HRSA Seeks Comments on Development of ACA 340B Drug Pricing Program Enforcement Rules
On September 20, 2010, the Health Resources and Services Administration (HRSA) is publishing two advance notices of proposed rulemaking and request for comments regarding the 340B drug pricing program as the agency seeks to implement certain Affordable Care Act (ACA) provisions. Under the 340B program, manufacturers who sell covered outpatient drugs to particular covered entities listed in the statute must agree to charge a price that will not exceed the amount determined under a statutory formula. The first notice seeks input as the HHS Secretary develops regulations to establish and implement an administrative dispute resolution process for the 340B program. Areas for which HRSA is expressly seeking comment include: (1) Administrative Procedures; (2) Existing Models; (3) Threshold Requirements; (4) Hearings; (5) Decisionmaking Official or Body; (6) Appropriate Appeals Procedures; (7) Deadlines; (8) Discovery Procedures; (9) Manufacturer Audits; (10) Consolidation of Manufacturer Claims; (11) Covered Entity Consolidation of Claims; (12) Claims by Organizations Representing Covered Entities; and (13) Integration of Dispute Resolutions with Other Provisions in the ACA. The second notice establishing standards for the imposition of sanctions in the form of civil monetary penalties (CMPs) for manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug. Areas for which HRSA is expressly seeking comment include: (1) Existing Models; (2) Threshold Determination; (3) Administrative Process Elements; (4) Hearing; (5) Appeals Process; (6) Definitions; (7) Penalty Computation; (8) Payment of Penalty; and (9) Integration of CMPs with Other Provisions in the ACA. Comments on both notices will be accepted until November 19, 2010.
