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June 2, 2023 (WASHINGTON, D.C.) The Partnership to Fight Chronic Disease (PFCD) released the following statement in response to the Centers for Medicare and Medicaid Services (CMS) announcement related to the current National Coverage Determination (NCD) with Coverage with Evidence Development (CED) for an entire class of Alzheimer’s disease treatments.
“Yesterday, CMS confirmed its unprecedented decision to restrict access to innovative, FDA-approved Alzheimer’s disease therapies by requiring Medicare beneficiaries to enroll in a clinical trial or clinical registry to qualify for coverage.
“This decision sets a dangerous precedent for Medicare to deny beneficiaries access to FDA-approved therapies for any number of other serious illnesses. By erecting coverage limitations for a such a prominent, fatal illness without treatment options, CMS is indicating that the agency could erect similar barriers in the future.
“CMS’s announcement highlights the continuing absence of patient registries required by the agency to allow patients’ access to new FDA-approved treatments. Whether beneficiaries will have access to approved treatments as they receive traditional FDA approval remains uncertain at best.
“A mere week before CMS hosts its first ever Health Equity Summit, it has confirmed its refusal to reconsider its decision despite evidence that it will disproportionately affect beneficiaries with higher rates of illness, including Hispanic and Black patients.
“CMS’ citation of its TAVR NCD and accompanying registry is concerning given the fact that this registry has been in place for more than a decade and documented ongoing issues with disparate access for this live-saving procedure for communities of color and rural residents.
“Every day 2,000 Alzheimer’s patients progress deeper into this irreversible disease and lose the window of opportunity to benefit from these early-stage treatments. The Alzheimer’s community, and several other patient advocates are calling on Congress and the White House to intervene and stand up for patient access to FDA-approved treatments before this becomes a precedent that will deliver an unrecoverable blow to our health care system, and budget.”
To learn more about these access issues and the long road to Alzheimer’s treatment via the patient registry process, please visit: