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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 Medicare 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. 
 
a. If additional organisms are not included in a panel, testing for those organisms separately for the same 
indication may be reasonable and necessary in limited circumstances. 
b. More than 1 panel may not be performed on the same date of service for the same clinical indication, except 
for bloodstream and meningoencephalitis panels; in such circumstances, a second panel may be performed for 
non-duplicative content. 
 
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. Documentation of the following is clearly started in the medical record: 
 
a. Specific clinical indications for testing (i.e., clinical suspicion of a pathogen as the cause of the patients 
condition) 
b. Specific reasons for performing panel testing 
c. Provider type/specialty and Place of Service 
 
8. 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 (L39001). 
 
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.