This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Chlamydia Trachomatis 

Testing may be considered medically necessary in asymptomatic individuals when the following criteria are met:

• Routine annual screening of all sexually active women aged less than or equal to 25 years.
• Screening of sexually active women greater than 25 years with risk factors (e.g., those who have a new sex partner or multiple sex partners).
• Routine screening for all pregnant women during one of the first prenatal visits.
• Retesting of all pregnant women aged less than or equal to 25 years performed during the third trimester.
• Retesting of all pregnant women over age 25 during the third trimester when at increased risk for Chlamydia (e.g., women who have a new or multiple sex partners, women with a history of a previous STI, high risk behavior such as inconsistent condom use, sex work)
• Screening of sexually active men with risk factors (e.g., men in correctional facilities, presenting to STI clinics, or who have infected partner).

Indications for testing in symptomatic individuals:

• Cervicitis
• Urethritis
• Repeat testing to document eradication of infection after completing an appropriate treatment regimen is recommended only in the following settings: patient is pregnant, symptoms persist, re-infection is suspected, or compliance with therapy is in question. Routine test of cure is not recommended.
• Non-pregnant recently infected women should be retested 3 to 12 months after treatment.

Testing Policy:

• Nucleic acid amplification testing (NAAT) for Chlamydia trachomatis may be considered medically necessary for individuals with clinical indications as outlined above.
• When testing is indicated, the following limitations apply:
  • Either direct (87490) or amplified (87491) probe studies are reasonable, although amplified methodologies are generally preferred.  
  • NAAT may be performed on urine, vaginal, or cervical samples. It is usually sufficient to test one site. When necessary to test more than one site:
    • Additional units must be billed with modifier 59.
    • No more than 3 units of 87490 or 87491 for Chlamydia trachomatis molecular testing may be billed for the same date of service.
  • More than one type of molecular test for the same organism will not be reimbursed for the same date of service (e.g., 87490 and 87491 may not be billed together).
  • Repeat testing will not be reimbursed if performed within three weeks (less than 21 days) from a previous test based on the following:
    • When indicated, repeat testing to document eradication should not be performed until 3-4 weeks after the positive result.
  • Based on guidelines for initial and repeat testing, no more than five screenings in a year should be necessary regardless of pregnancy or other risk factors.

Quantitative testing for chlamydia trachomatis (87492) is considered experimental/investigational and, therefore, non-covered due to lack of scientific evidence demonstrating medical necessity.

Neisseria Gonorrhoeae (N. Gonorrhoeae)

Testing may be considered medically necessary for individuals when the following criteria are met:

• Indications for testing in asymptomatic individuals:
  • Annual screening of all sexually active women aged less than or equal to 25 years.
  • Screening of women greater than 25 years who are at increased risk for infection (e.g., women with previous gonorrhea infection, other STIs, new or multiple sex partners, and inconsistent condom use, sex workers, or women living in communities with a high prevalence of disease).
  • All pregnant women at increased risk for gonorrhea (as defined in 1 and 2 above) should be screened at the first prenatal visit for N. gonorrhoeae.
  • Uninfected pregnant women who remain at high risk for gonococcal infection also should be retested during the third trimester.
  • Screening of sexually active individuals who have an infected partner.
• Indications for testing in symptomatic individuals
  • Cervicitis
  • Urethritis
  • Pregnant women diagnosed with gonococcal infection during the first trimester should be retested within approximately 3–6 months, preferably in the third trimester.
  • Recently infected women should be retested 3-12 months after treatment.

Testing policy:

• NAAT for N. gonorrhoeae may be considered medically necessary for individuals with clinical indications as outlined above.
• When testing is indicated, the following limitations apply:
  • Either direct (87590) or amplified (87591) probe studies are reasonable, although amplified methodologies are generally preferred.
  • NAAT may be performed on urine, vaginal, or cervical samples. It is usually sufficient to test one site. When necessary to test more than one site:
    • Additional units must be billed with modifier 59.
    • No more than 3 units of 87590 or 87591 for N. gonorrhoeae molecular testing may be billed for the same date of service.
  • More than one type of molecular test for the same organism will not be reimbursed for the same date of service (e.g., 87590 and 87591 may not be billed together).
  • Repeat testing will not be reimbursed if performed within three weeks (less than 21 days) from a previous test based on the following:
    • When indicated, repeat testing to document eradication should not be performed until 3-4 weeks after the positive result.
  • Based on guidelines for initial and repeat testing, no more than five (5) screenings in a year should be necessary regardless of pregnancy or other risk factors.

