Humana Molecular Diagnostic Testing for Reproductive Health Form

Description

Vaginitis is a general term for disorders of the vagina (and vulva) caused by infection, inflammation or changes in the normal vaginal flora (e.g., Lactobacillus species). Symptoms may include vaginal or urethral discharge, discomfort, itching and/or odor. The infections responsible for these symptoms include one or more of the following:

• Bacterial vaginosis is an abnormal, noninflammatory condition of the vagina caused by an overgrowth or imbalance of anaerobic bacteria (e.g., Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, Bacterial Vaginosis Associated Bacteria-2 [BVAB-2], Prevotella species and/or Mobiluncus species) that is generally characterized by a white (or gray), malodorous discharge
• Candidiasis is a fungal infection of the vagina and vulva caused by a species of yeast (e.g., C. albicans, C. glabrata, C. parapsilosis, C. kefyr, C. kruseii, C. tropicalis, C. dubliniensis, C. lusitaniae, C. auris)
• Trichomoniasis or trichomonas is a common sexually transmitted disease caused by a protozoan parasite called Trichomonas vaginalis

Men may also experience symptoms associated with an overgrowth of anaerobic bacteria, candidiasis or trichomoniasis including, but may not be limited to, balanitis (inflammation of the glans penis), penile discharge, rash or urinary burning.

Vaginitis and balanitis are diagnosed with a series of standardized clinical tests, such as bacterial culture, physical examination, microscopy and/or vaginal pH. Molecular diagnostic testing for vaginitis may also be used and includes:

• Direct deoxynucleic acid (DNA) probe assays (nucleic acid hybridization) (e.g., Affirm VP III) - A test that uses a DNA probe to detect the DNA of candida species, Gardnerella vaginalis and Trichomonas vaginalis in vaginal fluid specimens
• Nucleic acid amplification testing (NAAT) - A technique used to detect a particular virus or bacteria in blood, tissue or body fluid by locating and amplifying (making extra copies of the nucleic acids) the ribonucleic acid (RNA) or DNA of the pathogen using polymerase chain reaction (PCR), transcription-mediated amplification (TMA) or strand displacement amplification (SDA). Examples include, but may not be limited to (Refer to Coverage Limitations section):
  • Aptima BV & CV/TV molecular assays
  • BD MAX Vaginal Panel (PCR)
  • MYCODART Dual Amplification Real Time PCR Panel
  • NuSwab VG (PCR)
  • SureSwab Bacterial Vaginosis/Vaginitis Panels (PCR and TMA)
  • Xpert Xpress MVP

Sexually transmitted infections (STIs), also known as sexually transmitted diseases (STDs), are typically acquired through sexual contact and affect both females and males. Symptoms may include cervicitis, genital pain or ulceration(s), penile or vaginal discharge, urethritis or vaginitis. In many situations, the health complications caused by the STI can be more serious for women. If a pregnant woman has an STI, it can cause health problems for the fetus.

Examples of STIs include, but are not limited to:

• Chlamydia (Chlamydia trachomatis)
• Gonorrhea (Neisseria gonorrhoeae)
• Herpes simplex virus (HSV) type 1 (HSV-1) and type 2 (HSV-2)
• Human Papillomavirus (HPV)
• Mycoplasma (Mycoplasma genitalium and Mycoplasma hominis)
• Trichomoniasis (Trichomonas vaginalis)

Many STIs are diagnosed with the same methods as vaginitis, including molecular diagnostic techniques such as direct DNA probe assays and NAAT. Examples include, but may not be limited to:

• Alinity m STI assay (PCR) (urine or vaginal/endocervical swab)
• Aptima mycoplasma genitalium assay
• Aptima trichomonas vaginalis assay (TMA) (vaginal/endocervical swab)
• BD CTGCTV2 assay
• Binx Health CT/NG assay (PCR) (urine or vaginal/endocervical swab)
• Cobas 4800/6800/8800 CT/NG and TV/MG tests (PCR) (urine or vaginal/endocervical swab)
• GenPap – Cervicitis Profile, High Risk STI Profile, STI Lesion Profile (PCR) (vaginal/endocervical swab)
• NuSwab STD (PCR) (vaginal [preferred] or unisex swab)

