GOP to HHS Secretary Becerra: CMS Proposed Medicare Coverage Would Deny Alzheimer’s Treatments to Patients Who Need Them
Washington, D.C. — Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Ways and Means Committee Republican Leader Kevin Brady (R-TX), Energy and Commerce Health Subcommittee Republican Leader Brett Guthrie (R-KY), Ways and Means Health Subcommittee Republican Leader Vern Buchanan (R-FL) and 74 Republicans in the House sent the Department of Health and Human Services Secretary Xavier Becerra a letter urging him to “to abandon and re-propose the Nation Coverage Determination (NCD) to provide for reasonable access to FDA-approved [Alzheimer’s] treatments for a broader population of Medicare beneficiaries, including Americans suffering from other neurological diseases and medical conditions such as Down Syndrome.”
In a recent Health subcommittee hearing, Leader Rodgers said: “I was shocked to find out that the CMS proposed National Coverage Determination (NCD) severely restricts Medicare coverage for a whole class of Alzheimer’s treatments, including the recently FDA-approved Aduhelm, to only cover these drugs in CMS-approved clinical trials.
“It also excludes those with Down Syndrome from participating in covered trials, even though Alzheimer’s may affect greater than 90 percent of those with Down Syndrome over the age of 60. This is wrong.”
In their letter to HHS Secretary Becerra, the lawmakers wrote:
"On January 11, 2022, the Center for Medicare and Medicaid Services (CMS) issued a proposed National Coverage Determination (NCD) decision memorandum that would set a new precedent for restricting coverage of all Food and Drug Administration (FDA)-approved drugs using monoclonal antibodies directed against amyloid for Medicare beneficiaries suffering from Alzheimer’s Disease (AD). We have significant concerns about what this decision, if finalized, could mean for the more than 6 million American families suffering from AD, including those with other neurological or medical conditions such as Down Syndrome, who may be effectively prohibited from receiving the drug under the proposed process.
"We are concerned that finalizing a decision to prohibit Medicare coverage for FDA- approved AD treatments outside of government sanctioned randomized controlled trials could unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions. Our communities are already facing an unprecedented crisis of surging deaths of despair and a fleeting sense of community as a result of the COVID-19 pandemic response from government and public health leaders. Preventing potentially millions of seniors suffering from a deadly disease from accessing an FDA-approved treatment without a reasonable policy and explanation will send mixed signals about the respective agencies’ roles and sow greater confusion."
Specifically, regarding Down syndrome, the members wrote:
"Furthermore, it is extremely concerning and unacceptable that the proposed NCD appears entirely to exclude Americans with Down Syndrome from any form of coverage through these trials for Aduhelm and any future amyloid-related treatments. As stated in the draft decision, covered patients “must not have: any neurological or other medical condition (other than Alzheimer’s disease) that may significantly contribute to cognitive decline.” This effectively excludes patients with intellectual and developmental disabilities like Down Syndrome. This is a startling exclusion of a significant population that might otherwise benefit from coverage of Aduhelm."
The letter also cites numerous patient advocacy groups and caretakers who have spoken out against the proposed NCD and warned against the inevitable consequences of reduced access to treatment for millions of seniors, in particular vulnerable populations. These groups cited include:
- The Alliance of Aging Research
- The Alzheimer’s Association
- Us Against Alzheimer’s
- The National Down Syndrome Society
CLICK HERE To read the full letter to HHS Secretary Becerra.