Quantitative testing for N. gonorrhoeae (87592) is considered experimental/investigational and, therefore, non-covered due to lack of scientific evidence demonstrating medical necessity.

Trichomonas Vaginalis

Testing may be considered medically necessary for individuals when the following criteria are met:

• Indications for testing in asymptomatic individuals:
  • Evidence does not support routine screening for Trichomonas vaginalis in asymptomatic women (pregnant or non-pregnant) or men who are not at high risk for infection.
  • Screening can be considered in those at increased risk for Trichomonas vaginalis infection for reasons such as new or multiple sex partners, history of STIs, sex work, or drug use.
  • Screening should also be performed in sexually active women who are HIV positive at entry into care and then at least annually.
• Indications for testing in symptomatic individuals:
  • Vaginitis, abnormal vaginal discharge, cervicitis, nongonococcal urethritis, vulvar pruritis, or pelvic inflammatory disease.
  • Sexually active women with trichomoniasis may be rescreened for Trichomonas vaginalis at three (3) months following initial infection.
  • Screening of sexually active individuals who have an infected partner.

Testing Policy:

• NAAT for Trichomonas vaginalis may be considered medically necessary for individuals with clinical indications as outlined above. The medical necessity of testing will be determined based on the following:
  • When testing asymptomatic individuals, an ICD code that supports increased risk, infected partner, or positive HIV status must be submitted. For guidance, see attachment Table 1: High Risk Indications, Table 2: Infected Partner, and Table 3: HIV Positive Status.
  • When testing symptomatic individuals, an ICD code that describes the common symptoms, as defined in Table 4: Symptoms of STIs, must be submitted.
• When testing is indicated, the following limitations apply:
  • Either direct (87660) or amplified (87661) probe studies are reasonable, although amplified methodologies are generally preferred.
  • NAAT may be performed on urine, vaginal, or cervical samples. It is usually sufficient to test one site. When necessary to test more than one site:
    • Additional units must be billed with modifier 59.
    • No more than 3 units of 87660 or 87661 for Trichomonas vaginalis molecular testing may be billed for the same date of service.
  • More than one type of molecular test for the same organism will not be reimbursed for the same date of service (e.g., 87660 and 87661 may not be billed together).
  • Based on guidelines for initial and repeat testing, no more than five (5) screenings in a year may be considered medically necessary regardless of pregnancy or other risk factors.

Repeat testing more frequently than every three months is considered not medically necessary.

Candida Species

Testing may be considered medically necessary for individuals when the following criteria are met:

• Indications for asymptomatic individuals:
  • Evidence does not support routine screening for Candida species in asymptomatic pregnant women, non-pregnant women, or men.
• Indications for symptomatic individuals:
  • Candida testing is generally diagnosed by non-molecular methods (clinical criteria, microscopy, culture, etc.). Molecular testing for Candida should rarely be necessary.
  • However, guidelines do support molecular testing for Candida in symptomatic females when microscopy is not available.

Testing Policy:

• NAAT for Candida albicans may be considered medically necessary for individuals with the limited clinical indications outlined above. The medical necessity of testing will be determined based on the following:
  • When testing asymptomatic males or females, an ICD code that supports positive HIV status must be submitted (see Table 3: HIV Positive Status). Note that testing for males is only indicated when HIV positive (i.e., no symptomatic or other testing indications).
  • When testing symptomatic females, an ICD code that describes the common symptoms must be submitted (see Table 4: Symptoms of STIs).
• Post-service medical necessity review may be employed to ensure appropriate non-molecular methods have been utilized or were unavailable.
• When testing is indicated, the following limitations apply:
  • Either direct (87480) or amplified (87481) probe studies are reasonable, although amplified methodologies are generally preferred.
  • It should only be necessary to test one site. Therefore, only one unit per date of service is reimbursable.
  • Candida subtyping for C. glabrata and other nonalbicans Candida species is not routinely medically necessary, so only one unit will be routinely approved. Exceptions may be considered if complicated vulvovaginal candidiasis (VVC) is diagnosed. Complicated VVC may include
    • Recurrent VVC (defined as 4 or more episodes of symptomatic VVC within one (1) year); or
    • Severe VVC (i.e. extensive vulvar erythema, edema, excoriation, and fissure formation).

