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Date Printed: August 18, 2017: 07:57 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-86000-30

Original Effective Date: 06/15/11

Reviewed: 04/24/14

Revised: 07/15/16

Subject: Human Papillomavirus (HPV) Testing

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Human papillomavirus (HPV) has been associated with the development of cervical intraepithelial neoplasia (CIN) that can then progress to invasive cervical cancer. This has lead to the development of screening techniques for the presence of certain high-risk HPV strains in an attempt to improve the specificity of traditional Papanicolaou (Pap) smears.

While HPV infection has been associated with the development of cervical cancer, many infections are cleared spontaneously, and low-grade lesions may regress or disappear, particularly in younger women.

Several HPV test kits have received premarket approval through the U.S Food and Drug Administration (FDA) including DigeneĀ® HPV test (Qiagen Inc., Valencia, CA), Cervista™ HPV HR (Hologic, Bedford, MA), and CobasĀ® HPV test (Roche, Basel, Switzerland). The tests are approved by the FDA for only two indications: for follow-up testing of women who have abnormal Pap test results and for cervical cancer screening in combination with a Pap test among women over age 30.

POSITION STATEMENT:

HPV testing, in conjunction with Pap smears, meets the definition of medical necessity for the purpose of screening women aged 30 years and older for cervical abnormalities.

HPV testing meets the definition of medical necessity for the purpose of following-up prior positive HPV tests in women aged 30 years and older.

HPV testing of Pap smears that have an interpretation of atypical cells of undetermined significance (ASCUS) meets the definition of medical necessity for women of any age that are high-risk*, symptomatic, or have a prior abnormal Pap smear.

*(Risk factors may include HIV infection, a compromised immune system, in utero exposure to diethylstilbestrol (DES), and previous treatment of a high-grade precancerous lesion or cervical cancer.)

HPV testing is considered experimental or investigational for all other indications including:

The clinical evidence in peer-reviewed literature is insufficient to permit conclusions on efficacy and net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

87623

Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (e.g., 6, 11, 42, 43, 44)

87624

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)

87625

Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed

REIMBURSEMENT INFORMATION:

HPV testing is limited to 1 in 3 years for low-risk women aged 30 years or older who receive negative test results on both cervical cytology screening and HPV testing.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L29288) located at fcso.com

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

OTHER:

None applicable.

REFERENCES:

  1. American College of Obstetricians and Gynecologists (ACOG), Office of Communications News Release. Exceptions to Pap Screening in Adolescents (HPV Testing Not Recommended), July 21, 2010.
  2. American College of Obstetricians and Gynecologists (ACOG), Practice Bulletin Number 109 Cervical Cytology Screening, December 2009.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual, 2.04.09, Cervical Cancer Screening Technologies with Pap and HPV, 10/11 (archived).
  4. Centers for Disease Control and Prevention (CDC), Cervical Cancer Screening Guidelines for Average-Risk Women, accessed at cdc.gov 03/18/14.
  5. First Coast Service Options, Inc. Local Coverage Determination (LCD): Noncovered Services (L29288), 03/14.
  6. Leinonen M, et al, Age-Specific Evaluation of Primary Human Papillomavirus Screening vs. Conventional cytology in a Randomized Setting, J Natl Cancer Inst 2009; 101:1612-1623.
  7. National Cancer Institute (NCI), Fact Sheet- HPV and Cancer (Reviewed: 05/15/12). Accessed at cancer.gov 03/18/14.
  8. National Comprehensive Cancer Network (NCCN), Clinical Practice Guidelines in Oncology – Cervical Cancer Screening, Version 2.2012.
  9. Saslow D, Solomon D, et al, American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer, 2012 American Journal of Clinical Pathology, 137, 516-542.
  10. Solomon, D, et al on behalf of the Cytopathology Education and Technology Consortium (CETC), Statement on HPV DNA Test Utilization, Am J Clin Pathol 2009, 131:768-769.
  11. U.S. Food and Drug Administration (FDA), Premarket Approval, CERVISTA HPV, 03/09.
  12. U.S. Food and Drug Administration (FDA), Premarket Approval, COBAS HPV TEST, 04/11.
  13. U.S. Food and Drug Administration (FDA), Premarket Approval, Digene HPV DNA Test, 03/03.
  14. U.S. Preventive Services Task Force (USPSTF), Screening for Cervical Cancer, 03/12. Accessed at: uspreventiveservicestaskforce.org 03/18/14.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/24/14.

GUIDELINE UPDATE INFORMATION:

06/15/11

New Medical Coverage Guideline.

06/15/12

Annual review; position statement, description section, Medicare Advantage program exception, and references updated.

06/15/13

Annual review; position statements maintained and references updated; formatting changes.

05/15/14

Annual review; position statements maintained and references updated.

01/01/15

Annual HCPCS/CPT update. Added codes 87623-87625; removed codes 87620-87622.

07/15/16

Revision; position statement section updated; formatting changes.

Date Printed: August 18, 2017: 07:57 PM