COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers — CMS (updated October 13, 2022)
Summary
CMS guidance titled COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, updated October 13, 2022. It says CMS is empowered to take steps through section 1135 waivers and, where applicable, section 1812(f) of the Social Security Act, and that the blanket waivers are in effect with a retroactive effective date of March 1, 2020, through the end of the emergency declaration. Waivers described include telehealth practitioner eligibility and audio-only telehealth services, each ending 151 days after the conclusion of the PHE, and an Emergency Medical Treatment & Labor Act (EMTALA) waiver of section 1867(a) allowing hospitals to screen patients offsite. The document ends with a section on CMS Oversight.
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“COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers — CMS (updated October 13, 2022).”
Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/cms-covid-19-emergency-declaration-blanket-waivers-flexibilities-for-health-care-providers-pdf-www-cms-gov-e35/
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COVID-19 Emergency Declaration Blanket Waivers for
Health Care Providers
The Administration is taking aggressive actions and exercising regulatory flexibilities to help
healthcare providers contain the spread of 2019 Novel Coronavirus Disease (COVID-19). CMS is
empowered to take proactive steps through 1135 waivers as well as, where applicable, authority
granted under section 1812(f) of the Social Security Act (the Act) and rapidly expand the
Administration’s aggressive efforts against COVID-19. As a result, the following blanket waivers
are in effect, with a retroactive effective date of March 1, 2020, through the end of the
emergency declaration. For general information about waivers, see Attachment A to this
document. These waivers DO NOT require a request to be sent to the 1135waiver@cms.hhs.gov
mailbox or that notification be made to any of CMS’ regional offices.
Unless otherwise noted, these waivers will terminate at the end of the COVID-19 public health
emergency (PHE).
Flexibility for Medicare Telehealth Services
• Eligible Practitioners. Pursuant to authority granted under the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act) that broadens the waiver authority under section 1135 of
the Social Security Act, the Secretary has authorized additional telehealth waivers. CMS is
waiving the requirements of section 1834(m)(4)(E) of the Act and 42 CFR § 410.78 (b)(2),
which specify the types of practitioners that may bill for their services when furnished as
Medicare telehealth services from the distant site. The waiver of these requirements expands
the types of health care professionals who can furnish distant site telehealth services to
include all those who are eligible to bill Medicare for their professional services. This allows
health care professionals who were previously ineligible to furnish and bill for Medicare
telehealth services, including physical therapists, occupational therapists, speech language
pathologists, and others, to receive payment for Medicare telehealth services. This waiver will
end 151 days after the conclusion of the PHE.
• Audio-Only Telehealth for Certain Services. Pursuant to authority granted under the CARES
Act, CMS is waiving the requirements of section 1834(m)(1) of the Act and 42 CFR §
410.78(a)(3) for use of interactive telecommunications systems to furnish telehealth services,
to the extent they require use of video technology, for certain services. This waiver allows the
use of audio-only equipment to furnish services described by the codes for audio-only
telephone evaluation and management services, and behavioral health counseling and
educational services (see designated codes https://www.cms.gov/Medicare/Medicare-
General-Information/Telehealth/Telehealth-Codes). Unless provided otherwise, other services
included on the Medicare telehealth services list must be furnished using, at a minimum,
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audio and video equipment permitting two-way, real-time interactive communication
between the patient and distant site physician or practitioner. This waiver will end 151 days
after the conclusion of the PHE.
Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs), including Cancer
Centers and Long-Term Care Hospitals (LTCHs)
• Emergency Medical Treatment & Labor Act (EMTALA). CMS is waiving the enforcement of
section 1867(a) of the Act. This will allow hospitals, psychiatric hospitals, and critical access
hospitals (CAujHs) to screen patients at a location offsite from the hospital’s campus to prevent
the spread of COVID-19, as long as it is consistent with a state’s emergency preparedness or
pandemic plan.
• Verbal Orders. CMS is waiving the requirements of 42 CFR §482.23, §482.24 and
§485.635(d)(3) to provide additional flexibility related to verbal orders where read-back
verification is required but authentication may occur later than 48 hours. This will allow more
efficient treatment of patients in surge situations. Specifically, the following requirements are
waived:
o §482.23(c)(3)(i) — If verbal orders are used for the use of drugs and biologicals (except
immunizations), they are to be used infrequently.
o §482.24(c)(2) — All orders, including verbal orders, must be dated, timed, and
authenticated promptly by the ordering practitioner or by another practitioner who is
responsible for the care of the patient.
o §482.24(c)(3) — Hospitals may use pre-printed and electronic standing orders, order
sets, and protocols for patient orders. This would include all subparts at §482.24(c)(3).
o §485.635(d)(3) — Although the regulation requires that medication administration be
based on a written, signed order, this does not preclude the CAH from using verbal
orders. A practitioner responsible for the care of the patient must authenticate the
order in writing as soon as possible after the fact.
• Reporting Requirements. CMS is waiving the requirements at 42 CFR §482.13(g) (1)(i)-(ii),
which require that hospitals report patients in an intensive care unit whose death is caused by
their disease, but who required soft wrist restraints to prevent pulling tubes/IVs, no later than
the close of business on the next business day. Due to current hospital surge, CMS is waiving
this requirement to ensure that hospitals are focusing on increased patient care demands and
increased patient census, provided any death where the restraint may have contributed is still
reported within standard time limits (i.e., close of business on the next business day following
knowledge of the patient’s death).
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• Patient Rights. CMS is waiving requirements under 42 CFR §482.13 only for hospitals that are
considered to be impacted by a widespread outbreak of COVID-19. Hospitals that are located
in a state that has widespread confirmed cases (i.e., 51 or more confirmed cases*), as updated
on the CDC website at, CDC States Reporting Cases of COVID-19, would not be required to
meet the following requirements:
o §482.13(d)(2) — With respect to timeframes in providing a copy of a medical record.
o §482.13(h) — Related to patient visitation, including the requirement to have written
policies and procedures on visitation of patients who are in COVID-19 isolation and
quarantine processes.
o §482.13(e)(1)(ii) — Regarding seclusion.
*The waiver flexibility is based on the number of confirmed cases as reported by CDC and will
be assessed accordingly when COVID-19 confirmed cases decrease.
• Sterile Compounding. CMS is waiving requirements (also outlined in USP797) at 42 CFR
§482.25(b)(1) and §485.635(a)(3) in order to allow used face masks to be removed and
retained in the compounding area to be re-donned and reused during the same work shift in
the compounding area only. This will conserve scarce face mask supplies. CMS will not review
the use and storage of face masks under these requirements.
• Detailed Information Sharing for Discharge Planning for Hospitals and CAHs. CMS is waiving
the requirement 42 CFR §482.43(a)(8), §482.61(e), and §485.642(a)(8) to provide detailed
information regarding discharge planning, described below:
o The hospital, psychiatric hospital, and CAH must assist patients, their families, or the
patient’s representative in selecting a post-acute care provider by using and sharing
data that includes, but is not limited to, home health agency (HHA), skilled nursing
facility (SNF), inpatient rehabilitation facility (IRF), and long-term care hospital (LTCH)
quality measures and resource use measures. The hospital must ensure that the post-
acute care data on quality measures and resource use measures is relevant and
applicable to the patient’s goals of care and treatment preferences.
o CMS is maintaining the discharge planning requirements that ensure a patient is
discharged to an appropriate setting with the necessary medical information and goals
of care as described in 42 CFR §482.43(a)(1)-(7) and (b).
• Limiting Detailed Discharge Planning for Hospitals. During the PHE, CMS is waiving all the
requirements and subparts at 42 CFR §482.43(c) related to post-acute care services so as to
expedite the safe discharge and movement of patients among care settings and to be
responsive to fluid situations in various areas of the country. CMS is maintaining the discharge
planning requirements that ensure a patient is discharged to an appropriate setting with the
necessary medical information and goals of care as described in 42 CFR §482.43(a)(1)-(7) and
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(b). CMS is waiving the more detailed requirement that, for patients discharged home and
referred for HHA services, transferred to a SNF for post-hospital extended care services, or
transferred to an IRF or LTCH for specialized hospital services, hospitals must:
o §482.43(c)(1): Include in the discharge plan a list of HHAs, SNFs, IRFs, or LTCHs that are
available to the patient.
o §482.43(c)(2): Inform the patient or the patient’s representative of their freedom to
choose among participating Medicare providers and suppliers of post-discharge
services.
o §482.43(c)(3): Identify in the discharge plan any HHA or SNF to which the patient is
referred in which the hospital has a disclosable financial interest, as specified by the
Secretary, and any HHA or SNF that has a disclosable financial interest in a hospital
under Medicare.
• Medical Staff. CMS is waiving requirements under 42 CFR §482.22(a)(1)-(4) to allow for
physicians whose privileges will expire to continue practicing at the hospital and for new
physicians to be able to practice before full medical staff/governing body review and approval
to address workforce concerns related to COVID-19. CMS is waiving §482.22(a) (1)-(4)
regarding details of the credentialing and privileging process. (Please also refer to Practitioner
Locations Blanket Waiver listed below.)
• Medical Records. CMS is waiving requirements under 42 CFR §482.24(a) through (c), which
cover the subjects of the organization and staffing of the medical records department,
requirements for the form and content of the medical record, and record retention
requirements, and these flexibilities may be implemented as long as they are consistent with a
state’s emergency preparedness or pandemic plan. CMS is waiving §482.24(c)(4)(viii) related to
medical records to allow flexibility in completion of medical records within 30 days following
discharge from a hospital. This flexibility will allow clinicians to focus on the patient care at the
bedside during the pandemic.
• Flexibility in Patient Self Determination Act Requirements (Advance Directives). CMS is
waiving the requirements at sections 1902(a)(58) and 1902(w)(1)(A) of the Act (for Medicaid);
1852(i) of the Act (for Medicare Advantage); and 1866(f) of the Act and 42 CFR §489.102 (for
Medicare), which require hospitals and CAHs to provide information about their advance
directive policies to patients. CMS is waiving this requirement to allow staff to more efficiently
deliver care to a larger number of patients.
• Physical Environment. CMS is waiving certain physical environment requirements under the
Medicare conditions of participation at 42 CFR §482.41 and 42 CFR §485.623 to allow for
increased flexibilities for surge capacity and patient quarantine at hospitals, psychiatric
hospitals, and critical access hospitals (CAHs) as a result of COVID-19. CMS will permit facility
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and non-facility space that is not normally used for patient care to be utilized for patient care
or quarantine, provided the location is approved by the state (ensuring that safety and comfort
for patients and staff are sufficiently addressed) and is consistent with the state’s emergency
preparedness or pandemic plan. This allows for increased capacity and promotes appropriate
cohorting of COVID-19 patients. States are still subject to obligations under the integration
mandate of the Americans with Disabilities Act, to avoid subjecting persons with disabilities to
unjustified institutionalization or segregation1.
• Telemedicine. CMS is waiving the provisions related to telemedicine at 42 CFR §482.12(a) (8)–
(9) for hospitals and §485.616(c) for CAHs, making it easier for telemedicine services to be
furnished to the hospital’s patients through an agreement with an off-site hospital. This allows
for increased access to necessary care for hospital and CAH patients, including access to
specialty care. CMS will end this waiver at the conclusion of the PHE.
• Physician Services. CMS is waiving requirements under 42 CFR §482.12(c)(1)–(2) and
§482.12(c)(4), which requires that Medicare patients be under the care of a physician. This
waiver may be implemented as long as it is consistent with a state’s emergency preparedness
or pandemic plan. This allows hospitals to use other practitioners to the fullest extent possible.
• Anesthesia Services. CMS is waiving requirements under 42 CFR §482.52(a)(5), §485.639(c) (2),
and §416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision
of a physician in paragraphs §482.52(a)(5) and §485.639(c)(2). CRNA supervision will be at the
discretion of the hospital and state law. This waiver applies to hospitals, CAHs, and Ambulatory
Surgical Centers (ASCs). These waivers will allow CRNAs to function to the fullest extent of their
licensure, and may be implemented as long as they are consistent with a state’s emergency
preparedness or pandemic plan.
• Utilization Review. CMS is waiving certain requirements under 42 CFR §482.1(a)(3) and 42 CFR
§482.30, which address the statutory basis for hospitals and includes the requirement that
hospitals participating in Medicare and Medicaid must have a utilization review plan that
meets specified requirements.
o CMS is waiving the entire utilization review condition of participation: Utilization
Review (UR), at §482.30, requires that a hospital must have a UR plan with a UR
committee that provides for a review of services furnished to Medicare and Medicaid
beneficiaries to evaluate the medical necessity of the admission, duration of stay, and
services provided. These flexibilities may be implemented as long as they are
1Please note that consistent with the integration mandate of Title II of the ADA and the Olmstead vs LC decision, states are
obligated to offer/ provide discharge planning and/or case management/ transition services, as appropriate, to individuals who are
removed from their Medicaid home and community based services under these authorities during the course of the public health
emergency as well as to individuals with disabilities who may require these services in order to avoid unjustified institutionalization
or segregation. Transition services/ case management and/or discharge planning would be provided to facilitate these individuals
in their return to the community when their condition and public health circumstances permit.
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consistent with a state’s emergency preparedness or pandemic plan. Removing these
administrative requirements will allow hospitals to focus more resources on providing
direct patient care.
• Written Policies and Procedures for Appraisal of Emergencies at Off Campus Hospital
Departments. CMS is waiving 42 CFR §482.12(f)(3), emergency services, with respect to surge
facilities only, such that written policies and procedures for staff to use when evaluating
emergencies are not required for surge facilities. This removes the burden on facilities to
develop and establish additional policies and procedures at their surge facilities or surge sites
related to the assessment, initial treatment, and referral of patients. These flexibilities may be
implemented as long as they are consistent with a state’s emergency preparedness or
pandemic plan.
