Health Care Compliance and Regulatory Counseling

Mintz Levin regularly advises health care clients on complex regulatory matters, with a particular focus on issues related to Medicare and Medicaid participation. Our attorneys have years of experience dealing with compliance and regulatory issues, in both the private and public sectors, and with government agencies with enforcement and oversight responsibilities. This experience gives us the insight necessary to help our clients comply with the many complex federal and state regulatory requirements imposed on the health industry.

We provide day-to-day regulatory and compliance counseling, design and implement compliance programs, conduct risk assessments, and provide compliance training. When compliance concerns arise, we conduct internal investigations, advise clients on the risks and benefits of self-disclosure, and, if necessary, shepherd them through disclosures to appropriate government agencies, including the Office of Inspector General for the Department of Health and Human Services (OIG) and offices of U.S. Attorneys across the country. We also help health care clients prepare for and respond to government audits and investigations, and negotiate and oversee the implementation of Corporate Integrity Agreements (CIAs).

Our attorneys provide health care compliance advice to hospitals, pharmaceutical companies, laboratories, pharmacies, managed care organizations, durable medical equipment suppliers, long term care providers, and many others in the health industry. Examples of our work include:

• designing and implementing a client’s company-wide risk assessment tool across multiple lines of business, including its specialty pharmacy business
• conducting a state-by-state analysis and audit of operations for fraud, abuse, and waste compliance for licensed Medicaid managed care companies
• drafting numerous requests for Advisory Opinions submitted to OIG and the Centers for Medicare & Medicaid Services
• representing clients in internal investigations and subsequent voluntary disclosures to OIG
  providing compliance training for employees at all levels in connection with compliance programs and CIAs.

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