Non-Substantive change request justification

Non-Substantive Change Request to 0938-1384: Submissions of 1135 Waiver Request
Automated Process
August 31, 2021
This is a non-substantive change request to the CMS 1135 Waiver/Flexibility Request from the
‘Submission of 1135 Waiver Request Automated Process’ that was approved as OMB number
0938-1384. In a disaster or emergency, CMS must be able to apply waivers and flexibilities to
assist health care providers/suppliers in providing timely healthcare and services as well as
ensure beneficiaries have continued access to care. As a result, CMS developed a publicallyaccessible web based form to create a standardized, user-friendly submission that’s a more
efficient processing of 1135 waiver requests.
As emergencies quickly occur (e.g., Hurricane Ida), CMS would like to have flexibilities to
update the values of the “Public Health Emergency” (PHE) and “Waiver Types” fields for each
specific emergent event (e.g., hurricanes, wildfires, COVID-19, etc.). Allowing these
flexibilities will expedite the process and prevent gaps in care for beneficiaries/healthcare
providers. As a result of the million lives currently impacted by Hurricane Ida, CMS is making
this urgent request. CMS is requesting approval of the following updates effective August 31,
2021 to allow the agency to quickly provide necessary assistance to those impacted by Hurricane
Ida:
CMS 1135 Waiver/Flexibility Request web page
• Add a Public Health Emergency (PHE) on page 2, such that “2021 Hurricane Ida (LA
and MS) ” is added in the drop-down values for the “Select a Public Health Emergency”
section of the web form
• Add waiver types on page 2 (new drop-down values reflected on page 3), such that the
following waiver request types are added in the drop-down values for the “Waiver
Request Type” portion in the “Describe Your 1135 Waiver/Flexibility Request” section
of the web form:
Waive r Re quest Type
Flexibility for Medicare T elehealth Services - Eligible Practitioners
Flexibility for Medicare T elehealth Services - Audio-Only T elehealth for Certain Services
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - EMT ALA
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Verbal Orders
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Reporting Requirements
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Patient Rights [Only for hospitals that
are considered to be impacted by a widespread outbreak of COVID-19]
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Sterile Compounding
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Detailed Information Sharing for
Discharge Planning for Hospitals and CAHs
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Limiting Detailed Discharge Planning
for Hospitals
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Medical Staff
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Medical Records
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Flexibility inPatient Self Determination
Act Requirements (Advance Directives)

1

Non-Substantive Change Request to 0938-1384: Submissions of 1135 Waiver Request
Automated Process
August 31, 2021
Waive r Re quest Type
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Physical Environment
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - T elemedicine
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Physician Services
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Anesthesia Services
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Utilization Review
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Written Policies and Procedures for
Appraisal of Emergencies at Off Campus Hospital Departments [With respect to surge facilities only]
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Emergency Preparedness Policies and
Procedures
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Quality Assessment and Performance
Improvement Program
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Nursing Services
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Food and Dietetic Services
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Respiratory Care Services
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Expanded Ability for Hospitals to Offer
Long-term Care Services (“ Swing-Beds”) for Patients Who do not Require Acute Care but do Meet the Skilled
Nursing Facility (SNF) Level of Care Criteria as Set Forth at 42 CFR 409.31
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Medicare Graduate Medical Education
(GME) Affiliation Agreement
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - CAH Personnel Qualifications
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - CAH Staff Licensure
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - CAH Status and Location
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - T emporary Expansion Locations
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Responsibilities of Physicians in CAHs
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - Long T erm Care Hospitals - Site
Neutral Payment Rate Provisions
Hospitals, Psych. Hospitals, and CAHs, including Cancer Ctrs and LT CHs - CoP for COVID-19 Vaccinations
Hospitals Classified as Sole Community Hospitals (SCHs)
Hospitals Classified as Medicare-Dependent, Small Rural Hospitals (MDHs)
RHCs and FQHCs - Certain Staffing Requirements
RHCs and FQHCs - Physician Supervision of NPs in RHCs and FQHCs
RHCs and FQHCs - T emporary Expansion Locations
Flexibility for Inpatient Rehabilitation Facilities Regarding the “ 60 Percent Rule”
Inpatient Rehabilitation Facility – Intensity of T herapy Requirement (“ 3-Hour Rule”)
Supporting Care for Patients in LT CHs
Care for Patients in Extended Neoplastic Disease Care Hospitals
Care for Patients in Extended Neoplastic Disease Care Hospitals - Comprehensive Care for Joint Replacement (CJR)
Model
LT C Facilities and SNFs and/or NFs - PASARR
LT C Facilities and SNFs and/or NFs - Physical Environment
LT C Facilities and SNFs and/or NFs - Resident Groups
LT C Facilities and SNFs and/or NFs - T raining and Certification of Nurse Aides

