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 health care 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 health 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 health regulators to resolve new issues and settle disputes. Our regulatory expertise is crucial to structuring successful health care provider transactions, financings and other arrangements; and our knowledge base and understanding of technical health 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 health care fraud counsel in numerous delicate compliance matters, and have negotiated favorable settlements.
We have a particular expertise in CMS-based health care regulation, including health care 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 draw from our deep health care service provider and FDA product expertise to 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 on-going 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 health care payer, and structuring compliant promotional and distribution arrangements.