CMS Pub. 100-03, ch. 1, § 220.6.13

Diseases (Effective September 15, 2004)

(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, Implementation: Upon Implementation of ICD-10)

A. General

Medicare covers FDG Positron Emission Tomography (PET) scans for either the differential diagnosis of

fronto-temporal dementia (FTD) and Alzheimer’s disease (AD) under specific requirements; OR, its use in a

Centers for Medicare & Medicaid Services (CMS)-approved practical clinical trial focused on the utility of

FDG PET in the diagnosis or treatment of dementing neurodegenerative diseases. Specific requirements for

each indication are clarified below:

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 1 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:

o Date of onset of symptoms;

o Diagnosis of clinical syndrome (normal aging; mild cognitive impairment (MCI); mild, moderate or

severe dementia);

o Mini mental status exam (MMSE) or similar test score;

o Presumptive cause (possible, probable, uncertain AD);

o Any neuropsychological testing performed;

o Results of any structural imaging (MRI or CT) performed;

o Relevant laboratory tests (B12, thyroid hormone); and,

o 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 MACs 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 non-covered.

D. Other

Not applicable.