Biden Administration officials may effectively prohibit treatment of more than 6 million American families suffering from Alzheimer’s, including those with other neurological or medical conditions such as Down Syndrome, if they finalize new restrictions on FDA-approved drugs in Medicare. In a new letter, top House Republicans urged Health and Human Services Secretary Xavier Becerra to protect these families rather than move forward with these regulations.
The letter, signed by Ways and Means Committee Republican Leader Kevin Brady (R-TX), Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Ways and Means Health Subcommittee Republican Leader Vern Buchanan (R-FL), Energy and Commerce Health Subcommittee Republican Leader Brett Guthrie (R-KY), and 74 Republicans in the House, urges the HHS Secretary “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.”
As currently written, the 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.
- “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.”
- “…[f]inalizing 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.”
- “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.”
- “[i]t 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. …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 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.