[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75720-75768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25812]



[[Page 75719]]

Vol. 85

Wednesday,

No. 228

November 25, 2020

Part IV





Department of Health and Human Services





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Regulatory Relief to Support Economic Recovery; Request for Information 
(RFI); Notice

  Federal Register / Vol. 85 , No. 228 / Wednesday, November 25, 2020 / 
Notices  

[[Page 75720]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Regulatory Relief To Support Economic Recovery; Request for 
Information (RFI)

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Request for information.

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SUMMARY: Under an Executive Order that directs federal agencies to 
address the economic emergency created by the COVID-19 pandemic by 
rescinding, modifying, waiving, or providing exemptions from 
regulations and other requirements that may inhibit economic recovery, 
consistent with applicable law and with protection of the public health 
and safety, with national and homeland security, and with budgetary 
priorities and operational feasibility. The Order directs agencies to 
``identify regulatory standards that may inhibit economic recovery'' 
and to take appropriate action such as rescission or suspension of 
regulations, including by use of good cause or emergency authorities 
where appropriate. Agencies have likewise been called on to assess the 
various temporary deregulatory actions they have taken to fight COVID-
19 and its impact on our economy to determine which temporary 
regulatory actions should be made permanent. The Order directs agencies 
to assist businesses and other entities in complying with the law 
through prompt issuance of pre-enforcement rulings and to formulate 
policies of enforcement discretion that recognize such entities' 
efforts to comply with the law.

DATES: To be assured consideration, comments must be received at the 
address provided below, no later than 11:59 p.m. on December 28, 2020.

ADDRESSES: Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted 
electronically at http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Allison Beattie, Department of Health 
and Human Services, 200 Independence Avenue SW, Room 713F, Washington, 
DC 20201. Email: [email protected]. Telephone: (202) 690-7741.

SUPPLEMENTARY INFORMATION: Executive Order 13924, Regulatory Relief To 
Support Economic Recovery, 85 FR 31353 (May 19, 2020) calls on agencies 
to address the economic emergency caused by the COVID-19 pandemic by 
rescinding, modifying, waiving, or providing exemptions from 
regulations and other requirements that may inhibit economic recovery, 
consistent with applicable law and with protection of the public health 
and safety, with national and homeland security, and with budgetary 
priorities and operational feasibility. To implement the directives of 
E.O. 13924, the U.S. Department of Health and Human Services (``HHS'' 
or ``the Department'') identified in in response to this E.O. 382 
regulatory actions that it is considering to make permanent or keep as 
temporary made in response to the COVID-19 crisis to improve access to 
care and reduce costs that it is considering to make permanent or keep 
as temporary. See Attachment A (this list is not intended to be 
comprehensive: Additional actions have been made by the Department and 
will continue to occur in response to the PHE and pandemic) HHS is 
issuing this Request for Information (RFI) to collect information for 
the purpose of considering the costs and benefits, consistent with 
applicable law and with protection of the public health and safety, of 
retaining these particular regulatory changes beyond the COVID-19 
public health emergency. In addition to the costs and benefits of these 
actions, the Department seeks input on any barriers that may exist to 
making these deregulatory actions permanent including any evidence or 
experience that commenters have.
    Invitation to Comment: HHS invites comments regarding the questions 
included in this notice. To ensure that your comments are clearly 
stated, please identify the specific question, or other section of this 
notice, that your comments address. Please also refer to any specific 
HHS policy or policies listed in the Appendix to this notice (see 
Attachment A), if applicable, by reference to the numbers associated in 
the Appendix with these policies.\1\
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    \1\ Commenters on FDA guidance may also wish to refer to FDA's 
website COVID-19-Related Guidance Documents for Industry, FDA Staff, 
and Other Stakeholders, available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders and submit comments to the relevant docket associated 
with each guidance listed, in addition to responding to this RFI.
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    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

I. Background

    In December 2019, a novel coronavirus known as SARS-CoV-2 (``the 
virus'') was first noted by the People's Republic of China as having 
been detected in Wuhan, Hubei Province, People's Republic of China, 
causing an outbreak of the disease COVID-19, which has now spread 
globally. The Secretary of Health and Human Services declared a public 
health emergency (PHE) effective January 27, 2020, under section 319 of 
the Public Health Service Act (42 U.S.C. 247d), in response to COVID-
19, and has extended the declaration several times, most recently on 
October 2, 2020 effective October 23. In Proclamation 9994 of March 13, 
2020 (Declaring a National Emergency Concerning the Novel Coronavirus 
Disease (COVID-19) Outbreak), President Trump declared that the COVID-
19 outbreak in the United States constituted a national emergency, 
beginning March 1, 2020.
    The federal government has taken sweeping action to control the 
spread of the virus in the United States. HHS and its federal partners 
are working together with state, local, tribal and territorial 
governments, public health officials, healthcare providers, 
researchers, private sector organizations and the public to execute a 
whole-of-America response to the COVID-19 pandemic to protect the 
health and safety of the American people.
    In February 2020, Secretary Azar declared that circumstances 
justified the authorization of emergency use for tests to detect and 
diagnose COVID-19. In March 2020, the Secretary declared that 
circumstances justified the authorization of emergency use for drugs 
and biological products during the COVID-19 pandemic. Emergency Use 
Authorizations (EUAs) allow medical countermeasures to be authorized by 
the U.S. Food and Drug Administration (FDA), pursuant to certain 
criteria, during emergencies.\2\ Operation Warp Speed is a partnership 
among components of HHS, the Department of Defense, and industry

[[Page 75721]]

and academic partners with a goal to produce and deliver 300 million 
doses of safe and effective vaccines, with the initial doses available 
by January 2021, as part of a broader strategy to accelerate the 
development, manufacturing, and distribution of COVID-19 vaccines, 
therapeutics, and diagnostics (collectively known as 
countermeasures).\3\ The CDC is providing $10.25 billion to states, 
territories, and local jurisdictions, and the Indian Health Service is 
providing $750 million to tribal health programs for COVID-19 
testing.\4\ The CARES Act Provider Relief Fund supports American 
families, workers, and healthcare providers in the battle against the 
COVID-19 pandemic. HHS is distributing $175 billion to hospitals and 
healthcare providers on the front lines of the coronavirus response.\5\
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    \2\ Coronavirus (COVID-19) Testing, U.S. Dep't of Health and 
Human Serv.'s, https://www.hhs.gov/coronavirus/testing/index.html 
(last updated Aug. 19, 2020).
    \3\ Fact Sheet: Explaining Operation Warp Speed, U.S. Dep't of 
Health and Human Serv.'s https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html (last updated Sep. 1, 2020).
    \4\ Id.
    \5\ CARES Act Provider Relief Fund, U.S. Dep't of Health and 
Human Serv.'s, https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html (last updated Aug. 14, 2020).
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    During the COVID-19 PHE, HHS has taken steps to make it easier to 
provide telehealth services so patients may receive care without going 
to healthcare facilities.\6\ For example, the HHS Office for Civil 
Rights (OCR) has issued guidance stating that OCR will not impose 
penalties for violations of the HIPAA Privacy, Security, and Breach 
Notification Rules when healthcare providers covered by the Health 
Insurance Portability and Accountability Act (HIPAA) in good faith, 
provide telehealth services to patients using remote communication 
technologies, such as commonly used apps--including FaceTime, Facebook 
Messenger, Google Hangouts, Zoom, or Skype--for telehealth services. 
CMS has issued temporary measures to make it easier for people enrolled 
in Medicare, Medicaid, and the Children's Health Insurance Program 
(CHIP) to receive medical care through telehealth services during the 
COVID-19 PHE. It also significantly expanded the list of covered 
telehealth services that can be covered by Medicare providers through 
telehealth. During the public health emergency, Federally Qualified 
Health Centers (FQHCs) and Rural Health Clinics (RHCs) may serve as 
distant telehealth sites and provide telehealth services to patients in 
their homes.\7\ Likewise, FDA established a process to more rapidly 
disseminate and implement agency recommendations and policies related 
to COVID-19.\8\
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    \6\ Telehealth: Delivering Care Safely During COVID-19, U.S. 
Dep't of Health and Human Serv.'s, https://www.hhs.gov/coronavirus/telehealth/index.html (last updated Jul. 15, 2020).
    \7\ Id.
    \8\ United States, Food and Drug Administration. ``Process for 
Making Available Guidance Documents Related to Coronavirus Disease 
2019.'' 85 FR 16949 (March 25, 2020).
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    To continue the federal response to the COVID-19 pandemic, 
President Trump signed Executive Order 13924 on May 19, 2020, to direct 
agencies to continue to remove regulatory barriers that could be 
stymying American economic recovery.\9\ HHS is fulfilling this 
obligation by reviewing certain regulatory practices that could aid in 
economic recovery in ways that improve healthcare delivery.
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    \9\ Exec. Order No. 13924 (May 19, 2020).
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II. Request for Information

    To respond to the COVID-19 pandemic and its impact on the 
healthcare industry, HHS made changes to numerous regulations, agency 
guidance materials, or compliance obligations, or announced enforcement 
discretion (see Attachment A for a list of 382 of these actions) on 
either a temporary or permanent basis. Looking to the future, HHS 
intends that some of these regulatory changes (inclusive in this 
context of Agency guidance) will remain temporary and some will be made 
permanent, or permanent with modification. It may not be possible to 
make some of these changes permanent absent statutory changes, but HHS 
is still interested in comments to help us gauge the need for such 
changes. HHS will also consider phasing out or discontinuing regulatory 
changes that commenters show through evidence have negative impacts 
that outweigh the benefit of the regulatory change on a temporary basis 
or would have negative impacts that outweigh the benefits if continued 
beyond the PHE. Through this RFI, HHS seeks to gather feedback and 
relevant evidence from our stakeholders--healthcare providers and 
advocacy groups; industry trade groups; Medicare and Medicaid 
beneficiaries and caregivers; primary care and specialty providers; 
health insurance issuers offering health insurance coverage in the 
individual and group markets, group health plans sponsored by non-
federal governmental entities, and supplemental insurers; \10\ state, 
local, and territorial governments; research and policy experts; 
industry and professional associations; patients and patient advocacy 
groups; long-term care facilities, hospice providers, pharmacists, and 
pharmacy associations; nonprofit human services providers; and other 
interested members of the public. The information gathered in response 
to the RFI will be used to better inform HHS' decisions regarding which 
regulatory flexibilities used in the COVID-19 response should be kept 
temporary or made permanent. HHS and the entire U.S. government are 
committed to a healthy and resilient America. COVID-19 has had a 
sizable impact on the healthcare industry, which was forced to adjust 
to, among other things, remote and contactless care of patients in 
addition to caring for those directly affected by the virus, as well as 
on human services and other agencies working to promote well-being and 
economic mobility. Evidence-based feedback on how the 382 regulatory 
actions identified in Attachment A affect commenters' ability to 
provide or receive healthcare and services is welcome. Please note, 
however, that the Department may take or have taken steps to 
institutionalize or terminate items listed in Attachment A independent 
of the results of this RFI.
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    \10\ FAQs on Availability and Usage of Telehealth Services 
through Private Health Insurance Coverage in Response to Coronavirus 
Disease 2019 (COVID-19), Ctrs. for Medicare & Medicaid Servs. Ctr. 
for Consumer Info. and Ins. Oversight (Mar. 24, 2020), https://www.cms.gov/files/document/faqs-telehealth-covid-19.pdf.
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III. Key Questions

    1. Of the regulatory changes that have been made by the HHS in 
response to the COVID-19 PHE and the pandemic, please identify which 
changes;
    a. Have been beneficial to healthcare or human services providers, 
healthcare or human services systems, or to the patients and clients 
using these providers and systems, and under what circumstances; or
    b. Have been detrimental to healthcare or human services providers, 
healthcare or human services systems, or to the patients and clients 
using these providers and systems, and under what circumstances; or
    c. Have been beneficial to healthcare or human services providers, 
healthcare or human services systems, or to the patients and clients 
using these providers and systems on a temporary basis, but would be 
detrimental if continued, absent the exigencies of the COVID-19 PHE and 
pandemic.
    Please explain and provide any evidence you have of benefit or 
detriment.
    2. Of the regulatory changes that have been made by the Department 
of Health and Human Services in response to the COVID-19 PHE and the 
pandemic, please identify which changes:
    a. Should be maintained only for the duration of the PHE and 
pandemic;

[[Page 75722]]

    b. Should be maintained after the expiration of the PHE or the end 
of the pandemic; i.e., made permanent;
    c. Should be extended for a period of time after the expiration of 
the PHE or the end of the pandemic without being made permanent;
    d. Should be modified but maintained after the expiration of the 
PHE or the end of the pandemic, and thus made permanent with 
modifications, and what modifications are being proposed; or
    e. Should be discontinued immediately.
    Please explain and provide the rationale for your recommendation, 
including evidence for or against the short-term or long-term 
suitability of these regulatory changes. Please describe all suggested 
modifications for those changes that should be maintained with 
modification. Of the regulatory changes that have been made or been 
issued by the Department of Health and Human Services in response to 
the COVID-19 PHE, please identify which changes should be discontinued 
only following a transition period, and what type of transition period 
is recommended.

IV. Submission of Comments and Collection of Information Requirements 
Exemption

    Commenters may respond to any and all of the key questions as they 
pertain to any of the regulatory changes with which commenters have 
experience. HHS requests that commenters provide any evidence or 
experience they may have to support their recommendations. HHS asks 
that commenters identify by number the regulatory action(s) from 
Attachment A to which they are responding and submit their comments to 
the docket associated with this notice.\11\ Commenters may otherwise 
provide their responses in any format compatible with the instructions 
in this Request for Information they believe is appropriate for 
presenting their responses. Finally, HHS asks commenters to provide 
feedback and evidence explaining any unintended consequences of the 
particular regulatory actions.
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    \11\ Commenters on FDA guidance may also wish to refer to FDA's 
website COVID-19-Related Guidance Documents for Industry, FDA Staff, 
and Other Stakeholders, available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders and submit comments to the relevant docket associated 
with each guidance listed, in addition to responding to this RFI.
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    Please note, this is a RFI only. In accordance with the 
implementing regulations of the Paperwork Reduction Act of 1995 (PRA), 
specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt 
from the PRA. Facts or opinions submitted in response to general 
solicitations of comments from the public, published in the Federal 
Register or other publications, regardless of the form or format 
thereof, provided that no person is required to supply specific 
information pertaining to the commenter, other than that necessary for 
self-identification, as a condition of the agency's full consideration, 
are not generally considered information collections and therefore not 
subject to the PRA.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a Request for Proposal (RFP), applications, 
proposal abstracts, or quotations. This RFI does not commit the U.S. 
Government to contract for any supplies or services or make a grant 
award. Further, we are not seeking proposals through this RFI and will 
not accept unsolicited proposals. Responders are advised that the U.S. 
Government will not pay for any information or administrative costs 
incurred in response to this RFI; all costs associated with responding 
to this RFI will be solely at the interested party's expense. We note 
that not responding to this RFI does not preclude participation in any 
future procurement, if conducted. It is the responsibility of the 
potential responders to monitor this RFI announcement for additional 
information pertaining to this request. In addition, we note that HHS 
will not respond to questions about potential policy issues raised in 
this RFI.
    We will actively consider all input as we develop future regulatory 
proposals or future policy guidance. We may or may not choose to 
contact individual responders. Such communications would be for the 
sole purpose of clarifying statements in the responders' written 
responses. Contractor support personnel may be used to review responses 
to this RFI. Responses to this notice are not offers and cannot be 
accepted by the Government to form a binding contract or issue a grant. 
Information obtained as a result of this RFI may be used by the 
Government for program planning on a non-attribution basis. Respondents 
should not include any information that might be considered proprietary 
or confidential. This RFI should not be construed as a commitment or 
authorization to incur cost for which reimbursement would be required 
or sought. All submissions become U.S. Government property and will not 
be returned. In addition, we may publicly post the public comments 
received or a summary of those public comments.

    Dated: November 5, 2020.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.

                                                                      Attachment A
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      Action              Agency            Sub-agency          Type of action      RIN (if applicable)     Title of action     Brief summary of action
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................  HHS...............  SAMHSA............  Other regulatory       ....................  42 CFR part 2         SAMHSA provided guidance
                                                             action.                                      statement.            as to how 42 CFR part 2
                                                                                                                                may apply during the
                                                                                                                                COVID-19 emergency
                                                                                                                                (https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf).
2.................  HHS...............  SAMHSA............  Guidance.............  ....................  Take home medication  SAMHSA provided a blanket
                                                                                                                                exception to opioid
                                                                                                                                treatment programs to
                                                                                                                                permit take-home
                                                                                                                                medication for patients
                                                                                                                                receiving medication-
                                                                                                                                assisted treatment of up
                                                                                                                                to 28 days.
3.................  HHS...............  OIG...............  Guidance.............  n/a.................  FAQs-Application of   OIG is accepting
                                                                                                          OIG's                 inquiries from the
                                                                                                          Administrative        health care community
                                                                                                          Enforcement           regarding the
                                                                                                          Authorities to        application of OIG's
                                                                                                          Arrangements          administrative
                                                                                                          Directly Connected    enforcement authorities,
                                                                                                          to the Coronavirus    including the Federal
                                                                                                          Disease 2019 (COVID-  anti-kickback statute
                                                                                                          19) Public Health     and civil monetary
                                                                                                          Emergency.            penalty (CMP) provision
                                                                                                                                prohibiting inducements
                                                                                                                                to beneficiaries. On
                                                                                                                                this website, OIG
                                                                                                                                responds to fact-
                                                                                                                                specific inquiries
                                                                                                                                regarding arrangements
                                                                                                                                that are directly
                                                                                                                                connected to the public
                                                                                                                                health emergency and
                                                                                                                                implicate these
                                                                                                                                authorities.
4.................  HHS...............  OCR...............  Other regulatory       ....................  Notification of       Exercise of enforcement
                                                             action.                                      Enforcement           discretion to not impose
                                                                                                          Discretion for        penalties for HIPAA
                                                                                                          Telehealth Remote     violations against
                                                                                                          Communications.       healthcare providers in
                                                                                                                                connection with their
                                                                                                                                good faith provision of
                                                                                                                                telehealth using remote
                                                                                                                                communication
                                                                                                                                technologies during the
                                                                                                                                COVID-19 nationwide
                                                                                                                                public health emergency.

[[Page 75723]]

 
5.................  HHS...............  OCR...............  Other regulatory       ....................  Notification of       Exercise of enforcement
                                                             action.                                      Enforcement           discretion to not impose
                                                                                                          Discretion for        penalties for violations
                                                                                                          Business Associates.  of certain provisions of
                                                                                                                                the HIPAA Privacy Rule
                                                                                                                                against covered health
                                                                                                                                care providers or their
                                                                                                                                business associates for
                                                                                                                                the good faith uses and
                                                                                                                                disclosures of protected
                                                                                                                                health information (PHI)
                                                                                                                                by business associates
                                                                                                                                for public health and
                                                                                                                                health oversight
                                                                                                                                activities during the
                                                                                                                                COVID-19 nationwide
                                                                                                                                public health emergency.
6.................  HHS...............  OCR...............  Other regulatory       ....................  Notification of       Exercise of enforcement
                                                             action.                                      Enforcement           discretion to not impose
                                                                                                          Discretion for        penalties for violations
                                                                                                          Community-Based       of the HIPAA Rules
                                                                                                          Testing Sites.        against covered entities
                                                                                                                                or business associates
                                                                                                                                in connection with the
                                                                                                                                good faith participation
                                                                                                                                in the operation of
                                                                                                                                COVID-19 testing sites
                                                                                                                                during the COVID-19
                                                                                                                                nationwide public health
                                                                                                                                emergency.
7.................  HHS...............  NIH...............  Waiver...............  ....................  Flexibility with      Allows applicants to
                                                                                                          System for Awards     submit applications for
                                                                                                          Management ``SAM''    Federal awards without
                                                                                                          Registration (2 CFR   an active SAM
                                                                                                          Sec.   200.205).      registration. Provided
                                                                                                                                automatic extension to
                                                                                                                                expiring SAM
                                                                                                                                registrations.
8.................  HHS...............  NIH...............  Waiver...............  ....................  Flexibility with      Allows agencies to accept
                                                                                                          Application           late applications due to
                                                                                                          Deadlines (2 CFR      the COVID-19 emergency.
                                                                                                          Sec.   200.202).
9.................  HHS...............  NIH...............  Waiver...............  ....................  Waiver for Notice of  Awarding agencies can
                                                                                                          Funding               publish emergency Notice
                                                                                                          Opportunities         of Funding Opportunities
                                                                                                          (NOFOs)               (NOFOs) for less than
                                                                                                          Publication. (2 CFR   thirty (30) days without
                                                                                                          Sec.   200.203).      separately justifying
                                                                                                                                shortening the timeframe
                                                                                                                                for each NOFO.
10................  HHS...............  NIH...............  Waiver...............  ....................  No-cost extensions    Awarding agencies may
                                                                                                          on expiring awards.   extend awards which are
                                                                                                          (2 CFR Sec.           active as of March 31,
                                                                                                          200.308).             2020 and scheduled to
                                                                                                                                expire prior or up to
                                                                                                                                December 31, 2020,
                                                                                                                                automatically at no-cost
                                                                                                                                for a period up to
                                                                                                                                twelve (12) months.
11................  HHS...............  NIH...............  Waiver...............  ....................  Abbreviated non-      For continuation requests
                                                                                                          competitive           scheduled to come in
                                                                                                          continuation          from April 1, 2020 to
                                                                                                          requests. (2 CFR      December 31, 2020, from
                                                                                                          Sec.   200.308).      projects with planned
                                                                                                                                future support, awarding
                                                                                                                                agencies may accept a
                                                                                                                                brief statement from
                                                                                                                                recipients to verify
                                                                                                                                that they are in a
                                                                                                                                position to: (1) Resume
                                                                                                                                or restore their project
                                                                                                                                activities; and (2)
                                                                                                                                accept a planned
                                                                                                                                continuation award.
12................  HHS...............  NIH...............  Waiver...............  ....................  Allowability of       Awarding agencies may
                                                                                                          salaries and other    allow recipients to
                                                                                                          project activities.   continue to charge
                                                                                                          (2 CFR Sec.           salaries and benefits to
                                                                                                          200.403, 2 CFR Sec.   currently active Federal
                                                                                                            200.404, 2 CFR      awards consistent with
                                                                                                          Sec.   200.405).      the recipients' policy
                                                                                                                                of paying salaries
                                                                                                                                (under unexpected or
                                                                                                                                extraordinary
                                                                                                                                circumstances) from all
                                                                                                                                funding sources, Federal
                                                                                                                                and non-Federal.
13................  HHS...............  NIH...............  Waiver...............  ....................  Allowability of       Agencies may allow
                                                                                                          Costs not Normally    recipients to charge
                                                                                                          Chargeable to         full cost of
                                                                                                          Awards. (2 CFR Sec.   cancellation when the
                                                                                                            200.403, 2 CFR      event, travel, or other
                                                                                                          Sec.   200.404, 2     activities are conducted
                                                                                                          CFR Sec.   200.405).  under the auspices of
                                                                                                                                the grant. Awarding
                                                                                                                                agencies must advise
                                                                                                                                recipients that they
                                                                                                                                should not assume
                                                                                                                                additional funds will be
                                                                                                                                available should the
                                                                                                                                charging of cancellation
                                                                                                                                or other fees result in
                                                                                                                                a shortage of funds to
                                                                                                                                eventually carry out the
                                                                                                                                event or travel.
14................  HHS...............  NIH...............  Waiver...............  ....................  Prior approval        Awarding agencies are
                                                                                                          requirement           authorized to waive
                                                                                                          waivers. (2 CPR       prior approval
                                                                                                          Sec.   200.407).      requirements as
                                                                                                                                necessary to effectively
                                                                                                                                address the response.
15................  HHS...............  NIH...............  Waiver...............  ....................  Exemption of certain  Awarding agencies may
                                                                                                          procurement           waive the procurement
                                                                                                          requirements. (2      requirements contained
                                                                                                          CPRSec.               in 2 CPRSec.
                                                                                                          200.319(b), 2         200.319(b) regarding
                                                                                                          CPRSec.   200.321).   geographical preferences
                                                                                                                                and 2 CPRSec.   200.321
                                                                                                                                regarding contracting
                                                                                                                                small and minority
                                                                                                                                businesses, women's
                                                                                                                                business enterprises,
                                                                                                                                and labor surplus area
                                                                                                                                firms.
16................  HHS...............  NIH...............  Waiver...............  ....................  Extension of          Awarding agencies may
                                                                                                          financial,            allow grantees to delay
                                                                                                          performance, and      submission of financial,
                                                                                                          other reporting. (2   performance and other
                                                                                                          CPRSec.   200.327,    reports up to three (3)
                                                                                                          2 CPRSec.             months beyond the normal
                                                                                                          200.328).             due date.
17................  HHS...............  NIH...............  Waiver...............  ....................  Extension of          Awarding agencies may
                                                                                                          currently approved    allow grantees to
                                                                                                          indirect cost         continue to use the
                                                                                                          rates. (2 CPRSec.     currently approved
                                                                                                          200.414(c)).          indirect cost rates
                                                                                                                                (i.e., predetermined,
                                                                                                                                fixed, or provisional
                                                                                                                                rates) to recover their
                                                                                                                                indirect costs on
                                                                                                                                Federal awards.
18................  HHS...............  NIH...............  Waiver...............  ....................  Extension of          Awarding agencies may
                                                                                                          closeout. (2          allow the grantee to
                                                                                                          CPRSec.   200.343).   delay submission of any
                                                                                                                                pending financial,
                                                                                                                                performance and other
                                                                                                                                reports required by the
                                                                                                                                terms of the award for
                                                                                                                                the closeout of expired
                                                                                                                                projects, provided that
                                                                                                                                proper notice about the
                                                                                                                                reporting delay is given
                                                                                                                                by the grantee to the
                                                                                                                                agency.
19................  HHS...............  NIH...............  Waiver...............  ....................  Extension of Single   Awarding agencies, in
                                                                                                          Audit submission.     their capacity as
                                                                                                          (2 CFR Sec.           cognizant or oversight
                                                                                                          200.512).             agencies for audit,
                                                                                                                                should allow recipients
                                                                                                                                and subrecipients that
                                                                                                                                have not yet filed their
                                                                                                                                single audits with the
                                                                                                                                Federal Audit
                                                                                                                                Clearinghouse as of the
                                                                                                                                date of the issuance of
                                                                                                                                this memorandum that
                                                                                                                                have fiscal year-ends
                                                                                                                                through June 30, 2020,
                                                                                                                                to delay the completion
                                                                                                                                and submission of the
                                                                                                                                Single Audit reporting
                                                                                                                                package, as required
                                                                                                                                under Subpart F of 2 CFR
                                                                                                                                Sec.   200.501--Audit
                                                                                                                                Requirements, to six (6)
                                                                                                                                months beyond the normal
                                                                                                                                due date.
20................  HHS...............  NIH...............  Waiver...............  ....................  OMB Memo M-20-20:     OMB is issuing a class
                                                                                                          Repurposing           exception that allows
                                                                                                          Existing Federal      Federal awarding
                                                                                                          Financial             agencies to repurpose
                                                                                                          Assistance Programs.  their federal assistance
                                                                                                                                awards (in whole or
                                                                                                                                part) to support the
                                                                                                                                COVID-19 response, as
                                                                                                                                consistent with
                                                                                                                                applicable laws--
                                                                                                                                includes donation of
                                                                                                                                personal protective
                                                                                                                                equipment.
21................  HHS...............  NIH...............  Waiver...............  ....................  National Research     NIH has provided
                                                                                                          Service Awards.       flexibility to NRSA
                                                                                                                                recipients to continue
                                                                                                                                charging stipends to NIH
                                                                                                                                awards while no worked
                                                                                                                                is performed due to
                                                                                                                                COVID-19. This
                                                                                                                                flexibility is in
                                                                                                                                separate from salary
                                                                                                                                flexibilities provided
                                                                                                                                to employees of
                                                                                                                                recipient institutions.
22................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Clinical          to provide a policy to
                                                                                                          Electronic            help expand the
                                                                                                          Thermometers During   availability of clinical
                                                                                                          the Coronavirus       electronic thermometers
                                                                                                          Disease 2019 (COVID-  to address this public
                                                                                                          19) Public Health     health emergency.
                                                                                                          Emergency.

[[Page 75724]]

 
23................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Imaging Systems   to provide a policy to
                                                                                                          During the            help expand the
                                                                                                          Coronavirus Disease   availability and
                                                                                                          2019 (COVID-19)       capability of medical x-
                                                                                                          Public Health         ray, ultrasound, and
                                                                                                          Emergency.            magnetic resonance
                                                                                                                                imaging systems, and
                                                                                                                                image analysis software
                                                                                                                                that are used to
                                                                                                                                diagnose and monitor
                                                                                                                                medical conditions while
                                                                                                                                mitigating circumstances
                                                                                                                                that could lead to
                                                                                                                                patient, healthcare
                                                                                                                                provider, and healthcare
                                                                                                                                technology management
                                                                                                                                (HTM) exposure to COVID-
                                                                                                                                19 for the duration of
                                                                                                                                the COVID-19 public
                                                                                                                                health emergency (PHE).
24................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Face Masks and    to provide a policy to
                                                                                                          Respirators During    help expand the
                                                                                                          the Coronavirus       availability of general
                                                                                                          Disease (COVID-19)    use face masks for the
                                                                                                          Public Health         general public and
                                                                                                          Emergency (Revised).  particulate filtering
                                                                                                                                face piece respirators
                                                                                                                                (including N95
                                                                                                                                respirators) for
                                                                                                                                healthcare personnel
                                                                                                                                (HCP)1 for the duration
                                                                                                                                of the COVID-19 public
                                                                                                                                health emergency.
25................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy on   FDA issued this guidance
                                                                                                          Prescription Drug     to address questions FDA
                                                                                                          Marketing Act         has received asking for
                                                                                                          Requirements for      clarification regarding
                                                                                                          Distribution of       FDA's enforcement of
                                                                                                          Drug Samples During   certain requirements
                                                                                                          the COVID-19 Public   relating to the
                                                                                                          Health Emergency.     distribution of drug
                                                                                                                                samples under the
                                                                                                                                Prescription Drug
                                                                                                                                Marketing Act of 1987
                                                                                                                                (PDMA) during the COVID-
                                                                                                                                19 public health
                                                                                                                                emergency (PHE). PDMA is
                                                                                                                                part of the Federal
                                                                                                                                Food, Drug, and Cosmetic
                                                                                                                                Act (FD&C Act), and the
                                                                                                                                relevant implementing
                                                                                                                                regulations regarding
                                                                                                                                drug samples are in 21
                                                                                                                                CFR part 203 (part 203),
                                                                                                                                subpart D.
26................  HHS...............  FDA...............  Guidance.............  N/A.................  Returning             FDA has been asked
                                                                                                          Refrigerated          whether refrigerated
                                                                                                          Transport Vehicles    food transport vehicles
                                                                                                          and Refrigerated      and refrigerated food
                                                                                                          Storage Units to      storage units used for
                                                                                                          Food Uses After       the temporary
                                                                                                          Using Them to         preservation of human
                                                                                                          Preserve Human        remains during the COVID-
                                                                                                          Remains During the    19 pandemic subsequently
                                                                                                          COVID-19 Pandemic.    can be used to transport
                                                                                                                                and store human and
                                                                                                                                animal food. FDA issued
                                                                                                                                this guidance to provide
                                                                                                                                information and
                                                                                                                                resources related to the
                                                                                                                                cleaning and
                                                                                                                                disinfection of such
                                                                                                                                vehicles and storage
                                                                                                                                units to address food
                                                                                                                                safety before they are
                                                                                                                                used again to transport
                                                                                                                                and store food. The
                                                                                                                                recommendations in this
                                                                                                                                guidance are intended to
                                                                                                                                supplement existing food
                                                                                                                                safety regulations and
                                                                                                                                guidance.
27................  HHS...............  FDA...............  Guidance.............  N/A.................  CVM GFI #271          FDA has been closely
                                                                                                          Reporting and         monitoring the animal
                                                                                                          Mitigating Animal     drug supply chain for
                                                                                                          Drug Shortages        supply disruptions or
                                                                                                          during the COVID-19   shortages in the United
                                                                                                          Public Health         States during the COVID-
                                                                                                          Emergency.            19 pandemic. FDA issued
                                                                                                                                this guidance to assist
                                                                                                                                sponsors in providing
                                                                                                                                FDA timely, informative
                                                                                                                                notifications about
                                                                                                                                changes in the
                                                                                                                                production of animal
                                                                                                                                drugs that will, in
                                                                                                                                turn, help the Agency in
                                                                                                                                its efforts to prevent
                                                                                                                                or mitigate shortages of
                                                                                                                                these products.
28................  HHS...............  FDA...............  Guidance.............  N/A.................  CVM GFI #270--        FDA issued this guidance
                                                                                                          Guidance on the       to provide
                                                                                                          Conduct and Review    recommendations for
                                                                                                          of Studies to         sponsors conducting
                                                                                                          Support New Animal    studies to support new
                                                                                                          Drug Development      animal drug development
                                                                                                          during the COVID-19   to help ensure the
                                                                                                          Public Health         safety of animals, their
                                                                                                          Emergency.            owners, and study
                                                                                                                                personnel, maintain
                                                                                                                                compliance with good
                                                                                                                                laboratory practice
                                                                                                                                regulations and good
                                                                                                                                clinical practice, and
                                                                                                                                maintain the scientific
                                                                                                                                integrity of the data
                                                                                                                                during the COVID-19
                                                                                                                                pandemic.
29................  HHS...............  FDA...............  Guidance.............  N/A.................  Notifying FDA of a    Due to the COVID-19
                                                                                                          Permanent             pandemic, FDA has been
                                                                                                          Discontinuance or     closely monitoring the
                                                                                                          Interruption in       medical product supply
                                                                                                          Manufacturing Under   chain with the
                                                                                                          Section 506C of the   expectation that it may
                                                                                                          FD&C Act Guidance     be impacted by the COVID-
                                                                                                          for Industry.         19 outbreak, potentially
                                                                                                                                leading to supply
                                                                                                                                disruptions or shortages
                                                                                                                                of drug and biological
                                                                                                                                products in the United
                                                                                                                                States. FDA issued this
                                                                                                                                guidance to assist
                                                                                                                                applicants and
                                                                                                                                manufacturers in
                                                                                                                                providing FDA timely,
                                                                                                                                informative
                                                                                                                                notifications about
                                                                                                                                changes in the
                                                                                                                                production of certain
                                                                                                                                drugs and biological
                                                                                                                                products that will, in
                                                                                                                                turn, help the Agency in
                                                                                                                                its efforts to prevent
                                                                                                                                or mitigate shortages of
                                                                                                                                such products. The
                                                                                                                                guidance discusses the
                                                                                                                                requirement under
                                                                                                                                section 506C of the
                                                                                                                                Federal Food, Drug, and
                                                                                                                                Cosmetic Act (FD&C Act)
                                                                                                                                (21 U.S.C. 356c) and
                                                                                                                                FDA's implementing
                                                                                                                                regulations for
                                                                                                                                applicants and
                                                                                                                                manufacturers to notify
                                                                                                                                FDA of a permanent
                                                                                                                                discontinuance in the
                                                                                                                                manufacture of certain
                                                                                                                                products or an
                                                                                                                                interruption in the
                                                                                                                                manufacture of certain
                                                                                                                                products that is likely
                                                                                                                                to lead to a meaningful
                                                                                                                                disruption in supply of
                                                                                                                                that product in the
                                                                                                                                United States. This
                                                                                                                                guidance also recommends
                                                                                                                                that applicants and
                                                                                                                                manufacturers provide
                                                                                                                                additional details and
                                                                                                                                follow additional
                                                                                                                                procedures to ensure FDA
                                                                                                                                has the specific
                                                                                                                                information it needs to
                                                                                                                                help prevent or mitigate
                                                                                                                                shortages. In addition,
                                                                                                                                the guidance explains
                                                                                                                                how FDA communicates
                                                                                                                                information about
                                                                                                                                products in shortage to
                                                                                                                                the public.
30................  HHS...............  FDA...............  Guidance.............  N/A.................  Exemption and         Due to the COVID-19
                                                                                                          Exclusion from        pandemic, FDA has been
                                                                                                          Certain               monitoring requests
                                                                                                          Requirements of the   related to provisions of
                                                                                                          Drug Supply Chain     the Drug Supply Chain
                                                                                                          Security Act During   Security Act (DSCSA)
                                                                                                          the COVID-19 Public   because the provisions
                                                                                                          Health Emergency.     may affect the
                                                                                                                                prescription drug supply
                                                                                                                                chain during the COVID-
                                                                                                                                19 outbreak. FDA issued
                                                                                                                                this guidance to clarify
                                                                                                                                the scope of the public
                                                                                                                                health emergency
                                                                                                                                exemption and exclusion
                                                                                                                                under the DSCSA for the
                                                                                                                                duration of the COVID-19
                                                                                                                                public health emergency
                                                                                                                                (PHE), to help ensure
                                                                                                                                adequate distribution of
                                                                                                                                finished prescription
                                                                                                                                drug products throughout
                                                                                                                                the supply chain to
                                                                                                                                combat COVID-19. In
                                                                                                                                addition, this guidance
                                                                                                                                announces FDA's policy
                                                                                                                                regarding the exercise
                                                                                                                                of its discretion in the
                                                                                                                                enforcement of
                                                                                                                                authorized trading
                                                                                                                                partner requirements
                                                                                                                                under section 582(b)(3),
                                                                                                                                (c)(3), (d)(3), and
                                                                                                                                (e)(3) of the FD&C Act
                                                                                                                                for certain
                                                                                                                                distributions during the
                                                                                                                                COVID-19 PHE involving
                                                                                                                                other trading partners
                                                                                                                                that may not be
                                                                                                                                authorized trading
                                                                                                                                partners.
31................  HHS...............  FDA...............  Guidance.............  N/A.................  Alternative           FDA issued this guidance
                                                                                                          Procedures for        to provide a notice of
                                                                                                          Blood and Blood       exceptions and
                                                                                                          Components During     alternatives to certain
                                                                                                          the COVID-19 Public   requirements in Title 21
                                                                                                          Health Emergency.     of the Code of Federal
                                                                                                                                Regulations (CFR)
                                                                                                                                regarding blood and
                                                                                                                                blood components. This
                                                                                                                                notice of exception or
                                                                                                                                alternatives to certain
                                                                                                                                requirements is being
                                                                                                                                issued under 21 CFR
                                                                                                                                640.120(b) to respond to
                                                                                                                                a national public health
                                                                                                                                need and address the
                                                                                                                                urgent and immediate
                                                                                                                                need for blood and blood
                                                                                                                                components. We expect
                                                                                                                                that the alternative
                                                                                                                                procedures will improve
                                                                                                                                availability of blood
                                                                                                                                and blood components
                                                                                                                                while helping to ensure
                                                                                                                                adequate protections for
                                                                                                                                donor health and
                                                                                                                                maintaining a safe blood
                                                                                                                                supply for patients.

[[Page 75725]]

 
32................  HHS...............  FDA...............  Guidance.............  N/A.................  Postmarketing         This guidance provides
                                                                                                          Adverse Event         recommendations to
                                                                                                          Reporting for         industry regarding
                                                                                                          Medical Products      postmarketing adverse
                                                                                                          and Dietary           event reporting for
                                                                                                          Supplements During    drugs, biologics,
                                                                                                          a Pandemic.           medical devices,
                                                                                                                                combination products,
                                                                                                                                and dietary supplements
                                                                                                                                during a pandemic. FDA
                                                                                                                                anticipates that during
                                                                                                                                a pandemic, industry and
                                                                                                                                FDA workforces may be
                                                                                                                                reduced because of high
                                                                                                                                employee absenteeism
                                                                                                                                while reporting of
                                                                                                                                adverse events related
                                                                                                                                to widespread use of
                                                                                                                                medical products
                                                                                                                                indicated for the
                                                                                                                                treatment or prevention
                                                                                                                                of the pathogen causing
                                                                                                                                the pandemic may
                                                                                                                                increase. The extent of
                                                                                                                                these possible changes
                                                                                                                                is unknown. This
                                                                                                                                guidance discusses FDA's
                                                                                                                                intended approach to
                                                                                                                                enforcement of adverse
                                                                                                                                event reporting
                                                                                                                                requirements for medical
                                                                                                                                products and dietary
                                                                                                                                supplements during a
                                                                                                                                pandemic.
33................  HHS...............  FDA...............  Guidance.............  N/A.................  Institutional Review  During the COVID-19
                                                                                                          Board (IRB) Review    public health emergency,
                                                                                                          of Individual         FDA has received a
                                                                                                          Patient Expanded      substantially increased
                                                                                                          Access Requests for   volume of individual
                                                                                                          Investigational       patient expanded access
                                                                                                          Drugs and             requests for COVID-19
                                                                                                          Biological Products   investigational drugs.
                                                                                                          During the COVID-19   Although FDA has issued
                                                                                                          Public Health         guidance on expanded
                                                                                                          Emergency.            access requests,
                                                                                                                                including expanded
                                                                                                                                access for individual
                                                                                                                                patients, the Agency is
                                                                                                                                aware that Institutional
                                                                                                                                Review Boards (IRBs)
                                                                                                                                seek clarity regarding
                                                                                                                                the key factors and
                                                                                                                                procedures IRBs should
                                                                                                                                consider when reviewing
                                                                                                                                individual patient
                                                                                                                                expanded access
                                                                                                                                submissions, including
                                                                                                                                for reviews conducted by
                                                                                                                                a single member of the
                                                                                                                                IRB, to fulfill its
                                                                                                                                obligations under 21 CFR
                                                                                                                                part 56. Therefore, FDA
                                                                                                                                issued this guidance to
                                                                                                                                provide recommendations
                                                                                                                                regarding the key
                                                                                                                                factors and procedures
                                                                                                                                IRBs should consider
                                                                                                                                when reviewing expanded
                                                                                                                                access submissions for
                                                                                                                                individual patient
                                                                                                                                access to
                                                                                                                                investigational drugs
                                                                                                                                for treating COVID-19.
34................  HHS...............  FDA...............  Guidance.............  N/A.................  FDA Guidance on       FDA issued this guidance
                                                                                                          Conduct of Clinical   to provide general
                                                                                                          Trials of Medical     considerations to assist
                                                                                                          Products during       sponsors in assuring the
                                                                                                          COVID-19 Public       safety of trial
                                                                                                          Health Emergency.     participants,
                                                                                                                                maintaining compliance
                                                                                                                                with good clinical
                                                                                                                                practice (GCP), and
                                                                                                                                minimizing risks to
                                                                                                                                trial integrity for the
                                                                                                                                duration of the COVID-19
                                                                                                                                public health emergency.
                                                                                                                                The appendix to this
                                                                                                                                guidance further
                                                                                                                                explains those general
                                                                                                                                considerations by
                                                                                                                                providing answers to
                                                                                                                                questions that the
                                                                                                                                Agency has received
                                                                                                                                about conducting
                                                                                                                                clinical trials during
                                                                                                                                the COVID-19 public
                                                                                                                                health emergency.
35................  HHS...............  FDA...............  Guidance.............  N/A.................  COVID-19: Developing  FDA issued this guidance
                                                                                                          Drugs and             to assist sponsors in
                                                                                                          Biological Products   the clinical development
                                                                                                          for Treatment or      of drugs for the
                                                                                                          Prevention.           treatment or prevention
                                                                                                                                of COVID-19.
                                                                                                                                Preventative vaccines
                                                                                                                                and convalescent plasma
                                                                                                                                are not within the scope
                                                                                                                                of this guidance.
36................  HHS...............  FDA...............  Guidance.............  N/A.................  Investigational       FDA issued this guidance
                                                                                                          COVID-19              to provide
                                                                                                          Convalescent          recommendations to
                                                                                                          Plasma; Guidance      health care providers
                                                                                                          for Industry          and investigators on the
                                                                                                          (Updated: May 1,      administration and study
                                                                                                          2020).                of investigational
                                                                                                                                convalescent plasma
                                                                                                                                collected from
                                                                                                                                individuals who have
                                                                                                                                recovered from COVID-19
                                                                                                                                (COVID-19 convalescent
                                                                                                                                plasma) during the
                                                                                                                                public health emergency.
                                                                                                                                The guidance also
                                                                                                                                provides recommendations
                                                                                                                                to blood establishments
                                                                                                                                on the collection of
                                                                                                                                COVID-19 convalescent
                                                                                                                                plasma.
37................  HHS...............  FDA...............  Guidance.............  N/A.................  Revised               This revised guidance
                                                                                                          Recommendations for   document provides blood
                                                                                                          Reducing the Risk     establishments that
                                                                                                          of Human              collect blood or blood
                                                                                                          Immunodeficiency      components, including
                                                                                                          Virus Transmission    Source Plasma, with
                                                                                                          by Blood and Blood    FDA's revised donor
                                                                                                          Products.             deferral recommendations
                                                                                                                                for individuals with
                                                                                                                                increased risk for
                                                                                                                                transmitting human
                                                                                                                                immunodeficiency virus
                                                                                                                                (HIV) infection. We
                                                                                                                                (FDA) are also
                                                                                                                                recommending that you
                                                                                                                                make corresponding
                                                                                                                                revisions to your donor
                                                                                                                                educational materials,
                                                                                                                                donor history
                                                                                                                                questionnaires and
                                                                                                                                accompanying materials,
                                                                                                                                along with revisions to
                                                                                                                                your donor
                                                                                                                                requalification and
                                                                                                                                product management
                                                                                                                                procedures. This
                                                                                                                                guidance also
                                                                                                                                incorporates certain
                                                                                                                                other recommendations
                                                                                                                                related to donor
                                                                                                                                educational materials
                                                                                                                                and supersedes the
                                                                                                                                December 2015 guidance
                                                                                                                                of the same title
                                                                                                                                (Notice of Availability,
                                                                                                                                80 FR 79913 (December
                                                                                                                                17, 2015)). The
                                                                                                                                recommendations
                                                                                                                                contained in this
                                                                                                                                guidance apply to the
                                                                                                                                collection of blood and
                                                                                                                                blood components,
                                                                                                                                including Source Plasma.
                                                                                                                                The recommendations in
                                                                                                                                this revised guidance
                                                                                                                                reflect the Agency's
                                                                                                                                current thinking on
                                                                                                                                donor deferral
                                                                                                                                recommendations for
                                                                                                                                individuals with
                                                                                                                                increased risk for
                                                                                                                                transmitting HIV
                                                                                                                                infection. Based on the
                                                                                                                                Agency's careful
                                                                                                                                evaluation of the
                                                                                                                                available data,
                                                                                                                                including data regarding
                                                                                                                                the detection
                                                                                                                                characteristics of
                                                                                                                                nucleic acid testing,
                                                                                                                                FDA expects
                                                                                                                                implementation of these
                                                                                                                                revised recommendations
                                                                                                                                will not be associated
                                                                                                                                with any adverse effect
                                                                                                                                on the safety of the
                                                                                                                                blood supply.
                                                                                                                                Furthermore, early
                                                                                                                                implementation of the
                                                                                                                                recommendations in this
                                                                                                                                guidance may help to
                                                                                                                                address significant
                                                                                                                                blood shortages that are
                                                                                                                                occurring as a result of
                                                                                                                                a current and ongoing
                                                                                                                                public health emergency.
38................  HHS...............  FDA...............  Guidance.............  N/A.................  Revised               The recommendations in
                                                                                                          Recommendations to    this revised guidance
                                                                                                          Reduce the Risk of    reflect the Agency's
                                                                                                          Transfusion-          current thinking on
                                                                                                          Transmitted Malaria.  recommendations for
                                                                                                                                reducing the risk of
                                                                                                                                Transfusion-Transmitted
                                                                                                                                Malaria (TTM). Based on
                                                                                                                                the Agency's careful
                                                                                                                                evaluation of the
                                                                                                                                available scientific and
                                                                                                                                epidemiological data on
                                                                                                                                malaria risk, and data
                                                                                                                                on FDA-approved pathogen
                                                                                                                                reduction devices, FDA
                                                                                                                                expects implementation
                                                                                                                                of these revised
                                                                                                                                recommendations will not
                                                                                                                                be associated with any
                                                                                                                                adverse effect on the
                                                                                                                                safety of the blood
                                                                                                                                supply. Furthermore,
                                                                                                                                early implementation of
                                                                                                                                the recommendations in
                                                                                                                                this guidance may help
                                                                                                                                to address significant
                                                                                                                                blood shortages that are
                                                                                                                                occurring as a result of
                                                                                                                                a current and ongoing
                                                                                                                                public health emergency.

