340B Mega-Reg Update and the Impact on FQHCs

The National Leadership Summit on 340B in Washington, DC last week was very informative. The general theme of the day was the increased need for transparency through compliance and federal regulatory oversight.

The Director of the Office of Pharmacy Affairs, Krista Pedley, presented an overview of the HRSA Mega-Reg that could “possibly” be released this summer. She stated that they support the current intent of the 340B program, which is to allow covered entities to stretch scarce resources. She also stated that there is no timeline of when the regulations will be released. The court is currently reviewing the regulations that were presented and suggested by HRSA. They can either agree and approve for open comment or do nothing and leave the current regulations as they are written.

The Director commented that she expects to work closely with Congress, but she thinks they will most likely continue to regulate existing statutes and ensure covered entities are in compliance with the law.

The OPA budget was also recently increased by $6 million to improve and support the current intent of the 340B program. They continue to strongly support the recommendation for covered entities to have an annual independent 340B audit to ensure program compliance.

I believe FQHCs are under no threat of losing access to 340B medications. The core mission of the health center movement is to increase access to care for vulnerable populations.  HRSA and OPA will continue to advocate for the intent and support of the 340B program. Director Pedley stated that she has an open door policy and encourages communication to understand the needs of the covered entities.

If you have a story to tell about how the revenue associated with your 340B program has made an impact on your health center, please contact your legislature and OPA to share your story.


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Colleen DiClaudio is the Vice President of 340Basics.  

340Basics was built by industry experts well versed in the drawbacks of other software systems, generating auditable reports and records in a user friendly environment to ensure compliance with all federal regulations. 

340B can be managed effectively with the assistance of a comprehensive and robust management software system.  A virtual inventory solution can provide an audit trail of all 340B medications dispensed, history of purchase orders, and essential financial reports. The added benefit of working with a company that has direct knowledge of FQHC operations and compliance issues will increase your capability to manage the program.  

Click here to learn more about 340Basics.