Cutting-edge medical devices will soon be covered by Medicare
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Cutting-edge medical devices will be eligible for Medicare coverage while manufacturers continue to gather data on how they perform under a new plan finalized by the Biden administration Wednesday.
Why it matters: The long-awaited plan offers America's seniors access to new technologies that have been cleared by the Food and Drug Administration but still have outstanding questions. It also gives manufacturers a streamlined pathway to having devices covered by Medicare, which other insurers often follow.
- The plan could potentially speed up patient access to devices like Elon Musk's Neuralink brain implant and AI-powered cancer evaluation technology.
How it works: Under the plan, Medicare will temporarily cover select medical devices from the time FDA grants them market authorization, while additional research is conducted on their safety and efficacy.
- The Centers for Medicare and Medicaid Services expects to accept five device candidates into the coverage pathway per year.
- The temporary coverage could last for five or more years as evidence is gathered. When the research is finished, a third-party contractor will review the data, then CMS will make a long-term coverage determination.
- The final plan hews to a proposal CMS put out last year but has some changes. For example, CMS will review nominations for devices to be included in the pathway on a quarterly basis, instead of within 30 days of submission.
It represents "a step toward a stronger, more robust policy, but doesn't go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering," Scott Whitaker, CEO of device trade group AdvaMed, said in a statement.
- "The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS," he added.
Flashback: The new policy comes after the Biden administration scrapped a Trump-era policy that automatically gave FDA-approved breakthrough devices and diagnostic products four years of national Medicare coverage.
- Biden's Medicare team said that FDA-approved devices may not automatically be suitable for Medicare beneficiaries, and needed more evaluation before the program could cover them.
- A House committee advanced a bill in June that would let CMS decide which breakthrough devices should get temporary coverage and give the agency $10 million annually for the program.
