Regulation, Survey, & Inspection

Health care providers live and breathe under a mountain of state and federal statutes, regulations, and official policy interpretations. We help clients understand both the letter and the application of those laws. We guide our clients in every sector of health care as they implement these laws through training, policies/procedures, help with government inspectors and surveyors alleging noncompliance, plans of protection and correction, and litigation to challenge unfair or unfounded allegations of noncompliance. And, we help clients navigate the laws governing the entry into a health care space, including licensure (personal and institutional), certification, enrollment, and accreditation.

We regularly represent health care clients in successful challenges of state and federal government agency survey/inspection findings, and associated fines and sanctions across all sectors of health care, both individual licensed providers and institutional providers.

North Carolina is a Certificate of Need (CON) state, and providers must have a CON to start or expand various new institutional health services, including hospitals and their satellite facilities, long term care, home care, hospice, ambulatory surgery centers, dialysis centers, and radiation oncology, and to purchase many types of expensive medical equipment. We have handled some of the most complicated CON matters in the state and are currently defending the statute in state court on behalf of both institutional and association clients.

Confidentiality of patient information is highly regulated as well. Our team understands HIPAA and the related state and federal laws of patient privilege and confidentiality of medical records generally and for mental health and substance abuse in particular. To read more about our work with clients to protect patient privacy click here.

Confidentiality of peer review is equally important, and our health care lawyers fully understand these protections for both practitioners and institutions. We help our clients understand and safeguard these protections and assist with the implementation of policies and procedures to ensure that confidentiality is maintained to the highest degree.

Further regulatory issues can arise with site surveys. We counsel clients on the substantive and procedural law and rules governing the survey and inspections of many types of health care facilities. We can help prepare for inspection and surveys, deal with surprise inspections, respond to deficiencies, and assist with Plans of Correction.

Additionally, as counsel for hospitals and physicians—especially emergency physicians—our team handles EMTALA matters. We advise on the transfer of patients and we represent physicians on appeal.

Finally, anti-trust and competition issues can, and do, come into play. Clients rely on us to help them navigate these regulatory minefields.

For more about how we support health care organizations, please contact one of the related professionals on this page.

 

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