Regulatory Relief To Support Economic Recovery; Request for Information (RFI), 75720-75768 [2020-25812]
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Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Regulatory Relief To Support
Economic Recovery; Request for
Information (RFI)
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Request for information.
AGENCY:
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 preenforcement 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 https://
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: COVID.Regs@hhs.gov.
Telephone: (202) 690–7741.
SUPPLEMENTARY INFORMATION: Executive
Order 13924, Regulatory Relief To
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SUMMARY:
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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
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
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-19related-guidance-documents-industry-fda-staff-andother-stakeholders and submit comments to the
relevant docket associated with each guidance
listed, in addition to responding to this RFI.
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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
2 Coronavirus (COVID–19) Testing, U.S. Dep’t of
Health and Human Serv.’s, https://www.hhs.gov/
coronavirus/testing/ (last updated Aug.
19, 2020).
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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
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
3 Fact Sheet: Explaining Operation Warp Speed,
U.S. Dep’t of Health and Human Serv.’s https://
www.hhs.gov/coronavirus/explaining-operationwarp-speed/ (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).
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.
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Likewise, FDA established a process to
more rapidly disseminate and
implement agency recommendations
and policies related to COVID–19.8
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.
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
8 United States, Food and Drug Administration.
‘‘Process for Making Available Guidance
Documents Related to Coronavirus Disease 2019.’’
85 FR 16949 (March 25, 2020).
9 Exec. Order No. 13924 (May 19, 2020).
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/faqstelehealth-covid-19.pdf.
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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.
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;
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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.
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.
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ATTACHMENT A
Action
Agency
Sub-agency
1 ....................
HHS .............
SAMHSA .....
2 ....................
HHS .............
3 ....................
4 ....................
Type of action
RIN (if applicable)
Title of action
Brief summary of action
Other regulatory
action.
...............................
42 CFR part 2 statement ...........
SAMHSA .....
Guidance ...............
...............................
Take home medication ...............
HHS .............
OIG ..............
Guidance ...............
n/a .........................
HHS .............
OCR ............
Other regulatory
action.
...............................
FAQs–Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the
Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
Notification of Enforcement Discretion for Telehealth Remote
Communications.
SAMHSA provided guidance 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-guidance03192020.pdf).
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.
OIG is accepting inquiries from the health care community regarding the application of OIG’s administrative enforcement authorities, including the Federal anti-kickback statute and civil
monetary 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.
Exercise of enforcement discretion to not impose penalties for
HIPAA violations against healthcare providers in connection
with their good faith provision of telehealth using remote communication technologies during the COVID–19 nationwide public health emergency.
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://
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www.fda.gov/emergency-preparedness-andresponse/coronavirus-disease-2019-covid-19/covid19-related-guidance-documents-industry-fda-staffand-other-stakeholders and submit comments to the
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relevant docket associated with each guidance
listed, in addition to responding to this RFI.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
5 ....................
HHS .............
OCR ............
6 ....................
HHS .............
7 ....................
RIN (if applicable)
Title of action
Brief summary of action
Other regulatory
action.
...............................
Notification of Enforcement Discretion for Business Associates.
OCR ............
Other regulatory
action.
...............................
Notification of Enforcement Discretion for Community-Based
Testing Sites.
HHS .............
NIH ..............
Waiver ...................
...............................
8 ....................
HHS .............
NIH ..............
Waiver ...................
...............................
9 ....................
HHS .............
NIH ..............
Waiver ...................
...............................
10 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Flexibility with System for
Awards Management ‘‘SAM’’
Registration (2 CFR
§ 200.205).
Flexibility with Application Deadlines (2 CFR § 200.202).
Waiver for Notice of Funding
Opportunities (NOFOs) Publication. (2 CFR § 200.203).
No-cost extensions on expiring
awards. (2 CFR § 200.308).
Exercise of enforcement discretion to not impose penalties for
violations 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.
Exercise of enforcement discretion to not impose penalties for
violations of the HIPAA Rules 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.
Allows applicants to submit applications for Federal awards without an active SAM registration. Provided automatic extension
to expiring SAM registrations.
11 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Abbreviated non-competitive
continuation requests. (2 CFR
§ 200.308).
12 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Allowability of salaries and other
project activities. (2 CFR
§ 200.403, 2 CFR § 200.404, 2
CFR § 200.405).
13 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Allowability of Costs not Normally Chargeable to Awards.
(2 CFR § 200.403, 2 CFR
§ 200.404, 2 CFR § 200.405).
14 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
15 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Prior approval requirement waivers. (2 CPR § 200.407).
Exemption of certain procurement requirements. (2
CPR§ 200.319(b), 2
CPR§ 200.321).
16 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
17 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
18 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Extension of closeout. (2
CPR§ 200.343).
19 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
Extension of Single Audit submission. (2 CFR § 200.512).
20 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
OMB Memo M–20–20:
Repurposing Existing Federal
Financial Assistance Programs.
21 ..................
HHS .............
NIH ..............
Waiver ...................
...............................
National Research Service
Awards.
22 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Enforcement Policy for Clinical
Electronic Thermometers During the Coronavirus Disease
2019 (COVID–19) Public
Health Emergency.
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Extension of financial, performance, and other reporting. (2
CPR§ 200.327, 2
CPR§ 200.328).
Extension of currently approved
indirect cost rates. (2
CPR§ 200.414(c)).
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Allows agencies to accept late applications due to the COVID–19
emergency.
Awarding agencies can publish emergency Notice of Funding
Opportunities (NOFOs) for less than thirty (30) days without
separately justifying shortening the timeframe for each NOFO.
Awarding agencies may extend awards which are active as of
March 31, 2020 and scheduled to expire prior or up to December 31, 2020, automatically at no-cost for a period up to twelve
(12) months.
For continuation requests scheduled to come in from April 1,
2020 to December 31, 2020, from 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.
Awarding agencies may allow recipients to continue to charge
salaries and benefits to currently active Federal awards consistent with the recipients’ policy of paying salaries (under unexpected or extraordinary circumstances) from all funding
sources, Federal and non-Federal.
Agencies may allow recipients to charge full cost of cancellation
when the event, travel, or other activities are conducted 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.
Awarding agencies are authorized to waive prior approval requirements as necessary to effectively address the response.
Awarding agencies may waive the procurement requirements
contained in 2 CPR§ 200.319(b) regarding geographical preferences and 2 CPR§ 200.321 regarding contracting small and
minority businesses, women’s business enterprises, and labor
surplus area firms.
Awarding agencies may allow grantees to delay submission of financial, performance and other reports up to three (3) months
beyond the normal due date.
Awarding agencies may allow grantees to continue to use the
currently approved indirect cost rates (i.e., predetermined,
fixed, or provisional rates) to recover their indirect costs on
Federal awards.
Awarding agencies may allow the grantee to 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.
Awarding agencies, in their capacity as cognizant or oversight
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
§ 200.501—Audit Requirements, to six (6) months beyond the
normal due date.
OMB is issuing a class exception that allows Federal awarding
agencies to repurpose 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.
NIH has provided 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.
FDA issued this guidance to provide a policy to help expand the
availability of clinical electronic thermometers to address this
public health emergency.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
23 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Enforcement Policy for Imaging
Systems During the
Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
24 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
25 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Enforcement Policy for Face
Masks and Respirators During
the Coronavirus Disease
(COVID–19) Public Health
Emergency (Revised).
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of
Drug Samples During the
COVID–19 Public Health
Emergency.
26 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Returning Refrigerated Transport Vehicles and Refrigerated
Storage Units to Food Uses
After Using Them to Preserve
Human Remains During the
COVID–19 Pandemic.
27 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
CVM GFI #271 Reporting and
Mitigating Animal Drug Shortages during the COVID–19
Public Health Emergency.
28 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
CVM GFI #270—Guidance on
the Conduct and Review of
Studies to Support New Animal Drug Development during
the COVID–19 Public Health
Emergency.
29 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Notifying FDA of a Permanent
Discontinuance or Interruption
in Manufacturing Under Section 506C of the FD&C Act
Guidance for Industry.
30 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Exemption and Exclusion from
Certain Requirements of the
Drug Supply Chain Security
Act During the COVID–19
Public Health Emergency.
31 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Alternative Procedures for Blood
and Blood Components During the COVID–19 Public
Health Emergency.
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Brief summary of action
FDA issued this guidance to provide a policy to help expand the
availability and capability of medical x-ray, ultrasound, and
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).
FDA issued this guidance to provide a policy to help expand the
availability of general use face masks for the general public
and particulate filtering face piece respirators (including N95
respirators) for healthcare personnel (HCP)1 for the duration of
the COVID–19 public health emergency.
FDA issued this guidance to address questions FDA has received asking for clarification regarding FDA’s enforcement of
certain requirements relating to the 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.
FDA has been asked whether refrigerated food transport vehicles
and refrigerated food storage units used for the temporary
preservation of human remains during the COVID–19 pandemic subsequently 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.
FDA has been closely monitoring the animal drug supply chain
for supply disruptions or shortages in the United States during
the COVID–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.
FDA issued this guidance to provide recommendations for sponsors conducting studies to support new animal drug development to help ensure the safety of animals, their 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.
Due to the COVID–19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation
that it may be impacted by the COVID–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.
Due to the COVID–19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security
Act (DSCSA) because the provisions 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.
FDA issued this guidance to provide a notice of exceptions and
alternatives to certain requirements in Title 21 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
32 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements
During a Pandemic.
33 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Institutional Review Board (IRB)
Review of Individual Patient
Expanded Access Requests
for Investigational Drugs and
Biological Products During the
COVID–19 Public Health
Emergency.
34 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
FDA Guidance on Conduct of
Clinical Trials of Medical Products during COVID–19 Public
Health Emergency.
35 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
COVID–19: Developing Drugs
and Biological Products for
Treatment or Prevention.
36 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Investigational COVID–19 Convalescent Plasma; Guidance
for Industry (Updated: May 1,
2020).
37 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Revised Recommendations for
Reducing the Risk of Human
Immunodeficiency Virus
Transmission by Blood and
Blood Products.
38 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Revised Recommendations to
Reduce the Risk of Transfusion-Transmitted Malaria.
This guidance provides recommendations to industry regarding
postmarketing adverse event reporting for drugs, biologics,
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.
During the COVID–19 public health emergency, FDA has received a substantially increased volume of individual patient
expanded access requests for COVID–19 investigational
drugs. Although FDA has issued guidance on expanded 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.
FDA issued this guidance to provide general considerations to
assist sponsors in assuring the safety of trial 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.
FDA issued this guidance to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID–19.
Preventative vaccines and convalescent plasma are not within
the scope of this guidance.
FDA issued this guidance to provide recommendations to health
care providers and investigators on the administration and
study 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.
This revised guidance document provides blood establishments
that collect blood or blood components, including Source Plasma, with FDA’s revised donor 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.
The recommendations in this revised guidance reflect the Agency’s current thinking on 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
39 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
CVM GFI #269—Enforcement
Policy Regarding Federal
VCPR Requirements to Facilitate Veterinary Telemedicine
During the COVID–19 Outbreak.
40 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration
Requirements During the
COVID–19 Public Health
Emergency.
41 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy Regarding
Preventive Controls and FSVP
Food Supplier Verification Onsite Audit Requirements During the COVID–19 Public
Health Emergency.
42 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
43 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy During the
COVID–19 Public Health
Emergency Regarding the
Qualified Exemption from the
Standards for the Growing,
Harvesting, Packing, and
Holding of Produce for Human
Consumption.
Reporting a Temporary Closure
or Significantly Reduced Production by a Human Food Establishment and Requesting
FDA Assistance During the
COVID–19 Public Health
Emergency.
FDA recognizes the vital role veterinarians play in protecting public health. FDA is aware that during the COVID–19 outbreak
some States are modifying their requirements for 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.
The Accredited Third-Party Certification Program regulation (21
CFR part 1, subpart M) establishes a voluntary program for the
recognition of accreditation bodies (ABs) that accredit thirdparty 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.
The purpose of this guidance is to state the current intent of the
Food and Drug Administration (FDA, we, or the Agency), in
certain circumstances related to the impact of the coronavirus
outbreak (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’’).
FDA issued this guidance to announce flexibility in the eligibility
criteria for the qualified exemption from the Standards for the
Growing, Harvesting, Packing, and Holding of Produce for
Human Consumption (Produce Safety Rule) (21 CFR part 112)
due to disruptions to the supply chain for the duration of the
COVID–19 public health emergency.
44 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
45 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
46 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
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Temporary Policy Regarding Nutrition Labeling of Certain
Packaged Food During the
COVID–19 Public Health
Emergency.
Temporary Policy Regarding
Certain Food Labeling Requirements During the
COVID–19 Public Health
Emergency: Minor Formulation Changes and Vending
Machines.
Temporary Policy Regarding Enforcement of 21 CFR Part 118
(the Egg Safety Rule) During
the COVID–19 Public Health
Emergency.
Fmt 4701
Sfmt 4703
FDA issued this guidance to provide certain FDA-regulated food
establishments (i.e., human food facilities and farms, but not
restaurants and retail food establishments), with a convenient
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.
FDA issued this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they
can sell certain packaged foods during the COVID–19 pandemic. This guidance does not apply to foods prepared by restaurants.
FDA issued this guidance to food manufacturers to provide temporary and limited flexibilities in food labeling requirements
under certain circumstances. Our goal is to provide 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.
We encourage all shell egg producers to continue to comply with
applicable requirements of 21 CFR part 118 (the Egg Safety
Rule). However, due to the 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
47 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
FDA issued this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they
can sell certain packaged foods during the COVID–19 pandemic. This guidance does not apply to foods prepared by restaurants.
48 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
49 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
50 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
51 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy Regarding Nutrition Labeling of Standard
Menu Items in Chain Restaurants and Similar Retail
Food Establishments During
the COVID–19 Public Health
Emergency.
