Extension of the Flexibility in Evaluating “Close Proximity of Time” To Evaluate Changes in Healthcare Following the COVID-19 Public Health Emergency, 67081-67089 [2023-21671]
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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Rules and Regulations
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BILLING CODE 3510–DS–P
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
Social Security Administration.
Temporary final rule with
request for comments.
AGENCY:
ACTION:
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 postPHE 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.
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SUMMARY:
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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.
You may submit comments
by any one of three methods—internet,
fax, or mail. Do not submit the same
comment(s) multiple times or by more
than one method. Regardless of which
method you choose, please state that
your comment(s) refer to Docket No.
SSA–2023–0023 so that we may
associate your comment(s) with the
correct regulation.
Caution: You should be careful to
include in your comment(s) only
information that you wish to make
publicly available. We strongly urge you
not to include any personal information
in your comment(s), such as Social
Security numbers or medical
information.
1. Internet: We strongly recommend
that you submit your comment(s) via the
internet. Please visit the Federal
eRulemaking portal at https://
www.regulations.gov. Use the ‘‘search’’
function to find docket number SSA–
2023–0023. The system will issue a
tracking number to confirm your
submission. You will not be able to
view your comment(s) immediately
because we must post each comment
manually. It may take up to one week
for your comment(s) to be viewable.
2. Fax: Fax comments to 1–833–410–
1631.
3. Mail: Mail your comments to the
Office of Legislation and Congressional
Affairs Regulations and Reports
Clearance Staff, Mail Stop 3253,
Altmeyer, 6401 Security Blvd.,
Baltimore, MD 21235.
Comments are available for public
viewing on the Federal eRulemaking
portal at https://www.regulations.gov or
in person, during regular business
hours, by arranging with the contact
person identified below.
FOR FURTHER INFORMATION CONTACT:
Michael J. Goldstein, Office of Disability
Policy, Social Security Administration,
6401 Security Boulevard, Baltimore, MD
21235–6401, (410) 965–1020. For
information on eligibility or filing for
benefits, call our national toll-free
number, 1–800–772–1213 or TTY 1–
800–325–0778, or visit our internet site,
Social Security Online, at https://
www.ssa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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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 4month period’’ (emphasis in original).7
We also provided that ‘‘[w]hen the
criterion is imaging, we mean that we
1 85
FR 78164 (2020).
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).
2 For
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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Rules and Regulations
could reasonably expect the findings on
imaging to have been present at the date
of impairment or date of onset.’’ 8
We established the consecutive 4month 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.
8 Id.
9 See
85 FR at 78169–78170.
FR 20646 (2018).
11 Id. at 20647.
12 85 FR at 78169 n.37 (citing Bavafa, H., Savin,
S., & Terwiesch, C. (2019). Redesigning Primary
Care Delivery: Customized Office Revisit Intervals
and E-Visits. https://dx.doi.org/10.2139/ssrn.
2363685. Paper referenced by Bavafa: Schectman,
G., G. Barnas, P. Laud, L. Cantwell, M. Horton, E.J.
Zarling. 2005. Prolonging the return visit interval in
primary care. The American Journal of Medicine,
118(4) 393–399).
13 85 FR at 78169 n.34 (citing Gore, M., Sadosky,
A., Stacey, B.R., Tai, K.S., & Leslie, D. (2012). The
burden of chronic low back pain: Clinical
comorbidities, treatment patterns, and health care
costs in usual care settings. Spine, 37(11), E668–
E677. https://doi.org/10.1097/BRS.0b013e318241
e5de).
14 85 FR at 78169 n.35 (citing BMUS: The Burden
of Musculoskeletal Diseases in the United States. In:
BMUS: The Burden of Musculoskeletal Diseases in
the United States [internet]. [cited 15 July 2020].
https://www.boneandjointburden.org/fourthedition/viiic2/utilization-condition-group).
15 See 85 FR at 78169 n.36 (citing J Gen Intern
Med. 1999 Apr; 14(4): 230–235. doi: 10.1046/
j.1525–1497.1999.00322.x Lisa M Schwartz, MD,
MS, Steven Woloshin, MD, MS, John H Wasson,
MD, Roger A Renfrew, MD, and H Gilbert Welch,
MD, MPH, Dartmouth Primary Care Cooperative
Research Network).
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Onset of COVID–19
In 2020, COVID–19 began to spread
throughout the country, prompting the
Secretary of Health and Human Services
to declare a national PHE on January 31,
2020.16 With the outbreak of COVID–19,
access to and the provision of healthcare
changed significantly. Throughout the
PHE, individuals across the country—
including those with musculoskeletal
disorders—altered their frequency and
manner of seeking access to healthcare.
This was due in part to healthcare
organizations and government agencies
such as the Centers for Medicare &
Medicaid Services (CMS) 17 prioritizing
the most urgent services and
encouraging patients to delay other
procedures during the PHE. Likewise,
many individuals delayed or deferred
important treatments due to closures of
medical offices, fears of contracting
COVID–19 infection (including fear of
exposing high-risk individuals living in
their household to infection), and other
challenges created or exacerbated by the
pandemic, such as difficulty accessing
transportation.
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 inperson 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
16 Determination That A Public Health Emergency
Exists by Alex M. Azar II, Secretary of Health &
Human Services (Jan. 31. 2020) (https://
aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx).
17 Centers for Medicare & Medicaid Services
(CMS) Recommendations: Re-opening Facilities to
Provide Non-emergent Non-COVID–19 Healthcare
(https://www.cms.gov/files/document/covidrecommendations-reopening-facilities-provide-nonemergent-care.pdf); see also Non-Emergent, Elective
Medical Services, and Treatment Recommendations
(https://www.cms.gov/files/document/cms-nonemergent-elective-medical-recommendations.pdf).
18 86 FR 38920 (2021).
19 Id.
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‘‘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.
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
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.
With this temporary rule, we are
partially adopting this comment.
Although we provided support for the
consecutive 4-month period in our 2020
20 86
FR at 38925.
FR at 38924.
22 See Comment from National Organization of
Social Security Claimants’ Representatives on
Document SSA–2021–0010–0001, https://
www.regulations.gov/comment/SSA-2021-00100002.
21 86
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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 postPHE 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
23 See, e.g., Neri, A. J., Whitfield, G. P.,
Umeakunne, E. T., Hall, J. E., DeFrances, C. J., Shah,
A. B., Sandhu, P. K., Demeke, H. B., Board, A. R.,
Iqbal, N. J., Martinez, K., Harris, A. M., & Strona,
F. V. (2022). Telehealth and Public Health Practice
in the United States-Before, During, and After the
COVID–19 Pandemic. Journal of public health
management and practice: JPHMP, 28(6), 650–656.
https://doi.org/10.1097/PHH.0000000000001563.
24 20 CFR part 404, subpart P, Appendix 1,
1.00C7c and 101.00C7c.
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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.
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
25 Becarra, X. (2023, May 11). Statement on End
of the COVID–19 Public Health Emergency.
Department of Health and Human Services. https://
www.hhs.gov/about/news/2023/05/11/hhssecretary-xavier-becerra-statement-on-end-of-thecovid-19-public-health-emergency.html.
26 Tsai, D. (2023, Jan 5). CMS Informational
Bulletin: Key Dates Related to the Medicaid
Continuous Enrollment Condition Provisions in the
Consolidated Appropriations Act, 2023. Centers for
Medicare & Medicaid Services, U.S. Department of
Health & Human Services. https://
www.medicaid.gov/federal-policy-guidance/
downloads/cib010523.pdf.
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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.
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
27 See, e.g., Samson, L., Tarazi, W., Turrini, G.,
Sheingold, S. (2021, Dec.). Medicare Beneficiaries’
Use of Telehealth Services in 2020—Trends by
Beneficiary Characteristics and Location (Issue Brief
No. HP–2021-27). Office of the Assistant Secretary
for Planning & Evaluation, U.S. Department of
Health & Human Services. https://aspe.hhs.gov/
sites/default/files/documents/
a1d5d810fe3433e18b192be42dbf2351/medicaretelehealth-report.pdf ; Centers for Medicare &
Medicaid Services (2022, Dec.). Medicare
Telehealth Trends Report. Centers for Medicare &
Medicaid Services, U.S. Department of Health &
Human Services. https://data.cms.gov/sites/default/
files/2022-12/a7c3a319-5ded-4baf-ad7c9aa2a897263a/MedicareTelehealth
TrendsSnapshot20221201.pdf; Patel, S. Y.,
Mehrotra, A., Huskamp, H. A., Uscher-Pines, L.,
Ganguli, I., & Barnett, M. L. (2021). Trends in
Outpatient Care Delivery and Telemedicine During
the COVID–19 Pandemic in the US. JAMA internal
medicine, 181(3), 388–391. https://doi.org/10.1001/
jamainternmed.2020.5928; Cortez, C., Mansour, O.,
Qato, D. M., Stafford, R. S., & Alexander, G. C.
