Does C4A.70 require prior authorization?

No, C4A.70 does not require prior authorization (high confidence). Covered without prior authorization.

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`C4A.70`, Merkel cell carcinoma of unspecified lower limb, including hip

ICD-10-CM

Prior Authorization

No Prior Auth Required

Covered without prior authorization (high confidence)

Documentation Required

The medical record must document that the testing is expected to influence treatment and include the ordering physician/NPP history and physical, exam findings, problems/diagnoses, and relevant data (e.g., lab tests, imaging).
The laboratory or billing provider must retain the physician requisition that sets forth the diagnosis/ICD-10-CM code that warrants the test(s).
Performing laboratory documentation (when requested) must include lab accreditation, test requisition, test records/procedures, preliminary and final reports, and quality control records.
For laboratory-developed tests (LDTs)/protocols (when requested) documentation must include assay description, lab/manufacturer, comparable assays/services (if relevant), and evidence of analytical validity, clinical validity, and clinical utility.

Key Coverage Criteria

Coverage is allowed for targeted genomic sequence analysis panels for treatment of solid organ neoplasms when the panel is a DNA analysis panel containing at least 5 gene tests for molecular biomarkers that meet Medicare coverage criteria.
Coverage is allowed when the genomic testing is expected to influence the treatment of the condition (i.e., documentation supports that test results will affect clinical management of the solid organ neoplasm).
Genomic testing of acquired conditions such as malignancies, including separate malignancies developing at different times, is permitted when medically reasonable and necessary to assess response or other clinically relevant criteria.
Initial MRD testing is covered for patients with cancer when baseline tumor profiling from a prior analysis is utilized, using listed bespoke/plasma-series MRD tests (e.g., Signatera Bespoke Assay Design + Plasma Series Bundle, RaDaR Bespoke Assay Design + Plasma Series Bundle, Oncodetect Bespoke Assay Design + Plasma Test Bundle, Guardant Reveal MRD Bundle, Guardant360 Response).
Subsequent MRD testing for patients with cancer is covered only if there is clinical evidence of an a priori change in tumor genetic content in accordance with NCD 90.2.
Initial MRD testing is covered for patients without current cancer (per policy definition) when baseline tumor profiling from a prior analysis is utilized, using listed recurrence-monitoring bespoke + single-plasma tests (e.g., Signatera Recurrence Monitoring Bespoke Assay Design + single Plasma Test, RaDaR Recurrence Monitoring, Oncodetect Bespoke Assay, Pathlight Recurrence Monitoring).

20 Active Policies

CGS-J15-L38065, MolDX: Plasma-Based Genomic Profiling in Solid Tumors

J15

CGS-J15-L38067, MolDX: Next-Generation Sequencing for Solid Tumors

J15

CGS-J15-L40225, MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer

J15

CGS-J15-L38822, MolDX: Minimal Residual Disease Testing for Cancer

J15

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C4A.70, Merkel cell carcinoma of unspecified lower limb, including hip