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# CMS Working with FDA on New Device Coverage Rule
- URL: https://www.fdaweb.com/cms-working-with-fda-on-new-device-coverage-rule/
- Published: 2022-10-13T12:00:00.000Z
- Updated: 2026-09-14T18:03:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152967

Two Centers for Medicare and Medicaid Services (CMS) officials say the center continues to work with FDA and other stakeholders on a new coverage rule for innovative medical devices. The new rule will replace one withdrawn by CMS after doctors and others raised concerns that the policy did not have sufficient patient protections and that there was frequently a lack of evidence of clinical benefit for the newly-approved medical devices in the Medicare population.

Writing in a *JAMA Internal Medicine* Viewpoint [column](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2797447?guestAccessKey=7d1de373-4ebe-4843-bb2b-0504c4eb0021&utm%5Fsource=For%5FThe%5FMedia&utm%5Fmedium=referral&utm%5Fcampaign=ftm%5Flinks&utm%5Fcontent=tfl&utm%5Fterm=101222), the two officials say the rule that is being developed will meet these principles:

- manufacturers may enter the process voluntarily and the process will be limited to medical devices that fall within the Medicare statute and are relevant to the Medicare population;
- CMS may conduct an early evidence review before a device secures FDA marketing authorization and discuss with the manufacturer the best Medicare coverage pathway, depending on the strength of the evidence collected;
- at a manufacturer’s request, CMS may open the coverage review before FDA market authorization; and
- if CMS determines that further evidence development is the best coverage pathway, it would explore how to reduce the burden on manufacturers, clinicians, and patients while maintaining rigorous evidence requirements.

“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,” the article concludes.