Lawyers at Locke Lord have advised retail, mail service, internet, infusion, specialty, and institutional pharmacies with respect to licensure, change of control requirements, FDA and DEA regulations and compliance, Medicare and Medicaid supplier numbers and reimbursement, and other compliance matters, and have negotiated contractual arrangements involving pharmacies. We also regularly advise pharmacy clients regarding HIPAA obligations, security breaches, diversion or theft of controlled substances, e-prescribing, internet prescribing, fraud and abuse analyses, Medicare Part D, and 340b matters.
Locke Lord lawyers also provide operational, regulatory and transactional support to pharmacy benefit management companies and other organizations that provide various pharmacy benefit administration services or support (collectively, PBMs). Our lawyers have represented PBMs since their emergence in the early 1990s and have provided legal and strategic guidance with respect to the development of PBM contracts with pharmaceutical companies, pharmacies and their clients, including prepaid health plans, indemnity health insurers, workers' compensation insurers, third party administrators, Taft-Hartley trusts and other self-funded clients. Our lawyers also counsel PBMs with respect to compliance with Medicare Part D, fraud and abuse laws, HIPAA, licensure or exemptions from licensure (e.g., TPA licensure, utilization review licensure, licensure or certification under emerging state PBM disclosure laws and third party prescription drug reimbursement programs).
Our lawyers structure, negotiate and close mergers and acquisitions, strategic alliances and commercial transactions involving our pharmacy clients and our PBM clients.
Our representative projects include:
- Represented national PBM in the acquisition of a regional PBM.
- Represented purchaser in the acquisition of an e-prescribing business in an asset purchase transaction.
- Represented pharmacy industry entrepreneur in the development, structure and financing of a hybrid business model that offers pharmacy benefit administration and drug utilization in a group purchasing organization (GPO) model; and developed the business' standard operating contracts for use with its customers and drug company vendors.
- Represented PBM in the development of various standard operating contracts necessary to support the PBM's clients that were seeking authorization to participate in the Part D, Medicare Prescription Drug Program.
- Represented PBM in competitive bid protest against County government.
- Represented national trade association of workers' compensation PBMs in the development of a 50-state online database of regulatory requirements applicable to workers' compensation.
- Represented infusion pharmacy in all start up and operating matters including licensure, Medicare reimbursement matters, physician contracts and relationships, fraud and abuse analysis, and negotiations with pharmaceutical companies on contracting and dispute matters.
- Represented a regional pharmacy in a compliance audit and identification of potential overpayments.
- Represented a statewide pharmacy specializing in HIV/AIDS drugs with 340b contract pharmacy matters, Ryan White Act Part B issues, Medicare Part D compliance, fraud and abuse, and responding to state RFPs for pharmacy services relating to the treatment of HIV/AIDS patients.
- Represented a private equity fund in its investment in a regional pharmacy and subsequent change of ownership, licensure, and Medicare regulatory matters.
- Represented a pharmacy in negotiating and drafting contract relationships with skilled nursing facilities, assisted living facilities and hospitals in compliance with fraud and abuse laws.
- Represented a physician group in establishing and licensing a pharmacy and advising on related regulatory matters including the Stark Law and Anti-Kickback Act.
- Represented a large physician group in the sale of its internal pharmacy to a third party.
- Represented pharmacies and pharmacists before the Texas Board of Pharmacy.
- Assisted pharmacy with DEA regulatory requirements associated with closure of pharmacy location, transfer of controlled substances, termination of DEA number, change of ownership of DEA numbers, and related DEA enforcement and regulatory matters.
- Represented a pharmacy in analysis, reporting and notification obligations arising from the theft and diversion of controlled substances.
- Advised pharmacies on FDA regulatory compliance matters.