HHS withdraws 340B Mega Guidance

On January 30, 2017, the United States Department of Health and Human Services (HHS) decided to withdraw “Mega Guidance” related to the 340B drug discount program. This withdrawal comes after the Trump administration put a freeze on new regulations.

The 340B drug discount program is a United States federal government program that requires drug manufacturers participating in Medicaid to provide outpatient drugs to eligible health care organizations, known as covered entities, at significantly reduced prices. In order to participate in the 340B program, eligible organizations/covered entities must register and be enrolled with the 340B program and comply with 340B requirements.

The Mega Guidance sought to address standards impacting covered entities, drug manufacturers, and contract pharmacies of the 340B drug discount program. Some other notable features of the Mega Guidance included addressing the definition of a 340B eligible patient, outpatient status determination, Disproportionate Share Hospital, 340B “Child Site” eligibility, record retention requirements, and contract pharmacy arrangements. The Mega Guidance further described when safety net hospitals and clinics qualify for discounted drugs, however, it likely would have scaled back savings considerably for covered entities.

It will be important for 340B stakeholders to monitor future 340B guidance releases or any updates on Frequently Asked Questions (FAQs) on the Health Resources and Services Administration (HRSA) 340B website. Although, it is probably must notable to mention that 340B stakeholders should remain vigilant for any 340B audits to which they are subjected, to ensure that they are not being held to the stricter 340B guidance standards that were never implemented, but rather ensure they are still held to the current 340B standards that remain in place. Regardless, it remains uncertain what the future holds for the 340B program.

For additional information about the 340B program, contact Frier Levitt today.

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