[[Page 75726]]

 
39................  HHS...............  FDA...............  Guidance.............  N/A.................  CVM GFI #269--        FDA recognizes the vital
                                                                                                          Enforcement Policy    role veterinarians play
                                                                                                          Regarding Federal     in protecting public
                                                                                                          VCPR Requirements     health. FDA is aware
                                                                                                          to Facilitate         that during the COVID-19
                                                                                                          Veterinary            outbreak some States are
                                                                                                          Telemedicine During   modifying their
                                                                                                          the COVID-19          requirements for
                                                                                                          Outbreak.             veterinary telemedicine,
                                                                                                                                including State
                                                                                                                                requirements regarding
                                                                                                                                the veterinarian-client-
                                                                                                                                patient relationship
                                                                                                                                (VCPR). Given that the
                                                                                                                                Federal VCPR definition
                                                                                                                                requires animal
                                                                                                                                examination and/or
                                                                                                                                medically appropriate
                                                                                                                                and timely visits to the
                                                                                                                                premises where the
                                                                                                                                animal(s) are kept, the
                                                                                                                                Federal VCPR definition
                                                                                                                                cannot be met solely
                                                                                                                                through telemedicine. To
                                                                                                                                further facilitate
                                                                                                                                veterinarians' ability
                                                                                                                                to utilize telemedicine
                                                                                                                                to address animal health
                                                                                                                                needs during the COVID-
                                                                                                                                19 outbreak, FDA intends
                                                                                                                                to temporarily suspend
                                                                                                                                enforcement of a portion
                                                                                                                                of the Federal VCPR
                                                                                                                                requirements.
                                                                                                                                Specifically, FDA
                                                                                                                                generally intends not to
                                                                                                                                enforce the animal
                                                                                                                                examination and premises
                                                                                                                                visit VCPR requirements
                                                                                                                                relevant to FDA
                                                                                                                                regulations governing
                                                                                                                                Extralabel Drug Use in
                                                                                                                                Animals (21 CFR part
                                                                                                                                530) and Veterinary Feed
                                                                                                                                Directive Drugs (21 CFR
                                                                                                                                558.6). Given the
                                                                                                                                temporary nature of this
                                                                                                                                policy, we plan to
                                                                                                                                reassess it periodically
                                                                                                                                and provide revision or
                                                                                                                                withdrawal of this
                                                                                                                                guidance as necessary.
40................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      The Accredited Third-
                                                                                                          Regarding             Party Certification
                                                                                                          Accredited Third-     Program regulation (21
                                                                                                          Party Certification   CFR part 1, subpart M)
                                                                                                          Program Onsite        establishes a voluntary
                                                                                                          Observation and       program for the
                                                                                                          Certificate           recognition of
                                                                                                          Duration              accreditation bodies
                                                                                                          Requirements During   (ABs) that accredit
                                                                                                          the COVID-19 Public   third-party
                                                                                                          Health Emergency.     certification bodies
                                                                                                                                (CBs) to conduct food
                                                                                                                                safety audits and issue
                                                                                                                                food or facility
                                                                                                                                certifications to
                                                                                                                                eligible foreign
                                                                                                                                entities for the
                                                                                                                                purposes specified in
                                                                                                                                sections 801(q) and 806
                                                                                                                                of the FD&C Act (21
                                                                                                                                U.S.C. 381 and 384b).
                                                                                                                                The regulation requires
                                                                                                                                that recognized ABs and
                                                                                                                                accredited CBs perform
                                                                                                                                certain onsite
                                                                                                                                observations and
                                                                                                                                examinations. Due to the
                                                                                                                                impact of the public
                                                                                                                                health emergency related
                                                                                                                                to COVID-19, FDA issued
                                                                                                                                this guidance to provide
                                                                                                                                the Accredited Third-
                                                                                                                                Party Certification
                                                                                                                                Program's currently-
                                                                                                                                recognized ABs and
                                                                                                                                accredited CBs
                                                                                                                                flexibility, in certain
                                                                                                                                circumstances, regarding
                                                                                                                                certain requirements.
41................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      The purpose of this
                                                                                                          Regarding             guidance is to state the
                                                                                                          Preventive Controls   current intent of the
                                                                                                          and FSVP Food         Food and Drug
                                                                                                          Supplier              Administration (FDA, we,
                                                                                                          Verification Onsite   or the Agency), in
                                                                                                          Audit Requirements    certain circumstances
                                                                                                          During the COVID-19   related to the impact of
                                                                                                          Public Health         the coronavirus outbreak
                                                                                                          Emergency.            (COVID-19), not to
                                                                                                                                enforce requirements in
                                                                                                                                three foods regulations
                                                                                                                                to conduct onsite audits
                                                                                                                                of food suppliers if
                                                                                                                                other supplier
                                                                                                                                verification methods are
                                                                                                                                used instead. The three
                                                                                                                                regulations are Current
                                                                                                                                Good Manufacturing
                                                                                                                                Practice, Hazard
                                                                                                                                Analysis, and Risk-Based
                                                                                                                                Preventive Controls for
                                                                                                                                Human Food (21 CFR part
                                                                                                                                117) (``part 117''),
                                                                                                                                Current Good
                                                                                                                                Manufacturing Practice,
                                                                                                                                Hazard Analysis, and
                                                                                                                                Risk-Based Preventive
                                                                                                                                Controls for Food for
                                                                                                                                Animals (21 CFR part
                                                                                                                                507) (``part 507''), and
                                                                                                                                Foreign Supplier
                                                                                                                                Verification Programs
                                                                                                                                for Importers of Food
                                                                                                                                for Humans and Animals
                                                                                                                                (21 CFR part 1 subpart
                                                                                                                                L) (``FSVP
                                                                                                                                regulation'').
42................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      FDA issued this guidance
                                                                                                          During the COVID-19   to announce flexibility
                                                                                                          Public Health         in the eligibility
                                                                                                          Emergency Regarding   criteria for the
                                                                                                          the Qualified         qualified exemption from
                                                                                                          Exemption from the    the Standards for the
                                                                                                          Standards for the     Growing, Harvesting,
                                                                                                          Growing,              Packing, and Holding of
                                                                                                          Harvesting,           Produce for Human
                                                                                                          Packing, and          Consumption (Produce
                                                                                                          Holding of Produce    Safety Rule) (21 CFR
                                                                                                          for Human             part 112) due to
                                                                                                          Consumption.          disruptions to the
                                                                                                                                supply chain for the
                                                                                                                                duration of the COVID-19
                                                                                                                                public health emergency.
43................  HHS...............  FDA...............  Guidance.............  N/A.................  Reporting a           FDA issued this guidance
                                                                                                          Temporary Closure     to provide certain FDA-
                                                                                                          or Significantly      regulated food
                                                                                                          Reduced Production    establishments (i.e.,
                                                                                                          by a Human Food       human food facilities
                                                                                                          Establishment and     and farms, but not
                                                                                                          Requesting FDA        restaurants and retail
                                                                                                          Assistance During     food establishments),
                                                                                                          the COVID-19 Public   with a convenient
                                                                                                          Health Emergency.     mechanism to voluntarily
                                                                                                                                report to FDA if they
                                                                                                                                have temporarily ceased
                                                                                                                                or significantly reduced
                                                                                                                                production or if they
                                                                                                                                are considering doing
                                                                                                                                so. This reporting
                                                                                                                                mechanism may also be
                                                                                                                                used to request dialogue
                                                                                                                                with FDA on issues
                                                                                                                                related to continuing or
                                                                                                                                restarting safe food
                                                                                                                                production during the
                                                                                                                                pandemic.
44................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      FDA issued this guidance
                                                                                                          Regarding Nutrition   to provide restaurants
                                                                                                          Labeling of Certain   and food manufacturers
                                                                                                          Packaged Food         with flexibility
                                                                                                          During the COVID-19   regarding nutrition
                                                                                                          Public Health         labeling so that they
                                                                                                          Emergency.            can sell certain
                                                                                                                                packaged foods during
                                                                                                                                the COVID-19 pandemic.
                                                                                                                                This guidance does not
                                                                                                                                apply to foods prepared
                                                                                                                                by restaurants.
45................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      FDA issued this guidance
                                                                                                          Regarding Certain     to food manufacturers to
                                                                                                          Food Labeling         provide temporary and
                                                                                                          Requirements During   limited flexibilities in
                                                                                                          the COVID-19 Public   food labeling
                                                                                                          Health Emergency:     requirements under
                                                                                                          Minor Formulation     certain circumstances.
                                                                                                          Changes and Vending   Our goal is to provide
                                                                                                          Machines.             regulatory flexibility,
                                                                                                                                where fitting, to help
                                                                                                                                minimize the impact of
                                                                                                                                supply chain disruptions
                                                                                                                                associated with the
                                                                                                                                current COVID-19
                                                                                                                                pandemic on product
                                                                                                                                availability. For
                                                                                                                                example, we are
                                                                                                                                providing flexibility
                                                                                                                                for manufacturers to use
                                                                                                                                existing labels, without
                                                                                                                                making otherwise
                                                                                                                                required changes, when
                                                                                                                                making minor formula
                                                                                                                                adjustments due to
                                                                                                                                unforeseen shortages or
                                                                                                                                supply chain disruptions
                                                                                                                                brought about by the
                                                                                                                                COVID-19 pandemic.
                                                                                                                                Additionally, this
                                                                                                                                guidance will provide
                                                                                                                                temporary flexibility to
                                                                                                                                the vending machine
                                                                                                                                industry regarding the
                                                                                                                                vending machine labeling
                                                                                                                                requirements under
                                                                                                                                section
                                                                                                                                403(q)(5)(H)(viii) of
                                                                                                                                the FD&C Act (21 U.S.C.
                                                                                                                                343(q)(5)(H)(viii)) and
                                                                                                                                21 CFR 101.8 during the
                                                                                                                                duration of the public
                                                                                                                                health emergency.
46................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      We encourage all shell
                                                                                                          Regarding             egg producers to
                                                                                                          Enforcement of 21     continue to comply with
                                                                                                          CFR Part 118 (the     applicable requirements
                                                                                                          Egg Safety Rule)      of 21 CFR part 118 (the
                                                                                                          During the COVID-19   Egg Safety Rule).
                                                                                                          Public Health         However, due to the
                                                                                                          Emergency.            increased consumer
                                                                                                                                demand for eggs in the
                                                                                                                                table egg market (e.g.,
                                                                                                                                sold directly to
                                                                                                                                consumers in retail
                                                                                                                                establishments), we are
                                                                                                                                providing temporary
                                                                                                                                flexibility to allow
                                                                                                                                producers who currently
                                                                                                                                only sell eggs to
                                                                                                                                facilities for further
                                                                                                                                processing (e.g., into
                                                                                                                                ``egg products'') to
                                                                                                                                sell to the table egg
                                                                                                                                market, provided certain
                                                                                                                                circumstances are
                                                                                                                                present.

[[Page 75727]]

 
47................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      FDA issued this guidance
                                                                                                          Regarding Nutrition   to provide restaurants
                                                                                                          Labeling of           and food manufacturers
                                                                                                          Standard Menu Items   with flexibility
                                                                                                          in Chain              regarding nutrition
                                                                                                          Restaurants and       labeling so that they
                                                                                                          Similar Retail Food   can sell certain
                                                                                                          Establishments        packaged foods during
                                                                                                          During the COVID-19   the COVID-19 pandemic.
                                                                                                          Public Health         This guidance does not
                                                                                                          Emergency.            apply to foods prepared
                                                                                                                                by restaurants.
48................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      FDA issued this guidance
                                                                                                          Regarding Packaging   to provide temporary
                                                                                                          and Labeling of       flexibility regarding
                                                                                                          Shell Eggs Sold by    certain packaging and
                                                                                                          Retail Food           labeling requirements
                                                                                                          Establishments        for shell eggs sold in
                                                                                                          During the COVID-19   retail food
                                                                                                          Public Health         establishments so that
                                                                                                          Emergency.            industry can meet the
                                                                                                                                increased demand for
                                                                                                                                shell eggs during the
                                                                                                                                COVID-19 pandemic.
49................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Gowns, Other      to provide a policy to
                                                                                                          Apparel, and Gloves   help expand the
                                                                                                          During the            availability of surgical
                                                                                                          Coronavirus Disease   apparel for health care
                                                                                                          (COVID-19) Public     professionals, including
                                                                                                          Health Emergency.     gowns (togas), hoods,
                                                                                                                                and surgeon's and
                                                                                                                                patient examination
                                                                                                                                gloves during this
                                                                                                                                pandemic.
50................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Sterilizers,      to provide a policy to
                                                                                                          Disinfectant          help expand the
                                                                                                          Devices, and Air      availability and
                                                                                                          Purifiers During      capability of
                                                                                                          the Coronavirus       sterilizers,
                                                                                                          Disease 2019 (COVID-  disinfectant devices,
                                                                                                          19) Public Health     and air purifiers during
                                                                                                          Emergency.            this public health
                                                                                                                                emergency.
51................  HHS...............  FDA...............  Guidance.............  N/A.................  Recommendations for   FDA issued this guidance
                                                                                                          Sponsors Requesting   to provide
                                                                                                          EUAs for              recommendations for
                                                                                                          Decontamination and   sponsors of
                                                                                                          Bioburden Reduction   decontamination and
                                                                                                          Systems for Face      bioburden reduction
                                                                                                          Masks and             systems about what
                                                                                                          Respirators During    information should be
                                                                                                          the Coronavirus       included in a pre-
                                                                                                          Disease 2019 (COVID-  Emergency Use
                                                                                                          19) Public Health     Authorization (pre-EUA)
                                                                                                          Emergency.            and/or EUA request to
                                                                                                                                help facilitate FDA's
                                                                                                                                efficient review of such
                                                                                                                                request. This guidance
                                                                                                                                provides these
                                                                                                                                recommendations based on
                                                                                                                                the device's intended
                                                                                                                                use with respect to the
                                                                                                                                level (tier) of
                                                                                                                                decontamination or
                                                                                                                                bioburden reduction,
                                                                                                                                based on the sponsor's
                                                                                                                                available data.
                                                                                                                                Decontamination and
                                                                                                                                bioburden reduction
                                                                                                                                systems play an
                                                                                                                                important role in the
                                                                                                                                ongoing efforts to help
                                                                                                                                address shortages of
                                                                                                                                surgical masks and
                                                                                                                                respirators intended for
                                                                                                                                a medical purpose during
                                                                                                                                COVID-19 or reduce the
                                                                                                                                bioburden of surgical
                                                                                                                                masks and filtering face
                                                                                                                                piece respirators
                                                                                                                                (including N95
                                                                                                                                respirators) used as
                                                                                                                                personal protective
                                                                                                                                equipment (PPE) by
                                                                                                                                healthcare personnel for
                                                                                                                                the duration of the
                                                                                                                                COVID-19 public health
                                                                                                                                emergency.
52................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Digital Health    to provide a policy to
                                                                                                          Devices For           help expand the
                                                                                                          Treating              availability of digital
                                                                                                          Psychiatric           health therapeutic
                                                                                                          Disorders During      devices for psychiatric
                                                                                                          the Coronavirus       disorders to facilitate
                                                                                                          Disease 2019 (COVID-  consumer and patient use
                                                                                                          19) Public Health     while reducing user and
                                                                                                          Emergency.            healthcare provider
                                                                                                                                contact and potential
                                                                                                                                exposure to COVID-19
                                                                                                                                during this pandemic.
53................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Extracorporeal    to provide a policy to
                                                                                                          Membrane              help expand the
                                                                                                          Oxygenation and       availability of devices
                                                                                                          Cardiopulmonary       used in extracorporeal
                                                                                                          Bypass Devices        membrane oxygenation
                                                                                                          During the            (ECMO) therapy to
                                                                                                          Coronavirus Disease   address this public
                                                                                                          2019 (COVID-19)       health emergency.
                                                                                                          Public Health
                                                                                                          Emergency.
54................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Infusion Pumps    to provide a policy to
                                                                                                          and Accessories       help expand the
                                                                                                          During the            availability and remote
                                                                                                          Coronavirus Disease   capabilities of infusion
                                                                                                          2019 (COVID-19)       pumps and their
                                                                                                          Public Health         accessories for health
                                                                                                          Emergency.            care professionals
                                                                                                                                during the COVID-19
                                                                                                                                pandemic.
55................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Non-Invasive      to provide a policy to
                                                                                                          Fetal and Maternal    help expand the
                                                                                                          Monitoring Devices    availability and
                                                                                                          Used to Support       capability of non-
                                                                                                          Patient Monitoring    invasive fetal and
                                                                                                          During the            maternal monitoring
                                                                                                          Coronavirus Disease   devices to facilitate
                                                                                                          2019 (COVID-19)       patient monitoring while
                                                                                                          Public Health         reducing patient and
                                                                                                          Emergency.            healthcare provider
                                                                                                                                contact and potential
                                                                                                                                exposure to COVID-19
                                                                                                                                during this pandemic.
56................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Non-Invasive      to provide a policy to
                                                                                                          Remote Monitoring     help expand the
                                                                                                          Devices Used to       availability and
                                                                                                          Support Patient       capability of non-
                                                                                                          Monitoring During     invasive remote
                                                                                                          the Coronavirus       monitoring devices to
                                                                                                          Disease-2019 (COVID-  facilitate patient
                                                                                                          19) Public Health     monitoring while
                                                                                                          Emergency.            reducing patient and
                                                                                                                                healthcare provider
                                                                                                                                contact and exposure to
                                                                                                                                COVID-19 for the
                                                                                                                                duration of the COVID-19
                                                                                                                                public health emergency.
57................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Remote Digital    to provide a policy to
                                                                                                          Pathology Devices     help expand the
                                                                                                          During the            availability of devices
                                                                                                          Coronavirus Disease   for remote reviewing and
                                                                                                          2019 (COVID-19)       reporting of scanned
                                                                                                          Public Health         digital images of
                                                                                                          Emergency.            pathology slides
                                                                                                                                (``digital pathology
                                                                                                                                slides'') during this
                                                                                                                                pandemic.
58................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Remote            to provide a policy to
                                                                                                          Ophthalmic            help expand the
                                                                                                          Assessment and        capability of remote
                                                                                                          Monitoring Devices    ophthalmic assessment
                                                                                                          During the            and monitoring devices
                                                                                                          Coronavirus Disease   to facilitate patient
                                                                                                          2019 (COVID-19)       care while reducing
                                                                                                          Public Health         patient and healthcare
                                                                                                          Emergency.            provider contact and
                                                                                                                                exposure to COVID-19
                                                                                                                                during this pandemic.
59................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for                   to provide a policy to
                                                                                                          Telethermographic     help expand the
                                                                                                          Systems During the    availability of
                                                                                                          Coronavirus Disease   telethermographic
                                                                                                          2019 (COVID-19)       systems used for body
                                                                                                          Public Health         temperature measurements
                                                                                                          Emergency.            for triage use for the
                                                                                                                                duration of the public
                                                                                                                                health emergency
                                                                                                                                declared by the
                                                                                                                                Secretary of Health and
                                                                                                                                Human Services (HHS) on
                                                                                                                                January 31, 2020.

[[Page 75728]]

 
60................  HHS...............  FDA...............  Guidance.............  N/A.................  Enforcement Policy    FDA issued this guidance
                                                                                                          for Ventilators and   to provide a policy to
                                                                                                          Accessories and       help expand the
                                                                                                          Other Respiratory     availability of
                                                                                                          Devices During the    ventilators as well as
                                                                                                          Coronavirus Disease   other respiratory
                                                                                                          2019 (COVID-19)       devices and their
                                                                                                          Public Health         accessories during this
                                                                                                          Emergency.            pandemic.
61................  HHS...............  FDA...............  Guidance.............  N/A.................  Notifying CDRH of a   FDA issued this guidance
                                                                                                          Permanent             to implement section
                                                                                                          Discontinuance or     506J of the Federal
                                                                                                          Interruption in       Food, Drug, and Cosmetic
                                                                                                          Manufacturing of a    Act (FD&C Act) (21
                                                                                                          Device Under          U.S.C. 351 et seq.), as
                                                                                                          Section 506J of the   added by section 3121 of
                                                                                                          FD&C Act During the   the Coronavirus Aid,
                                                                                                          COVID-19 Public       Relief, and Economic
                                                                                                          Health Emergency.     Security Act (CARES
                                                                                                                                Act), as it relates to
                                                                                                                                device shortages and
                                                                                                                                potential device
                                                                                                                                shortages occurring
                                                                                                                                during the COVID-19
                                                                                                                                pandemic, for the
                                                                                                                                duration of the COVID-19
                                                                                                                                public health emergency.
                                                                                                                                Section 506J of the FD&C
                                                                                                                                Act requires
                                                                                                                                manufacturers to notify
                                                                                                                                FDA of a permanent
                                                                                                                                discontinuance in the
                                                                                                                                manufacture of certain
                                                                                                                                devices or an
                                                                                                                                interruption in the
                                                                                                                                manufacture of certain
                                                                                                                                devices that is likely
                                                                                                                                to lead to a meaningful
                                                                                                                                disruption in supply of
                                                                                                                                that device in the
                                                                                                                                United States. This
                                                                                                                                guidance is intended to
                                                                                                                                assist manufacturers in
                                                                                                                                providing FDA timely,
                                                                                                                                informative
                                                                                                                                notifications about
                                                                                                                                changes in the
                                                                                                                                production of certain
                                                                                                                                medical device products
                                                                                                                                that will help the
                                                                                                                                Agency prevent or
                                                                                                                                mitigate shortages of
                                                                                                                                such devices during the
                                                                                                                                COVID-19 public health
                                                                                                                                emergency. This guidance
                                                                                                                                also recommends that
                                                                                                                                manufacturers
                                                                                                                                voluntarily provide
                                                                                                                                additional details to
                                                                                                                                better ensure FDA has
                                                                                                                                the specific information
                                                                                                                                it needs to help prevent
                                                                                                                                or mitigate shortages
                                                                                                                                during the COVID-19
                                                                                                                                public health emergency.
62................  HHS...............  FDA...............  Guidance.............  N/A.................  COVID-19 Public       FDA issued this guidance
                                                                                                          Health Emergency:     to provide general
                                                                                                          General               considerations to assist
                                                                                                          Considerations for    sponsors in preparing
                                                                                                          Pre-IND Meeting       pre-investigational new
                                                                                                          Requests for COVID-   drug application (pre-
                                                                                                          19 Related Drugs      IND) meeting requests
                                                                                                          and Biological        for COVID-19 related
                                                                                                          Products.             drugs for the duration
                                                                                                                                of the COVID-19 public
                                                                                                                                health emergency. As
                                                                                                                                described in further
                                                                                                                                detail in this guidance,
                                                                                                                                FDA recommends that
                                                                                                                                sponsors initiate all
                                                                                                                                drug development
                                                                                                                                interactions for COVID-
                                                                                                                                19 related drugs through
                                                                                                                                pre-IND meeting
                                                                                                                                requests.
63................  HHS...............  FDA...............  Guidance.............  N/A.................  Effects of the COVID- FDA issued this guidance
                                                                                                          19 Public Health      to provide answers to
                                                                                                          Emergency on Formal   frequently asked
                                                                                                          Meetings and User     questions about
                                                                                                          Fee Applications--    regulatory and policy
                                                                                                          Questions and         issues related to drug
                                                                                                          Answers.              development for the
                                                                                                                                duration of the COVID-19
                                                                                                                                public health emergency.
64................  HHS...............  FDA...............  Guidance.............  N/A.................  Policy for Certain    FDA issued this guidance
                                                                                                          REMS Requirements     to communicate its
                                                                                                          During the COVID-19   temporary policy for
                                                                                                          Public Health         certain risk evaluation
                                                                                                          Emergency Guidance    and mitigation
                                                                                                          for Industry and      strategies (REMS)
                                                                                                          Health Care           requirements for the
                                                                                                          Professionals.        duration of the public
                                                                                                                                health emergency (PHE)
                                                                                                                                declared by the
                                                                                                                                Secretary of Health and
                                                                                                                                Human Services (HHS)1 on
                                                                                                                                January 31, 2020.
65................  HHS...............  FDA...............  Guidance.............  N/A.................  Policy for the        FDA issued this guidance
                                                                                                          Temporary Use of      to communicate its
                                                                                                          Portable Cryogenic    policy for the temporary
                                                                                                          Containers Not in     use of certain gas
                                                                                                          Compliance With 21    containers for oxygen
                                                                                                          CFR 211.94(e)(1)      and nitrogen intended
                                                                                                          For Oxygen and        for medical use for the
                                                                                                          Nitrogen During the   duration of the current
                                                                                                          COVID-19 Public       public health emergency.
                                                                                                          Health Emergency.
66................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy on   FDA issued this guidance
                                                                                                          Repackaging or        to communicate its
                                                                                                          Combining Propofol    temporary policy
                                                                                                          Drug Products         regarding the
                                                                                                          During the COVID-19   repackaging or combining
                                                                                                          Public Health         of propofol drug
                                                                                                          Emergency.            products by a licensed
                                                                                                                                pharmacist in a State
                                                                                                                                licensed pharmacy, a
                                                                                                                                Federal facility, or an
                                                                                                                                outsourcing facility
                                                                                                                                registered pursuant to
                                                                                                                                section 503B of the
                                                                                                                                Federal Food, Drug, and
                                                                                                                                Cosmetic Act (FD&C Act)
                                                                                                                                (21 U.S.C. 353b) as
                                                                                                                                outlined in this
                                                                                                                                guidance for the
                                                                                                                                duration of the public
                                                                                                                                health emergency
                                                                                                                                declared by the
                                                                                                                                Secretary of Health and
                                                                                                                                Human Services (HHS) on
                                                                                                                                January 31, 2020, or for
                                                                                                                                such shorter time as FDA
                                                                                                                                may announce through
                                                                                                                                updated guidance.
67................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy for  FDA issued this guidance
                                                                                                          Compounding of        to communicate its
                                                                                                          Certain Drugs for     temporary policy for the
                                                                                                          Hospitalized          compounding of certain
                                                                                                          Patients by           human drug products for
                                                                                                          Outsourcing           hospitalized patients by
                                                                                                          Facilities During     outsourcing facilities
                                                                                                          the COVID-19 Public   that have registered
                                                                                                          Health Emergency      with FDA under section
                                                                                                          (Revised).            503B of the Federal
                                                                                                                                Food, Drug, and Cosmetic
                                                                                                                                Act (FD&C Act) (21
                                                                                                                                U.S.C. 353b).
68................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy for  FDA has received a number
                                                                                                          Compounding of        of reports related to
                                                                                                          Certain Drugs for     increased demand and
                                                                                                          Hospitalized          supply interruptions
                                                                                                          Patients by           involving FDA-approved
                                                                                                          Pharmacy              drug products used in
                                                                                                          Compounders not       the treatment of
                                                                                                          Registered as         hospitalized patients
                                                                                                          Outsourcing           with COVID-19. Many of
                                                                                                          Facilities During     these drug products are
                                                                                                          the COVID-19 Public   needed to support COVID-
                                                                                                          Health Emergency      19 patients who have
                                                                                                          Guidance for          been intubated, or for
                                                                                                          Industry (Revised).   other procedures
                                                                                                                                involved in the care of
                                                                                                                                such patients. Some
                                                                                                                                reports involve drug
                                                                                                                                products that appear on
                                                                                                                                the drug shortage list
                                                                                                                                in effect under section
                                                                                                                                506E of the FD&C Act (21
                                                                                                                                U.S.C. 356e) (``FDA's
                                                                                                                                drug shortage list'').
                                                                                                                                In addition, with
                                                                                                                                respect to certain other
                                                                                                                                drug products needed to
                                                                                                                                support hospitalized
                                                                                                                                COVID-19 patients but
                                                                                                                                that do not appear on
                                                                                                                                FDA's drug shortage
                                                                                                                                list, certain hospitals
                                                                                                                                have concerns about
                                                                                                                                accessing them due, for
                                                                                                                                example, to regional
                                                                                                                                disparities in COVID-19
                                                                                                                                infection rates, or
                                                                                                                                other regional
                                                                                                                                conditions that may
                                                                                                                                evolve quickly during
                                                                                                                                the public health
                                                                                                                                emergency. FDA is
                                                                                                                                working with
                                                                                                                                manufacturers in the
                                                                                                                                global pharmaceutical
                                                                                                                                supply chain to prevent
                                                                                                                                and mitigate drug
                                                                                                                                shortages and access
                                                                                                                                problems, using all of
                                                                                                                                the Agency's authorities
                                                                                                                                to restore or increase
                                                                                                                                the supply of FDA-
                                                                                                                                approved drug products.

[[Page 75729]]

 
69................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy      Due to the COVID-19
                                                                                                          Regarding Non-        pandemic, FDA has
                                                                                                          Standard PPE          received a number of
                                                                                                          Practices for         queries from compounders
                                                                                                          Sterile Compounding   related to the impact of
                                                                                                          by Pharmacy           supply interruptions of
                                                                                                          Compounders not       face masks, gowns,
                                                                                                          Registered as         gloves, and other garb,
                                                                                                          Outsourcing           which we refer to
                                                                                                          Facilities During     collectively in this
                                                                                                          the COVID-19 Public   document as personal
                                                                                                          Health Emergency.     protective equipment
                                                                                                                                (PPE). FDA issued this
                                                                                                                                guidance to communicate
                                                                                                                                its temporary policy
                                                                                                                                related to PPE use
                                                                                                                                during human drug
                                                                                                                                compounding at State-
                                                                                                                                licensed pharmacies or
                                                                                                                                Federal facilities that
                                                                                                                                are not registered with
                                                                                                                                FDA as outsourcing
                                                                                                                                facilities.
70................  HHS...............  FDA...............  Guidance.............  N/A.................  Supplements for       FDA issued this guidance
                                                                                                          Approved Premarket    to provide a policy to
                                                                                                          Approval (PMA) or     help address current
                                                                                                          Humanitarian Device   manufacturing
                                                                                                          Exemption (HDE)       limitations or supply
                                                                                                          Submissions During    chain issues due to
                                                                                                          the Coronavirus       disruptions caused by
                                                                                                          Disease 2019 (COVID-  the COVID-19 public
                                                                                                          19) Public Health     health emergency.
                                                                                                          Emergency.
71................  HHS...............  FDA...............  Guidance.............  N/A.................  Policy for Temporary  The Agency issued this
                                                                                                          Compounding of        guidance to communicate
                                                                                                          Certain Alcohol-      its policy for the
                                                                                                          Based Hand            temporary compounding of
                                                                                                          Sanitizer Products    certain alcohol-based
                                                                                                          During the Public     hand sanitizer products
                                                                                                          Health Emergency.     by pharmacists in State-
                                                                                                                                licensed pharmacies or
                                                                                                                                Federal facilities and
                                                                                                                                registered outsourcing
                                                                                                                                facilities (referred to
                                                                                                                                collectively in this
                                                                                                                                guidance as compounders)
                                                                                                                                for the duration of the
                                                                                                                                public health emergency.
72................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy for  FDA issued this guidance
                                                                                                          Manufacture of        in response to a number
                                                                                                          Alcohol for           of queries from entities
                                                                                                          Incorporation Into    that are not currently
                                                                                                          Alcohol-Based Hand    registered drug
                                                                                                          Sanitizer Products    manufacturers that would
                                                                                                          During the Public     like to produce alcohol
                                                                                                          Health Emergency      (ethanol) for
                                                                                                          (COVID-19).           incorporation into
                                                                                                                                alcohol-based hand
                                                                                                                                sanitizers. This policy
                                                                                                                                does not extend to other
                                                                                                                                types of active
                                                                                                                                ingredients for
                                                                                                                                incorporation into
                                                                                                                                alcohol-based hand
                                                                                                                                sanitizers, such as
                                                                                                                                isopropyl alcohol. The
                                                                                                                                Agency issued this
                                                                                                                                guidance to communicate
                                                                                                                                its policy for the
                                                                                                                                temporary manufacture of
                                                                                                                                ethanol products by
                                                                                                                                firms that manufacture
                                                                                                                                alcohol for
                                                                                                                                incorporation into
                                                                                                                                alcohol-based hand
                                                                                                                                sanitizer products under
                                                                                                                                the circumstances
                                                                                                                                described in this
                                                                                                                                guidance (alcohol
                                                                                                                                production firms) for
                                                                                                                                the duration of the
                                                                                                                                public health emergency.
                                                                                                                                At such time when the
                                                                                                                                public health emergency
                                                                                                                                is over, as declared by
                                                                                                                                the Secretary, FDA
                                                                                                                                intends to discontinue
                                                                                                                                this enforcement
                                                                                                                                discretion policy and
                                                                                                                                withdraw this guidance.
                                                                                                                                FDA is continually
                                                                                                                                assessing the needs and
                                                                                                                                circumstances related to
                                                                                                                                this temporary policy,
                                                                                                                                and as relevant needs
                                                                                                                                and circumstances
                                                                                                                                evolve, FDA intends to
                                                                                                                                update, modify, or
                                                                                                                                withdraw this policy as
                                                                                                                                appropriate.
73................  HHS...............  FDA...............  Guidance.............  N/A.................  Temporary Policy for  FDA issued this guidance
                                                                                                          Preparation of        in response to a number
                                                                                                          Certain Alcohol-      of queries from entities
                                                                                                          Based Hand            that are not currently
                                                                                                          Sanitizer Products    licensed or registered
                                                                                                          During the Public     drug manufacturers that
                                                                                                          Health Emergency      would like to prepare
                                                                                                          (COVID-19).           alcohol-based hand
                                                                                                                                sanitizers, either for
                                                                                                                                public distribution or
                                                                                                                                for their own internal
                                                                                                                                use. The Agency issued
                                                                                                                                this guidance to
                                                                                                                                communicate its policy
                                                                                                                                for the temporary
                                                                                                                                preparation of certain
                                                                                                                                alcohol-based hand
                                                                                                                                sanitizer products by
                                                                                                                                firms that register
                                                                                                                                their establishment with
                                                                                                                                FDA as an over-the-
                                                                                                                                counter (OTC) drug
                                                                                                                                manufacturer, re-
                                                                                                                                packager, or re-labeler
                                                                                                                                to prepare alcohol-based
                                                                                                                                hand sanitizers under
                                                                                                                                the circumstances
                                                                                                                                described in this
                                                                                                                                guidance (``firms'') for
                                                                                                                                the duration of the
                                                                                                                                public health emergency.
                                                                                                                                At such time when the
                                                                                                                                public health emergency
                                                                                                                                is over, as declared by
                                                                                                                                the Secretary, FDA
                                                                                                                                intends to discontinue
                                                                                                                                this enforcement
                                                                                                                                discretion policy and
                                                                                                                                withdraw this guidance.
74................  HHS...............  FDA...............  Guidance.............  N/A.................  Policy for            FDA issued this guidance
                                                                                                          Coronavirus Disease-  to provide a policy to
                                                                                                          2019 Tests During     help accelerate the
                                                                                                          the Public Health     availability of novel
                                                                                                          Emergency (Revised).  coronavirus (COVID-19)
                                                                                                                                tests developed by
                                                                                                                                laboratories and
                                                                                                                                commercial manufacturers
                                                                                                                                for the duration of the
                                                                                                                                public health emergency.
                                                                                                                                Rapid detection of COVID-
                                                                                                                                19 cases in the United
                                                                                                                                States requires wide
                                                                                                                                availability of testing
                                                                                                                                to control the emergence
                                                                                                                                of this rapidly
                                                                                                                                spreading, severe
                                                                                                                                illness. This guidance
                                                                                                                                describes a policy for
                                                                                                                                laboratories and
                                                                                                                                commercial manufacturers
                                                                                                                                to help accelerate the
                                                                                                                                use of tests they
                                                                                                                                develop in order to
                                                                                                                                achieve more rapid and
                                                                                                                                widespread testing
                                                                                                                                capacity in the United
                                                                                                                                States.
75................  HHS...............  CDC...............  Interim Final Rule...  0920-AA76...........  Control of            Suspends the introduction
                                                                                                          Communicable          of persons from
                                                                                                          Diseases; Foreign     designated countries
                                                                                                          Quarantine:           into the U.S. for public
                                                                                                          Suspension of         health reasons.
                                                                                                          Introduction of
                                                                                                          Persons into the US
                                                                                                          from Designated
                                                                                                          Foreign Countries
                                                                                                          or Places for
                                                                                                          Public Health.
76................  HHS...............  CDC...............  Other regulatory       ....................  No Sail Order and     Order applies to all
                                                             action.                                      Suspension of         cruise ships that do not
                                                                                                          Further Embarkation.  voluntarily suspend
                                                                                                                                operation.
77................  HHS...............  ACF...............  Guidance.............  ....................  New Guidance on       Modified policy to permit
                                                                                                          Caseworker Visits.    monthly child welfare
                                                                                                                                caseworker visits to be
                                                                                                                                conducted via
                                                                                                                                videoconference instead
                                                                                                                                of in-person; postponing
                                                                                                                                title IV-E eligibility
                                                                                                                                reviews and National
                                                                                                                                Youth in Transition
                                                                                                                                Database reviews.
78................  HHS...............  ACF...............  Guidance.............  ....................  Permit provisional    Allows for abbreviated
                                                                                                          licensure of foster   licensing and re-
                                                                                                          family homes.         licensing process for
                                                                                                                                foster family homes, so
                                                                                                                                that the agency does not
                                                                                                                                need to assess the
                                                                                                                                home's safety and
                                                                                                                                appropriateness during
                                                                                                                                the pandemic in as
                                                                                                                                rigorous of a fashion,
                                                                                                                                which requires in-person
                                                                                                                                interaction.
79................  HHS...............  ACF...............  Guidance.............  ....................  Permit name-based     Allowed name-based
                                                                                                          criminal background   background checks only,
                                                                                                          checks on             in the absence of FBI
                                                                                                          prospective foster    fingerprint checks, when
                                                                                                          parents and other     fingerprint sites are
                                                                                                          care providers.       unavailable.
80................  HHS...............  ACF...............  Guidance.............  ....................  Simplify process for  Administrative
                                                                                                          title IV-E            streamlining allows for
                                                                                                          assistance to youth   quicker access to title
                                                                                                          age 18 and older.     IV-E assistance for
                                                                                                                                youth who may be aging
                                                                                                                                out of the child welfare
                                                                                                                                system in the absence of
                                                                                                                                a permanent family,
                                                                                                                                using the Stafford Act.
81................  HHS...............  ACF...............  Guidance.............  ....................  Modify requirement    Using Stafford Act
                                                                                                          for older youth to    flexibility, ACF
                                                                                                          meet education or     temporarily waived the
                                                                                                          employment            requirement that youth
                                                                                                          requirement.          aging out of the foster
                                                                                                                                care system be actively
                                                                                                                                engaged in education and/
                                                                                                                                or employment.

