Coverage Policy Manual
Policy #: 2011021
Category: PPACA Preventive
Initiated: November 2018
Last Review: November 2023
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: CERVICAL CANCER AND HUMAN PAPILLOMAVIRUS (HPV) SCREENING

Description:
Cervical
 
The Federal Patient Protection and Preventive Care Act was passed by Congress and signed into law by the President in March 2010.  The preventive services component of the law became effective 23 September 2010. A component of the law was a requirement that all “non-grandfathered” health insurance plans are required to cover those preventive medicine services given an “A” or “B” recommendation by the U.S. Preventive Services Task Force and consistent with the Health Resources and Services Administration ‘s (HRSA’s) Women's Preventive Services: Required Health Plan Coverage Guidelines without cost sharing (i.e., deductible, co-insurance, or co-pay).  
 
Task Force recommendations are graded on a five-point scale (A-E), reflecting the strength of evidence in support of the intervention.  Grade A: There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade B: There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade C: There is insufficient evidence to recommend for or against the inclusion of the condition in a periodic health examination, but recommendations may be made on other grounds.  Grade D: There is fair evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.  Grade E: There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.
 
Those preventive medicine services listed as Grade A & B recommendations are covered without cost sharing (i.e., deductible, co-insurance, or co-pay) by Health Plans for appropriate preventive care services provided by an in-network provider.  If the primary purpose for the office visit is for other than Grade A or B USPSTF preventive care services, deductible, co-insurance, or copay may be applied.
 
The HRSA-supported health plan coverage guidelines were developed by the Department of Health and Human Services (HHS) commissioned Institute of Medicine (IOM). HHS commissioned an IOM study to review what preventive services are necessary for women’s health and well-being and should be considered in the development of comprehensive guidelines for preventive services for women.  HRSA supports the IOM’s recommendations on preventive services that address health needs specific to women and fill gaps in existing guidelines.
 
Non-grandfathered plans and issuers are required to provide coverage without cost sharing consistent with these guidelines starting August 1, 2012.  
 
Plans are not required to provide coverage for the preventive services if they are delivered by out-of-network providers.

Policy/
Coverage:
1. For women aged 21 to 29 years:
 
Screening for cervical cancer is covered for women of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay) with cytology (Pap smear) alone every 3 years.
 
2. For women aged 30 to 65 years:
 
Screening for cervical cancer is covered for women of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay) with cytology (Pap smear) alone every 3 years
 
                         OR
 
High-risk human papillomavirus DNA testing is covered for members of “non-grandfathered” plans, without cost sharing (i.e., deductible, co-insurance or co-pay) for women no more frequently than every 5 years
 
                         OR
 
High-risk human papillomavirus DNA testing in combination with cytology (cotesting) is covered for members of “non-grandfathered” plans, without cost sharing (i.e., deductible, co-insurance or co-pay) for women no more frequently than every 5 years
 
 
 
CODING
 
Cervical Cancer Screening
 
The appropriate ICD 10 codes to report these services are Z00.00, Z00.01, Z01.411, Z01.419, Z01.42, Z12.4 and Z12.72
 
The codes used to report this service are 88141-88143, 88147, 88148, 88150, 88152-88153, 88164-88167, 88174, 88175, G0101, G0123, G0124, G0141, G0143-G0145, G0147, G0148, P3000, P3001, Q0091, S0610 and S0612.
 
High-risk Human Papillomavirus
 
The appropriate ICD-10 codes to report these services are Z00.00, Z00.01, Z01.411, Z01.419, Z11.51, or Z12.4.
 
The codes that may be used to report this service are CPT 87623, 87624, 87625, and G0476.
 
 
When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-10 and CPT or HCPCS codes are also required.

Rationale:
Cervical Cancer Screening
 
The U.S. Preventive Services Task Force (USPSTF) strongly recommends screening for cervical cancer in women who have been sexually active and have a cervix (Grade A recommendation).
 