• Emergency Preparedness Policies and Procedures. CMS is waiving 42 CFR §482.15(b) and
§485.625(b), which requires the hospital and CAH to develop and implement emergency
preparedness policies and procedures, and §482.15(c)(1)–(5) and §485.625(c)(1)–(5), which
requires that the emergency preparedness communication plans for hospitals and CAHs to
contain specified elements with respect to the surge site. The requirement under the
communication plan requires hospitals and CAHs to have specific contact information for staff,
entities providing services under arrangement, patients’ physicians, other hospitals and CAHs,
and volunteers. This would not be an expectation for the surge site. This waiver applies to both
hospitals and CAHs, and removes the burden on facilities to establish these policies and
procedures for their surge facilities or surge sites.
• Quality Assessment and Performance Improvement Program. CMS is waiving 42 CFR
§482.21(a)–(d) and (f), and §485.641(a), (b), and (d), which provide details on the scope of the
program, the incorporation and setting of priorities for the program’s performance
improvement activities and integrated Quality Assurance & Performance Improvement (QAPI)
programs (for hospitals that are part of a hospital system). These flexibilities, which apply to
both hospitals and CAHs, may be implemented as long as they are consistent with a state’s
emergency preparedness or pandemic plan. We expect any improvements to the plan to focus
on the Public Health Emergency (PHE). While this waiver decreases burden associated with the
development of a hospital or CAH QAPI program, the requirement that hospitals and CAHs
maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance
improvement program will remain. This waiver applies to both hospitals and CAHs.
• Nursing Services. CMS is waiving the requirements at 42 CFR §482.23(b)(4), which requires the
nursing staff to develop and keep current a nursing care plan for each patient, and
§482.23(b)(7), which requires the hospital to have policies and procedures in place establishing
which outpatient departments are not required to have a registered nurse present. These
waivers allow nurses increased time to meet the clinical care needs of each patient and allow
for the provision of nursing care to an increased number of patients. In addition, we expect
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that hospitals will need relief for the provision of inpatient services and, as a result, the
requirement to establish nursing-related policies and procedures for outpatient departments is
likely of lower priority. These flexibilities apply to both hospitals and CAHs §485.635(d)(4), and
may be implemented as long as they are consistent with a state’s emergency preparedness or
pandemic plan.
• Food and Dietetic Services. CMS is waiving the requirement at paragraph 42 CFR §482.28(b)
(3), which requires providers to have a current therapeutic diet manual approved by the
dietitian and medical staff readily available to all medical, nursing, and food service personnel.
Such manuals would not need to be maintained at surge capacity sites. These flexibilities may
be implemented as long as they are consistent with a state’s emergency preparedness or
pandemic plan. Removing these administrative requirements will allow hospitals to focus more
resources on providing direct patient care.
• Respiratory Care Services. CMS is waiving the requirements at 42 CFR §482.57(b)(1) that
require hospitals to designate in writing the personnel qualified to perform specific respiratory
care procedures and the amount of supervision required for personnel to carry out specific
procedures. These flexibilities may be implemented as long as they are consistent with a state’s
emergency preparedness or pandemic plan. Not being required to designate these
professionals in writing will allow qualified professionals to operate to the fullest extent of
their licensure and training in providing patient care.
• 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. Under section 1135(b)(1) of the Act, CMS is waiving the
requirements at 42 CFR 482.58, special requirements for hospital providers of long-term care
services (swing beds), subsections (a)(1)-(4) “Eligibility,” to allow hospitals to establish SNF
swing beds payable under the SNF prospective payment system (PPS) to provide additional
options for hospitals with patients who no longer require acute care but are unable to find
placement in a SNF.
In order to qualify for this waiver, hospitals must:
o Not use SNF swing beds for acute level care.
o Comply with all other hospital conditions of participation and those SNF provisions set
out at 42 CFR 482.58(b) to the extent not waived.
o Be consistent with the state’s emergency preparedness or pandemic plan.
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Hospitals must call the CMS Medicare Administrative Contractor (MAC) enrollment hotline to
add swing-bed services. The hospital must attest to CMS that:
o They have made a good faith effort to exhaust all other options.
o There are no skilled nursing facilities within the hospital’s catchment area that under
normal circumstances would have accepted SNF transfers, but are currently not willing
to accept or able to take patients because of the COVID-19 public health emergency
(PHE).
o The hospital meets all waiver eligibility requirements.
o They have a plan to discharge patients as soon as practicable, when a SNF bed becomes
available or when the PHE ends, whichever is earlier.
This waiver applies to all Medicare enrolled hospitals, except psychiatric and long-term care
hospitals that need to provide post-hospital SNF level swing-bed services for non-acute
care patients in hospitals, as long as the waiver is consistent with the state’s emergency
preparedness or pandemic plan. The hospital shall not bill for SNF PPS payment using swing
beds when patients require acute level care or continued acute care at any time while this
waiver is in effect. This waiver is permissible for swing-bed admissions during the COVID-19
PHE with an understanding that the hospital must have a plan to discharge swing-bed
patients as soon as practicable, when a SNF bed becomes available, or when the PHE ends,
whichever is earlier.
• Medicare Graduate Medical Education (GME) Affiliation Agreement: Due to the COVID-19
Public Health Emergency (PHE), under the authority of section 1135(b)(5) of the Social Security
Act (the Act), extended the submission deadline for both new Medicare GME affiliation
agreements and amendments to existing Medicare GME affiliation agreements to January 1,
2022. CMS previously waived the July 1 submission deadline under 42 CFR 413.79(f)(1) for new
Medicare GME affiliation agreements and the June 30 deadline under the May 12, 1998, Health
Care Financing Administration Final Rule (63 FR 26318, 26339, 26341) for amendments of
existing Medicare GME affiliation agreements. That is, during the COVID-19 PHE, instead of
requiring that new Medicare GME affiliation agreements be submitted to CMS and the MACs
by July 1, 2020 (for the academic year starting July 1, 2020), and that amendments to Medicare
GME affiliation agreements be submitted to CMS and the MACs by June 30, 2020 (for the
academic year ending June 30, 2020), CMS allowed hospitals to submit new and/or amended
Medicare GME affiliation agreements as applicable to CMS and the MACs by January 1, 2021.
This waiver is no longer applicable.
• CAH Personnel Qualifications. CMS is waiving the minimum personnel qualifications for clinical
nurse specialists at paragraph 42 CFR §485.604(a)(2), nurse practitioners, at paragraph
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§485.604(b)(1)–(3), and physician assistants at paragraph §485.604(c)(1)–(3). Removing these
federal personnel requirements will allow CAHs to employ individuals in these roles who meet
state licensure requirements and provide maximum staffing flexibility. These flexibilities should
be implemented as long as they are consistent with a state’s emergency preparedness or
pandemic plan.
• CAH Staff Licensure. CMS is deferring to staff licensure, certification, or registration to state
law by waiving 42 CFR §485.608(d) regarding the requirement that staff of the CAH be licensed,
certified, or registered in accordance with applicable federal, state, and local laws and
regulations. This waiver will provide maximum flexibility for CAHs to use all available clinicians.
These flexibilities may be implemented as long as they are consistent with a state’s emergency
preparedness or pandemic plan.
• CAH Status and Location. CMS is waiving the requirement at 42 CFR §485.610(b) that the CAH
be located in a rural area or an area being treated as being rural, allowing the CAH flexibility in
the establishment of surge site locations. CMS is also waiving the requirement at §485.610(e)
regarding the CAH’s off-campus and co-location requirements, allowing the CAH flexibility in
establishing temporary off-site locations. In an effort to facilitate the establishment of CAHs
without walls, these waivers will suspend restrictions on CAHs regarding their rural location
and their location relative to other hospitals and CAHs. These flexibilities may be implemented
as long as they are consistent with a state’s emergency preparedness or pandemic plan.
• CAH Length of Stay. CMS is waiving the requirements that CAHs limit the number of beds to 25
and that the length of stay be limited to 96 hours under the Medicare conditions of
participation for number of beds and length of stay at 42 CFR §485.620.
• Temporary Expansion Locations: For the duration of the PHE related to COVID-19, CMS is
waiving certain requirements, under the Medicare conditions of participation at 42 CFR
§482.41 and §485.623 (as noted elsewhere in this waiver document) and the provider-based
department requirements at §413.65, to allow hospitals to establish and operate as part of the
hospital any location meeting those conditions of participation, for hospitals that continue to
apply during the PHE. This waiver also allows hospitals to change the status of their current
provider-based department locations to the extent necessary to address the needs of hospital
patients as part of the state or local pandemic plan. This extends to any entity operating as a
hospital (whether a current hospital establishing a new location or an Ambulatory Surgical
Center (ASC) enrolling as a hospital during the PHE, pursuant to a streamlined enrollment and
survey and certification process), as long as the relevant location meets the conditions of
participation and other requirements not waived by CMS. This waiver will enable hospitals to
meet the needs of Medicare beneficiaries.
• Responsibilities of Physicians in Critical Access Hospitals (CAHs). 42 CFR § 485.631(b)(2). CMS
is waiving the requirement for CAHs that a doctor of medicine or osteopathy be physically
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present to provide medical direction, consultation, and supervision for the services provided in
the CAH at § 485.631(b)(2). CMS is retaining the regulatory language in the second part of the
requirement at § 485.631(b)(2) that a physician be available “through direct radio or telephone
communication, or electronic communication for consultation, assistance with medical
emergencies, or patient referral.” Retaining this longstanding CMS policy, and related
longstanding subregulatory guidance that further described communication between CAHs and
physicians, will assure an appropriate level of physician direction and supervision for the
services provided by the CAH. This will allow the physician to perform responsibilities remotely,
as appropriate. This also allows CAHs to use nurse practitioners and physician assistants to the
fullest extent possible, while ensuring necessary consultation and support as needed.
• Postponement of Application Deadline to the Medicare Geographic Classification Review
Board (New since 7/29 Release). Per requirements at section 1886(d)(10)(C)(ii), of the Social
Security Act (the Act), and 42 CFR 412.256(a)(2), September 1, 2020 is the deadline to submit
an application to the Medicare Geographic Classification Review Board (MGCRB) for FY 2022
reclassifications. These provisions require applications to be filed through OH CDMS
(https://www.cms.gov/Regulations-and-Guidance/Review-Boards/MGCRB/Electronic-Filing)
not later than the first day of the 13-month period preceding the federal fiscal year for which
reclassification is requested.
Due to the COVID-19 Public Health Emergency (PHE), under the authority of section 1135(b)(5)
of the Act, CMS postponed the September 1 deadline until 15 days after the public display date
of the FY 2021 IPPS/LTCH final rule by the Office of the Federal Register. CMS did not modify
the September 1, 2021 deadline for submission of applications for FY 2023 reclassifications to
the MGCRB due to the COVID-19 PHE. Similarly, the deadline for submission of applications for
FY 2024 reclassifications to the MGCRB is expected to be September 1, 2022, consistent with
the existing requirements.
• Long-Term Care Hospitals — Site Neutral Payment Rate Provisions. Also as required by
section 3711(b) of the CARES Act, during the Public Health Emergency (PHE) due to COVID-19,
the Secretary has waived section 1886(m)(6) of the Social Security Act relating to certain site
neutral payment rate provisions for long-term care hospitals (LTCHs).
o Section 3711(b)(1) of the CARES Act waives the payment adjustment under section
1886(m)(6)(C)(ii) of the Act for LTCHs that do not have a discharge payment percentage
(DPP) for the period that is at least 50% during the COVID-19 public health emergency
period. Under this provision, for the purposes of calculating an LTCH’s DPP, all
admissions during the COVID-19 public health emergency period will be counted in the
numerator of the calculation, that is, LTCH cases that were admitted during the COVID-
19 public health emergency period will be counted as discharges paid the LTCH PPS
standard federal payment rate.
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o Section 3711(b)(2) of the CARES Act provides a waiver of the application of the site
neutral payment rate under section 1886(m)(6)(A)(i) of the Act for those LTCH
admissions that are in response to the public health emergency and occur during the
COVID-19 public health emergency (PHE) period. Under this provision, all LTCH cases
admitted during the COVID-19 public health emergency period (that is, admissions
occurring on or after January 27, 2020 through the duration of the COVID-19 PHE)
were paid the relatively higher LTCH PPS standard federal rate. When the PHE ends, all
LTCH admissions, except those that meet the requirements for exclusion from the site
neutral rate, are subject to the site neutral payment rate under section
1886(m)(6)(A)(i) of the Act.
• Conditions of Participation (CoP) for COVID-19 Vaccinations. (New since 12/1/20 Release).
Under the authority afforded by Section 1135 of the Social Security Act, for the duration of the
Public Health Emergency, CMS is modifying the following regulation:
§ 482.23 Condition of participation: Nursing services.
(c) Standard: Preparation and administration of drugs.
(3) With the exception of influenza and pneumococcal vaccines, which may be
administered per physician-approved hospital policy after an assessment of
contraindications, orders for drugs and biologicals must be documented and signed by
a practitioner who is authorized to write orders in accordance with state law and
hospital policy, and who is responsible for the care of the patient.
To allow for hospital and community administration of COVID-19 vaccines, the following
highlighted language is being incorporated into this regulation for the duration of the PHE:
§ 482.23 Condition of participation: Nursing services.
(c) Standard: Preparation and administration of drugs.
(3) With the exception of influenza, pneumococcal, and COVID-19 vaccines (either
currently approved by the FDA or authorized under an FDA Emergency Use
Authorization), which may be administered per physician-approved hospital policy
after an assessment of contraindications, orders for drugs and biologicals must be
documented and signed by a practitioner who is authorized to write orders in
accordance with state law and hospital policy, and who is responsible for the care of
the patient.
