Lawmakers Seek Transparency in 340B Program

Recently, Sen Bill Cassidy, MD (R-LA), introduced the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP ACT) as an effort to close loopholes in the 340B drug discount program. This bill would also hold hospitals accountable for passing savings on to patients, according to a press release.
Under the current 340B program, hospitals are reimbursed for prescription drugs at a higher rate but are not required to pass the profits on to patients. The dramatic growth of participation in the program has resulted in higher overall costs within the supply chain, Dr Cassidy argues.
“The 340B program is an important resource for hospitals serving low-income areas,” Dr Cassidy said. “But too often the program’s discounts are used to pad hospitals’ bottom lines instead of helping disadvantaged patients afford their treatments. This bill will increase transparency and accountability and help ensure these discounts reach patients.”
Previously, the Government Accountability Office, the Department of Health and Human Services (HHS), the Office of the Inspector General, and the Medicare Payment Advisory Commission expressed concerns regarding the transparency and loopholes in 340B that may increase reimbursement but doesn’t necessarily translate to patient savings, according to the release.
The newly-introduced HELP ACT aims to increase transparency and reporting requirements to prevent diversions and assure that discounts are used to lower costs.
Additionally, the bill would prevent new participants from enrolling in the program for at least 2 years and require the HHS secretary to revise reporting requirements, according to the release.
The Community Oncology Alliance (COA) recently released a press release expressing their support for the HELP ACT.
“340B is an invaluable program for patients in need at community and safety-net providers, including rural hospitals. However, after 25 years, it has gone horribly wrong. I regularly hear about how the patients that 340B is intended to help are often actually being harmed by the program, cut off from timely and high-quality care by hospitals seeking to make profits from it. This is outrageous and must be stopped,” said Jeff Vacirca, MD, FACP, oncologist, CEO of NY Cancer Specialists in Long Island, NY, and president of COA. “Policymakers in DC need to act to ensure that we have a clear understanding of the scale of the 340B program, where funds are going, and accountability so that patients are directly benefiting.”
Notably, the HELP ACT would not prevent critical access hospitals, rural referral centers, sole community hospitals, grantees, and PPS-exempt children’s or cancer hospitals from enrolling in 340B, Dr Cassidy reported. Grantees, rural, and critical access hospitals would also not be subject to new reporting requirements.
COA noted that research has found significant problems with oversight, reporting, and data for 340B, according to the release.
“After more than 25 years in operation, the 340B program has grown so large and unwieldy in the shadows of Washington that policymakers have no idea how big it is, where the savings go, or who is really benefitting,” said Ted Okon, executive director of COA. “The 340B HELP ACT, other legislation, and administrative actions are finally shining a light on the 340B black hole in hospitals so that there is finally some transparency and accountability. It is critical that Congress push through the misinformation and rhetoric and get a true understanding of how this critically important program is truly operating.”
Dr Cassidy also discussed the necessity of health care reform at the 2017 National Association of Specialty Pharmacy Annual Meeting and Educational Conference. During the session, Dr Cassidy talked about how the Affordable Care Act—which lead to an increase in 340B participants—increases costs for the government and for patients.

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In this clip, Christopher Topoleski, Director of Federal Legislative Affairs for the American Society of Health-System Pharmacists (ASHP), talks about how the legislative landscape of the 340B Drug Pricing Program has evolved and what's to come.
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