April 9, 2014—The Health Resources and Services Administration said yesterday that it has revised the instructions hospitals must follow to enroll themselves or their outpatient facilities in the 340B drug discount program. HRSA simultaneously published an outline of its process for ensuring that each applicant meets all requirements before it is deemed eligible. [ms-protect-content id=”2799″]
HRSA made the announcement in an update on the Office of Pharmacy Affairs home page. OPA “understands that registering hospitals and outpatient sites can be challenging,” the message begins. “The registration process is more than just paperwork—it is a critical compliance check for entities entering the 340B program. As OPA analysts review each entity for eligibility, we are ensuring that each entity, including hospitals and outpatient sites, are eligible for the program as outlined by the 340B statute.”
HRSA called the new registration instructions and outline of eligibility review procedures “two important steps toward improving the process for all stakeholders.”
Hospitals and other covered entities can enroll in 340B during four 15-day periods per year: Jan. 1-15, April 1-15, July 1-15, and Oct. 1-15. Entities are currently enrolling to begin participating effective July 1.
HRSA has said that its forthcoming 340B “mega-reg” will address hospital eligibility criteria and eligibility of off-site facilities.
In yesterday’s announcement, HRSA noted that, in addition to completing forms online, hospitals enrolling in 340B must submit several worksheets from their most recently filed Medicare cost report. “Please note, ALL documents must be sent to OPA on the SAME day that hospitals submit registrations,” the announcement stated (emphasis in original). “Registrations without required documents will be deleted without being reviewed and the hospital will be notified. When submitting their documents via email, hospitals MUST include their Medicare provider number in the subject line of their e-mail and any subsequent communication to OPA to facilitate a smooth review.”
In the accompanying outline of the eligibility review process, HRSA lists the Medicare cost report worksheets that hospitals must submit and specifies the information it reviews on those documents.
The announcement also includes an “important note about registering campuses medical centers, and other locations providing more than one service.” It reads:
“All outpatient clinics and services that are located outside of the 4 walls of the hospital and intend to use or purchase 340B drugs for its patients must register in the 340B program. They must appear on the hospital’s most recently filed cost report in order to register. If there is an off-site location that is a hospital or medical center, or even a small office with several services being provided, each clinic/department/service must be registered separately. For example, if there is a single off-site location that provides radiology services, physical therapy services, and pediatric services, the covered entity should register that one location as 3 separate 340B listings if they would like to provide the patients of all 3 services with 340B drugs.” [/ms-protect-content]