Omnibus COVID-19 Health Care Staff Vaccination (IFC) (CMS-10801)

Forms and Documents

Document Name	Status
CMS-10801 Supporting Statement 12-23-21.docx Supporting Statement A	2021-12-23

IC Document Collections

IC ID	Document Title	Status
250944	ESRD facilities documentation	New
250943	ESRD facilities Policies and procedures	New
250942	RHCs and FQHCs documentation	New
250941	RHCs and FQHCs policies and procedures	New
250940	HIT documentation	New
250938	HIT suppliers Policies and procedures	New
250937	CMHCs documentation	New
250936	CMHC Policies and procedures	New
250935	Organizations documentation	New
250934	Organizations policies and procedures	New
250933	CAHs Policies and procedures	New
250932	CORFs documentation	New
250931	CORF Policies and procedures	New
250930	HHA documentation	New
250929	HHA Policies and procedures	New
250928	ICFDs/IIDs documentation	New
250927	iCFs/IIDs Policies and procedures	New
250926	LTC Policies and Procedures	New
250925	Hospital Documentation	New
250924	Hospitals Policies and procedures	New
250923	PACE documentation	New
250922	PACE Policies and procedures	New
250921	PRTF documentation	New
250920	PRTFs Policies and procedures	New
250919	Hospice documentation	New
250912	Hospices - Policies and procedures	New
250911	ASC documentation	New
250910	ASC Policies and procedures	New

ICR Details

OMB Control No:	ICR Reference No: 202112-0938-015
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Omnibus COVID-19 Health Care Staff Vaccination (IFC) (CMS-10801)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/27/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	9,417,420	0
Time Burden (Hours)	1,555,487	0
Cost Burden (Dollars)	0	0

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Abstract: The purpose of this package is to request the Office of Management and Budget (OMB) approval of the information collection requirements (ICRs) for the requirements for mandatory staff COVID-19 vaccinations for the 15 providers and suppliers covered in CMS-3415-IFC, Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination (IFC). All 15 of those providers and suppliers are required to meet these requirements in order to participate in the Medicare and Medicaid Programs. Those providers and suppliers are listed below with the Code of Federal Regulations (CFR) section that sets forth the new requirements: ● Ambulatory Surgical Centers (ASCs) (§ 416.51) ● Hospices (§ 418.60) ● Psychiatric residential treatment facilities (PRTFs) (§ 441.151) ● Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74) ● Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42) ● Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80) ● Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430) ● Home Health Agencies (HHAs) (§ 484.70) ● Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70) ● Critical Access Hospitals (CAHs) (§ 485.640) ● Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725) ● Community Mental Health Centers (CMHCs) (§ 485.904) ● Home Infusion Therapy (HIT) suppliers (§ 486.525) ● Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8) ● End-Stage Renal Disease (ESRD) Facilities (§ 494.30)

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Authorizing Statute(s): US Code: 42 USC 1302 Name of Law: Social Security Act
   US Code: 42 USC 1395 Name of Law: Social Security Act
   US Code: 42 USC 1396 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:
0938-AU75	Final or interim final rulemaking	86 FR 61555	11/05/2021

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 61555	11/05/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 61555	11/05/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 28

IC Title	Form No.	Form Name
ASC Policies and procedures
ASC documentation
CAHs Policies and procedures
CMHC Policies and procedures
CMHCs documentation
CORF Policies and procedures
CORFs documentation
ESRD facilities Policies and procedures
ESRD facilities documentation
HHA Policies and procedures
HHA documentation
HIT documentation
HIT suppliers Policies and procedures
Hospice documentation
Hospices - Policies and procedures
Hospital Documentation
Hospitals Policies and procedures
ICFDs/IIDs documentation
LTC Policies and Procedures
Organizations documentation
Organizations policies and procedures
PACE Policies and procedures
PACE documentation
PRTF documentation
PRTFs Policies and procedures
RHCs and FQHCs documentation
RHCs and FQHCs policies and procedures
iCFs/IIDs Policies and procedures

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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	9,417,420	0	0	9,417,420	0	0
Annual Time Burden (Hours)	1,555,487	0	0	1,555,487	0	0
Annual Cost Burden (Dollars)	0	0	0	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: This is a new information collection request.

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Annual Cost to Federal Government: $11,400,000

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? Yes

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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: 12/27/2021

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