AHA, National Associations Amicus Brief – 340B Contact Pharmacy Legal Challenge by Sanofi - June 15, 2021

INTRODUCTION

The 340B program, established by section 340B of the Public Health Service
Act, 42 U.S.C. § 256b, requires as a condition of participating in Medicaid and Medicare Part B that pharmaceutical manufacturers sell outpatient drugs at a
discounted price to certain public and not-for-profit hospitals, community health
centers, and other providers that serve patients with low incomes (340B providers or
covered entities). The purpose of the program is to stretch the funding 340B
providers have available to meet the needs of their patients. H.R. Rep. No. 102-
384(II), at 12 (1992). A 2011 report from the U.S. Government Accountability
Office (GAO) found that the 340B program has had this exact effect. Specifically,
GAO found that 340B providers have used the benefit made available through the
drug discounts to provide critical health care services to communities with
underserved populations that could not otherwise afford these services—for
instance, by increasing service locations, developing patient education programs,
and providing translation and transportation services. GAO, Report to Congressional
Committees, GAO-11-836, Manufacturer Discounts in the 340B Program Offer
Benefits, but Federal Oversight Needs Improvement 17–18 (Sept. 2011),
https://www.gao.gov/assets/gao-11-836.pdf.

View the entire amicus brief below.