Meet authorization & medical necessity

Services must meet authorization and medical necessity guidelines for the procedure, diagnosis, and the member’s state of residence; coverage does not guarantee reimbursement.

Prior authorization not specified — follow manufacturer labeling

No explicit prior authorization requirements are stated in the policy excerpt; follow manufacturer indications (e.g., BD Onclarity) and standard laboratory regulations when ordering assays.

No PA requirements listed in excerpt

This policy excerpt does not list specific prior authorization requirements or identify affected billing codes for STI diagnostic tests.

Order tests per labeling and guideline indications

Providers must follow the explicit clinical and laboratory guidance in the policy when ordering tests; use manufacturer labeling and guideline-based indications to justify testing.

No PA for routine STI tests in excerpt

No prior authorization requirement for STI diagnostic tests is specified in these sections of the policy.

Reference applicable procedure codes when billing

Procedure codes for syphilis, chlamydia, gonorrhea, HSV, HPV, Trichomonas, Mycoplasma genitalium and other STI tests are listed in the policy and should be referenced when submitting claims.

Use listed procedure & proprietary test codes for claims

Proprietary and procedure codes (CPT/HCPCS and PLA codes) are provided for reference in the policy; use the appropriate code per payer rules and match specimen source to billed code.

• Match specimen type (vaginal, endocervical, rectal swab, urine) to the code and claim.
• Use proprietary PLA codes (e.g., 0210U, 0483U, 0484U) as applicable for proprietary assays.

No prior authorization requirements in this section

This section of the policy does not specify any prior authorization requirements for the listed STI diagnostic services.

Submit accurate coding and documentation

Providers should ensure submitted claims include accurate coding and supporting documentation per industry-standard coding guidelines; failure may result in denial or recoupment.

• Code claims according to CPT, HCPCS, ICD-10 and other standard coding guidance.
• Submit documentation supporting medical necessity and the procedure performed.

Use two-tiered serologic testing for syphilis

For syphilis diagnosis, use a two-tiered serologic testing algorithm combining treponemal and nontreponemal tests; relying on a single serologic test is insufficient for diagnosis.

• Perform both a treponemal test (e.g., TP-PA, EIA/CLIA) and a nontreponemal test (e.g., RPR or VDRL) per standard algorithms.
• Recognize NAAT/PCR for T. pallidum is not FDA-approved for routine genital syphilis diagnosis.

No step therapy requirements stated

No step therapy requirements are described in this policy section.

Document age, cytology, screening history for BD Onclarity

Providers must document patient age, cervical cytology results (e.g., ASC-US), screening history, and risk factors when ordering BD Onclarity HPV testing to support appropriate use per manufacturer indications.

Document prenatal STI testing and repeat tests as indicated

Pregnancy screening must include documentation of syphilis, HIV, hepatitis B and C testing early in pregnancy; repeat testing may be required at 28–32 weeks and at delivery for individuals at increased risk.

• Document timing and results of maternal syphilis testing to support newborn management.
• Rescreen pregnant individuals per risk (e.g., age <25, new partner, ongoing risk).

Perform quantitative RPR/VDRL for syphilis reflex testing

When serologic testing for syphilis is used, perform quantitative non-treponemal testing (RPR or VDRL) quantitatively to allow reflex/interpretation and follow reflex confirmatory testing per algorithm.

• Quantitative NTT titers (RPR/VDRL) should be reported to permit reflex testing and interpretation.
• Reflex to confirmatory treponemal tests as described by testing algorithm.

Use correct specimen type per assay labeling

Use the appropriate specimen type and follow assay labeling when ordering proprietary or multiplex assays; the policy lists specimen types matched to each assay.

• Match billed procedure codes to the specimen source (vaginal, endocervical, rectal swab, female or male urine).
• Follow manufacturer specimen instructions for proprietary assays (e.g., Abbott Alinity, Cepheid).

Claims may be denied or recouped for improper coding/documentation

Failure to follow coding/billing guidelines, reimbursement policies, or to submit required documentation may result in claim denial or recoupment.

Do not use assays outside manufacturer indications

Using assays outside FDA or manufacturer indications (for example BD Onclarity outside indicated age or cytology contexts) may lead to unsupported testing decisions and denials.

Avoid single-test syphilis diagnoses — use combined tests

Using only one type of serologic test (nontreponemal or treponemal) is insufficient for syphilis diagnosis and can produce false-negative or false-positive conclusions; perform combined testing as required.

Verify procedure codes — policy list is for reference only

Procedure codes shown in Medical Policy documents are provided as a general reference and may not be all-inclusive; verify codes and payer rules before billing.