CurrentWellCarePolicy N/A

Outpatient infectious disease screening: HPV, HCV, GBS

Defines medical necessity criteria for outpatient screening tests for high-risk and low-risk HPV genotyping, hepatitis C antibody and nucleic acid (PCR) testing, and group B streptococcus (GBS) vaginal-rectal screening; applies to members/enrollees of the Health Plan in outpatient settings.

Policy Summary

PayerWellCare

PolicyOutpatient infectious disease screening: HPV, HCV, GBS

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrder testing only when medical necessity criteria are met and document age, cervix status, exposure history or gestational age as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3test areas

30-65HPV age range

18-79HCV screening age

36–37wGBS gestation window

9 codesCPT referenced

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Medical Necessity and Coverage Criteria

Genotyping of High Risk Human Papillomavirus (HPV) Types for Cervical Cancer Screening

Covered when ALL of the following are met:

High-risk HPV genotyping - primary criteria

Supporting conditions: Has NOT had a hysterectomy with removal of the cervix OR has a history of high-grade precancerous lesion (CIN 2 or 3) OR has a history of cervical cancer
If younger than 30 or older than 65, genotyping may be considered only if increased risk for cervical cancer (e.g., immunocompromised, HIV infection, in‑utero DES exposure, history of cervical lesion or cervical cancer)

Genotyping of Low Risk Human Papillomavirus (HPV) Types

Low-risk HPV genotyping: Current evidence does not support genotyping of low risk HPV types

No medical indication per AAFP; not recommended for clinical management

Hepatitis C Antibody Screening Tests

Covered when ALL of the following are met:

HCV antibody screening primary: Member does NOT have a known past positive HCV antibody test result AND does not have a known history of chronic HCV infection AND meets at least one of the listed age/risk/request criteria

At least one of: pregnant; asymptomatic adult 18–79 years; younger than 18 or older than 79 with increased risk (eg past/current injection drug use, chronic hemodialysis, HIV, organ transplant/transfusion history, partners of HCV-infected individuals); or the member requests screening

Hepatitis C Nucleic Acid/PCR Tests

Covered when ANY of the following are met:

HCV-PCR indications: Member is immunocompromised (e.g., receives chronic hemodialysis) OR has suspected HCV exposure within the past 6 months OR has an initial HCV antibody positive test OR is undergoing monitoring for chronic HCV infection (prior to, during, or after DAA therapy) OR has history of HCV with SVR and has ongoing risk factors for reinfection6 months for exposure

Reflex HCV-RNA PCR from positive antibody tests is considered an appropriate initial approach; quantitative HCV-RNA testing recommended for baseline, monitoring during therapy, and to document SVR

Group B Streptococcus Screening Tests of Vaginal-Rectal Specimens

Covered when ALL of the following are met:

GBS screening antepartum: Member is pregnant AND pregnancy is between 36 weeks 0 days and 37 weeks 6 days gestation36 0/7 - 37 6/7 weeks

NAAT-based testing is an acceptable alternative to culture; screening is not supported for those with GBS bacteriuria during the current pregnancy or with a history of a previous GBS‑infected newborn

Coverage for the tests in this policy is limited to the specific indications and thresholds described in each criteria section. HPV high-risk genotyping is covered only for members born with a cervix who meet the age and supporting-condition requirements and, absent increased risk factors, is limited to once every 5 years (see high-risk HPV criteria). The policy explicitly states that genotyping for low-risk HPV types is not supported. Hepatitis C antibody screening is covered only when the member has no known prior positive antibody and meets the listed age/risk/request criteria; reflex or PCR testing has defined indications (e.g., antibody positive, immunocompromised, recent exposure, or monitoring), and is not covered for routine screening outside those indications. Group B Streptococcus (GBS) vaginal-rectal screening is limited to pregnant members within the specified gestational window and is not supported for other indications such as existing GBS bacteriuria or prior GBS-infected newborns.

State and federal coverage rules take precedence where applicable. For Medicaid members, state Medicaid coverage provisions override this clinical policy when there is a conflict; consult the applicable state Medicaid manual. For Medicare members, applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) and Medicare Coverage Articles should be reviewed and followed in conjunction with this policy.

The policy lists several unsupported uses and general exclusions. HPV low-risk genotyping is not supported. HPV genotyping for evaluation of genital warts or general STI screening is also not supported. Hepatitis C antibody or PCR testing is not supported when the specific criteria are not met (for example, antibody testing when there is a known prior positive result, or PCR testing for routine screening absent listed indications such as recent exposure, immunocompromise, or antibody positivity). GBS vaginal-rectal screening is not supported outside the 36 0/7 – 37 6/7 weeks gestation window except for specified exceptions (e.g., GBS bacteriuria or prior GBS-infected newborn where routine screening is not indicated).

