The Centers for Medicare and Medicaid Services (CMS) is creating a rule for expedited Medicare coverage for new and emerging technologies.
According to CMS, the proposed rule will meet the following principles:
- “Manufacturers may enter the process on a voluntary basis. This process will be limited to medical devices that fall within the Medicare statute and are relevant to the Medicare population.
- The CMS may conduct an early evidence review (before the device secures FDA marketing authorization) and discuss with the manufacturer the best Medicare coverage pathway, depending on the strength of the evidence collected.
- At the manufacturer’s request, CMS may initiate the coverage review process before FDA market authorization, which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.
- If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufacturers, clinicians, and patients while maintaining rigorous evidence requirements.”
According to the CMS, a rule guided by the above principles will “strike a balance between promoting access to emerging medical technologies and maintaining the protections and rigorous evidence standards that are essential to the welfare of Medicare beneficiaries.” The CMS is also “considering whether the proposed rule would establish a clear timeline for decisions requiring coverage with evidence development.”
You can find additional information on the new rule here.
The proposed rule is a follow-up to a prior rule that was rescinded last year, “The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary.’” The rescinded rule would have provided an automatic four years of Medicare coverage for newly approved medical devices. This would have accelerated the availability of medical devices approved through the FDA breakthrough pathway for innovative technologies.
Commentators on the rescinded rule raised concerns about patient protections and commented “that there was frequently a lack of evidence of clinical benefit for the newly approved medical devices in the Medicare population.”
