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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 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 Medicares 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 tests associated detail 
information on file and the submitted claim detail line(s) required to adjudicate each tests 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 Medicares 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 these rules in the Local Coverage Determination (LCD) MolDX: Molecular Diagnostic Tests 
(MDT) L35025. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.