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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 policy describes and clarifies coverage for Lab-Developed Tests (LDTs), Federal Drug 
Administration (FDA)-cleared, and FDA-approved clinical laboratory tests in hereditary cancer tests including 
Next-Generation Sequencing (NGS) tests as allowable under the National Coverage Determination (NCD) 
90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage. This 
policys scope is specific for hereditary germline testing, and is exclusive of polygenic risk scores, solid tumor, 
hematologic malignancies, circulating tumor deoxyribonucleic acid (DNA) testing (ctDNA), and other acquired 
cancer-related tests. 
 
Criteria for Coverage 
All the following must be present for coverage eligibility: 
 
    a. The patient must have: 
        1. Any cancer diagnosis 
        2. AND a clinical indication for germline (inherited) testing for hereditary cancer 
        3. AND a risk factor for germline (inherited) cancer 
        4. AND has not been previously tested for the same germline genetic content. 
    b. The test has satisfactorily completed a Technical Assessment (TA) by Molecular Diagnostic Services 
Program (MolDX) for the stated indications of the test. 
    c. The test performed includes at least the minimum genetic content (genes or genetic variants) with 
definitive or well-established guidelines-based evidence required for clinical decision making for its intended 
use that can be reasonably detected by the test. 
        1. Because these genes and variants will change as the literature and drug indications evolve, they are 
listed separately in associated documents, such as the MolDX TA forms. 
        2. A single gene or variant may be tested if it is the only gene or variant considered to be reasonable and 
necessary for a cancer type. 
    d. If a previous test was performed with a similar/duplicative intended use, a subsequent test is only 
reasonable and necessary if the non-duplicative genetic content of the second test is reasonable and necessary. 
    e. If the test is an NGS test, it must abide by all conditions listed in the NCD 90.2. 
 Situations in which a test should not be used, or coverage is denied: 
The test in question will be non-covered if: 
 
    a. It is an NGS test and does not fulfill all the criteria set forth in the NCD 90.2 
    b. A previous test was performed for the same genetic content 
    c. It is a panel or single gene test used to identify a known familial variant(s) that could be identified with a 
test targeted to that specific variant(s) 
    d. It is a panel or single gene test used to confirm a variant(s) detected by somatic tumor testing that can be 
confirmed by a test targeted to that specific variant(s) 
    e. A satisfactory TA is not completed 
    f. For tests that are currently covered but a TA submission has not been made, providers must submit 
complete TA materials by the original effective date of the policy or coverage will be denied. 
 
Because of the number of variables described above, additional work must be performed to assess if any given 
test is both reasonable and necessary for Medicare beneficiaries and to ensure that Medicare claims are 
properly understood and executed. MolDX has instituted a process for completing a TA that ensures that tests 
are appropriate for their indications and are properly validated according to published guidelines described 
above (when applicable). Specifically, in order to understand if a test is both reasonable and necessary, it must 
be delineated if a test has the properly validated technology, variant types, gene and variant coverage, and 
bioinformatics capability to deliver a clinically useful result for the Medicare beneficiary, given their diagnosis. 
 
Labs seeking coverage for LDTs, FDA-cleared, or FDA-approved tests that are not nationally covered must 
submit documentation to allow MolDX to complete a TA. Forms to complete the process are available on the 
MolDX website. Tests that are currently covered by Palmetto GBA are not exempt from this process. Tests 
that are currently covered and have not undergone a TA by MolDX will be non-covered unless complete 
documents to perform a TA are submitted in a timely manner.  
 
You can find this rule in the Local Coverage Determination (LCD) MolDX: Lab-Developed Tests for Inherited 
Cancer Syndromes in Patients with Cancer L39040. 
 
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.