Hospital Conditions of Participation (COP) and Supporting Regulations (CMS-R-48)
Reinstatement with change of a previously approved collection
No
Regular
Approved with change
11/16/2024
10/16/2024
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
11/30/2027
36 Months From Approved
69,034
0
0
3,566,521
0
0
0
0
0
This is a reinstatement of the information collection request that expired on 11/30/2017. The previous iteration of this OMB No. 0938-0328 (approved November 14, 2014) had a burden of 14,424,655 annual hours. For this requested reinstatement, with changes, the adjusted annual hourly burden for industry is 3,566,521 hours at an annual cost of $310,989,894.
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.
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
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.
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:
(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;
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.
CMS-R-48 (0938-0328) Hospitals PRA Supporting Statement A (final 11-15-24).docx
42CFR482.12(d)(1-2) and (d)(4)