Pharmacy & Therapeutics - October 2008 - (Page 607)

HEALTH CARE AND LAW Why Is Health Care Regulation So Complex? Robert I. Field, JD, MPH, PhD Dr. Field chairs the Department of Health Policy and Public Health and is Professor of Health Policy at University of the Sciences in Philadelphia, Pennsylvania. of external supervision of this field. Policy debates, for the most part, swirl not around whether oversight should exist but, instead, around the way it should be structured. However, the present regulatory structure is neither uniform nor consistent. A broad range of regulatory bodies and programs apply in different ways to various aspects of the industry. Health care regulations are developed and enforced by all levels of government—federal, state, and local—and also by a large assortment of private organizations. At times, they operate without coordination. and Prevention (CDC) ser ves as an essential resource for collaboration on a national level. Private regulators entered the scene in the early 20th century. The American Medical Association (AMA) sponsored the creation of a number of organizations that remain central today in the oversight of the medical profession, including those that accredit medical schools, administer licensure examinations, and certify specialists. These bodies supplement the work of governmental regulators. State medical boards, for example, use privately administered examinations in granting medical licenses, and the Medicare program relies on specialty certification as an indicator of physician quality. Along similar lines, the hospital industry accredits its own members as a supplemental step to state licensure through the Joint Commission (JCAHO). The array of regulations that govern health care can seem overwhelming to people who work in the industry. Almost every aspect of the field is overseen by one regulator y body or another, and sometimes by several. Health care professionals may feel that they spend more time complying with rules that direct their work than actually doing the work itself. The scope and complexity of health care regulation is the subject of a book that I recently published, entitled Health Care Regulation in America: Complexity, Confrontation and Compromise.1 With apologies for some admitted self-promotion, I’d like to summarize my conclusions, which may add a context for the topic. My book describes an underlying logic behind the bewildering regulatory maze. The tangled web of health care regulation arises largely from a set of confrontations between opposing interests that created the system. Fortunately, an ongoing process of compromise keeps things in balance. To understand these forces is to appreciate why the complexity may actually serve a purpose. THE ORIGINS AND EXTENT OF COMPLEXITY The origins of this complex system lie in a series of turf wars between opposing interests that have been waged in one form or another over the past 150 years. The contest between federal and state authority is enshrined in the federalist structure of American government, and the debates of today echo early disputes over which kinds of power should reside at each level. Most of the power to govern day-to-day activities resides with the states under the Constitution, but it is subject to pre-emption at the federal level when various enumerated concerns come into play, such as defense, foreign relations, and interstate commerce. This division of control created a source of ongoing tension in health care oversight from the start. To take a longstanding example, basic oversight of many of the central players in the health care system, including physicians, hospitals, and insurance companies, is accomplished by agencies at the state level. In every case, however, it is coordinated by federal authorities. Similarly, most public health programs, including sanitation, restaurant inspections, and investigations of epidemics, are the responsibility of state and local regulators, but the federal Centers for Disease Control THE REGULATORY MAZE: TWO EXAMPLES As a result of this network of oversight bodies, those individuals and organizations subject to regulation must turn to multiple competing authorities for guidance. Two examples illustrate this dynamic. The path to practicing medicine is paved with an array of regulatory hurdles implemented by an assortment of bureaucracies. A potential physician must attend a medical school that has received accreditation by a private body, take a national examination administered by another nongovernmental organization, obtain licensure from a state medical board, complete a hospital residency that is funded and governed by the federal Medicare program, achieve certification from a private specialty board, and obtain clinical privileges at a hospital that may operate as either a private or public entity. To receive payment for services and actually earn a living, it is often also necessary for a physician to qualify for THE NATURE OF HEALTH CARE REGULATION The pervasive nature of health care regulation stems from the fundamental concerns that are at stake. Most observers acknowledge that some form of oversight is needed when factors as essential as life and health are involved. Even those who are especially suspicious of heavy-handed government bureaucracy see a public interest in some form Vol. 33 No. 10 • October 2008 • P&T® 607

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - October 2008

Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.