First Circuit Reaffirms Rebate Pilot Pause; CMS Proposes Models Requiring Drug Manufacturers to Pay Additional Rebates on Medicare Drugs if the Net Prices Under the IRA Exceed Prices in Similar Countries

1/8/2026 – First Circuit Reaffirms Rebate Pilot Pause; CMS Proposes Models Requiring Drug Manufacturers to Pay Additional Rebates on Medicare Drugs if the Net Prices Under the IRA Exceed Prices…

Rebate Pilot Litigation Update: Parties Agree to “Drop” Appeal

1/12/2025 – Rebate Pilot Litigation Update: Parties Agree to “Drop” Appeal This morning, DOJ filed a letter with the First Circuit Court of Appeals (First Circuit) stating that the government and hospital plaintiffs…

HRSA Confirms Suspension of Rebate Pilot

12/31/2025 – HRSA Confirms Suspension of Rebate Pilot Today, HRSA updated its website to confirm that its controversial 340B rebate model pilot program (rebate pilot) is suspended. HRSA states that…

District Court Halts Rebate Pilot for all Covered Entities, Appeal Pending

12/29/2025 – District Court Halts Rebate Pilot for all Covered Entities Today, Chief Judge Lance E. Walker from the U.S. District Court for the District of Maine issued an order…

CMS To Survey Hospitals on Acquisition Costs for Outpatient Drugs; Postpones Acceleration of Non-Drug Reimbursement Cuts

12/2/2025 – CMS To Survey Hospitals on Acquisition Costs for Outpatient Drugs; Postpones Acceleration of Non-Drug Reimbursement Cuts On November 25, CMS published its annual 2026 Outpatient Prospective Payment System Final…

CMS Finalizes Methods for Excluding 340B Claims for 2026

11/6/2025 – CMS Finalizes Methods for Excluding 340B Claims for 2026 Yesterday’s Federal Register includes CMS’s annual 2026 Physician Fee Schedule Final Rule, which describes how CMS will exclude 340B claims…

HRSA Approves Manufacturer Proposals to Offer 340B Pricing Through Rebate Model

11/03/2025 – HRSA Approves Manufacturer Proposals to Offer 340B Pricing Through Rebate Model On October 30, 2025, HRSA updated its website to announce that it has approved eight manufacturers’ proposals to offer…

Senate HELP Committee Holds Hearing on 340B Program

10/28/2025 – Senate HELP Committee Holds Hearing on 340B Program On Thursday, October 23rd the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled “The 340B Program:…

Hospitals Sue HRSA, HHS Over Failure to Act in Alternative Dispute Resolution Proceeding

Hospitals Sue HRSA, HHS Over Failure to Act in Alternative Dispute Resolution Proceeding On September 29, 2025, fifty-nine hospitals and health systems filed a lawsuit against the Health Resources and…

Amgen’s Restrictive 340B Policy

Amgen’s Restrictive 340B Policy – 10-16-2025 On September 2, RWC-340B sent a letter to Amgen’s CEO objecting to Amgen’s unilateral decision to refuse to honor 340B pricing for STD clinics. The Policy: Amgen…