The government wants to know

Medical Laboratory Observer, Feb, 2006 by Linda Kohl

In July 2005, Sue A. Blevins, president of the Institute for Health Freedom, wrote an essay as editor of its Health Freedom Watch: "For the first time in our nation's history, a local health department has proposed compelling medical laboratories to report blood-sugar-test results. The New York City Department of Health and Mental Hygiene floated the proposal in early July. The New York Times says that although medical laboratories have been mandated to report information about infectious diseases (such as hepatitis), they have never been ordered to pass along information about chronic diseases.

"According to the Times, the rationale for mandatory reporting of blood-sugar-test (A1c) results is to exercise 'surveillance' of diabetes and employ 'more aggressive intervention.' City health officials are hoping to collect data on at least 90% of those with diabetes--meaning the government would obtain and analyze millions of test results. It is estimated that the New York City government would keep information on approximately 500,000 citizens, including their names."

Blevins pointed out that in proposing mandatory reporting, health officials noted that at least seven other registries are already in operation in New York and at the national Veterans Administration. She informed her readers of an August public hearing on the issue, encouraging them to become informed about the role and responsibilities of their local boards of health. "After all," Blevins wrote, "tax dollars support them, and health officials are working for the citizenry .... Whether you live in New York City or not, you should consider how such a trend could affect your health privacy and freedom. In a free society, government serves the citizens--it is not the master, not even when it comes to public-health activities."

Reason for worry

The Association of American Physicians and Surgeons, the National Lawyers Guild, and the National Libertarian Party all saw the plan as an invasion of patient privacy and physicians' prerogatives. In several recent newspaper articles, however, the fact that the government has a long history of tracking infectious diseases to protect the public was noted. New York health officials claimed that tracking diabetes--which has become a crisis due to the American obesity epidemic--is no different than the government's ongoing tracking of lead poisoning, cancer clusters, and low birth weights.

In the past, they say, public health officials have also quarantined travelers, confined tuberculosis patients, and notified STD patients' sex partners. But the New York plan is the first instance of required routine reporting of lab test results for a major chronic, non-infectious disease so that government officials can scrutinize how well doctors and patients are treating it.

Despite the argument from many health experts that this is a gallant effort to improve diabetes treatment, ethicists and privacy advocates are alarmed at this type of intrusion into medical care. Some critics indicate that such a registry could also lead to higher insurance premiums for patients or denial of life, health, or car insurance coverage. Officials at the American Diabetes Association, however, say the plan has merit as long as confidentiality is protected.

A new twist on 'intervention'

So, on January 15, 2006, New York City started monitoring the blood-sugar levels of some 500,000 diabetic residents and creating a database. (In 2007, their initial plan will be expanded with a pilot treatment program in the Bronx.) Since diabetics undergo an annual A1c blood test to provide a long-term measurement of how well they are controlling their condition, the city now requires all 120 New York medical laboratories with electronic data transmission ability to report results of these tests within 24 hours. A laboratory failing to report would be in violation of the city's health code and could face warnings and possible fines, according to the NYC Health Department's counsel.

The data compiled based on those medical laboratory reports will then be used to directly intervene in individual patient's care. Not only will city officials alert patients whose blood-sugar levels are not being well controlled, but they will also contact doctors about those patients and will offer advice.

Lawrence O. Gostin, director of the Center for Law and the Public's Health at Georgetown and Johns Hopkins universities, says, "There are lots of good reasons to do this kind of thing, but ... should the government be collecting this kind of information? Should it be intervening like this? You can imagine it getting to the point where you have a public health worker showing up at your door and asking, 'Did you remember to exercise, eat right, and take your medication today?'"

Or showing up at the door of your laboratory mandating transmission of test results for segments of your patient population.

By Linda Kohl, Associate Editor

As has been the history of MLO's "Washington Report," this space is devoted in 2006 to keeping readers abreast of ongoing issues and new legislation affecting the clinical laboratory and its professional managers and technicians. If there is a particular legislative question or a legislative topic of special interest to your organization, please e-mail: washingtonreport@mlo-online.com.