Coding and Age/Gestation Thresholds

Referenced CPT CodesCPT

86803	Hepatitis C antibody;
86804	Hepatitis C antibody; confirmatory test (eg, immunoblot).
87520	Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, direct probe technique.
87521	Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, amplified probe technique, includes reverse transcription when performed.
87522	Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, quantification, includes reverse transcription when performed.
87623	Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (eg, 6, 11, 42, 43, 44).
87624	Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68).
87625	Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed.
87653	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group B, amplified probe technique

Age / gestation thresholds - HPV, HCV, GBS

HPV genotyping age range and intervalMedically necessary for members born with a cervix aged 30–65 years; repeat genotyping once every 5 years in absence of increased risk

HPV alternative criteria outside routine agesMembers younger than 30 or older than 65 may be eligible only if at increased risk (e.g., immunocompromised, HIV, in‑utero DES exposure, history of high‑grade lesion or cervical cancer)

HCV antibody screening age rangeUniversal screening supported for asymptomatic adults age 18–79 years; also indicated in pregnancy or when requested

HCV PCR (nucleic acid) use related to exposure timeframeHCV‑RNA PCR indicated for suspected exposure within the past 6 months or when antibody positive; quantitative testing for baseline, on‑treatment, and post‑treatment monitoring/SVR documentation

GBS gestational window for antepartum screeningVaginal‑rectal screening is medically necessary when pregnancy is between 36 weeks 0 days and 37 weeks 6 days gestation

Provider Responsibilities, Documentation, and Billing Rules

Prior Authorization

Policy Guides Prior Authorization

This clinical policy is used as a guide for prior authorization and medical necessity determinations. Prior authorization may be required per the Health Plan's administrative policies; providers should submit supporting clinical documentation when requesting prior authorization.

Policy criteria drive medical necessity reviews and prior authorization decisions.
Submit prior authorization requests with relevant clinical notes, test results, and indication for testing.

Denial Risk

HPV Genotyping — Inappropriate Indications

HPV genotyping for high-risk types is limited to the indications defined in the policy. Use of HPV genotyping outside those indications risks denial as not medically necessary.

Not indicated for evaluation of genital warts or routine STI screening.

Background and Rationale

Human papillomavirus (HPV) encompasses low-risk types that typically cause anogenital warts and high-risk types that are associated with cervical cancer; screening efforts focus on individuals born with a cervix and on identifying high-risk infection. The policy supports targeted high-risk HPV genotyping for cervical cancer screening within specified age and risk criteria, while stating that genotyping of low-risk types and use of HPV genotyping for general STI evaluation are not supported. Hepatitis C (HCV) screening follows population and risk-based guidance with antibody screening for defined age/risk groups and HCV RNA/PCR testing reserved for confirmed antibody positivity, recent exposure, immunocompromised states, or monitoring of known infection. Group B Streptococcus (GBS) antepartum screening is intended to detect maternal colonization to guide intrapartum prophylaxis and is limited to the 36 0/7 – 37 6/7 weeks gestational window.

Definitions and Test Descriptions

HPV genotyping of high risk types - definition / key point

DefinitionGenotyping of high‑risk HPV types refers to nucleic acid detection of oncogenic HPV types (eg, types such as 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) for cervical cancer screening

IndicationCovered when member was born with a cervix and meets age and risk criteria (see coverage criteria); not supported for evaluation of genital warts or general STI screening

IntervalOnce every 5 years when performed as routine screening in members age 30–65 without increased risk

Hepatitis C Nucleic Acid / PCR tests - definition / usage

Definition and purposeHepatitis C nucleic acid (HCV‑RNA) PCR testing detects and quantifies HCV RNA for diagnosis, confirmation of infection, and monitoring of antiviral therapy

Indications for use

Policy Revision History

2024-03-24last_reviewLatest

Clinical policy last reviewed on 2024-03-24.

2023copyright

Policy text copyrighted by Centene Corporation in 2023.

Policy Summary

PayerWellCare

PolicyOutpatient infectious disease screening: HPV, HCV, GBS

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrder testing only when medical necessity criteria are met and document age, cervix status, exposure history or gestational age as applicable.

SourceLink

On This Page

Denial risk if ordered for ages or conditions not meeting policy criteria (see medical necessity section).

Denial Risk

HCV PCR Testing — Restricted Indications

HCV nucleic acid/PCR testing is restricted to specific indications. Routine or reflex PCR testing without meeting criteria may be denied.