(2021). Changes in Short-term, Long-term, and
Preventive Care Delivery in US Office-Based and
Telemedicine Visits During the COVID–19
Pandemic. JAMA health forum, 2(7), e211529.
https://doi.org/10.1001/jamahealthforum.
2021.1529.
28 86 FR 38920 (2021) (citing Tanaka et al. (2020).
Telemedicine in the Era of COVID–19: The Virtual
Orthopaedic Examination. The Journal of bone and
joint surgery. American volume, 102(12), e57.
https://dx.doi.org/10.2106/JBJS.20.00609).
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claimants to provide the necessary
findings in the medical record to satisfy
some of the musculoskeletal disorders
listing criteria within a consecutive 4month period.
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 prePHE 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.
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 postPHE ‘‘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
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
29 Veterans Health Administration (2022, Dec. 5).
VHA COVID–19 Response Report, Annex C.
Veterans Health Administration, U.S. Department
of Veterans Affairs. https://www.va.gov/HEALTH/
docs/VHA-COVID-19-Response-2022-Annex-C.pdf.
30 Centers for Medicare & Medicaid Services
(2022, Dec.). Medicare Telehealth Trends Report.
Centers for Medicare & Medicaid Services, U.S.
Department of Health & Human Services. https://
data.cms.gov/sites/default/files/2022-12/a7c3a3195ded-4baf-ad7c-9aa2a897263a/MedicareTelehealth
TrendsSnapshot20221201.pdf.
31 Karimi, M., Lee, E., Couture, S., Gonzales, A.,
Grigorescu, V., Smith, S., De Lew, N., and Sommers,
B. (2022, Feb.). National Trends in Telehealth Use
in 2021: Disparities in Utilization and Audio vs.
Video Services. (Research Report No. HP–2022–04).
Office of the Assistant Secretary for Planning &
Evaluation, U. S. Department of Health & Human
Services. https://aspe.hhs.gov/sites/default/files/
documents/4e1853c0b4885112b2994680a58af9ed/
telehealth-hps-ib.pdf.
32 American Medical Association (2022). 2021
Telehealth Survey Report. American Medical
Association. https://www.ama-assn.org/system/
files/telehealth-survey-report.pdf.
33 Mazarakis, N. K., Koutsarnakis, C., Komaitis, S.,
Drosos, E., & Demetriades, A. K. (2022). Reflections
on the future of telemedicine and virtual spinal
clinics in the post COVID–19 era. Brain & spine, 2,
100930. https://doi.org/10.1016/j.bas.2022.100930;
Greven, A. C. M., McGinley, B. M., Guisse, N. F.,
McGee, L. J., Pirkle, S., Malcolm, J. G., Rodts, G. E.,
Refai, D., & Gary, M. F. (2021). Telemedicine in the
Evaluation and Management of Neurosurgical Spine
Patients: Questionnaire Assessment of 346
Consecutive Patients. Spine, 46(7), 472–477.
https://doi.org/10.1097/BRS.0000000000003821 ;
Kolcun, J. P. G., Ryu, W. H. A., & Traynelis, V. C.
(2020). Systematic review of telemedicine in spine
surgery. Journal of neurosurgery. Spine, 1–10.
Advance online publication. https://doi.org/
10.3171/2020.6.SPINE20863; Satin, A. M., Shenoy,
K., Sheha, E. D., Basques, B., Schroeder, G. D.,
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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
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
Vaccaro, A. R., Lieberman, I. H., Guyer, R. D., &
Derman, P. B. (2022). Spine Patient Satisfaction
With Telemedicine During the COVID–19
Pandemic: A Cross-Sectional Study. Global spine
journal, 12(5), 812–819. https://doi.org/10.1177/
2192568220965521.
34 Hurley, E. T., Haskel, J. D., Bloom, D. A.,
Gonzalez-Lomas, G., Jazrawi, L. M., Bosco, J. A., III,
& Campbell, K. A. (2021). The Use and Acceptance
of Telemedicine in Orthopedic Surgery During the
COVID–19 Pandemic. Telemedicine journal and ehealth: the official journal of the American
Telemedicine Association, 27(6), 657–662. https://
doi.org/10.1089/tmj.2020.0255.
35 Cascella, M., Miceli, L., Cutugno, F., Di
Lorenzo, G., Morabito, A., Oriente, A., Massazza, G.,
Magni, A., Marinangeli, F., Cuomo, A., & on behalf
of the Delphi Panel (2021). A Delphi Consensus
Approach for the Management of Chronic Pain
during and after the COVID–19 Era. International
journal of environmental research and public
health, 18(24), 13372. https://doi.org/10.3390/
ijerph182413372.
36 Mazarakis, N. K., Koutsarnakis, C., Komaitis, S.,
Drosos, E., & Demetriades, A. K. (2022). Reflections
on the future of telemedicine and virtual spinal
clinics in the post COVID–19 era. Brain & spine, 2,
100930. https://doi.org/10.1016/j.bas.2022.100930.
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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
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 4month ‘‘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
37 American College of Rheumatology (2023).
2023 ACR Health Policy Statements. American
College of Rheumatology. https://
assets.contentstack.io/v3/assets/
bltee37abb6b278ab2c/bltd84782969d741aba/acrhealth-policy-statements.pdf.
38 American Medical Association (2022). AMA
Future of Health Closing the Digital Health
Disconnect: A Blueprint for Optimizing Digitally
Enabled Care. American Medical Association.
https://www.ama-assn.org/system/files/ama-futurehealth-report.pdf. (Accessed March 22, 2023).
39 85 FR at 78169 n.38 (2020) (citing Veterans
Health Administration & Department of Defense.
(2001). VHA/DoD Clinical Practice Guideline for
the Management of Medically Unexplained
Symptoms: Chronic Pain and Fatigue. https://
www.healthquality.va.gov/guidelines/MR/mus/
mus_fulltext.pdf). See also 86 FR at 38922 (2021).
40 Id.
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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, patientcentered 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.
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
41 Veterans Health Administration & Department
of Defense (2021). VA/DoD Clinical Practice
Guideline for the Management of Chronic
Multisystem Illness, Version 3.0–2021. https://
www.healthquality.va.gov/guidelines/MR/cmi/
VADoDCMICPG508.pdf.
42 85 FR at 78169–70 (citing Veterans Health
Administration & Department of Defense. (2017).
VA/DoD Clinical Practice Guideline for Diagnosis
and Treatment of Low Back Pain. https://
www.healthquality.va.gov/guidelines/Pain/lbp/
VADoDLBPCPG092917.pdf.)
43 Veterans Health Administration & Department
of Defense (2022, Feb.). VA/DoD Clinical Practice
Guideline for Diagnosis and Treatment of Low Back
Pain (Version 3.0–2022). https://www.healthquality.
va.gov/guidelines/Pain/lbp/
VADoDLBPCPGFinal508.pdf.
44 87 FR 69404 at 69466.
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67085
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.
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
45 U.S. Department of Health & Human Services
(2023, Feb. 9). Fact Sheet: COVID–19 Public Health
Emergency Transition Roadmap. https://
www.hhs.gov/about/news/2023/02/09/fact-sheetcovid-19-public-health-emergency-transitionroadmap.html.
46 U.S. Department of Health & Human Services
(2023, May 9). Fact Sheet: End of the COVID–19
Public Health Emergency https://www.hhs.gov/
about/news/2023/05/09/fact-sheet-end-of-the-covid19-public-health-emergency.html.
47 Centers for Medicare & Medicaid Services
(2023, May 5). Frequently Asked Questions: CMS
Waivers, Flexibilities, and the End of the COVID–
19 Public Health Emergency. Centers for Medicare
& Medicaid Services, U.S. Department of Health &
Human Services. https://www.cms.gov/files/
document/frequently-asked-questions-cms-waiversflexibilities-and-end-covid-19-public-healthemergency.pdf; See also American Hospital
Association (2023, Feb. 7). Special Bulletin: Public
Health Emergency to End May 11. American
Hospital Association. https://www.aha.org/system/
files/media/file/2023/02/Special-Bulletin-PublicHealth-Emergency-to-End-May-11.pdf.
48 Office of the Assistant Secretary for Planning &
Evaluation (2022, August 19). Unwinding the
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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
Initial evidence also suggests that the
ongoing impacts of the COVID–19 PHE
and the increased use of telehealth may
also affect certain populations
Medicaid Continuous Enrollment Provision:
Projected Enrollment Effects and Policy Approaches
(Issue Brief HP–2022–20). Office of the Assistant
Secretary for Planning & Evaluation, U.S.
