The eighth edition of AHLA's Fundamentals of Health Law provides a comprehensive overview of the health care industry's legal and regulatory landscape. For any health law professional, a fundamental understanding of these key concepts and their far-reaching implications is a prerequisite.
Anjali N.C. Downs is a partner of Epstein Becker Green’s Health Care and Life Sciences Practice in the firm’s Washington, D.C., office. She practices in the firm’s Health Care Fraud Practice Group, which focuses on federal and state fraud issues, including anti-kickback, self-referral, false claims, secondary payer issues, and false billings. Ms. Downs represents a variety of health care and life science organizations including health systems, pharmaceutical and medical device manufacturers, pharmacies, clinical laboratories, academic medical centers, physician group practices, dialysis providers, and medical transportation providers.Ms. Downs’ experiences include conducting internal health regulatory investigations; assisting clients in preparing self-disclosures and advisory opinion requests; representing and defending health care entities undergoing government investigations, inquiries and audits; assisting clients in developing, implementing, and evaluating corporate compliance programs; and advising clients on physician contracting arrangements in a variety of health care joint ventures.
In 2017, Ms. Downs was selected to the Washington DC Rising Stars list in the area of Health Care.
Bernadette M. Broccolo (Editor), is a partner in the Chicago office of McDermott Will & Emery LLP and has been counseling health industry organizations for more than 38 years on complex health industry innovation strategies, most recently including provider networks and big data strategies for transitioning to value-based care, development and deployment of digital health solutions, formation of electronic health information networks and exchanges to support improvements health care quality and accountability, and collaborations for streamlining and accelerating innovations in digital health, translational research and precision medicine. Her specialties include the full scope of legal and regulatory compliance in the areas of federal taxation of exempt organizations and not-for-profit corporate governance, privacy, human subject protection, and technology contracting. Bernadette is a frequent speaker and author on topics in her areas of practice.
She is co-author of Tax-Exempt Status of Health Care Organizations, which is part of BNA’s Health Law & Business Series. She has served in numerous leadership positions for organizations serving the health industry and the legal profession, including the Board of Directors of the American Health Lawyers Association (AHLA) and she is an AHLA Fellow. She has been selected by her peers to be included in The Best Lawyers in America for her expertise in health care law and was named Best Lawyers’ Chicago Health Care Lawyer of the Year for 2010. Bernadette is listed as a leading individual in health care in Chambers USA: America’s Leading Lawyers for Business, US Healthcare Expert Guide (EuroMoney Legal Media Group), Illinois Super Lawyer, and Leading Lawyers Network.
Anita Beth Adams is a member of the Health Care Group at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, with a primary focus on advising clients on practice acquisitions, mergers and joint ventures. Clients have included physician practice management companies, individual physicians, physician groups and ambulatory surgery centers. Ms. Adams builds her health care experience on a broad background of business law, which includes assisting clients with tax issues, transaction structuring, strategic planning and entity formation, joint ventures, mergers and acquisitions, corporate reorganizations, sale and lease agreements, and master service agreements.
Prior to moving to Jackson and joining Baker Donelson, Ms. Adams practiced at Willkie, Farr & Gallagher, LLP, in New York City, and at Neese & Adams in Corinth, Mississippi.
Barry D. Alexander is a Shareholder of Polsinelli PC, where he provides strategic legal advice to a wide range of health care providers, specialty pharmaceutical and medical device companies, and private equity investors on the complex legal and regulatory environment surrounding the health care industry including reimbursement, billing, and compliance matters arising under the Medicare and Medicaid programs and the implications to business operations in a dynamically changing health care market. He defends health care providers and suppliers under government investigations and audits including those charged with violations of the Federal Civil False Claims Act and he represents organizations in reimbursement-related commercial payer disputes.
Barry is a frequent lecturer on Medicare reimbursement matters, an author of numerous publications, and a past Board Member of the American Health Lawyers Association.
Anthony H. Choe is a Counsel with Polsinelli PC. He advises provider-sponsored health plans, health care providers, telehealth companies, private equity sponsors and other industry stakeholders on health care regulatory, compliance, and transactional matters. He routinely advises clients on matters involving Medicare Advantage, Prescription Drug Program, Medicaid managed care, TRICARE and commercial payer reimbursement issues and disputes. Tony speaks regularly at national conferences and currently serves on the planning committee for the AHLA Fundamentals of Health Law program.
Anthea R. Daniels is Vice President and General Counsel at Akron Children’s Hospital. Anthea is the past president of the American Health Lawyers Association (AHLA). She also chaired AHLA’s Fundamentals of Law Program, the Women’s Leadership Council, and the AHLA Mentoring Program and is an AHLA Fellow. Anthea is past chairman and president of the Northeast Ohio Chapter of The Healthcare Financial Management Association where she received its Founders, Merit, and Muncie Gold Awards. Anthea is recognized as a “Leading Lawyer for Healthcare” by Chambers USA and has been named an Ohio “Super Lawyer.”
