HRSA 340B Rebate Model Pilot Program: More Limited Than Anticipated, But Still Concerning to Covered Entities on Several Fronts

8/1/2025 – HRSA 340B Rebate Model Pilot Program: More Limited Than Anticipated, But Still Concerning to Covered Entities on Several Fronts HRSA issued a Federal Register Notice detailing the terms of its…

CMS Proposes Changes That Would Impact 340B Covered Entities

7/22/2025 – CMS Proposes Changes That Would Impact 340B Covered Entities Last week, CMS published two proposed rules impacting 340B covered entities.  On July 16, CMS published its annual 2026 Physician…

State 340B Covered Entity Reporting Laws Roundup

7/22/2025 – State 340B Covered Entity Reporting Laws Roundup The trend continues among state legislatures to introduce and enact state-level 340B reporting bills. Six states – Colorado, Idaho, Indiana, Ohio,…

“One Big Beautiful Bill” Act Signed Into Law

7/8/2025 – “One Big Beautiful Bill” Act Signed Into Law  On Friday, President Trump signed the reconciliation bill (“The One Big Beautiful Bill” Act) into law.  The bill passed the…

HHS 340B Rebate Guidance Heads to OMB for Review

HHS 340B Rebate Guidance Heads to OMB for Review This week, HHS submitted proposed 340B Rebate Guidance to the Office of Management and Budget (OMB) for review. The proposed guidance appears to be…

Federal Judge Rules That HHS Has Authority to Approve 340B Rebate Models

Federal Judge Rules That HHS Has Authority to Approve 340B Rebate Models Last week, the United States District Court for the District of Columbia issued an opinion declaring that HHS has authority…

Trump Executive Order on Most-Favored-Nation Drug Pricing Could Have Impacts on 340B Covered Entities

Trump Executive Order on Most-Favored-Nation Drug Pricing Could Have Impacts on 340B Covered Entities On Monday, President Trump signed an Executive Order asking drug manufacturers to voluntarily lower drug prices to meet…

RWC-340B Reacts to Sen. Cassidy Report on 340B Drug Pricing Program

RWC-340B Reacts to Sen. Cassidy Report on 340B Drug Pricing Program WASHINGTON – Ryan White Clinics for 340B Access (RWC-340B) expresses concerns about the recently released report from Senate HELP…

HHS Will Issue Guidance on 340B Rebate Models within 30 Days

HHS Will Issue Guidance on 340B Rebate Models within 30 Days In response to prodding by Judge Dabney Friedrich, HHS submitted a filing to the United States District Court for the District…

HRSA Finds Two Drugmakers Overcharged Covered Entities for 340B Drugs

HRSA Finds Two Drugmakers Overcharged Covered Entities for 340B Drugs HRSA’s fiscal year 2025 manufacturer audit results show that Cycle Pharmaceuticals Ltd. and Rhodes Pharmaceuticals L.P. overcharged covered entities for their 340B…