HIV and Hepatitis Policy Institute et al. v. U.S. Department of Health and Human Services et al.

Docket No.
Appellate Court
D.C. Circuit


  • Invalidate all or part of a federal regulation
  • Stop the government from enforcing the statute or regulation

Litigation Content

Why this Matters: 

The plaintiffs allege that a federal regulation allowing insurers and pharmacy benefit managers to not apply financial support from a drug manufacturer towards a patient’s deductible or annual out-of-pocket maximum violates the Affordable Care Act and Administrative Procedure Act. Coupons and other discount programs for branded drugs can help consumers with chronic conditions reduce their out-of-pocket costs at the pharmacy counter. But there are concerns that such measures encourage patients to use more expensive medications over less costly treatments, and also contribute to higher drug and health care spending and thus higher premiums.

Potential Impact: 

Policies related to copay accumulator programs can promote the use of more expensive branded prescription drugs, which may contribute to higher drug spending and higher premiums for all consumers.