Affordable Care Act Implementation
Although some aspects of the ACA remain controversial, implementation of the law is proceeding rapidly. We help strategically position our clients to navigate the opportunities and challenges emerging from the implementation of healthcare reform, and to deal most effectively with how these issues will affect their organizations. We are well poised to address any ACA issues impacting providers, employers, investors, health plans, drug and device manufacturers, states, beneficiary groups and other healthcare stakeholders.
For more than half a century, we have provided hands-on guidance and innovative solutions for domestic and international antitrust problems. Our antitrust lawyers have significant experience counseling healthcare institutions and physicians on the antitrust aspects of affiliations, mergers, acquisitions, joint ventures and trade associations. We have frequently represented healthcare clients before the US Federal Trade Commission (FTC), the Department of Justice (DOJ) and state competition authorities in connection with transactions and government investigations.
Corporate and Transactional
For more than 100 years, we have advised clients on a wide range of transactional and governance matters – offering legal advice on corporate mandates across the spectrum, from smaller, more straightforward deals to complex multibillion-dollar, multi-jurisdictional and multidisciplinary transactions. We provide integrated management of the commercial and regulatory issues inherent in these transactions. Our experience, for example, covers an array of structures and relationships, including hospital and health system reorganizations, hospital-to-hospital affiliations, sole member substitutions, special member arrangements, joint operating arrangements, and entity and asset transactions.
Data Privacy and Security
We provide expert counsel on compliance with HIPAA, the HITECH Act and state law analogues, both before and after data breaches. We also advise healthcare organizations that do business on a global scale, to achieve compliance with international cross-border data privacy and security rules, such as the European Union Privacy Directive.
Finance – Public and Private
We have substantial experience in helping companies at all stages of development, from startups to mature global businesses, to secure public and private financing. Ranked 4th nationally for healthcare finance issues by Thomson Reuters, our public finance team has substantial experience advising on healthcare infrastructure projects – both governments and private interests party to public-private partnerships, including project sponsors and awarding authorities, as well as both borrowers and lenders on project funding. Likewise, our nationally recognized public finance team, has substantial experience representing borrowers, underwriters, credit enhancers and issuing authorities in all kinds of tax-exempt and tax-leveraged financing.
Fraud and Abuse and False Claims
We provide a full range of services relating to healthcare fraud and abuse statutes and regulations, including the False Claims Act (FCA) and its qui tam (whistleblower) provisions, the Federal Anti-Kickback Statute, the Self-Referral (Stark) Laws, the Food, Drug and Cosmetic Act (FDCA) and analogous state laws. Many of our professionals have served in senior positions in federal and state enforcement agencies, giving us particular expertise in counseling clients on establishing and improving compliance programs and proactively addressing related issues. We are also well versed in handling complex civil, criminal and administrative matters for a full spectrum of healthcare clients.
Health IT and Communications
We provide comprehensive legal, regulatory and legislative counsel on a number of health information technology (HIT) initiatives, including remote monitoring, the use of mobile devices and the evolution of the “digital hospital.” We represent a number of successful state-wide health information exchanges, all-payer claims databases and related initiatives, as well as advise on national HIT infrastructure projects and issues associated with electronic health records.
We are familiar with the culture and perspective of health insurers, health maintenance organizations (HMOs) and other managed care organizations, hospitals, health systems, physicians, physician groups, medical staffs, long-term care providers, ancillary service providers and other payers and purchasers of healthcare. We have utilized this expertise to assist several providers in developing and carrying out alignment strategies with health insurers. Our experience enables us to bring unique insights to the rapidly evolving relationships among these various groups.
Intellectual Property (IP)
Many of our healthcare clients rely on the extensive experience of our specialist IP lawyers. We guide patent applications through the approval process and obtain broad, valuable patent protection, gain trademark and copyright protection, draft and implement licensing and distribution agreements, and litigate to enforce patent or trademark rights or defend against claims.