The USPSTF recommendations include the following information:
 
        • The goal of cytologic screening is to sample the transformation zone, the area where physiologic transformation from columnar endocervical epithelium to squamous (ectocervical) epithelium takes place and where dysplasia and cancer arise. A meta-analysis of randomized trials supports the combined use of an extended tip spatula to sample the ectocervix and a cytobrush to sample the endocervix.
        • The optimal age to begin screening is unknown. Data on natural history of HPV infection and the incidence of high-grade lesions and cervical cancer suggest that screening can safely be delayed until 3 years after onset of sexual activity or until age 21, whichever comes first. Although there is little value in screening women who have never been sexually active, many U.S. organizations recommend routine screening by age 18 or 21 for all women, based on the generally high prevalence of sexual activity by that age in the U.S. and concerns that clinicians may not always obtain accurate sexual histories.
        • Discontinuation of cervical cancer screening in older women is appropriate, provided women have had adequate recent screening with normal Pap results. The optimal age to discontinue screening is not clear, but risk of cervical cancer and yield of screening decline steadily through middle age. The USPSTF found evidence that yield of screening was low in previously screened women after age 65. New American Cancer Society (ACS) recommendations suggest stopping cervical cancer screening at age 70. Screening is recommended in older women who have not been previously screened, when information about previous screening is unavailable, or when screening is unlikely to have occurred in the past (e.g., among women from countries without screening programs). Evidence is limited to define "adequate recent screening." The ACS guidelines recommend that older women who have had three or more documented, consecutive, technically satisfactory normal/negative cervical cytology tests, and who have had no abnormal/positive cytology tests within the last 10 years, can safely stop screening.
        • The USPSTF found no direct evidence that annual screening achieves better outcomes than screening every 3 years. Modeling studies suggest little added benefit of more frequent screening for most women. The majority of cervical cancers in the United States occur in women who have never been screened or who have not been screened within the past 5 years; additional cases occur in women who do not receive appropriate followup after an abnormal Pap smear.  Because sensitivity of a single Pap test for high-grade lesions may only be 60-80 percent; however, most organizations in the United States recommend that annual Pap smears be performed until a specified number (usually two or three) are cytologically normal before lengthening the screening interval.
        •  The ACS guidelines suggest waiting until age 30 before lengthening the screening interval; the American College of Obstetricians and Gynecologists (ACOG) identifies additional risk factors that might justify annual screening, including a history of cervical neoplasia, infection with HPV or other sexually transmitted diseases (STDs), or high-risk sexual behavior, but data are limited to determine the benefits of these strategies.
        • Discontinuation of cytological screening after total hysterectomy for benign disease (e.g., no evidence of cervical neoplasia or cancer) is appropriate given the low yield of screening and the potential harms from false-positive results in this population.  Clinicians should confirm that a total hysterectomy was performed (through surgical records or inspecting for absence of a cervix); screening may be appropriate when the indications for hysterectomy are uncertain. ACS and ACOG recommend continuing cytologic screening after hysterectomy for women with a history of invasive cervical cancer or DES exposure due to increased risk for vaginal neoplasms, but data on the yield of such screening are sparse.
        • A majority of cases of invasive cervical cancer occur in women who are not adequately screened.  Clinicians, hospitals, and health plans should develop systems to identify and screen the subgroup of women who have had no screening or who have had inadequate past screening.
        • Newer Food and Drug Administration (FDA)-approved technologies, such as the liquid-based cytology (e.g., ThinPrep®), may have improved sensitivity over conventional Pap smear screening, but at a considerably higher cost and possibly with lower specificity. Even if sensitivity is improved, modeling studies suggest these methods are not likely to be cost-effective unless used with screening intervals of 3 years or longer. Liquid-based cytology permits testing of specimens for HPV, which may be useful in guiding management of women whose Pap smear reveals atypical squamous cells. HPV DNA testing for primary cervical cancer screening has not been approved by the FDA and its role in screening remains uncertain.
 
In 2012, the USPSTF updated the recommendation statement for Cervical Cancer Screening. The updated Final Recommendation Statement for Cervical Cancer Screening gives a grade A for cervical cancer screening in women age 21 to 65 years with cytology every 3 years or, for women age 30 to 65 years who want to lengthen the screening interval, screening with a combination of cytology and human papillomavirus (HPV) testing every 5 years.
 
Additionally, the USPSTF recommends against (Grade D) cervical cancer screening in women younger than age 21 years.
 
The recommendation statement gives the following information (USPSTF, 2012):
 
        • “The USPSTF found little evidence to determine whether and how sexual history should affect the age at which to begin screening. Although exposure of cervical cells to sexually transmitted HPV during vaginal intercourse may lead to cervical carcinogenesis, the process has multiple steps, involves regression, and is generally not rapid. There is evidence that screening earlier than age 21 years, regardless of sexual history, would lead to more harm than benefit. The harms are greater in this younger age group because abnormal test results are likely to be transient and to resolve on their own; in addition, resulting treatment may have an adverse effect on future child-bearing”.
 