Temporary Policy Regarding
Packaging and Labeling of
Shell Eggs Sold by Retail
Food Establishments During
the COVID–19 Public Health
Emergency.
Enforcement Policy for Gowns,
Other Apparel, and Gloves
During the Coronavirus Disease (COVID–19) Public
Health Emergency.
Enforcement Policy for Sterilizers, Disinfectant Devices,
and Air Purifiers During the
Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
Recommendations for Sponsors
Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face
Masks and Respirators During
the Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
52 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
53 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
54 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
55 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
56 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
57 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
58 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
59 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
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Enforcement Policy for Digital
Health Devices For Treating
Psychiatric Disorders During
the Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
Enforcement Policy for
Extracorporeal Membrane
Oxygenation and
Cardiopulmonary Bypass Devices During the Coronavirus
Disease 2019 (COVID–19)
Public Health Emergency.
Enforcement Policy for Infusion
Pumps and Accessories During the Coronavirus Disease
2019 (COVID–19) Public
Health Emergency.
Enforcement Policy for NonInvasive Fetal and Maternal
Monitoring Devices Used to
Support Patient Monitoring
During the Coronavirus Disease 2019 (COVID–19) Public
Health Emergency.
Enforcement Policy for NonInvasive Remote Monitoring
Devices Used to Support Patient Monitoring During the
Coronavirus Disease-2019
(COVID–19) Public Health
Emergency.
Enforcement Policy for Remote
Digital Pathology Devices During the Coronavirus Disease
2019 (COVID–19) Public
Health Emergency.
Enforcement Policy for Remote
Ophthalmic Assessment and
Monitoring Devices During the
Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease
2019 (COVID–19) Public
Health Emergency.
Fmt 4701
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FDA issued this guidance to provide temporary flexibility regarding certain packaging and labeling requirements for shell eggs
sold in retail food establishments so that industry can meet the
increased demand for shell eggs during the COVID–19 pandemic.
FDA issued this guidance to provide a policy to help expand the
availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this pandemic.
FDA issued this guidance to provide a policy to help expand the
availability and capability of sterilizers, disinfectant devices,
and air purifiers during this public health emergency.
FDA issued this guidance to provide recommendations for sponsors of decontamination and bioburden reduction systems
about what information should be included in a pre-Emergency
Use Authorization (pre-EUA) 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.
FDA issued this guidance to provide a policy to help expand the
availability of digital health therapeutic devices for psychiatric
disorders to facilitate consumer and patient use while reducing
user and healthcare provider contact and potential exposure to
COVID–19 during this pandemic.
FDA issued this guidance to provide a policy to help expand the
availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address this public health emergency.
FDA issued this guidance to provide a policy to help expand the
availability and remote capabilities of infusion pumps and their
accessories for health care professionals during the COVID–19
pandemic.
FDA issued this guidance to provide a policy to help expand the
availability and capability of non-invasive fetal and maternal
monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and potential exposure to COVID–19 during this pandemic.
FDA issued this guidance to provide a policy to help expand the
availability and capability of non-invasive remote monitoring
devices to facilitate patient monitoring while reducing patient
and healthcare provider contact and exposure to COVID–19
for the duration of the COVID–19 public health emergency.
FDA issued this guidance to provide a policy to help expand the
availability of devices for remote reviewing and reporting of
scanned digital images of pathology slides (‘‘digital pathology
slides’’) during this pandemic.
FDA issued this guidance to provide a policy to help expand the
capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and
healthcare provider contact and exposure to COVID–19 during
this pandemic.
FDA issued this guidance to provide a policy to help expand the
availability of telethermographic systems used for body temperature measurements 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
60 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
61 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Enforcement Policy for Ventilators and Accessories and
Other Respiratory Devices
During the Coronavirus Disease 2019 (COVID–19) Public
Health Emergency.
Notifying CDRH of a Permanent
Discontinuance or Interruption
in Manufacturing of a Device
Under Section 506J of the
FD&C Act During the COVID–
19 Public Health Emergency.
62 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
COVID–19 Public Health Emergency: General Considerations for Pre-IND Meeting
Requests for COVID–19 Related Drugs and Biological
Products.
63 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
64 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
65 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
66 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Effects of the COVID–19 Public
Health Emergency on Formal
Meetings and User Fee Applications—Questions and Answers.
Policy for Certain REMS Requirements During the
COVID–19 Public Health
Emergency Guidance for Industry and Health Care Professionals.
Policy for the Temporary Use of
Portable Cryogenic Containers
Not in Compliance With 21
CFR 211.94(e)(1) For Oxygen
and Nitrogen During the
COVID–19 Public Health
Emergency.
Temporary Policy on Repackaging or Combining Propofol
Drug Products During the
COVID–19 Public Health
Emergency.
67 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
68 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
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Temporary Policy for
Compounding of Certain
Drugs for Hospitalized Patients by Outsourcing Facilities
During the COVID–19 Public
Health Emergency (Revised).
Temporary Policy for
Compounding of Certain
Drugs for Hospitalized Patients by Pharmacy
Compounders not Registered
as Outsourcing Facilities During the COVID–19 Public
Health Emergency Guidance
for Industry (Revised).
Fmt 4701
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Brief summary of action
FDA issued this guidance to provide a policy to help expand the
availability of ventilators as well as other respiratory devices
and their accessories during this pandemic.
FDA issued this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351
et seq.), as added by section 3121 of the Coronavirus Aid, Relief, and Economic 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.
FDA issued this guidance to provide general considerations to
assist sponsors in preparing pre-investigational new drug application (pre-IND) meeting requests for COVID–19 related 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.
FDA issued this guidance to provide answers to frequently asked
questions about regulatory and policy issues related to drug
development for the duration of the COVID–19 public health
emergency.
FDA issued this guidance to communicate its temporary policy
for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency
(PHE) declared by the Secretary of Health and Human Services (HHS)1 on January 31, 2020.
FDA issued this guidance to communicate its policy for the temporary use of certain gas containers for oxygen and nitrogen
intended for medical use for the duration of the current public
health emergency.
FDA issued this guidance to communicate its temporary policy
regarding the repackaging or combining of propofol drug 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.
FDA issued this guidance to communicate its temporary policy
for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered
with FDA under section 503B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353b).
FDA has received a number of reports related to increased demand and supply interruptions involving FDA-approved drug
products used in the treatment of hospitalized patients with
COVID–19. Many of these drug products are needed to support COVID–19 patients who have been intubated, or for 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
69 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy Regarding
Non-Standard PPE Practices
for Sterile Compounding by
Pharmacy Compounders not
Registered as Outsourcing
Facilities During the COVID–
19 Public Health Emergency.
70 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
71 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions During
the Coronavirus Disease 2019
(COVID–19) Public Health
Emergency.
Policy for Temporary
Compounding of Certain Alcohol-Based Hand Sanitizer
Products During the Public
Health Emergency.
72 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand
Sanitizer Products During the
Public Health Emergency
(COVID–19).
73 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Temporary Policy for Preparation of Certain Alcohol-Based
Hand Sanitizer Products During the Public Health Emergency (COVID–19).
74 ..................
HHS .............
FDA .............
Guidance ...............
N/A ........................
Policy for Coronavirus Disease2019 Tests During the Public
Health Emergency (Revised).
75 ..................
HHS .............
CDC ............
Interim Final Rule ..
0920–AA76 ...........
76 ..................
HHS .............
CDC ............
...............................
77 ..................
HHS .............
ACF .............
Other regulatory
action.
Guidance ...............
Control of Communicable Diseases; Foreign Quarantine:
Suspension of Introduction of
Persons into the US from
Designated Foreign Countries
or Places for Public Health.
No Sail Order and Suspension
of Further Embarkation.
New Guidance on Caseworker
Visits.
78 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Permit provisional licensure of
foster family homes.
79 ..................
HHS .............
ACF .............
Guidance ...............
...............................
80 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Permit name-based criminal
background checks on prospective foster parents and
other care providers.
Simplify process for title IV–E
assistance to youth age 18
and older.
81 ..................
HHS .............
ACF .............
Guidance ...............
...............................
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Title of action
Modify requirement for older
youth to meet education or
employment requirement.
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Brief summary of action
Due to the COVID–19 pandemic, FDA has received a number of
queries from compounders related to the impact of supply
interruptions of face masks, gowns, gloves, and other garb,
which we refer to collectively in this document as personal 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.
FDA issued this guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to
disruptions caused by the COVID–19 public health emergency.
The Agency issued this guidance to communicate its policy for
the temporary compounding of certain alcohol-based hand
sanitizer products 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.
FDA issued this guidance in response to a number of queries
from entities that are not currently registered drug manufacturers that would like to produce alcohol (ethanol) for 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.
FDA issued this guidance in response to a number of queries
from entities that are not currently licensed or registered drug
manufacturers that would like to prepare 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, repackager, 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.
FDA issued this guidance to provide a policy to help accelerate
the availability of novel 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.
Suspends the introduction of persons from designated countries
into the U.S. for public health reasons.
Order applies to all cruise ships that do not voluntarily suspend
operation.
Modified policy to permit 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.
Allows for abbreviated licensing and re-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.
Allowed name-based background checks only, in the absence of
FBI fingerprint checks, when fingerprint sites are unavailable.
Administrative streamlining allows for quicker access to title 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.
Using Stafford Act flexibility, ACF temporarily waived the requirement that youth aging out of the foster care system be actively
engaged in education and/or employment.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
82 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Qualified Residential Treatment
Program claiming exemption.
83 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Delegating authority to State
CSBG agencies to approve
equipment purchases.
84 ..................
HHS .............
ACF .............
Waiver ...................
...............................
Allowability of Costs not Normally Chargeable to Awards
(Item 7 from OMB M–20–17).
85 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Streamlining CSBG eligibility determinations.
86 ..................
HHS .............
ACF .............
Guidance ...............
...............................
87 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Non-Competing Continuation
(NCC) Grants application.
Ability to pay salaries and other
project activities.
88 ..................
HHS .............
ACF .............
Guidance ...............
...............................
Increase in micro-purchase
threshold.
89 ..................
HHS .............
ACF .............
Guidance ...............
...............................
90 ..................
HHS .............
ACF .............
Guidance ...............
...............................
91 ..................
HHS .............
ACF .............
Guidance ...............
...............................
92 ..................
HHS .............
ACF .............
Waiver ...................
...............................
93 ..................
HHS .............
ACF .............
Waiver ...................
...............................
94 ..................
HHS .............
ACF .............
Waiver ...................
...............................
95 ..................
HHS .............
ACF .............
Waiver ...................
...............................
96 ..................
HHS .............
ACF .............
NPRM ....................
...............................
97 ..................
HHS .............
ACF .............
Other regulatory
action.
...............................
98 ..................
HHS .............
ACF .............
Waiver ...................
...............................
99 ..................
HHS .............
ACF .............
Waiver ...................
...............................
100 ................
HHS .............
ACF .............
Waiver ...................
...............................
101 ................
HHS .............
ACF .............
Waiver ...................
...............................
102 ................
HHS .............
ACF .............
Waiver ...................
...............................
103 ................
HHS .............
ACF .............
Waiver ...................
...............................
104 ................
HHS .............
ACF .............
NPRM ....................
...............................
105 ................
HHS .............
ACF .............
Other regulatory
action.
...............................
Waiver of detail and formality of
acquisition plans above the
simplified acquisition threshold.
Flexibility with Application Dead- This was applied by multiple ACF programs to provide relief durlines (2 CFR § 200.202).
ing the period of the pandemic by providing additional time to
complete grant applications.
Enforcement discretion for Work Signals that ACF will exercise maximum enforcement discretion
Participation Rate failures durin levying financial penalties against states for their failure to
ing the pandemic.
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.
Waiver of on-site health and
This waived the requirement that annual inspections of child care
safety inspections.
facilities occur, with an on-site component.
Fingerprint background check
Waive the requirement that FBI fingerprint-based background
waivers.
checks be evaluated for child care workers, if fingerprinting
sites are unavailable and name-based checks return no red
flags.
Waiver of 12 month continuing
Waives the requirement that those receiving CCDF child care
eligibility requirement.
support 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.
Waive co-pays for all families .... Allows states to fully pay for child care costs for parents, without
cost-sharing.
Provisional hire flexibility ............ Waiver allowed 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.
Grant match requirements ......... Provide Secretary authority to waive matching requirements in 42
U.S.C. 10407(a)(2)(A) in situations of public health emergencies.
Waive declaration requirements
Allows waiver of requirements at 45 CFR 400.43, which require
for refugee assistance.
written attestation and documentation of certain eligibility requirements; allows for telephonic attestation until such time as
providing this documentation and written declaration is possible.
Waive certain income requireAllows waiver of certain components of 45 CFR 400.59 and
ments for refugee assistance.
§ 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.
Waive restrictions on Refugee
Allows funds for RSS to be used to meet emergent needs assoSupport Services funds use.
ciated with the COVID–19 pandemic (e.g., food, shelter).
Waives requirements at 45 CFR 400.146.
Extend eligibility period for RefAllows individuals receiving RSS support/services to continue reugee Supportive Services.
ceiving 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.
Refugee medical screening
Waive 90 day timeline for the medical screening to take place (at
timeframes.
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.
Permitting virtual refugee conQuarterly stakeholder consultations are required in the refugee
sultations.
program. This flexibility allows such consultations to take place
virtually rather than in-person.
Various timeframe and adminisUtilizing Stafford Act flexibilities, OCSE granted waivers to many
trative elements, Child Supstates on a host of service-related timeline requirements (sepaport Enforcement.
rate 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.
Raise prior approval requirement Raise prior approval threshold for purchases from $5k to $25k in
at 45 CFR § 75.407; 2 CFR
the normal course.
§ 200.407.
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Using Stafford Act flexibilities, this allows title IV–E 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.
Same as title. Prior internal practice required federal 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.
Note: Not an ACF regulation. Modify 45 CFR 75.405 (and 2 CFR
200.405) to allow the 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).
