
Hospital Groups Sue HHS Over Delayed Implementation of 340B Ceiling Prices, Penalties for Overcharging
The lawsuit—filed by the American Hospital Association, America’s Essential Hospitals, the Association of American Medical Colleges, 340B Health, Genesis Healthcare System, Kearny County Hospital, and Rutland Regional Medical Center—is asking a federal court to order HHS to make the final rule effective within 30 days.
The American Hospital Association (AHA) and 6 other 340B stakeholders
The final rule has been delayed 5 times since HHS
According to HHS, the delays have been to “provide affected parties sufficient time to make needed changes to facilitate compliance.”
Under the final rule, which includes information for manufacturers to calculate the ceiling price, manufacturers can be fined up to $5000 for each incident of knowing and intentional overcharging of 340B hospitals for drugs purchased under the program. The rule also requires manufacturers to offer refunds for overcharges on new drugs instead of maintaining, rather than requiring covered entities to request refunds.
The lawsuit—filed by AHA, America’s Essential Hospitals, the Association of American Medical Colleges, 340B Health, Genesis Healthcare System, Kearny County Hospital, and Rutland Regional Medical Center—is asking a federal court to order HHS to make the final rule effective within 30 days. The lawsuit states that delays of the effective date of the rule are causing harm to those who filed the lawsuit and, in turn, are causing harm to vulnerable patients.
“As prescription drug prices continue to skyrocket, the 340B program is as crucial as ever in helping hospitals and health systems provide access to healthcare services for vulnerable patients and communities,” said Rick Pollack, president and CEO of AHA,
The final rule was the first of a few for the 340B program in the past year. Months after HHS issued the final rule for the ceiling prices and penalties,
This July, CMS announced that it was
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