ASHP’s Advocacy to Protect the 340B Drug Pricing Program Yields Important HRSA Ruling
Dear Colleagues,
ASHP has been leading patient-focused efforts to protect the 340B Drug Pricing Program, and I am pleased to share with you that our steadfast advocacy has paid off. The Health Resources and Services Administration (HRSA), which manages the 340B program, recently announced that it has directed six drug manufacturers to comply with 340B pricing requirements or risk financial penalties.
The 340B program is essential to many hospitals’ ability to provide healthcare services to vulnerable patients and communities, including providing access to medications for uninsured and underinsured patients. The 340B program is designed to allow providers flexibility to allocate resources where they are needed — largely to support programs that benefit patients but are not reimbursed by federal or private payers.
Hospitals use 340B savings to support patients in myriad ways: to enable patient access to free or low-cost services, to offset the cost of uncompensated care, which may include critical services such as chemotherapy and HIV treatments, and to provide expanded clinical services. Without 340B savings to fund them, many of these vital patient benefits would be financially unsustainable, forcing hospitals to reduce their scope or eliminate them for the very patients that often need these services the most.
Without the sustained advocacy campaign of ASHP, our members, and our partners, including 340B Health, the American Hospital Association (AHA), America’s Essential Hospitals (AEH), the Association of American Medical Colleges (AAMC), and the Children’s Hospital Association (CHA), pharmaceutical manufacturers might never have been held accountable. I would like to highlight a few of the important advocacy milestones that led to this decision by HRSA to enforce 340B pricing, which is vital in helping pharmacy teams meet the needs of the patients they serve.
Destabilization of 340B Drug Pricing Program
Pharmaceutical manufacturers have long attempted to erode the 340B program. Beginning in July 2020, some pharmaceutical manufacturers began to chip away at the foundation of the federal 340B program by implementing arbitrary restrictions on the covered entities’ use of contract pharmacies. Under federal law, the 340B program allows hospitals to contract with pharmacies to provide 340B pricing at the contracted locations. This policy is designed to improve patient access and generate savings to support patient programs that would not otherwise receive funding. Cutting out contract pharmacies destabilizes the 340B program and restricts patients’ access to medications.
ASHP took quick action following the initial reports of manufacturers not complying with the 340B rules. In August 2020, ASHP, 340B Health, AEH, AHA, AAMC, the Catholic Health Association, and CHA requested that Alex Azar, then serving as secretary of the Department of Health and Human Services (HHS), require manufacturers to comply with all federal requirements of the 340B program. In response, HRSA and the House Energy & Commerce Committee launched investigations into manufacturers’ actions to strip patients of access to medications through contract pharmacies.
In October 2020, we participated in a national advocacy effort to safeguard the 340B program. Along with our partners, we launched a digital advertising campaign opposing pharmaceutical manufacturers’ actions that threaten to undermine this program.
ASHP’s Ongoing Advocacy Efforts
ASHP, along with 340B Health, AHA, AEH, AAMC, and CHA, continued our ongoing efforts to advocate in court and with federal regulators to protect 340B pricing.
Most recently, in collaboration with our partner organizations, we sent a letter to HHS urging the agency to take action against the six pharmaceutical companies. This letter led to HRSA’s decision to take enforcement action against drug manufacturers that failed to comply with 340B program requirements. HRSA cited the manufacturers for program violations, including imposing limits on the availability of 340B discounts, refusing to offer the 340B ceiling prices on drugs dispensed through contract pharmacies, and requiring specific data submission and/or the use of certain reporting platforms.
Looking Ahead
ASHP has worked aggressively to protect the 340B program and the patients who benefit from it. We would not be where we are today without the advocacy efforts of our members, our staff, and our volunteers.
The 340B program is of critical importance to many of our members, and we would like to hear how this decision will impact your pharmacy practice and your patients. I invite you to share your perspective by sending an email to [email protected] so that we can share these stories with others on our social media channels.
We remain fully committed to ensuring that the 340B program remains a robust resource for providing access to affordable lifesaving medications and patient services for our members and their patients.
As always, thank you for supporting ASHP and for all that you do for your patients and our profession.
Sincerely,
Paul
Posted on May 25, 2021