The American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), America’s Essential Hospitals, 340B Health, Genesis Healthcare System, Kearny County Hospital and Rutland Regional Medical Center asked a federal court to order the Department of Health and Human Services (DHS) to make effective within 30 days a final rule requiring drug companies to disclose the ceiling price for 340B outpatient drugs.
The AHA said that to ensure accuracy and compliance with the 340B drug savings program, the rule also describes how ceiling prices must be calculated and would allow the federal government to levy civil monetary penalties against drug companies that intentionally overcharge 340B providers.
HHS has delayed five times the effective date for the rule, required by Congress in 2010.
Arizona has 33 hospitals participating in the 340B program – for a complete list go to 340B Health
The coalition wants the district court to declare the delay unlawful and to enact the regulation. Healthcare Finance reports that the suit challenges the most recent delay of the final rule on the grounds that it is arbitrary and capricious and an unreasonable delay in violation of the Administrative Procedure Act.
As explained in Healthcare Finance, under the rule, drug companies must disclose the maximum per unit ceiling price that can be charged to 340B providers for outpatient drugs. The 340B program, created in 1992 and expanded under the Affordable Care Act, requires drug manufacturers to provide outpatient drugs to eligible providers at discounts of 20 to 50 percent. The suit was filed Tuesday, September 11, 2018 in the U.S. District Court for the District of Columbia.
AHA President and CEO Rick Pollack said in a statement,
As prescription drug prices continue to skyrocket, the 340B program is as crucial as ever in helping hospitals and health systems provide access to health care services for vulnerable patients and communities. Our lawsuit will promote the transparency and accuracy that the government has found lacking and hold price gouging drug companies accountable.
AAMC President and CEO Darrell G. Kirch, MD. released this statement,
The continued success of the 340B program must rely on compliance by all parties, including drug manufacturers. Providers need access to the information that Congress said they are entitled to. The final regulation provides important transparency for this vital program. Delaying implementation of that rule ultimately harms vulnerable patients and the teaching hospitals they rely on for care.
The 340B program allows hospitals and other organizations that care for many low-income and uninsured patients to purchase certain outpatient drugs from pharmaceutical manufacturers at discounted prices. The program allows participating hospitals to use savings from the discounts to provide comprehensive health services to local communities, such as increased access to care, clinical pharmacy services, community outreach programs, free vaccines and transportation to follow-up appointments.
Read more from Healthcare Finance
Read the press release from American Hospital Association
Read the press release from America’s Essential Hospitals