International Dispute Resolution (IDR)
Healthcare businesses working across borders need sophisticated IDR counsel when conflicts arise from business transactions, contracts or the provision of services to foreign patients. We are one of only a small number of legal practices able to serve the IDR needs of clients on a truly global basis, with long-established practice groups throughout the Americas, Central and Eastern Europe, the Middle East and North Africa, the Asia Pacific region and Australia.
International Healthcare Projects
We are actively engaged in domestic cross-border, and wholly international, healthcare transactions, often with the ability to bring extensive knowledge of local law to the documentation and implementation of our clients’ interests. In addition, we are experienced advisors to sovereigns and other government interests, particularly in relation to the creation or modernization of legal and regulatory healthcare infrastructure.
Labor and Employment
We provide practical guidance and assistance on related legal matters ranging from employment litigation and risk management to discrimination and harassment, executive agreements and wellness programs. We also advise on the sponsorship and employment of foreign nationals throughout the world and a host of immigration issues.
Legislative Advocacy and Regulatory Policy
Nationally recognized for our advocacy and regulatory knowledge, we have strong ties to leading policymakers and an impressive 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 assist clients that want to achieve changes to statutory and committee report language, thus preventing or minimizing unintended or adverse consequences. Team members regularly participate in the development of legislation and regulations, and are consulted as a resource for policy analysis. We frequently interact with congressional support agencies and have a unique history of building and managing large healthcare coalitions.
With an exceptional complement of health sector litigation capabilities, we resolve multifaceted legal matters efficiently. We counsel and defend clients faced with pending and threatened litigation and governmental investigations stemming from sweeping regulatory reform and significant advancements in science and technologies focused on patient care and services. We can represent you in state and federal courts through jury and bench trials, in administrative procedures and hearings, and throughout the appellate process. Our experience spans a variety of cases, including complex, bet-the-company litigation. We also advise on liability and risk mitigation options related to corporate agreements and on precedent-setting issues and rules shaping the industry.
Medicare and Medicaid
A core focus of our practice involves helping clients navigate the overlapping statutes, regulations and agency directives governing Medicare and Medicaid coverage and reimbursement. Through sophisticated counseling, analysis and advocacy, we can help you to obtain coverage and adequate reimbursement under these programs for products and services. Our nationally recognized team of Medicare and Medicaid litigators has successfully handled hundreds of appeals before the PRRB and routinely represents significant groups of hospitals in their large dollar appeals in federal court. Not infrequently, these appeals turn on successful challenges to the validity of Medicare or Medicaid regulations and sub-regulatory manual provisions.
We represent developers, contractors, major utilities, commercial lenders and financing institutions, governments and governmental agencies in real estate matters in the healthcare sector. This includes property acquisitions, planning, construction and project funding. Our attorneys can share the benefit of their broad experience, having participated in all phases of the real estate development process, from both business and legal perspectives. We are familiar with all governmental regulatory matters and environmental concerns that you may confront.
Tougher international, federal and state regulations challenge the healthcare sector every day. Our lawyers are familiar with all relevant regulations and can help with compliance issues, as well as in negotiations with regulators and investigators, around the world. We develop and execute clients’ offensive and defensive regulatory strategies by engaging the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), state departments of health (facility licensing) and other federal and state agencies. Our familiarity with the Food & Drug Administration allows us to anticipate potential coverage and payment challenges for products awaiting approval.
We provide expert help in navigating the federal and international regulations that affect the practice of medicine across borders, the exchange of electronic patient information and the relationships amongst hospitals, physicians and other providers that participate in telehealth networks. We have, for example, assisted US hospitals in their procurement of teleradiology services from Australia, negotiated telemedicine contracts on behalf of a major hospital in India, and negotiated agreements with outsourcing and technology vendors.
Taxation and Benefits
Healthcare clients look to us for advice on tax exemption matters, community benefit and the new IRC §501(r) requirements, unrelated business taxable income (UBIT), reorganization and diversification, physician recruitment programs, charitable giving vehicles, qualified and non-qualified tax-deferred compensation programs, and tax agency audits and appeals. We are also able to provide advice on employee benefits and pension scheme matters in most of the countries in which health sector participants are investing for growth.