Department of Health & Human Services. Accessed
on March 3, 2023 at: https://aspe.hhs.gov/sites/
default/files/documents/404a7572048090
ec1259d216f3fd617e/aspe-end-mcaid-continuouscoverage_IB.pdf.
49 National Center for Health Statistics.
Percentage of being uninsured at the time of
interview for adults aged 18–64, United States, 2019
Q1, Jan-Mar—2022 Q3, Jul-Sep. National Health
Interview Survey. Generated interactively: Mar 06
2023 from https://wwwn.cdc.gov/
NHISDataQueryTool/ER_Quarterly/index_
quarterly.html.
50 Kaiser Family Foundation (2023, June 13).
Medicaid Enrollment and Unwinding Tracker.
Kaiser Family Foundation. https://www.kff.org/
medicaid/issue-brief/medicaid-enrollment-andunwinding-tracker/.
51 McGough, M., Krutika, A., & Cox, C., (2023, Jan.
24). How has healthcare utilization changed since
the pandemic? Peterson Center on HealthcareKaiser Family Foundation Health System Tracker.
https://www.healthsystemtracker.org/chartcollection/how-has-healthcare-utilization-changedsince-the-pandemic/.
52 Brenan, Megan (2023, Jan. 17). Record High in
U.S. Put Off Medical Care Due to Cost in 2022.
Gallup. https://news.gallup.com/poll/468053/
record-high-put-off-medical-care-due-cost2022.aspx.
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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 audioonly 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
53 Karimi, M., Lee, E., Couture, S., Gonzales, A.,
Grigorescu, V., Smith, S., De Lew, N., and Sommers,
B. (2022, Feb.). National Trends in Telehealth Use
in 2021: Disparities in Utilization and Audio vs.
Video Services. (Research Report No. HP–2022–04).
Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health and Human
Services. https://aspe.hhs.gov/sites/default/files/
documents/4e1853c0b4885112b2994680a58af9ed/
telehealth-hps-ib.pdf.
54 Bipartisan Policy Center, Ananya Health
Solutions LLC, and L&M Policy Research (2022,
Oct.). Medicare Telehealth Utilization and
Spending Impacts 2019–2021. Bipartisan Policy
Center. https://bipartisanpolicy.org/download/
?file=/wp-content/uploads/2022/09/BPC-MedicareTelehealth-Utilization-and-Spending-Impacts-20192021-October-2022.pdf.
55 Gurewich, D., Beilstein-Wedel, E., Shwartz, M.,
Davila, H., & Rosen, A.K. (2023). Disparities in Wait
Times for Care Among US Veterans by Race and
Ethnicity. JAMA network open, 6(1), e2252061.
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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 longterm 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
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
https://doi.org/10.1001/jamanetworkopen.
2022.52061.
56 Neri, A.J., Whitfield, G.P., Umeakunne, E.T.,
Hall, J.E., DeFrances, C.J., Shah, A.B., Sandhu, P.K.,
Demeke, H.B., Board, A.R., Iqbal, N.J., Martinez, K.,
Harris, A.M., & Strona, F.V. (2022). Telehealth and
Public Health Practice in the United States—Before,
During, and After the COVID–19 Pandemic. Journal
of public health management and practice: JPHMP,
28(6), 650–656. https://doi.org/10.1097/
PHH.0000000000001563.
57 U.S. Government Accountability Office (2022,
Sept. 26). Medicare Telehealth: Actions Needed to
Strengthen Oversight and Help Providers Educate
Patients on Privacy and Security Risks (GAO–22–
104454). Accessed March 3, 2023 at: https://
www.gao.gov/products/gao-22-104454.
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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 audioonly 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
Because healthcare provision has not
returned to pre-pandemic norms and
emerging evidence suggests that ongoing
changes may lead to decreased use of inperson 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
58 Bipartisan Policy Center & Ananya Health
Solutions LLC (2022, Oct.). The Future of
Telehealth After COVID–19. Bipartisan Policy
Center. https://bipartisanpolicy.org/download/
?file=/wp-content/uploads/2022/09/BPC-TheFuture-of-Telehealth-After-COVID-19-October2022.pdf.
59 The Medicare Payment Advisory Commission
(2022, Sept. 29). MedPAC Mandatory report: Study
on the Expansion of Telehealth. https://
www.medpac.gov/wp-content/uploads/2021/10/
Telehealth-MedPAC-29-Sept-2022.pdf.
60 Samson, L., Tarazi, W., Turrini, G., Sheingold,
S. (2021, Dec.). Medicare Beneficiaries’ Use of
Telehealth Services in 2020—Trends by Beneficiary
Characteristics and Location (Issue Brief No. HP–
2021–27). Office of the Assistant Secretary for
Planning and Evaluation, U.S. Department of
Health and Human Services. https://aspe.hhs.gov/
sites/default/files/documents/a1d5d810fe3433
e18b192be42dbf2351/medicare-telehealthreport.pdf.
61 The Consolidated Appropriations Act, 2023,
Public Law 117–328.
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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
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:
• The appropriate standard for ‘‘close
proximity of time’’ to account for
barriers to access to care or changes in
healthcare delivery;
• Information about barriers to access
to care, changes in healthcare delivery,
and disproportionate burdens faced by
any subset of the population; and
• The expiration date of this rule.
62 86
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FR 7009 (2021).
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67087
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 4month ‘‘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
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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for over two years, we would delay
adjudicating affected claims until the
effective date of this TFR.
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.
For good cause shown, to avoid
delaying benefits to vulnerable
individuals while providing appropriate
flexibility to account for COVID–19related 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
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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:
• Would more, but shorter, sections
be better?
• Are the requirements in the rule
clearly stated?
• Have we organized the material to
suit your needs?
• Could we improve clarity by adding
tables, lists, or diagrams?
• What else could we do to make the
rule easier to understand?
• Does the rule contain technical
language or jargon that is not clear?
• Would a different format make the
rule easier to understand, e.g., grouping
and order of sections, use of headings,
paragraphing?
65 42
U.S.C. 1382(a); 20 CFR 416.202.
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16:15 Sep 28, 2023
Jkt 259001
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 nonsignificant 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 CostSavings 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:
• 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.
• 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
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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
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).
2. In appendix 1 to subpart P of part
404:
■ a. In part A, amend section 1.00C7 by
revising paragraph a; and
■
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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
*
*
*
Russian Harmful Foreign Activities
Sanctions Regulations
*
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
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 587
Publication of Russian Harmful
Foreign Activities Sanctions
Regulations Web General Licenses
55A and 72
Office of Foreign Assets
Control, Treasury.
ACTION: Publication of web general
licenses.
AGENCY:
The Department of the
Treasury’s Office of Foreign Assets
Control (OFAC) is publishing two
general licenses (GLs) issued pursuant
to the Russian Harmful Foreign
Activities Sanctions Regulations: GLs
55A and 72, each of which was
previously made available on OFAC’s
website.
DATES: GLs 55A and 72 were issued on
September 14, 2023. See SUPPLEMENTARY
INFORMATION for additional relevant
dates.
FOR FURTHER INFORMATION CONTACT:
OFAC: Assistant Director for Licensing,
202–622–2480; Assistant Director for
Regulatory Affairs, 202–622–4855; or
Assistant Director for Compliance, 202–
622–2490.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
16:15 Sep 28, 2023
Background
On September 14, 2023, OFAC issued
GLs 55A and 72 to authorize certain
transactions otherwise prohibited by the
Russian Harmful Foreign Activities
Sanctions Regulations, 31 CFR part 587.
GL 55A has an expiration date of June
28, 2024. GL 72 has an expiration date
of December 13, 2023. Each GL was
made available on OFAC’s website
(https://ofac.treasury.gov) at the time of
publication. The text of these GLs is
provided below.
OFFICE OF FOREIGN ASSETS CONTROL
Musculoskeletal Disorders
*
Electronic Availability
This document and additional
information concerning OFAC are
available on OFAC’s website: https://
ofac.treasury.gov.
Jkt 259001
31 CFR Part 587
GENERAL LICENSE NO. 55A
Authorizing Certain Services Related to
Sakhalin-2
(a) Except as provided in paragraph (b) of
this general license, all transactions
prohibited by the determination of November
21, 2022 made pursuant to section 1(a)(ii) of
Executive Order 14071 (‘‘Prohibitions on
Certain Services as They Relate to the
Maritime Transport of Crude Oil of Russian
Federation Origin’’) related to the maritime
transport of crude oil originating from the
Sakhalin-2 project (‘‘Sakhalin-2 byproduct’’)
are authorized through 12:01 a.m. eastern
daylight time, June 28, 2024, provided that
the Sakhalin-2 byproduct is solely for
importation into Japan.
