5582 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

1 85 FR 78164 (2020). 

2For 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 

§ 1.98 Adjustment of civil monetary 

penalty amounts. 

This section makes inflation 

adjustments in the dollar amounts of 

civil monetary penalties provided by 

law within the Commission’s 

jurisdiction. The following maximum 

civil penalty amounts apply only to 

penalties assessed after January 17, 

2025, including those penalties whose 

associated violation predated January 

17, 2025. 

(a) Section 7A(g)(1) of the Clayton 

Act, 15 U.S.C. 18a(g)(1)—$53,088; 

(b) Section 11(l) of the Clayton Act, 15 

U.S.C. 21(l)—$28,205; 

(c) Section 5(l) of the FTC Act, 15 

U.S.C. 45(l)—$53,088; 

(d) Section 5(m)(1)(A) of the FTC Act, 

15 U.S.C. 45(m)(1)(A)—$53,088; 

(e) Section 5(m)(1)(B) of the FTC Act, 

15 U.S.C. 45(m)(1)(B)—$53,088; 

(f) Section 10 of the FTC Act, 15 

U.S.C. 50—$698; 

(g) Section 5 of the Webb-Pomerene 

(Export Trade) Act, 15 U.S.C. 65—$698; 

(h) Section 6(b) of the Wool Products 

Labeling Act, 15 U.S.C. 68d(b)—$698; 

(i) Section 3(e) of the Fur Products 

Labeling Act, 15 U.S.C. 69a(e)—$698; 

(j) Section 8(d)(2) of the Fur Products 

Labeling Act, 15 U.S.C. 69f(d)(2)—$698; 

(k) Section 333(a) of the Energy Policy 

and Conservation Act, 42 U.S.C. 

6303(a)—$575; 

(l) Sections 525(a) and (b) of the 

Energy Policy and Conservation Act, 42 

U.S.C. 6395(a) and (b), respectively— 

$28,205 and $53,088, respectively; 

(m) Section 621(a)(2) of the Fair 

Credit Reporting Act, 15 U.S.C. 

1681s(a)(2)—$4,983; 

(n) Section 1115(a) of the Medicare 

Prescription Drug Improvement and 

Modernization Act of 2003, Public Law 

108–173, as amended by Public Law 

115–263, 21 U.S.C. 355 note—$18,768; 

(o) Section 814(a) of the Energy 

Independence and Security Act of 2007, 

42 U.S.C. 17304—$1,510,803; and 

(p) Civil monetary penalties 

authorized by reference to the Federal 

Trade Commission Act under any other 

provision of law within the jurisdiction 

of the Commission—refer to the 

amounts set forth in paragraphs (c), (d), 

(e) and (f) of this section, as applicable. 

By direction of the Commission. 

April J. Tabor, 

Secretary. 

[FR Doc. 2025–01361 Filed 1–16–25; 8:45 am] 

BILLING CODE 6750–01–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Parts 404 and 416 

[Docket No. SSA–2024–0056] 

RIN 0960–AI93 

Further Extension of the Flexibility in 

Evaluating ‘‘Close Proximity of Time’’ 

To Evaluate Ongoing Changes in 

Healthcare 

AGENCY: Social Security Administration. 

ACTION: Temporary final rule with 

request for comments. 

SUMMARY: We are extending the 

flexibility in the ‘‘close proximity of 

time’’ standard, as defined in two prior 

temporary final rules (TFR), through 

May 11, 2029. We issued a TFR 

providing the ‘‘close proximity of time’’ 

flexibility on July 23, 2021, because the 

COVID–19 national public health 

emergency (PHE) caused many 

individuals to experience barriers that 

prevented them from timely accessing 

in-person healthcare. On September 29, 

2023, we extended the flexibility to 

evaluate evolving healthcare practices 

and consumption in a post-PHE 

environment. We determined that we 

need additional time to fully evaluate 

still-evolving healthcare practices after 

the PHE. We are therefore issuing this 

TFR to extend the ‘‘close proximity of 

time’’ flexibility until May 11, 2029, so 

we can continue to evaluate changes in 

healthcare practices and determine the 

proper ‘‘close proximity of time’’ 

standard for the musculoskeletal 

disorders listings. 