STI TriPlex Assay (PCR) (male urine)

Molecular Diagnostic Testing for Reproductive Health

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 07/27/2023
Policy Number: HUM-0554-019
Page: 4 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Some labs offer expanded panel testing in which vaginitis and STIs are incorporated. Examples include, but may not be limited to (Refer to Coverage Limitations section):

• GenPap – PID/Infertility/Pregnancy Loss Profile (PCR)
• NuSwab – Select, VG, VG+ (PCR)
• OneSwab (PCR)
• SureSwab Vaginosis/Vaginitis Plus (PCR)

HPV is the most common sexually transmitted infection in the United States. Approximately 100 types of HPV have been identified, at least 40 of which can infect the genital area. Oncogenic, high-risk HPV (types 16 and 18) causes most anal, cervical, oropharyngeal, penile, vaginal, vulvar cancers and precancers. Nononcogenic, low-risk HPV (types 6 and 11) cause genital warts.

HPV tests are available to detect oncogenic types of HPV infection and are used in cervical cancer screening and management or follow-up of abnormal cervical cytology or histology. These tests should not be used for male partners of women with HPV.

HPV infection can also contribute to the pathogenesis of squamous cell carcinomas of the head and neck. Although oropharyngeal swab testing has been proposed for this indication, there are currently no US Food & Drug Administration (FDA) approved tests. Biopsy and in situ hybridization or PCR testing to detect HPV DNA are considered the gold standard for appropriate staging and treatment.

Cervical cancer screening utilizes combinations of cervical cytology with Papanicolaou (Pap) testing and testing for HPV strains that are high risk for causing cervical cancer.

Current US FDA approved methods for detecting cervical HPV infection are HPV DNA or HPV ribonucleic acid (RNA) testing which may be used in conjunction with Pap testing or alone for primary screening. These tests are also proposed as an alternative approach to repeat cytology for women with borderline or low-grade cytologic abnormalities. Examples of HPV DNA and HPV RNA tests include:

• APTIMA HPV 16 18/45 Genotype assay

Molecular Diagnostic Testing for Reproductive Health

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 07/27/2023
Policy Number: HUM-0554-019
Page: 5 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• APTIMA HPV assay
• BD Onclarity HPV assay
• Cervista HPV HR test
• Cobas HPV test
• Hybrid Capture 2 High-Risk HPV test

For information regarding direct-to-consumer testing for reproductive health, please refer to Code Compendium (Laboratory) Medical Coverage Policy.

Coverage Determination

Vaginitis

Humana members may be eligible under the Plan for molecular diagnostic testing with direct DNA probe assay (87480, 87510, 87660) (e.g., Affirm VP III [indicated for vaginal specimens]) for vaginitis (BV, trichomoniasis, vaginal candidiasis) for the diagnosis of symptomatic women (e.g., vaginal discharge).

Sexually Transmitted Infections

Humana members may be eligible under the Plan for molecular diagnostic testing for chlamydia and/or gonorrhea with multitarget testing (e.g., Alinity [0402U]), direct DNA probe assay or NAAT (87490, 87491, 87492, 87590, 87591, 87592, 0353U) for the following indications:

• Diagnosis for symptomatic men (e.g., urethral discharge) or women (e.g., vaginal discharge); OR
• Screening* for asymptomatic men or women (including pregnancy) when the following criteria are met:
  • Individuals at high risk for infection (e.g., history of STIs, new or multiple sexual partners or sexual contact with an individual with active chlamydia or gonorrhea infection); OR
  • Individuals infected with HIV; OR
  • Individuals that are sexually active and age 24 years or younger; OR
  • Men who engage in sexual activity with men

Molecular Diagnostic Testing for Reproductive Health
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 07/27/2023
Policy Number: HUM-0554-019
Page: 6 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for molecular diagnostic testing for genital or oral HSV with PCR assay (87528, 87529) when active lesions are present.

Humana members may be eligible under the Plan for molecular diagnostic testing for mycoplasma (e.g., genitalium, hominis) with multitarget testing (e.g., Alinity [0402U]) or NAAT (87563) to diagnose symptomatic men (e.g., urethritis) or women (e.g., cervicitis or pelvic inflammatory disease).

