Pharmacy/PBM
Powers Pyles Sutter & Verville has decades of experience representing pharmacies on a myriad of legal, regulatory and compliance issues, both federal and state.
Powers attorneys advise major chain pharmacies, independent pharmacies, mail order pharmacies, durable medical equipment, prosthetics/orthotics and supplies (DMEPOS) providers, specialty pharmacies and pharmacies owned and operated by health systems, hospitals and clinics.
Powers attorneys have assisted pharmacy clients with a wide range of issues, including structuring in-house pharmacy arrangements; providing guidance on Medicare Part B and Medicaid enrollment, coverage, rules for participation, and competitive bidding; negotiating and reviewing contract pharmacy relationships, including 340B program contract pharmacy arrangements; complying with DEA registration requirements and related standards, including those applicable to electronic prescribing of controlled substances; drafting contracts, including data sharing and privacy agreements, and providing general transactional support; negotiating contracts with private payers, PBMs, and PSAOs; counseling on state law regulation and licensing; facilitating compliance with track-and-trace requirements; developing and evaluating charitable assistance programs; and observing state and federal regulation of 503B outsourcing facilities. We have also worked closely with clients on pharmacy-related matters involving the Medicare Part D program including, for example, PBM and Part D plan contracting issues, cost sharing waivers, claims submission (as well as PDE reporting), rebate/discount reporting and administrative issues such as marketing.
Powers is especially active in helping pharmacies address coverage, billing and reimbursement issues. We have substantial experience advising pharmacies with respect to the Medicare Part B and Part D programs, as well as Medicaid fee-for-service and Medicaid managed care. Our attorneys have also navigated the requirements for pharmacy participation in the Federal Employees Health Benefit Program (FEHBP), TRICARE, and other federal health care programs, including those administered by the VA and the DOD. Powers’ drug pricing and pharmacy practices intersect in numerous areas, which means Powers regularly advises clients on pharmacy-related 340B issues, including the unique billing and reimbursement requirements applicable to 340B pharmacies.
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