ARTICLE SUMMARY:
In this week’s Pathways Picks: A major week for Medicare policies including a new CMS model supporting digital health for chronic care, diabetes devices entering competitive bidding, and market-based inpatient procedure rates; FDA adopts agentic AI, negotiates MDUFA, and downclassifies companion diagnostics; EUDAMED mandates will finally kick in in Europe, and more policy updates from South America, Asia, and beyond.
Medicare: Tech Support, Diabetes Bids
CMS aims to advance digital health, control diabetes device costs in a major week of pay policy updates:
Pay model promotes tech use. CMS launched an outcomes-based chronic care payment model this week focused on expanding use of digital health technologies. Under the ACCESS Model, clinical provider organizations can volunteer to offer integrated, technology-supported care, leveraging FDA-approved digital therapeutics, wearable devices, and telehealth software that may not be reimbursed under standard fee-for-service Medicare, to improve outcomes in chronic conditions including high blood pressure, diabetes, musculoskeletal pain, depression, and more. CMS will pay participants in fixed installments to manage a patient’s condition, only receiving the full amount if they achieve certain measurable clinical outcomes. Due to lack of benefit categories and other barriers, digital health has struggled to gain traction in Medicare. The model is intended to help address that gap, CMS says. The first ACCESS performance period will begin July 1; applications to participate must be in by April 1.
