There were two prevailing topics that dominated this year’s 340B Coalition Winter Conference: mega-guidance and 340B entity audits. While these terms are not mutually exclusive, they each received significant airtime throughout the conference.
The mystery of mega-guidance
According to 340B Health, mega-guidance (aka omnibus guidance) is a ruling designed to be a ‘one-stop-shop’ of 340B-related regulations, including definitions, guidelines and procedures for all entities within the 340B Program. At the 340B Coalition Winter Conference, the general consensus was that mega-guidance was not a one size fits all type of deal. According to Health Care Law Today, the Health Resources and Services Administration (HRSA) first introduced mega-guidance to 340B audiences in the fall of 2015. Due to its widespread potential impact on 340B entities, the HRSA received over 800 comment submissions from various healthcare stakeholders discussing proposed edits to the ruling. As a result, there’s still a lot of speculation on the official publishing date of the final ruling, as well as which mega-guidance sections will be approved, removed or modified. What’s the latest update? While several final dates have been proposed by the HRSA, nothing has been set in stone. The most recent possible date to be mentioned is September 2016.
Along with the multiple conference opportunities dedicated to educating 340B entities about mega-guidance, a significant portion of the conference was spent on clarifying audit procedures for audit-naïve 340B entities. The audit presentations were separated into several categories, including a step-by-step audit procedure break down, what to expect, what resources to utilize and general prevention tips. The word alone – audit – can cause one to feel nauseated because of the complex process and because failing an audit can lead to costly, negative results.
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