INDIANA IIEAITB LAW REVIEW VOLUMES 2008 ARTICLES Dances with Elephants: Administrative Resolution of Medical Injury Claims by Medicare Beneficiaries Achieving Quality and Responding to Consumers The Medicare Beneficiary Complaint Process: Who Should Respond? NOTES Expanded Hospital Liability Under the Federal False Claims Act: An Unexpected Solution to the Resident Duty Hour Controversy A Flawed Solution to the Sex Offender Situation in the United States: The Legality of Chemical Castration for Sex Offenders Live or Let Die: Will the Courts Recognize In Terminally m Patients a Fundamental Right to Choose Non-FDA Approved Drugs or Does the FDA's Stringent Approval Process Carry Sufficient Merit? Closing the Deal: Making the Right Congressional Decision About Patent Settlement Agreements FELLOWSIDP SYMPOSIUM ISSUE 1 Eleanor D. Kinney Wzlliam M. Sage Diane E. Hoffman Yuginia Rowthorn Robert R. Elder Matthew V. Daley Clayton R. Portell Amy C. Waltz WELLNESS IN THE LAW: STATE GOVERNMENTS' ROLE IN ADDRESSING AMERICA'S PUBLIC HEALTH CRISIS October 5, 2007 Program on Law & State Government Indiana University School of Law -lndillnopolis Bottom Lines and Waist Lines: State Governments Weigh In on Wellness Cynthia A. Baker Taking Roll: An Assessment of State and Local Governance of School Wellness Policies Sally Hubbard t INDIANA UNIVERSITY SCHOOL OF LAW Indianapolis IUPUI INDIANA HEALTH LAW REVIEW VolumeS Executive Managing Editor Mark E. Douglas Executive Production Editor Lour J. Britton Clayton R. Portell Executive Business Editor Jacob V. Bradley Note Development Editors Matthew V. Daley Heather A. Barnes Billi J. Lycett John P. Taylor Kyra R. Wagoner Joseph E. Bruno Meghan A. Cox Elizabeth G. Currid Ravinder S. Deol Brenda K. DeVries Adam D. Dolce Brian N. Dunkel E. Paige Boggs Shelley R. Hallberg James Blake Hike Bruce D. Jones Editor-in-Chief Robert R. Elder Articles Editors Keith A. Butler Matthew S. Dionne Robin E. Ebert Michael J. Kyle Blake C. Reed Members Fuculty Advisors Executive Notes Editor Amy C. Waltz Executive Articles Editor EmmaL.Haw Jonathan D. Stowers 2008 Associate Editors Robert W. Cochrane Brendan W. Miller Erin M. Saylor Jessica D. Williams Kevin D. Koons Amanda G. Koziura Jackie S. Landess Allison L. Matters Matthew H. McCoy Jennifer Miller Triplett Heidi A. Reed Ann Speidel Sarah J. Steinhart Jennifer L. Strange Andrew J. VanLandingham Lawrence P. Wilkins (Chair) Eleanor D. Kinney David Orentlicher Robert A. Katz INDIANA HEALTH LAW REVIEW (ISSN 1549-3199) Content. The Indiana Health Law Review publishes articles submitted by academics, practitioners, and students on the topics ofhealth law and policy. The scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. The Indiana Health Law Review will be published twice during the 2007-08 academic year. Disclaimer. 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Inlow Hall 530 West New York Street Indianapolis, Indiana 46202-3225 For an academic year, the subscription rate for four issues is: Domestic, $30; Foreign. $35; Student, $20 Single Issue, $10; Survey Issue $20 Symposium Issue, $15 INDIANA UNIVERSITY SCHOOL OF LAW Indianapolis IUPUI Indiana University School of Law-Indianapolis 2007-2008 ADMINISTRATIVE OFFICERS AND FACULTY Administrative Oftkers MICHAEL A. McRoBBIE, President of the University. Ph.D., Australian National University. CHARLES R. BANTZ, Chancellor, Indiana University-Purdue University-Indianapolis. B.A., M.A., University of Minnesota; Ph.D., The Ohio State University. GARY