INDIANA HEALTH LAW REVIEW Volume 10 2013 Issue 2 TABLE OF CONTENTS Preface ................. ........................... ........... i AALS SYMPOSIUM ARTICLES: IMAGINING THE NEXT QUARTER CENTURY OF HEALTH CARE LAW Gaia Bernstein Unintended Consequences: Prohibitions on Gamete Donor Anonymity and the Fragile Practice of Surrogacy................... ............ 291 Kristin Madison Donabedian's Legacy: The Future of Health Care Quality Law and Policy.................... .............................. ..... 325 Barbara J. Evans Why the Common Rule is Hard to Amend ........................ 365 Peter J. Hammer Health Evolution: (Quality = Learning) + (Ethics = Justice) .......... .... 415 Efthimios Parasidis Health Outcomes Metrics and the Role of Financial Derivative Instruments in the Health Care Industry ............................ 447 ARTICLES Crystal T. Williams Where's the Beef? An Examination of the "Pink Slime" Controversy and the Implications of the REAL Beef Act on State Truth-in-Menu Laws............... Jennifer S. Bard Putting Patients First: How the FDA Could Use Its Existing Powers To Reduce Post-Market Adverse Events.. ......................... 473 495 NOTES Kyle R. Wood NCAA Student-Athlete Health Care: Antitrust Concerns Regarding the Insurance Coverage Certification Requirement............... ..... 561 Frandy St. Louis The Decline of Mandatory Physical Education in Grade Schools Resulted in the Current Childhood Obesity Crisis and Consequently an Unsustainable Rise in Health Care Spending...................... 629 Julia Hudson Have Your Cake and Eat It, Too: How States Could Leverage Data on Quality to Promote Health Care Transparency & Patient Privacy Within Consumer-Driven Health Care Initiatives ..................... 663 Jacob O'Brien A Review and Evaluation of Indiana's INSPECT System and Governing Legislation: Maximizing Potential Impact on Public Health .. ............ 701 PREFACE Upon reflection, the Indiana Health Law Review is quite a story. Unlike so many products of corporate America and academic institutions, it was not a concept hatched as part of a long (or short) term strategic plan. It was, simply, a wild hair. But, ten years and ten volumes later, perspective tells us that it was fueled by tremendous will, supported by common sense, and the timing was right. The origins of the Indiana Health Law Review, as it is being told for the first time, is one of fate.. .and a little luck. In 2000 and 2001, when we started our law school careers, the Indiana University Robert H. McKinney School of Law had consistently been recognized as one of the top health law programs in the country. As students interested in health law, we were acutely aware of this. The program's reputation was no accident. After all, the Center for Law and Health (as it was called then), had been established in 1987 to expand the curriculum and teaching of health law and provide opportunities for student participation in Center-sponsored research, educational programs, and health law field placements. This strategy was laid by the Center's co-directors, Eleanor Kinney and David Orentlicher. Professor Kinney, the founding director, had a distinguished academic background, had worked for the U.S. Department of Health and Human Services and the American Hospital Association, and was a widely published author and respected lecturer. Professor Orentlicher was a physician, an adjunct professor of medicine at the IU School of Medicine, and in 2002 became a six-year member of the Indiana House of Representatives. Fortunately for us, they were committed to sharing their intellect and talents with the law school and its students. In the summer of 2001, the law school moved into a new building providing the Center for Law and Health with a new and improved space. This sparked new enthusiasm among faculty and students. The health law course offerings were expanding and the school was more frequently hosting distinguished health law speakers and i CLE programs, further energizing the members of the student interest group Health Law Society. And the school's downtown Indianapolis location placed it near several major pharmaceutical firms, many of the state's leading medical centers, health insurers, health law firms, and the health agencies of state government. Among other things, this helped support the development of more internships, placements, a professional network of alumnus and a robust adjunct faculty. It seemed to be a perfect recipe - the possibilities were endless. And then came the light bulb. Nearly all of the other ranked health law programs had a journal. In many respects, the journal was the public face of the program. A ubiquitous reminder of the program, the faculty and students and even the university. Why didn't our school have one? Academics, practitioners, students and even the University would benefit from it. Professor Kinney will confess that she originally thought the idea was lofty...actually, crazy. But, she eventually came around and convinced the Dean it was a good idea. A few of us were in the initial startup group that set out to draft a business plan. We knew nothing about business plans, but fortunately we didn't have to start from scratch. The school already had two very successful journals - The Indiana Law Review and the Indiana International and Comparative Law Review. Throughout the process, they graciously shared their time and resources to assist us. To this day, we remain indebted for their startup support. We expanded our small startup to a core group of students with critical professional, academic and law review experience to serve as the proposed first editorial board. With the business plan complete and a leadership team complete, we presented it (and ourselves) to the full faculty....a presentation that nearly didn't happen. It was the end of the 2003 spring semester and our hopeful editorial board would be starting our final year of law school in the fall. We were asked to postpone our faculty presentation until the fall due to an already busy agenda. Postponing would have set us back an entire school year and our core group would graduate before we could get the ii journal off the ground. Any necessary momentum would have been lost. Instead, we successfully advocated through Professor Kinney to stay on agenda. That was a defining moment, along with the Dean delivering the good news. And the Indiana Health Law Review was born - at least conceptually. As luck would have it, the Center for Law and Health had already outgrown its space and that summer we were permitted to join them in their newly dedicated William S. and Christine S. Hall Center for Law and Health. But, we didn't have any money and we nearly overstayed our welcome in the first week when we furnished the office with refurbished desks and not-so- gently used chairs. Professor Kinney was so mortified that she bought us new chairs! The next twelve months were a blur. The other two law reviews were kind enough to include us in their joint writing competition so we could populate the journal with student members. We are indebted to those 18 students who took the leap of faith to join us that year - to be Volume 1. They were - and are - the lifeblood. Our other debt of gratitude goes to the talented authors who responded to our callout and were willing to send their prized academic work to a startup journal. Without content, there is no book to publish. A startup journal could have easily failed in its early years. But it didn't. Volume 2 picked up where we left off, and so on. The Indiana Health Law Review has thrived in these first ten years, just as we would have hoped. It has expanded to multiple issues per year, continued to publish valuable and relevant content, hosted symposia, and in 2011 the highly-regarded Professor Nicolas Terry joined the faculty for the retiring Eleanor Kinney. The future continues to be bright. Our Volume 1 journey was guided at every step by the sage and steady advice of our chief faculty advisor, Professor Larrie Wilkins. His guidance and moral support were crucial to our success. As we celebrated Volume 1, Professor Wilkins shared with us his thoughts on our first year and the future. We borrow his eloquence and share it iii with the past, current, and future members of the Indiana Health Law Review: So, to you all, [we] ask that you raise a glass. [We] offer a toast to your great success. And while you have those glasses raised, [we] ask that you look your colleagues in the eye and pledge yourself to continued and palpable support of those who will come after you as they strive to meet your standards and carry on the traditions that you have established for them. Congratulations to all past, current and future members of the Indiana Health Law Review. [We] salute you! Sincerely, Volume 1 Editorial Board Indiana Health Law Review Brian C. Betner Gina M. Brown Leeanne R. Coons Shelley S. Fraser Kelly J. (Green) Greene Heidi K. Hughes Julie D. Reed iv AALS SYMPOSIUM ARTICLES: IMAGINING THE NEXT QUARTER CENTURY OF HEALTH CARE LAW 12_10IndHealthLRev[xv](2012-2013) 13_10IndHealthLRevi(2012-2013)