Nelson Mullins partner Brooks Andrews wrote an article for the December 2025 of The Health Lawyer, published by the American Bar Association’s Health Law Section, discussing why pharmacies and pharmacy benefit managers (PBMs) have become primary targets in the Department of Justice's renewed False Claims Act (FCA) enforcement strategy. 

Regulatory agencies increasingly view pharmacies and PBMs as influential gatekeepers rather than functionary players in healthcare. In 2025, this shift has materialized through major enforcement actions: a $350 million Walgreens settlement for illegally filling opioid prescriptions, a $290 million judgment against CVS Caremark for inflated Medicare Part D pricing, and even an $825,000 settlement with a single-location Pennsylvania pharmacy for billing undispensed drugs. 

"As PBMs have grown in both size and influence, they have attracted scrutiny from regulators, Congressional investigators, and consumer groups for their pricing and reimbursement practices. At the same time, regulators have also started to pay more attention to the dispensing practices of pharmacies, which some view to have contributed to the opioid epidemic," Andrews noted. "In recent years, the size, pricing power, and ability of PBMs and pharmacies to control public access to drugs has led regulatory agencies, including the United States Department of Justice (DOJ), to view them less as functionary players in the health care ecosystem and more as influential gatekeepers.”

Andrews shared how PBMs face accusations of padding drug prices submitted to Medicare and Medicaid, while pharmacies confront scrutiny over opioid dispensing and algorithmic prescription screening. The Caremark case demonstrated how spread pricing practices can result in massive liability, while the Walgreens matter showed how CSA violations become the basis for false claims.

"With new and likely enhanced regulatory scrutiny, PBMs should prioritize internal controls around data reporting," he wrote. "This includes creating clear audit trails for all pricing submissions, ensuring that prices are accurately captured, and documenting how benchmark data is derived. Independent review of pricing methodologies can help demonstrate good-faith compliance. Just as importantly, boards and senior executives should own data governance, assigning clear accountability (e.g., through the audit/compliance committee), integrating data risk into enterprise risk management, and receiving regular, metrics-driven reporting."

Subscribers may read the full article here.