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Summary

A CMS fact sheet, Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities): CMS Flexibilities to Fight COVID-19, with pages dated May 10, 2023. It describes the waivers and flexibilities CMS used during the COVID-19 public health emergency (PHE) and how they end, and notes that it covers Medicare and Medicaid flexibilities only. It states that CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in most outpatient settings until the end of the calendar year in which the EUA declaration ends, after which the rate will be approximately $30 per dose. Other sections cover monoclonal antibodies, remdesivir, over-the-counter tests and waivers such as the three-day prior hospitalization requirement. The fact sheet closes with SARS-CoV-2 testing requirements for long-term care facilities, effective September 2, 2020.

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“Ppr Int 9580332C6C21Ded7 Long Term Care Facilities Skilled Nursing Facilities And Or Nursi - Ppr Int 9580332C6C21Ded7 Long Term Care.” Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/ppr-int-9580332c6c21ded7-long-term-care-facilities-skilled-nursing-facilities-and-or-nursing-facilities-p-1c116f157a/, SHA-256 de2ed473c5b92c1676e6f6d31ff330f6e0dc945b116044945064b31f33a5daf1.

Full text

   Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing
            Facilities): CMS Flexibilities to Fight COVID-19
At the beginning of the COVID-19 Public Health Emergency (PHE), CMS used emergency waiver
authorities and various regulatory authorities to enable flexibilities so providers could rapidly
respond to people impacted by COVID-19. CMS developed a cross-cutting initiative to use a
comprehensive, streamlined approach to reestablish certain health and safety standards and
other financial and program requirements at the eventual end of the COVID-19 public health
emergency.

This CMS cross-cutting initiative focused on evaluating CMS-issued PHE waivers and flexibilities
to prepare the health care system for operation after the PHE. This review happened in three
concurrent phases:

1. CMS assessed the need for continuing certain waivers based on the current phase of the
   PHE. Since the beginning of the PHE, CMS has both added and terminated flexibilities and
   waivers as needed. In doing so, CMS considered the impacts on communities — including
   underserved communities — and the potential barriers and opportunities that the
   flexibilities may address.

2. CMS assessed which flexibilities would be most useful in a future PHE, such as natural and
   man-made disasters and other emergencies, to ensure a rapid response to future
   emergencies, both locally and nationally, or to address the unique needs of communities
   that may experience barriers to accessing health care.

3. CMS is continuing to collaborate with federal partners and the health care industry to
   ensure that the health care system is holistically prepared for addressing future
   emergencies.

As CMS identified barriers and opportunities for improvement, the needs of each person and
community served were considered and assessed with a health equity lens to ensure our
analysis, stakeholder engagement, and policy decisions account for health equity impacts on
members of underserved communities and health care professionals disproportionately serving
these communities.

Please note: This fact sheet focuses on Medicare and Medicaid flexibilities only.

COVID-19 Vaccines
On October 28, 2020, CMS released an Interim Final Rule with comment period (IFC)
announcing that Medicare Part B would establish coding and payment rates for COVID-19
vaccines and their administration as preventive vaccines, without cost-sharing, as soon as the


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Food and Drug Administration (FDA) authorized or approved the product through an
Emergency Use Authorization (EUA) or Biologics License Application (BLA). The IFC also
implemented provisions of the CARES Act to ensure swift coverage of COVID-19 vaccines by
private health insurance plans participating in the Health Insurance Marketplace, without cost
sharing, from both in- and out-of-network providers, during the course of the public health
emergency (PHE).

For patients in a Part A-covered SNF stay, CMS exercised “enforcement discretion,” which
allowed Medicare-enrolled immunizers, including but not limited to pharmacies working with
the United States, to bill directly and receive direct payment from the Medicare program for
vaccinating Medicare SNF residents.

Payment After the End of the PHE
CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in
most outpatient settings for Medicare beneficiaries through the end of the calendar year in
which the Secretary ends the EUA declaration for drugs and biologicals with respect to COVID-
19.

Effective January 1 of the year following the year in which the EUA declaration ends, CMS will
set the payment rate for administering COVID-19 vaccines to align with the payment rate for
administering other Part B preventive vaccines, that is, approximately $30 per dose.

The enforcement discretion described above associated with vaccinating Medicare SNF
residents will end on June 30th, 2023, meaning that immunizers will no longer be able to bill
Medicare directly for vaccines furnished to patients for a Medicare Part A-covered SNF stay.
Beginning on July 1, typical SNF consolidated billing regulations will be in place, which require
SNFs to bill for all services furnished to patients in a Medicare-covered SNF stay, including
vaccines.

