Leah has over 25 years of experience working with healthcare systems, hospitals, academic medical centers, physician groups, and pharmaceutical and device manufacturers. She advises clients on complex compliance issues and assists with government disclosure determinations and investigations. Her practice is concentrated mainly in clinical research matters including infrastructure development, development and execution of research strategy, and research compliance.
Representative examples of Leah’s engagement experience include:
- Led project with academic medical center to coordinate their audit, risk management and compliance activities to better manage risk and develop more effective reporting mechanisms to executive management and Audit Board Committee.
- Led multiple projects to evaluate the effectiveness of compliance programs for complex provider systems and integrated delivery systems.
- Assisted Midwestern regional healthcare system with scientific misconduct matter from allegation through investigation and Office of Research Integrity reporting. Developed the necessary infrastructure for client to manage future allegations.
- Led project team to develop clinical research billing compliance program for a major pharmaceutical company.
- Led a project team at a major West Coast cancer hospital to assess the infrastructure of the clinical research billing operations, examine charges against coverage reviews to facilitate proper billing going forward, and assess potential overpayments in research trials in the context of a voluntary disclosure.
- Developed and implemented a clinical research billing unit at a major Midwestern academic medical center. Trained more than 1,000 research personnel regarding the rules and regulations for Medicare billing.
- Prepared an expert witness in a research misconduct matter for Office for Human Research Protection as well as Office of Research Integrity compliance matters.
- Conducted internal investigations to determine the validity of alleged wrongdoing related to regulatory compliance.
- Created a project plan for the interplay between research records and medical records of a major West Coast academic medical center to promote privacy and contract/regulatory compliance.
- Conducted regulatory due diligence of target healthcare entities for venture capital firms.
- Provided general compliance and regulatory advice and counsel to healthcare systems and their component entities including hospitals, skilled nursing facilities, hospice and home healthcare, and ambulance companies.
Prior to joining Huron, Leah practiced healthcare law in Washington, DC and New York focusing on defending clients under government investigations.
- Juris Doctorate, Jacob D. Fuchsberg Law Center, Touro College, Huntington, New York
- Master of Arts, Counseling, Chapman University, Tucson, Arizona
- Bachelor of Science, Psychology, Louisiana State University, Shreveport, Louisiana
- Admission, New York State Bar
- Admission, District of Columbia Bar
- Admission, Eastern District of New York
- Member, Health Care Compliance Association
- Member, American Health Lawyers Association
- Vice Chair, Strategic Activities AMC Practice Group (2014-2016)
- Member, District of Columbia Bar Association
Speaking and Writing engagements
- Leah is a frequent speaker at national and regional conferences including American Health Lawyers Association, Health Care Compliance Association, and the Association of Clinical Research Professionals on topics related to clinical research and general healthcare compliance issues.
- Leah has also written frequently in relevant trade journals and publications on matters related to research operations, research compliance and risk management. Copies of these materials are available upon request