CER Daily Newsfeed

More Transparency, Definitions Needed Around 340B Program

(10/9, Karen Blum, Specialty Pharmacy Continuum) reports “...John O’Brien, PharmD, MPH, the president and CEO of the National Pharmaceutical Council...also emphasized the importance of the 340B program. ‘I really do believe in the intent of the program for the population that the statute was originally intending to serve,’ he said. However, the growth of the program now isn’t related to clinics or patients but by profiteering, he said. ‘I would like to see more transparency and better definitions to make sure that the people who need the benefits of this program are receiving it.’” Full

CDRH Releases List Of Priority Guidance Topics Including RWE, PCCPs

(10/8, Jessica Karins, Inside Health Policy) reports “FDA’s device center has laid out a guidance agenda for fiscal 2026 that includes high-profile topics like use of real-world evidence and predetermined change control plans for which final guidance is expected...FDA has emphasized real-world evidence as a tool in approvals in recent years, and Commissioner Marty Makary has said the evidence should also be used in safety surveillance.” Subscription Required

Century Health and Balboa Nephrology to Advance RWE and AI-Driven Insights for Chronic Kidney Disease Research

(10/9, Joanne Walker, The Evidence Base) reports “...Through this collaboration, Balboa Nephrology will use Century Health’s clinical AI models to analyze electronic health records (EHR) and extract detailed, previously inaccessible information from unstructured data sources such as physician notes and lab reports. This information will help researchers better understand disease progression, treatment effectiveness, and patient outcomes in CKD and related conditions, including IgA nephropathy, lupus nephritis, and C3 glomerulonephritis.” Full

Expanding Prior Authorization In FFS Medicare: Three Implementation Priorities

(10/9, Joshua M. Liao, Health Affairs Forefront) comments “In 2026, the Centers for Medicare and Medicaid Services (CMS) will expand prior authorization in the fee-for-service program through the Wasteful and Inappropriate Service Reduction (WISeR) Model. While Medicare already uses prior authorization in limited situations, WISeR is poised to expand this scope...WISeR is intended to target a set of services that can be overused, have variable evidence of clinical benefit, or possess potential associations with fraud, waste, or abuse (such as skin and tissue substitutes, electrical nerve stimulator implants). The model does not change Medicare coverage or payment policy.” Full

EMA Mapping RWD Landscape To Bridge Evidence Gap For Duchenne Drugs

(10/9, Vibha Sharma, Pink Sheet) reports “...A new EU study will assess the potential of existing Duchenne muscular dystrophy patient registries and other real-world data sources to address regulatory questions for emerging therapies.” Subscription Required