CG.CP.MP.07 Concert Infectious Disease: Genitourinary Testing 2025.1 Date of Last Revision: 11/2024

CENTENE Corporation

Coding Implications Revision Log

CONCERT INFECTIOUS DISEASE: GENITOURINARY TESTING

See Important Reminder at the end of this policy for important regulatory and legal information.

OVERVIEW

Genitourinary diseases are common ailments that affect all age ranges. Urinary tract infections are caused by microorganisms that enter the urethra from the surrounding skin which can be contaminated by vaginal pathogens, fecal remnants, or mechanically introduced (e.g., during urinary catheter insertion or sexual intercourse, or less commonly, arrive to the kidney via its blood flow from infection at a different site). Pathogens can infect the lower urinary tract, causing inflammation and painful urination, or the upper urinary tract, leading to complications such as kidney infection.

Vaginitis is inflammation specifically affecting the vagina. Bacterial vaginosis (BV) is a major cause of vaginitis along with yeast infections and infection with the protozoa Trichomonas vaginalis. Vaginitis, particularly when observed with cervicitis, can indicate chlamydia or gonorrhea infection. The cause of vaginitis cannot be determined based on symptoms alone. Additionally, coinfection with more than one organism is not uncommon. Untreated or improperly treated infectious vaginitis can lead to poor health outcomes and increased need for follow-up visits.

Testing urine and genital secretions may enable providers to choose precise therapy and afford the patient a better outcome. Cultures, microscopic examination and molecular identification are all common testing methods for evaluating the infectious causes of various genitourinary conditions.

This policy is intended for use in the outpatient setting.

POLICY REFERENCE TABLE

CRITERIA

It is the policy of health plans affiliated with Centene Corporation® that the specific tests noted below are medically necessary when meeting the related criteria:

VAGINITIS AND VAGINOSIS PATHOGEN TESTS

Targeted Vaginitis/Vaginosis Pathogen Testing

I. Targeted vaginitis/vaginosis pathogen testing via direct probe for Gardnerella vaginalis, Candida albicans, and/or Trichomonas vaginalis, OR nucleic acid/PCR tests for bacterial vaginosis, candidiasis, and/or trichomoniasis, OR multipathogen panel of six targets or fewer, with or without chlamydia and/or gonorrhea is considered medically necessary when:

A. The member/enrollee has at least one of the following:

1. Abnormal vaginal discharge, OR
2. Vulvovaginal itching, irritation, or redness (e.g., pruritus, erythema, edema), OR
3. Painful sexual intercourse (dyspareunia), OR
4. Painful urination (dysuria), OR
5. Postcoital or contact bleeding.

II. Targeted vaginitis/vaginosis pathogen testing via direct probe for Gardnerella vaginalis, Candida albicans, and/or Trichomonas vaginalis, OR nucleic acid/PCR tests for bacterial vaginosis, candidiasis, and/or trichomoniasis, OR multipathogen panel of six targets or fewer, with or without chlamydia and/or gonorrhea is considered investigational for all other indications, including:

A. Asymptomatic pregnant members/enrollees (regardless of preterm labor risk).

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Expanded Multiplex Vaginitis/Vaginosis Pathogen Panels

I. Expanded multiplex vaginitis/vaginosis pathogen panels with more than six targets are considered investigational.

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URINARY TRACT AND KIDNEY INFECTIONS

Urine Culture for Asymptomatic Bacteriuria

I. Urine culture for asymptomatic bacteriuria is considered medically necessary when:

A. The member/enrollee is pregnant, OR B. The member/enrollee will undergo an endoscopic urologic procedure with mucosal trauma.

II. Urine culture for asymptomatic bacteriuria is considered investigational for all other indications.

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Molecular/Multiplex UTI Panels

I. Molecular/multiplex UTI Panels are investigational for all indications.

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NOTES AND DEFINITIONS

1. Endoscopic urologic procedure with mucosal trauma: examples of such procedures include, but are not limited to: transurethral surgery of the prostate or bladder, ureteroscopy including lithotripsy, and percutaneous stone surgery.

