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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 medically necessary services are those that are reasonable and necessary for the diagnosis or treatment of an illness or injury. Medically necessary services include services to improve the functioning of a malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). The rules say that services that are not medically necessary are not covered. The rules also say that experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 411.15(o). The rules say that this coverage policy provides the following information: defines tests required to register for a unique identifier defines tests required to submit a complete technical assessment (TA) for coverage determination defines the payment rules applied to covered tests that are not reported with specific codes from a code set recognized in 45 CFR 162.1002 (a)(5), and termed "HIPAA compliant code sets" throughout the remainder of this LCD lists specific covered tests that have completed the registration and TA process and meets Medicare's reasonable and necessary criteria for coverage. Tests evaluated through the application process and/or technical assessment will be reviewed to answer the following questions: Is the test performed in the absence of clinical signs and symptoms of disease? Will the test results provide the clinician with information that will improve patient outcomes and/or change physician care and treatment of the patient? Will the test results confirm a diagnosis or known information? Is the test performed to determine risk for developing a disease or condition? Will risk assessment change management of the patient? Is there a diagnosis specific indication to perform the test? Is the test performed to measure the quality of a process or for Quality Control/Quality Assurance (QC/QA), i.e., a test to ensure a tissue specimen matches the patient? MDT Policy Specific Definitions MDT: Any test that involves the detection or identification of nucleic acid(s) (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test may or may not include multiple components. An MDT may consist of a single mutation analysis/identification, and/or may or may not rely upon an algorithm or other form of data evaluation/derivation. Laboratory developed test (LDT): Any test developed by a laboratory developed without Food and Drug Administration (FDA) approval or clearance. Applicable Tests/Assays In addition to the MDT definition, this coverage policy applies to all tests that meet at least one of the following descriptions: All non-FDA approved/cleared laboratory developed tests (LDT) All modified FDA-approved/cleared kits/tests/assays
All tests/assays billed with more than one code from a HIPAA compliant code set to identify the service, including combinations of method-based, serology-based, and anatomic pathology codes All tests that meet the first three bullets and are billed with a Not Otherwise Classified (NOC) code Unique Test Identifier Requirement Because the available language in the current HIPAA compliant code sets used to describe the pathology and laboratory categories and the tests included in those categories are not specific to the actual test results provided, all MDT services must include an identifier as additional claim documentation. Test providers must receive an identifier specific to the applicable test and submit the test assigned identifier with the claim for reimbursement. The assigned identifier will provide a crosswalk between the test's associated detail information on file and the submitted claim detail line(s) required to adjudicate each test's claim. The unique identifier limits the need to submit the required additional information about the test on each claim. Technology Assessments (TA) MolDX will review all new test/assay clinical information to determine if a test meets Medicare's reasonable and necessary requirement. Labs must submit a comprehensive dossier on each new test/assay prior to claim submission. MolDX will only cover and reimburse tests that demonstrate analytical and clinical validity, and clinical utility at a level that meets the Medicare reasonable and necessary requirement. You can find this information in Medicare's Local Coverage Determination (LCD): MolDX: Molecular Diagnostic Tests (MDT) (L36807).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.