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Rebecca M. Schaefer

Partner
+1.919.466.1111
Fax +1.919.831.7040
Rebecca Schaefer is a partner at the firm’s Research Triangle Park office. She is a member of the health care practice group, focusing her practice on healthcare regulatory and transactional matters. Ms. Schaefer has specialized knowledge of issues affecting academic medical centers, including those related to faculty practices, clinical research, mission support, governance and privacy. She provides counseling to health systems, physician practice groups and in-house pharmacies related to strategic affiliations, joint ventures, and compliance matters.  

Prior to joining the firm, Ms. Schaefer served as an associate university counsel at The University of North Carolina at Chapel Hill, where she was the senior health care attorney for the UNC School of Medicine, UNC Faculty Physicians, and other health affairs schools. In this capacity, Ms. Schaefer advised campus and school-based leadership on myriad regulatory, transactional, institutional policy, and governance matters. Ms. Schaefer has counseled clients in the areas of fraud and abuse, privacy, human subjects research, and life sciences regulation. Her transactional experience includes joint ventures and physician practice acquisitions, as well as professional service, academic affiliation, timeshare, and data use agreements. Ms. Schaefer has drafted and counseled on faculty physician employment matters, including physician compensation plans, employment agreements, and restrictive covenants. Overall, her work for the university applied health care regulatory and transactional expertise to structure and facilitate various opportunities that furthered the patient care, clinical research, and medical education missions of the institution. Prior to UNC-Chapel Hill, Ms. Schaefer was in private practice with a large firm in Washington, D.C. representing clients from various sectors of the health care industry – including hospitals, medical management companies, physician groups, pharmaceutical and medical device companies, patient advocacy groups, and trade associations – on matters such as clinical trial agreements, regulatory compliance counseling, health care transactional due diligence, and the research, analysis, and compilation of legal and policy positions to comment on various agencies’ rulemaking on behalf of clients.

Professional/Civic Activities

  • American Health Lawyers Association
  • Represented multiple health system clients in the acquisition of community hospitals, including conducting due diligence, crafting definitive transaction agreements and advising on integration and operational considerations.
  • Advised a major medical center on transactional and compliance considerations related to a strategic specialty pharmacy partnership.
  • Counseled an academic medical center on privacy and consent considerations with respect to a biobank repository, and another on privacy and human subjects research regulations pertinent to a precision medicine artificial intelligence start-up.
  • Assisted a newly established health care facility in the development of an active clinical research program, including developing policies necessary for receipt of federal grants and proper administration of clinical trial billing, and negotiated multiple clinical trial agreements.
  • Drafted policies for a physician practice related to compliance with federal and state controlled substances regulations.
  • Prepared draft legislation on behalf of mental and behavioral health services organization to facilitate organizational changes in anticipation of Medicaid reform.
  • Counseled health care start-ups on entity formation, corporate practice of medicine, licensure, enrollment, reimbursement and contracting considerations.
  • Prepared memoranda advising an academic medical regarding 340B billing compliance.
  • Advised health system on Stark compliance related to physician non-monetary compensation.
  • Developed positions with relevant University and School of Medicine leadership across a range of integration considerations and drafted components of the Academic Affiliation Agreement in connection with the formerly proposed partnership between UNC Health Care and Atrium Health. Advised on various other academic affiliations.
  • Advised on faculty physician employment and compensation agreements, including related Stark Law considerations.
  • Represented faculty practices in the negotiation of joint venture, management services, professional services, space lease, and other agreements.
  • Advised on the organization of a HIPAA hybrid entity and privacy considerations related to clinical research. Advised on breach analysis and providing notice of unauthorized uses and disclosures of protected health information. Drafted and negotiated business associate agreements and other HIPAA required documents.
  • Drafted a suite of inter-related agreements in furtherance of establishing a clinical trials research network within a health system.
  • Drafted, revised and negotiated a variety of agreements between clinical trial sponsors, clinical research organizations (CROs), principal investigators and other third parties to govern the conduct of numerous clinical trials.
  • Advised on AMC-specific considerations related to mission support and institutional funds flow between the hospital and faculty practice components of an academic medical center.
  • Conducted healthcare regulatory due diligence and identified required regulatory consents and approvals in connection with private equity and other investments in health care companies.