End Stage Renal Disease (ESRD) Facilities: CMS Flexibilities to Fight COVID-19
Summary
A CMS fact sheet, End Stage Renal Disease (ESRD) Facilities: CMS Flexibilities to Fight COVID-19. It states that at the beginning of the COVID-19 Public Health Emergency CMS used emergency waiver authorities and regulatory authorities to enable flexibilities, and that CMS developed a cross-cutting initiative to reestablish health and safety standards and other requirements at the eventual end of the emergency. It describes a review in three concurrent phases and notes that the fact sheet focuses on Medicare and Medicaid flexibilities only. It then covers COVID-19 vaccines, stating that on October 28, 2020 CMS released an Interim Final Rule with comment period on Medicare Part B coding and payment for COVID-19 vaccines.
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“End Stage Renal Disease (ESRD) Facilities: CMS Flexibilities to Fight COVID-19.”
Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/ppr-int-03861bf8caf17773-end-stage-renal-disease-esrd-facilities-pdf-9ffb4eee4e/
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End Stage Renal Disease (ESRD) 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 COVID-19 public
health emergency (PHE).
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. The EUA declaration is distinct from, and not dependent on, the PHE for 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.
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.
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
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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
Payment After the End of the PHE
Effective January 1 of the year following 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.
Monoclonal antibodies would not be considered renal dialysis services and would not be paid
under the ESRD PPS. Monoclonal antibodies furnished to ESRD patients might be separately
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payable to the dialysis facility if the drug was not used for the treatment of ESRD. The facility
must include the modifier AY to indicate it was not for the treatment of ESRD.
Reducing Administrative Burden
• Training Program and Periodic Audits: CMS has been waiving the requirement at
494.40(d) 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. CMS will end this waiver at the conclusion of the COVID-19 PHE.
• Equipment Maintenance & Fire Safety Inspections: CMS has been waiving requirements
at §494.60(b) and §94.60(d) to reduce non-essential people entering the facility to
reduce risk of exposure to the virus. These waivers are intended to ensure that dialysis
facilities are able to focus on the operations related to the public health emergency.
(This waiver terminated on 6/6/2022).
• Emergency Preparedness: CMS has been waiving the requirements at §494.62(d)(1)(iv),
which requires ESRD facilities to demonstrate as part of their Emergency Preparedness
Training and Testing Program that, at a minimum, its patient care staff maintains
current CPR certification. CMS has been waiving the requirement for maintenance of
CPR certification during the COVID-19 emergency due to the limited availability of CPR
classes. CMS will end this waiver at the conclusion of the COVID-19 PHE.
• Ability to Delay Some Patient Assessments: To ensure that dialysis facility staff can focus
on the increased care demands related to the COVID-19 pandemic, CMS has been
waiving certain requirements at §494.80(b) related to the frequency of assessment for
patients admitted to the dialysis facility. CMS has been 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. CMS is not waiving
subsections (a) or (c) of 42 CFR §494.80. We maintain expectations for conducting the
assessment, ensuring the adequacy of the dialysis treatment, and assessing the patient’s
needs when there is a change in condition.
Specifically, CMS has been 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
30calendar days or 13 outpatient hemodialysis sessions beginning with the first
outpatient dialysis session. CMS will end this waiver at the conclusion of the
COVID-19 PHE.
o §494.80(b) (2): A follow-up comprehensive reassessment must occur within
three months after the completion of the initial assessment to provide
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information to adjust the patient's plan of care specified in §494.90. CMS will
end this waiver at the conclusion of the COVID-19 PHE.
• 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.
• 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
• 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.)
o Revalidation: CMS postponed all revalidation actions. This did not prevent a provider
who wanted to submit a revalidation application from doing so; MACs processed
revalidation applications. (This waiver terminated on 10/31/2021 and CMS
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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.
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 Contractors (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
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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.
• 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.
Medicare Telehealth for ESRD
• Time period for initiation of care planning and monthly physician visits: CMS is modifying
two requirements related to care planning, specifically:
o §494.90(b)(2): CMS has modified the requirement that the dialysis facility
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 to the plan of care within 15 days of the
completion of the additional patient assessments. CMS has been waiving the time
requirement for plan of care implementation during the time period of the national
emergency. CMS will end this waiver at the conclusion of the COVID-19 PHE.
o §494.90(b)(4): CMS has modified the requirement that the ESRD dialysis facility
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 has
been 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. After the PHE ends, the Consolidated
Appropriations Act, 2023 provides for an extension of telehealth flexibility through
December 31, 2024.
• Dialysis home visits to assess adaptation and home dialysis machine designation: CMS
has been waiving the requirement at 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
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patients to receive their dialysis treatments in the home or long-term care facility,
reference QSO-20-19-ESRD. CMS will end this waiver at the conclusion of the COVID-19
PHE.
Temporary Expansion Sites
• Special Purpose Renal Dialysis Facilities (SPRDF) designation expanded: During the PHE,
CMS has authorized the establishment of SPRDFs to address access to care issues due to
COVID-19 and the need to mitigate transmission among this vulnerable population. This
did not include the normal determination regarding whether there was a lack of access
to care as that standard was automatically met during the nationwide PHE. Approval as
a Special Purpose Renal Dialysis Facility does not require federal survey prior to
providing services. CMS will end this flexibility at the conclusion of the COVID-19 PHE.
• Furnishing dialysis services on the main premises: ESRD requirements at §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 has been waiving this
requirement to allow dialysis facilities to provide service to its patients in 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 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: furnish all dialysis care and
services; provide all equipment and supplies necessary; maintain equipment and
supplies in the off-premises location; and complete all equipment maintenance,
cleaning, and disinfection using appropriate infection control procedures and
manufacturer’s instructions for use. CMS will end this waiver at the conclusion of the
COVID-19 PHE.
• Clarification for billing procedures: Typically, ESRD beneficiaries are transported from an
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 bills 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 also applies
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 has their trained personnel administer the treatment in the SNF/NF.
In addition, the provider follows the CFCs. In particular, under the CFCs is the
requirement that to use a dialysis machine, the FDA-approved labeling must be adhered
05/10/2023 8
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). CMS will end this billing guidance at the conclusion of the COVID-19 PHE.
Workforce
• Dialysis Patient Care Technician certification: CMS has modified the requirement at §
494.140(e)(4) for patient care dialysis technicians, which requires certification under a
state certification program or a national commercially available certification program
within 18 months of being hired as a dialysis patient care technician for newly employed
dialysis patient care technicians. We are aware of the challenges that technicians are
facing with the limited availability and closures of testing sites during the time of this
crisis. CMS has allowed patient care technicians to continue working even if they have
not achieved certification within 18 months or have not met on-time renewals. CMS will
end this flexibility at the conclusion of the COVID-19 PHE; however, staff hired within
the last 18 months still have the remainder of their 18-month time period to become
certified.
• Transferability of physician credentialing: CMS has modified the requirement at
§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. CMS has allowed physicians who are
appropriately credentialed at a certified dialysis facility to provide care at designated
isolation locations (or separate COVID-19- only facilities designed to mitigate
transmission of the virus) without separate credentialing at that facility. This has been
implemented while remaining consistent with a state’s emergency preparedness or
pandemic plan. CMS will end this flexibility at the conclusion of the COVID-19 PHE.
Additional Guidance
• The Interim Final Rules 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 providers related to relaxed reporting requirements for
quality reporting programs 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 in dialysis facilities. We also described additional flexibilities for
dialysis facilities to mitigate transmission and expand home dialysis options.
https://www.cms.gov/files/document/qso-20-19-esrd.pdf.
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