Flexibility in Evaluating “Close Proximity of Time” Due to COVID-19 Related Barriers to Healthcare, 38920-38925 [2021-15423]
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Rules and Regulations
participate in this rulemaking effort by
submitting written comments on the
proposal to the FAA, none were
received.
Class E5 airspace designations are
published in paragraph 6005 of FAA
Order 7400.11E, dated July 21, 2020,
and effective September 15, 2020, which
is incorporated by reference in 14 CFR
71.1. The Class E airspace designation
listed in this document will be
published subsequently in the Order.
Availability and Summary of
Documents for Incorporation by
Reference
This document amends FAA Order
7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020,
and effective September 15, 2020. FAA
Order 7400.11E is publicly available as
listed in the ADDRESSES section of this
document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
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The Rule
This amendment to 14 CFR part 71
establishes Class E airspace, extending
upward from 700 feet above the surface,
at Crooked Creek Airport. The Class E
airspace is established within a 2 mile
radius of the airport, excluding that area
within the Stony B Military Operations
Area, and that airspace within 2 miles
each side of the 332° bearing extending
from the 2-mile radius to 8.5 miles
northwest of the airport. This airspace
protects aircraft using the RNAV
approach to runway 14 and departures
until reaching 1,200 feet AGL.
FAA Order 7400.11, Airspace
Designations and Reporting Points, is
published yearly and effective on
September 15.
Regulatory Notices and Analyses
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current, is non-controversial, and
unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, would not have a
significant economic impact on a
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substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
SOCIAL SECURITY ADMINISTRATION
Environmental Review
[Docket No. SSA–2021–0010]
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 5–6.5a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant the preparation of an
environmental assessment.
RIN 0960–AI64
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting
Points, dated July 21, 2020, and
effective September 15, 2020, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
AAL AK E5
*
*
*
Crooked Creek, AK (NEW)
Crooked Creek Airport, AK
(Lat. 61°52′4″ N, long. 158°8′6″ W)
That airspace extending upward from 700
feet above the surface within a 2-mile radius
of Crooked Creek Airport, and that airspace
within 2 miles each side of the 332° bearing
extending from the 2-mile radius to 8.5 miles
northwest of the airport excluding that
airspace within the Stony B MOA.
Issued in Des Moines, Washington, on July
15, 2021.
B.G. Chew,
Acting Group Manager, Operations Support
Group, Western Service Center.
[FR Doc. 2021–15491 Filed 7–22–21; 8:45 am]
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20 CFR Parts 404 and 416
Flexibility in Evaluating ‘‘Close
Proximity of Time’’ Due to COVID–19
Related Barriers to Healthcare
Social Security Administration.
Temporary final rule with
request for comments.
AGENCY:
ACTION:
Since the outset of the
COVID–19 national public health
emergency, many individuals have
experienced barriers that prevent them
from timely accessing healthcare. In
response to those barriers, we are
issuing this rule to temporarily revise
our requirement in the Listing of
Impairments (listings) that, for purposes
of applying several of our
musculoskeletal disorder listings, all
relevant medical criteria be present
simultaneously or ‘‘within a close
proximity of time,’’ which we define as
being ‘‘within a consecutive 4-month
period.’’ While this rule is in effect, we
will find that the evidence of a
musculoskeletal disorder is present
‘‘within a close proximity of time’’ if the
available evidence establishes such a
condition within a consecutive 12month period. We expect that this
temporary change to our rules will
allow us to make findings of disability
in appropriate cases in which
individuals have experienced barriers to
access to healthcare because of the
COVID–19 national public health
emergency.
SUMMARY:
DATES:
Effective date: This temporary final
rule is effective on July 23, 2021. For
more information, see SUPPLEMENTARY
INFORMATION.
Comment date: We invite written
comments. Comments must be
submitted on or before September 21,
2021.
Expiration date: Unless we extend the
expiration date by a final rule published
in the Federal Register, this temporary
final rule will cease to be effective 6
months after the effective date of a
determination by the Secretary of Health
and Human Services under section 319
of the Public Health Service Act, 42
U.S.C. 247d, that the COVID–19
national public health emergency no
longer exists. We will publish a
document in the Federal Register
announcing the expiration date. For
more information, see SUPPLEMENTARY
INFORMATION.
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You may submit comments
by any one of three methods—internet,
fax, or mail. Do not submit the same
comments multiple times or by more
than one method. Regardless of which
method you choose, please state that
your comments refer to Docket No.
SSA–2021–0010 so that we may
associate your comments with the
correct rule.
Caution: You should be careful to
include in your comments only
information that you wish to make
publicly available. We strongly urge you
not to include in your comments any
personal information, such as Social
Security numbers or medical
information.
1. Internet: We strongly recommend
that you submit your comments via the
internet. Please visit the Federal
eRulemaking portal at https://
www.regulations.gov. Use the search
function to find docket number SSA–
2021–0010. The system will issue a
tracking number to confirm your
submission. You will not be able to
view your comment immediately
because we must post each comment
manually. It may take up to a week for
your comments to be viewable.
2. Fax: Fax comments to (410) 966–
2830.
3. Mail: Mail your comments to the
Office of Regulations and Reports
Clearance, Social Security
Administration, 3100 West High Rise
Building, 6401 Security Boulevard,
Baltimore, Maryland 21235–6401.
Comments are available for public
viewing on the Federal eRulemaking
portal at https://www.regulations.gov or
in person, during regular business
hours, by arranging with the contact
person identified in FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Edward Sosar, Office of Regulations and
Reports Clearance, Social Security
Administration, 6401 Security
Boulevard, Baltimore, MD 21235–6401,
(410) 966–2341. For information on
eligibility or filing for benefits, call our
national toll-free number, 1–800–772–
1213 or TTY 1–800–325–0778, or visit
our internet site, Social Security Online,
at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION: The
Secretary of Health and Human Services
issued a determination under section
319 of the Public Health Service Act on
January 31, 2020 that a national public
health emergency exists as of January
27, 2020 because of the COVID–19
pandemic.1 The Secretary has renewed
his determination several times since
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ADDRESSES:
1 (https://www.phe.gov/emergency/news/
healthactions/phe/Pages/2019-nCoV.aspx).
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then, most recently on July 19, 2021
(effective July 20, 2021).2 We are issuing
this temporary final rule to address the
ongoing effects of the COVID–19
national public health emergency. The
effective date of this temporary final
rule will help us ensure that we provide
affected claimants with the benefit of
the flexibilities offered by this rule. On
April 1, 2021, we instructed our
adjudicators to temporarily hold claims
in which all elements of
musculoskeletal disorders listings 1.15,
1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22, 1.23,
101.15, 101.16, 101.17, 101.18, 101.20C,
101.20D, 101.22, or 101.23 were present
within a consecutive 12-month period,
but not within a consecutive 4-month
period, and it was not possible to
process a fully favorable determination
or decision in some other way. By
holding claims that would benefit from
the flexibilities in this rule, we will
process claims affected by this rule on
or after the effective date of this rule. As
we explain in more detail below, we
will continue to apply this rule until 6
months after effective date of a
determination by the Secretary of Health
and Human Services under section 319
of the Public Health Service Act that the
national public health emergency
related to the COVID–19 pandemic no
longer exists.
Background
On December 3, 2020, we published
the final rule, Revised Medical Criteria
for Evaluating Musculoskeletal
Disorders, which became effective on
April 2, 2021, revising the criteria in the
listings that we use to evaluate
disability claims involving
musculoskeletal disorders in adults and
children at the third step of our
sequential evaluation process under
titles II and XVI of the Social Security
Act (Act).3 The final rule, among other
things, revised the listings in response
to the decision in Radford v. Colvin, 734
F.3d 288 (4th Cir. 2013). The final rule
required that, for the purposes of
applying certain listings,4 all of the
required medical criteria must be
present simultaneously, or within a
close proximity of time, to satisfy the
level of severity needed to meet the
listing.5 We defined the phrase ‘‘within
a close proximity of time’’ to mean ‘‘that
all of the relevant criteria must appear
in the medical record within a
2 https://www.phe.gov/emergency/news/
healthactions/phe/Pages/COVID-19July2021.aspx.
3 85 FR 78164 (2020).
4 Listings 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D,
1.22, 1.23, 101.15, 101.16, 101.17, 101.18, 101.20D,
101.22, and 101.23.
5 See 20 CFR appendix 1 to subpart P of part 404
1.00C7b and 101.00C7b.