(b) This general license does not authorize
any transactions otherwise prohibited by the
Russian Harmful Foreign Activities Sanctions
Regulations, 31 CFR part 587 (RuHSR),
including transactions involving any person
blocked pursuant to the RuHSR, unless
separately authorized.
(c) Effective September 14, 2023, General
License No. 55, dated November 22, 2022, is
replaced and superseded in its entirety by
this General License No. 55A.
Bradley T. Smith,
Director, Office of Foreign Assets Control.
Dated: September 14, 2023.
OFFICE OF FOREIGN ASSETS CONTROL
one or more of the following blocked persons
(collectively, the ‘‘Blocked Entities’’) are
authorized through 12:01 a.m. eastern
standard time, December 13, 2023, provided
that any payment to a Blocked Entity is made
into a blocked account in accordance with
the Russian Harmful Foreign Activities
Sanctions Regulations, 31 CFR part 587
(RuHSR):
(1) Joint Stock Company Russian Copper
Company;
(2) Joint Stock Company United
Metallurgical Company;
(3) Transmashholding JSC;
(4) Joint Stock Company Avtovaz;
(5) Joint Stock Company Moscow
Automotive Factory Moskvich;
(6) Limited Liability Company Machine
Building Plant Tonar;
(7) Publichnoe Aktsionernoe Obschestvo
Sollers;
(8) Arctic Transshipment Limited Liability
Company; or
(9) Any entity in which one or more of the
above persons own, directly or indirectly,
individually or in the aggregate, a 50 percent
or greater interest.
(b) This general license does not authorize:
(1) Any transactions prohibited by
Directive 2 under E.O. 14024, Prohibitions
Related to Correspondent or PayableThrough Accounts and Processing of
Transactions Involving Certain Foreign
Financial Institutions;
(2) Any transactions prohibited by
Directive 4 under E.O. 14024, Prohibitions
Related to Transactions Involving the Central
Bank of the Russian Federation, the National
Wealth Fund of the Russian Federation, and
the Ministry of Finance of the Russian
Federation; or
(3) Any transactions otherwise prohibited
by the RuHSR, including transactions
involving any person blocked pursuant to the
RuHSR other than the Blocked Entities
described in paragraph (a) of this general
license, unless separately authorized.
Bradley T. Smith,
Director, Office of Foreign Assets Control.
Dated: September 14, 2023.
Bradley T. Smith,
Director, Office of Foreign Assets Control.
[FR Doc. 2023–21396 Filed 9–28–23; 8:45 am]
BILLING CODE 4810–AL–P
DEPARTMENT OF HOMELAND
SECURITY
Russian Harmful Foreign Activities
Sanctions Regulations
Coast Guard
31 CFR Part 587
33 CFR Part 165
GENERAL LICENSE NO. 72
[Docket Number USCG–2023–0721]
Authorizing the Wind Down of Transactions
Involving Certain Entities Blocked on
September 14, 2023
(a) Except as provided in paragraph (b) of
this general license, all transactions
prohibited by Executive Order (E.O.) 14024
that are ordinarily incident and necessary to
the wind down of any transaction involving
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RIN 1625–AA00
Safety Zone; Ohio River Mile Markers
79.5–80, Wellsburg, WV
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
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]]>Agencies
[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Rules and Regulations]
[Pages 67081-67089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21671]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: On July 23, 2021, we issued a temporary final rule (TFR) with
request for comments to lengthen the ``close proximity of time''
standard in the Listing of Impairments (the listings) for
musculoskeletal disorders because the COVID-19 national public health
emergency (PHE) caused many individuals to experience barriers that
prevented them from timely accessing in-person healthcare. That prior
TFR is effective until six months after the effective date of a
determination by the Secretary of Health and Human Services (HHS) that
a PHE resulting from the COVID-19 pandemic no longer exists. The
Secretary of HHS made that determination, and the COVID-19 national PHE
ended on May 11, 2023. However, healthcare practices in a post-PHE
world are still evolving. We are therefore issuing this new TFR to
extend the flexibility provided by the prior TFR until May 11, 2025, so
we can evaluate changes in healthcare practices and determine the
proper ``close proximity of time'' standard for the musculoskeletal
disorders listings.
DATES:
Effective date: This TFR is effective on October 30, 2023.
Comment date: We invite written comments. Comments must be
submitted no later than November 28, 2023.
Expiration date: Unless we extend the provisions of this TFR by a
final rule published in the Federal Register, it will cease to be
effective on May 11, 2025.
ADDRESSES: You may submit comments by any one of three methods--
internet, fax, or mail. Do not submit the same comment(s) multiple
times or by more than one method. Regardless of which method you
choose, please state that your comment(s) refer to Docket No. SSA-2023-
0023 so that we may associate your comment(s) with the correct
regulation.
Caution: You should be careful to include in your comment(s) only
information that you wish to make publicly available. We strongly urge
you not to include any personal information in your comment(s), such as
Social Security numbers or medical information.
1. Internet: We strongly recommend that you submit your comment(s)
via the internet. Please visit the Federal eRulemaking portal at
https://www.regulations.gov. Use the ``search'' function to find docket
number SSA-2023-0023. The system will issue a tracking number to
confirm your submission. You will not be able to view your comment(s)
immediately because we must post each comment manually. It may take up
to one week for your comment(s) to be viewable.
2. Fax: Fax comments to 1-833-410-1631.
3. Mail: Mail your comments to the Office of Legislation and
Congressional Affairs Regulations and Reports Clearance Staff, Mail
Stop 3253, Altmeyer, 6401 Security Blvd., Baltimore, MD 21235.
Comments are available for public viewing on the Federal
eRulemaking portal at https://www.regulations.gov or in person, during
regular business hours, by arranging with the contact person identified
below.
FOR FURTHER INFORMATION CONTACT: Michael J. Goldstein, Office of
Disability Policy, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235-6401, (410) 965-1020. For information on
eligibility or filing for benefits, call our national toll-free number,
1-800-772-1213 or TTY 1-800-325-0778, or visit our internet site,
Social Security Online, at https://www.ssa.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 3, 2020, we published the final rule, Revised Medical
Criteria for Evaluating Musculoskeletal Disorders (final rule),\1\
which became effective on April 2, 2021. This final rule revised the
criteria in the listings that we use to evaluate disability claims
involving musculoskeletal disorders in adults and children at the third
step of our sequential evaluation process under titles II and XVI of
the Social Security Act (Act).\2\ The final rule, among other things,
revised the listings in response to the decision in Radford v.
Colvin,\3\ which interpreted former listing 1.04A to require a
disability claimant to show only ``that each of the symptoms are
present, and that the claimant has suffered or can be expected to
suffer from [the condition] continuously for at least 12 months.'' \4\
Under the court's interpretation of the former listing, a claimant did
not need to show that each necessary criterion was present
simultaneously or in particularly close proximity, as required by our
interpretation of that listing.\5\ The final rule clarified that, for
the purposes of applying certain musculoskeletal disorders listings,\6\
all of the required medical criteria must be present simultaneously, or
within a close proximity of time, to satisfy the level of severity
needed for the impairment to meet the listing. The final rule further
defined the phrase ``within a close proximity of time'' to mean ``that
all of the relevant criteria must appear in the medical record within a
consecutive 4-month period'' (emphasis in original).\7\ We also
provided that ``[w]hen the criterion is imaging, we mean that we
[[Page 67082]]
could reasonably expect the findings on imaging to have been present at
the date of impairment or date of onset.'' \8\
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\1\ 85 FR 78164 (2020).
\2\ For adults, the listings describe, for each of the major
body systems, impairments that we consider to be severe enough to
prevent an individual from doing any gainful activity regardless of
his or her age, education, or work experience. 20 CFR 404.1525(a)
and 416.925(a). For children, the listings describe impairments we
consider severe enough to cause marked and severe functional
limitations. 20 CFR 416.925(a). We use the listings at step 3 of the
sequential evaluation process to identify claims in which the
individual is clearly disabled under our rules. 20 CFR 404.1520,
416.920, and 416.924). We do not deny a claim when a person's
medical impairment(s) does not satisfy the criteria of a listing.
Instead, we continue the sequential evaluation process. 20 CFR
404.1520(a)(4) and 416.920(a)(4).
\3\ Radford v. Colvin, 734 F.3d 288 (4th Cir. 2013).
\4\ Id. at 294.
\5\ See Acquiescence Ruling 15-1(4). We rescinded that
Acquiescence Ruling after we revised the listings in 2020. 85 FR
79063 (2020).
\6\ Listings 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22, 1.23,
101.15, 101.16, 101.17, 101.18, 101.20C, 101.20D, 101.22, and
101.23.
\7\ See 85 FR 78164 (2020) (revising 20 CFR part 404, subpart P,
Appendix 1, 1.00C7c and 101.00C7c).
\8\ Id.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\9\ See 85 FR at 78169-78170.
