Association Files Amicus Brief Defending 340B Patient Definition

America's Essential Hospitals on July 14 joined a group of hospital associations and health care providers defending the 340B Drug Pricing Program from a lawsuit filed by pharmaceutical manufacturer AbbVie seeking to change the definition of a patient within 340B.

In an April lawsuit, AbbVie alleges the Health Resources and Service Administration's (HRSA's) longstanding definition of a patient is "outdated, overly expansive and erroneous." AbbVie further argues the definition denies manufacturers their right to audit providers and enables "widespread 340B program abuse." AbbVie is suing after HRSA rejected the manufacturer's attempt to conduct audits using their own proprietary and restrictive definition of a patient.

AbbVie seeks to replace the 1996 patient definition with a far more restrictive version. The manufacturer proposes that a prescription can only qualify for a 340B discount if the medication was prescribed because of an appointment at a 340B facility, the patient received medical care at the facility, and the prescriber is managing the patient's care, which was provided in the last 12 months.

The brief, also signed by the American Hospital Association, the Children's Hospital Association, the Association of American Medical Colleges, and the American Society of Health System Pharmacists, notes several problems with "AbbVie's attempt to rewrite the rules of the 340B program." Specifically, the brief highlights that the lawsuit lacks legal standing and AbbVie's preferred definition would deprive 340B participants of due process rights, while emphasizing harms to 340B providers and patients.

Contact Director of Policy Rob Nelb, MPH, at [email protected] or 202.585.0127 with questions.