As you may have heard, the 340B Drug Pricing Program Omnibus Guidance (Mega-Guidance) was published for public comment last Friday, August 28, 2015. You can find it HERE. Please note, comments should be submitted on or before TUESDAY, OCTOBER 27, 2015. While the Mega-Guidance addressed numerous areas of the 340B program, the most significant proposed changes were in the areas of:
patient definition
physician administered drugs (stricter guidance)
record retention standards
duplicate discounts including Medicaid Managed Care
contract pharmacy
Expanding on contract pharmacy, this is one of the areas that Health and Human Services (HHS) is proposing enhanced compliance mechanisms for covered entities. The guidance does not limit a covered entity on their number of contract pharmacy arrangements; however, it did clarify the expectation of an annual independent audit and added a requirement for a minimum of quarterly reviews of each contract pharmacy. They also added a five (5) year record retention standard.
HHS states in the guidance that they are “proposing standards for audit and quarterly reviews to ensure that compliance efforts related to contract pharmacies result in the early identification of problems, implementation of corrections and the prevention of future compliance issues”. The guidance also states, “a covered entity should correct any instances of diversion or duplicate discounts found during either the annual audit or quarterly review and report corrective action to HHS”. Since they did not specifically address reporting instances that constitute a material breach of compliance, some are interpreting this to mean each instance of diversion or duplicate discounts would need to be reported to HHS after it has been corrected.
The proposed guidance repeats that the covered entity is responsible for contract pharmacy compliance with 340B program requirements. Regular internal self-auditing and external audits have been an expectation for program compliance and the proposed guidance now outlines that quarterly reviews are the minimum standard.
As stated in our previous Mega-Guidance post, we will be publishing a series of articles over the next month covering the proposed changes as addressed in the 340B Drug Pricing Program Omnibus Guidance and what effects this proposed Guidance could have on 340B covered entities participating in the 340B Program. Check back soon or subscribe now to our blog so that you don't miss the next update (we promise we’ll find your inbox)!