R. ROBERTS, Dean and Gerald L. Bepko Professor of Law. B.A, Bradley University; J.D., Stanford University. PAUL N. Cox, Vice Dean and Centennial Professor of Law. B.S., Utah State University; J.D., University ofUtah; LL.M., University of Virginia. ANGELA M. ESPADA, Associate Dean for Student Services. B.A., Indiana Central University; M.A., Indiana University; J.D., Indiana University School of Law-Bloomington. JaNNA KANE MAcDoUGALL, Assistant Dean for Institutional Advancement. B.S., M.A., In diana University; J.D., Indiana University School of Law-Indianapolis. CLAIRE GROVE, Assistant Dean for Graduate Studies. B.A., Indiana University; J.D., Indiana University School of Law-Indianapolis. TERESA (TERRI) J. CUELLAR, Director of Technology Services. B.S., St. Bonaventure University, New York. ELIZABETHALUNGTON, Director of External Affairs. B.A., Indiana University; M.A., M. Phil., New York University. JOYCE M. HERTKO, Director of Major Gifts. B.A., Knox College; M.S., Western Illinois University; Ph.D., Indiana University. PATRICIA KiMBERLY KINNEY, Director of Admissions. B.S., Purdue University; J.D., Indiana University School of Law-Indianapolis. AMANDA KAMMAN, Director of Development. B.A., Indiana University. VIRGINIA MARSCHAND, Director of Administrative and Fiscal Affairs. B.A., M.P .A., Indiana University; J.D., Indiana University School of Law-Indianapolis. HEATHER McCABE, Director, Public Health Law Program, WilliamS. and Christine S. Hall Center for Law and Health. B.A., M.S.W., Indiana University; J.D., Indiana Uni­ versity School of Law-Indianapolis. CHASTITY THOMPSON, Director of Professional Development. A.S., B.A., Alabama State University; M.B.A., Auburn University; J.D., Indiana University School of Law­ Indianapolis. LAW ANDA W. WARD, Director of Pro Bono Program and Public Interest. B.A., Murray State University; M.A., Illinois State University; M.S., Old Dominion University; J.D., Indiana University School of Law-Indianapolis. Faculty CYNTHIA M. ADAMS, Clinical Associate Professor of Law. B.A., Kentucky Wesleyan College; J.D., Indiana University School of Law-Indianapolis. JUDITH FORD ANSPACH, Professor of Law and Director, Ruth Lilly Law Library. B.S., M.L.S., Kent State University; J.D., Mississippi College School of Law. CYNTHIA BAKER, Clinical Associate Professor of Law and Director, Program on Law and State Government. B.A., J.D., Valparaiso University. GERALD L. BEPKO, Indiana University-Purdue University-Indianapolis Chancellor Emeritus, Indiana University Trustee Professor and Professor of Law. B.S., Northern Illinois University; J.D., ITI'/Chicago-Kent College ofLaw; LL.M., Yale Law School. KAREN E. BRAVO, Assistant Professor Law. B.A., The University of the West Indies; J.D., Columbia University School of Law; LL.M., New York University School of Law. ROBERT BROOKINS, Professor of Law. B.S., University of South Florida; J.D., Ph.D., Cornell University. KENNErn D. CHESTEK, Clinical Associate Professor of Law. B.A., Pennsylvania State University; J.D., University ofPittsburgb School of Law. DANIEL H. CoLE, R. Bruce Townsend Professor of Law. A.B., Occidental College; A.M., University of Chicago; J.D., Lewis and Clark Law School; J.S.M., J.S.D., Stanford Law School. JEFFREY 0. COOPER, Associate Professor of Law. A.B., Harvard University; J.D., University of Pennsylvania Law School. PAUL N. Cox, Vice Dean and Centennial Professor of Law. B.S., Utah State University; J.D., University ofUtah College ofLaw; LL.M., University ofVirginia