[[Page 75730]]

 
82................  HHS...............  ACF...............  Guidance.............  ....................  Qualified             Using Stafford Act
                                                                                                          Residential           flexibilities, this
                                                                                                          Treatment Program     allows title IV-E
                                                                                                          claiming exemption.   agencies to continue
                                                                                                                                claiming federal
                                                                                                                                reimbursement for
                                                                                                                                children in QRTP
                                                                                                                                settings, even if the
                                                                                                                                facility has not
                                                                                                                                completed statutorily
                                                                                                                                required accreditation
                                                                                                                                due to the pandemic.
83................  HHS...............  ACF...............  Guidance.............  ....................  Delegating authority  Same as title. Prior
                                                                                                          to State CSBG         internal practice
                                                                                                          agencies to approve   required federal
                                                                                                          equipment purchases.  approval for CSBG-funded
                                                                                                                                equipment purchases,
                                                                                                                                even when states served
                                                                                                                                as pass-through
                                                                                                                                entities. The authority
                                                                                                                                exists for pass-through
                                                                                                                                entities to approve such
                                                                                                                                purchases, and ACF would
                                                                                                                                further emphasize this
                                                                                                                                authority and encourage
                                                                                                                                pass-through entities to
                                                                                                                                utilize it.
84................  HHS...............  ACF...............  Waiver...............  ....................  Allowability of       Note: Not an ACF
                                                                                                          Costs not Normally    regulation. Modify 45
                                                                                                          Chargeable to         CFR 75.405 (and 2 CFR
                                                                                                          Awards (Item 7 from   200.405) to allow the
                                                                                                          OMB M-20-17).         awarding agency to set
                                                                                                                                an amount that may be
                                                                                                                                charged that would not
                                                                                                                                normally be allowed in
                                                                                                                                dollar or percentage
                                                                                                                                terms, with a reporting
                                                                                                                                requirement if
                                                                                                                                exercised.
                                                                                                                                Alternatively, a class-
                                                                                                                                wide exemption for CSBG
                                                                                                                                may also address the
                                                                                                                                issue (75.102).
85................  HHS...............  ACF...............  Guidance.............  ....................  Streamlining CSBG     Guidance was provided to
                                                                                                          eligibility           states that streamlined
                                                                                                          determinations.       certain eligibility
                                                                                                                                requirements, such as
                                                                                                                                attestation to, rather
                                                                                                                                than production of,
                                                                                                                                documentation for
                                                                                                                                emergency food
                                                                                                                                assistance.
86................  HHS...............  ACF...............  Guidance.............  ....................  Non-Competing         Allows abbreviated
                                                                                                          Continuation (NCC)    application process for
                                                                                                          Grants application.   grantees and eliminates
                                                                                                                                burdens for non-
                                                                                                                                competing continuation
                                                                                                                                grant awards.
87................  HHS...............  ACF...............  Guidance.............  ....................  Ability to pay        Allows programs to
                                                                                                          salaries and other    continue paying salaries
                                                                                                          project activities.   to grantee staff during
                                                                                                                                business disruptions,
                                                                                                                                and activities aligned
                                                                                                                                with grant purpose but
                                                                                                                                not in SOW, to do so. M-
                                                                                                                                20-17.
88................  HHS...............  ACF...............  Guidance.............  ....................  Increase in micro-    HHS authorized an
                                                                                                          purchase threshold.   increase in the
                                                                                                                                simplified acquisition
                                                                                                                                thresholds for all COVID-
                                                                                                                                19 acquisitions (to $20k
                                                                                                                                for micro-purchase and
                                                                                                                                $750k for simplified
                                                                                                                                acquisition threshold).
89................  HHS...............  ACF...............  Guidance.............  ....................  Waiver of detail and  HHS authorized this
                                                                                                          formality of          waiver for all COVID-19
                                                                                                          acquisition plans     related contracts and
                                                                                                          above the             only required them to
                                                                                                          simplified            have an informal
                                                                                                          acquisition           acquisition plan.
                                                                                                          threshold.
90................  HHS...............  ACF...............  Guidance.............  ....................  Flexibility with      This was applied by
                                                                                                          Application           multiple ACF programs to
                                                                                                          Deadlines (2 CFR      provide relief during
                                                                                                          Sec.   200.202).      the period of the
                                                                                                                                pandemic by providing
                                                                                                                                additional time to
                                                                                                                                complete grant
                                                                                                                                applications.
91................  HHS...............  ACF...............  Guidance.............  ....................  Enforcement           Signals that ACF will
                                                                                                          discretion for Work   exercise maximum
                                                                                                          Participation Rate    enforcement discretion
                                                                                                          failures during the   in levying financial
                                                                                                          pandemic.             penalties against states
                                                                                                                                for their failure to
                                                                                                                                meet the Temporary
                                                                                                                                Assistance for Needy
                                                                                                                                Families (TANF)
                                                                                                                                program's work
                                                                                                                                participation rate
                                                                                                                                during the period of the
                                                                                                                                pandemic, when such
                                                                                                                                failure is attributable
                                                                                                                                to the pandemic.
92................  HHS...............  ACF...............  Waiver...............  ....................  Waiver of on-site     This waived the
                                                                                                          health and safety     requirement that annual
                                                                                                          inspections.          inspections of child
                                                                                                                                care facilities occur,
                                                                                                                                with an on-site
                                                                                                                                component.
93................  HHS...............  ACF...............  Waiver...............  ....................  Fingerprint           Waive the requirement
                                                                                                          background check      that FBI fingerprint-
                                                                                                          waivers.              based background checks
                                                                                                                                be evaluated for child
                                                                                                                                care workers, if
                                                                                                                                fingerprinting sites are
                                                                                                                                unavailable and name-
                                                                                                                                based checks return no
                                                                                                                                red flags.
94................  HHS...............  ACF...............  Waiver...............  ....................  Waiver of 12 month    Waives the requirement
                                                                                                          continuing            that those receiving
                                                                                                          eligibility           CCDF child care support
                                                                                                          requirement.          retain eligibility for
                                                                                                                                not less than 12 months.
                                                                                                                                This was used, for
                                                                                                                                example, to provide
                                                                                                                                short-term eligibility
                                                                                                                                for emergency workers
                                                                                                                                who did not require long-
                                                                                                                                term services.
95................  HHS...............  ACF...............  Waiver...............  ....................  Waive co-pays for     Allows states to fully
                                                                                                          all families.         pay for child care costs
                                                                                                                                for parents, without
                                                                                                                                cost-sharing.
96................  HHS...............  ACF...............  NPRM.................  ....................  Provisional hire      Waiver allowed
                                                                                                          flexibility.          individuals who have not
                                                                                                                                completed the
                                                                                                                                comprehensive (7
                                                                                                                                component) inter-state
                                                                                                                                background check process
                                                                                                                                to start work as child
                                                                                                                                care workers, to ensure
                                                                                                                                adequate staffing in
                                                                                                                                emergent situations.
97................  HHS...............  ACF...............  Other regulatory       ....................  Grant match           Provide Secretary
                                                             action.                                      requirements.         authority to waive
                                                                                                                                matching requirements in
                                                                                                                                42 U.S.C. 10407(a)(2)(A)
                                                                                                                                in situations of public
                                                                                                                                health emergencies.
98................  HHS...............  ACF...............  Waiver...............  ....................  Waive declaration     Allows waiver of
                                                                                                          requirements for      requirements at 45 CFR
                                                                                                          refugee assistance.   400.43, which require
                                                                                                                                written attestation and
                                                                                                                                documentation of certain
                                                                                                                                eligibility
                                                                                                                                requirements; allows for
                                                                                                                                telephonic attestation
                                                                                                                                until such time as
                                                                                                                                providing this
                                                                                                                                documentation and
                                                                                                                                written declaration is
                                                                                                                                possible.
99................  HHS...............  ACF...............  Waiver...............  ....................  Waive certain income  Allows waiver of certain
                                                                                                          requirements for      components of 45 CFR
                                                                                                          refugee assistance.   400.59 and Sec.
                                                                                                                                400.66, such that one-
                                                                                                                                time payments (e.g.,
                                                                                                                                Economic Impact
                                                                                                                                Payments) do not
                                                                                                                                preclude eligibility
                                                                                                                                based on income. Also,
                                                                                                                                allows waiver of
                                                                                                                                employment requirements
                                                                                                                                at 45 CFR 400.75 when
                                                                                                                                services are unavailable
                                                                                                                                due to the public health
                                                                                                                                emergency.
100...............  HHS...............  ACF...............  Waiver...............  ....................  Waive restrictions    Allows funds for RSS to
                                                                                                          on Refugee Support    be used to meet emergent
                                                                                                          Services funds use.   needs associated with
                                                                                                                                the COVID-19 pandemic
                                                                                                                                (e.g., food, shelter).
                                                                                                                                Waives requirements at
                                                                                                                                45 CFR 400.146.
101...............  HHS...............  ACF...............  Waiver...............  ....................  Extend eligibility    Allows individuals
                                                                                                          period for Refugee    receiving RSS support/
                                                                                                          Supportive Services.  services to continue
                                                                                                                                receiving services if
                                                                                                                                they would otherwise
                                                                                                                                have exhausted the
                                                                                                                                program's 60 month time
                                                                                                                                limit at 45 CFR
                                                                                                                                400.152(b) during the
                                                                                                                                period of the pandemic.
102...............  HHS...............  ACF...............  Waiver...............  ....................  Refugee medical       Waive 90 day timeline for
                                                                                                          screening             the medical screening to
                                                                                                          timeframes.           take place (at 45 CFR
                                                                                                                                400.107), if that is not
                                                                                                                                possible given
                                                                                                                                availability of medical
                                                                                                                                services. Also encourage
                                                                                                                                telehealth options as
                                                                                                                                alternative if in-person
                                                                                                                                screening is
                                                                                                                                unavailable.
103...............  HHS...............  ACF...............  Waiver...............  ....................  Permitting virtual    Quarterly stakeholder
                                                                                                          refugee               consultations are
                                                                                                          consultations.        required in the refugee
                                                                                                                                program. This
                                                                                                                                flexibility allows such
                                                                                                                                consultations to take
                                                                                                                                place virtually rather
                                                                                                                                than in-person.
104...............  HHS...............  ACF...............  NPRM.................  ....................  Various timeframe     Utilizing Stafford Act
                                                                                                          and administrative    flexibilities, OCSE
                                                                                                          elements, Child       granted waivers to many
                                                                                                          Support Enforcement.  states on a host of
                                                                                                                                service-related timeline
                                                                                                                                requirements (separate
                                                                                                                                attachment). Some of
                                                                                                                                these timelines are in
                                                                                                                                regulation, but the
                                                                                                                                regulations do not
                                                                                                                                provide authority to
                                                                                                                                waive certain regulatory
                                                                                                                                provisions in other
                                                                                                                                disasters or health
                                                                                                                                emergency situations.
                                                                                                                                This rulemaking would
                                                                                                                                provide such a provision
                                                                                                                                in existing regulation.
105...............  HHS...............  ACF...............  Other regulatory       ....................  Raise prior approval  Raise prior approval
                                                             action.                                      requirement at 45     threshold for purchases
                                                                                                          CFR Sec.   75.407;    from $5k to $25k in the
                                                                                                          2 CFR Sec.            normal course.
                                                                                                          200.407.

[[Page 75731]]

 
106...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Merit-based           BB. MIPS Improvement
                                                                                                          Incentive Payment     Activities Inventory
                                                                                                          System (MIPS)         Update to add new or
                                                                                                          Updates.              make modifications to
                                                                                                                                existing improvement
                                                                                                                                activities in the
                                                                                                                                Inventory through notice-
                                                                                                                                and-comment rulemaking.
                                                                                                                               1. Table 1 in RIN 0938-
                                                                                                                                AU31 outlines the new
                                                                                                                                improvement activity:
                                                                                                                                COVID-19 Clinical
                                                                                                                                Trials.
                                                                                                                               2. To provide additional
                                                                                                                                relief to individual
                                                                                                                                clinicians, groups, and
                                                                                                                                virtual groups for whom
                                                                                                                                sufficient MIPS measures
                                                                                                                                and activities may not
                                                                                                                                be available for the
                                                                                                                                2019 MIPS performance
                                                                                                                                period due to the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic, extending the
                                                                                                                                deadline to submit an
                                                                                                                                application for
                                                                                                                                reweighting the quality,
                                                                                                                                cost and improvement
                                                                                                                                activities performance
                                                                                                                                categories based on
                                                                                                                                extreme and
                                                                                                                                uncontrollable
                                                                                                                                circumstances from 12/31/
                                                                                                                                19 to 4/30/20.
                                                                                                                               Also, modifying existing
                                                                                                                                policy for the 2019
                                                                                                                                performance period/2021
                                                                                                                                MIPS payment year only.
107...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU32.......  Update to the         The Hospital Value-Based
                                                                                                          Hospital Value-       Purchasing (VBP) Program
                                                                                                          Based Purchasing      Extraordinary
                                                                                                          (VBP) Program         Circumstance Exception
                                                                                                          Extraordinary         (ECE) policy was revised
                                                                                                          Circumstance          to allow CMS to grant an
                                                                                                          Exception (ECE)       exception to hospitals
                                                                                                          Policy.               located in an entire
                                                                                                                                region or locale without
                                                                                                                                having to make an
                                                                                                                                individual request and
                                                                                                                                we codified the updated
                                                                                                                                policy at CFR
                                                                                                                                412.165(c). This policy
                                                                                                                                was updated as a
                                                                                                                                permanent change in the
                                                                                                                                interim final rule with
                                                                                                                                comment period when it
                                                                                                                                became effective on
                                                                                                                                April 30, 2020.
108...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU33.......  Quality Reporting:    This IFC updates the
                                                                                                          Updates to the        extraordinary
                                                                                                          Extraordinary         circumstances exceptions
                                                                                                          Circumstances         (ECEs) we granted on
                                                                                                          Exceptions (ECE)      March 22, 2020 for the
                                                                                                          Granted for Four      ESRD Quality Incentive
                                                                                                          Value-Based           Program (QIP), Hospital-
                                                                                                          Purchasing Programs   Acquired Condition (HAC)
                                                                                                          in Response to the    Reduction Program,
                                                                                                          PHE for COVID-19,     Hospital Readmissions
                                                                                                          and Update to the     Reduction Program, and
                                                                                                          Performance Period    Hospital Value-Based
                                                                                                          for the FY 2022 SNF   Purchasing (VBP) Program
                                                                                                          VBP Program.          in response to the COVID-
                                                                                                                                19 PHE, revises the FY
                                                                                                                                2022 performance period
                                                                                                                                under the Skilled
                                                                                                                                Nursing Facility (SNF)
                                                                                                                                VBP Program as a result
                                                                                                                                of the COVID-19 PHE, and
                                                                                                                                changes the
                                                                                                                                Extraordinary
                                                                                                                                Circumstances Exception
                                                                                                                                (ECE) policies for the
                                                                                                                                Hospital VBP, HAC
                                                                                                                                Reduction, Hospital
                                                                                                                                Readmissions Reduction,
                                                                                                                                ESRD QIP, and SNF VBP
                                                                                                                                Programs, to provide
                                                                                                                                that if, as a result of
                                                                                                                                the extension of the ECE
                                                                                                                                for the whole country or
                                                                                                                                the submission of
                                                                                                                                individual ECE requests,
                                                                                                                                we do not have enough
                                                                                                                                data to reliably compare
                                                                                                                                national performance on
                                                                                                                                measures, we would not
                                                                                                                                score facilities based
                                                                                                                                on such limited data or
                                                                                                                                make the associated
                                                                                                                                payment adjustments for
                                                                                                                                the affected program
                                                                                                                                year.
109...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  National Coverage     National Coverage
                                                                                                          Determination.        Determinations (NCDs)
                                                                                                                                and Local Coverage
                                                                                                                                Determinations (LCDs) on
                                                                                                                                Respiratory Related
                                                                                                                                Devices, Oxygen and
                                                                                                                                Oxygen Equipment, Home
                                                                                                                                Infusion Pumps and Home
                                                                                                                                Anticoagulation Therapy:
                                                                                                                                Clinicians now have
                                                                                                                                maximum flexibility in
                                                                                                                                determining patient
                                                                                                                                needs for respiratory
                                                                                                                                related devices and
                                                                                                                                equipment and the
                                                                                                                                flexibility for more
                                                                                                                                patients to manage their
                                                                                                                                treatments at the home.
                                                                                                                                The current NCDs and
                                                                                                                                LCDs that restrict
                                                                                                                                coverage of these
                                                                                                                                devices and services to
                                                                                                                                patients with certain
                                                                                                                                clinical characteristics
                                                                                                                                do not apply during the
                                                                                                                                public health emergency.
110...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Independent Lab       During the PHE, Medicare
                                                                                                          Payment for           established two new
                                                                                                          Specimen collection.  level II HCPCS Codes for
                                                                                                                                Medicare payment of a
                                                                                                                                nominal specimen
                                                                                                                                collection fee and
                                                                                                                                associated travel
                                                                                                                                allowance. Independent
                                                                                                                                labs must use one of
                                                                                                                                these HCPCS codes when
                                                                                                                                billing Medicare for the
                                                                                                                                nominal specimen fee for
                                                                                                                                COVID-19 testing for the
                                                                                                                                duration of the PHE for
                                                                                                                                COVID-19 pandemic.

[[Page 75732]]

 
111...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Communication         D. Medicare routinely
                                                                                                          Technology-Based      pays for many kinds of
                                                                                                          Services (CTBBS).     services that are
                                                                                                                                furnished via
                                                                                                                                telecommunications
                                                                                                                                technology (83 FR
                                                                                                                                59482), but are not
                                                                                                                                considered Medicare
                                                                                                                                telehealth services.
                                                                                                                                These communication
                                                                                                                                technology-based
                                                                                                                                services (CTBS) include,
                                                                                                                                for example, certain
                                                                                                                                kinds of remote patient
                                                                                                                                monitoring (either as
                                                                                                                                separate services or as
                                                                                                                                parts of bundled
                                                                                                                                services), and
                                                                                                                                interpretations of
                                                                                                                                diagnostic tests when
                                                                                                                                furnished remotely. In
                                                                                                                                the context of the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic, when brief
                                                                                                                                communications with
                                                                                                                                practitioners and other
                                                                                                                                non-face-to-face
                                                                                                                                services might mitigate
                                                                                                                                the need for an in-
                                                                                                                                person visit that could
                                                                                                                                represent an exposure
                                                                                                                                risk for vulnerable
                                                                                                                                patients, we believe
                                                                                                                                that these services
                                                                                                                                should be available to
                                                                                                                                as large a population of
                                                                                                                                Medicare beneficiaries
                                                                                                                                as possible. During the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic, we are
                                                                                                                                finalizing that these
                                                                                                                                services, which may only
                                                                                                                                be reported if they do
                                                                                                                                not result in a visit,
                                                                                                                                including a telehealth
                                                                                                                                visit, can be furnished
                                                                                                                                to both new and
                                                                                                                                established patients.
                                                                                                                                Consent to receive these
                                                                                                                                services can be
                                                                                                                                documented by auxiliary
                                                                                                                                staff under general
                                                                                                                                supervision. We are
                                                                                                                                finalizing on an interim
                                                                                                                                basis during the PHE for
                                                                                                                                the COVID-19 pandemic
                                                                                                                                that, while consent to
                                                                                                                                receive these services
                                                                                                                                must be obtained
                                                                                                                                annually, it may be
                                                                                                                                obtained at the same
                                                                                                                                time that a service is
                                                                                                                                furnished. We are re-
                                                                                                                                emphasizing that this
                                                                                                                                consent may be obtained
                                                                                                                                by auxiliary staff under
                                                                                                                                general supervision, as
                                                                                                                                well as by the billing
                                                                                                                                practitioner. In the
                                                                                                                                context of the PHE for
                                                                                                                                the COVID-19 pandemic,
                                                                                                                                where communications
                                                                                                                                with practitioners might
                                                                                                                                mitigate the need for an
                                                                                                                                in-person visit that
                                                                                                                                could represent an
                                                                                                                                exposure risk for
                                                                                                                                vulnerable patients, we
                                                                                                                                do not believe the
                                                                                                                                limitation of these
                                                                                                                                services to established
                                                                                                                                patients is warranted.
                                                                                                                                While some of the code
                                                                                                                                descriptors refer to
                                                                                                                                ``established patient,''
                                                                                                                                during the PHE, we are
                                                                                                                                exercising enforcement
                                                                                                                                discretion on an interim
                                                                                                                                basis to relax
                                                                                                                                enforcement of this
                                                                                                                                aspect of the code
                                                                                                                                descriptors. We will not
                                                                                                                                conduct review to
                                                                                                                                consider whether those
                                                                                                                                services were furnished
                                                                                                                                to established patients.
                                                                                                                                On an interim basis,
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic, we
                                                                                                                                are also broadening the
                                                                                                                                availability of HCPCS
                                                                                                                                codes G2010 and G2012
                                                                                                                                that describe remote
                                                                                                                                evaluation of patient
                                                                                                                                images/video and virtual
                                                                                                                                check-ins. We recognize
                                                                                                                                that in the context of
                                                                                                                                the PHE for the COVID-19
                                                                                                                                pandemic, practitioners
                                                                                                                                such as licensed
                                                                                                                                clinical social workers,
                                                                                                                                clinical psychologists,
                                                                                                                                physical therapists,
                                                                                                                                occupational therapists,
                                                                                                                                and speech-language
                                                                                                                                pathologists might also
                                                                                                                                utilize virtual check-
                                                                                                                                ins and remote
                                                                                                                                evaluations instead of
                                                                                                                                other, in-person
                                                                                                                                services within the
                                                                                                                                relevant Medicare
                                                                                                                                benefit to facilitate
                                                                                                                                the best available
                                                                                                                                appropriate care while
                                                                                                                                mitigating exposure
                                                                                                                                risks. We note that this
                                                                                                                                is not an exhaustive
                                                                                                                                list and we are seeking
                                                                                                                                input on other kinds of
                                                                                                                                practitioners who might
                                                                                                                                be furnishing these
                                                                                                                                kinds of services as
                                                                                                                                part of the Medicare
                                                                                                                                services they furnish in
                                                                                                                                the context of the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic. To facilitate
                                                                                                                                billing of the CTBS
                                                                                                                                services by therapists
                                                                                                                                for the reasons
                                                                                                                                described above, we are
                                                                                                                                designating HCPCS codes
                                                                                                                                G2010, G2012, G2061,
                                                                                                                                G2062, or G2063 as CTBS
                                                                                                                                ``sometimes therapy''
                                                                                                                                services that would
                                                                                                                                require the private
                                                                                                                                practice occupational
                                                                                                                                therapist, physical
                                                                                                                                therapist, and speech-
                                                                                                                                language pathologist to
                                                                                                                                include the
                                                                                                                                corresponding GO, GP, or
                                                                                                                                GN therapy modifier on
                                                                                                                                claims for these
                                                                                                                                services. CTBS therapy
                                                                                                                                services include those
                                                                                                                                furnished to a new or
                                                                                                                                established patients
                                                                                                                                that the occupational
                                                                                                                                therapist, physical
                                                                                                                                therapist, and speech-
                                                                                                                                language pathologist
                                                                                                                                practitioner is
                                                                                                                                currently treating under
                                                                                                                                a plan of care.
112...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Direct Supervision    For the duration of the
                                                                                                          by Interactive        PHE for the COVID-19
                                                                                                          Telecommunications    pandemic, for purposes
                                                                                                          Technology.           of limiting exposure to
                                                                                                                                COVID-19, we adopted an
                                                                                                                                interim final policy
                                                                                                                                revising the definition
                                                                                                                                of direct supervision to
                                                                                                                                include virtual presence
                                                                                                                                of the supervising
                                                                                                                                physician or
                                                                                                                                practitioner using
                                                                                                                                interactive audio/video
                                                                                                                                real-time communications
                                                                                                                                technology (85 FR
                                                                                                                                19245). We recognized
                                                                                                                                that in some cases, the
                                                                                                                                physical proximity of
                                                                                                                                the physician or
                                                                                                                                practitioner might
                                                                                                                                present additional
                                                                                                                                infection exposure risk
                                                                                                                                to the patient and/or
                                                                                                                                practitioner.

[[Page 75733]]

 
113...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Telephone Evaluation  S. We are finalizing, on
                                                                                                          and Management (E/    an interim basis for the
                                                                                                          M) Services Codes.    duration of the PHE for
                                                                                                                                the COVID-19 pandemic,
                                                                                                                                separate payment for CPT
                                                                                                                                codes 98966-98968 and
                                                                                                                                CPT codes 99441-99443.
                                                                                                                                For these codes, we are
                                                                                                                                finalizing on an interim
                                                                                                                                basis for the duration
                                                                                                                                of the PHE for the COVID-
                                                                                                                                19 pandemic, work RVUs
                                                                                                                                as recommended by the
                                                                                                                                AMA Health Care
                                                                                                                                Professionals Advisory
                                                                                                                                Committee (HCPAC), and
                                                                                                                                work RVUs as recommended
                                                                                                                                by the AMA Relative
                                                                                                                                Value Scale Update
                                                                                                                                Committee (RUC). We are
                                                                                                                                finalizing the HCPAC and
                                                                                                                                RUC-recommended direct
                                                                                                                                PE inputs which consist
                                                                                                                                of 3 minutes of post-
                                                                                                                                service RN/LPN/MTA
                                                                                                                                clinical labor time for
                                                                                                                                each code. Similar to
                                                                                                                                the CTBS described in
                                                                                                                                section II.D. of this
                                                                                                                                IFC, we believe it is
                                                                                                                                important during the PHE
                                                                                                                                to extend these services
                                                                                                                                to both new and
                                                                                                                                established patients.
                                                                                                                                While some of the code
                                                                                                                                descriptors refer to
                                                                                                                                ``established patient,''
                                                                                                                                during the PHE we are
                                                                                                                                exercising enforcement
                                                                                                                                discretion on an interim
                                                                                                                                basis to relax
                                                                                                                                enforcement of this
                                                                                                                                aspect of the code
                                                                                                                                descriptors.
                                                                                                                                Specifically, we will
                                                                                                                                not conduct review to
                                                                                                                                consider whether those
                                                                                                                                services were furnished
                                                                                                                                to established patients.
                                                                                                                                CPT codes 98966-98968
                                                                                                                                described assessment and
                                                                                                                                management services
                                                                                                                                performed by
                                                                                                                                practitioners who cannot
                                                                                                                                separately bill for E/
                                                                                                                                Ms. We are noting that
                                                                                                                                these services may be
                                                                                                                                furnished by, among
                                                                                                                                others, LCSWs, clinical
                                                                                                                                psychologists, and
                                                                                                                                physical therapists,
                                                                                                                                occupational therapists,
                                                                                                                                and speech language
                                                                                                                                pathologists when the
                                                                                                                                visit pertains to a
                                                                                                                                service that falls
                                                                                                                                within the benefit
                                                                                                                                category of those
                                                                                                                                practitioners. To
                                                                                                                                facilitate billing of
                                                                                                                                these services by
                                                                                                                                therapists, we are
                                                                                                                                designating CPT codes
                                                                                                                                98966-98968 as CTBS
                                                                                                                                ``sometimes therapy''
                                                                                                                                services that would
                                                                                                                                require the private
                                                                                                                                practice occupational
                                                                                                                                therapist, physical
                                                                                                                                therapist, and speech-
                                                                                                                                language pathologist to
                                                                                                                                include the
                                                                                                                                corresponding GO, GP, or
                                                                                                                                GN therapy modifier on
                                                                                                                                claims for these
                                                                                                                                services.
114...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Clarification of      Homebound Definition:
                                                                                                          Homebound Status      Broadening homebound
                                                                                                          under the Medicare    definition to include
                                                                                                          Home Health Benefit.  beneficiaries whose
                                                                                                                                physician advises them
                                                                                                                                not to leave the home
                                                                                                                                because of a confirmed
                                                                                                                                or suspected COVID-19
                                                                                                                                diagnosis or if patient
                                                                                                                                has a condition that
                                                                                                                                makes them more
                                                                                                                                susceptible to contract
                                                                                                                                COVID-19.
115...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Use of                H. For the duration of
                                                                                                          Telecommunications    the PHE for the COVID-19
                                                                                                          Technology Under      pandemic, we are
                                                                                                          the Medicare Home     amending the hospice
                                                                                                          Health Benefit.       regulations at 42 CFR
                                                                                                                                418.204 on an interim
                                                                                                                                basis to specify that
                                                                                                                                when a patient is
                                                                                                                                receiving routine home
                                                                                                                                care, hospices may
                                                                                                                                provide services via a
                                                                                                                                telecommunications
                                                                                                                                system if it is feasible
                                                                                                                                and appropriate to do so
                                                                                                                                to ensure that Medicare
                                                                                                                                patients can continue
                                                                                                                                receiving services that
                                                                                                                                are reasonable and
                                                                                                                                necessary for the
                                                                                                                                palliation and
                                                                                                                                management of a
                                                                                                                                patients' terminal
                                                                                                                                illness and related
                                                                                                                                conditions without
                                                                                                                                jeopardizing the
                                                                                                                                patients' health or the
                                                                                                                                health of those who are
                                                                                                                                providing such services
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic. To
                                                                                                                                appropriately recognize
                                                                                                                                the role of technology
                                                                                                                                in furnishing services
                                                                                                                                under the hospice
                                                                                                                                benefit, the use of such
                                                                                                                                technology must be
                                                                                                                                included on the plan of
                                                                                                                                care. The inclusion of
                                                                                                                                technology on the plan
                                                                                                                                of care must continue to
                                                                                                                                meet the requirements at
                                                                                                                                Sec.   418.56, and must
                                                                                                                                be tied to the patient-
                                                                                                                                specific needs as
                                                                                                                                identified in the
                                                                                                                                comprehensive assessment
                                                                                                                                and the measurable
                                                                                                                                outcomes that the
                                                                                                                                hospice anticipates will
                                                                                                                                occur as a result of
                                                                                                                                implementing the plan of
                                                                                                                                care. There is no
                                                                                                                                payment beyond the per
                                                                                                                                diem amount for the use
                                                                                                                                of technology in
                                                                                                                                providing services under
                                                                                                                                the hospice benefit. For
                                                                                                                                the purposes of the
                                                                                                                                hospice claim
                                                                                                                                submission, only in-
                                                                                                                                person visits (with the
                                                                                                                                exception of social work
                                                                                                                                telephone calls) should
                                                                                                                                be reported on the
                                                                                                                                claim. However, hospices
                                                                                                                                can report the costs of
                                                                                                                                telecommunications
                                                                                                                                technology used to
                                                                                                                                furnish services under
                                                                                                                                the routine home care
                                                                                                                                level of care during the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic as ``other
                                                                                                                                patient care services''
                                                                                                                                using Worksheet A, cost
                                                                                                                                center line 46, or a
                                                                                                                                subscript of line 46
                                                                                                                                through 46.19, cost
                                                                                                                                center code 4600 through
                                                                                                                                4619, and identifying
                                                                                                                                this cost center as
                                                                                                                                ``PHE for COVID-19''.

[[Page 75734]]

 
116...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Use of                H. For the duration of
                                                                                                          Telecommunications    the PHE for the COVID-19
                                                                                                          Technology Under      pandemic, we are
                                                                                                          the Medicare          amending the hospice
                                                                                                          Hospice Benefit.      regulations at 42 CFR
                                                                                                                                418.204 on an interim
                                                                                                                                basis to specify that
                                                                                                                                when a patient is
                                                                                                                                receiving routine home
                                                                                                                                care, hospices may
                                                                                                                                provide services via a
                                                                                                                                telecommunications
                                                                                                                                system if it is feasible
                                                                                                                                and appropriate to do so
                                                                                                                                to ensure that Medicare
                                                                                                                                patients can continue
                                                                                                                                receiving services that
                                                                                                                                are reasonable and
                                                                                                                                necessary for the
                                                                                                                                palliation and
                                                                                                                                management of a
                                                                                                                                patients' terminal
                                                                                                                                illness and related
                                                                                                                                conditions without
                                                                                                                                jeopardizing the
                                                                                                                                patients' health or the
                                                                                                                                health of those who are
                                                                                                                                providing such services
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic. To
                                                                                                                                appropriately recognize
                                                                                                                                the role of technology
                                                                                                                                in furnishing services
                                                                                                                                under the hospice
                                                                                                                                benefit, the use of such
                                                                                                                                technology must be
                                                                                                                                included on the plan of
                                                                                                                                care. The inclusion of
                                                                                                                                technology on the plan
                                                                                                                                of care must continue to
                                                                                                                                meet the requirements at
                                                                                                                                Sec.   418.56, and must
                                                                                                                                be tied to the patient-
                                                                                                                                specific needs as
                                                                                                                                identified in the
                                                                                                                                comprehensive assessment
                                                                                                                                and the measurable
                                                                                                                                outcomes that the
                                                                                                                                hospice anticipates will
                                                                                                                                occur as a result of
                                                                                                                                implementing the plan of
                                                                                                                                care. There is no
                                                                                                                                payment beyond the per
                                                                                                                                diem amount for the use
                                                                                                                                of technology in
                                                                                                                                providing services under
                                                                                                                                the hospice benefit. For
                                                                                                                                the purposes of the
                                                                                                                                hospice claim
                                                                                                                                submission, only in-
                                                                                                                                person visits (with the
                                                                                                                                exception of social work
                                                                                                                                telephone calls) should
                                                                                                                                be reported on the
                                                                                                                                claim. However, hospices
                                                                                                                                can report the costs of
                                                                                                                                telecommunications
                                                                                                                                technology used to
                                                                                                                                furnish services under
                                                                                                                                the routine home care
                                                                                                                                level of care during the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic as ``other
                                                                                                                                patient care services''
                                                                                                                                using Worksheet A, cost
                                                                                                                                center line 46, or a
                                                                                                                                subscript of line 46
                                                                                                                                through 46.19, cost
                                                                                                                                center code 4600 through
                                                                                                                                4619, and identifying
                                                                                                                                this cost center as
                                                                                                                                ``PHE for COVID-19''.
117...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Frequency             B. Given our assessment
                                                                                                          Limitations on        that under the PHE for
                                                                                                          Subsequent Care       the COVID-19 pandemic,
                                                                                                          Services in           there is a patient
                                                                                                          Inpatient and         population that would
                                                                                                          Nursing Facility      otherwise not have
                                                                                                          Settings, and         access to clinically
                                                                                                          Critical Care         appropriate in-person
                                                                                                          Consultations and     treatment, we do not
                                                                                                          Required ``Hands-     believe these frequency
                                                                                                          on'' Visits for       limitations are
                                                                                                          ESRD Monthly          appropriate or
                                                                                                          Capitation Payments.  necessary. In our prior
                                                                                                                                analysis, for example,
                                                                                                                                we were concerned that
                                                                                                                                patients might not
                                                                                                                                receive the necessary in-
                                                                                                                                person services for
                                                                                                                                nursing facility or
                                                                                                                                hospital inpatient
                                                                                                                                services. Since in the
                                                                                                                                context of this PHE,
                                                                                                                                telehealth visits
                                                                                                                                mitigate exposure risk,
                                                                                                                                fewer in-person visits
                                                                                                                                may reflect the most
                                                                                                                                appropriate care,
                                                                                                                                depending on the needs
                                                                                                                                of individual patients.
                                                                                                                                Consequently, on an
                                                                                                                                interim basis, we are
                                                                                                                                removing the frequency
                                                                                                                                restrictions for each of
                                                                                                                                the following listed
                                                                                                                                codes for subsequent
                                                                                                                                inpatient visits and
                                                                                                                                subsequent NF visits
                                                                                                                                furnished via Medicare
                                                                                                                                telehealth for the
                                                                                                                                duration of the PHE for
                                                                                                                                the COVID-19 pandemic.
                                                                                                                                Similarly, we note that
                                                                                                                                we previously limited
                                                                                                                                critical care
                                                                                                                                consultations through
                                                                                                                                telehealth to only once
                                                                                                                                per day, given the
                                                                                                                                patient acuity involved
                                                                                                                                in critical care.
                                                                                                                                However, we also
                                                                                                                                understand that critical
                                                                                                                                care patients have
                                                                                                                                significant exposure
                                                                                                                                risks such that more
                                                                                                                                frequent services
                                                                                                                                furnished via telehealth
                                                                                                                                may reflect the best
                                                                                                                                available care in the
                                                                                                                                context and for the
                                                                                                                                duration of the PHE for
                                                                                                                                the COVID-19 pandemic.
                                                                                                                                For this reason, we are
                                                                                                                                also removing the
                                                                                                                                restriction that
                                                                                                                                critical care
                                                                                                                                consultation codes may
                                                                                                                                only be furnished to a
                                                                                                                                Medicare beneficiary
                                                                                                                                once per day. These
                                                                                                                                restrictions were
                                                                                                                                established through
                                                                                                                                rulemaking and
                                                                                                                                implemented through
                                                                                                                                systems edits.
118...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Inpatient Hospital    CC. Understanding that
                                                                                                          Services Furnished    our current policy may
                                                                                                          Under Arrangements    inhibit use of capacity
                                                                                                          Outside the           in settings that might
                                                                                                          Hospital.             otherwise be effective
                                                                                                                                in the efforts to
                                                                                                                                mitigate the impact of
                                                                                                                                the pandemic on Medicare
                                                                                                                                beneficiaries and the
                                                                                                                                American public, we are
                                                                                                                                changing our
                                                                                                                                arrangements policy
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic so
                                                                                                                                that hospitals are
                                                                                                                                allowed broader
                                                                                                                                flexibilities to furnish
                                                                                                                                inpatient services,
                                                                                                                                including routine
                                                                                                                                services outside the
                                                                                                                                hospital. We are
                                                                                                                                changing our under
                                                                                                                                arrangements policy
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic
                                                                                                                                beginning March 1, 2020,
                                                                                                                                so that hospitals are
                                                                                                                                allowed broader
                                                                                                                                flexibilities to furnish
                                                                                                                                inpatient services,
                                                                                                                                including routine
                                                                                                                                services outside the
                                                                                                                                hospital. Hospitals
                                                                                                                                would be treating
                                                                                                                                patients in locations
                                                                                                                                outside the hospital for
                                                                                                                                a variety of reasons,
                                                                                                                                including limited beds
                                                                                                                                and/or limited
                                                                                                                                specialized equipment
                                                                                                                                such as ventilators, and
                                                                                                                                for a limited time
                                                                                                                                period. While we are
                                                                                                                                changing our under
                                                                                                                                arrangements policy
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic to
                                                                                                                                allow hospitals broader
                                                                                                                                flexibilities in
                                                                                                                                furnishing inpatient
                                                                                                                                services, we emphasize
                                                                                                                                that we are not changing
                                                                                                                                our policy that a
                                                                                                                                hospital needs to
                                                                                                                                exercise sufficient
                                                                                                                                control and
                                                                                                                                responsibility over the
                                                                                                                                use of hospital
                                                                                                                                resources in treating
                                                                                                                                patients, as discussed
                                                                                                                                in the FY 2012 IPPS/LTCH
                                                                                                                                PPS final rule and
                                                                                                                                Section 10.3 of Chapter
                                                                                                                                5 of the Medicare
                                                                                                                                General Information,
                                                                                                                                Eligibility, and
                                                                                                                                Entitlement Manual (Pub.
                                                                                                                                100-01). Nothing in the
                                                                                                                                current PHE for the
                                                                                                                                COVID-19 pandemic has
                                                                                                                                changed our policy or
                                                                                                                                thinking with respect to
                                                                                                                                this issue and we are
                                                                                                                                making no modifications
                                                                                                                                to this aspect of the
                                                                                                                                policy. Hospitals need
                                                                                                                                to continue to exercise
                                                                                                                                sufficient control and
                                                                                                                                responsibility over the
                                                                                                                                use of hospital
                                                                                                                                resources in treating
                                                                                                                                patients regardless of
                                                                                                                                whether that treatment
                                                                                                                                occurs in the hospital
                                                                                                                                or outside the hospital
                                                                                                                                under arrangements. If a
                                                                                                                                hospital cannot exercise
                                                                                                                                sufficient control and
                                                                                                                                responsibility over the
                                                                                                                                use of hospital
                                                                                                                                resources in treating
                                                                                                                                patients outside the
                                                                                                                                hospital under
                                                                                                                                arrangements, the
                                                                                                                                hospital should not
                                                                                                                                provide those services
                                                                                                                                outside the hospital
                                                                                                                                under arrangements.

[[Page 75735]]

 
119...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Modification of the   J. During the PHE for the
                                                                                                          Inpatient             COVID-19 pandemic, we
                                                                                                          Rehabilitation        believe that it is
                                                                                                          Facility (IRF) Face-  essential to temporarily
                                                                                                          to-Face Requirement.  allow the face-to-face
                                                                                                                                visit requirements at
                                                                                                                                Sec.  Sec.
                                                                                                                                412.622(a)(3)(iv) and
                                                                                                                                412.29(e) to be
                                                                                                                                conducted via telehealth
                                                                                                                                to safeguard the health
                                                                                                                                and safety of Medicare
                                                                                                                                beneficiaries and the
                                                                                                                                rehabilitation
                                                                                                                                physicians treating
                                                                                                                                them. This allows
                                                                                                                                rehabilitation
                                                                                                                                physicians to use
                                                                                                                                telehealth services as
                                                                                                                                defined in section
                                                                                                                                1834(m)(4)(F) of the
                                                                                                                                Act, to conduct the
                                                                                                                                required 3 physician
                                                                                                                                visits per week during
                                                                                                                                the PHE for the COVID-19
                                                                                                                                pandemic. By increasing
                                                                                                                                access to telehealth,
                                                                                                                                this IFC will provide
                                                                                                                                the necessary
                                                                                                                                flexibility for Medicare
                                                                                                                                beneficiaries to be able
                                                                                                                                to receive medically
                                                                                                                                necessary services
                                                                                                                                without jeopardizing
                                                                                                                                their health or the
                                                                                                                                health of those who are
                                                                                                                                providing those
                                                                                                                                services, while
                                                                                                                                minimizing the overall
                                                                                                                                risk to public health.
                                                                                                                                To effectuate these
                                                                                                                                changes, on an interim
                                                                                                                                basis we are finalizing
                                                                                                                                revisions to the
                                                                                                                                regulations at Sec.
                                                                                                                                Sec.   412.622(a)(3)(iv)
                                                                                                                                and 412.29(e) during the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic.
                                                                                                                               In Sec.
                                                                                                                                412.622(a)(3)(iv), we
                                                                                                                                are revising this
                                                                                                                                paragraph to state that
                                                                                                                                physician supervision by
                                                                                                                                a rehabilitation
                                                                                                                                physician is required,
                                                                                                                                except that during the
                                                                                                                                PHE, as defined in Sec.
                                                                                                                                 400.200, such visits
                                                                                                                                may be conducted using
                                                                                                                                telehealth services (as
                                                                                                                                defined in section
                                                                                                                                1834(m)(4)(F) of the
                                                                                                                                Act).
                                                                                                                               In Sec.   412.29(e), we
                                                                                                                                are revising this
                                                                                                                                paragraph to state that
                                                                                                                                a procedure must be in
                                                                                                                                effect to ensure that
                                                                                                                                patients receive close
                                                                                                                                medical supervision, as
                                                                                                                                evidenced by at least 3
                                                                                                                                face-to-face visits per
                                                                                                                                week by a licensed
                                                                                                                                physician with
                                                                                                                                specialized training and
                                                                                                                                experience in inpatient
                                                                                                                                rehabilitation to assess
                                                                                                                                the patient both
                                                                                                                                medically and
                                                                                                                                functionally, as well as
                                                                                                                                to modify the course of
                                                                                                                                treatment as needed to
                                                                                                                                maximize the patient's
                                                                                                                                capacity to benefit from
                                                                                                                                the rehabilitation
                                                                                                                                process, except that
                                                                                                                                during the PHE, as
                                                                                                                                defined in Sec.
                                                                                                                                400.200, such visits may
                                                                                                                                be conducted using
                                                                                                                                telehealth services (as
                                                                                                                                defined in section
                                                                                                                                1834(m)(4)(F) of the
                                                                                                                                Act).
120...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Removal of the IRF    K. We are removing the
                                                                                                          Post-Admission        post-admission physician
                                                                                                          Physician             evaluation requirement
                                                                                                          Evaluation            at Sec.
                                                                                                          Requirement.          412.622(a)(4)(ii) for
                                                                                                                                all IRFs during the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic. We believe
                                                                                                                                that removal of this
                                                                                                                                requirement will greatly
                                                                                                                                reduce the amount of
                                                                                                                                time rehabilitation
                                                                                                                                physicians in IRFs spend
                                                                                                                                on completing paperwork
                                                                                                                                requirements when a
                                                                                                                                patient is admitted to
                                                                                                                                the IRF, and will free
                                                                                                                                up their time to focus
                                                                                                                                instead on caring for
                                                                                                                                patients and helping
                                                                                                                                where they may be needed
                                                                                                                                with the PHE for the
                                                                                                                                COVID-19 pandemic.
                                                                                                                                Accordingly, we are
                                                                                                                                amending Sec.
                                                                                                                                412.622(a)(4)(ii) to
                                                                                                                                note that the post-
                                                                                                                                admission physician
                                                                                                                                evaluation is not
                                                                                                                                required during the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic. To effectuate
                                                                                                                                this change, on an
                                                                                                                                interim basis, we are
                                                                                                                                revising Sec.
                                                                                                                                412.622(a)(4)(ii) to
                                                                                                                                specify that the post-
                                                                                                                                admission physician
                                                                                                                                evaluation is not
                                                                                                                                required during the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic.
121...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Requirements for      N. In light of the PHE
                                                                                                          Opioid Treatment      for the COVID-19
                                                                                                          Programs (OTP).       pandemic, during which
                                                                                                                                the public has been
                                                                                                                                instructed to practice
                                                                                                                                self-isolation or social
                                                                                                                                distancing, and because
                                                                                                                                interactive audio-video
                                                                                                                                communication technology
                                                                                                                                may not be available to
                                                                                                                                all beneficiaries, we
                                                                                                                                are revising Sec.
                                                                                                                                410.67(b)(3) and (4) to
                                                                                                                                allow the therapy and
                                                                                                                                counseling portions of
                                                                                                                                the weekly bundles, as
                                                                                                                                well as the add-on code
                                                                                                                                for additional
                                                                                                                                counseling or therapy,
                                                                                                                                to be furnished using
                                                                                                                                audio-only telephone
                                                                                                                                calls rather than via
                                                                                                                                two-way interactive
                                                                                                                                audio-video
                                                                                                                                communication technology
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic if
                                                                                                                                beneficiaries do not
                                                                                                                                have access to two-way
                                                                                                                                audio/video
                                                                                                                                communications
                                                                                                                                technology, provided all
                                                                                                                                other applicable
                                                                                                                                requirements are met.
122...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Physician             T. We changed the minimum
                                                                                                          Supervision           default level of
                                                                                                          Flexibility for       supervision to general
                                                                                                          Outpatient            supervision for NSEDTS
                                                                                                          Hospitals--Outpatie   during the initiation of
                                                                                                          nt Hospital           the service to give
                                                                                                          Therapeutic           providers additional
                                                                                                          Services Assigned     flexibility they need to
                                                                                                          to the Non-Surgical   handle the burdens
                                                                                                          Extended Duration     created by the PHE for
                                                                                                          Therapeutic           the COVID-19 pandemic.
                                                                                                          Services (NSEDTS)     We assigned, on an
                                                                                                          Level of              interim basis, all
                                                                                                          Supervision.          outpatient hospital
                                                                                                                                therapeutic services
                                                                                                                                that fall under Sec.
                                                                                                                                410.27(a)(1)(iv)(E), a
                                                                                                                                minimum level of general
                                                                                                                                supervision to be
                                                                                                                                consistent with the
                                                                                                                                minimum default level of
                                                                                                                                general supervision that
                                                                                                                                applies for most
                                                                                                                                outpatient hospital
                                                                                                                                therapeutic services,
                                                                                                                                and we revised Sec.
                                                                                                                                410.27(a)(1)(iv)(E) to
                                                                                                                                reflect this change in
                                                                                                                                the minimum level of
                                                                                                                                supervision. General
                                                                                                                                supervision, as defined
                                                                                                                                in our regulation at
                                                                                                                                Sec.   410.32(b)(3)(i)
                                                                                                                                means that the procedure
                                                                                                                                is furnished under the
                                                                                                                                physician's overall
                                                                                                                                direction and control,
                                                                                                                                but that the physician's
                                                                                                                                presence is not required
                                                                                                                                during the performance
                                                                                                                                of the procedure.
123...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Rural Health Clinics  Allow Professionals
                                                                                                          (RHC) and Federally   working at Rural Health
                                                                                                          Qualified Health      Clinics (RHCs) and
                                                                                                          Centers (FQHC)        Federally-Qualified
                                                                                                          Telehealth.           Health Centers (FQHCs)
                                                                                                                                to furnish telehealth
                                                                                                                                services. We are
                                                                                                                                expanding the services
                                                                                                                                that can be included in
                                                                                                                                the payment for HCPCS
                                                                                                                                code G0071, and update
                                                                                                                                payment rates of other
                                                                                                                                codes.

[[Page 75736]]

 
                                                                                                                               We are finalizing that
                                                                                                                                all virtual
                                                                                                                                communication services
                                                                                                                                that are billable using
                                                                                                                                HCPCS code G0071 will
                                                                                                                                also be available to new
                                                                                                                                patients that have not
                                                                                                                                been seen in the RHC or
                                                                                                                                FQHC within the previous
                                                                                                                                12 months. Also, in
                                                                                                                                situations where
                                                                                                                                obtaining prior
                                                                                                                                beneficiary consent
                                                                                                                                would interfere with the
                                                                                                                                timely provision of
                                                                                                                                these services, or the
                                                                                                                                timely provision of the
                                                                                                                                monthly care management
                                                                                                                                services, during the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic consent can
                                                                                                                                obtained when the
                                                                                                                                services are furnished
                                                                                                                                instead of prior to the
                                                                                                                                service being furnished,
                                                                                                                                but must be obtained
                                                                                                                                before the services are
                                                                                                                                billed. We will also
                                                                                                                                allow patient consent to
                                                                                                                                be acquired by staff
                                                                                                                                under the general
                                                                                                                                supervision of the RHC
                                                                                                                                or FQHC practitioner for
                                                                                                                                the virtual
                                                                                                                                communication and
                                                                                                                                monthly care management
                                                                                                                                codes during the PHE for
                                                                                                                                the COVID-19 pandemic.
124...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Change to Medicare    V. The 2019 MIPS data
                                                                                                          Shared Savings        submission deadline will
                                                                                                          Program Extreme and   be extended by 30 days
                                                                                                          Uncontrollable        until April 30, 2020, to
                                                                                                          Circumstances         give eligible clinicians
                                                                                                          Policy.               more time to report
                                                                                                                                quality and other data
                                                                                                                                for purposes of MIPS.
                                                                                                                                The MIPS automatic
                                                                                                                                extreme and
                                                                                                                                uncontrollable
                                                                                                                                circumstances policy
                                                                                                                                will apply to MIPS
                                                                                                                                eligible clinicians, who
                                                                                                                                do not submit their MIPS
                                                                                                                                data by the extended
                                                                                                                                timeline. Under this
                                                                                                                                automatic extreme and
                                                                                                                                uncontrollable
                                                                                                                                circumstances policy,
                                                                                                                                MIPS eligible
                                                                                                                                clinicians, who are not
                                                                                                                                participants in APMs,
                                                                                                                                who do not submit any
                                                                                                                                MIPS data will have all
                                                                                                                                performance categories
                                                                                                                                reweighted to zero
                                                                                                                                percent, resulting in a
                                                                                                                                score equal to the
                                                                                                                                performance threshold,
                                                                                                                                and a neutral MIPS
                                                                                                                                payment adjustment.
                                                                                                                                However, under the
                                                                                                                                policy, if a MIPS
                                                                                                                                eligible clinician
                                                                                                                                submits data on two or
                                                                                                                                more MIPS performance
                                                                                                                                categories, they will be
                                                                                                                                scored and receive a
                                                                                                                                2021 MIPS payment
                                                                                                                                adjustment based on
                                                                                                                                their final score.
125...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Payment for Medicare  A. To facilitate the use
                                                                                                          Telehealth Services   of telecommunications
                                                                                                          Under Section         technology as a safe
                                                                                                          1834(m) of the Act.   substitute for in-person
                                                                                                                                services, we are, on an
                                                                                                                                interim basis, adding
                                                                                                                                many services to the
                                                                                                                                list of eligible
                                                                                                                                Medicare telehealth
                                                                                                                                services, eliminating
                                                                                                                                frequency limitations
                                                                                                                                and other requirements
                                                                                                                                associated with
                                                                                                                                particular services
                                                                                                                                furnished via
                                                                                                                                telehealth, and
                                                                                                                                clarifying several
                                                                                                                                payment rules that apply
                                                                                                                                to other services that
                                                                                                                                are furnished using
                                                                                                                                telecommunications
                                                                                                                                technologies that can
                                                                                                                                reduce exposure risks.
                                                                                                                               The list of telehealth
                                                                                                                                services, including the
                                                                                                                                additions described
                                                                                                                                later in this section,
                                                                                                                                can be located on the
                                                                                                                                CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
                                                                                                                               Additional CPT Codes and
                                                                                                                                explanations provided in
                                                                                                                                the IFC.
126...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Telehealth and the    I. We are amending the
                                                                                                          Medicare Hospice      regulations at Sec.
                                                                                                          Face-to-Face          418.22(a)(4) on an
                                                                                                          Encounter             interim basis to allow
                                                                                                          Requirement.          the use of
                                                                                                                                telecommunications
                                                                                                                                technology by the
                                                                                                                                hospice physician or NP
                                                                                                                                for the face-to-face
                                                                                                                                visit when such visit is
                                                                                                                                solely for the purpose
                                                                                                                                of recertifying a
                                                                                                                                patient for hospice
                                                                                                                                services during the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic. By
                                                                                                                                telecommunications
                                                                                                                                technology, we mean the
                                                                                                                                use of multimedia
                                                                                                                                communications equipment
                                                                                                                                that includes, at a
                                                                                                                                minimum, audio and video
                                                                                                                                equipment permitting two-
                                                                                                                                way, real-time
                                                                                                                                interactive
                                                                                                                                communication between
                                                                                                                                the patient (from home,
                                                                                                                                or any other site
                                                                                                                                permissible for
                                                                                                                                receiving services under
                                                                                                                                the hospice benefit) and
                                                                                                                                distant site hospice
                                                                                                                                physician or hospice NP.
127...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Home Health Orders    Z. Allow a home health
                                                                                                          from APPs.            patient to be under the
                                                                                                                                care of a NP or clinical
                                                                                                                                nurse specialist or a PA
                                                                                                                                and allow such
                                                                                                                                practitioner to: (1)
                                                                                                                                Order home health
                                                                                                                                services; (2) establish
                                                                                                                                and periodically review
                                                                                                                                a plan of care for home
                                                                                                                                health services; and (3)
                                                                                                                                certify and re-certify
                                                                                                                                that the patient is
                                                                                                                                eligible for Medicare
                                                                                                                                home health services.
128...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Health Insurance      X. For Qualified health
                                                                                                          Issuer Standards      plan (QHP) issuers to
                                                                                                          under the ACA,        devote resources to
                                                                                                          Including Standards   respond to the COVID-19
                                                                                                          related to            PHE, revising 45 CFR
                                                                                                          Exchanges: Separate   156.280(e)(2)(ii) to
                                                                                                          Billing and           delay implementation of
                                                                                                          Segregation of        the separate billing
                                                                                                          Funds for Abortion    policy for 60 days from
                                                                                                          Services.             the effective date for
                                                                                                                                those offering coverage
                                                                                                                                of non-Hyde abortion
                                                                                                                                services for the portion
                                                                                                                                of their premium. Under
                                                                                                                                the Program Integrity
                                                                                                                                rule, issuers of
                                                                                                                                individual market QHPs
                                                                                                                                are required to begin
                                                                                                                                separately billing
                                                                                                                                policy holders for the
                                                                                                                                portion of the policy
                                                                                                                                holder's premium
                                                                                                                                attributable to non-Hyde
                                                                                                                                abortion services on or
                                                                                                                                before the QHP issuer's
                                                                                                                                first billing cycle
                                                                                                                                following June 27, 2020.
                                                                                                                                The date has been
                                                                                                                                changed to the QHP
                                                                                                                                issuer's first billing
                                                                                                                                cycle following August
                                                                                                                                26, 2020.
129...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Updates to the        R. Delaying the
                                                                                                          Quality Payment       implementation by 1 year
                                                                                                          Program: Merit-       that beginning with the
                                                                                                          based Incentive       2022 performance period,
                                                                                                          Payment System        QCDRs are required to
                                                                                                          (MIPS) Third Party    collect data on a QCDR
                                                                                                          Intermediary          measure, appropriate to
                                                                                                          Approval Criteria.    the measure type, prior
                                                                                                                                to submitting the QCDR
                                                                                                                                measure for CMS
                                                                                                                                consideration during the
                                                                                                                                self-nomination period
                                                                                                                                so that they can
                                                                                                                                complete QCDR measure
                                                                                                                                testing and collect
                                                                                                                                data.
130...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Application of        S. Continuous Glucose
                                                                                                          Certain National      Monitors: CMS will not
                                                                                                          Coverage              enforce certain clinical
                                                                                                          Determination and     criteria in LCDs that
                                                                                                          Local Coverage        limit access to
                                                                                                          Determination         therapeutic continuous
                                                                                                          Requirements: CGMs.   glucose monitors for
                                                                                                                                beneficiaries with
                                                                                                                                diabetes.

[[Page 75737]]

 
131...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Reporting             Y. Revising the
                                                                                                          Requirement for       requirements to
                                                                                                          Facilities to         establish explicit
                                                                                                          Report Nursing Home   reporting requirements
                                                                                                          Residents and Staff   for confirmed or
                                                                                                          Infections,           suspected cases.
                                                                                                          Potential             Specifically, we are
                                                                                                          Infections, and       revising our
                                                                                                          Deaths.               requirements by adding a
                                                                                                                                new provision at Sec.
                                                                                                                                483.80(g)(1), to require
                                                                                                                                facilities to
                                                                                                                                electronically report
                                                                                                                                information about COVID-
                                                                                                                                19 in a standardized
                                                                                                                                format specified by the
                                                                                                                                Secretary. The report
                                                                                                                                includes, but is not
                                                                                                                                limited to, information
                                                                                                                                on: Suspected and
                                                                                                                                confirmed COVID-19
                                                                                                                                infections among
                                                                                                                                residents and staff,
                                                                                                                                including residents
                                                                                                                                previously treated for
                                                                                                                                COVID-19; total deaths
                                                                                                                                and COVID-19 deaths
                                                                                                                                among residents and
                                                                                                                                staff; personal
                                                                                                                                protective equipment and
                                                                                                                                hand hygiene supplies in
                                                                                                                                the facility; ventilator
                                                                                                                                capacity and supplies
                                                                                                                                available in the
                                                                                                                                facility; resident beds
                                                                                                                                and census; access to
                                                                                                                                COVID-19 testing while
                                                                                                                                the resident is in the
                                                                                                                                facility; staffing
                                                                                                                                shortages; and other
                                                                                                                                information specified by
                                                                                                                                the Secretary. At Sec.
                                                                                                                                483.80(g)(3), we are
                                                                                                                                adding a new provision
                                                                                                                                to require facilities to
                                                                                                                                inform residents, their
                                                                                                                                representatives, and
                                                                                                                                families of those
                                                                                                                                residing in facilities
                                                                                                                                of confirmed or
                                                                                                                                suspected COVID-19 cases
                                                                                                                                in the facility among
                                                                                                                                residents and staff.
                                                                                                                                This reporting
                                                                                                                                requirement supports the
                                                                                                                                overall health and
                                                                                                                                safety of residents by
                                                                                                                                ensuring they are
                                                                                                                                informed participants in
                                                                                                                                the care that they
                                                                                                                                receive as well as
                                                                                                                                providing assurances of
                                                                                                                                the mitigating steps the
                                                                                                                                facility is taking to
                                                                                                                                prevent and control the
                                                                                                                                spread of COVID-19.
                                                                                                                                Facilities must inform
                                                                                                                                residents, their
                                                                                                                                representatives, and
                                                                                                                                families by 5 p.m. the
                                                                                                                                next calendar day
                                                                                                                                following the occurrence
                                                                                                                                of either: A single
                                                                                                                                confirmed infection of
                                                                                                                                COVID-19; or three or
                                                                                                                                more residents or staff
                                                                                                                                with new-onset of
                                                                                                                                respiratory symptoms
                                                                                                                                that occur within 72
                                                                                                                                hours of each other.
                                                                                                                                Also, cumulative updates
                                                                                                                                to residents, their
                                                                                                                                representatives, and
                                                                                                                                families must be
                                                                                                                                provided at least weekly
                                                                                                                                by 5 p.m. the next
                                                                                                                                calendar day following
                                                                                                                                the subsequent
                                                                                                                                occurrence of either:
                                                                                                                                Each time a confirmed
                                                                                                                                infection of COVID-19 is
                                                                                                                                identified; or whenever
                                                                                                                                three or more residents
                                                                                                                                or staff with new onset
                                                                                                                                of respiratory symptoms
                                                                                                                                occur within 72 hours of
                                                                                                                                each other.
132...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Delayed Adoption of   T. We are delaying the
                                                                                                          the Transfer of       compliance date by which
                                                                                                          Health (TOH)          IRFs, LTCH, and HHAs
                                                                                                          Information           must collect and report
                                                                                                          Measures and          data on two Transfer of
                                                                                                          Standard Patient      Health (TOH) Information
                                                                                                          Assessment Data       quality measures and
                                                                                                          Elements (SPADEs).    certain Standardized
                                                                                                                                Patient Assessment Data
                                                                                                                                Elements (SPADEs)
                                                                                                                                adopted for the IRF QRP,
                                                                                                                                LTCH QRP, and HH QRP.
                                                                                                                                Specifically, we will
                                                                                                                                require IRFs to use IRF-
                                                                                                                                PAI V4.0 and LTCHs to
                                                                                                                                use LTCH CARE Data Set
                                                                                                                                V5.0 to begin collecting
                                                                                                                                data on the two TOH
                                                                                                                                Information Measures
                                                                                                                                beginning with
                                                                                                                                discharges on October
                                                                                                                                1st of the year that is
                                                                                                                                at least 1 full fiscal
                                                                                                                                year after the end of
                                                                                                                                the COVID-19 PHE. For
                                                                                                                                example, if the COVID-19
                                                                                                                                PHE ends on September
                                                                                                                                20, 2020, IRFs and LTCHs
                                                                                                                                will be required to
                                                                                                                                begin collecting data on
                                                                                                                                these measures beginning
                                                                                                                                with patients discharged
                                                                                                                                on October 1, 2021. We
                                                                                                                                will also require IRFs
                                                                                                                                and LTCHs to begin
                                                                                                                                collecting data on the
                                                                                                                                SPADEs for admissions
                                                                                                                                and discharges (except
                                                                                                                                for the hearing, vision,
                                                                                                                                race, and ethnicity
                                                                                                                                SPADEs, which would be
                                                                                                                                collected for admissions
                                                                                                                                only) on October 1st of
                                                                                                                                the year that is at
                                                                                                                                least 1 full fiscal year
                                                                                                                                after the end of the
                                                                                                                                COVID-19 PHE. HHAs will
                                                                                                                                be required to use OASIS-
                                                                                                                                E to begin collecting
                                                                                                                                data on the two TOH
                                                                                                                                Information Measures
                                                                                                                                beginning with
                                                                                                                                discharges and transfers
                                                                                                                                on January 1st of the
                                                                                                                                year that is at least 1
                                                                                                                                full calendar year after
                                                                                                                                the end of the COVID-19
                                                                                                                                PHE. For example, if the
                                                                                                                                COVID-19 PHE ends on
                                                                                                                                September 20, 2020, HHAs
                                                                                                                                will be required to
                                                                                                                                begin collecting data on
                                                                                                                                those measures beginning
                                                                                                                                with patients discharged
                                                                                                                                or transferred on
                                                                                                                                January 1, 2022.
133...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Care Planning for     J. NPs, CNSs, and PAs
                                                                                                          Medicare Home         would be able to
                                                                                                          Health Services.      practice to the top of
                                                                                                                                their state licensure to
                                                                                                                                certify eligibility for
                                                                                                                                home health services, as
                                                                                                                                well as establish and
                                                                                                                                periodically review the
                                                                                                                                home health plan of
                                                                                                                                care. We are also
                                                                                                                                amending the regulations
                                                                                                                                at parts 409, 424, and
                                                                                                                                484 to define a NP, a
                                                                                                                                CNS, and a PA (as such
                                                                                                                                qualifications are
                                                                                                                                defined at Sec.  Sec.
                                                                                                                                410.74 through 410.76)
                                                                                                                                as an ``allowed
                                                                                                                                practitioner''. This
                                                                                                                                means that in addition
                                                                                                                                to a physician, as
                                                                                                                                defined at section
                                                                                                                                1861(r) of the Act, an
                                                                                                                                ``allowed practitioner''
                                                                                                                                may certify, establish
                                                                                                                                and periodically review
                                                                                                                                the plan of care, as
                                                                                                                                well as supervise the
                                                                                                                                provision of items and
                                                                                                                                services for
                                                                                                                                beneficiaries under the
                                                                                                                                Medicare home health
                                                                                                                                benefit. Additionally,
                                                                                                                                we are amending the
                                                                                                                                regulations to reflect
                                                                                                                                that we would expect the
                                                                                                                                allowed practitioner to
                                                                                                                                also perform the face-to-
                                                                                                                                face encounter for the
                                                                                                                                patient for whom they
                                                                                                                                are certifying
                                                                                                                                eligibility; however, if
                                                                                                                                a face-to-face encounter
                                                                                                                                is performed by an
                                                                                                                                allowed NPP, as set out
                                                                                                                                at 42 CFR
                                                                                                                                424.22(a)(1)(v)(A), in
                                                                                                                                an acute or post-acute
                                                                                                                                facility, from which the
                                                                                                                                patient was directly
                                                                                                                                admitted to home health,
                                                                                                                                the certifying
                                                                                                                                practitioner may be
                                                                                                                                different from the
                                                                                                                                provider performing the
                                                                                                                                face-to-face encounter.
                                                                                                                                These regulation changes
                                                                                                                                will become permanent
                                                                                                                                and are not time limited
                                                                                                                                to the period of the PHE
                                                                                                                                for COVID-19.

[[Page 75738]]

 
134...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Inpatient             K. In the March 31st
                                                                                                          Rehabilitation--Int   COVID-19 IFC (85 FR
                                                                                                          ensity of Therapy     19252, 19287), we
                                                                                                          Requirement (``3-     provided a clarification
                                                                                                          Hour Rule'') and      regarding Sec.
                                                                                                          Related IRF           412.622(a)(3)(ii)
                                                                                                          Coverage              (commonly referred to as
                                                                                                          Requirements.         the ``3-hour rule''). On
                                                                                                                                March 27, 2020, the
                                                                                                                                CARES Act was enacted
                                                                                                                                and further addressed
                                                                                                                                Sec.
                                                                                                                                412.622(a)(3)(ii).
                                                                                                                                Specifically, section
                                                                                                                                3711(a) of the CARES Act
                                                                                                                                requires the Secretary
                                                                                                                                to waive Sec.
                                                                                                                                412.622(a)(3)(ii) during
                                                                                                                                the emergency period
                                                                                                                                described in section
                                                                                                                                1135(g)(1)(B) of the
                                                                                                                                Act. This waiver was
                                                                                                                                issued on April 15 2020,
                                                                                                                                and is available at
                                                                                                                                https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
                                                                                                                                We note that the
                                                                                                                                clarification provided
                                                                                                                                in the March 31st COVID-
                                                                                                                                19 IFC does not address
                                                                                                                                section 3711(a) of the
                                                                                                                                CARES Act as it was
                                                                                                                                developed prior to the
                                                                                                                                enactment of the CARES
                                                                                                                                Act. Because Sec.
                                                                                                                                412.622(a)(3)(ii) is
                                                                                                                                more directly and
                                                                                                                                comprehensively
                                                                                                                                addressed by section
                                                                                                                                3711(a) of the CARES
                                                                                                                                Act, the clarification
                                                                                                                                provided in the March
                                                                                                                                31st COVID-19 IFC is
                                                                                                                                moot and hereby
                                                                                                                                rescinded.
135...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  IRF Coverage          C. We are amending Sec.
                                                                                                          Criteria--Surge       412.622(a)(3)(i), (ii),
                                                                                                          Capacity.             (iii), and (iv) to state
                                                                                                                                that these IRF coverage
                                                                                                                                criteria continue to be
                                                                                                                                required, except for
                                                                                                                                care furnished to
                                                                                                                                patients in a
                                                                                                                                freestanding IRF
                                                                                                                                hospital solely to
                                                                                                                                relieve acute care
                                                                                                                                hospital capacity in a
                                                                                                                                state (or region, as
                                                                                                                                applicable) that is
                                                                                                                                experiencing a surge
                                                                                                                                during the PHE, as
                                                                                                                                defined in Sec.
                                                                                                                                400.200. Similarly, in
                                                                                                                                Sec.   412.622(a)(4), we
                                                                                                                                are amending this
                                                                                                                                paragraph to state that
                                                                                                                                the IRF documentation
                                                                                                                                requirements must be
                                                                                                                                present in the IRF
                                                                                                                                medical record, except
                                                                                                                                for care furnished to
                                                                                                                                patients in a
                                                                                                                                freestanding IRF
                                                                                                                                hospital solely to
                                                                                                                                relieve acute care
                                                                                                                                hospital capacity in a
                                                                                                                                state (or region, as
                                                                                                                                applicable) that is
                                                                                                                                experiencing a surge
                                                                                                                                during the PHE, as
                                                                                                                                defined in Sec.
                                                                                                                                400.200. In Sec.
                                                                                                                                412.622(a)(5), we are
                                                                                                                                amending this paragraph
                                                                                                                                to state that an
                                                                                                                                interdisciplinary team
                                                                                                                                approach to care is
                                                                                                                                required, except for
                                                                                                                                care furnished to
                                                                                                                                patients in a
                                                                                                                                freestanding IRF
                                                                                                                                hospital solely to
                                                                                                                                relieve acute care
                                                                                                                                hospital capacity in a
                                                                                                                                state (or region, as
                                                                                                                                applicable) that is
                                                                                                                                experiencing a surge
                                                                                                                                during the PHE, as
                                                                                                                                defined in Sec.
                                                                                                                                400.200.
136...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Laboratory Tests:     BB. We are providing
                                                                                                          Payment for COVID-    additional payment for
                                                                                                          19 Specimen           assessment and COVID-19
                                                                                                          Collection to         specimen collection to
                                                                                                          Physicians, Non-      support testing by
                                                                                                          Physician             HOPDs, and physicians
                                                                                                          Practitioners and     and other practitioners,
                                                                                                          Hospitals.            to recognize the
                                                                                                                                significant resources
                                                                                                                                involved in safely
                                                                                                                                collecting specimens
                                                                                                                                from many beneficiaries
                                                                                                                                during a pandemic. We
                                                                                                                                are also allowing
                                                                                                                                physicians and
                                                                                                                                practitioners to bill
                                                                                                                                for services provided by
                                                                                                                                clinical staff to assess
                                                                                                                                symptoms and take
                                                                                                                                specimens for COVID-19
                                                                                                                                laboratory testing for
                                                                                                                                all patients, not just
                                                                                                                                established patients. We
                                                                                                                                are creating and
                                                                                                                                updating payment codes
                                                                                                                                to account for these
                                                                                                                                changes.
137...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Indirect Medical      Indirect Medical
                                                                                                          Education.            Education. Beds
                                                                                                                                temporarily added during
                                                                                                                                the COVID-19 PHE do not
                                                                                                                                reduce a teaching
                                                                                                                                hospital's Indirect
                                                                                                                                Medical Education
                                                                                                                                payments.
138...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Medical Education:    Direct Graduate Medical
                                                                                                          Time Spent by         Education and Indirect
                                                                                                          Residents at          Medical Education.
                                                                                                          Another Hospital      During the COVID-19 PHE,
                                                                                                          during the COVID-19   hospitals may claim time
                                                                                                          PHE.                  spent by residents
                                                                                                                                training at another
                                                                                                                                hospital so that a
                                                                                                                                hospital which sends
                                                                                                                                residents to another
                                                                                                                                hospital can claim those
                                                                                                                                FTE residents on its
                                                                                                                                Medicare cost report
                                                                                                                                while they are training
                                                                                                                                at another hospital in
                                                                                                                                its FTE count, if
                                                                                                                                certain conditions are
                                                                                                                                met. Also the presence
                                                                                                                                of residents in the
                                                                                                                                receiving hospital would
                                                                                                                                not trigger per-resident
                                                                                                                                amounts.
139...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Medicare Shared       L. We are modifying
                                                                                                          Savings Programs.     Shared Savings Program
                                                                                                                                policies to: (1) Allow
                                                                                                                                ACOs whose current
                                                                                                                                agreement periods expire
                                                                                                                                on December 31, 2020,
                                                                                                                                the option to extend
                                                                                                                                their existing agreement
                                                                                                                                period by 1-year, and
                                                                                                                                allow ACOs in the BASIC
                                                                                                                                track's glide path the
                                                                                                                                option to elect to
                                                                                                                                maintain their current
                                                                                                                                level of participation
                                                                                                                                for PY 2021; (2) clarify
                                                                                                                                the applicability of the
                                                                                                                                program's extreme and
                                                                                                                                uncontrollable
                                                                                                                                circumstances policy to
                                                                                                                                mitigate shared losses
                                                                                                                                for the period of the
                                                                                                                                COVID-19 PHE; (3) adjust
                                                                                                                                program calculations to
                                                                                                                                mitigate the impact of
                                                                                                                                COVID-19 on ACOs; and
                                                                                                                                (4) expand the
                                                                                                                                definition of primary
                                                                                                                                care services for
                                                                                                                                purposes of determining
                                                                                                                                beneficiary assignment
                                                                                                                                to include telehealth
                                                                                                                                codes for virtual check-
                                                                                                                                ins, e-visits, and
                                                                                                                                telephonic
                                                                                                                                communication. We are
                                                                                                                                revising our policies
                                                                                                                                under the Shared Savings
                                                                                                                                Program to exclude from
                                                                                                                                Shared Savings Program
                                                                                                                                calculations all Parts A
                                                                                                                                and B FFS payment
                                                                                                                                amounts for an episode
                                                                                                                                of care for treatment of
                                                                                                                                COVID-19, triggered by
                                                                                                                                an inpatient service,
                                                                                                                                and as specified on
                                                                                                                                Parts A and B claims
                                                                                                                                with dates of service
                                                                                                                                during the episode. We
                                                                                                                                are relying on our
                                                                                                                                authority under section
                                                                                                                                1899(d)(1)(B)(ii) of the
                                                                                                                                Act to adjust benchmark
                                                                                                                                expenditures for other
                                                                                                                                factors in order to
                                                                                                                                remove COVID-19-related
                                                                                                                                expenditures from the
                                                                                                                                determination of
                                                                                                                                benchmark expenditures.
                                                                                                                                As discussed elsewhere
                                                                                                                                in this section, we are
                                                                                                                                also exercising our
                                                                                                                                authority under section
                                                                                                                                1899(i)(3) of the Act to
                                                                                                                                apply this adjustment to
                                                                                                                                certain other program
                                                                                                                                calculations, including
                                                                                                                                the determination of
                                                                                                                                performance year
                                                                                                                                expenditures.
140...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Opioid Treatment      D. Allow telehealth in
                                                                                                          Programs (OTP)--      place of required visits
                                                                                                          Furnishing Periodic   for opioid treatment
                                                                                                          Assessments via       programs (OTP).
                                                                                                          Communication
                                                                                                          Technology.

[[Page 75739]]

 
141...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Furnishing Hospital   F. Hospital and CMHC
                                                                                                          Outpatient Services   staff can furnish
                                                                                                          Remotely.             certain outpatient
                                                                                                                                therapy, counseling, and
                                                                                                                                educational services
                                                                                                                                (including PHP services)
                                                                                                                                incident to a
                                                                                                                                physician's service
                                                                                                                                during the COVID-19 PHE
                                                                                                                                to a beneficiary in
                                                                                                                                their home or other
                                                                                                                                temporary expansion
                                                                                                                                location using
                                                                                                                                telecommunications
                                                                                                                                technology. In these
                                                                                                                                circumstances, the
                                                                                                                                hospital can furnish
                                                                                                                                services to a
                                                                                                                                beneficiary in a
                                                                                                                                temporary expansion
                                                                                                                                location (including the
                                                                                                                                beneficiary's home) if
                                                                                                                                that beneficiary is
                                                                                                                                registered as an
                                                                                                                                outpatient; and the CMHC
                                                                                                                                can furnish services in
                                                                                                                                an expanded CMHC
                                                                                                                                (including the
                                                                                                                                beneficiary's home) to a
                                                                                                                                beneficiary who is
                                                                                                                                registered as an
                                                                                                                                outpatient. We also
                                                                                                                                clarified that hospitals
                                                                                                                                can furnish clinical
                                                                                                                                staff services (for
                                                                                                                                example, drug
                                                                                                                                administration) in the
                                                                                                                                patient's home, which is
                                                                                                                                considered provider-
                                                                                                                                based to the hospital
                                                                                                                                during the COVID-19 PHE,
                                                                                                                                and to bill and be paid
                                                                                                                                for these services when
                                                                                                                                the patient is
                                                                                                                                registered as a hospital
                                                                                                                                outpatient. Further, we
                                                                                                                                clarified that when a
                                                                                                                                patient is receiving a
                                                                                                                                professional service via
                                                                                                                                telehealth in a location
                                                                                                                                that is considered a
                                                                                                                                hospital PBD, and the
                                                                                                                                patient is a registered
                                                                                                                                outpatient of the
                                                                                                                                hospital, the hospital
                                                                                                                                in which the patient is
                                                                                                                                registered may bill the
                                                                                                                                originating site
                                                                                                                                facility fee for the
                                                                                                                                service. Finally, we
                                                                                                                                clarified the
                                                                                                                                applicability of section
                                                                                                                                603 of the BBA 2015 to
                                                                                                                                hospitals furnishing
                                                                                                                                care in the
                                                                                                                                beneficiaries' homes (or
                                                                                                                                other temporary
                                                                                                                                expansion locations),
                                                                                                                                and whether those
                                                                                                                                locations are considered
                                                                                                                                relocated, partially
                                                                                                                                relocated, or new PBDs.
142...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Treatment of New and  E. We are adopting a
                                                                                                          Certain Relocating    temporary extraordinary
                                                                                                          Provider-Based        circumstances relocation
                                                                                                          Departments.          exception policy for
                                                                                                                                excepted off-campus PBDs
                                                                                                                                that relocate off-campus
                                                                                                                                during the COVID-19 PHE.
                                                                                                                                We are extending that
                                                                                                                                temporary policy to on-
                                                                                                                                campus PBDs that
                                                                                                                                relocate off-campus
                                                                                                                                during the COVID-19 PHE,
                                                                                                                                and permitting the
                                                                                                                                relocating PBDs to
                                                                                                                                continue to be paid
                                                                                                                                under the OPPS. Finally,
                                                                                                                                we are streamlining the
                                                                                                                                process for relocating
                                                                                                                                PBDs to obtain the
                                                                                                                                temporary extraordinary
                                                                                                                                circumstances policy
                                                                                                                                exception.
143...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Payment for Remote    CC. We are establishing a
                                                                                                          Physiologic           policy on an interim
                                                                                                          Monitoring (RPM)      final basis for the
                                                                                                          Services.             duration of the COVID-19
                                                                                                                                PHE to allow RPM codes
                                                                                                                                to be billed for a
                                                                                                                                minimum of 2 days of
                                                                                                                                data collection over a
                                                                                                                                30-day period, rather
                                                                                                                                than the required 16
                                                                                                                                days of data collection
                                                                                                                                over a 30-day period as
                                                                                                                                provided in the CPT code
                                                                                                                                descriptors.
144...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Rural Health Clinics  H. Due to the COVID-19
                                                                                                          (RHC).                pandemic, health care
                                                                                                                                providers such as
                                                                                                                                hospitals have been or
                                                                                                                                are planning to increase
                                                                                                                                inpatient bed capacity
                                                                                                                                to address the surge in
                                                                                                                                need for inpatient care.
                                                                                                                                Given this, we do not
                                                                                                                                believe that RHCs that
                                                                                                                                are currently exempt
                                                                                                                                from the national per-
                                                                                                                                visit payment limit
                                                                                                                                should now be subject to
                                                                                                                                the per-visit payment
                                                                                                                                limit due to the COVID-
                                                                                                                                19 PHE, and we do not
                                                                                                                                want to discourage them
                                                                                                                                from increasing bed
                                                                                                                                capacity if needed.
                                                                                                                                Allowing for these
                                                                                                                                provider-based RHCs to
                                                                                                                                continue to receive the
                                                                                                                                payment amounts they
                                                                                                                                would otherwise receive
                                                                                                                                in the absence of the
                                                                                                                                PHE will help maintain
                                                                                                                                their ability to provide
                                                                                                                                necessary health care
                                                                                                                                services to underserved
                                                                                                                                communities. We are
                                                                                                                                implementing, on an
                                                                                                                                interim basis, a change
                                                                                                                                to the period of time
                                                                                                                                used to determine the
                                                                                                                                number of beds in a
                                                                                                                                hospital at Sec.
                                                                                                                                412.105(b) for purposes
                                                                                                                                of determining which
                                                                                                                                provider-based RHCs are
                                                                                                                                subject to the payment
                                                                                                                                limit. For the duration
                                                                                                                                of the PHE, we will use
                                                                                                                                the number of beds from
                                                                                                                                the cost reporting
                                                                                                                                period prior to the
                                                                                                                                start of the PHE as the
                                                                                                                                official hospital bed
                                                                                                                                count for application of
                                                                                                                                this policy. As such,
                                                                                                                                RHCs with provider-based
                                                                                                                                status that were exempt
                                                                                                                                from the national per-
                                                                                                                                visit payment limit in
                                                                                                                                the period prior to the
                                                                                                                                effective date of the
                                                                                                                                PHE (January 27, 2020)
                                                                                                                                would continue to be
                                                                                                                                exempt for the duration
                                                                                                                                of the PHE for the COVID-
                                                                                                                                19 pandemic, as defined
                                                                                                                                at Sec.   400.200.
145...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Scope of Practice:    Allow nurse practitioners
                                                                                                          Supervision of        (NPs), clinical nurse
                                                                                                          Diagnostic Tests by   specialists (CNSs),
                                                                                                          Certain Non-          physician assistants
                                                                                                          Physician             (PAs) and certified
                                                                                                          Practitioners.        nurse-midwives (CNMs) to
                                                                                                                                supervise the
                                                                                                                                performance of
                                                                                                                                diagnostic tests in
                                                                                                                                addition to physicians.
146...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Scope of Practice:    B. 4. We are clarifying
                                                                                                          Pharmacists Working   explicitly that
                                                                                                          Incident to a         pharmacists fall within
                                                                                                          Physicians' Service.  the regulatory
                                                                                                                                definition of auxiliary
                                                                                                                                personnel under our
                                                                                                                                regulations at Sec.
                                                                                                                                410.26. As such,
                                                                                                                                pharmacists may provide
                                                                                                                                services incident to the
                                                                                                                                services, and under the
                                                                                                                                appropriate level of
                                                                                                                                supervision, of the
                                                                                                                                billing physician or
                                                                                                                                NPP, if payment for the
                                                                                                                                services is not made
                                                                                                                                under the Medicare Part
                                                                                                                                D benefit. This includes
                                                                                                                                providing the services
                                                                                                                                incident to the services
                                                                                                                                of the billing physician
                                                                                                                                or NPP and in accordance
                                                                                                                                with the pharmacist's
                                                                                                                                state scope of practice
                                                                                                                                and applicable state
                                                                                                                                law.
147...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  COVID-19 Serology     Section V of the rule.
                                                                                                          Testing.              Antibody Testing:
                                                                                                                                Medicare will cover
                                                                                                                                certain serology
                                                                                                                                (antibody) tests, which
                                                                                                                                may aid in determining
                                                                                                                                whether a person may
                                                                                                                                have developed an immune
                                                                                                                                response and may not be
                                                                                                                                at immediate risk for
                                                                                                                                COVID-19 reinfection.
                                                                                                                                FDA approved or cleared
                                                                                                                                COVID-19 serology
                                                                                                                                testing as a Medicare
                                                                                                                                covered diagnostic test
                                                                                                                                for patients that have
                                                                                                                                reason to believe they
                                                                                                                                have been exposed to
                                                                                                                                COVID-19. The serology
                                                                                                                                test for COVID-19 is a
                                                                                                                                covered service under
                                                                                                                                Medicare Parts A and B
                                                                                                                                and may be considered a
                                                                                                                                hospital service
                                                                                                                                (section 1861(b) of the
                                                                                                                                Act) or diagnostic
                                                                                                                                laboratory test (section
                                                                                                                                1861(s)(3) of the Act).

[[Page 75740]]

 
148...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Additional            M. Allow the teaching
                                                                                                          Flexibility under     physician to meet the
                                                                                                          the Teaching          requirement to review
                                                                                                          Physician             the service with the
                                                                                                          Regulations.          resident, during or
                                                                                                                                immediately after the
                                                                                                                                visit, through virtual
                                                                                                                                or remote means via
                                                                                                                                interactive audio/video
                                                                                                                                real-time communications
                                                                                                                                technology. Given the
                                                                                                                                circumstances of the
                                                                                                                                COVID-19 PHE, the
                                                                                                                                teaching physician may
                                                                                                                                be under quarantine or
                                                                                                                                otherwise not physically
                                                                                                                                available to review the
                                                                                                                                service with the
                                                                                                                                resident. We are
                                                                                                                                reinstating the former
                                                                                                                                paragraph (b) and adding
                                                                                                                                a new paragraph (c) to
                                                                                                                                allow that, on an
                                                                                                                                interim basis for the
                                                                                                                                duration of the PHE for
                                                                                                                                the COVID-19 pandemic,
                                                                                                                                the teaching physician
                                                                                                                                may not only direct the
                                                                                                                                care furnished by
                                                                                                                                residents, but also
                                                                                                                                review the services
                                                                                                                                provided with the
                                                                                                                                resident, during or
                                                                                                                                immediately after the
                                                                                                                                visit, remotely through
                                                                                                                                virtual means via audio/
                                                                                                                                video real time
                                                                                                                                communications
                                                                                                                                technology.
149...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Updating the          AA. Due to the urgency of
                                                                                                          Medicare Telehealth   minimizing unnecessary
                                                                                                          List on a Sub-        contact between
                                                                                                          regulatory Basis.     beneficiaries and
                                                                                                                                practitioners, we
                                                                                                                                believe that, for
                                                                                                                                purposes of the PHE for
                                                                                                                                the COVID-19 pandemic,
                                                                                                                                we should modify the
                                                                                                                                process we established
                                                                                                                                for adding or deleting
                                                                                                                                services from the
                                                                                                                                Medicare telehealth
                                                                                                                                services list under our
                                                                                                                                regulation at Sec.
                                                                                                                                410.78(f) to allow for
                                                                                                                                an expedited process
                                                                                                                                during the PHE that does
                                                                                                                                not involve notice and
                                                                                                                                comment rulemaking.
                                                                                                                                Therefore, for the
                                                                                                                                duration of the PHE for
                                                                                                                                the COVID-19 pandemic,
                                                                                                                                we are revising our
                                                                                                                                regulation at Sec.
                                                                                                                                410.78(f) to specify
                                                                                                                                that, during a PHE, as
                                                                                                                                defined in Sec.
                                                                                                                                400.200 of this chapter,
                                                                                                                                we will use a
                                                                                                                                subregulatory process to
                                                                                                                                modify the services
                                                                                                                                included on the Medicare
                                                                                                                                telehealth list.
                                                                                                                               While we are not
                                                                                                                                codifying a specific
                                                                                                                                process to be in effect
                                                                                                                                during the PHE for the
                                                                                                                                COVID-19 pandemic, we
                                                                                                                                note that we could add
                                                                                                                                services to the Medicare
                                                                                                                                telehealth list on a
                                                                                                                                subregulatory basis by
                                                                                                                                posting new services to
                                                                                                                                the web listing of
                                                                                                                                telehealth services when
                                                                                                                                the agency receives a
                                                                                                                                request to add (or
                                                                                                                                identifies through
                                                                                                                                internal review) a
                                                                                                                                service that can be
                                                                                                                                furnished in full, as
                                                                                                                                described by the
                                                                                                                                relevant code, by a
                                                                                                                                distant site
                                                                                                                                practitioner to a
                                                                                                                                beneficiary in a manner
                                                                                                                                that is similar to the
                                                                                                                                in-person service. We
                                                                                                                                also note that any
                                                                                                                                additional services
                                                                                                                                added using the revised
                                                                                                                                process would remain on
                                                                                                                                the list only during the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic.
150...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Therapy--Therapy      B. 2. To increase
                                                                                                          Assistants            availability of needed
                                                                                                          Furnishing            health care services
                                                                                                          Maintenance Therapy   during the COVID-19 PHE,
                                                                                                          (PFS).                we believe it is
                                                                                                                                appropriate to
                                                                                                                                synchronize our Part B
                                                                                                                                payment policies as
                                                                                                                                suggested by the
                                                                                                                                stakeholders, and to
                                                                                                                                permit the PT or OT who
                                                                                                                                established the
                                                                                                                                maintenance program to
                                                                                                                                delegate the performance
                                                                                                                                of maintenance therapy
                                                                                                                                services to a PTA or OTA
                                                                                                                                when clinically
                                                                                                                                appropriate. We believe
                                                                                                                                that, by allowing PTAs
                                                                                                                                and OTAs to perform
                                                                                                                                maintenance therapy
                                                                                                                                services, PTs and OTs
                                                                                                                                will be freed up to
                                                                                                                                furnish other services,
                                                                                                                                including such services
                                                                                                                                as non-medication pain
                                                                                                                                management therapies
                                                                                                                                that may reduce reliance
                                                                                                                                on opioids or other
                                                                                                                                medications, as well as
                                                                                                                                those services related
                                                                                                                                to the COVID-19 PHE that
                                                                                                                                require a therapist's
                                                                                                                                assessment and
                                                                                                                                evaluation skills,
                                                                                                                                including communication
                                                                                                                                technology-based
                                                                                                                                services (CTBS) that
                                                                                                                                were made available for
                                                                                                                                PTs, OTs and speech-
                                                                                                                                language pathologists
                                                                                                                                (SLPs) during the PHE in
                                                                                                                                the March 31st COVID-19
                                                                                                                                IFC (85 FR 19245 and
                                                                                                                                19265 through 19266).

