Georgia Mountain News

WASHINGTON – U.S. Representatives Earl L. "Buddy" Carter (R-GA), Larry Buschon, MD (R-IN), and Diana Harshbarger (R-TN) introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). This legislation aims to establish oversight and transparency in the 340B program, providing solutions to ensure its effectiveness in the nation's healthcare safety net.

“340B was intended to give low-income and vulnerable patients access to affordable medicines. The program has rapidly expanded, and a lack of transparency has allowed some entities to pocket the savings without passing them on to patients. Congress must act to restore the integrity of the program to better protect vulnerable patients served by safety-net providers. The 340B ACCESS Act will save lives and improve outcomes by ensuring patient access to affordable, quality health care. I want to thank Dr. Bucshon and Rep. Harshbarger for joining with me to protect the 340B drug pricing program for Georgians and all Americans,” said Rep. Carter.

"The 340B drug pricing program was originally created to serve as a lifeline for thousands of Hoosiers and millions of Americans who struggle to afford life-saving medications," said Dr. Bucshon. "However, in recent years the program has rapidly expanded, with a lack of transparency, clarity, and accountability threatening its future. As a physician, I know the importance of providing patients with reliable access to affordable medications. It's imperative that we address these concerns and safeguard the 340B drug pricing program, ensuring its benefits are reaching and helping vulnerable patients. I am proud to lead the 340B ACCESS Act, which seeks to restore integrity to the program, enhance transparency, and uphold its original mission of providing affordable medications to those who need them most."

“The 340B program is a vital resource for safety-net providers serving low-income and vulnerable patients, but current loopholes have allowed the benefits of discounted drug costs to be misused instead of helping disadvantaged patients afford their treatments,” said Rep. Harshbarger. “As a pharmacist, I know first-hand the critical need for enhancing access to affordable medications and healthcare services. That’s why I’m proud to join Dr. Bucshon and Rep. Carter in introducing the 340B ACCESS Act, which will put in place much-needed reforms.”

“Today is a great day for patients who depend on 340B,” said Thomas Johnson, Executive Director of the Alliance to Save America’s 340B Program (ASAP). “This bill will lower out-of-pocket prescription drug costs for up to 48 million uninsured and low-income patients nationwide — an unprecedented step for the program.”

“We applaud Representatives Bucshon, Carter, and Harshbarger for their leadership in developing this critical legislation that delivers on a solution,” said Kyu Rhee, MD, MPP President & CEO of NACHC.

“The 340B program supports over 650,000 Hoosiers who depend on Community Health Centers,” said Ben Harvey Chief Executive Officer Indiana Primary Health Care Association.

The background information provided outlines that while originally established in 1992 as an important tool aiding hospitals serving low-income or uninsured patients through discounted drug purchases; it has grown substantially over recent years operating with little oversight or transparency.

The principles guiding this new legislation include:

- Making it a true safety-net program.

- Ensuring prescriptions are offered at discounts.

- Updating patient definitions.

- Establishing clear criteria for contract pharmacy arrangements.

- Preventing profit from middlemen.

- Updating hospital eligibility requirements.

- Setting standards for child sites/subgrantee eligibility.

- Creating neutral claims data clearinghouse.

- Facilitating public reporting on data.

- Establishing enforceable rules enhancing federal administration/oversight.

To ensure it helps vulnerable patients directly:

1) Patient affordability requirements will reduce out-of-pocket costs,

2) Codifying patient definitions,

3) Recognizing contract pharmacies subjecting them under consistent rules,

4) Imposing hospital eligibility requirements varying by type ensuring service towards true safety nets,

5) Establishing statutory standards requiring proof satisfying standards prior participation with penalties if non-compliance occurs,

6) Restrict PBMs preventing excessive profits from safety-net programs using modeled non-discrimination rules.

Transparency measures including mandatory grantee reports based upon standardized HHS rules akin Uniform Data System (UDS).