(CMS-10578) Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers

Forms and Documents

Document	Type	Status	Availability
CMS-2025-0141-0006.html.pdf	Public Comments	Uploaded 2025-08-19	Repair queued
CMS-2025-0141-0005.html	Public Comments	Uploaded 2025-08-11	Available
CMS-2025-0141-0004.html	Public Comments	Uploaded 2025-08-07	Repair queued
CMS-2025-0141-0003.html	Public Comments	Uploaded 2025-08-05	Repair queued
CMS-2025-0141-0002.html.pdf	Public Comments	Uploaded 2025-07-16	Repair queued
Attachment A - Response to 60 Day Public Comments for CMS-10578_Final 12.9.25.docx	Supplementary Document	Uploaded 2026-02-06	Repair queued
CMS-10578 Emergency Preparedness Supporting Statement 2-6-26.docx	Supporting Statement A	Uploaded 2026-02-06	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
224134	Conditions of Partcipation: Emergency Preparedness		Modified

ICR Details

OMB Control No: 0938-1325	ICR Reference No: 202602-0938-005
Status: Received in OIRA	Previous ICR Reference No: 202001-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: (CMS-10578) Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/09/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	180,915	0
Time Burden (Hours)	1,215,158	0
Cost Burden (Dollars)	0	0

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Abstract: In response to past terrorist attacks, natural disasters, and the subsequent national need to refine the nation’s strategy to handle emergency situations, there continues to be a coordinated effort across Federal agencies to establish a foundation for development and expansion of emergency preparedness systems. This information collection captures the burden necessary to support the development and implementation of emergency preparedness requirements that will be consistent and enforceable across 17 affected Medicare and Medicaid providers and suppliers. We obtained the data used in this discussion on the number of the various Medicare and Medicaid providers and suppliers from Medicare’s Certification and Survey Provider Enhanced Reporting (CASPER) as of , 2015.June 1, 2016. We have not included data for health care facilities that are not Medicare and/or Medicaid certified. This information collection consists primarily of the review, revision, and/or development of emergency plans, policies and procedures, and training and testing materials to ensure on-going compliance with the requirements contained in the regulation, discussed above.

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Authorizing Statute(s): US Code: 42 USC 1396r Name of Law: Social Security Act
   US Code: 42 USC 1395i Name of Law: Social Security Act
   US Code: 42 USC 1395x Name of Law: Social Security Act
   US Code: 42 USC 1396d Name of Law: Social Security Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 26301	06/20/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 5480	02/06/2026
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Conditions of Partcipation: Emergency Preparedness

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	180,915	0	0	58,796	0	122,119
Annual Time Burden (Hours)	1,215,158	0	0	-45,316	0	1,260,474
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This package has been updated to reflect changes in information collection requirements related to new or revised Conditions of Participation. For this reinstatement, the total annual burden hours for industry are 1,251,158 hours and the annual burden costs are $401,106,506. See Table 13. The annual burden to industry decreased from 1,260,474 burden hours to 1,251,158 for the following reasons: • Exclusion of LTC facilities • Addition of new facility type, Rural Emergency Hospitals • Differentiation between which CoPs that are ongoing requirements vs. the one-time development at the time a facility is newly certified. • Reduction in frequency of required ongoing training of staff for IC-7 from annual to biennial for all facilities per the 2019 Final Rule. • Reduction in quantity of required testing exercises per year for facilities that provide outpatient services from 2 testing exercises to 1 per year with no change to facilities that provide inpatient services per the 2019 Final Rule.

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Annual Cost to Federal Government: $14,212,032

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/09/2026

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