Health Care Regulatory Counseling

Foundations in Privacy Toolkit

Gray Plant Mooty has partnered with the Minnesota Department of Health to develop a set of tools to support the exchange of patient health information in Minnesota. Although many patients desire and benefit from care coordination and the sharing of their medical history, conflicting federal and state laws and regulations inhibit providers from exchanging such information.

The Foundations in Privacy Toolkit was developed to guide providers through these conflicting state and federal privacy requirements. The toolkit includes template policies and procedures, flow charts, template agreements, and checklists and is available for free via the link below.


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Health care is one of the most highly scrutinized and regulated industries in the country. A vast array of ever-changing and highly technical laws and regulations govern the U.S. health care system. Failure to comply with these complex regulations can have staggering consequences for health care providers, including criminal liability, loss of licensure, exclusion from the Medicare and Medicaid programs, and severe financial penalties. Since 1997, more than $15.6 billion has been returned to the Medicare program through government efforts to crack down on health care fraud. With federal regulators recovering $17 for every $1 they invest fighting health care fraud and abuse, it is no wonder that this industry continues to be at the forefront of enforcement activities.

When the stakes are this high, you want the assurance of legal counsel with industry-specific knowledge and experience on your side. We have helped clients respond to regulatory investigations and audits at all stages of the process, from meeting with government officials early on in an investigation to understand and proactively address their concerns, to conducting full-scale compliance audits and reviews of business activities, to actively litigating complex cases. Our work in this regard includes assisting providers in defending against regulatory inquiries in a wide range of areas, including:

  • Enrollment, reimbursement, billing/coding, and participation requirements under the Medicare, Medicaid, and other federal and state health care programs
  • Health care fraud and abuse laws, such as federal and state Anti-kickback statutes and the federal Stark Law
  • Issues related to medical records confidentiality and HIPAA privacy and security compliance
  • Compliance matters associated with specific types of ancillary service providers, such as clinical laboratories, durable medical equipment suppliers, ambulatory surgery centers, and independent diagnostic testing facilities
  • Professional licensure matters
  • Federal False Claims Act and its qui tam whistleblower provisions

Gray Plant Mooty health care and litigation attorneys work hand in hand to leverage their deep expertise to assist providers with the most cost-effective and efficient defense possible. With a team that includes both former government prosecutors and senior health care regulatory attorneys who have been practicing for over 20 years, the health care team is well-positioned to aid providers in all stages of any regulatory inquiry or investigation.

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