Pharmacy

We help pharmacy clients conduct complex commercial transactions, M&A, resolve investigations, audits and disputes and navigate government regulation so that they can grow and prosper. Whether you are seeking capital, acquiring or selling, restructuring your business, resolving regulatory matters, dealing with workforce issues, trimming your tax burden or settling a dispute, chances are a Goodwin lawyer has already handled a case or transaction like yours.

Our clients include a wide range of retail, specialty compounding and long-term care pharmacies, as well as pharmacy group purchasing organizations and co-ops, pharmacy networks and other industry entities.

Transactions

We assist with mergers and acquisitions, joint ventures and partnering arrangements, restructurings and reorganizations, dispositions and carve-outs, and venture capital and other transactions. We also advise clients on a wide range of agreements with vendors, suppliers, payors, PBMs, PDPs, wholesalers and customers. We are experienced in advising pharmacy clients on the regulatory compliance issues attendant to transactions, including fraud and abuse issues, safe harbor regulations, and regulatory issues impacting relationships with other participants in the medical supply chain.

Regulatory and Compliance

We handle regulatory issues affecting commercial healthcare transactions, as well as those involving members in the medical and pharmaceutical supply chains, including pharmaceutical manufacturers and suppliers, wholesalers, skilled nursing facilities, assisted living facilities, physicians, GPOs, outsourcing companies and other providers and suppliers. Our regulatory experience includes issues under state licensure, DEA, fraud and abuse laws, (including the federal Anti-Kickback Statute and safe harbors), Stark, civil monetary penalties law, the False Claims Act, healthcare fraud statutes and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

We also assist retail, specialty and long-term care pharmacies, and other healthcare entities in dealing with billing, reimbursement and claims issues, including issues under Medicare Parts A, B and D, Medicaid and commercial payor requirements. We advise pharmacy clients about their membership in or relations with group purchasing organizations, co-ops and pharmacy networks, including advice about compliance with the federal Anti-Kickback Statute, and how to take advantage of the “safe harbors” that may be available. We also advise on the federal and state law regulatory issues affecting the practice of pharmacy, including the practices of pharmacy benefits managers (PBMs) related to potential risk areas, including relationships with formulary committee members, payments to PBMs, and formulary.

Real Estate

We have significant experience in representing developers and property owners in the acquisition, financing and development of retail pharmacy properties. Our experience includes all aspects of site acquisition, including title, purchase agreements, joint development agreements, reciprocal easement agreements, access agreements, all types of municipal agreements, and developer agreements with municipalities for the site and access to sewer and water.

Retail Health Clinics

Retail health clinics are increasingly popular with consumers. We help clients interested in sponsoring or operating such clinics to navigate the financial, legal and marketplace issues for involvement in convenient care, and help forge alliances and agreements between the clinics and hospitals, physicians, and other healthcare entities. We help physicians who partner with retail care centers as a means of providing a collaboration and referral system for patients who use the clinics, and assist the centers in responding to and complying with increasing calls from physician associations and medical standards groups for increased regulation of this growing industry.

State Board of Pharmacy Inspections and Audits

All pharmacies are subject to compliance inspections and audits by state boards of pharmacy. We help pharmacy clients adopt policies and procedures to be best prepared for inspections, and defend against disciplinary actions resulting from inspection and audit findings. Our experience includes advising national and multi-state pharmacies on compliance with state board of pharmacy licensing requirements, inspections, and audits across the United States.

Litigation and Enforcement

From commercial disputes to consumer class actions and employment litigation, we have pharmacy clients covered when it comes to resolving litigation. We also defend pharmacy clients in investigations, audits and enforcement actions by federal and state regulators.