ARTICLE SUMMARY:
CMS wants to add ADHD to its list of reimbursed digital therapeutics. Excerpted from Pathways’ Picks July 16: CDRH Separations, Medicare Rules, Global Guidelines, and More.
CMS is proposing to build on a seminal policy launched last year to start reimbursing physicians for FDA-authorized digital therapeutics in mental health. The agency said in its July 14 Physician Fee Schedule (PFS) proposed rule that starting January 1 it plans to pay for FDA-vetted, clinical grade apps that are purchased by clinicians and provided to patients to deliver behavioral therapy for attention deficit and hyperactivity disorder (ADHD). In last year’s rule, CMS created new billing codes, with payment rates set by individual Medicare contractors, for a specific FDA-regulated category of software to treat insomnia, substance use disorder, depression, and anxiety. This was the first time Medicare has agreed to pay for standalone software not embedded in a physical medical device. (See “CMS Opens New Reimbursement Avenue For Digital Therapeutics,” Market Pathways, July 17, 2024.) The 2026 proposal would extend the policy to the ADHD category, which currently includes two Akili Interactive Labs’ video game-based treatment systems, and a June 510(k)-cleared system from Lumos Labs. CMS also says it is considering future inclusion for systems targeting gastrointestinal conditions, sleep disturbances from psychiatric conditions, and fibromyalgia. “We acknowledge that the field of digital therapeutics is evolving and continue to solicit comments from the public on this topic,” the agency notes.