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Rep. Blake Moore urges temporary Medicare coverage for FDA-designated breakthrough devices
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Summary
Rep. Blake Moore of Utah told a House committee during markup that the Ensuring Patient Access to Critical Breakthrough Products Act would create a voluntary, streamlined pathway for temporary Medicare coverage of FDA-designated breakthrough devices while preserving safety and efficacy safeguards.
Rep. Blake Moore of Utah urged a House committee during a markup session to back the Ensuring Patient Access to Critical Breakthrough Products Act, saying the bill would create a streamlined pathway for temporary Medicare coverage of Food and Drug Administration-designated breakthrough medical devices.
“This bill is significant because it opens the door to the most cutting edge medical technology available for Medicare patients and gets them the treatments they need sooner,” Rep. Blake Moore said. He added the proposal “creates a streamlined pathway for temporary Medicare coverage of FDA designated breakthrough devices, while ensuring that safety and efficacy are not compromised.”
Moore said the measure uses a voluntary application process for manufacturers to reduce what he called “duplicative reviews at CMS that delays patient access.” He thanked Rep. Suzan DelBene of Washington for working with him on the legislation and said he looks “forward to continuing to work with her to resolve the inclusion of diagnostics in this policy, and ensuring there is no abuse of this pathway.”
Moore also cited Utah’s role in medical-device innovation and the University of Utah as an example of local partnerships that have supported device development. He named Novacor and Advomed as stakeholders that had signed on as supporters and asked that their statements be submitted for the record.
The transcript provided does not record any formal vote on the bill in the excerpt. Moore closed his remarks by urging his colleagues to support the bill and yielding back his time.
No formal committee action or vote was recorded in the provided excerpt; details such as bill number, committee name, and any amendments were not specified in the transcript.
