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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 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). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based 
on the new code series) is not a statement of coverage since the service may not have been audited for 
compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary. Certain molecular pathology procedures may be subject to prepayment medical review (records 
requested) and paid claims must be supportable, if selected, for post payment audit by the MAC or other 
contractors. Molecular pathology tests for diseases or conditions that manifest severe signs or symptoms in 
newborns and in early childhood or that result in early death (e.g., Canavan disease) could be subject to 
automatic denials since these tests are not usually relevant to a Medicare beneficiary. 
 
Indications: 
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. 
 
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.