Within the nation’s complex healthcare delivery system, disputes arise in countless contexts. Healthcare providers challenge payors’ claims adjudication policies and practices, and health insurance beneficiaries and care providers dispute coverage decisions. As provider groups consolidate and healthcare systems turn toward the direct employment of providers, restrictive covenant disputes are a growing problem.
McGuireWoods represents clients in a full range of healthcare commercial, regulatory and related litigation. Drawing on our decades of experience, we have developed particular concentrations in medical devices, drugs and pharmaceuticals, risk management, white-collar criminal defense, fraud and abuse, and antitrust matters, among other areas.
In the current heightened regulatory environment, healthcare companies face a significant increase in investigations, inquiries and law-enforcement actions involving federal and state policies, regulations and legislation. We regularly represent clients in matters related to U.S. Food and Drug Administration (FDA), Medicare and Medicaid guidelines, the Hatch-Waxman Act, the Employee Retirement Income Security Act (ERISA), the Health Insurance Portability and Accountability Act (HIPAA), the Consolidated Omnibus Budget Reconciliation Act (COBRA) and related healthcare laws.
In order to minimize the likelihood of litigation, we work proactively with clients to develop and implement compliance programs and corporate integrity agreements, and to conduct internal audits designed to uncover and correct potential non-compliance. When claims of non-compliance do arise, we have represented clients in inquiries opened by the U.S. Centers for Medicare and Medicaid Services (CMS) (formerly the Health Care Financing Agency or HCFA), the Department of Health and Human Services (HHS) Office of Inspector General (OIG), the Federal Trade Commission (FTC), the Department of Justice (DOJ), state health departments, and state professional licensure boards.
Allegations of False Claims Act (FCA) and other regulatory violations can have serious, negative consequences for healthcare providers. At McGuireWoods, we blend our deep industry knowledge as well as our extensive experience with government regulations to assist clients in preventing federal and state fraud and abuse violations, including failures to comply with anti-kickback, self-referral and false claims laws. We also counsel healthcare providers who are being actively investigated for fraud and abuse violations, and represent clients in litigation, at trial, and in appearances before boards and panels of regulatory agencies.
Insurance matters typically require detailed and complex analyses of the language of insurance agreements. We have counseled and represented a broad range of insurers and all varieties of providers on complex federal and state insurance laws and the ways in which these laws are incorporated into insurance policies. In the area of billing and reimbursement, we regularly counsel providers in setting up and maintaining information systems and procedures.