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OIG green lights drug manufacturer-sponsored genetic testing program
13 April 2022
PartnerWashington, D.C.
Email [email protected]hoganlovells.com
Phone +1 202 637 5658
Fax +1 202 637 5910
Practice groupGlobal Regulatory
For health care and life sciences companies uncompromising in their commitments to both business success and regulatory compliance, Ron Wisor is a valued strategic advisor, counselor, and advocate.
Whether it be a cutting-edge business plan, a key acquisition, or a high-stakes government investigation, Ron brings his deep understanding of health care regulation and his practical problem solving skills to bear in guiding health industry leaders through their most challenging legal compliance issues.
The primary focus of Ron's practice is health care fraud and abuse compliance, with an emphasis on helping clients navigate application of the anti-kickback statute and false claims prohibitions in ways that allow them to engage in competitive business arrangements and promote greater access to their products and services.
The head of our Health practice and a recognized leader among Washington, D.C. health care lawyers, Ron also regularly advises clients on coverage and reimbursement of new technologies, assists clients in addressing Medicare and Medicaid billing issues, and has vast experience in dealing with other complex regulatory issues in areas such as digital health, research compliance, genomics, personalized medicine, and telemedicine.
When the government comes calling through audits and investigations, Ron is a respected and effective advocate with the U.S. Department of Justice, the HHS Office of Inspector General, and the Centers for Medicare & Medicaid Services.
His clients include multinational companies in the pharmaceutical, biotech, medical device, and clinical lab industries, as well as a number of leading health care providers and academic medical centers. Ron's broad client base and depth of experience allows him to benchmark clients' compliance safeguards against industry norms and evolving expectations of government regulators and enforcement authorities.
Education
J.D., Boston University School of Law, cum laude, 1993
B.A., Cornell University, 1986
Memberships
Member, American Health Lawyers Association
Bar admissions and qualifications
Connecticut
District of Columbia
Counseling a leading biologics manufacturer on structure and compliance safeguards for its multinational digital health initiative.
Advising a gene therapy manufacturer on market entry compliance issues, including the structuring of unique distribution service arrangements, patient access matters, and value-based payer agreements.
Advising a global biotech company on the structure of reimbursement support and nurse educator programs, and successfully defending those programs in a Department of Justice investigation.
In response to the COVID-19 pandemic, advising a global pharmaceutical company on its "telemedicine sprint" initiative to accelerate the company's connections with telemedicine service providers.
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