340B Mega Guidance

PhRMA appreciates the Health Resources and Services Administration’s (HRSA) efforts in releasing the 340B mega guidance and is pleased to have an opportunity to comment before the guidance is finalized.

A first look at the guidance indicates both positive signs that HRSA is taking steps to curb abuses of the program as well as some causes for concern.

Specifically, PhRMA was pleased to see that the guidance attempts to provide a clearer patient definition, something the Government Accountability Office has recommended and which has the potential to enable better enforcement of program integrity.

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At the same time, the guidance will allow hospitals and other 340B entities that have violated 340B rules to reenter the program with minimal delay, raising questions about whether there are sufficient consequences for entities shown to be violating program rules. The guidance also continues to allow hospitals unlimited contract pharmacies despite a Department of Health and Human Services Office of Inspector General report, as well as HRSA’s own audits, showing contract pharmacies raise compliance risks and also enrich for-profit pharmacy chains with no clear benefit to patients.

PhRMA supports the 340B program and hopes future reforms will better enable the program to meet its original goals, which were to improve access to medicines for vulnerable or uninsured patients and not to enrich hospitals and for-profit retail pharmacies.

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