[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Rules and Regulations]
[Pages 67081-67089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21671]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2023-0023]
RIN 0960-AI85


Extension of the Flexibility in Evaluating ``Close Proximity of 
Time'' To Evaluate Changes in Healthcare Following the COVID-19 Public 
Health Emergency

AGENCY: Social Security Administration.

ACTION: Temporary final rule with request for comments.

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SUMMARY: On July 23, 2021, we issued a temporary final rule (TFR) with 
request for comments to lengthen the ``close proximity of time'' 
standard in the Listing of Impairments (the listings) for 
musculoskeletal disorders because the COVID-19 national public health 
emergency (PHE) caused many individuals to experience barriers that 
prevented them from timely accessing in-person healthcare. That prior 
TFR is effective until six months after the effective date of a 
determination by the Secretary of Health and Human Services (HHS) that 
a PHE resulting from the COVID-19 pandemic no longer exists. The 
Secretary of HHS made that determination, and the COVID-19 national PHE 
ended on May 11, 2023. However, healthcare practices in a post-PHE 
world are still evolving. We are therefore issuing this new TFR to 
extend the flexibility provided by the prior TFR until May 11, 2025, so 
we can evaluate changes in healthcare practices and determine the 
proper ``close proximity of time'' standard for the musculoskeletal 
disorders listings.

DATES: 
    Effective date: This TFR is effective on October 30, 2023.
    Comment date: We invite written comments. Comments must be 
submitted no later than November 28, 2023.
    Expiration date: Unless we extend the provisions of this TFR by a 
final rule published in the Federal Register, it will cease to be 
effective on May 11, 2025.

ADDRESSES: You may submit comments by any one of three methods--
internet, fax, or mail. Do not submit the same comment(s) multiple 
times or by more than one method. Regardless of which method you 
choose, please state that your comment(s) refer to Docket No. SSA-2023-
0023 so that we may associate your comment(s) with the correct 
regulation.
    Caution: You should be careful to include in your comment(s) only 
information that you wish to make publicly available. We strongly urge 
you not to include any personal information in your comment(s), such as 
Social Security numbers or medical information.
    1. Internet: We strongly recommend that you submit your comment(s) 
via the internet. Please visit the Federal eRulemaking portal at 
https://www.regulations.gov. Use the ``search'' function to find docket 
number SSA-2023-0023. The system will issue a tracking number to 
confirm your submission. You will not be able to view your comment(s) 
immediately because we must post each comment manually. It may take up 
to one week for your comment(s) to be viewable.
    2. Fax: Fax comments to 1-833-410-1631.
    3. Mail: Mail your comments to the Office of Legislation and 
Congressional Affairs Regulations and Reports Clearance Staff, Mail 
Stop 3253, Altmeyer, 6401 Security Blvd., Baltimore, MD 21235.
    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 
below.

FOR FURTHER INFORMATION CONTACT: Michael J. Goldstein, Office of 
Disability Policy, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235-6401, (410) 965-1020. 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 http://www.ssa.gov.

SUPPLEMENTARY INFORMATION:

Background

    On December 3, 2020, we published the final rule, Revised Medical 
Criteria for Evaluating Musculoskeletal Disorders (final rule),\1\ 
which became effective on April 2, 2021. This final rule revised 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).\2\ The final rule, among other things, 
revised the listings in response to the decision in Radford v. 
Colvin,\3\ which interpreted former listing 1.04A to require a 
disability claimant to show only ``that each of the symptoms are 
present, and that the claimant has suffered or can be expected to 
suffer from [the condition] continuously for at least 12 months.'' \4\ 
Under the court's interpretation of the former listing, a claimant did 
not need to show that each necessary criterion was present 
simultaneously or in particularly close proximity, as required by our 
interpretation of that listing.\5\ The final rule clarified that, for 
the purposes of applying certain musculoskeletal disorders listings,\6\ 
all of the required medical criteria must be present simultaneously, or 
within a close proximity of time, to satisfy the level of severity 
needed for the impairment to meet the listing. The final rule further 
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).\7\ We also 
provided that ``[w]hen the criterion is imaging, we mean that we

[[Page 67082]]

could reasonably expect the findings on imaging to have been present at 
the date of impairment or date of onset.'' \8\
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    \1\ 85 FR 78164 (2020).
    \2\ For adults, the listings describe, for each of the major 
body systems, impairments that we consider to be severe enough to 
prevent an individual from doing any gainful activity regardless of 
his or her age, education, or work experience. 20 CFR 404.1525(a) 
and 416.925(a). For children, the listings describe impairments we 
consider severe enough to cause marked and severe functional 
limitations. 20 CFR 416.925(a). We use the listings at step 3 of the 
sequential evaluation process to identify claims in which the 
individual is clearly disabled under our rules. 20 CFR 404.1520, 
416.920, and 416.924). We do not deny a claim when a person's 
medical impairment(s) does not satisfy the criteria of a listing. 
Instead, we continue the sequential evaluation process. 20 CFR 
404.1520(a)(4) and 416.920(a)(4).
    \3\ Radford v. Colvin, 734 F.3d 288 (4th Cir. 2013).
    \4\ Id. at 294.
    \5\ See Acquiescence Ruling 15-1(4). We rescinded that 
Acquiescence Ruling after we revised the listings in 2020. 85 FR 
79063 (2020).
    \6\ 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.
    \7\ See 85 FR 78164 (2020) (revising 20 CFR part 404, subpart P, 
Appendix 1, 1.00C7c and 101.00C7c).
    \8\ Id.
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    We established the consecutive 4-month period as a criterion to 
meet the level of severity in some of the musculoskeletal disorders 
listings based on our research of relevant medical literature and 
clinical guidelines.\9\ When we proposed this requirement as part of a 
notice of proposed rulemaking (NPRM),\10\ we specifically asked 
interested members of the public to comment on this issue and provide 
us with any studies and data that supported their comments for a 
different standard; \11\ however, no studies or data were submitted in 
response. In the final rule, we concluded that the consecutive 4-month 
period was consistent with the timeframe medical providers were 
generally trained to use for scheduling their patients,\12\ the general 
standard of care,\13\ and the frequency of healthcare visits by 
individuals with musculoskeletal conditions.\14\ At the same time, the 
consecutive 4-month period provided some leeway for claimants, because 
the standard for patient revisits was once every 3 months.\15\ 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 provided a 
sufficient period to ensure the criteria were present ``within a close 
proximity of time'' and that the musculoskeletal disorder met the 
requisite severity for the listing.
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    \9\ See 85 FR at 78169-78170.
    \10\ 83 FR 20646 (2018).
    \11\ Id. at 20647.
    \12\ 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).
    \13\ 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).
    \14\ 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).
    \15\ 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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Onset of COVID-19

    In 2020, COVID-19 began to spread throughout the country, prompting 
the Secretary of Health and Human Services to declare a national PHE on 
January 31, 2020.\16\ With the outbreak of COVID-19, access to and the 
provision of healthcare changed significantly. Throughout the PHE, 
individuals across the country--including those with musculoskeletal 
disorders--altered their frequency and manner of seeking access to 
healthcare. This was due in part to healthcare organizations and 
government agencies such as the Centers for Medicare & Medicaid 
Services (CMS) \17\ prioritizing the most urgent services and 
encouraging patients to delay other procedures during the PHE. 
Likewise, many individuals delayed or deferred important treatments due 
to closures of medical offices, fears of contracting COVID-19 infection 
(including fear of exposing high-risk individuals living in their 
household to infection), and other challenges created or exacerbated by 
the pandemic, such as difficulty accessing transportation.
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    \16\ Determination That A Public Health Emergency Exists by Alex 
M. Azar II, Secretary of Health & Human Services (Jan. 31. 2020) 
(https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx).
    \17\ 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).
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    In July 2021, we published a TFR entitled Flexibility in Evaluating 
``Close Proximity of Time'' Due to COVID-19 Related Barriers to 
Healthcare \18\ (prior TFR), which recognized the changes in healthcare 
provision and consumption described above. In the prior TFR, we 
acknowledged that the response to the COVID-19 pandemic dramatically 
changed the provision of, and access to, healthcare services throughout 
the country, and we cited evidence showing that significant numbers of 
people had foregone or delayed care, or replaced in-person medical 
visits with telehealth visits.\19\ Therefore, we concluded that 
individuals with musculoskeletal impairments who, before the pandemic, 
would have sought and received healthcare at a frequency consistent 
with the standards in our final rule, now might be unable or choose not 
to seek care for their condition in the same manner and frequency. 
Affected individuals whose impairments might have previously met the 
listings requirements may now fail to meet the ``close proximity of 
time'' standard because of the changes in the provision of healthcare 
resulting from COVID-19. We therefore extended the timeframe for an 
individual's record to demonstrate the necessary listing criteria 
throughout the pandemic period.
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    \18\ 86 FR 38920 (2021).
    \19\ Id.
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    The prior TFR defined the ``pandemic period'' for the purposes of 
our regulations and provided that during the pandemic period, the 
phrase ``within a close proximity of time'' meant that all of the 
relevant criteria must appear in the medical record within a 
consecutive 12-month period.'' \20\ The prior TFR defined the 
``pandemic period'' as beginning on April 2, 2021 and ending 6 months 
after the Secretary of HHS determined that the COVID-19 national PHE no 
longer existed. We extended the ``pandemic period'' for 6 months after 
the end of the COVID-19 national PHE to allow time for healthcare 
access to normalize and return to pre-pandemic period levels as well as 
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. We also indicated that we would study the 
application of the TFR on our programs.\21\
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    \20\ 86 FR at 38925.
    \21\ 86 FR at 38924.
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Public Comment on the Prior TFR

    When we published the prior TFR in the Federal Register, we 
provided the public with a 60-day comment period, which ended on 
September 21, 2021. We specifically contemplated extending the prior 
TFR, and we invited comments on all aspects of the rule, including the 
definition of ``pandemic period'' and the expiration date. We received 
one comment from the National Organization of Social Security 
Claimants' Representatives (NOSSCR) \22\ that encouraged us to make 
permanent the temporary 12-month standard. The commenter also 
recommended, if we chose not to make the 12-month standard permanent, 
that we extend the period covered by the prior TFR to one year after 
the end of the PHE. They argued that access to care issues exist 
regardless of the pandemic and that it would take longer than 6 months 
for healthcare delivery to normalize after the end of the PHE.
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    \22\ See Comment from National Organization of Social Security 
Claimants' Representatives on Document SSA-2021-0010-0001, https://www.regulations.gov/comment/SSA-2021-0010-0002.
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    With this temporary rule, we are partially adopting this comment. 
Although we provided support for the consecutive 4-month period in our 
2020

[[Page 67083]]

final rule, we agree with NOSSCR that some of the changes in healthcare 
caused by the COVID-19 pandemic may last longer than 6 months after the 
end of the PHE and that some changes may become permanent, including 
the increased use of telehealth, the nature of which limits 
documentation of clinical findings needed for certain listings. 
However, as discussed in the Rationale for this Rule section below, the 
healthcare data that was captured during the PHE has limitations both 
in data collection and in the ability to make ultimate conclusions 
about post-PHE healthcare delivery, particularly in light of policy 
changes affecting healthcare that will occur throughout calendar years 
2023 and 2024.\23\ Therefore, we are extending the flexibility provided 
in the prior TFR by extending the definition of ``pandemic period'' 
through May 11, 2025, so we can continue to review emerging evidence 
about post-PHE healthcare access and use. At the conclusion of that 
period, we expect to be able to determine whether we should extend the 
TFR again, make the flexibility in the TFR permanent, as the commenter 
recommended, propose a different standard for ``close proximity of 
time,'' or let the TFR expire, so that we would revert to the 4-month 
rule on ``close proximity of time'' in our 2020 final rule. The 
commenter also raised issues regarding general barriers to accessing 
care that disability benefit applicants may be disproportionally likely 
to experience. These comments are outside the scope of this very 
limited TFR, so we are not addressing them here. We will address these 
comments in a future venue. We also note that although the commenter 
provided significant discussion of the wait times for imaging, 
including citing research about these wait times, they appear to have 
mischaracterized the ``close proximity of time'' requirement for 
imaging. The listings specify at 1.00C7c and 101.00C7c 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.'' \24\ Therefore, in listings that have an imaging 
criterion, we do not require the imaging to have been taken within a 
close proximity of time to the other required elements, as long as we 
can reasonably expect the findings on imaging to have been present 
within a close proximity of time to the other required elements.
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    \23\ See, e.g., Neri, A. J., Whitfield, G. P., Umeakunne, E. T., 
Hall, J. E., DeFrances, C. J., Shah, A. B., Sandhu, P. K., Demeke, 
H. B., Board, A. R., Iqbal, N. J., Martinez, K., Harris, A. M., & 
Strona, F. V. (2022). Telehealth and Public Health Practice in the 
United States-Before, During, and After the COVID-19 Pandemic. 
Journal of public health management and practice: JPHMP, 28(6), 650-
656. https://doi.org/10.1097/PHH.0000000000001563.
    \24\ 20 CFR part 404, subpart P, Appendix 1, 1.00C7c and 
101.00C7c.
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Rationale for This Rule

    We are extending the flexibility provided by the prior TFR through 
May 11, 2025 to allow for additional time to study changes in 
healthcare access and provision, and to account for the ongoing 
increased use of telehealth services following the COVID-19 PHE. We 
will evaluate these evolving practices and their effects to determine 
the appropriate ``close proximity of time'' standard to include in the 
musculoskeletal disorders listings going forward.
    We published the prior TFR to provide a more flexible 12-month 
``close proximity of time'' standard in the musculoskeletal disorders 
listings to account for changes in the provision of and access to 
healthcare during the COVID-19 PHE. Although the PHE has now ended,\25\ 
the state of healthcare has not fully returned to pre-pandemic norms 
and the impact of ending the PHE and related flexibilities will not be 
fully understood for some time. For example, and as discussed in more 
detail below, studies and reports from multiple government agencies as 
well as professional medical associations document an ongoing 
prevalence of telehealth service methodologies at higher levels than 
seen pre-PHE. In addition, several PHE-related policy flexibilities 
aimed at increasing healthcare access through telehealth have been 
extended through 2023 or 2024. At the same time, Medicaid and the 
Children's Health Insurance Program's (CHIP) continuous coverage 
protections, which had required states to maintain ongoing eligibility 
for Medicaid and CHIP for individuals who were enrolled on or after 
March 18, 2020, ended on March 31, 2023, leaving states until May 31, 
2024, to complete eligibility redeterminations,\26\ potentially leading 
to an increase in uninsured individuals. These factors suggest that 
U.S. healthcare will be in a state of rapid change in the period 
immediately following the PHE, so we will need to study the changes in 
healthcare provision before defining the appropriate ``close proximity 
of time'' interval going forward.
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    \25\ Becarra, X. (2023, May 11). Statement on End of the COVID-
19 Public Health Emergency. Department of Health and Human Services. 
https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-becerra-statement-on-end-of-the-covid-19-public-health-emergency.html.
    \26\ Tsai, D. (2023, Jan 5). CMS Informational Bulletin: Key 
Dates Related to the Medicaid Continuous Enrollment Condition 
Provisions in the Consolidated Appropriations Act, 2023. Centers for 
Medicare & Medicaid Services, U.S. Department of Health & Human 
Services. https://www.medicaid.gov/federal-policy-guidance/downloads/cib010523.pdf.
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    As we discussed in the prior TFR, after the initial sharp drop in 
total healthcare capacity due to PHE-related closures and disruptions 
of care, policy flexibilities around telehealth provision and 
reimbursement allowed for the use of telehealth to increase 
substantially from pre-pandemic norms, partially offsetting the decline 
in in-person care, particularly for management of chronic conditions 
and for established patients.\27\ Although telehealth visits can 
provide the information that clinicians need to care for patients, 
audio-only telehealth appointments do not provide clinical signs and 
findings, and video telehealth musculoskeletal examinations have 
inherent limitations, including in provocative testing (that is, 
testing that manipulates the areas where an individual has 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), strength or stability testing, and 
precise measurements, such as range of motion or reflexes.\28\ 
Therefore, use of telehealth in place of in-person visits may make it 
more difficult for some

[[Page 67084]]

claimants to provide the necessary findings in the medical record to 
satisfy some of the musculoskeletal disorders listing criteria within a 
consecutive 4-month period.
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    \27\ See, e.g., Samson, L., Tarazi, W., Turrini, G., Sheingold, 
S. (2021, Dec.). Medicare Beneficiaries' Use of Telehealth Services 
in 2020--Trends by Beneficiary Characteristics and Location (Issue 
Brief No. HP-2021-27). Office of the Assistant Secretary for 
Planning & Evaluation, U.S. Department of Health & Human Services. 
https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf ; 
Centers for Medicare & Medicaid Services (2022, Dec.). Medicare 
Telehealth Trends Report. Centers for Medicare & Medicaid Services, 
U.S. Department of Health & Human Services. https://data.cms.gov/sites/default/files/2022-12/a7c3a319-5ded-4baf-ad7c-9aa2a897263a/MedicareTelehealthTrendsSnapshot20221201.pdf; Patel, S. Y., 
Mehrotra, A., Huskamp, H. A., Uscher-Pines, L., Ganguli, I., & 
Barnett, M. L. (2021). Trends in Outpatient Care Delivery and 
Telemedicine During the COVID-19 Pandemic in the US. JAMA internal 
medicine, 181(3), 388-391. https://doi.org/10.1001/jamainternmed.2020.5928; Cortez, C., Mansour, O., Qato, D. M., 
Stafford, R. S., & Alexander, G. C. (2021). Changes in Short-term, 
Long-term, and Preventive Care Delivery in US Office-Based and 
Telemedicine Visits During the COVID-19 Pandemic. JAMA health forum, 
2(7), e211529. https://doi.org/10.1001/jamahealthforum.2021.1529.
    \28\ 86 FR 38920 (2021) (citing Tanaka et al. (2020). 
Telemedicine in the Era of COVID-19: The Virtual Orthopaedic 
Examination. The Journal of bone and joint surgery. American volume, 
102(12), e57. http://dx.doi.org/10.2106/JBJS.20.00609).
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    Trends suggest telehealth usage will continue into the foreseeable 
future. Since the prior TFR was published, the use of telehealth as a 
percentage of total use has remained stable, with total healthcare 
visits and in-person visits trending higher than in 2020, but with an 
increased use of telehealth compared to pre-PHE norms. For example, the 
Veterans' Health Administration's (VHA) update to Congress covering the 
period from August 2021 to March 2022 showed that total visits had 
surpassed pre-PHE 2019 visits during this period, but in-person visits 
remained below pre-PHE totals, with both video and audio telehealth 
visits showing steady use over the period. VHA concluded that the data 
marked ``positive progress for resumption of services with continued 
use of telehealth encounters.'' \29\ Similarly, Medicare data showed 
telehealth use leveling off between 16 and 19 percent of eligible users 
in all quarters beginning in the second quarter of 2021 and through the 
second quarter of 2022, which is significantly higher than the 7 
percent of eligible users who used telehealth services in the first 
quarter of 2020.\30\ An HHS summary of national survey trends from the 
Census Bureau's April to October 2021 Household Pulse Survey found that 
23.1 percent of respondents reported use of telehealth in the previous 
four weeks, with the data showing a leveling off around the 20 percent 
mark in July 2021.\31\ The results of these studies suggest that the 
changes in healthcare delivery related to the PHE have continued, and 
we may not know the long-term effects of those changes before the prior 
TFR expires. Consequently, we are extending the expiration date of the 
TFR so we can continue to analyze evolving changes and new norms in 
healthcare delivery, including the use of telehealth, and devise the 
appropriate definition of ``close proximity of time'' for the 
musculoskeletal disorders listings. We will also continue to study 
other related factors such as those raised by the commenter.
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    \29\ Veterans Health Administration (2022, Dec. 5). VHA COVID-19 
Response Report, Annex C. Veterans Health Administration, U.S. 
Department of Veterans Affairs. https://www.va.gov/HEALTH/docs/VHA-COVID-19-Response-2022-Annex-C.pdf.
    \30\ Centers for Medicare & Medicaid Services (2022, Dec.). 
Medicare Telehealth Trends Report. Centers for Medicare & Medicaid 
Services, U.S. Department of Health & Human Services. https://data.cms.gov/sites/default/files/2022-12/a7c3a319-5ded-4baf-ad7c-9aa2a897263a/MedicareTelehealthTrendsSnapshot20221201.pdf.
    \31\ Karimi, M., Lee, E., Couture, S., Gonzales, A., Grigorescu, 
V., Smith, S., De Lew, N., and Sommers, B. (2022, Feb.). National 
Trends in Telehealth Use in 2021: Disparities in Utilization and 
Audio vs. Video Services. (Research Report No. HP-2022-04). Office 
of the Assistant Secretary for Planning & Evaluation, U. S. 
Department of Health & Human Services. https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf.
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    Extending the TFR will further allow us to review and adapt to new 
clinical guidelines evolving in a post-PHE landscape. Although the 
research is still developing and most professional organizations have 
yet to update their clinical practice guidelines for a post-PHE ``new 
normal,'' the emerging research and data suggest that patients and 
providers generally appreciate the increased use of telehealth, and 
such increased use is expected to continue post-PHE. This increased use 
appears true for both audio-only and video telehealth modalities and 
includes specialties, such as orthopedic surgery and spine surgery, 
that previously used telehealth only sparingly. For example, an 
American Medical Association (AMA) survey of 2,232 physicians released 
in 2022 revealed that 85 percent of responding physicians continued to 
use telehealth, that nearly 70 percent of respondents reported their 
organization was motivated to continue using telehealth in their 
practice, that physicians felt telehealth increased timely access to 
care, and that physicians anticipated providing telehealth services for 
chronic disease management and ongoing medical management, care 
coordination, mental/behavioral health, and specialty care after the 
pandemic.\32\
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    \32\ American Medical Association (2022). 2021 Telehealth Survey 
Report. American Medical Association. https://www.ama-assn.org/system/files/telehealth-survey-report.pdf.
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    Similarly, studies specific to the field of spine medicine 
generally found that practitioners and patients expected to continue 
using telehealth and that the majority of patients and providers only 
felt a need for in-person visits for the initial encounter and, if 
applicable, the pre-operative visit.\33\ Studies of orthopedic medicine 
showed similar results, with a large study of orthopedic surgeons 
reporting that physician use of telehealth has increased significantly 
as a result of the COVID-19 pandemic (from 21 percent using telehealth 
prior to the pandemic to 85 percent using it during the pandemic), and 
the majority of surgeons were satisfied with its use in their practice 
and planned on incorporating telehealth in their practices beyond the 
pandemic, particularly for follow-up or postoperative patients.\34\ In 
the realm of chronic pain, a Delphi consensus article about management 
of chronic pain concluded that telemedicine and remote monitoring 
improves management of chronic pain and that the remote management of 
chronic diseases can improve access to care, but that at least the 
first assessment should be performed in person.\35\
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    \33\ Mazarakis, N. K., Koutsarnakis, C., Komaitis, S., Drosos, 
E., & Demetriades, A. K. (2022). Reflections on the future of 
telemedicine and virtual spinal clinics in the post COVID-19 era. 
Brain & spine, 2, 100930. https://doi.org/10.1016/j.bas.2022.100930; 
Greven, A. C. M., McGinley, B. M., Guisse, N. F., McGee, L. J., 
Pirkle, S., Malcolm, J. G., Rodts, G. E., Refai, D., & Gary, M. F. 
(2021). Telemedicine in the Evaluation and Management of 
Neurosurgical Spine Patients: Questionnaire Assessment of 346 
Consecutive Patients. Spine, 46(7), 472-477. https://doi.org/10.1097/BRS.0000000000003821 ; Kolcun, J. P. G., Ryu, W. H. A., & 
Traynelis, V. C. (2020). Systematic review of telemedicine in spine 
surgery. Journal of neurosurgery. Spine, 1-10. Advance online 
publication. https://doi.org/10.3171/2020.6.SPINE20863; Satin, A. 
M., Shenoy, K., Sheha, E. D., Basques, B., Schroeder, G. D., 
Vaccaro, A. R., Lieberman, I. H., Guyer, R. D., & Derman, P. B. 
(2022). Spine Patient Satisfaction With Telemedicine During the 
COVID-19 Pandemic: A Cross-Sectional Study. Global spine journal, 
12(5), 812-819. https://doi.org/10.1177/2192568220965521.
    \34\ Hurley, E. T., Haskel, J. D., Bloom, D. A., Gonzalez-Lomas, 
G., Jazrawi, L. M., Bosco, J. A., III, & Campbell, K. A. (2021). The 
Use and Acceptance of Telemedicine in Orthopedic Surgery During the 
COVID-19 Pandemic. Telemedicine journal and e-health: the official 
journal of the American Telemedicine Association, 27(6), 657-662. 
https://doi.org/10.1089/tmj.2020.0255.
    \35\ Cascella, M., Miceli, L., Cutugno, F., Di Lorenzo, G., 
Morabito, A., Oriente, A., Massazza, G., Magni, A., Marinangeli, F., 
Cuomo, A., & on behalf of the Delphi Panel (2021). A Delphi 
Consensus Approach for the Management of Chronic Pain during and 
after the COVID-19 Era. International journal of environmental 
research and public health, 18(24), 13372. https://doi.org/10.3390/ijerph182413372.
---------------------------------------------------------------------------

    Some clinical practice organizations have provided recommendations 
or policy statements regarding the use of telehealth after the acute 
phase of the pandemic, suggesting an ongoing, but potentially more 
limited, role in healthcare provision for people with musculoskeletal 
disorders going forward. An international set of recommendations 
published in June 2022, and endorsed by the North American Spine 
Society, included a recommendation to expand telehealth for spine care 
in order to help patients with spinal diseases obtain timely advice 
toward alleviating pain and recognizing critical symptoms that need 
urgent care, and thus obtain treatment in a timely manner.\36\ 
Additionally, the American College of Rheumatology (ACR) released a 
2023 health policy statement in which it supported ongoing

[[Page 67085]]

expanded use of telehealth as a ``tool that can increase access and 
improve outcomes for patients with rheumatic diseases when used [with] 
face-to-face assessments.'' However, it cautioned that telehealth 
should not replace essential face-to-face assessments conducted at 
medically appropriate intervals.\37\ The AMA also released a blueprint 
for digitally-enabled care, in which it recommended fully integrated 
in-person and virtual care models that based the type of care on 
clinical appropriateness and other factors, such as convenience and 
cost, and focused on health equity and centering the needs of patients 
and providers.\38\
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    \36\ Mazarakis, N. K., Koutsarnakis, C., Komaitis, S., Drosos, 
E., & Demetriades, A. K. (2022). Reflections on the future of 
telemedicine and virtual spinal clinics in the post COVID-19 era. 
Brain & spine, 2, 100930. https://doi.org/10.1016/j.bas.2022.100930.
    \37\ American College of Rheumatology (2023). 2023 ACR Health 
Policy Statements. American College of Rheumatology. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltd84782969d741aba/acr-health-policy-statements.pdf.
    \38\ American Medical Association (2022). AMA Future of Health 
Closing the Digital Health Disconnect: A Blueprint for Optimizing 
Digitally Enabled Care. American Medical Association. https://www.ama-assn.org/system/files/ama-future-health-report.pdf. 
(Accessed March 22, 2023).
---------------------------------------------------------------------------

    The expected shift towards greater use of telehealth in medical 
practice after the PHE, compared to prior to the PHE, could mean that 
the evidence upon which we based the consecutive 4-month ``close 
proximity of time'' period may no longer accurately describe the 
standard frequency of in-person healthcare visits. In fact, some of the 
sources cited in the 2020 final rule and prior TFR have provided new 
guidance that removed specific revisit intervals. For example, in both 
rules, we noted that our use of the consecutive 4-month proximity of 
time requirement was also consistent with the standard recognized by 
the VHA and Department of Defense (DoD), as set out in their clinical 
practice guidelines.\39\ We noted that the VHA and DoD's Clinical 
Practice Guideline for the Management of Medically Unexplained 
Symptoms: Chronic Pain and Fatigue directed initial revisits at 2 to 3 
week intervals, with visits every 3 to 4 months once the patient is 
doing well.\40\ However, a 2021 updated VHA and DoD Clinical Practice 
Guideline for Management of Chronic Multisymptom Illness (formerly 
known as Medically Unexplained Symptoms) does not provide suggested 
revisit intervals. Instead, it includes recommendations to ``[d]evelop 
personal health plan and timeline for follow-up and monitor progress 
toward personal goals'' and ``[m]aintain continuity and [a] caring 
relationship via in-person and/or virtual modalities,'' without 
specifying intervals.\41\ Similarly, the previous version of the VHA's 
and DoD's Clinical Practice Guideline for Diagnosis and Treatment of 
Low Back Pain, which we also cited in our prior rulemaking, described 
the duration of time for intervention, based on a systematic review, as 
requiring a minimum follow-up for effectiveness of 12 weeks and 
recommended monthly reassessment after initiation of therapy if low 
back pain continued and no serious specific underlying cause of low 
back pain was found.\42\ However, the updated 2022 version of this 
guideline allows for a more flexible, patient-centered approach and has 
replaced the specific interval language with recommendations to 
``assess response as appropriate'' and ``reassess as appropriate.'' 
\43\ We need the additional time provided by this TFR to assess whether 
and how these changes in clinical practice guidelines may affect the 
period we chose to use in our 2020 final rule.
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    \39\ 85 FR at 78169 n.38 (2020) (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). See 
also 86 FR at 38922 (2021).
    \40\ Id.
    \41\ Veterans Health Administration & Department of Defense 
(2021). VA/DoD Clinical Practice Guideline for the Management of 
Chronic Multisystem Illness, Version 3.0-2021. https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG508.pdf.
    \42\ 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.)
    \43\ Veterans Health Administration & Department of Defense 
(2022, Feb.). VA/DoD Clinical Practice Guideline for Diagnosis and 
Treatment of Low Back Pain (Version 3.0-2022). https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPGFinal508.pdf.
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    In addition to the extension of telehealth flexibilities, other 
policy changes related to the end of the PHE may impact healthcare use 
and create a period of rapid changes in healthcare. Some national 
telehealth flexibilities have been extended until the end of calendar 
year 2023 (for example, payment parity for audio and video telehealth 
visits, which allows providers to be reimbursed for telehealth visits 
originated at the patient's home at the same rate and using the same 
``place of service'' code as they would be if provided in-person).\44\ 
Other flexibilities have been extended through December 31, 2024 (for 
example, Medicare coverage of audio-only and of video telehealth 
services no matter where in the United States a patient lives, rather 
than covering telehealth services for beneficiaries living in rural 
areas only, and with the ability to access telehealth services from 
their home, rather than going to a health care facility).\45\ 
Conversely, certain other flexibilities, such as flexibilities related 
to telehealth platforms and the continuous enrollment provision for 
Medicaid, began winding down at the end of the PHE.\46\ Extra federal 
payments to hospitals during the PHE, including a 20 percent increase 
in the Medicare payment rate for inpatient treatment of patients 
diagnosed with COVID-19 and the ability to charge ``facility fees'' for 
telehealth services to patients who are not located at the hospital, 
were also phased out at the end of the PHE,\47\ putting additional 
financial strain on the medical system.
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    \44\ 87 FR 69404 at 69466.
    \45\ U.S. Department of Health & Human Services (2023, Feb. 9). 
Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap. 
https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html.
    \46\ U.S. Department of Health & Human Services (2023, May 9). 
Fact Sheet: End of the COVID-19 Public Health Emergency https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html.
    \47\ Centers for Medicare & Medicaid Services (2023, May 5). 
Frequently Asked Questions: CMS Waivers, Flexibilities, and the End 
of the COVID-19 Public Health Emergency. Centers for Medicare & 
Medicaid Services, U.S. Department of Health & Human Services. 
https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf; 
See also American Hospital Association (2023, Feb. 7). Special 
Bulletin: Public Health Emergency to End May 11. American Hospital 
Association. https://www.aha.org/system/files/media/file/2023/02/Special-Bulletin-Public-Health-Emergency-to-End-May-11.pdf.
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    In particular, the expected substantial rise in the uninsured 
population after the PHE-related Medicaid and CHIP continuous 
enrollment provision ends will exacerbate access to care challenges 
during this transitional time, making it more difficult to predict 
revisit intervals and use of healthcare, particularly for people facing 
barriers to healthcare.
    An HHS issue brief published in 2022 projected that 17.4 percent of 
Medicaid and CHIP enrollees (approximately 15 million individuals) will 
leave the programs after the continuous enrollment provisions end based 
on historical patterns of coverage loss, including 7.9 percent (6.8 
million) of Medicaid enrollees losing Medicaid coverage despite still 
being eligible (sometimes referred to as ``administrative churning''). 
HHS predicted there would be a disproportionate impact on historically 
underserved populations, although they noted they were taking steps to 
reduce that outcome.\48\ Information from the

