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HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

By Amanda Bogle on June 26, 2025
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On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA encouraged health centers to “begin implementing these updated award terms immediately to ensure full compliance and maximize patient benefit.” The announcement comes in response to the Trump Administration’s April 14, 2025 Executive Order on “Lowering Drug Prices by Once Again Putting Americans First” (the “Executive Order”).[1] The Executive Order had instructed the Secretary of the Department of Health and Human Services to, within 90 days, ensure grants available under section 330(e) of the Public Health Services Act are conditioned upon health centers establishing practices to make insulin and injectable epinephrine available to low-income patients at or below the 340B price paid by the health center.

In a Q&A session hosted by HRSA on June 24, 2025, HRSA representatives clarified that this requirement does not currently apply to FQHC Look-Alikes, nor does it apply to any grantees that do not participate in the 340B Program. HRSA also stated that grantees would be required to report and demonstrate on their Form 1C (in conjunction with the annual Budget Period Progress Report (or “BPR”)) that they have the necessary practices and policies in place to comply with these requirements.

Although HRSA issued this condition to its grant terms, HRSA did not specify how HRSA grantees must implement this requirement. Thus, HRSA grantees must individually come up with internal practices and methods to ensure that low-income patients obtain the insulin or injectable epinephrine at the 340B price paid. Because 340B drug prices typically change on a quarterly basis, HRSA grantees should consider methods that update the patients’ cost of these drugs based on the mostly recent 340B price paid.

FOOTNOTES

[1] Exec. Order No. 14273, 90 Fed. Reg. 16441 (April 18, 2025).

Photo of Amanda Bogle Amanda Bogle

Amanda provides counsel on healthcare transactional, regulatory and operational issues, assisting clients as they navigate an ever-evolving regulatory landscape. She frequently addresses questions regarding:

  • Mergers & Acquisitions, including Medicare changes of ownership (CHOW)
  • Fraud and abuse laws, such as the Anti-Kickback Statute, Stark
…

Amanda provides counsel on healthcare transactional, regulatory and operational issues, assisting clients as they navigate an ever-evolving regulatory landscape. She frequently addresses questions regarding:

  • Mergers & Acquisitions, including Medicare changes of ownership (CHOW)
  • Fraud and abuse laws, such as the Anti-Kickback Statute, Stark Law and False Claims Act
  • Reimbursement (e.g. Outpatient Prospective Payment System, Medicare Physician Fee Schedule)
  • 340B Program
  • Telehealth expansion, particularly during the COVID-19 pandemic
  • Hospital licensure
  • Joint Commission accreditation
  • Certificates of Need
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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Healthcare Law Blog
  • Organization:
    Sheppard, Mullin, Richter & Hampton LLP
  • Article: View Original Source

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