Rule2023-21671
Extension of the Flexibility in Evaluating “Close Proximity of Time” To Evaluate Changes in Healthcare Following the COVID-19 Public Health Emergency
Primary source
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Published
September 29, 2023
Effective
October 30, 2023
Issuing agencies
Social Security Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 188 (Friday, September 29, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <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="http://www.ssa.gov">http://www.ssa.gov</a>.
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. <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).
\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. <a href="https://doi.org/10.1097/BRS.0b013e318241e5de">https://doi.org/10.1097/BRS.0b013e318241e5de</a>).
\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]. <a href="https://www.boneandjointburden.org/fourth-edition/viiic2/utilization-condition-group">https://www.boneandjointburden.org/fourth-edition/viiic2/utilization-condition-group</a>).
\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)
(<a href="https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx">https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx</a>).
\17\ 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 \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, <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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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. <a href="https://doi.org/10.1097/PHH.0000000000001563">https://doi.org/10.1097/PHH.0000000000001563</a>.
\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.
<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>.
\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. <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/cib010523.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/cib010523.pdf</a>.
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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.
<a href="https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf">https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf</a> ;
Centers for Medicare & Medicaid Services (2022, Dec.). Medicare
Telehealth Trends Report. Centers for Medicare & Medicaid Services,
U.S. Department of Health & Human Services. <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>; 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. <a href="https://doi.org/10.1001/jamainternmed.2020.5928">https://doi.org/10.1001/jamainternmed.2020.5928</a>; 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. <a href="https://doi.org/10.1001/jamahealthforum.2021.1529">https://doi.org/10.1001/jamahealthforum.2021.1529</a>.
\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. <a href="http://dx.doi.org/10.2106/JBJS.20.00609">http://dx.doi.org/10.2106/JBJS.20.00609</a>).
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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. <a href="https://www.va.gov/HEALTH/docs/VHA-COVID-19-Response-2022-Annex-C.pdf">https://www.va.gov/HEALTH/docs/VHA-COVID-19-Response-2022-Annex-C.pdf</a>.
\30\ Centers for Medicare & Medicaid Services (2022, Dec.).
Medicare Telehealth Trends Report. Centers for Medicare & Medicaid
Services, U.S. Department of Health & Human Services. <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>.
\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. <a href="https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf">https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf</a>.
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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. <a href="https://www.ama-assn.org/system/files/telehealth-survey-report.pdf">https://www.ama-assn.org/system/files/telehealth-survey-report.pdf</a>.
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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. <a href="https://doi.org/10.1016/j.bas.2022.100930">https://doi.org/10.1016/j.bas.2022.100930</a>;
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. <a href="https://doi.org/10.1097/BRS.0000000000003821">https://doi.org/10.1097/BRS.0000000000003821</a> ; 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. <a href="https://doi.org/10.3171/2020.6.SPINE20863">https://doi.org/10.3171/2020.6.SPINE20863</a>; 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. <a href="https://doi.org/10.1177/2192568220965521">https://doi.org/10.1177/2192568220965521</a>.
\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.
<a href="https://doi.org/10.1089/tmj.2020.0255">https://doi.org/10.1089/tmj.2020.0255</a>.
\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. <a href="https://doi.org/10.3390/ijerph182413372">https://doi.org/10.3390/ijerph182413372</a>.
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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. <a href="https://doi.org/10.1016/j.bas.2022.100930">https://doi.org/10.1016/j.bas.2022.100930</a>.
\37\ American College of Rheumatology (2023). 2023 ACR Health
Policy Statements. American College of Rheumatology. <a href="https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltd84782969d741aba/acr-health-policy-statements.pdf">https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltd84782969d741aba/acr-health-policy-statements.pdf</a>.
\38\ American Medical Association (2022). AMA Future of Health
Closing the Digital Health Disconnect: A Blueprint for Optimizing
Digitally Enabled Care. American Medical Association. <a href="https://www.ama-assn.org/system/files/ama-future-health-report.pdf">https://www.ama-assn.org/system/files/ama-future-health-report.pdf</a>.
(Accessed March 22, 2023).
