iStock_000022216040_FullThis year we once again had boots on the ground for 340B University and the 340B Winter Coalition Conference for a four-day 340B Drug Pricing Program (340B Program) adventure. 340B University is free of charge and is put on by the 340B Prime Vendor, Apexus. The 340B Coalition Conference, on the other hand, charges a fee and is organized by 340B Health, a membership organization that advocates for covered entities (CEs).

In this post, we disclose the number one lesson from this four-day, 340B Program extravaganza—compliance is hard, and it will only get harder. In the posts to come, we will explore other takeaways.

Compliance is Hard, and it Will Only Get Harder

The oft-mentioned proposed 340B Drug Pricing Program Omnibus Guidance (Guidance), more colloquially referred to as the Mega Reg or Mega Guidance (foreboding, right?), was on every stakeholder’s mind. This 25-page document, published in the Federal Register on August 28, 2015, sparked a lot of concern.  CEs have much to potentially contend with in this proposed Guidance, from updating the Medicaid Exclusion File to reworking their referral and infusion center arrangements.

State Medicaid programs and manufacturers weren’t left out.  Under the proposed Guidance, manufacturers will face increased Health Resources and Services Administration oversight in limited distribution networks, annual recertification, and refunding procedures. In addition, the Medicaid Program; Covered Outpatient Drugs final rule published in the Federal Register on February 1, 2016, promises to cause confusion by giving incomplete direction regarding 340B Medicaid Managed Care claims.

All 340B Program stakeholders will have to work together to continue operating in this ever-changing space.