Rebecca E. Dittrich is an associate in Reed Smith’s Life Sciences Health Industry Group, practicing in the area of health care regulatory law. Her work focuses on fraud and abuse issues, regulatory compliance, health care licensing, and Medicare reimbursement. She has assisted a variety of health care providers, suppliers, and manufacturers in regulatory, compliance, and transactional matters, including DMEPOS suppliers, pharmacies, postacute care providers, and medical device and pharmaceutical manufacturers. Rebecca received her J.D. from Georgetown University Law Center and her M.P.H from Johns Hopkins Bloomberg School of Public Health.
Sandra M. DiVarco is a partner in the law firm of McDermott Will & Emery LLP and is based in the firm’s Chicago office. Sandy focuses her practice on the representation of hospitals and health systems. She has counseled health care facility and system clients regarding all aspects of health law transactions and health system restructurings.
In addition to maintaining an active transactional practice, Sandy has a deep knowledge of regulatory, licensing and accreditation issues of particular concern to health care providers in today’s heightened enforcement climate. Sandy regularly advises clients on the legal aspects of clinical regulatory issues and policy/procedure and operational matters. A significant component of her practice involves assisting health care provider clients across the United States with regulatory, licensure, and accreditation issues, including state-level and Centers for Medicare and Medicaid Services (CMS) survey responses, formulation of successful plans of correction, Joint Commission complaint responses, and Emergency Medical Treatment and Active Labor Act (EMTALA)/regulatory investigations. Drawing on her experience as a registered nurse, and holding a current license in the state of Illinois, Sandy brings a pragmatic perspective and first-hand knowledge of health care operations to these complex and mission-critical matters. Sandy has worked extensively with Catholic organizations within health care and other business areas on transactions, restructurings and internal inquiries. Prior to practicing law, Sandy worked in an intensive care unit as a registered nurse and as a risk manager at a large academic medical center in Chicago. While in law school, she was a member of the Loyola Law Journal and served as a student articles editor. Sandy is a member of the Firm’s Gender Diversity Committee.
Sandy is recognized by The Best Lawyers in America 2013 to 2018, Health Care Law and Chambers USA 2013 to 2017.
Geoff A. Drucker oversees the Dispute Resolution Service of the American Health Lawyers Association. He is also an adjunct professor at the George Washington University School of Law, teaching Mediation and Alternative Dispute Resolution.
Geoff is on the Board of Directors of the Northern Virginia Mediation Service. His first book, Resolving 21st Century Disputes: Best Practices for a Fast-Paced World (Prospecta Press) was published in 2012. Geoff received a B.A. with distinction from Stanford University in 1982, a J.D. from the UCLA School of Law in 1985, and an M.S. in Conflict Analysis and Resolution from George Mason University in 1997.
Catherine (Katie) A. Hurley is counsel in Reed Smith’s Life Sciences Health Industry Group, specializing in health care regulatory matters. Katie’s practice covers a wide range of complex regulatory matters ranging from government health care fraud investigations to conducting regulatory due diligence and obtaining regulatory approvals in connection with health care transactions. She has particular experience with health care anti-fraud laws, such as the federal anti-kickback statute and related prohibitions under federal and state law and the physician self-referral or Stark law.
Raymond J. Lindholm is an Associate of Polsinelli PC. He provides guidance on matters ranging from government investigations in fraud and abuse, and administrative audits and appeals, to regulatory advisement related to general corporate contracting and operational issues. Raymond has experience assisting health care organizations under government investigation, representing clients in third party payment disputes with commercial and government payers, and negotiating and drafting agreements related to joint ventures. In addition, he has extensive experience assisting clients with licensure and enrollment issues.
Carol Colborn Loepere is a partner and former Chair of Reed Smith’s Life Sciences Health Industry Group, practicing in the area of health care regulatory law. She also serves on the firm’s Executive Committee. For over 30 years, she has counseled on regulatory and legislative initiatives affecting health care providers and suppliers including Medicare and Medicaid coverage and reimbursement issues, survey and certification, and contractual arrangements. She also advises clients on business transactions for compliance with physician self-referral and anti-kickback laws, and represents clients in False Claims Act and other government proceedings and investigations.
Carol specializes in advising clients on the regulatory requirements and business considerations in connection with health care transactions in the health care industry, focusing on due diligence, change of ownership (CHOW) issues, regulatory approvals and related regulatory issues. Carol is recognized as a leading lawyer in health care law by Chambers USA (2009–2016), as a leading lawyer by Legal 500, and as a Life Sciences Star by LMG Life Sciences (2013–2015).
