Client Services / Health / Academic Medical Centers

Academic Medical Centers

Our Firm represents all components of the complex entities known as academic medical centers (AMCs). These include medical schools, teaching hospitals, faculty practice foundations and research institutes.  Our lawyers have assisted academic medical centers with respect to a wide variety of legal, regulatory and corporate issues.  In addition, lawyers in our Health, Intellectual Property, White Collar Crime and Trial groups represent academic medical centers in a wide range of disputes, including governmental investigations.  The following represents a summary of the types of matters we typically handle on behalf of AMCs and universities.


ACQUISITIONS/TRANSACTIONS

Our Firm has a vast base of experience in acquisitions, affiliations and other AMC transactions.  For example, we represented a proprietary hospital chain in its acquisition of a medical school and its affiliated seven-hospital academic health system.  We also represents public universities in a variety of transactional matters, including joint ventures with for-profit hospitals, assisting a large state university-affiliated medical center in the development of affiliation models with its voluntary faculty; assisting another state university in its efforts to assist a medical group “disengage” from a joint venture with a proprietary hospital chain; and advising in connection with the integration of the physician faculty of state-affiliated medical school with a for-profit private medical group.  Additionally, we have served as borrower’s counsel and bond counsel in the financing of AMCs and advised the medical centers on routine tax, employee benefit and corporate governance matters.


DRUGS & MEDICAL DEVICES

Our lawyers have experience in advising AMCs on Food and Drug Administration (FDA) compliance, payor reimbursement, drug pricing and pharmaceutical matters.  Our medical device and pharmaceutical lawyers have provided legislative assistance to many of our AMC clients.


FDA, NIH, NCI & APHIS COMPLIANCE

We represent AMCs on FDA, National Institutes of Health (NIH), National Cancer Institute (NCI) and Animal and Plant Health Inspection Service (APHIS) human subjects, laboratory, and animal welfare related regulatory matters.  Our experience includes advising AMCs on FDA and NIH policies, procedures and other compliance matters; preparation for and representation during inspections and audits of device and drug trials; representation in enforcement actions including replies to 483s, warning letters, and administrative, civil and criminal matters; and advising on establishing organizations to conduct clinical research, including negotiating clinical trial agreements on behalf of sponsors and clinical investigators.  Recently, our lawyers represented a large teaching hospital in a highly visible FDA and NIH investigation that involved allegations of use of unapproved drugs in clinical studies.  In addition, McDermott Will & Emery continues to represent a major teaching hospital and its IRB in review of actions by clinical investigators and audits by FDA and the Office of Human Subjects Research (OHSR)/Office of Human Research Protection (OHRP), including conducting unauthorized device studies, unauthorized drug studies, and irregularities involving informed consent, confidentiality, protocol deviations and unauthorized use of tissues.  We have also represented a hospital and affiliated research institute in an FDA inspection of IRB and sponsor/investigator conduct of drug studies involving numerous allegations of protocol violations, lapsed protocols, and other IND and MPA violations.


HIPAA FOR AMCs

We have advised academic medical center clients on Health Insurance Accountability and Portability Act (HIPAA) implementation, including hybrid entity and affiliated group analyses, HIPAA/Family Educational Rights and Privacy Act (FERPA), research and IRB issues, fundraising and other AMC-specific issues.  Our Firm has developed a comprehensive, user-friendly course in conjunction with the University of Southern California for educating the work force at medical schools and AMCs on HIPAA related issues.  Our lawyers have frequently lectured on the impact of HIPAA on both AMC clinical operations and research.


INTELLECTUAL PROPERTY & TECHNOLOGY

We represent universities, research institutes and teaching hospitals in patent prosecution, technology transfer and other intellectual property issues.  Our intellectual property lawyers have worked in-house in university technology development and transfer offices.


MANAGED CARE

We assist numerous AMCs with managed care relationships and issues.  These engagements include everything from establishing physician-hospital organizations (often in conjunction with community physicians), advising medical centers on managed care contracting strategies, to creating university-sponsored HMOs.


PATH & MEDICARE TEACHING PHYSICIAN RULES

Our Firm has extensive historical experience with the Medicare teaching physician rules, IL-372 and Physicians at Teaching Hospitals (PATH) audits as well as the types of coding, payment and documentation issues that arise in the Office of Inspector General (OIG) PATH audit process and related qui tam lawsuits.  Upon the introduction of the Medicare teaching physician rules in June 1996, one of our lawyers conducted a national education series with Jim Sheehan, Esq., U.S. Attorney's Office, Philadelphia, who had recently spearheaded the University of Pennsylvania PATH I settlement, and with Grant Bagley, M.D., J.D., who co-authored the teaching physician rules while at the Health Care Financing Administration (HCFA).  Our lawyers speak and write frequently on the Medicare and Medicaid claims process, coding, documentation, medical necessity and false claims defense, including presentations for the American Health Law Association (AHLA) and American Bar Association (ABA) on PATH issues.


PRACTICE PLANS

We have represented numerous clients in connection with formation, operation, and tax exemption of practice plans, and conducting internal compliance audits.  One of our lawyers authored the leading treatise on faculty practice plans.


