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Darlene S. Davis

Fax +1.919.516.2119

Ms. Davis is a partner in the Research Triangle Park office. She focuses her practice exclusively on health law, primarily representing academic medical centers, health systems, hospitals, home health agencies, hospices, nursing homes, and ancillary service providers, such as laboratories, pharmacies, and durable medical equipment suppliers.

In that capacity, she advises clients on a wide range of regulatory and transactional matters, including the HIPAA privacy, security and breach notification rules; Medicare and Medicaid enrollment and certification, coverage and reimbursement; North Carolina licensure rules; the 340B drug pricing program; contracting; health care regulatory diligence; and compliance with fraud and abuse laws (including Stark Law and Anti-Kickback Statute).

Prior to attending law school, Ms. Davis worked for the Centers for Medicare & Medicaid Services in its Boston Regional Office.


  • Listed by Chambers USA for Health Care in North Carolina

Additional Information

  • Site Neutral Payments - Transaction Concerns, ABA Business and Transactions Interest Group Business Wire, Fall 2016
  • “Health-Related Quality of Life in Patients Treated for Hypertension: A Review of the Literature from 1990 to 2000,” co-authored article, Clinical Therapeutics, 2002
  • “How do Precepting Physicians Select Patients for Teaching Medical Students in the Ambulatory Primary Care Setting?” co-authored article, Journal of General Internal Medicine, 2003
  • Advise clients regarding Medicare and Medicaid billing requirements, including physician/non-physician practitioner billing and “incident to” requirements, provider-based rules, requirements for supervision of diagnostic and therapeutic services, the 3-day payment window, laboratory/pathology, DMEPOS, and hospital billing, and hospice reimbursement.
  • Assist clients with drafting and review of contracts with physicians and non-physician practitioners, other health care providers, and vendors, including, as applicable, compliance with fraud and abuse laws (including the Stark Law and Anti-Kickback Statute), federal conditions of participation, and HIPAA (including business associate agreements).
  • Advise clients regarding regulatory notifications and requirements associated with the structuring of complex health care transactions, health system reorganizations, and the opening of new facilities. This includes certification, billing, and 340B implications; Medicare and Medicaid enrollment of all provider and supplier types, such as physician practices, hospital, home health agencies, IDTFs, and DMEPOS suppliers; and unique considerations related to the creation of or increase in bed capacity of PPS-excluded psychiatric and rehabilitation units, the hospital-within-a-hospital and satellite facility rules, and the acquisition/opening of long-term care hospitals, rehabilitation hospitals, and home health agencies.
  • Assist clients with internal compliance reviews and appeals of Medicare and Medicaid enrollment and payment denials.
  • Advise clients on health information privacy and security matters, including compliance with the HIPAA privacy, security, and breach notification rules, business associate obligations, and the sharing of health information.