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	2022-01-07

IC Document Collections

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

ICR Details

OMB Control No:	ICR Reference No: 202201-0938-004
Status: Received in OIRA	Previous ICR Reference No: 202112-0938-015
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: Emergency	Approval Requested By: 01/21/2022
Date Submitted to OIRA: 01/07/2022

	Requested	Previously Approved
Expiration Date	6 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)

Emergency Justfication: Because SARS-CoV-2, the virus that causes COVID-19 disease, is highly transmissible, Centers for Disease Control and Prevention (CDC) has recommended, and CMS reiterated, that health care providers and suppliers implement robust infection prevention and control practices, including source control measures, physical distancing, universal use of personal protective equipment (PPE), SARS CoV-2 testing, environmental controls, and patient isolation or quarantine. , , , Available evidence suggests these infection prevention and control practices have been highly effective when implemented correctly and consistently. , Studies have also shown, however, that consistent adherence to recommended infection prevention and control practices can prove challenging—and those lapses can place patients in jeopardy. , , , A retrospective analysis from England found up to 1 in 6 SARS-CoV-2 infections among hospitalized patients with COVID-19 in England during the first 6 months of the pandemic could be attributed to healthcare-associated transmission. In outbreaks reported from acute care settings in the U.S. following implementation of universal masking, unmasked exposures to other health care workers were frequently implicated. A retrospective cohort study of health care staff behaviors, exposures, and cases between June and December 2020 in a large health system found more employees were exposed via coworkers than patients—and secondary cases among employees typically followed unmasked interactions with infected colleagues (for example, convening in breakrooms without proper source control). The same study found that cases of health care worker infection associated with patient exposures could often be attributed to failure to adhere to PPE requirements (for example, eye protection). Past experience with influenza, and available evidence, suggest that vaccination of health care staff offers a critical layer of protection against healthcare-associated COVID-19 (HA-COVID-19). For example, evidence has shown that influenza vaccination of health care staff is associated with declines in nosocomial influenza in hospitalized patients, , , and among nursing home residents. , , , , , , As a result, CDC, the Society for Healthcare Epidemiology of America, and others recommend—and a number of states require-- annual influenza vaccination for health care staff. , ,

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments

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: 01/07/2022

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