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New York State Office of Professional Medical Conduct: Are Its Policies and Performance Becoming a Political Liability? - overview of medical regulation in New York State

"But I am not guilty," said K., "it's a misunderstanding. And if it comes to that how can any man be called guilty. We an all simply men here, one as much as the other."

"That is true," said the priest, "but that's how all guilty men talk."

New York State Office of Professional Medical Conduct: Are Its Policies and Performance Becoming a Political Liability? - overview of medical regulation in New York StateFranz Kafka, The Trial

Part 2: Complementary and Alternative Physicians

The following installment continues a three-part article on state regulation of medicine. The opening installment, in last month's Townsend Letter, began with a brief history of laws that define the practice of medicine in each state, set medical licensing requirements, and establish boards to supervise physicians.

Every state in the US now has at least one board, [1] and these boards, the only government agencies in the US authorized to investigate and discipline physicians for misconduct, influence the quality and availability of medical care. Yet while virtually every American lies within their sphere of activity, few people know very, much about the boards' disciplinary policies and procedures - physicians included.

As a case study of the state disciplinary process, this article examines New York's Office of Professional Medical Conduct (OPMC). That New York licenses one in ten physicians in the US is sufficient justification for choosing this agency to illustrate the complex process and issues involved in protecting the public against substandard MDs.

Much of the opening installment dea1t with the creation of the OPMC in the New York Department of Health in 1975, major legislative reforms of the agency, and the three periods during which criticism of its policies and actions markedly intensified. The discussion dwelt on OPMC cases against mainstream physicians charged with incompetence or negligence during treatment that essentially consisted of errors in performance or judgment.

Toward the close of the first installment, the agency's prosecution of several physicians giving long-term antibiotic therapy for Lyme disease, a minority approach to treatment of this condition, prompted questions about the agency's rationale for its basic charge against these physicians - improper drug use. As that installment observed, a dispute has simmered between specialists over appropriate treatment for Lyme disease for more than a decade. Customarily, peer review of data reported in medical journals and conferences settles many uncertainties about treatment. Why, in this dispute, hasn't the OPMC been willing to let the peer review process run its normal course?

Further, if the agency has intervened in favor of the majority approach to Lyme, doesn't this amount to a de facto evaluation of therapy, a trespassing, in effect, into studies that determine appropriate care - the province of the "evaluative clinical sciences"? [2]

OPMC's Growing Fixation on Standards of Care Rather than Results

The issue of appropriate care has dominated a bitter debate, over health care policy in the US for nearly two decades. In 1988, Dr. John Wennberg, a pioneer in tying analyses of results of treatment to formulations of policy, predicted that this debate would become "increasingly acrimonious and divisive, pitting physician against physician, specialty group against specialty group, and the profession itself against the payer and the government, with the patient lost somewhere in the rhetoric." [3]

Wennberg did not name the state medical boards among the disputants, but a story in The New York Times earlier this year reported that half the boards have recently joined or are prepared to join in the infighting over appropriate care. According to the Times, "16 states now explicitly require HMO medical directors to be licensed physicians in the state where the health plan resides; most of those rules were enacted in the past two years.... Nine more states require medical directors to have valid physician's licenses, but not necessarily from that state." [4]

State legislation requiring HMO medical directors to hold a license brings their decisions on coverage within the disciplinary reach of the state boards- so, apparently, some boards think. The Times' story detailed an attempt last year by the Texas Board of Medical Examiners to discipline a physician employed as a medical director by one of the largest US insurers. In response, the insurance company brought the matter before a federal court. [5]

Two statements quoted by the Times underscore the feeling among state medical boards that physicians employed as medical directors by managed care companies fall under their disciplinary purview.

In its motion to dismiss the HMO's suit, the Texas attorney general's office said: "Nothing is more critical to the regulation of health care than the regulation of medical decision-making.... It is for the board, not an insurance company, to decide if medical judgment was exercised by a physician and if that judgment was exercised appropriately" (emphasis added).

Commenting on the issue of accountability,, the, executive vice president of the, Federation of State Medical Boards (FSMB) declared: "Physicians who direct treatment need to be accountable to the public for their conduct.... Doctors, shouldn't be able to claim a safe harbor, simply because they work for an insurance company. I expect to see more and more litigation coming as a result of this issue."

Note that the FSMB official anticipates more lawsuits over the issue of accountability for medical decisions and makes HMO physicians directing treatment accountable to the public, a smooth cover from the looks of it for the FSMB's interest in extending the medical boards' disciplinary reach to HMOs.

Should this come about; not only may litigation between the boards and HMOs increase, but so may third-guessing by the boards of second guessing by insurers of treatment decisions by clinicians. One must bear in mind here that what regulators see in their position as a clear line between appropriate and inappropriate therapy may seem unclear to physicians making pragmatic treatment decisions in atypical individual cases.

The previous installment of this article pointed to two critical findings in late 20th-century analyses of treatments originated and accepted by mainstream medicine (an approximate definition, by the way, of community practice, the essential standard followed by state medical boards):

1. Most treatments are not well tested, resting on a weak evidentiary base.

2. Medical experts disagree more often than generally supposed on appropriate therapy; thus, their judgments are not always reliable and should not be adhered to dogmatically.

That installment also observed that the OPMC most probably has some perception, hazy as it may be, that community practice and expert consensus offer inconsistent standards for determining misconduct by physicians. But state law authorizes the agency to investigate and discipline "bad doctors" (the preferred term in newspapers), leaving it latitude to choose standards and experts that, cynically speaking, maximize prospects for prosecution and conviction of misconduct.

The whole notion of standards needs more pragmatic definition. An interview in American Medical News (AMN) in 1989 with the senior deputy vice president of the American Medical Association (AMA) discussed substituting "parameters" for standards.

"We need to make a distinction between parameters and standards," said the high AMA official, "because if you talk about standards, then it becomes impossible to rationally review physicians' care. When do you step in - after one deviation from a standard? . . .No one knows how to define a standard of practice [emphasis added], but we can clearly define appropriate indications and methods of treatment that allow room for the infinite variation of patients and diseases." [6]

In light of the AMN interview, one has to look at the purposes served by the OPMC's disregard of the weak evidentiary basis of community practice, the variability of expert testimony, the lack of agreed-upon standards. For starters, it affords them optimal discretion in going after and nabbing more physicians for misconduct in periods when criticism of their performance heats past the comfort zone - a prime concern of all regulatory and administrative agencies.

Almost as practical, the OPMC's stress on standards enables them to concentrate on improper conduct in cases where the physicians or treatments under inquiry apparently improve patients. In a hearing on probation violation in the early 1990s, when the attorney defending the physician fought valiantly though vainly to introduce evidence that this physician's unconventional therapy benefited patients, the OPMC attorney countered testily: "Patients can have bad outcomes given the best of medical care. Patients can have good outcomes despite poor care. So it's an irrelevant topic." [7]