Guidance was provided to states that streamlined certain eligibility requirements, such as attestation to, rather than production of, documentation for emergency food assistance.
Allows abbreviated application process for grantees and eliminates burdens for non-competing continuation grant awards.
Allows programs to continue paying salaries to grantee staff during business disruptions, and activities aligned with grant purpose but not in SOW, to do so. M–20–17.
HHS authorized an increase in the simplified acquisition thresholds for all COVID–19 acquisitions (to $20k for micro-purchase
and $750k for simplified acquisition threshold).
HHS authorized this waiver for all COVID–19 related contracts
and only required them to have an informal acquisition plan.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
106 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Merit-based Incentive Payment
System (MIPS) Updates.
107 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU32 ....
Update to the Hospital ValueBased Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE)
Policy.
108 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU33 ....
Quality Reporting: Updates to
the Extraordinary Circumstances Exceptions (ECE)
Granted for Four Value-Based
Purchasing Programs in Response to the PHE for
COVID–19, and Update to the
Performance Period for the
FY 2022 SNF VBP Program.
109 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
National Coverage Determination.
110 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Independent Lab Payment for
Specimen collection.
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BB. MIPS Improvement Activities Inventory Update to add new or
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.
The Hospital Value-Based Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE) policy was revised to
allow CMS to grant an exception to hospitals 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.
This IFC updates the extraordinary circumstances exceptions
(ECEs) we granted on March 22, 2020 for the ESRD Quality
Incentive Program (QIP), Hospital-Acquired Condition (HAC)
Reduction Program, Hospital Readmissions Reduction Program, and Hospital Value-Based Purchasing (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.
National Coverage 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.
During the PHE, Medicare established two new 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
111 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Communication TechnologyBased Services (CTBBS).
112 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Direct Supervision by Interactive
Telecommunications Technology.
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D. Medicare routinely pays for many kinds of 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.
For the duration of the PHE for the COVID–19 pandemic, for purposes 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
113 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Telephone Evaluation and Management (E/M) Services
Codes.
114 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Clarification of Homebound Status under the Medicare Home
Health Benefit.
115 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Use of Telecommunications
Technology Under the Medicare Home Health Benefit.
S. We are finalizing, on an interim basis for the 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.
Homebound Definition: Broadening homebound definition to include 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.
H. For the duration of the PHE for the COVID–19 pandemic, we
are amending the hospice 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 § 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’’.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
116 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Use of Telecommunications
Technology Under the Medicare Hospice Benefit.
117 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Frequency Limitations on Subsequent Care Services in Inpatient and Nursing Facility
Settings, and Critical Care
Consultations and Required
‘‘Hands-on’’ Visits for ESRD
Monthly Capitation Payments.
118 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Inpatient Hospital Services Furnished Under Arrangements
Outside the Hospital.
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H. For the duration of the PHE for the COVID–19 pandemic, we
are amending the hospice 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 § 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’’.
B. Given our assessment that under the PHE for the COVID–19
pandemic, there is a patient population that would otherwise
not have access to clinically appropriate in-person treatment,
we do not believe these frequency limitations are appropriate
or 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.
CC. Understanding that our current policy may inhibit use of capacity in settings that might 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
119 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Modification of the Inpatient Rehabilitation Facility (IRF) Faceto-Face Requirement.
120 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Removal of the IRF Post-Admission Physician Evaluation Requirement.
121 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Requirements for Opioid Treatment Programs (OTP).
122 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Physician Supervision Flexibility
for Outpatient Hospitals—Outpatient Hospital Therapeutic
Services Assigned to the NonSurgical Extended Duration
Therapeutic Services
(NSEDTS) Level of Supervision.
123 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Rural Health Clinics (RHC) and
Federally Qualified Health
Centers (FQHC) Telehealth.
J. During the PHE for the COVID–19 pandemic, we believe that
it is essential to temporarily allow the face-to-face visit requirements at §§ 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
§§ 412.622(a)(3)(iv) and 412.29(e) during the PHE for the
COVID–19 pandemic.
In § 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 § 400.200, such visits may be conducted using telehealth services (as defined in
section 1834(m)(4)(F) of the Act).
In § 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 § 400.200, such visits may be
conducted using telehealth services (as defined in section
1834(m)(4)(F) of the Act).
K. We are removing the post-admission physician evaluation requirement at § 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 § 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
§ 412.622(a)(4)(ii) to specify that the post-admission physician
evaluation is not required during the PHE for the COVID–19
pandemic.
N. In light of the PHE for the COVID–19 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 § 410.67(b)(3) and (4) to allow the therapy and
counseling portions of the weekly bundles, as well as the addon 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.
T. We changed the minimum default level of supervision to general supervision for NSEDTS during the initiation of the service
to give providers additional flexibility they need to handle the
burdens created by the PHE for the COVID–19 pandemic. We
assigned, on an interim basis, all outpatient hospital therapeutic services that fall under § 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
§ 410.27(a)(1)(iv)(E) to reflect this change in the minimum level
of supervision. General supervision, as defined in our regulation at § 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.
Allow Professionals working at Rural Health Clinics (RHCs) and
Federally-Qualified 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
124 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Change to Medicare Shared
Savings Program Extreme
and Uncontrollable Circumstances Policy.
125 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Payment for Medicare Telehealth Services Under Section
1834(m) of the Act.
126 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Telehealth and the Medicare
Hospice Face-to-Face Encounter Requirement.
127 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Home Health Orders from APPs
128 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Health Insurance Issuer Standards under the ACA, Including
Standards related to Exchanges: Separate Billing and
Segregation of Funds for
Abortion Services.
129 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Updates to the Quality Payment
Program: Merit-based Incentive Payment System (MIPS)
Third Party Intermediary Approval Criteria.
130 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Application of Certain National
Coverage Determination and
Local Coverage Determination
Requirements: CGMs.
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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.
V. The 2019 MIPS data submission deadline will be extended by
30 days until April 30, 2020, to give eligible clinicians 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.
A. To facilitate the use of telecommunications technology as a
safe 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/.
Additional CPT Codes and explanations provided in the IFC.
I. We are amending the regulations at § 418.22(a)(4) on an interim basis to allow 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.
Z. Allow a home health 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.
X. For Qualified health plan (QHP) issuers to devote resources to
respond to the COVID–19 PHE, revising 45 CFR
156.280(e)(2)(ii) to delay implementation of the separate billing
policy for 60 days from 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.
R. Delaying the implementation by 1 year that beginning with the
2022 performance period, QCDRs are required to collect data
on a QCDR measure, appropriate to 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.
S. Continuous Glucose Monitors: CMS will not enforce certain
clinical criteria in LCDs that limit access to therapeutic continuous glucose monitors for beneficiaries with diabetes.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
131 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Reporting Requirement for Facilities to Report Nursing
Home Residents and Staff Infections, Potential Infections,
and Deaths.
132 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Delayed Adoption of the Transfer of Health (TOH) Information Measures and Standard
Patient Assessment Data Elements (SPADEs).
133 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Care Planning for Medicare
Home Health Services.
Y. Revising the requirements to establish explicit reporting requirements for confirmed or suspected cases. Specifically, we
are revising our requirements by adding a new provision at
§ 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
§ 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 newonset 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.
T. We are delaying the compliance date by which IRFs, LTCH,
and HHAs must collect and report data on two Transfer of
Health (TOH) Information quality measures and 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.
J. NPs, CNSs, and PAs would be able to 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 §§ 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
134 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Inpatient Rehabilitation—Intensity of Therapy Requirement
(‘‘3-Hour Rule’’) and Related
IRF Coverage Requirements.
135 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
IRF Coverage Criteria—Surge
Capacity.
136 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Laboratory Tests: Payment for
COVID–19 Specimen Collection to Physicians, Non-Physician Practitioners and Hospitals.
137 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Indirect Medical Education .........
138 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Medical Education: Time Spent
by Residents at Another Hospital during the COVID–19
PHE.
139 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Medicare Shared Savings Programs.
140 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Opioid Treatment Programs
(OTP)—Furnishing Periodic
Assessments via Communication Technology.
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K. In the March 31st COVID–19 IFC (85 FR 19252, 19287), we
provided a clarification regarding § 412.622(a)(3)(ii) (commonly
referred to as the ‘‘3-hour rule’’). On March 27, 2020, the
CARES Act was enacted and further addressed
§ 412.622(a)(3)(ii). Specifically, section 3711(a) of the CARES
Act requires the Secretary to waive § 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-19emergency-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
§ 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.
C. We are amending § 412.622(a)(3)(i), (ii), (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 § 400.200. Similarly, in § 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 § 400.200. In § 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 § 400.200.
BB. We are providing additional payment for assessment and
COVID–19 specimen collection to support testing by HOPDs,
and physicians and other practitioners, 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.
Indirect Medical Education. Beds temporarily added during the
COVID–19 PHE do not reduce a teaching hospital’s Indirect
Medical Education payments.
Direct Graduate Medical Education and Indirect Medical Education. During the COVID–19 PHE, hospitals may claim time
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.
L. We are modifying 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.
D. Allow telehealth in place of required visits for opioid treatment
programs (OTP).
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
141 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Furnishing Hospital Outpatient
Services Remotely.
142 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Treatment of New and Certain
Relocating Provider-Based
Departments.
143 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Payment for Remote Physiologic
Monitoring (RPM) Services.
144 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Rural Health Clinics (RHC) ........
145 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Scope of Practice: Supervision
of Diagnostic Tests by Certain
Non-Physician Practitioners.
146 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Scope of Practice: Pharmacists
Working Incident to a Physicians’ Service.
147 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
COVID–19 Serology Testing ......
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F. Hospital and CMHC staff can furnish 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.
E. We are adopting a temporary extraordinary circumstances relocation 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.
CC. We are establishing a policy on an interim final basis for the
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.
H. Due to the COVID–19 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 § 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 § 400.200.
Allow nurse practitioners (NPs), clinical nurse specialists (CNSs),
physician assistants (PAs) and certified nurse-midwives
(CNMs) to supervise the performance of diagnostic tests in addition to physicians.
B. 4. We are clarifying explicitly that pharmacists fall within the
regulatory definition of auxiliary personnel under our regulations at § 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.
Section V of the rule. 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).
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
148 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Additional Flexibility under the
Teaching Physician Regulations.
149 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Updating the Medicare Telehealth List on a Sub-regulatory Basis.
150 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Therapy—Therapy Assistants
Furnishing Maintenance Therapy (PFS).
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M. Allow the teaching physician to meet the requirement to review the service with the 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.
AA. Due to the urgency of minimizing unnecessary contact between 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 § 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 § 410.78(f) to specify
that, during a PHE, as defined in § 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.
B. 2. To increase availability of needed health care services during the COVID–19 PHE, 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 technologybased 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).
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
151 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Modification to Medicare Provider Enrollment Provision
Concerning Certification of
Home Health Services.
152 ................
HHS .............
CMS ............
Waiver ...................
...............................
Verbal Orders .............................
153 ................
HHS .............
CMS ............
Waiver ...................
...............................
Medical Records ........................
154 ................
HHS .............
CMS ............
Waiver ...................
...............................
Nursing Care Plan ......................
155 ................
HHS .............
CMS ............
Waiver ...................
...............................
Upkeep of current therapeutic
diet manual.
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W. Several of our previous provider enrollment rulemaking efforts
have focused on strengthening existing enrollment procedures
and eliminating existing 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 § 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 § 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.
Waiving the requirements of 42 CFR § 482.23, § 482.24 and
§ 485.635(d)(3) to provide additional flexibility related to verbal
orders where read-back verification is required, but authentication may occur later than 48 hours. This will allow more efficient treatment of patients in surge situations.
Waiving requirements under 42 CFR § 482.24(a) through (c),
which cover the subjects of the organization and staffing of the
medical records department, requirements for the form and
content of the medical record, and record retention requirements, and these flexibilities may be implemented so long as
they are not inconsistent with a state’s emergency preparedness or pandemic plan. CMS is waiving § 482.24(c)(4)(viii) related to medical records to allow flexibility in completion of
medical records within 30 days following discharge from a hospital. This flexibility will allow clinicians to focus on the patient
care at the bedside during the pandemic. CMS is waiving
§ 482.24(c)(4)(viii) related to medical records to allow flexibility
in completion of medical records within 30 days following discharge from a hospital. This flexibility will allow clinicians to
focus on the patient care at the bedside during the pandemic.
Waiving the requirements at 42 CFR § 482.23(b)(4), which requires the nursing staff to develop and keep current a nursing
care plan for each patient, and § 482.23(b)(7), which requires
the hospital to have policies and procedures in place establishing which outpatient departments are not required to have a
registered nurse present. These waivers allow nurses increased time to meet the clinical care needs of each patient
and allow for the provision of nursing care to an increased
number of patients. In addition, we expect that hospitals will
need relief for the provision of inpatient services and as a result, the requirement to establish nursing-related policies and
procedures for outpatient departments is likely of lower priority.
These flexibilities apply to both hospitals and CAHs
§ 485.635(d)(4), and may be implemented so long as they are
not inconsistent with a state’s emergency preparedness or
pandemic plan.
Food and Dietetic Services—Manual. CMS is waiving the requirement at paragraph 42 CFR § 482.28(b)(3), which requires
providers to have a current therapeutic diet manual approved
by the dietitian and medical staff readily available to all medical, nursing, and food service personnel. Such manuals would
not need to be maintained at surge capacity sites. These flexibilities may be implemented 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
156 ................
HHS .............
CMS ............
Waiver ...................
...............................
Written policies and procedures
for appraisal of emergencies
at off campus hospital departments.
157 ................
HHS .............
CMS ............
Waiver ...................
...............................
Emergency Preparedness Policies and Procedures.
158 ................
HHS .............
CMS ............
Waiver ...................
...............................
Emergency Preparedness ..........
159 ................
HHS .............
CMS ............
Waiver ...................
...............................
Reporting Requirements ............
