Good Stewardship Principles Aim to Strengthen 340B Program
The American Hospital Association and individual hospitals have initiated new principles for ensuring good stewardship of the 340B drug program.
The American Hospital Association (AHA) and individual hospitals have initiated new principles for ensuring good stewardship of the 340B drug program. The goals are to ensure that the 340B program increases transparency, and assists participating hospitals in better communicating the program’s value for vulnerable patients and communities.1
“The 340B stewardship principles will help hospitals better tell their story of how this crucial program is delivering a variety of important benefits to patients and communities,” said Rick Pollack, president and CEO of the AHA, in a prepared statement.1 “In an era of skyrocketing drug prices, 340B has been critical in helping hospitals expand access to comprehensive health services, including lifesaving prescription drugs.”
According to the AHA, these new principles serve as the foundation for every 340B hospital’s good stewardship of the program:1
- Communicate the Value of the 340B Program:The hospital commits to preparing and publishing a narrative, on an annual basis, that describes how it uses 340B savings to benefit the community. The narrative would address those programs and services funded, in whole or in part, by 340B savings, including those services that support community access to care that the hospital could not continue without 340B savings. Examples of such programs and services will be particular for each hospital and could include programs that expand access to drugs for vulnerable populations, as well as a wide range of other services, such as preventive care, emergency services, cancer treatment, vaccinations, home-based care, and mental and behavioral health services.
- Disclose Hospital’s 340B Estimated Savings:The hospital commits to publicly disclosing, on an annual basis, its 340B estimated savings calculated using a standardized method. That method would compare the 340B acquisition price to group purchasing organization (GPO) pricing. If GPO pricing is not available for a 340B drug, the 340B acquisition price for a drug would be compared to another acceptable pricing source. To provide context for the estimated savings, hospitals could compare their 340B estimated savings to the hospitals’ total drug expenditures, as well as provide examples of their top 340B drugs.
- Continue Rigorous Internal Oversight.The hospital commits to continuing to conduct internal reviews to ensure that the hospital’s 340B program meets Health Resurces and Services Administration program rules and guidance. Included in this effort is a commitment to regular and periodic training for their interdisciplinary 340B teams that encompasses C-suite executives, pharmacy, legal, and financial assistance, as well as community outreach and government relations staff if applicable.
The new 340B principles were viewed as a positive step forward by the Alliance for Integrity and Reform of 340B (AIR340B) Coalition, a partnership of patient advocacy groups, clinical care providers, and biopharmaceutical innovators. In a prepared statement, AIR340B officials said they were encouraged that the AHA recognized the need for changes to the program, but that patients would still not know whether or not they are benefitting directly from the 340B program.2
"In addition to the commitments the AHA is suggesting, we urge lawmakers to build on this momentum and continue working side-by-side across Congress, the Administration, and all stakeholders to bring this program back to helping the communities it was meant to serve and putting patients above profits," said AIR340B officials in their statement.2
Members of the AHA 340B Board Task Force said they see the positive effect that 340B has in their communities. In prepared statements, they referenced programs at that are working through the Carilion Clinic in Virginia, Eastern Maine Healthcare Systems, Tidelands Health in South Carolina, and UC San Diego Health in California.1
“The 340B program has helped deliver immense benefits to the rural South Carolina communities that Tidelands Health is proud to serve, including free care to uninsured patients, community programs to promote health and wellbeing, and professional hospital pharmacy services 24/7 for all patients,” said Bruce Bailey, president and CEO of Tidelands Health and chair of the AHA 340B Board Task Force.1 “These new principles will help 340B hospitals across the country communicate why this vital program is so important to their patients and communities.”
The good stewardship principles have been endorsed by America’s Essential Hospitals, the Association of American Medical Colleges, the Catholic Health Association of the United States, the Children’s Hospital Association, and 340B Health, according to the AHA1
- AHA, Hospital Leaders Announce 340B Good Stewardship Principles [news release]. Washington, DC; September 18, 2018: AHA website. https://www.aha.org/press-releases/2018-09-18-aha-hospital-leaders-announce-340b-good-stewardship-principles-0. Accessed September 18, 2018.
- AIR340B Encouraged by 340B Principles Announced by AHA, Looks to Regulatory and Congressional Action to Keep Momentum Going [news release]. Washington, DC; September 18, 2018. [email]