\10\ 83 FR 20646 (2018).
\11\ Id. at 20647.
\12\ 85 FR at 78169 n.37 (citing Bavafa, H., Savin, S., &
Terwiesch, C. (2019). Redesigning Primary Care Delivery: Customized
Office Revisit Intervals and E-Visits. https://dx.doi.org/10.2139/ssrn.2363685. Paper referenced by Bavafa: Schectman, G., G. Barnas,
P. Laud, L. Cantwell, M. Horton, E.J. Zarling. 2005. Prolonging the
return visit interval in primary care. The American Journal of
Medicine, 118(4) 393-399).
\13\ 85 FR at 78169 n.34 (citing Gore, M., Sadosky, A., Stacey,
B.R., Tai, K.S., & Leslie, D. (2012). The burden of chronic low back
pain: Clinical comorbidities, treatment patterns, and health care
costs in usual care settings. Spine, 37(11), E668- E677. https://doi.org/10.1097/BRS.0b013e318241e5de).
\14\ 85 FR at 78169 n.35 (citing BMUS: The Burden of
Musculoskeletal Diseases in the United States. In: BMUS: The Burden
of Musculoskeletal Diseases in the United States [internet]. [cited
15 July 2020]. https://www.boneandjointburden.org/fourth-edition/viiic2/utilization-condition-group).
\15\ See 85 FR at 78169 n.36 (citing J Gen Intern Med. 1999 Apr;
14(4): 230-235. doi: 10.1046/j.1525-1497.1999.00322.x Lisa M
Schwartz, MD, MS, Steven Woloshin, MD, MS, John H Wasson, MD, Roger
A Renfrew, MD, and H Gilbert Welch, MD, MPH, Dartmouth Primary Care
Cooperative Research Network).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\16\ Determination That A Public Health Emergency Exists by Alex
M. Azar II, Secretary of Health & Human Services (Jan. 31. 2020)
(https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx).
\17\ Centers for Medicare & Medicaid Services (CMS)
Recommendations: Re-opening Facilities to Provide Non-emergent Non-
COVID-19 Healthcare (https://www.cms.gov/files/document/covid-recommendations-reopening-facilities-provide-non-emergent-care.pdf);
see also Non-Emergent, Elective Medical Services, and Treatment
Recommendations (https://www.cms.gov/files/document/cms-non-emergent-elective-medical-recommendations.pdf).
---------------------------------------------------------------------------
In July 2021, we published a TFR entitled Flexibility in Evaluating
``Close Proximity of Time'' Due to COVID-19 Related Barriers to
Healthcare \18\ (prior TFR), which recognized the changes in healthcare
provision and consumption described above. In the prior TFR, we
acknowledged that the response to the COVID-19 pandemic dramatically
changed the provision of, and access to, healthcare services throughout
the country, and we cited evidence showing that significant numbers of
people had foregone or delayed care, or replaced in-person medical
visits with telehealth visits.\19\ Therefore, we concluded that
individuals with musculoskeletal impairments who, before the pandemic,
would have sought and received healthcare at a frequency consistent
with the standards in our final rule, now might be unable or choose not
to seek care for their condition in the same manner and frequency.
Affected individuals whose impairments might have previously met the
listings requirements may now fail to meet the ``close proximity of
time'' standard because of the changes in the provision of healthcare
resulting from COVID-19. We therefore extended the timeframe for an
individual's record to demonstrate the necessary listing criteria
throughout the pandemic period.
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\18\ 86 FR 38920 (2021).
\19\ Id.
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The prior TFR defined the ``pandemic period'' for the purposes of
our regulations and provided that during the pandemic period, the
phrase ``within a close proximity of time'' meant that all of the
relevant criteria must appear in the medical record within a
consecutive 12-month period.'' \20\ The prior TFR defined the
``pandemic period'' as beginning on April 2, 2021 and ending 6 months
after the Secretary of HHS determined that the COVID-19 national PHE no
longer existed. We extended the ``pandemic period'' for 6 months after
the end of the COVID-19 national PHE to allow time for healthcare
access to normalize and return to pre-pandemic period levels as well as
to account for potential backlogs in medical care that may continue to
interfere with access to the relevant care and documentation needed to
satisfy the listing criteria. We also indicated that we would study the
application of the TFR on our programs.\21\
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\20\ 86 FR at 38925.
\21\ 86 FR at 38924.
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Public Comment on the Prior TFR
When we published the prior TFR in the Federal Register, we
provided the public with a 60-day comment period, which ended on
September 21, 2021. We specifically contemplated extending the prior
TFR, and we invited comments on all aspects of the rule, including the
definition of ``pandemic period'' and the expiration date. We received
one comment from the National Organization of Social Security
Claimants' Representatives (NOSSCR) \22\ that encouraged us to make
permanent the temporary 12-month standard. The commenter also
recommended, if we chose not to make the 12-month standard permanent,
that we extend the period covered by the prior TFR to one year after
the end of the PHE. They argued that access to care issues exist
regardless of the pandemic and that it would take longer than 6 months
for healthcare delivery to normalize after the end of the PHE.
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\22\ See Comment from National Organization of Social Security
Claimants' Representatives on Document SSA-2021-0010-0001, https://www.regulations.gov/comment/SSA-2021-0010-0002.
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With this temporary rule, we are partially adopting this comment.
Although we provided support for the consecutive 4-month period in our
2020
[[Page 67083]]
final rule, we agree with NOSSCR that some of the changes in healthcare
caused by the COVID-19 pandemic may last longer than 6 months after the
end of the PHE and that some changes may become permanent, including
the increased use of telehealth, the nature of which limits
documentation of clinical findings needed for certain listings.
However, as discussed in the Rationale for this Rule section below, the
healthcare data that was captured during the PHE has limitations both
in data collection and in the ability to make ultimate conclusions
about post-PHE healthcare delivery, particularly in light of policy
changes affecting healthcare that will occur throughout calendar years
2023 and 2024.\23\ Therefore, we are extending the flexibility provided
in the prior TFR by extending the definition of ``pandemic period''
through May 11, 2025, so we can continue to review emerging evidence
about post-PHE healthcare access and use. At the conclusion of that
period, we expect to be able to determine whether we should extend the
TFR again, make the flexibility in the TFR permanent, as the commenter
recommended, propose a different standard for ``close proximity of
time,'' or let the TFR expire, so that we would revert to the 4-month
rule on ``close proximity of time'' in our 2020 final rule. The
commenter also raised issues regarding general barriers to accessing
care that disability benefit applicants may be disproportionally likely
to experience. These comments are outside the scope of this very
limited TFR, so we are not addressing them here. We will address these
comments in a future venue. We also note that although the commenter
provided significant discussion of the wait times for imaging,
including citing research about these wait times, they appear to have
mischaracterized the ``close proximity of time'' requirement for
imaging. The listings specify at 1.00C7c and 101.00C7c that ``[w]hen
the criterion is imaging, we mean that we could reasonably expect the
findings on imaging to have been present at the date of impairment or
date of onset.'' \24\ Therefore, in listings that have an imaging
criterion, we do not require the imaging to have been taken within a
close proximity of time to the other required elements, as long as we
can reasonably expect the findings on imaging to have been present
within a close proximity of time to the other required elements.
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\23\ See, e.g., Neri, A. J., Whitfield, G. P., Umeakunne, E. T.,
Hall, J. E., DeFrances, C. J., Shah, A. B., Sandhu, P. K., Demeke,
H. B., Board, A. R., Iqbal, N. J., Martinez, K., Harris, A. M., &
Strona, F. V. (2022). Telehealth and Public Health Practice in the
United States-Before, During, and After the COVID-19 Pandemic.
Journal of public health management and practice: JPHMP, 28(6), 650-
656. https://doi.org/10.1097/PHH.0000000000001563.
\24\ 20 CFR part 404, subpart P, Appendix 1, 1.00C7c and
101.00C7c.
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Rationale for This Rule
We are extending the flexibility provided by the prior TFR through
May 11, 2025 to allow for additional time to study changes in
healthcare access and provision, and to account for the ongoing
increased use of telehealth services following the COVID-19 PHE. We
will evaluate these evolving practices and their effects to determine
the appropriate ``close proximity of time'' standard to include in the
musculoskeletal disorders listings going forward.
