The College of American Pathologists is pleased to submit this statement for the record of the Health And Environment Subcommittee's hearing on women's health and raising the awareness of cervical cancer. The College is a medical specialty society representing nearly 16, 000 physicians who practice clinical and/or anatomic pathology in community hospitals, independent clinical laboratories, academic medical centers, and federal and state health facilities.

Raising the awareness of cervical cancer and the Pap smear and improving the socioeconomic climate for this important service has been a priority of the CAP for most of this decade. We are very glad to see the attention that is now being focused on cervical cancer and its diagnosis and treatment.

Cervical cancer was one of the leading causes of cancer deaths in women in the United States 50 years ago. It is still a major killer of women worldwide. The death rate has decreased over 70%, largely due to the advent of cytology screening by Papanicoloau smears -- Pap smears. However, invasive cervical cancer is still diagnosed with regularity. The 1998 annual estimates were 13,700 new annual U.S. cases and 4,900 deaths. It is the second cause of cancer deaths in young women age 20-39 worldwide. There appears to be a trend of increasing rates in certain segments of the population, after years of declining rates.

Currently there is inadequate Pap smear screening of the entire U.S. population at risk. According to a 1996 National Institutes of Health Consensus Conference, most women diagnosed with cervical cancer have never had cytology screening (50%) or have not been screened within the past five years (10%). Far too many women who are past childbearing years, who are of Asian or Hispanic origin, or who are Native American do not receive regular screening. The most effective way to decrease cervical cancer mortality is to provide for annual screening of all women at risk.

The usual natural history of cervical cancer is several years of a precancerous process. Therefore, any evidence of cervical cancer that is missed on one Pap test will likely be detected the next time the Pap test is given. This makes annual testing critical to detection of the disease at a time when it is usually easily treatable. Therefore, the CAP advocates that, in general, all women who are or have been sexually active, or have reached 18 years of age, should have an annual cervical cytologic examination (Pap test) and pelvic examination.

There are several major issues related to cervical cancer and Pap smear testing that the CAP will discuss. Those issues are:

1. Less than ideal sensitivity of a single Pap smear screening test, and the importance of regular screening
2. Inability to predict which women with atypical cytology results are at high risk for cancer
3. Unrealistic expectations of cytology screening, causing a liability crisis for laboratories
4. Below cost reimbursement of cytology screening

Sensitivity of Pap smear Screening and the Importance of Regular Screening

Sensitivity refers to the ability of a test to identify an abnormality. The Pap smear, while very effective, is a screening test with several limitations. A single Pap test will certainly not detect all cancers and precancers. Cervical cytology screening has several phases, and any one can be plagued by problems. The practitioner must first obtain an adequate sample representative of any cervical cancers/precancers. Second, the laboratory must prepare and stain the sample. Next, specially trained and certified cytotechnologists screen the entire sample for abnormal cells. Finally, any suspected abnormalities are reviewed and confirmed by a pathologist.

The Agency for Health Care Policy and Research recently released an evidence report entitled "Evaluation of Cervical Cytology." One of the main conclusions was "the conventional Pap test is less sensitive than it is generally believed to be". Only a few studies were used for the AHCPR analysis, and sensitivity was estimated to be 51%. A recent population-based study sponsored by the National Cancer Institute of 7,323 women in the high-risk Guanacaste region of Costa Rica was published after the AHCPR analysis. Because of the extensive testing of all women with any atypical result, as well as colposcopy on a fraction of women with negative results, this type of population-based study has advantages over those studies analyzed by the AHCPR. The sensitivity of the Pap smear for any abnormality was 69.5%, and it increased to 79.8% when only high-grade precancers and cancers were considered.

