Tag Archives: HRSA

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B covered entities for covered outpatient drugs more than the statutory ceiling price. The regulation addresses the ceiling price calculation for drugs purchased … Continue reading this entry

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. As proposed, the ADR process would be available for covered entities to submit claims that they have … Continue reading this entry

Mid-Year 340B Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program.  Providers participating in the … Continue reading this entry