Clinton may ease rules on labs to woo doctors


WASHINGTON -- In an apparent attempt to gain physicians' support for the president's health care reform plan, the White House is considering relaxing federal regulation of lucrative tests done by doctor-run laboratories.

Such a move, which physicians have been seeking since a 1988 law held them to the same standards as independent labs, would increase the doctors' competitive edge in the testing market.

But weaker regulations of doctor labs could lead to inaccurate tests for deadly diseases, laboratory organizations and consumer groups warn. They argue patient safety depends on strong regulation of doctor-run labs.

"As a [member of] the public I would be concerned," said Michele Best, an officer of the American Society of Clinical Pathologists and a member of a federal advisory committee on lab testing. "It is my impression that the AMA is looking for a significant modification."

The AMA is the American Medical Association, the most powerful physicians' group and an important player in the health care reform process.

It is leading the effort by doctors to change some of the regulations, which govern hundreds of tests on samples of blood, bodily fluids and tissue. They range from calculations of blood sugar levels to detection of cancer.

Bob Boorstin, a White House spokesman, confirmed that some changes being considered "could result in less regulation." The purpose is not to woo doctors, but to deal with "some stuff that's pretty weird" in federal lab rules, he said, without being specific.

Dr. James S. Todd, executive vice president of the AMA, also denied that the administration was seeking to trade changes in regulation of labs for the medical association's support of health reform. He said Ira Magaziner, who coordinates the president's task force on health reform, came to the organization and asked, "What are some of the lab regulations on physicians that don't necessarily result" in improved care.

The AMA has been fighting aspects of lab regulation since 1988, when the Clinical Laboratory Improvement Act was passed. That law brought under regulation labs run directly by doctors, usually in their offices. Until then they were exempt from regulations affecting commercial and hospital labs.

The law was passed amid rising public concern about reports of shoddy testing, particularly Pap smears used to detect cervical cancer. Commercial labs also were concerned about growing competition from doctor office labs, which had a profitable edge because they didn't have to pay costs related to regulation.

More and more doctors have set up labs, aided by equipment manufacturers that have succeeded in producing smaller, more efficient testing devices. Of 45,000 labs registered with the government, 85,000 are physician-run, though the doctors' facilities usually have a much smaller volume than commercial labs.

"A primary goal of ours is doctors be allowed to return to practicing medicine," Mr. Boorstin said. "There are a lot of regulations, a lot of pieces of paper, that are really onerous and harm the ability of doctors to do what they do, which is help their patient. So you don't want to be in the position of hurting doctors."

"Obviously we're equally concerned with public safety," he said, indicating changes wouldn't be made affecting reliability of lab tests.

Mr. Boorstin added that the White House also is studying the issue of physicians who refer their patients to labs in which they have a financial interest. He did not elaborate.

The talks between the AMA and the White House are occurring while the administration is seeking support from doctors for the health reform plan to be announced next month. Officials of consumer groups, which advocate strong regulation of all labs, suspect the talks are part of the campaign to gain support.

"I know that people have been told that the administration is offering physicians a series of things," said Mark Cooper, research director of Consumer Federation of America.

Some congressional officials say that's true. But one congressional aide involved in the laboratory issue said such a trade-off might be worth it. "If you can get the AMA to support a broad-based health care package, then it might well be that it's worth changing [the regulations]," he said.

The doctors argue that their office lab tests are generally not as complicated as those done by hospitals and commercial labs and do not have to be as tightly regulated.

Doctors remain concerned about the modified rules, which began taking effect last year, partly because of the additional cost of hiring and training personnel, the extra paperwork and inspections.

The rules require labs to register, pay fees, submit to unannounced inspections and undergo proficiency examinations in which they are judged on the quality of their testing.

Dr. Todd said the 1988 law "went way beyond" what was necessary to protect consumers. He said that regular proficiency tests of labs should be sufficient to monitor quality.

The AMA also has submitted its views on other regulations, such as those governing the Medicare and Medicaid programs -- "a whole list of what we saw as regulatory hassles."

But Ms. Best, who sits on the federal advisory committee on labs, said doctors are trying to avoid necessary regulation. They have been asking the committee to recommend exemption from regulation "tests that have significant risk to the patient if performed erroneously."

The rules already have been "watered down" by the Department of Health and Human Services, Ms. Best said. Personnel standards are so weak that 75 percent of all tests can be done by high school graduates with on the job training.

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