2017 Health Law & Policy Summer Institute Faculty
John T. Boese is a nationally recognized expert on the civil False Claims Act and its unique qui tam enforcement mechanism. He is the author of Civil False Claims and Qui Tam Actions (Wolters Kluwer Law & Business 4th ed.), a comprehensive, two-volume treatise on the civil False Claims Act and qui tam enforcement at both the federal and state levels. This book is cited as authority by courts at all levels—including the United States Supreme Court, eleven US Courts of Appeals, most federal district courts, and many state courts. It was cited by the Securities and Exchange Commission as a source for the SEC's rules on whistleblower awards.
Mr. Boese is of counsel in Fried, Frank, Harris, Shriver & Jacobson's Washington, DC office, where he served as managing partner as well as co-chair of its litigation department for many years. He has represented, and continues to represent, a broad range of defendants in numerous False Claims Act cases brought by qui tam relators or by the Department of Justice. These clients include defense contractors, pharmaceutical companies, construction companies, insurance companies, oil & gas companies, major retailers, import/export firms, computer manufacturers and service providers, hospitals, churches, universities, and airports. He has appeared in over 40 federal district courts, and has argued in most of the US Courts of Appeals.
Daniel Kracov is a partner at Arnold & Porter LLP, where he co-chairs the firm's FDA and Healthcare Practice Group. Mr. Kracov assists clients, including investors, start-up companies, trade associations, and large manufacturing companies, in negotiating the legal requirements relating to the development, approval, and marketing of drugs, biologics, and medical devices. He routinely handles FDA inspections, investigations, and enforcement matters. He also helps clients develop global corporate compliance programs, conducts compliance reviews and audits, and manages regulatory due diligence for financings, mergers and acquisitions. He has a widely-recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative initiatives. His expertise in FDA matters has been recognized by Chambers, the Legal Times, and numerous other publications.
Rosemary Maxwell focuses on healthcare compliance and public policy issues, Medicare and Medicaid coverage and reimbursement (including the Medicare Part D prescription drug benefit), Medicaid rebate calculations and related price reporting requirements, healthcare privacy law, and related regulatory issues affecting pharmaceutical and medical device manufacturers. Ms. Maxwell has represented drug and device manufacturers in preparing submissions to the Centers for Medicare and Medicaid Services, the US Department of Health and Human Services (HHS) Office of Inspector General, and other HHS agencies; in conducting compliance reviews and preparing compliance policies; in litigation matters involving allegations of fraud against Medicare and Medicaid; in internal investigations; and in a wide variety of counseling matters.
Joel Michaels advises clients on health care insurance and health care delivery system organization, financing and regulation. He provides legal counsel to national and regional health insurers across the United States, in addition to advising pharmacy benefit managers, specialty health care service vendors and national health care associations. He served as the partner-in-charge of the Washington Health Industry Advisory Practice Group for over 15 years and is the co-chair of the Firm's Insurance/Payers Affinity Group. He is one of the few health care attorneys nationwide to receive top-tier recognition by Chambers in both the transactional and health care regulatory categories.
Mr. Michaels assists clients in health insurance regulatory issues at the state and federal levels, including the new demands presented by the Affordable Care Act. He also has been instrumental in developing new payment and provider contracting strategies that reflect value-based purchasing between payors and providers. His work has extended to today's cutting-edge issues related to prescription drug pricing and the challenges they present to health insurers and pharmacy benefit managers. He has a long-standing relationship with the Blue Cross Blue Shield Association and works closely with the Pharmaceutical Care Management Association.
Asha Scielzo is Law and Government Health Law & Policy Fellow and Adjunct Associate Professor of Law. In this leadership role, Professor Scielzo assists with development of the health law and policy curriculum, recruitment of adjunct professors, expansion of health law externships, career counseling, career panels and other programming. She advises the student-led Health Law & Policy Brief and Health Law & Policy Students Association. She founded and manages the annual WCL National Health Law Writing Competition and directs the annual Health Law & Policy Summer Institute.
Professor Scielzo brings over 15 years of large law firm practice experience to the law school. As a practitioner, she concentrated her practice on health care regulatory counseling, with significant expertise in fraud and abuse and reimbursement considerations and their impact on day-to-day operations, corporate compliance and governance, and transactions.
Allison Shuren co-chairs the Life Sciences and Healthcare Regulation Practice and advises a wide range of health care clients on regulatory, compliance, enforcement, and legislative matters. Her clients include large international manufacturers of medical devices, pharmaceuticals, biologics, emerging companies with early stage concepts, hospitals and integrated health networks, ambulatory surgery centers, diagnostic testing facilities, clinical laboratories, dialysis centers physicians, physician practice management companies, and developers of mobile and digital health technology. A primary focus of Ms. Shuren’s practice is compliance with health regulatory requirements, especially the healthcare fraud and abuse laws. She counsels on complex referral arrangements as well as sales and marketing programs, including discounts and rebates, represents clients in government investigations and qui tam actions involving False Claims Act, Anti-Kickback Statute, Stark Law, and health care fraud allegations. She regularly interacts with the US Department of Health and Human Services Office of Inspector General, the US Department of Justice, and the Centers for Medicare and Medicaid Services. She also leads internal compliance investigations and regulatory due diligence related acquisitions and investments.