Demystifying Hospital Provider-Based Status: Regulatory Requirements, Process Complexities, Pitfalls to Avoid

In addition to Ms. Cook’s role as a national authority on the 340B drug pricing program, she helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. Ms. Cook partners with a wide range of organizations, including non-traditional service providers and new market entrants to identify, protect and expand revenue opportunities, including via private-equity-backed ventures. Her comprehensive counsel encompasses evolving issues such as No Surprises Act implementation, development of new provider types, Medicare provider-based and co-location rules, and trends in qui tam litigation and government investigations. Ms. Cook’s deep insights into U.S. healthcare regulation stem from her previous tenure at the HHS Health Resources and Services Administration.

Ms. DiVarco focuses her practice on the representation of hospitals and health systems. She counsels healthcare facility and system clients regarding all aspects of health law transactions and health system restructurings. She has a deep knowledge of regulatory, licensing and accreditation issues of particular concern to healthcare providers. She regularly advises clients on the legal aspects of clinical regulatory issues and policy/procedure and operational matters. She is a registered nurse, and holding a current license in Illinois, she brings a pragmatic perspective and first-hand knowledge of health care operations to these complex and mission-critical matters.

Ms. Reignley provides strategic legal, regulatory and compliance counsel to for-profit and nonprofit hospitals, health systems, other healthcare providers, life sciences and technology companies. She counsels clients on interpretation and risk mitigation under the Anti-Kickback Statute, Stark Law and EKRA. She also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statue. Ms. Reignley advises clients involved in digital health on the applicable legal and regulatory infrastructure, with a particular focus on remote patient monitoring programs. She also advises Medicare providers, consultants and vendors on a wide range of business, legal and regulatory issues. She has extensive experience advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding. She also advises clients on professional licensure, scope of practice, physician and health care professional clinician relationships and supervision, together with overall corporate compliance.