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Experience / Health / Health Care Regulatory & Compliance

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Health Care Regulatory & Compliance

Overview

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.

Related Capabilities

  • Affordable Care Act Resources

    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.

  • Clinical & Database Research

    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.  

  • Fraud & Abuse/Stark

    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.

  • FDA/Product Regulation

    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. 

  • Tax-Exempt 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.

Key Contacts

Results

CLINICAL & DATABASE RESEARCH

  • A large international pharmaceutical company in developing and maintaining a comprehensive and robust clinical research program that meets US regulatory requirements
  • Rush University Medical Center on the regulatory issues surrounding frozen embryo storage and destruction
  • A US-based research institute in developing a clinical trials program with UK-based collaboration
  • 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 health care 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

FDA/PRODUCT REGULATION

  • 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 health care system responding to an FDA inspection and findings of deviations in connection with hospital pharmacy drug compounding operations
  • A national provider of home health care services and equipment, in relation to a product recall involving Medicare reimbursement issues as well as CMS and FDA interaction
  • A national nonprofit health care system in response to an FDA inspection and findings of deviations in connection with hospital pharmacy drug compounding operations

TAX-EXEMPT ORGANIZATIONS

  • Health care 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 health care 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

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