[[Page 75741]]

 
151...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Modification to       W. Several of our
                                                                                                          Medicare Provider     previous provider
                                                                                                          Enrollment            enrollment rulemaking
                                                                                                          Provision             efforts have focused on
                                                                                                          Concerning            strengthening existing
                                                                                                          Certification of      enrollment procedures
                                                                                                          Home Health           and eliminating existing
                                                                                                          Services.             vulnerabilities; in
                                                                                                                                other words, the
                                                                                                                                objectives have been to
                                                                                                                                enhance our ability to:
                                                                                                                                (1) Conduct strict
                                                                                                                                screening activities;
                                                                                                                                (2) take prompt action
                                                                                                                                against problematic
                                                                                                                                providers and suppliers;
                                                                                                                                and (3) implement
                                                                                                                                important safeguards
                                                                                                                                against improper
                                                                                                                                Medicare payments. Yet
                                                                                                                                we believe that the
                                                                                                                                current COVID-19 PHE
                                                                                                                                requires us to undertake
                                                                                                                                provider enrollment
                                                                                                                                rulemaking for a
                                                                                                                                different reason;
                                                                                                                                specifically, the need
                                                                                                                                to help providers and
                                                                                                                                suppliers concentrate
                                                                                                                                their resources on
                                                                                                                                treating those
                                                                                                                                beneficiaries affected
                                                                                                                                by COVID-19. Therefore,
                                                                                                                                as discussed in section
                                                                                                                                III. of this IFC,
                                                                                                                                ``Waiver of Proposed
                                                                                                                                Rulemaking,'' we believe
                                                                                                                                the urgency of this
                                                                                                                                COVID-19 PHE constitutes
                                                                                                                                good cause to waive the
                                                                                                                                normal notice-and-
                                                                                                                                comment process under
                                                                                                                                the Administrative
                                                                                                                                Procedure Act and
                                                                                                                                statute. Accordingly,
                                                                                                                                this IFC contains an
                                                                                                                                important revision to
                                                                                                                                part 424, subpart P that
                                                                                                                                will give providers and
                                                                                                                                suppliers certain
                                                                                                                                flexibilities in their
                                                                                                                                activities during the
                                                                                                                                existing COVID-19 PHE.
                                                                                                                                Section 3708 of the
                                                                                                                                CARES Act made several
                                                                                                                                important amendments to
                                                                                                                                sections 1814(a)(2) and
                                                                                                                                1835(a)(2) of the Act
                                                                                                                                (as well as other
                                                                                                                                related sections of the
                                                                                                                                statute). One amendment
                                                                                                                                was that NPs, CNSs, and
                                                                                                                                PAs (as those terms are
                                                                                                                                defined in section
                                                                                                                                1861(aa)(5) of the Act)
                                                                                                                                working in accordance
                                                                                                                                with state law may also
                                                                                                                                certify the need for
                                                                                                                                home health services.
                                                                                                                                Section 3708(f) of the
                                                                                                                                CARES Act authorizes us
                                                                                                                                to promulgate an interim
                                                                                                                                final rule, if
                                                                                                                                necessary, to implement
                                                                                                                                the provisions in
                                                                                                                                section 3708 by the
                                                                                                                                statutory deadline.
                                                                                                                                Further, given the need
                                                                                                                                for flexibility in the
                                                                                                                                provision of health care
                                                                                                                                services in the COVID-19
                                                                                                                                PHE, we believe it is
                                                                                                                                appropriate to implement
                                                                                                                                these statutory changes
                                                                                                                                in this IFC, rather than
                                                                                                                                through notice-and-
                                                                                                                                comment rulemaking.
                                                                                                                                Consequently, we are
                                                                                                                                revising Sec.
                                                                                                                                424.507(b)(1) to include
                                                                                                                                ordering/certifying
                                                                                                                                physicians, PAs, NPs,
                                                                                                                                and CNSs as individuals
                                                                                                                                who can certify the need
                                                                                                                                for home health
                                                                                                                                services. We note that,
                                                                                                                                for reasons similar to
                                                                                                                                those related to our
                                                                                                                                other modifications to
                                                                                                                                Medicare rules
                                                                                                                                concerning the
                                                                                                                                certification and
                                                                                                                                provision of home health
                                                                                                                                services, this change to
                                                                                                                                Sec.   424.507 is final
                                                                                                                                and applicable to
                                                                                                                                services provided on or
                                                                                                                                after March 1, 2020.We
                                                                                                                                will review and respond
                                                                                                                                to any comments thereon
                                                                                                                                in the CY 2021 HH PPS
                                                                                                                                final rule or in another
                                                                                                                                future rule.
152...............  HHS...............  CMS...............  Waiver...............  ....................  Verbal Orders.......  Waiving the requirements
                                                                                                                                of 42 CFR Sec.   482.23,
                                                                                                                                Sec.   482.24 and Sec.
                                                                                                                                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.
153...............  HHS...............  CMS...............  Waiver...............  ....................  Medical Records.....  Waiving requirements
                                                                                                                                under 42 CFR Sec.
                                                                                                                                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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan. CMS is waiving
                                                                                                                                Sec.
                                                                                                                                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. CMS is waiving
                                                                                                                                Sec.
                                                                                                                                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.
154...............  HHS...............  CMS...............  Waiver...............  ....................  Nursing Care Plan...  Waiving the requirements
                                                                                                                                at 42 CFR Sec.
                                                                                                                                482.23(b)(4), which
                                                                                                                                requires the nursing
                                                                                                                                staff to develop and
                                                                                                                                keep current a nursing
                                                                                                                                care plan for each
                                                                                                                                patient, and Sec.
                                                                                                                                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 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
                                                                                                                                Sec.   485.635(d)(4),
                                                                                                                                and may be implemented
                                                                                                                                so long as they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
155...............  HHS...............  CMS...............  Waiver...............  ....................  Upkeep of current     Food and Dietetic
                                                                                                          therapeutic diet      Services--Manual. CMS is
                                                                                                          manual.               waiving the requirement
                                                                                                                                at paragraph 42 CFR Sec.
                                                                                                                                  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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent 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.

[[Page 75742]]

 
156...............  HHS...............  CMS...............  Waiver...............  ....................  Written policies and  Waiving 42 CFR Sec.
                                                                                                          procedures for        482.12(f)(3), emergency
                                                                                                          appraisal of          services, with respect
                                                                                                          emergencies at off    to surge facilities
                                                                                                          campus hospital       only, such that written
                                                                                                          departments.          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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
157...............  HHS...............  CMS...............  Waiver...............  ....................  Emergency             Waiving 42 CFR Sec.
                                                                                                          Preparedness          482.15(b) and Sec.
                                                                                                          Policies and          485.625(b), which
                                                                                                          Procedures.           requires the hospital
                                                                                                                                and CAH to develop and
                                                                                                                                implement emergency
                                                                                                                                preparedness policies
                                                                                                                                and procedures, and Sec.
                                                                                                                                  482.15(c)(1)-(5) and
                                                                                                                                Sec.   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.
158...............  HHS...............  CMS...............  Waiver...............  ....................  Emergency             CMS is waiving the
                                                                                                          Preparedness.         requirements at 42 CFR
                                                                                                                                Sec.   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
                                                                                                                                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.
159...............  HHS...............  CMS...............  Waiver...............  ....................  Reporting             Waiving the requirements
                                                                                                          Requirements.         at 42 CFR Sec.
                                                                                                                                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).
160...............  HHS...............  CMS...............  Waiver...............  ....................  Extension for         CMS collects data every 3
                                                                                                          Inpatient             years on the
                                                                                                          Prospective Payment   occupational mix of
                                                                                                          System (IPPS) Wage    employees for each short-
                                                                                                          Index Occupational    term, acute care
                                                                                                          Mix Survey            hospital participating
                                                                                                          Submission.           in the Medicare program.
                                                                                                                                Completed 2019
                                                                                                                                Occupational Mix
                                                                                                                                Surveys, Hospital
                                                                                                                                Reporting Form CMS-
                                                                                                                                10079, for the Wage
                                                                                                                                Index Beginning FY 2022,
                                                                                                                                are 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 is
                                                                                                                                currently granting an
                                                                                                                                extension for hospitals
                                                                                                                                nationwide affected by
                                                                                                                                COVID-19 until August 3,
                                                                                                                                2020. If hospitals
                                                                                                                                encounter difficulty
                                                                                                                                meeting this extended
                                                                                                                                deadline date, hospitals
                                                                                                                                should communicate their
                                                                                                                                concerns to CMS via
                                                                                                                                their MAC, and CMS may
                                                                                                                                consider an additional
                                                                                                                                extension if CMS
                                                                                                                                determines it is
                                                                                                                                warranted.
161...............  HHS...............  CMS...............  Waiver...............  ....................  HHA Reporting.......  CMS is providing relief
                                                                                                                                to HHAs on the
                                                                                                                                timeframes related to
                                                                                                                                OASIS Transmission
                                                                                                                                through the following
                                                                                                                                actions below:
                                                                                                                                   Extending the
                                                                                                                                   5-day completion
                                                                                                                                   requirement for the
                                                                                                                                   comprehensive
                                                                                                                                   assessment to 30
                                                                                                                                   days.
                                                                                                                                   Waiving the
                                                                                                                                   30-day OASIS
                                                                                                                                   submission
                                                                                                                                   requirement. Delayed
                                                                                                                                   submission is
                                                                                                                                   permitted during the
                                                                                                                                   PHE.
162...............  HHS...............  CMS...............  Waiver...............  ....................  SNF Reporting         Waiving 42 CFR 483.20 to
                                                                                                          Minimum Data Set.     provide relief to SNFs
                                                                                                                                on the timeframe
                                                                                                                                requirements for Minimum
                                                                                                                                Data Set assessments and
                                                                                                                                transmission.
163...............  HHS...............  CMS...............  Waiver...............  ....................  SNF Staffing Data     Waiving 42 CFR 483.70(q)
                                                                                                          Submission.           to provide relief to
                                                                                                                                long-term care
                                                                                                                                facilities on the
                                                                                                                                requirements for
                                                                                                                                submitting staffing data
                                                                                                                                through the Payroll-
                                                                                                                                Based Journal system.
164...............  HHS...............  CMS...............  Waiver...............  ....................  Physical              CMS is waiving certain
                                                                                                          Environment..         requirements under the
                                                                                                                                Medicare conditions of
                                                                                                                                participation at 42 CFR
                                                                                                                                Sec.   482.41 and Sec.
                                                                                                                                485.623 to allow for
                                                                                                                                flexibilities during
                                                                                                                                hospital, psychiatric
                                                                                                                                hospital, and CAH
                                                                                                                                surges. CMS will permit
                                                                                                                                non-hospital buildings/
                                                                                                                                space to be used for
                                                                                                                                patient care and
                                                                                                                                quarantine sites,
                                                                                                                                provided that the
                                                                                                                                location is approved by
                                                                                                                                the state (ensuring that
                                                                                                                                safety and comfort for
                                                                                                                                patients and staff are
                                                                                                                                sufficiently addressed)
                                                                                                                                and so long as it is not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
165...............  HHS...............  CMS...............  Waiver...............  ....................  CAH Status and        Waiving the requirement
                                                                                                          Location.             at 42 CFR Sec.
                                                                                                                                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 Sec.
                                                                                                                                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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.

[[Page 75743]]

 
166...............  HHS...............  CMS...............  Waiver...............  ....................  Hospitals Classified  Waiving certain
                                                                                                          as Sole Community     eligibility requirements
                                                                                                          Hospitals (SCH).      at 42 CFR Sec.
                                                                                                                                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 Sec.   412.92, and
                                                                                                                                is also waiving the
                                                                                                                                ``market share'' and bed
                                                                                                                                requirements (as
                                                                                                                                applicable) at 42 CFR
                                                                                                                                Sec.   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.
167...............  HHS...............  CMS...............  Waiver...............  ....................  RHC and FQHC          Waiving the requirements
                                                                                                          Temporary Expansion   at 42 CFR Sec.
                                                                                                          Locations.            491.5(a)(3)(iii) which
                                                                                                                                require RHCs and FQHCs
                                                                                                                                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
                                                                                                                                services locations to
                                                                                                                                meet the needs of
                                                                                                                                Medicare beneficiaries.
                                                                                                                                This flexibility
                                                                                                                                includes areas which may
                                                                                                                                be outside of the
                                                                                                                                location requirements 42
                                                                                                                                CFR Sec.   491.5(a)(1)
                                                                                                                                and (2) but will end
                                                                                                                                when the HHS Secretary
                                                                                                                                determines there is no
                                                                                                                                longer a PHE due to
                                                                                                                                COVID-19.
168...............  HHS...............  CMS...............  Waiver...............  ....................  Care for Excluded     CMS is allowing acute
                                                                                                          Inpatient             care hospitals with
                                                                                                          Psychiatric and       excluded distinct part
                                                                                                          Inpatient             inpatient psychiatric
                                                                                                          Rehabilitation Unit   units and inpatient
                                                                                                          Patients in the       rehabilitation units to
                                                                                                          Acute Care Unit of    relocate inpatients from
                                                                                                          a Hospital.           the excluded distinct
                                                                                                                                part psychiatric unit or
                                                                                                                                inpatient rehabilitation
                                                                                                                                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 or
                                                                                                                                inpatient rehabilitation
                                                                                                                                services under the
                                                                                                                                Inpatient Psychiatric
                                                                                                                                Facility Prospective
                                                                                                                                Payment System or
                                                                                                                                Inpatient Rehabilitation
                                                                                                                                Facility Prospective
                                                                                                                                Payment System for these
                                                                                                                                patients 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 or
                                                                                                                                rehabilitation patients
                                                                                                                                and the staff and
                                                                                                                                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.
169...............  HHS...............  CMS...............  Waiver...............  ....................  Specific Life Safety  CMS is waiving
                                                                                                          Code (LSC) Waivers    requirements that would
                                                                                                          for Multiple          otherwise not permit
                                                                                                          Providers:            temporary walls and
                                                                                                          Temporary             barriers between
                                                                                                          Construction.         patients.
                                                                                                                               Refer to: 2012 LSC,
                                                                                                                                sections 18/19.3.3.2.
170...............  HHS...............  CMS...............  Waiver...............  ....................  Community Mental      42 CFR
                                                                                                          Health Clinics        485.918(b)(1)(iii). We
                                                                                                          (CMHC) Provision of   are waiving the specific
                                                                                                          Service.              requirement at Sec.
                                                                                                                                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 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 comply with the
                                                                                                                                nonwaived 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.
171...............  HHS...............  CMS...............  Waiver...............  ....................  RAPs................  CMS is allowing Medicare
                                                                                                                                Administrative
                                                                                                                                Contractors (MACs) to
                                                                                                                                extend the auto-
                                                                                                                                cancellation date of
                                                                                                                                Requests for Anticipated
                                                                                                                                Payment (RAPs) during
                                                                                                                                emergencies.
172...............  HHS...............  CMS...............  Waiver...............  ....................  Utilization Review    CMS is waiving certain
                                                                                                          (UR).                 requirements under 42
                                                                                                                                CFR Sec.   482.1(a)(3)
                                                                                                                                and 42 CFR Sec.   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.
173...............  HHS...............  CMS...............  Waiver...............  ....................  Training Program and  CMS is waiving the
                                                                                                          Periodic Audits.      requirement at 42 CFR
                                                                                                                                Sec.   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.
174...............  HHS...............  CMS...............  Waiver...............  ....................  Appeals Extensions..  CMS is allowing Medicare
                                                                                                                                Administrative
                                                                                                                                Contractors (MACs) and
                                                                                                                                Qualified Independent
                                                                                                                                Contractors (QICs) in
                                                                                                                                the FFS program pursuant
                                                                                                                                to 42 CFR Sec.   405.942
                                                                                                                                and 42 CFR Sec.
                                                                                                                                405.962 (including for
                                                                                                                                MA and Part D plans), as
                                                                                                                                well as the MA and Part
                                                                                                                                D Independent Review
                                                                                                                                Entities (IREs) under 42
                                                                                                                                CFR Sec.   422.562, 42
                                                                                                                                CFR Sec.   423.562, 42
                                                                                                                                CFR Sec.   422.582 and
                                                                                                                                42 CFR Sec.   423.582,
                                                                                                                                to allow extensions to
                                                                                                                                file an appeal. CMS is
                                                                                                                                allowing MACs and QICs
                                                                                                                                in the FFS program under
                                                                                                                                42 CFR Sec.   405.950
                                                                                                                                and 42 CFR Sec.
                                                                                                                                405.966 and the MA and
                                                                                                                                Part D IREs to waive
                                                                                                                                requests for timeliness
                                                                                                                                requirements for
                                                                                                                                additional information
                                                                                                                                to adjudicate appeals.

[[Page 75744]]

 
                                                                                                                                   CMS is
                                                                                                                                   allowing MACs and
                                                                                                                                   QICs in the FFS
                                                                                                                                   program under 42 CFR
                                                                                                                                   Sec.   405.910 and MA
                                                                                                                                   and Part D plans, as
                                                                                                                                   well as the MA and
                                                                                                                                   Part D IREs, to
                                                                                                                                   process an appeal
                                                                                                                                   even with incomplete
                                                                                                                                   Appointment of
                                                                                                                                   Representation forms
                                                                                                                                   as outlined under 42
                                                                                                                                   CFR Sec.   422.561
                                                                                                                                   and 42 CFR Sec.
                                                                                                                                   423.560. However, any
                                                                                                                                   communications will
                                                                                                                                   only be sent to the
                                                                                                                                   beneficiary.
                                                                                                                                   CMS is
                                                                                                                                   allowing MACs and
                                                                                                                                   QICs in the FFS
                                                                                                                                   program under 42 CFR
                                                                                                                                   Sec.   405.950 and 42
                                                                                                                                   CFR Sec.   405.966
                                                                                                                                   (also including MA
                                                                                                                                   and Part D plans), as
                                                                                                                                   well as the MA and
                                                                                                                                   Part D IREs, to
                                                                                                                                   process requests for
                                                                                                                                   appeals that do not
                                                                                                                                   meet the required
                                                                                                                                   elements using
                                                                                                                                   information that is
                                                                                                                                   available as outlined
                                                                                                                                   within 42 CFR Sec.
                                                                                                                                   422.561 and 42 CFR
                                                                                                                                   Sec.   423.560.
                                                                                                                                   CMS is
                                                                                                                                   allowing MACs and
                                                                                                                                   QICs in the FFS
                                                                                                                                   program under 42 CFR
                                                                                                                                   Sec.   405.950 and 42
                                                                                                                                   CFR Sec.   405.966
                                                                                                                                   (also including MA
                                                                                                                                   and Part D plans), as
                                                                                                                                   well as the MA and
                                                                                                                                   Part D IREs under 42
                                                                                                                                   CFR Sec.   422.562
                                                                                                                                   and 42 CFR Sec.
                                                                                                                                   423.562 to utilize
                                                                                                                                   all flexibilities
                                                                                                                                   available in the
                                                                                                                                   appeal process as if
                                                                                                                                   good cause
                                                                                                                                   requirements are
                                                                                                                                   satisfied.
175...............  HHS...............  CMS...............  Waiver...............  ....................  Risk Adjusted Factor  CMS is allowing MACs and
                                                                                                          (RAF) Extensions.     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; 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 Sec.
                                                                                                                                422.568(b)(1)(i), Sec.
                                                                                                                                422.572(b)(1) and Sec.
                                                                                                                                422.590(f)(1).
176...............  HHS...............  CMS...............  Waiver...............  ....................  SNF 3-Day Prior       Using the authority under
                                                                                                          Hospitalization and   Section 1812(f) of the
                                                                                                          60-day ``wellness     Act, CMS is waiving the
                                                                                                          period''.             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 a one-time
                                                                                                                                renewal of SNF coverage
                                                                                                                                without first having to
                                                                                                                                start a new benefit
                                                                                                                                period (this waiver will
                                                                                                                                apply only for those
                                                                                                                                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).
177...............  HHS...............  CMS...............  Waiver...............  ....................  Supporting Care for   CMS has determined it is
                                                                                                          Patients in Long-     appropriate to issue a
                                                                                                          Term Care Acute       blanket waiver to long-
                                                                                                          Hospitals (LTCHs).    term care hospitals
                                                                                                                                (LTCHs) to exclude
                                                                                                                                patient stays 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, which
                                                                                                                                allows these facilities
                                                                                                                                to be paid as LTCHs. In
                                                                                                                                addition, during the
                                                                                                                                applicable waiver time
                                                                                                                                period, we would also
                                                                                                                                apply this waiver to
                                                                                                                                facilities not yet
                                                                                                                                classified as LTCHs, but
                                                                                                                                seeking classification
                                                                                                                                as an LTCH.
178...............  HHS...............  CMS...............  Waiver...............  ....................  CAH Bed Count and     Waiving the requirements
                                                                                                          Length of Stay.       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 Sec.
                                                                                                                                485.620.
179...............  HHS...............  CMS...............  Waiver...............  ....................  Hospitals Classified  For hospitals classified
                                                                                                          as Medicare-          as MDHs prior to the
                                                                                                          Dependent, Small      PHE, CMS is waiving the
                                                                                                          Rural Hospitals       eligibility requirement
                                                                                                          (MDH).                at 42 CFR Sec.
                                                                                                                                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
                                                                                                                                Sec.
                                                                                                                                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 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.
180...............  HHS...............  CMS...............  Waiver...............  ....................  Hospice Aide          Temporarily modifying the
                                                                                                          Competency testing    requirement in Sec.
                                                                                                          Allow Use of Pseudo   418.76(c)(1) that a
                                                                                                          Patients.             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).
181...............  HHS...............  CMS...............  Waiver...............  ....................  Onsite Visits for     Waiving the requirements
                                                                                                          Hospice Aide          at 42 CFR Sec.
                                                                                                          Supervision.          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 this may not be
                                                                                                                                physically possible for
                                                                                                                                a period of time.

[[Page 75745]]

 
182...............  HHS...............  CMS...............  Waiver...............  ....................  Patient Self          Waiving the requirements
                                                                                                          Determination Act     at sections 1902(a)(58)
                                                                                                          Requirements          and 1902(w)(1)(A) of the
                                                                                                          (Advance              Act (for Medicaid);
                                                                                                          Directives).          1852(i) of the Act (for
                                                                                                                                Medicare Advantage); and
                                                                                                                                1866(f) of the Act and
                                                                                                                                42 CFR Sec.   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.
183...............  HHS...............  CMS...............  Waiver...............  ....................  Resident Roommates    Waiving the requirements
                                                                                                          and Grouping.         in 42 CFR 483.10(e) (5),
                                                                                                                                (6), 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.
184...............  HHS...............  CMS...............  Waiver...............  ....................  Defer Equipment       Waiving the requirement
                                                                                                          Maintenance & Fire    at 42 CFR Sec.
                                                                                                          Safety Inspections.   494.60(b) for on-time
                                                                                                                                preventive maintenance
                                                                                                                                of dialysis machines and
                                                                                                                                ancillary dialysis
                                                                                                                                equipment. Additionally,
                                                                                                                                CMS is also waiving the
                                                                                                                                requirements under Sec.
                                                                                                                                 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.
185...............  HHS...............  CMS...............  Waiver...............  ....................  Ability to Delay      CMS is not waiving
                                                                                                          Some Patient          subsections (a) or (c)
                                                                                                          Assessments.          of 42 CFR Sec.   494.80,
                                                                                                                                but is waiving the
                                                                                                                                following requirements
                                                                                                                                at 42 CFR Sec.
                                                                                                                                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:
                                                                                                                                   Sec.
                                                                                                                                   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.
                                                                                                                                   Sec.
                                                                                                                                   494.80(b)(2): A
                                                                                                                                   follow up
                                                                                                                                   comprehensive
                                                                                                                                   reassessment must
                                                                                                                                   occur within 3 months
                                                                                                                                   after the completion
                                                                                                                                   of the initial
                                                                                                                                   assessment to provide
                                                                                                                                   information to adjust
                                                                                                                                   the patient's plan of
                                                                                                                                   care specified in
                                                                                                                                   Sec.   494.90.
186...............  HHS...............  CMS...............  Waiver...............  ....................  SNF-Waiving Pre-      Waiving 42 CFR 483.20(k),
                                                                                                          Admission Screening   allowing nursing homes
                                                                                                          and Annual Resident   to admit new residents
                                                                                                          Review (PASARR).      who have not received
                                                                                                                                Level 1 or Level 2
                                                                                                                                Preadmission Screening.
                                                                                                                                Level 1 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 2
                                                                                                                                Resident Review.
187...............  HHS...............  CMS...............  Waiver...............  ....................  Physician Self-       Waivers of Sanctions
                                                                                                          Referral              under the Stark Law. CMS
                                                                                                          Regulations.          will permit certain
                                                                                                                                referrals and the
                                                                                                                                submission of related
                                                                                                                                claims that would
                                                                                                                                otherwise violate the
                                                                                                                                Stark Law. These
                                                                                                                                flexibilities include:
                                                                                                                                (1) Hospitals and other
                                                                                                                                health care providers
                                                                                                                                can pay above or below
                                                                                                                                fair market value for
                                                                                                                                the personal services of
                                                                                                                                a physician (or an
                                                                                                                                immediate family member
                                                                                                                                of a physician), and
                                                                                                                                parties may pay below
                                                                                                                                fair market value to
                                                                                                                                rent equipment or
                                                                                                                                purchase items or
                                                                                                                                services. (2) Health
                                                                                                                                care providers can
                                                                                                                                support each other
                                                                                                                                financially to ensure
                                                                                                                                continuity of health
                                                                                                                                care operations. (3)
                                                                                                                                Hospitals can provide
                                                                                                                                benefits to their
                                                                                                                                medical staffs, such as
                                                                                                                                multiple daily meals,
                                                                                                                                laundry service to
                                                                                                                                launder soiled personal
                                                                                                                                clothing, or child care
                                                                                                                                services while the
                                                                                                                                physicians are at the
                                                                                                                                hospital and engaging in
                                                                                                                                activities that benefit
                                                                                                                                the hospital and its
                                                                                                                                patients. (4) Health
                                                                                                                                care providers may offer
                                                                                                                                certain items and
                                                                                                                                services that are solely
                                                                                                                                related to COVID-19
                                                                                                                                Purposes (as defined in
                                                                                                                                the waivers), even when
                                                                                                                                the provision of the
                                                                                                                                items or services would
                                                                                                                                exceed the annual non-
                                                                                                                                monetary compensation
                                                                                                                                cap; (5) Physician-owned
                                                                                                                                hospitals can
                                                                                                                                temporarily increase the
                                                                                                                                number of their licensed
                                                                                                                                beds, operating rooms,
                                                                                                                                and procedure rooms,
                                                                                                                                even though such
                                                                                                                                expansion would
                                                                                                                                otherwise be prohibited
                                                                                                                                under the Stark Law; (6)
                                                                                                                                Some of the restrictions
                                                                                                                                when a group practice
                                                                                                                                can furnish medically
                                                                                                                                necessary designated
                                                                                                                                health services (DHS) in
                                                                                                                                a patient's home are
                                                                                                                                loosened. (7) Group
                                                                                                                                practices can furnish
                                                                                                                                medically necessary
                                                                                                                                MRIs, CT scans or
                                                                                                                                clinical laboratory
                                                                                                                                services from locations
                                                                                                                                like mobile vans in
                                                                                                                                parking lots that the
                                                                                                                                group practice rents on
                                                                                                                                a part-time basis.

[[Page 75746]]

 
188...............  HHS...............  CMS...............  Waiver...............  ....................  Medicare Graduate     Due to the COVID-19
                                                                                                          Medical Education     Public Health Emergency
                                                                                                          (GME) Affiliation     (PHE), under the
                                                                                                          Agreement.            authority of section
                                                                                                                                1135(b)(5) of the Social
                                                                                                                                Security Act (the Act),
                                                                                                                                CMS is waiving 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
                                                                                                                                academic year ending
                                                                                                                                June 30, 2020), CMS is
                                                                                                                                allowing hospitals to
                                                                                                                                submit new and/or
                                                                                                                                amended Medicare GME
                                                                                                                                affiliation agreements
                                                                                                                                as applicable to CMS and
                                                                                                                                the MACs by October 1,
                                                                                                                                2020. As under existing
                                                                                                                                procedures, hospitals
                                                                                                                                should email new and/or
                                                                                                                                amended agreements to
                                                                                                                                CMS at
                                                                                                                                [email protected],
                                                                                                                                and indicate in the
                                                                                                                                subject line whether the
                                                                                                                                affiliation agreement is
                                                                                                                                a new one or an amended
                                                                                                                                one.
189...............  HHS...............  CMS...............  Waiver...............  ....................  Allow use of audio-   Pursuant to authority
                                                                                                          only equipment to     granted under the CARES
                                                                                                          furnish audio-only    Act, CMS is waiving the
                                                                                                          telephone E/M,        requirements of section
                                                                                                          counseling, and       1834(m)(1) of the ACT
                                                                                                          educational           and 42 CFR Sec.
                                                                                                          services.             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/MedicareGeneral-Information/Telehealth/Telehealth-Codes).
                                                                                                                                Unless provided
                                                                                                                                otherwise, other
                                                                                                                                services included on the
                                                                                                                                Medicare telehealth
                                                                                                                                services list must be
                                                                                                                                furnished using, at a
                                                                                                                                minimum, audio and video
                                                                                                                                equipment permitting two-
                                                                                                                                way, real-time
                                                                                                                                interactive
                                                                                                                                communication between
                                                                                                                                the patient and distant
                                                                                                                                site physician or
                                                                                                                                practitioner.
190...............  HHS...............  CMS...............  Waiver...............  ....................  Hospital              Waiving the provisions
                                                                                                          Telemedicine.         related to telemedicine
                                                                                                                                at 42 CFR Sec.
                                                                                                                                482.12(a)(8)-(9) for
                                                                                                                                hospitals and Sec.
                                                                                                                                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.
191...............  HHS...............  CMS...............  Waiver...............  ....................  Hospital Care of      Waiving requirements
                                                                                                          Patients.             under 42 CFR Sec.
                                                                                                                                482.12(c)(1)-(2) and
                                                                                                                                Sec.   482.12(c)(4),
                                                                                                                                which requires that
                                                                                                                                Medicare patients be
                                                                                                                                under the care of a
                                                                                                                                physician. This waiver
                                                                                                                                may be implemented so
                                                                                                                                long as it is not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan. This allows
                                                                                                                                hospitals to use other
                                                                                                                                practitioners to the
                                                                                                                                fullest extent possible.
192...............  HHS...............  CMS...............  Waiver...............  ....................  Responsibilities of   42 CFR Sec.
                                                                                                          Physicians in         485.631(b)(2). CMS is
                                                                                                          Critical Access       waiving the requirement
                                                                                                          Hospitals (CAHs).     for CAHs that a doctor
                                                                                                                                of medicine or
                                                                                                                                osteopathy be physically
                                                                                                                                present to provide
                                                                                                                                medical direction,
                                                                                                                                consultation, and
                                                                                                                                supervision for the
                                                                                                                                services provided in the
                                                                                                                                CAH at Sec.
                                                                                                                                485.631(b)(2). CMS is
                                                                                                                                retaining the regulatory
                                                                                                                                language in the second
                                                                                                                                part of the requirement
                                                                                                                                at Sec.   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.
193...............  HHS...............  CMS...............  Waiver...............  ....................  Anesthesia Services.  Waiving requirements
                                                                                                                                under 42 CFR Sec.
                                                                                                                                482.52(a)(5), Sec.
                                                                                                                                485.639(c)(2), and Sec.
                                                                                                                                 416.42 (b)(2) that a
                                                                                                                                certified registered
                                                                                                                                nurse anesthetist (CRNA)
                                                                                                                                is under the supervision
                                                                                                                                of a physician in
                                                                                                                                paragraphs Sec.
                                                                                                                                482.52(a)(5) and Sec.
                                                                                                                                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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
194...............  HHS...............  CMS...............  Waiver...............  ....................  Physician             42 CFR 491.8(b)(1). We
                                                                                                          Supervision of NPs    are modifying the
                                                                                                          in RHCs and FQHCs.    requirement that
                                                                                                                                physicians must provide
                                                                                                                                medical direction for
                                                                                                                                the clinic's or center's
                                                                                                                                health 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.

[[Page 75747]]

 
195...............  HHS...............  CMS...............  Waiver...............  ....................  Staffing              Waiving the requirement
                                                                                                          Requirements for      in the second sentence
                                                                                                          RCHs and FQHCs.       of Sec.   491.8(a)(6)
                                                                                                                                that a nurse
                                                                                                                                practitioner, physician
                                                                                                                                assistant, or certified
                                                                                                                                nurse-midwife be
                                                                                                                                available to furnish
                                                                                                                                patient care services at
                                                                                                                                least 50 percent of the
                                                                                                                                time the RHC operates.
                                                                                                                                CMS is not waiving the
                                                                                                                                first sentence of Sec.
                                                                                                                                491.8(a)(6) that
                                                                                                                                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.
196...............  HHS...............  CMS...............  Waiver...............  ....................  CAH Staff Licensure.  Deferring to staff
                                                                                                                                licensure,
                                                                                                                                certification, or
                                                                                                                                registration to state
                                                                                                                                law by waiving 42 CFR
                                                                                                                                Sec.   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 so long
                                                                                                                                as they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
197...............  HHS...............  CMS...............  Waiver...............  ....................  CAH Personnel         Waiving the minimum
                                                                                                          Qualifications.       personnel qualifications
                                                                                                                                for clinical nurse
                                                                                                                                specialists at paragraph
                                                                                                                                42 CFR Sec.
                                                                                                                                485.604(a)(2), nurse
                                                                                                                                practitioners at
                                                                                                                                paragraph Sec.
                                                                                                                                485.604(b)(1)-(3), and
                                                                                                                                physician assistants at
                                                                                                                                paragraph Sec.
                                                                                                                                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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
198...............  HHS...............  CMS...............  Waiver...............  ....................  Physician Delegation  42 CFR 483.30(e)(4).
                                                                                                          of Tasks in SNFs.     Waiving the requirement
                                                                                                                                in Sec.   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 Sec.
                                                                                                                                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.
199...............  HHS...............  CMS...............  Waiver...............  ....................  Allow Occupational    CMS is waiving the
                                                                                                          Therapists (OTs),     requirements in 42 CFR
                                                                                                          Physical Therapists   Sec.   484.55(a)(2) and
                                                                                                          (PTs), and Speech     Sec.   484.55(b)(3) that
                                                                                                          Language              rehabilitation skilled
                                                                                                          Pathologists (SLPs)   professionals may only
                                                                                                          to Perform Initial    perform the initial and
                                                                                                          and Comprehensive     comprehensive assessment
                                                                                                          Assessment for all    when only therapy
                                                                                                          Patients.             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 Sec.
                                                                                                                                484.55(a) and (b)(2)
                                                                                                                                would continue to apply;
                                                                                                                                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.
200...............  HHS...............  CMS...............  Waiver...............  ....................  Physician Visits....  42 CFR 483.30(c)(3). CMS
                                                                                                                                is waiving the
                                                                                                                                requirement at Sec.
                                                                                                                                483.30(c)(3) that all
                                                                                                                                required physician
                                                                                                                                visits (not already
                                                                                                                                exempted in Sec.
                                                                                                                                483.30(c)(4) and (f))
                                                                                                                                must be made by the
                                                                                                                                physician personally. We
                                                                                                                                are modifying 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.
201...............  HHS...............  CMS...............  Waiver...............  ....................  Practitioner          42 CFR 424.510
                                                                                                          Locations.            (d)(2)(III)(A). 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.

[[Page 75748]]

 
                                                                                                                                   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.
202...............  HHS...............  CMS...............  Waiver...............  ....................  Waive Onsite Visits   CMS is waiving the
                                                                                                          for HHA Aide          requirements at 42 CFR
                                                                                                          Supervision.          Sec.   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 Sec.
                                                                                                                                484.80(h)(1), but
                                                                                                                                virtual supervision is
                                                                                                                                encouraged during the
                                                                                                                                period of the waiver.
203...............  HHS...............  CMS...............  Waiver...............  ....................  ESRD Telemedicine     For Medicare patients
                                                                                                          and Report Patient    with End Stage Renal
                                                                                                          Care.                 Disease (ESRD),
                                                                                                                                clinicians no longer
                                                                                                                                must have one ``hands
                                                                                                                                on'' visit per month for
                                                                                                                                the current required
                                                                                                                                clinical examination of
                                                                                                                                the vascular access
                                                                                                                                site.
204...............  HHS...............  CMS...............  Waiver...............  ....................  ESRD Telemedicine     For Medicare patients
                                                                                                          and Report Patient    with ESRD, we are
                                                                                                          Care.                 exercising enforcement
                                                                                                                                discretion on the
                                                                                                                                following requirement so
                                                                                                                                that clinicians can
                                                                                                                                provide this service via
                                                                                                                                telehealth: Individuals
                                                                                                                                must receive a face-to-
                                                                                                                                face visit, without the
                                                                                                                                use of telehealth, at
                                                                                                                                least monthly in the
                                                                                                                                case of the initial 3
                                                                                                                                months of home dialysis
                                                                                                                                and at least once every
                                                                                                                                3 consecutive months
                                                                                                                                after the initial 3
                                                                                                                                months.
205...............  HHS...............  CMS...............  Waiver...............  ....................  Medical Staff         Waiving requirements
                                                                                                          Eligibility.          under 42 CFR Sec.
                                                                                                                                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
                                                                                                                                Sec.   482.22(a)(1)-(4)
                                                                                                                                regarding details of the
                                                                                                                                credentialing and
                                                                                                                                privileging process.
206...............  HHS...............  CMS...............  Waiver...............  ....................  Physician Visits in   CMS is waiving the
                                                                                                          Skilled Nursing       requirement in 42 CFR
                                                                                                          Facilities/Nursing    483.30 for physicians
                                                                                                          Facilities.           and non-physician
                                                                                                                                practitioners to perform
                                                                                                                                in-person visits for
                                                                                                                                nursing home residents
                                                                                                                                and allow visits to be
                                                                                                                                conducted, as
                                                                                                                                appropriate, via
                                                                                                                                telehealth options.
207...............  HHS...............  CMS...............  Waiver...............  ....................  12 hour Annual in-    42 CFR 418.76(d). CMS is
                                                                                                          service Training      waiving the requirement
                                                                                                          Requirement for       that hospices must
                                                                                                          Hospice Aides.        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.
208...............  HHS...............  CMS...............  Waiver...............  ....................  Dialysis Patient      Modifying the requirement
                                                                                                          Care Technician       at 42 CFR Sec.
                                                                                                          (PCT) Certification.  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.
209...............  HHS...............  CMS...............  Waiver...............  ....................  Transferability of    Modifying the requirement
                                                                                                          Physician             at 42 CFR Sec.
                                                                                                          Credentialing.        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 so
                                                                                                                                long as they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
210...............  HHS...............  CMS...............  Waiver...............  ....................  Remote Patient        Clinicians can provide
                                                                                                          Monitoring            remote patient
                                                                                                          Reporting.            monitoring services to
                                                                                                                                both new and established
                                                                                                                                patients. These services
                                                                                                                                can be provided for both
                                                                                                                                acute and chronic
                                                                                                                                conditions and can now
                                                                                                                                be provided for patients
                                                                                                                                with only one disease.
                                                                                                                                For example, remote
                                                                                                                                patient monitoring can
                                                                                                                                be used to monitor a
                                                                                                                                patient's oxygen
                                                                                                                                saturation levels using
                                                                                                                                pulse oximetry. (CPT
                                                                                                                                codes 99091, 99457-
                                                                                                                                99458, 99473-99474,
                                                                                                                                99493-99494).
211...............  HHS...............  CMS...............  Waiver...............  ....................  Remote Evaluations,   Medicare patients may
                                                                                                          Virtual Check-Ins &   have a brief
                                                                                                          E-Visits.             communication service
                                                                                                                                with practitioners via a
                                                                                                                                number of communication
                                                                                                                                technology modalities
                                                                                                                                including synchronous
                                                                                                                                discussion over a
                                                                                                                                telephone or exchange of
                                                                                                                                information through
                                                                                                                                video or image.
                                                                                                                                Clinicians can provide
                                                                                                                                remote evaluation of
                                                                                                                                patient video/images and
                                                                                                                                virtual check-in
                                                                                                                                services (HCPCS codes
                                                                                                                                G2010, G2012) to both
                                                                                                                                new and established
                                                                                                                                patients. These services
                                                                                                                                were previously limited
                                                                                                                                to established patients.
212...............  HHS...............  CMS...............  Waiver...............  ....................  Remote Evaluations,   111 E-visits are non-face-
                                                                                                          Virtual Check-Ins &   to-face communications
                                                                                                          E-Visits.             with their practitioner
                                                                                                                                by using online patient
                                                                                                                                portals. (HCPCS codes
                                                                                                                                G2061-G2063).

[[Page 75749]]

 
213...............  HHS...............  CMS...............  Waiver...............  ....................  Flexibility for IRF   Allowing IRFs to exclude
                                                                                                          Regarding the ``60    patients from the
                                                                                                          Percent Rule''.       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 percent 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.
214...............  HHS...............  CMS...............  Waiver...............  ....................  LTCH Site Neutral     As required by section
                                                                                                          Payment Rate          3711(b) of the CARES
                                                                                                          Provisions.           Act, during the Public
                                                                                                                                Health Emergency (PHE)
                                                                                                                                due to COVID-19, certain
                                                                                                                                provisions of section
                                                                                                                                1886(m)(6) of the Social
                                                                                                                                Security Act have been
                                                                                                                                waived relating to
                                                                                                                                certain site neutral
                                                                                                                                payment rate provisions
                                                                                                                                for long-term care
                                                                                                                                hospitals (LTCHs).
                                                                                                                                   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 percent
                                                                                                                                   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. In other
                                                                                                                                   words, 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.
                                                                                                                                   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 period.
                                                                                                                                   Under this provision,
                                                                                                                                   all LTCH cases
                                                                                                                                   admitted during the
                                                                                                                                   COVID-19 public
                                                                                                                                   health emergency
                                                                                                                                   period will be paid
                                                                                                                                   the relatively higher
                                                                                                                                   LTCH PPS standard
                                                                                                                                   Federal rate. A new
                                                                                                                                   LTCH PPS Pricer
                                                                                                                                   software package
                                                                                                                                   released in April
                                                                                                                                   2020 includes this
                                                                                                                                   temporary payment
                                                                                                                                   policy effective for
                                                                                                                                   claims with an
                                                                                                                                   admission date
                                                                                                                                   occurring on or after
                                                                                                                                   January 27, 2020 and
                                                                                                                                   continuing through
                                                                                                                                   the duration of the
                                                                                                                                   COVID-19 public
                                                                                                                                   health emergency
                                                                                                                                   period. Claims
                                                                                                                                   received on or after
                                                                                                                                   April 21, 2020, will
                                                                                                                                   be processed in
                                                                                                                                   accordance with this
                                                                                                                                   waiver. Claims
                                                                                                                                   received April 20,
                                                                                                                                   2020, and earlier
                                                                                                                                   will be reprocessed.
                                                                                                                                   LTCHs should add the
                                                                                                                                   ``DR'' condition code
                                                                                                                                   to applicable claims.
215...............  HHS...............  CMS...............  Waiver...............  ....................  Eligibility for       Pursuant to authority
                                                                                                          Telehealth.           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 that can
                                                                                                                                furnish distant site
                                                                                                                                telehealth services to
                                                                                                                                include all those that
                                                                                                                                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.
216...............  HHS...............  CMS...............  Waiver...............  ....................  IRF Intensity of      As required by section
                                                                                                          Therapy Requirement   3711(a) of the
                                                                                                          (``3-Hour Rule'').    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'' (RIN
                                                                                                                                0938-AU31). (85 Federal
                                                                                                                                Register 19252, 19287,
                                                                                                                                April 6, 2020). The
                                                                                                                                information in that
                                                                                                                                rulemaking (RIN 0938-
                                                                                                                                AU31) about Inpatient
                                                                                                                                Rehabilitation
                                                                                                                                Facilities was
                                                                                                                                contemplated prior to
                                                                                                                                the passage of the CARES
                                                                                                                                Act.
217...............  HHS...............  CMS...............  Waiver...............  ....................  Emergency Medical     Waiving the enforcement
                                                                                                          Treatment & Labor     of section 1867(a) of
                                                                                                          Act (EMTALA)          the Act. This will allow
                                                                                                          Section 1867(a).      hospitals, psychiatric
                                                                                                                                hospitals, and critical
                                                                                                                                access hospitals (CAHs)
                                                                                                                                to screen patients at a
                                                                                                                                location offsite from
                                                                                                                                the hospital's campus to
                                                                                                                                prevent the spread of
                                                                                                                                COVID-19, so long as it
                                                                                                                                is not inconsistent with
                                                                                                                                a state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.

