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Ex-CMS Louis Jacques On Partnering With FDA And Keeping It Local

This article was originally published in The Gray Sheet

Executive Summary

In this second portion of a two-part Q&A with Louis Jacques, he talks to “The Gray Sheet” about the importance of CMS’ growing collaboration with FDA, tensions between national and local Medicare coverage policymaking and the impact of resource constraints on CMS. Jacques left his post as CMS coverage director last month.

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Report: Unmet Need Can Trump Modest Data In Quest For Reimbursement

A higher level of evidence did not correlate well with subsequent payer reimbursement, according to a comparison of the coverage success for devices approved via HDE and PMA conducted by Avalere Health for the Pew Charitable Trusts. Perceptions of unmet need tended to serve a bigger factor for coverage, the report said.

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