Code is covered without prior authorization (high confidence)
Documentation Required
Pathology reports, molecular testing reports (KRAS, NRAS, BRAF, EGFR), and treatment history (prior therapies, lines of chemotherapy, prior EGFR-targeted therapy use and outcomes) to substantiate alignment with the listed indication-specific criteria.
No documentation requirements, medical necessity criteria, or required clinical records are specified in this bibliographic excerpt.
CPT 88363 — Examination and selection of retrieved archival (previously diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational analysis) — documentation of the archival tissue selection and molecular test request/results
For head and neck coverage: documentation that the tumor is squamous cell carcinoma (histology) is required (coverage limited to squamous cell carcinoma of the head and neck)
Key Coverage Criteria
Locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) — radiotherapy +/- cetuximab referenced (Bonner et al.)
Colorectal cancer (including appendiceal adenocarcinoma and anal adenocarcinoma) for unresectable/inoperable, advanced, or metastatic disease when the member has not previously experienced clinical failure on panitumumab and either of the following sets of criteria are met:
Unresectable squamous cell carcinoma of the skin — Phase II study referenced (Maubec et al.)
- The member meets all of the following criteria: The RAS (KRAS and NRAS) mutation status is negative (wild-type); and if the tumor is positive for BRAF V600E mutation, the requested medication will be used in combination with encorafenib (Braftovi); and for colon cancer, the tumor is left-sided only.
- OR the member meets all of the following criteria: The disease is KRAS G12C mutation positive; and the requested medication will be used in combination with sotorasib (Lumakras) or adagrasib (Krazati); and the member previously received treatment with chemotherapy.
Squamous cell carcinoma of the head and neck — for treatment when any of the following is met: disease is locally or regionally advanced, unresectable, recurrent, persistent, or metastatic; OR member is unfit for surgery; OR the requested medication will be used in combination with radiation.
Ask Verity about documentation requirements, denial risks, or coverage in your state.
For small bowel advanced/metastatic adenocarcinoma coverage under Z85.038/Z85.048: documentation of KRAS wild-type status (molecular test result) is required
Precertification required — call (866) 752-7021 or fax (888) 267-3277 and submit Statement of Medical Necessity (SMN) precertification forms via Specialty Pharmacy Precertification.