[[Page 75750]]

 
218...............  HHS...............  CMS...............  Waiver...............  ....................  Quality Assessment    Waiving 42 CFR 482.21(a)-
                                                                                                          and Performance       (d) and (f), and
                                                                                                          Improvement (QAPI)    485.641(a), (b), and
                                                                                                          Program.              (d), which provide
                                                                                                                                details on the scope of
                                                                                                                                the program, the
                                                                                                                                incorporation, and
                                                                                                                                setting priorities for
                                                                                                                                the program's
                                                                                                                                performance improvement
                                                                                                                                activities, and
                                                                                                                                integrated Quality
                                                                                                                                Assurance & Performance
                                                                                                                                Improvement programs
                                                                                                                                (for hospitals that are
                                                                                                                                part of a hospital
                                                                                                                                system). These
                                                                                                                                flexibilities, which
                                                                                                                                apply to both hospitals
                                                                                                                                and CAHs, may be
                                                                                                                                implemented so long as
                                                                                                                                they are not
                                                                                                                                inconsistent 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.
219...............  HHS...............  CMS...............  Waiver...............  ....................  Signature and Proof   CMS is waiving signature
                                                                                                          of Delivery           and proof of delivery
                                                                                                          Requirements.         requirements for Part B
                                                                                                                                drugs and Durable
                                                                                                                                Medical Equipment when a
                                                                                                                                signature cannot be
                                                                                                                                obtained because of the
                                                                                                                                inability to collect
                                                                                                                                signatures. Suppliers
                                                                                                                                should document in the
                                                                                                                                medical record the
                                                                                                                                appropriate date of
                                                                                                                                delivery and that a
                                                                                                                                signature was not able
                                                                                                                                to be obtained because
                                                                                                                                of COVID-19.
220...............  HHS...............  CMS...............  Guidance.............  ....................  Accelerated/Advance   In order to increase cash
                                                                                                          Payments.             flow to providers
                                                                                                                                impacted by COVID-19,
                                                                                                                                CMS has expanded our
                                                                                                                                current Accelerated and
                                                                                                                                Advance Payment Program.
                                                                                                                                An accelerated/advance
                                                                                                                                payment is a payment
                                                                                                                                intended to provide
                                                                                                                                necessary funds when
                                                                                                                                there is a disruption in
                                                                                                                                claims submission and/or
                                                                                                                                claims processing. CMS
                                                                                                                                is authorized to provide
                                                                                                                                accelerated or advance
                                                                                                                                payments during the
                                                                                                                                period of the public
                                                                                                                                health emergency to any
                                                                                                                                Medicare provider/
                                                                                                                                supplier who submits a
                                                                                                                                request to the
                                                                                                                                appropriate Medicare
                                                                                                                                Administrative
                                                                                                                                Contractor (MAC) and
                                                                                                                                meets the required
                                                                                                                                qualifications. Each MAC
                                                                                                                                will work to review
                                                                                                                                requests and issue
                                                                                                                                payments within seven
                                                                                                                                calendar days of
                                                                                                                                receiving the request.
                                                                                                                                Traditionally repayment
                                                                                                                                of these advance/
                                                                                                                                accelerated payments
                                                                                                                                begins at 90 days,
                                                                                                                                however for the purposes
                                                                                                                                of the COVID-19
                                                                                                                                pandemic, CMS has
                                                                                                                                extended the repayment
                                                                                                                                of these accelerated/
                                                                                                                                advance payments to
                                                                                                                                begin 120 days after the
                                                                                                                                date of issuance of the
                                                                                                                                payment. CMS has amended
                                                                                                                                existing regulation to
                                                                                                                                allow for the lowering
                                                                                                                                of interest rates on
                                                                                                                                overpayments related to
                                                                                                                                accelerated and advance
                                                                                                                                payments issued during
                                                                                                                                the PHE associated with
                                                                                                                                COVID-19.
221...............  HHS...............  CMS...............  Guidance.............  ....................  Part D ``Refill-Too-  Consistent with section
                                                                                                          Soon'' Edits and      3714 of the CARES Act,
                                                                                                          Maximum Day Supply.   during the public health
                                                                                                                                emergency for COVID-19,
                                                                                                                                Part D sponsors must
                                                                                                                                permit enrollees to
                                                                                                                                obtain the total supply
                                                                                                                                prescribed for a covered
                                                                                                                                Part D drug up to a 90-
                                                                                                                                day supply in one fill
                                                                                                                                or refill if requested
                                                                                                                                by the enrollee, prior
                                                                                                                                authorization or step
                                                                                                                                therapy requirements
                                                                                                                                have been satisfied, and
                                                                                                                                no safety edits
                                                                                                                                otherwise limit the
                                                                                                                                quantity or days'
                                                                                                                                supply. Part D plan also
                                                                                                                                sponsors must relax
                                                                                                                                their ``refill-too-
                                                                                                                                soon'' edits. Part D
                                                                                                                                sponsors continue to
                                                                                                                                have operational
                                                                                                                                discretion as to how
                                                                                                                                these edits are relaxed
                                                                                                                                as long as access to
                                                                                                                                Part D drugs is provided
                                                                                                                                at the point of sale.
                                                                                                                                For purposes of section
                                                                                                                                3714 of the CARES Act,
                                                                                                                                relaxed refill-too-soon
                                                                                                                                edits are safety edits,
                                                                                                                                and Part D sponsors must
                                                                                                                                not permit enrollees to
                                                                                                                                obtain a single fill or
                                                                                                                                refill that is
                                                                                                                                inconsistent with a
                                                                                                                                safety edit.
222...............  HHS...............  CMS...............  Guidance.............  ....................  Long-Term Care        CMS intends to exercise
                                                                                                          Dispensing.           enforcement discretion
                                                                                                                                with respect to the
                                                                                                                                requirement at 42 CFR
                                                                                                                                423.154(a)(1)(i) that
                                                                                                                                limits dispensing of
                                                                                                                                solid oral doses of
                                                                                                                                brand-name drugs, as
                                                                                                                                defined in Sec.   423.4,
                                                                                                                                to enrollees in long-
                                                                                                                                term care (LTC)
                                                                                                                                facilities to no greater
                                                                                                                                than 14-day increments
                                                                                                                                at a time. For enrollees
                                                                                                                                residing in LTC
                                                                                                                                facilities, Part D
                                                                                                                                sponsors may permit
                                                                                                                                pharmacies to expand the
                                                                                                                                use of submission
                                                                                                                                clarification code 21
                                                                                                                                (LTC dispensing, 14 days
                                                                                                                                or less not applicable)
                                                                                                                                to allow for greater
                                                                                                                                than 14 day supplies for
                                                                                                                                all applicable Part D
                                                                                                                                drugs to provide more
                                                                                                                                flexibility for LTC
                                                                                                                                facilities and
                                                                                                                                pharmacies to coordinate
                                                                                                                                with each other.
223...............  HHS...............  CMS...............  Guidance.............  ....................  Audit Reviews.......  CMS is reprioritizing
                                                                                                                                scheduled program audits
                                                                                                                                and contract-level Risk
                                                                                                                                Adjustment Data
                                                                                                                                Validation audits for MA
                                                                                                                                organizations, Part D
                                                                                                                                sponsors, Medicare-
                                                                                                                                Medicaid Plans, and
                                                                                                                                Programs of All-
                                                                                                                                Inclusive Care for the
                                                                                                                                Elderly organizations.
                                                                                                                                Reprioritizing these
                                                                                                                                audit activities will
                                                                                                                                allow providers, CMS and
                                                                                                                                the organizations to
                                                                                                                                focus on patient care.
224...............  HHS...............  CMS...............  Guidance.............  ....................  Part D Enforcement    CMS is exercising its
                                                                                                          Discretion.           enforcement discretion
                                                                                                                                to adopt a temporary
                                                                                                                                policy of relaxed
                                                                                                                                enforcement in
                                                                                                                                connection with, but not
                                                                                                                                limited to, the
                                                                                                                                following:
                                                                                                                                   Waiving Part
                                                                                                                                   D medication delivery
                                                                                                                                   documentation and
                                                                                                                                   signature log
                                                                                                                                   requirements;
                                                                                                                                   Relaxing to
                                                                                                                                   the greatest extent
                                                                                                                                   possible prior
                                                                                                                                   authorization
                                                                                                                                   requirements, where
                                                                                                                                   appropriate; and/or
                                                                                                                                   Suspending
                                                                                                                                   plan-coordinated
                                                                                                                                   pharmacy audits.
225...............  HHS...............  CMS...............  Guidance.............  ....................  Special Requirements  MAOs must follow the
                                                                                                                                requirements for
                                                                                                                                disasters and
                                                                                                                                emergencies outlined in
                                                                                                                                42 CFR 422.100(m). Under
                                                                                                                                42 CFR 422.100(m), MAOs
                                                                                                                                must ensure access to
                                                                                                                                benefits in the
                                                                                                                                following manner:
                                                                                                                                   Cover
                                                                                                                                   Medicare Parts A and
                                                                                                                                   B services and
                                                                                                                                   supplemental Part C
                                                                                                                                   plan benefits
                                                                                                                                   furnished at non-
                                                                                                                                   contracted facilities
                                                                                                                                   subject to Sec.
                                                                                                                                   422.204(b)(3), which
                                                                                                                                   requires that
                                                                                                                                   facilities that
                                                                                                                                   furnish covered A/B
                                                                                                                                   benefits have
                                                                                                                                   participation
                                                                                                                                   agreements with
                                                                                                                                   Medicare.
                                                                                                                                   Waive, in
                                                                                                                                   full, requirements
                                                                                                                                   for gatekeeper
                                                                                                                                   referrals where
                                                                                                                                   applicable.

[[Page 75751]]

 
                                                                                                                                   Provide the
                                                                                                                                   same cost-sharing for
                                                                                                                                   the enrollee as if
                                                                                                                                   the service or
                                                                                                                                   benefit had been
                                                                                                                                   furnished at a plan-
                                                                                                                                   contracted facility.
                                                                                                                                   Make changes
                                                                                                                                   that benefit the
                                                                                                                                   enrollee effective
                                                                                                                                   immediately without
                                                                                                                                   the 30-day
                                                                                                                                   notification
                                                                                                                                   requirement at Sec.
                                                                                                                                   422.111(d)(3). (Such
                                                                                                                                   changes could include
                                                                                                                                   reductions in cost-
                                                                                                                                   sharing and waiving
                                                                                                                                   prior authorizations
                                                                                                                                   as described below.)
226...............  HHS...............  CMS...............  Guidance.............  ....................  Prior Authorization.  Consistent with
                                                                                                                                flexibilities available
                                                                                                                                to Medicare Advantage
                                                                                                                                Organizations absent a
                                                                                                                                disaster, declaration of
                                                                                                                                a state of emergency, or
                                                                                                                                public health emergency,
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations may choose
                                                                                                                                to waive or relax plan
                                                                                                                                prior authorization
                                                                                                                                requirements at any time
                                                                                                                                in order to facilitate
                                                                                                                                access to services with
                                                                                                                                less burden on
                                                                                                                                beneficiaries, plans,
                                                                                                                                and providers. Any such
                                                                                                                                relaxation or waiver
                                                                                                                                must be uniformly
                                                                                                                                provided to similarly
                                                                                                                                situated enrollees who
                                                                                                                                are affected by the
                                                                                                                                disaster or emergency.
                                                                                                                                We encourage plans to
                                                                                                                                consider utilizing this
                                                                                                                                flexibility.
227...............  HHS...............  CMS...............  Guidance.............  ....................  Home or Mail          In situations when a
                                                                                                          Delivery of Part D    disaster or emergency
                                                                                                          Drugs.                makes it difficult for
                                                                                                                                enrollees to get to a
                                                                                                                                retail pharmacy, or
                                                                                                                                enrollees are prohibited
                                                                                                                                from going to a retail
                                                                                                                                pharmacy (e.g., in a
                                                                                                                                quarantine situation),
                                                                                                                                Part D sponsors are
                                                                                                                                permitted to voluntarily
                                                                                                                                relax any plan-imposed
                                                                                                                                policies that may
                                                                                                                                discourage certain
                                                                                                                                methods of delivery,
                                                                                                                                such as mail or home
                                                                                                                                delivery, for retail
                                                                                                                                pharmacies that choose
                                                                                                                                to offer these delivery
                                                                                                                                services in these
                                                                                                                                instances.
228...............  HHS...............  CMS...............  Guidance.............  ....................  Pharmacies Enrolling  Pharmacies may enroll in
                                                                                                          as Labs.              Medicare as a Clinical
                                                                                                                                Laboratory Improvement
                                                                                                                                Act (CLIA) laboratory if
                                                                                                                                they have their CLIA
                                                                                                                                certification.
229...............  HHS...............  CMS...............  Guidance.............  Survey Guidance QSO-  Suspension of         During the prioritization
                                                                                    20-12-All.            Enforcement           period, the following
                                                                                                          Activities.           surveys will not be
                                                                                                                                authorized:
                                                                                                                                   Standard
                                                                                                                                   surveys for long term
                                                                                                                                   care facilities
                                                                                                                                   (nursing homes),
                                                                                                                                   hospitals, home
                                                                                                                                   health agencies
                                                                                                                                   (HHAs), intermediate
                                                                                                                                   care facilities for
                                                                                                                                   individuals with
                                                                                                                                   intellectual
                                                                                                                                   disabilities (ICF/
                                                                                                                                   IIDs), and hospices.
                                                                                                                                   This includes the
                                                                                                                                   life safety code and
                                                                                                                                   Emergency
                                                                                                                                   Preparedness elements
                                                                                                                                   of those standard
                                                                                                                                   surveys;
                                                                                                                                   Revisits that
                                                                                                                                   are not associated
                                                                                                                                   with IJ. As a result,
                                                                                                                                   the following
                                                                                                                                   enforcement actions
                                                                                                                                   will be suspended,
                                                                                                                                   until revisits are
                                                                                                                                   again authorized:
                                                                                                                                  [cir] For nursing
                                                                                                                                   homes--Imposition of
                                                                                                                                   Denial of Payment for
                                                                                                                                   New Admissions
                                                                                                                                   (DPNA), including
                                                                                                                                   situations where
                                                                                                                                   facilities that are
                                                                                                                                   not in substantial
                                                                                                                                   compliance at 3
                                                                                                                                   months, will be
                                                                                                                                   lifted to allow for
                                                                                                                                   new admissions during
                                                                                                                                   this time;
                                                                                                                                  [cir] For HHAs--
                                                                                                                                   Imposition of
                                                                                                                                   suspension of
                                                                                                                                   payments for new
                                                                                                                                   admissions (SPNA)
                                                                                                                                   following the last
                                                                                                                                   day of the survey
                                                                                                                                   when termination is
                                                                                                                                   imposed will be
                                                                                                                                   lifted to allow for
                                                                                                                                   new admissions during
                                                                                                                                   this time;
                                                                                                                                  [cir] For nursing
                                                                                                                                   homes and HHAs--
                                                                                                                                   Suspend per day civil
                                                                                                                                   money penalty (CMP)
                                                                                                                                   accumulation, and
                                                                                                                                   imposition of
                                                                                                                                   termination for
                                                                                                                                   facilities that are
                                                                                                                                   not in substantial
                                                                                                                                   compliance at 6
                                                                                                                                   months.
                                                                                                                                   For CLIA, we
                                                                                                                                   intend to prioritize
                                                                                                                                   immediate jeopardy
                                                                                                                                   situations over
                                                                                                                                   recertification
                                                                                                                                   surveys.
230...............  HHS...............  CMS...............  Guidance.............  ....................  Medicare Provider     42 CFR 424.514 42 CFR
                                                                                                          Enrollment Relief.    424.518. Exercise 1135
                                                                                                                                waiver authority to
                                                                                                                                establish toll-free
                                                                                                                                hotlines to allow
                                                                                                                                certain providers and
                                                                                                                                suppliers to enroll and
                                                                                                                                receive temporary
                                                                                                                                Medicare billing
                                                                                                                                privileges. Waive
                                                                                                                                certain screening
                                                                                                                                requirements for
                                                                                                                                providers and suppliers
                                                                                                                                (e.g., finger-print
                                                                                                                                based criminal
                                                                                                                                background checks, site
                                                                                                                                visits, etc.). All
                                                                                                                                enrollment applications
                                                                                                                                received on or after
                                                                                                                                March 1, 2020 will be
                                                                                                                                expedited. Expedite
                                                                                                                                pending applications as
                                                                                                                                well. Postpone all
                                                                                                                                revalidation actions.
231...............  HHS...............  CMS...............  Guidance.............  ....................  Temporary Expansion   Temporary Expansion
                                                                                                          Locations.            Locations: Waiving
                                                                                                                                requirements at 42 CFR
                                                                                                                                491.5(a)(3)(iii) which
                                                                                                                                require RHCs and FQHCs
                                                                                                                                be independently
                                                                                                                                considered for Medicare
                                                                                                                                approval if services are
                                                                                                                                furnished in more than
                                                                                                                                one permanent location.
                                                                                                                                This flexibility
                                                                                                                                includes areas which may
                                                                                                                                be outside of the
                                                                                                                                location requirements 42
                                                                                                                                CFR 491.5(a)(1) and (2)
                                                                                                                                for the duration of the
                                                                                                                                PHE.
232...............  HHS...............  CMS...............  Waiver...............  ....................  Long Term Care        Waive requirements at 42
                                                                                                          Facility Training     CFR 483.35(d) (with the
                                                                                                          and Certification     exception of 42 CFR
                                                                                                          of Nurse Aides.       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 Sec.
                                                                                                                                 483.35(d).
233...............  HHS...............  CMS...............  Waiver...............  ....................  Modification of       Allows a physician or
                                                                                                          Substitute Billing    physical therapist to
                                                                                                          Arrangements          use the same substitute
                                                                                                          Timetable.            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.
234...............  HHS...............  CMS...............  Waiver...............  ....................  Ambulatory Surgical   During the PHE, CMS has
                                                                                                          Centers &             created streamlined and
                                                                                                          Freestanding          temporary enrollment
                                                                                                          Emergency             process for ASCs and
                                                                                                          Departments (EDs)     licensed Freestanding
                                                                                                          Hospital Conversion.  EDs that wish to convert
                                                                                                                                to a hospital in order
                                                                                                                                to expand capacity and
                                                                                                                                treat patients. ASCs and
                                                                                                                                Freestanding EDs that
                                                                                                                                convert to become a
                                                                                                                                hospital must meet the
                                                                                                                                Hospital Conditions of
                                                                                                                                Participation that
                                                                                                                                remain in effect during
                                                                                                                                the PHE, including 24-7
                                                                                                                                nursing and others. They
                                                                                                                                must also be able to act
                                                                                                                                as a hospital, and
                                                                                                                                cannot (for example) act
                                                                                                                                as just an outpatient
                                                                                                                                surgical department of a
                                                                                                                                hospital.
235...............  HHS...............  CMS...............  Waiver...............  42 CFR 424.36E......  Beneficiary claims    CMS has determined that
                                                                                                          signature             there is good cause to
                                                                                                          requirements for      accept transport staff
                                                                                                          ambulance services.   signatures in cases
                                                                                                                                where it would not be
                                                                                                                                possible or practical
                                                                                                                                (such as a difficult to
                                                                                                                                clean surface) to
                                                                                                                                disinfect an electronic
                                                                                                                                patient reporting device
                                                                                                                                used after being touched
                                                                                                                                by a beneficiary with
                                                                                                                                known or suspected COVID-
                                                                                                                                19; documentation should
                                                                                                                                note the verbal consent.

[[Page 75752]]

 
236...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Durable Medical       I. Changes to the
                                                                                                          Equipment Interim     Medicare regulations to
                                                                                                          Pricing in the        revise payment rates for
                                                                                                          CARES Act.            certain durable medical
                                                                                                                                equipment and enteral
                                                                                                                                nutrients, supplies, and
                                                                                                                                equipment as part of
                                                                                                                                implementation of
                                                                                                                                section 3712 of the
                                                                                                                                CARES Act. We are making
                                                                                                                                conforming changes to
                                                                                                                                Sec.   414.210(g)(9),
                                                                                                                                consistent with section
                                                                                                                                3712(a) and (b) of the
                                                                                                                                CARES Act, but we are
                                                                                                                                omitting the language in
                                                                                                                                section 3712(b) of the
                                                                                                                                CARES Act that
                                                                                                                                references an effective
                                                                                                                                date that is 30 days
                                                                                                                                after the date of
                                                                                                                                enactment of the law. We
                                                                                                                                are revising Sec.
                                                                                                                                414.210(g)(9)(iii),
                                                                                                                                which describes the 50/
                                                                                                                                50 fee schedule
                                                                                                                                adjustment blend for
                                                                                                                                items and services
                                                                                                                                furnished in rural and
                                                                                                                                noncontiguous areas, to
                                                                                                                                address dates of service
                                                                                                                                from June 1, 2018
                                                                                                                                through December 31,
                                                                                                                                2020 or through the
                                                                                                                                duration of the
                                                                                                                                emergency period
                                                                                                                                described in section
                                                                                                                                1135(g)(1)(B) of the Act
                                                                                                                                (42 U.S.C. 1320b-
                                                                                                                                5(g)(1)(B)), whichever
                                                                                                                                is later. We are also
                                                                                                                                adding Sec.
                                                                                                                                414.210(g)(9)(v) which
                                                                                                                                will state that, for
                                                                                                                                items and services
                                                                                                                                furnished in areas other
                                                                                                                                than rural or
                                                                                                                                noncontiguous areas with
                                                                                                                                dates of service from
                                                                                                                                March 6, 2020, through
                                                                                                                                the remainder of the
                                                                                                                                duration of the
                                                                                                                                emergency period
                                                                                                                                described in section
                                                                                                                                1135(g)(1)(B) of the Act
                                                                                                                                (42 U.S.C. 1320b-
                                                                                                                                5(g)(1)(B)), based on
                                                                                                                                the fee schedule amount
                                                                                                                                for the area is equal to
                                                                                                                                75 percent of the
                                                                                                                                adjusted payment amount
                                                                                                                                established under ``this
                                                                                                                                section'' (by which we
                                                                                                                                mean Sec.
                                                                                                                                414.210(g)(1) through
                                                                                                                                (8)), and 25 percent of
                                                                                                                                the unadjusted fee
                                                                                                                                schedule amount. For
                                                                                                                                items and services
                                                                                                                                furnished in areas other
                                                                                                                                than rural or
                                                                                                                                noncontiguous areas with
                                                                                                                                dates of service from
                                                                                                                                the expiration date of
                                                                                                                                the emergency period
                                                                                                                                described in section
                                                                                                                                1135(g)(1)(B) of the Act
                                                                                                                                (42 U.S.C. 1320b-
                                                                                                                                5(g)(1)(B)) through
                                                                                                                                December 31, 2020, based
                                                                                                                                on the fee schedule
                                                                                                                                amount for the area is
                                                                                                                                equal to 100 percent of
                                                                                                                                the adjusted payment
                                                                                                                                amount established under
                                                                                                                                Sec.   414.210(g)(1)
                                                                                                                                through (8) (referred to
                                                                                                                                as ``this section'' in
                                                                                                                                the regulation text). In
                                                                                                                                addition, we are
                                                                                                                                revising Sec.
                                                                                                                                414.210(g)(9)(iv) to
                                                                                                                                specify for items and
                                                                                                                                services furnished in
                                                                                                                                areas other than rural
                                                                                                                                and noncontiguous areas
                                                                                                                                with dates of service
                                                                                                                                from June 1, 2018
                                                                                                                                through March 5, 2020,
                                                                                                                                based on the fee
                                                                                                                                schedule amount for the
                                                                                                                                area is equal to 100
                                                                                                                                percent of the adjusted
                                                                                                                                payment amount
                                                                                                                                established under Sec.
                                                                                                                                414.210(g)(1) through
                                                                                                                                (8) (``this section'' in
                                                                                                                                the regulation text).
237...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Basic Health Program  This IFC revises 42 CFR
                                                                                                          Blueprint Revisions.  Sec.   600.125(b) and
                                                                                                                                adds the new paragraph
                                                                                                                                42 CFR 600.125(c) to
                                                                                                                                permit states operating
                                                                                                                                a BHP to submit revised
                                                                                                                                BHP Blueprints for
                                                                                                                                temporary substantial
                                                                                                                                changes that could be
                                                                                                                                effective retroactive to
                                                                                                                                the first day the COVID-
                                                                                                                                19 PHE. These changes
                                                                                                                                must be directly tied to
                                                                                                                                the PHE for the COVID-19
                                                                                                                                pandemic and increase
                                                                                                                                access to coverage, and
                                                                                                                                must not be restrictive
                                                                                                                                in nature. For example,
                                                                                                                                states might want to
                                                                                                                                revise a BHP Blueprint
                                                                                                                                retroactively during the
                                                                                                                                COVID-19 PHE to
                                                                                                                                implement provisions
                                                                                                                                such as temporarily
                                                                                                                                allowing continuous
                                                                                                                                eligibility or
                                                                                                                                temporarily waiving
                                                                                                                                limitations on certain
                                                                                                                                benefits covered under
                                                                                                                                its BHP to ensure
                                                                                                                                enrollees have access to
                                                                                                                                necessary services. The
                                                                                                                                state would need to
                                                                                                                                demonstrate to HHS that
                                                                                                                                the significant changes
                                                                                                                                in its revised Blueprint
                                                                                                                                are tied to the COVID-19
                                                                                                                                PHE and that the changes
                                                                                                                                are not restrictive in
                                                                                                                                nature. This flexibility
                                                                                                                                is similar to the
                                                                                                                                flexibility that states
                                                                                                                                currently have with
                                                                                                                                Medicaid and CHIP state
                                                                                                                                plan amendments.
238...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Flexibility for       This IFC amends the CMS
                                                                                                          Medicaid Laboratory   regulation at 42 CFR
                                                                                                          Services.             440.30 to provide
                                                                                                                                flexibility with respect
                                                                                                                                to Medicaid coverage of
                                                                                                                                certain COVID-19 related
                                                                                                                                laboratory tests in a
                                                                                                                                greater variety of
                                                                                                                                circumstances and
                                                                                                                                settings. For example,
                                                                                                                                the IFC provides states
                                                                                                                                with flexibility to
                                                                                                                                cover, under their
                                                                                                                                Medicaid programs, a
                                                                                                                                COVID-19 test without it
                                                                                                                                being first ordered by a
                                                                                                                                physician or other
                                                                                                                                licensed practitioner,
                                                                                                                                as well as to cover
                                                                                                                                COVID-19 tests
                                                                                                                                administered in certain
                                                                                                                                non-office settings that
                                                                                                                                are intended to minimize
                                                                                                                                transmission of COVID-
                                                                                                                                19, such as parking
                                                                                                                                lots. Given the nature
                                                                                                                                and scope of the
                                                                                                                                pandemic, it is
                                                                                                                                important to accommodate
                                                                                                                                the evolution of COVID-
                                                                                                                                19 diagnostic
                                                                                                                                mechanisms. The
                                                                                                                                regulatory updates would
                                                                                                                                also allow Medicaid to
                                                                                                                                cover laboratory
                                                                                                                                processing of self-
                                                                                                                                collected COVID-19 tests
                                                                                                                                that the FDA has
                                                                                                                                authorized for home use.

[[Page 75753]]

 
239...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Improving Care        P. Section 3708 of the
                                                                                                          Planning for          CARES Act amended
                                                                                                          Medicaid Home         Medicare requirements at
                                                                                                          Health Services.      sections 1814(a) and
                                                                                                                                1835(a) of the Act to
                                                                                                                                expand the list of
                                                                                                                                practitioners who can
                                                                                                                                order home health
                                                                                                                                services. Specifically,
                                                                                                                                sections 1814(a)(2)(C)
                                                                                                                                of the Act under Part A
                                                                                                                                and section
                                                                                                                                1835(a)(2)(A) of the Act
                                                                                                                                under Part B of the
                                                                                                                                Medicare program were
                                                                                                                                amended to allow an NP,
                                                                                                                                CNS or PA to order home
                                                                                                                                health services in
                                                                                                                                addition to physicians
                                                                                                                                so long as these NPPs
                                                                                                                                are permitted to provide
                                                                                                                                such services under the
                                                                                                                                scope of practice laws
                                                                                                                                in the state. Section
                                                                                                                                3708(e) of the CARES Act
                                                                                                                                also provides that the
                                                                                                                                requirements for
                                                                                                                                ordering home health
                                                                                                                                services shall apply
                                                                                                                                under title XIX in the
                                                                                                                                same manner and to the
                                                                                                                                same extent as such
                                                                                                                                requirements apply under
                                                                                                                                title XVIII of such Act.
                                                                                                                                In accordance with this
                                                                                                                                language on applying
                                                                                                                                these requirements ``in
                                                                                                                                the same manner'' as
                                                                                                                                Medicare is, in light of
                                                                                                                                the urgent need to
                                                                                                                                provide these
                                                                                                                                flexibilities during the
                                                                                                                                COVID-19 PHE, and
                                                                                                                                because this provision
                                                                                                                                will increase
                                                                                                                                flexibility in the
                                                                                                                                delivery of benefits and
                                                                                                                                make Medicaid coverage
                                                                                                                                of home health services
                                                                                                                                more available, the
                                                                                                                                Medicaid regulations
                                                                                                                                discussed in this
                                                                                                                                section will take effect
                                                                                                                                on the same date as the
                                                                                                                                Medicare regulations
                                                                                                                                implementing section
                                                                                                                                3708 discussed in
                                                                                                                                section II.J. of this
                                                                                                                                IFC, ``Care Planning for
                                                                                                                                Medicare Home Health
                                                                                                                                Services.'' Further, the
                                                                                                                                language in section 3708
                                                                                                                                of the CARES Act is not
                                                                                                                                time limited to the
                                                                                                                                period of the COVID-19
                                                                                                                                PHE; the revisions to
                                                                                                                                the Medicaid home health
                                                                                                                                program will be
                                                                                                                                permanently in effect.
                                                                                                                               The purpose of this
                                                                                                                                regulation is to
                                                                                                                                implement this statutory
                                                                                                                                directive in the CARES
                                                                                                                                Act within the Medicaid
                                                                                                                                program. In implementing
                                                                                                                                the CARES Act home
                                                                                                                                health provisions, it is
                                                                                                                                important to note the
                                                                                                                                structural differences
                                                                                                                                between the Medicare
                                                                                                                                home health benefit and
                                                                                                                                the Medicaid home health
                                                                                                                                benefit that require
                                                                                                                                some adaptation for the
                                                                                                                                requirement to apply the
                                                                                                                                new Medicare rules in
                                                                                                                                section 3708 of the
                                                                                                                                CARES Act to Medicaid
                                                                                                                                ``in the same manner and
                                                                                                                                to the same extent as
                                                                                                                                such requirements
                                                                                                                                apply'' under Medicare.
                                                                                                                                Under the Medicare
                                                                                                                                program, the home health
                                                                                                                                benefit includes skilled
                                                                                                                                part-time or
                                                                                                                                intermittent nursing,
                                                                                                                                home health aide
                                                                                                                                service, therapies and
                                                                                                                                medical social services.
                                                                                                                                DME is a separate
                                                                                                                                benefit under Medicare,
                                                                                                                                and could already be
                                                                                                                                ordered, prior to the
                                                                                                                                enactment of section
                                                                                                                                3708 of the CARES Act,
                                                                                                                                by a more extensive list
                                                                                                                                of NPPs than the
                                                                                                                                practitioners identified
                                                                                                                                in section 3708 of the
                                                                                                                                CARES Act for Medicare
                                                                                                                                home health services.
                                                                                                                                Comparatively, as noted
                                                                                                                                previously in this
                                                                                                                                section of the IFC, the
                                                                                                                                Medicaid home health
                                                                                                                                benefit includes part-
                                                                                                                                time or intermittent
                                                                                                                                nursing, home health
                                                                                                                                aide services, and
                                                                                                                                medical supplies,
                                                                                                                                equipment and
                                                                                                                                appliances, also known
                                                                                                                                as DME. Therapy services
                                                                                                                                can be included at the
                                                                                                                                state's option.
                                                                                                                               As discussed earlier in
                                                                                                                                this section, Medicare
                                                                                                                                allows a more extensive
                                                                                                                                list of NPPs to order
                                                                                                                                DME, than the
                                                                                                                                practitioners identified
                                                                                                                                for Medicaid or the
                                                                                                                                practitioners identified
                                                                                                                                in the CARES Act.
                                                                                                                                Because DME (``medical
                                                                                                                                supplies, equipment and
                                                                                                                                appliances'') is covered
                                                                                                                                under the Medicaid home
                                                                                                                                health benefit, this
                                                                                                                                would mean applying the
                                                                                                                                current Medicare rules
                                                                                                                                on who can order DME
                                                                                                                                under that Medicare
                                                                                                                                benefit to that
                                                                                                                                component of the
                                                                                                                                Medicaid home health
                                                                                                                                benefit. We believe that
                                                                                                                                aligning the Medicaid
                                                                                                                                program with Medicare
                                                                                                                                regarding who can order
                                                                                                                                medical supplies,
                                                                                                                                equipment and appliances
                                                                                                                                promotes access to
                                                                                                                                services for Medicaid
                                                                                                                                beneficiaries, including
                                                                                                                                those who are dually
                                                                                                                                eligible, and will
                                                                                                                                eliminate burden to
                                                                                                                                states and providers on
                                                                                                                                dealing with
                                                                                                                                inconsistencies between
                                                                                                                                the Medicare and
                                                                                                                                Medicaid programs.
                                                                                                                                Specifically, we are
                                                                                                                                amending the home health
                                                                                                                                regulation at Sec.
                                                                                                                                440.70(a)(3) to allow
                                                                                                                                other licensed
                                                                                                                                practitioners, to order
                                                                                                                                medical equipment,
                                                                                                                                supplies and appliances
                                                                                                                                in addition to
                                                                                                                                physicians, when
                                                                                                                                practicing in accordance
                                                                                                                                with state laws.
                                                                                                                               For other services
                                                                                                                                covered under the
                                                                                                                                Medicaid home health
                                                                                                                                benefit, we are applying
                                                                                                                                the new list of
                                                                                                                                practitioners set forth
                                                                                                                                in section 3708 of the
                                                                                                                                CARES Act to who can
                                                                                                                                order those services,
                                                                                                                                specifically, part-time
                                                                                                                                or intermittent nursing
                                                                                                                                services, home health
                                                                                                                                aide services, and if
                                                                                                                                included in the state's
                                                                                                                                home health benefit,
                                                                                                                                therapy services.
                                                                                                                                Specifically, Sec.
                                                                                                                                440.70(a)(2) is amended
                                                                                                                                to allow a NP, CNS and
                                                                                                                                PA to order home health
                                                                                                                                services described in
                                                                                                                                Sec.   440.70(b)(1), (2)
                                                                                                                                and (4).
                                                                                                                               Through this IFC, we are
                                                                                                                                also amending the
                                                                                                                                current regulation to
                                                                                                                                remove the requirement
                                                                                                                                that the NPPs described
                                                                                                                                in Sec.   440.70(a)(2)
                                                                                                                                have to communicate the
                                                                                                                                clinical finding of the
                                                                                                                                face-to-face encounter
                                                                                                                                to the ordering
                                                                                                                                physician. With
                                                                                                                                expanding authority to
                                                                                                                                order home health
                                                                                                                                services, the CARES Act
                                                                                                                                also provides that such
                                                                                                                                practitioners are now
                                                                                                                                capable of independently
                                                                                                                                performing the face-to-
                                                                                                                                face encounter for the
                                                                                                                                patient for whom they
                                                                                                                                are the ordering
                                                                                                                                practitioner, in
                                                                                                                                accordance with state
                                                                                                                                law. If state law does
                                                                                                                                not allow such
                                                                                                                                flexibility, the NPP is
                                                                                                                                required to work in
                                                                                                                                collaboration with a
                                                                                                                                physician.
                                                                                                                               Finally, we note that the
                                                                                                                                flexibility allowed in
                                                                                                                                this IFC to NPs, CNSs
                                                                                                                                and PAs to order home
                                                                                                                                health services must be
                                                                                                                                done in accordance with
                                                                                                                                state law. Individual
                                                                                                                                states have varying
                                                                                                                                requirements for
                                                                                                                                conditions of practice,
                                                                                                                                which determine whether
                                                                                                                                a practitioner may work
                                                                                                                                independently, without a
                                                                                                                                written collaborative
                                                                                                                                agreement or supervision
                                                                                                                                from a physician, or
                                                                                                                                whether general or
                                                                                                                                direct supervision and
                                                                                                                                collaboration is
                                                                                                                                required. State Medicaid
                                                                                                                                Agencies can consult the
                                                                                                                                specific practitioner
                                                                                                                                association or relevant
                                                                                                                                state agency website to
                                                                                                                                ensure that
                                                                                                                                practitioners are
                                                                                                                                working within their
                                                                                                                                scope of practice and
                                                                                                                                prescriptive authority.

[[Page 75754]]

 
240...............  HHS...............  CMS...............  Interim Final Rule...  RIN 0938-AU31.......  Clarification on      A. Through this IFC, we
                                                                                                          Reporting Under the   are implementing a
                                                                                                          Home Health Value-    policy to align the Home
                                                                                                          Based Purchasing      Health Value-Based
                                                                                                          Model for CY 2020.    Purchasing (HHVBP) Model
                                                                                                                                data submission
                                                                                                                                requirements with any
                                                                                                                                exceptions or extensions
                                                                                                                                granted for purposes of
                                                                                                                                the Home Health Quality
                                                                                                                                Reporting Program (HH
                                                                                                                                QRP) during the PHE for
                                                                                                                                COVID-19. We are also
                                                                                                                                implementing a policy
                                                                                                                                for granting exceptions
                                                                                                                                to the New Measures data
                                                                                                                                reporting requirements
                                                                                                                                under the HHVBP Model
                                                                                                                                during the PHE for COVID-
                                                                                                                                19. Specifically, during
                                                                                                                                the PHE for COVID-19, to
                                                                                                                                the extent that the data
                                                                                                                                that participating HHAs
                                                                                                                                in the nine HHVBP Model
                                                                                                                                states are required to
                                                                                                                                report are the same data
                                                                                                                                that those HHAs are also
                                                                                                                                required to report for
                                                                                                                                the HH QRP, HHAs are
                                                                                                                                required to report those
                                                                                                                                data for the HHVBP Model
                                                                                                                                in the same time, form
                                                                                                                                and manner that HHAs are
                                                                                                                                required to report those
                                                                                                                                data for the HH QRP. As
                                                                                                                                such, if CMS grants an
                                                                                                                                exception or extension
                                                                                                                                that either excepts HHAs
                                                                                                                                from reporting certain
                                                                                                                                quality data altogether,
                                                                                                                                or otherwise extends the
                                                                                                                                deadlines by which HHAs
                                                                                                                                must report those data,
                                                                                                                                the same exceptions and/
                                                                                                                                or extensions apply to
                                                                                                                                the submission of those
                                                                                                                                same data for the HHVBP
                                                                                                                                Model. In addition, in
                                                                                                                                this IFC, we are
                                                                                                                                adopting a policy to
                                                                                                                                allow exceptions or
                                                                                                                                extensions to New
                                                                                                                                Measure reporting for
                                                                                                                                HHAs participating in
                                                                                                                                the HHVBP Model during
                                                                                                                                the PHE for COVID-19.
                                                                                                                               As authorized by section
                                                                                                                                1115A of the Act and
                                                                                                                                finalized in the CY 2016
                                                                                                                                HH PPS final rule (80 FR
                                                                                                                                68624), the HHVBP Model
                                                                                                                                has an overall purpose
                                                                                                                                of improving the quality
                                                                                                                                and delivery of home
                                                                                                                                health care services to
                                                                                                                                Medicare beneficiaries.
                                                                                                                                The specific goals of
                                                                                                                                the Model are to: (1)
                                                                                                                                Provide incentives for
                                                                                                                                better quality care with
                                                                                                                                greater efficiency; (2)
                                                                                                                                study new potential
                                                                                                                                quality and efficiency
                                                                                                                                measures for
                                                                                                                                appropriateness in the
                                                                                                                                home health setting; and
                                                                                                                                (3) enhance the current
                                                                                                                                public reporting
                                                                                                                                process. All Medicare
                                                                                                                                certified HHAs providing
                                                                                                                                services in Arizona,
                                                                                                                                Florida, Iowa, Nebraska,
                                                                                                                                North Carolina,
                                                                                                                                Tennessee, Maryland,
                                                                                                                                Massachusetts, and
                                                                                                                                Washington are required
                                                                                                                                to compete in the Model.
                                                                                                                                The HHVBP Model uses the
                                                                                                                                waiver authority under
                                                                                                                                section 1115A(d)(1) of
                                                                                                                                the Act to adjust
                                                                                                                                Medicare payment rates
                                                                                                                                under section 1895(b) of
                                                                                                                                the Act based on the
                                                                                                                                competing HHAs'
                                                                                                                                performance on
                                                                                                                                applicable measures. The
                                                                                                                                maximum payment
                                                                                                                                adjustment percentage
                                                                                                                                increases incrementally
                                                                                                                                over the course of the
                                                                                                                                HHVBP Model in the
                                                                                                                                following manner, upward
                                                                                                                                or downward: (1) 3
                                                                                                                                percent in CY 2018; (2)
                                                                                                                                5 percent in CY 2019;
                                                                                                                                (3) 6 percent in CY
                                                                                                                                2020; (4) 7 percent in
                                                                                                                                CY 2021; and (5) 8
                                                                                                                                percent in CY 2022.
                                                                                                                                Payment adjustments are
                                                                                                                                based on each HHA's
                                                                                                                                Total Performance Score
                                                                                                                                (TPS) in a given
                                                                                                                                performance year (PY),
                                                                                                                                which is comprised of
                                                                                                                                performance on: (1) A
                                                                                                                                set of measures already
                                                                                                                                reported via the Outcome
                                                                                                                                and Assessment
                                                                                                                                Information Set (OASIS),
                                                                                                                                5 completed Home Health
                                                                                                                                Consumer Assessment of
                                                                                                                                Healthcare Providers and
                                                                                                                                Systems (HHCAHPS)
                                                                                                                                surveys, and select
                                                                                                                                claims data elements;
                                                                                                                                and (2) three New
                                                                                                                                Measures for which
                                                                                                                                points are achieved for
                                                                                                                                reporting data.
241...............  HHS...............  CMS...............  Waiver...............  ....................  Respiratory Care      Waiving the requirements
                                                                                                          Services.             at 42 CFR Sec.
                                                                                                                                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 so long as
                                                                                                                                they are not
                                                                                                                                inconsistent with a
                                                                                                                                state's emergency
                                                                                                                                preparedness or pandemic
                                                                                                                                plan.
242...............  HHS...............  CMS...............  Waiver...............  ....................  Documentation of      Scope of authority
                                                                                                          Progress Notes.       extended for non-
                                                                                                                                physician practitioners
                                                                                                                                to document progress
                                                                                                                                notes of patients
                                                                                                                                receiving services in
                                                                                                                                psychiatric hospitals.
243...............  HHS...............  CMS...............  Waiver...............  ....................  DMEPOS Replacement    Where Durable Medical
                                                                                                          Requirements.         Equipment Prosthetics,
                                                                                                                                Orthotics, and Supplies
                                                                                                                                (DMEPOS) is lost,
                                                                                                                                destroyed, irreparably
                                                                                                                                damaged, or otherwise
                                                                                                                                rendered unusable, DME
                                                                                                                                Medicare Administrative
                                                                                                                                Contractors have the
                                                                                                                                flexibility to waive
                                                                                                                                replacements
                                                                                                                                requirements under
                                                                                                                                Medicare 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
                                                                                                                                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.
244...............  HHS...............  CMS...............  Waiver...............  ....................  Modified Discharge    Waiving the requirement
                                                                                                          Planning.             42 CFR Sec.
                                                                                                                                482.43(a)(8), Sec.
                                                                                                                                482.61(e), and Sec.
                                                                                                                                485.642(a)(8) to provide
                                                                                                                                detailed information
                                                                                                                                regarding discharge
                                                                                                                                planning, described
                                                                                                                                below:
                                                                                                                                   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 postacute
                                                                                                                                   care data on quality
                                                                                                                                   measures and resource
                                                                                                                                   use measures is
                                                                                                                                   relevant and
                                                                                                                                   applicable to the
                                                                                                                                   patient's goals of
                                                                                                                                   care and treatment
                                                                                                                                   preferences.
                                                                                                                                   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.

[[Page 75755]]

 
245...............  HHS...............  CMS...............  Waiver...............  ....................  Detailed Information  Waiving the requirements
                                                                                                          Sharing for           of 42 CFR Sec.
                                                                                                          Discharge Planning    484.58(a) to provide
                                                                                                          for Home Health       detailed information
                                                                                                          Agencies.             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.
                                                                                                                                   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.
246...............  HHS...............  CMS...............  Waiver...............  ....................  DMEPOS Signature on   DMEPOS items, except for
                                                                                                          Orders.               Power Mobility Devices
                                                                                                                                (PMDs), can be provided
                                                                                                                                via a verbal order. A
                                                                                                                                signature is required
                                                                                                                                prior to submitting
                                                                                                                                claims for payment but
                                                                                                                                the order can be signed
                                                                                                                                electronically. PMDs
                                                                                                                                require a signed,
                                                                                                                                written order prior to
                                                                                                                                delivery.
247...............  HHS...............  CMS...............  Waiver...............  ....................  Specific Physical     42 CFR Sec.   482.41(d)
                                                                                                          Environment Waivers   for hospitals, Sec.
                                                                                                          for Inspection,       485.623(b) for CAH, Sec.
                                                                                                          Testing and             418.110(c)(2)(iv) for
                                                                                                          Maintenance.          inpatient hospice, Sec.
                                                                                                                                 483.470(j) for ICF/IID;
                                                                                                                                and Sec.   483.90 for
                                                                                                                                SNFs/NFs all require
                                                                                                                                these facilities and
                                                                                                                                their equipment to be
                                                                                                                                maintained to ensure an
                                                                                                                                acceptable 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.
248...............  HHS...............  CMS...............  Waiver...............  ....................  Special Purpose       Authorizes the
                                                                                                          Renal Dialysis        establishment of SPRDFs
                                                                                                          Facilities (SPRDF)    under 42 CFR Sec.
                                                                                                          Designation           494.120 to address
                                                                                                          Expanded.             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 Sec.
                                                                                                                                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.
249...............  HHS...............  CMS...............  Waiver...............  ....................  Expanded Ability for  Under section 1135(b)(1)
                                                                                                          Hospitals to Offer    of the Act, CMS is
                                                                                                          Long-term Care        waiving the requirements
                                                                                                          Services (``Swing-    at 42 CFR 482.58,
                                                                                                          Beds'') for           ``Special Requirements
                                                                                                          Patients Who do not   for hospital providers
                                                                                                          Require Acute Care    of long-term care
                                                                                                          but do Meet the       services (``swing-
                                                                                                          Skilled Nursing       beds'')'' subsections
                                                                                                          Facility (SNF)        (a)(1)-(4)
                                                                                                          Level of Care         ``Eligibility'', to
                                                                                                          Criteria as Set       allow hospitals to
                                                                                                          Forth at 42 CFR       establish SNF swing beds
                                                                                                          409.31.               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:
                                                                                                                                   Not use SNF
                                                                                                                                   swing beds for acute
                                                                                                                                   level care.
                                                                                                                                   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.
                                                                                                                                   Be consistent
                                                                                                                                   with the state's
                                                                                                                                   emergency
                                                                                                                                   preparedness or
                                                                                                                                   pandemic plan
                                                                                                                                   currently not willing
                                                                                                                                   to accept or able to
                                                                                                                                   take patients because
                                                                                                                                   of the COVID-19
                                                                                                                                   public health
                                                                                                                                   emergency (PHE);
                                                                                                                                   Hospitals must call
                                                                                                                                   the CMS Medicare
                                                                                                                                   Administrative
                                                                                                                                   Contractor (MAC)
                                                                                                                                   enrollment hotline to
                                                                                                                                   add swing bed
                                                                                                                                   services. The
                                                                                                                                   hospital must attest
                                                                                                                                   to CMS that:
                                                                                                                                   They have
                                                                                                                                   made a good faith
                                                                                                                                   effort to exhaust all
                                                                                                                                   other options;
                                                                                                                                   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);
                                                                                                                                   The hospital
                                                                                                                                   meets all waiver
                                                                                                                                   eligibility
                                                                                                                                   requirements; and
                                                                                                                                   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, so long as
                                                                                                                                   the waiver is not
                                                                                                                                   inconsistent 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.
250...............  HHS...............  CMS...............  Waiver...............  ....................  Housing Acute Care    Waiving requirements to
                                                                                                          Patients in the IRF   allow acute care
                                                                                                          or IPF Excluded       hospitals to house acute
                                                                                                          Distinct Part Units.  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.
251...............  HHS...............  CMS...............  Waiver...............  ....................  Resident Transfer     Waiving requirements in
                                                                                                          and Discharge.        42 CFR 483.10(c)(5);
                                                                                                                                483.15(c)(3),
                                                                                                                                (c)(4)(ii), (c)(5)(i)
                                                                                                                                and (iv), (c)(9), and
                                                                                                                                (d); and Sec.
                                                                                                                                483.21(a)(1)(i),
                                                                                                                                (a)(2)(i), and (b)(2)(i)
                                                                                                                                (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:

[[Page 75756]]

 
                                                                                                                                   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;
                                                                                                                                   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
                                                                                                                                   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 Sec.
                                                                                                                                   483.10, we are only
                                                                                                                                   waiving the
                                                                                                                                   requirement, under
                                                                                                                                   Sec.   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 Sec.
                                                                                                                                   483.10 are not
                                                                                                                                   waived. Similarly, in
                                                                                                                                   Sec.   483.15, we are
                                                                                                                                   only waiving the
                                                                                                                                   requirement, under
                                                                                                                                   Sec.   483.15(c)(3),
                                                                                                                                   (c)(4)(ii), (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 Sec.
                                                                                                                                   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.
                                                                                                                                   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 not
                                                                                                                                   inconsistent 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
                                                                                                                                   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.
                                                                                                                                  [cir] 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-andGuidance/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.
252...............  HHS...............  CMS...............  Waiver...............  ....................  Furnishing Dialysis   ESRD requirements at 42
                                                                                                          Services on the       CFR 494.180(d) require
                                                                                                          Main Premises.        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 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.

