Today, Sen. Chuck Grassley (R-Iowa) sent a letter to the Department of Health & Human Services (HHS) Office of Inspector General (OIG) asking for an update on seven drug manufacturer referrals for 340B Drug Pricing Program (340B Program) non-compliance.
The 340B Program helps maintain health care access for low-income patients. Last year, the Health Resources & Services Administration (HRSA) reviewed policies in place by seven drug manufacturing companies under the 340B Program. HRSA determined these manufacturers were not complying with the 340B program, resulting in overcharges. The HRSA referred these seven manufacturers to the HHS OIG, in accordance with the 340B Program Ceiling Price and Civil Monetary Penalties Final Rule, for further investigation. However, no enforcement action has been taken since the referrals were made.
“Living in rural Iowa, I understand the importance of access to health care close to home,” Grassley said. “I’ve heard from Iowa hospitals and pharmacists about how drug manufacturers have ended 340B Program pricing at contract pharmacies and placed administrative burdens on health care providers. It’s important to understand what the inspector general is doing to take action following referrals by HRSA.”
A total of 16 drug manufacturers have placed restrictions on covered entities under the 340B Program. In May 2021, HRSA reviewed policies in place by six drug manufacturers who placed “restrictions on 340B pricing to covered entities that dispense medication through pharmacies.” HRSA sent letters to those six drug manufacturers determining their “actions have resulted in overcharges and are in direct violation of the 340B statute.” In September 2021, HRSA referred the matter to the HHS-OIG. Since the September 2021 referrals, HRSA has referred an additional drug manufacturer.
Grassley has consistently supported more transparency for the 340B Program and maintained his commitment to ensuring the program works as Congress intended.
- Grassley was a sponsor of bipartisan legislation allowing 340B Program hospitals to keep their eligibility in the program even if the hospital saw a reduction in inpatient hospital admissions of low-income Medicare and Medicaid patients, a program requirement for 340B participation. Many hospitals saw a reduction in admissions as the result of limited elective procedures throughout the COVID-19 pandemic. The 2022 Consolidated Appropriations Act included the Grassley-backed provision.
- In October 2021, Grassley asked HHS General Counsel-nominee Mr. Samuel Bagenstos how the Biden administration would protect the 340B Program and ensure there is more transparency in how it operates.
In addition, Grassley has never stopped working to pass his balanced, bipartisan and comprehensive drug pricing bill, the Prescription Drug Pricing Reduction Act (PDPRA). Beginning in 2019, as chairman of the Senate Finance Committee, Grassley held three hearings on lowering the cost of prescription drug prices and conducted numerous bipartisan meetings to advance a bipartisan solution. Under Grassley’s leadership, PDPRA passed the Finance Committee on a bipartisan vote, 19 to 9. According to the nonpartisan Congressional Budget Office (CBO), PDPRA would lower costs for seniors, saving $72 billion, and it would save taxpayers $95 billion. It is the only comprehensive prescription drug bill that could pass the U.S. Senate with more than 60 votes.
Throughout 2021 and 2022, Grassley has spoken about his bipartisan efforts to lower prescription drugs costs with President Biden, Speaker Pelosi, HHS Secretary Becerra, members of the Problem Solvers Caucus Health Care Working Group, rank-and-file members of Congress and White House staff.
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