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Hospitals Classified as Sole Community Hospitals (SCHs)
• CMS is waiving certain eligibility requirements at 42 CFR § 412.92(a) for hospitals classified as
SCHs prior to the PHE. Specifically, CMS is waiving the distance requirements at paragraphs
(a), (a)(1), (a)(2), and (a)(3) of 42 CFR § 412.92, and is also waiving the “market share” and bed
requirements (as applicable) at 42 CFR § 412.92(a)(1)(i) and (ii). CMS is waiving these
requirements for the duration of the PHE to allow these hospitals to meet the needs of the
communities they serve during the PHE, such as to provide for increased capacity and
promote appropriate cohorting of COVID-19 patients. MACs will resume their standard
practice for evaluation of all eligibility requirements after the conclusion of the PHE period.
Hospitals Classified as Medicare-Dependent, Small Rural Hospitals (MDHs)
(updated 10/7/21)
• Hospitals Classified as Medicare-Dependent, Small Rural Hospitals (MDHs): During the PHE,
for hospitals classified as MDHs prior to the beginning of the emergency period, and hospitals
that became newly classified as MDHs during the PHE without the application of this wavier,
CMS has been waiving the eligibility requirement at 42 CFR § 412.108(a)(1)(ii) that the hospital
has 100 or fewer beds during the cost reporting period, and the eligibility requirement at 42
CFR § 412.108(a)(1)(iv)(C) that at least 60 percent of the hospital's inpatient days or discharges
were attributable to individuals entitled to Medicare Part A benefits during the specified
hospital cost reporting periods. CMS has been waiving these requirements for the duration of
the PHE to allow these hospitals to meet the needs of the communities they serve during the
PHE, such as to provide for increased capacity and promote appropriate cohorting of COVID-
19 patients. When the PHE ends, MACs will resume their standard practice for evaluation of all
eligibility requirements.
Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
• Certain staffing requirements: CMS has been waiving the requirement in the second sentence
of 42 CFR §491.8(a)(6) that a nurse practitioner, physician assistant, or certified nurse-midwife
be available to furnish patient care services at least 50% of the time the RHC and FQHC
operates. CMS is not waiving the first sentence of §491.8(a)(6), which requires a physician,
nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, or clinical
psychologist to be available to furnish patient care services at all times the clinic or center
operates. This will assist in addressing potential staffing shortages by increasing flexibility
regarding staffing mixes during the PHE. CMS is exploring options to make this flexibility
permanent.
• Physician Supervision of NPs in RHCs and FQHCs. 42 CFR 491.8(b)(1). We are modifying the
requirement that physicians must provide medical direction for the clinic’s or center’s health
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care activities and consultation for, and medical supervision of, the health care staff, only with
respect to medical supervision of nurse practitioners, and only to the extent permitted by state
law. The physician, either in person or through telehealth and other remote communications,
continues to be responsible for providing medical direction for the clinic or center’s health care
activities and consultation for the health care staff, and medical supervision of the remaining
health care staff. This allows RHCs and FQHCs to use nurse practitioners to the fullest extent
possible and allows physicians to direct their time to more critical tasks. This flexibility is
currently set to return to pre-PHE rules at the end of the calendar year that the PHE ends.
CMS is exploring options to make this flexibility permanent.
• Temporary Expansion Locations. CMS is waiving the requirements at 42 CFR §491.5(a)(3)(iii),
which require RHCs and FQHCs to be independently considered for Medicare approval if
services are furnished in more than one permanent location. Due to the current PHE, CMS is
temporarily waiving this requirement, removing the location restrictions to allow flexibility for
existing RHCs/FQHCs to expand service locations to meet the needs of Medicare beneficiaries.
This flexibility includes areas that may be outside of the location requirements 42 CFR
§491.5(a)(1) and (2), but will end when the HHS Secretary determines there is no longer a PHE
due to COVID-19.
Housing Acute Care Patients in the IRF or Inpatient Psychiatric Facility (IPF) Excluded
Distinct Part Units
• CMS is waiving requirements to allow acute care hospitals to house acute care inpatients in
excluded distinct part units, such as excluded distinct part unit IRFs or IPFs, where the distinct
part unit’s beds are appropriate for acute care inpatients. The Inpatient Prospective Payment
System (IPPS) hospital should bill for the care and annotate the patient’s medical record to
indicate the patient is an acute care inpatient being housed in the excluded unit because of
capacity issues related to the disaster or emergency.
Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital
• CMS is allowing acute care hospitals, with excluded distinct part inpatient psychiatric units, to
relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and
unit, as a result of a disaster or emergency. The hospital should continue to bill for inpatient
psychiatric services for these patients, under the Inpatient Psychiatric Facility Prospective
Payment System, and annotate the medical record to indicate the patient is a psychiatric
inpatient being cared for in an acute care bed, because of capacity or other exigent
circumstances related to the COVID-19 emergency. This waiver may be utilized where the
hospital’s acute care beds are appropriate for psychiatric patients and the staff and
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environment are conducive to safe care. For psychiatric patients, this includes assessment of the
acute care bed and unit location to ensure those patients at risk of harm to self and others are
safely cared for.
Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a
Hospital
• CMS is allowing acute care hospitals with excluded distinct part inpatient rehabilitation units
that, as a result of a disaster or emergency, need to relocate inpatients from the excluded
distinct part rehabilitation unit to an acute care bed and unit as a result of this PHE. The
hospital should continue to bill for inpatient rehabilitation services for these patients, under
the inpatient rehabilitation facility prospective payment system, and annotate the medical
record to indicate the patient is a rehabilitation inpatient being cared for in an acute care bed,
because of capacity or other exigent circumstances related to the disaster or emergency. This
waiver may be utilized where the hospital’s acute care beds are appropriate for providing care
to rehabilitation patients, and such patients continue to receive intensive rehabilitation
services. When the PHE ends, inpatients receiving rehabilitation services, paid under the IRF
PPS and furnished by the excluded distinct part rehabilitation unit of an acute care hospital,
cannot be housed in an acute care bed and unit.
Flexibility for Inpatient Rehabilitation Facilities Regarding the “60% Rule”
• CMS is allowing IRFs to exclude patients from the freestanding hospital’s or excluded distinct
part unit’s inpatient population for purposes of calculating the applicable thresholds associated
with the requirements to receive payment as an IRF (commonly referred to as the “60% rule”)
if an IRF admits a patient solely to respond to the emergency and the patient’s medical record
properly identifies the patient as such. In addition, during the applicable waiver time period,
we would also apply the exception to facilities not yet classified as IRFs, but that are attempting
to obtain classification as an IRF. When the PHE ends, all inpatients will again be included in the
freestanding hospital’s or excluded distinct part unit’s inpatient population for purposes of
calculating the applicable thresholds associated with the requirements to receive payment as
an IRF (commonly referred to as the “60% rule”).
Inpatient Rehabilitation Facility – Intensity of Therapy Requirement (“3-Hour Rule”)
• As required by section 3711(a) of the Coronavirus Aid, Relief, and Economic Security (CARES)
Act, during the COVID-19 public health emergency, the Secretary has waived 42 CFR
§ 412.622(a)(3)(ii), which provides that payment generally requires that patients of an
inpatient rehabilitation facility receive at least 15 hours of therapy per week. This waiver
clarifies information provided in “Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency” (CMS-1744-IFC). (85 Federal
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Register 19252, 19287, April 6, 2020). The information in that rulemaking (CMS-1744-IFC)
about Inpatient Rehabilitation Facilities was contemplated prior to the passage of the CARES
Act.
Extension for Inpatient Prospective Payment System (IPPS) Wage Index Occupational
Mix Survey Submission
• CMS collects data every three years on the occupational mix of employees for each short-term,
acute care hospital participating in the Medicare program. Completed 2019 Occupational Mix
Surveys, Hospital Reporting Form CMS-10079, for the Wage Index Beginning FY 2022, were
initially due to the Medicare Administrative Contractors (MACs) on the Excel hospital reporting
form available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/Wage-Index-Files.html by July 1, 2020. CMS granted an extension for
hospitals nationwide affected by COVID-19 until August 3, 2020. Due to continued COVID
related concerns from hospitals about meeting this deadline, CMS is further extending this
deadline to September 3, 2020. Hospitals must submit their occupational mix surveys along
with complete supporting documentation to their MACs by no later than September 3, 2020.
Hospitals may then submit revisions to their occupational mix surveys to their MACs, if needed,
by no later than September 10, 2020. The next collection of the wage index occupational mix
survey data (based on 2022 data) is expected to be collected in Summer 2023.
Supporting Care for Patients in Long-Term Care Acute Hospitals (LTCHs)
• CMS determined it was appropriate to issue a blanket waiver to long-term care hospitals
(LTCHs) where an LTCH admits or discharges patients in order to meet the demands of the
emergency from the 25-day average length of stay requirement at § 412.23(e)(2), which allows
these hospitals to participate in the LTCH PPS. In addition, during the applicable waiver time
period, CMS determined it is appropriate to issue a blanket waiver to hospitals not yet classified as
LTCHs, but seeking classification as an LTCH, to exclude patient stays where the hospital admits or
discharges patients in order to meet the demands of the emergency from the 25-day average length
of stay requirement, which must be met in order for these hospitals to be eligible to participate in
the LTCH PPS. Hospitals should add the “DR” condition code to applicable claims.
Care for Patients in Extended Neoplastic Disease Care Hospitals
• CMS is allowing extended neoplastic disease care hospitals to exclude inpatient stays where the
hospital admits or discharges patients in order to meet the demands of the emergency from
the greater than 20-day average length of stay requirement, which allows these facilities to be
excluded from the hospital inpatient prospective payment system and paid an adjusted
payment for Medicare inpatient operating and capital-related costs under the reasonable cost-
based reimbursement rules as authorized under Section 1886(d)(1)(B)(vi) of the Act and §42
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CFR 412.22(i). At the end of the PHE, Extended Neoplastic Disease Care Hospitals must comply
with the 20-day average length of stay requirement at § 412.23(i)(1).
Comprehensive Care for Joint Replacement (CJR) Model: Due to the COVID-19 public health
emergency, the appeals timeline for the Comprehensive Care for Joint Replacement (CJR) model
Performance Year (PY) three final and PY four initial reconciliation reports was modified for
participant hospitals. Specifically, CMS modified participant hospital deadlines set forth at 42 CFR
§510.310(a)(1)-(2), for (a) all participant hospitals that owe repayment to CMS for PY three final
reconciliation and PY four initial reconciliation; and (b) upon request, any participant hospital that
is eligible for a reconciliation payment for PY three final reconciliation and PY four initial
reconciliation. The regulations provide that unless the participant hospital provides written notice
of a calculation error, CMS deems the CJR reconciliation report to be final 45 calendar days after it
is issued and that CMS responds to the notice of calculation error if it is received within 45
calendar days of the issuance of the reconciliation report.
We are modifying the participant hospital deadlines to permit the participant hospital 120
calendar days after the reconciliation report is issued to appeal a determination that such hospital
owes repayment to CMS, or upon request, to appeal a determination that such hospital is eligible
for a reconciliation payment. If a notice of calculation error is received by CMS within the 120-day
period, then consistent with the existing regulation, CMS responds in writing within 30 calendar
days to either confirm that there was an error in the calculation or verify that the calculation is
correct, although CMS reserves the right to an extension upon written notice to the participant
hospital.
Hospitals receiving a reconciliation payment that do not request a 120-day appeal period have 45
days to provide a notice of calculation error. Unless the participant hospital provides written
notice of the calculation error, CMS deems the CJR reconciliation report to be final 45 calendar
days after it is issued, and proceeds with the payment. This waiver was no longer applicable after
10/7/2020.
Long-Term Care Facilities and Skilled Nursing Facilities (SNFs) and/or Nursing Facilities
(NFs)
• 3-Day Prior Hospitalization. Using the authority under Section 1812(f) of the Act, CMS is
waiving the requirement for a 3-day prior hospitalization for coverage of a SNF stay, which
provides temporary emergency coverage of SNF services without a qualifying hospital stay, for
those people who experience dislocations, or are otherwise affected by COVID-19. In addition,
for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF
coverage without first having to start a new benefit period (this waiver will apply only for those
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beneficiaries who have been delayed or prevented by the emergency itself from commencing
or completing the process of ending their current benefit period and renewing their SNF
benefits that would have occurred under normal circumstances).
• Reporting Minimum Data Set. CMS is waiving 42 CFR 483.20 to provide relief to SNFs on the
timeframe requirements for Minimum Data Set assessments and transmission. (Terminated
effective 5/10/21 per QSO-21-17-NH)
• Staffing Data Submission. CMS is waiving 42 CFR 483.70(q) to provide relief to long-term care
facilities on the requirements for submitting staffing data through the Payroll-Based Journal
system. (Terminated effective 6/25/2020)
• Waive Pre-Admission Screening and Annual Resident Review (PASARR). CMS is waiving 42 CFR
483.20(k), allowing nursing homes to admit new residents who have not received Level one or
Level two Preadmission Screening. Level one assessments may be performed post-admission. On
or before the 30th day of admission, new patients admitted to nursing homes with a mental illness
(MI) or intellectual disability (ID) should be referred promptly by the nursing home to state
PASARR program for Level two Resident Review.
