Patton Boggs’ Health Care Policy practice is widely recognized for leadership in this complex area, leveraging extensive knowledge of U.S. federal, state and local health care law and policy to counsel and defend clients on issues under congressional consideration, on federal administrative rulemaking processes and on federal or state investigations.
Our work encompasses legislative and regulatory advocacy, Medicare and Medicaid coverage and reimbursement, FDA regulation and enforcement, and fraud and abuse and False Claims Act litigation and counseling. We advise and represent clients on health care innovations and breakthrough technology, funding health care initiatives, privacy and HIPAA compliance, and health care finance transactions. The Patton Boggs team specializes in holistic strategies that integrate our legal, public policy and scientific expertise with the resources of a full-service firm; and we arrange our client service teams to meet the unique needs of each client’s representation.
We advise the full range of health care entities, large and small, public and private. We represent Fortune-500 corporations, major trade associations and national, state, and local governments and organizations, including insurers, employers, physicians and providers, hospitals, pharmaceutical companies, device manufacturers, biotechnology companies, not-for-profit organizations, and municipal interests before both the Congress and federal agencies. Our practice has a unique history of building and managing large coalitions in the health care sector. Our understanding of legislative and regulatory processes coupled with our ability to manage the coalition format has helped these clients achieve impressive victories time and again.
Legislative Advocacy and Regulatory Policy
Patton Boggs is nationally recognized for its sophistication on intricate regulatory issues and authorizing legislation, its strong ties to leading policymakers and its track record of success. Part of this reputation can be attributed to our long-standing working relationships with Members of Congress and senior staff on each of the House and Senate health-related committees as well as Congressional leadership.
These relationships often enable us to achieve clients’ desired changes to statutory and committee report language—and are particularly useful in preventing unintended or adverse consequences. Members of our team often participate in the development of legislation on issues of concern to our clients and are frequently consulted as a resource for policy analysis. In addition, we regularly interact with congressional support agencies such as the Congressional Budget Office (CBO), the Medicare Payment Advisory Commission (MedPAC), and the Medicaid and CHIP Payment and Access Commission (MACPAC).
Our team also encompasses a diverse regulatory practice. We develop and execute clients’ offensive and defensive regulatory strategies by engaging the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and the Department of Defense (DOD), among other federal agencies. Our close working relationships with key officials allow us to carefully follow regulatory developments, including implementation of legislation and development of agency rules and guidance.
Medicare and Medicaid Coverage and Reimbursement
A core focus of our practice involves helping clients navigate the overlapping statutes, regulations and agency directives governing Medicare and Medicaid coverage and reimbursement. We have a depth of historical knowledge about the Medicare and Medicaid programs and pride ourselves on our battle-tested familiarity with the range of possible approaches to success, as well as our creative responses to challenging problems facing our clients.
Through sophisticated counseling, analysis and advocacy, we help clients obtain coverage and adequate reimbursement for products and services under these programs. We work closely with our FDA team to anticipate and address potential coverage and payment challenges for new products in the pipeline for approval. Attorneys in Patton Boggs’ Litigation and Dispute Resolution Practice are also well-versed in Medicare and Medicaid payment-related litigation, regularly representing both individual and group clients before the Provider Reimbursement Review Board (PRRB) and in federal court.
Implementation of the ACA
Although many aspects of the Affordable Care Act (ACA) remain controversial, with debates still ongoing about its future, implementation of the law is proceeding at a rapid pace. Patton Boggs’ multidisciplinary team can help strategically position clients to navigate the new opportunities and challenges emerging from the implementation of health care reform. Using our team's broad-based expertise gained working in the private sector and with key government agencies, we help clients achieve their business goals.
Our experience includes assessing and shaping the requirements for private insurance and health care exchanges, evaluating Medicaid expansions, promoting innovations in program design in Medicare (including Accountable Care Organizations and bundled payments), and implementing programs for beneficiaries dually eligible for Medicare and Medicaid. We are well poised to address issues impacting employers, beneficiary groups, states, providers, health plans, drug and device manufacturers, investors and other health care stakeholders.
Food and Drug Administration (FDA)
Patton Boggs represents a diverse range of clients in all FDA-regulated areas, including prescription drugs, biologics, over-the-counter drugs, nutritional supplements and medical devices. We address a wide spectrum of matters for our clients, which range from large multi-national companies to trade associations and start-ups, including providing advice on effective strategies to obtain approval to market a new product, assisting in determining which regulatory pathway to follow, assessing regulatory and business risks associated with a particular strategy, responding to and defending enforcement matters, or counseling on public policy issues.
Our FDA team routinely interacts with our public policy, health, corporate and intellectual property colleagues to ensure multidisciplinary representation of our clients. By leveraging our multidisciplinary expertise, we are uniquely positioned to help growing companies navigate the entire range of FDA regulatory and related issues within the confines of a single firm. Due to the importance of CMS coverage decisions, we are particularly adept at advising clients of the value of initiating strong CMS advocacy positions concurrent with FDA approval strategies. We also help clients prepare for and defend themselves in connection with Congressional oversight, understand the challenges and opportunities presented by new or proposed legislation, organize and convey their views on proposed legislation, and use the legislative process to achieve their objectives.
Fraud and Abuse and False Claims Act Litigation
Our fraud and abuse professionals offer a full range of services relating to health care fraud and abuse statutes and regulations, including the False Claims Act and its qui tam (whistleblower) provisions, the Anti-Kickback Statute, the Self-Referral (“Stark”) Laws and the Food, Drug and Cosmetic Act.
The experienced professionals in this practice area, many of whom served in senior positions in the Department of Justice, have particular expertise in handling complex civil, criminal, and administrative matters for a full spectrum of health care and life science clients, from traditional care providers to pharmaceutical and device manufacturers. We defend clients in civil and criminal investigations and actions initiated by the government, including the Department of Justice, United States Attorneys’ Offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), the FBI, state Medicaid Fraud Control Units, and other federal and state regulators.
Diverse and Broad-ranging Experience
Our institutional knowledge gained over years of involvement in matters ranging from major national policy debates to discrete technical issues gives us an exceptional level of understanding – and our clients a distinctive level of insight. Our diverse team combines the talents of former high-ranking federal officials, congressional committee staff and an array of private sector attorneys and policy professionals. Collectively, we provide our clients decades of regulatory and legislative experience, including comprehensive, substantive authority on complicated health policy issues and access to policymakers at the highest levels of the federal government.
We have both the technical depth and political expertise to address our clients’ full range of advocacy, legal and transactional issues. The breadth and creativity of our litigation practice, often employed in combination with our public policy efforts, provides excellent results for clients. Our transactional specialists also have completed hundreds of deals in the health care industry, ranging from company formation to acquisition, and corporate finance, mergers and workout.