Medicare Compliance & Reimbursement

The Centers for Medicare & Medicaid Services (CMS) offered its thoughts on the future of fast-tracking medical devices in coordination with the U.S. Food & Drug Administration (FDA) and Medicare coverage, which suggest another change in the policy saga.

Reminder: The “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” final rule was finalized on Jan. 14, 2021 under the Trump administration. The rule was then delayed twice and eventually repealed by the Biden administration in September 2021 (see Medicare Compliance & Reimbursement, Vol. 47, No. 20).

“CMS is committed to making sure Medicare beneficiaries are able to access emerging technologies,” say CMS Principal Deputy Administrator and Chief Operating Officer Jon Blum and CMS Chief Medical Officer and Director of Clinical Standards and Quality Lee Fleischer, MD, in a CMS summary of an article for the Journal of the American Medical Association (JAMA) Internal Medicine. “CMS plans to do this by initiating notice and comment rulemaking in the coming months to explore policy options that would create an accelerated approval pathway. This pathway would build off of prior initiatives, including coverage with evidence development,” the agency explains.

CMS proposes following four guidelines in its future rulemaking. The agency plans to focus on the following in the forthcoming proposed rule, according to the JAMA article:

• Promoting medical devices that impact Medicare beneficiaries;
• Supporting manufacturers that want to join on a voluntary basis;
• Utilizing the research and review process to authorize products with the manufacturer and the FDA before determining Medicare coverage;
• “Initiat[ing] the coverage process before FDA market authorization [at manufacturer’s request], which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries;” and
• Reducing administrative burdens for all entities involved in the coverage process — clinicians, manufacturers, and beneficiaries.

Read the full article at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2797447?guestAccessKey =7d1de373-4ebe-4843-bb2b-0504c4eb0021&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=101222.