HRSA issues proposed rule on 340B drug ceiling prices, manufacturer penalties

The Health Resources and Services Administration today released a proposed 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 would amend 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 proposed rule also would require greater transparency in calculating the 340B ceiling drug prices to ensure that drug manufacturers are not overcharging 340B covered entities. Section 340B of the Public Health Service Act requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients.