CMS Prior Authorization, FDA Cybersecurity Guide, and UK Funding Guarantees

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ARTICLE SUMMARY:

In this week’s Pathways Picks: CMS rolls out an AI-enabled prior authorization program in six states to curb “wasteful” device use, and adds reimbursement support for patients to upgrade diabetes devices; FDA publishes updated cybersecurity guide; South Korea revises its innovative device guidance; the UK plans funding guarantees for medtech; and more global policy updates.

Editor’s note: We will not publish Pathways Picks next week, July 9. It will be back in your inbox on July 16.

Medicare Picks

Expanding prior authorization, and paying for diabetes device upgrades:

AI-based prior authorization. Starting January 1, CMS says it will be testing prior authorization featuring artificial intelligence review of planned medical device-enabled treatments in six states to help weed out “wasteful care.” The agency has identified 15 items and services, including electrical nerve stimulators, deep brain stimulation for Parkinson’s disease, knee arthroscopy, and cervical spinal fusions, that will be subject to pre-treatment, or at least pre-payment, review under the newly announced payment model. “Combining the speed of technology and the experienced clinicians, this new model helps bring Medicare into the 21st century by testing a streamlined prior authorization process, while protecting Medicare beneficiaries from being given unnecessary and often costly procedures,” said Mehmet Oz, MD, administrator of CMS. (For more details, see in Market Pathways, “Medicare Tests AI-Based Prior Authorization for Devices.”)

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