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38921
consecutive 4-month period’’ (emphasis
in original).6 We also provided that
‘‘[w]hen the criterion is imaging, we
mean that we could reasonably expect
the findings on imaging to have been
present at the date of impairment or
date of onset.’’ 7
We established the consecutive 4month period as a criterion to meet the
level of severity in the listings based on
our extensive research of relevant
medical literature and clinical
guidelines. In our notice of proposed
rulemaking, we also specifically asked
interested members of the public to
comment on this issue and provide us
with any studies and data that
supported their comments; 8 however,
no studies or data were submitted. In
the final rule, we concluded that the
consecutive 4-month period is
consistent with instructions providers
receive for scheduling patients,9 the
general standard of care,10 and the
frequency of healthcare visits by
individuals with musculoskeletal
conditions.11 At the same time, the
consecutive 4-month period in the rules
provides some leeway for the claimant,
because the standard for patient revisits
is once every 3 months.12 Our rules
recognize that one visit alone may not
ensure all necessary criteria required for
a medical listing will be appropriately
documented; however, the consecutive
4-month time period provides a
sufficient period to ensure the criteria
are present within a close proximity of
time and that the claimant’s
6 Id.
7 Id.
8 83
FR 20646, 20647 (May 7, 2018).
FR at 78169 n.37 (citing Bavafa, H., Savin,
S., & Terwiesch, C. (2019). Redesigning Primary
Care Delivery: Customized Office Revisit Intervals
and E-Visits. https://dx.doi.org/10.2139/
ssrn.2363685. Paper referenced by Bavafa:
Schectman, G., G. Barnas, P. Laud, L. Cantwell, M.
Horton, E.J. Zarling. 2005. Prolonging the return
visit interval in primary care. The American Journal
of Medicine, 118(4) 393–399.)
10 85 FR at 78169 n.34 (citing Gore, M., Sadosky,
A., Stacey, B.R., Tai, K.S., & Leslie, D. (2012). The
burden of chronic low back pain: Clinical
comorbidities, treatment patterns, and health care
costs in usual care settings. Spine, 37(11), E668–
E677. https://doi.org/10.1097/
BRS.0b013e318241e5de.)
11 85 FR at 78169 n.35 (citing BMUS: The Burden
of Musculoskeletal Diseases in the United States. In:
BMUS: The Burden of Musculoskeletal Diseases in
the United States [internet]. [cited 15 July 2020].
https://www.boneandjointburden.org/fourthedition/viiic2/utilization-condition-group.)
12 See 85 FR at 78169 n.36 (citing J Gen Intern
Med. 1999 Apr; 14(4): 230–235. doi: 10.1046/
j.1525–1497.1999.00322.x Lisa M Schwartz, MD,
MS, Steven Woloshin, MD, MS, John H Wasson,
MD, Roger A Renfrew, MD, and H Gilbert Welch,
MD, MPH, Dartmouth Primary Care Cooperative
Research Network.)
9 85
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Rules and Regulations
musculoskeletal disorder meets the
requisite severity for the listing.
Our use of the consecutive 4-month
proximity of time requirement is also
consistent with the standard recognized
by the Veterans Health Administration
(VHA) and Department of Defense
(DoD), as set out in their clinical
practice guidelines.13 For example, the
VHA and DoD’s Clinical Practice
Guideline for the Management of
Medically Unexplained Symptoms:
Chronic Pain and Fatigue directs initial
revisits at 2 to 3 week intervals, with
visits every 3 to 4 months once the
patient is doing well.14 Similarly, the
VHA’s and DoD’s Clinical Practice
Guideline for Diagnosis and Treatment
of Low Back Pain describes the duration
of time for intervention, based on a
systematic review, as requiring a
minimum follow-up for effectiveness of
12 weeks and recommends monthly
reassessment after initiation of therapy
if low back pain continues and no
serious specific underlying cause of low
back pain is found.15
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Rationale for This Rule
As noted above, on January 31, 2020,
the Secretary of Health and Human
Services declared COVID–19 a national
public health emergency. The COVID–
19 national public health emergency has
dramatically changed the provision of,
and access to, healthcare services
throughout the country. Individuals
with musculoskeletal impairments who,
before the national public health
emergency, would seek and receive
healthcare at a frequency consistent
with the standards cited above, now
might be unable or choose not to seek
care in the same manner and frequency.
This is due in part to healthcare
organizations and government agencies
such as the Centers for Medicare &
Medicaid Services (CMS) 16 prioritizing
the most urgent services and
13 85 FR at 78169 n.38 (citing Veterans Health
Administration & Department of Defense. (2001).
VHA/DoD Clinical Practice Guideline for the
Management of Medically Unexplained Symptoms:
Chronic Pain and Fatigue. https://
www.healthquality.va.gov/guidelines/MR/mus/
mus_fulltext.pdf.)
14 Id.
15 85 FR at 78169–70 (citing Veterans Health
Administration & Department of Defense. (2017).
VA/DoD Clinical Practice Guideline for Diagnosis
and Treatment of Low Back Pain. https://
www.healthquality.va.gov/guidelines/Pain/lbp/
VADoDLBPCPG092917.pdf.)
16 Centers for Medicare & Medicaid Services
(CMS) Recommendations: Re-opening Facilities to
Provide Non-emergent Non-COVID–19 Healthcare
(https://www.cms.gov/files/document/covidrecommendations-reopening-facilities-provide-nonemergent-care.pdf); see also Non-Emergent, Elective
Medical Services, and Treatment Recommendations
(https://www.cms.gov/files/document/cms-nonemergent-elective-medical-recommendations.pdf.)
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encouraging patients to delay other
procedures during the pandemic. For
example, the North American Spine
Society (NASS) provided guidance for
delaying non-emergent procedures for
people with chronic spinal
conditions.17
Likewise, many individuals have
delayed or deferred important treatment
due to closures of medical offices, fears
of contracting COVID–19 infection
(including having a high risk individual
in the household), and other challenges
created or exacerbated by the pandemic,
such as difficulty accessing
transportation. According to one source,
among the general U.S. population
reporting delayed care for serious
problems during the pandemic, 69%
cited nonfinancial access barriers, such
as being unable to get an appointment,
find a physician who would see them,
or access the care location.18
Additionally, the National Center for
Health Statistics estimated that 41% of
U.S. adults had delayed or avoided
medical care, including urgent or
emergency care (12%) and routine care
(32%) because of concerns about
COVID–19.19
We are also temporarily changing the
consecutive 4-month close proximity of
time rule to a consecutive 12-month rule
because the manner of care provided
changed throughout the COVID–19
national public health emergency. To be
responsive to this change in the manner
of care, we instructed our adjudicators
to temporarily hold claims that would
benefit from the flexibilities in this rule,
so we will process claims affected by
this rule on or after the effective date of
this rule. Due to safety concerns, many
healthcare providers shifted to
emphasizing or exclusively scheduling
telehealth or virtual visits. The
optimization of telehealth is consistent
with the guidance issued by many
specialist organizations, such as
NASS,20 the American College of
17 https://www.spine.org/Portals/0/assets/
downloads/Publications/NASSInsider/
NASSGuidanceDocument040320.pdf.
18 Delayed Care with Harmful Health
Consequences—Reported Experiences from
National Surveys During Coronavirus Disease 2019
| Infectious Diseases | JAMA Health Forum | JAMA
Network. See also The Impact of Coronavirus on
Households Across America (https://
cdn1.sph.harvard.edu/wp-content/uploads/sites/
21/2020/09/NPR-RWJF-Harvard-National-Report_
092220_Final1-4.pdf) and COVID–19: Experiences
Among the Medicare Population (https://
www.cms.gov/files/document/medicare-currentbeneficiary-survey-covid-19-data-snapshot.pdf.)
19 Reduced Access to Care: Household Pulse
Survey (National Center for Health Statistics)
(https://www.cdc.gov/nchs/covid19/pulse/reducedaccess-to-care.htm.)
20 https://www.spine.org/Portals/0/assets/
downloads/Publications/NASSInsider/
NASSGuidanceDocument040320.pdf.
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Surgeons (ACS),21 the American
Academy of Orthopedic Surgeons
(AAOS),22 and the American College of
Rheumatology (ACR).23
Although many individuals access
telehealth visits successfully, the
clinical signs and findings required by
some of the listings may not be present
in the telehealth record due to the
limitations of telemedicine. While
testing by the patient is possible through
telehealth, there are limits in
provocative testing (that is, testing that
manipulates the areas where you have
pain in order to reproduce the pain),
discrete palpation (that is, a technique
that uses targeted pressure to identify
and quantify the abnormalities of the
musculoskeletal system, such as
warmth, swelling, pain, tenderness, and
trigger points), and strength or stability
testing.24 During the beginning of the
COVID–19 pandemic, orthopedists
created guidelines for virtual
examinations of patients through
telemedicine, and found that while the
patient could perform many tests, there
are inherent limitations to testing in this
manner. For example, the authors
recommend using another person to
hold the camera during gait examination
to get a better view of the patient’s gait
mechanics, which is not always
possible.25 Further, the VHA has found
that although patients appreciate
telehealth, many are unable to complete
exams that require precise
measurements, such as range of motion
or reflexes.26
Consequently, disability claimants
with musculoskeletal disorders of the
severity required by the listings who
would have been able to provide
evidence that their musculoskeletal
disorder met the consecutive 4-month
close proximity of time requirement
21 COVID–19 Guidelines for Triage of
Orthopaedic Patients (https://www.facs.org/covid19/clinical-guidance/elective-case/orthopaedics).
