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 molecular pathology procedures (Tier1 and Tier 2) may be eligible for coverage when ALL 
of the following criteria are met: 
 
    Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are 
unavailable or results are clearly equivocal; AND 
    Availability of a clinically valid test, based on published peer reviewed medical literature; AND 
    Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) 
or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) of analytical 
validity and clinical utility; AND 
    Results of the testing must directly impact treatment or management of the Medicare beneficiary; AND 
    For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a 
tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test 
that are reasonable and necessary to obtain necessary information for therapeutic decision making; AND 
    Individual has not previously received genetic testing for the disease/condition. (In general, diagnostic 
genetic testing for a disease should be performed once in a lifetime.) Exceptions include clinical scenarios 
whereby repeat testing of somatically acquired mutations (for example, pre- and post- therapy) may be required 
to inform appropriate therapeutic decision-making. 
 
 Limitations: 
 
    Any procedures required prior to cell lysis should be reported separately and utilization must be clearly 
supported based on the application and clinical utility. Such claims may be subject to prepayment medical 
review. 
    The medically necessary interpretation and report of a molecular pathology test, written by a pathologist, 
which is above and beyond the report of standard laboratory results may not be reported by Non- physician 
practitioners (e.g., PhD, scientists etc.); only physicians are eligible to report this service. 
    Testing for quality assurance component of the service is not separately billable. 
 
 A list of individual Tier 2 genetic tests are unlikely to impact therapeutic decision-making, directly impact 
treatment, outcome and/or clinical management in the care of the beneficiary and will be denied as not 
medically necessary (Please note that this list of non-covered genes is not exhaustive, and the fact that a 
specific gene is not mentioned does not mean it is covered. In addition, many genes have several names that are 
used. The most common names have been used in this policy). You can find these rules in the Local Coverage 
Determination (LCD) Molecular Pathology Procedures L35000. 
 
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.