Executive Summary

Action: The Centers for Medicare and Medicaid Services recently determined that under certain circumstances, a brain scan will be covered by Medicare when used for the diagnosis and treatment of patients that may be suffering from either Alzheimer’s Disease or Fronto- Temporal Dementia.

Impact: The use of a certain type of brain scan may be considered reasonable and necessary for patients suffering from dementia, who have displayed a cognitive decline of at least six months. A brain scan is covered under Medicare for patients who meet the diagnostic criteria for both Alzheimer’s disease and frontotemporal dementia if the scan will be useful for identifying the cause for their clinical symptoms.

Effective Date: September 15, 2004.

Summary

A brain scan known as fluoro-Dglucose Positron Emission Tomography (FDG-PET), is now available for Medicare beneficiaries with certain types of dementia. FDG-PET can also aid in the assessment and prognosis of individuals at increased risk for dementia. The recent coverage determination issued by The Centers for Medicare and Medicaid Services (.CMS.) on September 15, 2004, states that the use of FDG-PET may be reasonable and necessary for beneficiaries, diagnosed with dementia, who have suffered from a cognitive decline for at least six months and who meet the diagnostic criteria for both Alzheimer's disease (Alzheimer's) and fronto-temporal dementia (FTD).

FDG-PET

FDG-PET is a minimally invasive. diagnostic imaging procedure, which can be used to evaluate glucose metabolism in the brain. The procedure begins with an injection into the patient of fluoro-D-glucose (FDG), a radioactive substance that emits subatomic particles, known as positrons, as it decays. The test involves a visual interpretation of the scan's images, because metabolically active areas of the body .light up. on an FDG-PET scan more than less active areas. FDG-PET is used to differentiate abnormalities in metabolic functions and displays this information as differences in the brightness of various parts of the brain.

Distinguishing Alzheimer’s Disease and Fronto-Temporal Dementia

Although Medicare covers position emission tomography (PET) for diseases such as cancer, ischemic heart disease, and certain neurological disorders, until now, CMS refused to cover PET for the evaluation of elderly patients diagnosed with dementia. CMS has recently reconsidered its coverage decision and has determined that under certain circumstances, FDG-PET will be covered. As an example, FDGPET will be covered when used to distinguish between Alzheimer's and FTD, which may prove useful in patient management because of the distinct variation in the course of the respective diseases. CMS has also approved coverage of FDG-PET when used to evaluate whether a patient (suffering from dementia) should be diagnosed as having either Alzheimer's or FTD.

Alzheimer's is an age-related and irreversible brain disorder that occurs gradually and results in memory loss, behavior and personality changes, and a decline in thought processes. It is the most common dementia of old age.

FTD, on the other hand, is a less common neurodegenerative condition, which includes such symptoms as neglect of hygiene and grooming, sexually provocative or demanding behavior, and impulsiveness out of proportion to memory deficits, which in turn often appear to result from lack of concern or effort.

Although Alzheimer's and FTD are, clinically, different types of dementia, FTD is often misdiagnosed as Alzheimer's. Distinguishing FTD and Alzheimer's early in the course of disease and providing information on the likely progression of the disease, as well as appropriate counseling, may assist patients and caregivers to cope with either condition more appropriately, and may lead to more effective treatment.

Conditions for Coverage

There are a number of conditions that must first be established in order to obtain coverage for Medicare beneficiaries with a history and diagnosis of dementia. The beneficiary: (1) must meet the diagnostic criteria for both Alzheimer's and FTD and (2) must have been evaluated for specific alternate neurodegenerative diseases or causative factors.

In addition:

  • the onset, clinical presentation, or course of cognitive impairment is not typical for Alzheimer's, and FTD is the suspected cause of the cognitive decline. (For example, symptoms such as social disinhibition, awkwardness, difficulties with language, or loss of executive function are more prominent early in the course of FTD, while the memory loss is typical of Alzheimer's);
  • the patient has had a comprehensive clinical evaluation that includes a medical history from the patient and a well-acquainted informant; a physical and mental examination aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging such as magnetic resonance imaging or computed tomography;
  • the patient has been evaluated by a physician experienced in the diagnosis and assessment of dementia; i the evaluation does not identify a likely cause for the clinical symptoms, and information available through FDG-PET is expected to help clarify whether either Alzheimer .s or FTD is a likely cause;
  • the FDG-PET scan is performed in facilities that have all the accreditation necessary to operate such equipment. The reading of the scan must be by an expert in nuclear medicine, radiology, neurology, or psychiatry, with substantial experience interpreting scans;
  • a brain scan has not been obtained for the same purpose;
  • there is adequate documentation that the conditions of coverage have been met.

Finally, the billing provider must furnish, upon request, a copy of the FDG-PET scan result for use by CMS and its contractors in Medicare quality assessment and improvement activities.

Risks

CMS. decision to restrict reimbursement for FDG-PET to these situations was influenced by concerns that broader approval of reimbursement might lead to potential abuse, which could result in unnecessary exposure to radiation, and excessive costs for the public. CMS also cautioned that the potential for abuse of FDGPET could be exacerbated by the increased use of direct advertising to patients.

Clinical Trials

As a result of this new coverage determination, FDG-PET may now be used in clinical trials when the use of the scan is clinically beneficial. In fact, CMS encourages its use in clinical trials which focus on treatment or quality of life outcomes for both patients and their caregivers. CMS anticipates that the use of FDG-PET in clinical trials will be most effective and beneficial when the trials are designed to test: (1) whether patients who receive an FDG-PET scan have improved outcomes compared to patients who have not received the scan; and (2) whether patients (or their caregivers) who receive prognostic information based on an FDG-PET scan benefit in some measurable way compared to patients who do not have this information. However, specific criteria must be met before Medicare coverage will be available in the clinical trials, and are detailed in the CMS National Coverage Analysis for FDG-PET (CAG- 00088R), which can be accessed through the CMS website.

CMS has also made assurances that it will work with the National Institute on Aging, the Agency for Healthcare Research and Quality, the Alzheimer's Association, device manufacturers, and experts in Alzheimer's and imaging to develop a large practical clinical trial to address these issues.

Conclusion

Medicare now covers FDG-PET, when it is used for the diagnosis and treatment of patients with suspected dementia, if the foregoing conditions are met. Because CMS has restricted reimbursement to a narrow subset of patients, providers should verify that all the required conditions for coverage are met before billing the program.

If you would like more information regarding this decision, please contact Denise Rios Rodriguez or Jeff Bates in our Los Angeles office, Fred Entin in our Chicago office, Maria Gonzalez Knavel in our Milwaukee office, Diane Racicot in our San Diego office, Mike Scarano in our San Diego/Del Mar office, Judith Waltz in our San Francisco office, Lena Robins in our Washington, DC office, or the member of the firm who normally handles your legal matters.

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