Rule2025-01283
Further Extension of the Flexibility in Evaluating “Close Proximity of Time” To Evaluate Ongoing Changes in Healthcare
Primary source
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Published
January 17, 2025
Effective
February 18, 2025
Issuing agencies
Social Security Administration
Abstract
We are extending the flexibility in the "close proximity of time" standard, as defined in two prior temporary final rules (TFR), through May 11, 2029. We issued a TFR providing the "close proximity of time" flexibility on July 23, 2021, because the COVID-19 national public health emergency (PHE) caused many individuals to experience barriers that prevented them from timely accessing in-person healthcare. On September 29, 2023, we extended the flexibility to evaluate evolving healthcare practices and consumption in a post-PHE environment. We determined that we need additional time to fully evaluate still-evolving healthcare practices after the PHE. We are therefore issuing this TFR to extend the "close proximity of time" flexibility until May 11, 2029, so we can continue to evaluate changes in healthcare practices and determine the proper "close proximity of time" standard for the musculoskeletal disorders listings.
Full Text
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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Rules and Regulations]
[Pages 5582-5590]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01283]
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SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA-2024-0056]
RIN 0960-AI93
Further Extension of the Flexibility in Evaluating ``Close
Proximity of Time'' To Evaluate Ongoing Changes in Healthcare
AGENCY: Social Security Administration.
ACTION: Temporary final rule with request for comments.
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SUMMARY: We are extending the flexibility in the ``close proximity of
time'' standard, as defined in two prior temporary final rules (TFR),
through May 11, 2029. We issued a TFR providing the ``close proximity
of time'' flexibility on July 23, 2021, because the COVID-19 national
public health emergency (PHE) caused many individuals to experience
barriers that prevented them from timely accessing in-person
healthcare. On September 29, 2023, we extended the flexibility to
evaluate evolving healthcare practices and consumption in a post-PHE
environment. We determined that we need additional time to fully
evaluate still-evolving healthcare practices after the PHE. We are
therefore issuing this TFR to extend the ``close proximity of time''
flexibility until May 11, 2029, so we can continue to 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 February 18, 2025.
Comment date: We invite written comments. Comments must be
submitted no later than March 18, 2025.
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, 2029.
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-2024-
0056 so that we may associate your comment(s) with the correct rule.
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the ``search'' function to find docket
number SSA-2024-0056. 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 21235-6401.
Comments are available for public viewing on the Federal
eRulemaking portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.ssa.gov/">https://www.ssa.gov/</a>.
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
[[Page 5583]]
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 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 then 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\ In response, a number of commenters raised
concerns regarding barriers to accessing medical providers or
documenting medical listing criterion.\12\ However, none of the
commenters submitted studies or data. 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,\13\ the general standard of care,\14\ and the frequency of
healthcare visits by individuals with musculoskeletal conditions.\15\
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.\16\
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\9\ See 85 FR at 78169-78170.
\10\ 83 FR 20646 (2018).
\11\ Id. at 20647.
\12\ See, e.g., comment from Community Legal Services of
Philadelphia on Document SSA-2006-0112-0010, <a href="https://www.regulations.gov/comment/SSA-2006-0112-0046">https://www.regulations.gov/comment/SSA-2006-0112-0046</a>.
\13\ 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).
\14\ 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>).
\15\ 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>).
\16\ 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, the COVID-19 virus began to spread throughout the country,
prompting the Secretary of Health and Human Services (HHS) to declare a
national PHE on January 31, 2020.\17\ 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) \18\ 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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\17\ Determination That A Public Health Emergency Exists by Alex
M. Azar II, Secretary of Health & Human Services (Jan. 31. 2020)
(<a href="https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx">https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx</a>).
\18\ 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>).
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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 \19\ (2021 TFR). We acknowledged at that time 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.\20\ 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, might have become unable to seek, or might have chosen
not to seek, care for their condition in the same manner and frequency.
Affected individuals whose impairments might have previously met the
applicable listing requirements might have subsequently failed 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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\19\ 86 FR 38920 (2021).
\20\ Id.
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The 2021 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.'' \21\ We further 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 and
provision to normalize and return to pre-pandemic period levels as well
as to account for potential backlogs in medical care that may have
continued to interfere with
[[Page 5584]]
access to the relevant care and documentation needed to satisfy the
listing criteria. We also indicated that we would study the application
of ``close proximity of time'' flexibility on our programs.\22\
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\21\ 86 FR at 38925.
\22\ 86 FR at 38924.
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When we published the 2021 TFR in the Federal Register, we provided
the public with a 60-day comment period, which ended on September 21,
2021. We specifically contemplated the possibility of extending the
flexibility 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) \23\ that encouraged us to
make the temporary 12-month standard permanent. The commenter also
recommended, if we chose not to make the 12-month standard permanent,
that we extend the period 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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\23\ See Comment from National Organization of Social Security
Claimants' Representatives on Document SSA-2021-0010-0001, <a href="https://www.regulations.gov/comment/SSA-2021-0010-0002">https://www.regulations.gov/comment/SSA-2021-0010-0002</a>.
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Issuance of the 2023 TFR Extending the 12-Month Standard
The 2021 TFR was effective until six months after the effective
date of a determination by the Secretary of HHS that a PHE resulting
from the COVID-19 pandemic ended. The Secretary of HHS made that
determination on May 11, 2023.\24\ Consequently, the 2021 TFR was set
to expire in November 2023.
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\24\ Becarra, X. (2023, May 11). Statement on End of the COVID-
19 Public Health Emergency. Department of Health and Human Services.
<a href="https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-becerra-statement-on-end-of-the-covid-19-public-health-emergency.html">https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-becerra-statement-on-end-of-the-covid-19-public-health-emergency.html</a>.
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On September 29, 2023, we extended the ``close proximity of time''
flexibility through May 11, 2025.\25\ We explained at the time that we
intended the extension to allow for time to study changes in healthcare
access and provision, and to account for the ongoing increased use of
telehealth services following the PHE. We further explained that we
would continue to 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.\26\
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\25\ 88 FR 67081 (2023).
\26\ 88 FR 67082.
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In issuing the extension, we also discussed the public comment we
received from NOSSCR about the 2021 TFR, encouraging us to make the 12-
month standard permanent or extend it to apply for one year after the
end of the PHE. We explained that by May 2025, we expected to determine
whether we should extend the TFR again, make the flexibility in the TFR
permanent, as the commenter recommended, propose a different standard,
or let the TFR expire and revert to the 4-month ``close proximity of
time'' standard. Additionally, we noted that while the commenter raised
issues regarding general barriers to accessing care that disability
benefit applicants may be disproportionally likely to experience, we
considered the comment outside the scope of the second TFR and
committed to addressing these comments in a future venue.
Public Comment on the 2023 TFR
When we extended the flexibility again in 2023, we received one
comment, from The Connected Health Initiative. The commenter was
supportive of us extending the flexibility provided in the TFR and our
commitment to continuing to study the appropriate time period for
``close proximity of findings,'' noting that ``data indicates that,
going forward, telehealth will likely replace some in-person visits for
some people with musculoskeletal disorders post-PHE, which could lead
to extended revisit intervals between thorough examinations.'' \27\ We
appreciate this commenter's feedback and, consistent with the comment,
intend to continue studying these impacts.
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\27\ See Comment from The Connected Health Initiative on
Document SSA-2023-0023-0002, <a href="https://www.regulations.gov/comment/SSA-2023-0023-0002">https://www.regulations.gov/comment/SSA-2023-0023-0002</a>.
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Rationale for This Rule
We are extending the ``close proximity of time'' flexibility
through May 11, 2029, 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 PHE. We will
evaluate these evolving practices and their effects to determine the
appropriate time standard to include in the musculoskeletal disorders
listings going forward.
The PHE caused changes in healthcare provision and access, which
led to a decrease in health care use and a shift from in-person
healthcare to telehealth (phone or video). In response, we published
the 2021 TFR, which temporarily amended the introductory text of the
musculoskeletal disorders listings to define the ``close proximity of
time'' standard as presence of the required findings in the record
within a consecutive 12-month period. This flexibility was limited to
the ``pandemic period,'' originally defined as the period beginning
April 2, 2021, until 6 months after the end of the COVID-19 national
PHE, November 11, 2023. Due to the ongoing increased use of telehealth
services following the PHE and the many changes to healthcare rules and
legislation that were set to be phased out over a two-year period, we
concluded that healthcare would be in a state of rapid change in the
period immediately following the PHE, so we would need to study the
changes in healthcare provision before defining the appropriate ``close
proximity of time'' interval going forward. We thus published an
extension of the flexibility provided in the TFR by redefining the
``pandemic period'' to end on May 11, 2025, two years after the end of
the PHE.
After studying the available data regarding the changes in
healthcare immediately following the PHE, we have concluded that a
further extension is necessary because healthcare access and provision
remains different from what it was prior to the PHE and we are
continuing to evaluate whether the 4-month period is supported. There
is still uncertainty and change in the medical and legal framework
regarding telehealth, and the limited data available about telehealth
use immediately after the PHE shows ongoing increased telehealth use
compared to the period prior to the PHE. For example, Medicare data
shows that telehealth usage across all medical specialties increased
significantly during the pandemic, and while telehealth usage gradually
declined from its peak, it has not returned to pre-pandemic levels.\28\
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\28\ Centers for Medicare & Medicaid Services (2024, July).
Medicare Telehealth Trends Report. Centers for Medicare and Medicaid
Services, U.S. Department of Health & Human Services (HHS). .https:/
/<a href="http://data.cms.gov/sites/default/files/2024-09/c213a5e9-9e70-4b46-b5f1-2fb941ea0f6c/Medicare%20Telehealth%20Trends%20Snapshot%2020240827_508.pdf">data.cms.gov/sites/default/files/2024-09/c213a5e9-9e70-4b46-b5f1-2fb941ea0f6c/Medicare%20Telehealth%20Trends%20Snapshot%2020240827_508.pdf</a>.
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Telehealth examinations may provide continuity of care, but they
generally cannot provide all the medical findings required under the
musculoskeletal disorders listings. Additionally, anecdotal evidence
from after the PHE suggests that healthcare costs and workforce
shortages, which were exacerbated by the pandemic, have led
[[Page 5585]]
to deferment of care and long wait times to see providers. These issues
are projected to get worse over the next decade,\29\ which could result
in further delays in accessing in-person examinations, which provide
the evidence we need to evaluate musculoskeletal disorders. We need
further data to establish a permanent definition for ``close proximity
of time.''
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\29\ See, e.g., Blumenthal, D., Gumas, E., & Shah, A. (2024).
The Failing U.S. Health System. The New England journal of medicine,
391(17), 1566-1568. <a href="https://doi.org/10.1056/NEJMp2410855">https://doi.org/10.1056/NEJMp2410855</a>, and
GlobalData Plc. (2024, March) The Complexities of Physician Supply
and Demand: Projections From 2021 to 2036. AAMC; <a href="https://www.aamc.org/media/75236/download?attachment">https://www.aamc.org/media/75236/download?attachment</a>.
