Court Decision on 340B “Patient Definition” Causing Reassessment of Policies – By Both Covered Entities and Manufacturers

The November 3 court decision regarding how a “patient” should be defined under 340B is continuing to reverberate through the 340B world. Some media reports are hailing it as a “major victory” for covered entities (CEs), and many CEs are re-examining their current policies to determine if/how they can safely fill more prescriptions with 340B drugs. On the other hand, manufacturers are reportedly very concerned about the decision, pointing to a recent study suggesting that it will cause the program to expand by 50 to 100 percent. It is expected that many manufacturers will respond by further tightening restrictions on the program (e.g., contract pharmacy restrictions) and increase their efforts to convince Congress to address the program. These slides will help explain the decision and its impacts on Community Health Centers. If your health center intends to review your 340B patient definition considering the ruling, this template policy and procedure will help you address what types of services qualify an individual as a patient and how recently an individual must be seen at the health center to retain their “patient” status.