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 if medically necessary and reasonable, Medicare will cover one Fluorodeoxyglucose (FDG) 
Positron Emission Tomography (PET) scan to determine the initial level of cancer treatment needed for an 
enrollee. After the completion of the initial anti-cancer therapy, additional FDG PET scans may be covered at 
the discretion of Medicare. You can find this rule in the National Coverage Determinations Manual, Section 
220.6.17. 
 
The rules say Indications and Limitations of Coverage 
 
B. Nationally Covered Indications 
 
   1. FDG PET Requirements for Coverage in the Differential Diagnosis of AD and FTD 
 
    An FDG PET scan is considered reasonable and necessary in patients with a recent diagnosis of dementia 
and documented cognitive decline of at least 6 months, who meet diagnostic criteria for both AD and FTD. 
These patients have been evaluated for specific alternate neurodegenerative diseases or other causative factors, 
but the cause of the clinical symptoms remains uncertain. 
 
    The following additional conditions must be met before an FDG PET scan will be covered: 
 
        a. The patient?s onset, clinical presentation, or course of cognitive impairment is such that FTD is 
suspected as an alternative neurodegenerative cause of the cognitive decline. Specifically, symptoms such as 
social disinhibition, awkwardness, difficulties with language, or loss of executive function are more prominent 
early in the course of FTD than the memory loss typical of AD; 
 
b. The patient has had a comprehensive clinical evaluation (as defined by the American Academy of Neurology 
encompassing a medical history from the patient and a well-acquainted informant (including assessment of 
activities of daily living), physical and mental status examination (including formal documentation of cognitive 
decline occurring over at least 6 months) aided by cognitive scales or neuropsychological testing, laboratory 
tests, and structural imaging such as magnetic resonance imaging (MRI) or computed tomography (CT); 
 
c. The evaluation of the patient has been conducted by a physician experienced in the diagnosis and assessment 
of dementia; 
 
d. The evaluation of the patient did not clearly determine a specific neurodegenerative disease or other cause 
for the clinical symptoms, and information available through FDG PET is reasonably expected to help clarify 
the diagnosis between FTD and AD and help guide future treatment; 
 
e. The FDG PET scan is performed in a facility that has all the accreditation necessary to operate nuclear 
medicine equipment. The reading of the scan should be done by an expert in nuclear medicine, radiology, 
neurology, or psychiatry, with experience interpreting such scans in the presence of dementia; 
 
f. A brain single photon emission computed tomography (SPECT) or FDG PET scan has not been obtained for 
the same indication. (The indication can be considered to be different in patients who exhibit important changes 
in scope or severity of cognitive decline, and meet all other qualifying criteria listed above and below 
(including the judgment that the likely diagnosis remains uncertain.) The results of a prior SPECT or FDG PET 
scan must have been inconclusive or, in the case of SPECT, difficult to interpret due to immature or inadequate 
technology. In these instances, an FDG PET scan may be covered after one year has passed from the time the 
first SPECT or FDG PET scan was performed.) 
 
 
 
g. The referring and billing provider(s) have documented the appropriate evaluation of the Medicare 
beneficiary. Providers should establish the medical necessity of an FDG PET scan by ensuring that the 
following information has been collected and is maintained in the beneficiary medical record: 
 
 
        Date of onset of symptoms; 
        Diagnosis of clinical syndrome (normal aging; mild cognitive impairment (MCI); mild, moderate or 
severe dementia); 
        Mini mental status exam (MMSE) or similar test score; 
        Presumptive cause (possible, probable, uncertain AD); 
        Any neuropsychological testing performed; 
        Results of any structural imaging (MRI or CT) performed; 
        Relevant laboratory tests (B12, thyroid hormone); and, 
        Number and name of prescribed medications. 
 
The billing provider must furnish a copy of the FDG PET scan result for use by CMS and its Medicare 
Administrative Contractors upon request. These verification requirements are consistent with Federal 
requirements set forth in 42 Code of Federal Regulations, section 410.32 generally for diagnostic x-ray tests, 
diagnostic laboratory tests, and other tests. In summary, section 410.32 requires the billing physician and the 
referring physician to maintain information in the medical record of each patient to demonstrate medical 
necessity [410.32(d) (2)] and submit the information demonstrating medical necessity to CMS and/or its agents 
upon request [410.32(d)(3)(I)] (OMB number 0938-0685). 
 
2.  
 
FDG PET Requirements for Coverage in the Context of a CMS-approved Practical Clinical Trial Utilizing a 
Specific Protocol to Demonstrate the Utility of FDG PET in the Diagnosis, and Treatment of 
Neurodegenerative Dementing Diseases 
 
An FDG PET scan is considered reasonable and necessary in patients with MCI or early dementia (in clinical 
circumstances other than those specified in subparagraph 1) only in the context of an approved clinical trial that 
contains patient safeguards and protections to ensure proper administration, use and evaluation of the FDG 
PET scan. 
 
The clinical trial must compare patients who do and do not receive an FDG PET scan and have as its goal to 
monitor, evaluate, and improve clinical outcomes. In addition, it must meet the following basic criteria: 
 
    a. Written protocol on file; 
   b. Institutional Review Board review and approval; 
    c. Scientific review and approval by two or more qualified individuals who are not part of the research team; 
and, 
    d. Certification that investigators have not been disqualified. 
 
 C. Nationally Non- Covered Indications 
 
All other uses of FDG PET for patients with a presumptive diagnosis of dementia-causing neurodegenerative 
disease (e.g., possible or probable AD, clinically typical FTD, dementia of Lewy bodies, or Creutzfeld-Jacob 
disease) for which CMS has not specifically indicated coverage continue to be noncovered.  
 
You can find this information in Medicare's National Coverage Determination (NCD) for FDG PET for 
Dementia and Neurodegenerative Diseases (220.6.13). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.