A "false negative" Pap smear is one, which fails to identify evidence of disease that is present in the patient. It is estimated that at least half of false negative Pap smear results are due to sampling error, that is, abnormal cells are not captured by the cervix-sampling device or are not present on the slide. Routine reporting of specimen adequacy parameters by laboratories has been promoted by the Bethesda Terminology for Reporting Cervical/Vaginal Cytologic Diagnoses, and a recent questionnaire survey conducted by the CAP found that nearly all U.S. laboratories (92%) were currently doing so. Improved methods of sampling in the future may also help decrease sampling errors. However, some cervical cancers are not sampled because of their location high in the cervical canal, and certain cancers do not shed cells on the surface where they are accessible to sampling devices. Also, just because a smear appears to the laboratory to be satisfactory, there is no guarantee that the practitioner sampled the entire circumference of the cervix. Practitioners and patients need to be educated that suspicious symptoms and lesions require biopsy or other intervention, even if a cytology sample is negative.

The screening and interpretation of cytology slides takes immense concentration and human judgment. The cytotechnologist may be searching for a few abnormal cells among 200,000 or more normal cells. Both cytotechnologists and pathologists may make interpretive errors, mistaking abnormal cells for normal ones, and vice versa. Cells of the cervix are affected by a multitude of factors, including age, time of menstrual cycle, hormonal status, and drug therapy, etc. Some cancer cells closely resemble those found in infectious and benign conditions, and experts often fail to interpret the same sample in the same way.

Under the Clinical Laboratory Improvement Amendments of 1988, laboratories must comply with complex cytology regulations which emphasize numerous ongoing quality assurance parameters that are designed to improve Pap smear accuracy and reduce the false negative rate. A large number of laboratories also participate in voluntary peer-review programs such as those of the CAP. Cytology laboratories inspected by the CAP's Laboratory Accreditation Program participate in peer-review interlaboratory comparison glass slide programs. The glass slide program of the CAP enrolls nearly 2000 laboratories, and similar programs enroll several hundred more.

While a national proficiency testing program has not yet been implemented, most pathologists and cytotechnologists do not believe that such testing will significantly affect cervical cancer mortality and morbidity. Proficiency testing is an artificial view of screening/interpretive skills, since individuals are aware they are being tested. Other quality measures already in use have a larger impact on false negative rates.

The CAP does not believe that a lower false negative rate can be legislated or regulated. Several studies rescreening large numbers of slides have found that there is an irreducible laboratory false negative rate of at least 5% in high quality laboratories. Recent Food and Drug Administration trials, also performed in high quality laboratories provide a more realistic estimate of laboratory false negative rates. In such analyses, about 15% of precancers and cancers are missed on the first screening event, and detected on the second. If one assumes that laboratory false negatives account for about half of all errors, this provides a similar estimate to the 30% false negative rate found in the Guanacaste study.

New cytology technologies may decrease but will not eliminate false negative results and screening devices will impact almost exclusively on screening errors. As sampling errors are the largest single cause of false negative results, it is unrealistic to expect that new technologies alone will eliminate cervical cancer deaths.

Given the inherent limitations of a single screening event and the less than ideal sensitivity, it is vital that women be screened regularly. As indicated above, the usual natural history of cervical cancer is several years of a precancerous process. Therefore, lesions missed on one screening event will likely be detected the following year. A false negative rate of even 30% declines to less than 5% with three screening events; this means the sensitivity increases from 70% to over 95%. Further annual screens can increase the sensitivity to over 98%.

Limitations in Ability to Predict Which Women with Abnormal Cytology Results are Actually at Risk for Cancer and High Grade Lesions

Precancerous processes are considered to be either high grade (high risk for cancer) or low grade (low risk for cancer) lesions. High grade precancers are most likely to progress to cancer, but such processes account for the minority of abnormal cytology results. The majority of low grade lesions regress without treatment. The largest single category of cytology abnormality is Atypical Squamous Cells of Undetermined Significance (ASCUS). Women with ASCUS have a variety of diagnoses on follow-up, including infections and precancers. According to a recent CAP questionnaire survey, the median reporting rates for various types of abnormal cytology results were as follows:

ASCUS: 4.5% Low Grade Squamous Intraepithelial Lesion (LSIL): 1.6% High Grade Squamous Intraepithelial Lesion: 0.5%

High grade lesions are the least frequent of the precursors, and all women with such diagnoses require further evaluation and treatment. While most women with ASCUS and LSIL have either benign processes or low grade lesions which will regress, about 5-20% have high grade lesions or cancers upon further evaluation and follow-up. This is the reason that colposcopy and histologic biopsy studies are generally performed on such women. However, such aggressive evaluation in so many women with abnormal cytology results is very expensive. Clinicians and pathologists need better tools to identify which women with ASCUS and LSIL are more likely to progress. The CAP supports federally sponsored research studies like the ASCUS/LSIL Triage Study now being performed under the direction of the National Cancer Institute.