160 ................
HHS .............
CMS ............
Waiver ...................
...............................
Extension for Inpatient Prospective Payment System (IPPS)
Wage Index Occupational Mix
Survey Submission.
161 ................
HHS .............
CMS ............
Waiver ...................
...............................
HHA Reporting ...........................
162 ................
HHS .............
CMS ............
Waiver ...................
...............................
SNF Reporting Minimum Data
Set.
163 ................
HHS .............
CMS ............
Waiver ...................
...............................
SNF Staffing Data Submission ..
164 ................
HHS .............
CMS ............
Waiver ...................
...............................
Physical Environment. ................
165 ................
HHS .............
CMS ............
Waiver ...................
...............................
CAH Status and Location ..........
Waiving 42 CFR § 482.12(f)(3), emergency services, with respect
to surge facilities only, such that written policies and procedures for staff to use when evaluating emergencies are not required for surge facilities. This removes the burden on facilities
to develop and establish additional policies and procedures at
their surge facilities or surge sites related to the assessment,
initial treatment, and referral of patients. These flexibilities may
be implemented so long as they are not inconsistent with a
state’s emergency preparedness or pandemic plan.
Waiving 42 CFR § 482.15(b) and § 485.625(b), which requires
the hospital and CAH to develop and implement emergency
preparedness policies and procedures, and § 482.15(c)(1)–(5)
and § 485.625(c)(1)–(5) which requires that the emergency
preparedness communication plans for hospitals and CAHs to
contain specified elements with respect to the surge site. The
requirement under the communication plan requires hospitals
and CAHs to have specific contact information for staff, entities
providing services under arrangement, patients’ physicians,
other hospitals and CAHs, and volunteers. This would not be
an expectation for the surge site. This waiver applies to both
hospitals and CAHs, and removes the burden on facilities to
establish these policies and procedures for their surge facilities
or surge sites.
CMS is waiving the requirements at 42 CFR § 494.62(d)(1)(iv)
which requires ESRD facilities to demonstrate as part of their
Emergency Preparedness Training and Testing Program, that
staff can demonstrate that, at a minimum, its patient care staff
maintains 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.
Waiving the requirements at 42 CFR § 482.13(g)(1)(i)–(ii), which
require that hospitals report patients in an intensive care unit
whose death is caused by their disease, but who required soft
wrist restraints to prevent pulling tubes/IVs, no later than the
close of business on the next business day. Due to current
hospital surge, CMS is waiving this requirement to ensure that
hospitals are focusing on increased patient care demands and
increased patient census, provided any death where the restraint may have contributed is still reported within standard
time limits (i.e., close of business on the next business day following knowledge of the patient’s death).
CMS collects data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in
the Medicare program. Completed 2019 Occupational Mix Surveys, Hospital Reporting Form CMS–10079, for the Wage
Index Beginning FY 2022, are due to the Medicare Administrative Contractors (MACs) on the Excel hospital reporting form
available at https://www.cms.gov/Medicare/Medicare-Fee-forService-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.
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.
Waiving 42 CFR 483.20 to provide relief to SNFs on the timeframe requirements for Minimum Data Set assessments and
transmission.
Waiving 42 CFR 483.70(q) to provide relief to long-term care facilities on the requirements for submitting staffing data through
the Payroll-Based Journal system.
CMS is waiving certain requirements under the Medicare conditions of participation at 42 CFR § 482.41 and § 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.
Waiving the requirement at 42 CFR § 485.610(b) that the CAH
be located in a rural area or an area being treated as being
rural, allowing the CAH flexibility in the establishment of surge
site locations. CMS is also waiving the requirement at
§ 485.610(e) regarding the CAH’s off-campus and co-location
requirements, allowing the CAH flexibility in establishing temporary off-site locations. In an effort to facilitate the establishment of CAHs without walls, these waivers will suspend restrictions on CAHs regarding their rural location and their location
relative to other hospitals and CAHs. These flexibilities may be
implemented so long as they are not inconsistent with a state’s
emergency preparedness or pandemic plan.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
166 ................
HHS .............
CMS ............
Waiver ...................
...............................
Hospitals Classified as Sole
Community Hospitals (SCH).
167 ................
HHS .............
CMS ............
Waiver ...................
...............................
RHC and FQHC Temporary Expansion Locations.
168 ................
HHS .............
CMS ............
Waiver ...................
...............................
Care for Excluded Inpatient Psychiatric and Inpatient Rehabilitation Unit Patients in the
Acute Care Unit of a Hospital.
169 ................
HHS .............
CMS ............
Waiver ...................
...............................
Specific Life Safety Code (LSC)
Waivers for Multiple Providers:
Temporary Construction.
170 ................
HHS .............
CMS ............
Waiver ...................
...............................
Community Mental Health Clinics (CMHC) Provision of Service.
171 ................
HHS .............
CMS ............
Waiver ...................
...............................
RAPs ..........................................
172 ................
HHS .............
CMS ............
Waiver ...................
...............................
Utilization Review (UR) ..............
173 ................
HHS .............
CMS ............
Waiver ...................
...............................
Training Program and Periodic
Audits.
174 ................
HHS .............
CMS ............
Waiver ...................
...............................
Appeals Extensions ....................
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Waiving certain eligibility requirements at 42 CFR § 412.92(a) for
hospitals classified as SCHs prior to the PHE. Specifically,
CMS is waiving the distance requirements at paragraphs (a),
(a)(1), (a)(2), and (a)(3) of 42 CFR § 412.92, and is also
waiving the ‘‘market share’’ and bed requirements (as applicable) at 42 CFR § 412.92(a)(1)(i) and (ii). CMS is waiving these
requirements for the duration of the PHE to allow these hospitals to meet the needs of the communities they serve during
the PHE, such as to provide for increased capacity and promote appropriate cohorting of COVID–19 patients. MACs will
resume their standard practice for evaluation of all eligibility requirements after the conclusion of the PHE period.
Waiving the 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. 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 § 491.5(a)(1) and (2) but will end
when the HHS Secretary determines there is no longer a PHE
due to COVID–19.
CMS is allowing acute care hospitals with excluded distinct part
inpatient psychiatric units and inpatient rehabilitation units to
relocate inpatients from 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.
CMS is waiving requirements that would otherwise not permit
temporary walls and barriers between patients.
Refer to: 2012 LSC, sections 18/19.3.3.2.
42 CFR 485.918(b)(1)(iii). We are waiving the specific requirement at § 485.918(b)(1)(iii) that prohibits CMHCs from providing partial hospitalization services and other CMHC services
in an individual’s home so that clients can safely shelter in
place during the PHE while continuing to receive needed care
and services from the CMHC. This waiver is a companion to
recent regulatory changes 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.
CMS is allowing Medicare Administrative Contractors (MACs) to
extend the auto-cancellation date of Requests for Anticipated
Payment (RAPs) during emergencies.
CMS is waiving certain requirements under 42 CFR § 482.1(a)(3)
and 42 CFR § 482.30 which address the statutory basis for
hospitals and includes the requirement that hospitals participating in Medicare and Medicaid must have a utilization review
plan that meets specified requirements.
CMS is waiving the requirement at 42 CFR § 494.40(a) related to
the condition on Water & Dialysate Quality, specifically that ontime periodic audits for operators of the water/dialysate equipment are waived to allow for flexibilities.
CMS is allowing Medicare Administrative Contractors (MACs)
and Qualified Independent Contractors (QICs) in the FFS program pursuant to 42 CFR § 405.942 and 42 CFR § 405.962
(including for MA and Part D plans), as well as the MA and
Part D Independent Review Entities (IREs) under 42 CFR
§ 422.562, 42 CFR § 423.562, 42 CFR § 422.582 and 42 CFR
§ 423.582, to allow extensions to file an appeal. CMS is allowing MACs and QICs in the FFS program under 42 CFR
§ 405.950 and 42 CFR § 405.966 and the MA and Part D IREs
to waive requests for timeliness requirements for additional information to adjudicate appeals.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
175 ................
HHS .............
CMS ............
Waiver ...................
...............................
Risk Adjusted Factor (RAF) Extensions.
176 ................
HHS .............
CMS ............
Waiver ...................
...............................
SNF 3-Day Prior Hospitalization
and 60-day ‘‘wellness period’’.
177 ................
HHS .............
CMS ............
Waiver ...................
...............................
Supporting Care for Patients in
Long-Term Care Acute Hospitals (LTCHs).
178 ................
HHS .............
CMS ............
Waiver ...................
...............................
CAH Bed Count and Length of
Stay.
179 ................
HHS .............
CMS ............
Waiver ...................
...............................
Hospitals Classified as Medicare-Dependent, Small Rural
Hospitals (MDH).
180 ................
HHS .............
CMS ............
Waiver ...................
...............................
Hospice Aide Competency testing Allow Use of Pseudo Patients.
181 ................
HHS .............
CMS ............
Waiver ...................
...............................
Onsite Visits for Hospice Aide
Supervision.
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• CMS is allowing MACs and QICs in the FFS program
under 42 CFR § 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 § 422.561 and 42 CFR
§ 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 § 405.950 and 42 CFR § 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 § 422.561 and 42 CFR
§ 423.560.
• CMS is allowing MACs and QICs in the FFS program
under 42 CFR § 405.950 and 42 CFR § 405.966 (also including MA and Part D plans), as well as the MA and Part
D IREs under 42 CFR § 422.562 and 42 CFR § 423.562 to
utilize all flexibilities available in the appeal process as if
good cause requirements are satisfied.
CMS is allowing MACs and QICs in the FFS program 42 CFR
405.950 and 42 CFR 405.966 and the Part C and Part D IREs
to waive requirements for timeliness for requests for additional
information to adjudicate appeals; MA plans may extend the
timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B
drugs) by up to 14 calendar days if: The enrollee requests the
extension; the extension is justified and in the enrollee’s interest due to the need for additional medical evidence from a
noncontract provider that may change an MA organization’s
decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest 42 CFR
§ 422.568(b)(1)(i), § 422.572(b)(1) and § 422.590(f)(1).
Using the authority under Section 1812(f) of the Act, CMS is
waiving the requirement for a 3-day prior hospitalization for
coverage of a SNF stay, which provides temporary emergency
coverage of SNF services without a qualifying hospital stay, for
those people who experience dislocations, or are otherwise affected by COVID–19. In addition, for certain beneficiaries who
recently exhausted their SNF benefits, it authorizes 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).
CMS has determined it is appropriate to issue a blanket waiver
to long-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.
Waiving the requirements that CAHs limit the number of beds to
25, and that the length of stay be limited to 96 hours under the
Medicare conditions of participation for number of beds and
length of stay at 42 CFR § 485.620.
For hospitals classified as MDHs prior to the PHE, CMS is
waiving the eligibility requirement at 42 CFR § 412.108(a)(1)(ii)
that the hospital has 100 or fewer beds during the cost reporting period, and the eligibility requirement at 42 CFR
§ 412.108(a)(1)(iv)(C) that at least 60 percent of the hospital’s
inpatient days or discharges were attributable to individuals entitled to Medicare Part A benefits during the specified hospital
cost reporting periods. CMS 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.
Temporarily modifying the requirement in § 418.76(c)(1) that a
hospice aide must be evaluated by observing an aide’s performance of certain tasks with a patient. This modification allows hospices to utilize pseudo patients such as a person
trained to participate in a role-play situation or a computerbased 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).
Waiving the requirements at 42 CFR § 418.76(h), which require a
nurse to conduct an onsite supervisory visit every two weeks.
This would include waiving the requirements for a nurse or
other professional to conduct an onsite visit every two weeks
to evaluate if aides are providing care consistent with the care
plan, as this may not be physically possible for a period of
time.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
182 ................
HHS .............
CMS ............
Waiver ...................
...............................
Patient Self Determination Act
Requirements (Advance Directives).
183 ................
HHS .............
CMS ............
Waiver ...................
...............................
Resident Roommates and
Grouping.
184 ................
HHS .............
CMS ............
Waiver ...................
...............................
Defer Equipment Maintenance &
Fire Safety Inspections.
185 ................
HHS .............
CMS ............
Waiver ...................
...............................
Ability to Delay Some Patient
Assessments.
186 ................
HHS .............
CMS ............
Waiver ...................
...............................
SNF-Waiving Pre-Admission
Screening and Annual Resident Review (PASARR).
187 ................
HHS .............
CMS ............
Waiver ...................
...............................
Physician Self-Referral Regulations.
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Waiving the requirements at sections 1902(a)(58) and
1902(w)(1)(A) of the Act (for Medicaid); 1852(i) of the Act (for
Medicare Advantage); and 1866(f) of the Act and 42 CFR
§ 489.102 (for Medicare), which require hospitals and CAHs to
provide information about their advance directive policies to
patients. CMS is waiving this requirement to allow staff to more
efficiently deliver care to a larger number of patients.
Waiving the requirements 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.
Waiving the requirement at 42 CFR § 494.60(b) for on-time preventive maintenance of dialysis machines and ancillary dialysis
equipment. Additionally, CMS is also waiving the requirements
under § 494.60(d) which requires ESRD facilities to conduct
on-time fire inspections. These waivers are intended to ensure
that dialysis facilities are able to focus on the operations related to the Public Health Emergency.
CMS is not waiving subsections (a) or (c) of 42 CFR § 494.80,
but is waiving the following requirements at 42 CFR
§ 494.80(b) related to the frequency of assessments for patients admitted to the dialysis facility. CMS is waiving the ‘‘on
time’’ requirements for the initial and follow up comprehensive
assessments within the specified timeframes as noted below.
This waiver applies to assessments conducted by members of
the interdisciplinary team, including: A registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. These waivers are intended to ensure that dialysis facilities are able to focus on the operations related to the Public
Health Emergency. Specifically, CMS is waiving:
• § 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.
• § 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 § 494.90.
Waiving 42 CFR 483.20(k), allowing nursing homes to admit new
residents 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.
