CER Daily Newsfeed

FDA Official Updates on Advancing RWE Program, Lists Common Reasons for Rejection

(9/25, Joanne S. Eglovitch, Regulatory Focus) reports “Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world data (RWD) studies will use heterogeneous patient populations or that the studies will provide supportive, rather than primary evidence, to support regulatory decisions. Kristen Miller, FDA health science policy advisor, shared this information during a 23 September workshop sponsored by the Duke Margolis Institute for Health Policy in Washington, DC.” Full

Study Throws Shade at Fee-for-Service in Medicare Advantage

(9/26, Shannon Firth, Medpage Today) reports “...Among more than 3 million MA enrollees, value-based payment models outperformed fee-for-service models for all 15 clinical quality outcomes, with a mean score difference of +6.7% (all P<0.001), reported Kelly J. Thomas Craig, PhD, of CVS Health in Hartford, Connecticut, and co-authors...Craig and team explained that ‘value-based payment and value-based care delivery models align clinician reimbursement with high-quality, cost-effective, evidence-based, patient-centered care, while fee-for-service models incentivize volume over health outcomes.’” Full

Video: Effective Collaboration Between PCPs, Oncologists Enhances Patient Care: Mark Fendrick, MD

(9/26, Brooke McCormick, The American Journal of Managed Care) “Teamwork between primary care providers and oncologists helps patients get needed care and achieve better results, according to Mark Fendrick, MD, at the Patient-Centered Oncology Care (PCOC) conference.” View Video