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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. <a href="https://www.healthquality.va.gov/guidelines/MR/mus/mus_fulltext.pdf">https://www.healthquality.va.gov/guidelines/MR/mus/mus_fulltext.pdf</a>). 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. <a href="https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG508.pdf">https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG508.pdf</a>.
\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. <a href="https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPG092917.pdf">https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPG092917.pdf</a>.)
\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). <a href="https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPGFinal508.pdf">https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPGFinal508.pdf</a>.
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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.
<a href="https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html">https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html</a>.
\46\ U.S. Department of Health & Human Services (2023, May 9).
Fact Sheet: End of the COVID-19 Public Health Emergency <a href="https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html">https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html</a>.
\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.
<a href="https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf">https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf</a>;
See also American Hospital Association (2023, Feb. 7). Special
Bulletin: Public Health Emergency to End May 11. American Hospital
Association. <a href="https://www.aha.org/system/files/media/file/2023/02/Special-Bulletin-Public-Health-Emergency-to-End-May-11.pdf">https://www.aha.org/system/files/media/file/2023/02/Special-Bulletin-Public-Health-Emergency-to-End-May-11.pdf</a>.
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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: <a href="https://aspe.hhs.gov/sites/default/files/documents/404a7572048090ec1259d216f3fd617e/aspe-end-mcaid-continuous-coverage_IB.pdf">https://aspe.hhs.gov/sites/default/files/documents/404a7572048090ec1259d216f3fd617e/aspe-end-mcaid-continuous-coverage_IB.pdf</a>.
\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 <a href="https://wwwn.cdc.gov/NHISDataQueryTool/ER_Quarterly/index_quarterly.html">https://wwwn.cdc.gov/NHISDataQueryTool/ER_Quarterly/index_quarterly.html</a>.
\50\ Kaiser Family Foundation (2023, June 13). Medicaid
Enrollment and Unwinding Tracker. Kaiser Family Foundation. <a href="https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/">https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/</a>.
\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.
<a href="https://www.healthsystemtracker.org/chart-collection/how-has-healthcare-utilization-changed-since-the-pandemic/">https://www.healthsystemtracker.org/chart-collection/how-has-healthcare-utilization-changed-since-the-pandemic/</a>.
\52\ Brenan, Megan (2023, Jan. 17). Record High in U.S. Put Off
Medical Care Due to Cost in 2022. Gallup. <a href="https://news.gallup.com/poll/468053/record-high-put-off-medical-care-due-cost-2022.aspx">https://news.gallup.com/poll/468053/record-high-put-off-medical-care-due-cost-2022.aspx</a>.
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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. <a href="https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf">https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf</a>.
\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. <a href="https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-Medicare-Telehealth-Utilization-and-Spending-Impacts-2019-2021-October-2022.pdf">https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-Medicare-Telehealth-Utilization-and-Spending-Impacts-2019-2021-October-2022.pdf</a>.
\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.
<a href="https://doi.org/10.1001/jamanetworkopen.2022.52061">https://doi.org/10.1001/jamanetworkopen.2022.52061</a>.
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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. <a href="https://doi.org/10.1097/PHH.0000000000001563">https://doi.org/10.1097/PHH.0000000000001563</a>.
\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: <a href="https://www.gao.gov/products/gao-22-104454">https://www.gao.gov/products/gao-22-104454</a>.
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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. <a href="https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-The-Future-of-Telehealth-After-COVID-19-October-2022.pdf">https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-The-Future-of-Telehealth-After-COVID-19-October-2022.pdf</a>.
\59\ The Medicare Payment Advisory Commission (2022, Sept. 29).
MedPAC Mandatory report: Study on the Expansion of Telehealth.
<a href="https://www.medpac.gov/wp-content/uploads/2021/10/Telehealth-MedPAC-29-Sept-2022.pdf">https://www.medpac.gov/wp-content/uploads/2021/10/Telehealth-MedPAC-29-Sept-2022.pdf</a>.
\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. <a href="https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf">https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf</a>.
\61\ The Consolidated Appropriations Act, 2023, Public Law 117-
328.
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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.
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\65\ 42 U.S.C. 1382(a); 20 CFR 416.202.
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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
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</html>Indexed from Federal Register on September 29, 2023.
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