The Alliance submitted comments CMS on its proposed outline of a new Transitional Coverage of Emerging Technologies (TCET) pathway for certain devices designated as “breakthrough” by the FDA. While the Alliance applauds efforts by CMS bring medically necessary and valuable products to market faster, the proposal does not go far enough, the Alliance told CMS. "This proposal contains a lengthy evidence development process without a predictable or transparent coverage pathway – which was purportedly the purpose of the TCET being issued. There is no accountability being placed on the Agency to ensure the process is speedy and timeframes for review are met." Read more.

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