REIMBURSEMENT

Our Firm has represented numerous clients in connection with Medicare and other appeals of their direct medical education (GME) and indirect medical education (IME) expenses.  For example, our lawyers represented Thomas Jefferson University in an appeal before the United States Supreme Court, and obtained a favorable decision for Loyola University of Chicago in the Seventh Circuit Court of Appeals.  Additionally, for Barnes Hospital, we obtained one of the largest GME awards ordered in the history of the Provider Reimbursement Review Board.  Our lawyers also have advised many AMCs on Medicare reimbursement issues involving routine cost limit matters.  We have also structured GME/IME FTE cap affiliation agreements, outpatient training site agreements, and assisted clients in analyzing the GME/IME effects of closing residency programs, accepting “stranded” residents, and expanding and contracting programs.


RESEARCH

We offer a full range of legal services related to human subjects research and OHPR regulatory matters.  Among our lawyers are physicians, pharmacists, former FDA, Justice Department and other government officials, Institutional Review Board (IRB) members, and others who advise and assist teaching hospitals, medical schools, faculty practice foundations and research institutes, with issues relating to clinical trials and epidemiological studies, both in the U.S. and internationally.  We regularly advise clients with respect to OHRP regulations, including, for example, informed consent and privacy issues.  We also advise clients in responding to OHRP inquiries regarding research protocols and IRB procedures, and assist clients in developing compliance plans, revising and streamlining IRB operations manuals, and implementing carefully-designed internal audits to identify areas in need of improvement. Our Health Department has created an IRB Binder containing statutes, regulations, articles and other information of use to research institutions and their IRBs and provides periodic updates of these materials through IRB Updates.  Clients can also request electronic IRB Blasts, which provide weekly citations to articles and events related to human subjects research.


RESIDENCIES

We represent residency training programs in AMCs across the United States.  Our experience extends across the range of disciplines and covers virtually all of the specialties in which training is provided under the auspices of the Accreditation Council on Graduate Medical Education (ACGME).  Our involvement ranges from general consultation and advice to programs at teaching hospitals about the accreditation process to far more detailed evaluation and representation in accreditation disputes.  Specifically, our lawyers have counseled many residency training programs on proper evaluation of data, preparation of Program Information Forms, planning for site surveys, avoiding accreditation difficulties, and strategies for maintaining compliance with the Institutional Requirements and the various Program Requirements contained in the Essentials of Accredited Residencies as published by the ACGME.  We have also represented residency training programs that have been cited as deficient in specific areas by the applicable RRC by reviewing the citations assessed and advising appropriate courses of action for residencies to follow.


STARK/FRAUD & ABUSE

Our Firm has substantial experience in the fraud and abuse and Stark self-referral areas and has advised numerous AMC clients on the consequences of the many and varied payment arrangements that typically exist between hospitals, medical schools, and teaching physicians.  Our lawyers have designed and conducted compliance audits of teaching hospitals, faculty practice plans and medical schools.


TAX

Our Firm maintains a significant practice in representing AMCs and universities on matters affecting their tax exemptions, both tax and property.  One of our lawyers, while at the IRS, authored its University Audit Guidelines, which provide valuable insight on exemption issues.  Our Employee Benefits Department has also created benefit plans for AMC clients and affiliated faculty practice plans.


REPRESENTATIVE TRANSACTIONS

Representation of Partners HealthCare System in the merger of seven faculty practice plans to form Brigham and Women’s Physician Organization.

Ongoing representation of Dana-Farber/Partners Cancer Care, a pathbreaking clinical and financial joint venture among Dana-Farber Cancer Institute, Massachusetts General Hospital and Brigham and Women’s Hospital.

Representation of Florida Proton Therapy Institute, an affiliate of the University of Florida College of Medicine, in securing tax-exempt status and creating a unique debt structure.

Ongoing representation of University of Southern California in the formation and ongoing operational and compliance issues for 18 departmental faculty practice plans, and development of HIPAA compliance and training.

Representation of a large western public university’s medical center and school of medicine in faculty, compliance and PATH issues.

Representation of Doheny Eye Institute in the formation of a dedicated retina institute and ongoing technology development and transfer activities. 

Representation of a major research university in an OHRP investigation.

Representation of a large teaching hospital in the renegotiation of its contractual arrangements with a medical school.  Representation of proprietary hospital chain in its acquisition of a medical school and its affiliated seven-hospital academic health system; spin-off and long-term affiliation of medical school’s Department of Pediatrics.

Representation of a multi-campus system during its five-year PATH audit process, including negotiation with the Office of the Inspector General regarding the applicable protocols to be used in selection and review of the PATH chart audits and applicable standards for the review, participation in chart audit conferences, and settlement negotiation. 

Representation of a medical specialty group in negotiating the settlement of qui tam allegations relating to Medicaid teaching physician rules and an AMC-based emergency medical group in connection with an OIG audit of claims including issues of coding and compliance with the Medicare teaching physician supervision requirements.  In concert with our coding consultants, we were able to significantly reduce the OIG’s adverse findings.

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Health Client Services

McDermott Will & Emery

McDermott Will and Emery