News | August 08, 2013

CMS Draft Decision Could Limit Patient Access to Imaging for Diagnosing Dementia

The Centers for Medicare and Medicaid Services (CMS) released its proposed decision memorandum regarding the use of beta-amyloid imaging in dementia and neurodegenerative disease. [1]

Piramal Imaging is concerned about CMS' proposal, which appears to take an overly cautious approach to expanding Medicare coverage for positron emission tomography (PET) tracers to include beta-amyloid imaging agents. Limiting Medicare coverage only to patients enrolled in CMS-approved clinical trials imposes restrictions that reduce patient access to long-awaited diagnostic tools.

"We are concerned that the CMS draft coverage decision is too restrictive and, if finalized in its current form, will place an undue burden on physicians, patients and caregivers by delaying the definitive diagnosis of certain types of dementia and neurodegenerative disease, including Alzheimer's," said Ludger Dinkelborg, director of the board, Piramal Imaging SA.

In Piramal Imaging's view, the CMS decision needs to be reviewed for the following reasons:

  • The draft decision does not reference the Appropriate Use Criteria (AUC) that was developed by the Society for Nuclear Medicine and Molecular Imaging (SNMMI) and the Alzheimer's Association. The taskforce was comprised of a cross-section of experts including radiologists, nuclear medicine specialists and neurologists. [2]
  • It lacks clear guidance on clinical trial designs that should be practical and provide CMS with the requested evidence in a reasonable timeframe.
  • There is general disagreement with the relevance of autopsy as an appropriate endpoint to demonstrate clinical utility in the intended population.

The use of new beta-amyloid imaging agents should help to reduce uncertainties in the diagnosis of Alzheimer's disease and related dementias, which is of importance for patients and their caregivers. Piramal Imaging is hopeful that CMS will moderate its position when it renders its final decision by finding less restrictive ways to gather the information it seeks regarding health outcomes.

CMS is accepting public comments on its proposed decision from all stakeholder groups and is accepting public comments now through Aug. 2, 2013. Comments can be posted at: http://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-close....

"We urge anyone concerned with Alzheimer's disease — patients, caregivers, healthcare professionals, patient advocacy groups and the general public — to share opinions on the value of beta-amyloid PET imaging during the initial 30-day public comment period," said Dinkelborg. "Every letter will have an impact on CMS' final decision in September."

For more information: imaging.piramalenterprises.com

References

1 Centers for Medicare & Medicaid Services. Proposed decision memo for beta amyloid positron emission tomography in dementia and neurodegenerative disease (CAG-00431N). http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decis.... Published July 3, 2013. Accessed July 3, 2013.

2 Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: a report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association [published online ahead of print January 28, 2013]. Alzheimer's Dement. doi:10.1016/j.jalz.2013.01.002.

Related Content

Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Imaging | August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
Carestream Launches MR Brain Perfusion and Diffusion Modules for Vue PACS
Technology | Advanced Visualization | August 16, 2017
Carestream Health recently introduced new MR (magnetic resonance) Brain Perfusion and MR Brain Diffusion modules that...
Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
MRI Reveals Striking Brain Differences in People with Genetic Autism

Example images for a control participant , a deletion carrier, and a duplication carrier. In the sagittal image of the deletion carrier, the thick corpus callosum, dens and craniocervical abnormality, and cerebellar ectopia are shown. For the duplication carrier, the sagittal image shows the thin corpus callosum and the axial image shows the increased ventricle size and decreased white matter volume. Image courtesy of the Radiological Society of North America (RSNA).

News | Neuro Imaging | August 09, 2017
August 9, 2017 — In the first major study of its kind, researchers using magnetic...
brain with chronic traumatic injury
News | Magnetic Resonance Imaging (MRI) | August 02, 2017
Fighters are exposed to repeated mild traumatic brain injury (mTBI), which has been associated with neurodegenerative...
NIH-funded scientists have discovered that Parkinson’s disease increases the amount of “free” water in a particular brain area

NIH-funded scientists have discovered that Parkinson’s disease increases the amount of “free” water in a particular brain area. Image courtesy of David Vaillancourt, Ph.D., University of Florida.

News | Neuro Imaging | July 31, 2017
Scientists at the University of Florida have discovered a new method of observing the brain changes caused by Parkinson...
NeuroQuant Software Compatible With Hitachi 1.2T, 1.5T and 3.0T Hitachi MRI Scanners
Technology | Magnetic Resonance Imaging (MRI) | July 27, 2017
July 27, 2017 — CorTechs Labs recently announced that Hitachi 1.2T Oasis, 1.5T Echelon Oval and 3.0T Trillium Oval...
"Residual Echo" of Ancient Humans May Hold Clues to Mental Disorders

MRI data shows (left) areas of the skull preferentially affected by the amount of Neanderthal-derived DNA and (right) areas of the brain’s visual system in which Neanderthal gene variants influenced cortex folding (red) and gray matter volume (yellow). Image courtesy of Michael Gregory, M.D., NIMH Section on Integrative Neuroimaging

News | Neuro Imaging | July 26, 2017
Researchers from the National Institute of Mental Health (NIMH) have produced the first direct evidence that parts of...
Overlay Init