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BACKGROUND AND RATIONALE

VAGINITIS AND VAGINOSIS PATHOGEN TESTS

Targeted Vaginitis/Vaginosis Pathogen Testing

UpToDate

“Ideally, the abnormal vaginal discharge is tested for evidence of BV, Candida species, and trichomonas when the patient is symptomatic… The traditional gold standard tests have been culture (for candida species and trichomoniasis) and microscopy with Nugent score, followed by Amsel criteria for indeterminate tests, for BV. However, NAATs have become an established alternative to both as NAATs have similar or better test sensitivity and specificity… NAATs can be used as the initial diagnostic tool or as a follow-up to negative microscopy in patients with high clinical suspicion”

American College of Obstetricians and Gynecologists (ACOG)

In ACOG Practice Bulletin #215 which discusses vaginitis in nonpregnant patients, Table 1 delineates the symptoms and clinical findings associated with the various causes of vaginitis: abnormal textured/colored/malodorous vaginal discharge; pruritus, irritation, dysuria, burning, dyspareunia; vaginal or cervical-vaginal erythema with petechiae; edema, excoriations, and fissures. (p. e4) The guidelines also state that “…symptomatic patients with trichomoniasis may report…postcoital bleeding” (p. e2)

“Nucleic acid amplification testing is recommended for the diagnosis of trichomoniasis.” (p. e11)

Kong et al.

“This study tracks health care spending among women diagnosed with vaginitis and finds that nucleic acid amplification tests (NAATs) are cost-effective for the diagnosis of vaginal symptoms. Women who receive a NAAT on the day of their diagnosis have significantly lower 12-month follow-up costs compared to women who receive a direct probe test or those women who are clinically evaluated without the use of a molecular test.” (p. 515)

United States Preventive Services Task Force

The USPSTF published guidelines in 2020 discussing bacterial vaginosis (BV) screening in pregnant individuals. The guidelines recommend against screening for BV in pregnant patients who are not at increased risk for preterm labor. These guidelines also state that there is insufficient evidence to conclusively determine if BV screening for pregnant patients at increased risk for preterm labor is beneficial.

Expanded Multiplex Vaginitis/Vaginosis Pathogen Panels

There are no professional guidelines or recommendations we identified to support the use of these tests. The following guidelines and publications were reviewed in-depth in September 2023: United States Preventive Services Task Force, UpToDate, American College of Obstetricians and Gynecologists, Kong et al.

URINARY TRACT AND KIDNEY INFECTIONS

Urine Culture for Asymptomatic Bacteriuria

Infectious Diseases Society of America

The IDSA published an updated guideline in 2019 with clinical practice recommendations for the management of asymptomatic bacteriuria (ASB). The guidelines recommend screening for ASB in pregnant individuals (p. e85), and in individuals who are undergoing endoscopic urologic procedures associated with mucosal trauma (p. e86).

The guidelines recommend against screening for ASB, or make no recommendations for or against screening for ASB, in most other individuals, including:

• Infants and children
• Healthy nonpregnant people
• Functionally impaired older adults
• Older residents of long-term care facilities
• Recipients of a solid organ transplant (including kidney)
• Individuals with neutropenia
• Individuals with impaired voiding following a spinal cord injury
• Individuals with an indwelling urethral catheter
• Individuals undergoing elective nonurologic surgery
• Individuals with a urologic implant, or who are undergoing surgical implantation of a urologic device (p. e85 and e86)

Molecular/Multiplex UTI Panels

There are no professional guidelines or recommendations we identified to support the use of these tests. The following guidelines and publications were reviewed in-depth in May 2024: Infectious Disease Society of America, American College of Obstetricians and Gynecologists.

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®, CPT® is a registered trademark of the American Medical Association. All rights reserved. All CPT codes and descriptions are copyrighted 2024, American Medical Association. All rights reserved. CPT codes and descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should refer to the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

CG.CP.MP.07 Concert Infectious Disease: Genitourinary Testing 2025.1 Date of Last Revision: 11/2024

CENTENE Corporation

11 CG.CP.MP.07 Concert Infectious Disease: Genitourinary Testing 2025.1 Date of Last Revision: 11/2024

CENTENE Corporation

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Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

13 CG.CP.MP.07 Concert Infectious Disease: Genitourinary Testing 2025.1 Date of Last Revision: 11/2024

CENTENE Corporation

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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