Quantitative testing for Candida albicans (87482) is considered experimental/investigational and, therefore, non-covered due to lack of scientific evidence demonstrating medical necessity.

Gardnerella Vaginalis

Gardnerella Vaginalis may be considered medically necessary when the following criteria are met:

Indications for asymptomatic individuals

• Evidence does not support routine screening for Gardnerella vaginalis in asymptomatic pregnant women, non-pregnant women, or men for any indications.

Indications for symptomatic individuals

• Gardnerella vaginalis testing is generally diagnosed by non-molecular methods (clinical criteria and microscopy.). Molecular testing for Gardnerella vaginalis should rarely be necessary.
• However, guidelines do support molecular testing for Gardnerella vaginalis in symptomatic females only when microscopy is not available.

Testing Policy:

• NAAT for Gardnerella vaginalis may be considered medically necessary for women with the limited clinical indications outlined above. The medical necessity of testing will be determined based on the following:
  • When testing symptomatic females, an ICD code that describes the common symptoms must be submitted (see Table 4: Symptoms of STIs).
• Post-service medical necessity review may be employed to ensure appropriate non-molecular methods have been utilized or were unavailable.
• When testing is indicated, the following limitations apply:
  • Either direct (87510) or amplified (87511) probe studies are reasonable, although amplified methodologies are generally preferred.
  • It should only be necessary to test one site. Therefore, only one unit per date of service is reimbursable.
  • More than one type of molecular test for the same organism will not be reimbursed for the same date of service (e.g., 87510 and 87511 may not be billed together).

Testing in males is considered not medically necessary.

Quantitative testing for Gardnerella vaginalis (87512) is considered experimental/investigational and, therefore, non-covered due to lack of scientific evidence demonstrating medical necessity.

Herpes simplex virus (HSV)

Testing may be considered medically necessary for individuals when the following criteria are met:

• Indications for testing in asymptomatic Individuals:
  • Current guidelines explicitly recommend against testing asymptomatic individuals for HSV.
• Indications for testing in symptomatic Individuals:
  • New or recurrent vesicular and/or ulcerative lesions, vesicles or ulcers on or around the genitals, rectum, buttocks, thighs.
  • Recurrent genital symptoms or atypical symptoms and negative HSV cultures.

Testing Policy:

• NAAT for HSV may be considered medically necessary for individuals with clinical indications as outlined above.
• When testing is indicated, the following limitations apply:
  • Either direct (87528) or amplified (87529) probe studies are reasonable, although amplified methodologies are generally preferred.
  • Medical necessity of quantitative testing for HSV (87530) may be reasonable for monitoring disease in some circumstances.
  • It should only be necessary to test one site. Therefore, only one unit per date of service is reimbursable.
  • More than one type of molecular test for the same organism will not be reimbursed for the same date of service (e.g., 87528 and 87529 may not be billed together).

Human Papillomavirus (HPV)

Testing may be considered medically necessary for individuals when the following criteria are met:

