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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 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? 
 
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. 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. 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 
 
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. 
 
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. 
 
The rules say that molecular diagnostic laboratory tests must undergo an application and technical assessment 
process through the Molecular Diagnostics (MolDX) contractor. 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. This rule requires that all tests that are approved by this 
process be assigned a unique test identifier from the DEXTM Diagnostics Exchange. Only approved tests will be 
reimbursed consistent with the effective date of the coverage determination. This unique identifier must be 
reported on the claim. You can find these rules in the Local Coverage Determination (LCD): MolDX: 
Molecular Diagnostic Tests (MDT) L36256. 
 
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.