2

Non-Substantive Change Request to 0938-1384: Submissions of 1135 Waiver Request
Automated Process
August 31, 2021
Waive r Re quest Type
LT C Facilities and SNFs and/or NFs - Physician Visits in Skilled Nursing Facilities/Nursing Facilities
LT C Facilities and SNFs and/or NFs - Resident Roommates and Grouping
LT C Facilities and SNFs and/or NFs - Resident T ransfer and Discharge
LT C Facilities and SNFs and/or NFs - Physician Services - Physician Delegation of T asks in SNFs
LT C Facilities and SNFs and/or NFs - Physician Services - Physician Visits
LT C Facilities and SNFs and/or NFs - Physician Services - Note to Facilities
LT C Facilities and SNFs and/or NFs - Quality Assurance and Performance Improvement (QAPI).
LT C Facilities and SNFs and/or NFs - In-Service T raining
LT C Facilities and SNFs and/or NFs - Detailed Information Sharing for Discharge Planning for Long-T erm Care
(LT C) Facilities
LT C Facilities and SNFs and/or NFs - Clinical Records
LT C Facilities and SNFs and/or NFs - Paid Feeding Assistants
HHAs - Initial Assessments
HHAs - Waive Onsite Visits for HHA Aide Supervision
HHAs - Allow OT s, PT s, and SLPs to Perform Initial and Comprehensive Assessment for all Patients.
HHAs - 12-hour Annual In-service T raining Requirement for Home Health Aides
HHAs - Detailed Information Sharing for Discharge Planning for Home Health Agencies
HHAs - Clinical Records
HHAs - T raining and Assessment of Aides
HHAs - Quality Assurance and Performance Improvement (QAPI)
Hospice - Waive Requirement for Hospices to Use Volunteers
Hospice - Comprehensive Assessments
Hospice - Waive Non-Core Services
Hospice - Waived Onsite Visits for Hospice Aide Supervision
Hospice - Hospice Aide Competency T esting Allow Use of Pseudo Patients
Hospice - 12 hour Annual In-service T raining Requirement for Hospice Aides
Hospice - Annual T raining
ESRD Facilities - T raining Program and Periodic Audits
ESRD Facilities - Defer Equipment Maintenance & Fire Safety Inspections
ESRD Facilities - Emergency Preparedness
ESRD Facilities - Ability to Delay Some Patient Assessments
ESRD Facilities - T ime Period for Initiation of Care Planning and Monthly Physician Visits
ESRD Facilities - Dialysis Home Visits to Assess Adaptation and Home Dialysis Machine Designation
ESRD Facilities - Home Dialysis Machine Designation – Clarification
ESRD Facilities - Special Purpose Renal Dialysis Facilities (SPRDF) Designation Expanded
ESRD Facilities - Dialysis Patient Care T echnician (PCT) Certification
ESRD Facilities - T ransferability of Physician Credentialing
ESRD Facilities - Expanding Availability of Renal Dialysis Services to ESRD Patients - Furnishing Dialysis
Services on the Main Premises

3

Non-Substantive Change Request to 0938-1384: Submissions of 1135 Waiver Request
Automated Process
August 31, 2021
Waive r Re quest Type
ESRD Facilities - Clarification for Billing Procedures
Physical Environment for Multiple Providers/Suppliers - Inspection, T esting & Maintenance (ITM) under the
Physical Environment Conditions of Participation - Specific Physical Environment Waiver Information
Specific LSC for Mulitple Providers - Waiver Information - Alcohol-based Hand-Rub (ABHR) Dispensers
Specific LSC for Mulitple Providers - Waiver Information - Fire Drills
Specific LSC for Mulitple Providers - Waiver Information - T emporary Construction
ICF/IID - Staffing Flexibilities
ICF/IID - Suspension of Community Outings
ICF/IID - Suspend Mandatory T raining Requirements
ICF/IID - Modification of Adult T raining Programs and Active T reatment
ASCs - Medical Staff
ASCs - Nursing Services
CMHCs - Quality assessment and performance improvement (QAPI)
CMHCs - Provision of Services
CMHCs- 40 Percent Rule
Ambulance Services - Medicare Ground Ambulance Data Collection System
Ambulance Services - Ambulance T reat in Place
Practitioner Locations
Modification of 60-Day Limit for Substitute Billing Arrangements (Locum T enens)
Medicare Appeals in Fee for Service (FFS), Medicare Advantage (MA) and Part D
Medicaid and CHIP (as of 3/13/2020)

CMS 1135 Inquiry web page
• Add a Public Health Emergency (PHE) on page 5, such that “2021 Hurricane Ida (LA
and MS)” is added in the drop-down values for the “Select a Public Health Emergency”
section of the web form ORGANIZATION WORKFLOW: Correct an error on page 4,
such that an
These changes have no impact on the previously stated burden associated with this collection.

4