For more than 90 years, our lawyers have provided legal counsel to medical schools, academic medical centers and hospitals, and other teaching institutions that have a health care component – many of them public institutions and subdivisions of states – in all 50 states.
Our lawyers advise academic medical centers and teaching hospitals on virtually all legal issues affecting their operations, including faculty/medical staff organization and quality assurance, state and federal reimbursement, fraud and abuse compliance, mergers and acquisitions, disaffiliations, antitrust, joint ventures, managed health care, risk management and general liability, certificate of need and legislative affairs.
Hospitals in the public realm include state-owned, county, municipal and special districts, all of which we have represented extensively. Several of our lawyers have served as in-house general counsel for academic medical centers. We bring a broad understanding of how functionally integrated medical schools and teaching hospitals operate, and the perspective to provide practical, efficient counsel to these clients.
Clinical Research and Compliance
Many institutions of higher education are at the forefront of quality clinical research. With these efforts comes exposure to liability from regulators and research subjects alike, most often rooted in allegations of regulatory noncompliance. We partner with our clients to review their various research functions and to update their research programs to ensure regulatory compliance. For example, we work with clients to critically assess and update their human subjects protection programs, e.g., IRB procedures, informed consent processes and conflicts-of-interest policies, and then devise an efficient and practical strategy to operationalize these clinical research policies.
Our lawyers assist clients in defending against allegations of noncompliance, as well as preparing for inspections by government regulators, e.g., the Office of Research Integrity, the Food and Drug Administration and the Office for Human Research Protections. Our clinical research compliance lawyers are nationally recognized in the fields of health care, and pharmaceutical and biotechnology law, and team with our top-flight scientists and policy analysts to keep our clients current and compliant in a constantly changing enforcement environment.
Our health care experience includes:
- Advised an academic medical center in the establishment of an Accountable Care Organization for participation in a Medicare Shared Savings Program.
- Defended academic medical centers in False Claims Act litigation alleging violations of Stark Law.
- Assisted academic medical centers in numerous joint ventures involving multiple parties.
- Conducted a comprehensive internal legal compliance review for a large medical school and advised the client on follow-up corrective actions.
Our compliance experience includes:
- Focused compliance assessments for large university medical research programs and assist clients in follow-up corrective actions.
- Represented a research institute in working with the National Institutes of Health to resolve grants management issues and in developing grants management policies.
- Assisted academic medical centers and other research institutions in drafting and negotiating research agreements and forming research consortia.
- Assisted research institutions to achieve and maintain accreditation for their human subjects protection programs.
- Assisted research institutions with research misconduct investigations and reports.