Additional Payment for Administering the Vaccine in the Patient’s Home
In calendar year 2023, CMS will pay approximately $36 in addition to the standard
administration amount (approximately $40) per dose to administer COVID-19 vaccines in the
home for certain Medicare patients. For vaccines requiring multiple doses, this payment applies
for each dose in the series, including any additional or booster doses. We also geographically
adjust the additional amount and administration rate based on where you administer the
vaccine. Starting January 1, 2023, we’ll also annually update the additional in-home payment
rate for administering the COVID-19 vaccine to reflect changes in costs related to administering
preventive vaccines.




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Additional Payment for Administering the Vaccine in the Patient’s Home After the End of the
PHE
We’ll continue to pay a total payment of approximately $76 per dose to administer COVID-19
vaccines in the home for certain Medicare patients through calendar year 2023. The additional
payment is not affected by the end of the PHE.

More information: COVID-19 vaccine toolkits
   • Providers
          o Payment
          o Billing
          o Coding
   • Health & Drug Plans
   • State Medicaid programs

COVID-19 Monoclonal Antibodies
There are currently no COVID-19 monoclonal antibodies approved or authorized for use
against the dominant strains of COVID-19 in the United States.
The FDA issued emergency use authorizations (EUA) for monoclonal antibody therapies used
for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive
COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or
hospitalization. The FDA also issued an EUA for a monoclonal antibody product used as a pre-
exposure prophylaxis of COVID-19 in adults and pediatric patients with certain conditions.

During the EUA declaration for drugs and biologicals with respect to COVID-19, CMS covers and
pays for these infusions or injections the same way it covers and pays for COVID-19 vaccines
when furnished consistent with the EUA. There’s also no beneficiary cost sharing and no
deductible for COVID-19 monoclonal antibody products when providers administer them. In the
event these products become approved or authorized for use, they will continue to be covered
and paid under the Medicare Part B preventive vaccine benefit until the end of the calendar
year in which the Secretary ends the EUA declaration. This coverage and payment will continue
even if the PHE ends.

CMS doesn’t pay for the COVID-19 monoclonal antibody product when a health care setting has
received it for free. If a health care setting purchased the product from the manufacturer,
Medicare pays the reasonable cost or 95% of the average wholesale price.

More information: COVID-19 Monoclonal Antibodies




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Payment After the End of the PHE
Effective January 1 of the year in which the Secretary ends the EUA declaration for drugs and
biologicals with respect to COVID-19, CMS will pay for monoclonal antibodies used for the
treatment or for post-exposure prophylaxis of COVID-19:

   •   As we pay for biological products under Section 1847A of the Social Security Act.

   •   Through the applicable payment system, using the appropriate coding and payment
       rates, similar to the way we pay for administering other complex biological products.

Monoclonal antibodies that are used for pre-exposure prophylaxis prevention of COVID-19 will
continue to be paid under the Part B preventive vaccine benefit if they meet applicable
coverage requirements.
COVID-19 VEKLURYTM (remdesivir)
 As of April 25, 2022, the FDA updated the approval of VEKLURYTM (remdesivir) as approved for
the treatment of COVID-19. The federal government didn’t purchase a supply of remdesivir.
Medicare Part B provides payment for the drug and its administration under the applicable
Medicare Part B payment policy when a facility or practitioner provides it in the outpatient
setting, according to the FDA approval. In most cases, the Medicare patient’s yearly Part B
deductible and 20% co-insurance apply. Beginning on January 1, 2024, for beneficiaries in a
Medicare Part A-covered SNF stay, payment for remdesivir would be subject to SNF
consolidated billing and would not be separately billable to Part B.

Medicare Coverage for Over-the-Counter COVID-19 Tests. On April 4, 2022, Medicare
implemented a demonstration program to allow people with Medicare to receive up to eight
tests per calendar month at no cost. This is the first time that Medicare has covered an over-
the-counter, self-administered, test. This new initiative enables people with Medicare Part B,
including those enrolled in a Medicare Advantage plan, to receive tests at no cost from
providers and suppliers who are eligible to participate. Pharmacies and other health care
providers interested in participating in this initiative can get more information here:
https://www.cms.gov/COVIDOTCtestsProvider. This program will end at the end of the COVID-
19 public health emergency.




