CHA News Article

Final Rule Issued on 340B Drug Ceiling Prices, Manufacturer Penalties
Enforcement to begin April 1

The Health Resources and Services Administration has released its final rule addressing drug ceiling prices and civil monetary penalties for manufacturers in the 340B Drug Pricing program. Required by the Affordable Care Act, the rule amends Section 340B of the Public Health Service Act to impose monetary sanctions on drug manufacturers who intentionally charge a 340B hospital or covered entity more than the ceiling price established under the procedures of the 340B program. It also establishes a new drug pricing policy when sufficient information to establish a 340B ceiling price for a new drug is not yet available, requires manufacturers to refund 340B covered entities within 120 days if the manufacturer determines an overcharge occurred, and requires greater transparency in calculating the 340B ceiling drug prices to ensure that drug manufacturers are not overcharging 340B covered entities.

HRSA plans to begin enforcing the final rule on April 1, and to issue further guidance on the 340B ceiling price reporting system and how 340B covered entities can access ceiling price information.

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