[[Page 75757]]

 
253...............  HHS...............  CMS...............  Waiver...............  ....................  Specific Physical     42 CFR 482.41(b)(9) for
                                                                                                          Environment Waiver    hospitals, Sec.
                                                                                                          for Outside Window    485.623(c)(7) for CAHs,
                                                                                                          and Outside Door      Sec.   418.110(d)(6) for
                                                                                                          Requirements.         inpatient hospices, Sec.
                                                                                                                                  483.470(e)(1)(i) for
                                                                                                                                ICF/IIDs, and Sec.
                                                                                                                                483.90(a)(7) for SNFs/
                                                                                                                                NFs 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.
254...............  HHS...............  CMS...............  Waiver...............  ....................  Temporary Expansion   For the duration of the
                                                                                                          Locations.            PHE related to COVID-19,
                                                                                                                                CMS is waiving certain
                                                                                                                                requirements under the
                                                                                                                                Medicare conditions of
                                                                                                                                participation at 42 CFR
                                                                                                                                482.41 and Sec.
                                                                                                                                485.623 (as noted
                                                                                                                                elsewhere in this waiver
                                                                                                                                document) and the
                                                                                                                                provider-based
                                                                                                                                department requirements
                                                                                                                                at Sec.   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)
                                                                                                                                so 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.
255...............  HHS...............  CMS...............  Waiver...............  RIN 0938-AU31.......  IRF and IPF Teaching  To ensure that teaching
                                                                                                          Status Adjustment     IRFs and IPFs can
                                                                                                          Payments.             alleviate bed capacity
                                                                                                                                issues by taking
                                                                                                                                patients from the
                                                                                                                                inpatient acute care
                                                                                                                                hospitals without being
                                                                                                                                penalized by lower
                                                                                                                                teaching status
                                                                                                                                adjustments, we are
                                                                                                                                freezing the IRFs' and
                                                                                                                                IPFs' teaching status
                                                                                                                                adjustment payments at
                                                                                                                                their values prior to
                                                                                                                                the PHE. For the
                                                                                                                                duration of the COVID-19
                                                                                                                                PHE, an IRF's teaching
                                                                                                                                status adjustment
                                                                                                                                payments will be the
                                                                                                                                same as they were on the
                                                                                                                                day before the COVID-19
                                                                                                                                PHE was declared.
256...............  HHS...............  CMS...............  Waiver...............  ....................  Care for Patients in  CMS is allowing extended
                                                                                                          Extended Neoplastic   neoplastic disease care
                                                                                                          Disease Care          hospitals to exclude
                                                                                                          Hospitals.            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 CFR
                                                                                                                                412.22(i).
257...............  HHS...............  CMS...............  Waiver...............  ....................  Community Mental      Waiving the requirement
                                                                                                          Health Clinic         at Sec.
                                                                                                          (CMHC) 40 Percent     485.918(b)(1)(v) that a
                                                                                                          Rule.                 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.
258...............  HHS...............  CMS...............  Waiver...............  ....................  Resident Groups.....  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.
259...............  HHS...............  CMS...............  Waiver...............  ....................  Non-Core Services...  Waiving the requirement
                                                                                                                                for hospices to provide
                                                                                                                                certain noncore hospice
                                                                                                                                services during the
                                                                                                                                national emergency,
                                                                                                                                including the
                                                                                                                                requirements at 42 CFR
                                                                                                                                418.72 for physical
                                                                                                                                therapy, occupational
                                                                                                                                therapy, and speech-
                                                                                                                                language pathology.
260...............  HHS...............  CMS...............  Waiver...............  ....................  Time Period for       Modifying two
                                                                                                          Initiation of Care    requirements related to
                                                                                                          Planning and          care planning,
                                                                                                          Monthly Physician     specifically:
                                                                                                          Visits.
                                                                                                                                   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.
                                                                                                                                   Sec.
                                                                                                                                   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.

[[Page 75758]]

 
261...............  HHS...............  CMS...............  Waiver...............  ....................  Dialysis Home Visits  Waiving the requirement
                                                                                                          to Assess             at 42 CFR
                                                                                                          Adaptation and Home   494.100(c)(1)(i) which
                                                                                                          Dialysis Machine      requires the periodic
                                                                                                          Designation.          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,
                                                                                                                                referenceQSO-20-19-ESRD.
262...............  HHS...............  CMS...............  Waiver...............  ....................  ICF/IID Suspension    Waiving the requirements
                                                                                                          of Community          at 42 CFR 483.420(a)(11)
                                                                                                          Outings.              which requires clients
                                                                                                                                have the opportunity to
                                                                                                                                participate in social,
                                                                                                                                religious, and community
                                                                                                                                group activities. The
                                                                                                                                federal and/or state
                                                                                                                                emergency restrictions
                                                                                                                                will dictate 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.
263...............  HHS...............  CMS...............  Waiver...............  ....................  ICF/IID Modification  CMS is waiving those
                                                                                                          of Adult Training     components of
                                                                                                          Programs and Active   beneficiaries' active
                                                                                                          Treatment.            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 Sec.
                                                                                                                                 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.
264...............  HHS...............  CMS...............  Waiver...............  ....................  Timeframes for        CMS is waiving certain
                                                                                                          Hospice               requirements at 42 CFR
                                                                                                          Comprehensive         418.54 related to
                                                                                                          Assessments.          updating comprehensive
                                                                                                                                assessments of patients.
                                                                                                                                This waiver applies the
                                                                                                                                timeframes for updates
                                                                                                                                to the comprehensive
                                                                                                                                assessment found at Sec.
                                                                                                                                  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.
265...............  HHS...............  CMS...............  Waiver...............  ....................  Clinical Records for  Pursuant to section
                                                                                                          Long-Term Care        1135(b)(5) of the Act,
                                                                                                          (LTC) Facilities.     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.
266...............  HHS...............  CMS...............  Waiver...............  ....................  Clinical Records for  In accordance with
                                                                                                          HHAs.                 section 1135(b)(5) of
                                                                                                                                the Act, CMS is
                                                                                                                                extending 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 will allow HHAs ten
                                                                                                                                business days to provide
                                                                                                                                a patient's clinical
                                                                                                                                record, instead of four.
267...............  HHS...............  CMS...............  Waiver...............  ....................  Ambulance Services:   Modifying the data
                                                                                                          Medicare Ground       collection period and
                                                                                                          Ambulance Data        data reporting period,
                                                                                                          Collection System.    as defined at 42 CFR
                                                                                                                                Sec.   414.626(a), for
                                                                                                                                ground ambulance
                                                                                                                                organizations (as
                                                                                                                                defined at 42 CFR Sec.
                                                                                                                                414.605) that were
                                                                                                                                selected by CMS under 42
                                                                                                                                CFR Sec.   414.626(c) to
                                                                                                                                collect data beginning
                                                                                                                                between January 1, 2020
                                                                                                                                and December 31, 2020
                                                                                                                                (year 1) for purposes of
                                                                                                                                complying with the data
                                                                                                                                reporting requirements
                                                                                                                                described at 42 CFR Sec.
                                                                                                                                  414.626. Under this
                                                                                                                                modification, these
                                                                                                                                ground ambulance
                                                                                                                                organizations can select
                                                                                                                                a new continuous 12-
                                                                                                                                month data collection
                                                                                                                                period that begins
                                                                                                                                between January 1, 2021
                                                                                                                                and December 31, 2021,
                                                                                                                                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.
                                                                                                                               As a result of this
                                                                                                                                modification, ground
                                                                                                                                ambulance organizations
                                                                                                                                selected for year 1 data
                                                                                                                                collection and reporting
                                                                                                                                will collect and report
                                                                                                                                data during the same
                                                                                                                                period of time that will
                                                                                                                                apply to ground
                                                                                                                                ambulance organizations
                                                                                                                                selected by CMS under 42
                                                                                                                                CFR Sec.   414.626(c) 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 Sec.
                                                                                                                                  414.626.

[[Page 75759]]

 
268...............  HHS...............  CMS...............  Waiver...............  ....................  Paid Feeding          Modifying the
                                                                                                          Assistants for Long-  requirements at 42 CFR
                                                                                                          Term Care             483.60(h)(1)(i) and
                                                                                                          Facilities (LTCF).    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).
269...............  HHS...............  CMS...............  Waiver...............  42 CFR 483.430(e)(1)  ICF/IID Mandatory     Waiving, in-part, the
                                                                                                          Training              requirements at 42 CFR
                                                                                                          Requirements          483.430(e)(1) related to
                                                                                                          Suspension.           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.
270...............  HHS...............  CMS...............  Waiver...............  ....................  Requirement for       Waiving the requirement
                                                                                                          Hospices to Use       at 42 CFR 418.78(e) that
                                                                                                          Volunteers.           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.
271...............  HHS...............  CMS...............  Waiver...............  ....................  ICF/IID Staffing      Waiving the requirements
                                                                                                          Flexibilities.        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 Sec.   483.430(d)(3).
272...............  HHS...............  CMS...............  Waiver...............  ....................  Ambulatory Surgical   Waiving the requirement
                                                                                                          Center (ASC)          at Sec.   416.45(b) that
                                                                                                          Medical Staff.        medical staff privileges
                                                                                                                                must be periodically
                                                                                                                                reappraised, and the
                                                                                                                                scope of procedures
                                                                                                                                performed in 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.
273...............  HHS...............  CMS...............  Waiver...............  ....................  Sterile Compounding.  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.
274...............  HHS...............  CMS...............  Waiver...............  ....................  Patient Rights......  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 which
                                                                                                                                has widespread confirmed
                                                                                                                                cases (i.e., 51 or more
                                                                                                                                confirmed cases*) as
                                                                                                                                updated on the CDC
                                                                                                                                website, CDC States
                                                                                                                                Reporting Cases of COVID-
                                                                                                                                19, at https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html, would
                                                                                                                                not be required to meet
                                                                                                                                the following
                                                                                                                                requirements:
                                                                                                                                   Sec.
                                                                                                                                   482.13(d)(2)--With
                                                                                                                                   respect to timeframes
                                                                                                                                   in providing a copy
                                                                                                                                   of a medical record.
                                                                                                                                   Sec.
                                                                                                                                   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.
                                                                                                                                   Sec.
                                                                                                                                   482.13(e)(1)(ii)--Reg
                                                                                                                                   arding seclusion.
275...............  HHS...............  CMS...............  Waiver...............  ....................  Certification         Waiving requirements
                                                                                                          related to Long-      related at 42 CFR
                                                                                                          Term Care             483.90, specifically the
                                                                                                          Facilities            following:
                                                                                                          (Physical
                                                                                                          Environment).
                                                                                                                                   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 Sec.   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.

[[Page 75760]]

 
                                                                                                                                   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.
                                                                                                                                   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
                                                                                                                                   department.
276...............  HHS...............  CMS...............  Guidance.............  ....................  Review Choice         Effective March 29, 2020,
                                                                                                          Demonstration for     certain claims
                                                                                                          Home Health           processing for the
                                                                                                          Services Claims       Review Choice
                                                                                                          Processing            Demonstration (RCD) for
                                                                                                          Requirements.         Home Health Services
                                                                                                                                will be paused in
                                                                                                                                Illinois, Ohio, and
                                                                                                                                Texas, until the PHE for
                                                                                                                                the COVID-19 pandemic
                                                                                                                                has ended. During the
                                                                                                                                pause, the MACs will
                                                                                                                                process claims submitted
                                                                                                                                prior to the emergency
                                                                                                                                period under normal
                                                                                                                                claims processing
                                                                                                                                requirements. Claims for
                                                                                                                                home health services
                                                                                                                                furnished on or after
                                                                                                                                March 29, 2020 and
                                                                                                                                before the end of the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic in these states
                                                                                                                                will not be subject to
                                                                                                                                the review choices made
                                                                                                                                by the home health
                                                                                                                                agency under the
                                                                                                                                demonstration. However,
                                                                                                                                the MAC will continue to
                                                                                                                                review any pre-claim
                                                                                                                                review requests that
                                                                                                                                have already been
                                                                                                                                submitted, and providers
                                                                                                                                may continue to submit
                                                                                                                                new pre-claim review
                                                                                                                                requests for review
                                                                                                                                during the pause. Claims
                                                                                                                                that have received a
                                                                                                                                provisional affirmative
                                                                                                                                pre-claim review
                                                                                                                                decision and are
                                                                                                                                submitted with an
                                                                                                                                affirmed Unique Tracking
                                                                                                                                Number (UTN) will
                                                                                                                                continue to be excluded
                                                                                                                                from future medical
                                                                                                                                review. Home health
                                                                                                                                agencies participating
                                                                                                                                in pre-claim review may
                                                                                                                                submit their claims
                                                                                                                                without requesting such
                                                                                                                                approval from the MAC
                                                                                                                                and claims submitted
                                                                                                                                without a UTN will not
                                                                                                                                be stopped for
                                                                                                                                prepayment review and
                                                                                                                                will not receive a 25%
                                                                                                                                payment reduction. HHAs
                                                                                                                                participating in the
                                                                                                                                other review choices
                                                                                                                                (prepayment or
                                                                                                                                postpayment review) will
                                                                                                                                not receive Additional
                                                                                                                                Documentation Requests
                                                                                                                                (ADRs) during the pause,
                                                                                                                                and ADRs that were
                                                                                                                                issued prior to the PHE
                                                                                                                                will be released and
                                                                                                                                processed as normal.
                                                                                                                                Following the end of the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic, the MAC will
                                                                                                                                conduct postpayment
                                                                                                                                review on claims subject
                                                                                                                                to the demonstration
                                                                                                                                that were submitted and
                                                                                                                                paid during the pause.
                                                                                                                                The demonstration will
                                                                                                                                not begin in North
                                                                                                                                Carolina and Florida on
                                                                                                                                May 4, 2020, as
                                                                                                                                previously scheduled.
                                                                                                                                CMS will provide notice
                                                                                                                                on its demonstration
                                                                                                                                website rescheduling the
                                                                                                                                start of the
                                                                                                                                demonstration, once the
                                                                                                                                PHE has ended.
277...............  HHS...............  CMS...............  Guidance.............  ....................  Cost and Utilization  Part D sponsors must
                                                                                                          Management            suspend all quantity and
                                                                                                          Requirements.         days' supply limits
                                                                                                                                under 90 days for all
                                                                                                                                covered Part D drugs (as
                                                                                                                                defined in 42 CFR
                                                                                                                                423.100) other than such
                                                                                                                                limits resulting from
                                                                                                                                safety edits (discussed
                                                                                                                                below). Part D sponsors
                                                                                                                                may otherwise continue
                                                                                                                                to utilize their
                                                                                                                                formularies, tiered cost-
                                                                                                                                sharing benefit
                                                                                                                                structures, and approved
                                                                                                                                prior authorization (PA)
                                                                                                                                and step therapy (ST)
                                                                                                                                requirements. There are
                                                                                                                                no alterations to mid-
                                                                                                                                year formulary change
                                                                                                                                requirements, and we
                                                                                                                                remind sponsors that new
                                                                                                                                drugs may be added and
                                                                                                                                utilization management
                                                                                                                                requirements removed at
                                                                                                                                any time.
278...............  HHS...............  CMS...............  Guidance.............  ....................  Opioid Safety Edits.  Part D sponsors are
                                                                                                                                expected to continue to
                                                                                                                                apply existing opioid
                                                                                                                                point-of-sale safety
                                                                                                                                edits during the COVID-
                                                                                                                                19 emergency, including
                                                                                                                                the care coordination
                                                                                                                                edit at 90 morphine
                                                                                                                                milligram equivalents
                                                                                                                                (MME) per day, optional
                                                                                                                                hard edit at 200 MME per
                                                                                                                                day or more, hard edit
                                                                                                                                for seven-day supply
                                                                                                                                limit for initial opioid
                                                                                                                                fills (opioid
                                                                                                                                na[iuml]ve), soft edit
                                                                                                                                for concurrent opioid
                                                                                                                                and benzodiazepine use,
                                                                                                                                and soft edit for
                                                                                                                                duplicative long-acting
                                                                                                                                (LA) opioid therapy.
                                                                                                                                However, due to the
                                                                                                                                increased burden on the
                                                                                                                                healthcare system as a
                                                                                                                                result of the COVID-19
                                                                                                                                pandemic, we encourage
                                                                                                                                plans to waive
                                                                                                                                requirements for
                                                                                                                                pharmacist consultation
                                                                                                                                with the prescriber to
                                                                                                                                confirm intent to lessen
                                                                                                                                the administrative
                                                                                                                                burden on prescribers
                                                                                                                                and pharmacists.
                                                                                                                                Additionally, CMS is
                                                                                                                                exercising its
                                                                                                                                enforcement discretion
                                                                                                                                to adopt a temporary
                                                                                                                                policy of relaxed
                                                                                                                                enforcement in
                                                                                                                                connection with any Part
                                                                                                                                D medication delivery
                                                                                                                                documentation and
                                                                                                                                signature log
                                                                                                                                requirements related to
                                                                                                                                these edits during the
                                                                                                                                COVID-19 emergency, as
                                                                                                                                noted above.

[[Page 75761]]

 
279...............  HHS...............  CMS...............  Guidance.............  ....................  Additional or         In response to the unique
                                                                                                          Expanded Benefit      circumstances resulting
                                                                                                          Offerings.            from the outbreak of
                                                                                                                                COVID-19, CMS is
                                                                                                                                exercising its
                                                                                                                                enforcement discretion
                                                                                                                                to adopt a temporary
                                                                                                                                policy of relaxed
                                                                                                                                enforcement in
                                                                                                                                connection with the
                                                                                                                                prohibition on mid-year
                                                                                                                                benefit enhancements (73
                                                                                                                                Federal Register 43628),
                                                                                                                                such as expanded or
                                                                                                                                additional benefits or
                                                                                                                                more generous cost-
                                                                                                                                sharing under the
                                                                                                                                conditions outlined in
                                                                                                                                this memorandum, when
                                                                                                                                such mid-year benefit
                                                                                                                                enhancements are
                                                                                                                                provided in connection
                                                                                                                                with the COVID-19
                                                                                                                                outbreak, are beneficial
                                                                                                                                to enrollees, and are
                                                                                                                                provided uniformly to
                                                                                                                                all similarly situated
                                                                                                                                enrollees. MAOs may
                                                                                                                                implement additional or
                                                                                                                                expanded benefits that
                                                                                                                                address issues or
                                                                                                                                medical needs raised by
                                                                                                                                the COVID-19 outbreak,
                                                                                                                                such as covering meal
                                                                                                                                delivery or medical
                                                                                                                                transportation services
                                                                                                                                to accommodate the
                                                                                                                                efforts to promote
                                                                                                                                social distancing during
                                                                                                                                the COVID-19 public
                                                                                                                                health emergency. CMS
                                                                                                                                will exercise its
                                                                                                                                enforcement discretion
                                                                                                                                regarding the
                                                                                                                                administration of MAOs'
                                                                                                                                benefit packages as
                                                                                                                                approved by CMS until it
                                                                                                                                is determined that the
                                                                                                                                exercise of this
                                                                                                                                discretion is no longer
                                                                                                                                necessary in conjunction
                                                                                                                                with the COVID-19
                                                                                                                                outbreak.
280...............  HHS...............  CMS...............  Guidance.............  ....................  Medicare Advantage    MAOs may waive or reduce
                                                                                                          Cost-Sharing.         enrollee cost-sharing
                                                                                                                                for beneficiaries
                                                                                                                                enrolled in their
                                                                                                                                Medicare Advantage plans
                                                                                                                                impacted by the
                                                                                                                                outbreak. For example,
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations may waive
                                                                                                                                or reduce enrollee cost-
                                                                                                                                sharing for COVID-19
                                                                                                                                treatment, telehealth
                                                                                                                                benefits or other
                                                                                                                                services to address the
                                                                                                                                outbreak provided that
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations waive or
                                                                                                                                reduce cost-sharing for
                                                                                                                                all similarly situated
                                                                                                                                plan enrollees on a
                                                                                                                                uniform basis. CMS
                                                                                                                                clarifies that this
                                                                                                                                flexibility is limited
                                                                                                                                to when a waiver or
                                                                                                                                reduction in cost-
                                                                                                                                sharing can be tied to
                                                                                                                                the COVID-19 outbreak.
                                                                                                                                CMS consulted with the
                                                                                                                                HHS Office of Inspector
                                                                                                                                General (OIG) and HHS
                                                                                                                                OIG advised that should
                                                                                                                                an Medicare Advantage
                                                                                                                                Organization choose to
                                                                                                                                voluntarily waive or
                                                                                                                                reduce enrollee cost-
                                                                                                                                sharing, as approved by
                                                                                                                                CMS herein, such waivers
                                                                                                                                or reductions would
                                                                                                                                satisfy the safe harbor
                                                                                                                                to the Federal anti-
                                                                                                                                kickback statute set
                                                                                                                                forth at 42 CFR
                                                                                                                                1001.952(l).
281...............  HHS...............  CMS...............  Guidance.............  ....................  Telehealth..........  Medicare Advantage
                                                                                                                                Organizations may also
                                                                                                                                provide enrollees access
                                                                                                                                to Medicare Part B
                                                                                                                                services via telehealth
                                                                                                                                in any geographic area
                                                                                                                                and from a variety of
                                                                                                                                places, including
                                                                                                                                beneficiaries' homes.
                                                                                                                                Should a Medicare
                                                                                                                                Advantage Organization
                                                                                                                                wish to expand coverage
                                                                                                                                of telehealth services
                                                                                                                                beyond those approved by
                                                                                                                                CMS in the plan's
                                                                                                                                benefit package for
                                                                                                                                similarly situated
                                                                                                                                enrollees impacted by
                                                                                                                                the outbreak, CMS will
                                                                                                                                exercise its enforcement
                                                                                                                                discretion regarding the
                                                                                                                                administration of
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations' benefit
                                                                                                                                packages as approved by
                                                                                                                                CMS until it is
                                                                                                                                determined that the
                                                                                                                                exercise of this
                                                                                                                                discretion is no longer
                                                                                                                                necessary in conjunction
                                                                                                                                with the PHE. CMS
                                                                                                                                consulted with the HHS
                                                                                                                                OIG and HHS OIG advised
                                                                                                                                that should a Medicare
                                                                                                                                Advantage Organization
                                                                                                                                choose to expand
                                                                                                                                coverage of telehealth
                                                                                                                                benefits, as approved by
                                                                                                                                CMS herein, such
                                                                                                                                additional coverage
                                                                                                                                would satisfy the safe
                                                                                                                                harbor to the Federal
                                                                                                                                anti-kickback statute
                                                                                                                                set forth at 42 CFR
                                                                                                                                1001.952(l).
282...............  HHS...............  CMS...............  Guidance.............  ....................  Model of Care         CMS also recognizes that
                                                                                                          Flexibility.          in light of the COVID-19
                                                                                                                                outbreak, an MAO with
                                                                                                                                one or more special
                                                                                                                                needs plans (SNPs) may
                                                                                                                                need to implement
                                                                                                                                strategies that do not
                                                                                                                                fully comply with their
                                                                                                                                approved SNP model of
                                                                                                                                care (MOC) in order to
                                                                                                                                provide care to
                                                                                                                                enrollees while ensuring
                                                                                                                                that enrollees and
                                                                                                                                health care providers
                                                                                                                                are also protected from
                                                                                                                                the spread of COVID-19.
                                                                                                                                CMS will consider the
                                                                                                                                special circumstances
                                                                                                                                presented by the COVID-
                                                                                                                                19 outbreak when
                                                                                                                                conducting MOC
                                                                                                                                monitoring or oversight
                                                                                                                                activities.
283...............  HHS...............  CMS...............  Guidance.............  ....................  Involuntary           Due to the public health
                                                                                                          Disenrollment--Temp   emergency posed by COVID-
                                                                                                          orary Absence         19 and the urgent need
                                                                                                          Flexibilities.        to ensure that enrollees
                                                                                                                                have continued coverage
                                                                                                                                and access to sufficient
                                                                                                                                health care items and
                                                                                                                                services to meet their
                                                                                                                                medical needs, CMS is
                                                                                                                                exercising its
                                                                                                                                enforcement discretion
                                                                                                                                to adopt a temporary
                                                                                                                                policy of relaxed
                                                                                                                                enforcement with respect
                                                                                                                                to MA organizations that
                                                                                                                                choose to delay to a
                                                                                                                                later date the
                                                                                                                                involuntary
                                                                                                                                disenrollment of
                                                                                                                                enrollees who are
                                                                                                                                temporarily absent from
                                                                                                                                the service area for
                                                                                                                                greater than 6 months
                                                                                                                                when that absence is due
                                                                                                                                to the COVID-19 national
                                                                                                                                emergency. CMS will not
                                                                                                                                enforce the requirement
                                                                                                                                at Sec.   422.74(d)(4)
                                                                                                                                and will allow MA
                                                                                                                                organizations to extend
                                                                                                                                the period of time
                                                                                                                                members may remain
                                                                                                                                enrolled while
                                                                                                                                temporarily absent from
                                                                                                                                the plan service area
                                                                                                                                through the end of the
                                                                                                                                year, or the end of the
                                                                                                                                public health emergency,
                                                                                                                                whichever is earlier.
                                                                                                                                Individuals who remain
                                                                                                                                absent from the service
                                                                                                                                area will be disenrolled
                                                                                                                                January 1, 2021, if the
                                                                                                                                public health emergency
                                                                                                                                is still in effect at
                                                                                                                                that time, or 6 months
                                                                                                                                after the individual
                                                                                                                                left the service area,
                                                                                                                                whichever is later.

[[Page 75762]]

 
284...............  HHS...............  CMS...............  Guidance.............  ....................  Involuntary           Due to the public health
                                                                                                          Disenrollment--Loss   emergency posed by COVID-
                                                                                                          of Special Needs      19 and the urgent need
                                                                                                          Status.               to ensure that enrollees
                                                                                                                                have continued coverage
                                                                                                                                and access to sufficient
                                                                                                                                health care items and
                                                                                                                                services to meet their
                                                                                                                                medical needs, CMS will
                                                                                                                                also exercise
                                                                                                                                enforcement discretion
                                                                                                                                during calendar year
                                                                                                                                2020 to adopt a
                                                                                                                                temporary policy of
                                                                                                                                relaxed enforcement with
                                                                                                                                respect to MA
                                                                                                                                organizations that
                                                                                                                                choose to delay to a
                                                                                                                                later date the
                                                                                                                                involuntary
                                                                                                                                disenrollment of
                                                                                                                                enrollees who are losing
                                                                                                                                special needs status and
                                                                                                                                cannot recertify SNP
                                                                                                                                eligibility due to the
                                                                                                                                COVID-19 national
                                                                                                                                emergency. Under this
                                                                                                                                policy, CMS will also
                                                                                                                                not take action against
                                                                                                                                MA organizations that
                                                                                                                                have a policy of deemed
                                                                                                                                continued eligibility
                                                                                                                                and choose to delay to a
                                                                                                                                later date the
                                                                                                                                involuntary
                                                                                                                                disenrollment of
                                                                                                                                enrollees who fail to
                                                                                                                                regain special needs
                                                                                                                                status during the period
                                                                                                                                of deemed continued
                                                                                                                                eligibility (see Sec.
                                                                                                                                422.52(d)) due to the
                                                                                                                                COVID-19 national
                                                                                                                                emergency. CMS will not
                                                                                                                                enforce the requirement
                                                                                                                                for mandatory
                                                                                                                                disenrollment at Sec.
                                                                                                                                422.74(b)(2)(iv) and
                                                                                                                                will allow MA
                                                                                                                                organizations to extend
                                                                                                                                the period of deemed
                                                                                                                                continued eligibility
                                                                                                                                under Sec.   422.52(d)
                                                                                                                                during 2020. Individuals
                                                                                                                                who do not regain
                                                                                                                                eligibility must be
                                                                                                                                disenrolled the later of
                                                                                                                                January 1, 2021, or upon
                                                                                                                                expiration of the usual
                                                                                                                                period of deemed
                                                                                                                                continued eligibility
                                                                                                                                that begins the first of
                                                                                                                                the month following the
                                                                                                                                month in which
                                                                                                                                information regarding
                                                                                                                                the loss is available to
                                                                                                                                the MA organization and
                                                                                                                                communicated to the
                                                                                                                                enrollee, including
                                                                                                                                cases of retroactive
                                                                                                                                Medicaid terminations.
                                                                                                                               SNPs are not required
                                                                                                                                under existing
                                                                                                                                regulations to have a
                                                                                                                                policy of deemed
                                                                                                                                continued eligibility;
                                                                                                                                however, plans must
                                                                                                                                apply the same policy
                                                                                                                                consistently for all
                                                                                                                                enrollees of the
                                                                                                                                applicable SNP. For
                                                                                                                                those SNPs that have
                                                                                                                                elected not to have a
                                                                                                                                policy of deemed
                                                                                                                                continued eligibility,
                                                                                                                                CMS encourages the SNP
                                                                                                                                to consider establishing
                                                                                                                                one. For those plans
                                                                                                                                that have a policy of
                                                                                                                                deemed continued
                                                                                                                                eligibility for a period
                                                                                                                                of less than 6 months,
                                                                                                                                CMS encourages the SNP
                                                                                                                                to increase this to 6
                                                                                                                                months. SNPs may make
                                                                                                                                these types of changes
                                                                                                                                mid-year as long as the
                                                                                                                                change is applied to
                                                                                                                                everyone in the plan and
                                                                                                                                the plan notifies its
                                                                                                                                CMS account manager.
285...............  HHS...............  CMS...............  Guidance.............  ....................  Prior Authorization.  Consistent with
                                                                                                                                flexibilities available
                                                                                                                                to Medicare Advantage
                                                                                                                                Organizations absent a
                                                                                                                                disaster, declaration of
                                                                                                                                a state of emergency, or
                                                                                                                                public health emergency,
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations may choose
                                                                                                                                to waive or relax plan
                                                                                                                                prior authorization
                                                                                                                                requirements at any time
                                                                                                                                in order to facilitate
                                                                                                                                access to services with
                                                                                                                                less burden on
                                                                                                                                beneficiaries, plans,
                                                                                                                                and providers. Any such
                                                                                                                                relaxation or waiver
                                                                                                                                must be uniformly
                                                                                                                                provided to similarly
                                                                                                                                situated enrollees who
                                                                                                                                are affected by the
                                                                                                                                disaster or emergency.
                                                                                                                                We encourage plans to
                                                                                                                                consider utilizing this
                                                                                                                                flexibility.
286...............  HHS...............  CMS...............  Guidance.............  ....................  Medicare Advantage    Given both the rapidly
                                                                                                          Organization (MAO)    changing landscape and
                                                                                                          and Part D Sponsors   the need for Part D
                                                                                                          Additional            sponsors to act quickly
                                                                                                          Flexibilities.        to ensure enrollee and
                                                                                                                                employee safety during
                                                                                                                                this pandemic, we
                                                                                                                                encourage Part D
                                                                                                                                sponsors to take the
                                                                                                                                actions you deem
                                                                                                                                reasonable and necessary
                                                                                                                                to keep your enrollees
                                                                                                                                and employees safe and
                                                                                                                                curb the spread of this
                                                                                                                                virus, while still
                                                                                                                                ensuring beneficiary
                                                                                                                                access to needed Part D
                                                                                                                                drugs (example actions
                                                                                                                                listed below). CMS fully
                                                                                                                                supports plans taking
                                                                                                                                actions to accommodate
                                                                                                                                the efforts to promote
                                                                                                                                social distancing. We
                                                                                                                                recognize that there may
                                                                                                                                be circumstances where a
                                                                                                                                Part D sponsor may need
                                                                                                                                to implement strategies
                                                                                                                                or actions they deem
                                                                                                                                reasonable and
                                                                                                                                necessary, but which do
                                                                                                                                not fully comply with
                                                                                                                                program requirements, in
                                                                                                                                order to provide
                                                                                                                                qualified prescription
                                                                                                                                drug coverage to
                                                                                                                                enrollees while ensuring
                                                                                                                                their enrollees and
                                                                                                                                employees are also
                                                                                                                                protected from the
                                                                                                                                spread of COVID-19. CMS
                                                                                                                                will consider the
                                                                                                                                special circumstances
                                                                                                                                presented by the COVID-
                                                                                                                                19 outbreak when
                                                                                                                                conducting monitoring or
                                                                                                                                oversight activities.
287...............  HHS...............  CMS...............  Guidance.............  ....................  Reimbursements for    Consistent with Sec.
                                                                                                          Enrollees for         423.124(a) of the Part D
                                                                                                          Prescriptions         regulations, Part D
                                                                                                          Obtained from Out-    sponsors must ensure
                                                                                                          of-Network            enrollees have adequate
                                                                                                          Pharmacies.           access to covered Part D
                                                                                                                                drugs dispensed at out-
                                                                                                                                of-network pharmacies
                                                                                                                                when those enrollees
                                                                                                                                cannot reasonably be
                                                                                                                                expected to obtain
                                                                                                                                covered Part D drugs at
                                                                                                                                a network pharmacy.
                                                                                                                                Enrollees remain
                                                                                                                                responsible for any cost
                                                                                                                                sharing under their plan
                                                                                                                                and additional charges
                                                                                                                                (i.e., the out-of-
                                                                                                                                network pharmacy's usual
                                                                                                                                and customary charge),
                                                                                                                                if any, that exceed the
                                                                                                                                plan allowance.
288...............  HHS...............  CMS...............  Guidance.............  ....................  Prior Authorization   As is the case for
                                                                                                          for Part D Drugs.     Medicare Advantage
                                                                                                                                Organizations,
                                                                                                                                consistent with
                                                                                                                                flexibilities available
                                                                                                                                to Part D Sponsors
                                                                                                                                absent a disaster or
                                                                                                                                emergency, Part D
                                                                                                                                Sponsors may choose to
                                                                                                                                waive prior
                                                                                                                                authorization
                                                                                                                                requirements at any time
                                                                                                                                that they otherwise
                                                                                                                                would apply to Part D
                                                                                                                                drugs used to treat or
                                                                                                                                prevent COVID-19, if or
                                                                                                                                when such drugs are
                                                                                                                                identified. Sponsors can
                                                                                                                                also choose to waive or
                                                                                                                                relax PA requirements at
                                                                                                                                any time for other
                                                                                                                                formulary drugs in order
                                                                                                                                to facilitate access
                                                                                                                                with less burden on
                                                                                                                                beneficiaries, plans,
                                                                                                                                and providers. Any such
                                                                                                                                waiver must be uniformly
                                                                                                                                provided to similarly
                                                                                                                                situated enrollees who
                                                                                                                                are affected by the
                                                                                                                                disaster or emergency.
                                                                                                                                We encourage plans to
                                                                                                                                consider utilizing this
                                                                                                                                flexibility.
289...............  HHS...............  CMS...............  Guidance.............  ....................  Drug Shortages......  Part D plan sponsors
                                                                                                                                should follow the
                                                                                                                                existing drug shortage
                                                                                                                                guidance in Section
                                                                                                                                50.13 of Chapter 5 of
                                                                                                                                the Prescription Drug
                                                                                                                                Benefit Manual in
                                                                                                                                response to any
                                                                                                                                shortages that result
                                                                                                                                from this emergency.

[[Page 75763]]

 
290...............  HHS...............  CMS...............  Guidance.............  ....................  Involuntary           To ensure that Medicare
                                                                                                          Disenrollment--MA     Advantage and Part D
                                                                                                          and Part D Premium    beneficiaries continue
                                                                                                          and Grace Period      to have access to needed
                                                                                                          Flexibilities.        care during the COVID-19
                                                                                                                                national emergency, CMS
                                                                                                                                would like to remind
                                                                                                                                plans of their ability
                                                                                                                                to apply flexible
                                                                                                                                policies to members who
                                                                                                                                are unable to pay plan
                                                                                                                                premiums. Plans are not
                                                                                                                                required under existing
                                                                                                                                regulations to disenroll
                                                                                                                                members due to failure
                                                                                                                                to pay plan premiums;
                                                                                                                                however, plans must
                                                                                                                                apply the same policy
                                                                                                                                consistently for all
                                                                                                                                enrollees of the
                                                                                                                                applicable plan. For
                                                                                                                                those plans that have
                                                                                                                                elected a policy to
                                                                                                                                disenroll for non-
                                                                                                                                payment of premium, we
                                                                                                                                encourage you to
                                                                                                                                consider changing the
                                                                                                                                policy so that the plan
                                                                                                                                would not disenroll
                                                                                                                                members for non-payment
                                                                                                                                of premium. If a plan
                                                                                                                                chooses not to eliminate
                                                                                                                                its disenrollment
                                                                                                                                policy, we encourage the
                                                                                                                                plan to increase the
                                                                                                                                mandatory grace period
                                                                                                                                (at least two months) to
                                                                                                                                a longer period of time.
                                                                                                                                Plans may make these
                                                                                                                                types of changes mid-
                                                                                                                                year as long as the
                                                                                                                                change is applied to
                                                                                                                                everyone in the plan and
                                                                                                                                the plan notifies its
                                                                                                                                CMS account manager.
                                                                                                                                Detailed information
                                                                                                                                regarding disenrollment
                                                                                                                                and non-payment of
                                                                                                                                premiums requirements
                                                                                                                                are at Sec.
                                                                                                                                422.74(b)(1)(i) and
                                                                                                                                section 50.3.1 of
                                                                                                                                Chapter 2 of the
                                                                                                                                Medicare Managed Care
                                                                                                                                Manual for MA and at
                                                                                                                                Sec.   423.44(b)(1)(i)
                                                                                                                                and section 50.3.1 of
                                                                                                                                Chapter 3 of the
                                                                                                                                Medicare Prescription
                                                                                                                                Drug Benefit Manual for
                                                                                                                                Part D.
291...............  HHS...............  CMS...............  Guidance.............  ....................  MA and Part D Plan    MAOs may waive or reduce
                                                                                                          Flexibility to        enrollee cost-sharing
                                                                                                          Waive Cost Sharing    for beneficiaries
                                                                                                          and to Provide        enrolled in their
                                                                                                          Expanded Telehealth   Medicare Advantage plans
                                                                                                          Benefits.             impacted by the
                                                                                                                                outbreak. For example,
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations may waive
                                                                                                                                or reduce enrollee cost-
                                                                                                                                sharing for COVID-19
                                                                                                                                treatment, telehealth
                                                                                                                                benefits or other
                                                                                                                                services to address the
                                                                                                                                outbreak provided that
                                                                                                                                Medicare Advantage
                                                                                                                                Organizations waive or
                                                                                                                                reduce cost-sharing for
                                                                                                                                all similarly situated
                                                                                                                                plan enrollees on a
                                                                                                                                uniform basis. CMS
                                                                                                                                clarifies that this
                                                                                                                                flexibility is limited
                                                                                                                                to when a waiver or
                                                                                                                                reduction in cost-
                                                                                                                                sharing can be tied to
                                                                                                                                the COVID-19 outbreak.
                                                                                                                                CMS consulted with the
                                                                                                                                HHS Office of Inspector
                                                                                                                                General (OIG) and HHS
                                                                                                                                OIG advised that should
                                                                                                                                an Medicare Advantage
                                                                                                                                Organization choose to
                                                                                                                                voluntarily waive or
                                                                                                                                reduce enrollee cost-
                                                                                                                                sharing, as approved by
                                                                                                                                CMS herein, such waivers
                                                                                                                                or reductions would
                                                                                                                                satisfy the safe harbor
                                                                                                                                to the Federal anti-
                                                                                                                                kickback statute set
                                                                                                                                forth at 42 CFR
                                                                                                                                1001.952(l).
292...............  HHS...............  CMS...............  Guidance.............  ....................  Coverage of Testing   Under Section 6003 of the
                                                                                                          and Testing-Related   Families First
                                                                                                          Services for COVID-   Coronavirus Response Act
                                                                                                          19.                   and Section 3713 of the
                                                                                                                                CARES Act, MAOs must not
                                                                                                                                charge cost sharing
                                                                                                                                (including deductibles,
                                                                                                                                copayments, and
                                                                                                                                coinsurance) for:
                                                                                                                                   Clinical
                                                                                                                                   laboratory tests for
                                                                                                                                   the detection of SARS-
                                                                                                                                   CoV-2 or the
                                                                                                                                   diagnosis of the
                                                                                                                                   virus that causes
                                                                                                                                   COVID-19 and the
                                                                                                                                   administration of
                                                                                                                                   such tests;
                                                                                                                                   specified
                                                                                                                                   COVID-19 testing-
                                                                                                                                   related services (as
                                                                                                                                   described in section
                                                                                                                                   1833(cc)(1)) for
                                                                                                                                   which payment would
                                                                                                                                   be payable under a
                                                                                                                                   specified outpatient
                                                                                                                                   payment provision
                                                                                                                                   described in section
                                                                                                                                   1833(cc)(2); and
                                                                                                                                   COVID-19
                                                                                                                                   vaccines and the
                                                                                                                                   administration of
                                                                                                                                   such vaccines, as
                                                                                                                                   described in section
                                                                                                                                   1861(s)(10)(A).
                                                                                                                               The limit on cost sharing
                                                                                                                                (including deductibles,
                                                                                                                                copayments, and
                                                                                                                                coinsurance) for COVID-
                                                                                                                                19 testing and specified
                                                                                                                                testing-related services
                                                                                                                                applies to services
                                                                                                                                furnished on or after
                                                                                                                                March 18, 2020, and
                                                                                                                                during the emergency
                                                                                                                                period identified in
                                                                                                                                section 1135(g)(1)(B) of
                                                                                                                                the Act (that is, the
                                                                                                                                public health emergency
                                                                                                                                declared by the
                                                                                                                                Secretary pursuant to
                                                                                                                                section 319 of the
                                                                                                                                Public Health Service
                                                                                                                                Act on January 31, 2020,
                                                                                                                                entitled ``Determination
                                                                                                                                that a Public Health
                                                                                                                                Emergency Exists
                                                                                                                                Nationwide as the Result
                                                                                                                                of the 2019 Novel
                                                                                                                                Coronavirus,'' and any
                                                                                                                                extensions thereof)
                                                                                                                                (``applicable emergency
                                                                                                                                period''). In addition,
                                                                                                                                MAOs may not impose any
                                                                                                                                prior authorization or
                                                                                                                                other utilization
                                                                                                                                management requirements
                                                                                                                                with respect to the
                                                                                                                                coverage of these
                                                                                                                                services when those
                                                                                                                                items or services are
                                                                                                                                furnished on or after
                                                                                                                                March 18, 2020, and
                                                                                                                                during the applicable
                                                                                                                                emergency period.
293...............  HHS...............  CMS...............  Waiver...............  ....................  In-Service Training.  Modifying the nurse aide
                                                                                                                                training requirements at
                                                                                                                                Sec.   483.95(g)(1) for
                                                                                                                                SNFs and NFs, which
                                                                                                                                requires the nursing
                                                                                                                                assistant to receive at
                                                                                                                                least 12 hours of in-
                                                                                                                                service training
                                                                                                                                annually.
294...............  HHS...............  CMS...............  Waiver...............  ....................  12-hour Annual In-    Modifying the requirement
                                                                                                          service Training      at 42 CFR 484.80(d) that
                                                                                                          Requirement for       home health agencies
                                                                                                          Home Health Aides.    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.
295...............  HHS...............  CMS...............  Waiver...............  ....................  Annual Training for   Modifying the requirement
                                                                                                          Hospice Aides.        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.

