Prior Authorization Recommended for Emerging/Precision Tests

Prior authorization consideration — Some advanced or emerging tests may require prior authorization. When using precision or investigational modalities (e.g., Mind.Px, Orlucent, novel genomic assays), confirm benefit coverage and obtain authorization if plan rules or local medical management require it before testing.

• When CPT 96904 (whole body integumentary photography) is used, ensure selection criteria and diagnosis codes align with policy.
• Emerging/precision tests without established clinical outcome data (Mind.Px, Orlucent) should trigger discussion with the plan for prior authorization due to uncertain utility.

Denial Risk for Investigational Technologies

Denial risk for investigational technologies — Tests and services described in the policy as experimental, investigational, or lacking evidence may be denied if submitted for coverage. Document medical necessity thoroughly when requesting coverage for less-established technologies.

• Services billed using codes for computerized TBP systems or listed experimental technologies (e.g., MelaFind, MoleMapCD, MoleMate, Orlucent, Mind.Px) may be denied.
• If submitting requests for investigational tests, include supportive evidence, rationale for clinical use, and prior authorization outcomes where applicable.

Document PLA Result and Follow-up Plan

Document PLA results and management plan — For DermTech PLA (pigmented lesion assay), document the test result (positive/negative and gene findings) and the subsequent management decision (biopsy type or surveillance interval).

• Record whether PLA detected LINC00518, PRAME, or both and the corresponding clinical interpretation.
• If PLA(−), document the planned surveillance strategy (interval, modality — e.g., dermoscopy/TBP) and follow-up duration; if PLA(+), document biopsy approach and pathology follow-up.

Follow-up Documentation for PLA(−) Results

Follow-up documentation for PLA(−) results — Studies routinely managed PLA(−) lesions with clinical surveillance rather than biopsy. When choosing surveillance, clearly document rationale, follow-up intervals (eg, 3–12 months), and criteria that would prompt biopsy.

• Describe surveillance method (dermoscopy, TBP, teledermatology) and expected reassessment timeframe (e.g., 3–6 months; note some lesions may require longer follow-up up to 12 months).
• If additional risk factors, persistent clinical suspicion, or patient concern exist, document reasons for opting for biopsy despite PLA(−).

Document Clinical Decision-Making and Role of Adjunctive Tests

Clinical decision-making documentation — Noninvasive tests are adjuncts to, not replacements for, clinical evaluation and dermoscopy. Document that test selection was based on clinical history, naked-eye exam, and dermoscopic findings, and how adjunctive test results informed the management plan.

• State that dermoscopic evaluation was performed and summarize key findings (7-point checklist or equivalent).
• Document that adjunctive tests (PLA, RCM, HFUS, CAD systems) were used to supplement, not substitute, the clinical/dermoscopic assessment and how results changed management.

MoleSafe / TBP Documentation Elements

MoleSafe and TBP documentation elements — When using comprehensive imaging systems (e.g., MoleSafe, TBP), include description of the imaging series and dermoscopy elements in the record to support medical necessity for monitoring high-risk patients.

• Document that total body photography captured the expected series (eg, ~25 images covering ~96% of body surface for MoleSafe) and whether total body dermoscopy was performed.
• When billing CPT 96904, include indication (history of atypical/dysplastic nevi, personal/family history of melanoma) and frequency justification (usually not more frequent than every 24 months).

Reference-Standard and Pathology Documentation

Reference-standard and pathology documentation — For validation or diagnostic confirmation, document the reference standard used (histologic confirmation or clinical follow-up) and include biopsy pathology reports and any second opinions when pathology is ambiguous.

• If a lesion is biopsied, include histopathology results and note concordance with noninvasive test findings.
• For intermediate or discordant pathology (eg, moderately dysplastic to early invasive melanoma), document any additional pathology review or expert consultation.

Dermoscopy as First-line and Adjunctive Test Use / Best Practice

Adjunctive test use and best practice — Dermoscopy remains the recommended first-line noninvasive evaluation. Adjunctive modalities (gene expression assays, RCM, HFUS, CAD systems) may be used selectively as supplements to systematic clinical assessment (history, naked-eye exam, 7-point checklist, dermoscopy).

• Document that standard diagnostic steps (history, naked-eye exam, 7-point checklist, dermoscopy) were completed prior to adjunctive testing.
• Use adjunctive tests for specific clinical questions (eg, avoid unnecessary biopsy, margin assessment) and document why the adjunctive test was chosen.

Investigational / Insufficient Evidence — Coverage Considerations

Investigational / insufficient evidence — Novel tests without robust, generalizable outcome data (e.g., Mind.Px, Orlucent, some RCM uses, electrical impedance devices) are considered investigational or have insufficient evidence for routine coverage. Use within research or with prior authorization and strong documentation of rationale if considered clinically necessary.

• Mind.Px and Orlucent currently lack published clinical outcome data demonstrating net health benefit.
• Reflectance confocal microscopy (RCM) and other emerging modalities have variable evidence quality; document applicability and limitations if used in practice.

No Specific Authorization/Denial Trigger Specified

No specific authorization/denial trigger specified in this section — The policy lists experimental/investigational technologies and covered CPTs (eg, 96904) but does not define explicit automatic authorization or denial triggers; providers should follow standard prior authorization processes and submit clinical documentation when requesting coverage for nonstandard tests.

• When in doubt, obtain prior authorization and include clinical history, dermoscopic findings, prior management steps, and rationale for the requested test.
• Absent explicit PA rules here, local plan requirements and medical management teams determine authorization; maintain complete documentation to expedite review.