The Pap-smear test is inexpensive and takes just a few minutes in a doctor's office or health clinic. Since widespread use of the test began in the 1950s, cervical-cancer mortality among American women has fallen by up to 80 percent. That trend may soon be reversed.
Last September federal regulators began enforcing the Clinical Laboratory Improvement Act of 1988, which brings all medical laboratories and anyone reading lab tests under the supervision of federal regulators. Dermatologists, for example, must demonstrate three times a year that they can tell the difference between red (positive for athlete's foot) and orange (negative).
Congress had passed the act in response to several cases in which women died of cervical cancer after getting false negative Pap-test readings from high-volume, state-contracted laboratories. At the time, cytologists (doctors certified as experts in Pap testing) had argued that none of the "Pap mills" responsible for erroneous test readings were accredited by the American Society of Cytology or the College of American Pathologists.
The ASC, the CAP, and the American Society of Clinical Pathologists all opposed CLIA. Cytologists would prefer federal regulations that simply require nonaccredited labs, such as the infamous Pap mills, to seek accreditation by the already established ASC and CAP programs. They also encourage women to take on some of the oversight responsibility by asking their doctor if the lab he uses is accredited by either association.
A survey by the Association of American Physicians and Surgeons estimates that complying with the new regulations will cost doctors about $1,800 a year. All physicians with in-office labs are now subject to periodic unannounced visits by federal regulators. Anyone reading Pap-smear tests must be certified by the government and must spend one day away from the office each quarter for a review.
Cytopathologist Marshall Austin, head of the South Carolina Pathology Society, says the red tape, inconvenience, and expense will be enough to convince many doctors to eliminate in-office laboratories. Physicians who continue to provide in-office Pap-test readings will soon find that many patients can no longer afford them. Says Austin, "Low-income women, if they have to choose between buying a bag of groceries and having a Pap smear, they'll buy a bag of groceries."
The effects of regulating Pap tests are already visible in New York, where state rules similar to the federal cytology regulations have been in force since 1988. Since then, the average cost of a Pap test in New York has tripled, from $10 to $30. (With the stricter federal regulations in effect, Planned Parenthood estimates that the price could hit $50 nationwide.)