< Back to Thought Leadership

340B Program HRSA Response to Pharmaceutical Manufacturers

After months of pharmaceutical manufacturers placing restrictions on the 340B Program to both contract pharmacies and covered entities, HRSA sent letters to six pharmaceutical manufacturers stating they violated the 340B Statute. The HRSA Acting Administrator declared these pharmaceutical manufacturers violated the 340B statue by placing restrictions on the 340B Program pricing at both contract pharmacy locations and covered entities.

Six Pharmaceutical Manufacturers Violated the 340B Statute

In HRSA’s response, they detail some of the ways manufacturers were in violation of the 340B Statute:

  • Limiting covered entity’s access to the drugs they were able to purchase through the 340B Program
  • Stopped providing the 340B ceiling price
  • Dispensing drugs through contract pharmacies
  • Required specific data submissions to limit sales

HRSA instructed the pharmaceutical manufacturers remove the restrictions and begin offering the covered outpatient drugs at the 340B Program ceiling price at covered entities contract pharmacies. The pharmaceutical manufacturers have until June 1, 2021 to comply.

The full release from HRSA can be found on the OPA webpage.

Have Questions about What this Means for Your Organization? 

Our team will continue to provide updates as more information is released about the 340B Program and HRSA’s response. We recommend that you begin working with your TPA vendor to begin to assess what savings are owed to your location from the months of restrictions. If you would like one of our 340B Program experts to reach out to you, please fill out the form below and they will contact you within 24 hours.


Blue & Co., LLC acquires Alerding CPA Group

Blue & Co., LLC acquires Alerding CPA Group

Carmel, Ind. (November 23, 2022) – The accounting and consulting firms of Alerding CPA Group (Indianapolis, Ind.) and Blue & Co., LLC (Carmel, Ind.) have announced their merger. The combined firm will operate as Blue & Co., LLC (Blue & Co.), effective December 1, 2022. This acquisition will provide Blue & Co. with greater market […]

Learn More

Not-for-Profit Single Audit Requirements – Evaluation of Revenue Sources

By: Holly Fields, CPA, Senior Manager Not-for-profit organizations (NFPs) that receive federal financial assistance over certain levels, either directly from a federal agency or indirectly through state or local agencies, may be required to have a single audit performed under Federal Uniform Guidance. Single Audit Requirements A single audit includes not only an audit of […]

Learn More

Occupational Mix Survey: What You Need to Know

Every three years, the Centers for Medicare and Medicaid Services (CMS) requires any Hospital that is subject to the Inpatient Prospective Payment System (IPPS) to complete an Occupational Mix Survey (OMS). This data is then used to calculate an Occupational Mix Adjustment Factor (OMAF). The occupational mix adjustment impacts a hospital’s average hourly wage and […]

Learn More