22 Navigating the COVID–19 Pandemic (https://
www.aaos.org/globalassets/about/covid-19/aaosclinical-considerations-during-covid-19.pdf).
23 COVID–19 Clinical Guidance for Adult Patients
with Rheumatic Diseases (https://
www.rheumatology.org/Portals/0/Files/ACRCOVID-19-Clinical-Guidance-Summary-Patientswith-Rheumatic-Diseases.pdf).
24 Tanaka et al. (2020). Telemedicine in the Era
of COVID–19: The Virtual Orthopaedic
Examination. The Journal of Bone and Joint
Surgery, Incorporated, 00:e1 (1–7) https://dx.doi.org/
10.2106/JBJS.20.00609.
25 Laskowski, et al. (2020). The Telemedicine
Musculoskeletal Examination. Mayo Clinic Proc.
95(8) https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC7395661/.
26 Baus, Shanna, PA–C. Telehealth & Disability
Items: Veterans Health Administration.
Presentation to the Standing Committee of the
National Academies of Science and Medicine
Health and Medicine Division, on December 1,
2020.
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Rules and Regulations
before the COVID–19 national public
health emergency may now have more
difficulty producing evidence to meet
the standard. It is possible that, in light
of the pandemic and the temporary
changes in healthcare described above,
claimants have scheduled fewer clinical
visits or have been afforded fewer
appointments that would allow them to
provide the necessary evidence. Because
such a claimant would lack the
necessary documentation to meet the
listing in the absence of this temporary
change, we would not find the claimant
disabled under the listings, although we
could make a finding of disability at
later steps of our sequential evaluation
process in appropriate cases.
In recognition of the economic and
social services crisis caused by the
COVID–19 national public health
emergency, the President published
Executive Order 14002 Economic Relief
Related to the COVID–19 Pandemic,27
which directed Federal agencies to
consider actions to improve access to
and reduce unnecessary barriers to
Federally-funded programs. We are
issuing this rule in furtherance of the
goals in the Executive Order.
This rule will remain in effect until 6
months after the effective date of a
determination by the Secretary of Health
and Human Services under section 319
of the Public Health Service Act, 42
U.S.C. 247d, that the national public
health emergency resulting from the
COVID–19 pandemic no longer exists,
which will afford claimants the
opportunity to attend scheduled
appointments that may have been
delayed during the national public
health emergency, allow us time to
adjudicate claims affected by the rule,
and allow sufficient time to notify the
adjudicative community of the change.
We will continue to apply the
consecutive 12-month period until 6
months after the Secretary of HHS
determines that the COVID–19 national
public health emergency no longer
exists to allow time for health care
access to normalize back to prepandemic period levels and to account
for potential backlogs in medical care
that may continue to interfere with
access to the relevant care and
documentation needed to satisfy the
listing criteria. Additionally, the
expiration date included in this
temporary final rule will provide us
with the time necessary to publish a
document in the Federal Register to
advise the public of the date on which
this rule will no longer be effective,
communicate the change to adjudicators
and the public, update our materials
27 86
FR 7229 (2021).
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that reference the consecutive 12-month
period, and process claims where the
medical care was received prior to the
end of the COVID–19 national public
health emergency.
Summary of the Changes
This rule adds a new section 1.00C7a
and 101.00C7a to the musculoskeletal
disorders listings. The rule also
redesignates current sections 1.00C7a
and 1.00C7b as 1.00C7b and 1.00C7c,
respectively, and 101.00C7a and
101.00C7b as 101.00C7b and 101.00C7c,
respectively. New sections 1.00C7a and
101.00C7a define the term ‘‘pandemic
period’’ to mean ‘‘the period beginning
on April 2, 2021 and ending on the date
that is 6 months after the effective date
of a determination by the Secretary of
Health and Human Services under
section 319 of the Public Health Service
Act, 42 U.S.C. 247d, that the national
public health emergency resulting from
the COVID–19 pandemic no longer
exists.’’ Redesignated and revised
sections 1.00C7c and 101.00C7c provide
that, for purposes of listings 1.15, 1.16,
1.17, 1.18, 1.20C, 1.20D, 1.22, 1.23,
101.15, 101.16, 101.17, 101.18, 101.20C,
101.20D, 101.22, and 101.23, the phrase
‘‘within a close proximity of time’’
means that all of the relevant criteria
must appear in the medical record
within a consecutive 4-month period,
except for claims determined or decided
during the pandemic period. For claims
that we determine or decide during the
pandemic period, we provide that all of
the relevant criteria must appear in the
medical record within a consecutive 12month period.
Regulatory Procedures
Justification for Issuing a Rule Without
Notice and Comment
We follow the Administrative
Procedure Act’s (APA) rulemaking
procedures specified in 5 U.S.C. 553
when we develop regulations.
Generally, the APA requires that an
agency provide prior notice and
opportunity for public comment before
issuing a final rule. The APA provides
exceptions to its notice and public
comment procedures when an agency
finds there is good cause for dispensing
with such procedures because they are
impracticable, unnecessary, or contrary
to the public interest (5 U.S.C.
553(b)(B)).
We find that there is good cause
under 5 U.S.C. 553(b)(B) to issue this
rule without prior public comment
because prior public comment is
impracticable and contrary to public
interest.
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38923
We find that public comment is
impracticable because the delay
associated with the public comment
process would impede our ability to
provide this flexibility to claimants
affected by the changed nature of
healthcare. The delay associated with
the public comment process would also
affect our ability to operate efficiently
and provide appropriate public service
because it would require us to hold or
readjudicate cases affected by this
change, possibly delaying benefits to
disabled individuals. People eligible for
disability benefits are, by definition, not
able to engage in substantial gainful
activity.28 Therefore, many applicants
may experience immediate and severe
financial hardship,29 placing them at
risk of losing their homes, means of
transportation, access to health care,
and other important resources, in
addition to experiencing increased
stress as they await the outcome of their
case and their award of benefits. This is
particularly true for the population that
is eligible for Supplemental Security
Income (SSI) benefits, which has, by
definition, severely limited income and
financial resources.30 An unnecessary
delay during this vulnerable period,
particularly in the context of the
economic and other hardships caused
by the pandemic, would cause
significant harm and detract
substantially from the effectiveness of
the disability program in providing
meaningful economic relief for disabled
28 42 U.S.C. 223(d)(1) and 1614(a)(3)(A), 20 CFR
404.1505, 404.1572, 416.905, 416.972.
29 See Bailey, Michelle Stegman and Jeffrey
Hemmeter. Characteristics of Noninstitutionalized
DI and SSI Program Participants, 2013 Update,
Research and Statistics Note No. 2015–02.
Washington, DC: Office of Research, Evaluation,
and Statistics, Office of Retirement and Disability
Policy, Social Security Administration, September
2015, https://www.ssa.gov/policy/docs/rsnotes/
rsn2015-02.html, which shows that 51 percent of DI
beneficiaries and 63 percent of SSI beneficiaries
have household incomes below the poverty level,
excluding their DI and SSI payments. The study
also found that DI payments represented an 85
percent reduction in the poverty gap and SSI
payments represented a 68 percent reduction in the
poverty gap for beneficiaries. See also [SSA] Social
Security Administration, National Beneficiary
Survey: Disability Statistics, 2015, SSA Publication
No. 13–11826. Washington, DC: SSA. https://
www.ssa.gov/policy/docs/statcomps/nbs/2015/nbsstatistics-2015.pdf, which shows that over 45
percent of disability beneficiaries have a household
income lower than the poverty level. Additionally,
see Mathews v. Eldridge, 424 U.S. 319, 342 (1976)
(‘‘in view of . . . the typically modest resources of
the family unit of the physically disabled worker,
the hardship imposed upon the erroneously
terminated disability recipient may be
significant.’’); White v. Mathews, 559 F.2d 852 (2d
Cir. 1977) (‘‘The disability insurance program is
designed to alleviate the immediate and often
severe hardships that result from a wage-earner’s
disability. In that context, delays . . . detract
seriously from the effectiveness of the program.’’).
30 42 U.S.C. 1611(a), 20 CFR 416.202.
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Rules and Regulations
khammond on DSKJM1Z7X2PROD with RULES
individuals. 31 Even if they receive the
same benefits at a later date, these
individuals may suffer from long term
or permanent consequences of the lost
income during the period of delay.
We also find that delaying immediate
implementation of this temporary final
rule to obtain public comment would be
contrary to the public interest because it
would prolong the time it would take to
adjudicate claims and provide benefits
to claimants. This rule is intended to
provide us with flexibility to determine
that an individual’s musculoskeletal
disorder meets the requirements of the
listings, considering the emerging
evidence regarding changes in
healthcare delivery that have resulted
from the COVID–19 national public
health emergency. It also provides for
claimants to receive needed benefits at
a time when they are financially and
medically vulnerable due to onset of
disability and the COVID–19 pandemic,
based on the evidence that is likely to
be in their file during the pandemic.
