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GLOBAL Advocacy – Elongating Life & Improving Health

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The Issue

The Centers for Medicare and Medicaid Services (CMS) recently proposed a National Coverage Determination that would exclude people with Down syndrome from taking part in clinical trials for an Alzheimer’s drug, and possibly deny them coverage for this drug. With YOUR support, GLOBAL helped remove the discriminatory language from the CMS’ determination. This is a small but important step toward our final goal of equitable access to coverage for Alzheimer’s treatments and participation in such clinical trials.

Background Information

If the CMS’ proposed National Coverage Determination on Medicare coverage for this new Alzheimer’s drug had been implemented as written, people with Down syndrome would not be included in CMS-approved clinical trials, including trials at the National Institutes of Health (NIH). You can read more about the proposal here: CMS Proposes Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. GLOBAL opposed the exclusion of people with Down syndrome from these clinical trials and the real possibility that our community wouldn’t be eligible for Medicare coverage of these drugs. It is estimated that over 70% of people with Down syndrome over forty-years-old will be diagnosed with Alzheimer’s disease, so it is important to make our voices heard. Read More

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CMS follows a long-standing process established by Congress to determine whether a medical item or service can be covered nationally by Medicare, including when an item or service is reasonable and necessary for the diagnosis of and/or treatment of an illness or injury. CMS develops National Coverage Determinations following this process, which uses all relevant published evidence and feedback received from stakeholders with multiple opportunities for public input.

The proposed National Coverage Determination followed an evidence-based analysis CMS initiated in July 2021 to examine whether Medicare would establish a national policy for coverage of a new Alzheimer’s drug which uses monoclonal antibodies directed against amyloid in the brain which is associated with dementia. During the 2021 national coverage analysis public comment period, CMS held two national listening sessions, reviewed 131 public comments and more than 250 relevant peer-reviewed documents.

CMS proposed to review each submitted clinical trial to determine whether it met the criteria specified in the proposed National Coverage Determination. All CMS-approved clinical trials will be posted on the CMS Coverage website. CMS-approved trials, including National Institutes of Health (NIH) sponsored clinical trials, will be covered under this proposal. Medicare patients participating in these trials will be eligible to receive coverage of the drug, related services, and other routine costs, which may include PET scans if required by a clinical trial protocol. Additionally, Global Down Syndrome Foundation, President & CEO, Michelle Sie Whitten, submitted public comments to CMS opposing this discriminatory proposal and urged that it be reversed.

GLOBAL's Response to CMS Decision

The Global Down Syndrom Foundation (GLOBAL) appreciates that the Centers for Medicare and Medicaid Services (CMS) recently removed discriminatory language that explicitly excluded people with Down syndrome from coverage for Alzheimer’s treatments. However, GLOBAL remains concerned that CMS has not delivered on our two key issues: (1) ensuring inclusion in clinical trials for this new class of Alzheimer’s treatments, and (2) ensuring that people with Down syndrome will be covered by Medicare associated with these new Alzheimer’s drugs.

Thousands of people with Down syndrome and their families who provided comments on the proposed National Coverage Decision (NCD), not including those who wrote directly to CMS Administrator Chiquita Brooks-LaSure to oppose the exclusionary nature of the determination.

In addition to joining the Down Syndrome Coalition joint effort during the commentary period, GLOBAL launched a major digital awareness campaign to bring the issue to lawmakers and CMS employees. The campaign included a letter-writing initiative to CMS resulting in nearly 200 letters.

It is estimated that 70% of people with Down syndrome will experience the early onset of Alzheimer’s disease in their 40s or 50s.

On April 7, 2022, CMS announced a final Medicare national coverage determination to approve the coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease for patients in clinical trials. In the NCD, CMS removed explicit language that would potentially exclude people with Down Syndrome from coverage for Alzheimer’s treatments, instead deferring to study investigators to make decisions about exclusion criteria.

“GLOBAL is deeply appreciative for our self-advocates and families getting behind this issue and our campaign,” says Michelle Sie Whitten, President & CEO of GLOBAL. “We will need to galvanize our community again as two of our key issues of clinical trial inclusion and related Medicare coverage have not been addressed. Given the high rate of early onset of Alzheimer’s, people with Down syndrome must be provided every opportunity to access treatments.”

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