As promised, the blog will be taking an in-depth look at discrete topics included in the proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”), which was published August 28, 2015. The proposed Guidance touches on almost every aspect of the 340B Program, including covered entity (“CE”) eligibility; the patient definition; Group Purchasing Organization prohibitions; contract pharmacies; duplicate discounts; and CE audits. It also includes enhanced program integrity requirements for CEs, contract pharmacies, and pharmaceutical manufacturers participating in the 340B Program. Today’s blog will take a look at CE eligibility, registration, and termination.
Let’s start with the basics. Only CEs are eligible to participate in the 340B Program. These CEs are both non-hospital (e.g., STD clinic) and hospital (e.g., children’s hospital) entities. The proposed Guidance delineates the eligibility elements that have been established by the law, existing regulations, and past guidance. Once an eligible CE registers in the 340B Program, it is listed on the public 340B database. The registration conditions, deadlines, and procedures remain the same as outlined in previous guidance. As is the current practice, CEs must immediately notify the Health Resources and Services Administration (“HRSA”) regarding any changes in eligibility and CEs will still be required to annually recertify with HRSA.