Providing the opportunity for public
comment before we implement this rule
would prevent us from acting within a
meaningful timeframe to account for
current access-to-care limitations that
prevent claimants who may meet the
listing from establishing requisite
evidence to show it, because the
pandemic-related barriers to access of
care that this rule attempts to alleviate
would continue to occur. Providing
opportunity for prior public comment
could also result in the rule taking effect
only after the proposed expiration date,
when access to care has returned to prepandemic norms, which would negate
the need for the rule. Consequently, if
we offered the opportunity for public
comment prior to immediate temporary
implementation, we would be unable to
31 See Deshpande, Manasi, Tal Gross, and Yalun
Su. 2021. ‘‘Disability and Distress: The Effect of
Disability Programs on Financial Outcomes.’’
American Economic Journal: Applied Economics,
13 (2): 151–78, https://pubs.aeaweb.org/doi/
pdfplus/10.1257/app.20190709, which found that
rates of bankruptcy, foreclosure, and eviction
among disability applicants are higher than in the
general population; rates of these adverse financial
events increase leading up to the application date
and peak around the application date; and rates of
these adverse financial events decline for both
allowed and denied applicants after the initial
disability decision, but they decline more for the
allowed. This suggests that delaying the disability
decision can cause long-term or permanent
financial harm at a time when applicants are most
vulnerable. In fact, the researchers concluded that
awarding disability benefits sooner could avert a
substantial amount of financial distress among
applicants. See also Gross, T., & Trenkamp, B.
(2015). Risk of Bankruptcy among Applicants to
Disability Insurance. Journal of health care for the
poor and underserved, 26(4), 1149–1156. https://
doi.org/10.1353/hpu.2015.0118, which found that
SSDI benefits decrease the risk of bankruptcy to a
statistically significant degree among all age groups.
VerDate Sep<11>2014
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offer relief to affected claimants in a
timely manner, and we would be
required to delay our adjudications of
certain disability claims impacted by
this temporary final rule and be unable
to pay needed benefits to affected
individuals in a timely manner. The
delay associated with a public comment
period would also be contrary to the
public interest because it would reduce
the effectiveness of the rule and the
more flexible timeframe we are
establishing. Prior public comment
would therefore defeat the purpose of
this rule, which is to provide effective
and timely relief and ensure economic
security to individuals affected by the
changed nature of healthcare delivery.
In addition, for the reasons cited
above, we find good cause for
dispensing with the 30-day delay in the
date of this rule provided for in 5 U.S.C.
553(d)(3). So, we are making this
temporary final rule effective upon
publication.
We are making this temporary final
rule effective on the date of publication.
However, we invite public comment on
all aspects of the temporary final rule as
they may apply after the effective date,
including: The definition of the
‘‘pandemic period’’ during which we
will apply expanded flexibility in the
‘‘close proximity of time’’ standard; the
appropriate standard for ‘‘close
proximity of time’’ to account for
barriers to access to care; information
about barriers to access to care and
disproportionate burdens faced by any
subset of the population; and the
expiration date of this rule. Please share
any supporting information that you
might have. We will consider any
substantive comments we receive
within 60 days of the publication of this
temporary final rule and will issue a
revised final rule if necessary after we
consider the public comments. We will
also study the application of this
temporary final rule in our program.
Executive Order 12866, as
Supplemented by Executive Order
13563
We consulted with the Office of
Management and Budget (OMB) and
determined that this temporary final
rule meets the criteria for a significant
regulatory action under Executive Order
12866 and is subject to OMB review.
Executive Order 13132 (Federalism)
We analyzed this rule under the
principles and criteria established by
Executive Order 13132 and determined
that the rule will not have sufficient
Federalism implications to warrant the
preparation of a Federalism assessment.
We also determined that this rule will
PO 00000
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Fmt 4700
Sfmt 4700
not preempt any State law or State
regulation or affect the States’ abilities
to discharge traditional State
governmental functions.
Regulatory Flexibility Act
We certify that this rule will not have
a significant economic impact on a
substantial number of small entities,
because it affects only individuals.
Therefore, a Regulatory Flexibility Act,
as amended, does not require us to
prepare a regulatory flexibility analysis.
Anticipated Costs to Our Programs:
Our Office of the Chief Actuary
(OCACT) was not able to provide a
specific cost estimate for this temporary
final rule, as it does not have any
reliable information on which to base
program cost estimates. Additionally,
this temporary final rule is to be in
effect until 6 months after the Secretary
of Health and Human Services
determines the COVID–19 national
public health emergency no longer
exists, and it is unknown how long it
will be until such declaration is made.
Anticipated Administrative Costs to
SSA: Our Office of Budget, Finance, and
Management notes the unknown
magnitude on allowance rates and
ambiguity in the effective time period
for this temporary final rule, but expects
this change will have a minimal
administrative effect on the agency.
Paperwork Reduction Act
This rule does not create any new or
affect any existing collections and,
therefore, does not require Office of
Management and Budget approval
under the Paperwork Reduction Act.
(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social Security—
Disability Insurance; 96.002, Social
Security—Retirement Insurance; 96.004,
Social Security—Survivors Insurance; and
96.006, Supplemental Security Income)
List of Subjects
20 CFR Part 404
Administrative practice and
procedure; Blind, Disability benefits;
Old-age, survivors, and disability
insurance; Reporting and recordkeeping
requirements; Social Security.
20 CFR Part 416
Administrative practice and
procedure; Aged, Blind, Disability cash
payments; Public assistance programs;
Reporting and recordkeeping
requirements; Supplemental Security
Income (SSI).
The Acting Commissioner of Social
Security, Kilolo Kijakazi, having
reviewed and approved this document,
is delegating the authority to
electronically sign this document to
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Rules and Regulations
Faye I. Lipsky, who is the primary
Federal Register Liaison for the Social
Security Administration, for purposes of
publication in the Federal Register.
Faye I. Lipsky,
Federal Register Liaison, Office of Legislation
and Congressional Affairs, Social Security
Administration.
For the reasons stated in the
preamble, we are amending subpart P of
part 404 of chapter III of title 20 of the
Code of Federal Regulations as set forth
below:
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950– )
Subpart P—Determining Disability and
Blindness
1. The authority citation for subpart P
of part 404 continues to read as follows:
■
Authority: Secs. 202, 205(a)–(b) and (d)–
(h), 216(i), 221(a) and (h)–(j), 222(c), 223,
225, and 702(a)(5) of the Social Security Act
(42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i),
421(a) and (h)–(j), 422(c), 423, 425, and
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108–203,
118 Stat. 509 (42 U.S.C. 902 note).
2. In appendix 1 to subpart P of part
404:
■ a. In part A, amend section 1.00C7 by
redesignating paragraphs a. and b. as b.
and c., by adding a new paragraph a.,
and by revising newly redesignated
paragraph c.; and
■ b. In part B, amend section 101.00C7
by redesignating paragraphs a. and b. as
b. and c., by adding a new paragraph a.,
and by revising newly redesignated
paragraph c.
The additions and revisions read as
follows:
■
Appendix 1 to Subpart P of Part 404—
Listing of Impairments
*
*
*
*
*
*
*
*
khammond on DSKJM1Z7X2PROD with RULES
Part A
*
*
1.00
Musculoskeletal Disorders.
*
*
*
*
*
C. * * *
7. * * *
a. The term pandemic period as used in
1.00C7c means the period beginning on April
2, 2021, and ending on the date that is 6
months after the effective date of a
determination by the Secretary of Health and
Human Services under section 319 of the
Public Health Service Act, 42 U.S.C. 247d,
that the national public health emergency
resulting from the COVID–19 pandemic no
longer exists.
*
*
*
*
*
c. For 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D,
1.22, and 1.23, all of the required criteria
must be present simultaneously, or within a
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15:54 Jul 22, 2021
Jkt 253001
close proximity of time, to satisfy the level
of severity needed to meet the listing. The
phrase ‘‘within a close proximity of time’’
means that all of the relevant criteria must
appear in the medical record within a
consecutive 4-month period, except for
claims determined or decided during the
pandemic period. For claims determined or
decided during the pandemic period, all of
the relevant criteria must appear in the
medical record within a consecutive 12month period. When the criterion is imaging,
we mean that we could reasonably expect the
findings on imaging to have been present at
the date of impairment or date of onset. For
listings that use the word ‘‘and’’ to link the
elements of the required criteria, the medical
record must establish the simultaneous
presence, or presence within a close
proximity of time, of all the required medical
criteria. Once this level of severity is
established, the medical record must also
show that this level of severity has
continued, or is expected to continue, for a
continuous period of at least 12 months.
*
*
*
*
*
*
*
*
Part B
*
*
101.00
*
Musculoskeletal Disorders.
*
*
*
*
C. * * *
7. * * *
a. The term pandemic period as used in
101.00C7c means the period beginning on
April 2, 2021, and ending on the date that is
6 months after the effective date of a
determination by the Secretary of Health and
Human Services under section 319 of the
Public Health Service Act, 42 U.S.C. 247d,
that the national public health emergency
resulting from the COVID–19 pandemic no
longer exists.