• Physical Environment. CMS is waiving requirements related at 42 CFR 483.90, specifically the
following: (Terminated on 6-6-2022 per QSO-22-15-NH & NLTC & LSC)
o Provided that the state has approved the location as one that sufficiently addresses
safety and comfort for patients and staff, CMS is waiving requirements under § 483.90
to allow for a non-SNF building to be temporarily certified and available for use by a
SNF in the event there are needs for isolation processes for COVID-19 positive residents,
which may not be feasible in the existing SNF structure to ensure care and services
during treatment for COVID-19 are available while protecting other vulnerable adults.
o CMS believes this will also provide another measure that will free up inpatient care
beds at hospitals for the most acute patients while providing beds for those still in
need of care. CMS will waive certain conditions of participation and certification
requirements for opening a NF if the state determines there is a need to quickly stand
up a temporary COVID-19 isolation and treatment location.
o CMS is also waiving requirements under 42 CFR 483.90 to temporarily allow for rooms
in a long-term care facility not normally used as a resident’s room, to be used to
accommodate beds and residents for resident care in emergencies and situations
needed to help with surge capacity. Rooms that may be used for this purpose include
activity rooms, meeting/conference rooms, dining rooms, or other rooms, as long as
residents can be kept safe, comfortable, and other applicable requirements for
participation are met. This can be done so long as it is not inconsistent with a state’s
emergency preparedness or pandemic plan, or as directed by the local or state health
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department.
• Resident Groups. CMS is waiving the requirements at 42 CFR 483.10(f)(5), which ensure
residents can participate in-person in resident groups. This waiver would only permit the
facility to restrict in-person meetings during the national emergency given the
recommendations of social distancing and limiting gatherings of more than ten people.
Refraining from in-person gatherings will help prevent the spread of COVID-19. (Terminated on
5-7-2022 per QSO-22-15-NH & NLTC & LSC)
• Training and Certification of Nurse Aides. CMS is waiving the requirements at 42 CFR 483.35(d)
(with the exception of 42 CFR 483.35(d)(1)(i)), which require that a SNF and NF may not employ
anyone for longer than four months unless they met the training and certification
requirements under § 483.35(d). CMS is waiving these requirements to assist in potential
staffing shortages seen with the COVID-19 pandemic. To ensure the health and safety of
nursing home residents, CMS is not waiving 42 CFR § 483.35(d)(1)(i), which requires facilities to
not use any individual working as a nurse aide for more than four months, on a full-time basis,
unless that individual is competent to provide nursing and nursing related services. We further
note that we are not waiving § 483.35(c), which requires facilities to ensure that nurse aides
are able to demonstrate competency in skills and techniques necessary to care for residents’
needs, as identified through resident assessments, and described in the plan of care.
(Terminated on 06-06-2022 per QSO-22-15-NH&NLTC&LSC; Nurse aides hired under the
current waiver (on or before June 6, 2022) have until October 6, 2022 to complete a NATCEP).
• Physician Visits in Skilled Nursing Facilities/Nursing Facilities. CMS is waiving the requirement
in 42 CFR 483.30 for physicians and non-physician practitioners to perform in- person visits for
nursing home residents and allow visits to be conducted, as appropriate, via telehealth options.
(Terminated on 5-7-2022 per QSO-22-15-NH & NLTC & LSC)
• Resident Roommates and Grouping. CMS is waiving the requirements in 42 CFR 483.10(e) (5),
(6) (Terminated on 05/10/2021 per QSO-21-17), and (7) solely for the purposes of grouping or
cohorting residents with respiratory illness symptoms and/or residents with a confirmed
diagnosis of COVID-19, and separating them from residents who are asymptomatic or tested
negative for COVID-19. This action waives a facility’s requirements, under 42 CFR 483.10, to
provide for a resident to share a room with his or her roommate of choice in certain
circumstances, to provide notice and rationale for changing a resident’s room, and to provide
for a resident’s refusal a transfer to another room in the facility. This aligns with CDC guidance
to preferably place residents in locations designed to care for COVID-19 residents, to prevent
the transmission of COVID-19 to other residents.
• Resident Transfer and Discharge. CMS is waiving requirements in 42 CFR 483.10(c)(5);
483.15(c)(3), (c)(4)(ii) (Terminated on 05/10/2021 per QSO-21-17), (c)(5)(i) and (iv), (c)(9), and
(d); and § 483.21(a)(1)(i), (a)(2)(i), and (b) (2)(i) (Terminated on 05/10/2021 per QSO-21-17)
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(with some exceptions) to allow a long-term care (LTC) facility to transfer or discharge residents
to another LTC facility solely for the following cohorting purposes:
1. Transferring residents with symptoms of a respiratory infection or confirmed diagnosis
of COVID-19 to another facility that agrees to accept each specific resident, and is
dedicated to the care of such residents;
2. Transferring residents without symptoms of a respiratory infection or confirmed to not
have COVID-19 to another facility that agrees to accept each specific resident, and is
dedicated to the care of such residents to prevent them from acquiring COVID-19; or
3. Transferring residents without symptoms of a respiratory infection to another facility
that agrees to accept each specific resident to observe for any signs or symptoms of a
respiratory infection over 14 days.
Exceptions:
• These requirements are only waived in cases where the transferring facility receives
confirmation that the receiving facility agrees to accept the resident to be transferred
or discharged. Confirmation may be in writing or verbal. If verbal, the transferring
facility needs to document the date, time, and person that the receiving facility
communicated agreement.
• In § 483.10, we are only waiving the requirement, under § 483.10(c)(5), that a facility
provide advance notification of options relating to the transfer or discharge to another
facility. Otherwise, all requirements related to § 483.10 are not waived. Similarly, in §
483.15, we are only waiving the requirement, under § 483.15(c)(3), (c)(4)(ii)
(Terminated on 05/10/2021 per QSO-21-17), (c)(5)(i) and (iv), and (d), for the written
notice of transfer or discharge to be provided before the transfer or discharge. This
notice must be provided as soon as practicable.
• In § 483.21, we are only waiving the timeframes for certain care planning requirements
for residents who are transferred or discharged for the purposes explained in 1–3
above. Receiving facilities should complete the required care plans as soon as
practicable, and we expect receiving facilities to review and use the care plans for
residents from the transferring facility, and adjust as necessary to protect the health
and safety of the residents the apply to. (Terminated on 05/10/2021 per QSO-21-17)
• These requirements are also waived when the transferring residents to another facility,
such as a COVID-19 isolation and treatment location, with the provision of services
“under arrangements,” as long as it is consistent with a state’s emergency
preparedness or pandemic plan, or as directed by the local or state health department.
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In these cases, the transferring LTC facility need not issue a formal discharge, as it is still
considered the provider and should bill Medicare normally for each day of care. The
transferring LTC facility is then responsible for reimbursing the other provider that
accepted its resident(s) during the emergency period.
o If the LTC facility does not intend to provide services under arrangement, the
COVID-19 isolation and treatment facility is the responsible entity for Medicare
billing purposes. The LTC facility should follow the procedures described in
40.3.4 of the Medicare Claims Processing Manual
(https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/clm104c06.pdf) to submit a
discharge bill to Medicare. The COVID-19 isolation and treatment facility should
then bill Medicare appropriately for the type of care it is providing for the
beneficiary. If the COVID-19 isolation and treatment facility is not yet an
enrolled provider, the facility should enroll through the provider enrollment
hotline for the Medicare Administrative Contractor that services their
geographic area to establish temporary Medicare billing privileges.
We remind LTC facilities that they are responsible for ensuring that any transfers (either within a
facility, or to another facility) are conducted in a safe and orderly manner, and that each
resident’s health and safety is protected.
We also remind states that under 42 CFR 488.426(a)(1), in an emergency, the state has the
authority to transfer Medicaid and Medicare residents to another facility.
• Physician Services. CMS is providing relief to long-term care facilities related to provision of
physician services through the following actions:
o Physician Delegation of Tasks in SNFs. 42 CFR 483.30(e)(4). CMS is waiving the
requirement in § 483.30(e)(4) that prevents a physician from delegating a task when
the regulations specify that the physician must perform it personally. This waiver gives
physicians the ability to delegate any tasks to a physician assistant, nurse practitioner,
or clinical nurse specialist who meets the applicable definition in 42 CFR 491.2 or, in
the case of a clinical nurse specialist, is licensed as such by the State and is acting
within the scope of practice laws as defined by State law. We are temporarily
modifying this regulation to specify that any task delegated under this waiver must
continue to be under the supervision of the physician. This waiver does not include the
provision of § 483.30(e)(4) that prohibits a physician from delegating a task when the
delegation is prohibited under State law or by the facility’s own policy. (Terminated on
5-7-2022 per QSO-22-15-NH & NLTC & LSC)
o Physician Visits. 42 CFR 483.30(c)(3). CMS is waiving the requirement at § 483.30(c)(3)
that all required physician visits (not already exempted in § 483.30(c)(4) and (f)) must
be made by the physician personally. We are modifying this provision to permit
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physicians to delegate any required physician visit to a nurse practitioner (NPs),
physician assistant, or clinical nurse specialist who is not an employee of the facility,
who is working in collaboration with a physician, and who is licensed by the State and
performing within the state’s scope of practice laws. (Terminated on 5-7-2022 per
QSO-22-15-NH & NLTC & LSC)
o Note to Facilities. These actions will assist in potential staffing shortages, maximize the
use of medical personnel, and protect the health and safety of residents during the
PHE. We note that we are not waiving the requirements for the frequency of required
physician visits at § 483.30(c)(1). As set out above, we have only modified the
requirement to allow for the requirement to be met by an NP, physician assistant, or
clinical nurse specialist, and via telehealth or other remote communication options, as
appropriate. In addition, we note that we are not waiving our requirements for
physician supervision in § 483.30(a)(1), and the requirement at § 483.30(d)(3) for the
facility to provide or arrange for the provision of physician services 24 hours a day, in
case of an emergency. It is important that the physician be available for consultation
regarding a resident’s care. (Terminated on 5-7-2022 per QSO-22-15-NH & NLTC &
LSC)
• Quality Assurance and Performance Improvement (QAPI). CMS is modifying certain
requirements in 42 CFR §483.75, which require long-term care facilities to develop,
implement, evaluate, and maintain an effective, comprehensive, data-driven QAPI
program. Specifically, CMS is modifying §483.75(b)–(d) and (e)(3) to the extent necessary
to narrow the scope of the QAPI program to focus on adverse events and infection control.
This will help ensure facilities focus on aspects of care delivery most closely associated
with COVID-19 during the PHE. (Terminated on 5-7-2022 per QSO-22-15-NH & NLTC &
LSC)
• In-Service Training: CMS is modifying the nurse aide training requirements at
§483.95(g)(1) for SNFs and NFs, which requires the nursing assistant to receive at least 12
hours of in-service training annually. In accordance with section 1135(b)(5) of the Act, we
are postponing the deadline for completing this requirement throughout the COVID-19
PHE until the end of the first full quarter after the declaration of the PHE concludes.
(Terminated on 06-06-2022 per QSO-22-15-NH&NLTC&LSC; Nurse aides hired prior to and
under the current waiver (on or before June 6, 2022) will have 12 months from this date
to complete the required annual training.)
• Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC) Facilities.
CMS is waiving the discharge planning requirement in §483.21(c)(1)(viii), which requires
LTC facilities to assist residents and their representatives in selecting a post-acute care
provider using data, such as standardized patient assessment data, quality measures and
resource use. This temporary waiver is to provide facilities the ability to expedite discharge
and movement of residents among care settings. CMS is maintaining all other discharge
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planning requirements, such as but not limited to, ensuring that the discharge needs of
each resident are identified and result in the development of a discharge plan for each
resident; involving the interdisciplinary team, as defined at 42 CFR §483.21(b)(2)(ii), in the
ongoing process of developing the discharge plan address the resident's goals of care and
treatment preferences. (Terminated on 5-7-2022 per QSO-22-15-NH & NLTC & LSC)
• Clinical Records. Pursuant to section 1135(b)(5) of the Act, CMS is modifying the
requirement at 42 CFR §483.10(g)(2)(ii) which requires long-term care (LTC) facilities to
provide a resident a copy of their records within two working days (when requested by the
resident). Specifically, CMS is modifying the timeframe requirements to allow LTC facilities
ten working days to provide a resident’s record rather than two working days.
(Terminated on 5-7-2022 per QSO-22-15-NH & NLTC & LSC)
• Paid Feeding Assistants. CMS is modifying the requirements at 42 CFR §§ 483.60(h)(1)(i)
and 483.160(a) regarding required training of paid feeding assistants. Specifically, CMS is
modifying the minimum timeframe requirements in these sections, which require this
training to be a minimum of 8 hours. CMS is modifying to allow that the training can be a
minimum of 1 hour in length. CMS is not waiving any other requirements under 42 CFR
§483.60(h) related to paid feeding assistants or the required training content at 42 CFR
§483.160(a)(1)-(8), which contains infection control training and other elements.
Additionally, CMS is also not waiving or modifying the requirements at 42 CFR
§483.60(h)(2)(i), which requires that a feeding assistant must work under the supervision
of a registered nurse (RN) or licensed practical nurse (LPN). (Terminated on 6-6-2022 per
QSO-22-15-NH & NLTC & LSC)
• Director of Food and Nutrition Services (New as of 11/26/21). CMS is issuing an 1135
waiver for 42 CFR 483.60(a)(1) and 483.60(a)(2) that requires dietitians hired or
contracted with prior to November 28, 2016, to meet the specified requirements no later
than five years after November 28, 2016 or as required by state law and to designate a
person to serve as the director of food and nutrition services who, for designations prior
to November 28, 2016, meets the specified requirements no later than five years after
November 28, 2016, or no later than one year after November 28, 2016 for designations
after November 28, 2016. The specified requirements involve specialized education or
training in food service management and safety resulting in an associate’s or higher
degree in hospitality or food service management, a bachelor’s or higher degree granted
by a regionally accredited college or university in the United States, a certified dietary
manager, or a certified food service manager. These educational and training
requirements range in length, at a minimum, of 18 months to four years. It has been
unusually challenging for these requirements to be met due to the COVID-19 Public
Health Emergency (PHE). Therefore, CMS is waiving this requirement due to the inability
for individuals to enroll in, attend, or complete a certification program due to
circumstances related to the COVID-19 PHE. (Terminated on 10-01-2022 per Fiscal Year
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(FY) 2023 Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Final Rule (CMS
1765-F)).
