The Biden administration is considering creating a quicker process to review new medical devices for Medicare coverage after a controversial Trump-era rule was scrapped.
Officials with the Centers for Medicare & Medicaid Services (CMS) wrote in the Journal of the American Medical Association its vision for a new pathway for the device review process that will be released in a proposal in the coming months.
“This pathway will build on prior initiatives, including coverage with evidence development,” the article said. “Coverage with evidence development allows Medicare to cover technologies, including medical devices, on the condition that the product is used in clinical studies approved by the agency.”
CMS laid out some of the principles the pathway is expected to include, such as that it will be voluntary and only be limited to devices that are relevant to the Medicare population and fall within the program’s statute, the article said.
If the manufacturer agrees, CMS could start a coverage review process before the Food and Drug Administration clears the product for the market. This option could require an “additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.”
If CMS decides that a devicemaker needs to get more evidence of the product’s benefits, it will explore “how to reduce the burden on manufacturers, clinicians and patients while maintaining rigorous evidence requirements,” the JAMA article said.
The officials wrote that the principles could help strike a balance between narrowing the gap for coverage decisions and ensuring any product meets “rigorous evidence standards.”
The agency did not think that a rule passed at the tail end of the Trump administration in early 2021 met those standards.
If that rule had moved forward, it would have given devices cleared through the FDA’s breakthrough device designation four years of Medicare coverage automatically. The goal was to remove the gap between the time a device clears the FDA and gets approved for Medicare coverage, which could in some cases take up to a year.
However, the rule drew a swift rebuke from patient advocates and insurers that were worried it would introduce unsafe devices to Medicare beneficiaries.
The group AHIP wrote in comments that the rule enabled a less rigorous process for reviewing cleared devices and that CMS and FDA look for different things when they are reviewing a device.
The medical device industry group AdvaMed wrote in comments that the Trump-era rule rewards manufacturers that took a risk on researching and developing new products.
AdvaMed told Fierce Healthcare that the principles appear encouraging.
"It is important to remember, though, that details matter," said Scott Whitaker, presdent and CEO of AdvaMed, in a statement. "I will reiterate that it is critical that the final rule for transitional coverage for emerging technologies provides us with clarity, transparency and predictability."