CER Daily Newsfeed

Making Value-Based Payment The Best Choice For Providers

(7/16, Hoangmai H. Pham, Lauren Erickson, Health Affairs Forefront) comments “...Providers will only make a decisive pivot toward value and health generation if the business case for VBP is compelling and other paths to sustainable revenues are closed off. CMMI can catalyze such a pivot by deploying its resources and legal flexibilities to broaden VBP participation and diminish arbitrage opportunities. Doing so will require political courage.” Full

CMS Seeks To Exclude 340B From Inflation Rebates, Factor Negotiated Prices In ASP

(7/15, Gabrielle Wanneh, Inside Health Policy) reports “CMS is proposing a new claims-based approach to ensure units of prescription drugs sold under the 340B drug discount program are not included in Medicare Part D inflation-related rebate calculations at the start of next year, and the agency also plans to factor negotiated drug prices into average sales price (ASP) calculations. The policies are laid out in the draft 2026 physician fee schedule rule proposed by CMS Monday.” Subscription Required

340B Pulled $6.5B in Drug Rebates from Medicaid in 2024, PhRMA-Backed Report Finds

(7/15, Dave Muoio, Fierce Healthcare) reports “The pharmaceuticals lobby shored up its campaign against increasing use of the 340B Drug Discount Program with a new analysis estimating its broader use pulled $6.5 billion in rebates away from the Medicaid program in 2024. The tally comes from a Berkeley Research Group (BRG) research brief funded by [PhRMA]...PhRMA, in a blog post sharing BRG’s analysis, described the $6.5 billion as ‘a hidden tax on patients, taxpayers and employers’ that will rise ‘as more tax-exempt hospitals exploit the 340B program as a profit center.’” Full

UK: NICE Responds to Publication of the Government’s Life Sciences Sector Plan

(7/16, Dr. Sam Roberts, NICE Blog) comments “...On medicines, the plan will transform how we work with the Medicines and Healthcare products Regulatory Agency (MHRA), creating an aligned pathway to bring new medicines to patients 3 to 6 months faster than today. Together, we’ll deliver streamlined decisions on medicines, joint advice and parallel approvals that will boost the speed of decisions, contribute to reducing admin costs by 25% and create clearer routes to market for groundbreaking new treatments.” Full

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

(7/16, Eliza Slawther, Pink Sheet) reports “...Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.” Subscription Required

From HIMSS25 Europe: How Do Clinicians View the Advent of Real-World Evidence?

(7/16, Mariam Khalil Fernández, Wolters Kluwer) comments “...[T]he potential of RWE can’t be realized unless it is successfully operationalized. What matters is the transition from real-world data (RWD) to real-world evidence (RWE), and ultimately to real-world answers (RWA). That’s where the real transformative power lies — not just in having data, but in turning it into timely, trustworthy, and actionable insights that inform both clinical practice and system-level decisions.” Full