Home Health Agencies (HHAs)
• Requests for Anticipated Payment (RAPs). CMS is allowing Medicare Administrative
Contractors (MACs) to extend the auto-cancellation date of Requests for Anticipated Payment
(RAPs) during emergencies.
• Reporting. CMS is providing relief to HHAs on the timeframes related to OASIS Transmission
through the following actions below:
o Extending the 5-day completion requirement for the comprehensive assessment to 30
days.
o Waiving the 30-day OASIS submission requirement. Delayed submission is permitted
during the PHE.
• Initial Assessments. CMS is waiving the requirements at 42 CFR §484.55(a) to allow HHAs to
perform Medicare-covered initial assessments and determine patients’ homebound status
remotely or by record review. This will allow patients to be cared for in the best environment for
them while supporting infection control and reducing impact on acute care and long-term care
facilities. This will allow for maximizing coverage by already scarce physician, and advanced
practice clinicians, and allow those clinicians to focus on caring for patients with the greatest
acuity.
• Waive Onsite Visits for HHA Aide Supervision. CMS is waiving the requirements at 42 CFR
§484.80(h), which require a nurse to conduct an onsite visit every two weeks. This would include
waiving the requirements for a nurse or other professional to conduct an onsite visit every two
weeks to evaluate if aides are providing care consistent with the care plan, as this may not be
physically possible for a period of time. This waiver is also temporarily suspending the 2-week aide
supervision by a registered nurse for home health agencies requirement at §484.80(h)(1), but
virtual supervision is encouraged during the period of the waiver.
• Allow Occupational Therapists (OTs), Physical Therapists (PTs), and Speech Language
Pathologists (SLPs) to Perform Initial and Comprehensive Assessment for all Patients. CMS is
waiving the requirements in 42 CFR § 484.55(a)(2) and § 484.55(b)(3) that rehabilitation skilled
professionals may only perform the initial and comprehensive assessment when only therapy
services are ordered. This temporary blanket modification allows any rehabilitation
professional (OT, PT, or SLP) to perform the initial and comprehensive assessment for all
patients receiving therapy services as part of the plan of care, to the extent permitted under
state law, regardless of whether or not the service establishes eligibility for the patient to be
receiving home care. The existing regulations at § 484.55(a) and (b)(2) would continue to apply;
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rehabilitation skilled professionals would not be permitted to perform assessments in nursing-
only cases. We would continue to expect HHAs to match the appropriate discipline that
performs the assessment to the needs of the patient to the greatest extent possible. Therapists
must act within their state scope of practice laws when performing initial and comprehensive
assessments, and access a registered nurse or other professional to complete sections of the
assessment that are beyond their scope of practice. Expanding the category of therapists who
may perform initial and comprehensive assessments provides HHAs with additional flexibility
that may decrease patient wait times for the initiation of home health services. This waiver was
made permanent in the Consolidated Appropriations Act of 2021 (CAA, 2021).
• 12-hour Annual In-service Training Requirement for Home Health Aides. CMS is modifying the
requirement at 42 CFR §484.80(d) that home health agencies must assure that each home
health aide receives 12 hours of in-service training in a 12-month period. In accordance with
section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement
throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the
PHE concludes. This will allow aides and the registered nurses (RNs) who teach in-service
training to spend more time delivering direct patient care and additional time for staff to
complete this requirement.
• Detailed Information Sharing for Discharge Planning for Home Health Agencies. CMS is
waiving the requirements of 42 CFR §484.58(a) to provide detailed information regarding
discharge planning, to patients and their caregivers, or the patient’s representative in selecting
a post-acute care provider by using and sharing data that includes, but is not limited to,
(another) home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation
facility (IRF), and long-term care hospital (LTCH) quality measures and resource use measures.
o This temporary waiver provides facilities the ability to expedite discharge and
movement of residents among care settings. CMS is maintaining all other discharge
planning requirements.
• Clinical Records: In accordance with section 1135(b)(5) of the Act, CMS extended the deadline
for completion of the requirement at 42 CFR §484.110(e), which requires HHAs to provide a
patient a copy of their medical record at no cost during the next visit or within four business
days (when requested by the patient). Specifically, CMS has allowed HHAs ten business days to
provide a patient’s clinical record, instead of four.
Home Health Agencies (HHAs) and Hospice
• Training and Assessment of Aides: CMS has been waiving the requirement at 42 CFR
§418.76(h)(2) for Hospice and 42 CFR §484.80(h)(1)(iii) for HHAs, which require a registered
nurse, or in the case of an HHA a registered nurse or other appropriate skilled professional
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(physical therapist/occupational therapist, speech language pathologist) to make an annual
onsite supervisory visit (direct observation) for each aide that provides services on behalf of
the agency. In accordance with section 1135(b)(5) of the Act, we are postponing completion of
these visits. All postponed onsite assessments must be completed by these professionals no
later than 60 days after the expiration of the PHE. CMS will end this waiver at the conclusion of
the PHE.
• Quality Assurance and Performance Improvement (QAPI). CMS is modifying the requirement
at 42 CFR §418.58 for Hospice and §484.65 for HHAs, which requires these providers to
develop, implement, evaluate, and maintain an effective, ongoing, hospice/HHA-wide, data-
driven QAPI program. Specifically, CMS is modifying the requirements at §418.58(a)–(d) and
§484.65(a)–(d) to narrow the scope of the QAPI program to concentrate on infection control
issues, while retaining the requirement that remaining activities should continue to focus on
adverse events. This modification decreases burden associated with the development and
maintenance of a broad-based QAPI program, allowing the providers to focus efforts on
aspects of care delivery most closely associated with COVID-19, and tracking adverse events
during the PHE. The requirement that HHAs and hospices maintain an effective, ongoing,
agency-wide, data-driven quality assessment and performance improvement program will
remain.
Hospice
• Waive Requirement for Hospices to Use Volunteers. CMS is waiving the requirement at 42 CFR
§418.78(e) that hospices are required to use volunteers (including at least 5% of patient care
hours). It is anticipated that hospice volunteer availability and use will be reduced related to
COVID-19 surge and potential quarantine.
• Comprehensive Assessments. CMS is waiving certain requirements at 42 CFR §418.54 related
to updating comprehensive assessments of patients. This waiver applies the timeframes for
updates to the comprehensive assessment found at §418.54(d). Hospices must continue to
complete the required assessments and updates; however, the timeframes for updating the
assessment may be extended from 15 to 21 days.
• Waive Non-Core Services. CMS is waiving the requirement for hospices to provide certain non-
core hospice services during the national emergency, including the requirements at 42 CFR
§418.72 for physical therapy, occupational therapy, and speech-language pathology.
• Waived Onsite Visits for Hospice Aide Supervision. CMS is waiving the requirements at 42 CFR
§418.76(h), which require a nurse to conduct an onsite supervisory visit every two weeks. This
would include waiving the requirements for a nurse or other professional to conduct an onsite
visit every two weeks to evaluate if aides are providing care consistent with the care plan, as
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this may not be physically possible for a period of time.
• Hospice Aide Competency Testing Allow Use of Pseudo Patients. 42 CFR 418.76(c)(1). CMS is
temporarily modifying the requirement in § 418.76(c)(1) that a hospice aide must be evaluated
by observing an aide’s performance of certain tasks with a patient. This modification allows
hospices to utilize pseudo patients such as a person trained to participate in a role-play
situation or a computer-based mannequin device, instead of actual patients, in the
competency testing of hospice aides for those tasks that must be observed being performed on
a patient. This increases the speed of performing competency testing and allows new aides to
begin serving patients more quickly without affecting patient health and safety during the
public health emergency (PHE).
• 12 hour Annual In-service Training Requirement for Hospice Aides. 42 CFR 418.76(d). CMS is
waiving the requirement that hospices must assure that each hospice aide receives 12 hours of
in-service training in a 12 month period. This allows aides and the registered nurses (RNs) who
teach in-service training to spend more time delivering direct patient care.
• Annual Training. CMS is modifying the requirement at 42 CFR §418.100(g)(3), which requires
hospices to annually assess the skills and competence of all individuals furnishing care and
provide in-service training and education programs where required. Pursuant to section
1135(b)(5) of the Act, we are postponing the deadline for completing this requirement
throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the
PHE concludes. This does not alter the minimum personnel requirements at 42 CFR §418.114.
Selected hospice staff must complete training and have their competency evaluated in
accordance with unwaived provisions of 42 CFR Part 418.
End-Stage Renal Dialysis (ESRD) Facilities
• Training Program and Periodic Audits. CMS is waiving the requirement at 42 CFR §494.40(a)
related to the condition on Water & Dialysate Quality, specifically that on-time periodic audits
for operators of the water/dialysate equipment are waived to allow for flexibilities.
• Defer Equipment Maintenance & Fire Safety Inspections. CMS is waiving the requirement at
42 CFR §494.60(b) for on-time preventive maintenance of dialysis machines and ancillary
dialysis equipment. Additionally, CMS is also waiving the requirements under §494.60(d) which
requires ESRD facilities to conduct on-time fire inspections. These waivers are intended to
ensure that dialysis facilities are able to focus on the operations related to the Public Health
Emergency. (Terminated on 6-6-2022 per QSO-22-15-NH & NLTC & LSC)
Emergency Preparedness. CMS is waiving the requirements at 42 CFR §494.62(d)(1)(iv), which
requires ESRD facilities to demonstrate as part of their Emergency Preparedness Training and
Testing Program, that staff can demonstrate that, at a minimum, its patient care staff maintains
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current CPR certification. CMS is waiving the requirement for maintenance of CPR certification
during the COVID-19 emergency due to the limited availability of CPR classes.
• Ability to Delay Some Patient Assessments. CMS is not waiving subsections (a) or (c) of 42
CFR §494.80, but is waiving the following requirements at 42 CFR §494.80(b) related to the
frequency of assessments for patients admitted to the dialysis facility. CMS is waiving the “on-
time” requirements for the initial and follow up comprehensive assessments within the
specified timeframes as noted below. This waiver applies to assessments conducted by
members of the interdisciplinary team, including: a registered nurse, a physician treating the
patient for ESRD, a social worker, and a dietitian. These waivers are intended to ensure that
dialysis facilities are able to focus on the operations related to the Public Health Emergency.
Specifically, CMS is waiving:
o §494.80(b)(1): An initial comprehensive assessment must be conducted on all new
patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar
days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis
session.
o §494.80(b)(2): A follow up comprehensive reassessment must occur within three
months after the completion of the initial assessment to provide information to adjust
the patient’s plan of care specified in §494.90.
• Time Period for Initiation of Care Planning and Monthly Physician Visits. CMS is modifying two
requirements related to care planning, specifically:
o 42 CFR §494.90(b)(2): CMS is modifying the requirement that requires the dialysis
facility to implement the initial plan of care within the latter of 30 calendar days after
admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with
the first outpatient dialysis session. This modification will also apply to the requirement
for monthly or annual updates of the plan of care within 15 days of the completion of
the additional patient assessments.
o §494.90(b)(4): CMS is modifying the requirement that requires the ESRD dialysis facility
to ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical
nurse specialist, or physician’s assistant providing ESRD care at least monthly, and
periodically while the hemodialysis patient is receiving in-facility dialysis. CMS is waiving
the requirement for a monthly in-person visit if the patient is considered stable and also
recommends exercising telehealth flexibilities; e.g., phone calls to ensure patient safety.
• Dialysis Home Visits to Assess Adaptation and Home Dialysis Machine Designation. CMS is
waiving the requirement at 42 CFR §494.100(c)(1)(i), which requires the periodic monitoring of
the patient’s home adaptation, including visits to the patient’s home by facility personnel. For
more information on existing flexibilities for in-center dialysis patients to receive their dialysis
treatments in the home, or long-term care facility, reference QSO-20-19-ESRD.
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• Home Dialysis Machine Designation — Clarification. The ESRD Conditions for Coverage (CFCs)
do not explicitly require that each home dialysis patient have their own designated home
dialysis machine. The dialysis facility is required to follow FDA labeling and manufacturer’s
directions for use to ensure appropriate operation of the dialysis machine and ancillary
equipment. Dialysis machines must be properly cleaned and disinfected to minimize the risk of
infection based on the requirements at 42 CFR §494.30 Condition: Infection Control if used to
treat multiple patients.
• Special Purpose Renal Dialysis Facilities (SPRDF) Designation Expanded. CMS authorizes the
establishment of SPRDFs under 42 CFR §494.120 to address access to care issues due to COVID-
19 and the need to mitigate transmission among this vulnerable population. This will not
include the normal determination regarding lack of access to care at §494.120(b) as this
standard has been met during the period of the national emergency. Approval as a Special
Purpose Renal Dialysis Facility related to COVID-19 does not require federal survey prior to
providing services.
• Dialysis Patient Care Technician (PCT) Certification. CMS is modifying the requirement at 42
CFR §494.140(e)(4) for dialysis PCTs that requires certification under a state certification
program or a national commercially available certification program within 18 months of being
hired as a dialysis PCT for newly employed patient care technicians. CMS is aware of the
challenges that PCTs are facing with the limited availability and closures of testing sites during
the time of this crisis. CMS will allow PCTs to continue working even if they have not achieved
certification within 18 months or have not met on time renewals.
• Transferability of Physician Credentialing. CMS is modifying the requirement at 42 CFR
§494.180(c)(1), which requires that all medical staff appointments and credentialing are in
accordance with state law, including attending physicians, physician assistants, nurse
practitioners, and clinical nurse specialists. These waivers will allow physicians that are
appropriately credentialed at a certified dialysis facility to function to the fullest extent of their
licensure to provide care at designated isolation locations without separate credentialing at
that facility, and may be implemented as long as they are consistent with a state’s emergency
preparedness or pandemic plan.