Humana members may be eligible under the Plan for molecular diagnostic testing for trichomoniasis with multitarget testing (e.g., Alinity [0402U]), direct DNA probe assay or NAAT (87660, 87661) when the following criteria are met:

• Diagnosis for symptomatic men (e.g., urethral discharge) or women (e.g., vaginal discharge); OR
• Screening* of asymptomatic women who are at high risk for infection (e.g., women who have a history of STIs or multiple sexual partners)

*Refers to annual screening unless otherwise indicated such as part of routine screening during pregnancy.

Humana members may be eligible under the Plan for molecular diagnostic testing for HPV (FDA-approved HPV DNA and HPV RNA tests) (G0476, 87624, 87625) when the following criteria are met:

• Assessment or follow-up of women with atypical glandular cells not otherwise specified (AGC NOS); OR
• Assessment of women with atypical squamous cells of undetermined significance (ASCUS); OR
• Stand-alone testing (primary screening) every 5 years in women 30 to 65 years of age OR in combination with Pap testing (co-testing) every 5 years for women 30 to 65 years of age

Molecular Diagnostic Testing for Reproductive Health
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 07/27/2023
Policy Number: HUM-0554-019
Page: 7 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Note: The criteria for molecular diagnostic testing for vaginitis and sexually transmitted infections are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for molecular diagnostic testing for vaginitis and sexually transmitted infections for any indications other than those listed above including, but may not be limited to:

• Biomarker-based HPV testing (eg, CINtec PLUS Cytology)
• HSV quantification PCR testing (87530)
• HSV serology testing (86694, 86695 and 86696)
• mRNA HPV oncogene expression testing (eg, HPV E6/E7 QuantaSURE, PreTect HPV-Proofer'7 [0354U])
• MYCODART Dual Amplification Real Time PCR Panel (0068U)
• NAAT (87481, 87511) or subsequent quantification testing for BV (eg, Gardnerella vaginalis) or vaginal candidiasis (87482 and 87512)
• Oropharyngeal swab testing for HPV (0429U)
• Screening for low-risk (nononcogenic) HPV types (87623)
• Self-collected or self-sampling HPV tests for screening of cervical cancer (0500T)
• Testing for HPV, high risk types (16, 18 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, via male urine [0096U])

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Molecular Diagnostic Testing for Reproductive Health
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 07/27/2023
Policy Number: HUM-0554-019
Page: 8 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for molecular diagnostic testing for vaginitis and sexually transmitted infections for general population screening. This is considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for multipathogen panels** unless ALL pathogens being tested in the panel meet the criteria above. Examples of multipathogen tests include but may not be limited to, the following:

• BD MAX Vaginal Panel (81514)
• Bridge Women's Health Infectious Disease Detection Test (0330U)
• GenPap – PID/Infertility/Pregnancy Loss Profile (PCR)
• NuSwab
• OneSwab
• Simple Swab
• SureSwab (81513)
• Xpert Xpress MVP (0352U)
• INFINITI Bacterial Vaginosis Quad Assay (PCR)
• INFINITI Candida Vaginosis Quad Assay (PCR)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. **Individual pathogen targets (eg, chlamydia, gonorrhea, mycoplasma, trichomoniasis) within a multipathogen panel (eg, GenPap, BD MAX Vaginal Panel, NuSwab, OneSwab, SureSwab) may be medically necessary if criteria in the Coverage Determination are met

Additional information about balanitis, vaginitis or sexually transmitted infections may be found from the following websites:

• American College of Obstetricians and Gynecologists
• Centers for Disease Control and Prevention

Molecular Diagnostic Testing for Reproductive Health
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 07/27/2023
Policy Number: HUM-0554-019
Page: 9 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled.

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Medical Alternatives

Alternatives to molecular diagnostic testing for balanitis, vaginitis or sexually transmitted infections include, but may not be limited to, the following:

• Culture of penile/vaginal discharge
• Direct visualization
• Gram or immunofluorescence staining
• Measurement of sialidase enzyme activity
• Measurement of vaginal pH
• Microscopy (potassium hydroxide or saline wet mount, whiff-amine test)
• Papanicolaou (Pap) testing for cervical cancer screening

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.