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 CFR 422.101.The rules say that CPT 81291 (mthfr gene) is not covered. You can find this rule in Local Coverage Determination (LCD): Biomarkers Overview (L35062) -Effective January 1, 2019.The rules say that 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 US Food and Drug Administration.-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 this rule in Local Coverage Determination (LCD): Biomarkers Overview (L35062) -Effective January 1, 2019.The rules say that Medicare considers genetic testing medically necessary to establish a molecular diagnosis of an inheritable disease when all of the following criteria are met:-The beneficiary must display clinical features of an associated disease, but noting that coverage of molecular testing for carrier status or family studies is considered screening and is statutorily excluded from coverage; and-The result of the test will directly impact the treatment being delivered to the beneficiary; and-A definitive diagnosis remains uncertain after history, physical examination, pedigree analysis, genetic counseling, and completion of conventional diagnostic studies.
You can find this rule in Local Coverage Determination (LCD): Biomarkers Overview (L35062) -Effective January 1, 2019.The rules say that Medicare generally considersvitamin assay panels (more than one vitamin assay) a screening procedure and therefore, non-covered. Similarly, assays for micronutrient testing for nutritional deficiencies that include multiple tests for vitamins, minerals, antioxidants and various metabolic functions are never necessary. Medicare reimburses for covered clinical laboratory studies that are reasonable and necessary for the diagnosis or treatment of an illness. Many vitamin deficiency problems can be determined from a comprehensive historyand physical examination. Any diagnostic evaluation should be targeted at the specific vitamin deficiency suspected and not a general screen. Most vitamin deficiencies are nutritional in origin and may be corrected with supplemented vitamins. ost vitamin deficiencies are suggested by specific clinical findings. The presence of those specific clinical findings may prompt laboratory testing for evidence of a deficiency of that specific vitamin. Certain other clinical states may also lead to vitamin deficiencies (malabsorption syndromes, etc.). You can find this rule in Local Coverage Determination (LCD): Assays for Vitamins and Metabolic Function (L34914) -Effective October 1, 2018.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