Medicare Registry Plan For Alzheimer’s Drugs Pairs CMS Web Portal With Health System Efforts
Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.
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As the FDA flies the Progressive Pride Flag in honor of Pride Month, an appropriations bill provision would limit the flags that could be flown at it and other federal agency buildings. Plus news on Medicare's amyloid PET NCD, reimbursement for new end-stage renal disease drugs, opioid disposal and what FDA can't use its user fees for in 2024.
BIO Worried CMS’ Alzheimer’s Coverage Is ‘Trial Balloon’ For Lower Accelerated Approval Reimbursement
In a Pink Sheet interview, BIO Chief Advocacy Officer Nick Shipley raised concerns that Medicare’s Alzheimer’s coverage decision is indicative of a broader agency view on accelerated approval that could limit drug reimbursement in both the public and private sector.
New details from CMS about the information that providers will be required to submit for Medicare beneficiaries taking anti-amyloid Alzheimer’s drugs indicate the agency could have a hard time getting answers to some of the key questions outlined in its National Coverage Determination.