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Available research and data on post-PHE healthcare provides an
uncertain picture of the long-term impact of the COVID-19 pandemic.
Although the PHE ended on May 11, 2023, several flexibilities provided
during the PHE to increase telehealth access have been extended through
March 31, 2025 (e.g., Medicare coverage of audio-only telehealth,
telehealth originating at a patient's home, and
telerehabilitation).\30\ Additionally, Congress is considering
permanent changes to provide additional flexibilities for
telehealth.\31\ In addition to the evolving nature of telehealth, there
are also significant delays in care provision due to healthcare
workforce shortages and access issues that have persisted and, in many
cases, worsened after the PHE.
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\30\ HHS (2023, May 10). HHS Fact Sheet: Telehealth
Flexibilities and Resources and the COVID-19 Public Health
Emergency. HHS <a href="https://www.hhs.gov/about/news/2023/05/10/hhs-fact-sheet-telehealth-flexibilities-resources-covid-19-public-health-emergency.html">https://www.hhs.gov/about/news/2023/05/10/hhs-fact-sheet-telehealth-flexibilities-resources-covid-19-public-health-emergency.html</a>; see also American Physical Therapy Association
(2023, May) Three Years of Physical Therapy in a Public Health
Emergency: the Impact of the COVID-19 Pandemic on the Physical
Therapy Profession. APTA and The American Relief Act of 2025, Public
Law 118-158. BILLS-118hr10545eh.pdf. <a href="https://www.apta.org/contentassets/143242e710e147cfa30c0405f5c8ef64/apta_covid19_report2023.pdf">https://www.apta.org/contentassets/143242e710e147cfa30c0405f5c8ef64/apta_covid19_report2023.pdf</a>.
\31\ Cottrill, A. & Cubanski, J. & Neuman, T., (2024, October
2). What to Know about Medicare Coverage of Telehealth. The Kaiser
Family Foundation. <a href="https://www.kff.org/medicare/issue-brief/what-to-know-about-medicare-coverage-of-telehealth/">https://www.kff.org/medicare/issue-brief/what-to-know-about-medicare-coverage-of-telehealth/</a>.
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Although the research is still developing and most professional
organizations still have yet to update their clinical practice
guidelines for post-pandemic healthcare, the emerging research and data
suggest that the increased use of telehealth (including in place of
some in-person visits) is generally appreciated by patients and
providers and expected to continue for some time, but at a lower level
than at the height of the pandemic.\32\ This appears true for both
audio-only and audio-visual telehealth modalities, and for specialties
that previously only sparingly used telehealth, such as orthopedic
surgery, spine surgery, and rehabilitation.\33\ In the field of
rehabilitation, the American Physical Therapy Association recently
published clinical practice guidelines supporting telerehabilitation as
a mode of delivering physical therapist services to patients who would
benefit from services and whose barriers can be accommodated. At the
same time, they noted that additional telerehabilitation research is
needed for all ages, digital health applications, physical therapist
measures, and interventions.\34\ Nevertheless, there is a yearslong
research lag that limits availability of post-PHE data, making it
difficult to fully quantify the post-PHE utilization of telehealth and
in-person care in practice.\35\
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\32\ Shaver J. (2022). The State of Telehealth Before and After
the COVID-19 Pandemic. Primary care, 49(4), 517-530. <a href="https://doi.org/10.1016/j.pop.2022.04.002">https://doi.org/10.1016/j.pop.2022.04.002</a>.
\33\ Bartelt, K., Piff, A., Allen, S., & Barkley, E. (2023,
November 21). Telehealth Utilization Higher Than Pre-Pandemic
Levels, but Down from Pandemic Highs. Epic Research. <a href="https://epicresearch.org/articles/telehealth-utilization-higher-than-pre-pandemic-levels-but-down-from-pandemic-highs">https://epicresearch.org/articles/telehealth-utilization-higher-than-pre-pandemic-levels-but-down-from-pandemic-highs</a>. Accessed on November
27, 2024.
\34\ Lee, A.C., Deutsch, J.E., Holdsworth, L., Kaplan, S.L.,
Kosakowski, H., Latz, R., McNeary, L.L., O'Neil, J., Ronzio, O.,
Sanders, K., Sigmund-Gaines, M., Wiley, M., & Russell, T. (2024).
Telerehabilitation in Physical Therapist Practice: A Clinical
Practice Guideline From the American Physical Therapy Association.
Physical therapy, 104(5), pzae045. <a href="https://doi.org/10.1093/ptj/pzae045">https://doi.org/10.1093/ptj/pzae045</a>.
\35\ Standaert, Christopher, M.D. COVID Disruptions and their
Impact on Musculoskeletal Care. Presentation to the Standing
Committee of the National Academies of Science and Medicine Health
and Medicine Division, on June 20, 2024.
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The initial data from CMS and the Department of Veterans Affairs
(VA) appears to show that rates of telehealth use for the first few
months after the end of the PHE remained steady and generally
consistent with utilization rates in late 2021 and 2022.\36\ VA data
showed an overall increase in the proportion of telehealth visits from
20 percent prior to the pandemic to about 35 percent leading up to and
for the first few months after the end of the PHE. Researchers
analyzing the VA data through August 2023 indicated that telehealth
rates stabilized around May 2021 and that ``although primary care and
subspecialty telemedicine is often limited by the need for in-person
evaluations (for example, physical examinations), about 10% of in-
person primary and subspecialty care has converted to telemedicine.''
\37\ Additionally, Medicare data trends through the second quarter of
2024 showed rates of telehealth stabilizing between 12 and 15 percent
of Medicare users in 2022 through June 2024, compared to 7 percent of
users prior to the pandemic. They also showed differences in telehealth
use by race, ethnicity, age, disability status, and dual enrollment
status with Medicaid. The data shows that Medicare users who were
disabled or who were dually eligible for Medicare and Medicaid tended
to use telehealth more both during and after the PHE.\38\
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\36\ Ferguson, J.M., Wray, C.M., Van Campen, J., & Zulman, D.M.
(2024). A New Equilibrium for Telemedicine: Prevalence of In-Person,
Video-Based, and Telephone-Based Care in the Veterans Health
Administration, 2019-2023. Annals of internal medicine, 177(2), 262-
264. <a href="https://doi.org/10.7326/M23-2644">https://doi.org/10.7326/M23-2644</a>; see also Centers for Medicare
& Medicaid Services (2022, December). Medicare Telehealth Trends
Report. Centers for Medicare & Medicaid Services, HHS. <a href="https://data.cms.gov/sites/default/files/2022-12/a7c3a319-5ded-4baf-ad7c-9aa2a897263a/MedicareTelehealthTrendsSnapshot20221201.pdf">https://data.cms.gov/sites/default/files/2022-12/a7c3a319-5ded-4baf-ad7c-9aa2a897263a/MedicareTelehealthTrendsSnapshot20221201.pdf</a>.
\37\ Ferguson, J.M., Wray, C.M., Van Campen, J., & Zulman, D.M.
(2024). A New Equilibrium for Telemedicine: Prevalence of In-Person,
Video-Based, and Telephone-Based Care in the Veterans Health
Administration, 2019-2023. Annals of internal medicine, 177(2), 262-
264. <a href="https://doi.org/10.7326/M23-2644">https://doi.org/10.7326/M23-2644</a>.
\38\ Centers for Medicare & Medicaid Services (2024, November).
Medicare Telehealth Trends Report. Centers for Medicare & Medicaid
Services, HHS <a href="https://data.cms.gov/sites/default/files/2024-12/f5b35fbf-002a-425d-924d-f99aa362a63f/Medicare%20Telehealth%20Trends%20Snapshot%2020241127_508.pdf">https://data.cms.gov/sites/default/files/2024-12/f5b35fbf-002a-425d-924d-f99aa362a63f/Medicare%20Telehealth%20Trends%20Snapshot%2020241127_508.pdf</a>; see
also Centers for Medicare & Medicaid Services (2024, May). Medicare
Telehealth Trends Report. Centers for Medicare & Medicaid Services,
HHS <a href="https://data.cms.gov/sites/default/files/2024-05/Medicare%20Telehealth%20Trends%20Snapshot%2020240528_508.pdf">https://data.cms.gov/sites/default/files/2024-05/Medicare%20Telehealth%20Trends%20Snapshot%2020240528_508.pdf</a>.
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Anecdotal evidence supports that telehealth is still being used at
higher rates than prior to the pandemic, but that additional research
is needed to describe the role of telehealth in healthcare after the
PHE. At their presentation to the National Academies of Science,
Engineering, and Medicine (NASEM) Standing Committee of Medical and
Vocational Experts for the Social Security Administration's Disability
Programs, two experts in musculoskeletal care affirmed that although
telehealth is more common now than prior to the pandemic and provides
benefits for those who use it, there is no currently available data
that provides a picture of telehealth use following the PHE. They
concluded that there is not an industry standard for telehealth
utilization at this time, with more research, consensus, and
standardization needed in the field.\39\
[[Page 5586]]
The conclusions of the experts are supported by a report from the
Outcomes Planning Committee of the VHA Office of Health Services
Research and Development's State-of-the-Art Conference on Virtual Care.
The report concluded that there is a need for additional research to
identify the specific scenarios in which virtual care can be leveraged
to improve patient outcomes, and that additional research regarding the
use of hybrid models ``will be critical in determining whether virtual
visits should function primarily as periodic check-ins before patients
can receive certain examinations or procedures in-person, or whether
virtual care can fully replace in-person care in specific clinical
scenarios.'' \40\
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\39\ Standaert, Christopher, M.D. COVID Disruptions and their
Impact on Musculoskeletal Care. Presentation to the Standing
Committee of the National Academies of Science and Medicine Health
and Medicine Division, on June 20, 2024; see also Escorpizo, Reuben,
P.T., M.Sc., D.P.T. Musculoskeletal Health, and Telehealth--Rapid
Overview. Presentation to the Standing Committee of the National
Academies of Science and Medicine Health and Medicine Division, on
June 20, 2024.
\40\ Connolly, S.L., Sherman, S.E., Dardashti, N., Duran, E.,
Bosworth, H.B., Charness, M.E., Newton, T.J., Reddy, A., Wong, E.S.,
Zullig, L.L., & Gutierrez, J. (2024). Defining and Improving
Outcomes Measurement for Virtual Care: Report from the VHA State-of-
the-Art Conference on Virtual Care. Journal of general internal
medicine, 39(Suppl 1), 29-35. <a href="https://doi.org/10.1007/s11606-023-08464-1">https://doi.org/10.1007/s11606-023-08464-1</a>.
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Although many individuals access telehealth visits successfully,
the clinical signs and findings required by some of the musculoskeletal
disorders 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
(testing that manipulates the areas where an individual has pain in
order to reproduce the pain), discrete palpation (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.\41\ 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.\42\ 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.\43\
While it appears that since the end of the PHE there have been some
post-surgical innovations to conduct follow-up spine care virtually,
such as applications that can be used on a smartphone,\44\ a recent
survey of orthopedic trauma care providers shows that concerns still
exist about the generalizability of telemedicine to the field of
orthopedic trauma care, as a majority of orthopedic physicians felt
that virtual physical examinations allowed for only limited
information.\45\ Thus, the utility of telehealth examination in the
specific context of surgical and/or orthopedic trauma care remains
uncertain.
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\41\ Tanaka, M.J., Oh, L.S., Martin, S.D., & Berkson, E.M.
(2020). Telemedicine in the Era of COVID-19: The Virtual Orthopaedic
Examination. The Journal of Bone and Joint Surgery, American volume,
102(12), e57. <a href="http://dx.doi.org/10.2106/JBJS.20.00609">http://dx.doi.org/10.2106/JBJS.20.00609</a>.
\42\ Laskowski, E.R., Johnson, S.E., Shelerud, R.A., Lee, J.A.,
Rabatin, A.E., Driscoll, S.W., Moore, B.J., Wainberg, M.C., &
Terzic, C.M. (2020). The Telemedicine Musculoskeletal Examination.
Mayo Clinic Proc. 95(8). doi: <a href="https://doi.org/10.1016/j.mayocp.2020.05.026">https://doi.org/10.1016/j.mayocp.2020.05.026</a>.
\43\ 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; see also Cannedy, S., Leung, L.,
Wyte-Lake, T., Balut, M.D., Dobalian, A., Heyworth, L., Paige, N.M.,
& Der-Martirosian, C. (2023). Primary Care Team Perspectives on the
Suitability of Telehealth Modality (Phone vs Video) at the Veterans
Health Administration. Journal of primary care & community health,
14, 21501319231172897. <a href="https://doi.org/10.1177/21501319231172897">https://doi.org/10.1177/21501319231172897</a>.
\44\ Leyendecker, J., Prasse, T., Bieler, E., Yap, N., Eysel,
P., Bredow, J., Hofstetter, C.P., & Members of the Endoscopic Spine
Research Group (ESRG) (2024). Smartphone applications for remote
patient monitoring reduces clinic utilization after full-endoscopic
spine surgery. Journal of telemedicine and telecare,
1357633X241229466. Advance online publication. <a href="https://doi.org/10.1177/1357633X241229466">https://doi.org/10.1177/1357633X241229466</a>.; see also Murhekar, S., Relwani, S., Lau,
S., & Virani, S. (2024). Evaluation of the Effectiveness of Virtual
Telephone Consultations Against Traditional Face-to-Face
Consultations in Spine Surgery Using an Objective Metric. Cureus,
16(9), e69433. <a href="https://doi.org/10.7759/cureus.69433">https://doi.org/10.7759/cureus.69433</a>.
\45\ Gammel, J., Rivas, G., Horn, R., Munford, J., Reid, K., &
Harstock, L. (2024, September 4). A survey of telehealth and its
role in orthopaedic trauma during and after COVID-19. Journal of
Public Health (Berl.) <a href="https://doi.org/10.1007/s10389-024-02347-3">https://doi.org/10.1007/s10389-024-02347-3</a>.
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Additionally, an increasing number of people are unable to access
needed healthcare due to cost as the PHE flexibilities are phased out.
Medicaid redeterminations restarted at the end of the PHE, leading to
an increase in the uninsured, and the enhanced health insurance
marketplace subsidies will expire in 2025.\46\ According to data from
the Kaiser Family Foundation (KFF), over 25 million people have been
disenrolled from Medicaid since April 2023, when the ``unwinding'' of
the continuous enrollment provision began, leading to an increase in
the uninsured population.\47\
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\46\ Tolbert, J., & Corallo, B. (2024, September 18). An
examination of Medicaid Renewal Outcomes and enrollment changes at
the end of the Unwinding. The Kaiser Family Foundation. <a href="https://www.kff.org/medicaid/issue-brief/an-examination-of-medicaid-renewal-outcomes-and-enrollment-changes-at-the-end-of-the-unwinding/">https://www.kff.org/medicaid/issue-brief/an-examination-of-medicaid-renewal-outcomes-and-enrollment-changes-at-the-end-of-the-unwinding/</a>; See
also Minicozzi, A., & Masi, S. (2024, June 18). CBO Publishes New
Projections Related to Health Insurance for 2024 to 2034, CBO.
<a href="https://www.cbo.gov/publication/60383">https://www.cbo.gov/publication/60383</a>.
\47\ Tolbert, J., & Corallo, B. (2024, September 18). An
examination of Medicaid Renewal Outcomes and enrollment changes at
the end of the Unwinding. The Kaiser Family Foundation. <a href="https://www.kff.org/medicaid/issue-brief/an-examination-of-medicaid-renewal-outcomes-and-enrollment-changes-at-the-end-of-the-unwinding/">https://www.kff.org/medicaid/issue-brief/an-examination-of-medicaid-renewal-outcomes-and-enrollment-changes-at-the-end-of-the-unwinding/</a>.
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The Congressional Budget Office predicts an increase in the share
and number of people without insurance over the next decade, with a
predicted increase in the uninsured population from 24 million in 2023
to 32 million in 2027, primarily driven by changes in Medicaid and
Children's Health Insurance Program (CHIP) enrollment over the next few
years resulting from the expiration of PHE-era programs.\48\ National
surveys from KFF and the Federal Reserve in 2022 and 2023 showed that a
large percentage of people (25 to 28 percent) postponed or went without
needed medical care due to cost regardless of insurance status, and
that the uninsured population was significantly more likely to forego
or postpone care (42 to 60 percent) than the insured population.\49\
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\48\ Hale, J., Hong, N., Hopkins, B., Lyons, S., Molloy, E., &
The Congressional Budget Office Coverage Team (2024). Health
Insurance Coverage Projections for the US Population and Sources Of
Coverage, By Age, 2024-34. Health affairs (Project Hope), 43(7),
922-932. <a href="https://doi.org/10.1377/hlthaff.2024.00460">https://doi.org/10.1377/hlthaff.2024.00460</a>.
