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Top Hill Staffer Says CMS Breakthrough Coverage Pulled Due to Cost

This article was originally published in The Gray Sheet

Executive Summary

A House Energy and Commerce staffer said the committee dropped a Medicare reimbursement provision for breakthrough devices from their Cures draft bill because of cost but lawmakers haven't given up on the issue yet.

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Device tax, reimbursement predictability and empowering women in the medtech industry are some of Martha Shadan's top priorities for her two-year term as board chair of AdvaMed Accel, the small-company-advocacy arm of the trade group.

Medicare Will Look To Informal Pathways For Faster Medtech Reimbursement

The US Centers for Medicare and Medicaid Services has withdrawn efforts on a proposed rule to offer faster Medicare reimbursement to novel devices, but the agency still plans to work on different approaches to provide "timely patient access" to device innovations, a spokeswoman said. AdvaMed says it is disappointed by CMS's decision to withdraw the rule after a 10-month review by the Office of Management and Budget.

Senate Poised To Vote On Cures Bill; Headed To Likely Enactment This Term

Following House passage of a combined House/Senate 21st Century Cures package Nov. 30, the Senate will take up the bill on Dec. 5 or 6, said Senate HELP Committee Chair Lamar Alexander, R-Tenn., who shepherded a similar package of medical innovation bills through the committee earlier this year. While some Democrats remain vocal in opposing the bill based on worries that it will water-down FDA safety protections and funding concerns, the House vote showed lopsided support, and the Senate is expected to pass it and the president to sign.

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