Hospitals Concerned with Delay of Pricing Enforcement Rule

March 17, 2017 in 340B in the News

March 17, 2017— The US Department of Health and Human Services announced today that it will delay the long-awaited 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalty rule until May 22, 2017 or perhaps longer.

By specifying how 340B ceiling prices should be calculated, the regulation would help ensure those prices are right. Under the new rule, a drug manufacturer that knowingly and intentionally overcharges a 340B hospital or other 340B provider can be fined up to $5,000 for each instance of overcharging. Manufacturers also will have to ensure that their distributors give providers the 340B ceiling price.

The following comment may be attributed to Ted Slafsky, President and Chief Executive Officer of 34OB Health:

“We are disappointed and concerned by the government’s decision to delay the effective date of the new 340B ceiling price and manufacturer civil monetary penalty rule. This much-needed regulation has been many years in the making and included two opportunities for the public to submit comments. It was mandated by Congress and is based on HHS Office of Inspector General reports that showed pharmaceutical manufacturers were routinely overcharging providers serving the poor. Correct 340B pricing and enforcement of manufacturers’ 340B obligations are vital for hospitals to be able to meet their missions to care for the underserved.”

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340B Health is an association of more than 1,300 hospitals. We are the leading advocate and resource for those providers who serve their communities through participation in the 340B drug pricing program. For more information about us and the 340B program, visit www.340bhealth.org.