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Clintons float CLIA changes as part of reform strategy.

THE PRESIDENT and Mrs. Clinton have suddenly emerged as agents for change in the Clinical Laboratory Improvement Amendments of 1988. It appears the Administration is considering altering the CLIA rules to grow support--particularly among physicians--for comprehensive health care reform.

Hillary Rodham Clinton hit the road earlier this summer to gain support for the Administration's reform package, which at this writing still had not been formally announced.

In the process, she suggested that the clinical laboratory regulations were an example of the Government's attempt to "micromanage" the health industry to the detriment of provider autonomy. Representatives of the lab community were called in for two meetings with a member of the Clinton health care team, and efforts were under way to organize an ad hoc coalition that would advise on potential changes in the CLIA framework.

* Courting the AMA. In a speech to a labor union in early June, the First Lady chided unspecified health care providers for "price gouging, cost shifting, and unconscionable profiteering." But the tone shifted dramatically 2 weeks later when she addressed 2,000 doctors at the annual convention of the American Medical Association in Chicago.

During that presentation, Mrs. Clinton offered physicians a "new bargain" in which malpractice laws would be reformed and the profession freed from burdensome laboratory regulations--all in return for their support of the White House health care package.

Hitting all the right buttons with her audience, Mrs. Clinton pledged support for reforms that would give patients the freedom to select their own doctors. She also blasted managed care plans that impinge on a physician's professional judgment.

"I can understand how many of you must feel when, instead of being trusted for your expertise, you're expected to call an 800 number and get approval for even basic medical procedures from a total stranger," she said to warm applause.

The result of such excessive oversight, she said, is backward incentives that reward providers for overprescribing and ordering unnecessary medical tests. "Let us remove the kind of micromanagement and regulation that has not improved quality and has wasted billions of dollars," she told the AMA.

* Burdensome regs assailed. For example, Mrs. Clinton said, "We have to simplify and eliminate the burdensome regulations" imposed on clinical laboratories. Many doctors had previously asserted they will be unable to continue office testing under CLIA rules.

Other aspects of the "new bargain" include a proposal to curb malpractice problems. There were no details in the speech, but White House officials have said they favor mandatory arbitration of claims and limits on settlements to malpractice victims and their lawyers.

Overall, Hillary Clinton's remarks seemed well received. "She held out a hand in partnership, telling AMA leaders that she was looking not just for suggestions and ideas but for cooperation to make reform work," observed Nancy Dickey, M.D., of the AMA board of trustees.

The positive reviews continued a few days later after Mrs. Clinton addressed a meeting of the Democratic Governors' Association. While seeming to test out other themes the Administration will use to sell its health care proposals, Mrs. Clinton said that no reform plan will succeed unless every American and every employer "bears their fair share of responsibility."

Specifically, she said health care providers can no longer expect to keep raising prices faster than the rate of inflation, and employers not providing health insurance for their workers must do so. "We will have to tell companies that do not cover their workers today and therefore drive up the costs for all those other companies that do, it is time for everybody in America to take responsibility," the First Lady declared.

* Lab groups called in. Meanwhile, back in Washington, a member of the Administration's health care team called together representatives from leading laboratory associations for a heart-to-heart discussion of CLIA. The first meeting, held in late May, was called by Arnie Epstein, M.D., chairman of the White House task force's quality of care work group. Epstein apparently got the drop on the lab representatives, who were not told in advance what he would address. By most accounts, the session lasted longer and became more technical than the participants anticipated.

The burdens that CLIA presumably places on physicians' office labs was a central topic of discussion. Although Epstein did not offer any clues as to what CLIA changes the Administration may have in mind, he did lay out a number of issues for the laboratory groups to consider. Among them:

* Why does the Government need to track tests placed in the CLIA waived category (because they are low risk)? Why require physicians to obtain a certificate and pay a fee if those tests are not regulated?

* Does the Government need to specify an educational degree requirement for moderate complexity testing? Do stringent quality control (QC) requirements suffice? Should degree requirements be higher than that of a high school diploma? If so, why? What level of lab training is necessary to perform moderate complexity testing?

* What QC requirements should be kept and which expanded, and why?

* What justification is there for requiring proficiency testing? What role should sanctions play?

Being unprepared to address those questions in detail, the lab participants were asked to meet with Epstein again after they had readied their responses.

* CLIA changes undisclosed. At that second meeting, held June 29, attendees presented a unified front in responding to the questions. Again, Epstein did not divulge what CLIA changes the Administration has in mind. Sources say he asked meeting participants not to discuss the session with the press.

Observers speculate, however, that the task force may be considering a repeal of CLIA provisions that require physicians' office laboratories to pay registration fees for certificates of waiver and to participate in proficiency testing for regulated tests. The debate appears to center on the balance between public safety requirements and adequate access to laboratory services.

Participants in the meetings included representatives from the American Society of Clinical Pathologists, College of American Pathologists, American Society for Medical Technology, American Association for Clinical Chemistry, American Society for Microbiology, American Association of Bioanalysts, and the Clinical Laboratory Management Association.

While respecting the White House's wishes that discussions not be aired, sources who took part in the meetings say they viewed them as an opportunity to offer broad support for the guiding principles of CLIA.

Although they hope that no legislative bombshells are on the way, these representatives allow that some modification of the regulations might be appropriate. The irony, not lost on those who have followed CLIA '88 since its inception more than 6 years ago, is that the law could be alluded to as the Government's attempt to "micromanage" an industry.

* Lab coalition formed. To help shape the discussions, the lab groups invited to speak with Epstein have formed an ad hoc Coalition to Preserve Quality Patient Testing, as it is currently being called. Members will strive to present a unified front on key issues, although each is likely to press harder on matters of special interest, such as the role of proficiency testing and quality control for physicians' office labs.

One dominating concern among members of the lab industry is that, for all the turmoil and good-faith effort entailed, CLIA could be shunted aside as a bargaining chip to win support for comprehensive health care reform. Given the statements recently offered to the AMA, the final result may already be out of the lab industry's hands.
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Title Annotation:Washington Report; Bill and Hillary Clinton; Clinical Laboratory Improvement Amendments of 1988; health care reform
Author:Albertson, David
Publication:Medical Laboratory Observer
Date:Aug 1, 1993
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