Final Rule Implements HRSA 340B Regulations Jan. 1

Posted on November 28, 2018

Note: This article was updated Nov. 29, following the release of the final 340B rule.

In response to comments received regarding the 340B drug discount program ceiling price and manufacturer civil monetary penalties, the Health Resources and Services Administration (HRSA) released a final rule to implement the Jan. 1, 2019, effective date of long-delayed 340B program regulations, as requested by the MHA, the American Hospital Association, and others.

The implementation of the final regulation had previously been delayed five times since its initial January 2017 release, which in some cases resulted in 340B-eligible healthcare providers being overcharged for some prescription drugs purchased under this program. Prompt implementation of this rule is important for the approximately 75 Michigan hospitals that participate in the program and the low-income patients they serve.

On. Nov. 21, the MHA submitted comments to the HRSA regarding the proposed Jan. 1, 2019, implementation date. The MHA also encouraged the HRSA to ensure that the rule’s policy changes remain substantially unchanged and to release pricing information as soon as possible after the effective date via a secure web-based portal that 340B hospitals and other participating providers can access. Members with questions should contact Vickie Kunz at the MHA. 

Tags: 340B Drug Pricing Program, prescription drugs, HRSA, 340B

Posted in: Issues in Healthcare, Member News

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