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Reducing Administrative Burden
   •   Physical Environment: Provided that the state has approved the location as one that
       sufficiently addresses safety and comfort for patients and staff, CMS waived
       requirements under 42 CFR §483.90 to allow for a non-SNF/NF building to be
       temporarily certified as, 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 is
       available while protecting other vulnerable adults. CMS believed that this flexibility
       provided another measure that relinquished inpatient care beds at hospitals for the
       most acute patients, while providing beds for those still in need of care. CMS waived
       certain conditions of participation and certification requirements for opening a SNF/NF
       if the state determines there is a need to quickly stand up a temporary COVID-19
       isolation and treatment location. To assist with isolation needs, CMS also temporarily
       allowed 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 flexibility was allowed so long as it was not inconsistent with
       a state’s emergency preparedness or pandemic plan, or as directed by the local or state
       health department. (This waiver terminated on 06-06-2022 per QSO-22-15-
       NH&NLTC&LSC)

   •   Three-Day Prior Hospitalization: Using the statutory flexibility under Section 1812(f) of
       the Social Security Act, CMS temporarily waived the requirement for a three-day prior
       hospitalization for coverage of a skilled nursing facility (SNF) stay. This waiver provides
       temporary emergency coverage of SNF services without a qualifying hospital stay. In
       addition, for certain beneficiaries who exhausted their SNF benefits, it authorizes a one-
       time renewed SNF coverage without first having to start and complete a 60-day
       “wellness period” (that is, the 60-day period of non-inpatient status that is normally
       required in order to end the current benefit period and renew SNF benefits). This waiver
       will apply only for those beneficiaries who have been delayed or prevented by the
       emergency itself from commencing or completing the 60-day “wellness period” that
       would have occurred under normal circumstances. By contrast, if the patient has a
       continued skilled care need (such as a feeding tube) that is unrelated to the COVID-19
       emergency, then the beneficiary cannot renew his or her SNF benefits under the Section
       1812(f) waiver, as it is this continued skilled care in the SNF rather than the emergency
       that is preventing the beneficiary from beginning the 60-day “wellness period.” This
       waiver will terminate at the end of the COVID-19 PHE.




                                                                                       05/10/2023    5
•   Reporting Minimum Data Set: CMS waived 42 CFR §483.20 to provide relief to SNFs on
    the timeframe requirements for Minimum Data Set assessments and transmission. This
    waiver terminated and reporting of Minimum Data Set was reinstated May 10, 2021
    QSO-21-17-NH.

•   Staffing Data Submission: CMS waived 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. This waiver terminated and submission of staffing data through
    the Payroll Based Journal system was reinstated on June 25, 2020.

•   Waive Pre-Admission Screening and Annual Resident Review (PASRR): CMS has been
    allowing states and nursing homes to suspend these assessments for new residents for
    30 days. After 30 days, new patients admitted to nursing homes with a mental illness
    (MI) or intellectual disability (ID) should receive the assessment as soon as resources
    become available. CMS will end this waiver at the conclusion of the COVID-19 PHE.

•   Resident Groups: CMS waived the requirements at §483.10(f)(5) to allow for residents to
    have the right to participate in-person in resident groups. This waiver only permitted the
    facility to restrict having 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. (This
    waiver was terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC.0)

•   Quality Assurance and Performance Improvement (QAPI). CMS modified certain
    requirements in 42 CFR §483.75, which required long-term care facilities to develop,
    implement, evaluate, and maintain an effective, comprehensive, data-driven QAPI
    program. Specifically, CMS modified §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 waiver helped to ensure facilities focused on aspects of care delivery most closely
    associated with COVID-19 during the PHE. (This waiver was terminated on 05-07-2022
    per QSO-22-15-NH&NLTC&LSC)

•   In-Service Training: CMS modified 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, CMS
    postponed 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
    waiver was terminated on 06-06-2022 per QSO-22-15-NH&NLTC&LSC).

•   Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC)
    Facilities. CMS waived the discharge planning requirement in §483.21(c)(1)(viii), which
    required LTC facilities to assist residents and their representatives in selecting a post-


                                                                                     05/10/2023   6
    acute care provider using data, such as standardized patient assessment data, quality
    measures and resource use. This temporary waiver provided facilities the ability to
    expedite discharge and movement of residents among care settings. CMS maintained all
    other discharge planning requirements, such as but not limited to, ensuring that the
    discharge needs of each resident were identified and resulted in the development of a
    discharge plan for each resident; and involving the interdisciplinary team, as defined at
    42 CFR §483.21(b)(2)(ii), in the ongoing process of developing the discharge plan to
    address the resident's goals of care and treatment preferences. (This waiver was
    terminated on 05-07-2022 per QSO-22-15-NH&NLTC&LSC)

•   Clinical Records. Pursuant to section 1135(b)(5) of the Act, CMS modified the
    requirement at 42 CFR §483.10(g)(2)(ii), which required 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 modified the timeframe requirements to allow LTC
    facilities ten working days to provide a resident’s record rather than two working days.
    (This waiver was terminated on 05-07-2022 per QSO-22-15-NH&NLTC&LSC)

•   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 07-06-2020 and CMS, in
             accordance with 42 CFR §§ 424.517 and 424.518, resumed all provider
             enrollment site visits.)

           •   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, Opioid Treatment Programs). (This waiver terminated
               on 10/31/2021 and CMS, in accordance with 42 CFR § 424.518, resumed
               requesting fingerprints for all newly enrolling high-risk providers and
               suppliers.)

    o 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 CFR §
      424.514, resumed collecting application fees.)



                                                                                   05/10/2023    7
       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 November 2021 with due dates in early 2022.)

       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


Establish data reporting vehicle critical to addressing the pandemic
    • Required Facility Reporting: Under §483.80(g), long-term care facilities are required to
        report COVID-19 cases in their facility to the CDC National Health Safety Network
        (NHSN) on a weekly basis. CDC and CMS will use information collected through the new
        NHSN Long-term Care COVID-19 Module to strengthen COVID-19 surveillance locally
        and nationally; monitor trends in infection rates; and help local, state, and federal
        health authorities get help to nursing homes faster. Nursing home reporting to the CDC
        is a critical component of the national COVID-19 surveillance system and to efforts to
        reopen America. The information will also be posted online for the public to be aware of
        how the COVID-19 pandemic is affecting nursing homes. In COVID-19 Public Health
        Emergency Interim Final Rule #3 (CMS-3401-IFC), CMS is codifying enforcement actions
        for facilities’ noncompliance with this requirement. Failure to report will result in the
        imposition of a civil money penalty for each occurrence of non-reporting as follows: A
        civil money penalty of $1,000 for the first occurrence, followed by $500 added to the
        previously imposed civil money penalty for each subsequent occurrence, not to exceed
        the maximum amount set forth in § 488.408(d)(1)(iii).

       Facilities are also required to notify residents, their representatives, and families of
       residents in facilities of the status of COVID-19 in the facility, which includes any new
       cases of COVID-19 as they are identified. This action supports CMS’ commitment to
       transparency so that individuals know important information about their environment,
       or the environment of a loved one. The 2022 CY Home Health PPS Rule extended this
       mandatory COVID-19 reporting requirement beyond the current COVID-19 PHE until
       December 31, 2024.

   Payment
   • COVID-19 Accelerated and Advance Payments (CAAP): For the most up to date
      information related to the CAAP Program please visit
      https://www.cms.gov/medicare/covid-19-accelerated-and-advance-payments


                                                                                      05/10/2023    8
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 COVID-19 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 COVID-19
    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
    405.910) 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 COVID-19 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 use
    information that is available (42 CFR 422.562 and 42 CFR 423.562). When the COVID-19
    PHE ends, requests for appeals must meet the existing regulatory requirements.


                                                                                    05/10/2023    9
   •   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 may only be provided consistent with
       existing regulatory authority.

   •   Cost Reporting. Providers that continue to experience the impacts of the PHE and
       require additional time to file their cost report may submit a request to their MAC in
       accordance with our regulation at 42 CFR 413.24 (f)(2)(ii). The MAC has the authority to
       grant up to a 60-day extension of the due date for filing a cost report if the provider's
       operations are significantly adversely affected due to extraordinary circumstances over
       which the provider has no control, such as the PHE.

Temporary Expansion Sites
  • Transfers of COVID -19 Patients: A long term care (LTC) facility can temporarily transfer
     its COVID-19 positive resident(s) to another facility, such as a COVID-19 isolation and
     treatment location, with the provision of services “under arrangements.” The
     transferring LTC facility need not issue a formal discharge in this situation, 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. This is consistent with recent CDC
     guidance, and helps residents with COVID-19 by placing them into facilities that are
     prepared to care for them. It also helps residents without COVID-19 by placing them in
     facilities without other COVID-19 residents, thus helping to protect them from being
     infected.