*
*
*
*
*
c. For 101.15, 101.16, 101.17, 101.18,
101.20C, 101.20D, 101.22, and 101.23, all of
the required criteria must be present
simultaneously, or within a close proximity
of time, to satisfy the level of severity needed
to meet the listing. The phrase ‘‘within a
close proximity of time’’ means that all of the
relevant criteria must appear in the medical
record within a consecutive 4-month period,
except for claims determined or decided
during the pandemic period. For claims
determined or decided during the pandemic
period, all of the relevant criteria must
appear in the medical record within a
consecutive 12-month period. When the
criterion is imaging, we mean that we could
reasonably expect the findings on imaging to
have been present at the date of impairment
or date of onset. For listings that use the
word ‘‘and’’ to link the elements of the
required criteria, the medical record must
establish the simultaneous presence, or
presence within a close proximity of time, of
all the required medical criteria. Once this
level of severity is established, the medical
record must also show that this level of
severity has continued, or is expected to
PO 00000
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38925
continue, for a continuous period of at least
12 months.
*
*
*
*
*
[FR Doc. 2021–15423 Filed 7–22–21; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number: USCG–2021–0381]
Safety Zone; Recurring Events in
Captain of the Port Duluth Zone—
Pointe to La Pointe Swim, Bayfield, WI
Coast Guard, Department of
Homeland Security (DHS).
ACTION: Notice of enforcement of
regulation.
AGENCY:
The Coast Guard will enforce
the safety zone for the Pointe to La
Pointe Swim event in Bayfield, WI, from
7 a.m. through 11 a.m. on August 7,
2021. This action is necessary to protect
participants and spectators during the
event. During the enforcement period,
entry into, transiting, or anchoring
within the safety zone is prohibited
unless authorized by the Captain of the
Port Duluth or a designated on-scene
representative.
SUMMARY:
The regulations in 33 CFR
165.943(a) will be enforced for the
location listed in Table 1 to § 165.943,
entry (9), from 7 a.m. through 11 a.m.
on August 7, 2021.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email MST2 Jeremy
Davis, telephone (218)725–3818, email
DuluthWWM@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce special local
regulations in 33 CFR 165.943(a) for the
location listed in Table 1 to § 165.943,
entry (9), for the annual Pointe to La
Pointe Swim event from 7 a.m. through
11 a.m. on August 7, 2021 on all waters
between Bayfield, WI, and Madeline
Island, WI, within an imaginary line
created by the following coordinates:
46°48′27.55″ N, 090°48′56°.86″ W,
moving southeast to 46°48′21.2″ N,
090°48′59.9″ W, moving south to
46°47′19.91″ N, 090°49′46.18″ W,
moving east 46′47′21.18″ N,
090°49′02.39″ W, then moving north to
46°48′21.20″ N, 090°48′56.86″ W and
finally running back to the starting
point. Pursuant to 33 CFR 165.33 and
165.943(a), entry into, transiting, or
anchoring within the safety zone is
prohibited unless authorized by the
DATES:
E:\FR\FM\23JYR1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Rules and Regulations]
[Pages 38920-38925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15423]
=======================================================================
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA-2021-0010]
RIN 0960-AI64
Flexibility in Evaluating ``Close Proximity of Time'' Due to
COVID-19 Related Barriers to Healthcare
AGENCY: Social Security Administration.
ACTION: Temporary final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: Since the outset of the COVID-19 national public health
emergency, many individuals have experienced barriers that prevent them
from timely accessing healthcare. In response to those barriers, we are
issuing this rule to temporarily revise our requirement in the Listing
of Impairments (listings) that, for purposes of applying several of our
musculoskeletal disorder listings, all relevant medical criteria be
present simultaneously or ``within a close proximity of time,'' which
we define as being ``within a consecutive 4-month period.'' While this
rule is in effect, we will find that the evidence of a musculoskeletal
disorder is present ``within a close proximity of time'' if the
available evidence establishes such a condition within a consecutive
12-month period. We expect that this temporary change to our rules will
allow us to make findings of disability in appropriate cases in which
individuals have experienced barriers to access to healthcare because
of the COVID-19 national public health emergency.
DATES:
Effective date: This temporary final rule is effective on July 23,
2021. For more information, see SUPPLEMENTARY INFORMATION.
Comment date: We invite written comments. Comments must be
submitted on or before September 21, 2021.
Expiration date: Unless we extend the expiration date by a final
rule published in the Federal Register, this temporary final rule will
cease to be effective 6 months after the effective date of a
determination by the Secretary of Health and Human Services under
section 319 of the Public Health Service Act, 42 U.S.C. 247d, that the
COVID-19 national public health emergency no longer exists. We will
publish a document in the Federal Register announcing the expiration
date. For more information, see SUPPLEMENTARY INFORMATION.
[[Page 38921]]
ADDRESSES: You may submit comments by any one of three methods--
internet, fax, or mail. Do not submit the same comments multiple times
or by more than one method. Regardless of which method you choose,
please state that your comments refer to Docket No. SSA-2021-0010 so
that we may associate your comments with the correct rule.
Caution: You should be careful to include in your comments only
information that you wish to make publicly available. We strongly urge
you not to include in your comments any personal information, such as
Social Security numbers or medical information.
1. Internet: We strongly recommend that you submit your comments
via the internet. Please visit the Federal eRulemaking portal at https://www.regulations.gov. Use the search function to find docket number
SSA-2021-0010. The system will issue a tracking number to confirm your
submission. You will not be able to view your comment immediately
because we must post each comment manually. It may take up to a week
for your comments to be viewable.
2. Fax: Fax comments to (410) 966-2830.
3. Mail: Mail your comments to the Office of Regulations and
Reports Clearance, Social Security Administration, 3100 West High Rise
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
Comments are available for public viewing on the Federal
eRulemaking portal at https://www.regulations.gov or in person, during
regular business hours, by arranging with the contact person identified
in FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Edward Sosar, Office of Regulations
and Reports Clearance, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235-6401, (410) 966-2341. For information on
eligibility or filing for benefits, call our national toll-free number,
1-800-772-1213 or TTY 1-800-325-0778, or visit our internet site,
Social Security Online, at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION: The Secretary of Health and Human Services
issued a determination under section 319 of the Public Health Service
Act on January 31, 2020 that a national public health emergency exists
as of January 27, 2020 because of the COVID-19 pandemic.\1\ The
Secretary has renewed his determination several times since then, most
recently on July 19, 2021 (effective July 20, 2021).\2\ We are issuing
this temporary final rule to address the ongoing effects of the COVID-
19 national public health emergency. The effective date of this
temporary final rule will help us ensure that we provide affected
claimants with the benefit of the flexibilities offered by this rule.
On April 1, 2021, we instructed our adjudicators to temporarily hold
claims in which all elements of musculoskeletal disorders listings
1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22, 1.23, 101.15, 101.16,
101.17, 101.18, 101.20C, 101.20D, 101.22, or 101.23 were present within
a consecutive 12-month period, but not within a consecutive 4-month
period, and it was not possible to process a fully favorable
determination or decision in some other way. By holding claims that
would benefit from the flexibilities in this rule, we will process
claims affected by this rule on or after the effective date of this
rule. As we explain in more detail below, we will continue to apply
this rule until 6 months after effective date of a determination by the
Secretary of Health and Human Services under section 319 of the Public
Health Service Act that the national public health emergency related to
the COVID-19 pandemic no longer exists.
---------------------------------------------------------------------------
\1\ (https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).
\2\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx.
---------------------------------------------------------------------------
Background
On December 3, 2020, we published the final rule, Revised Medical
Criteria for Evaluating Musculoskeletal Disorders, which became
effective on April 2, 2021, revising the criteria in the listings that
we use to evaluate disability claims involving musculoskeletal
disorders in adults and children at the third step of our sequential
evaluation process under titles II and XVI of the Social Security Act
(Act).\3\ The final rule, among other things, revised the listings in
response to the decision in Radford v. Colvin, 734 F.3d 288 (4th Cir.
2013). The final rule required that, for the purposes of applying
certain listings,\4\ all of the required medical criteria must be
present simultaneously, or within a close proximity of time, to satisfy
the level of severity needed to meet the listing.\5\ We defined the
phrase ``within a close proximity of time'' to mean ``that all of the
relevant criteria must appear in the medical record within a
consecutive 4-month period'' (emphasis in original).\6\ We also
provided that ``[w]hen the criterion is imaging, we mean that we could
reasonably expect the findings on imaging to have been present at the
date of impairment or date of onset.'' \7\
---------------------------------------------------------------------------
\3\ 85 FR 78164 (2020).
\4\ Listings 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22, 1.23,
101.15, 101.16, 101.17, 101.18, 101.20D, 101.22, and 101.23.
\5\ See 20 CFR appendix 1 to subpart P of part 404 1.00C7b and
101.00C7b.
\6\ Id.
\7\ Id.
---------------------------------------------------------------------------
We established the consecutive 4-month period as a criterion to
meet the level of severity in the listings based on our extensive
research of relevant medical literature and clinical guidelines. In our
notice of proposed rulemaking, we also specifically asked interested
members of the public to comment on this issue and provide us with any
studies and data that supported their comments; \8\ however, no studies
or data were submitted. In the final rule, we concluded that the
consecutive 4-month period is consistent with instructions providers
receive for scheduling patients,\9\ the general standard of care,\10\
and the frequency of healthcare visits by individuals with
musculoskeletal conditions.\11\ At the same time, the consecutive 4-
month period in the rules provides some leeway for the claimant,
because the standard for patient revisits is once every 3 months.\12\
Our rules recognize that one visit alone may not ensure all necessary
criteria required for a medical listing will be appropriately
documented; however, the consecutive 4-month time period provides a
sufficient period to ensure the criteria are present within a close
proximity of time and that the claimant's
[[Page 38922]]
musculoskeletal disorder meets the requisite severity for the listing.
---------------------------------------------------------------------------
\8\ 83 FR 20646, 20647 (May 7, 2018).
\9\ 85 FR at 78169 n.37 (citing Bavafa, H., Savin, S., &
Terwiesch, C. (2019). Redesigning Primary Care Delivery: Customized
Office Revisit Intervals and E-Visits. https://dx.doi.org/10.2139/ssrn.2363685. Paper referenced by Bavafa: Schectman, G., G. Barnas,
P. Laud, L. Cantwell, M. Horton, E.J. Zarling. 2005. Prolonging the
return visit interval in primary care. The American Journal of
Medicine, 118(4) 393-399.)
\10\ 85 FR at 78169 n.34 (citing Gore, M., Sadosky, A., Stacey,
B.R., Tai, K.S., & Leslie, D. (2012). The burden of chronic low back
pain: Clinical comorbidities, treatment patterns, and health care
costs in usual care settings. Spine, 37(11), E668-E677. https://doi.org/10.1097/BRS.0b013e318241e5de.)
\11\ 85 FR at 78169 n.35 (citing BMUS: The Burden of
Musculoskeletal Diseases in the United States. In: BMUS: The Burden
of Musculoskeletal Diseases in the United States [internet]. [cited
15 July 2020]. https://www.boneandjointburden.org/fourth-edition/viiic2/utilization-condition-group.)
\12\ See 85 FR at 78169 n.36 (citing J Gen Intern Med. 1999 Apr;
14(4): 230-235. doi: 10.1046/j.1525-1497.1999.00322.x Lisa M
Schwartz, MD, MS, Steven Woloshin, MD, MS, John H Wasson, MD, Roger
A Renfrew, MD, and H Gilbert Welch, MD, MPH, Dartmouth Primary Care
Cooperative Research Network.)
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Our use of the consecutive 4-month proximity of time requirement is
also consistent with the standard recognized by the Veterans Health
Administration (VHA) and Department of Defense (DoD), as set out in
their clinical practice guidelines.\13\ For example, the VHA and DoD's
Clinical Practice Guideline for the Management of Medically Unexplained
Symptoms: Chronic Pain and Fatigue directs initial revisits at 2 to 3
week intervals, with visits every 3 to 4 months once the patient is
doing well.\14\ Similarly, the VHA's and DoD's Clinical Practice
Guideline for Diagnosis and Treatment of Low Back Pain describes the
duration of time for intervention, based on a systematic review, as
requiring a minimum follow-up for effectiveness of 12 weeks and
recommends monthly reassessment after initiation of therapy if low back
pain continues and no serious specific underlying cause of low back
pain is found.\15\
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\13\ 85 FR at 78169 n.38 (citing Veterans Health Administration
& Department of Defense. (2001). VHA/DoD Clinical Practice Guideline
for the Management of Medically Unexplained Symptoms: Chronic Pain
and Fatigue. https://www.healthquality.va.gov/guidelines/MR/mus/mus_fulltext.pdf.)
\14\ Id.
\15\ 85 FR at 78169-70 (citing Veterans Health Administration &
Department of Defense. (2017). VA/DoD Clinical Practice Guideline
for Diagnosis and Treatment of Low Back Pain. https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPG092917.pdf.)
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Rationale for This Rule
As noted above, on January 31, 2020, the Secretary of Health and
Human Services declared COVID-19 a national public health emergency.
The COVID-19 national public health emergency has dramatically changed
the provision of, and access to, healthcare services throughout the
country. Individuals with musculoskeletal impairments who, before the
national public health emergency, would seek and receive healthcare at
a frequency consistent with the standards cited above, now might be
unable or choose not to seek care in the same manner and frequency.
This is due in part to healthcare organizations and government agencies
such as the Centers for Medicare & Medicaid Services (CMS) \16\
prioritizing the most urgent services and encouraging patients to delay
other procedures during the pandemic. For example, the North American
Spine Society (NASS) provided guidance for delaying non-emergent
procedures for people with chronic spinal conditions.\17\
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\16\ Centers for Medicare & Medicaid Services (CMS)
Recommendations: Re-opening Facilities to Provide Non-emergent Non-
COVID-19 Healthcare (https://www.cms.gov/files/document/covid-recommendations-reopening-facilities-provide-non-emergent-care.pdf);
see also Non-Emergent, Elective Medical Services, and Treatment
Recommendations (https://www.cms.gov/files/document/cms-non-emergent-elective-medical-recommendations.pdf.)
\17\ https://www.spine.org/Portals/0/assets/downloads/Publications/NASSInsider/NASSGuidanceDocument040320.pdf.
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Likewise, many individuals have delayed or deferred important
treatment due to closures of medical offices, fears of contracting
COVID-19 infection (including having a high risk individual in the
household), and other challenges created or exacerbated by the
pandemic, such as difficulty accessing transportation. According to one
source, among the general U.S. population reporting delayed care for
serious problems during the pandemic, 69% cited nonfinancial access
barriers, such as being unable to get an appointment, find a physician
who would see them, or access the care location.\18\ Additionally, the
National Center for Health Statistics estimated that 41% of U.S. adults
had delayed or avoided medical care, including urgent or emergency care
(12%) and routine care (32%) because of concerns about COVID-19.\19\
---------------------------------------------------------------------------
\18\ Delayed Care with Harmful Health Consequences--Reported
Experiences from National Surveys During Coronavirus Disease 2019
[verbar] Infectious Diseases [verbar] JAMA Health Forum [verbar]
JAMA Network. See also The Impact of Coronavirus on Households
Across America (https://cdn1.sph.harvard.edu/wp-content/uploads/sites/21/2020/09/NPR-RWJF-Harvard-National-Report_092220_Final1-4.pdf) and COVID-19: Experiences Among the Medicare Population
(https://www.cms.gov/files/document/medicare-current-beneficiary-survey-covid-19-data-snapshot.pdf.)
\19\ Reduced Access to Care: Household Pulse Survey (National
Center for Health Statistics) (https://www.cdc.gov/nchs/covid19/pulse/reduced-access-to-care.htm.)
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We are also temporarily changing the consecutive 4-month close
proximity of time rule to a consecutive 12-month rule because the
manner of care provided changed throughout the COVID-19 national public
health emergency. To be responsive to this change in the manner of
care, we instructed our adjudicators to temporarily hold claims that
would benefit from the flexibilities in this rule, so we will process
claims affected by this rule on or after the effective date of this
rule. Due to safety concerns, many healthcare providers shifted to
emphasizing or exclusively scheduling telehealth or virtual visits. The
optimization of telehealth is consistent with the guidance issued by
many specialist organizations, such as NASS,\20\ the American College
of Surgeons (ACS),\21\ the American Academy of Orthopedic Surgeons
(AAOS),\22\ and the American College of Rheumatology (ACR).\23\
---------------------------------------------------------------------------
\20\ https://www.spine.org/Portals/0/assets/downloads/Publications/NASSInsider/NASSGuidanceDocument040320.pdf.
\21\ COVID-19 Guidelines for Triage of Orthopaedic Patients
(https://www.facs.org/covid-19/clinical-guidance/elective-case/orthopaedics).
\22\ Navigating the COVID-19 Pandemic (https://www.aaos.org/globalassets/about/covid-19/aaos-clinical-considerations-during-covid-19.pdf).
\23\ COVID-19 Clinical Guidance for Adult Patients with
Rheumatic Diseases (https://www.rheumatology.org/Portals/0/Files/ACR-COVID-19-Clinical-Guidance-Summary-Patients-with-Rheumatic-Diseases.pdf).
