Industries: Health Care

Regulatory

Compliance

Our health care team has extensive experience counseling clients on health care specific regulation, including:

  • Federal and state anti-kickback and fraud and abuse laws
  • Federal and state self-referral laws, including the federal Stark law
  • Restrictions on patient transfers, including the Federal Emergency Medical Treatment and Active Labor Act (EMTALA)
  • Health Care Quality Improvement Act
  • Patient consent issues
  • Death and end of life issues
  • Corporate practice of medicine restrictions
  • Medicare and Medicaid conditions of participation
  • Federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA)
  • False Claims Act
  • Food and Drug Administration regulations
  • Employee Retirement Income Security Act (ERISA)

McGuireWoods also assists clients in:

  • Developing and implementing compliance programs
  • Developing corporate integrity agreements
  • Conducting internal audits to assess regulatory compliance

The health care team routinely advises clients on compliance matters of daily operations, as well as during investigations and enforcement proceedings initiated by various federal and state agencies including Centers for Medicare and Medicaid Services (CMS) (formerly the Health Care Financing Agency or HCFA), Health and Human Services (HHS), Office of Inspector General (OIG), Federal Trade Commission (FTC), Department of Justice (DOJ), state health departments, and state professional licensure boards. We advise clients on self-disclosure rules, as well as when to seek advisory opinions.

Privacy and Confidentiality

McGuireWoods has extensive experience advising clients on the significant legal restrictions regarding the collection, maintenance, and use of patient information. We routinely help clients to understand and comply with federal and state privacy laws, including the HIPAA privacy rules. We also have experience with various patients’ rights issues, including various patients’ bill of rights.

Hospital Law

We advise hospitals and other institutional providers regarding reimbursement, fraud and abuse prohibitions, staff privileges, physician contracting, managed care, certificates of public need, informed consent, risk management, hospital reorganizations, medical staff bylaws, credentialing, disciplinary hearings, and other peer review processes.

We routinely advise and serve on hospital committees, including ethics committees, board of directors, medical executive committees, quality review committees, and Institutional Review Boards (IRBs).

Licensure and Certification

The health care team routinely represents, at all levels of professional and facility licensure and certification, individuals and institutions, including: hospitals, ambulatory surgical centers (ASCs), freestanding diagnostic facilities, continuing care retirement communities, nursing homes, assisted living facilities, hospices, pharmacies, emergency medical services agencies, and individual health professionals. We also assist health care organizations in preparing for Joint Commission on Accreditation of Healthcare Organizations (JCAHO) reviews. We advise clients on dismissal and appeals proceedings.

Insurance

McGuireWoods represents clients, particularly providers and major insurance plans, in all areas of insurance. Typical issues addressed in this diverse representation include managed care contracting, formation and operation of integrated delivery systems, Medicare and Medicaid reimbursement issues and regulation, defending against state and federal fraud and abuse allegations, insurance licensing, TRICARE, HIPAA, COBRA, multi-state provider issues, underwriter’s contracting and other issues, Hill-Burton Act, insurance financing, and ERISA.

Reimbursement

As counsel to both insurers and all varieties of providers, McGuireWoods has experience advising clients on the many issues involved in dealing with the array of billing and reimbursement methods. We counsel providers in setting up and maintaining billings systems and mechanisms for reimbursement. We also counsel clients involved in reimbursement disputes with federal and state programs, including Medicare, Medicaid, TRICARE (formerly CHAMPUS), Children’s Health Insurance Program (CHIP), as well as with all varieties of private payers. We both represent and help providers to work with insurance companies, third-party administrators, and Medicare intermediaries and carriers.

Certificates of Need

McGuireWoods has extensive experience with the certificate of need process (CON). The firm has successfully represented many applicants in obtaining CON approval for a variety of expansion and new services projects. Additionally, McGuireWoods has extensive experience opposing the CON applications of competing providers. With our strong regulatory background on both sides of the CON process, McGuireWoods provides valuable strategic planning and counseling services related to significant capital projects such as hospital relocations and replacements, facility expansions, introduction of new clinical services, and other significant expenditures.

Antitrust

We advise clients, including managed care plans and hospital and physician networks, on a variety of health care antitrust issues, such as joint ventures between insurers and providers, hospital/medical staff relationships, hospital downstream expansion, mergers, information sharing, exclusivity agreements, non-compete clauses, Racketeer Influenced and Corrupt Organizations Act (RICO), unfair or deceptive trade practices, Federal Trade Commission Act (FTC Act), and Hart-Scott-Rodino reporting.

OSHA and Infectious Waste

We provide a variety of environmental counsel services for health care clients including infectious waste management and OSHA compliance within the many occupational settings found in health care facilities.

Client Education

In addition to providing on-site education services, we advise clients on professional ethics, particularly compliance with the American Medical Association’s Code of Ethics, preparation for JCAHO reviews, regulatory compliance, privacy and confidentiality issues, and other general risk management topics.

Patient Rights and Ethics

The health care team counsels hospitals and other providers about patient autonomy, informed consent, privacy, and other patient rights and ethics issues. We have experience drafting and reviewing various consent and release documents. We are also familiar with state patients’ bill of rights and have been actively monitoring federal patient rights developments. We serve as counsel to numerous hospital ethics committees. Furthermore, one of our attorneys has a Master’s Degree in Bioethics.

McGuireWoods Consulting

McGuireWoods Consulting is part of the integrated services available with McGuireWoods. A wholly-owned subsidiary of McGuireWoods, LLP, the consulting group concentrates on government relations initiatives across the United States at both the federal and state levels. We can direct public relations campaigns on legislative and budgetary matters and direct grassroots campaigns or community awareness efforts anywhere in the United States. Current and past projects include legislation effecting CON laws, grassroots initiatives, public relations and government relations on individual CON applications, pharmaceutical issues, health insurance, funding for indigent health care in state budgets, as well as numerous initiatives at the federal level.