The CAP also supports ongoing research on methods which may prevent cases of cervical cancer and precancers in the future. These include the development of vaccines and measures to prevent transmission of etiologic agents including the Human papillomvirus.

Unrealistic Expectations of Pap Smear Screening Causing a Liability Crisis for Laboratories

The success of the Pap smear in decreasing cervical cancer mortality has led to unrealistic expectations by the public and even other medical professionals. The public now expects perfection and lawsuits for alleged errors are commonplace. Some advertisements in the popular press inform patients that, if they have cervical cancer, they should file a lawsuit. Pap smears are now the leading cause of liability for pathologists and laboratories and most of these lawsuits allege that laboratories are not meeting the standard of practice because of a false negative result. As discussed earlier, the sensitivity of the Pap is less than ideal and false negative cases are found in every laboratory.

A related problem is that expert witnesses may not, in their opinions, reflect an understanding of the inherent limitations of the Pap smear and the irreducible false negative rate. To assist states in addressing the Pap smear liability problem, the CAP developed Guidelines for Review of Pap Smears in the Context of Litigation or Potential Litigation. The guidelines set forth standards for evaluation of Pap smear cases that can be used by courts and others involved in litigation. The guidelines, in part, recognize that a false negative result is not sufficient proof of negligence and set a "reasonable and prudent practitioner" standard of care. The guidelines also say that compensation of a physician-witness should reasonably reflect the time and effort expended by the witness in preparation, depositions, and trial and should not be contingent on the outcome of the case.

These guidelines have been adopted by the American Society of Cytopathology and several state cytology organizations. Many state pathology, cytology and medical societies have either adopted the guidelines or developed similar recommendations.

Below Cost Payment for Pap Smear Screening

Although Congress has acted twice in the last decade to establish and expand the Medicare screening Pap smear benefit, the payment policy has not been supportive of community provision or promotion of the benefit. Medicare payment for this important cytology service is capped at $7.15 nationwide whereas the cost of the service is between $13.00 and $17.00 in most laboratories.

The CAP believes that it is important to encourage local community provision of Pap smears so that correlation of cytology and histology findings is easier and communication between the pathologist and the attending physician is facilitated. When Pap smears are provided at a laboratory that has not provided the histology service such as the cervical biopsy, cytology-histology correlation becomes more time consuming and thus more costly and may be waived in the spirit of cost containment that now pervades health care provision. Communication with the attending physician also becomes more cumbersome.

We believe that there are strong community service and quality of care motives among pathologists, hospitals and others to provide the Pap smear locally were it not plagued with such strong economic disincentives. But most Pap smears are not provided locally and the service is not promoted with the same vigor that breast cancer, prostate cancer, HIV, osteoporosis, heart disease and many other disease prevention and detection programs receive. We believe that this lack of community health care provider promotion is tied to the poor socioeconomic climate for the service.

We have asked the Health Care Financing Administration to increase payment for the Pap smear to somewhere between $13.00 and $17.00 so that the costs of the service will be covered in most local laboratories. Last year, Congress agreed with us when, as part of the conference report accompanying the Omnibus Appropriations legislation for fiscal year 1999, the Secretary of the Department of Health and Human Services was "urged to act as soon as possible to increase the Medicare payment for the screening Pap smear." The report expressed concern about the large disparity between the average $13.00 to $17.00 costs and the Medicare payment to $7.15 and stated the belief that adequate payment is a necessary component of ensuring women's access to quality Pap smears. The CAP agrees.

