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test with an outdated grading nomenclature could tip the balance for pathologists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provisions out of date and out of synch with modern science.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
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.
Dr. Kass welcomes communication from CAP members.
Send your letters to her at firstname.lastname@example.org.