340B Drug Pricing Program
Omnibus Guidance Compliance, Operations, and Contract Pharmacy Auditing Services
On August 28, 2015, the Department of Health and Human Services (“HHS”) through the Health Resources and Services Administration (“HRSA”) issued a notice of proposed rulemaking (“NPRM”) entitled “340B Drug Pricing Omnibus Guidance.” The NPRM updates and clarifies current 340B Program guidance.
HRSA administers section 340B of the Public Health Service Act (“PHSA”) which is referred to as the “340B Drug Pricing Program” or the “340B Program.” The intent of the 340B Program is to allow covered entities to utilize scarce federal resources in order to deliver comprehensive care to individuals participating in eligible government programs. This NPRM proposes updated comprehensive guidance for covered entities participating in the 340B Drug Pricing Program, participating drug manufacturers, and other stakeholders. HHS has proposed the Omnibus Guidance to provide increased clarity in the marketplace for all 340B Program stakeholders and to strengthen HHS’ ability to effectively administer the program.
Key provisions of the 340B Drug Pricing Omnibus Guidance place greater emphasis on a covered entity’s administration of the program and contracted pharmacy oversight. Increased administrative costs could result in reduced savings from the program. The accumulating cost of inefficiency and non-compliance with HRSA’s Omnibus Guidance is certainly something that 340B covered entities must be aware of and take preventative measures against. Since most covered entities are expected to have robust administration and oversight of their contracted pharmacies, risks to the financial, operational, and compliance standing of your entity are ones you cannot afford to take.
FTI Consulting can assist 340B eligible health care providers with determining whether your entity and your contract pharmacies are meeting regulatory and contractual requirements by offering a comprehensive suite of review services to best suit your entity’s particular needs.