\49\ Tolbert, J., & Corallo, B. (2024, September 18). An
examination of Medicaid Renewal Outcomes and enrollment changes at
the end of the Unwinding. The Kaiser Family Foundation. <a href="https://www.kff.org/medicaid/issue-brief/an-examination-of-medicaid-renewal-outcomes-and-enrollment-changes-at-the-end-of-the-unwinding/">https://www.kff.org/medicaid/issue-brief/an-examination-of-medicaid-renewal-outcomes-and-enrollment-changes-at-the-end-of-the-unwinding/</a>.
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The Commonwealth Fund's 2024 report, which compared the performance
of health systems of 10 high-income countries using data from 2020 or
later and is the first such report to account for the effects of the
COVID-19 pandemic, found that the United States ranked last on several
measures, including access to care, and this was attributed largely to
cost-related barriers, such as the percentage of uninsured residents as
well as inadequate coverage and high deductibles and copayments.\50\
The Commonwealth Fund's 2023 survey noted that nearly half of adults
with lower or average incomes in the U.S., and nearly one of three with
higher incomes, reported at least one cost-related problem accessing
health care in the prior year. The problems included
[[Page 5587]]
having a medical issue but not visiting a doctor, skipping a medical
test, treatment, or follow-up that was recommended by a doctor, not
filling a prescription, or skipping medication doses.\51\ Given the
projected increases in the uninsured population and the impact of cost
and insurance status on access to care, postponed and foregone health
care is expected to remain an issue for the foreseeable future,
potentially limiting the frequency of visits.
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\50\ Blumenthal, D., Gumas, E., & Shah, A. (2024). The Failing
U.S. Health System. The New England journal of medicine, 391(17),
1566-1568. <a href="https://doi.org/10.1056/NEJMp2410855">https://doi.org/10.1056/NEJMp2410855</a>.
\51\ Gunja MZ, Gumas ED, Williams RD II, Doty MM, Shah A, Fields
K. The cost of not getting care: income disparities in the
affordability of health services across high-income countries. New
York: Commonwealth Fund, November 16, 2023 (<a href="https://www.commonwealthfund.org/publications/surveys/2023/nov/cost-not-getting-care-income-disparities-affordability-health">https://www.commonwealthfund.org/publications/surveys/2023/nov/cost-not-getting-care-income-disparities-affordability-health</a>).
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Additional research suggests that certain individuals, such as
those who are uninsured or low-income, may face barriers to regular or
recommended health care treatment, and that these barriers appear to
have increased after the pandemic, which may warrant a longer standard
to allow for developing the necessary evidence. In a separate
publication, summarizing recent research, KFF notes that studies
repeatedly demonstrate that uninsured individuals are less likely than
those with insurance to receive preventive care and services for major
health conditions and chronic diseases.\52\ For example, a 2023 KFF
survey found that 61 percent of uninsured adults skipped or postponed
getting treatment due to cost compared to 21 percent for insured
adults.\53\ Similarly, a 2019 National Center for Health Statistics
survey found that 36.5 percent of uninsured adults delayed or did not
receive needed medical care due to cost as compared to eight percent of
insured individuals.\54\ That same study found that over 20 percent of
individuals living at or below 200 percent of the federal poverty
threshold delayed or did not receive medical care due to cost as
compared to 8.5 percent of all individuals. Notably, the 2019 study
showed fewer people missing care than the 2023 KFF survey, again
suggesting that problems accessing care have been exacerbated by the
pandemic. Given that individuals who apply for disability benefits are
disproportionately uninsured \55\ or low-income, a standard which helps
to accommodate cost barriers to healthcare access may be appropriate.
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\52\ Tolbert, J, Drake, P., & Damic, A., (2023, December 18).
Key Facts about the Uninsured Population. The Kaiser Family
Foundation. <a href="https://www.kff.org/report-section/key-facts-about-the-uninsured-population-issue-brief/#endnote_link_607642-9">https://www.kff.org/report-section/key-facts-about-the-uninsured-population-issue-brief/#endnote_link_607642-9</a>.
\53\ Lopes, L., Montero, A., Presiado, M., & Hamel, L. (2024,
March 01). Americans' Challenges with Health Care Costs. The Kaiser
Family Foundation. <a href="https://www.kff.org/health-costs/issue-brief/americans-challenges-with-health-care-costs/">https://www.kff.org/health-costs/issue-brief/americans-challenges-with-health-care-costs/</a>
\54\ National Center for Health Statistics, National Health
Interview Survey. See Sources and Definitions, National Health
Interview Survey (NHIS) and Health, United States, 2020-2021 Table
UnmtNd.
\55\ For example, a 2009 study found that recent SSDI recipients
were uninsured at substantially higher rates than the general
population. See, Livermore, G., Stapleton, D., & Claypool, H. Health
Insurance and Health Care Access Before and After SSDI Entry. New
York: Commonwealth Fund, May 20, 2009. <a href="https://www.commonwealthfund.org/publications/fund-reports/2009/may/health-insurance-and-health-care-access-and-after-ssdi-entry">https://www.commonwealthfund.org/publications/fund-reports/2009/may/health-insurance-and-health-care-access-and-after-ssdi-entry</a>.
