The Centers for Medicare & Medicaid Services (CMS) has again delayed a rule that would significantly accelerate Medicare coverage for breakthrough medical devices.
The rule was initially set to take effect March 15 after being finalized in mid-January but was pushed back to May 15. In a filing (PDF) Tuesday, CMS has further delayed the start date to Dec. 15.
The rule would allow devices that secure approval through the Food and Drug Administration’s “breakthrough” pathway to also gain immediate Medicare coverage approval. Typically, it can take a year or more for new devices to be approved in Medicare once they are OK’d by the FDA.
The rule was previously postponed as part of the Biden administration’s regulatory freeze, in which it reviewed regulations approved at the tail end of the Trump administration.
The agency said in the filing that it heard concerns from the rule’s detractors, namely insurers, about providing blanket Medicare approvals to devices that may not have been tested in seniors.
“We share commenters’ concerns that guaranteeing coverage for all breakthrough devices receiving market-authorization for any Medicare patient with possibly minimal or no evidence on the Medicare population and no requirement to develop evidence on the Medicare population could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries,” CMS said in the latest document.
CMS said in the filing that it will take the additional time to dig further into these concerns and ensure the rule balances the needs of all stakeholders and Medicare beneficiaries.
The rule, when initially filed, was considered a significant tailwind for medical device manufacturers, according to analysts and experts.