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AdvaMed disagrees with administration on ‘breakthrough’ technology

AdvaMed disagrees with administration on ‘breakthrough’ technology

WASHINGTON – AdvaMed says the administration’s decision to fully repeal a final rule on Medicare Coverage of Innovative Technology is “unfortunate.” In a statement, AdvaMed President and CEO Scott Whitaker said the federal government should be providing incentives to access new breakthrough technologies. “Any Medicare patient and their doctor who has exhausted all existing medical options should have immediate access to FDA-approved breakthrough medical technologies,” he said. “Repealing MCIT is the wrong decision for countless Medicare patients, and it’s the wrong decision for American medical innovation. Our goal in this country should be to spur and not inhibit innovation that will change patient’s lives. We will continue to make this important case with the administration and Congress, and we are hopeful they will make the right decision.” CMS did say that it intends to conduct future rulemaking to expediate a coverage pathway for innovative technologies (balanced with evidence development to ensure beneficial health outcomes for beneficiaries). Under the final rule, Medicare would have provided immediate national coverage for four years for any new device or diagnostic designated as a “breakthrough” technology and deemed safe and effective by the U.S. Food and Drug Administration. During that four-year coverage period, manufacturers could continue to provide the additional data needed to maintain coverage after the four-year coverage period expired.  

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