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Healthcare workforce analyses have also shown significant
healthcare workforce shortages and delays in care, exacerbated by the
pandemic, and have projected ongoing healthcare workforce shortages for
at least a decade, further impacting access to care, with disparate
access to care for different communities.\56\ Preliminary data from the
pandemic shows that stress during the pandemic led to burnout and
retirement earlier than projected for many physicians and nurses,
exacerbating workforce shortages that were already increasing due to an
aging healthcare workforce.\57\ At the same time, healthcare demand has
increased and is expected to continue to increase due to population
growth, the increase in individuals with multiple chronic conditions,
and the aging population.\58\ Experts in musculoskeletal care
presenting to the NASEM Standing Committee reported significant
persisting delays in specialty care appointments compared to pre-
pandemic norms.\59\ The Commonwealth Fund's 2024 report also noted that
timely access to care in the United States is limited by a worsening
shortage of primary care clinicians and the time spent by healthcare
providers on administrative issues related to billing.\60\
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\56\ GlobalData Plc. (2024, March). The Complexities of
Physician Supply and Demand: Projections From 2021 to 2036. AAMC;
<a href="https://www.aamc.org/media/75236/download?attachment">https://www.aamc.org/media/75236/download?attachment</a>.
\57\ Martin, B., Kaminski-Ozturk, N., O'Hara, C., & Smiley, R.
(2023). Examining the Impact of the COVID-19 Pandemic on Burnout and
Stress Among U.S. Nurses. Journal of nursing regulation, 14(1), 4-
12. <a href="https://doi.org/10.1016/S2155-8256">https://doi.org/10.1016/S2155-8256</a>(23)00063-7.
\58\ GlobalData Plc. (2024, March). The Complexities of
Physician Supply and Demand: Projections From 2021 to 2036. AAMC;
<a href="https://www.aamc.org/media/75236/download?attachment">https://www.aamc.org/media/75236/download?attachment</a>.
\59\ Standaert, Christopher, M.D. COVID Disruptions and their
Impact on Musculoskeletal Care. Presentation to the Standing
Committee of the National Academies of Science and Medicine Health
and Medicine Division, on June 20, 2024; see also Escorpizo, Reuben,
P.T., M.Sc., D.P.T. Musculoskeletal Health, and Telehealth--Rapid
Overview. Presentation to the Standing Committee of the National
Academies of Science and Medicine Health and Medicine Division, on
June 20, 2024.
\60\ Blumenthal, D., Gumas, E., & Shah, A. (2024). The Failing
U.S. Health System. The New England journal of medicine, 391(17),
1566-1568. <a href="https://doi.org/10.1056/NEJMp2410855">https://doi.org/10.1056/NEJMp2410855</a>.
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The Health Resources and Services Administration (HRSA) reported in
November 2023 that approximately 102 million Americans live in a
primary care health professional shortage area and that maldistribution
of the healthcare workforce results in severe shortages in rural
communities.\61\ Additionally, a 2024 HRSA report projects average
physician shortages of 56 percent in non-metro areas by 2036.\62\
Similarly, the Association of American Medical Colleges recently
projected a shortage of up to 139,000 physicians by 2033 and concluded
that if communities historically underserved by our health care system
had fewer access barriers and comparable access was provided for all,
the shortfall would be three to six times the magnitude of current
estimates.\63\
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\61\ National Center for Health Workforce Analysis (2024, May).
State of the U.S. Health Care Workforce, 2023 HRSA; <a href="https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/state-of-the-health-workforce-report-2023.pdf">https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/state-of-the-health-workforce-report-2023.pdf</a>.
\62\ Bureau of Health Workforce. (2024, November). Health
Workforce Projections. HRSA; Retrieved November 22, 2024, from
<a href="https://bhw.hrsa.gov/data-research/projecting-health-workforce-supply-demand">https://bhw.hrsa.gov/data-research/projecting-health-workforce-supply-demand</a>.
\63\ GlobalData Plc. (2024, March) The Complexities of Physician
Supply and Demand: Projections From 2021 to 2036. AAMC; <a href="https://www.aamc.org/media/75236/download?attachment">https://www.aamc.org/media/75236/download?attachment</a>.
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Any ongoing decrease in the frequency of, or increase in wait times
for, in-person medical visits could lead to additional barriers or
delays in documenting certain findings in the medical record that are
needed to meet or equal the musculoskeletal disorders listings. This is
true even if the decrease in in-person visits is offset with telehealth
visits that make healthcare more accessible for some, because
telehealth visits cannot reliably provide all the findings provided
during in-person visits. The anecdotal evidence we have suggests the
possibility of ongoing changes in healthcare related to the pandemic,
including significant post-PHE delays in in-person care and ongoing
telehealth utilization at a higher rate than prior to the pandemic.
Although this evidence may support additional flexibility in the
proximity standard, there is also an overall lack of published and
available data on healthcare access and utilization following the PHE
on which to rely. Therefore, an extension until May 11,
[[Page 5588]]
2029, is necessary to ensure a sufficient research base for a permanent
standard.
We are extending the flexibility until May 11, 2029, to provide
time for published research to demonstrate utilization data after the
PHE. Experts in musculoskeletal care presenting to the NASEM Standing
Committee in June 2024 noted that there was almost no published
research about musculoskeletal health care utilization in 2022 and
beyond. One expert explained that this is largely due to the logistics
of scientific research, where data is collected in large databases on a
delay, and researchers must obtain funding and access to the database,
analyze the data, and seek peer review and publication, which typically
takes several years.\64\ Therefore, in order to provide time for
development of the evidence base and for full notice-and-comment
rulemaking, we are extending the flexibility in the proximity standard
until May 11, 2029. However, we will begin the rulemaking process for a
permanent proximity standard as soon as the evidence base is available.
