Article - Billing and Coding: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (A56867)

CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms.Coding Information:Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.The diagnosis code(s) must best describe the patient's condition for which the service was performed.Specific Coding Information:Regarding Non-Small Cell Lung Cancer (NSCLC) and Metastatic Colorectal Cancer (mCRC), the following guidelines apply:Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, 5-50 genes (CPT 81445 or 81449) is a useful representation of the aggregate of these gene tests, and may be used (along with other listed panel codes) as long as the panel contains, at a minimum, 5 or more gene tests for molecular biomarkers determined to meet Medicare coverage criteria as listed above. Evaluation of other genes or genomic sequences not addressed by NCCN or other professional guidelines are not precluded, but their inclusion in panels recognized by this code should not be interpreted as endorsement of such testing by genomic sequencing procedures and laboratories and users of such testing are advised to adhere to traditional regulatory and institutional oversight mechanisms to assure their clinical validity and utility.Documentation Requirements:Documentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition (ICD-10-CM code) that warrants the test(s).Examples of documentation requirements of the ordering physician/non-physician practitioner (NPP) include, but are not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results).Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.Documentation requirements for LDT(s)/protocols (when requested) include diagnostic test/assay, lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence, clinical validity evidence, and clinical utility.Providers are required to code to specificity however, if CPT 81479 (unlisted molecular pathology procedure) is used the documentation must clearly identify the unique molecular pathology procedure performed. When multiple procedure codes are submitted on a claim (unique and/or unlisted) the documentation supporting each code should be easily identifiable. If on review the contractor cannot link a billed code to the documentation, these services will be denied based on Title XVIII of the Social Security Act, 1833(e).For these tests, the ordering provider must provide to the laboratory copies of the signed informed consent documentation.Utilization Guidelines:Screening services such as pre-symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a Medicare benefit and are not covered. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk of a condition unless the risk assessment clearly and directly affects the management of the patient.A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage.