On September 9, AMCP submitted comments praising CMS’s proposal to cover Digital Mental Health Treatment devices (DMHTs) under Medicare Part B. AMCP urges CMS to use its authority to cover all FDA-cleared, prescription only digital health products and develop appropriate coding and payment methodologies to promote adoption of these innovative technologies.
AMCP Comment Letter on Biosimilar Interchangeability with a Biologic Reference Product
On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic products.
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