The one-cent figure in HRSA's January 5, 2017 drug-pricing rule is an exception within a formula. Manufacturers calculate a ceiling for each covered outpatient drug by National Drug Code, quarterly. The final text uses the preceding quarter's average manufacturer price for the smallest unit of measure, minus the unit rebate amount. If the result is below $0.01, the ceiling becomes $0.01. [2016-31935]
This is the maximum program price for sales to eligible 340B covered entities, not a national retail price list. The rule defines a covered entity through statutory eligibility, program requirements and registration in the 340B database. A patient's pharmacy charge is therefore a different question from whether a manufacturer's sale complies with this ceiling. [2016-31935]
The June 2015 proposal helps distinguish a calculation input from a replacement price. It rejected using the previous quarter's price or a non-340B contract price instead of penny pricing. That did not reject using preceding-quarter data to calculate the ceiling. The earlier proposal and the final provision belong to the same HRSA rulemaking; they show how the exception was designed, not independent evidence of its effects. [2016-31935][2015-14648]
The publication also separates two dates. March 6, 2017 was the original effective date; HRSA said it planned to begin enforcement with the April 1 quarter. Neither date makes publication-day purchases subject to newly begun enforcement. This historical account describes the schedule as issued, without treating later implementation or patient savings as established by the rule itself. [2016-31935]
Source documents
- 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulationhttps://www.govinfo.gov/content/pkg/FR-2017-01-05/html/2016-31935.htm
- 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulationhttps://www.govinfo.gov/content/pkg/FR-2015-06-17/html/2015-14648.htm