We published the prior TFR to provide a more flexible 12-month
``close proximity of time'' standard in the musculoskeletal disorders
listings to account for changes in the provision of and access to
healthcare during the COVID-19 PHE. Although the PHE has now ended,\25\
the state of healthcare has not fully returned to pre-pandemic norms
and the impact of ending the PHE and related flexibilities will not be
fully understood for some time. For example, and as discussed in more
detail below, studies and reports from multiple government agencies as
well as professional medical associations document an ongoing
prevalence of telehealth service methodologies at higher levels than
seen pre-PHE. In addition, several PHE-related policy flexibilities
aimed at increasing healthcare access through telehealth have been
extended through 2023 or 2024. At the same time, Medicaid and the
Children's Health Insurance Program's (CHIP) continuous coverage
protections, which had required states to maintain ongoing eligibility
for Medicaid and CHIP for individuals who were enrolled on or after
March 18, 2020, ended on March 31, 2023, leaving states until May 31,
2024, to complete eligibility redeterminations,\26\ potentially leading
to an increase in uninsured individuals. These factors suggest that
U.S. healthcare will be in a state of rapid change in the period
immediately following the PHE, so we will need to study the changes in
healthcare provision before defining the appropriate ``close proximity
of time'' interval going forward.
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\25\ Becarra, X. (2023, May 11). Statement on End of the COVID-
19 Public Health Emergency. Department of Health and Human Services.
https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-becerra-statement-on-end-of-the-covid-19-public-health-emergency.html.
\26\ Tsai, D. (2023, Jan 5). CMS Informational Bulletin: Key
Dates Related to the Medicaid Continuous Enrollment Condition
Provisions in the Consolidated Appropriations Act, 2023. Centers for
Medicare & Medicaid Services, U.S. Department of Health & Human
Services. https://www.medicaid.gov/federal-policy-guidance/downloads/cib010523.pdf.
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As we discussed in the prior TFR, after the initial sharp drop in
total healthcare capacity due to PHE-related closures and disruptions
of care, policy flexibilities around telehealth provision and
reimbursement allowed for the use of telehealth to increase
substantially from pre-pandemic norms, partially offsetting the decline
in in-person care, particularly for management of chronic conditions
and for established patients.\27\ Although telehealth visits can
provide the information that clinicians need to care for patients,
audio-only telehealth appointments do not provide clinical signs and
findings, and video telehealth musculoskeletal examinations have
inherent limitations, including in provocative testing (that is,
testing that manipulates the areas where an individual has pain in
order to reproduce the pain), discrete palpation (that is, a technique
that uses targeted pressure to identify and quantify the abnormalities
of the musculoskeletal system, such as warmth, swelling, pain,
tenderness, and trigger points), strength or stability testing, and
precise measurements, such as range of motion or reflexes.\28\
Therefore, use of telehealth in place of in-person visits may make it
more difficult for some
[[Page 67084]]
claimants to provide the necessary findings in the medical record to
satisfy some of the musculoskeletal disorders listing criteria within a
consecutive 4-month period.
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\27\ See, e.g., Samson, L., Tarazi, W., Turrini, G., Sheingold,
S. (2021, Dec.). Medicare Beneficiaries' Use of Telehealth Services
in 2020--Trends by Beneficiary Characteristics and Location (Issue
Brief No. HP-2021-27). Office of the Assistant Secretary for
Planning & Evaluation, U.S. Department of Health & Human Services.
https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf ;
Centers for Medicare & Medicaid Services (2022, Dec.). Medicare
Telehealth Trends Report. Centers for Medicare & Medicaid Services,
U.S. Department of Health & Human Services. https://data.cms.gov/sites/default/files/2022-12/a7c3a319-5ded-4baf-ad7c-9aa2a897263a/MedicareTelehealthTrendsSnapshot20221201.pdf; Patel, S. Y.,
Mehrotra, A., Huskamp, H. A., Uscher-Pines, L., Ganguli, I., &
Barnett, M. L. (2021). Trends in Outpatient Care Delivery and
Telemedicine During the COVID-19 Pandemic in the US. JAMA internal
medicine, 181(3), 388-391. https://doi.org/10.1001/jamainternmed.2020.5928; Cortez, C., Mansour, O., Qato, D. M.,
Stafford, R. S., & Alexander, G. C. (2021). Changes in Short-term,
Long-term, and Preventive Care Delivery in US Office-Based and
Telemedicine Visits During the COVID-19 Pandemic. JAMA health forum,
2(7), e211529. https://doi.org/10.1001/jamahealthforum.2021.1529.
\28\ 86 FR 38920 (2021) (citing Tanaka et al. (2020).
Telemedicine in the Era of COVID-19: The Virtual Orthopaedic
Examination. The Journal of bone and joint surgery. American volume,
102(12), e57. https://dx.doi.org/10.2106/JBJS.20.00609).
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Trends suggest telehealth usage will continue into the foreseeable
future. Since the prior TFR was published, the use of telehealth as a
percentage of total use has remained stable, with total healthcare
visits and in-person visits trending higher than in 2020, but with an
increased use of telehealth compared to pre-PHE norms. For example, the
Veterans' Health Administration's (VHA) update to Congress covering the
period from August 2021 to March 2022 showed that total visits had
surpassed pre-PHE 2019 visits during this period, but in-person visits
remained below pre-PHE totals, with both video and audio telehealth
visits showing steady use over the period. VHA concluded that the data
marked ``positive progress for resumption of services with continued
use of telehealth encounters.'' \29\ Similarly, Medicare data showed
telehealth use leveling off between 16 and 19 percent of eligible users
in all quarters beginning in the second quarter of 2021 and through the
second quarter of 2022, which is significantly higher than the 7
percent of eligible users who used telehealth services in the first
quarter of 2020.\30\ An HHS summary of national survey trends from the
Census Bureau's April to October 2021 Household Pulse Survey found that
23.1 percent of respondents reported use of telehealth in the previous
four weeks, with the data showing a leveling off around the 20 percent
mark in July 2021.\31\ The results of these studies suggest that the
changes in healthcare delivery related to the PHE have continued, and
we may not know the long-term effects of those changes before the prior
TFR expires. Consequently, we are extending the expiration date of the
TFR so we can continue to analyze evolving changes and new norms in
healthcare delivery, including the use of telehealth, and devise the
appropriate definition of ``close proximity of time'' for the
musculoskeletal disorders listings. We will also continue to study
other related factors such as those raised by the commenter.
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\29\ Veterans Health Administration (2022, Dec. 5). VHA COVID-19
Response Report, Annex C. Veterans Health Administration, U.S.
Department of Veterans Affairs. https://www.va.gov/HEALTH/docs/VHA-COVID-19-Response-2022-Annex-C.pdf.
\30\ Centers for Medicare & Medicaid Services (2022, Dec.).
Medicare Telehealth Trends Report. Centers for Medicare & Medicaid
Services, U.S. Department of Health & Human Services. https://data.cms.gov/sites/default/files/2022-12/a7c3a319-5ded-4baf-ad7c-9aa2a897263a/MedicareTelehealthTrendsSnapshot20221201.pdf.
\31\ Karimi, M., Lee, E., Couture, S., Gonzales, A., Grigorescu,
V., Smith, S., De Lew, N., and Sommers, B. (2022, Feb.). National
Trends in Telehealth Use in 2021: Disparities in Utilization and
Audio vs. Video Services. (Research Report No. HP-2022-04). Office
of the Assistant Secretary for Planning & Evaluation, U. S.
Department of Health & Human Services. https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf.
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Extending the TFR will further allow us to review and adapt to new
clinical guidelines evolving in a post-PHE landscape. Although the
research is still developing and most professional organizations have
yet to update their clinical practice guidelines for a post-PHE ``new
normal,'' the emerging research and data suggest that patients and
providers generally appreciate the increased use of telehealth, and
such increased use is expected to continue post-PHE. This increased use
appears true for both audio-only and video telehealth modalities and
includes specialties, such as orthopedic surgery and spine surgery,
that previously used telehealth only sparingly. For example, an
American Medical Association (AMA) survey of 2,232 physicians released
in 2022 revealed that 85 percent of responding physicians continued to
use telehealth, that nearly 70 percent of respondents reported their
organization was motivated to continue using telehealth in their
practice, that physicians felt telehealth increased timely access to
care, and that physicians anticipated providing telehealth services for
chronic disease management and ongoing medical management, care
coordination, mental/behavioral health, and specialty care after the
pandemic.\32\
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\32\ American Medical Association (2022). 2021 Telehealth Survey
Report. American Medical Association. https://www.ama-assn.org/system/files/telehealth-survey-report.pdf.
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Similarly, studies specific to the field of spine medicine
generally found that practitioners and patients expected to continue
using telehealth and that the majority of patients and providers only
felt a need for in-person visits for the initial encounter and, if
applicable, the pre-operative visit.\33\ Studies of orthopedic medicine
showed similar results, with a large study of orthopedic surgeons
reporting that physician use of telehealth has increased significantly
as a result of the COVID-19 pandemic (from 21 percent using telehealth
prior to the pandemic to 85 percent using it during the pandemic), and
the majority of surgeons were satisfied with its use in their practice
and planned on incorporating telehealth in their practices beyond the
pandemic, particularly for follow-up or postoperative patients.\34\ In
the realm of chronic pain, a Delphi consensus article about management
of chronic pain concluded that telemedicine and remote monitoring
improves management of chronic pain and that the remote management of
chronic diseases can improve access to care, but that at least the
first assessment should be performed in person.\35\
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\33\ Mazarakis, N. K., Koutsarnakis, C., Komaitis, S., Drosos,
E., & Demetriades, A. K. (2022). Reflections on the future of
telemedicine and virtual spinal clinics in the post COVID-19 era.