School of Law. ERic DANNENMAIER, Associate Professor of Law. B.A., Drury College; J.D., Boston University; LL.M., Columbia University; M. St., Oxford University ( cand. ). JAMES D. l>IMrrRI. Clinical Associate Professor of Law. B.S., Indiana University; J.D., Valparaiso University School of Law. JENNIFER. ANN DROBAC, Professor of Law. B.A, M.A, Stanford University; J.D., J.S.D., Stanford Law School. GEORGE E. EDWARDS, Carl M Gray Professor of Law and Director, Program in International Human Rights Law. BA, North Carolina State University; J.D., Harvard Law Sche><>l. FRANK EMMERT, JohnS. Grimes Professor of Law and Executive Director, Center for International and Comparative Law. Erstes Juristisches Staatsexamen (J.D.), University of Munich Law School; LL.M., The University ofMichigan Law School; Ph.D., University ofMaastricht; Diploma, European University Institute. NICHOLAS GEORGAKOPOULOS, Harold R. Woodard Professor of Law. Ptyhion Nomilds, Athens University School of Law; LL.M., S.J.D., Harvard Law School. FRANCES WATSON HARDY, Clinical Associate Professor of Law. B.S., Ball State University; J.D., Indiana University School of Law-Indianapolis. JoHNLAWRENCEHILL, Professor of Law. B.A, Northern Illinois University; J.D., Ph.D., Georgetown University. LINDA KELLY HILL, M Dale Palmer Professor of Law. B.A., J.D., University ofVirginia. LAWRENCE A. JEGEN, III, Thomas F. Sheehan Professor ofT ax Law and Policy. A.B., Beloit College; J.D., M.B.A., The University of Michigan; LL.M., New York University School of Law. HENRY C. KARLsoN, Professor of Law. A.B., J.D., LL.M., University oflllinois College of Law. ROBERT A. KATZ, Professor of Law. A.B., Harvard College; J.D., University of Chicago Law School. ELEANOR D. KINNEY, Hall Render Professor of Law, Co-Director of the WilliamS. and Christine S. Hall Center for Law and Health and Executive Director, Latin American Law Program. B.A., Duke University; M.A, University of Chicago; J.D., Duke University School ofLaw; M.P.H., University ofNorth Carolina. ANDREW R. KLEIN, Paul E. Beam Professor of Law. B.A, University of Wisconsin; J.D., Emory University School of Law. ROBERT E. LANCASTER, Clinical Professor of Law, Director, Chinese Law Summer Program. B.A., Millsaps College; J.D., Tulane Law School. NORMAN LEFSTEIN, Professor of Law and Dean Emeritus. LL.B., University of Illinois College of Law; LL.M., Georgetown University Law School. MARiA P AB6N L6PEz, Associate Professor of Law and Director, Latin American Law Program. BA, Princeton University; J.D., University of Pennsylvania Law School. GERARD N. MAouoccA, Professor of Law. B.A., Stanford University; J.D., Yale Law School. ALLISON MARTIN, Clinical Associate Professor Law. B.S., J.D., University of Illinois. DEBORAH McGREGoR, Clinical Associate Professor of Law and Assistant Director of Legal Analysis, Research and Communication. B.A., University of Evansville; J.D., Georgetown University Law School. SUSANAH M. MEAD, Professor of Law. B.A., Smith College; J.D., Indiana University School of Law-Indianapolis. MARY H. MITcHELL, Alan H. Cohen Professor of Law. A.B., Butler University; J.D., Cornell Law School. NoVELLA NEDEFF, Clinical Associate Professor of Law. B.A., J.D., Indiana University. JAMES P. NEHF, Cleon H. Foust Fellow and Professor of Law. B.A., Knox College; J.D., University of North Carolina Law School. DAVID ORENTUCHER, Samuel R. Rosen Professor of Law and Co-Director of the WilliamS. and Christine S. Hall Center for Law and Health. A.B., Brandeis