Information reps can use to provide value and consulting services for cervical cancer prevention and diagnosis.
By Jim Poggi, Principal, Tested Insights
This month’s POL article is devoted to providing information about the changing landscape regarding vaccination and testing for cervical cancer. Morbidity and mortality from all forms of cancer have declined in the U.S. over the past 20 years, due to earlier and better diagnosis as well as changes in lifestyle, including a substantial reduction in smoking, adoption of fitness programs and healthier eating habits. Cancer rates from all types currently stand at 144 cases per 100,000 of the U.S. population in 2020, down from 146 in 2019. These trends are encouraging, and as low dose CT scans for lung cancer and improved cancer tumor markers for multiple types of cancers continue to be introduced into the market, I expect the decline in cancer mortality to continue.
About cervical cancer
Where does cervical cancer fit into the picture and how is the landscape changing? Cervical cancer is the 16th most commonly diagnosed cancer, affecting 7 patients per 100,000 of population, down from 8 in 2019. It has lower incidence than other female cancers including breast at 119 and uterus at 26. Non-gender specific cancers including lung and colorectal are also still far ahead of cervical cancer in incidence among females.
With the relatively low incidence of cervical cancer, why is this topic important to us and the customers we serve? It is important because testing recommendations by the American Cancer Society, United States Preventive Services Taskforce and others have reduced the frequency of testing for cervical cancer due to clear and compelling evidence that we were over-testing previously. In itself, this change has created a level of concern and confusion in the medical community. At the same time, experts have recommended the use of HPV testing in conjunction with traditional Pap testing. Studies over the past 30 years have shown that HPV incidence has been linked to cervical cancer and one of the on-going discussions in medical circles today is: “do we test for cervical cancer using the time-honored Pap smear technology or do we use HPV? Or is there some sort of hybrid testing algorithm we should be using?” Recent recommendations hope to clear up this confusion.
Finally newer vaccinations are available for HPV and there is evidence building that early HPV vaccination all by itself will reduce the incidence of cervical cancer. For the distributor account manager looking to stay informed to be a respected consultant to their customers, there is a LOT to know here.
Cervical cancer testing background
The Pap smear was originally conceived by a Greek physician, Georgios Papanikolaou, in 1928. It began to be widely accepted as a diagnostic tool for cervical cancer in the 1940s. In 1957, Dr. Anna Marion Hilliard developed a simplified version of the Pap test. The principle of the test is for the clinician to obtain a sample of cells from the cervix and to place them onto multiple (typically three) microscope slides for examination and interpretation by a pathologist. One of the early limitations of the test involved samples that included multiple cell layers which made interpretation more difficult. For optimal microscope evaluation, a “monolayer” of cells is required.
In 1996, the FDA cleared the first thin layer prep methods for Pap smear sample preparation aimed at overcoming this concern. Since then, computer-assisted screening has been developed with the aim of reducing human error and providing a more consistent and accurate initial screen. Any equivocal computer-assisted screens are subject to final interpretation by a pathologist.
There are multiple CPT codes reimbursed by Medicare for Pap smears as well as combination Pap smear and HPV testing scenarios. The primary ones are listed below. Other codes may be appropriate. Your customer is advised to consult a billing expert for the proper codes since this area of medicine is complex and frequently changing.
| HCPCS Code | Code Descriptor |
| G0123 | Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, screening by cytotechnologist under physician supervision |
| G0143 | Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with manual screening and rescreening by cytotechnologist under physician supervision |
| G0144 | Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with screening by automated system, under physician supervision |
| G0145 | Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with screening by automated system and manual rescreening under physician supervision |
| G0147 | Screening cytopathology smears, cervical or vaginal, performed by automated system under physician supervision |
| G0148 | Screening cytopathology smears, cervical or vaginal, performed by automated system with manual rescreening |
| G0476 | Infectious agent detection by nucleic acid (dna or rna); human papillomavirus (hpv), high-risk types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) for cervical cancer screening, must be performed in addition to pap test |
| P3000 | Screening papanicolaou smear, cervical or vaginal, up to three smears, by technician under physician supervision |
How does HPV fit into the cervical cancer diagnostic picture?
