CHA News Article

HRSA Proposes Delay of 340B Program Ceiling Prices, CMPs
Also releases update on new information, registration system

The Health Resources and Services Administration (HRSA) last week released a proposed rule that would delay the effective date of its final rule addressing ceiling prices and civil monetary penalties in the 340B Drug Pricing Program. The final rule, which was scheduled to take effect Oct. 1, may now be delayed until July 1, 2018. As previously reported in CHA News, the final rule had been delayed on multiple occasions to allow time to more fully consider the substantial questions of fact, law and policy raised by the rule. HRSA also believes additional time is needed to more fully consider previous objections about the timing of the effective date and challenges associated with complying with the rule.

HRSA also announced last week that the current 340B database is offline as of Aug. 15, and 340B covered entities are currently unable to submit change requests or terminations. HRSA expects the registration component of its new 340B Office of Pharmacy Affairs Information System to be available in mid-September, with the new pricing system released at a later date. HRSA plans to provide more information and updates on its website.