Volume 25 | Issue 1 Fall 2015 ANNALS OF HEALTH LAW THE HEALTH POLICY AND LAW REVIEW OF LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW BEAZLEY INSTITUTE FOR HEALTH LAW AND POLICY EDITOR-IN-CHIEF Ryan B. Marcus PUBLICATIONS EDITOR TECHNICAL PRODUCTION EDITOR Morgan Carr Amy Michelau ADVANCE DIRECTIVE EDITOR ADVANCE DIRECTIVE EDITOR Jennifer Fenton Elise Robie MARKETING & COORDINATING EDITOR SYMPOSIUM EDITOR Sumaya Noush Sarah Kitlinski ANNALS SENIOR EDITORS James Flannery Christopher MacKenzie Holly McCurdy Joseph Willuweit MEMBERS Amanda Bast Fannie Fang Matthew Meidell Arielle Berens Alyse Fischer Christian Morgan Yi Bu Melvin Gaddy Dennis Pangindian Gilbert Carillo MaryKathryn Hurd Victor Ramos Sarah Costa Marika Iszczyszyn Chloe Schultz Lindsey Croasdale Erica Jewell Brittany Tomkies Erin Dine Alanna Kroeker Stephanie Toth Laura Doyen Kaitlin Lavin Xavier Vergara FACULTY ADVISORS Lawrence E. Singer, J.D., M.H.S.A. Director and Professor of Law, Beazley Institute for Health Law and Policy Loyola University Chicago School of Law John D. Blum, J.D., M.H.S. John J. Waldron Research Professor of Health Law Loyola University Chicago School of Law BUSINESS MANAGER Kristin Finn VOLUME 25, ISSUE 1 WINTER 2016 ANNALS OF HEALTH LAW Advance Directive THE STUDENT HEALTH POLICY AND LAW REVIEW OF LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW BRINGING YOU THE LATEST DEVELOPMENTS IN HEALTH LAW Beazley Institute for Health Law and Policy VOLUME 25, STUDENT ISSUE 1 FALL 2015 CONTENTS Editor’s Note Elise Robie and Jennifer Fenton ARTICLES Integrating Legal Aid in the Medicaid Managed Care Model Lindsey Croasdale .............................................................................................................. 1 ACOs Face the Demographics Dilemma of Managed Care Matthew Meidell .............................................................................................................. 14 A for Effort, I for Innovation: Hospital Readmissions Reduction Program and Its Positive Progress Xavier Vergara ................................................................................................................. 26 The Sunshine Act: Casting a Shadow on Health Care Innovation Alanna Kroeker ................................................................................................................ 36 Uniting All Interests: Law and Regulation Must Facilitate Pharmacogenomic Development Melvin Gaddy .................................................................................................................. 50 Analyzing Recent Trends in the Debate Over Gene Patents: United States and Australia Christian Morgan ............................................................................................................. 64 Drug Transparency Laws Will Not Drive Pharmaceutical Prices Down and Will Only Stifle Innovation Gilbert Carrillo ................................................................................................................. 77 Power to the People: How Medical Mobile Apps Are Increasing Patient Knowledge and Changing the Doctor-Patient Relationship Sarah Costa ...................................................................................................................... 87 Tough Love: Why Patients Should Change Physician Expectations Alyse Fischer ................................................................................................................... 97 ANNALS OF HEALTH LAW Advance Directive Editors’ Note The Annals of Health Law is proud to present the Fifteenth Issue of our online, student-written publication, Advance Directive. Advance Directive aims to support and encourage student scholarship in the area of health law and policy. In this vein, this issue explores the legal, regulatory, and economic challenges to innovation in health care. Healthcare innovation may conventionally be thought of as limited to issues related to technology, or development of new drugs and therapies or medical devices; however, healthcare innovation is decidedly broader, encompassing a vast array of different industries, providers, and legal frameworks. Here, the authors examine a variety of topics on the issue of healthcare innovation, ranging from the integration of social services into the traditional medical model to policies relating to increased transparency within the pharmaceutical industry. This issue begins with a discussion of the managed care model. Our first author examines how integration of legal aid into the managed care model could expand access to preventive care, thereby decreasing overall healthcare costs for individuals. Thereafter, another author critiques the financial success of managed care models, focusing on how demographics might negatively impact such success. Our discussion continues