Also known as: CMS
HRSA announced a revised 340B Rebate Model Pilot Program effective January 1, 2027, letting manufacturers use rebates instead of upfront discounts. Rebate plans are due August 24, 2026.
Xolair may be dropped from Medicare price negotiations as a biosimilar launch looms. The CMS must decide if the biosimilar is a true competitor. The outcome could set precedent for future biosimilar-facing selections.
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
The Trump administration terminates a Medicare Part D premium subsidy program for nearly 25 million seniors, while the One Big Beautiful Bill Act triggers automatic Medicare cuts of $536 billion through 2034 and delays drug price negotiations for certain orphan drugs. Changes could raise costs for beneficiaries and delay assistance for low-income seniors.
The Trump administration is terminating a $3.6 billion subsidy program for Medicare Part D premiums, potentially raising costs for millions of seniors. The CMS administrator confirmed the subsidies will end after 2026, affecting roughly 75% of the 25 million beneficiaries with possible out-of-pocket increases.
HHS and CMS issued a proposed rule to codify the Medicare Drug Price Negotiation Program, largely formalizing existing guidance. The rule includes new provisions, such as clarifications for new drug formulations. The proposal is now open for public comment.
UCLA-led research finds telemedicine has not significantly increased healthcare visits or costs across all payer types from 2019-2023, published in JAMA Network Open. A separate study of Medicare patients reveals nearly half of telehealth visits are for non-mental health conditions, particularly chronic diseases like diabetes and high blood pressure. Both findings address questions about telehealth's role and impact since the COVID-19 pandemic.
Anterior raised $40M to accelerate health plan AI adoption, bringing total funding to $64M. Other deals include Findhelp's $250M investment, Grow Therapy's $150M Series D, and Bexorg's $23M Series A.
CVRx announced first-patient enrollment in the BENEFIT-HF trial, a 2,500-patient heart failure study across about 150 U.S. and German centers. The trial will evaluate all-cause mortality and heart failure decompensation events through 2032.
The 340B rebate pilot remains on hold; HRSA extended the comment period to April 20. The pilot would shift manufacturers to post-purchase rebates, raising cash-flow concerns. HRSA seeks input on the model's structure and scope.