[[Page 75764]]

 
296...............  HHS...............  CMS...............  Waiver...............  ....................  Training and          Waiving the requirement
                                                                                                          Assessment of HHA     at 42 CFR 418.76(h)(2)
                                                                                                          and Hospice Aides.    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
                                                                                                                                (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.
297...............  HHS...............  CMS...............  Guidance.............  N/A.................  Repetitive Scheduled  Effective March 29, 2020,
                                                                                                          Non-Emergent          certain claims
                                                                                                          Ambulance Transport   processing requirements
                                                                                                          Claims Processing     for the Repetitive,
                                                                                                          Requirements.         Scheduled Non-Emergent
                                                                                                                                Ambulance Transport
                                                                                                                                Prior Authorization
                                                                                                                                Model will be paused in
                                                                                                                                the model states of
                                                                                                                                Delaware, the District
                                                                                                                                of Columbia, Maryland,
                                                                                                                                New Jersey, North
                                                                                                                                Carolina, Pennsylvania,
                                                                                                                                South Carolina,
                                                                                                                                Virginia, and West
                                                                                                                                Virginia until the PHE
                                                                                                                                for the COVID-19
                                                                                                                                pandemic has ended.
                                                                                                                                During the pause, claims
                                                                                                                                for repetitive,
                                                                                                                                scheduled non-emergent
                                                                                                                                ambulance transports
                                                                                                                                submitted on or after
                                                                                                                                March 29, 2020, and
                                                                                                                                before the end of the
                                                                                                                                PHE for the COVID-19
                                                                                                                                pandemic in these states
                                                                                                                                will not be stopped for
                                                                                                                                pre-payment review if
                                                                                                                                prior authorization has
                                                                                                                                not been requested by
                                                                                                                                the fourth round trip in
                                                                                                                                a 30-day period. During
                                                                                                                                the pause, the MAC will
                                                                                                                                continue to review any
                                                                                                                                prior authorization
                                                                                                                                requests that have
                                                                                                                                already been submitted,
                                                                                                                                and ambulance suppliers
                                                                                                                                may continue to submit
                                                                                                                                new prior authorization
                                                                                                                                requests for review
                                                                                                                                during the pause.
298...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Temporarily relax     Allows states to apply
                                                                                                          provider enrollment   for the ability to:
                                                                                                          requirements.         Waive payment of
                                                                                                                                application fee to
                                                                                                                                temporarily enroll a
                                                                                                                                provider. Waive criminal
                                                                                                                                background checks
                                                                                                                                associated with
                                                                                                                                temporarily enrolling
                                                                                                                                providers. Waive site
                                                                                                                                visits to temporarily
                                                                                                                                enroll a provider.
                                                                                                                                Permit providers located
                                                                                                                                out-of-state/territory
                                                                                                                                to provide care to an
                                                                                                                                emergency State's
                                                                                                                                Medicaid enrollee and be
                                                                                                                                reimbursed for that
                                                                                                                                service. Streamline
                                                                                                                                provider enrollment
                                                                                                                                requirements when
                                                                                                                                enrolling providers.
                                                                                                                                Postpone deadlines for
                                                                                                                                revalidation of
                                                                                                                                providers who are
                                                                                                                                located in the state or
                                                                                                                                otherwise directly
                                                                                                                                impacted by the
                                                                                                                                emergency. Waive
                                                                                                                                requirements that
                                                                                                                                physicians and other
                                                                                                                                health care
                                                                                                                                professionals be
                                                                                                                                licensed in the state in
                                                                                                                                which they are providing
                                                                                                                                services, so long as
                                                                                                                                they have equivalent
                                                                                                                                licensing in another
                                                                                                                                state. Waive conditions
                                                                                                                                of participation or
                                                                                                                                conditions for coverage
                                                                                                                                for existing providers
                                                                                                                                for facilities for
                                                                                                                                providing services in
                                                                                                                                alternative settings,
                                                                                                                                including using an
                                                                                                                                unlicensed facility, if
                                                                                                                                the provider's licensed
                                                                                                                                facility has been
                                                                                                                                evacuated.
299...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Suspend PASRR         Suspend PASRR Level I and
                                                                                                          Assessments.          Level II Assessments for
                                                                                                                                30 Days.
300...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Extend Fair Hearing   Allow managed care
                                                                                                          Requests and Appeal   enrollees to proceed
                                                                                                          Timelines.            almost immediately to a
                                                                                                                                state fair hearing
                                                                                                                                without having a managed
                                                                                                                                care plan resolve the
                                                                                                                                appeal first by
                                                                                                                                permitting the state to
                                                                                                                                modify the timeline for
                                                                                                                                managed care plans to
                                                                                                                                resolve appeals to one
                                                                                                                                day so the impacted
                                                                                                                                appeals satisfy the
                                                                                                                                exhaustion requirements.
                                                                                                                                Give enrollees more than
                                                                                                                                120 days (if a managed
                                                                                                                                care appeal) or more
                                                                                                                                than 90 days (if an
                                                                                                                                eligibility for fee-for-
                                                                                                                                service appeal) to
                                                                                                                                request a state fair
                                                                                                                                hearing by permitting
                                                                                                                                extensions of the
                                                                                                                                deadline for filing
                                                                                                                                those appeals by a set
                                                                                                                                number of days (e.g., an
                                                                                                                                additional 120 days).
301...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Temporarily Suspend   Suspend Medicaid fee-for-
                                                                                                          Medicaid FFS Prior    service prior
                                                                                                          Authorization         authorization
                                                                                                          Requirements.         requirements. Section
                                                                                                                                1135(b)(1)(C) allows for
                                                                                                                                a waiver or modification
                                                                                                                                of pre-approval
                                                                                                                                requirements if prior
                                                                                                                                authorization processes
                                                                                                                                are outlined in detail
                                                                                                                                in the State Plan for
                                                                                                                                particular.
302...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Permit Provision of   Waive conditions of
                                                                                                          Services in           participation or
                                                                                                          Alternative           conditions for coverage
                                                                                                          Settings.             for existing providers
                                                                                                                                for facilities for
                                                                                                                                providing services in
                                                                                                                                alternative settings,
                                                                                                                                including using an
                                                                                                                                unlicensed facility, if
                                                                                                                                the provider's licensed
                                                                                                                                facility has been
                                                                                                                                evacuated.
303...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Extend Pre-Existing   Require fee-for-service
                                                                                                          Prior                 providers to extend pre-
                                                                                                          Authorizations        existing authorizations
                                                                                                          through PHE.          through which a
                                                                                                                                beneficiary has
                                                                                                                                previously received
                                                                                                                                prior authorization
                                                                                                                                through the termination
                                                                                                                                of the emergency
                                                                                                                                declaration.
304...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Submission            Grant Flexibility on SPA
                                                                                                          Flexibilities.        Submission Deadline,
                                                                                                                                Public Notice and Tribal
                                                                                                                                Consultation.
305...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  HCBS Flexibilities..  Temporarily Allow
                                                                                                                                Beneficiaries to
                                                                                                                                Relocate to Settings Not
                                                                                                                                Meeting HCBS Settings
                                                                                                                                Requirements.
                                                                                                                                Temporarily Eliminate
                                                                                                                                Requirement to Obtain
                                                                                                                                Signatures on HCBS
                                                                                                                                Person-Centered Service
                                                                                                                                Plans.
306...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Conflict of Interest  Waive Conflict of
                                                                                                          Requirements.         Interest Requirements
                                                                                                                                for Case Management.
307...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Provide Additional    Allows states to add home
                                                                                                          Benefits and          delivered meals and
                                                                                                          services.             other services including
                                                                                                                                medical equipment and
                                                                                                                                supplies to their
                                                                                                                                Medicaid program.
308...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Modify Licensure or
                                                                                                          Other Requirements
                                                                                                          for Wavier Services
                                                                                                          Settings
309...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Exceed Service        Suspend Medicaid fee-for-
                                                                                                          Limitations or        service prior
                                                                                                          Requirements for      authorization
                                                                                                          Amount, Duration      requirements.
                                                                                                          and Prior
                                                                                                          Authorization.
                                                                                                                               Section 1135(b)(1)(C)
                                                                                                                                allows for a waiver or
                                                                                                                                modification of pre-
                                                                                                                                approval requirements if
                                                                                                                                prior authorization
                                                                                                                                processes are outlined
                                                                                                                                in detail in the State
                                                                                                                                Plan for particular
                                                                                                                                benefits. Require fee-
                                                                                                                                for-service providers to
                                                                                                                                extend pre-existing
                                                                                                                                authorizations through
                                                                                                                                which a beneficiary has
                                                                                                                                previously received
                                                                                                                                prior authorization
                                                                                                                                through the termination
                                                                                                                                of the emergency
                                                                                                                                declaration.

[[Page 75765]]

 
310...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Opportunities for     This allows states to
                                                                                                          Self Direction.       temporarily add or
                                                                                                                                expand requirements for
                                                                                                                                Medicaid self-direction
                                                                                                                                during the PHE.
311...............  HHS...............  CMS...............  Section 1135 Waiver..  N/A.................  Increase the Cost     Temporarily Increase the
                                                                                                          Limits.               Cost Limits for Entry
                                                                                                                                into the Waiver.
312...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Waive Visitors        Not comply with the HCBS
                                                             Waiver.                                      Settings              settings requirement at
                                                                                                          Requirements.         42 CFR
                                                                                                                                441.301(c)(4)(vi)(D)
                                                                                                                                that individuals are
                                                                                                                                able to have visitors of
                                                                                                                                their choosing at any
                                                                                                                                time, for settings added
                                                                                                                                after March 17, 2014, to
                                                                                                                                minimize the spread of
                                                                                                                                infection during the
                                                                                                                                COVID-19 pandemic.
313...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Reassessment    Allow an extension for
                                                             Waiver.                                      and Reevaluation      reassessments and
                                                                                                          Extensions.           reevaluations for up to
                                                                                                                                one year past the due
                                                                                                                                date.
314...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Add Electronic        Add an electronic method
                                                             Waiver.                                      Service Delivery.     of service delivery
                                                                                                                                (e.g., telephonic)
                                                                                                                                allowing services to
                                                                                                                                continue to be provided
                                                                                                                                remotely in the home
                                                                                                                                setting for: Case
                                                                                                                                management; Personal
                                                                                                                                care services that only
                                                                                                                                require verbal cueing;
                                                                                                                                In-home habilitation;
                                                                                                                                Monthly monitoring
                                                                                                                                (i.e., in order to meet
                                                                                                                                the reasonable
                                                                                                                                indication of need for
                                                                                                                                services requirement in
                                                                                                                                1915(c) waivers); Other
                                                                                                                                [as described]:
315...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Virtual/Remote  Allow the option to
                                                             Waiver.                                      Evaluations,          conduct evaluations,
                                                                                                          Assessments and       assessments, and person-
                                                                                                          Person-Centered       centered service
                                                                                                          Services Planning.    planning meetings
                                                                                                                                virtually/remotely in
                                                                                                                                lieu of face-to-face
                                                                                                                                meetings.
316...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Add Electronic        Add an electronic method
                                                             Waiver.                                      Method for Signing    of signing off on
                                                                                                          Required Documents.   required documents such
                                                                                                                                as the person-centered
                                                                                                                                service plan.
317...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Spouses and     Allow spouses and parents
                                                             Waiver.                                      Parents of Minor      of minor children to
                                                                                                          Children to Provide   provide personal care
                                                                                                          Services.             services.
318...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Family Member   Allow a family member to
                                                             Waiver.                                      to Provide Services.  be paid to render
                                                                                                                                services to an
                                                                                                                                individual.
319...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Modify Providers of   Modify service providers
                                                             Waiver.                                      Home-Delivered        for home-delivered meals
                                                                                                          Meals.                to allow for additional
                                                                                                                                providers, including non-
                                                                                                                                traditional providers.
320...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Other           Allows states to apply
                                                             Waiver.                                      Practitioners to      for flexibilities like
                                                                                                          Provide Services.     the ability to Allow
                                                                                                                                Other Practitioners to
                                                                                                                                Provide Services and
                                                                                                                                Allow other
                                                                                                                                practitioners in lieu of
                                                                                                                                approved providers
                                                                                                                                within the waiver.
321...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Waive Conflict of     Case management entity
                                                             Waiver.                                      Interest              qualifies under 42 CFR
                                                                                                          Requirements for      441.301(c)(1)(vi) as the
                                                                                                          Case Management.      only willing and
                                                                                                                                qualified entity.
322...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Modify Services.....  Allows for states to
                                                             Waiver.                                                            apply to provide
                                                                                                                                additional services such
                                                                                                                                as: Home-delivered
                                                                                                                                meals, medical supplies,
                                                                                                                                equipment and appliances
                                                                                                                                (over and above that
                                                                                                                                which is in the state
                                                                                                                                plan), and assistive
                                                                                                                                technology.
323...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Retainer        Temporarily include
                                                             Waiver.                                      Payments.             retainer payments to
                                                                                                                                address emergency
                                                                                                                                related issues. States
                                                                                                                                must describe the
                                                                                                                                circumstances under
                                                                                                                                which such payments are
                                                                                                                                authorized and
                                                                                                                                applicable limits on
                                                                                                                                their duration. Retainer
                                                                                                                                payments are available
                                                                                                                                for habilitation and
                                                                                                                                personal care only.]
324...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Changes to            Postponing 372 Reporting
                                                             Waiver.                                      Participant           Requirements.
                                                                                                          Safeguards.           Temporarily modify
                                                                                                                                incident reporting
                                                                                                                                requirements, medication
                                                                                                                                management or other
                                                                                                                                participant safeguards
                                                                                                                                to ensure individual
                                                                                                                                health and welfare, and
                                                                                                                                to account for emergency
                                                                                                                                circumstances.
325...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Modify Person-        Temporarily modify person-
                                                             Waiver.                                      Centered Planning     centered service plan
                                                                                                          Requirements.         development process and
                                                                                                                                individual(s)
                                                                                                                                responsible for person-
                                                                                                                                centered service plan
                                                                                                                                development, including
                                                                                                                                qualifications.
                                                                                                                               States must describe any
                                                                                                                                modifications including
                                                                                                                                qualifications of
                                                                                                                                individuals responsible
                                                                                                                                for service plan
                                                                                                                                development, and address
                                                                                                                                Participant Safeguards.
                                                                                                                                Also include strategies
                                                                                                                                to ensure that services
                                                                                                                                are received as
                                                                                                                                authorized.
326...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Payment in      Temporarily allow for
                                                             Waiver.                                      Institutional         payment for services for
                                                                                                          Settings.             the purpose of
                                                                                                                                supporting waiver
                                                                                                                                participants in an acute
                                                                                                                                care hospital or short-
                                                                                                                                term institutional stay
                                                                                                                                when necessary supports
                                                                                                                                (including communication
                                                                                                                                and intensive personal
                                                                                                                                care) are not available
                                                                                                                                in that setting, or when
                                                                                                                                the individual requires
                                                                                                                                those services for
                                                                                                                                communication and
                                                                                                                                behavioral
                                                                                                                                stabilization, and such
                                                                                                                                services are not covered
                                                                                                                                in such settings.
327...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Allow Virtual LOC     Temporarily modify
                                                             Waiver.                                      Determinations.       processes for level of
                                                                                                                                care evaluations or re-
                                                                                                                                evaluations (within
                                                                                                                                regulatory
                                                                                                                                requirements).
328...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Increase or Modify    Temporarily increase
                                                             Waiver.                                      Payments Rates.       payment rates. States
                                                                                                                                provide an explanation
                                                                                                                                for the increase; List
                                                                                                                                the provider types,
                                                                                                                                rates by service, and
                                                                                                                                specify whether this
                                                                                                                                change is based on a
                                                                                                                                rate development method
                                                                                                                                that is different from
                                                                                                                                the current approved
                                                                                                                                waiver. If the rate
                                                                                                                                varies by provider, they
                                                                                                                                list the rate by service
                                                                                                                                and by provider.]
329...............  HHS...............  CMS...............  HCBS Appendix K        N/A.................  Extend Dates for LOC  Temporarily modify
                                                             Waiver.                                      Determinations.       processes for level of
                                                                                                                                care evaluations or re-
                                                                                                                                evaluations (within
                                                                                                                                regulatory requirements.
330...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Adopt Optional COVID- Furnishes medical
                                                             Relief SPA.                                  19 Testing Group.     assistance to the new
                                                                                                                                optional group described
                                                                                                                                at section
                                                                                                                                1902(a)(10)(A)(ii)(XXIII
                                                                                                                                ) and 1902(ss) of the
                                                                                                                                Act providing coverage
                                                                                                                                for uninsured
                                                                                                                                individuals.
331...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Establish Residency   Considers individuals who
                                                             Relief SPA.                                  for Individuals       are evacuated from the
                                                                                                          Temporarily Out of    state, who leave the
                                                                                                          State Due to a        state for medical
                                                                                                          Disaster.             reasons related to the
                                                                                                                                disaster or public
                                                                                                                                health emergency, or who
                                                                                                                                are otherwise absent
                                                                                                                                from the state due to
                                                                                                                                the disaster or public
                                                                                                                                health emergency and who
                                                                                                                                intend to return to the
                                                                                                                                state, to continue to be
                                                                                                                                residents of the state
                                                                                                                                under 42 CFR
                                                                                                                                435.403(j)(3).
332...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Extend PE to non-     Allow hospitals to make
                                                             Relief SPA.                                  MAGI Populations.     presumptive eligibility
                                                                                                                                determinations for the
                                                                                                                                following additional
                                                                                                                                state plan populations,
                                                                                                                                or for populations in an
                                                                                                                                approved section 1115
                                                                                                                                demonstration, in
                                                                                                                                accordance with section
                                                                                                                                1902(a)(47)(B) of the
                                                                                                                                Act and 42 CFR 435.1110,
                                                                                                                                provided that the agency
                                                                                                                                has determined that the
                                                                                                                                hospital is capable of
                                                                                                                                making such
                                                                                                                                determinations.

[[Page 75766]]

 
333...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Extend the ROP for    Provides for an extension
                                                             Relief SPA.                                  good faith effort.    of the reasonable
                                                                                                                                opportunity period for
                                                                                                                                non-citizens declaring
                                                                                                                                to be in a satisfactory
                                                                                                                                immigration status, if
                                                                                                                                the non-citizen is
                                                                                                                                making a good faith
                                                                                                                                effort to resolve any
                                                                                                                                inconsistences or obtain
                                                                                                                                any necessary
                                                                                                                                documentation, or the
                                                                                                                                agency is unable to
                                                                                                                                complete the
                                                                                                                                verification process
                                                                                                                                within the 90-day
                                                                                                                                reasonable opportunity
                                                                                                                                period due to the
                                                                                                                                disaster or public
                                                                                                                                health emergency.
334...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Establish Income and  Agency applies less
                                                             Relief SPA.                                  Resource Disregards   restrictive financial
                                                                                                          for non-MAGI          methodologies to
                                                                                                          Eligibility Groups.   individuals excepted
                                                                                                                                from financial
                                                                                                                                methodologies based on
                                                                                                                                modified adjusted gross
                                                                                                                                income (MAGI).
335...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Designate Other       Agency designates itself
                                                             Relief SPA.                                  Entities as a         as a qualified entity
                                                                                                          Qualified Entity      for purposes of making
                                                                                                          for PE.               presumptive eligibility
                                                                                                                                determinations described
                                                                                                                                below in accordance with
                                                                                                                                sections 1920, 1920A,
                                                                                                                                1920B, and 1920C of the
                                                                                                                                Act and 42 CFR part 435
                                                                                                                                Subpart L. Also allow
                                                                                                                                the agency to designate
                                                                                                                                the following entities
                                                                                                                                as qualified entities
                                                                                                                                for purposes of making
                                                                                                                                presumptive eligibility
                                                                                                                                determinations or adds
                                                                                                                                additional populations
                                                                                                                                as described below in
                                                                                                                                accordance with sections
                                                                                                                                1920, 1920A, 1920B, and
                                                                                                                                1920C of the Act and 42
                                                                                                                                CFR part 435 Subpart L.
336...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Adopt Continuous      Agency adopts continuous
                                                             Relief SPA.                                  Eligibility for       eligibility for children
                                                                                                          Children.             regardless of changes in
                                                                                                                                circumstances in
                                                                                                                                accordance with section
                                                                                                                                1902(e)(12) of the Act
                                                                                                                                and 42 CFR 435.926.
337...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Extend Residency to   Agency provides Medicaid
                                                             Relief SPA.                                  Individuals who May   coverage to the
                                                                                                          be Considered         following individuals
                                                                                                          Residents of Other    living in the state, who
                                                                                                          States.               are non-residents.
338...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Extend the            Agency conducts
                                                             Relief SPA.                                  Redetermination       redeterminations of
                                                                                                          Period for Non-MAGI   eligibility for
                                                                                                          Populations.          individuals excepted
                                                                                                                                from MAGI-based
                                                                                                                                financial methodologies
                                                                                                                                under 42 CFR 435.603(j)
                                                                                                                                less frequently (but at
                                                                                                                                least once every 12
                                                                                                                                months) in accordance
                                                                                                                                with 42 CFR 435.916(b).
339...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Suspend Deductibles,  Agency suspends
                                                             Relief SPA.                                  Copayments,           deductibles, copayments,
                                                                                                          Coinsurance and       coinsurance, and other
                                                                                                          other Cost Sharing    cost sharing charges.
                                                                                                          Charges.
340...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Suspend Enrollment    Agency suspends
                                                             Relief SPA.                                  Fees, Premiums and    enrollment fees,
                                                                                                          Similar Charges.      premiums and similar
                                                                                                                                charges.
341...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Add a Variance to     State elects a new
                                                             Relief SPA.                                  the Basic PETI        variance to the basic
                                                                                                          Personal Needs        personal needs allowance
                                                                                                          Allowance.            for institutionalized
                                                                                                                                individuals.
342...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Establish an Undue    Agency allows waiver of
                                                             Relief SPA.                                  Hardship Waiver for   payment of the
                                                                                                          Payment of            enrollment fee, premiums
                                                                                                          Enrollment Fees,      and similar charges for
                                                                                                          Premiums and Other    undue hardship.
                                                                                                          Similar Charges.
343...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Adjust Covered        Give state flexibility to
                                                             Relief SPA.                                  Benefits.             adjust or make changes
                                                                                                                                to the covered benefits
                                                                                                                                under their Medicaid
                                                                                                                                program.
344...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Establish Preferred   Agency makes exceptions
                                                             Relief SPA.                                  Drug List             to their published
                                                                                                          Exceptions.           Preferred Drug List if
                                                                                                                                drug shortages occur.
345...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Extend Telehealth     Agency makes changes to
                                                             Relief SPA.                                  Utilization.          telehealth utilization,
                                                                                                                                which may be different
                                                                                                                                than outlined in the
                                                                                                                                state's approved state
                                                                                                                                plan.
346...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Apply New or          Applies new or adjusted
                                                             Relief SPA.                                  Adjusted Benefits     benefits to ABPs.
                                                                                                          to ABPs.
347...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Compliance with       Attest to compliance with
                                                             Relief SPA.                                  Existing              existing benefit
                                                                                                          Requirements for      requirements.
                                                                                                          New and Adjusted
                                                                                                          benefits.
348...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Expand Prior          Prior authorization for
                                                             Relief SPA.                                  Authorization.        medications is expanded
                                                                                                                                by automatic renewal
                                                                                                                                without clinical review,
                                                                                                                                or time/quantity
                                                                                                                                extensions.
349...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Adjust Days' Supply   Agency adjusts day supply
                                                             Relief SPA.                                  or Quantity Limits.   or quantity limit for
                                                                                                                                covered outpatient
                                                                                                                                drugs, if current state
                                                                                                                                plan pages have limits
                                                                                                                                on the amount of
                                                                                                                                medication dispensed.
350...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Add New Optional      Adds optional benefits in
                                                             Relief SPA.                                  Benefits.             its state plan (include
                                                                                                                                service descriptions,
                                                                                                                                provider qualifications,
                                                                                                                                and limitations on
                                                                                                                                amount, duration or
                                                                                                                                scope of the benefit).
351...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Add Temporary         Agency makes payment
                                                             Relief SPA.                                  Supplemental          adjustment to the
                                                                                                          Payment to the        professional dispensing
                                                                                                          Professional          fee when additional
                                                                                                          Dispensing Fee.       costs are incurred by
                                                                                                                                the providers for
                                                                                                                                delivery.
352...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Miscellaneous         Includes supplemental
                                                             Relief SPA.                                  Payment Changes.      payments--Creating new
                                                                                                                                targeted supplemental
                                                                                                                                payments for hospitals,
                                                                                                                                nursing facilities, and
                                                                                                                                other providers types or
                                                                                                                                modifying existing
                                                                                                                                supplemental payments,
                                                                                                                                such as to accelerate
                                                                                                                                the timing of the
                                                                                                                                payments or to allow for
                                                                                                                                additional flexibility
                                                                                                                                in qualification.
353...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Increase Payment      Nursing facility rate
                                                             Relief SPA.                                  Rates for Current     increases or add-ons--
                                                                                                          State Plan Services.  Increases can be per
                                                                                                                                diem dollar increases
                                                                                                                                (ranging from $12 to $40
                                                                                                                                per day) or percentage
                                                                                                                                increases (ranging from
                                                                                                                                4% to 30%). Some
                                                                                                                                increases are across-the-
                                                                                                                                board, while others are
                                                                                                                                targeted to residents
                                                                                                                                diagnosed with COVID-19.
                                                                                                                                Other changes involve
                                                                                                                                temporarily modifying
                                                                                                                                existing rate setting
                                                                                                                                methodologies (such as
                                                                                                                                allowing additional
                                                                                                                                costs to be considered),
                                                                                                                                removing certain payment
                                                                                                                                penalties, and setting
                                                                                                                                payments for isolation
                                                                                                                                centers.
                                                                                                                               Telehealth payment--
                                                                                                                                Removing existing state
                                                                                                                                plan language
                                                                                                                                restricting use of
                                                                                                                                telehealth/telephonic
                                                                                                                                delivery of services and
                                                                                                                                paying for such services
                                                                                                                                at either the same face-
                                                                                                                                to-face state plan rates
                                                                                                                                or alternative rates.
                                                                                                                               Supplemental payments--
                                                                                                                                Creating new targeted
                                                                                                                                supplemental payments
                                                                                                                                for hospitals, nursing
                                                                                                                                facilities, and other
                                                                                                                                providers types or
                                                                                                                                modifying existing
                                                                                                                                supplemental payments,
                                                                                                                                such as to accelerate
                                                                                                                                the timing of the
                                                                                                                                payments or to allow for
                                                                                                                                additional flexibility
                                                                                                                                in qualification.
                                                                                                                               Bed hold days--Increasing
                                                                                                                                the number of inpatient
                                                                                                                                facility bed hold days
                                                                                                                                that the state will pay
                                                                                                                                for or removing the
                                                                                                                                limit altogether,
                                                                                                                                subject to certain
                                                                                                                                conditions, such as
                                                                                                                                state pre-authorization
                                                                                                                                for COVID-19-related
                                                                                                                                leave of absences.
                                                                                                                               Laboratory testing--
                                                                                                                                Adding COVID-19 testing
                                                                                                                                codes to state fee
                                                                                                                                schedules and modifying
                                                                                                                                payments of these codes
                                                                                                                                to 100% of Medicare.

[[Page 75767]]

 
                                                                                                                               Hospital rate increases--
                                                                                                                                Increasing hospital
                                                                                                                                payment rates by a
                                                                                                                                certain percentage,
                                                                                                                                ranging from 5-12%
                                                                                                                                increase for general
                                                                                                                                hospital rates to
                                                                                                                                targeting inpatient
                                                                                                                                stays with COVID-19
                                                                                                                                diagnosis for 20%
                                                                                                                                increase.
                                                                                                                               Various provider rate
                                                                                                                                increases or add-ons--
                                                                                                                                Increasing rates across
                                                                                                                                multiple provider/
                                                                                                                                service types from 5 to
                                                                                                                                15% to providing
                                                                                                                                increases to multiple
                                                                                                                                provider types based on
                                                                                                                                the hours worked by
                                                                                                                                direct care workers,
                                                                                                                                tiered based on the
                                                                                                                                treatment of COVID-19
                                                                                                                                patients.
354...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Payments for          Removing existing state
                                                             Relief SPA.                                  Telehealth Services.  plan language
                                                                                                                                restricting use of
                                                                                                                                telehealth/telephonic
                                                                                                                                delivery of services and
                                                                                                                                paying for such services
                                                                                                                                at either the same face-
                                                                                                                                to-face state plan rates
                                                                                                                                or alternative rates.
355...............  HHS...............  CMS...............  Medicaid Disaster      N/A.................  Establish a Payment   Establish payment
                                                             Relief SPA.                                  Methodology for New   methodology for newly
                                                                                                          Covered Optional      covered benefits.
                                                                                                          Benefits.
356...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Delay Renewal         At State discretion,
                                                             SPA.                                         Processing and        requirements related to
                                                                                                          Deadlines.            timely processing of
                                                                                                                                renewals and/or
                                                                                                                                deadlines for families
                                                                                                                                to respond to renewal
                                                                                                                                requests may be
                                                                                                                                temporarily waived for
                                                                                                                                CHIP beneficiaries who
                                                                                                                                reside and/or work in a
                                                                                                                                State or Federally
                                                                                                                                declared disaster area.
357...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Delay Acting on       At State discretion, the
                                                             SPA.                                         Changes in            waiting period policy
                                                                                                          Circumstance.         will be temporarily
                                                                                                                                suspended for CHIP
                                                                                                                                applicants and current
                                                                                                                                enrollees who reside and/
                                                                                                                                or work in a State or
                                                                                                                                Federally declared
                                                                                                                                disaster area.
358...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Delay Application     At State discretion,
                                                             SPA.                                         Processing.           requirements related to
                                                                                                                                timely processing of
                                                                                                                                applications may be
                                                                                                                                temporarily waived for
                                                                                                                                CHIP applicants who
                                                                                                                                reside and/or work in a
                                                                                                                                State or Federally
                                                                                                                                declared disaster area.
359...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Delay Tribal          To address the COVID-19
                                                             SPA.                                         Consultation.         public health emergency,
                                                                                                                                the State seeks a waiver
                                                                                                                                under section 1135 of
                                                                                                                                the Act to modify the
                                                                                                                                tribal consultation
                                                                                                                                process by shortening
                                                                                                                                the number of days
                                                                                                                                before submission of the
                                                                                                                                SPA and/or conducting
                                                                                                                                consultation after
                                                                                                                                submission of the SPA.
360...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Waive Cost Sharing..  At State discretion, cost
                                                             SPA.                                                               sharing may be
                                                                                                                                temporarily waived for
                                                                                                                                CHIP applicants and/or
                                                                                                                                existing beneficiaries
                                                                                                                                who reside and/or work
                                                                                                                                in a State or Federally
                                                                                                                                declared disaster area.
361...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Waive Premiums/       At State discretion, non-
                                                             SPA.                                         Enrollment Fees.      payment of premium or
                                                                                                                                enrollment fees may be
                                                                                                                                temporarily forgiven/
                                                                                                                                waived for CHIP
                                                                                                                                applicants and/or
                                                                                                                                existing beneficiaries
                                                                                                                                who reside and/or work
                                                                                                                                in a State or Federally
                                                                                                                                declared disaster area.
362...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Waive Premium Lock-   At State discretion, the
                                                             SPA.                                         Out Policy.           premium lock-out policy
                                                                                                                                is temporarily suspended
                                                                                                                                and coverage is
                                                                                                                                available regardless of
                                                                                                                                whether the family has
                                                                                                                                paid their outstanding
                                                                                                                                premium for existing
                                                                                                                                beneficiaries who reside
                                                                                                                                and/or work in a State
                                                                                                                                or Federally declared
                                                                                                                                disaster area.
363...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Extend the ROP for    At State discretion, the
                                                             SPA.                                         Good Faith Effort.    agency may provide for
                                                                                                                                an extension of the
                                                                                                                                reasonable opportunity
                                                                                                                                period for non-citizens
                                                                                                                                declaring to be in a
                                                                                                                                satisfactory immigration
                                                                                                                                status, if the non-
                                                                                                                                citizen is making a good
                                                                                                                                faith effort to resolve
                                                                                                                                any inconsistences or
                                                                                                                                obtain any necessary
                                                                                                                                documentation, or the
                                                                                                                                agency is unable to
                                                                                                                                complete the
                                                                                                                                verification process
                                                                                                                                within the 90-day
                                                                                                                                reasonable opportunity
                                                                                                                                period due to the State
                                                                                                                                or Federally declared
                                                                                                                                disaster or public
                                                                                                                                health emergency.
364...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Institute More        At State discretion, the
                                                             SPA.                                         Frequent PE Periods.  presumptive eligibility
                                                                                                                                period will be extended
                                                                                                                                to (insert State
                                                                                                                                specific timeframe) for
                                                                                                                                CHIP applicants and
                                                                                                                                current enrollees who
                                                                                                                                reside and/or work in a
                                                                                                                                State or Federally
                                                                                                                                declared disaster area.
365...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Extend Premium        At State discretion,
                                                             SPA.                                         Deadlines.            families may temporarily
                                                                                                                                be given additional time
                                                                                                                                to pay their premiums
                                                                                                                                for existing
                                                                                                                                beneficiaries who reside
                                                                                                                                and/or work in a State
                                                                                                                                or Federally declared
                                                                                                                                disaster are a.
366...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Provide 12-Month      At State discretion, it
                                                             SPA.                                         Continuous            may temporarily provide
                                                                                                          Eligibility.          continuous eligibility
                                                                                                                                to CHIP enrollees who
                                                                                                                                reside and/or work in a
                                                                                                                                State or Federally
                                                                                                                                declared disaster area.
367...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Allow Phone Triage    At State discretion, it
                                                             SPA.                                         for Dental Services.  may temporarily use a
                                                                                                                                simplified application
                                                                                                                                for CHIP enrollees who
                                                                                                                                reside and/or work in a
                                                                                                                                State or Federally
                                                                                                                                declared disaster area.
368...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Provide Additional    At State discretion,
                                                             SPA.                                         Benefits.             requirements related to
                                                                                                                                timely processing of
                                                                                                                                renewals and/or
                                                                                                                                deadlines for families
                                                                                                                                to respond to renewal
                                                                                                                                requests may be
                                                                                                                                temporarily waived for
                                                                                                                                CHIP beneficiaries who
                                                                                                                                reside and/or work in a
                                                                                                                                State or Federally
                                                                                                                                declared disaster area.
369...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Waive Affordability   At State discretion,
                                                             SPA.                                         Test and Private      premiums or enrollment
                                                                                                          Insurance Lookback.   fees and co-payments may
                                                                                                                                be temporarily waived
                                                                                                                                for CHIP applicants and/
                                                                                                                                or existing
                                                                                                                                beneficiaries who reside
                                                                                                                                and/or work in a State
                                                                                                                                or Federally declared
                                                                                                                                disaster area.
370...............  HHS...............  CMS...............  CHIP Disaster Relief   N/A.................  Add More Qualified    At State discretion, non-
                                                             SPA.                                         Entities to Make PE   payment of premium or
                                                                                                          Determinations.       enrollment fees may be
                                                                                                                                temporarily forgiven/
                                                                                                                                waived for CHIP
                                                                                                                                applicants and/or
                                                                                                                                existing beneficiaries
                                                                                                                                who reside and/or work
                                                                                                                                in a State or Federally
                                                                                                                                declared disaster area.
371...............  HHS...............  CMS...............  Other regulatory       N/A.................  Payment and Grace     Announces enforcement
                                                             action.                                      Period                discretion to permit
                                                                                                          Flexibilities         issuers that offer
                                                                                                          Associated with the   coverage through
                                                                                                          COVID-19 National     HealthCare.gov to extend
                                                                                                          Emergency.            premium payment
                                                                                                                                deadlines and delay
                                                                                                                                cancellation for non-
                                                                                                                                payment of premiums.
372...............  HHS...............  CMS...............  Guidance.............  N/A.................  FAQs on Catastrophic  Announces enforcement
                                                                                                          Plan Coverage and     discretion to permit
                                                                                                          COVID-19.             issuers to amend their
                                                                                                                                catastrophic plans to
                                                                                                                                provide coverage without
                                                                                                                                imposing cost-sharing
                                                                                                                                requirements for COVID-
                                                                                                                                19 related services
                                                                                                                                before an enrollee meets
                                                                                                                                the catastrophic plan's
                                                                                                                                deductible.
373...............  HHS...............  CMS...............  Other regulatory       N/A.................  Postponement of 2019  Announces temporarily
                                                             action.                                      Benefit year HHS-     policy of relaxed
                                                                                                          operated Risk         enforcement to postpone
                                                                                                          Adjustment Data       issuer requirements
                                                                                                          Validation (HHS-      related to the 2019
                                                                                                          RADV).                benefit year HHS-RADV
                                                                                                                                process, delaying the
                                                                                                                                timeline for release of
                                                                                                                                2019 benefit year HHS-
                                                                                                                                RADV error rates, as
                                                                                                                                well as the publication
                                                                                                                                of 2019 benefit year HHS-
                                                                                                                                RADV results to issuers.

[[Page 75768]]

 
374...............  HHS...............  CMS...............  Other regulatory       N/A.................  Risk Adjustment       Provides clarification
                                                             action.                                      Telehealth and        that telephonic codes
                                                                                                          Telephone Services    will be valid for 2020
                                                                                                          During COVID-19       benefit year risk
                                                                                                          FAQs.                 adjustment data
                                                                                                                                submissions for the HHS-
                                                                                                                                operated risk adjustment
                                                                                                                                program.
375...............  HHS...............  CMS...............  Other regulatory       N/A.................  Temporary Period of   Announces temporary
                                                             action.                                      Relaxed Enforcement   policy of relaxed
                                                                                                          for Submitting the    enforcement with respect
                                                                                                          2019 MLR Annual       to the regulatory
                                                                                                          Reporting Form and    timeframe for issuers to
                                                                                                          Issuing MLR Rebates   submit the 2019 MLR
                                                                                                          in Response to the    Annual Reporting Form
                                                                                                          COVID-19 Public       and for issuers that
                                                                                                          Health Emergency.     elect to pay a portion
                                                                                                                                or all of their
                                                                                                                                estimated 2019 MLR
                                                                                                                                rebates in the form of
                                                                                                                                premium credits.
376...............  HHS...............  CMS...............  Other regulatory       N/A.................  Temporary Period of   The Departments of Labor
                                                             action.                                      Relaxed Enforcement   and the Treasury
                                                                                                          of Certain            released a joint Federal
                                                                                                          Timeframes Related    Register Notice
                                                                                                          to Group Market       providing relief from
                                                                                                          Requirements Under    certain timing
                                                                                                          the Public Health     requirements under ERISA
                                                                                                          Service Act in        and the Code that affect
                                                                                                          Response to the       private employer group
                                                                                                          COVID-19 Outbreak.    health plans, and their
                                                                                                                                participants and
                                                                                                                                beneficiaries in
                                                                                                                                response to the COVID-19
                                                                                                                                PHE. This guidance
                                                                                                                                announces a temporary
                                                                                                                                policy of relaxed
                                                                                                                                enforcement to extend
                                                                                                                                similar time frames
                                                                                                                                otherwise applicable to
                                                                                                                                non-Federal governmental
                                                                                                                                group health plans and
                                                                                                                                health insurance issuers
                                                                                                                                offering coverage in
                                                                                                                                connection with a group
                                                                                                                                health plan, and their
                                                                                                                                participants and
                                                                                                                                beneficiaries.
377...............  HHS...............  CMS...............  Other regulatory       N/A.................  Temporary Policy on   Announces temporary
                                                             action.                                      2020 Premium          policy of relaxed
                                                                                                          Credits Associated    enforcement to allow
                                                                                                          with the COVID-19     health insurance issuers
                                                                                                          Public Health         in the individual and
                                                                                                          Emergency.            small group markets to
                                                                                                                                temporarily offer
                                                                                                                                premium credits for 2020
                                                                                                                                coverage.
378...............  HHS...............  CMS...............  Other regulatory       N/A.................  TDL.................  On March 30 CMS suspended
                                                             action.                                                            most Medicare Fee-For-
                                                                                                                                Service (FFS) medical
                                                                                                                                review because of the
                                                                                                                                COVID-19 pandemic. This
                                                                                                                                included pre-payment
                                                                                                                                medical reviews
                                                                                                                                conducted by Medicare
                                                                                                                                Administrative
                                                                                                                                Contractors (MACs) under
                                                                                                                                the Targeted Probe and
                                                                                                                                Educate program, and
                                                                                                                                post-payment reviews
                                                                                                                                conducted by the MACs,
                                                                                                                                Supplemental Medical
                                                                                                                                Review Contractor (SMRC)
                                                                                                                                reviews and Recovery
                                                                                                                                Audit Contractor (RAC).
379...............  HHS...............  CMS...............  Other regulatory       ....................  Prior Authorization   Effective March 29. 2020,
                                                             action.                                      for Certain DMEPOS    certain claims
                                                                                                          items.                processing requirements
                                                                                                                                were paused for power
                                                                                                                                mobility devices and
                                                                                                                                pressure reducing
                                                                                                                                support surfaces that
                                                                                                                                required prior
                                                                                                                                authorization. During
                                                                                                                                this pause, claims for
                                                                                                                                these items would not be
                                                                                                                                denied for failing to
                                                                                                                                obtain a provisional
                                                                                                                                affirmation prior
                                                                                                                                authorization decision.
                                                                                                                                Additionally, CMS
                                                                                                                                delayed the
                                                                                                                                implementation of prior
                                                                                                                                authorization for
                                                                                                                                certain lower limb
                                                                                                                                prosthetic codes. Prior
                                                                                                                                to the COVID-19 PHE, CMS
                                                                                                                                had announced that prior
                                                                                                                                authorization for the
                                                                                                                                specified LLPs would be
                                                                                                                                required in California,
                                                                                                                                Michigan, Pennsylvania,
                                                                                                                                and Texas beginning May
                                                                                                                                11, 2020 and the
                                                                                                                                remaining states
                                                                                                                                beginning October 8,
                                                                                                                                2020.
380...............  HHS...............  CMS...............  Other regulatory       ....................  Opt-Out Physicians    42 CFR 405.445. Allow
                                                             action.                                      and Practitioners.    opted-out physicians and
                                                                                                                                non-physician
                                                                                                                                practitioners to
                                                                                                                                terminate their opt-out
                                                                                                                                status early and enroll
                                                                                                                                in Medicare to provide
                                                                                                                                care to more patients.
381...............  HHS...............  CMS...............  Waiver...............  ....................  Medicaid Provider     42 CFR 455.414, 42 CFR
                                                                                                          Enrollment Relief.    455.432, 42 CFR 455.434,
                                                                                                                                42 CFR 455.460 42 CFR
                                                                                                                                455.436. Exercise 1135
                                                                                                                                waiver authority to
                                                                                                                                allow providers to
                                                                                                                                enroll and receive
                                                                                                                                temporary Medicaid
                                                                                                                                billing privileges using
                                                                                                                                an abbreviated
                                                                                                                                enrollment process;
                                                                                                                                waive certain screening
                                                                                                                                and enrollment
                                                                                                                                requirements for
                                                                                                                                temporary billing
                                                                                                                                privileges established
                                                                                                                                on all enrollment
                                                                                                                                applications received on
                                                                                                                                or after March 1, 2020
                                                                                                                                including collection of
                                                                                                                                the application fee,
                                                                                                                                site visits, and
                                                                                                                                fingerprinting for
                                                                                                                                ``moderate'' and
                                                                                                                                ``high'' risk provider
                                                                                                                                types; continue to
                                                                                                                                require screening
                                                                                                                                against HHS OIG
                                                                                                                                exclusion list and Death
                                                                                                                                Master File to ensure
                                                                                                                                provider is not excluded
                                                                                                                                or deceased; provided
                                                                                                                                states with the ability
                                                                                                                                to postpone all
                                                                                                                                revalidation actions.
382...............  HHS...............  CMS...............  Waiver...............  ....................  Medicare Provider     Waive several DME
                                                                                                          Medicare Provider     supplier standards,
                                                                                                          Enrollment Relief:    including supplier
                                                                                                          DME Suppliers 42      standard 7 that requires
                                                                                                          CFR 424.57.           facility access/
                                                                                                                                maintaining a facility.
                                                                                                                                Waive DME accreditation
                                                                                                                                (at initial enrollment
                                                                                                                                and re-accreditation
                                                                                                                                requirement.
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[FR Doc. 2020-25812 Filed 11-23-20; 8:45 am]
BILLING CODE 4150-26-P