Rule2021-15423

Flexibility in Evaluating “Close Proximity of Time” Due to COVID-19 Related Barriers to Healthcare

Primary source

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Published
July 23, 2021
Effective
July 23, 2021

Issuing agencies

Social Security Administration

Abstract

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.

Full Text

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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15423]


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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.

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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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.socialsecurity.gov">http://www.socialsecurity.gov</a>.

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.
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    \1\ (<a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx</a>).
    \2\ <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx</a>.
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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\
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    \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.
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    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.
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    \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. <a href="https://dx.doi.org/10.2139/ssrn.2363685">https://dx.doi.org/10.2139/ssrn.2363685</a>. 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. <a href="https://doi.org/10.1097/BRS.0b013e318241e5de">https://doi.org/10.1097/BRS.0b013e318241e5de</a>.)
    \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]. <a href="https://www.boneandjointburden.org/fourth-edition/viiic2/utilization-condition-group">https://www.boneandjointburden.org/fourth-edition/viiic2/utilization-condition-group</a>.)
    \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. <a href="https://www.healthquality.va.gov/guidelines/MR/mus/mus_fulltext.pdf">https://www.healthquality.va.gov/guidelines/MR/mus/mus_fulltext.pdf</a>.)
    \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. <a href="https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPG092917.pdf">https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPG092917.pdf</a>.)
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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 (<a href="https://www.cms.gov/files/document/covid-recommendations-reopening-facilities-provide-non-emergent-care.pdf">https://www.cms.gov/files/document/covid-recommendations-reopening-facilities-provide-non-emergent-care.pdf</a>); 
see also Non-Emergent, Elective Medical Services, and Treatment 
Recommendations (<a href="https://www.cms.gov/files/document/cms-non-emergent-elective-medical-recommendations.pdf">https://www.cms.gov/files/document/cms-non-emergent-elective-medical-recommendations.pdf</a>.)
    \17\ <a href="https://www.spine.org/Portals/0/assets/downloads/Publications/NASSInsider/NASSGuidanceDocument040320.pdf">https://www.spine.org/Portals/0/assets/downloads/Publications/NASSInsider/NASSGuidanceDocument040320.pdf</a>.
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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\
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    \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 (<a href="https://cdn1.sph.harvard.edu/wp-content/uploads/sites/21/2020/09/NPR-RWJF-Harvard-National-Report_092220_Final1-4.pdf">https://cdn1.sph.harvard.edu/wp-content/uploads/sites/21/2020/09/NPR-RWJF-Harvard-National-Report_092220_Final1-4.pdf</a>) and COVID-19: Experiences Among the Medicare Population 
(<a href="https://www.cms.gov/files/document/medicare-current-beneficiary-survey-covid-19-data-snapshot.pdf">https://www.cms.gov/files/document/medicare-current-beneficiary-survey-covid-19-data-snapshot.pdf</a>.)
    \19\ Reduced Access to Care: Household Pulse Survey (National 
Center for Health Statistics) (<a href="https://www.cdc.gov/nchs/covid19/pulse/reduced-access-to-care.htm">https://www.cdc.gov/nchs/covid19/pulse/reduced-access-to-care.htm</a>.)
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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\
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    \20\ <a href="https://www.spine.org/Portals/0/assets/downloads/Publications/NASSInsider/NASSGuidanceDocument040320.pdf">https://www.spine.org/Portals/0/assets/downloads/Publications/NASSInsider/NASSGuidanceDocument040320.pdf</a>.
    \21\ COVID-19 Guidelines for Triage of Orthopaedic Patients 
(<a href="https://www.facs.org/covid-19/clinical-guidance/elective-case/orthopaedics">https://www.facs.org/covid-19/clinical-guidance/elective-case/orthopaedics</a>).
    \22\ Navigating the COVID-19 Pandemic (<a href="https://www.aaos.org/globalassets/about/covid-19/aaos-clinical-considerations-during-covid-19.pdf">https://www.aaos.org/globalassets/about/covid-19/aaos-clinical-considerations-during-covid-19.pdf</a>).
    \23\ COVID-19 Clinical Guidance for Adult Patients with 
Rheumatic Diseases (<a href="https://www.rheumatology.org/Portals/0/Files/ACR-COVID-19-Clinical-Guidance-Summary-Patients-with-Rheumatic-Diseases.pdf">https://www.rheumatology.org/Portals/0/Files/ACR-COVID-19-Clinical-Guidance-Summary-Patients-with-Rheumatic-Diseases.pdf</a>).
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    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) <a href="http://dx.doi.org/10.2106/JBJS.20.00609">http://dx.doi.org/10.2106/JBJS.20.00609</a>.
    \25\ Laskowski, et al. (2020). The Telemedicine Musculoskeletal 
Examination. Mayo Clinic Proc. 95(8) <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395661/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395661/</a>.
    \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, <a href="https://www.ssa.gov/policy/docs/rsnotes/rsn2015-02.html">https://www.ssa.gov/policy/docs/rsnotes/rsn2015-02.html</a>, 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. <a href="https://www.ssa.gov/policy/docs/statcomps/nbs/2015/nbs-statistics-2015.pdf">https://www.ssa.gov/policy/docs/statcomps/nbs/2015/nbs-statistics-2015.pdf</a>, 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, <a href="https://pubs.aeaweb.org/doi/pdfplus/10.1257/app.20190709">https://pubs.aeaweb.org/doi/pdfplus/10.1257/app.20190709</a>, 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. <a href="https://doi.org/10.1353/hpu.2015.0118">https://doi.org/10.1353/hpu.2015.0118</a>, which found that SSDI benefits decrease the risk of 
bankruptcy to a statistically significant degree among all age 
groups.
---------------------------------------------------------------------------

    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


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