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Medical PolicyCervical Cancer Screening Technologies with Pap and HPV

Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies

Policy: Medicare Description References

Authorization Information Policy History

Policy Number: 629BCBSA Reference Number: 2.04.09A

Related Policies Speculoscopy, #568

PolicyCommercial Members: Managed Care (HMO and POS), PPO, and IndemnityFor average-risk asymptomatic women aged 21 to 65: Preparation of Papanicolaou (Pap) smears using conventional or a monolayer slide preparation

system may be MEDICALLY NECESSARY every 2 to 3 years. Primary screening and rescreening of Pap smears using the FocalPoint™ or ThinPrep® automated

slide reading systems may be MEDICALLY NECESSARY. HPV testing, in conjunction with Pap smears, for the purpose of screening women over age 30 for

cervical abnormalities may be MEDICALLY NECESSARY.

For high-risk or symptomatic women or those with a prior abnormal Pap: Human papillomavirus (HPV) testing of Pap smears that have an interpretation of atypical squamous

cells of undetermined significance (ASCUS) may be MEDICALLY NECESSARY. HPV testing for the purpose of following-up prior positive HPV tests in women over age 30 may be

MEDICALLY NECESSARY. Primary screening and rescreening of Pap smears using the FocalPoint™ system automated slide

reading system in high-risk patients is INVESTIGATIONAL.

Medicare HMO BlueSM and Medicare PPO BlueSM MembersBCBSMA covers a screening pap smear and related medically necessary services provided to a womanfor the early detection of cervical cancer (including collection of the sample of cells and a physician'sinterpretation of the test results) and pelvic examination (including clinical breast examination) under anyof the following conditions for Medicare HMO Blue and Medicare PPO Blue members in accordance withCMS NCD: No previous test during the preceding two years or the patient is a woman of childbearing age

(§1861(nn) of the Act).

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There is evidence (on the basis of her medical history or other findings) that she is at high risk ofdeveloping cervical cancer and her physician (or authorized practitioner) recommends that she havethe test performed more frequently than every two years.

National Coverage Determination (NCD) for Screening Pap Smears and Pelvic Examinations forEarly Detection of Cervical or Vaginal Cancer (210.2)https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=185&ncdver=3&bc=AgAAQAAAAAAA&

BCBSMA covers diagnostic pap smear and related medically necessary services under any of thefollowing conditions for Medicare HMO Blue and Medicare PPO Blue members in accordance with CMSNCD: Previous cancer of the cervix, uterus, or vagina that has been or is presently being treated; Previous abnormal pap smear; Any abnormal findings of the vagina, cervix, uterus, ovaries, or adnexa; Any significant complaint by the patient referable to the female reproductive system; or Any signs or symptoms that might in the physician's judgment reasonably be related to a gynecologic

disorder.

National Coverage Determination (NCD) for Diagnostic Pap Smears (190.2)https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=184&ncdver=2&bc=AgAAQAAAAAAA&

Prior Authorization InformationCommercial Members: Managed Care (HMO and POS)Prior authorization is NOT required.

Commercial Members: PPO, and IndemnityPrior authorization is NOT required.

Medicare Members: HMO BlueSM

Prior authorization is NOT required.

Medicare Members: PPO BlueSM

Prior authorization is NOT required.

CPT Codes / HCPCS Codes / ICD-9 CodesThe following codes are included below for informational purposes. Inclusion or exclusion of a code doesnot constitute or imply member coverage or provider reimbursement. Please refer to the member’scontract benefits in effect at the time of service to determine coverage or non-coverage as it applies to anindividual member. A draft of future ICD-10 Coding related to this document, as it might look today, isincluded below for your reference.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, anddiagnosis codes, including modifiers where applicable.

