Earlier this week, Astellas submitted to the Centers for Medicare and Medicaid Services (CMS) comments on the agency’s Medicare Part B drug payment model proposed rule. Joining many organizations across the healthcare spectrum, our comments outline a number of concerns with the proposal as written and urge the agency to withdraw the proposed rule.
Most notably, our comments point to unintended consequences of the proposed rule that, if implemented, would threaten access to needed medicines for Medicare beneficiaries and deter future innovation in areas of unmet medical need.
We also outline several ways in which the proposal is inconsistent with underlying statute and exceeds CMS’ authority. For example, we observe that the proposed rule fails to include care quality measures or outcomes metrics, contrary to statute which specifies that Center for Medicare and Medicaid Innovation (CMMI) models must maintain or improve care quality.
Please find our full comments here.