ADVAMED supports a bipartisan Senate bill to support Medicare coverage of FDA-reviewed Breakthrough products.
The Senate bill, from Sen. Todd Young (R IN) and Sen. Alex Padilla (D CA), parallels HR 1691, which passed the House Ways and Means committee in June 2024.
In a nutshell, the bill would restore the short-lived "MCIT" policy at the end of the "Trump I" administration, which was replaced by a much weaker "TCET" policy during the Biden administration.
Read more about the ADVAMED position here:
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June 2024 press release on House bill HR 1691, from ADVAMED.
The committee bill passed by 36 yeas, 5 nays.
The bill contains a clause that CMS is not blocked from affecting coverage if the device is shown to have no benefit (or to have harms) to Medicare beneficiaries. There is a special category called "specified breakthrough device" [SBTD] which is one with no prior benefit category. SBTD's get special reports-to-congress. The June 2024 House passage refers to amendments, but the Congress.gov home page doesn't list any.
