San Diego—Implementing the 340B Drug Pricing Program can be daunting, with many covered entities lacking an in-depth understanding of the program’s complex rules, regulations and reporting requirements, which often result in lost savings opportunities and increased risks. That was the heady backdrop for the 340B Coalition Winter Conference, the largest 340B meeting to date, where experts from around the country gathered to provide insights, solutions and debate on high-risk issues facing 340B managers.

I have worked in health-system pharmacy for more than 30 years, much of it as a director of pharmacy, and have a deep operational and compliance expertise, but this was my first time attending this important meeting. So I was particularly happy to keep a journal of my perspectives as a pharmacist veteran but a conference rookie, focusing not just on the program content but also the buzz I was hearing in the hallways. Everyone I encountered at the conference—pharmacy executives and managers, pharmacy technicians and other stakeholders—came seeking a deeper understanding of 340B’s complex rules and ways to navigate risks. Here are my key takeaways from the meeting.

HRSA Audits

The 340B Drug Pricing Program is in a “new era” of integrity versus implementation, noted Krista Pedley, the director of the federal government’s Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs, during a pre-conference 340B University event. She said the program is moving from a time of access to one of responsibility, compliance and accountability.

For pharmacies, this means that compliance and HRSA auditing are big issues. And with HRSA conducting 200 audits a year, covered entities can be assured that their number will come up.

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