Director, Federal Affairs
January 20, 2012
Louis Jacques, M.D.
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Director, Coverage and Analysis Group
7500 Security Boulevard
Baltimore, Maryland 21244
Re: Coverage with Evidence Development Public Solicitation
Dear Dr. Jacques:
The Alzheimer's Association appreciates the opportunity to comment on the Coverage with Evidence Development (CED) Public Solicitation. The Alzheimer’s Association is the leading voluntary health organization in Alzheimer care, support and research. Today, there are an estimated 5.4 million Americans diagnosed with Alzheimer’s disease, almost all of whom depend on the Medicare program for access to health coverage and services.
In its consideration of revising the CED process, the Alzheimer’s Association encourages the Centers for Medicare and Medicaid Services (CMS) to consider the impact of CED on the most vulnerable Medicare beneficiaries, including those with cognitive impairment, Alzheimer’s disease and other dementias.
CMS should develop procedures that improve the evidence development process when it is necessary, yet do not result in unnecessary delays to patients’ access to new technologies. Given the experience of the present CED program, we have the following recommendations which should enhance the process.
(1) The Alzheimer’s Association encourages a CED process that is transparent and engages the scientific, clinical and patient advocacy communities in its discussion regarding coverage development. Constructive, open dialogue with individuals who have knowledge and expertise in new technologies and the conditions for which they would be used will result in the best possible synthesis of opinion.
(2) The CED should clearly outline in advance the evidence to be collected and the outcomes to be measured to determine appropriate coverage. Further, well-defined information on the measures being used to evaluate the evidence and how the data will be evaluated for Medicare coverage is critical. Specifics such as how the data are collected and transmitted to CMS would also be helpful. We believe that the primary focus of the outcomes measured should be how the medical service benefits Medicare beneficiaries.
(3) Once a CED process has been approved, CMS should inform and engage all stakeholders about its existence and the requirements for participation. CMS should promote awareness of the CED with all stakeholders, including the research, provider and voluntary disease organization communities. In order for a CED to be successful, and garner the evidence desired, it is important to have a broad base of clinics and providers that are willing and available to participate in the program and that a broad population of beneficiaries have access to the subject of the CED.
We appreciate the opportunity to comment on this process. Please contact Rachel Conant at (202) 638-7121, or Rachel.Conant@alz.org if you have questions.
Senior Director, Public Policy