CMS Previews Reboot of Medical Device Approval Pathways

Three highlights from a future rule that would preserve a focus on approval speed and inter-agency collaboration.

Regulating innovation is a tough gig. Just ask CMS.

The agency withdrew a proposed rule that would have granted four years of automatic Medicare coverage for medical devices approved via the Food and Drug Administration's (FDA) Breakthrough Devices Program for innovative technologies. To be eligible for breakthrough submission, a device must provide more effective treatment and meet one of four additional criteria focused on innovation, advantage, and patient interest.

It was an aggressive proposal that CMS looks to replace in 2023 following stakeholder concerns for patient safety, sufficient evidence including for longer-term outcomes, and that approvals were tied to a more limited population that is covered by Medicare.

The new rule will be informed by existing stakeholder feedback and a September 2022 draft report on evidence-based coverage decisions from the Agency for Healthcare Research and Quality. In an article for the Internal Medicine publication of the Journal of the American Medical Association, CMS officials announced that its new proposed rule will reflect four principles and may include three additional components.

1. Participation is voluntary and the scope is limited.
    

Manufacturers are not required to participate and only medical devices that fall within Medicare statute will be included.

2. The review process will maintain a federal focus on speed and collaboration.
    

CMS may conduct an early evidence review—before FDA marketing authorization and at the manufacturer's request. This proactive approach would maintain CMS and FDA's intent to work in parallel for faster approvals. It would also alert manufacturers to the "best Medicare coverage pathway" based on the evidence presented and whether stronger evidence might be required.

In its article, the agency added: "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."

3. Possible additional components.
    

Where evidence is required, other elements of CMS's proposed rule could include:

• Clear decision timelines
   
• Whether the device is reasonable, necessary, and improves overall health
   
• Whether its easy for patients and providers to choose a new device

Summing up its intent, the agency writes: "The CMS believes that a rule guided by these principles would 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."