO Mark Leahey said in a statement.
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CMS proposed repealing the rule in September after first delaying its implementation in March and again in May. Without Friday's final rule, the policy would have gone into effect in mid-December.
But medical device manufacturers maintained that advancing access is crucial. DuVal & Associates, a regulatory law firm that represents medical device companies, predicted in comments to CMS' September proposal that repealing the rule will lead to a substantial loss of confidence in medical device industry investments.
Still, in Friday's final rule, CMS said its limited power to deny coverage for breakthrough devices in the pathway, the lack of requirement that Medicare beneficiaries be included in clinical studies before FDA market authorization and its overall inability to establish beneficiary safeguards in the program factored into its decision to axe the policy.
"Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions," CMS Chief Medical Officer Lee Fleisher said in a news release.
The final rule said CMS still wants to improve access to breakthrough technologies and may do this through existing pathways or future rulemaking. CMS plans to look into ways to make the national coverage determination process quicker and to work with the Agency for Healthcare Research and Quality to explore updating the criteria for coverage with evidence development, the agency said in the rule.
"[W]e want to reassure stakeholders that CMS does not intend to maintain the status quo. We remain committed to our goal of establishing an alternative expedited coverage pathway that better achieve the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards," the rule says.
MDMA said CMS needs to engage stakeholders quickly on a replacement for the rule and highlighted bipartisan support in Congress for fast access to breakthrough technology. A bipartisan group of ten senators sent CMS a letter last week saying breakthrough technology can improve Americans' quality of life and urging the agency to quickly issue a new proposed rule.
But Whitaker said he's not sure how much more CMS can glean from listening sessions that it hasn't already gotten from multiple comment periods on the policy.
"I'm not sure what new we learn in listening sessions in 2022. But we welcome the opportunity to say what we've said, you know, multiple times," he said.
The Trump-era rule would have codified a definition of what items or services are considered "reasonable and necessary" for diagnosis or treatment under Medicare. It would have, in part, allowed CMS and its contractors to determine if something is reasonable and necessary for Medicare coverage based on whether a majority of commercial insurers cover the item or service.
Medical device groups, AHIP and beneficiary advocates said this was a vague and inappropriate policy decision, and supported the repeal of the provision in comments on the proposal to repeal the rule.
Commenters on the proposed repeal of the rule recommended CMS cut the breakthrough coverage and reasonable and necessary elements into two separate rules. CMS said it would consider this in the future.