DATES: 

Effective date: This TFR is effective 

on February 18, 2025. 

Comment date: We invite written 

comments. Comments must be 

submitted no later than March 18, 2025. 

Expiration date: Unless we extend the 

provisions of this TFR by a final rule 

published in the Federal Register, it 

will cease to be effective on May 11, 

2029. 

ADDRESSES: You may submit comments 

by any one of three methods—internet, 

fax, or mail. Do not submit the same 

comment(s) multiple times or by more 

than one method. Regardless of which 

method you choose, please state that 

your comment(s) refer to Docket No. 

SSA–2024–0056 so that we may 

associate your comment(s) with the 

correct rule. 

Caution: You should be careful to 

include in your comment(s) only 

information that you wish to make 

publicly available. We strongly urge you 

not to include any personal information 

in your comment(s), such as Social 

Security numbers or medical 

information. 

1. Internet: We strongly recommend 

that you submit your comment(s) via the 

internet. Please visit the Federal 

eRulemaking portal at https://

www.regulations.gov. Use the ‘‘search’’ 

function to find docket number SSA– 

2024–0056. The system will issue a 

tracking number to confirm your 

submission. You will not be able to 

view your comment(s) immediately 

because we must post each comment 

manually. It may take up to one week 

for your comment(s) to be viewable. 

2. Fax: Fax comments to 1–833–410– 

1631. 

3. Mail: Mail your comments to the 

Office of Legislation and Congressional 

Affairs Regulations and Reports 

Clearance Staff, Mail Stop 3253, 

Altmeyer, 6401 Security Blvd., 

Baltimore, MD 21235–6401. 

Comments are available for public 

viewing on the Federal eRulemaking 

portal at 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/. 

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 


KHAMMOND on DSK9W7S144PROD with RULES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 5583 

the sequential evaluation process. 20 CFR 

404.1520(a)(4) and 416.920(a)(4). 

3Radford v. Colvin, 734 F.3d 288 (4th Cir. 2013). 

4 Id. at 294. 

5See Acquiescence Ruling 15–1(4). We rescinded 

that Acquiescence Ruling after we revised the 

listings in 2020. 85 FR 79063 (2020). 

6Listings 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. 

7See 85 FR 78164 (2020) (revising 20 CFR part 

404, subpart P, Appendix 1, 1.00C7c and 

101.00C7c). 

8 Id. 

9See 85 FR at 78169–78170. 

10 83 FR 20646 (2018). 

11 Id. at 20647. 

12See, e.g., comment from Community Legal 

Services of Philadelphia on Document SSA–2006– 

0112–0010, https://www.regulations.gov/comment/ 

SSA-2006-0112-0046. 

13 85 FR at 78169 n.37 (citing Bavafa, H., Savin, 

S., & Terwiesch, C. (2019). Redesigning Primary 

Care Delivery: Customized Office Revisit Intervals 

and E-Visits. 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). 

14 85 FR at 78169 n.34 (citing Gore, M., Sadosky, 

A., Stacey, B.R., Tai, K.S., & Leslie, D. (2012). The 

burden of chronic low back pain: Clinical 

comorbidities, treatment patterns, and health care 

costs in usual care settings. Spine, 37(11), E668– 

E677. https://doi.org/10.1097/BRS.

0b013e318241e5de). 

15 85 FR at 78169 n.35 (citing BMUS: The Burden 

of Musculoskeletal Diseases in the United States. In: 

BMUS: The Burden of Musculoskeletal Diseases in 

the United States [internet]. [cited 15 July 2020]. 

https://www.boneandjointburden.org/fourthedition/viiic2/utilization-condition-group). 

16See 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). 

17 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). 

18Centers 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). 

19 86 FR 38920 (2021). 

