Appeal type: unknown
Decision: unknown

 
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 emergence of personalized laboratory medicine has been characterized by a multitude of 
testing options which may more precisely pinpoint management needs of individual patients. As a result, the 
growing compendium of biomarkers requires a more careful evaluation by both clinicians and laboratorians as 
to what testing configurations can more optimally realize the promises of personalized medicine. There is a 
plethora of burgeoning tools, including both gene-based (genomic) and protein-based (proteomic) assay 
formats, in tandem with more conventional (longstanding) flow cytometric, cytogenetic, etc. biomarkers. 
Classified somewhat differently, there are highly diverse approaches ranging from single mutation biomarkers 
to multiple biomarker platforms, the latter of which often depend upon sophisticated biomathematical 
interpretative algorithms. This policy will provide guidance on the broad range of (recently coded) biomarkers, 
and how such a wide array of testing platforms can be best accommodated by this local Medicare 
Administrative Contractor. 
 
Medicare coverage for screening of those individuals with a family history of certain disease is covered only 
for a limited number of services as listed in the Section 280  Preventative and Screening Services of the IOM 
100-02, Medicare Benefit Policy Manual, Chapter 15. 
 
Tests performed without relationship to treatment or diagnosis of a patient with no findings or history for a 
specific illness, symptom, complaint or injury unless set exclusion are so noted in Title 42 CFR, Section 
411.15(a)(1). 
 
Local Medicare coverage of such biomarkers must be predicated upon three fundamental principles: 
 
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. 
 
Second, there must be an appreciation of evidence-in-transition where new biomarkers should be brought on-
line 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. 
 
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 these rules in the Local Coverage Determination (LCD) Biomarkers Overview L35062. 
 
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.