Waivers of Sanctions under the Stark Law. CMS 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
188 ................
HHS .............
CMS ............
Waiver ...................
...............................
Medicare Graduate Medical
Education (GME) Affiliation
Agreement.
189 ................
HHS .............
CMS ............
Waiver ...................
...............................
Allow use of audio-only equipment to furnish audio-only
telephone E/M, counseling,
and educational services.
190 ................
HHS .............
CMS ............
Waiver ...................
...............................
Hospital Telemedicine ................
191 ................
HHS .............
CMS ............
Waiver ...................
...............................
Hospital Care of Patients ...........
192 ................
HHS .............
CMS ............
Waiver ...................
...............................
Responsibilities of Physicians in
Critical Access Hospitals
(CAHs).
193 ................
HHS .............
CMS ............
Waiver ...................
...............................
Anesthesia Services ...................
194 ................
HHS .............
CMS ............
Waiver ...................
...............................
Physician Supervision of NPs in
RHCs and FQHCs.
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Due to the COVID–19 Public Health Emergency (PHE), under
the 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 Medicare_GME_Affiliation_
Agreement@cms.hhs.gov, and indicate in the subject line
whether the affiliation agreement is a new one or an amended
one.
Pursuant to authority granted under the CARES Act, CMS is
waiving the requirements of section 1834(m)(1) of the ACT and
42 CFR § 410.78(a)(3) for use of interactive telecommunications systems to furnish telehealth services, to the extent
they require use of video technology, for certain services. This
waiver allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services (see designated codes https://
www.cms.gov/Medicare/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.
Waiving the provisions related to telemedicine at 42 CFR
§ 482.12(a)(8)–(9) for hospitals and § 485.616(c) for CAHs,
making it easier for telemedicine services to be furnished to
the hospital’s patients through an agreement with an off-site
hospital.
Waiving requirements under 42 CFR § 482.12(c)(1)–(2) and
§ 482.12(c)(4), which requires that Medicare patients be under
the care of a physician. This waiver may be implemented 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.
42 CFR § 485.631(b)(2). CMS is waiving the requirement 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 § 485.631(b)(2).
CMS is retaining the regulatory language in the second part of
the requirement at § 485.631(b)(2) that a physician be available ‘‘through direct radio or telephone communication, or electronic communication for consultation, assistance with medical
emergencies, or patient referral.’’ Retaining this longstanding
CMS policy and related longstanding subregulatory guidance
that further described communication between CAHs and physicians will assure an appropriate level of physician direction
and supervision for the services provided by the CAH. This will
allow the physician to perform responsibilities remotely, as appropriate. This also allows CAHs to use nurse practitioners and
physician assistants to the fullest extent possible, while ensuring necessary consultation and support as needed.
Waiving requirements under 42 CFR § 482.52(a)(5),
§ 485.639(c)(2), and § 416.42 (b)(2) that a certified registered
nurse anesthetist (CRNA) is under the supervision of a physician in paragraphs § 482.52(a)(5) and § 485.639(c)(2). CRNA
supervision will be at the discretion of the hospital and state
law. This waiver applies to hospitals, CAHs, and Ambulatory
Surgical Centers (ASCs). These waivers will allow CRNAs to
function to the fullest extent of their licensure, and may be implemented so long as they are not inconsistent with a state’s
emergency preparedness or pandemic plan.
42 CFR 491.8(b)(1). We are modifying the requirement that physicians must provide medical direction for the clinic’s or center’s health 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
195 ................
HHS .............
CMS ............
Waiver ...................
...............................
Staffing Requirements for RCHs
and FQHCs.
196 ................
HHS .............
CMS ............
Waiver ...................
...............................
CAH Staff Licensure ..................
197 ................
HHS .............
CMS ............
Waiver ...................
...............................
CAH Personnel Qualifications ....
198 ................
HHS .............
CMS ............
Waiver ...................
...............................
Physician Delegation of Tasks in
SNFs.
199 ................
HHS .............
CMS ............
Waiver ...................
...............................
Allow Occupational Therapists
(OTs), Physical Therapists
(PTs), and Speech Language
Pathologists (SLPs) to Perform Initial and Comprehensive Assessment for all Patients.
200 ................
HHS .............
CMS ............
Waiver ...................
...............................
Physician Visits ..........................
201 ................
HHS .............
CMS ............
Waiver ...................
...............................
Practitioner Locations .................
Waiving the requirement in the second sentence of § 491.8(a)(6)
that a nurse practitioner, physician assistant, or certified nursemidwife 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 § 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.
Deferring to staff licensure, certification, or registration to state
law by waiving 42 CFR § 485.608(d) regarding the requirement
that staff of the CAH be licensed, certified, or registered in accordance with applicable federal, state, and local laws and regulations. This waiver will provide maximum flexibility for CAHs
to use all available clinicians. These flexibilities may be implemented so long as they are not inconsistent with a state’s
emergency preparedness or pandemic plan.
Waiving the minimum personnel qualifications for clinical nurse
specialists at paragraph 42 CFR § 485.604(a)(2), nurse practitioners at paragraph § 485.604(b)(1)–(3), and physician assistants at paragraph § 485.604(c)(1)–(3). Removing these Federal
personnel requirements will allow CAHs to employ individuals
in these roles who meet state licensure requirements and provide maximum staffing flexibility. These flexibilities should be
implemented so long as they are not inconsistent with a state’s
emergency preparedness or pandemic plan.
42 CFR 483.30(e)(4). Waiving the requirement in § 483.30(e)(4)
that prevents a physician from delegating a task when the regulations specify that the physician must perform it personally.
This waiver gives physicians the ability to delegate any tasks
to a physician assistant, nurse practitioner, or clinical nurse
specialist who meets the applicable definition in 42 CFR 491.2
or, in the case of a clinical nurse specialist, is licensed as such
by the State and is acting within the scope of practice laws as
defined by State law. We are temporarily modifying this regulation to specify that any task delegated under this waiver must
continue to be under the supervision of the physician. This
waiver does not include the provision of § 483.30(e)(4) that
prohibits a physician from delegating a task when the delegation is prohibited under State law or by the facility’s own policy.
CMS is waiving the requirements in 42 CFR § 484.55(a)(2) and
§ 484.55(b)(3) that rehabilitation skilled professionals may only
perform the initial and comprehensive assessment when only
therapy services are ordered. This temporary blanket modification allows any rehabilitation professional (OT, PT, or SLP) to
perform the initial and comprehensive assessment for all patients receiving therapy services as part of the plan of care, to
the extent permitted under state law, regardless of whether or
not the service establishes eligibility for the patient to be receiving home care. The existing regulations at § 484.55(a) and
(b)(2) would continue to apply; 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.
42 CFR 483.30(c)(3). CMS is waiving the requirement at
§ 483.30(c)(3) that all required physician visits (not already exempted in § 483.30(c)(4) and (f)) must be made by the physician personally. We are modifying this provision to permit 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.
42 CFR 424.510 (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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
202 ................
HHS .............
CMS ............
Waiver ...................
...............................
Waive Onsite Visits for HHA
Aide Supervision.
203 ................
HHS .............
CMS ............
Waiver ...................
...............................
ESRD Telemedicine and Report
Patient Care.
204 ................
HHS .............
CMS ............
Waiver ...................
...............................
ESRD Telemedicine and Report
Patient Care.
205 ................
HHS .............
CMS ............
Waiver ...................
...............................
Medical Staff Eligibility ...............
206 ................
HHS .............
CMS ............
Waiver ...................
...............................
Physician Visits in Skilled Nursing Facilities/Nursing Facilities.
207 ................
HHS .............
CMS ............
Waiver ...................
...............................
12 hour Annual in-service Training Requirement for Hospice
Aides.
208 ................
HHS .............
CMS ............
Waiver ...................
...............................
Dialysis Patient Care Technician
(PCT) Certification.
209 ................
HHS .............
CMS ............
Waiver ...................
...............................
Transferability of Physician
Credentialing.
210 ................
HHS .............
CMS ............
Waiver ...................
...............................
Remote Patient Monitoring Reporting.
211 ................
HHS .............
CMS ............
Waiver ...................
...............................
Remote Evaluations, Virtual
Check-Ins & E-Visits.
212 ................
HHS .............
CMS ............
Waiver ...................
...............................
Remote Evaluations, Virtual
Check-Ins & E-Visits.
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• In addition to the statutory limitations that apply to 1135based 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.
CMS is waiving the requirements at 42 CFR § 484.80(h), which
require a nurse to conduct an onsite visit every two weeks.
This would include waiving the requirements for a nurse or
other professional to conduct an onsite visit every two weeks
to evaluate if aides are providing care consistent with the care
plan, as this may not be physically possible for a period of
time. This waiver is also temporarily suspending the 2-week
aide supervision by a registered nurse for home health agencies requirement at § 484.80(h)(1), but virtual supervision is encouraged during the period of the waiver.
For Medicare patients with End Stage Renal Disease (ESRD),
clinicians no longer must have one ‘‘hands on’’ visit per month
for the current required clinical examination of the vascular access site.
For Medicare patients with ESRD, we are 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.
Waiving requirements under 42 CFR § 482.22(a)(1)–(4) to allow
for physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice before full medical staff/governing body review and approval to address workforce concerns related to COVID–19.
CMS is waiving § 482.22(a)(1)–(4) regarding details of the
credentialing and privileging process.
CMS is waiving the requirement in 42 CFR 483.30 for physicians
and non-physician practitioners to perform in-person visits for
nursing home residents and allow visits to be conducted, as
appropriate, via telehealth options.
42 CFR 418.76(d). CMS is waiving the requirement that hospices
must assure that each hospice aide receives 12 hours of inservice 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.
Modifying the requirement at 42 CFR § 494.140(e)(4) for dialysis
PCTs that requires certification under a state certification program or a national commercially available certification program
within 18 months of being hired as a dialysis PCT for newly
employed patient care technicians. CMS is aware of the challenges that PCTs are facing with the limited availability and
closures of testing sites during the time of this crisis. CMS will
allow PCTs to continue working even if they have not achieved
certification within 18 months or have not met on time renewals.
Modifying the requirement at 42 CFR § 494.180(c)(1) which requires that all medical staff appointments and credentialing are
in accordance with state law, including attending physicians,
physician assistants, nurse practitioners, and clinical nurse
specialists. These waivers will allow physicians that are appropriately credentialed at a certified dialysis facility to function to
the fullest extent of their licensure to provide care at designated isolation locations without separate credentialing at
that facility, and may be implemented so long as they are not
inconsistent with a state’s emergency preparedness or pandemic plan.
Clinicians can provide remote patient 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).
Medicare patients may have a brief 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.
111 E-visits are non-face-to-face communications with their practitioner by using online patient portals. (HCPCS codes G2061–
G2063).
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
213 ................
HHS .............
CMS ............
Waiver ...................
...............................
Flexibility for IRF Regarding the
‘‘60 Percent Rule’’.
214 ................
HHS .............
CMS ............
Waiver ...................
...............................
LTCH Site Neutral Payment
Rate Provisions.
215 ................
HHS .............
CMS ............
Waiver ...................
...............................
Eligibility for Telehealth ..............
216 ................
HHS .............
CMS ............
Waiver ...................
...............................
IRF Intensity of Therapy Requirement (‘‘3-Hour Rule’’).
217 ................
HHS .............
CMS ............
Waiver ...................
...............................
Emergency Medical Treatment &
Labor Act (EMTALA) Section
1867(a).
Allowing IRFs to exclude patients from the freestanding hospital’s
or excluded distinct part unit’s inpatient population for purposes
of calculating the applicable thresholds associated with the requirements to receive payment as an IRF (commonly referred
to as the ‘‘60 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.
As required by section 3711(b) of the CARES 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.
Pursuant to authority granted under the Coronavirus Aid, Relief,
and Economic Security Act (CARES Act) that broadens the
waiver authority under section 1135 of the Social Security Act,
the Secretary has authorized additional telehealth waivers.
CMS is waiving the requirements of section 1834(m)(4)(E) of
the Act and 42 CFR 410.78 (b)(2) which specify the types of
practitioners that may bill for their services when furnished as
Medicare telehealth services from the distant site. The waiver
of these requirements expands the types of health care professionals 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.
As required by section 3711(a) of the Coronavirus Aid, Relief,
and Economic Security (CARES) Act, during the COVID–19
public health emergency, the Secretary has waived 42 CFR
412.622(a)(3)(ii) which provides that payment generally requires that patients of an inpatient rehabilitation facility receive
at least 15 hours of therapy per week. This waiver clarifies information provided in ‘‘Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID–19
Public Health Emergency’’ (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.
Waiving the enforcement of section 1867(a) of the Act. This will
allow 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
218 ................
HHS .............
CMS ............
Waiver ...................
...............................
Quality Assessment and Performance Improvement (QAPI)
Program.
219 ................
HHS .............
CMS ............
Waiver ...................
...............................
Signature and Proof of Delivery
Requirements.
220 ................
HHS .............
CMS ............
Guidance ...............
...............................
Accelerated/Advance Payments
221 ................
HHS .............
CMS ............
Guidance ...............
...............................
Part D ‘‘Refill-Too-Soon’’ Edits
and Maximum Day Supply.
222 ................
HHS .............
CMS ............
Guidance ...............
...............................
Long-Term Care Dispensing ......
223 ................
HHS .............
CMS ............
Guidance ...............
...............................
Audit Reviews ............................
224 ................
HHS .............
CMS ............
Guidance ...............
...............................
Part D Enforcement Discretion ..
225 ................
HHS .............
CMS ............
Guidance ...............
...............................
Special Requirements ................
Waiving 42 CFR 482.21(a)–(d) and (f), and 485.641(a), (b), and
(d), which provide details on the scope of the program, the incorporation, and setting 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, datadriven quality assessment and performance improvement program will remain. This waiver applies to both hospitals and
CAHs.
CMS is waiving signature and proof of delivery 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.
In order to increase cash 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.