20 Id. 

21 86 FR at 38925. 

things, revised the listings in response 

to the decision in Radford v. Colvin,3

which interpreted former listing 1.04A 

to require a disability claimant to show 

only ‘‘that each of the symptoms are 

present, and that the claimant has 

suffered or can be expected to suffer 

from [the condition] continuously for at 

least 12 months.’’ 4 Under the court’s 

interpretation of the former listing, a 

claimant did not need to show that each 

necessary criterion was present 

simultaneously or in particularly close 

proximity, as required by our 

interpretation of that listing.5 The final 

rule clarified that, for the purposes of 

applying certain musculoskeletal 

disorders listings,6 all of the required 

medical criteria must be present 

simultaneously, or within a close 

proximity of time, to satisfy the level of 

severity needed for the impairment to 

meet the listing. The final rule further 

defined the phrase ‘‘within a close 

proximity of time’’ to mean ‘‘that all of 

the relevant criteria must appear in the 

medical record within a consecutive 4- 

month period’’ (emphasis in original).7

We also provided that ‘‘[w]hen the 

criterion is imaging, we mean that we 

could reasonably expect the findings on 

imaging to have been present at the date 

of impairment or date of onset.’’ 8

We established the consecutive 4- 

month period as a criterion to meet the 

level of severity in some of the 

musculoskeletal disorders listings based 

on our research of then relevant medical 

literature and clinical guidelines.9

When we proposed this requirement as 

part of a notice of proposed rulemaking 

(NPRM),10 we specifically asked 

interested members of the public to 

comment on this issue and provide us 

with any studies and data that 

supported their comments for a different 

standard.11 In response, a number of 

commenters raised concerns regarding 

barriers to accessing medical providers 

or documenting medical listing 

criterion.12 However, none of the 

commenters submitted studies or data. 

In the final rule, we concluded that the 

consecutive 4-month period was 

consistent with the timeframe medical 

providers were generally trained to use 

for scheduling their patients,13 the 

general standard of care,14 and the 

frequency of healthcare visits by 

individuals with musculoskeletal 

conditions.15 At the same time, the 

consecutive 4-month period provided 

some leeway for claimants, because the 

standard for patient revisits was once 

every 3 months.16

Onset of COVID–19 

In 2020, the COVID–19 virus began to 

spread throughout the country, 

prompting the Secretary of Health and 

Human Services (HHS) to declare a 

national PHE on January 31, 2020.17

With the outbreak of COVID–19, access 

to and the provision of healthcare 

changed significantly. Throughout the 

PHE, individuals across the country— 

including those with musculoskeletal 

disorders—altered their frequency and 

manner of seeking access to healthcare. 

This was due in part to healthcare 

organizations and government agencies 

such as the Centers for Medicare & 

Medicaid Services (CMS) 18 prioritizing 

the most urgent services and 

encouraging patients to delay other 

procedures during the PHE. Likewise, 

many individuals delayed or deferred 

important treatments due to closures of 

medical offices, fears of contracting 

COVID–19 infection (including fear of 

exposing high-risk individuals living in 

their household to infection), and other 

challenges created or exacerbated by the 

pandemic, such as difficulty accessing 

transportation. 

In July 2021, we published a TFR 

entitled Flexibility in Evaluating ‘‘Close 

Proximity of Time’’ Due to COVID–19 

Related Barriers to Healthcare 19 (2021 

TFR). We acknowledged at that time 

that the response to the COVID–19 

pandemic dramatically changed the 

provision of, and access to, healthcare 

services throughout the country, and we 

cited evidence showing that significant 

numbers of people had foregone or 

delayed care, or replaced in-person 

medical visits with telehealth visits.20

Therefore, we concluded that 

individuals with musculoskeletal 

impairments who, before the pandemic, 

would have sought and received 

healthcare at a frequency consistent 

with the standards in our final rule, 

might have become unable to seek, or 

might have chosen not to seek, care for 

their condition in the same manner and 

frequency. Affected individuals whose 

impairments might have previously met 

the applicable listing requirements 

might have subsequently failed to meet 

the ‘‘close proximity of time’’ standard 

because of the changes in the provision 

of healthcare resulting from COVID–19. 

We therefore extended the timeframe for 

an individual’s record to demonstrate 

the necessary listing criteria throughout 

the pandemic period. 

The 2021 TFR defined the ‘‘pandemic 

period’’ for the purposes of our 

regulations and provided that during the 

‘‘pandemic period,’’ the phrase ‘‘within 

a close proximity of time’’ meant that all 

of the relevant criteria must appear in 

the medical record within a consecutive 

12-month period.’’ 21 We further defined 

the ‘‘pandemic period’’ as beginning on 

April 2, 2021 and ending 6 months after 

the Secretary of HHS determined that 

the COVID–19 national PHE no longer 

existed. We extended the ‘‘pandemic 

period’’ for 6 months after the end of the 

COVID–19 national PHE to allow time 

for healthcare access and provision to 

normalize and return to pre-pandemic 

period levels as well as to account for 

potential backlogs in medical care that 

may have continued to interfere with 


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5584 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

22 86 FR at 38924. 

23See Comment from National Organization of 

Social Security Claimants’ Representatives on 

Document SSA–2021–0010–0001, https://

www.regulations.gov/comment/SSA-2021-0010- 

0002. 

24Becarra, 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. 

25 88 FR 67081 (2023). 

26 88 FR 67082. 

27See Comment from The Connected Health 

Initiative on Document SSA–2023–0023–0002, 

https://www.regulations.gov/comment/SSA-2023- 

0023-0002. 

28Centers for Medicare & Medicaid Services 

(2024, July). Medicare Telehealth Trends Report. 

Centers for Medicare and Medicaid Services, U.S. 

Department of Health & Human Services (HHS). 

.https://data.cms.gov/sites/default/files/2024-09/ 

c213a5e9-9e70-4b46-b5f1-2fb941ea0f6c/

Medicare%20Telehealth%20Trends%20Snapshot

%2020240827_508.pdf. 

access to the relevant care and 

documentation needed to satisfy the 

listing criteria. We also indicated that 

we would study the application of 

‘‘close proximity of time’’ flexibility on 

our programs.22

When we published the 2021 TFR in 

the Federal Register, we provided the 

public with a 60-day comment period, 

which ended on September 21, 2021. 

We specifically contemplated the 

possibility of extending the flexibility 

and we invited comments on all aspects 

of the rule, including the definition of 

‘‘pandemic period’’ and the expiration 

date. We received one comment from 

the National Organization of Social 

Security Claimants’ Representatives 

(NOSSCR) 23 that encouraged us to make 

the temporary 12-month standard 

permanent. The commenter also 

recommended, if we chose not to make 

the 12-month standard permanent, that 

we extend the period to one year after 

the end of the PHE. They argued that 

access to care issues exist regardless of 

the pandemic and that it would take 

longer than 6 months for healthcare 

delivery to normalize after the end of 

the PHE. 

Issuance of the 2023 TFR Extending the 

12-Month Standard 

The 2021 TFR was effective until six 

months after the effective date of a 

determination by the Secretary of HHS 

that a PHE resulting from the COVID– 

19 pandemic ended. The Secretary of 

HHS made that determination on May 

11, 2023.24 Consequently, the 2021 TFR 

was set to expire in November 2023. 

On September 29, 2023, we extended 

the ‘‘close proximity of time’’ flexibility 

through May 11, 2025.25 We explained 

at the time that we intended the 

extension to allow for time to study 

changes in healthcare access and 

provision, and to account for the 

ongoing increased use of telehealth 

services following the PHE. We further 

explained that we would continue to 

evaluate these evolving practices and 

their effects to determine the 

appropriate ‘‘close proximity of time’’ 

standard to include in the 

musculoskeletal disorders listings going 

forward.26

In issuing the extension, we also 

discussed the public comment we 

received from NOSSCR about the 2021 

TFR, encouraging us to make the 12- 

month standard permanent or extend it 

to apply for one year after the end of the 

PHE. We explained that by May 2025, 

we expected to determine whether we 

should extend the TFR again, make the 

flexibility in the TFR permanent, as the 

commenter recommended, propose a 

different standard, or let the TFR expire 

and revert to the 4-month ‘‘close 

proximity of time’’ standard. 

Additionally, we noted that while the 

commenter raised issues regarding 

general barriers to accessing care that 

disability benefit applicants may be 

disproportionally likely to experience, 

we considered the comment outside the 

scope of the second TFR and committed 

to addressing these comments in a 

future venue. 

