Article - Billing and Coding: Genetic Testing for Cardiovascular Disease (A58797)

CMS National Coverage PolicyInternet Only Manual (IOM) Citations:CMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 1, Section 60 Provider Billing of Non-covered Charges on Institutional ClaimsChapter 16, Laboratory ServicesChapter 23, Section 20.9 National Correct Coding Initiative (NCCI), Section 20.9.1.1 Instructions for Codes with Modifiers (A/B MACs (B) Only), and Section 40 Clinical Diagnostic Laboratory Fee ScheduleCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 3, Sections 3.4.1.3 Diagnosis Code Requirements and 3.6.2.3 Limitations of Liability DeterminationsNational Correct Coding Initiative (NCCI) Citation:NCCI Policy Manual for Medicare Services,Chapter 10, Pathology/Laboratory Services, (A) Introduction and (F) Molecular PathologySocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Title XVIII of the Social Security Act, Section 1834A(d) This section addresses payment for new advanced diagnostic laboratory tests.Code of Federal Register (CFR) References:CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CFR, Title 42, Volume 3, Chapter IV, Part 414, Subpart G Payment for Clinical Diagnostic Laboratory Tests.CFR, Title 42, Volume 3, Chapter IV, Part 414.50 Physician or other supplier billing for diagnostic tests performed or interpreted by a physician who does not share a practice with the billing physician or other supplier.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L39084 Genetic Testing for Cardiovascular Disease. Please refer to the LCD for reasonable and necessary requirements.Tier 2 CPT code 81406 is not appropriate to report for cardiovascular genetic testing because there are no genes associated with CPT code 81406 that meet the ClinGen evidence standards.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.All limitations of the LCD apply.No genes currently meet criteria for coverage as outlined in the LCD.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.The medical record must demonstrate the treating clinician who is responsible for the cardiovascular disease management is the ordering clinician.The medical record must clearly document the communication and discussion of pre-test and post-test counseling and the risk associated with genetic testing.The medical record must demonstrate disease appropriate phenotyping to establish clinical diagnosis or suspected diagnosis for which the test results would directly impact the management of the patients condition.The clinical actionability of the gene-disease relationship for the patient must be documented in the medical record.