Consistent with section 3714 of the CARES Act, 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.
CMS intends to exercise 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
§ 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.
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.
CMS is exercising its 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.
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 § 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
226 ................
HHS .............
CMS ............
Guidance ...............
...............................
Prior Authorization ......................
227 ................
HHS .............
CMS ............
Guidance ...............
...............................
Home or Mail Delivery of Part D
Drugs.
228 ................
HHS .............
CMS ............
Guidance ...............
...............................
Pharmacies Enrolling as Labs ...
229 ................
HHS .............
CMS ............
Guidance ...............
Survey Guidance
QSO–20–12–All.
Suspension of Enforcement Activities.
230 ................
HHS .............
CMS ............
Guidance ...............
...............................
Medicare Provider Enrollment
Relief.
231 ................
HHS .............
CMS ............
Guidance ...............
...............................
Temporary Expansion Locations
232 ................
HHS .............
CMS ............
Waiver ...................
...............................
Long Term Care Facility Training and Certification of Nurse
Aides.
233 ................
HHS .............
CMS ............
Waiver ...................
...............................
Modification of Substitute Billing
Arrangements Timetable.
234 ................
HHS .............
CMS ............
Waiver ...................
...............................
Ambulatory Surgical Centers &
Freestanding Emergency Departments (EDs) Hospital
Conversion.
235 ................
HHS .............
CMS ............
Waiver ...................
42 CFR 424.36E ...
Beneficiary claims signature requirements for ambulance
services.
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• 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
§ 422.111(d)(3). (Such changes could include reductions in
cost-sharing and waiving prior authorizations as described
below.)
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.
In situations when a disaster or emergency 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.
Pharmacies may enroll in Medicare as a Clinical Laboratory Improvement Act (CLIA) laboratory if they have their CLIA certification.
During the prioritization period, the following 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:
Æ 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;
Æ 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;
Æ 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.
42 CFR 424.514 42 CFR 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.
Temporary Expansion 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.
Waive requirements at 42 CFR 483.35(d) (with the exception of
42 CFR 483.35(d)(1)(i)), which require that a SNF and NF may
not employ anyone for longer than four months unless they
met the training and certification requirements under
§ 483.35(d).
Allows a physician or physical therapist to use the same substitute for the entire time he or she is unavailable to provide
services during the COVID–19 emergency plus an additional
period of no more than 60 continuous days after the public
health emergency expires.
During the PHE, CMS has created streamlined and temporary
enrollment process for ASCs and licensed Freestanding 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.
CMS has determined that there is good cause to accept transport staff 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
236 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Durable Medical Equipment Interim Pricing in the CARES
Act.
237 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Basic Health Program Blueprint
Revisions.
238 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Flexibility for Medicaid Laboratory Services.
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I. Changes to the Medicare regulations to revise payment rates
for 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 § 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 § 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 § 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
§ 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 § 414.210(g)(1)
through (8) (referred to as ‘‘this section’’ in the regulation text).
In addition, we are revising § 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 § 414.210(g)(1) through (8) (‘‘this
section’’ in the regulation text).
This IFC revises 42 CFR § 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.
This IFC amends the CMS regulation at 42 CFR 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
239 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
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Improving Care Planning for
Medicaid Home Health Services.
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P. Section 3708 of the CARES Act amended Medicare requirements at 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 § 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, § 440.70(a)(2) is
amended to allow a NP, CNS and PA to order home health
services described in § 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
§ 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
240 ................
HHS .............
CMS ............
Interim Final Rule ..
RIN 0938–AU31 ....
Clarification on Reporting Under
the Home Health Value-Based
Purchasing Model for CY
2020.
241 ................
HHS .............
CMS ............
Waiver ...................
...............................
Respiratory Care Services .........
242 ................
HHS .............
CMS ............
Waiver ...................
...............................
Documentation of Progress
Notes.
243 ................
HHS .............
CMS ............
Waiver ...................
...............................
DMEPOS Replacement Requirements.
244 ................
HHS .............
CMS ............
Waiver ...................
...............................
Modified Discharge Planning .....
A. Through this IFC, we are implementing a policy to align the
Home Health Value-Based 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.
Waiving the requirements at 42 CFR § 482.57(b)(1) that require
hospitals to designate in writing the personnel qualified to perform specific respiratory care procedures and the amount of
supervision required for personnel to carry out specific procedures. These flexibilities may be implemented so long as they
are not inconsistent with a state’s emergency preparedness or
pandemic plan.
Scope of authority extended for non-physician practitioners to
document progress notes of patients receiving services in psychiatric hospitals.
Where Durable Medical 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.
Waiving the requirement 42 CFR § 482.43(a)(8), § 482.61(e), and
§ 485.642(a)(8) to provide detailed information regarding discharge planning, described below:
• 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
245 ................
HHS .............
CMS ............
Waiver ...................
...............................
Detailed Information Sharing for
Discharge Planning for Home
Health Agencies.
246 ................
HHS .............
CMS ............
Waiver ...................
...............................
DMEPOS Signature on Orders ..
247 ................
HHS .............
CMS ............
Waiver ...................
...............................
Specific Physical Environment
Waivers for Inspection, Testing and Maintenance.
248 ................
HHS .............
CMS ............
Waiver ...................
...............................
Special Purpose Renal Dialysis
Facilities (SPRDF) Designation Expanded.
249 ................
HHS .............
CMS ............
Waiver ...................
...............................
Expanded Ability for Hospitals to
Offer Long-term Care Services (‘‘Swing-Beds’’) for Patients Who do not Require
Acute Care but do Meet the
Skilled Nursing Facility (SNF)
Level of Care Criteria as Set
Forth at 42 CFR 409.31.
250 ................
HHS .............
CMS ............
Waiver ...................
...............................
Housing Acute Care Patients in
the IRF or IPF Excluded Distinct Part Units.
251 ................
HHS .............
CMS ............
Waiver ...................
...............................
Resident Transfer and Discharge.
Waiving the requirements of 42 CFR § 484.58(a) to provide detailed information regarding discharge planning, to patients and
their caregivers, or the patient’s representative in selecting a
post-acute care provider by using and sharing data that includes, but is not limited to, (another) home health agency
(HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long-term care hospital (LTCH) quality measures and resource use measures.
• 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.
DMEPOS items, except for 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.
42 CFR § 482.41(d) for hospitals, § 485.623(b) for CAH,
§ 418.110(c)(2)(iv) for inpatient hospice, § 483.470(j) for ICF/
IID; and § 483.90 for SNFs/NFs all 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.
Authorizes the establishment of SPRDFs under 42 CFR
§ 494.120 to address access to care issues due to COVID–19
and the need to mitigate transmission among this vulnerable
population. This will not include the normal determination regarding lack of access to care at § 494.120(b) as this standard
has been met during the period of the national emergency. Approval as a Special Purpose Renal Dialysis Facility related to
COVID–19 does not require Federal survey prior to providing
services.
Under section 1135(b)(1) of the Act, CMS is waiving the requirements at 42 CFR 482.58, ‘‘Special Requirements for hospital
providers of long-term care services (‘‘swing-beds’’)’’ subsections (a)(1)–(4) ‘‘Eligibility’’, to allow hospitals to establish
SNF swing beds payable under the SNF prospective payment
system (PPS) to provide additional options for hospitals with
patients who no longer require acute care but are unable to
find placement in a SNF. In order to qualify for this waiver,
hospitals must:
• 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.
Waiving requirements to allow acute care hospitals to house
acute care inpatients in excluded distinct part units, such as
excluded distinct part unit IRFs or IPFs, where the distinct part
unit’s beds are appropriate for acute care inpatients. The Inpatient Prospective Payment System (IPPS) hospital should bill
for the care and annotate the patient’s medical record to indicate the patient is an acute care inpatient being housed in the
excluded unit because of capacity issues related to the disaster or emergency.
Waiving requirements in 42 CFR 483.10(c)(5); 483.15(c)(3),
(c)(4)(ii), (c)(5)(i) and (iv), (c)(9), and (d); and § 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:
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252 ................
Agency
HHS .............
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...............................
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• 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 § 483.10, we are only waiving the requirement, under
§ 483.10(c)(5), that a facility provide advance notification
of options relating to the transfer or discharge to another
facility. Otherwise, all requirements related to § 483.10 are
not waived. Similarly, in § 483.15, we are only waiving the
requirement, under § 483.15(c)(3), (c)(4)(ii), (c)(5)(i) and
(iv), and (d), for the written notice of transfer or discharge
to be provided before the transfer or discharge. This notice must be provided as soon as practicable.
• In § 483.21, we are only waiving the timeframes for certain
care planning requirements for residents who are transferred or discharged for the purposes explained in 1–3
above. Receiving facilities should complete the required
care plans as soon as practicable, and we expect receiving facilities to review and use the care plans for residents
from the transferring facility, and adjust as necessary to
protect the health and safety of the residents the apply to.
• 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.
Æ 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.
ESRD requirements at 42 CFR 494.180(d) require dialysis facilities to provide services directly on its main premises or on
other premises that are contiguous with the main premises.
CMS is waiving this requirement to allow dialysis facilities to
provide service to its patients who reside in the nursing homes,
long-term care facilities, assisted living facilities and similar
types of facilities, as licensed by the state (if applicable). CMS
continues to require that services 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
253 ................
HHS .............
CMS ............
Waiver ...................
...............................
Specific Physical Environment
Waiver for Outside Window
and Outside Door Requirements.
254 ................
HHS .............
CMS ............
Waiver ...................
...............................
Temporary Expansion Locations
255 ................
HHS .............
CMS ............
Waiver ...................
RIN 0938–AU31 ....
IRF and IPF Teaching Status
Adjustment Payments.
256 ................
HHS .............
CMS ............
Waiver ...................
...............................
Care for Patients in Extended
Neoplastic Disease Care Hospitals.
257 ................
HHS .............
CMS ............
Waiver ...................
...............................
Community Mental Health Clinic
(CMHC) 40 Percent Rule.
258 ................
HHS .............
CMS ............
Waiver ...................
...............................
Resident Groups ........................
259 ................
HHS .............
CMS ............
Waiver ...................
...............................
Non-Core Services .....................
260 ................
HHS .............
CMS ............
Waiver ...................
...............................
Time Period for Initiation of Care
Planning and Monthly Physician Visits.
Brief summary of action
42 CFR 482.41(b)(9) for hospitals, § 485.623(c)(7) for CAHs,
§ 418.110(d)(6) for inpatient hospices, § 483.470(e)(1)(i) for
ICF/IIDs, and § 483.90(a)(7) for SNFs/NFs 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.
For the duration of the PHE related to COVID–19, CMS is
waiving certain requirements under the Medicare conditions of
participation at 42 CFR 482.41 and § 485.623 (as noted elsewhere in this waiver document) and the provider-based department requirements at § 413.65 to allow hospitals to establish
and operate as part of the hospital any location meeting those
conditions of participation for hospitals that continue to apply
during the PHE. This waiver also allows hospitals to change
the status of their current provider-based department locations
to the extent necessary to address the needs of hospital patients as part of the state or local pandemic plan. This extends
to any entity operating as a hospital (whether a current hospital
establishing a new location or an Ambulatory Surgical Center
(ASC) enrolling as a hospital during the PHE pursuant to a
streamlined enrollment and survey and certification process) 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.
To ensure that teaching IRFs and IPFs can 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.
CMS is allowing extended neoplastic disease care hospitals to
exclude inpatient stays where the hospital admits or discharges patients in order to meet the demands of the emergency from the greater than 20-day average length of stay requirement, which allows these facilities to be excluded from the
hospital inpatient prospective payment system and paid an adjusted payment for Medicare inpatient operating and capital-related costs under the reasonable cost based reimbursement
rules as authorized under Section 1886(d)(1)(B)(vi) of the Act
and 42 CFR 412.22(i).
Waiving the requirement at § 485.918(b)(1)(v) that a CMHC provides at least 40 percent of its items and services to individuals who are not eligible for Medicare benefits. Waiving the 40
percent requirement will facilitate appropriate timely discharge
from inpatient psychiatric units and prevent admissions to
these facilities because CMHCs will be able to provide PHP
services to Medicare beneficiaries without restrictions on the
proportion of Medicare beneficiaries that they are permitted to
treat at a time. This will allow communities greater access to
health services, including mental health services.
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.
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.
Modifying two requirements related to care planning, specifically:
• 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.
• § 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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
261 ................
HHS .............
CMS ............
Waiver ...................
...............................
Dialysis Home Visits to Assess
Adaptation and Home Dialysis
Machine Designation.
262 ................
HHS .............
CMS ............
Waiver ...................
...............................
ICF/IID Suspension of Community Outings.
263 ................
HHS .............
CMS ............
Waiver ...................
...............................
ICF/IID Modification of Adult
Training Programs and Active
Treatment.
264 ................
HHS .............
CMS ............
Waiver ...................
...............................
Timeframes for Hospice Comprehensive Assessments.
265 ................
HHS .............
CMS ............
Waiver ...................
...............................
Clinical Records for Long-Term
Care (LTC) Facilities.
266 ................
HHS .............
CMS ............
Waiver ...................
...............................
Clinical Records for HHAs .........
267 ................
HHS .............
CMS ............
Waiver ...................
...............................
Ambulance Services: Medicare
Ground Ambulance Data Collection System.
Waiving the requirement at 42 CFR 494.100(c)(1)(i) which requires the periodic monitoring of the patient’s home adaptation,
including visits to the patient’s home by facility personnel. For
more information on existing flexibilities for in-center dialysis
patients to receive their dialysis treatments in the home, or
long-term care facility, referenceQSO–20–19–ESRD.
Waiving the requirements at 42 CFR 483.420(a)(11) which requires clients have the opportunity to participate in social, religious, and community group activities. The federal and/or state
emergency restrictions will dictate 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.
