The Pap smear is one of medicine’s oldest and most reliable tests.
Now, it has entered a new era of fine-tuning, with a better understanding of when to do the procedure and the introduction of technology that promises to improve it.
But a huge debate, brewing for several years, has mushroomed over whether new technologies are worth their price tags. They cost an additional $5 to $50 per test and aren’t covered by many insurance plans. The national implications are even larger: The tests could add $1 billion a year to the nation’s health-care budget, according to one manufacturer’s estimate.
The Pap smear usually is very accurate in detecting cervical cancer, doctors say. But because detection of abnormalities that could be earlier signs of cancer is tedious and prone to error, several manufacturers have begun to offer new devices that promise patients peace of mind and greater reliability. A further dispute with doctors has emerged because some companies advertise directly to consumers, painting the Pap test as imperfect.
“I don’t know the price tags of the new technology, but I know I’ll need medical care for the rest of my life and it already has cost $100,000,” said Carol Armenti of Toms River, N.J., a cervical cancer survivor and founder of the Center for Cervical Health.
The Hematology and Pathology Devices Panel of the Food and Drug Administration is reviewing studies by Neopath Inc., a Redmond, Wash., manufacturer of computer technology, to improve the Pap test. The company is seeking federal approval to pave the way for broader acceptance of its AutoPap program.
Meanwhile, doctors and medical journals are trying to regain what they say is balance needed in the debate. Several have been critical about the costs of the new devices and question whether they significantly improve detection.
In the Jan. 21 issue of Journal of the American Medical Association, Air Force doctors reported on a study of PapNet, another computer program to improve detection. It involved 5,478 women tested at Air Force clinics in the United States and Japan. The team concluded that PapNet found very few additional abnormalities that people didn’t spot under a microscope.
The cost of manual rechecking of Pap slides, resulting in detection of an abnormality, was $1,065, compared with $33,781 for each abnormality found when rechecked with the PapNet system, said Dr. Timothy O’Leary, the lead author, with the Air Forces Institute of Pathology in Washington, D.C.
A bigger fear is that technology might price Pap smears out of reach of the women who need them most.
Nationwide, 54 percent of American women have annual Pap smears; 50 million Pap smears are performed annually in the United States.
Some doctors ask: Wouldn’t money spent on new technologies that may not be vastly superior to conventional Pap tests — at least now — be better spent on expanding educational campaigns, or even providing free tests for women who can’t afford conventional Pap tests or who are most at risk of cervical cancer?
“Why shouldn’t we spend all this money, and probably less, for manual screening of underserved populations?” asked Dr. Michael Stanley, chairman of the department of pathology, Hennepin County Medical Center, Minneapolis, in an editorial in the American Journal of Clinical Pathology. Stanley says enough questions have been raised by experts studying the new technologies that “unless the industry has major surprises,” most computer Pap technologies are “an idea that’s time has not yet come.”
Dr. Carlos Bedrossian, a nationally recognized expert and president-elect of the Papanicolaou Society of Cytology, helped write the consensus guidelines for professionals and consumers. (His society is named after the Cornell University cell biologist who devised the test 50 years ago.) The consumer guidelines give brief descriptions of the new products but no endorsements.
“A major issue is reimbursement. Hospitals may feel they can absorb the costs of some of these systems if they receive adequate reimbursement. The problem is, it always has been under-reimbursed” by insurance plans, he said.
Nationwide, a new coalition of professionals, companies and women’s groups called the National Cervical Cancer Coalition is contacting legislators in many states to raise reimbursement rates.
Current rates from most insurance plans are $5 to $8 for a $15 test, according to the coalition. Even though annual tests are recommended by virtually all leading groups, Medicare pays for Pap smears only every three years unless a woman is at high risk of cancer. Medicare then pays for an annual test.
