CMS Invites Feedback on Medicare Data Collection Plans
Published Date: 12/30/2025
Notice
Summary
The Centers for Medicare & Medicaid Services (CMS) wants your thoughts on their plan to collect info from the public. This helps make sure the questions they ask are useful and not too much work. You’ve got until January 28, 2026, to share your ideas, so don’t miss out on shaping how this info is gathered!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Medicare Coverage for IDE Study Costs
Under Section 1862(m) of the Social Security Act and 42 CFR Subpart B (sections 405.201-405.215), Medicare may pay routine costs of care for Medicare beneficiaries in FDA investigational device exemption (IDE) Category A studies, but Medicare does not cover the experimental Category A device itself. Medicare may cover Category B (non-experimental) devices and associated routine costs if they are reasonable and necessary and all other Medicare coverage requirements are met.
CMS IDE Data Collection Burden
If you are a study sponsor or similar private-sector organization, CMS is extending an annual information collection using Form CMS-10511 (OMB control number 0938-1250). The collection is yearly, lists 118 respondents with 118 total annual responses, and carries a total burden of 236 hours per year; submissions can include an FDA IDE approval letter, IDE study protocol, IRB approval letter, National Clinical Trials (NCT) number, and supporting materials.
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Key Dates
Department and Agencies
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The Centers for Medicare & Medicaid Services (CMS) wants your feedback on their plan to collect some info from the public. This helps them follow rules that make sure they don’t ask for too much paperwork. If you have thoughts, send them by March 2, 2026—your input could help save time and effort for everyone!