SPECIAL EFFORTS WILL ALSO HELP DETERMINE PET POTENTIAL FOR ALZHEIMER’S DISEASE
The Centers for Medicare and Medicaid Services (CMS) announced today that it will expand coverage of positron emission tomography (PET) to improve the care of Medicare beneficiaries with thyroid cancer and those with potential cardiac diseases. The decision expands Medicare coverage of PET scans first made in December 2000. So far, PET scans are also covered by Medicare for diagnosis, staging and restaging of various cancers, including lung, esophogeal, colorectal, lympheme, head and neck, and breast. It is also covered for myocardial viability and pre-surgery evaluation of refractory seizures.
CMS also announced today that it is designing a demonstration to evaluate the potential role of PET for patients with suspected dementia, as well as a multi-disciplinary expert meeting to fully explore the value of PET for Alzheimer’s disease.
"We want to provide the best of emerging medical technology for Medicare beneficiaries, and these initiatives will assist us in doing just that," said CMS Administrator Tom Scully.
Cardiovascular disease is a broad term encompassing several conditions, such as hypertension, coronary artery disease, congestive heart failure, and stroke. CMS has reviewed the scientific evidence for the radiopharmacological ammonia N-13 with PET, and has determined that it also is useful in this type of evaluation. Therefore, ammonia N-13 PET will be covered under the Medicare program.
Although thyroid nodules are extremely common, thyroid cancer is less common, constituting less than 1 percent of all human malignant tumors. In a small number of these patients, the usually accurate Iodine-131 whole body scan is not helpful in localizing the disease. In these patients, CMS has determined that a PET scan may be helpful. This decision was supported by an exhaustive evidentiary review of the medical literature, a technology assessment, and recommendations from the CMS Medicare Coverage Advisory Committee.
"These are diseases that cause morbidity and mortality in our population, and this announcement will better outline the current evaluative options," said Sean Tunis, MD, MSc, acting CMS chief medical officer.
At the same time, CMS decided against extending Medicare coverage at this point for soft tissue sarcoma, a type of cancer that is extremely uncommon and for which current imaging techniques have good diagnostic capabilities. CMS’s review of the evidence concluded that PET did not improve patient outcomes in this group of beneficiaries and, therefore, CMS will continue its present noncoverage policy.
Medicare presently does not cover PET for Alzheimer’s disease, and the agency affirmed this position, saying clinical benefit to patients has not been demonstrated. Medicare coverage is provided for clinical evaluation of cognitive impairment, as recommended by the American Academy of Neurology. The available scientific evidence indicates that this work-up remains the most appropriate at present for the diagnosis and management of the disease, CMS determined.
However, in an effort to further explore PET’s potential for dementia, CMS will design a demonstration to evaluate the appropriate role of PET in patients with suspected dementia. and the agency will work with HHS’ National Institutes of Health to convene a multi-disciplinary expert meeting with geriatricians, neurologists, radiologists, PET experts, and patient advocates to fully explore the value of PET for Alzheimer’s.
Alzheimer’s disease is an age-related and irreversible brain disorder that occurs gradually and results in memory loss, behavior and personality changes, and a decline in thinking abilities. Alzheimer’s disease is the most common cause of dementia in the United States. PET scans have been proposed as a diagnostic tool in the management of patients with Alzheimer’s.
"These decisions are examples of Medicare ensuring that emerging medical technologies are made available to its beneficiaries when there is supporting medical evidence, " Tunis said. "PET already is approved for a variety of other applications and CMS continues to study its potential for improving health outcomes for Medicare patients."
All decision memoranda published today by CMS on its web site, 
www.cms.hhs.gov, resulted from a review of external requests. Positive coverage determinations will become effective upon publication of written instructions to CMS contractors.
More information is available at http://www.cms.hhs.gov/ncdr/ncdr_index.asp.