Health Regulatory & Compliance

Almost every aspect of healthcare is overseen at the federal, state or local levels, and often by a range of private organizations as well, creating a regulatory maze of transactional structuring and due diligence, operations, compliance plan implementation, self-disclosure and defense. With centuries of combined experience providing counsel to some of the world’s most important healthcare organizations, we have the diverse and expansive capabilities necessary to clear your path to success.

With our team of former prosecutors and Office of Inspector General officials, Health and Human Services and US Food and Drug Administration (FDA) regulators, and compliance leaders, we are able to provide clients with real-world, practical approaches to managing the most complex regulatory challenges. As a result, our client base extends across all facets of the healthcare industry.

Our healthcare regulatory lawyers have unrivaled experience in all key areas of healthcare, including anti-kickback and self-referral laws, False Claims Act defense, reimbursement counseling, patient data privacy under HIPAA and the HITECH Act, health reform initiatives and tax issues, especially in these key areas:

• Affordable Care Act
  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 these changes, advising on industry best practices and the development of educational programs. Drawing on the knowledge and resources of lawyers in our highly regarded health, employee benefits, life sciences, executive compensation, government strategies and tax groups, we offer comprehensive service to help clients meet the challenges of the new healthcare landscape.
• Clinical and Database Research
  Adherence to good clinical practices is fundamental to research. We represent academic medical centers, pharmaceutical companies and research institutions on all aspects of FDA, National Institutes of Health, National Cancer Institute, and Animal and Plant Health Inspection Service regulatory matters. Our experience includes advising on procedures and other compliance matters, preparation for and representation during inspections and audits of device and drug trials, representation in enforcement actions, and advising on establishing organizations to conduct clinical research.
• Fraud and Abuse/Stark Law
  Healthcare fraud and abuse costs the industry billions. Without adequate processes in place to prevent fraudulent activities, providers may be subject to costly investigations. 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. Our fraud and abuse consultation includes planning and structuring transactions to minimize fraud and abuse implications, and providing advisory opinions on potential concerns. We conduct audits and represent clients targeted in inspector general and grand jury investigations, often working with our white-collar defense team to provide effective, multifaceted representation.
• FDA/Product Regulation
  Members of our FDA and health industry advisory practices are nationally recognized by U.S. News – Best Lawyers and LMG Life Sciences. We provide comprehensive advice on 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.
• Tax-Exempt Organizations
  Tax-exempt healthcare organizations are subject to intense regulatory scrutiny by Congress, the Internal Revenue Service and state attorneys general. As the industry’s top-ranked healthcare law firm, and one of the largest and most-respected tax practices, we provide comprehensive tax planning, compliance and advocacy services to nonprofit hospitals and other tax-exempt healthcare organizations. We regularly advise healthcare 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.

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