On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil monetary penalties (Final Rule).  Enforcement on the Final Rule is delayed to July 1, 2019. 

The 340B Program permits eligible covered entities who are “safety net” providers (such as Federally Qualified Health Centers, Disproportionate Share Hospitals, Critical Access Hospitals, Children’s Hospitals and others) to purchase at a significant discount:

  • outpatient prescription drugs,
  • over-the-counter drugs that are accompanied by a prescription, and
  • clinic-administered drugs.

There are certain exceptions to what is covered, including vaccines.

The Final Rule contains provisions designed to prevent drug manufacturers from overcharging for 340B drugs. According to HRSA, the reason for the delay is to provide regulated entities more time to implement the requirements and to provide time for HRSA to consider alternative provisions, develop new comprehensive policies to address the rising costs of prescription drugs, and process additional rulemaking as needed. Covered entities have expressed disappointment in the repeated delays of the cost-limiting measures and enforcement provisions in the Final Rule.