CPT Codes

CPT codes: Code Description88141 Cytopathology, cervical or vaginal (any reporting system), requiring interpretation by

physician88142 Cytopathology, cervical or vaginal (any reporting system), collected in preservative

fluid, automated thin layer preparation; manual screening under physician supervision88143 Cytopathology, cervical or vaginal (any reporting system), collected in preservative

fluid, automated thin layer preparation; with manual screening and rescreening under

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physician supervision88147 Cytopathology smears, cervical or vaginal; screening by automated system under

physician supervision88148 Cytopathology smears, cervical or vaginal; screening by automated system with

manual rescreening under physician assistance88150 Cytopathology, slides, cervical or vaginal; manual screening under physician

supervision88152 Cytopathology, slides, cervical or vaginal; with manual screening and computer-

assisted rescreening under physician supervision88153 Cytopathology, slides, cervical or vaginal; with manual screening and rescreening

under physician supervision88154 Cytopathology, slides, cervical or vaginal; with manual screening and computer-

assisted rescreening using cell selection and review under physician supervision88164 Cytopathology, slides, cervical or vaginal (the Bethesda System); manual screening

under physician supervision88165 Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual

screening and rescreening under physician supervision88166 Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual

screening and computer-assisted rescreening under physician supervision88167 Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual

screening and computer-assisted rescreening using cell selection and review underphysician supervision.

88174 Cytopathology, cervical or vaginal (any reporting system), collected in preservativefluid, automated thin layer preparation; screening by automated system, underphysician supervision

88175 Cytopathology, cervical or vaginal (any reporting system), collected in preservativefluid, automated thin layer preparation; with screening by automated system andmanual rescreening, under physician supervision

87620 Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, directprobe technique

87621 Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human,amplified probe technique

87622 Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human,quantification

HCPCS CodesHCPCScodes: Code DescriptionG0123 Screening cytopathology, cervical or vaginal (any reporting system), collected in

preservative fluid, automated thin layer preparation, screening by cytotechnologistunder physician supervision

G0124 Screening cytopathology, cervical or vaginal (any reporting system), collected inpreservative fluid, automated thin layer preparation, requiring interpretation byphysician

P3000 Screening Papanicolaou smear, cervical or vaginal, up to 3 smears, by technicianunder physician supervision

P3001 Screening Papanicolaou smear, cervical or vaginal, up to 3 smears, requiringinterpretation by physician

ICD-9 Diagnosis CodesICD-9-CMdiagnosiscodes: Code Description

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180.0 Malignant neoplasm of endocervix180.1 Malignant neoplasm of exocervix180.8 Malignant neoplasm of other specified sites of cervix180.9 Malignant neoplasm of cervix uteri, unspecified site198.82 Secondary malignant neoplasm of genital organs236.0 Neoplasm of uncertain behavior of uterus239.5 Neoplasm of unspecified nature of other genitourinary organs795.09 Other abnormal Papanicolaou smear of cervix and cervical HPV795.10 Abnormal glandular Papanicolaou smear of vagina795.11 Papanicolaou smear of vagina with atypical squamous cells of undetermined

significance (ASC-US)795.12 Papanicolaou smear of vagina with atypical squamous cells cannot exclude high grade

squamous intraepithelial lesion (ASC-H)795.13 Papanicolaou smear of vagina with low grade squamous intraepithelial lesion (LGSIL)795.14 Papanicolaou smear of vagina with high grade squamous intraepithelial lesion (HGSIL)795.15 Vaginal high risk human papillomavirus (HPV) DNA test positive795.16 Papanicolaou smear of vagina with cytologic evidence of malignancy795.18 Unsatisfactory vaginal cytology smear795.19 Other abnormal Papanicolaou smear of vagina and vaginal HPVV72.31 Routine gynecological examinationV72.32 Encounter for Papanicolaou cervical smear to confirm findings of recent normal smear

following initial abnormal smearV73.81 Special screening examination for Human papillomavirus (HPV)V76.2 Screening for malignant neoplasms of cervixV76.47 Special screening for malignant neoplasms of vaginaV16.49 Family history of malignant neoplasm of other

ICD-10 Diagnosis CodesICD-10-CMDiagnosiscodes: Code DescriptionC53.0 Malignant neoplasm of endocervix

