The health care industry is one of the most closely regulated industries in the United States. Regulatory compliance encompasses all facets of legal advice, including transactional structuring and due diligence, operations, compliance plan implementation, self-disclosure and defense. To stay ahead of emerging regulations and minimize the risks associated with non-compliance, clients need legal counsel well versed in existing laws and with a finger on the pulse of new legal and regulatory developments.
The health law team at McDermott includes highly experienced regulatory lawyers in all key areas of health care. Our collective experience is expansive and covers such diverse areas as fraud and abuse, anti-kickback and self-referral laws, False Claims Act defense, reimbursement counseling, patient data privacy under HIPAA and the HITECH Act, Affordable Care Act and other health reform initiatives, clinical and database research, medical device and drug product regulation, and tax issues facing for-profit and not-for-profit entities.
Clients benefit from our ability to provide a “real world approach” derived from a team that includes former prosecutors and OIG officials, Health and Human Services and FDA regulators, and compliance specialists with centuries of combined experience. Similarly, our client base extends across all facets of the health care industry, including Fortune 500 companies, private equity firms, nonprofit institutions, hospitals and integrated delivery systems, health technology companies, ancillary and subacute providers, health plans, medical device and pharmaceutical manufacturers, teaching and research institutions, medical groups, group purchasing organizations and trade associations.
The historic passage of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively, the Affordable Care Act) has expanded access to health insurance for tens of millions of US citizens and generated a complete overhaul of the nation’s health system. We help clients understand and navigate the sweeping changes brought about by the Affordable Care Act, via frequent publication of articles, advising on industry best practices and the development of educational programs. Drawing on the knowledge and resources of lawyers in our highly regarded health industry advisory, employee benefits, life sciences, executive compensation, government strategies and tax groups, we offer comprehensive service to help clients meet the challenges of the new health care landscape.
We represent academic medical centers, pharmaceutical companies and research institutions on all aspects of FDA, National Institutes of Health (NIH), National Cancer Institute (NCI) and Animal and Plant Health Inspection Service (APHIS) human subjects, laboratory and animal welfare-related regulatory matters. Our experience includes advising AMCs on FDA and NIH policies, procedures and other compliance matters, preparation for and representation during inspections and audits of device and drug trials, representation in enforcement actions (including replies to 483s, warning letters, and administrative, civil and criminal matters), and advising on establishing organizations to conduct clinical research, including negotiating clinical trial agreements on behalf of sponsors and clinical investigators.
Members of McDermott’s US Food and Drug Administration (FDA) and Health Industry Advisory practices are nationally recognized as leading lawyers in FDA law by US News-Best Lawyers and LMG Life Sciences. We provide comprehensive advice to pharmaceutical, biotechnology, medical device, dietary supplement and food companies, clinical research organizations, and individuals, medical centers, physician practices and other health care providers in all aspects of the development, clinical research, product application and review, manufacture, distribution, marketing and reimbursement of drug, biologic, device and other products regulated by the FDA.
We advise clients in all areas of Medicare and Medicaid fraud and abuse statutes, the Stark Law, and other federal and state self-referral prohibitions, and provide guidance regarding safe harbor regulations. We represent clinics, physician practices, hospitals and health systems, medical centers, medical device manufacturers, trade associations, state hospital associations, trustees in bankruptcy and holding companies that control health care providers. Our fraud and abuse consultation includes planning and structuring transactions to minimize fraud and abuse implications, and—for transactions already formulated or implemented—we provide advisory opinions on potential fraud and abuse concerns. We conduct fraud and abuse audits and represent clients targeted in inspector general and grand jury investigations, often working with our white-collar criminal defense team to provide effective representation for individuals and organizations.
As one of the largest and most-recognized tax practices in the United States, we provide comprehensive tax planning, compliance and advocacy services to nonprofit hospitals and other tax-exempt health care organizations, including health maintenance organizations (HMOs), skilled nursing facilities, home health agencies and their affiliates, and industry trade associations and private foundations. We regularly advise health care clients on the special tax issues that arise in the context of joint operating arrangements, horizontal integrations, conversions and sales of assets and the resulting foundations, joint ventures, physician practice acquisitions, academic medical center relationships with physicians, and captive insurance and other risk-management arrangements.
CLINICAL & DATABASE RESEARCH
FRAUD & ABUSE/STARK LAW