        •  “Clinicians and patients should base the decision to end screening on whether the patient meets the criteria for adequate prior testing and appropriate follow-up per established guidelines. The ACS/ASCCP/ASCP guidelines define adequate prior screening as 3 consecutive negative cytology results or 2 consecutive negative HPV results within 10 years before cessation of screening, with the most recent test occurring within 5 years. They further state that routine screening should continue for at least 20 years after spontaneous regression or appropriate management of a high-grade precancerous lesion, even if this extends screening past age 65 years. The ACS further states that screening should not resume after cessation in women older than age 65 years, even if a woman reports having a new sexual partner”.
 
The 2014 Bright Futures/American Academy of Pediatrics Periodicity Schedule indicates that cervical screening should be performed at 21 years of age (AAP, 2014). Additionally, the schedule refers to the USPSTF recommendations (discussed above) for guidance.
 
In summary, the guidelines indicate screening for cervical cancer is not recommended prior to age 21. The coverage statement has been changed based on the USPSTF (USPSTF, 2012) recommendations and the Bright Futures Periodicity Schedule (AAP, 2014).
 
High-risk human papillomavirus DNA Screening
 
The HRSA-supported health plan coverage guidelines recommend high-risk human papillomavirus DNA testing in addition to cytology testing in women with normal cytology beginning at age 30. Screening should occur no more frequently than every 3 years. According to the committee, this recommendation is based on current federal practice policy from the U.S. Department of Defense and peer-reviewed studies.
 
High-risk HPV DNA testing detects the viral types most commonly associated with the development of cancer. The current USPSTF guidelines don’t address the role of screening for high-risk HPV.

CPT/HCPCS:
87623Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low risk types (eg, 6, 11, 42, 43, 44)
87624Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68)
87625Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed
88141Cytopathology, cervical or vaginal (any reporting system), requiring interpretation by physician
88142Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; manual screening under physician supervision
88143Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; with manual screening and rescreening under physician supervision
88147Cytopathology smears, cervical or vaginal; screening by automated system under physician supervision
88148Cytopathology smears, cervical or vaginal; screening by automated system with manual rescreening under physician supervision
88150Cytopathology, slides, cervical or vaginal; manual screening under physician supervision
88152Cytopathology, slides, cervical or vaginal; with manual screening and computer assisted rescreening under physician supervision
88153Cytopathology, slides, cervical or vaginal; with manual screening and rescreening under physician supervision
88164Cytopathology, slides, cervical or vaginal (the Bethesda System); manual screening under physician supervision
88165Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and rescreening under physician supervision
88166Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and computer assisted rescreening under physician supervision
88167Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and computer assisted rescreening using cell selection and review under physician supervision
88174Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; screening by automated system, under physician supervision
88175Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; with screening by automated system and manual rescreening or review, under physician supervision
G0101Cervical or vaginal cancer screening; pelvic and clinical breast examination
G0123Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, screening by cytotechnologist under physician supervision
G0124Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, requiring interpretation by physician
G0141Screening cytopathology smears, cervical or vaginal, performed by automated system, with manual rescreening, requiring interpretation by physician
G0143Screening 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
G0144Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with screening by automated system, under physician supervision
G0145Screening 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
G0147Screening cytopathology smears, cervical or vaginal, performed by automated system under physician supervision
G0148Screening cytopathology smears, cervical or vaginal, performed by automated system with manual rescreening
G0476Infectious 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
P3000Screening papanicolaou smear, cervical or vaginal, up to three smears, by technician under physician supervision
P3001Screening papanicolaou smear, cervical or vaginal, up to three smears, requiring interpretation by physician
Q0091Screening papanicolaou smear; obtaining, preparing and conveyance of cervical or vaginal smear to laboratory
S0610Annual gynecological examination, new patient
S0612Annual gynecological examination, established patient

References: Bright Futures/American Academy of Pediatrics (AAP) Periodicity Schedule. Recommendations for Preventive Pediatric Health Care. Bright Futures/American Academy of Pediatrics (AAP). Available at https://www.aap.org/en-us/professional-resources/practice-support/Periodicity/Periodicity%20Schedule_FINAL.pdf. Last accessed June 25, 2015.

IOM (Institute of Medicine).(2011) Clinical Preventive Services for Women: Closing the Gaps. Washington, DC: The National Acadamies Press.

PPACA & HECRA: Public Laws 111-148 & 111-152. The Patient Protection and Affordable Care Act

Screening for Cervical Cancer, Topic Page. May 2011. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspscerv.htm

U.S. Preventive Services Task Force (USPSTF).(2012) Final recommendation Statement. Cervical Cancer: Screening, March 2012. Available at http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening#update-of-previous-uspstf-recommendation. Last accessed June 25, 2015.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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