• Indications for testing in asymptomatic individuals:
  • Per the American College of Obstetrics and Gynecology cervical cancer clinical management guidelines, HPV testing should be performed only to detect high-risk (oncogenic) types of HPV.
  • Among women age 30-65, HPV testing may be performed every five (5) years in combination with pap smear (co-testing) for routine screening. NOTE: HPV co-testing should not be performed in women less than 30.
  • Women aged 30 years and older who are HPV+ but cytology negative may:
    • Test again by co-testing in one year; or
    • Be tested by HPV high risk oncogenic subtype genotyping.
  • Women aged 30 years and older with cytology reported as negative and with absent or insufficient endocervical/transformation zone (EC/TZ) component and no or unknown HPV test result.
• Indications for testing in symptomatic individuals:
  • Reflex to HPV testing for management of women with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results starting at age 21.
  • Co-testing at one (1) year post cervical intraepithelial neoplasia grade 1 (CIN1) or no lesion preceded by HPV-16 or HPV-18 positivity, persistent untyped oncogenic HPV, ASC-US, and low grade squamous intraepithelial lesion (LSIL) starting at age 25.
  • For women treated for cervical intraepithelial neoplasia (CIN 2, CIN 3, or CIN 2, 3), co-testing at 12 months and 24 months is recommended.
  • Post-menopausal women with LSIL.
• Only testing for high-risk (oncogenic) HPV types may be performed.
  • Per the American College of Obstetrics and Gynecology cervical cancer clinical management guidelines, HPV testing should be performed only to detect high-risk (oncogenic) types of HPV.
  • As stated in American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines, “testing for low-risk (nononcogenic) HPV types has no role in the evaluation of women with abnormal cervical cytologic results.”
  • Per the Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases guidelines, “HPV testing is not recommended for anogenital wart diagnosis, because test results are not confirmatory and do not guide genital wart management.”

Testing for low-risk (non-oncogenic) types of HPV (87623) is considered experimental/investigational and, therefore, non-covered due to lack of scientific evidence demonstrating medical necessity.

Testing policy:

• NAAT for human papillomavirus may be considered medically necessary for individuals with clinical indications as outlined above. Please note the following age restrictions:
  • Testing in asymptomatic individuals is not medically necessary before age 30.
• When testing is indicated, the following limitations apply:
  • Only testing for high-risk (oncogenic) HPV subtypes may be performed.
  • NAAT may be performed on endocervical samples. It is usually sufficient to test one specimen.
  • Therefore, no more than one (1) unit of 87624 or 87625 for human papillomavirus molecular testing may be billed for the same date of service.
  • More than one type of molecular test for the same organism will not be reimbursed for the same date of service. For example, nucleic acid detection of high risk subtypes HPV-16 and HPV-18 by two methodologies (87624 and 87625) cannot be billed together, and nucleic acid detection by either of these methodologies cannot be billed with a test using another molecular methodology (e.g., in situ hybridization, 88365).

HPV testing before age 21 for any indication (asymptomatic or symptomatic) is non-covered.

Low-risk (nononcogenic) HPV testing is considered not medically necessary.

Flow cytometry (e.g., HPV OncoTect) (88184, 88185, and/or 88187) methods for HPV detection is considered experimental/investigational and, therefore, non-covered due to lack of scientific evidence demonstrating medical necessity.

Streptococcus, Group B (GBS)

Testing may be considered medically necessary for individuals when the following criteria are met:

• Indications for testing:
  • Intrapartum testing at onset of labor if GBS status is unknown.

Testing policy:
NAAT for Group B streptococcus may be considered medically necessary for individuals with clinical indications as outlined above.

• When testing is indicated, the following limitations apply:
  • It should only be necessary to test one site. Therefore, only one unit per date of service is reimbursable.

Infectious Agent, Not Otherwise Specified

Testing may be considered medically necessary for individuals when the following criteria are met:

• There are no clinical indications for infectious agents not otherwise specified testing in the evaluation or management of sexually transmitted infections, including bacterial vaginosis that are supported by current evidence. The sexually transmitted organisms for which molecular testing is supported by guidelines are represented by organism- specific codes. Therefore, testing for organisms not otherwise specified (NOS) is considered not medically necessary in the setting of screening for STIs.

Testing policy:

• The following criteria are used to determine if testing for infectious agents NOS is being performed in the setting of sexually transmitted disease detection or management:
  • When billed with any ICD code included in Table 5: ICD Codes Indicating Testing Done for STIs.
  • When billed on the same date of service with any other organism-specific CPT code referenced in this policy.

NAAT for infectious agents not otherwise specified (87797, 87798, 87799) has not been demonstrated for the detection and management of sexually transmitted infections and is considered experimental/investigational and, therefore, non-covered.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Testing for Sexually Transmitted Infections: Molecular, is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider can bill the member for the non-covered service.

• Link to Provider Resource Center for the Medical Policy Update

10/2017, REMINDER: Molecular and Genomic Testing

• Link to Diagnosis Codes

• Link to Table Attachment(s)

• Link to References