On August 21, the Health Resources and Services Administration (HRSA), part of the U.S. Department of Health and Human Services, published a Proposed Rule that would further delay the effectiveness of a final rule on calculation of drug price ceilings and the imposition of civil monetary penalties for manufacturers that knowingly and intentionally overcharge covered entities under the 340B Drug Pricing Program. Comments on the Proposed Rule are due by September 20.

Implementation of the final rule, originally released in January and previously discussed here, had already been postponed three times this year, most recently until October 1, 2017. Under the Proposed Rule, it would be further delayed until July 1, 2018, while HRSA “continues to examine important substantive issues” covered under the final rule.