C53.1 Malignant neoplasm of exocervix

C53.8 Malignant neoplasm of overlapping sites of cervix uteri

C53.9 Malignant neoplasm of cervix uteri, unspecified

C79.82 Secondary malignant neoplasm of genital organs

D39.0 Neoplasm of uncertain behavior of uterus

D49.5 Neoplasm of unspecified behavior of other genitourinary organs

R87.610Atypical squamous cells of undetermined significance on cytologic smear of cervix(ASC-US)

R87.611Atypical squamous cells cannot exclude high grade squamous intraepithelial lesion oncytologic smear of cervix (ASC-H)

R87.612 Low grade squamous intraepithelial lesion on cytologic smear of cervix (LGSIL)

R87.613 High grade squamous intraepithelial lesion on cytologic smear of cervix (HGSIL)

R87.614 Cytologic evidence of malignancy on smear of cervix

R87.615 Unsatisfactory cytologic smear of cervix

R87.620Atypical squamous cells of undetermined significance on cytologic smear of vagina(ASC-US)

R87.621Atypical squamous cells cannot exclude high grade squamous intraepithelial lesion oncytologic smear of vagina (ASC-H)

R87.622 Low grade squamous intraepithelial lesion on cytologic smear of vagina (LGSIL)

R87.623 High grade squamous intraepithelial lesion on cytologic smear of vagina (HGSIL)

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R87.624 Cytologic evidence of malignancy on smear of vagina

R87.625 Unsatisfactory cytologic smear of vagina

R87.628 Other abnormal cytological findings on specimens from vagina

R87.810 Cervical high risk human papillomavirus (HPV) DNA test positive

R87.811 Vaginal high risk human papillomavirus (HPV) DNA test positive

R87.820 Cervical low risk human papillomavirus (HPV) DNA test positive

R87.821 Vaginal low risk human papillomavirus (HPV) DNA test positive

Z01.411 Encounter for gynecological examination (general) (routine) with abnormal findings

Z01.419 Encounter for gynecological examination (general) (routine) without abnormal findings

Z01.42Encounter for cervical smear to confirm findings of recent normal smear following initialabnormal smear

Z11.51 Encounter for screening for human papillomavirus (HPV)

Z12.4 Encounter for screening for malignant neoplasm of cervix

Z12.72 Encounter for screening for malignant neoplasm of vagina

Z80.49 Family history of malignant neoplasm of other genital organs

DescriptionData suggest that cytologic screening for cervical cancer reduces the incidence of cervical cancer by upto 50%. Cytologic screening, through the sampling of cells of the cervix, has been the gold-standard sincethe introduction of the Papanicolaou (Pap). The Pap smear involves sampling cells of the transformationzone of the cervix, the area most prone to malignant transformation. Appreciation of the causative effectof human papilloma virus (HPV) infection in most cervical cancers has led to the development ofscreening techniques for the presence of certain high-risk HPV strains in an attempt to improve thespecificity of traditional Pap smears.

The Bethesda classification system assigns a degree of atypia to cells seen on Pap smear; however abiopsy is necessary to gain information on the tissue structure, or histology, of lesions. The correlationbetween cytologic grade and histologic grade, and the natural history of cervical cancer has been an areaof rapidly evolving understanding. While HPV infection has been associated with the development ofcervical cancer, many infections are cleared spontaneously, and low-grade lesions may regress ordisappear, particularly in younger women.

Examples of slide reading systems for screening for cervical cancer include ThinPrep® Pap Test fromHologic, the AutoPap® Automatic Pap Screener, now FocalPoint™ from BD Diagnostics, and digene®HPV test from Qiagen Inc. All slide reading systems for cervical cancer screening are consideredinvestigational regardless of the commercial name, the manufacturer or FDA approval status except asnoted in the policy statement.

SummaryThe evidence regarding the use of liquid-based cytological screening methods for cervical cancerdemonstrates similar sensitivity to conventional cytology, possibly at the expense of specificity. The liquid-based system may add to the convenience of subsequent HPV testing, and in some locations,alternatives are not supported by pathology laboratories. Evidence firmly supports the use of HPV testingfor both initial screening in women older than age 30 and in triage of ASCUS results for all women. Theuse of automated slide reading systems is supported by a small body of evidence that the systems mayincrease sensitivity.

