2015 Health Law & Policy Summer Institute Faculty
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. He will be co-teaching Pharmaceuticals and the Law.
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.
Kristi Kung is a Senior Associate in Pillsbury Winthrop Shaw Pittman's Health Care practice, resident in the Washington, DC office. She represents health care industry clients in a range of regulatory, litigation, and transactional health care matters including: fraud and abuse counseling (anti-kickback statute, Stark Law, and False Claims Act issues), internal compliance investigations, responses to government anti-fraud enforcement actions and investigations, responses to government and third party payor audits (including RAC and ZPIC audits), Medicare/Medicaid enrollment and reimbursement issues, health information privacy and security compliance, licensing and accreditation of health care providers and suppliers, and contract drafting and deal structuring. She will be co-teaching Health Care Technology.
Her portfolio includes the evolving area of telemedicine, mobile health and social media, with an emphasis on federal and state regulatory compliance. Ms. Kung frequently advises telehealth companies and mobile health app developers on matters related to licensing, credentialing, reimbursement, corporate practice, privacy and security, 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 telehealth and mobile technology.
Prior to joining Pillsbury, Ms. Kung worked as a health care associate for another law firm and specialized in health care law. During law school, she worked at the Department of Health and Human Services - Office for Civil Rights in Atlanta, Georgia conducting legal research on the interaction between HIPAA and state laws and answering questions from the public and health care providers regarding HIPAA privacy.
Michael Ruggiero is Vice President, US Government Affairs and Policy for EMD Serono, the U.S.-based biopharmaceuticals division of Merck KGaA, of Darmstadt, Germany. He leads the function responsible for advising the company on the impact of U.S. policy on business strategy, and shaping the external policy environment to accomplish the company's business objectives. Mr. Ruggiero sits on the U.S. Country Leadership Team and the Global Government Affairs and Policy Leadership Team. Before joining EMD Serono, Mr. Ruggiero was Vice President, Government Strategy for Astellas Pharma US, Inc., where he led the function responsible for developing policy strategies to accomplish the company's business objectives; designed and led the first Astellas federal policy and government affairs function; and led cross-functional/regional initiatives to address government policy at a global level. He received his JD from Georgetown University Law Center. He will be co-teaching Pharmaceuticals and the Law.
Asha Scielzo is Special Counsel in the Health Care Group of Pillsbury Winthrop Shaw Pittman, LLP. Her practice consists of advising health systems, hospitals, academic medical centers, physician organizations, pharmaceutical companies and medical device companies in a broad range of health care transactional, compliance and regulatory matters, with specialized expertise in fraud and abuse counseling and transactions (hospital-physician, merger & acquisition, and private equity). Prior to joining Pillsbury, she practiced health care law for over eleven years with Jones Day. Professor Scielzo is an active leader and member of the American Health Lawyers Association (AHLA) and currently serves as the Chair of the Planning Committee for the AHLA Fundamentals of Health Law Conferences. In addition to teaching at American University Washington College of Law, she holds academic appointments at Loyola University Chicago School of Law and Georgetown University Law Center. She received her JD from Georgetown University Law Center. She will be teaching Health Care Fraud and Abuse and Health Care Mergers & Acquisitions. (Click here for a fuller bio.)