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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 the following types of tests are examples of services that are not relevant to a Medicare beneficiary, are not considered a Medicare benefit (statutorily excluded), and therefore will be denied as Medicare Excluded Tests: 1. Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law 2. Tests performed to determine carrier screening 3. Tests performed for screening hereditary cancer syndromes 4. Prenatal diagnostic testing 5. Tests performed on patients without signs or symptoms to determine risk for developing a disease or condition 6. Tests performed to measure the quality of a process 7. Tests without diagnosis specific indications 8. Tests identified as investigational by available literature and/or the literature supplied by the developer and are not a part of a clinical trial You can find this rule in the Local Coverage Article (LCA) - Billing and Coding: Molecular Pathology and Genetic Testing (A58917) - Effective December 30, 2021. The rules say that local Medicare coverage of biomarkers must be predicated upon three fundamental principles: 1. First, there must be an underlying performance of acceptable, high-quality analytical validity for all such laboratory testing. As a result, the laboratory shall have available upon request: -Analytical and clinical validation reports for Clinical Laboratory Improvement Amendments (CLIA), including the test description, intended use, and indications for testing. -If applicable, all formal, written minutes and correspondences (including any Q & A and supporting documentation) with the New York State Department of Health (NYSDOH) or the United States (U.S.) Food
and Drug Administration (FDA).
-Most recent inspection results (including recommendations) or scheduled inspection(s) from CLIA, College of
American Pathologists (CAP), or NYSDOH, as applicable.
2. Second, there must be an appreciation of evidence-in-transition where new biomarkers should be brought online
in harmonization with their proven clinical validity/utility (CVU). Although analytical validity is an
equally important metric, it remains more outside of a payer's purview to conduct such detailed evaluations.
Therefore, in the absence of a standard CVU referee process (e.g., although FDA labeling of biomarkers can be
a helpful adjunct, it may not always be relevant), the key imperative is for medical necessity to be reflected by
the clear articulation of a particular biomarker niche.
3. Third, there must be a recognized decision impact of such biomarkers by the clinical community. In other
words, there must be acceptance/uptake of specific testing into patient management. It should be taken into
account that to reach the medical necessity threshold, such acceptance should be based on the strongest
evidence available, ideally from along the spectrum of high-quality masked, randomized controlled clinical
trials, and much less preferably from lower levels of evidence, which are predicated upon expert opinion only
without primary study data.
You can find this rule in the Local Coverage Determination (LCD) - Biomarkers Overview (L35062) -
Effective October 1, 2015.
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