View Information Collection Request (ICR) Package

OMB Control No: 0938-0391	ICR Reference No: 202107-0938-004
Status: Historical Active	Previous ICR Reference No: 201912-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Statement of Deficiencies and Plan of Correction (CMS-2567)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 08/23/2021
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/25/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/13/2021
Terms of Clearance: CMS will work to expeditiously transition this into a standard collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	6 Months From Approved	05/31/2023
Responses	65,948	0	64,500
Time Burden (Hours)	1,210,376	0	139,750
Cost Burden (Dollars)	0	0	0

Abstract: This Paperwork package provides information regarding the form used by the Medicare, Medicaid, and the Clinical Laboratory Improvement Amendments (CLIA) programs to document a health care facility's compliance or noncompliance (deficiencies) with regard to the Medicare/Medicaid Conditions of Participation and Coverage, the requirements for participation for Skilled Nursing Facilities and Nursing Facilities, and for certification under CLIA. This form becomes the evidentiary basis for CMS certification decisions (including termination or denial of participation), and the form of public disclosure. In December, 2020, Congress passed the Consolidated Appropriations Act, 2021 (CAA, 2021). Section 407 of CAA, 2021, amended Part A of Title XVIII of the Social Security Act (the Act) at section 1822 establishing hospice program survey and enforcement requirements. This amendment, in part, now requires the Accrediting Organizations (AOs) that accredit hospice programs to include the form CMS-2567 to document the findings of their hospice program surveys beginning on October 1, 2021. As of June 2021, there are three AOs with CMS-approved hospice accreditation programs: Accreditation Commission for Health Care, Inc. (ACHC), Community Health Accreditation Partner (CHAP), and The Joint Commission (TJC). These three AOs survey approximately half of the over 5,000 Medicare-certified hospice programs, while the SAs survey the remaining half. To enable AOs to use the form CMS-2567, we must revise it by adding a field for the AO name. Also, the instructions must be updated to include AOs as another group which utilizes the form CMS-2567. We have also included the COI/RIA burden calculations from CMS-1747-P related to the one-time update needed to each AO’s proprietary electronic systems in order to use the form CMS-2567 as directed by the CAA, 2021.

Emergency Justfication: The Consolidated Appropriations Act of 2021 (CAA, 20211), passed on January 15, 2020, amends Title XVIII of the Social Security Act (Act), by adding nine provisions that establish survey and enforcement requirements for hospice programs. These statutory revisions became public law through Congress on December 27, 2020. The provisions of the CAA begin one year after its enactment, except for the following: (1) the requirement for use of multidisciplinary survey teams; (2) the prohibition of conflicts of interest; (3) expanding CMS-based surveyor training to accrediting organizations (AOs); and (4) the requirement for AOs to begin use of the form CMS-2567. These four (4) requirements are statutorily required to begin on October 1, 2021.2 In order for AOs that accredit hospice programs to use form CMS-2567, the form must first be revised and approved by OMB. The revisions are to include a data field in which to document the name of the AO completing the survey. This is critical information that must be included on the form CMS-2567 in order for the CMS locations and CMS central office to identify which AO performed the survey, or be able to distinguish an AO survey from a survey performed by the State Survey Agency (SA), as they also use the form CMS-2567 to document their survey findings. The use of normal PRA clearance procedures would most likely cause CMS to miss the statutorily mandated deadline of October 1, 2021 for AOs, with a hospice program, to begin using the form CMS-2567. Without emergency PRA approval, AOs will not have the revised form to include in their current survey documentation systems and processes and will not meet the deadline of October 1, 2021 for beginning use. If CMS misses the October 1, 2021 deadline, it will jeopardize another CAA, 2021 mandated provision deadline for public posting of these AO hospice program survey reports on our website. The purpose of this requirement is for public transparency of survey and certification information. This statutory provision requires that the hospice program survey reports be posted by no later than October 1, 2022. Emergency PRA approval is critical for AOs and CMS to meet our congressionally mandated responsibilities.

Authorizing Statute(s): US Code: 42 USC 488.28 Name of Law: Providers or Suppliers, other than SNFs and NFs, with deficiencies
   US Code: 42 USC 488.18 Name of Law: Documentation Findings
   US Code: 42 USC 488.26 Name of Law: Determining Compliance

Citations for New Statutory Requirements: None

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

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 36751	07/13/2021
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Statement of Deficiencies and Plan of Correction	CMS-2567	Statement of Deficiencies and Plan of Correction

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	65,948	64,500	1,448
Annual Time Burden (Hours)	1,210,376	139,750	1,070,626
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: No

Burden Reduction Due to:

Short Statement: The total number of responses has increased by 1,448. The total annual time burden has increased by 1,070,626 hours and the total annual cost burden has increased by $81,550,156. These increases are due to the reasons discussed below. First, in the previous PRA package for form CMS-2567, grossly underestimated the time and cost burden because it did not consider the burdens required to perform surveys. Second, due to the statutory changes brought on by the CAA, 2021 - AOs with hospice programs must begin use of the form CMS-2567 not later than October 1, 2021. Therefore, we have included additional users and a one-time systems update time/cost burden. It is important to note that the time and cost burden associated with hospice program AOs incorporation of the form CMS-2567 into their electronic documentation systems is a one-time burden and not annually. Finally, we have updated the wage rates used in the burden calculations to the most current wage rates produced by the U.S. Bureau of Labor Statistics. For example, the hourly wage for a Medical or Health Services Manager went from $100.22 to $110.74. This is an increase of $10.52 per hour and contributed to the increased cost burden.

Annual Cost to Federal Government: $0

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

View ICR - OIRA Conclusion