Brain & spine, 2, 100930. https://doi.org/10.1016/j.bas.2022.100930;
Greven, A. C. M., McGinley, B. M., Guisse, N. F., McGee, L. J.,
Pirkle, S., Malcolm, J. G., Rodts, G. E., Refai, D., & Gary, M. F.
(2021). Telemedicine in the Evaluation and Management of
Neurosurgical Spine Patients: Questionnaire Assessment of 346
Consecutive Patients. Spine, 46(7), 472-477. https://doi.org/10.1097/BRS.0000000000003821 ; Kolcun, J. P. G., Ryu, W. H. A., &
Traynelis, V. C. (2020). Systematic review of telemedicine in spine
surgery. Journal of neurosurgery. Spine, 1-10. Advance online
publication. https://doi.org/10.3171/2020.6.SPINE20863; Satin, A.
M., Shenoy, K., Sheha, E. D., Basques, B., Schroeder, G. D.,
Vaccaro, A. R., Lieberman, I. H., Guyer, R. D., & Derman, P. B.
(2022). Spine Patient Satisfaction With Telemedicine During the
COVID-19 Pandemic: A Cross-Sectional Study. Global spine journal,
12(5), 812-819. https://doi.org/10.1177/2192568220965521.
\34\ Hurley, E. T., Haskel, J. D., Bloom, D. A., Gonzalez-Lomas,
G., Jazrawi, L. M., Bosco, J. A., III, & Campbell, K. A. (2021). The
Use and Acceptance of Telemedicine in Orthopedic Surgery During the
COVID-19 Pandemic. Telemedicine journal and e-health: the official
journal of the American Telemedicine Association, 27(6), 657-662.
https://doi.org/10.1089/tmj.2020.0255.
\35\ Cascella, M., Miceli, L., Cutugno, F., Di Lorenzo, G.,
Morabito, A., Oriente, A., Massazza, G., Magni, A., Marinangeli, F.,
Cuomo, A., & on behalf of the Delphi Panel (2021). A Delphi
Consensus Approach for the Management of Chronic Pain during and
after the COVID-19 Era. International journal of environmental
research and public health, 18(24), 13372. https://doi.org/10.3390/ijerph182413372.
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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. https://doi.org/10.1016/j.bas.2022.100930.
\37\ American College of Rheumatology (2023). 2023 ACR Health
Policy Statements. American College of Rheumatology. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltd84782969d741aba/acr-health-policy-statements.pdf.
\38\ American Medical Association (2022). AMA Future of Health
Closing the Digital Health Disconnect: A Blueprint for Optimizing
Digitally Enabled Care. American Medical Association. https://www.ama-assn.org/system/files/ama-future-health-report.pdf.
(Accessed March 22, 2023).
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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. https://www.healthquality.va.gov/guidelines/MR/mus/mus_fulltext.pdf). See
also 86 FR at 38922 (2021).
\40\ Id.
\41\ Veterans Health Administration & Department of Defense
(2021). VA/DoD Clinical Practice Guideline for the Management of
Chronic Multisystem Illness, Version 3.0-2021. https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG508.pdf.
\42\ 85 FR at 78169-70 (citing Veterans Health Administration &
Department of Defense. (2017). VA/DoD Clinical Practice Guideline
for Diagnosis and Treatment of Low Back Pain. https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPG092917.pdf.)
\43\ Veterans Health Administration & Department of Defense
(2022, Feb.). VA/DoD Clinical Practice Guideline for Diagnosis and
Treatment of Low Back Pain (Version 3.0-2022). https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPGFinal508.pdf.
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In addition to the extension of telehealth flexibilities, other
policy changes related to the end of the PHE may impact healthcare use
and create a period of rapid changes in healthcare. Some national
telehealth flexibilities have been extended until the end of calendar
year 2023 (for example, payment parity for audio and video telehealth
visits, which allows providers to be reimbursed for telehealth visits
originated at the patient's home at the same rate and using the same
``place of service'' code as they would be if provided in-person).\44\
Other flexibilities have been extended through December 31, 2024 (for
example, Medicare coverage of audio-only and of video telehealth
services no matter where in the United States a patient lives, rather
than covering telehealth services for beneficiaries living in rural
areas only, and with the ability to access telehealth services from
their home, rather than going to a health care facility).\45\
Conversely, certain other flexibilities, such as flexibilities related
to telehealth platforms and the continuous enrollment provision for
Medicaid, began winding down at the end of the PHE.\46\ Extra federal
payments to hospitals during the PHE, including a 20 percent increase
in the Medicare payment rate for inpatient treatment of patients
diagnosed with COVID-19 and the ability to charge ``facility fees'' for
telehealth services to patients who are not located at the hospital,
were also phased out at the end of the PHE,\47\ putting additional
financial strain on the medical system.
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\44\ 87 FR 69404 at 69466.
\45\ U.S. Department of Health & Human Services (2023, Feb. 9).
Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap.
https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html.
\46\ U.S. Department of Health & Human Services (2023, May 9).
Fact Sheet: End of the COVID-19 Public Health Emergency https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html.
\47\ Centers for Medicare & Medicaid Services (2023, May 5).
Frequently Asked Questions: CMS Waivers, Flexibilities, and the End
of the COVID-19 Public Health Emergency. Centers for Medicare &
Medicaid Services, U.S. Department of Health & Human Services.
https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf;
See also American Hospital Association (2023, Feb. 7). Special
Bulletin: Public Health Emergency to End May 11. American Hospital
Association. https://www.aha.org/system/files/media/file/2023/02/Special-Bulletin-Public-Health-Emergency-to-End-May-11.pdf.
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In particular, the expected substantial rise in the uninsured
population after the PHE-related Medicaid and CHIP continuous
enrollment provision ends will exacerbate access to care challenges
during this transitional time, making it more difficult to predict
revisit intervals and use of healthcare, particularly for people facing
barriers to healthcare.
An HHS issue brief published in 2022 projected that 17.4 percent of
Medicaid and CHIP enrollees (approximately 15 million individuals) will
leave the programs after the continuous enrollment provisions end based
on historical patterns of coverage loss, including 7.9 percent (6.8
million) of Medicaid enrollees losing Medicaid coverage despite still
being eligible (sometimes referred to as ``administrative churning'').
HHS predicted there would be a disproportionate impact on historically
underserved populations, although they noted they were taking steps to
reduce that outcome.\48\ Information from the
[[Page 67086]]
Centers for Disease Control and Prevention (CDC) already shows an
uptick in the uninsured population beginning in late 2022, with the
uninsured population increasing to 12.6 percent of adults in the United
States in the third quarter of 2022 from a low of 11.8 percent in the
first quarter of 2022.\49\ Initial data on the end of Medicaid's
continuous enrollment provision from 20 states provided by the Kaiser
Family Foundation demonstrated that over 1 million people had already
been disenrolled from Medicaid, with many disenrolled for procedural
reasons, as of June 12, 2023.\50\ Data analyzed by the Kaiser Family
Foundation found that the uninsured population was the only population
that had delayed or foregone care due to cost more than due to the
pandemic, suggesting that gaps in access to care will remain high for a
growing uninsured population even as pandemic-related concerns are
expected to decrease.\51\ Additionally, a Gallup poll released in
January 2023 noted that a record high 38 percent of Americans reported
putting off medical treatment due to cost, up 12 percentage points from
2021, and that lower-income adults, younger adults, and women were more
likely than their counterparts to say they or a family member have
delayed care for a serious medical condition.\52\
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\48\ Office of the Assistant Secretary for Planning & Evaluation
(2022, August 19). Unwinding the Medicaid Continuous Enrollment
Provision: Projected Enrollment Effects and Policy Approaches (Issue
Brief HP-2022-20). Office of the Assistant Secretary for Planning &
Evaluation, U.S. Department of Health & Human Services. Accessed on
March 3, 2023 at: https://aspe.hhs.gov/sites/default/files/documents/404a7572048090ec1259d216f3fd617e/aspe-end-mcaid-continuous-coverage_IB.pdf.
\49\ National Center for Health Statistics. Percentage of being
uninsured at the time of interview for adults aged 18-64, United
States, 2019 Q1, Jan-Mar--2022 Q3, Jul-Sep. National Health
Interview Survey. Generated interactively: Mar 06 2023 from https://wwwn.cdc.gov/NHISDataQueryTool/ER_Quarterly/index_quarterly.html.
