CMS Opens New Reimbursement Avenue For Digital Therapeutics

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ARTICLE SUMMARY:

The Medicare agency for the first time says it will reimburse directly for FDA-authorized stand-alone mental health software. While the proposed policy has limitations, digital therapeutics advocates suggest it sets a good precedent for a field that has up until now run into a brick wall with the federal insurance system.

Editor’s note: This article was updated July 18 with additional insights from medtech industry stakeholders.

A concerted push by digital health developers and supportive lawmakers to break a reimbursement logjam for digital therapeutics bore fruit in CMS’ 2025 Physician Fee Schedule (PFS) proposal published last week.

In what one industry trade group calls a “monumental milestone,” the agency signaled plans to directly reimburse physicians and other practitioners for the cost of qualifying software provided to a patient as part of a behavioral health treatment plan. CMS also proposed three new billing codes to operationalize the change. “This sets a precedent for the future of the industry,” the Digital Therapeutics Alliance (DTA) said in a July 12 email to members.

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