CMS is waiving those components of beneficiaries’ active treatment programs and training that would violate current state
and local requirements for social distancing, staying at home,
and traveling for essential services only. For example, although
day habilitation programs and supported employment are important opportunities for training and socialization of clients at
intermediate care facilities for individuals with developmental
disabilities, these programs pose too high of a risk to staff and
clients for exposure to a person with suspected or confirmed
COVID–19. In accordance with § 483.440(c)(1), any modification to a client’s Individual Program Plan (IPP) in response to
treatment changes associated with the COVID–19 crisis requires the approval of the interdisciplinary team. For facilities
that have interdisciplinary team members who are unavailable
due to the COVID–19, CMS would allow for a retroactive review of the IPP under 483.440(f)(2) in order to allow IPPs to
receive modifications as necessary based on the impact of the
COVID–19 crisis.
CMS is waiving certain requirements at 42 CFR 418.54 related to
updating comprehensive assessments of patients. This waiver
applies the timeframes for updates to the comprehensive assessment found at § 418.54(d). Hospices must continue to
complete the required assessments and updates; however, the
timeframes for updating the assessment may be extended
from 15 to 21 days.
Pursuant to section 1135(b)(5) of the Act, CMS is modifying the
requirement at 42 CFR 483.10(g)(2)(ii) which requires longterm 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.
In accordance with 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.
Modifying the data collection period and data reporting period, as
defined at 42 CFR § 414.626(a), for ground ambulance organizations (as defined at 42 CFR § 414.605) that were selected
by CMS under 42 CFR § 414.626(c) to collect data beginning
between January 1, 2020 and December 31, 2020 (year 1) for
purposes of complying with the data reporting requirements
described at 42 CFR § 414.626. Under this modification, these
ground ambulance organizations can select a new continuous
12-month data collection period that begins between January
1, 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 § 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 § 414.626.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
268 ................
HHS .............
CMS ............
Waiver ...................
...............................
Paid Feeding Assistants for
Long-Term Care Facilities
(LTCF).
269 ................
HHS .............
CMS ............
Waiver ...................
42 CFR
483.430(e)(1).
ICF/IID Mandatory Training Requirements Suspension.
270 ................
HHS .............
CMS ............
Waiver ...................
...............................
Requirement for Hospices to
Use Volunteers.
271 ................
HHS .............
CMS ............
Waiver ...................
...............................
ICF/IID Staffing Flexibilities ........
272 ................
HHS .............
CMS ............
Waiver ...................
...............................
Ambulatory Surgical Center
(ASC) Medical Staff.
273 ................
HHS .............
CMS ............
Waiver ...................
...............................
Sterile Compounding ..................
274 ................
HHS .............
CMS ............
Waiver ...................
...............................
Patient Rights .............................
275 ................
HHS .............
CMS ............
Waiver ...................
...............................
Certification related to LongTerm Care Facilities (Physical
Environment).
Brief summary of action
Modifying the requirements at 42 CFR 483.60(h)(1)(i) and
483.160(a) regarding required training of paid feeding assistants. Specifically, CMS is modifying the minimum timeframe
requirements in these sections, which require this training to
be a minimum of 8 hours. CMS is modifying to allow that the
training can be a minimum of 1 hour in length. CMS is not
waiving any other requirements under 42 CFR 483.60(h) related to paid feeding assistants or the required training content
at 42 CFR 483.160(a)(1)–(8), which contains infection control
training and other elements. Additionally, CMS is also not
waiving or modifying the requirements at 42 CFR
483.60(h)(2)(i), which requires that a feeding assistant must
work under the supervision of a registered nurse (RN) or licensed practical nurse (LPN).
Waiving, in-part, the requirements at 42 CFR 483.430(e)(1) related to routine staff training programs unrelated to the public
health emergency. CMS is not waiving 42 CFR 483.430(e)(2)–
(4) which requires focusing on the clients’ developmental, behavioral and health needs and being able to demonstrate skills
related to interventions for inappropriate behavior and implementing individual plans. We are not waiving these requirements as we believe the staff ability to develop and implement
the skills necessary to effectively address clients’ developmental, behavioral and health needs are essential functions for
an ICF/IID. CMS is also not waiving initial training for new staff
hires or training for staff around prevention and care for the infection control of COVID–19. It is critical that new staff gain the
necessary skills and understanding of how to effectively perform their role as they work with this complex client population
and that staff understand how to prevent and care for clients
with COVID–19.
Waiving the requirement at 42 CFR 418.78(e) that hospices are
required to use volunteers (including at least 5% of patient
care hours). It is anticipated that hospice volunteer availability
and use will be reduced related to COVID–19 surge and potential quarantine.
Waiving the requirements at 42 CFR 483.430(c)(4), which requires the facility to provide sufficient Direct Support Staff
(DSS) so that Direct Care Staff (DCS) are not required to perform support services that interfere with direct client care. DSS
perform activities such as cleaning of the facility, cooking, and
laundry services. DSC perform activities such as teaching clients appropriate hygiene, budgeting, or effective communication and socialization skills. During the time of this waiver, DCS
may be needed to conduct some of the activities normally performed by the DSS. This will allow facilities to adjust staffing
patterns, while maintaining the minimum staffing ratios required
at § 483.430(d)(3).
Waiving the requirement at § 416.45(b) that 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.
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.
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:
• § 482.13(d)(2)—With respect to timeframes in providing a
copy of a medical record.
• § 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.
• § 482.13(e)(1)(ii)—Regarding seclusion.
Waiving requirements related at 42 CFR 483.90, specifically the
following:
• Provided that the state has approved the location as one
that sufficiently addresses safety and comfort for patients
and staff, CMS is waiving requirements under § 483.90 to
allow for a non-SNF building to be temporarily certified
and available for use by a SNF in the event there are
needs for isolation processes for COVID–19 positive residents, which may not be feasible in the existing SNF
structure to ensure care and services during treatment for
COVID–19 are available while protecting other vulnerable
adults.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
276 ................
HHS .............
CMS ............
Guidance ...............
...............................
Review Choice Demonstration
for Home Health Services
Claims Processing Requirements.
277 ................
HHS .............
CMS ............
Guidance ...............
...............................
Cost and Utilization Management Requirements.
278 ................
HHS .............
CMS ............
Guidance ...............
...............................
Opioid Safety Edits ....................
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Brief summary of action
• 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.
Effective March 29, 2020, certain claims processing for the Review Choice Demonstration (RCD) for 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 preclaim 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.
Part D sponsors must suspend all quantity and 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 midyear formulary change requirements, and we remind sponsors
that new drugs may be added and utilization management requirements removed at any time.
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 naı¨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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
279 ................
HHS .............
CMS ............
Guidance ...............
...............................
Additional or Expanded Benefit
Offerings.
280 ................
HHS .............
CMS ............
Guidance ...............
...............................
Medicare Advantage Cost-Sharing.
281 ................
HHS .............
CMS ............
Guidance ...............
...............................
Telehealth ...................................
282 ................
HHS .............
CMS ............
Guidance ...............
...............................
Model of Care Flexibility ............
283 ................
HHS .............
CMS ............
Guidance ...............
...............................
Involuntary Disenrollment—Temporary Absence Flexibilities.
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Brief summary of action
In response to the unique circumstances resulting 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.
MAOs may waive or reduce 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).
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).
CMS also recognizes that 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.
Due to the public health emergency posed by COVID–19 and the
urgent need 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 § 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
284 ................
HHS .............
CMS ............
Guidance ...............
...............................
Involuntary Disenrollment—Loss
of Special Needs Status.
285 ................
HHS .............
CMS ............
Guidance ...............
...............................
Prior Authorization ......................
286 ................
HHS .............
CMS ............
Guidance ...............
...............................
Medicare Advantage Organization (MAO) and Part D Sponsors Additional Flexibilities.
287 ................
HHS .............
CMS ............
Guidance ...............
...............................
Reimbursements for Enrollees
for Prescriptions Obtained
from Out-of-Network Pharmacies.
288 ................
HHS .............
CMS ............
Guidance ...............
...............................
Prior Authorization for Part D
Drugs.
289 ................
HHS .............
CMS ............
Guidance ...............
...............................
Drug Shortages ..........................
Due to the public health emergency posed by COVID–19 and the
urgent need 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
§ 422.52(d)) due to the COVID–19 national emergency. CMS
will not enforce the requirement for mandatory disenrollment at
§ 422.74(b)(2)(iv) and will allow MA organizations to extend the
period of deemed continued eligibility under § 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.
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.
Given both the rapidly changing landscape and the need for Part
D sponsors to act quickly 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.
Consistent with § 423.124(a) of the Part D regulations, Part D
sponsors must ensure enrollees have adequate 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.
As is the case for 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.
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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
290 ................
HHS .............
CMS ............
Guidance ...............
...............................
Involuntary Disenrollment—MA
and Part D Premium and
Grace Period Flexibilities.
291 ................
HHS .............
CMS ............
Guidance ...............
...............................
MA and Part D Plan Flexibility to
Waive Cost Sharing and to
Provide Expanded Telehealth
Benefits.
292 ................
HHS .............
CMS ............
Guidance ...............
...............................
Coverage of Testing and Testing-Related Services for
COVID–19.
293 ................
HHS .............
CMS ............
Waiver ...................
...............................
In-Service Training .....................
294 ................
HHS .............
CMS ............
Waiver ...................
...............................
12-hour Annual In-service Training Requirement for Home
Health Aides.
295 ................
HHS .............
CMS ............
Waiver ...................
...............................
Annual Training for Hospice
Aides.
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To ensure that Medicare Advantage and Part D beneficiaries
continue to have access to needed 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 § 422.74(b)(1)(i) and section 50.3.1 of Chapter 2 of the
Medicare Managed Care Manual for MA and at
§ 423.44(b)(1)(i) and section 50.3.1 of Chapter 3 of the Medicare Prescription Drug Benefit Manual for Part D.
MAOs may waive or reduce 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).
Under Section 6003 of the Families First Coronavirus Response
Act 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.
Modifying the nurse aide training requirements at § 483.95(g)(1)
for SNFs and NFs, which requires the nursing assistant to receive at least 12 hours of in-service training annually.
Modifying the requirement at 42 CFR 484.80(d) that home health
agencies must assure that each home health aide receives 12
hours of in-service training in a 12-month period. In accordance with section 1135(b)(5) of the Act, we are postponing the
deadline for completing this requirement throughout the
COVID–19 PHE until the end of the first full quarter after the
declaration of the PHE concludes. This will allow aides and the
registered nurses (RNs) who teach in-service training to spend
more time delivering direct patient care and additional time for
staff to complete this requirement.
Modifying the requirement at 42 CFR 418.100(g)(3), which requires hospices to annually assess the skills and competence
of all individuals furnishing care and provide in-service training
and education programs where required. Pursuant to section
1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID–19 PHE until
the end of the first full quarter after the declaration of the PHE
concludes. This does not alter the minimum personnel requirements at 42 CFR 418.114. Selected hospice staff must complete training and have their competency evaluated in accordance with unwaived provisions of 42 CFR part 418.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
296 ................
HHS .............
CMS ............
Waiver ...................
...............................
Training and Assessment of
HHA and Hospice Aides.
297 ................
HHS .............
CMS ............
Guidance ...............
N/A ........................
Repetitive Scheduled Non-Emergent Ambulance Transport
Claims Processing Requirements.
298 ................
HHS .............
CMS ............
Section 1135 Waiver.
N/A ........................
Temporarily relax provider enrollment requirements.
299 ................
HHS .............
CMS ............
Suspend PASRR Assessments
HHS .............
CMS ............
Section 1135 Waiver.
Section 1135 Waiver.
N/A ........................
300 ................
N/A ........................
Extend Fair Hearing Requests
and Appeal Timelines.
301 ................
HHS .............
CMS ............
Section 1135 Waiver.
N/A ........................
Temporarily Suspend Medicaid
FFS Prior Authorization Requirements.
302 ................
HHS .............
CMS ............
Section 1135 Waiver.
N/A ........................
Permit Provision of Services in
Alternative Settings.
303 ................
HHS .............
CMS ............
Section 1135 Waiver.
N/A ........................
Extend Pre-Existing Prior Authorizations through PHE.
304 ................
HHS .............
CMS ............
N/A ........................
Submission Flexibilities ..............
305 ................
HHS .............
CMS ............
Section 1135 Waiver.
Section 1135 Waiver.
N/A ........................
HCBS Flexibilities .......................
306 ................
HHS .............
CMS ............
N/A ........................
Conflict of Interest Requirements
307 ................
HHS .............
CMS ............
Section 1135 Waiver.
Section 1135 Waiver.
N/A ........................
Provide Additional Benefits and
services.
308 ................
HHS .............
CMS ............
Section 1135 Waiver.
N/A ........................
309 ................
HHS .............
CMS ............
Section 1135 Waiver.
N/A ........................
Modify Licensure or Other Requirements for Wavier Services Settings
Exceed Service Limitations or
Requirements for Amount, Duration and Prior Authorization.
Brief summary of action
Waiving the requirement at 42 CFR 418.76(h)(2) for Hospice and
42 CFR 484.80(h)(1)(iii) for HHAs, which require a registered
nurse, or in the case of an HHA a registered nurse or other
appropriate skilled professional (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.
Effective March 29, 2020, certain claims processing requirements
for the Repetitive, 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.
Allows states to apply for the ability to: 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.
Suspend PASRR Level I and Level II Assessments for 30 Days.
Allow managed care enrollees to proceed 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).
Suspend Medicaid fee-for-service prior authorization 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.
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.
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.
Grant Flexibility on SPA Submission Deadline, Public Notice and
Tribal Consultation.
Temporarily Allow Beneficiaries to Relocate to Settings Not Meeting HCBS Settings Requirements. Temporarily Eliminate Requirement to Obtain Signatures on HCBS Person-Centered
Service Plans.
Waive Conflict of Interest Requirements for Case Management.
Allows states to add home delivered meals and other services including medical equipment and supplies to their Medicaid program.
