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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. 

This Medicare Contractor will cover molecular syndromic infectious disease pathogen identification panel tests 
when ALL of the following criteria are met: 

1. The patient has a clinical indication for infectious disease testing:  
a. For immunocompetent patients, the clinical indication includes a presumption of active infection 
OR infection-associated complications (which may include exacerbation of underlying disease) 
that require the identification of a causative organism for appropriate management. Atypical 
clinical presentations of disease are considered appropriate indications for special populations 
who may not present with classic symptoms of infection (i.e., the elderly). 
b. For immunocompromised patients (i.e., those with weakened immune systems including those 
with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), 
patients who are taking immunosuppressive medications (i.e., chemotherapy, biologics, 
transplant-related immunosuppressive drugs, high-dose systemic corticosteroids) and those with 
inherited diseases that affect the immune system (i.e., congenital immunoglobulin deficiencies), 
atypical clinical presentations of disease are considered appropriate indications for testing. In 
this patient population, testing may be performed ONCE as part of a pre-transplant evaluation, 
regardless of the presence of symptoms. 
c. Note: For certain panels, such as the Urogenital/Anogenital Panel, epidemiologic indication or 
potential exposure to pathogens as a result of a high-risk experience is considered a covered 
clinical indication, even in the absence of clinical symptoms.  
2. The results of testing will impact clinical management in a manner already demonstrated in the peer-
reviewed published literature to improve patient outcomes. 
3. Testing is performed according to the intended use of the test in the intended patient population for 
which the test was developed and validated. 
 a. This includes performing the test using the intended sample types along with parallel testing that 
must accompany the test (i.e., the meningoencephalitis and bloodstream pathogen tests include 
requirements for parallel testing using conventional Gram stain and culture-based detection for 
correlation of results). 
b. This also includes the provision - by the laboratory to ordering providers - of the major 
limitations of a given panel test. 
4. An evaluation for more than 1 pathogen by molecular testing is necessary for patient management 
(testing for a single pathogen is NOT reasonable and necessary for the specific infection, patient, or 
indication). The panel performed includes at least the minimum pathogens required for clinical decision 
making for its intended use that can be reasonably detected by the test. 
5. Expanded panel testing is only indicated when targeted panel testing is not appropriate (i.e., will not 
provide sufficient information for the appropriate clinical management of the patient). 
6. Services that do not have Food and Drug Administration (FDA)-cleared/approved indicated uses, as 
well as FDA-approved tests performed in ways not consistent with their intended-use labeling 
directions, will require registration with Molecular Diagnostic Services Program (MolDX) and a 
Technical Assessment (TA) to demonstrate compliance of the service with this policy. Similarly, tests 
(and CPT codes) for which there are no accompanying ICD-10 codes in the associated Billing and 
Coding Article will require registration with MolDX and a TA to demonstrate compliance of the 
service with this policy. 
7. Registered tests must demonstrate equivalent or superior test performance characteristics - analytical 
validity (AV) and clinical validity (CV) - to established standard-of-care (SOC) methods (i.e., culture, 
pathogen-specific polymerase chain reaction [PCR]) for the majority of targets included on the panel.  
a. CV of any new organisms and analytes that are not already established as SOC or that do not 
have a predicate test that is covered by this contractor must be established through a study 
published in the peer-reviewed literature for the intended use of the test in the intended 
population. 
8. Documentation of the following is clearly stated in the medical record:  
a. Specific clinical indications for testing (i.e., clinical suspicion of a pathogen as the cause of the 
patient's condition) 
b. Specific reasons for performing panel testing 
c. Provider type/specialty and Place of Service 
9. Testing must be performed according to Clinical Laboratory Improvement Amendments (CLIA) and/or 
FDA regulations. For example, CLIA-non-waived tests may only be performed in certified laboratories 
and according to CLIA regulations. CLIA-waived tests may be performed in healthcare settings that 
operate under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation. 
Panels intended for home use (including those that have been FDA approved or cleared) do NOT meet 
the coverage criteria of this policy. 

You can find this rule in the Local Coverage Determination (LCD): MolDX: Molecular Syndromic Panels for 
Infectious Disease Pathogen Identification Testing (L39044). 
 
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.