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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 molecular pathology procedures have broad clinical and research applications. The following 
examples of applications may not be relevant to a Medicare beneficiary or may not meet a Medicare benefit 
category and/or reasonable and necessary threshold for coverage. Such examples include Genetic Testing and 
Genetic Counseling (when applicable) for: 
 
 Disease Risk, 
 Carrier Screening, 
 Hereditary Cancer Syndromes, 
 Gene Expression Profiling for certain cancers, 
 Prenatal Diagnostic testing, 
 Diagnosis and Monitoring Non-Cancer Indications, and 
 Several Pharmacogenomic applications. 
 
This Local Coverage Determination (LCD) addresses the circumstances under which the item or service may 
be reasonable and necessary. For laboratory services, a service may be reasonable and necessary if the service 
is safe and effective; and appropriate, including the duration and frequency that is considered appropriate for 
the item or service, in terms of whether it is furnished in accordance with accepted standards of medical 
practice for the diagnosis of the patient's condition; furnished in a setting appropriate to the patient's medical 
needs and condition; ordered and furnished by qualified personnel; one that meets, but does not exceed, the 
patient's medical need; and is at least as beneficial as an existing and available medically appropriate 
alternative. 
 
Many applications of the molecular pathology procedures are not covered services given lack of benefit 
category (e.g., preventive service or screening for a genetic abnormality in the absence of a suspicion of 
disease) and/or failure to the reasonable and necessary threshold for coverage (e.g., based on quality of clinical 
evidence and strength of recommendation or when the results would not reasonably be used in the management 
of a beneficiary). 
 
 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. 
F2 gene (prothrombin coagulation factor II) and F5 gene (coagulation factor V) The F2 and F5 genetic tests are 
not considered to be clinically efficacious; therefore, testing is not medically necessary. 
 
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.