Thomas Wm. Mayo is the Altshuler University Distinguished Teaching Professor and Professor of Law in the Dedman School of Law at Southern Methodist University, Adjunct Associate Professor of Internal Medicine at the University of Texas - Southwestern Medical School; and Of Counsel, Haynes and Boone, all in Dallas. He teaches courses in torts, legislation, nonprofit organizations, health care law, and bioethics and law, as well as a literature course for medical students and law students together (titled, unsurprisingly, “Law, Literature & Medicine”).
He co-chairs two hospital ethics committees and is co-founder of the Legal Hospice of Texas, the state’s first pro bono legal clinic for persons with HIV disease and persons with terminal illnesses. He also was the long-time poetry columnist for the Dallas Morning News.
John J. (Jeff) Miles is an attorney in the Washington, D.C. office of Baker Donelson. Jeff has limited his practice to antitrust law for over 35 years; the vast majority of his practice involves antitrust issues in the health-care sector. Previously, Jeff was the Assistant Attorney General in charge of the Virginia Attorney General’s Antitrust Unit and then a Trial Attorney with the Antitrust Division of the U.S. Department of Justice in Washington.
He has undergraduate and graduate degrees in economics from Virginia Tech and a law degree, magna cum laude, from the Washington & Lee University School of Law, where he now serves as an adjunct professor of law teaching the antitrust law course. In addition to his law practice and teaching, he writes and updates yearly a multi-volume treatise on health-care antitrust law. He is an AHLA Fellow.
Yetunde Oni is an associate in Reed Smith’s Life Sciences Health Industry Group, practicing in the area of health care regulatory law. Her practice focuses on regulatory and transactional matters for a variety of health industry clients, including but not limited to, drug and device manufacturers, health care providers and suppliers such as postacute providers, pharmacies, and DMEPOS suppliers. Yetunde’s practice also covers a broad range of regulatory matters including FDA compliance issues, fraud and abuse compliance, and health care transaction requirements such as due diligence, change of ownership, and facility or provider licensing.
Prior to joining Reed Smith, Yetunde worked in the pharmaceutical industry, with Pfizer Inc., as a research scientist focusing on clinical trials for vaccines. Yetunde has a Master’s degree in Biotechnology, from University of Pennsylvania, and received her law degree from University of Maryland, Francis King Carey School of Law.
Kristen Rosati is a partner at Coppersmith Brockelman, PLC. She has deep experience in all things “Big Data,” including HIPAA compliance and data breaches, health information exchange, data sharing for research and clinical integration initiatives, clinical research compliance, clinical trials contracting, and biobanking and genomic privacy. Kristen Rosati is a Past President of the American Health Lawyers Association and currently serves on the planning committee for the AHLA’s Academic Medical Centers and Teaching Hospitals Institute.
Kristen has been listed in Best Lawyers in America for health care since 2007, was Best Lawyers’ 2017 and 2014 Phoenix Health Care Law “Lawyer of the Year” and is ranked by Chambers and Superlawyers. She was chosen as one of the Outstanding Business Women in Arizona in 2017 and one of the 50 Most Influential Women in Arizona Business in 2013, and received the Health Care Leadership Award for Legal Advocate of the Year in 2014. Kristen received her B.A., with high honors, and her J.D., cum laude, from the University of Michigan. She clerked for the late Judge Thomas Tang of the U.S. Court of Appeals for the Ninth Circuit and for Judge Earl H. Carroll of the U.S. District Court for the District of Arizona.
Ross E. Sallade is a Shareholder in Polsinelli, PC. Ross helps clients navigate state and federal health care regulatory challenges. He regularly counsels clients on structuring business transactions and relationships in compliance with federal and state regulations, including change of ownership requirements and Medicare provider-based guidelines. He counsels clients on program enrollment, state licensure, provider and supplier reimbursement, health care operational matters, diligence support in connection with transactions, compliance with fraud and abuse laws including the Federal Anti-Kickback and Federal Physician Self-Referral (Stark) laws, and professional service and management service agreements, including controlled professional corporations.
Michael F. Schaff(Concept Editor) is co-chair of the Corporate and Health Law practice groups and a member of the Management Committee at Wilentz Goldman & Spitzer PA. He has over 30 years of experience representing hospitals, ambulatory surgical centers, physician groups, and other health care providers in all areas of health care law, including in connection with the formation and structure of joint ventures and private equity investments in health care. On the corporate side, Michael advises start-ups and established businesses of all sizes on matters ranging from simple to complex agreements, entity formation and regulatory compliance, to purchases or sales and strategic transactions.
Michael is an active member of the American Health Law Association, having served in several of the organization's leadership positions, including as a member of the Board of Directors, Executive and Finance Committees, and Chair of AHLA’s Physician Organizations Practice Group. In 2018, he was the recipient of the prestigious David J. Greenburg Service Award. Michael is currently an AHLA Fellow and a member of the AHLA Fellows Coordinating Committee. He is a Trustee of the New Jersey State Bar Association and an Emeritus Director of its Health Law Section.
Widely recognized as a leader in health care law, Michael has received numerous honors and awards. Chambers USA has consistently ranked him among the top health care attorneys in New Jersey since 2011, including as a "Star Individual" in 2020. Best Lawyers in America has recognized Michael every year since 2003, including as "Lawyer of the Year" for Business Organizations in 2021 and for Health Care Law in 2012 and 2016–2018. He has also been included in New Jersey Super Lawyers since its inception and in the "Top 100" list since 2007.
is General Counsel for Southwest General Health Center and serves Of Counsel at Kohrman Jackson & Krantz PLL in Cleveland, Ohio. Susan is known as one of Ohio’s leading health care attorneys and is the author of the book “Ohio Health Care Provider Law,” which has been relied upon in health care law across the state for more than 20 years. Susan works on regulatory and compliance matters, medical staff and licensing issues, contract negotiations, litigation, tax-exempt issues, and general corporate law. Susan also serves as the Editor-in-Chief of AHLA’s Journal of Health & Life Sciences Law. Susan’s contributions to the field of health care law across her 35-year legal career have been recognized locally and nationally. She is a current fellow and former board member of the American Health Law Association, was honored with the Distinguished Women in Healthcare award from the Visiting Nurse Association and is often called upon to speak on health care law topics and contribute to publications. She is an attorney equally respected among medical staffs and health care executives.
Daniel J. Schwartz is a Shareholder in the St. Louis, MO, law firm of Greensfelder, Hemker & Gale, PC. He has practiced primarily in the employee benefits area since 1977, during which he has provided advice on all facets of employee benefits and has represented clients in court in ERISA litigation matters.
In 2017, Mr. Schwartz represented a large health care organization in a landmark ERISA case before the U.S. Supreme Court. He is the author of a Bloomberg BNA Tax Management Portfolio entitled Employee Benefits for Tax-Exempt Organizations. Mr. Schwartz was named to the IRS Advisory Committee on Tax Exempt and Government Entities (ACT) by the United States Department of Treasury and served as an advisor to the IRS during 2006, 2007 and 2008.
In 2000, Mr. Schwartz was elected as a Charter Fellow of the American Academy of Employee Benefits Counsel. Mr. Schwartz received his undergraduate degree from the University of Missouri-Columbia (1974, Phi Beta Kappa) and his law degree from the University of Missouri-Kansas City (1977, Law Review).
Nancy A. Sheliga is a health policy analyst for Reed Smith’s Life Sciences Health Industry Group, focusing on health care regulatory law. She works primarily on matters involving licensing and enrollment of health care facilities, Medicare reimbursement, and other state and federal regulatory issues.
Nancy has a significant background and experience preparing state licensing and federal Medicare and Medicaid enrollment materials for pharmacies, durable medical equipment suppliers, skilled nursing facilities, and other health care businesses. She also has particular familiarity with compliance matters, having frequently been involved in analyzing the reporting requirements of prior sanctions and disciplinary actions.
Kerrin B. Slattery is a partner at McDermott Will & Emery LLP. Ms. Slattery represents hospitals and health systems, as well as other health industry providers and investors across the country. She has significant experience in all aspects of health industry transactions, including mergers, acquisitions, affiliations, joint ventures, and system restructurings. She also advises health industry clients on accountable care strategies and hospital-physician integration initiatives. Additionally, Ms. Slattery regularly advises health industry clients on corporate and regulatory compliance matters, including licensure, fraud and abuse laws, accreditation, and other state and federal regulations.
Craig H. Smith is a partner in the law firm of Hogan Lovells US LLP and is based in the firm’s Miami office. Craig is Board Certified in Health Law by the Florida Bar and is the partner-in-charge of the firm’s Health Care practice in Florida. Craig previously served as General Counsel for Florida’s Agency for Health Care Administration, where he supervised a team of 42 lawyers and oversaw all legal matters for the Florida agency that administers the nation’s third largest Medicaid program and licenses over 32,000 health care facilities. At Hogan Lovells, Craig advises healthcare industry clients on complex transactions as well as compliance and internal investigation matters, and Chambers USA ranks him in its top band of healthcare lawyers in Florida.
Melissa A. Soliz is a Partner at Coppersmith Brockelman PLC in Phoenix, Arizona. The focus of her regulatory health care practice is on federal and state confidentiality laws (with an emphasis on 42 C.F.R. Part 2), data sharing for health information exchange and research, data breach reporting, regulatory compliance and contracting for human subjects research, Arizona licensing and scope of practice requirements, and other state and federal regulatory requirements applicable to health care organizations.