Policy HistoryDate Action7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015.11/2011-4/2012

Medical policy ICD 10 remediation: Formatting, editing and coding updates.No changes to policy statements.

9/2011 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology.

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No changes to policy statements.10/2010 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology.

No changes to policy statements.10/2009 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology.

No changes to policy statements.10/2008 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology.

No changes to policy statements.9/2008 BCBSA National medical policy review.

No changes to policy statements.10/2007 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology.

No changes to policy statements.8/2007 BCBSA National medical policy review.

No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical PoliciesClick on any of the following terms to access the relevant information:Medical Policy Terms of UseManaged Care GuidelinesIndemnity/PPO GuidelinesClinical Exception ProcessMedical Technology Assessment Guidelines

References1. Arbyn M, Bergeron C, Klinkhamer P et al. Liquid compared with conventional cervical cytology: a

systematic review and meta-analysis. Obstet Gynecol 2008; 111(1):167-77.2. Sawaya GF. Evidence-based medicine versus liquid-based cytology. Obstet Gynecol 2008; 111(1):2-

3.3. Siebers AG, Klinkhamer PJ, Grefte JM et al. Comparison of liquid-based cytology with conventional

cytology for detection of cervical cancer precursors: a randomized controlled trial. JAMA 2009;302(16):1757-64.

4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Monolayer slidepreparation and automated slide reading systems for cervical cancer screening – clinicaleffectiveness analysis. TEC Assessments 1998; Volume 13, Tab 1.

5. Wilbur DC, Prey MU, Miller WM et al. Detection of high grade squamous intraepithelial lesions andtumors using the AutoPap System: results of a primary screening clinical trial. Cancer 1999;87(6):354-8.

6. Wilbur DC, Norton MK. The primary screening clinical trials of the TriPath AutoPap System.Epidemiology 2002; 13 Suppl 3:S30-3.

7. Biscotti CV, Dawson AE, Dziura B et al. Assisted primary screening using the automated ThinPrepImaging System. Am J Clin Pathol 2005; 123(2):281-7.

8. Chivukula M, Saad RS, Elishaev E et al. Introduction of the Thin Prep Imaging System (TIS):experience in a high volume academic practice. Cytojournal 2007; 4:6.

9. Solomon D, Schiffman M, Tarone R. Comparison of three management strategies for patients withatypical squamous cells of undetermined significance: baseline results from a randomized trial. J NatlCancer Inst 2001; 93(4):293-9.

10. Wright TC, Jr., Cox JT, Massad LS et al. 2001 Consensus Guidelines for the management of womenwith cervical cytological abnormalities. JAMA 2002; 287(16):2120-9.

11. Saslow D, Runowicz CD, Solomon D et al. American Cancer Society guideline for the early detectionof cervical neoplasia and cancer. CA Cancer J Clin 2002; 52(6):342-62.

12. American College of Obstetricians and Gynecologists (ACOG) Office of Communications NewsRelease. Cervical Cancer Screening: Testing Can Start Later and Occur Less Often Under NewACOG Recommendations. July 31, 2003; Washington, DC. Available online at:http://www.acog.org/from_home/publications/press_releases/nr07-31-03-1.cfm. Last accessedNovember 2010.

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13. U.S. Preventive Services Task Force. Screening for cervical cancer: recommendations and rationale.AHRQ Pub. No. 03-515A; January 2003. Available online at:http://www.ahrq.gov/clinic/3rduspstf/cervcan/cervcanrr.pdf . Last accessed November 2010.

14. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists. Number 61,April 2005. Human papillomavirus. Obstet Gynecol 2005; 105(4):905-18. .

15. Wright TC, Jr., Massad LS, Dunton CJ et al. 2006 consensus guidelines for the management ofwomen with cervical intraepithelial neoplasia or adenocarcinoma in situ. Am J Obstet Gynecol 2007;197(4):340-5.

16. ACOG Practice Bulletin no. 109: Cervical cytology screening. Obstet Gynecol 2009; 114(6):1409-20.