[[Page 67086]]

Centers for Disease Control and Prevention (CDC) already shows an 
uptick in the uninsured population beginning in late 2022, with the 
uninsured population increasing to 12.6 percent of adults in the United 
States in the third quarter of 2022 from a low of 11.8 percent in the 
first quarter of 2022.\49\ Initial data on the end of Medicaid's 
continuous enrollment provision from 20 states provided by the Kaiser 
Family Foundation demonstrated that over 1 million people had already 
been disenrolled from Medicaid, with many disenrolled for procedural 
reasons, as of June 12, 2023.\50\ Data analyzed by the Kaiser Family 
Foundation found that the uninsured population was the only population 
that had delayed or foregone care due to cost more than due to the 
pandemic, suggesting that gaps in access to care will remain high for a 
growing uninsured population even as pandemic-related concerns are 
expected to decrease.\51\ Additionally, a Gallup poll released in 
January 2023 noted that a record high 38 percent of Americans reported 
putting off medical treatment due to cost, up 12 percentage points from 
2021, and that lower-income adults, younger adults, and women were more 
likely than their counterparts to say they or a family member have 
delayed care for a serious medical condition.\52\
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    \48\ Office of the Assistant Secretary for Planning & Evaluation 
(2022, August 19). Unwinding the Medicaid Continuous Enrollment 
Provision: Projected Enrollment Effects and Policy Approaches (Issue 
Brief HP-2022-20). Office of the Assistant Secretary for Planning & 
Evaluation, U.S. Department of Health & Human Services. Accessed on 
March 3, 2023 at: https://aspe.hhs.gov/sites/default/files/documents/404a7572048090ec1259d216f3fd617e/aspe-end-mcaid-continuous-coverage_IB.pdf.
    \49\ National Center for Health Statistics. Percentage of being 
uninsured at the time of interview for adults aged 18-64, United 
States, 2019 Q1, Jan-Mar--2022 Q3, Jul-Sep. National Health 
Interview Survey. Generated interactively: Mar 06 2023 from https://wwwn.cdc.gov/NHISDataQueryTool/ER_Quarterly/index_quarterly.html.
    \50\ Kaiser Family Foundation (2023, June 13). Medicaid 
Enrollment and Unwinding Tracker. Kaiser Family Foundation. https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/.
    \51\ McGough, M., Krutika, A., & Cox, C., (2023, Jan. 24). How 
has healthcare utilization changed since the pandemic? Peterson 
Center on Healthcare-Kaiser Family Foundation Health System Tracker. 
https://www.healthsystemtracker.org/chart-collection/how-has-healthcare-utilization-changed-since-the-pandemic/.
    \52\ Brenan, Megan (2023, Jan. 17). Record High in U.S. Put Off 
Medical Care Due to Cost in 2022. Gallup. https://news.gallup.com/poll/468053/record-high-put-off-medical-care-due-cost-2022.aspx.
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    Initial evidence also suggests that the ongoing impacts of the 
COVID-19 PHE and the increased use of telehealth may also affect 
certain populations differently. For example, the HHS' summary of 
national survey trends from the Census Bureau's April to October 2021 
Household Pulse Survey found that the highest rates of telehealth 
visits were among those with Medicaid (29.3%) and Medicare (27.4%), 
Black individuals (26.8%), and those earning less than $25,000 (26.7%). 
The report found disparities in use of telehealth services, including 
the use of video versus audio modalities, along dimensions including 
race and ethnicity, age, education, income, and health insurance.\53\ 
Similarly, an October 2022 report on telehealth use in Medicare from 
2019 to 2021, issued by the Bipartisan Policy Center, found that, 
although the distribution of beneficiaries using telehealth by race and 
ethnicity was roughly proportionate to the distribution of the overall 
study population by race and ethnicity, there was variation in the 
telehealth visit rates for those who used telehealth across racial and 
ethnic groups. They noted that telehealth visit rates for American 
Indian/Alaska Native (AI/AN), Black/African American (AA), and Hispanic 
beneficiaries exceeded the overall telehealth rates, with AI/AN 
beneficiaries having the highest audio-only visit rates, and that non-
Hispanic/White beneficiary telehealth visit rates were lower than the 
overall telehealth visit rates by 2 percent, on average, across the 
study period.\54\ Further, a cross-sectional study of over a million 
veterans published in the Journal of the American Medical Association 
(JAMA) in January 2023 found that wait time disparities increased 
significantly from the pre-COVID-19 period (October 1, 2018 to March 
10, 2020) to the COVID-19 period (March 11, 2020 to September 30, 2021) 
for Black and Hispanic veterans, and that disparities in mean wait 
times for orthopedic services were statistically significant both 
before and after the COVID-19 period.\55\
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    \53\ Karimi, M., Lee, E., Couture, S., Gonzales, A., Grigorescu, 
V., Smith, S., De Lew, N., and Sommers, B. (2022, Feb.). National 
Trends in Telehealth Use in 2021: Disparities in Utilization and 
Audio vs. Video Services. (Research Report No. HP-2022-04). Office 
of the Assistant Secretary for Planning and Evaluation, U.S. 
Department of Health and Human Services. https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf.
    \54\ Bipartisan Policy Center, Ananya Health Solutions LLC, and 
L&M Policy Research (2022, Oct.). Medicare Telehealth Utilization 
and Spending Impacts 2019-2021. Bipartisan Policy Center. https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-Medicare-Telehealth-Utilization-and-Spending-Impacts-2019-2021-October-2022.pdf.
    \55\ Gurewich, D., Beilstein-Wedel, E., Shwartz, M., Davila, H., 
& Rosen, A.K. (2023). Disparities in Wait Times for Care Among US 
Veterans by Race and Ethnicity. JAMA network open, 6(1), e2252061. 
https://doi.org/10.1001/jamanetworkopen.2022.52061.
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    In sum, the emerging data suggests that an increased use of 
telehealth will likely replace some in-person visits for some people 
with musculoskeletal disorders even after the end of the PHE and that 
other policy and healthcare changes could impact access to care during 
the period immediately following the end of the PHE, possibly leading 
to extended revisit intervals between thorough examinations. However, 
evidence on expanded telehealth use and its expected long-term effect 
on healthcare quality and the use of in-person examinations is limited, 
partially by data challenges, although the research base is expected to 
grow during the period immediately following the end of the PHE. For 
example, a report published by CDC experts in 2022 stated that ``one of 
the central public health issues in the U.S. identified by CDC was the 
absence of telehealth identifiers in many datasets, including most of 
CDC's national surveillance datasets.'' The report authors stated that 
the CDC was working to improve access to data related to healthcare and 
telehealth.\56\ To this end, Medicare provided for additional use of 
telehealth identifiers in its 2023 fee schedule, including identifiers 
for audio-only telehealth.\57\
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    \56\ Neri, A.J., Whitfield, G.P., Umeakunne, E.T., Hall, J.E., 
DeFrances, C.J., Shah, A.B., Sandhu, P.K., Demeke, H.B., Board, 
A.R., Iqbal, N.J., Martinez, K., Harris, A.M., & Strona, F.V. 
(2022). Telehealth and Public Health Practice in the United States--
Before, During, and After the COVID-19 Pandemic. Journal of public 
health management and practice: JPHMP, 28(6), 650-656. https://doi.org/10.1097/PHH.0000000000001563.
    \57\ U.S. Government Accountability Office (2022, Sept. 26). 
Medicare Telehealth: Actions Needed to Strengthen Oversight and Help 
Providers Educate Patients on Privacy and Security Risks (GAO-22-
104454). Accessed March 3, 2023 at: https://www.gao.gov/products/gao-22-104454.
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    There are also inherent limitations in relying on healthcare use 
data gathered during the PHE to determine post-PHE outcomes. For 
example, in an October 2022 report, the Bipartisan Policy Center 
concluded that studies of telehealth use during the PHE would not 
provide enough information to understand the impact of permanently 
expanded telehealth use on healthcare utilization, quality, equity, 
cost, and other factors due to confounding pandemic-related changes in 
healthcare needs, and they urged further study of telehealth during the 
period following the end of the PHE. The report recommended a two-year 
extension of telehealth flexibilities after the end of the PHE and 
indicated that researchers should evaluate the benefits of hybrid (in-
person and virtual) care models for

[[Page 67087]]

primary and specialty care, including for which conditions and 
specialties it is most effective; further evaluate full telehealth 
flexibilities in the context of value-based payment models; and 
rigorously assess the quality of audio-only care.\58\ Similarly, in 
September 2022, the Medicare Payment Advisory Commission (MedPAC), an 
independent congressional agency that advises Congress on Medicare 
payment policy, recommended using a one- to two-year period of extended 
flexibilities after the PHE to allow policymakers to gather more 
evidence about the impact of telehealth on access, quality, and cost, 
which could inform permanent changes to telehealth policies.\59\ Along 
these lines, a 2021 Medicare telehealth report concluded that more 
research is needed on the impact of telehealth on health outcomes, 
stating that ``if telehealth flexibilities are temporarily extended 
post-pandemic . . . this would allow evaluations of whether telehealth 
use during non-pandemic times may increase overall healthcare 
utilization as suggested by some studies, or simply substitute for in-
person services.'' \60\ Recognizing the need for more data on 
telehealth use, Congress required HHS to report on Medicare telehealth 
use during the period immediately following the end of the PHE, with 
the interim report due in October 2024.\61\
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    \58\ Bipartisan Policy Center & Ananya Health Solutions LLC 
(2022, Oct.). The Future of Telehealth After COVID-19. Bipartisan 
Policy Center. https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-The-Future-of-Telehealth-After-COVID-19-October-2022.pdf.
    \59\ The Medicare Payment Advisory Commission (2022, Sept. 29). 
MedPAC Mandatory report: Study on the Expansion of Telehealth. 
https://www.medpac.gov/wp-content/uploads/2021/10/Telehealth-MedPAC-29-Sept-2022.pdf.
    \60\ Samson, L., Tarazi, W., Turrini, G., Sheingold, S. (2021, 
Dec.). Medicare Beneficiaries' Use of Telehealth Services in 2020--
Trends by Beneficiary Characteristics and Location (Issue Brief No. 
HP-2021-27). Office of the Assistant Secretary for Planning and 
Evaluation, U.S. Department of Health and Human Services. https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf.
    \61\ The Consolidated Appropriations Act, 2023, Public Law 117-
328.
---------------------------------------------------------------------------

    Because healthcare provision has not returned to pre-pandemic norms 
and emerging evidence suggests that ongoing changes may lead to 
decreased use of in-person healthcare, we need to continue to evaluate 
the evidence upon which we based the consecutive 4-month ``close 
proximity of time'' period. We need to determine whether the evidence 
we relied on in adopting the 4-month standard continues to match the 
current status of healthcare, including the standard frequency of in-
person healthcare visits. Consequently, we are extending the 
flexibility provided in the prior TFR until May 11, 2025.

Evidence To Review

    We will use the extension period to study the actual changes in 
healthcare access and provision after the expiration of the PHE. We 
expect this additional period will allow us to consider whether a 
permanent change to the consecutive 12-month ``close proximity of 
time'' period, or to a different timeframe, would be appropriate to 
account for ongoing changes in healthcare access and delivery. During 
the extension period, we will also continue to review information about 
disparities in access to care or modalities of care for people of color 
and others who have been historically underserved, marginalized, and 
adversely affected by persistent poverty and inequality and who have 
been affected by the changes in healthcare provision during the 
pandemic. This review is consistent with Executive Order 13985, 
entitled ``Advancing Racial Equity and Support for Underserved 
Communities Through the Federal Government,'' which directs agencies to 
recognize and work to redress inequities in their policies and programs 
that serve as barriers to equal opportunity.\62\
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    \62\ 86 FR 7009 (2021).
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    We will also continue to study the application of the ``close 
proximity of time'' rule in our programs after the expiration of the 
PHE. We expect that continued review of case trends over time can help 
inform our understanding of how the end of the PHE may affect 
claimants' ability to provide the required evidence within a 4-month or 
12-month period for the applicable musculoskeletal disorders. We will 
also continue to monitor the quality of our determinations and 
decisions to inform our policy decision and ensure the appropriate 
adjudication of claims for people with musculoskeletal disorders.

