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Health Care and FDA: Academic Medical Centers (AMCs)

As leaders of innovation in patient care, medical education, and clinical research, academic medical centers (AMCs) face enormous opportunities and challenges in navigating a constantly evolving legislative, regulatory and competitive landscape to advance their core missions. The health care, research, data privacy, and higher education teams at the firm provide a full range of legal services to address these challenges, drawing on broad experience gained over decades of counseling AMCs and other institutions of higher education in both the nonprofit and for-profit sectors.

We have one of the largest dedicated health care practices in the country, with a long history of and proficiency in representing AMCs. Similarly, our higher education practice leverages multidisciplinary experience to assist colleges and universities with an array of legal services. We offer swift, thoughtful, and creative solutions to our clients’ legal issues, mindful of their institutional structures and priorities.

Distinctive areas of our practice that can serve the specific needs of AMCs and institutions of higher education include:

Research

We advise our AMC clients on all aspects of federal and state regulation of pre-clinical and clinical research. Together with lawyers in our pharmaceutical and medical device practice, we provide counsel on clinical trial agreements; protocols, policies and informed consent issues; compliance with Food and Drug Administration and Office of Health Research Protections regulations; and creation and structuring of genetic and research repositories and databanks, including consent and privacy issues specific to the evolving field of genomics and precision medicine. We advise clients on all stages of government contracting, and we routinely advise AMCs on laws applicable to sponsored research arrangements, conflict of interest issues, research contracting and permitted program support. We have assisted in conducting and responding to research misconduct investigations, including inquiries related to work effort and federal grant reporting. Our global footprint has facilitated our representation of AMCs in international research programs, global clinical trial drug and device studies, and data aggregation of transfer projects among United States, European, Africa, and Asia sites.

Intellectual Property

The development, commercialization, and protection of intellectual property, and the formulation of business strategies are critical to the success of AMCs and universities in today’s competitive landscape. Whether through developing and implementing strategies for worldwide protection of a patent or trademark, drafting and negotiating licensing and strategic partnering agreements for innovative products and services, or creating spin-off companies from AMC and university-based innovations through faculty start-ups or otherwise, we help clients protect valuable intellectual property assets.

Graduate Medical Education

Graduate medical education (GME) is a hallmark component of an AMC. Our health care practice has experience counseling on Medicare billing requirements under the physicians at teaching hospitals rules and other GME-related regulations, as well as experience assisting with complex Medicare cost reporting disputes related to GME reimbursement. We provide education and advice on moonlighting, resident supervision, and inbound and outbound resident exchange agreements. We have also represented AMCs on faculty and resident corrective actions as well as international expansion efforts and foreign campus development.

School of Medicine

We have a number of lawyers on our team who were formerly in-house at various AMCs in roles that included supporting their respective schools of medicine in a variety of areas, including faculty physician employment and non-competition agreements, tenure policies, accreditation maintenance, academic affiliations with clinical sites, faculty personnel issues, and other medical education considerations.

AMC Affiliations and Health Care Transactions

Our experienced transactional lawyers represent AMCs in mergers and acquisitions, divestitures, joint ventures, and strategic alliances, all of which are becoming increasingly common as the health care industry consolidates. We routinely support AMCs in the consummation of acquisitions and affiliations, advising on the various fraud and abuse, licensure, enrollment, and corporate and tax considerations to structuring these initiatives. Additionally, we help AMCs access growth capital markets and invest in emerging companies. Our experience extends to assisting in a full range of financing vehicles to access the public finance market, venture capital, or strategic investment partnerships.

Mission Support, Funds Flow, and Faculty Physician Compensation Plans

Advising on compliance with federal fraud and abuse laws in an AMC-specific context is a core strength of our practice. We frequently advise AMC clients on Stark-compliant approaches to faculty physician compensation, mission support, and intra-AMC funds flow design. We also provide False Claims Act compliance counseling with respect to clinical research billing practices. In defending against investigations, audits, and qui tam actions, we provide deep regulatory and reimbursement knowledge, as well as significant experience in working with government regulators, defending enforcement actions and lawsuits, and successfully navigating investigations.

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