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

ICR 202201-0938-004


Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
Received in OIRA 202112-0938-015
Omnibus COVID-19 Health Care Staff Vaccination (IFC) (CMS-10801)
New collection (Request for a new OMB Control Number)   No
Emergency 01/21/2022
  Requested Previously Approved
6 Months From Approved
9,417,420 0
1,555,487 0
0 0

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)
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. , ,

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

Not associated with rulemaking


  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
Miscellaneous Actions
This is a new information collection request.

Denise King 410 786-1013 [email protected]


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.

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