       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 SNF 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.

   •   Resident Transfer and Discharge: CMS waived requirements in 42 CFR 483.10(c)(5);
       483.15(c)(3) (which was Terminated on 05/10/2021 per QSO-21-17); and (d), (which was
       also terminated on 05/10/2021 per QSO-21-17), with some exceptions noted below, to
       allow a long-term care facility to transfer or discharge residents to another LTC facility
       solely for the following cohorting purposes:



                                                                                         05/10/2023     10
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, as well as providing treatment or therapy for other conditions as required
   by the resident’s plan of care.

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:
   o 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.

   o 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
     continue to apply. Similarly, in § 483.15, we only waived the requirement, under
     § 483.15(c)(3), (c)(4)(ii) (which was 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.

   o In § 483.21, CMS only waived 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 expected 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 they apply to. (This
     waiver was terminated on 05/10/2021 per QSO-21-17).

   o 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,” while remaining consistent with a state’s
     emergency preparedness or pandemic plan, or as directed by the local or state
     health department. In these cases, the transferring LTC facility need not issue a
     formal discharge, as it is still considered the resident’s provider and should bill

                                                                                05/10/2023   11
           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.

•   Resident Roommates and Grouping: CMS has been waiving the requirements in 42 CFR
    483.10(e)(5), (6), (note that Section (6) was 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, 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.

•   Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of
    Participation: CMS has been waiving certain physical environment requirements for
    Hospitals, 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. (Waivers terminated 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 06-06-2022 per QSO-22-
    15-NH&NLTC&LSC).

                                                                                     05/10/2023     12
•   Specific Physical Environment Waiver Information: 42 CFR §482.41(d) for hospitals,
    §485.623(b) for CAH, §418.110(c)(2)(iv) for inpatient hospice, §483.470(j) for ICF/IID;
    and §483.90 for SNFs/NFs all required these facilities and their equipment to be
    maintained to ensure an acceptable level of safety and quality. CMS temporarily
    modified 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. (Waivers terminated 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 06-06-2022 per
    QSO-22-15-NH&NLTC&LSC).

•   42 CFR §482.41(b)(1)(i) and (c) for hospitals, §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 required these facilities to be in compliance
    with the Life Safety Code (LSC) and Health Care Facilities Code (HCFC). CMS temporarily
    modified 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:

       o Sprinkler system monthly electric motor-driven and weekly diesel engine-driven
         fire pump testing.

       o Portable fire extinguisher monthly inspection.

       o Elevators with firefighters’ emergency operations monthly testing.

       o Emergency generator 30 continuous minute monthly testing and associated
         transfer switch monthly testing.

       o 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. (Waivers terminated 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 06-06-2022 per
         QSO-22-15-NH&NLTC&LSC).



•   42 CFR §483.470(e)(1)(i) for ICF/IIDs, and §483.90(a)(7) for SNFs/NFs required these
    facilities to have an outside window or outside door in every sleeping room. CMS
    permitted 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. (Waivers
    terminated §483.470(e)(1)(i) for ICF/IID and §483.90(a)(7) for SNFs/NFs on 06-06-2022


                                                                                     05/10/2023   13
       per QSO-22-15-NH&NLTC&LSC.)

   •   Specific Life Safety Code (LSC) for Multiple Providers: CMS has been waiving and
       modifying particular waivers under 42 CFR §483.470(j) for ICF/IIDs and §483.90(a) for
       SNF/NFs. Specifically, CMS modified these requirements as follows:

       o 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 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 populations 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 §483.470(j)(5)(ii) for
           ICF/IIDs and §483.90(a)(4) for SNF/NFs. CMS will end this waiver at the conclusion of the
           PHE.

       o Fire Drills: Due to the inadvisability of quarterly fire drills that move and mass staff
         together, CMS permitted 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. Refer to: 2012 LSC, sections 18/19.7.1.6. (Waivers terminated for fire
         drills at §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a)
         for SNF/NFs on 06-06-2022 per QSO-22-15-NH&NLTC&LSC.)

       o Temporary Construction: CMS waived requirements that would otherwise not
         permit temporary walls and barriers between patients. Refer to: 2012 LSC, sections
         18/19.3.3.2. (Waivers terminated for temporary construction at §418.110(d) for
         inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a) for SNF/NFs on 06-06-
         2022 per QSO-22-15--NH&NLTC&LSC.)

