The proposed rule, released Monday, is in response to an executive order by President Donald Trump in late 2019 that tasked CMS with streamlining coverage for breakthrough medical devices. Manufacturers can voluntarily participate in FDA’s Breakthrough Devices Program to secure quicker review of their devices. The program is only open to devices that provide effective treatment or diagnosis of a life-threatening or debilitating condition and they must use a breakthrough technology, offer significant advantages compared to existing alternatives or have no approved clearance currently in existence.
Medicare currently doesn’t cover breakthrough devices. Under the proposed rule, Medicare will cover the use of a breakthrough device for four years after it receives FDA market authorization. CMS said it believes four years is enough time to “encourage” devicemakers to voluntarily study how the product impacts Medicare beneficiaries, although it’s not required. After the four years, manufacturers will have access to all the usual coverage options available including Medicare’s national coverage determination process, according to the agency.
Devicemakers must notify CMS if they are interested in the program, which is called the Medicare Coverage of Innovative Technology pathway. Only devices that fit under a Medicare benefit can be covered; some wearables aren’t covered by Medicare.
Medical Device Manufacturers Association CEO Mark Leahey on Monday applauded the proposal and noted his organization has advocated for these kinds of policies.
“We look forward to continue working with CMS, the administration, Congress and all stakeholders to narrow the gap between regulatory and reimbursement decisions that will bolster patient care,” he said in a statement
Not-for-profit patient-safety organization ECRI urged CMS to require manufacturers to study the safety of the device on Medicare beneficiaries in order to receive coverage rather than it being optional as is currently proposed in the rule. ECRI CEO Dr. Marcus Schabacker said there are concerns about the safety of new devices for Medicare patients because devices are usually tested on much smaller groups before clearance compared with drugs, and vulnerable seniors typically aren’t included in the studies. Breakthrough devices also go through an even faster, less rigorous clearance process.
“There should be requirements post-market for companies to ensure that the product is living up to safety standards,” Schabacker said. “We would strongly advocate that after the breakthrough clearance and the granting of CMS financing through Medicare, that formal studies for the Medicare population be conducted.”
The proposed rule also would change CMS standards for coverage determinations. Currently, CMS considers if a medical device should be covered by reviewing whether it’s safe and effective. The agency wants to add another standard, called appropriate for Medicare patients, to determine coverage. This would allow CMS to determine a device’s Medicare eligibility by seeing if it’s already covered by commercial insurance.
CMS is seeking public comments on the proposed rule until Nov. 2. The agency is specifically asking for feedback from stakeholders on the four-year duration of the Medicare Coverage of Innovative Technology pathway, if what’s covered should be expanded, and the proposed changes to the “reasonable and necessary” standards.