Neurosurgical Practice in the Current Regulatory Environment

John A. Kusske, M.D.

Disclosures

Neurosurg Focus. 2002;12(4) 

In This Article

Abstract and Introduction

The practice of neurosurgery has been complicated over the last 25 years by the enactment of a series of statutes that have significantly altered the time-honored means by which neurosurgeons manage their work. These laws deal with issues that neurosurgeons have not customarily had to consider. The author outlines some of the socioeconomic and political matters that led to the passage of these statutes. An assortment of the laws is then surveyed, to foster an appreciation for the variety and depth of health care law that affects neurosurgeons' practice and the delivery of care to their patients. Statutes discussed include the fraud and abuse laws, self-referral laws, the Emergency Medical Treatment and Labor Act, Health Insurance Portability and Accountability Act, and Employee Retirement Income Security Act.

It will be of little avail to the people that the laws are made by men of their own choice if the laws are so voluminous that they cannot be read or so incoherent they cannot be understood. Alexander Hamilton, The Federalist Papers

There was a time when the US health care industry was not wholly burdened by law and lawyers. There was a time when it was irrelevant for most neurosurgeons to be familiar with a wide body of law ranging from antitrust law to antikickback statutes, and from rules on self-referral to statutes regulating ER coverage. In the late 1960s the list of significant legal issues in health care was short. The leading topics were focused on a few fields of the law, primarily medical malpractice, the area of informed consent, licensure, abortion, prescription drug development, human experimentation, and the tort liability of hospitals. Although the Medicare and Medicaid programs were in place, they presented no major legal problems because they were still operating under widely-accepted principles borrowed from private, nonprofit health insurance. The latter issue itself had not yet become controversial or raised prominent legal issues. Workers in the field did not foresee an explosion of new laws and legal attacks on time-honored traditions in the practice of health care. Health care was viewed as a public service, not as a business requiring a complex legal scheme to ensure that it functioned responsibly. As Havighurst[16] has asserted, the law largely ignored the health care industry and nearly everyone thought such autonomy would always continue.

What has occurred since the 1960s to create the present legal morass? Are there explanations for the proliferation of legal rules and associated legal risks that have lately overwhelmed health care providers, payers, and others? Where did all these laws come from? The first portion of this discussion deals with events in the last 50 years that have led to the present situation. In the second portion of this paper, various statutes will be reviewed and their relationship to the current practice of neurosurgery in the US will be illustrated.

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