House Republicans Reintroduce “340B Access Act”

9/15/2025 – House Republicans Reintroduce “340B Access Act” On September 10th, 2025, Representatives Carter (R-GA) and Harshbarger (R-TN) reintroduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net…

RWC-340B Urges HRSA to Abandon Rebate Model Pilot

9/15/2025 – RWC-340B Urges HRSA to Abandon Rebate Model Pilot RWC-340B submitted comments last week in response to the Health Resources and Services Administration’s (HRSA’s) notice outlining its proposed 340B Rebate Model Pilot Program. …

HRSA Proposes Stricter Requirements for STD Clinic Registration and Recertification and Shipping Location Registration

8/25/2025 – HRSA Proposes Stricter Requirements for STD Clinic Registration and Recertification and Shipping Location Registration On August 7, 2025, HRSA published a notice proposing significant revisions to the data collection requirements…

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…