\50\ Kaiser Family Foundation (2023, June 13). Medicaid
Enrollment and Unwinding Tracker. Kaiser Family Foundation. https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/.
\51\ McGough, M., Krutika, A., & Cox, C., (2023, Jan. 24). How
has healthcare utilization changed since the pandemic? Peterson
Center on Healthcare-Kaiser Family Foundation Health System Tracker.
https://www.healthsystemtracker.org/chart-collection/how-has-healthcare-utilization-changed-since-the-pandemic/.
\52\ Brenan, Megan (2023, Jan. 17). Record High in U.S. Put Off
Medical Care Due to Cost in 2022. Gallup. https://news.gallup.com/poll/468053/record-high-put-off-medical-care-due-cost-2022.aspx.
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Initial evidence also suggests that the ongoing impacts of the
COVID-19 PHE and the increased use of telehealth may also affect
certain populations differently. For example, the HHS' summary of
national survey trends from the Census Bureau's April to October 2021
Household Pulse Survey found that the highest rates of telehealth
visits were among those with Medicaid (29.3%) and Medicare (27.4%),
Black individuals (26.8%), and those earning less than $25,000 (26.7%).
The report found disparities in use of telehealth services, including
the use of video versus audio modalities, along dimensions including
race and ethnicity, age, education, income, and health insurance.\53\
Similarly, an October 2022 report on telehealth use in Medicare from
2019 to 2021, issued by the Bipartisan Policy Center, found that,
although the distribution of beneficiaries using telehealth by race and
ethnicity was roughly proportionate to the distribution of the overall
study population by race and ethnicity, there was variation in the
telehealth visit rates for those who used telehealth across racial and
ethnic groups. They noted that telehealth visit rates for American
Indian/Alaska Native (AI/AN), Black/African American (AA), and Hispanic
beneficiaries exceeded the overall telehealth rates, with AI/AN
beneficiaries having the highest audio-only visit rates, and that non-
Hispanic/White beneficiary telehealth visit rates were lower than the
overall telehealth visit rates by 2 percent, on average, across the
study period.\54\ Further, a cross-sectional study of over a million
veterans published in the Journal of the American Medical Association
(JAMA) in January 2023 found that wait time disparities increased
significantly from the pre-COVID-19 period (October 1, 2018 to March
10, 2020) to the COVID-19 period (March 11, 2020 to September 30, 2021)
for Black and Hispanic veterans, and that disparities in mean wait
times for orthopedic services were statistically significant both
before and after the COVID-19 period.\55\
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\53\ Karimi, M., Lee, E., Couture, S., Gonzales, A., Grigorescu,
V., Smith, S., De Lew, N., and Sommers, B. (2022, Feb.). National
Trends in Telehealth Use in 2021: Disparities in Utilization and
Audio vs. Video Services. (Research Report No. HP-2022-04). Office
of the Assistant Secretary for Planning and Evaluation, U.S.
Department of Health and Human Services. https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf.
\54\ Bipartisan Policy Center, Ananya Health Solutions LLC, and
L&M Policy Research (2022, Oct.). Medicare Telehealth Utilization
and Spending Impacts 2019-2021. Bipartisan Policy Center. https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-Medicare-Telehealth-Utilization-and-Spending-Impacts-2019-2021-October-2022.pdf.
\55\ Gurewich, D., Beilstein-Wedel, E., Shwartz, M., Davila, H.,
& Rosen, A.K. (2023). Disparities in Wait Times for Care Among US
Veterans by Race and Ethnicity. JAMA network open, 6(1), e2252061.
https://doi.org/10.1001/jamanetworkopen.2022.52061.
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In sum, the emerging data suggests that an increased use of
telehealth will likely replace some in-person visits for some people
with musculoskeletal disorders even after the end of the PHE and that
other policy and healthcare changes could impact access to care during
the period immediately following the end of the PHE, possibly leading
to extended revisit intervals between thorough examinations. However,
evidence on expanded telehealth use and its expected long-term effect
on healthcare quality and the use of in-person examinations is limited,
partially by data challenges, although the research base is expected to
grow during the period immediately following the end of the PHE. For
example, a report published by CDC experts in 2022 stated that ``one of
the central public health issues in the U.S. identified by CDC was the
absence of telehealth identifiers in many datasets, including most of
CDC's national surveillance datasets.'' The report authors stated that
the CDC was working to improve access to data related to healthcare and
telehealth.\56\ To this end, Medicare provided for additional use of
telehealth identifiers in its 2023 fee schedule, including identifiers
for audio-only telehealth.\57\
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\56\ Neri, A.J., Whitfield, G.P., Umeakunne, E.T., Hall, J.E.,
DeFrances, C.J., Shah, A.B., Sandhu, P.K., Demeke, H.B., Board,
A.R., Iqbal, N.J., Martinez, K., Harris, A.M., & Strona, F.V.
(2022). Telehealth and Public Health Practice in the United States--
Before, During, and After the COVID-19 Pandemic. Journal of public
health management and practice: JPHMP, 28(6), 650-656. https://doi.org/10.1097/PHH.0000000000001563.
\57\ U.S. Government Accountability Office (2022, Sept. 26).
Medicare Telehealth: Actions Needed to Strengthen Oversight and Help
Providers Educate Patients on Privacy and Security Risks (GAO-22-
104454). Accessed March 3, 2023 at: https://www.gao.gov/products/gao-22-104454.
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There are also inherent limitations in relying on healthcare use
data gathered during the PHE to determine post-PHE outcomes. For
example, in an October 2022 report, the Bipartisan Policy Center
concluded that studies of telehealth use during the PHE would not
provide enough information to understand the impact of permanently
expanded telehealth use on healthcare utilization, quality, equity,
cost, and other factors due to confounding pandemic-related changes in
healthcare needs, and they urged further study of telehealth during the
period following the end of the PHE. The report recommended a two-year
extension of telehealth flexibilities after the end of the PHE and
indicated that researchers should evaluate the benefits of hybrid (in-
person and virtual) care models for
[[Page 67087]]
primary and specialty care, including for which conditions and
specialties it is most effective; further evaluate full telehealth
flexibilities in the context of value-based payment models; and
rigorously assess the quality of audio-only care.\58\ Similarly, in
September 2022, the Medicare Payment Advisory Commission (MedPAC), an
independent congressional agency that advises Congress on Medicare
payment policy, recommended using a one- to two-year period of extended
flexibilities after the PHE to allow policymakers to gather more
evidence about the impact of telehealth on access, quality, and cost,
which could inform permanent changes to telehealth policies.\59\ Along
these lines, a 2021 Medicare telehealth report concluded that more
research is needed on the impact of telehealth on health outcomes,
stating that ``if telehealth flexibilities are temporarily extended
post-pandemic . . . this would allow evaluations of whether telehealth
use during non-pandemic times may increase overall healthcare
utilization as suggested by some studies, or simply substitute for in-
person services.'' \60\ Recognizing the need for more data on
telehealth use, Congress required HHS to report on Medicare telehealth
use during the period immediately following the end of the PHE, with
the interim report due in October 2024.\61\
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\58\ Bipartisan Policy Center & Ananya Health Solutions LLC
(2022, Oct.). The Future of Telehealth After COVID-19. Bipartisan
Policy Center. https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2022/09/BPC-The-Future-of-Telehealth-After-COVID-19-October-2022.pdf.
\59\ The Medicare Payment Advisory Commission (2022, Sept. 29).
MedPAC Mandatory report: Study on the Expansion of Telehealth.
https://www.medpac.gov/wp-content/uploads/2021/10/Telehealth-MedPAC-29-Sept-2022.pdf.
\60\ Samson, L., Tarazi, W., Turrini, G., Sheingold, S. (2021,
Dec.). Medicare Beneficiaries' Use of Telehealth Services in 2020--
Trends by Beneficiary Characteristics and Location (Issue Brief No.
HP-2021-27). Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health and Human Services. https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf.
\61\ The Consolidated Appropriations Act, 2023, Public Law 117-
328.
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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:
The appropriate standard for ``close proximity of time''
to account for barriers to access to care or changes in healthcare
delivery;
Information about barriers to access to care, changes in
healthcare delivery, and disproportionate burdens faced by any subset
of the population; and
The expiration date of this rule.
Please share any supporting information that you might have. We
will consider any substantive comments we receive within 60 days of the
publication of this 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:
Would more, but shorter, sections be better?
Are the requirements in the rule clearly stated?
Have we organized the material to suit your needs?
Could we improve clarity by adding tables, lists, or
diagrams?
What else could we do to make the rule easier to
understand?
Does the rule contain technical language or jargon that is
not clear?
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:
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.
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