We are pleased to see that Congress is interested in pursuing this goal again this year. On January 6, bipartisan Concurrent Resolution 5 was introduced in the House of Representatives. This resolution recognizes the severity of the issue of cervical health and calls for support for cervical cancer patients and their families and education about the disease so that early detection can be ensured. On March 4, H.R. 976, the Investment in Women's Health Act of 1999, was introduced, also with bipartisan sponsorship. This bill would set a floor of $14.60 for Medicare payment for the Pap smear beginning in the year 2000. Sponsors of the bill are steadily increasing. In addition, a second Concurrent Resolution is expected to be introduced this month that emphasizes the importance of federally funded programs that provide Pap smear services.

We ask for the support of this committee in our efforts to increase payment for Medicare manual Pap smears.

We also want to ensure that, if Medicare payment is increased, it must not be allowed to erode in future years because of broad budget reduction initiatives aimed at other services. Very often the Congress legislatively eliminates or limits the CPI updates to the Medicare clinical laboratory fee schedule and/or reduces the percentage of the median of carrier fee schedules that is used to calculate the national limitation amounts (the caps). The Balanced Budget Act of 1997 eliminated the inflation updates through the year 2002. There is discussion among members of the Bipartisan Commission on the Future of Medicare of extending that provision through 2007. The Administration's budget proposal for 2000 included a reduction in the national cap formula from 74 percent to 72 percent of the median of carrier fee schedules.

We believe that it would be inconsistent with the intent of any decision to improve payment for Medicare Pap smears to allow that sound policy decision to be eroded by subjecting the service to eliminated inflation updates and reductions in national caps in subsequent years. Regardless of the amount of any improvement that is made in Pap smear payment, for that improvement to be meaningful in the long term it will be essential that the service receive inflation updates in subsequent years and not be the subject of national cap reductions.

We ask for your support in ensuring that the manual Pap smear receives full CPI updates and are not subject to reductions in the national caps. We believe that a legislative solution to this issue will be needed and we will be pursuing that approach at the appropriate time. We would appreciate your support in these efforts.

CAP Public Health Initiatives to Raise Awareness of Cervical Cancer

During the past decade the CAP has been a leader in raising the awareness of cervical cancer and the importance of annual Pap smear screening. The CAP brought together a coalition of major medical associations and consumer and government organizations in response to the growing concern that women are failing to have annual Pap smears for lack of information and time. A CAP-funded Gallup survey in 1997 revealed that nearly half of women aged 50 or older had not had a Pap test in the last year and sixteen percent had not had a test in five years or more. This is of great concern because studies show that nearly 60 percent of cervical cancers diagnosed each year are in women who are 55 or older.

The CAP public service toll free line, 800-LAB-5678, can be contacted for information about CAP Pap smear promotion material. Our brochure, Pap Examination: It Can Save Your Life and fact sheets, FACTS ABOUT CERVICAL CANCER AND PAP SMEARS and MYTHS AND FACTS provide useful information about the importance of Pap testing and dispel common myths about cervical cancer and the Pap smear. A copy of Pap Examination: It Can Save Your Life is attached to this statement.

In May 1999, the CAP is establishing a Web site where women can register to receive an e-mail reminder, on the date they choose, to schedule and have an annual Pap smear.

Conclusion

The CAP is pleased that the Subcommittee is addressing the important public health issue of awareness of cervical cancer. We would welcome the opportunity to work with the subcommittee to address the many issues raised in our statement. Several issues that we have discussed are interrelated. Together they discourage both the promotion of cervical cancer detection awareness and the expansion of Pap smear screening for segments of the population that are at highest risk--women who do not have annual Pap tests such as older women, Native Americans and women of Asian or Hispanic origin. Pathologists and local laboratories have a strong public health and quality assurance motive to provide Pap smears at the local level, but have strong economic disincentives not to do so. We would appreciate your support in correcting that problem.

We believe that the most effective action to reduce deaths from cervical cancer is through public education and programs targeted to women most at risk that encourage and support annual Pap smears.

Thank you for the opportunity of submitting this statement.