More recently still, human papilloma virus tests have entered the market as diagnostic tools for cervical cancer. While cellular changes were observed by pathologists based on Pap smears, the specific reasons why cells became pre-cancerous and ultimately led to cervical cancer were unclear. No etiological organism was known in the early days. The linkage of certain HPV sub-types with cervical cancer became known in the late 20th century and the American Cancer Society and American College of Obstetrics and Gynecology first recommended HPV screening in 2003.
While there are known to be over 150 strains of HPV and according to the National Institutes of Health, more than 99.7% of all cancers of the cervix are tied to persistent high risk genital HPV infection, there are only three strains usually associated with cervical cancer, HPV 16 accounts for about 51% of all cases of cervical cancer and HPV 18 accounts for another 16%. HPV 35 adds another 8.7%. The linkage between HPV infection and cervical cancer shows a higher correlation than that between smoking and lung cancer. This level of correlation is extraordinarily high and forms much of the basis for the latest recommendations in cervical cancer screening. Even more importantly, the federal Office on Women’s Health, within the U.S. department of Health and Human Services reports that human papilloma virus is the most common sexually transmitted infection in the U.S. Their data indicates that “about 80% of women will get at least one type of HPV at some point in their lifetime”.
Cervical cancer testing recommendations
Many professional societies and experts provide recommendations about the type of screening and frequency they recommend for cervical cancer, as well as a number of other clinical conditions. These recommendations change from time to time and it is best to consult with your trusted laboratory product supplier for the latest information they are providing to customers. They are in the best position to research and offer this guidance.
United States Preventive Services Taskforce
Recommendation
- Women between the ages of 21 and 65 should be screened every three years with cervical cytology only. For women between 30 and 65, their recommendation is screening by cytology every 3 years or every 5 years with high risk HPV testing or a combination of both. NOTE: this recommendation is from 2018 and is in the process of re-evaluation.
American College of Obstetrics and Gynecology:
Recommendation
- ACOG presently mirrors USPSTF guidelines.
American Cancer Society
Recommendation
ACS recommends that cervical cancer screening begins at age 25. A “primary HPV test” should be done every 5 years. In the absence of a primary HPV test, screening should include an HPV test along with a Pap test every 5 years or a Pap test every 3 years.
The FDA clears and defines a “primary HPV test.” Presently there are three tests that meet FDA criteria as “primary HPV tests,” with more likely to join the market in the near future. While there is some divergence in recommendations across medical societies and other experts, a few things are clear:
- No matter how you do Pap smears, they are still part of the current screening recommendations.
- HPV testing, including newly cleared primary methods, is becoming a more fundamental part of cervical cancer screening.
- Screening is not recommended after age 65 as long as the patient has had a history of recent negative screening tests.
- Since there is still some divergence in cervical cancer screening guidelines and the USPSTF guidelines are in review, you can expect more changes in available tests as well as new screening recommendations down the road. Stay current with your key lab manufacturers.
How does vaccination fit into the picture?
Development of vaccines against the most common and pathologic strains of HPV is an encouraging development. Two vaccines have been approved by the U.S. FDA since 2009. The vaccines are available for both males and females. Multiple studies have shown that early administration of the vaccine is remarkably effective in reducing the rate of HPV infection. The CDC recommends vaccination routinely at 11 or 12 and advocates vaccination through 26 years of age for persons who were not vaccinated earlier in life.
One landmark study, conducted in Sweden and reported by the National Cancer Institute has shown impressive results. In a study of nearly 2 million women, vaccination reduced the incidence of cervical cancer by more than 90% over an 11-year period. This study gives credence to the need to assure vaccination against known pathogens to reduce disease including cervical cancer.
Bottom line
For the savvy distribution account manager, the cervical cancer story presents an exceptional range of conversation starters with your customers, particularly with OB/GYN and pediatric practices. Many of you offer Pap testing products including swabs, microscope slides and even thin prep systems. In addition, there are several HPV tests available as part of an effective screening protocol.
Finally, for getting to the root of the problem, vaccination is a sensible adjunct to many of the practices you call on. The well-informed distribution account manager can provide valuable information and consulting services for cervical cancer prevention and diagnosis, further increasing their credentials as a go-to consulting resource.