Category: 340B Program

The Trump Administration and the Effect on the 340B Drug Program

The 340B Drug Program may experience some changes due to the new administration and Republican congress. Some anticipate that drug manufacturers interests will be addressed rather than the concerns of health plans or providers. Whether this is true has yet

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Get Ready for A HRSA 340B Program Audit

Many covered entities (“CE”)  have already experienced the Health Resources and Services Administration (“HRSA”) audit procedure. If your CE hasn’t already experienced a HRSA review yet, be assured it’s coming to you and perhaps sometime soon. 340B Program Audit Basics

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340B Drug Pricing Program ‘Mega Guidance’ – Key Takeaways

HRSA has released guidance on the 340B drug pricing program. The guidance will likely be published in the Federal Register late summer. While the guidance addresses a range of topics, it will presumably focus on the definition of patient, contract pharmacy

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Adapting to 340B Program Mega Guidance

Covered entities awaiting publication of HRSA’s mega-guidance should prepare to be compliant with the 340B program  on the effective date of new guidance.  Entities will need to assess its compliance with the final rules and implement processes that support a compliant

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Prudent Procurement of 340B Contractor Services

The first such step is to procure 340B contractor services in a prudent manner.  Ironically and importantly, federal law and regulation is such that covered entity procurements (or most of them) of pharmacy or vendor services are actually governed by

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340B Pharmacy and Vendor Contracts Raise Legal Concerns

Since the enactment of Section 340B in 1992,1 federal (and drug manufacturer) enforcement of legal requirements imposed by 340B on “covered entities” has been quite limited. Between health reform legislation and the likelihood that covered entities will expand their 340B

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HRSA Updates 340B Drug Pricing Program Audit Practices

As the Health Resources and Services Administration (HRSA) carries on to improve their function in the 340B drug pricing program administration, they have crafted three modifications which will affect covered entities. While the overall process continues to be mostly unchanged, recently-announced improvements

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