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Data suggest that cytological screening for cervical cancer reduces the incidence of cervical cancer by up to 50%. Several technologies have been investigated for their role in detecting cancerous and precancerous cervical lesions.
It is estimated that there will be 12,200 new cases, and 4210 deaths from cervical cancer in the United States in 2010. The high prevalence and natural history of cervical cancer, as well as the ability to cure patients in pre-invasive stages, create ideal conditions for wide-spread screening. Cytological screening, through the sampling of cells of the cervix, has been the gold-standard since the introduction of the Papanicolaou (Pap) smear in the 1940s. The Pap smear involves sampling cells of the transformation zone of the cervix, the area most prone to malignant transformation.
False-negative Pap smears are troubling, because a patient with undetected pre-invasive cancer may progress to invasive disease before she undergoes another Pap test, particularly if the patient does not undergo regular Pap smear screening. Pap smear cytology is associated with a false negative results ranging from 15% to 55%. False negative results may be explained by various factors, including sampling errors, errors in slide preparation, and errors in slide interpretation. Different approaches to reducing the false negative rate have targeted each step in the process. This policy addresses the technologies that attempt to improve the accurate detection of cervical abnormalities.
Appreciation of the causative effect of human papilloma virus (HPV) infection in most cervical cancers has led to the development of screening techniques for the presence of certain high-risk HPV strains in an attempt to improve the specificity of traditional Pap smears.
The Bethesda classification system assigns a degree of atypia to cells seen on Pap smear; however a biopsy is necessary to gain information on the tissue structure, or histology, of lesions. The correlation between cytological grade and histological grade, and the natural history of cervical cancer, has been an area of rapidly evolving understanding. 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.
Examples of available technologies are -
POLICYPreparation of Pap smears using a monolayer slide preparation system may be considered medically necessary.
Primary screening and rescreening of Pap smears using the FocalPointTM or ThinPrep® automated slide reading systems may be considered medically necessary.
HPV testing of Pap smears that have an interpretation of atypical cells of undetermined significance (ASC-US) may be considered medically necessary.
HPV testing may be considered medically necessary only if there is an abnormal Pap smear documented in the medical record.
Primary screening and rescreening of Pap smears using the FocalPointTM system automated slide reading system in high-risk patients (e.g., symptomatic patients, those with prior abnormalities or malignancies, or those with prior abnormal Pap diagnoses) is investigational.
HPV testing of Pap Smears to detect high and low risk forms of HPV for the likelihood of cervical cancer development using in situ hybridization (ISH) is considered investigational.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
8/21/2002: Policy Guidelines revised, CPT codes 88147, 88148, 88153, 88164, 88165 deleted, HCPCS P3000-P3001 deleted, HCPCS G0123-G0124, G0143-G0145 added
10/17/2005: Code reference section updated; CPT-4: 87620, 87621, 87622, 88147, 88148 added; 88144, 88145 deleted; ICD-9 Procedure: "Microscopic examination of specimen from female genital tract" deleted; ICD-9 Diagnosis: 233.1 added; HCPCS: G0141, G0147, G0148 added; "with manual screening and computer-assisted rescreening by cytotechnologist under physician supervision," "Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with manual screening and computer-assisted rescreening using cell selection and review under physician supervision" deleted
9/29/2006: Policy updated. Code reference section udpated. CPT codes 88174 and 88175; HCPCS P3000 and P3001 added to policy
11/14/2006: Code Reference section updated: CPT code 87622 deleted.
8/28/2007: In situ hybridization (ISH) for HPV testing is considered investigational.
7/22/2008: Policy reviewed, no changes
09/10/2010: Policy reviewed; policy statement unchanged. The following ICD-9 codes were added to the Covered Codes Table: 795.00-795.04, 795.06, 795.08, 795.10, 795.11, 795.71, 796.9, V73.81 and V72.3. CPT code 87622 was moved from non-covered to covered. Revised the description of HCPCS code G0141.
12/30/2010: Policy description updated. Policy title changed from "Monolayer Slide Preparation and AutoSlide Reading Systems for Cervical Cancer Screening" to "Cervical Cancer Screening Technologies with Pap and HPV."
05/01/2011: The policy statement regarding HPV testing in conjunction with Pap smears was revised to state that HPV testing may be considered medically necessary only if there is an abnormal Pap smear documented in the medical record. FEP coverage guidelines for HPV testing in conjunction with Pap smears was added to the Policy Exceptions section.
05/07/2013: Removed ICD-9 procedure code 91.46 from the Code Reference section.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 87623, 87624, 87625, 88364, and 88366. Revised the description of the following CPT code: 88365.
08/26/2015: Medical policy revised to add ICD-10 codes.
06/07/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions. Removed deleted CPT codes 87620, 87621, and 87622 from the Code Reference section.
06/17/2016: Policy Exceptions updated to remove language regarding HPV screening.
SOURCE(S)Hayes Medical Technology Directory
Blue Cross Blue Shield Association policy #2.04.09
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.