Solicitation for Public Comment

    Although we are publishing a temporary final rule, we invite public 
comment on all aspects of the rule, including:
    <bullet> The appropriate standard for ``close proximity of time'' 
to account for barriers to access to care or changes in healthcare 
delivery;
    <bullet> Information about barriers to access to care, changes in 
healthcare delivery, and disproportionate burdens faced by any subset 
of the population; and
    <bullet> 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 TFR.

Summary of the Changes

    This rule revises sections 1.00C7a and 101.00C7a of the 
musculoskeletal disorders listings to redefine the term ``pandemic 
period'' to mean ``the period beginning on April 2, 2021, and ending on 
May 11, 2025.''

Justification for Foregoing Notice and Comment Rulemaking

    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. However, 
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 to issue this TFR without prior 
notice.\63\ Because we have already been following the flexible 12-
month ``close proximity of time'' standard, it would be impracticable 
and contrary to the public interest to delay implementing this TFR. 
Delayed implementation of this TFR would require us to delay 
adjudicating affected claims, potentially resulting in delayed benefits 
to vulnerable individuals.\64\ Otherwise (if we did not delay 
adjudications), we would need to apply the 4-month ``close proximity of 
time'' standard, which does not consider changes in healthcare access 
and delivery related to the PHE, as discussed in the preamble. Thus, 
individuals might be unable to show that they meet a listing under the 
4-month ``close proximity of time'' standard merely due to changes in 
how the healthcare system works. To give individuals the benefit of the 
flexible standard that has already been in place

[[Page 67088]]

for over two years, we would delay adjudicating affected claims until 
the effective date of this TFR.
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    \63\ In our prior TFR, we provided notice that we would consider 
extending the expiration date of the rule, and we invited public 
comments on the expiration date. 86 FR at 38920, 38924. As discussed 
above, we received a public comment from NOSSCR that encouraged us 
to make the temporary 12-month standard permanent or, if we chose 
not to make the 12-month standard permanent, to extend the period 
covered by the prior TFR to one year after the end of the PHE.
    \64\ Individuals who are eligible for disability benefits are, 
by definition, not able to engage in substantial gainful activity, 
which means they may experience immediate and severe financial 
hardship.
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    Delay in implementing this TFR would be impracticable and contrary 
to the public interest because it may cause some applicants to 
experience immediate and severe financial hardship, 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), which has, by 
definition, severely limited income and financial resources.\65\ An 
unnecessary delay would cause significant harm and detract 
substantially from the effectiveness of the disability program in 
providing meaningful economic relief for disabled individuals. Even if 
affected claimants received 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.
---------------------------------------------------------------------------

    \65\ 42 U.S.C. 1382(a); 20 CFR 416.202.
---------------------------------------------------------------------------

    For good cause shown, to avoid delaying benefits to vulnerable 
individuals while providing appropriate flexibility to account for 
COVID-19-related healthcare changes, we are dispensing with prior 
notice and public comment on this rule pursuant to 5 U.S.C. 553(b)(B).

Regulatory Procedures

Clarity of This Rule

    Executive Order 12866, as supplemented by Executive Orders 13563 
and 14094, requires each agency to write all rules in plain language. 
In addition to your substantive comments on this rule, we invite your 
comments on how to make the rule easier to understand.
    For example:
    <bullet> Would more, but shorter, sections be better?
    <bullet> Are the requirements in the rule clearly stated?
    <bullet> Have we organized the material to suit your needs?
    <bullet> Could we improve clarity by adding tables, lists, or 
diagrams?
    <bullet> What else could we do to make the rule easier to 
understand?
    <bullet> Does the rule contain technical language or jargon that is 
not clear?
    <bullet> Would a different format make the rule easier to 
understand, e.g., grouping and order of sections, use of headings, 
paragraphing?

Executive Order 12866, as Supplemented by Executive Orders 13563 and 
14094

    We consulted with the Office of Management and Budget (OMB) and 
determined that this rule is a non-significant regulatory action under 
Executive Order 12866, as supplemented by Executive Orders 13563 and 
14094.

Anticipated Transfers to Our Program

    Our Office of the Chief Actuary estimates that implementation of 
this temporary final rule would result in negligible changes (i.e., 
less than $500,000) in scheduled Old-Age, Survivors, and Disability 
Insurance benefits and Federal SSI payments.

Anticipated Administrative Cost-Savings to the Social Security 
Administration

    The Office of Budget, Finance, and Management expects the extension 
provided by the TFR will have a minimal administrative effect on the 
agency.

Anticipated Time-Savings and Qualitative Benefits

    We anticipate the following qualitative benefits generated from 
this policy:
    <bullet> Provide a more flexible and appropriate 12-month ``close 
proximity of time'' standard in the musculoskeletal disorders listings 
to account for healthcare changes that have occurred since the 
beginning of the COVID-19 PHE.
    <bullet> Potentially allow for faster disability determinations and 
decisions by preventing adjudication delays for additional medical 
development, which would also have quantitative financial effects.

Anticipated Costs

    We do not believe there are any more than de minimis costs to the 
public associated with this rule. The requirements in this rule will 
not impose new additional costs outside of the normal course of 
business for applicants or change how the public interacts with our 
disability programs.

Executive Order 13132 (Federalism)

    We analyzed this temporary final rule in accordance with 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 temporary final rule will not have a 
significant economic impact on a substantial number of small entities 
because it affects individuals only. Therefore, a regulatory 
flexibility analysis is not required under the Regulatory Flexibility 
Act, as amended.

Paperwork Reduction Act

    These rules do not create any new or affect any existing 
collections and, therefore, do 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 in 20 CFR Part 404

    Administrative practice and procedure; Blind, Disability benefits; 
Old-age, survivors, and disability insurance; Reporting and 
recordkeeping requirements; Social Security.

    The Acting Commissioner of Social Security, Kilolo Kijakazi, Ph.D., 
M.S.W., having reviewed and approved this document, is delegating the 
authority to electronically sign this document to 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 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 is revised to read 
as follows:

    Authority: 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 revising paragraph a; and

[[Page 67089]]

0
b. In part B, amend section 101.00C7 by revising paragraph a.
    The 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 May 11, 2025.
* * * * *

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 May 11, 2025.
* * * * *
[FR Doc. 2023-21671 Filed 9-28-23; 8:45 am]
BILLING CODE 4191-02-P