ARTICLE SUMMARY:
In this week’s Pathways Picks: CDRH taps an orthopedic surgeon and value expert as new deputy director; digital chief leaves; FDA updates PCCP guidance; CMS approves record number of new-technology add-on payments; new HCPCS codes; a comprehensive EU report on AI in healthcare; Europe biotech rule coming; Portugal combines device-drug diabetes payments; regulatory updates from Brazil, Chile, Singapore, and Saudi Arabia; and more.
FDA Picks
CDRH personnel, PCCP guide, breakthrough numbers, and missing regulatory docs:
CDRH deputy hired. FDA has tapped orthopedic surgeon Richard Iorio, MD, as deputy center director for CDRH. Iorio, a professor of orthopedic surgery at Harvard Medical School, announced his new role on LinkedIn last week and said he has retired from active clinical practice. “I look forward to working with Drs. [Marty] Makary and [Michelle] Tarver,” he said. Iorio is known as an expert in value-based care in orthopedics, researching new reimbursement frameworks such as bundled payments. (See “As HHS Shifts Policy, Early Evidence Is In: Bundled Payments Work in TJA,” MedTech Strategist, September 18, 2017.) His focus on reimbursement and clinical practice might position him well to fill the deputy director role vacated earlier this year by Douglas Kelly, MD, who founded the TPLC Advisory Program (TAP) pilot and encouraged companies to broaden their focus to reimbursement and commercial buy-in as part of the FDA process.
