Pharmacy and Reimbursement

“The team has an outstanding ability to break down complex matters and their attention to detail is greatly appreciated. They provide a depth of knowledge.”

— Chambers USA 2022

BakerHostetler’s Pharmacy and Reimbursement team is set apart by our in-depth knowledge and real-world experience of the pharmacy industry.

As one of the few legal teams across the country to have multiple attorneys who are also registered pharmacists or healthcare practitioners, we bring real-world experience with our ability to help resolve legal, practical, and compliance-related issues. We have long-standing experience in advising retail, mail-order, specialty, compounding, and institutional pharmacies, as well as in working with pharmacy benefit managers (PBMs), managed care/insurance entities, academic medical centers, and wholesale distributors.

Represented a compounding pharmacy during a recall of compounded medications following an FDA and State Board of Pharmacy inspection.
Assisted pharmacies and PBMs with OIG self-disclosures.
Represented two pharmaceutical wholesalers in one of the largest antitrust class actions in U.S. history involving prescription drug pricing claims.
Advised a private equity fund with a high-value and multifaceted sale of a large specialty pharmacy company – representation included regulatory filings for almost 300 pharmacy licenses, permits, and Medicare and Medicaid applications involving significant coordination among agencies.
Represented a pharmacy during a DEA investigation into the loss of a Schedule II substance, which resulted in no charges being filed.
Assisted in the registration of several entities with the FDA as 503B outsourcing facilities and with developing standard operating procedures on cGMP compliance.
Advised a PBM in an acquisition of another PBM company. We served as the lead healthcare and FDA regulatory counsel for the transaction in matters involving FDA, CMS, and state pharmacy boards. During our representation, we drafted several disclosures to CMS and FDA involving the acquired company related to their employment of an excluded/debarred individual.
Served as healthcare regulatory counsel in connection with a complex and high-stakes sale of a national full-service PBM company. Our representation involved all aspects of the sale, including a corporate reorganization and numerous regulatory filings that required significant interaction with healthcare regulatory agencies throughout the process.