Centers for Medicare & Medicaid Services (CMS) officials revealed in an article in the Journal of the American Medical Association that the Biden administration is mulling a new review process for Medicare-covered medical devices. Details about the new process will be released shortly.
“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 [U.S FDA] 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.”
Read the full article on Fierce Healthcare.