2018 Health Law and Policy Summer Institute Faculty
Daniel Kracov is a partner with Arnold & Porter and co-head of the firm's Life Sciences and Healthcare Regulatory practice. He assists companies, trade associations and individuals in negotiating the broad range of regulatory and compliance challenges relating to the development, approval, manufacture, and marketing of drugs, biologics, medical devices and diagnostics. He handles complex investigations and enforcement matters, the development of corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized expertise in biomedical product-related public policy matters, including Congressional investigations. Mr. Kracov received his JD from the University of Virginia School of Law and his BA, magna cum laude, from the University of Maryland.
Mr. Kracov will be teaching Pharmaceuticals and the Law in the 2018 Health Law & Policy Summer Institute.
Derek Kung serves as the VP and General Counsel for MedAssist with broad expertise in corporate affairs and healthcare regulatory matters. He has worked with various provider types across the healthcare industry spectrum, including physician practices, laboratories, skilled nursing facilities and hospitals. Mr. Kung's experience includes advising clients on Stark, Anti-Kickback, and other fraud and abuse laws; investigating compliance related matters; HIPAA and various other federal and state privacy statutes and regulations. Mr. Kung has experience in mergers and acquisitions, structuring joint ventures, and other corporate transactional matters. Prior to joining MedAssist, he was with a law firm's corporate health care group and former general counsel of a clinical laboratory. Derek holds a BA, Economics from Georgetown University in Washington, DC as well as a Juris Doctor from Emory University School of Law in Atlanta, GA. He will be co-teaching Health Care Technology.
Professor Kung will be teaching Health Care Business Transactions in the 2018 Health Law & Policy Summer Institute.
Kristi Kung is a Counsel in Sheppard Mullin Richter & Hampton’s Health Care practice, located in the Washington, DC office. She represents health care industry clients in a range of regulatory, compliance, and transactional healthcare matters including: fraud and abuse counseling (Anti-Kickback Statute, Stark Law, and False Claims Act issues), federal and state health regulatory compliance counseling, risk assessments and compliance program development, health information privacy and security, billing and reimbursement matters, and licensing and accreditation of healthcare providers and suppliers.
Ms. Kung's portfolio includes the evolving area of telemedicine, mobile health and the use of big data, with an emphasis on federal and state regulatory compliance. She frequently advises telehealth companies and mobile health app developers on matters related to licensing, credentialing, reimbursement, corporate practice, privacy and security, fraud and abuse, and FDA oversight, among other legal and compliance obstacles. She also works with hospitals seeking to expand patient access and specialty coverage through the use of e-health technologies. Ms. Kung holds a Bachelor of Science in Interdisciplinary Studies – Law and Health from Michigan State University as well as a Juris Doctor from Emory University School of Law in Atlanta.
Professor Kung will be teaching Digital Health and the Law in the 2018 Health Law & Policy Summer Institute.
Rosemary Maxwell, counsel with Arnold & Porter, 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.
Ms. Maxwell will serve as an expert guest lecturer for Pharmaceuticals and the Law in the 2018 Health Law & Policy Summer Institute.
Allison Shuren is a partner with Arnold & Porter and 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.
Ms. Shuren will serve as an expert guest lecturer for Pharmaceuticals and the Law in the 2018 Health Law & Policy Summer Institute.