The Health Resources and Services Administration today released a final rule on 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 (not to exceed $5,000 per instance) 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. The final rule codifies current policy on “penny pricing” for ceiling price calculations resulting in a zero value. It also establishes new drug pricing policy when sufficient information to establish a 340B ceiling price for a new drug is not yet available and would require manufactures to refund 340B covered entities within 120 days if the manufacturer determines an overcharge occurred. The final rule also 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 requirements of 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 to establish instances of manufacturer overcharges.

Related News Articles

Headline
The Medicare Payment Advisory Commission Friday released its March report to Congress.
Perspective
As our country works to expand health coverage and improve access to care, “Medicare for All” is getting a lot of attention. There are many different flavors…
Headline
Legislative proposals for a Medicare public option could negatively affect patient access to care and significantly reduce payments to hospitals, AHA Executive…
Headline
Creating a government-run, Medicare-like option on the individual health insurance exchanges could negatively affect patient access to care and reduce hospital…
Headline
The House Energy and Commerce Health Subcommittee today held a hearing on the president’s fiscal year 2020 budget request for the Department of Health and…
Headline
President Trump today submitted to Congress his budget request for fiscal year 2020.