USA's HRSA initiates rulemaking to implement health reform changes to the 340B Drug Pricing Program

The US Health Resources and Services Administration (HRSA) has issued two Advanced Notices of Proposed Rulemaking and Requests for Comment announcing its preliminary plans, and requesting stakeholder input, on how best to implement new authorities over the 340B Drug Pricing Program conferred by section 7102(a) of the Patient Protection and Affordable Care Act (PPACA), reports US law firm Hyman, Phelps & McNamara.

Among other mandates relating to the 340B Program, PPACA Section 7102 requires the Department of Health and Human Service (HHS) to adopt regulations establishing the standards and procedures for imposing civil monetary penalties on manufacturers that “knowingly and intentionally” overcharge covered entities for 340B Program drugs, as well as regulations prescribing the procedures for resolution of claims by covered entities that they have been overcharged, and claims by manufacturers that covered entities have violated the prohibition on duplicate discounts or rebates, and resale of 340B Program drugs, the law firm notes on its FD Law Blog. The two recent Notices focus on these mandates.

In the Notice concerning “Manufacturer Civil Monetary Penalties,” the HRSA says it is reviewing the civil monetary (CMP) authorities currently used by other federal agencies such as the Office of Inspector General (OIG) of the Department of Health and Human Services, the Federal Aviation Administration, Treasury, the Food and Drug Administration and the Centers for Medicare & Medicaid Services to determine which parts of those procedures could be adapted for the 340B Program.