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View ICR - OIRA Conclusion

OMB Control No: 0938-0328	ICR Reference No: 202410-0938-011
Status: Active	Previous ICR Reference No: 201409-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Hospital Conditions of Participation (COP) and Supporting Regulations (CMS-R-48)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/16/2024
	Date Received in OIRA: 10/16/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2027	36 Months From Approved
Responses	69,034	0	0
Time Burden (Hours)	3,566,521	0	0
Cost Burden (Dollars)	0	0	0

Authorizing Statute(s): US Code: 42 USC 1320b-8 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
   US Code: 42 USC 1395f(a)(6) Name of Law: Conditions of and Limitations on Payment for Services
   US Code: 42 USC 1395x Name of Law: Definitions of Services, Institutions, Etc.
   US Code: 42 USC 1302 Name of Law: Rules and Regulations
   US Code: 42 USC 1395aa Name of Law: Use of State agencies to determine compliance by providers of services with CoP's

Citations for New Statutory Requirements: None

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	69,034	-17,210,683	17,279,717
Annual Time Burden (Hours)	3,566,521	-10,858,134	14,424,655
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The annual burden hours to industry decreased from 14,424,655 to 3,566,521. The decrease in burden hours is primarily due to the fact that many of the information collections that were previously required as CoPs by CMS are now customary and usual industry practice and would take place in the absence of the Medicare and Medicaid programs. In addition, where possible, CMS reduced the burden of CoPs with prior information collections. For example, the burden for individuals hospitals that are part of a multi-hospital system was reduced by allowing a multi-hospital system, which represent approximately 70% of hospitals today, to develop a unified Quality Assessment and Performance Improvement (QAPI) program rather than requiring each hospital in the system to maintain separate programs and reporting requirements.

Annual Cost to Federal Government: $10,774,197

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

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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