340B Proposed Rule on Ceiling Prices, Penalties Clears White House Review

June 9, 2015

Michelle Stein, of Inside Health Policy, reported that a rule of the Affordable Care Act (ACA) requiring the Health Resources and Services Administration (HRSA) to "impose sanctions ... on drug manufacturers that intentionally charge a covered entity more than the program's ceiling price" has cleared the White House Office of Management and Budget. 'OMB's website describes the proposal rule as follows: "This proposed rule is required under the Affordable Care Act. It would amend section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340B Program.'"