ARTICLE SUMMARY:
A newly cleared insomnia app will test oncoming reimbursement codes for digital therapeutics. Excerpted from Pathways’ Picks August 14: Digital Health Picks, Real-World Data Standards, and More.
FDA 510(k)-cleared Big Health’s Sleepio software for chronic insomnia August 5. The digital therapeutic, which employs Cognitive Behavioral Therapy for Insomnia (CBT-I), is the second ever insomnia app authorized by the agency (preceded by the Somryst system now marketed by Nox Health). The timing of the clearance gives Big Health the opportunity to try and leverage a new reimbursement route CMS is putting into place for 2025. In its recent Physician Fee Schedule proposal, CMS created the first billing codes that can be employed to pay for standalone digital therapeutics provided directly to patients by doctors as part of a behavioral health treatment plan. “This clearance, coupled with the new proposed reimbursement codes, will for the first time motivate US healthcare providers to prescribe safe and effective treatment alternatives to traditional medicine,” Big Health CEO Yael Berman said.