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\64\ Standaert, Christopher, M.D. COVID Disruptions and their
Impact on Musculoskeletal Care. Presentation to the Standing
Committee of the National Academies of Science and Medicine Health
and Medicine Division, on June 20, 2024.
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Evidence to Review
We will continue to use the extension period to study the changes
in healthcare access and provision after the expiration of the PHE.
During the extension period, we will also continue to review
information about disparities in access to care or modalities of care.
We expect this additional period will allow us to consider whether we
should revert to the 4-month ``close proximity of time'' standard,
adopt a permanent change to the consecutive 12-month ``close proximity
of time'' period, or use a different timeframe, to account for ongoing
changes in healthcare access and delivery.
We will also continue to study the application of the ``close
proximity of time'' rule in our programs. In addition, we will 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, and the justification or evidence for the standard the
commenter identifies as appropriate;
<bullet> Research, evidence, or information about barriers to
access to care, changes in healthcare delivery, and disproportionate
burdens faced by any subset of the population and how that impacts an
individual's ability to provide the required evidence for a medical
listing; 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 define a new term, ``post-
pandemic evaluation period,'' to mean ``the period beginning on May 12,
2025, and ending on May 11, 2029.'' We are adding this new term because
we are extending the more flexible ``close proximity of time'' standard
to six years after the end of the PHE. This rule also revises sections
1.00C7c and 101.00C7c to indicate that, for claims determined or
decided during the pandemic period or the post-pandemic evaluation
period, ``within a close proximity of time'' means that all the
relevant criteria must appear in the medical record within a
consecutive 12-month period.
We are making changes based on the Commissioner of Social
Security's rulemaking authority specified in sections 205(a),
702(a)(5), 1631(d)(1), 1631(e)(1)(A), and 1633(a) of the Social
Security Act. Under those sections, the Commissioner may adopt rules
regarding, among other things, the nature and extent of evidence needed
to establish benefit eligibility, as well as methods of taking and
furnishing such evidence.
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 and public comment.\65\ We have been following the more flexible
12-month ``close proximity of time'' standard for over three years, and
it would be impracticable and contrary to the public interest to
disrupt our claims adjudications by delaying implementation of this
TFR. Delayed implementation of this TFR would require us to either
delay adjudicating affected claims, potentially resulting in delayed
benefits to vulnerable individuals,\66\ or 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. If we applied the 4-month standard, 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. Implementing this TFR, without prior notice
and public comment, will allow us to maintain this more flexible
standard while we review and adapt to new clinical practices and
healthcare data that emerge in a post-PHE landscape.
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\65\ In our first 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 first TFR to one year after the end of the PHE.
Similarly, in our second TFR we provided notice that we would
consider extending the expiration date of the rule, and we invited
public comments on the expiration date. 88 FR at 67081, 67088. As
discussed above, we received a public comment from The Connected
Health Initiative which supported our decision to extend the
original TFR to continue to study the impacts of the PHE and
barriers to healthcare.
\66\ 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.\67\ An
unnecessary delay
[[Page 5589]]
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.
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\67\ 42 U.S.C. 1382(a); 20 CFR 416.202.
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Delaying implementation of this final rule to provide an
opportunity for prior notice and public comment is also unnecessary. As
noted above, we have applied the more flexible 12-month ``close
proximity of time'' standard for over three years, and its effects have
been negligible, merely resulting in more streamlined, faster
disability determinations for a very small number of claimants.
Moreover, we have given interested parties an opportunity to
provide public comment on the 12-month standard--including soliciting
comments about a possible extension--on two prior occasions: first when
we published the 2021 TFR and then, when we extended the flexibility in
September 2023. Altogether, we received two public comments. The first
commenter supported making the 12-month standard permanent or,
alternatively, extending it, and the second commenter supported an
extension of the 12-month standard. Accordingly, delaying
implementation of this rule to obtain further public comment is
unnecessary.
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> Providing a more flexible 12-month ``close proximity of
time'' standard in the musculoskeletal disorders listings will
potentially result in streamlined, faster disability determinations for
a small number of claimants. Absent this policy, a small number of
determinations might be delayed due to a need for additional medical or
vocational development.
Anticipated Costs
We do not believe there are 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.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act.\68\
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\68\ 5 U.S.C. 801 et seq.
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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
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, Carolyn W. Colvin,
having reviewed and approved this document, is delegating the authority
to electronically sign this document to Erik Hansen, who is a Federal
Register Liaison for the Social Security Administration, for purposes
of publication in the Federal Register.
Erik Hansen,
Associate Commissioner, Office of Legislative Development and
Operations, Social Security Administration.
For the reasons stated in the preamble, we are amending subpart P
of
[[Page 5590]]
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: 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 paragraphs a and c; and
0
b. In part B, amend section 101.00C7 by revising paragraphs a and c.
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. The term
post-pandemic evaluation period as used in 1.00C7c means the period
beginning on May 12, 2025, and ending on May 11, 2029.
* * * * *
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 or post-pandemic
evaluation period. For claims determined or decided during the
pandemic period or post-pandemic evaluation 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 May 11, 2025. The
term post-pandemic evaluation period as used in 101.00C7c means the
period beginning on May 12, 2025, and ending on May 11, 2029.
* * * * *
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 or post-pandemic evaluation period. For claims determined or
decided during the pandemic period or post-pandemic evaluation
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. 2025-01283 Filed 1-16-25; 8:45 am]
BILLING CODE 4191-02-P
</pre></body>
</html>Indexed from Federal Register on January 17, 2025.
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