Summary Of Evidence

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Analysis of Evidence

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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 meet 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?

Molecular Diagnostic Test (MDT) Policy Specific Definitions

MDT: Any test that involves the detection or identification of nucleic acid(s) deoxyribonucleic acid/ribonucleic acid (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test may or may not include multiple components. A 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)

Molecular Diagnostic Services Program (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.

Payment Rules

MolDX^® will reimburse:

• approved tests covered for dates of service consistent with the effective date of the coverage determination.

Covered Tests

Please refer to the MolDX^® website www.palmettogba.com/MolDX for covered and excluded tests' specific coding and billing information.

For additional MolDX^® Program information, go to the Medicare home page www.PalmettoGBA.com/MolDX.

MolDX^® expects laboratory providers to follow test indications published by the developer.