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Uncertainty Becomes the Norm…for 340B Rulemaking, at Least

On August 21, 2017, the Health Resources and Services Administration (HRSA) published a proposed rule (the Proposed Rule) that would entertain even further delays of 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). Comments on the Proposed Rule are due on September 20, 2017

Arent Fox’s Health Care Counsel blog has analyzed the provisions of the Final Rule, and has also been tracking the delay in its implementation over the past several months. Currently, the Final Rule is scheduled to be effective October 1, 2017. Pursuant to the Proposed Rule, HRSA is considering delaying effectiveness until July 1, 2018.  

In the most recent Proposed Rule, HRSA cites several reasons for approving a further delay, signaling at least to some that substantive changes could be in the works. The Proposed Rule clearly states that further delay may be necessary because the Department of Health and Human Services (HHS) “continues to examine important substantive issues in matters covered by the [Final] [R]ule” and that “HHS intends to engage in additional rulemaking on these issues.” In addition, HRSA states that delay may be necessary in order to comply with the Executive Order titled “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal” – which encourages the delay of certain mandates from the ACA, assuming that the Obama Administration health care bill, upon which many of the provisions of the Final Rule were based, will be repealed at some point.

Arent Fox LLP’s Pharmaceutical & Device Compliance 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 or Erin Atkins in our Washington, DC office, Thomas Jeffry in our Los Angeles office, or the Arent Fox professional who regularly handles your matters.