Allowed indications include: immunocompromised patients, suspected exposure within 6 months, initial antibody positive, monitoring chronic HCV treatment/response, and persons with prior HCV and ongoing reinfection risk.
Automatic reflex PCR from positive antibody is considered appropriate for initial screening when criteria are met; otherwise document indication.

Denial Risk

GBS Screening — Timing Restriction

Group B Streptococcus (GBS) vaginal-rectal screening is indicated only during the stated gestational window; testing outside 36 0/7–37 6/7 weeks may be considered not medically necessary unless another documented indication exists.

Routine GBS screening should be performed between 36 weeks 0 days and 37 weeks 6 days gestation.
Testing earlier or later without documented indication (e.g., intrapartum risk factors) may be denied.

Note

Coverage Conditional on Plan Documents

Coverage is subject to the member's plan terms, exclusions, limitations, and applicable state or federal requirements. This policy does not guarantee coverage or payment; benefits and prior authorization requirements may vary by contract.

Review the member's evidence of coverage, certificate of coverage, or contract for benefit specifics.
State Medicaid provisions and Medicare NCDs/LCDs take precedence where applicable.

Documentation Required

HCV Testing — Required Documentation

Documentation must demonstrate the absence of a prior positive HCV antibody or known chronic HCV when ordering HCV antibody screening. Include relevant history, risk factors, pregnancy status, or patient request as applicable.

Document prior HCV testing history and results; if prior positive antibody or known chronic HCV exists, antibody screening is not appropriate.
When ordering PCR testing, document the specific indication (e.g., exposure timeframe, immunocompromised status, monitoring for treatment).
For reflex PCR approaches, note that reflex testing is recommended by guideline sources for initial HCV testing; include lab ordering practices in the record.

Documentation Required

HPV Genotyping — Required Documentation

When ordering HPV genotyping, document the patient's age, cervix status (has/has not had hysterectomy with removal of the cervix), history of high-grade cervical lesions or cancer, and any increased risk factors that justify testing.

Document patient's age (30–65 for routine 5-year interval testing absent other risk factors).
Document prior history of CIN2/3, cervical cancer, immunocompromised status, or other increased risk conditions when applicable.

Documentation Required

GBS Screening — Required Documentation

For GBS vaginal-rectal screening orders, document pregnancy status and gestational age within the 36 0/7–37 6/7 week window, or provide a clear alternative indication if testing is outside that window.

Include estimated gestational age or last menstrual period and clinical rationale when testing outside the recommended window.
Document prior GBS bacteriuria or history of an infected newborn if relevant; note that routine screening is not supported in those contexts per policy.

Note

Provider Responsibility

Providers are expected to exercise independent clinical judgment. This policy is a guide to medical necessity determinations and is not a substitute for personalized clinical decision-making.

Providers retain responsibility for diagnosis and treatment decisions and must document clinical rationale.
This policy does not replace provider-patient shared decision-making or individualized care.

Note

HCV Reflex PCR Guidance

Guidelines recommend HCV-antibody testing with reflex HCV RNA PCR for initial testing. Reflex PCR testing is an acceptable workflow for initial HCV screening when laboratory processes and documentation support reflex testing; ensure the medical indication aligns with policy criteria.

Reflex HCV-RNA testing is particularly useful to confirm active infection after antibody positivity and is recommended by IDSA/AASLD for initial testing.
When reflex PCR is performed, ensure documentation captures that reflex testing is part of initial screening and that criteria (e.g., no prior positive antibody) are met.

Medically necessary when immunocompromised, suspected exposure within 6 months, initial HCV antibody positive, monitoring prior to/during/after treatment, or to assess reinfection risk after SVR

Reflex and quantitative testingReflex HCV‑RNA PCR from a positive antibody test is considered the most appropriate initial approach; quantitative PCR is recommended prior to DAA therapy and to document SVR

Group B Streptococcus screening - antepartum vaginal‑rectal testing definition

Definition and timingGroup B Streptococcus (GBS) antepartum vaginal‑rectal testing is culture or NAAT‑based screening performed at 36 0/7–37 6/7 weeks gestation to guide intrapartum prophylaxis

PurposeIdentify maternal GBS colonization to inform intrapartum antibiotic prophylaxis and reduce neonatal GBS disease

Methodology noteNAAT‑based testing is an acceptable and potentially more sensitive alternative to culture for antepartum screening

Health Plan - definition as used in this policy

Health Plan meaning'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

Policy roleThe clinical policy provides guidance on medical necessity to assist coverage decisions and benefit administration but is not a contract or guarantee of payment

Scope of applicabilityCoverage decisions remain subject to all terms, conditions, exclusions and limitations of the applicable coverage documents and to state/federal requirements