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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that effective for claims with dates of service on or after January 1, 2019, laboratories shall bill the HCPCS panel test code and not unbundle the individual components if all components of the HCPCS panel are performed. Claims will be returned as unprocessable/rejected if the HCPCS panel test code is not billed. Providers and suppliers are required to submit all AMCC laboratory test HCPCS for the same beneficiary, performed on the same date of service on the same claim. This billing policy applies when: a). Submitting a complete organ disease panel; or b). Submitting individual component tests of an organ disease panel when all components of the panel were not performed. You can find this information in the Centers for Medicare & Medicaid Services (CMS) Manual System Pub 100-04 Medicare Claims Processing Transmittal. The rules say that the order by the treating clinician must reflect whether the treating clinician is ordering a panel or single genes, and additionally, the patient's medical record must reflect that the service billed was reasonable and necessary. This would be considered a single procedural service, a single 5 gene panel, and it must be billed as such. This single panel must be reasonable and necessary to be billed to Medicare. You can find this information in Medicare's Local Coverage Article: Billing and Coding: MolDX: Testing of Multiple Genes (A57910). The rules say that Guardant360 is covered only when all of the following conditions are met: Patient has been diagnosed with a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did not originate from the central nervous system. Patients who would meet all of the indications on the Food and Drug Administration (FDA) label for larotrectinib if they are found to have a neurotrophic receptor tyrosine kinase (NTRK) mutation may be considered to have advanced cancer, and Patient has not previously been tested with the Guardant360 test for the same genetic content. For a patient who has been tested previously using
Guardant360 for cancer, that patient may not be tested again unless there is clinical evidence that the cancer has evolved wherein testing would be performed for different genetic content. Specifically, in patients with previously tested cancer, who have evidence of new malignant growth despite response to a prior targeted therapy, that growth may be considered to be sufficiently genetically different to require additional genetic testing, and Patient is untreated for the cancer being tested, or the patient is not responding to treatment (e.g., progression or new lesions on treatment), and The patient has decided to seek further cancer treatment with the following conditions: The patient is a candidate for further treatment with a drug that is either FDA-approved for that patient's cancer, or has a National Comprehensive Cancer Network (NCCN) 1 or NCCN 2A recommendation for that patient's cancer, and The FDA-approved indication or NCCN recommendation is based upon information about the presence or absence of a genetic biomarker tested for in the Guardant360 assay, and Tissue-based, comprehensive genomic profiling (CGP) is infeasible (e.g., quantity not sufficient for tissue-based CGP or invasive biopsy is medically contraindicated) or specifically in NSLC Tissue-based CGP has shown no actionable mutations. If no alteration is detected by Guardant360 or if circulating tumor deoxyribonucleic acid (ctDNA) is insufficient/not detected, tissue-based genotyping should be considered. Other liquid biopsies will be covered for the same indications if they display similar performance in their intended used applications to Guardant360. You can find this information in Medicare's Local Coverage Determination (LCD): MolDX: Plasma-Based Genomic Profiling in Solid Tumors (L38043).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.