Draft Article - Billing and Coding: Molecular Pathology Procedures (DA56199)

CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Molecular Pathology Procedures.Specific Coding of Molecular Testing PanelsThe submission of claims using individual gene CPT codes, when either 5-50 or >50 gene panels are ordered, is considered incorrect coding. Correct coding requires that when a panel code is ordered, it should be billed, rather than the individual gene codes. CPT code 81445, 81449, 81450, or 81451 should be billed when 5 to 50 genes are ordered.CPT code 81455, or 81456, should be billed when 51 or greater genes are ordered for molecular biomarkers.Please refer to Local Coverage Determination L37810 Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms and the associated Article A56867.When a panel with greater than one or less than five genes is ordered, use the corresponding existing panel CPT code or CPT code 81479 if none exists.Coding InformationCoding guidance in this article is categorized into four, distinct CPT/HCPCS sections: CPT/HCPCS section-Group1-Tier 1 Covered Codesfor which limited coverage may be provided for the genetic tests and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed CPT/ HCPCS section-Group 2-Tier 1 Codes that require Individual Reviewfor which coverage may be provided for the genetic tests submitted, if documentation supports medical necessity, and for which specific ICD-10-CM diagnosis to CPT procedure groupings may be listed. CPT/HCPCS section-Group 3-Tier 1 Non-covered Codesfor which genetic testing is unlikely to impact therapeutic decision-making in the clinical management of the patient and will be denied automatically as not medically necessary. CPT/HCPCS section-Group 4-Tier 2/NOC Covered Code/Gene Combinationsfor which limited coverage may be provided for specific genes listed in the Group 4 paragraph;Tier 2/NOC Individual Review Code/Gene Combinations;Tier 2/NOC Non-covered Code/Gene Combinations.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.Modifier 91Please use Modifier 91 as appropriate, based on the Medicare Claims Processing Manual Chapter 16, Laboratory Services Section 100.5.1. Modifier 91 may be is used"to indicate that a test was performed more than once on the same day forthe same patient., only when it is necessary to obtain multiple results in the course of treatment."Documentation RequirementsDocumentation 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/nonphysician 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.When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.Utilization GuidelinesScreening 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.