with the impact the Affordable Care Act (“ACA”) has had on innovation. First, one author considers the Hospital Readmissions Reduction Program, established in Section 3025 of the ACA, and argues that the Centers for Medicare & Medicaid Services successfully utilized this program to lower readmission rates, thus contributing to lower costs for healthcare organizations overall. The next article offers an author’s perspective on how the ACA has impacted innovation, with a specific focus on the influence of the Physician Payment Sunshine Act (“Sunshine Act”). The author examines how the Sunshine Act has possibly discouraged physician cooperation or participation in the development and advancement of the industry. Additionally, we navigate current debates within the pharmaceutical industry. One author discusses the role of genetics in the industry, arguing in favor of the use of genetic information to improve the effectiveness of medication. Another author discusses the patentability of genetic information. Finally, we end our focus on the pharmaceutical industry with an author who argues that drug transparency could potentially stifle innovation, rather than having the intended effect of decreasing cost. Lastly, we evaluate how innovation affects the traditional doctor-patient relationship. One author notes that medical mobile applications affect this traditional relationship by increasing consumer knowledge and participation in the health care process but argues that the Food & Drug Administration must increase regulation on these types of applications for them to remain safe and effective. We then discuss the ACA’s mandate that healthcare organizations meet a certain minimum level of patient satisfaction to receive Medicare funding. In this realm, our final author discusses the possibility that an increased focus on patient satisfaction, especially with an increasingly engaged consumer population might negatively impact the quality of care provided. We would like to thank Amy Michelau, our Technical Production Editor, because without her knowledge and commitment this Issue would not have been possible. We would like to give special thanks to our Annals Editor-in-Chief, Ryan Marcus, for his leadership and support. The Annals Executive Board Members, Sarah Kitlinski, Sumaya Noush, Amy Michelau, and Morgan Carr, and the Annals Senior Editors, Holly McCurdy, James Flannery, Joseph Willuweit, and Christopher MacKenzie provided invaluable editorial assistance with this Issue. The Annals members deserve special recognition for their thoughtful and topical articles and for editing the work of their peers. Lastly, we must thank the Beazley Institute for Health Law and Policy and our faculty advisors, Professor Lawrence Singer, Professor John Blum, and Kristin Finn for their guidance and support. We hope you enjoy our Fifteenth Issue of Advance Directive. Sincerely, Elise Robie Jennifer Fenton Advance Directive Editor Advance Directive Editor Annals of Health Law Annals of Health Law Loyola University Chicago School of Law Loyola University Chicago School of Law ANNALS OF HEALTH LAW Advance Directive VOLUME 25 FALL 2015 PAGES 1-13 Integrating Legal Aid in the Medicaid Managed Care Model Lindsey Croasdale* I. INTRODUCTION With federal and state budgets in crisis, government health care spending on the rise, the passage of the Patient Protection and Affordable Care Act (“PPACA”),1 and the moral commitment to provide affordable, high-quality health care to indigent populations, there has been a push in recent years for innovation in the public health care delivery system to contain the cost of providing quality care in the face of expanding access pressures.2 In particular, thirty-one states have expanded their Medicaid programs3 and many states have implemented a managed care delivery system, often administered by Managed Care Organizations (“MCOs”), into their Medicaid programs in an effort to make the delivery of care more efficient and to provide health care at a lower cost.4 Managed care is a type of health care delivery system in which state agencies contract with insurers who in turn contract with health care providers and medical facilities to provide care for patients at reduced costs.5 As of March 2015, there were 275 Medicaid MCOs nationwide.6 Managed Care Organizations open a window for innovation in the delivery * J.D. Candidate, May 2017, Loyola University Chicago School of Law. I thank Emily Benfer and John Blum for their gracious guidance and support. 1. See generally Patient Protection and Affordable Care Act, Pub. L. No. 111–148, 124 Stat. 119 (2010) (to be codified in scattered sections of 42 U.S.C.). 2. Managed Care, MEDICAID.GOV, http://www.medicaid.gov/medicaid-chip-program- information/by-topics/delivery-systems/managed-care/managed-care-site.html