Representatives Jake Auchincloss (D-MA), Scott Peters (D-CA) and Dr. John Joyce (R-PA) introduced the bipartisan Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency (SECURE) in 340B Act, the first-ever comprehensive, bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992. This bill is also co-sponsored by Reps. Nanette Barragán (D-CA) and Dan Crenshaw (R-TX).
“Employees' health premiums are too high, and the growth of the 340B program is one driver of that inflation,” said Congressman Auchincloss. “Instead of pointing fingers, it's time to fix the problems. This bill tackles the hard issues and asks every stakeholder to compromise for the common good.”
“For nearly a decade, I’ve fought to protect the 340B program for the safety-net providers and low-income patients in San Diego who depend on it to afford their prescription drugs. I’ve also pushed to make sure those savings actually reach the people for whom they’re intended. This bill does both,” Congressman Peters said. “The SECURE 340B Act closes the loopholes that have allowed the program to drift from its mission, stops the legal chaos that plagues the program today, and puts in place the kind of transparency and accountability that will keep 340B strong for decades to come.”
“Since its establishment, the 340B program has served as a critical lifeline for low-income patients to access lifesaving medications,” said Congressman John Joyce, M.D. “The statute has long needed additional clarity to reflect the way the program operates today and ensure that access to treatment remains available to patients most in need and the healthcare facilities that serve them. This bill, a bipartisan solution that I am proud to have worked on with my colleague Representative Scott Peters, seeks to close loopholes that have compromised the integrity of the program while ensuring a stable path forward for the many hospitals and patients in my district that rely on it.”
The 340B Program, the nation's second-largest federal prescription drug program, was created to help safety-net providers stretch limited resources through discounted drug prices. It allows these providers to purchase outpatient drugs at significantly reduced prices. The discounts have historically been applied upfront at the point of purchase.
However, since federal law never defined who qualifies as a 340B “patient,” the program became ambiguous, and was misused. In the absence of a legal “patient” definition, manufacturers attempted their own rebate verification systems. Courts have tried to block these rebate pilot programs, but only on procedural grounds. To this day, the federal government still has no uniform way to prevent discounted medicines from going to ineligible patients or duplicate discounts, or to validate pricing data across federal programs.
The SECURE 340B Act addresses these gaps. It pauses manufacturer rebate models for four years while a new patient definition is created and standards for contract pharmacies, data sharing, and transparency take effect. It establishes a clear, statutory definition of “patient” based on previous federal guidance. The bill also directs the Health Resources and Services Administration (HRSA) to use an independent, conflict-free clearinghouse to securely manage prescription-level data, verify claims, and protect privacy. It also strengthens HRSA's authority and provides transparency and federal guardrails.
“We support legislation that strengthens, stabilizes, and preserves this critical program for eligible hospitals and federally qualified health centers who care for our most vulnerable communities and patients. At BMC Health System, 340B savings are reinvested directly into services that expand access to care, improve health outcomes, and strengthen the healthcare safety net for underserved communities. We recognize that advancing and sustaining the 340B program, inclusive of addressing the rebate model, requires balancing the needs of patients, providers, and manufacturers. Establishing long-term regulatory certainty through durable, bipartisan solutions will help providers plan for the future and continue delivering high-quality, affordable care to those who need it most.” — David Twitchell, PharmD, MBA, SVP and Chief Innovation Officer, Boston Medical Center Health System
"The 340B program is vital to Community Health Centers (CHCs) and the 52 million people — one in seven Americans, including one in three in rural communities — who rely on CHCs for affordable, comprehensive, and high-quality care. We commend Representatives Joyce, Crenshaw, Peters, and Auchincloss for their bipartisan leadership in advancing this comprehensive legislation. Key provisions addressing contract pharmacies, providing a four-year delay of any potential rebate model, and establishing and evaluating a neutral clearinghouse are especially important. We look forward to working with these leaders and Members on both sides of the aisle to build upon the bill being introduced today and advance legislation that preserves and strengthens access to 340B for CHCs and their patients.” — Kyu Rhee, MD, MPP, President and CEO, National Association of Community Health Centers
“Recent polling shows that while most voters are unfamiliar with the 340B program, once they learn what it is, an overwhelming 91 percent say Congress should increase transparency and accountability. That tells us something important: even without getting everything they want, stakeholders and voters agree on the core reforms needed to protect patients and strengthen the program. Congressman Peters’ SECURE 340B Act reflects those areas of consensus; a clear patient definition, transparency without rigid spending mandates, and guardrails that keep the program focused on patient benefit.” — Scott Suckow, Chair of Patient Advocates United in San Diego and Executive Director of the Liver Coalition
“The SECURE 340B Act is an important and much-needed step toward bringing real guardrails, transparency, and accountability to a program that has grown well beyond its original design, and employers and other healthcare purchasers strongly support the introduction of this legislation. The bill provides a meaningful framework to help ensure the 340B program better serves patients and the communities it was intended to benefit, while creating a serious foundation for bipartisan policymaking. We look forward to working with policymakers to further strengthen the legislation, ensuring real accountability for 340B covered entities and drug makers alike while protecting flexibility for plan sponsors to ensure they can purchase affordable medications for working families.” — Shawn F. Gremminger, MPP, President and CEO, National Alliance of Healthcare Purchaser Coalitions
“Advocates for Community Health is deeply grateful for the work of Representatives Peters, Joyce, Auchincloss, and Crenshaw to advance commonsense 340B program reform. ACH is a longstanding advocate for legislation that would stabilize and clarify the 340B program, and we are encouraged that SECURE reflects many of our members' core principles for reform, including the piloting of a claims clearinghouse before we rush into a rebate model. We look forward to continuing to advance this legislation, including refinements to the patient definition that reflects current health center operating procedures, as soon as possible.” — Amanda Pears Kelly, CEO, Advocates for Community Health
“The Community Oncology Alliance (COA) appreciates the leadership of Representatives Peters, Joyce, Auchincloss, and Crenshaw for recognizing that the 340B program urgently needs bipartisan reform. The SECURE 340B Act includes important steps toward transparency, accountability, clearer patient eligibility, stronger oversight of child sites, and patient affordability protections. Those are reforms that COA has long called for to be urgently addressed. At the same time, Congress must ensure that any final legislation does not lock in the very abuses that have distorted 340B—particularly arrangements that allow PBMs from being contract pharmacies and hospital systems from capturing savings that should benefit vulnerable patients. We look forward to working with the sponsors to strengthen the legislation so that 340B discounts help patients in need, not profit PBMs and hospitals.” — Ted Okon, Executive Director, Community Oncology Alliance
Read the full bill text here - https://scottpeters.house.gov/sites/evo-subsites/scottpeters.house.gov/files/evo-media-document/peteca_096_xml.pdf