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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 state that 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 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 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. 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 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) 
 
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 this rule at the Medicare Local Coverage Determination (LCD) L36021: MolDX: Molecular 
Diagnostic Tests (MDT). 
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.