Attorneys at Locke Lord LLP 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 attorneys 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 attorneys 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 attorneys 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 attorneys structure, negotiate and close mergers and acquisitions, strategic alliances and commercial transactions involving our pharmacy clients and our PBM clients.
Our representative projects include:
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