HRSA Kicks the Can Down the Road (Again) on 340B Rules

The Health Resources and Services Administration (HRSA) published a notice in the Federal Register on May 7, 2018 (the Proposed Rule) proposing its intention to delay – for the fifth time – the implementation of a January 5, 2017 Final Rule (the Final Rule) regarding calculation of 340B ceiling prices and the imposition of civil monetary penalties on noncompliant organizations related to the 340B Drug Pricing Program (the 340B Program). A shortened notice and comment period means that comments on the Proposed Rule are due on or before May 22, 2018. 

Arent Fox’s Health Care Counsel blog has analyzed  the provisions of the Final Rule and has also been following the subsequent delay of its implementation. Currently, the Final Rule was slated to become effective on July 1, 2018; the Proposed Rule pushes the effective date another year, to July 1, 2019.

Although vague and lacking specifics, HRSA indicated that it “intends to engage in additional or alternative rulemaking” related to the 340B Program, which has certainly been under scrutiny in recent years for the value (or perceived lack thereof) that the Program provides to needy Federal health care beneficiaries. The timing of the Proposed Rule is also notable – proposals from the White House regarding how to address the rising costs of prescription drugs were supposed to be released this week, perhaps further signaling bigger changes coming to not only the 340B Program, but to the Medicare program and the practices of drug manufacturers as well.

Arent Fox’s Pharmaceuticals, Prescription Drugs & Medical Devices team regularly advises clients on commenting on proposed rules affecting the pharmaceutical industry, as well as on compliance with existing rules. If you have any questions or need assistance, please contact Stephanie Trunk in our Washington, DC office, Thomas Jeffry in our Los Angeles office, or the Arent Fox professional who regularly handles your matters.