Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Testing for human papillomavirus (HPV) can assist with prevention of cervical cancer.  This testing is covered every 60 months as routine screening for women age thirty or over (see BI062), and is covered as part of the medical benefit in women of any age with certain types of abnormal Papanicolaou tests,

2)    Tumor cell testing for HPV for men and women with diagnosis of head and neck cancer or urinary HPV testing for men are covered under medical benefit.

1)    Routine HPV DNA testing is covered as an adjunct to Pap smear in women ≥30 years of age once every five years under the preventive benefit.

2)    Additional testing (87623 or 87624) to determine the genotype of the HPV is covered under the medical benefit, only for follow up of women with abnormal pap smears: Dysplasia of cervix, ASCUS, ASC-H, LSIL or AGC NOS.

3)    Stratification into high or low risk types is appropriate with HPV high-risk type (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) OR HPV low-risk type (e.g., 6, 11, 42, 43, and 44) testing.

4)    CPT 87625 Testing for HPV types 16 & 18 only, incl type 45, is not covered, as these types are included in HPV high-risk type testing.

5)    (HPV) DNA testing in tumor cells is eligible for coverage for Head and Neck cancer.(NCCN guidelines)

Codes Used In This BI:

QualChoice considers HPV DNA testing experimental and investigational for the following indications:

1. Use as a primary screening test for cervical cancer in women younger than 30 years of age. According to evidence-based guidelines from the U.S. Preventive Services Task Force (2003), the medical literature does not support HPV testing as a screening test for cervical cancer for younger individuals whose cervical cytology is normal or is unknown. Hayes C
2. For selecting candidates for cervical cancer vaccine. The Centers for Disease Control and Prevention`s Advisory Committee on Immunization Practices does not recommend HPV testing to select persons for cervical cancer vaccine. 

1)    Ninety-five percent (95%) of cervical neoplasia is considered to be due to infection with human papillomavirus (HPV).

2)    Not all HPV viral types are oncogenic, not all infect the cervix, and only a small number of women who develop HPV infection, even with the oncogenic forms of HPV, will develop in-situ or invasive cervical cancer. It has been well established that the majority of squamous cell cancers of the cervix progress through a series of well-defined pre-invasive lesions and that during this usually lengthy process, the disease can be easily detected by Pap smear screening. During this pre-invasive stage, cervical squamous intraepithelial lesions (SIL) can be controlled with nearly uniform success.

3)    Frankly negative or positive smears are reported as such. In between these two extremes are various levels of equivocal abnormality. These may be due to inflammatory disease or may be precursors of a malignant process.

4)    Atypical squamous cells of unknown significance (ASCUS); atypical glandular cells of unknown significance (AGUS); low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL) are designations given to these undetermined cell types.

5)    Because the large majority of women with ASCUS. ASGUS or LSIL will not have HSIL or in-situ carcinoma, it has recently been recommended by some that testing for HPV infection could be an alternative to triaging women to biopsy or observation.

One HPV DNA test by Digene Corporation is FDA approved for marketing under a PMA developed in 1995. The Hybrid Capture HPV DNA Assay is approved to aid in the triage of patients with equivocal or ASCUS Pap smear results in order to better determine the need for referrals to colposcopy; to serve as an adjunct to the Pap smear in the identification of women who may be at increased risk for squamous intraepithelial lesions (SIL); to distinguish between infections with HPV types which are principally associated with low-grade squamous intraepithelial lesions (LSIL), and HPV types typically associated with SIL of all grades, especially high-grade SIL (HSIL) and invasive cancer of the cervix; to aid in the diagnosis of sexually transmitted disease. On 31 March 2003, the FDA expanded approval of the Digene HC2 High-Risk HPV DNA Test to include use for screening in conjunction with the Pap smear of women over the age of 30.

1)    Centers for Disease Control and Prevention (CDC). Human Papillomavirus: HPV Information for Clinicians. CS110004. Atlanta, GA: CDC; April 2007. at: http://www.cdc.gov/std/Hpv/common-clinicians/ClinicianBro-fp.pdf

2)    Hayes Inc. Medical Technology Directory; HPV testing for cervical cancer Feb. 6 2004

3)    NCCN Guidelines Index Head and Beck cancer. http://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf