This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and change its effective date and implementation date from July 1, 2019, to January 1, 2019. Comments on the Proposed Rule are due no later than November 23, 2018, or 21 days after publication in the Federal Register, which is scheduled for November 2, 2018. HRSA stated that the Department of Health and Human Services (HHS) has determined that making the CMP Final Rule effective would not interfere with its development of “comprehensive policies to address the rising costs of prescription drugs... in government programs, such as Medicare Parts B & D, Medicaid, and the 340B Program,” and that HHS therefore no longer believes that delaying the effective date is necessary.
Please see full publication below for more information.