
WASHINGTON — Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions to make the process more transparent and better incorporate diversity data.
The niche regulatory tool, called a Coverage with Evidence Development, has gotten outsized attention recently because it has been applied to a new class of Alzheimer’s drugs that target amyloid plaques in the brain. The tool allows some Medicare beneficiaries to access the product, but also forces drugmakers to continue to study their efficacy.
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