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PBMs & Pharmacies

Strategic Guidance Since the Start of the Industry and Through its Evolution

​Operating as a pharmacy benefit manager (PBM) or pharmacy amidst the complex web of state and federal laws and regulations poses countless challenges. Mintz’s attorneys have a unique depth and scope of experience in the industry and have advised participants throughout its evolution, including the implementation of the Part D program. Our understanding of the legal and policy complexities enables us to provide insightful and strategic counsel to PBMs and pharmacies on all aspects of their operations.

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Our Experience

Case Study
Mintz has advised a discount medical and pharmacy service company since its 2014 inception. Mintz attorney counsel the company on contractual arrangements, acquisitions, strategic initiatives, and all aspects of federal and state regulatory requirements.
Thousands

Agreements negotiated and drafted for PBMs, pharmacies, payors, suppliers, and manufacturers over the last 16 years

Case Study
Mintz represented a national pharmacy benefit management (PBM) provider in the drafting and negotiating of a $4 billion, 10-year PBM services agreement with a national health insurer. Mintz provided transactional and regulatory counsel and state, federal, and Medicare Part D compliance advice.

Our Approach

​Mintz’s interdisciplinary team has advised PBMs since the birth of the industry. We also represent a wide range of pharmacy clients, including retail, specialty, compounding, long-term care, as well as others serving the pharmacy industry. We counsel all of these entities on the full range of regulatory, operational, and transactional matters impacting their business. We also assist these entities, and those investing in them, by providing strategic advice and insight into industry trends and developments.

Contracting & Regulatory Compliance
  • Structure relationships and negotiate arrangements with entities throughout the supply chain
  • Structure, draft, and negotiate rebate, drug purchasing, and limited distribution agreements
  • Assist with Medicare Part D compliance, including payor contracting, and fraud and abuse compliance
  • Provide state and federal regulatory assistance, including state licensing requirements
  • Structure service arrangements with managed care organizations and with co-payment card, coupon, patient assistance, and rewards programs
  • Navigate outcomes and value-based drug purchasing arrangements
​Mergers, Acquisitions & Investments
  • Provide strategic counsel to pharmacies, PBMs, private equity firms, and others looking to invest in the industry.
  • Assist PBMs and pharmacies interested in mergers, acquisitions, and collaborations among industry players
  • Provide bid evaluation, due diligence, and purchase and investment agreement review
  • Assist with the assessment of legal, regulatory, and policy risks
  • Advise on complex licensure issues, including change of ownership requirements
Government Enforcement
  • Defend PBMs and pharmacies in federal and state administrative, criminal, and civil matters
  • Advise on reporting, refund, and self-disclosure requirements and protocols
  • Provide representation in all stages of state and federal enforcement actions, including defense of qui tam cases litigated by whistleblowers after government declination
  • Conduct internal investigations
  • Assist in conducting comprehensive compliance program internal reviews and audits to proactively identify compliance issues and ensure adherence to company policies
Federal & State Compliance Issues
  • Federal and state wholesale distributor requirements
  • Any state willing provider requirements
  • State MAC disclosure and transparency laws
  • State PBM, TPA, and UR licensure requirements
  • DEA and state controlled substances requirements
  • HIPAA and state patient privacy requirements
  • Drug Supply Chain Security Act compliance
  • FDA regulatory requirements

What Our Clients Are Saying

Meet Mintz

​Our team provides insightful and strategic counsel to PBMs and pharmacies on all aspects of their operations.