In a court filing in the lawsuit regarding the 340B Rebate Pilot Program, the U.S. Department of Health and Human Services (HHS) stated that it will drop the current version of the rebate pilot and potentially restart a fresh rulemaking.
Following the recent court injunction against the pilot program, there was speculation that HHS would simply re-promulgate the same 340B rebate pilot proposal. Instead, if HHS opts to restart the rulemaking, it will undergo a new notice-and-comment period and include an effective date no less than 90 days after the approval of manufacturer participation applications. In a recent letter to the Health Resources and Services Administration (HRSA), ASHP requested HRSA abandon the pilot program and instead focus on ensuring that 340B prices remain available as an up-front discount.
“We thank HHS for recognizing that the proposed 340B rebate pilot was unworkable and a threat to program integrity,” said Tom Kraus, ASHP vice president of government relations. “Rebates in both the 340B program and the Inflation Reduction Act negotiated pricing program improperly shift costs from manufacturers to providers, effectively raising the costs of medications in direct opposition to congressional intent.Providers should not shoulder increased costs for programs intended to require manufacturer discounts.”
ASHP will continue to update members regarding the 340B program. Concerns or questions regardingthe 340B program should be sent to Jillanne Schulte Wall, senior director of health and regulatory policy.
