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AAMC Submits Comment Letter on 340B Proposed Guidance

October 30, 2015—The AAMC Oct. 27 submitted comments  on the Health Resources and Services Administration (HRSA)’s proposed omnibus guidance on the 340B Drug Pricing Program, which was published in the Aug. 28 Federal Register [see Washington Highlights, Sept. 3].

In the letter, the AAMC reaffirms HRSA’s longstanding recognition that the program’s intent is to permit safety net hospitals and other covered entities “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” However, the association warns that “restricting the scope of the program would not yield substantial additional funds for the federal government, but could potentially leave patients who rely on these essential programs without the services they have looked to hospitals to provide.” Additionally, the AAMC is “concerned that a number of the proposed provisions would pose substantial financial and operational challenges to hospitals currently participating in the program, restricting the scope in a manner that is inconsistent with longstanding HRSA policy and the underlying goals of the statute.”

The AAMC’s letter outlines several concerns and comments about specific proposals in the guidance:

  • The proposed definition of “patient” would severely limit drugs eligible for 340B pricing –  including limitations on discharge prescriptions, infusion services, and hospital-provider relationships –  which would undermine hospitals’ efforts to expand care and services to underserved populations;
  • Greater flexibility for demonstrating eligibility of off-site outpatient facilities could help expedite the enrollment process for new child sites; and
  • It is unclear how HRSA plans to apply its proposal to exclude from 340B pricing, drugs that are reimbursed as part of a bundled Medicaid payment, which would result in programmatic and operational challenges for covered entities.

The association also urges, “Revising and reposting the proposed guidance for additional comment will help ensure that the final guidance strikes the appropriate balance between feasible, clear requirements to demonstrate compliance and sufficient flexibility for providers such that the patients ultimately served by the program continue to benefit from it.”

The letter also describes the challenges that hospitals will face in implementing new processes and technology to adhere to the proposed requirements, calling for the final guidance to include an effective date and a sufficient transition period to allow providers to come into compliance. As such, the AAMC suggests, “To enable hospitals to put in place the appropriate procedures and safeguards against inadvertent violations, and to allow vendors the opportunity to develop products that meet the new needs of covered entities, the AAMC recommends a transition period of one year, at minimum, before the compliance date.”


Tannaz Rasouli
Sr. Director, Public Policy & Strategic Outreach
Telephone: 202-828-0525

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


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