---------------------------------------------------------------------------
Although many individuals access telehealth visits successfully,
the clinical signs and findings required by some of the listings may
not be present in the telehealth record due to the limitations of
telemedicine. While testing by the patient is possible through
telehealth, there are limits in provocative testing (that is, testing
that manipulates the areas where you have pain in order to reproduce
the pain), discrete palpation (that is, a technique that uses targeted
pressure to identify and quantify the abnormalities of the
musculoskeletal system, such as warmth, swelling, pain, tenderness, and
trigger points), and strength or stability testing.\24\ During the
beginning of the COVID-19 pandemic, orthopedists created guidelines for
virtual examinations of patients through telemedicine, and found that
while the patient could perform many tests, there are inherent
limitations to testing in this manner. For example, the authors
recommend using another person to hold the camera during gait
examination to get a better view of the patient's gait mechanics, which
is not always possible.\25\ Further, the VHA has found that although
patients appreciate telehealth, many are unable to complete exams that
require precise measurements, such as range of motion or reflexes.\26\
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\24\ Tanaka et al. (2020). Telemedicine in the Era of COVID-19:
The Virtual Orthopaedic Examination. The Journal of Bone and Joint
Surgery, Incorporated, 00:e1 (1-7) https://dx.doi.org/10.2106/JBJS.20.00609.
\25\ Laskowski, et al. (2020). The Telemedicine Musculoskeletal
Examination. Mayo Clinic Proc. 95(8) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395661/.
\26\ Baus, Shanna, PA-C. Telehealth & Disability Items: Veterans
Health Administration. Presentation to the Standing Committee of the
National Academies of Science and Medicine Health and Medicine
Division, on December 1, 2020.
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Consequently, disability claimants with musculoskeletal disorders
of the severity required by the listings who would have been able to
provide evidence that their musculoskeletal disorder met the
consecutive 4-month close proximity of time requirement
[[Page 38923]]
before the COVID-19 national public health emergency may now have more
difficulty producing evidence to meet the standard. It is possible
that, in light of the pandemic and the temporary changes in healthcare
described above, claimants have scheduled fewer clinical visits or have
been afforded fewer appointments that would allow them to provide the
necessary evidence. Because such a claimant would lack the necessary
documentation to meet the listing in the absence of this temporary
change, we would not find the claimant disabled under the listings,
although we could make a finding of disability at later steps of our
sequential evaluation process in appropriate cases.
In recognition of the economic and social services crisis caused by
the COVID-19 national public health emergency, the President published
Executive Order 14002 Economic Relief Related to the COVID-19
Pandemic,\27\ which directed Federal agencies to consider actions to
improve access to and reduce unnecessary barriers to Federally-funded
programs. We are issuing this rule in furtherance of the goals in the
Executive Order.
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\27\ 86 FR 7229 (2021).
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This rule will remain in effect until 6 months after the effective
date of a determination by the Secretary of Health and Human Services
under section 319 of the Public Health Service Act, 42 U.S.C. 247d,
that the national public health emergency resulting from the COVID-19
pandemic no longer exists, which will afford claimants the opportunity
to attend scheduled appointments that may have been delayed during the
national public health emergency, allow us time to adjudicate claims
affected by the rule, and allow sufficient time to notify the
adjudicative community of the change. We will continue to apply the
consecutive 12-month period until 6 months after the Secretary of HHS
determines that the COVID-19 national public health emergency no longer
exists to allow time for health care access to normalize back to pre-
pandemic period levels and to account for potential backlogs in medical
care that may continue to interfere with access to the relevant care
and documentation needed to satisfy the listing criteria. Additionally,
the expiration date included in this temporary final rule will provide
us with the time necessary to publish a document in the Federal
Register to advise the public of the date on which this rule will no
longer be effective, communicate the change to adjudicators and the
public, update our materials that reference the consecutive 12-month
period, and process claims where the medical care was received prior to
the end of the COVID-19 national public health emergency.
Summary of the Changes
This rule adds a new section 1.00C7a and 101.00C7a to the
musculoskeletal disorders listings. The rule also redesignates current
sections 1.00C7a and 1.00C7b as 1.00C7b and 1.00C7c, respectively, and
101.00C7a and 101.00C7b as 101.00C7b and 101.00C7c, respectively. New
sections 1.00C7a and 101.00C7a define the term ``pandemic period'' to
mean ``the period beginning on April 2, 2021 and ending on the date
that is 6 months after the effective date of a determination by the
Secretary of Health and Human Services under section 319 of the Public
Health Service Act, 42 U.S.C. 247d, that the national public health
emergency resulting from the COVID-19 pandemic no longer exists.''
Redesignated and revised sections 1.00C7c and 101.00C7c provide that,
for purposes of listings 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22,
1.23, 101.15, 101.16, 101.17, 101.18, 101.20C, 101.20D, 101.22, and
101.23, the phrase ``within a close proximity of time'' means that all
of the relevant criteria must appear in the medical record within a
consecutive 4-month period, except for claims determined or decided
during the pandemic period. For claims that we determine or decide
during the pandemic period, we provide that all of the relevant
criteria must appear in the medical record within a consecutive 12-
month period.
Regulatory Procedures
Justification for Issuing a Rule Without Notice and Comment
We follow the Administrative Procedure Act's (APA) rulemaking
procedures specified in 5 U.S.C. 553 when we develop regulations.
Generally, the APA requires that an agency provide prior notice and
opportunity for public comment before issuing a final rule. The APA
provides exceptions to its notice and public comment procedures when an
agency finds there is good cause for dispensing with such procedures
because they are impracticable, unnecessary, or contrary to the public
interest (5 U.S.C. 553(b)(B)).
We find that there is good cause under 5 U.S.C. 553(b)(B) to issue
this rule without prior public comment because prior public comment is
impracticable and contrary to public interest.
We find that public comment is impracticable because the delay
associated with the public comment process would impede our ability to
provide this flexibility to claimants affected by the changed nature of
healthcare. The delay associated with the public comment process would
also affect our ability to operate efficiently and provide appropriate
public service because it would require us to hold or readjudicate
cases affected by this change, possibly delaying benefits to disabled
individuals. People eligible for disability benefits are, by
definition, not able to engage in substantial gainful activity.\28\
Therefore, many applicants may experience immediate and severe
financial hardship,\29\ placing them at risk of losing their homes,
means of transportation, access to health care, and other important
resources, in addition to experiencing increased stress as they await
the outcome of their case and their award of benefits. This is
particularly true for the population that is eligible for Supplemental
Security Income (SSI) benefits, which has, by definition, severely
limited income and financial resources.\30\ An unnecessary delay during
this vulnerable period, particularly in the context of the economic and
other hardships caused by the pandemic, would cause significant harm
and detract substantially from the effectiveness of the disability
program in providing meaningful economic relief for disabled
[[Page 38924]]
individuals. \31\ Even if they receive the same benefits at a later
date, these individuals may suffer from long term or permanent
consequences of the lost income during the period of delay.
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\28\ 42 U.S.C. 223(d)(1) and 1614(a)(3)(A), 20 CFR 404.1505,
404.1572, 416.905, 416.972.
\29\ See Bailey, Michelle Stegman and Jeffrey Hemmeter.
Characteristics of Noninstitutionalized DI and SSI Program
Participants, 2013 Update, Research and Statistics Note No. 2015-02.
Washington, DC: Office of Research, Evaluation, and Statistics,
Office of Retirement and Disability Policy, Social Security
Administration, September 2015, https://www.ssa.gov/policy/docs/rsnotes/rsn2015-02.html, which shows that 51 percent of DI
beneficiaries and 63 percent of SSI beneficiaries have household
incomes below the poverty level, excluding their DI and SSI
payments. The study also found that DI payments represented an 85
percent reduction in the poverty gap and SSI payments represented a
68 percent reduction in the poverty gap for beneficiaries. See also
[SSA] Social Security Administration, National Beneficiary Survey:
Disability Statistics, 2015, SSA Publication No. 13-11826.
Washington, DC: SSA. https://www.ssa.gov/policy/docs/statcomps/nbs/2015/nbs-statistics-2015.pdf, which shows that over 45 percent of
disability beneficiaries have a household income lower than the
poverty level. Additionally, see Mathews v. Eldridge, 424 U.S. 319,
342 (1976) (``in view of . . . the typically modest resources of the
family unit of the physically disabled worker, the hardship imposed
upon the erroneously terminated disability recipient may be
significant.''); White v. Mathews, 559 F.2d 852 (2d Cir. 1977)
(``The disability insurance program is designed to alleviate the
immediate and often severe hardships that result from a wage-
earner's disability. In that context, delays . . . detract seriously
from the effectiveness of the program.'').
\30\ 42 U.S.C. 1611(a), 20 CFR 416.202.
\31\ See Deshpande, Manasi, Tal Gross, and Yalun Su. 2021.
``Disability and Distress: The Effect of Disability Programs on
Financial Outcomes.'' American Economic Journal: Applied Economics,
13 (2): 151-78, https://pubs.aeaweb.org/doi/pdfplus/10.1257/app.20190709, which found that rates of bankruptcy, foreclosure, and
eviction among disability applicants are higher than in the general
population; rates of these adverse financial events increase leading
up to the application date and peak around the application date; and
rates of these adverse financial events decline for both allowed and
denied applicants after the initial disability decision, but they
decline more for the allowed. This suggests that delaying the
disability decision can cause long-term or permanent financial harm
at a time when applicants are most vulnerable. In fact, the
researchers concluded that awarding disability benefits sooner could
avert a substantial amount of financial distress among applicants.
