Government Asks Permission to Ask You Questions Later
Published Date: 1/17/2025
Notice
Summary
The Centers for Medicare & Medicaid Services (CMS) wants your thoughts on their plan to collect some info from the public. This is part of a routine check to make sure the questions they ask aren’t too much work and actually help them do their job better. If you have ideas or concerns, you’ve got until March 18, 2025, to speak up—no money changes, just your chance to help shape the process!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Annual CED Data-Collection Burden
CMS is reinstating the information collection for Coverage with Evidence Development (CED) under form CMS-10697 (OMB control number 0938-1387). The notice estimates 13 respondents, 13 total annual responses, and 1,300 total annual hours for this collection, with submissions expected annually.
Must Meet 17 CED Approval Criteria
Any approved CED study submission must satisfy the 17 criteria listed in the 2024 CMS Coverage with Evidence Development guidance to be acceptable for Medicare coverage with evidence development.
CMS May Publish Study Guidance/Templates
CMS may publish guidance and templates (for example, on real-world data study protocols) to assist manufacturers or other study sponsors in creating CED study protocols that satisfy CED requirements.
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