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Reviews in Medical Ethics: The Topography and Geography of U.S. Health Care Regulation

Published online by Cambridge University Press:  01 January 2021

Thaddeus Mason Pope ,
Joshua J. Gagne  and
Aaron S. Kesselheim
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Extract

Through the Louisiana Purchase in 1803, the United States expanded its size by over 800,000 square miles. But neither President Thomas Jefferson nor Congress knew exactly what they had bought until 1806, when Meriwether Lewis and William Clark returned from their famous expedition. One of the most significant contributions of the Expedition was a better perception of the geography of the Northwest. Lewis and Clark prepared approximately 140 maps and filled in the main outlines of the previously blank map of the northwestern United States. Robert I. Field has done much the same for the vast territory of U.S. health care regulation.

On the front cover of Fields new book, Health Care Regulation in America: Complexity, Confrontation, and Compromise, is a picture of a giant three-dimensional labyrinth. Rarely is cover art so perfectly appropriate.

Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 2 , Summer 2010 , pp. 427 - 435
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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References

References

See Allen, J. L., “Geographical Knowledge and American Images of the Louisiana Territory,” Voyages of Discovery: Essays on the Lewis and Clark Expedition, Ronda, J. P. ed., (Helena: Montana Historical Society Press, 1998): 39–58.Google Scholar
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At the time the book was published, Robert I. Field, J.D., M.P.H., Ph.D. was Chair of the Department of Health Policy and Public Health at the University of the Sciences in Philadelphia. Field is now Professor of Law at the Drexel University Earle Mack School of Law and Professor of Health Management and Policy at Drexel University School of Public Health.Google Scholar
Field, R. I., Health Care Regulation in America: Complexity, Confrontation, and Compromise (Oxford University Press, 2007).Google Scholar
Field discusses neither regulation pertaining to bioethics or the aging, nor the structure of regulatory entities such as state ombudsmen for the institutionalized elderly. Robert Gatter says this omission is understandable because such topics are “not essential to a survey of health law based on the themes of quality, access, and cost control.” Gatter, R., “Health Care Regulation in America,” (book review essay) Journal of Legal Medicine 28, no. 4 (2007): 593–599, at 598. I am not so sure. Quality, access, and cost control are often supplemented by a fourth key policy goal, autonomy. See, e.g., Furrow, B. R. et al., Health Law: Cases, Materials and Problems, 1 edition (St. Paul: West Pub. 1987): xviii–xix; Mariner, W. K., “Toward an Architecture of Health Law,” American Journal of Law & Medicine 35, no. 1 (2009): 67–87, at 83; Hall, M. A., “The History and Future of Health Care Law: An Essentialist View,” Wake Forest Law Review 41, no. 2 (2006): 347–364, at 353. Since there was good reason to include the theme of autonomy, there was good reason to include a discussion of regulation associated with bioethics. See Rosoff, A. J., “Health Law at Fifty Years: A Look Back,” Health Matrix 14, no. 1 (2004): 197–212, at 203 (“It is difficult to imagine a comprehensive health law text that would not have a substantial section devoted to these topics … .”); Capron, A. M., “A Bioethics Approach to Teaching Health Law,” Journal of Legal Education 38, no. 3 (1998): 505–510.Google Scholar
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31 U.S.C. §§ 3729–33. I discuss this omission in further detail, infra.Google Scholar
The entries would be more useful if each regulatory development were linked to a specific date, for example, “1965: Medicare and Medicaid enacted.”Google Scholar
See Pozgar, G. D., Legal Aspects of Health Care Administration, 10th ed. (Sudbury, MA: Jones & Bartlett, 2007).Google Scholar
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Field, R. I., Teacher's Guide for Health Care Regulation in America: Complexity, Confrontation, and Compromise (version 1.0, Aug. 2007), available at <http://www.healthcareregulation.net> (last visited May 5, 2010). Ideally, this website would not only promote the book but would also supplement the book. Using a website in such a way is a model successfully implemented by other books in this area. See for instance Hall, M. A., Bobinski, M. A., and Orentlicher, D., website for Health Law and Ethics, 7th ed. (Austin: Wolters Kluwer Law & Business: Aspen, 2008), available at <http://indylaw.indiana.edu/instructors/orentlicher/public_html/home.html> (last visited May 5, 2010). While not in the healthcare area, a particularly good supplemental website is that supporting Klein, W. A., Ramseyer, J. M., and Bainbridge, S. M., Business Associations: Agency, Partnerships and Corporations, 7th ed., (New York: Thomson Reuters/Foundation Press, 2009), avaliable at <http://www.business-associations.com> (last visited May 5, 2010).Google Scholar
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Another great example of federal-state tension, not discussed in Health Care Regulation in America, concerns the regulation of medical marijuana and the drugs used in physician-assisted suicide. See generally Gonzales v. Raich, 545 U.S. 1 (2005); Gonzales v. Oregon, 546 U.S. 243 (2006).Google Scholar
Field, R. I., “Why Is Health Care Regulation So Complex?” Pharmacy & Therapeutics 33, no. 10 (2008): 607–608, at 608.Google Scholar
The ERISA enforcement scheme, as interpreted by the courts, is bewilderingly complex. Judge Edward Becker described the ERISA regime as “unjust and increasingly tangled” and a “Serbonian bog.” DiFelice v. Aetna U.S. Healthcare, 346 F.3d 442, 453–54 (3d Cir. 2003) (Becker, J., concurring); see also Aetna Health, Inc. v. Davila, 542 U.S. 200, 222 (2004) (Ginsburg, J., concurring) (quoting Judge Becker's concurrence in DiFelice).Google Scholar
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Field does briefly mention qui tam actions in a discussion of the anti-kickback statute and Stark Amendments. Field, , supra note 5, at 187. But he omits any mention of the False Claims Act.Google Scholar
Field incidentally mentions criminal liability when briefly mentioning that the Department of Justice supplements the enforcement actions of the Office of Inspector General in the Department of Health and Human Services. Field, , supra note 5, at 188–89. Unlike the Office of Inspector General, he looks at neither the structure of the Department of Justice nor the nature of its regulation.Google Scholar
Field, , supra note 5, at viii.Google Scholar
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Gatter calls this a “critical hole.” Gatter, , supra note 6, at 597.Google Scholar
In addition to omitting significant indirect regulation of health care, Field omits discussion of some regulation that is specifically targeted at health care: International health law. See for instance Jost, T. S., “Comparative and International Health Law,” Health Matrix 14, no. 1 (2004): 141–147; Gostin, L. O. and Taylor, A. L., “Global Health Law: A Definition and Grand Challenges,” Public Health Ethics 1, no. 1 (2008): 53–63.Google Scholar
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