Chapter 10:  Introduction:

An excellent source for recent and ongoing trends in the health care system is the Center for Studying Health System Change.

Updating and commenting on Paul Starr's seminal book, see Symposium, Transforming American Medicine: A Twenty-Year Retrospective on The Social Transformation of American Medicine, 29 J. Health Politics, Policy & L. 557 (2004).

There has been a sharp increase in the number of specialty hospitals.  This is in response to several business factors:  physicians are creating for-profit specialized facilities that target more profitable areas of care; these hospitals tend to attract fewer Medicaid patients; and without emergency rooms, they tend to receive fewer uninsured patients.  For an overview of recent trends, see U.S. Government Accounting Office, Specialty Hospitals:  Geographic Location, Services Provided, and Financial Performance (GAO-04-167, Oct. 2003);  John K. Iglehart, The Emergence of Physician-Owned Specialty Hospitals, 352 New Eng. J. Med. 78 (2005); David Shactman, Specialty Hospitals, Ambulatory Surgery Centers, and General Hospiotals: Charting a Wise Public Policy Course, 24(3) Health Aff. 868 (June 2005);  Symposium, 24(5) Health Aff. w481 (Oct. 2005); Symposium, 25(1) Health Aff. 94 (Jan. 2006);
Robert A. Berenson, et al, Specialty-Service Lines: Salvos In The New Medical Arms Race, 25 Health Affairs w337 (2006).

To study this phenomenon, Congress placed a moratorium on Medicare payments to any new physician-owned speciality hospitals, pending study.  The moratorium was due to expire in August 2006 even though a final report had not yet been issued.  See 18(1) Health Lawyer 34 (Oct. 2005).

Chapter 10.A.1 -- Licensure and Accreditation

Claiming that health care regulation costs twice as much as its benefits are worth, see Christopher J. Conover, Health Care Regulation: A $169 Billion Hidden Tax (Cato Institute, 2004).  He further claims that this excess spending results in 22,000 deaths from diverting resources unnecessarily.

One possible of excess regulation may be to spur the the increasing trend, known of "medical tourism," of traveling overseas to receive medical care in foreign countries.  See Thomas R. McLean, The offshoring of American medicine: scope, economic issues and legal liabilities, 14 Annals Health L. 205-265 (2005).

For a thorough analysis of certification through Medicare and its relationship to JCAHO accreditation, see Lisa Sprague, Hospital Oversight in Medicare: Accreditation and Deeming Authority  (National Health Policy Forum, Issue Brief. 802, May 2005).

For a revealing narrative account of how one hospital went about preparing for a JCAHO inspection, see J.B. Sardis, Pills, Policies, and Patients, 18(5) Health Aff. 156 (Oct. 1999).

On nursing home quality and regulation, see Symposium, 26 J. Leg. Med. 1 (2005).

        OSHA and EPA Regulation. The federal Occupational Safety and Health Administration (OSHA) is quite involved in regulating health care facilities to ensure that health care workers are protected from occupational hazards. Some of the hazards confronted by health care workers are identical to those found in other job settings: dangerous machinery, exposure to chemicals, and so forth. See generally Mark Rothstein, Occupational Safety and Law (4th ed. 1998). The health care environment also creates unique risks, particularly through potential exposure to communicable diseases. In 1991, the OSHA enacted regulations designed to reduce the risk of workplace exposure to disease, particularly to HIV and hepatitis. Under the ``Bloodborne Pathogen'' rule employers must develop an exposure control plan, which means that they must identify workers whose jobs create a ``reasonably anticipated'' exposure to infectious body fluids and they must develop a training and protection program to reduce the risk of exposure. 29 C.F.R. §1910.1030.  Health care facilities must also provide employees with protective equipment, establish safe workplace practices, and employ ``engineering controls'' (such as use of puncture resistant containers for used needles). Employers are required to monitor exposures and to keep records of incidents. Each of these requirements imposes significant costs and administrative burdens on health care facilities. See, e.g., American Dental Association v. Martin, 984 F.2d 823 (7th Cir.). See also Paula E. Berg, When the Hazard Is Human: Irrationality, Inequity, and Unintended Consequences in Federal Regulation of Contagion, 75 Wash. U.L.Q. 1367 (1998). Health facilities in violation of OSHA standards can face significant fines.
Most people do not think of health care facilities as producing hazardous waste. Yet the point can be driven home—literally—when medical waste, including used needles and bloody refuse, washes up on our nation's beaches. In 1990, the EPA estimated that hospitals, medical offices, and other facilities produced about a half million tons of medical waste that `` `contains pathogens with sufficient virulences and quantity so that exposure to the waste by a susceptible host could result in an infectious disease.' '' Laura Carlan Battle, Regulation of Medical Waste in the United States, 11 Pace Envtl. L. Rev. 517, 518, 524 (1994). States have been the primary regulators of the disposal of medical waste produced by health care facilities. States regulate the ways in which the waste is transported, stored, and decontaminated or destroyed. See, e.g., Battle, supra, at 564-570; Shumaker, Infectious Waste: A Guide to State Regulation and a Cry for Federal Intervention, 66 Notre Dame L. Rev. 555 (1990). See also William B. Johnson, Annotation, Validity, Construction, and Application of State Hazardous Waste Regulations, 86 A.L.R.4th 401 (1991).
        The federal government briefly entered the regulatory arena with the Medical Waste Tracking Act of 1988, 42 U.S.C. §§6992-92k, which established a demonstration project. The EPA has not specifically regulated medical waste. Lisa A. Jensen, Medical Waste Regulation in the United States, 9 Nat. Resources & Env't 21, 21 (Fall 1994). Attempts to assert more federal control over medical waste under the various environmental statutes have been largely unsuccessful. See, Battle, supra, at 552-563. See also Comment, 13 Pace Envtl. L. Rev. 1063 (1996) (discussing problems with applying the federal Clean Water Act to medical waste dumping). In addition, improper waste disposal can result in tort liability to those exposed to hazardous substances. See, e.g., DeMilio v. Schrager, 666 A.2d 627 (N.J. L. Div. 1995)(negligence action based on dentist's improper disposal of dental instrument, which injured sanitation worker); Alan Bavley, Funeral Home Faces Lawsuit from State; Babies' Remains Disposed As Medical Waste, Kansas City Star, Aug. 27, 1996.

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