See also Gross, T., & Trenkamp, B. (2015). Risk of Bankruptcy among
Applicants to Disability Insurance. Journal of health care for the
poor and underserved, 26(4), 1149-1156. https://doi.org/10.1353/hpu.2015.0118, which found that SSDI benefits decrease the risk of
bankruptcy to a statistically significant degree among all age
groups.
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We also find that delaying immediate implementation of this
temporary final rule to obtain public comment would be contrary to the
public interest because it would prolong the time it would take to
adjudicate claims and provide benefits to claimants. This rule is
intended to provide us with flexibility to determine that an
individual's musculoskeletal disorder meets the requirements of the
listings, considering the emerging evidence regarding changes in
healthcare delivery that have resulted from the COVID-19 national
public health emergency. It also provides for claimants to receive
needed benefits at a time when they are financially and medically
vulnerable due to onset of disability and the COVID-19 pandemic, based
on the evidence that is likely to be in their file during the pandemic.
Providing the opportunity for public comment before we implement this
rule would prevent us from acting within a meaningful timeframe to
account for current access-to-care limitations that prevent claimants
who may meet the listing from establishing requisite evidence to show
it, because the pandemic-related barriers to access of care that this
rule attempts to alleviate would continue to occur. Providing
opportunity for prior public comment could also result in the rule
taking effect only after the proposed expiration date, when access to
care has returned to pre-pandemic norms, which would negate the need
for the rule. Consequently, if we offered the opportunity for public
comment prior to immediate temporary implementation, we would be unable
to offer relief to affected claimants in a timely manner, and we would
be required to delay our adjudications of certain disability claims
impacted by this temporary final rule and be unable to pay needed
benefits to affected individuals in a timely manner. The delay
associated with a public comment period would also be contrary to the
public interest because it would reduce the effectiveness of the rule
and the more flexible timeframe we are establishing. Prior public
comment would therefore defeat the purpose of this rule, which is to
provide effective and timely relief and ensure economic security to
individuals affected by the changed nature of healthcare delivery.
In addition, for the reasons cited above, we find good cause for
dispensing with the 30-day delay in the date of this rule provided for
in 5 U.S.C. 553(d)(3). So, we are making this temporary final rule
effective upon publication.
We are making this temporary final rule effective on the date of
publication. However, we invite public comment on all aspects of the
temporary final rule as they may apply after the effective date,
including: The definition of the ``pandemic period'' during which we
will apply expanded flexibility in the ``close proximity of time''
standard; the appropriate standard for ``close proximity of time'' to
account for barriers to access to care; information about barriers to
access to care and disproportionate burdens faced by any subset of the
population; and the expiration date of this rule. Please share any
supporting information that you might have. We will consider any
substantive comments we receive within 60 days of the publication of
this temporary final rule and will issue a revised final rule if
necessary after we consider the public comments. We will also study the
application of this temporary final rule in our program.
Executive Order 12866, as Supplemented by Executive Order 13563
We consulted with the Office of Management and Budget (OMB) and
determined that this temporary final rule meets the criteria for a
significant regulatory action under Executive Order 12866 and is
subject to OMB review.
Executive Order 13132 (Federalism)
We analyzed this rule under the principles and criteria established
by Executive Order 13132 and determined that the rule will not have
sufficient Federalism implications to warrant the preparation of a
Federalism assessment. We also determined that this rule will not
preempt any State law or State regulation or affect the States'
abilities to discharge traditional State governmental functions.
Regulatory Flexibility Act
We certify that this rule will not have a significant economic
impact on a substantial number of small entities, because it affects
only individuals. Therefore, a Regulatory Flexibility Act, as amended,
does not require us to prepare a regulatory flexibility analysis.
Anticipated Costs to Our Programs: Our Office of the Chief Actuary
(OCACT) was not able to provide a specific cost estimate for this
temporary final rule, as it does not have any reliable information on
which to base program cost estimates. Additionally, this temporary
final rule is to be in effect until 6 months after the Secretary of
Health and Human Services determines the COVID-19 national public
health emergency no longer exists, and it is unknown how long it will
be until such declaration is made.
Anticipated Administrative Costs to SSA: Our Office of Budget,
Finance, and Management notes the unknown magnitude on allowance rates
and ambiguity in the effective time period for this temporary final
rule, but expects this change will have a minimal administrative effect
on the agency.
Paperwork Reduction Act
This rule does not create any new or affect any existing
collections and, therefore, does not require Office of Management and
Budget approval under the Paperwork Reduction Act.
(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social
Security--Disability Insurance; 96.002, Social Security--Retirement
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006,
Supplemental Security Income)
List of Subjects
20 CFR Part 404
Administrative practice and procedure; Blind, Disability benefits;
Old-age, survivors, and disability insurance; Reporting and
recordkeeping requirements; Social Security.
20 CFR Part 416
Administrative practice and procedure; Aged, Blind, Disability cash
payments; Public assistance programs; Reporting and recordkeeping
requirements; Supplemental Security Income (SSI).
The Acting Commissioner of Social Security, Kilolo Kijakazi, having
reviewed and approved this document, is delegating the authority to
electronically sign this document to
[[Page 38925]]
Faye I. Lipsky, who is the primary Federal Register Liaison for the
Social Security Administration, for purposes of publication in the
Federal Register.
Faye I. Lipsky,
Federal Register Liaison, Office of Legislation and Congressional
Affairs, Social Security Administration.
For the reasons stated in the preamble, we are amending subpart P
of part 404 of chapter III of title 20 of the Code of Federal
Regulations as set forth below:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950- )
Subpart P--Determining Disability and Blindness
0
1. The authority citation for subpart P of part 404 continues to read
as follows:
Authority: Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a) and
(h)-(j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act
(42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a) and (h)-(j),
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42
U.S.C. 902 note).
0
2. In appendix 1 to subpart P of part 404:
0
a. In part A, amend section 1.00C7 by redesignating paragraphs a. and
b. as b. and c., by adding a new paragraph a., and by revising newly
redesignated paragraph c.; and
0
b. In part B, amend section 101.00C7 by redesignating paragraphs a. and
b. as b. and c., by adding a new paragraph a., and by revising newly
redesignated paragraph c.
The additions and revisions read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
Part A
* * * * *
1.00 Musculoskeletal Disorders.
* * * * *
C. * * *
7. * * *
a. The term pandemic period as used in 1.00C7c means the period
beginning on April 2, 2021, and ending on the date that is 6 months
after the effective date of a determination by the Secretary of
Health and Human Services under section 319 of the Public Health
Service Act, 42 U.S.C. 247d, that the national public health
emergency resulting from the COVID-19 pandemic no longer exists.
* * * * *
c. For 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22, and 1.23, all
of the required criteria must be present simultaneously, or within a
close proximity of time, to satisfy the level of severity needed to
meet the listing. The phrase ``within a close proximity of time''
means that all of the relevant criteria must appear in the medical
record within a consecutive 4-month period, except for claims
determined or decided during the pandemic period. For claims
determined or decided during the pandemic period, all of the
relevant criteria must appear in the medical record within a
consecutive 12-month period. When the criterion is imaging, we mean
that we could reasonably expect the findings on imaging to have been
present at the date of impairment or date of onset. For listings
that use the word ``and'' to link the elements of the required
criteria, the medical record must establish the simultaneous
presence, or presence within a close proximity of time, of all the
required medical criteria. Once this level of severity is
established, the medical record must also show that this level of
severity has continued, or is expected to continue, for a continuous
period of at least 12 months.
* * * * *
Part B
* * * * *
101.00 Musculoskeletal Disorders.
* * * * *
C. * * *
7. * * *
a. The term pandemic period as used in 101.00C7c means the
period beginning on April 2, 2021, and ending on the date that is 6
months after the effective date of a determination by the Secretary
of Health and Human Services under section 319 of the Public Health
Service Act, 42 U.S.C. 247d, that the national public health
emergency resulting from the COVID-19 pandemic no longer exists.
* * * * *
c. For 101.15, 101.16, 101.17, 101.18, 101.20C, 101.20D, 101.22,
and 101.23, all of the required criteria must be present
simultaneously, or within a close proximity of time, to satisfy the
level of severity needed to meet the listing. The phrase ``within a
close proximity of time'' means that all of the relevant criteria
must appear in the medical record within a consecutive 4-month
period, except for claims determined or decided during the pandemic
period. For claims determined or decided during the pandemic period,
all of the relevant criteria must appear in the medical record
within a consecutive 12-month period. When the criterion is imaging,
we mean that we could reasonably expect the findings on imaging to
have been present at the date of impairment or date of onset. For
listings that use the word ``and'' to link the elements of the
required criteria, the medical record must establish the
simultaneous presence, or presence within a close proximity of time,
of all the required medical criteria. Once this level of severity is
established, the medical record must also show that this level of
severity has continued, or is expected to continue, for a continuous
period of at least 12 months.
* * * * *
[FR Doc. 2021-15423 Filed 7-22-21; 8:45 am]
BILLING CODE 4191-02-P
