The Obama Administration Is At War With Itself Over Brain Research
The Obama administration is at war with itself over brain research.
President Obama announced in April of this year that a major initiative of his second term would be supporting research to unlock the secrets of the brain.
But a short time later, his administration announced plans to significantly limit access to a state-of-the-art test that is available now to help in the diagnosis and treatment of one of the most serious and deadly disorders of the brain - Alzheimer's disease.
The administration's decision also is in direct opposition to actions called for in the National Alzheimer's Project Act - legislation that passed Congress unanimously and was signed into law by President Obama in 2011. The law calls on agencies within the Department of Health and Human Services (HHS) to encourage and make available improved means to diagnose and care for patients with Alzheimer's.
The victims of this political and policy Catch-22 could be countless Alzheimer's patients who would be denied access to a diagnostic test that could aid in their treatment and care, and millions more who could benefit from robust research in the future.
Earlier this spring, the president unveiled a $100 million initiative to unlock the "enormous mystery" of the human brain in hopes of boosting the understanding and treatment of brain disorders. The initiative, dubbed Brain Research Through Advancing Innovative Neurotechnologies, or BRAIN, "aims to help researchers find new ways to treat, cure, and even prevent brain disorders, such as Alzheimer's disease, epilepsy, and traumatic brain injury," the White House said in a news release.
But this summer, the agency in the Obama administration that is charged with administering Medicare announced a preliminary decision not to cover the use of an important new brain imaging tool that helps doctors detect early evidence of brain disorders such as Alzheimer's. The test uses a contrast agent called Amyvid in a PET scan that can detect beta-amyloid plaques, malformed proteins that are associated with this degenerative neurological disorder. The Food and Drug Administration approved Amyvid, a radiopharmaceutical, in 2012 as safe and effective.
The test can help rule out Alzheimer's and help doctors develop treatments plans based upon a clearer diagnosis. On July 3, the Centers for Medicare and Medicaid Services (CMS) issued a proposed coverage decision that would mean Medicare would only pay for the imaging scan for patients enrolled in a new clinical trial that CMS is demanding as a condition of paying for the test.
The Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging recommended that CMS approve the test for patients who meet specific criteria, including patients with persistent or progressive unexplained memory problems and individuals with progressive dementia at an atypically early age (before age 65).
Five million Americans are living with Alzheimer's today, with millions more likely to get the disease as the Baby Boom generation ages. The interests of public health demand investment in early diagnostic technologies and development of new and better treatments. Early diagnosis improves outcomes and leads to a higher quality of life for patients and their caregivers by allowing families to build care teams and seek education and support services.
But the CMS decision would likely to lead to a seven year delay in broader access to the test, based on similar decisions in the past. And it certainly will discourage other pharmaceutical and medical companies from investing hundreds of millions of dollars in research and 12 or more years of development only to find that FDA approval of their product isn't enough and that they must also face another hurdle in getting the government to approve payment for their new technologies.
CMS could amend its decision and allow Medicare payment for the brain amyloid imaging in targeted populations. But if it refuses and throws up yet another roadblock to access, it will thwart the process of discovery and development of treatments for Alzheimer's that pose a significant threat to millions of patients and to the sustainability of public health programs that that will have to pay for expensive care if better treatments or a cure are not discovered.
The CMS draft decision shows what happens when broad government promises meet fiscal realities. CMS' initial coverage decision is in direct opposition to the president's stated goals of supporting innovative neurotechnologies, and it appears to be driven by short-sighted, short-term cost considerations with significant adverse long-term consequences.
The period for public comment closes on August 2. CMS would be well advised to listen to the president's determination to boost our understanding and treatment of brain disorders by allowing Medicare coverage for beta-amyloid imaging agents for those populations most at risk of Alzheimer's.