• Expanding Availability of Renal Dialysis Services to ESRD Patients. CMS is waiving the
following requirements related to Nursing Home residents:
o Furnishing Dialysis Services on the Main Premises: ESRD requirements at 42 CFR
§494.180(d) require dialysis facilities to provide services directly on its main premises
or on other premises that are contiguous with the main premises. CMS is waiving this
requirement to allow dialysis facilities to provide service to its patients who reside in
the nursing homes, long-term care facilities, assisted living facilities and similar types of
facilities, as licensed by the state (if applicable). CMS continues to require that services
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provided to these patients or residents are under the direction of the same governing
body and professional staff as the resident’s usual Medicare-certified dialysis facility.
Further, in order to ensure that care is safe, effective and is provided by trained and
qualified personnel, CMS requires that the dialysis facility staff: 1) furnish all dialysis
care and services; 2) provide all equipment and supplies necessary; 3) maintain
equipment and supplies in off-premises location; 4) and complete all equipment
maintenance, cleaning and disinfection using appropriate infection control procedures
and manufacturer’s instructions for use.
• Clarification for Billing Procedures. Typically, ESRD beneficiaries are transported from a SNF/NF
to an ESRD facility to receive renal dialysis services. In an effort to keep patients in their SNF/NF
and decrease their risk of being exposed to COVID-19, ESRD facilities may temporarily furnish
renal dialysis services to ESRD beneficiaries in the SNF/NF instead of the offsite ESRD facility.
The in-center dialysis center should bill Medicare using Condition Code 71 (Full care unit. Billing
for a patient who received staff-assisted dialysis services in a hospital or renal dialysis facility).
The in-center dialysis center should also apply condition code DR to claims if all the treatments
billed on the claim meet this condition or modifier CR on the line level to identify individual
treatments meeting this condition. The ESRD provider would need to have their trained
personnel administer the treatment in the SNF/ NF. In addition, the provider must follow the
CFCs. In particular, under the CFCs is the requirement that to use a dialysis machine, the FDA-
approved labeling must be adhered to § 494.100 and it must be maintained and operated in
accordance with the manufacturer’s recommendations (§ 494.60) and follow infection control
requirements at § 494.30.
Physical Environment for Multiple Providers/Suppliers
Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of
Participation: CMS is waiving certain physical environment requirements for Hospitals, and CAHs,
inpatient hospice, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential
exposure/transmission of COVID-19. The physical environment regulations require that facilities
and equipment be maintained to ensure an acceptable level of safety and quality.
CMS will permit facilities to adjust scheduled inspection, testing and maintenance (ITM)
frequencies and activities for facility and medical equipment.
• Specific Physical Environment Waiver Information:
o 42 CFR §482.41(d) for hospitals, and §485.623(b) for CAHs, §418.110(c)(2)(iv) for
inpatient hospice, §483.470(j) for ICF/IID; and §483.90 for SNFs/NFs (Terminated
waivers at 418.110(c)(2)(iv) for inpatient hospice, 483.470(j) for ICF/IID and
483.90(a)(1) and (b) for SNFs/NF on 6-6-2022 per QSO-22-15-NH & NLTC & LSC) all
require these facilities and their equipment to be maintained to ensure an acceptable
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level of safety and quality. CMS is temporarily modifying these requirements to the
extent necessary to permit these facilities to adjust scheduled inspection, testing and
maintenance (ITM) frequencies and activities for facility and medical equipment.
o 42 CFR §482.41(b)(1)(i) and (c) for hospitals, and §485.623(c)(1)(i) and (d) for CAHs,
§482.41(d)(1)(i) and (e) for inpatient hospices, §483.470(j)(1)(i) and (5)(v) for ICF/IIDs,
and §483.90(a)(1)(i) and (b) for SNFs/NFs (Terminated waivers at 482.41(d)(1)(i) and
(e) for inpatient hospices, §483.470(j)(1)(i) and (5)(v) for ICF/IIDs, and §483.90(a)(1)(i)
and (b) for SNFs/NFs on 6-6-2022 per QSO-22-15-NH & NLTC & LSC) require these
facilities to be in compliance with the Life Safety Code (LSC) and Health Care Facilities
Code (HCFC). CMS is temporarily modifying these provisions to the extent necessary to
permit these facilities to adjust scheduled ITM frequencies and activities required by
the LSC and HCFC. The following LSC and HCFC ITM are considered critical are not
included in this waiver:
▪ Sprinkler system monthly electric motor-driven and weekly diesel engine-
driven fire pump testing.
▪ Portable fire extinguisher monthly inspection.
▪ Elevators with firefighters’ emergency operations monthly testing.
▪ Emergency generator 30 continuous minute monthly testing and associated
transfer switch monthly testing.
▪ Means of egress daily inspection in areas that have undergone construction,
repair, alterations, or additions to ensure its ability to be used instantly in
case of emergency.
o 42 CFR §482.41(b)(9) for hospitals, and §485.623(c)(7) for CAHs, §418.110(d)(6) for
inpatient hospices, §483.470(e)(1)(i) for ICF/IIDs, and §483.90(a)(7) for SNFs/NFs
(Terminated waivers at §418.110(d)(6) for inpatient hospice, §483.470(e)(1)(i) for
ICF/IID and §483.90(a)(7) for SNFs/NFs on 6-6-2022 per QSO-22-15-NH & NLTC & LSC)
require these facilities to have an outside window or outside door in every sleeping
room. CMS will permit a waiver of these outside window and outside door requirements
to permit these providers to utilize facility and non-facility space that is not normally
used for patient care to be utilized for temporary patient care or quarantine.
Specific Life Safety Code (LSC) for Multiple Providers - Waiver Information:
CMS is waiving and modifying particular waivers under 42 CFR §482.41(b) for hospitals;
§485.623(c) for CAHs; §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs and §483.90(a)
for SNF/NFs. Specifically, CMS is modifying these requirements as follows:
• Alcohol-based Hand-Rub (ABHR) Dispensers: We are waiving the prescriptive requirements
for the placement of alcohol based hand rub (ABHR) dispensers for use by staff and others due
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to the need for the increased use of ABHR in infection control. However, ABHRs contain ethyl
alcohol, which is considered a flammable liquid, and there are restrictions on the storage and
location of the containers. This includes restricting access by certain patient/resident
population to prevent accidental ingestion. Due to the increased fire risk for bulk containers
(over five gallons) those will still need to be stored in a protected hazardous materials area.
Refer to: 2012 LSC, sections 18/19.3.2.6. In addition, facilities should continue to protect ABHR
dispensers against inappropriate use as required by 42 CFR §482.41(b)(7) for hospitals;
§485.623(c)(5) for CAHs; §418.110(d)(4) for inpatient hospice; §483.470(j)(5)(ii) for ICF/IIDs
and §483.90(a)(4) for SNF/NFs.
• Fire Drills: Due to the inadvisability of quarterly fire drills that move and mass staff together,
we will instead permit a documented orientation training program related to the current fire
plan, which considers current facility conditions. The training will instruct employees,
including existing, new or temporary employees, on their current duties, life safety procedures
and the fire protection devices in their assigned area. (Terminated waivers for fire drills at
§418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a) for SNF/NFs
terminated on 6-6-2022 per QSO-22-15-NH & NLTC & LSC).
Refer to: 2012 LSC, sections 18/19.7.1.6.
• Temporary Construction: CMS is waiving requirements that would otherwise not permit
temporary walls and barriers between patients. (Terminated waivers for temporary
construction at §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a)
for SNF/NFs on 6-6-2022 per QSO-22-15-NH & NLTC & LSC).
Refer to: 2012 LSC, sections 18/19.3.3.2.
Intermediate Care Facility for Individuals with Intellectual Disabilities
• Staffing Flexibilities. CMS is waiving the requirements at 42 CFR §483.430(c)(4), which requires
the facility to provide sufficient Direct Support Staff (DSS) so that Direct Care Staff (DCS) are
not required to perform support services that interfere with direct client care. DSS perform
activities such as cleaning of the facility, cooking, and laundry services. DSC perform activities
such as teaching clients appropriate hygiene, budgeting, or effective communication and
socialization skills. During the time of this waiver, DCS may be needed to conduct some of the
activities normally performed by the DSS. This will allow facilities to adjust staffing patterns,
while maintaining the minimum staffing ratios required at §483.430(d)(3).
• Suspension of Community Outings. CMS is waiving the requirements at 42 CFR
§483.420(a)(11), which requires clients have the opportunity to participate in social, religious,
and community group activities. The federal and/or state emergency restrictions will dictate
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the level of restriction from the community based on whether it is for social, religious, or
medical purposes. States may have also imposed more restrictive limitations. CMS is
authorizing the facility to implement social distancing precautions with respect to on and off-
campus movement. State and federal restrictive measures should be made in the context of
competent, person-centered planning for each client.
• Suspend Mandatory Training Requirements. CMS is waiving, in-part, the requirements at 42
CFR §483.430(e)(1) related to routine staff training programs unrelated to the public health
emergency. CMS is not waiving 42 CFR §483.430(e)(2)-(4), which requires focusing on the
clients’ developmental, behavioral and health needs and being able to demonstrate skills
related to interventions for inappropriate behavior and implementing individual plans. We are
not waiving these requirements as we believe the staff ability to develop and implement the
skills necessary to effectively address clients’ developmental, behavioral and health needs are
essential functions for an ICF/IID. CMS is also not waiving initial training for new staff hires or
training for staff around prevention and care for the infection control of COVID-19. It is critical
that new staff gain the necessary skills and understanding of how to effectively perform their
role as they work with this complex client population and that staff understand how to prevent
and care for clients with COVID-19.
• Modification of Adult Training Programs and Active Treatment. CMS recognizes that during
the public health emergency, active treatment will need to be modified. The requirements at
42 CFR §483.440(a)(1) require that each client must receive a continuous active treatment
program, which includes consistent implementation of a program of specialized and generic
training, treatment, health services and related services.
CMS is waiving those components of beneficiaries’ active treatment programs and training that
would violate current state and local requirements for social distancing, staying at home, and
traveling for essential services only. For example, although day habilitation programs and
supported employment are important opportunities for training and socialization of clients at
intermediate care facilities for individuals with developmental disabilities, these programs pose
too high of a risk to staff and clients for exposure to a person with suspected or confirmed
COVID-19. In accordance with §483.440(c)(1), any modification to a client’s Individual Program
Plan (IPP) in response to treatment changes associated with the COVID-19 crisis requires the
approval of the interdisciplinary team. For facilities that have interdisciplinary team members
who are unavailable due to the COVID-19, CMS would allow for a retroactive review of the IPP
under 483.440(f)(2) in order to allow IPPs to receive modifications as necessary based on the
impact of the COVID-19 crisis.
Ambulatory Surgical Centers (ASCs)
• Medical Staff. 42 CFR 416.45(b). CMS is waiving the requirement at § 416.45(b) that medical
staff privileges must be periodically reappraised, and the scope of procedures performed in
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the ASC must be periodically reviewed. This will allow for physicians whose privileges will
expire to continue practicing at the ambulatory surgical center, without the need for
reappraisal, and for ASCs to continue operations without performing these administrative
tasks during the PHE. This waiver will improve the ability of ASCs to maintain their current
workforce during the PHE.
• Nursing Services. 42 CFR 42 CFR §482.23(b)(1). For ASCs enrolling as hospitals during the PHE
as part of the Hospitals Without Walls Program, CMS is waiving the particular requirement at
42 CFR §482.23(b)(1), which requires the hospital to have a licensed practical nurse or
registered nurse on duty at all times. This waiver will only require ASCs enrolled as hospitals to
provide 24-hour nursing services when there is a patient in the facility. This flexibility will allow
ASCs enrolled as hospitals to provide nursing services on demand with a 24-7 on call service in
the event a surgeon requests to admit a patient for a required surgical procedure. Waiver
authority applies only to federal requirements and does not supersede state requirements for
licensure.
Community Mental Health Clinics (CMHCs)
• Quality assessment and performance improvement (QAPI). 42 CFR 485.917(a)-(d) We are
modifying the requirements for CMHC's quality assessment and performance improvement
(QAPI). Specifically, we are retaining the overall requirement that CMHC's maintain an
effective, ongoing, CMHC-wide, data-driven QAPI program, while providing flexibility for
CMHCs to use their QAPI resources to focus on challenges and opportunities for improvement
related to the PHE by waiving the specific detailed requirements for the QAPI program’s
organization and content at § 485.917(a)-(d). Waiving the requirements related to the details
of the QAPI program’s organization and content will make it easier for CMHCs to reconfigure
their QAPI programs, as needed, to adapt to specific needs and circumstances that arise
during the PHE. These flexibilities may be implemented as long as they are consistent with a
state’s emergency preparedness or pandemic plan.
• Provision of Services. 42 CFR 485.918(b)(1)(iii). We are waiving the specific requirement at §
485.918(b)(1)(iii) that prohibits CMHCs from providing partial hospitalization services and
other CMHC services in an individual’s home so that clients can safely shelter in place during
the PHE while continuing to receive needed care and services from the CMHC. This waiver is a
companion to recent regulatory changes
(https://www.federalregister.gov/documents/2020/05/08/2020-09608/medicare-and-
medicaid-programs-basic-health-program-and-exchanges-additional-policy-and-regulatory)
that clarify how CMHCs should bill for services provided in an individual’s home, and how such
services should be documented in the medical record. While this waiver will now allow
CMHCs to furnish services in client homes, including through the use of using
telecommunication technology, CMHCs continue to be, among other things, required to
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comply with the non-waived provisions of 42 CFR Part 485, Subpart J, requiring that CMHCs: 1)
assess client needs, including physician certification of the need for partial hospitalization
services, if needed; 2) implement and update each client’s individualized active treatment plan
that sets forth the type, amount, duration, and frequency of the services; and 3) promote
client rights, including a client’s right to file a complaint.
• 40 Percent Rule. 42 CFR 485.918(b)(1)(v) We are waiving the requirement at §
485.918(b)(1)(v) that a CMHC provides at least 40 percent of its items and services to
individuals who are not eligible for Medicare benefits. Waiving the 40 percent requirement
will facilitate appropriate timely discharge from inpatient psychiatric units and prevent
admissions to these facilities because CMHCs will be able to provide PHP services to Medicare
beneficiaries without restrictions on the proportion of Medicare beneficiaries that they are
permitted to treat at a time. This will allow communities greater access to health services,
including mental health services.
Ambulance Services
• Medicare Ground Ambulance Data Collection System (Modified since 11/25 Release). CMS is
modifying the data collection period and data reporting period, as defined at 42 CFR §
414.626(a), for ground ambulance organizations (as defined at 42 CFR § 414.605) that were
selected by CMS under 42 CFR § 414.626(c) to collect data beginning between January 1, 2020
and December 31, 2020 (year 1) and for ground ambulance organizations that were selected
to collect data beginning between January 1, 2021 and December 31, 2021 (year 2) for
purposes of complying with the data reporting requirements described at 42 CFR § 414.626.
Under this modification, these ground ambulance organizations can select a new continuous
12-month data collection period that begins between January 1, 2022 and December 31,
2022, to collect data necessary to complete the Medicare Ground Ambulance Data Collection
Instrument during their selected data collection period, and submit a completed Medicare
Ground Ambulance Data Collection Instrument during the data reporting period that
corresponds to their selected data collection period. CMS is modifying this data collection and
reporting period to increase flexibilities for ground ambulance organizations that would
otherwise be required to collect data in 2020-2021 so that they can focus on their operations
and patient care.
• Ambulance Treat in Place (New 5/5/2021). Pursuant to authority granted under section
9832 of the American Rescue Plan Act of 2021, CMS is waiving the requirements under section
1861(s)(7) and section 1834(l) of the Act that an ambulance service include the transport of an
individual to the extent necessary to allow payment for ground ambulance services furnished
in response to a 911 call (or the equivalent in areas without a 911 call system) in cases in
which an individual would have been transported to a destination permitted under Medicare
regulations (as described in section 410.40 to title 42, Code of Federal Regulations (or
successor regulations)) but such transport did not occur as a result of community-wide
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emergency medical service (EMS) protocols due to the public health emergency described in
subsection (g)(1)(B).
For purposes of this waiver, community-wide EMS protocols are those established by state,
local, or municipal authorities (including by a hospital, but only where a hospital has the
requisite legal authority) in response to the COVID-19 PHE that govern the provision of
ambulance services, and that require or allow, with patient consent, an ambulance provider or
supplier to “treat in place” a patient who otherwise, but for the COVID-19 PHE, would have
been transported to a Medicare covered destination (such as a hospital). Such protocols
were/will be issued in written format, and such format that may have included, but is not
limited to: state or local agency and official correspondence or electronic platforms that
provided just-in-time updates to standard operative procedure or protocols. However, to the
extent that a verbal protocol (such as from an individual hospital in a remote area) was/is in
effect at the time of transport, we expect the verbal protocol to be fully documented.
CMS will pay for treatment in place under this waiver in cases where the individual that would
have been transported would have met the Medicare criteria for a medically necessary ground
ambulance transport to the nearest appropriate facility that could have treated the patient’s
condition, but such transport did not occur as a result of community-wide EMS protocols due
to the COVID-19 PHE. The beneficiary’s condition must have required both the ambulance
transportation itself and the level of service provided in order for the billed service to be
considered medically necessary.
Under this waiver, ground ambulance services will be paid at the base rate that would have
been paid under the fee schedule established under 1834(l) (excluding any mileage payment)
if the individual had been so transported and, with respect to ambulance services furnished by
a critical access hospital or an entity described in paragraph (8) of such section, at the amount
that otherwise would be paid under such paragraph. Claims shall be submitted consistent with
instructions, including the use of appropriate modifiers, and documentation to support
medical necessity and the presence of a qualifying community-wide EMS protocol must be
maintained and provided to CMS contractors for medical review upon request.
The deadline to submit claims for services that were furnished under this waiver between
March 1, 2020 and May 5, 2021 is also modified. The deadline to submit such claims is May 5,
2022.
Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
• When DMEPOS is lost, destroyed, irreparably damaged, or otherwise rendered unusable, CMS
is allowing DME Medicare Administrative Contractors (MACs) to have the flexibility to waive
replacements requirements such that the face-to-face requirement, a new physician’s order,
and new medical necessity documentation are not required. Suppliers must still include a
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narrative description on the claim explaining the reason why the equipment must be replaced
and are reminded to maintain documentation indicating that the DMEPOS was lost, destroyed,
irreparably damaged, or otherwise rendered unusable or unavailable as a result of the
emergency.
Practitioner Locations
CMS is temporarily waiving requirements that out-of-state practitioners be licensed in the state
where they are providing services when they are licensed in another state. CMS will waive the
physician or non-physician practitioner licensing requirements when the following four conditions
are met: 1) must be enrolled as such in the Medicare program; 2) must possess a valid license to
practice in the state, which relates to his or her Medicare enrollment; 3) is furnishing services —
whether in person or via telehealth — in a state in which the emergency is occurring in order to
contribute to relief efforts in his or her professional capacity; and, 4) is not affirmatively excluded
from practice in the state or any other state that is part of the 1135 emergency area.
• In addition to the statutory limitations that apply to 1135-based licensure waivers, an 1135
waiver, when granted by CMS, does not have the effect of waiving state or local licensure
requirements or any requirement specified by the state or a local government as a condition for
waiving its licensure requirements. Those requirements would continue to apply unless waived
by the state. Therefore, in order for the physician or non-physician practitioner to avail him or
herself of the 1135 waiver under the conditions described above, the state also would have to
waive its licensure requirements, either individually or categorically, for the type of practice for
which the physician or non-physician practitioner is licensed in his or her home state. When
the PHE ends, current regulations will continue to allow for a deferral to state law.
Provider Enrollment
• During the PHE, CMS has established toll-free hotlines for physicians, non-physician
practitioners, and Part A certified providers and suppliers who have established isolation
facilities to enroll and receive temporary Medicare billing privileges. When the PHE ends, the
hotlines will be shut down. Additionally, CMS has provided the following flexibilities for
provider enrollment:
o Screening requirements:
• Site Visits: CMS waived provider enrollment site visits for moderate and high-risk
providers/suppliers. (This waiver terminated on 06-06-20202 and MACs resumed
all provider enrollment site visits per TDL-200540.)
• Fingerprint-based criminal background checks: CMS waived the requirement for
fingerprint-based criminal background checks for 5% or greater owners of newly
enrolling high risk categories of providers and suppliers (e.g., newly-enrolling Home
Health Agencies, DMEPOS suppliers, Medicare Diabetes Prevention Programs,
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Opioid Treatment Programs). (This waiver terminated on 10/31/2021 and CMS, in
accordance with 42 C.F.R. § 424.518, resumed requesting fingerprints for all
newly enrolling high risk providers and suppliers per TDL-210506.)
• Application Fees: CMS waived the collection of application fees for institutional
providers who are initially enrolling, revalidating, or adding a new practice location.
(This waiver terminated on 10/31/2021 and CMS, in accordance with 42 C.F.R. §
424.514, resumed collecting application fees per TDL-210506.)
o Revalidation: CMS postponed all revalidation actions. This did not prevent a provider who
wants to submit a revalidation application from doing so; MACs processed revalidation
applications. (This waiver terminated on 10/31/2021 and CMS resumed a phased-in
approach to revalidation activities; revalidation letters began being mailed again in
October 2021 with due dates in early 2022 per TDL-210506.)
o Expedited Enrollment: CMS expedited any pending or new applications from providers and
suppliers, including physicians and non-physician practitioners received on or after March
1, 2020. When the PHE ends, CMS will resume normal application processing times.
o Opt-Out Enrollment: CMS allowed practitioners to cancel their opt-out status early and
enroll in Medicare to provide care to more patients. CMS also allowed MACs to accept opt-
out cancellation requests via email, fax, or phone call to the hotline. CMS allowed a
provider to submit an application (an 855-I or 855-R for example) to cancel their opt-out.
Providers were not required to submit a written notification to cancel their opt-out status.
When the PHE ends, this waiver will terminate and opted-out practitioners will not be able
to cancel their opt-out statuses earlier than the applicable regulation at 42 CFR 405.445
allows for.
o Reporting Home Address: CMS allowed practitioners to render telehealth services from
their home without reporting their home address on their Medicare enrollment while
continuing to bill from their currently enrolled location. When the PHE ends, practitioners
will be required to resume reporting their home address on the Medicare enrollment.
o State Licensure: CMS allowed licensed providers to render services outside of their state of
enrollment when enrolled in Medicare, in possession of a valid license in the state of
Medicare enrollment, furnishing services (either in person or via telehealth) to contribute
to relief efforts in their professional capacity, and not affirmatively excluded from practice
in the state or any other state that is part of the 1135 emergency area. Also, CMS waived
the board certification requirement for new PAs and NPs wherever states have likewise
waived the requirement.
Modification of 60-Day Limit for Substitute Billing Arrangements (Locum Tenens)
CMS is modifying the 60-day limit in section 1842(b)(6)(D)(iii) of the Social Security Act to allow a
physician or physical therapist to use the same substitute for the entire time he or she is unavailable
to provide services during the COVID-19 emergency plus an additional period of no more than 60
continuous days after the public health emergency expires. On the 61st day after the public health
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emergency ends (or earlier if desired), the regular physician or physical therapist must use a different
substitute or return to work in his or her practice for at least one day in order to reset the 60-day
clock. Without this flexibility, the regular physician or physical therapist generally could not use a
single substitute for a continuous period of longer than 60 days, and would instead be required to
secure a series of substitutes to cover sequential 60-day periods. The modified timetable applies to
both types of substitute billing arrangements under Medicare fee-for-service (i.e., reciprocal billing
arrangements and fee-for-time compensation arrangements (formerly known as locum tenens)).
Notes: Under the Medicare statute, only 1) physicians and 2) physical therapists who furnish
outpatient physical therapy services in a health professional shortage area (HPSA), a medically
underserved area (MUA), or a rural area can receive Medicare fee-for-service payment for services
furnished by a substitute under a substitute billing arrangement. In addition, Medicare can pay for
services under a substitute billing arrangement only when the regular physician or physical therapist
is unavailable to provide the services. Finally, as provided by law, a regular physician or physical
therapist who has been called or ordered to active duty as a member of a reserve component of the
Armed Forces may continue to use the same substitute for an unlimited time even after the
emergency ends.
Medicare appeals in Traditional Medicare, Medicare Advantage (MA) and Part D
• During the PHE, CMS has been allowing Medicare Administrative Contractors (MACs) and
Qualified Independent Contractor (QICs) in the FFS program (42 CFR 405.942 and 42 CFR
405.962) and MA and Part D plans, as well as the Part C and Part D Independent Review Entity
(IREs) (42 CFR 422.582 and 42 CFR 423.582) to allow extensions to file an appeal. Specifically,
42 CFR 422.582(c) and 42 CFR 423.582(c) allow a Part C or Part D plan to extend the timeframe
for filing a request if there is good cause for the late filing. In addition, the Part D IRE may find
good cause for late filing of a request for reconsideration. When the PHE ends, these
flexibilities will continue to apply consistent with existing authority and requests for appeals
must meet the existing regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405. 950
and 42 CFR 405.966), and the Part C and Part D IREs, to waive requirements for timeliness for
requests for additional information to adjudicate appeals. In addition, under applicable
regulations, MA plans may extend the timeframe to adjudicate organization determinations
and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar
days if: the enrollee requests the extension; the extension is justified and in the enrollee's
interest due to the need for additional medical evidence from a noncontract provider that may
change an MA organization's decision to deny an item or service; or, the extension is justified
due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee's
interest (42 CFR 422.568(b)(1)(i), 42 CFR 422.572(b)(1) and 42 CFR 422.590(f)(1)). When the
PHE ends, these flexibilities will continue to apply consistent with existing authority and
requests for appeals must meet the existing regulatory requirements.
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• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.910)
and MA and Part D plans, as well as the Part C and Part D IREs to process an appeal even with
incomplete Appointment of Representation forms (see 42 CFR 422.561 and 42 CFR 423.560 for
definitions of “representative”. However, any communication was sent only to the beneficiary.
When the PHE ends, this flexibility will continue to apply, consistent with existing guidance for
the MACs and QIC in the FFS program. For MA and Part D plans, as well as the Part C and Part D
IREs, this flexibility will no longer apply. The MA and Part D plans, as well as the Part C and D
IREs, must process the appeals based on regulatory requirements (42 CFR 422.582(f)-(g), 42
CFR 423.582(e)-(f), 42 CFR 422.592(d)-(e), and 42 CFR 423.600(g)-(h)).
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405. 950
and 42 CFR 405.966) and MA and Part D plans, as well as the Part C and Part D IREs, to process
requests for appeal that don’t meet the required elements but instead using information that
is available (42 CFR 422.562 and 42 CFR 423.562). When the PHE ends, requests for appeals
must meet the existing regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405. 950
and 42 CFR 405.966) and MA and Part D plans, as well as the Part C and Part D IREs, to utilize all
flexibilities available in the appeal process as if good cause requirements are satisfied. When
the PHE ends, these flexibilities will continue to apply, consistent with existing regulatory
authority.
