Medicare coverage will soon include eligibility for some cutting-edge medical devices under a plan introduced by the Biden administration and finalized on Aug. 7.
Meanwhile, manufacturers are gathering data on the performance of these devices under the new plan.
The plan will allow America’s senior citizens access to new technologies currently cleared by the Food and Drug Administration (FDA) that are still subject to additional queries. It will also clear the way for devices covered by Medicare, in line with other insurers’ requirements.
Specifically, the plan could grant patients quicker access to newly introduced technologies, including Elon Musk’s Neuralink brain implant and AI-powered cancer evaluation technology.
The plan has been long-awaited. It has been more than three years since the Centers for Medicare & Medicaid Services (CMS) first promised to replace the bipartisan policy it repealed.
“This delay is actively harming seniors who cannot access the tests and treatments they need,” Scott Whitaker, President and CEO of AdvaMed, said in a statement in April.
In June last year, the CMS issued a proposed procedural notice “outlining a new Medicare coverage pathway to achieve more timely and predictable access to new medical technologies for people with Medicare.”
According to Whitaker, the new plan 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.”
“The exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection,” Whitaker said in an Aug. 8 statement.
Whitaker also stressed the need for greater resources at CMS and called on Congress to pass associated legislation, HR 1691, the “Ensuring Access to Critical Breakthrough Products Act.”
The bipartisan legislation was introduced by Rep. Suzan DelBene and Rep. Brad Wenstrup in March last year and was advanced in June this year by a House Committee, which said that CMS could decide which programs should receive coverage.
It would also grant the program an annual $10 million. The bill was approved 36-5.
The new policy comes after the Biden administration scrapped a policy introduced by former President Donald Trump, which automatically granted FDA-approved breakthrough devices and diagnostic products four years of national Medicare coverage.