CBSA advocates for policies that improve patient access to life-saving, novel technologies. This August, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Transitional Coverage for Emerging Technologies (TCET) Pathway Final Notice. Although this rule is a step in the right direction, CBSA continues to urge Congress to pass the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) to more fully address seniors’ need for access to breakthrough diagnostics and treatments soon after they are approved by the Food & Drug Administration (FDA).
The New TCET Pathway
In January 2021, CMS announced the Medicare Coverage of Innovative Technology (MCIT) rule, which would have provided four years of automatic coverage for FDA-approved breakthrough-designated products. CMS repealed the MCIT rule that November, a month before it was set to go into effect. At the repeal of MCIT,…
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