Workforce
      Physician Services: CMS provided 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 has waived 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 has
         given 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


                                                                                              05/10/2023   14
       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 temporarily
       modified this regulation to specify that any task delegated under this waiver must
       continue to be under the supervision of the physician. This waiver did 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.
       (This waiver terminated on 05-07-2022 per QSO-22-15-NH&NLTC&LSC.)


    o Physician Visits: 42 CFR 483.30(c)(3). CMS waived 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 modified this provision to permit
      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. (This waiver was
      terminated on 05-07-2022 per QSO-22-15-NH&NLTC&LSC.)

    o Note to Facilities: These actions assisted in potential staffing shortages, maximized
      use of medical personnel, and protecting the health and safety of residents during
      the PHE. We note that CMS did not waive the requirements for the frequency of
      required physician visits at § 483.30(c)(1). As set out above, we 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 did not waive 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. (This waiver terminated on 05-07-2022 per
      QSO-22-15-NH&NLTC&LSC.)

•   Training and Certification of Nurse Aides: CMS waived the requirements at 42 CFR
    §483.35(d), (except for 42 CFR §483.35(d)(1)(i)), which required 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 had waived 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 did not waive §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 did not waive §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. Achieving adequate staffing
    levels may be a concern for SNFs and NFs during the public health emergency. CMS

                                                                                      05/10/2023    15
    temporarily waived these requirements so they do not present barriers for SNFs and NFs
    to hire staff; the temporary waiver helped these facilities provide adequate levels of
    staffing for the duration of the COVID-19 pandemic. (This waiver terminated on 06-06-
    2022 per QSO-22-15-NH&NLTC&LSC.)

•   Paid Feeding Assistants: CMS modified the requirements at 42 CFR §§ 483.60(h)(1)(i)
    and 483.160(a) regarding required training of paid feeding assistants. Specifically, CMS
    modified the minimum timeframe requirements in these sections, which require this
    training to be a minimum of eight hours. CMS modified to allow that the training can be
    a minimum of one hour in length. CMS did not waive 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 did not waive or modify 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). (This waiver terminated on 06-06-2022 per
    QSO-22-15-NH&NLTC&LSC.)
•   In-Service Training: CMS modified 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
    postponed 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
    waiver terminated on 06-06-2022 per QSO-22-15-NH&NLTC&LSC.)

•   Clinical Records: Pursuant to section 1135(b)(5) of the Act, CMS modified 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 modified the timeframe requirements to allow LTC
    facilities ten working days to provide a resident’s record rather than two working days.
    (This waiver terminated on 05-07-2022 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


                                                                                   05/10/2023    16
         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 has been 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

   •   Established new requirements for Long Term Care Facilities to Conduct SARS-CoV-2
       Testing for Staff and Residents: Under the new 483.80(h) CMS is requiring Long-Term
       Care (LTC) Facilities to test Staff and Residents. Specifically, facilities are required to test
       residents and staff, including individuals providing services under arrangement and
       volunteers, for COVID-19 based on parameters set forth by the Secretary. This rule will
       enhance efforts to keep COVID-19 from entering and spreading through nursing homes.
       These regulations are effective on September 2, 2020. Applicability date: These
       regulations are applicable for the duration of the PHE for COVID–19. Note that section
       488.447 is applicable one year beyond the expiration of the PHE for COVID–19.

Medicare Telehealth
  • Physician Visits: 42 CFR 483.30(c)(3). CMS waived 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 modified this provision to permit 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. (This waiver terminated on 05-07-2022 per QSO-22-
      15-NH&NLTC&LSC.)

Additional Guidance
   • The Interim Final Rule and waivers can be found at: https://www.cms.gov/about-
       cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-
       waivers.
   • CMS has released guidance to describe standards of practice for infection control and
       prevention of COVID-19 at https://www.cms.gov/files/document/qso-20-14-nh-
       revised.pdf
   • CMS has released guidance to providers related to relaxed reporting requirements for
       quality reporting programs at https://www.cms.gov/files/document/guidance-memo-
       exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf
   • Additional COVID-19 resources for long-term care facilities are available at
       https://www.cms.gov/nursing-homes.




                                                                                           05/10/2023     17


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