Medicaid and CHIP (as of 3/13/2020)
States and territories can request approval that certain statutes and implementing regulations be
waived by CMS, pursuant to section 1135 of the Act. To assist states in this process, CMS released
an 1135 Waiver Checklist to make it easier for states to receive federal waivers and implement
flexibilities in their Medicaid and CHIP programs. States’ use of this 1135 checklist will expedite
their ability to apply for and receive approval for 1135 waivers that are now available under the
President’s national emergency declaration.
States and territories may submit a Section 1135 waiver request directly to their Center for
Medicaid & CHIP Services (CMCS) state lead or Jackie Glaze, Acting Director, Medicaid & CHIP
Operations Group, Center for Medicaid & CHIP Services at CMS by e-mail
(Jackie.Glaze@cms.hhs.gov) or letter.
The following are examples of flexibilities that states and territories may seek through a Section
1135 waiver request:
• Waive prior authorization requirements in fee-for-service programs.
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• Permits providers located out of state/territory to provide care to another state’s Medicaid
enrollee impacted by the emergency.
• Temporarily suspend certain provider enrollment and revalidation requirements to increase
access to care.
• Temporarily suspend requirements for certain pre-admission and annual screenings for nursing
home residents.
States and territories are encouraged to assess their needs and request these available
flexibilities, which are more completely outlined in the Medicaid and CHIP Disaster Response
Toolkit. For more information and to access the toolkit and the 1135 waiver checklist, visit:
https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/index.html.
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ATTACHMENT A
Blanket Waivers of Sanctions under the Physician Self-Referral
Law (also known as the “Stark Law”)
CMS has issued blanket waivers of sanctions under section 1877(g) of the Act. The blanket waivers
may be used now without notifying CMS. Individual waivers of sanctions under section 1877(g) of
the Act may be granted upon request. For more information, visit:
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Spotlight
For resources and additional information on 1135 Waivers, please also visit:
• https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-
Emergencies/Current-Emergencies-page
• https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf
For questions, please email: 1135waiver@cms.hhs.gov
Updated 10/13/22 41
1
Blanket Waivers: Stafford Act, Public Health Emergency (PHE)
and Section 1135 Waivers
Background
On March 13, 2020, the President issued an emergency declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”) to declare
a national health emergency. The Secretary of the Department of Health and Human Services (the
Secretary) is authorized to waive certain Medicare, Medicaid and Children’s Health Insurance
Program (CHIP) program requirements and conditions of participation under Section 1135 of the
Social Security Act once the President has declared an emergency through the Stafford Act2 and
the Secretary has declared a Public Health Emergency (PHE). The Secretary issued a PHE on
January 31, 20203. As a result of this authority, CMS can grant waivers that will ease certain
requirements for affected providers as stated under Section 1135 of the Social Security Act 4.
CMS can issue two types of waivers: blanket waivers and provider/supplier requested waivers.
Specifics about the two types of waivers are outlined in detail below. Examples of these 1135
waivers or modifications include:
• Conditions of participation or other certification requirements
• Program participation and similar requirements
• Preapproval requirements
• Requirements that physicians and other health care professionals be licensed in the state in
which they are providing services, as long as they have equivalent licensing in another state
(this waiver is for purposes of Medicare, Medicaid, and CHIP reimbursement only – state law
governs whether a non-Federal provider is authorized to provide services in the state without
state licensure)
• Emergency Medical Treatment and Labor Act (EMTALA)
• Sanctions under the physician self-referral law (also known as the “Stark Law”)
• Performance deadlines and timetables may be adjusted (but not waived)
• Limitations on payment for health care items and services furnished to Medicare Advantage
enrollees by non-network providers
2 https://www.whitehouse.gov/wp-content/uploads/2020/03/LetterFromThePresident.pdf
3 https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
4 https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx
Updated 10/13/22 42
Waivers under Section 1135 of the Social Security Act typically end no later than the termination
of the emergency period, or 60 days from the date the waiver or modification is first published.
The Secretary can extend the waiver by notice for additional periods of up to 60 days, up to the
end of the emergency period.
The 1135 waiver authority applies only to federal requirements and does not apply to state
requirements for licensure or conditions of participation.
In addition to the 1135 waiver authority, Section 1812(f) of the Social Security Act (the Act)
authorizes the Secretary to provide for Skilled Nursing Facilities (SNF) coverage in the absence of a
qualifying hospital stay, as long as this action does not increase overall program payments and
does not alter the SNF benefit’s “acute care nature” (that is, its orientation toward relatively short-
term and intensive care).
Federally certified/approved providers must continue to operate under normal rules and
regulations, unless they have sought and have been granted modifications under the waiver
authority from specific requirements.
In addition, the Coronavirus Preparedness and Response Supplemental Appropriations Act, as
signed into law by the President on March 6, 2020, includes a provision allowing the Secretary to
waive certain Medicare telehealth payment requirements during the PHE the Secretary declared
on January 31, 2020 to allow beneficiaries in all areas of the country to receive telehealth services,
including at their home. Under the waiver, limitations on where Medicare patients are eligible for
telehealth will be removed during the emergency. In particular, patients outside of rural areas,
and patients in their homes will be eligible for telehealth services, effective for services starting
March 6, 2020.5 This waiver will end 151 days after the conclusion of the PHE.
5 https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf
Updated 10/13/22 43
CMS Section 1135 Waiver Authority: Blanket Waivers, Provider/Supplier Individual
Waivers, Medicaid and Special Waivers
Medicare Blanket Waivers
• Approval: CMS implements specific waivers or modifications under the 1135 authority on a
“blanket” basis when a determination has been made that all similarly situated providers in the
emergency area need such a waiver or modification. These waivers prevent gaps in access to
care for beneficiaries impacted by the emergency. Once approved these waivers apply
automatically to all applicable providers and suppliers. Providers and suppliers do not need
to apply for an individual waiver if a blanket waiver is issued by CMS.
• Claims Submission for Blanket Waivers: When submitting claims covered by the blanket
waivers, the “DR” (disaster-related) condition code should be used for institutional billing (i.e.,
claims submitted using the ASC X12 837 institutional claims format or paper Form CMS-1450).
The “CR” (catastrophe/disaster-related) modifier should be used for Part B billing, both
institutional and non-institutional (i.e., claims submitted using the ASC X12 837 professional
claim format or paper Form CMS-1500 or, for pharmacies, in the NCPDP format). This
requirement does not apply for purposes of compliance with waivers (blanket or individual) of
sanctions under the physician self-referral law.
Medicare Provider/Supplier Individual Waivers
• Approval: Providers and suppliers can submit requests for individual 1135 waivers. These
requests must include a justification for the waiver and expected duration of the
modification requested. The State Survey Agency and CMS Survey Operations Group will
review the provider’s request and make appropriate decisions, usually on a case-by-case
basis. Providers and suppliers should keep careful records of beneficiaries to whom they
provide services, in order to ensure that proper payment may be made. Providers are
expected to come into compliance with any waived requirements prior to the end of the
emergency period.
• With the exception of physician self-referral law waivers, the process for requesting an 1135
waiver is managed through the Survey Operations Group, and CMS locations, previously
known as the CMS Regional Offices. More information on the process is located at
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertEmergPrep/1135-Waivers. The website includes contact information
for each CMS location. Facilities should ensure to review the process and identify the
appropriate contact based on the location of the facility.
Examples of Individual Requests for 1135 Waivers
An individual hospital may request a waiver of COPs related to doubling of single occupancy
patient rooms or a waiver of the requirement to discharge to a specified location or situation.
Updated 10/13/22 44
Waiver Request Process
You do not have to make a request for a blanket waiver that has already been issued, and you do
not have to notify CMS if you are taking action in accordance with a waiver during the time period
in which the waiver is valid. If you are requesting an 1135 waiver outside of those outlined in this
document or are already available at the CMS Current Emergencies page, please send your
request or questions about a request to 1135waiver@cms.hhs.gov.
Medicaid Waivers
Approval
CMS works with the states and territories to respond to public health emergencies and disasters.
States and territories have multiple strategies available to support Medicaid and CHIP Operations
and enrollees in times of crisis. Some of these strategies are available without needing approval
from CMS while some disaster-related and Public Health Emergency legal authorities include:
• Medicaid State Plan Amendments;
• CHIP Disaster Relief State Plan Amendments;
• Verification Plans;
• 1915(c) Waivers Appendix K;
• 1135 Waivers; and
• 1115 Demonstrations.
In Medicaid and CHIP, 1135 waivers can be used to implement a range of flexibilities. Some of
these include: provider enrollment and participation; Medicaid prior authorization requirements;
pre-admission screening and annual resident review (PASARR) Level I and Level II Assessments for
30 days; extend minimum data set authorizations for nursing facility and SNF residents; state fair
hearing and appeal process timelines; and reporting and oversight. Under 1135 waivers, states
also have flexibility on public notice, tribal consultation, and the effective dates of state plan
amendment (SPA) submissions. For public notice, Section 1135 authority can be used to provide
flexibility related to the need and timing for public notice associated with cost sharing, Alternative
Benefit Plan (ABP) benefit and payment SPAs. Section 1135 authority can be used to provide
flexibility related to the timing of tribal consultation including shortening consultation or
conducting tribal consultation after submission of the SPA. For SPA submission dates, Section
1135 authority can be utilized to effectively permit states to submit a Medicaid SPA after the end
of this quarter and still have an effective date retroactive to the date of the declaration by the
Secretary of a Public Health Emergency.
In the event of a disaster or public health emergency, state Medicaid agencies should contact CMS
for questions and waiver requests. More information on this process is located at:
https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/index.html
Updated 10/13/22 45
Special Waivers
EMTALA:
Only two aspects of the EMTALA requirements can be waived under 1135 Waiver Authority: 1)
Transfer of an individual who has not been stabilized, if the transfer arises out of an emergency
or, 2) Redirection to another location (offsite alternate screening location) to receive a medical
screening exam under a state emergency preparedness or pandemic plan. A waiver of EMTALA
sanctions is effective only if actions under the waiver do not discriminate as to source of payment
or ability to pay. Hospitals are generally able to manage the separation and flow of potentially
infectious patients through alternate screening locations on the hospital campus.
Therefore, waivers to provide Medical Screening Examinations at an offsite alternate screening
location not owned or operated by the hospital will be reviewed on a case-by-case basis. Please
note, there is no waiver authority available for any other EMTALA requirement.
For the duration of the COVID-19 national emergency, CMS is waiving the enforcement of section
1867(a) of the Social Security Act (the Emergency Medical Treatment and Active Labor Act, or
EMTALA). This will allow hospitals, psychiatric hospitals, and CAHs to screen patients at a location
offsite from the hospital’s campus to prevent the spread of COVID-19, in accordance with the
state emergency preparedness or pandemic plan.
Individual Physician Self-Referral Law Waiver Requests:
CMS has issued blanket waivers of sanctions under the physician self-referral law. The blanket
waivers may be used now without notifying CMS. For more information, visit: https://www.
cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Spotlight.
Unlike other 1135 waiver requests, any requests for individual waivers of sanctions under the
physician self-referral law related to COVID-19 will be handled by CMS Baltimore. Please send
your request to 1877CallCenter@cms.hhs.gov and include the words “Request for 1877(g)
Waiver” in the subject line of the email. All requests should include the following minimum
information:
• Name and address of requesting entity;
• Name, phone number and email address of person designated to represent the entity;
• CMS Certification Number (CCN) or Taxpayer Identification Number (TIN);
• Nature of request.
Individual waivers may be granted only upon request and on a case-by-case basis and require
specific details concerning the actual or proposed financial relationship between the referring
physician(s) and the referred-to entity. Unless and until a waiver of sanctions under the physician
self-referral law (i.e., a waiver of section 1877(g) of the Social Security Act) is granted to the
requesting party(ies), such party(ies) must comply with section 1877 of the Social Security Act and
the regulations at 42 CFR §411.350 et seq.
Updated 10/13/22 46
Helpful Website Resources
• Approved 1135 Waivers: https://www.cms.gov/files/document/covid19-emergency-
declaration-health-care-providers-fact-sheet.pdf
• Approved Telehealth Waivers: https://www.cms.gov/newsroom/fact-sheets/medicare-
telemedicine-health-care-provider-fact-sheet
• 1135 Waiver Request Information: https://www.cms.gov/Medicare/Provider-Enrollment-
and-Certification/SurveyCertEmergPrep/1135-Waivers
• Medicare Fee-For-Service Additional Emergency and Disaster-Related Policies and Procedures
That May Be Implemented Only With an §1135 Waiver: https://www. cms.gov/About-
CMS/Agency-Information/Emergency/Downloads/MedicareFFS-
EmergencyQsAs1135Waiver.pdf
• Blanket Waivers – Claims Submission: https://www.cms.gov/files/document/se20011.pdf
• Frequently Asked Questions – 1135 Waivers: https://www.cms.gov/About-CMS/Agency-
Information/Emergency/Downloads/MedicareFFS-EmergencyQsAs1135Waiver.pdf
• Frequently Asked Questions – non-1135 Waivers: https://www.cms.gov/About-CMS/ Agency-
Information/Emergency/Downloads/Consolidated_Medicare_FFS_Emergency_ QsAs.pdf
• Medicaid Disaster Response Toolkit: https://www.medicaid.gov/state-resource-center/
disaster-response-toolkit/index.html
CMS Oversight
CMS remains committed to ensuring continuity of oversight activities during a national public
health emergency. We continue to work State Survey Agencies and accrediting organizations,
charged with inspecting Medicare and Medicaid providers to ensure compliance with federal
requirements, to ensure these activities are prioritized to allow providers to focus on current
health and safety threats and provide needed care to beneficiaries. We will continue to monitor
program operations to support proper enrollment and accurate billing practices. CMS will
coordinate our oversight activities with the OIG and GAO.
Updated 10/13/22 47
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- www.cms.gov