Issues & Advocacy
In Funding HRSA, Congress Raises Concerns About 340B
WASHINGTON, D.C. (December 15, 2014)— As part of the official report accompanying the Continuing Resolution/Omnibus spending package enacted by Congress, the following concerns were raised about the 340B drug discount program:
There are concerns that HRSA has been unable to demonstrate that the 340B program benefits the most vulnerable patients. In order to best serve the public need, the program should examine its ability to ensure patients' access to 340B savings for outpatient drugs. HRSA is directed to work with covered entities to better understand the way these entities support direct patient benefits from 340B discounted sales."
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AIR 340B Statement on Uncompensated Care
WASHINGTON, D.C. (August 14, 2014)—The Alliance for Integrity and Reform of 340B (“AIR 340B”) today released the following statement on uncompensated care:
Recently, some groups opposed to reforming the 340B program have claimed that the 340B drug discount program should cover the cost of uncompensated care.
Let's get the facts straight. This was and is not the intention of the program.
The 340B program was created to help uninsured, indigent and vulnerable patients access needed medicines. The 340B program was not created to reimburse hospitals for uncompensated care. Uncompensated care is not charity care.
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New Report Shows Expanding 340B Contract Pharmacy Program Benefits Retail Pharmacies Instead of Vulnerable Patients
WASHINGTON, D.C. (July 14, 2014) - A new white paper released today by the Alliance for Integrity and Reform of 340B (AIR 340B) suggests that rapid contract pharmacy growth in the 340B program may not directly benefit the vulnerable patients for whom the program is intended. The paper, “The Impact of Growth in 340B Contract Pharmacy Arrangements,” highlights the growth of thousands of for-profit retail pharmacies -- many of which are located in wealthier areas of the country.
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IMS Finds 340B Drives Up Cancer Treatment Costs
WASHINGTON, D.C. (May 7, 2014) - The Alliance for Integrity and Reform of 340B (“AIR 340B”) called attention to the release of a new study, “Innovations in Cancer Care and Implications for Health Systems” by the IMS Institute for Healthcare Informatics, demonstrating that the 340B drug discount program is causing a rise in cancer patients’ treatment costs.
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New Analysis Shows Many 340B Hospitals Provide Minimal Charity Care; Small Percentage of 340B Hospitals Provide More
WASHINGTON, D.C. (March 25, 2014) - A new analysis released today by the Alliance for Integrity and Reform of 340B (AIR 340B) indicates that a substantial portion of hospitals enrolled in the 340B program provide only a minimal amount of charity care; as such, they may not be fulfilling Congress’ expectations.
The study, compiled from newly available public data analyzed by Avalere Health, noted that the 340B drug discount program was designed by Congress to help safety net providers improve access to prescription medicines for uninsured, vulnerable patients in the outpatient hospital setting. Yet, the analysis shows, most hospitals that benefit from the program provide less charity care than the national average for all hospitals, and charity care in about a quarter of all 340B hospitals represents 1% or less of total patient costs. A small number of 340B hospitals provide the lion’s share of all charity care delivered by 340B hospitals. These findings raise pressing questions about the 340B eligibility criteria for DSH hospitals. “340B is a valuable program, but it doesn’t always work the way Congress intended,” said AIR 340B spokesperson Stephanie Silverman.
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AIR 340B Reaffirms the Need for Improved Oversight of Critical Program for Vulnerable Patients
WASHINGTON, D.C. (March 4, 2014)— The Alliance for Integrity and Reform of 340B (“AIR 340B”) today released the following statement on President Obama’s Budget Request for Fiscal Year 2015, which calls for additional oversight for the 340B drug discount program:
“We agree that there is a pressing need for improved oversight and increased funding for the agency that oversees the 340B Drug Discount Program. A series of recent government reports has underscored the need for improved transparency and accountability within the 340B program. Serious questions have arisen regarding whether the program’s benefits are properly reaching uninsured, indigent patients, in the hospital setting, as Congress intended. Since 2011 the Government Accountability Office (GAO), the Department of Health and Human Services’ Office of Inspector General, and HRSA’s own independent audits have demonstrated the need for clear guidelines and oversight of the 340B program.”
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HHS Highlights Oversight Challenges With Drug Discount Program
WASHINGTON, D.C. (February 7, 2014)—The Alliance for Integrity and Reform of 340B (“AIR 340B”) today released the following statement on the Department of Health and Human Services Office of Inspector General Report on “Contract Pharmacy Arrangements in the 340B Program”:
The new report released by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) affirms many of the concerns expressed by the members of AIR 340B about the vast expansion and increased use of “contract pharmacy” arrangements in the 340B Drug Pricing Program. While the OIG study (which can be found online here) clearly demonstrates the importance of community-based pharmacies for providing discounted services to low income and uninsured patients, it also provides further evidence that weak oversight and lack of regulatory clarity puts patient needs and care at risk, while in many cases hospitals use contract pharmacy arrangements to capture savings—real dollars—intended for needy patients.
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AIR 340B Sends Letter to OPA Highlighting Priorities for Upcoming Rulemaking
(October 28, 2013) "As the Office of Pharmacy Affairs develops regulations for the 340B Drug Discount Program, we at the Alliance for Integrity and Reform of 340B (AIR 340B) wish to commend the leadership and staff of the Health Resources and Services Administration (HRSA) and the Office of Pharmacy Affairs (OPA) for your work thus far to improve oversight and bring some measure of transparency and accountability to the 340B program. We look forward to continuing to work with you to improve this important program. With these goals in mind, we wish to share our views on key issues that we hope will be addressed in the course of upcoming rulemaking. "
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"Scott Gottlieb: How ObamaCare Hurts Patients"
The Wall Street Journal, July 31, 2013
Scott Gottlieb of the American Enterprise Institute describes in depth how the 340B program has expanded dramatically from its original scope. The negative impacts of this unchecked expansion provide further evidence for why the program is in need of oversight.
"Oncology Clinics Caught in Financial Vise"
MedPage Today, July 27, 2013
According to the latest Practice Impact Report by the Community Oncology Alliance (COA), a member of the AIR 340B coalition, community oncology practices continue due to struggle due in large part to the unintended consequences of the 340B program. Since the COA issued its first report in 2010, the number of community oncology clinic closures has increased by 67% (from 172 to 288 clinics closed), including a 20% increase in closures in the last year alone. The report (availablehere) traces the reasons for this consolidation to “insufficient Medicare reimbursement to community oncology clinics and higher reimbursements and margins to hospital outpatient facilities, especially those eligible for 340B discounts.”
"The reality of today's booming 340B contract pharmacy market"
In a new analysis presented today on DrugChannels.net, Dr. Adam Fein writes that “the 340B contract pharmacy market has expanded in ways that no one anticipated. As the data show, hospitals are now building mega-networks that extend far beyond their "community," raising further questions about the economic motivations for this explosive growth.”
"Drugmakers accuse hospitals of profiting from federal discounts"
Pittsburgh Post-Gazette, July 9, 2013
Despite the intent of the 340B program to help uninsured indigent patients, mounting evidence shows a lack of controls and transparency have led to certain entities using the 340B program to generate enormous revenues with no guidelines or accountability over how that money is spent.