340B DRUG PRICING PROGRAM SUSTAINABILITY

To affirm the intent of the federal drug pricing program (the “340B program”) to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services; further,

To advocate for continued access to the 340B program in accordance with the intent of the program; further,

To advocate that reimbursement and contracting policies promote 340B program stability and to oppose reimbursement and savings reductions to covered entities; further,

To advocate for clarification and simplification of the 340B program and any future federal discount drug pricing programs with respect to program definitions, eligibility, and compliance measures to ensure the integrity of the program; further,

To encourage 340B participants to provide appropriate stewardship of the 340B program; further,

To educate pharmacy leaders and health-system administrators about the internal partnerships and accountabilities and the patient-care benefits of program participation; further,

To educate health-system administrators, risk managers, and pharmacists about the resources required to support 340B program compliance and documentation; further,

To encourage communication and education concerning the value of the 340B program; further,

To advocate that the Health Resources & Services Administration Office of Pharmacy Affairs have sufficient regulatory authority to enforce compliance for all stakeholders with the 340B program. 

Rationale

Statutory and other policy changes to the federal drug pricing (“340B”) program over the years have spurred an increase in the number of hospitals and other eligible entities that participate. Since the program’s inception, the number of 340B-eligible and participating hospitals has continued to grow. In response, policymakers and other stakeholders have raised questions over how the discounts are used by covered entities and what value the program brings to their respective communities. Congress has held hearings, and bills have been introduced to reform the program. Among the items Congress is considering are transparency, increasing authority of the Health Resources & Services Administration (HRSA) to oversee the program, reimbursement cuts imposed under Medicare Part B on 340B drugs, and examining policy that passes the discount along to the patient.

Expansion of Medicaid eligibility in 2014 (through provisions in the Affordable Care Act) allowed additional hospitals to participate in the program, further driving scrutiny and questions from policymakers and stakeholders. In response to policymaker and stakeholder concerns, ASHP recognizes the important intent and role of the 340B program and stresses the need for its continued sustainability. These developments demonstrate the need for pharmacy leaders to engage in a strategic response to this compliance environment.

The original intent of the 340B program was to “to enable these entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” (H.R. Rept. 102-384, pt. 2, at 12 [1992]). ASHP emphasizes the need for clarification and simplification (to the extent possible) of the program in order to enable compliance and maintain program integrity. Further, there is a need for communication and collaboration with public and private payers to ensure optimization of benefits from the 340B program and related contract and reimbursement policies.