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HRSA Posts Revised Requirements for 340B Drug Discount Program

April 11, 2014—The Health Resources and Service Administration (HRSA) Office of Pharmacy Affairs (OPA) April 8 posted revised requirements for new hospital registrations.  In addition to completing an online registration, hospitals must submit on the same day all required documents, including Worksheet S, Worksheet S-2, Worksheet E, Part A (for disproportionate share hospitals (DSH), rural referral centers (RRC), sole community hospitals (SCH), and freestanding cancer hospitals (CAN)), and Worksheet S-3 (children’s hospitals (PED) only). 

HRSA notes that all outpatient services located outside the four walls of the hospital must register in the 340B program and must appear on the hospital’s most recently filed cost report. In addition, if several services are being provided, each clinic/department/service must be registered separately. 

HRSA provides the following 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.”

HRSA expects to issue a notice of proposed rulemaking about the 340B drug discount program in June.  The AAMC will be working with members to understand the implications of the proposal and intends to comment.


Ivy Baer, J.D., M.P.H.
Senior Director and Regulatory Counsel
Telephone: 202-828-0499


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806