The Centers for Medicare & Medicaid Services wants to repeal a Trump-era rule allowing Medicare to cover medical devices designated as "breakthrough" technology by the Food and Drug Administration, according to a proposed rule on Monday.
Former President Donald Trump's administration had said the original rule was necessary because the existing Medicare coverage determination process is too slow and could delay beneficiaries' access to the latest medical technology.
Medical device companies lauded the plan when CMS first announced it last year. But patient-safety groups like ECRI worried it could threaten the safety of Medicare patients. Other experts agreed, and now CMS does too.
"While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on breakthrough devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population upon receipt of coverage," the proposed rule says.
The Biden administration hinted that it could decide to cover breakthrough devices in the future but that it must ensure the safety of Medicare beneficiaries.
"We believe it is important to evaluate how a device works for Medicare patients. This includes a potential decision to cover a device under Medicare in the context of collecting additional evidence (e.g., by requiring clinical trials or outcome registries) before broadly covering the device in the Medicare program," CMS said in a news release. "Seniors and people with disabilities who make up the Medicare population often have complex medical needs and unique health considerations compared to other patient populations. This can change the potential risks and benefits of a new device for Medicare patients, specifically."
The Trump administration claimed the original rule would encourage more innovation by streamlining Medicare coverage of new devices. Under the current system, Medicare Administrative Contractors—16 in total—decide whether to cover a device within their region. Device makers must apply separately to each contractor to get coverage approval.
Trump's CMS approved the original rule in January, shortly before President Joe Biden took office. It was slated to take effect in March, but the agency delayed its implementation until December 15 to give the president's team more time to review it.
Comments on the Biden administration's proposal to withdraw the Trump-era regulation are due October 15.
