Protecting the proven Pap test

June 2005
President’s Desk Column

Mary E. Kass, MD

Pap test screening is a wonderful public health success story, credited with a 74 percent drop in deaths from cervical cancer between 1955 and 1992. Those who remember when cervical cancer was the No. 1 cause of cancer deaths in women know that the Pap test is a fine screening tool that does exactly what it should do.

Regulations that discourage access and ultimately drive up cost are dangerous because effectiveness is tied to access. This is why we need to be concerned about increasing evidence that the mandated gynecologic cytology proficiency testing program launched by the Department of Health and Human Services in January is fundamentally flawed.

With each passing week, more excellent pathologists report dissatisfaction with a testing process that seems to measure only the limits of their patience. Pathologists are an uncommonly patient bunch, but even the wise have their limits, which is what makes this so dangerous. The current program meets the requirements of the 1992 regulations, but not those of modern science or current practice. Mandated participation in an expensive test with an outdated grading nomenclature could tip the balance for pathologists already discouraged by liability concerns and poor payment. With sufficient disincentives, many providers might abandon Pap smear interpretation entirely. From the look of my mail, that’s exactly where we’re headed and our ultimate destination would be a giant step backward.

Patience is useful in pathology, but requiring successful completion of a test based on standards more than a decade old would try anyone’s patience. The 2005 cytology proficiency testing program took its first breath more than a dozen years after rules were promulgated to implement CLIA 1988. Technology in the interim has rendered many of the original provisions out of date and out of synch with modern science.

Congress itself has expressed frustration over regulations published but not implemented in a timely fashion, and two years ago, in the Medicare Prescription Drug, Improvement, and Modernization Act, set a three-year limit on the interval from HHS proposed rule to final rule. The (eminently sensible) idea of that provision is to ensure that (well-meaning) regulators don’t implement enabling language that has already outlived its original intent. In that spirit, we are asking Congress to intervene and prevail upon HHS secretary Michael O. Leavitt to completely review the 13-year-old regulation.

In addition, this month the College, along with all the major national pathology organizations and virtually all the state pathology societies, sent a letter to secretary Leavitt asking for a re-evaluation of the relevance, validity, and ultimate effectiveness of the new program.

Our letter supports and amplifies the position taken in February by the secretary’s own Clinical Laboratory Improvement Advisory Committee, or CLIAC. This highly respected body unanimously recommended a re-examination of the regulations and grading criteria for consistency with the most current science and clinical practice guidelines. In so doing, CLIAC acknowledged the need to ensure that the new cytology PT program would not evaluate, let alone impose sanctions, on the basis of outdated standards.

There are many deep flaws in the regulations: the fact that they call for examination of individuals rather than laboratories, the fact that pathology is the only specialty whose accrediting boards and state licensing agencies are to be second-guessed, the fact that they address problems (such as the “Pap mills” of the 1980s) that have long since been resolved, the fact that they create and impose escalating sanctions never mentioned in the law itself. Yet this litany of sins does not address the core complaint. The absurdity of a mandatory testing program that relies upon an outdated grading scheme whose premises are at odds with current practice is where the rubber hits the road.

The College has provided gynecological proficiency testing for more than 15 years. Its Interlaboratory Comparison Program in Cervicovaginal Cytopathology, or Pap program, is a scientifically proven, field-tested approach that employs consistent interpretive categories and statistically validated grading to measure laboratory proficiency. So when HHS announced the launch of mandatory gynecology PT, the College reluctantly applied to be approved as a provider. We had avoided this step because we do not endorse the premises that support the program. However, if we are unable to modify this program or prevent it from being imposed on our profession, the College wants to ensure that its members have an opportunity to receive this testing from someone they trust.

We will keep you updated on our advocacy activities on this issue and we want to continue to hear from you. Please share with me your experience with the testing program during this interim period. Our work together will be critical to a positive outcome for pathologists and their patients.