2025-00593Notice

Agency Information Collection Activities: Proposed Collection; Comment Request

Published Date: 1/14/2025

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 paperwork isn’t too much and is useful. If you’re affected or interested, you have until March 17, 2025, to share your comments—no money changes yet, just your chance to help shape the process!

Analyzed Economic Effects

4 provisions identified: 4 benefits, 0 costs, 0 mixed.

ICF‑IID: Must Educate and Offer COVID Vaccine

If you live in an Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF‑IID), the rule says facilities must continue to educate you about COVID‑19 vaccine risks and benefits and offer the vaccine. As of the June 5, 2023 final rule, facilities must document this educate-and-offer activity in clients' medical records, but documentation of staff educate-and-offer was removed; the COVID‑19 public health emergency ended in May 2023.

ICF‑IID Paperwork Burden Reduced

CMS is requesting reinstatement with changes for the ICF‑IID Conditions of Participation information collection. The notice estimates 5,523 respondent facilities, with total annual hours of 75,721 and annual burden costs of $5,470,418 (compared with prior estimates of 114,478 hours and $7,375,654).

Data Use Agreements for CMS PHI Requests

When researchers or other entities request CMS personally identifiable or protected health information, they must complete a research request packet and enter into a Data Use Agreement (DUA) that requires protecting and destroying the data. The notice estimates 7,805 respondents and 4,234 total annual hours for the CMS‑R‑235 DUA collection.

HIPAA Compliance Review Forms Collected

CMS will collect Administrative Simplification HIPAA Compliance Review forms from covered entities to support compliance reviews. The notice lists form CMS‑10662 with an annual estimate of 100 respondents, 140 total annual responses, and 3,040 total annual hours.

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Key Dates

Published Date
1/14/2025

Department and Agencies

Department
Independent Agency
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