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.

Awards

Chambers USA 2023

Health Law Practice recognized Nationally and in Boston and Washington, DC

Legal 500 United States

Practice recommended in Health Care: Life Sciences, Health Care: Service Providers

BTI Industry Power Rankings

Recognized as a “Leading Core Firm” in the health care industry

U.S. News and Best Lawyers®

Nationally ranked Tier 1 for Health Care

Modern Healthcare 2023

Modern Healthcare Top Healthcare Law Firms 2023 Data Dive by the numbers.

Our Experience

DMPO Seek Deep Knowledge of Pharma Industry

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 20 years

National PBM Reaches Service Agreement with Health Insurer

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
Assist in conducting comprehensive compliance program internal reviews and audits to proactively identify compliance issues and ensure adherence to company policies
Conduct internal investigations

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

“They are an extremely strong group of health care attorneys with a particular expertise in pharmacy benefit management, pharmaceuticals and pharmacy matters. The team is able to provide business smart legal advice and is always willing to go above and beyond.”