University; J.D., M.D., Harvard College. JoANNE ORR, Clinical Professor of Law. B.S., Indiana State University; J.D., California Western School of Law. ANToNY PAGE, Associate Professor of Law. B. Comm., McGill University; M.B.A., Simon Fraser University; J.D., Stanford Law School. H. KATHLEEN PATCHEL, Associate Professor of Law. A.B., Huntington College; J.D., University ofNorth Carolina Law School; LL.M., Yale Law School. MICHAEL J. PllTS, Associate Professor of Law. B.SJ., Northwestern University; J.D., Georgetown University Law Center. FLORENCE WAGMAN ROISMAN, William F. Harvey Professor of Law. B.A., University of Connecticut; LL.B., Harvard Law School. JOAN M. RUHTENBERG, Clinical Professor of Law and Director of Legal Analysis, Research and Communication. B.A., Mississippi University for Women; JD., Indiana University School of Law-Indianapolis. JoELM. ScHUMM, Clinical Associate Professor of Law. B.A., Ohio Wesleyan University; M.A., University of Cincinnati; J.D., Indiana University School of Law­ Indianapolis. LAWRENCE P. Wn.KINs, William R. Neale Professor of Law. B.A., The Ohio State University; J.D., Capital University Law School; LL.M., University of Texas School of Law. LLOYD T. WILSON, JR., Associate Professor of Law and Director, Central and Eastern European Law Program. B.A., Wabash College; M.A., Duke University; J.D., Indiana University School of Law-Bloomington. MARY T. WoLF, Clinical Professor of Law and Director of Clinical Programs. B.A., Saint Xavier College; J.D., University oflowa College of Law. R. GEORGE WRIGHT, Lawrence A. Jegen III Professor of Law. A.B., University of Virginia; Ph.D., Indiana University; J.D., Indiana University School of Law-Indianapolis. Emeriti Faculty THOMAS B. ALLINGTON, Professor of Law Emeritus. B.S., J.D., University of Nebraska; LL.M., New York University School of Law. EDWARD P. ARCHER, Professor of Law Emeritus. B.M.E., Reoesselaer Polytechnic Institute; J.D., LL.M., Georgetown University Law School. JAMES F. BAILEY, ill, Professor of Law Emeritus. A.B., J.D., M.A.L.S., The University of Michigan. AGNES P. BARRETT, Associate Professor of Law Emerita. B.S., J.D., Indiana University. CLYDE HARRisoN CROCKETI, Professor of Law Emeritus. A.B., J.D., University of Texas; LL.M., University of London (The London School of Economics and Political Science). DEBRA A. FALENDER, Professor of Law Emerita. A.B., Mount Holyoke College; J.D., Indiana University School ofLaw-Indianapolis. DAVIDA. FuNK, Professor of Law Emeritus. A.B., College ofWooster; J.D., Case Western Reserve University School of Law; M.A., The Ohio State University; LL.M., Case Western Reserve University; LL.M., Columbia Law School. PAUL J. GALANTI, Professor of Law Emeritus. A.B., Bowdoin College; J.D., University of Chicago Law School. HELEN P. GARFIELD, Professor of Low Emerita. B.S.J., Northwestern University; J.D., University of Colorado School ofLaw. HAROlD GREENBERG, Professor of Low Emeritus. A.B., Temple University; J.D., University of Pennsylvania Law School. JEFFREY W. GROVE, Professor of Low Emeritus. A.B., Juniata College; J.D., George Washington University Law School. WILLIAM F. HARVEY, Carl M. Gray Professor of Low&: Advocacy Emeritus. A.B., University ofMissouri; J.D., LL.M., Georgetown University Law School. W. WILLIAM HODES, Professor of Low Emeritus, A.B., Harvard College; J.D., Rutgers University School ofLaw-Newark. WILLIAM ANDREW KERR, Professor of Low Emeritus. A.B., West University; B.S., Duke University; J.D., LL.M., Harvard Law