On June 17, 2015, the Health Resources and Services Administration (HRSA) published a Proposed Rule revising regulations governing the 340B Drug Pricing Program (340B Program) found in 42 C.F.R. Part 10. The Proposed Rule applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. Notably, it sets forth the calculation of the ceiling price and application of civil monetary penalties. The Proposed Rule does not address concerns that have been expressed by manufacturers about the recent expansion of entities able to be covered entities and the expansion of pharmacy outlets serving those patients. These revisions may indicate HRSA’s interest in more stringent compliance by manufacturers of drugs that are eligible for 340B Program pricing. Comments to the Proposed Rule are due August 17, 2015.


The Proposed Rule provides that a manufacturer must calculate the ceiling price for all of its covered outpatient drugs on a quarterly basis. The ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure and will be calculated using six decimal places. The number is then multiplied by the drug’s package size and case package.


To address the situation where the URA equals the AMP, resulting in a $0.00 per unit of measure 340B ceiling price, HRSA proposes that a manufacturer charge $0.01 per unit of measure for a drug with a ceiling price below $0.01. For those 340B drugs whose calculated price is less than $0.01, the effective ceiling price will be $0.01 per unit of measure. Prices for 340B products must be based on the immediately preceding calendar quarter pricing data.Continue Reading HRSA Proposes Rule on 340B Ceiling Pricing, Removes Orphan Drug Regulations and Sets Forth Civil Monetary Penalties