ARTICLE SUMMARY:
The two agencies are launching allied programs next year to jump-start market access for digital tools addressing chronic conditions. The nascent CMS ACCESS Model seeks to bypass Medicare barriers for digital health by offering outcome-aligned payments to technology-oriented clinics and companies. Meanwhile, FDA’s TEMPO pilot will grant regulatory enforcement discretion to some technologies used in the Medicare model. But implementation questions remain.
CMS and FDA are trying to accelerate the adoption of digital health technologies to improve treatment of chronic conditions with a novel collaborative approach. The two HHS agencies have worked together for years on programs attempting to shorten the time between FDA authorization and Medicare coverage and payment. But the newly announced frameworks move in a somewhat different direction, establishing a path for reimbursement that could serve to streamline the FDA premarket path for some products.
Under the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model announced December 3, CMS will enroll organizations that agree to deliver “technology-supported care,” leveraging AI, digital therapeutics, wearables, wellness apps, and telehealth solutions, to treat four categories of chronic disease. In return, they’ll receive recurring, outcome-based payments. A few days later, FDA announced the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot, which will allow select digital health products to be sold to and deployed by ACCESS-enrolled organizations in advance of premarket authorization or even formal clinical trials. Such “enforcement discretion” will be granted on the condition that participants collect real-world evidence and submit it back to FDA.
