Regulation in the healthcare industry is pervasive and extraordinarily complex. To stay ahead of emerging regulations and minimize the risks associated with non-compliance, health industry leaders need experienced legal counsel who are well-versed in existing laws and have a finger on the pulse of new legal and regulatory developments.
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 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.
A health system with the review and upgrade of a research conflict of interest program
A tax-exempt research organization with transfer support, patent work, and development of an individual and institutional research conflict of interest policy
A major cancer center’s institutional review board (IRB) in ongoing compliance advice and representation on various FDA, NCI and other enforcement matters
A medical device company concerning EU-related privacy matters in connection with registry and ongoing clinical trials
Numerous drug, device and other institutions on pre- and post-approval and advertising and promotion matters involving FDA and/or HHS OIG compliance
Multiple pharmaceutical companies, medical devices manufacturers, hospitals and academic institutions in German and EU regulatory law, unfair competition law, and compliance with national and European codes of conduct, including issues of pricing, market access and reimbursement by public health insurances, public procurement, research, clinical trials and related topics
FRAUD & ABUSE/STARK LAW
Publicly traded hospital companies, academic medical centers, drug and device manufacturers, health plans, group purchasing organizations, private equity investors and subacute providers as primary outside compliance counsel
Multiple healthcare providers in Stark self-disclosure settlements and Stark/kickback qui tam litigation
Numerous multi-hospital systems, rural hospitals and academic medical centers on issues relating to the 340B drug discount program, including self-disclosures, negotiations of corrective action with regulators and manufacturers, coordination of internal reviews, and implementation of 340B programs and policies
Corporate boards, in-house legal departments, compliance and revenue cycle staff with compliance training
Provider-side acquisitions, affiliations and joint ventures, providing joint regulatory and transactional counsel
Allergan with regard to a broad range of regulatory, reimbursement and compliance matters with particular emphasis on their Botox product
Abbott Laboratories on regulatory policy initiatives across their portfolio of products, with particular focus on the diagnostics and diabetes care portfolios
A multifaceted computer software technology company in connection with the regulation of computer software medical imaging technology
A major clinical research organization in ongoing compliance on a wide variety of FDA and HHS clinical trial and product approval matters, and FDA and USDA pre-clinical matters, involving testing and approval of drugs, medical devices and biological products, and compliance with the Animal Welfare Act
Exact Sciences in obtaining the first-ever parallel review FDA approval/CMS national coverage decision for its stool DNA colon cancer screening test
Covance in seeking FDA and Clinical Laboratory Improvement Amendments (CLIA) approval for a number of new products, as well as the regulatory aspects of LabCorp’s acquisition of Covance in 2014
A nonprofit healthcare system responding to an FDA inspection and findings of deviations in connection with hospital pharmacy drug compounding operations
A national provider of home healthcare services and equipment, in relation to a product recall involving Medicare reimbursement issues as well as CMS and FDA interaction
A national nonprofit healthcare system in response to an FDA inspection and findings of deviations in connection with hospital pharmacy drug compounding operations
Healthcare systems with structuring accountable care organizations, including Medicare Shared Savings Program ACOs and commercial ACOs
Tax-exempt organizations on permissible joint venture arrangements with other tax-exempt organizations and with for-profit organizations
Tax-exempt healthcare systems on tax and other regulatory issues raised by formation of technology transfer organizations and commercialization of intellectual property
Health systems with the development of compensation philosophy statements, charters and procedures for executive and physician compensation review procedures
Tax-exempt organizations in establishing data registries
A Section 501(c)(3) tax-exempt organization, on a partial conversion of a majority of its assets to for-profit status, including securing all necessary approvals
Multiple large health systems in issuing tax-exempt bonds
Tax-exempt organizations and for-profit corporations on structuring international philanthropy programs
International organizations on establishing exempt organizations in the United States
Foreign charitable organizations with providing equivalency determinations for seeking grants from US private foundations and for foreign charities seeking exemption from US withholding taxes
Foreign organizations on obtaining tax-exemption in the United States
Tax-exempt organizations and systems in IRS audits