We routinely work with a wide range of healthcare provider clients—including hospitals, skilled nursing facilities, physician groups, diagnostic centers, home health agencies, behavioral health providers, rehabilitation agencies, medical suppliers, and others, as well as the management, billing and other vendors that serve providers—on a variety of federal and state healthcare regulatory and compliance matters. We offer deep experience in the Medicare program coverage, reimbursement and certification requirements that define the service provider regulatory environment.

Our attorneys routinely advise providers and suppliers on federal and state healthcare regulatory matters, advocating for providers with the central and regional offices of the Centers for Medicare and Medicaid Services (CMS), fiscal intermediaries and carriers, state licensure and certification agencies, and other healthcare regulators to resolve new issues and settle disputes. Our regulatory background is crucial to structuring successful healthcare provider transactions, financings and other arrangements; our knowledgebase and understanding of technical healthcare regulatory matters often is pivotal in resolving litigation involving provider entities.

Through our deep and longstanding reimbursement and regulatory experience, we are well versed and qualified to counsel and defend against fraud and abuse risk. From kickbacks and rebates to false claims and civil monetary penalties, from potential criminal penalties to administrative sanctions, we regularly worked with U.S. attorneys, the Office of the Inspector General, and other enforcement authorities to resolve fraud allegations. We have served as special healthcare fraud counsel in numerous delicate compliance matters, and have negotiated favorable settlements.

We have particular knowledge of CMS-based healthcare regulation, including healthcare product and service coverage, coding, and reimbursement. We routinely work with complex technologies and appreciate the sophistication inherent in constructing a coverage, coding, and reimbursement strategy applicable to cutting-edge medical technologies. Our attorneys formulate targeted and practical regulatory advice to our product clients, streamlining the regulatory procedures and costs necessary to bring a product from concept to market.

A successful coding and reimbursement initiative facilitates the introduction of new technology to its intended sites of service. However, once public payers recognize coverage and reimbursement, professionals and facilities billing for covered items and services must maintain compliance with the payers’ technical coverage, reimbursement, and other billing rules and policies. We assist our clients in implementing post-coding policies and strategies to ensure successful ongoing commercialization of medial technology, such as providing advice regarding appropriate documentation of services, physician authorization of services, and proper claims filing with the fiscal intermediary, carrier, or other healthcare payer, and structuring compliant promotional and distribution arrangements.