Suspend Medicaid fee-for-service prior authorization requirements.
Section 1135(b)(1)(C) allows for a waiver or modification of preapproval 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
Brief summary of action
310 ................
HHS .............
CMS ............
Opportunities for Self Direction ..
HHS .............
CMS ............
N/A ........................
Increase the Cost Limits ............
This allows states to temporarily add or expand requirements for
Medicaid self-direction during the PHE.
Temporarily Increase the Cost Limits for Entry into the Waiver.
312 ................
HHS .............
CMS ............
Section 1135 Waiver.
Section 1135 Waiver.
HCBS Appendix K
Waiver.
N/A ........................
311 ................
N/A ........................
Waive Visitors Settings Requirements.
313 ................
HHS .............
CMS ............
N/A ........................
314 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
HCBS Appendix K
Waiver.
Allow Reassessment and Reevaluation Extensions.
Add Electronic Service Delivery
315 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
316 ................
HHS .............
CMS ............
N/A ........................
317 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
HCBS Appendix K
Waiver.
318 ................
HHS .............
CMS ............
N/A ........................
319 ................
HHS .............
CMS ............
320 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
HCBS Appendix K
Waiver.
HCBS Appendix K
Waiver.
321 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
322 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
Waive Conflict of Interest Requirements for Case Management.
Modify Services ..........................
323 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
Allow Retainer Payments ...........
324 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
Changes to Participant Safeguards.
325 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
Modify Person-Centered Planning Requirements.
326 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
N/A ........................
Allow Payment in Institutional
Settings.
327 ................
HHS .............
CMS ............
N/A ........................
328 ................
HHS .............
CMS ............
HCBS Appendix K
Waiver.
HCBS Appendix K
Waiver.
Allow Virtual LOC Determinations.
Increase or Modify Payments
Rates.
329 ................
HHS .............
CMS ............
HHS .............
CMS ............
HCBS Appendix K
Waiver.
Medicaid Disaster
Relief SPA.
N/A ........................
330 ................
331 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Establish Residency for Individuals Temporarily Out of State
Due to a Disaster.
332 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Extend PE to non-MAGI Populations.
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N/A ........................
N/A ........................
N/A ........................
N/A ........................
N/A ........................
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Allow Virtual/Remote Evaluations, Assessments and Person-Centered Services Planning.
Add Electronic Method for Signing Required Documents.
Allow Spouses and Parents of
Minor Children to Provide
Services.
Allow Family Member to Provide
Services.
Modify Providers of Home-Delivered Meals.
Allow Other Practitioners to Provide Services.
Extend Dates for LOC Determinations.
Adopt Optional COVID–19 Testing Group.
Fmt 4701
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Not comply with the HCBS settings requirement at 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.
Allow an extension for reassessments and reevaluations for up to
one year past the due date.
Add an electronic method 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]:
Allow the option to conduct evaluations, assessments, and person-centered service planning meetings virtually/remotely in
lieu of face-to-face meetings.
Add an electronic method of signing off on required documents
such as the person-centered service plan.
Allow spouses and parents of minor children to provide personal
care services.
Allow a family member to be paid to render services to an individual.
Modify service providers for home-delivered meals to allow for
additional providers, including non-traditional providers.
Allows states to apply for flexibilities like the ability to Allow Other
Practitioners to Provide Services and Allow other practitioners
in lieu of approved providers within the waiver.
Case management entity qualifies under 42 CFR
441.301(c)(1)(vi) as the only willing and qualified entity.
Allows for states to 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.
Temporarily include 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.]
Postponing 372 Reporting Requirements. Temporarily modify incident reporting requirements, medication management or
other participant safeguards to ensure individual health and
welfare, and to account for emergency circumstances.
Temporarily modify person-centered service plan 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.
Temporarily allow for payment for services for 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.
Temporarily modify processes for level of care evaluations or reevaluations (within regulatory requirements).
Temporarily increase 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.]
Temporarily modify processes for level of care evaluations or reevaluations (within regulatory requirements.
Furnishes medical 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.
Considers individuals who are evacuated from the state, who
leave the state for medical 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).
Allow hospitals to make 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.
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ATTACHMENT A—Continued
Action
Agency
Sub-agency
333 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Extend the ROP for good faith
effort.
334 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
335 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Establish Income and Resource
Disregards for non-MAGI Eligibility Groups.
Designate Other Entities as a
Qualified Entity for PE.
336 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Adopt Continuous Eligibility for
Children.
337 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
338 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Extend Residency to Individuals
who May be Considered Residents of Other States.
Extend the Redetermination Period for Non-MAGI Populations.
339 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
340 ................
HHS .............
CMS ............
N/A ........................
341 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
Medicaid Disaster
Relief SPA.
342 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
343 ................
HHS .............
CMS ............
HHS .............
CMS ............
345 ................
HHS .............
CMS ............
346 ................
HHS .............
CMS ............
347 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
Medicaid Disaster
Relief SPA.
Medicaid Disaster
Relief SPA.
Medicaid Disaster
Relief SPA.
Medicaid Disaster
Relief SPA.
N/A ........................
344 ................
348 ................
HHS .............
CMS ............
N/A ........................
349 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
Medicaid Disaster
Relief SPA.
N/A ........................
Adjust Days’ Supply or Quantity
Limits.
350 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Add New Optional Benefits ........
351 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
352 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Add Temporary Supplemental
Payment to the Professional
Dispensing Fee.
Miscellaneous Payment
Changes.
353 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
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N/A ........................
N/A ........................
N/A ........................
N/A ........................
N/A ........................
Frm 00048
Title of action
Suspend Deductibles, Copayments, Coinsurance and other
Cost Sharing Charges.
Suspend Enrollment Fees, Premiums and Similar Charges.
Add a Variance to the Basic
PETI Personal Needs Allowance.
Establish an Undue Hardship
Waiver for Payment of Enrollment Fees, Premiums and
Other Similar Charges.
Adjust Covered Benefits ............
Establish Preferred Drug List
Exceptions.
Extend Telehealth Utilization .....
Apply New or Adjusted Benefits
to ABPs.
Compliance with Existing Requirements for New and Adjusted benefits.
Expand Prior Authorization ........
Increase Payment Rates for
Current State Plan Services.
Fmt 4701
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Brief summary of action
Provides 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 disaster
or public health emergency.
Agency applies less restrictive financial methodologies to individuals excepted from financial methodologies based on modified
adjusted gross income (MAGI).
Agency designates itself as a qualified entity for purposes of
making 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.
Agency adopts continuous eligibility for children regardless of
changes in circumstances in accordance with section
1902(e)(12) of the Act and 42 CFR 435.926.
Agency provides Medicaid coverage to the following individuals
living in the state, who are non-residents.
Agency conducts redeterminations of eligibility for 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).
Agency suspends deductibles, copayments, coinsurance, and
other cost sharing charges.
Agency suspends enrollment fees, premiums and similar
charges.
State elects a new variance to the basic personal needs allowance for institutionalized individuals.
Agency allows waiver of payment of the enrollment fee, premiums and similar charges for undue hardship.
Give state flexibility to adjust or make changes to the covered
benefits under their Medicaid program.
Agency makes exceptions to their published Preferred Drug List
if drug shortages occur.
Agency makes changes to telehealth utilization, which may be
different than outlined in the state’s approved state plan.
Applies new or adjusted benefits to ABPs.
Attest to compliance with existing benefit requirements.
Prior authorization for medications is expanded by automatic renewal without clinical review, or time/quantity extensions.
Agency adjusts day supply or quantity limit for covered outpatient
drugs, if current state plan pages have limits on the amount of
medication dispensed.
Adds optional benefits in its state plan (include service descriptions, provider qualifications, and limitations on amount, duration or scope of the benefit).
Agency makes payment adjustment to the professional dispensing fee when additional costs are incurred by the providers for delivery.
Includes 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.
Nursing facility rate increases or add-ons—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.
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Action
Agency
Sub-agency
Type of action
RIN (if applicable)
Title of action
354 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
Payments for Telehealth Services.
355 ................
HHS .............
CMS ............
Medicaid Disaster
Relief SPA.
N/A ........................
356 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Establish a Payment Methodology for New Covered Optional Benefits.
Delay Renewal Processing and
Deadlines.
357 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Delay Acting on Changes in Circumstance.
358 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Delay Application Processing ....
359 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Delay Tribal Consultation ...........
360 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Waive Cost Sharing ...................
361 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Waive Premiums/Enrollment
Fees.
362 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Waive Premium Lock-Out Policy
363 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Extend the ROP for Good Faith
Effort.
364 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Institute More Frequent PE Periods.
365 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Extend Premium Deadlines .......
366 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Provide 12-Month Continuous
Eligibility.
367 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Allow Phone Triage for Dental
Services.
368 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Provide Additional Benefits ........
369 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Waive Affordability Test and Private Insurance Lookback.
370 ................
HHS .............
CMS ............
CHIP Disaster Relief SPA.
N/A ........................
Add More Qualified Entities to
Make PE Determinations.
371 ................
HHS .............
CMS ............
Other regulatory
action.
N/A ........................
372 ................
HHS .............
CMS ............
Guidance ...............
N/A ........................
Payment and Grace Period
Flexibilities Associated with
the COVID–19 National Emergency.
FAQs on Catastrophic Plan Coverage and COVID–19.
373 ................
HHS .............
CMS ............
Other regulatory
action.
N/A ........................
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Postponement of 2019 Benefit
year HHS-operated Risk Adjustment Data Validation
(HHS–RADV).
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Brief summary of action
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.
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.
Establish payment methodology for newly covered benefits.
At State discretion, 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.
At State discretion, the waiting period policy will be temporarily
suspended for CHIP applicants and current enrollees who reside and/or work in a State or Federally declared disaster area.
At State discretion, 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.
To address the COVID–19 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.
At State discretion, cost 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.
At State discretion, non-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.
At State discretion, the 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.
At State discretion, the 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.
At State discretion, the 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.
At State discretion, 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.
At State discretion, it may temporarily provide continuous eligibility to CHIP enrollees who reside and/or work in a State or
Federally declared disaster area.
At State discretion, it may temporarily use a simplified application
for CHIP enrollees who reside and/or work in a State or Federally declared disaster area.
At State discretion, 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.
At State discretion, premiums or enrollment 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.
At State discretion, non-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.
Announces enforcement discretion to permit issuers that offer
coverage through HealthCare.gov to extend premium payment
deadlines and delay cancellation for non-payment of premiums.
Announces enforcement discretion to permit 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.
Announces temporarily policy of relaxed enforcement to postpone issuer requirements related to the 2019 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.
E:\FR\FM\25NON2.SGM
25NON2
75768
Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
ATTACHMENT A—Continued
Action
Agency
Sub-agency
374 ................
HHS .............
CMS ............
375 ................
HHS .............
376 ................
Type of action
RIN (if applicable)
Title of action
Brief summary of action
Other regulatory
action.
N/A ........................
CMS ............
Other regulatory
action.
N/A ........................
Provides clarification that telephonic codes will be valid for 2020
benefit year risk adjustment data submissions for the HHS-operated risk adjustment program.
Announces temporary policy of relaxed enforcement with respect
to the regulatory timeframe for issuers to submit the 2019 MLR
Annual Reporting Form and for issuers that elect to pay a portion or all of their estimated 2019 MLR rebates in the form of
premium credits.
HHS .............
CMS ............
Other regulatory
action.
N/A ........................
Risk Adjustment Telehealth and
Telephone Services During
COVID–19 FAQs.
Temporary Period of Relaxed
Enforcement for Submitting
the 2019 MLR Annual Reporting Form and Issuing MLR
Rebates in Response to the
COVID–19 Public Health
Emergency.
Temporary Period of Relaxed
Enforcement of Certain Timeframes Related to Group Market Requirements Under the
Public Health Service Act in
Response to the COVID–19
Outbreak.
377 ................
HHS .............
CMS ............
Other regulatory
action.
N/A ........................
378 ................
HHS .............
CMS ............
Other regulatory
action.
N/A ........................
379 ................
HHS .............
CMS ............
Other regulatory
action.
...............................
Prior Authorization for Certain
DMEPOS items.
380 ................
HHS .............
CMS ............
Other regulatory
action.
...............................
Opt-Out Physicians and Practitioners.
381 ................
HHS .............
CMS ............
Waiver ...................
...............................
Medicaid Provider Enrollment
Relief.
382 ................
HHS .............
CMS ............
Waiver ...................
...............................
Medicare Provider Medicare
Provider Enrollment Relief:
DME Suppliers 42 CFR
424.57.
Temporary Policy on 2020 Premium Credits Associated with
the COVID–19 Public Health
Emergency.
TDL .............................................
The Departments of Labor and the Treasury released a joint
Federal Register Notice providing relief from certain timing requirements under ERISA and the Code that affect private employer group 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.
Announces temporary policy of relaxed enforcement to allow
health insurance issuers in the individual and small group markets to temporarily offer premium credits for 2020 coverage.
On March 30 CMS suspended 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).
Effective March 29. 2020, certain claims 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.
42 CFR 405.445. Allow opted-out physicians and non-physician
practitioners to terminate their opt-out status early and enroll in
Medicare to provide care to more patients.
42 CFR 455.414, 42 CFR 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.
Waive several DME supplier standards, including supplier standard 7 that requires facility access/maintaining a facility. Waive
DME accreditation (at initial enrollment and re-accreditation requirement.
[FR Doc. 2020–25812 Filed 11–23–20; 8:45 am]
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]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\2\ Coronavirus (COVID-19) Testing, U.S. Dep't of Health and
Human Serv.'s, https://www.hhs.gov/coronavirus/testing/
(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/ (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/ (last updated Aug. 14, 2020).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\6\ Telehealth: Delivering Care Safely During COVID-19, U.S.
Dep't of Health and Human Serv.'s, https://www.hhs.gov/coronavirus/telehealth/ (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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\9\ Exec. Order No. 13924 (May 19, 2020).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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/.
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
