MolDX: Molecular Diagnostic Tests (MDT)

LCD Information Document Information Source LCD ID N/A LCD ID L36021 Original ICD-9 LCD ID Not Applicable LCD Title MolDX: Molecular Diagnostic Tests (MDT) Proposed LCD in Comment Period N/A Source Proposed LCD DL36021 Opens in a new window Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 08/21/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 08/05/2015 Notice Period End Date 09/21/2015 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 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Issue Issue Description Annual review, no changes needed at this time. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Title XVIII of the Social Security Act, (SSA) §1862(a)(1)(A), states that no Medicare payment shall be made for items or services that "are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of malformed body member." Title XVIII of the Social Security Act, (SSA) §1862(a)(1)(D), Investigational or Experimental. Pub 100-08 PIM, Ch. 13, Sec 13.1.3, Program Integrity Manual, “LCDs consist of only “reasonable and necessary” information. 45 CFR §162.1002 (a)(5), Medical data code sets CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in LCDs Coverage Indications, Limitations, and/or Medical Necessity As of September 16, 2013 CGS Administrators accepts all coverage determinations made by Palmetto GBA through the MolDX Program, which are discussed in the details of this policy.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 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)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. LDT: Any test developed by a laboratory developed without FDA approval or clearance. Applicable Tests/AssaysIn 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 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 an NOC code Unique Test Identifier RequirementBecause the available language in the manuals 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 apply for 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 RulesMolDX® 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. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

As of September 16, 2013 CGS Administrators accepts all coverage determinations made by Palmetto GBA through the MolDX Program, which are discussed in the details of this policy. 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 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) 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. LDT: Any test developed by a laboratory developed without 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 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 an NOC code Unique Test Identifier Requirement Because the available language in the manuals 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 apply for 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.