School. WILLIAM E. MARsH, Professor of Low Emeritus. B.S., JD., University ofNebraska. RONAlD W. POLSTON, Professor of Low Emeritus. B.S., Eastern Dlinois University; LL.B., University of Illinois College ofLaw. KENNEm M. STROUD, Professor of Low Emeritus. A.B., JD., Indiana University­ Bloomington. JAMES W. TORKE, Carl M. Gray Professor of Low Emeritus. B.S., J.D., University of Wisconsin. JAMES PATRICK WHITE, Professor of Low Emeritus. A.B., University ofiowa; J.D., LL.M., George Washington University Law School. Law Library Faalty JUDflll FORD ANsPACH, Professor of Low and Director, Ruth Lilly Low Library. B.S., M.L.S., Kent State University; J.D., Mississippi College School of Law. DEBRA DENSLA w, Reference Librarian. B.A., Franklin College; M.S., University of Illinois, Urbana-Champaign; J.D., Valparaiso School of Law. RICHARD HUMPHREY, Reference Librarian. A.A., Brewton-Parker Junior College; B.A., Georgia Southwestern College; M.L.S., University ofKentucky. WENDELL E. JOHNTING, Assistant Director for TechnictJI Services. A.B., Taylor University; M.L.S., Indiana University. CHRis E. LoNG, Catalog Librarian. B.A., Indiana University; M.A., Indiana University; M.L.s.; Indiana University. STEVEN R. MILLER. Reference Librarian. B.S., Lebanon Valley College of Pennsylvania; M.A., Dominican University; M.S., Norlhwestem University; J.D., The John Marshall Law School. MAHNAZ K. MOSJJFEOH. Acquisition/Serials Librarian. B.A., National University of Iran; M.S., Tehran University; M.A., Ball State University; M.L.S., Ph.D., Indiana University. MIRIAM A. MURPHY, Associate Director of Low Library. B.A., Purdue University; J.D., M.L.S., Indiana University-Bloomington. KIYOSHI OTsu, Automated and Media Services Librarian. A.A., Parkland College; A.B., M.S., C.A.S., University oflllinois. INDIANA HEALTH LAW REVIEW VolumeS Issue 1 ARTICLES Dances with Elephants: Administrative Resolution of Medical Injury Claims by Medicare Beneficiaries .............•. ...•.• Eleanor D. Kinney Achieving Quality and Responding to Consumers The Medicare Beneficiary Complaint Process: · William M. Sage Who Should Respond? .......................................................................... Dian.e E. Hoffinan · Virginia Rowthom . 9 NOTES Expanded Hospital Liability Under the Federal False Claims Act: An Unexpected Solution to the Resident Duty Hour Controversy •. .•.••.•• Robert R. Elder 53 A Flawed Solution to the Sex Offender Situation in the United States: The Legality of Chemical Castration/or Sex O.ffenders ••••.•.. Matthew V. Daley 87 Live or Let Die: Will the Courts Recognize In Terminally Ill Patients a Fundamental Right to Choose Non-FDA Approved Drugs or Does the FDA's Stringent Approval Process Carry Sujjicient Merit? ..........................................................................••..... Clayton R. Portell 123 Closing the Deal: Making the Right Congressional Decision About Patent Settlement Agreements ................................................... Amy C. Waltz 155 FELLOWSHIP SYMPOSIUM WELLNESS IN THE LAW: STATE GOVERNMENTS' ROLE IN ADDRESSING AMERICA'S PUBLIC HEALTH CRISIS October S, 2007 Pro!J1'flm on Law &: State Government Jndiantl University School of Law -lndituulpolis Bottom Lines and Waist Lines: State Governments Weigh In on Wellness ...........•....••...........•.••••..•....•....••....•... CyntbiaA. Baker 185 Taking Roll: An Assessment of State and Local Governance of School Wellness Policies ......................... .•..••.••.•... .Sally Hubbard 201 2008