Pharmacy and Pharmacy Benefit Management
Kutak Rock’s national healthcare attorneys have significant experience in representing pharmacies, pharmacists, drug wholesalers and other entities involved in the drug delivery system.
Our lawyers regularly represent a pharmacies (including wholesale, retail, long-term care, mail order, specialty, and veterinary pharmacies) in transactional and regulatory matters from licensing, product acquisition and drug pedigree to proper procedures for customer dispensing and counseling. We have assisted our clients with the negotiation of product purchase agreements and wholesale/manufacturer relationships, developed promotional, distribution and pricing strategies, and advised on reimbursement matters and participating provider contracts, including Medicare and Medicaid and medical discount cards. Kutak Rock’s attorneys provide guidance to providers participating in the 340B Drug Pricing Program and other entities and vendors involved in the 340B Drug Pricing Program.
Our national healthcare lawyers are well versed on emerging pharmacy law matters such as internet pharmacies and e-commerce issues, including NABP VIPPS and VAWD accreditation, and tele-pharmacy.
Kutak Rock’s healthcare attorneys have helped pharmacy clients resolve regulatory, reimbursement, or litigation-related matters at both the state and federal levels. Our attorneys have handled matters involving numerous state boards of pharmacy, CMS, the FDA, the DEA, the OIG and Department of Justice. Our extensive, front-line experience with these serious, regulatory and enforcement matters enables our healthcare attorneys to also deal effectively and efficiently with responding to less formal and less serious compliance matters such as audits, licensing, accreditation and inspection compliance and investigative demands.
Our lawyers also represent pharmacy benefit mangers (PBMs) and other organizations that provide various pharmacy benefit administration services or support. We counsel PBMs with respect to a variety of regulatory matters, including compliance with Medicare Part D, fraud and abuse laws, HIPAA, licensure or exemptions from licensure. Further, Kutak Rock’s has experience and expertise in drafting and negotiating PBM contracts.