Public Comment on the 2023 TFR 

When we extended the flexibility 

again in 2023, we received one 

comment, from The Connected Health 

Initiative. The commenter was 

supportive of us extending the 

flexibility provided in the TFR and our 

commitment to continuing to study the 

appropriate time period for ‘‘close 

proximity of findings,’’ noting that ‘‘data 

indicates that, going forward, telehealth 

will likely replace some in-person visits 

for some people with musculoskeletal 

disorders post-PHE, which could lead to 

extended revisit intervals between 

thorough examinations.’’ 27 We 

appreciate this commenter’s feedback 

and, consistent with the comment, 

intend to continue studying these 

impacts. 

Rationale for This Rule 

We are extending the ‘‘close 

proximity of time’’ flexibility through 

May 11, 2029, to allow for additional 

time to study changes in healthcare 

access and provision, and to account for 

the ongoing increased use of telehealth 

services following the PHE. We will 

evaluate these evolving practices and 

their effects to determine the 

appropriate time standard to include in 

the musculoskeletal disorders listings 

going forward. 

The PHE caused changes in 

healthcare provision and access, which 

led to a decrease in health care use and 

a shift from in-person healthcare to 

telehealth (phone or video). In response, 

we published the 2021 TFR, which 

temporarily amended the introductory 

text of the musculoskeletal disorders 

listings to define the ‘‘close proximity of 

time’’ standard as presence of the 

required findings in the record within a 

consecutive 12-month period. This 

flexibility was limited to the ‘‘pandemic 

period,’’ originally defined as the period 

beginning April 2, 2021, until 6 months 

after the end of the COVID–19 national 

PHE, November 11, 2023. Due to the 

ongoing increased use of telehealth 

services following the PHE and the 

many changes to healthcare rules and 

legislation that were set to be phased 

out over a two-year period, we 

concluded that healthcare would be in 

a state of rapid change in the period 

immediately following the PHE, so we 

would need to study the changes in 

healthcare provision before defining the 

appropriate ‘‘close proximity of time’’ 

interval going forward. We thus 

published an extension of the flexibility 

provided in the TFR by redefining the 

‘‘pandemic period’’ to end on May 11, 

2025, two years after the end of the PHE. 

After studying the available data 

regarding the changes in healthcare 

immediately following the PHE, we 

have concluded that a further extension 

is necessary because healthcare access 

and provision remains different from 

what it was prior to the PHE and we are 

continuing to evaluate whether the 4- 

month period is supported. There is still 

uncertainty and change in the medical 

and legal framework regarding 

telehealth, and the limited data 

available about telehealth use 

immediately after the PHE shows 

ongoing increased telehealth use 

compared to the period prior to the 

PHE. For example, Medicare data shows 

that telehealth usage across all medical 

specialties increased significantly 

during the pandemic, and while 

telehealth usage gradually declined 

from its peak, it has not returned to prepandemic levels.28

Telehealth examinations may provide 

continuity of care, but they generally 

cannot provide all the medical findings 

required under the musculoskeletal 

disorders listings. Additionally, 

anecdotal evidence from after the PHE 

suggests that healthcare costs and 

workforce shortages, which were 

exacerbated by the pandemic, have led 


KHAMMOND on DSK9W7S144PROD with RULES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 5585 

29See, e.g., Blumenthal, D., Gumas, E., & Shah, 

A. (2024). The Failing U.S. Health System. The New 

England journal of medicine, 391(17), 1566–1568. 

https://doi.org/10.1056/NEJMp2410855, and 

GlobalData Plc. (2024, March) The Complexities of 

Physician Supply and Demand: Projections From 

2021 to 2036. AAMC; https://www.aamc.org/media/ 

75236/download?attachment. 30HHS (2023, May 10). HHS Fact Sheet: 

Telehealth Flexibilities and Resources and the 

COVID–19 Public Health Emergency. HHS https:// 

www.hhs.gov/about/news/2023/05/10/hhs-factsheet-telehealth-flexibilities-resources-covid-19- 

public-health-emergency.html; see also American 

Physical Therapy Association (2023, May) Three 

Years of Physical Therapy in a Public Health 

Emergency: the Impact of the COVID–19 Pandemic 

on the Physical Therapy Profession. APTA and The 

American Relief Act of 2025, Public Law 118–158. 

BILLS–118hr10545eh.pdf. https://www.apta.org/ 

contentassets/143242e710e147cfa30c0405f5c8ef64/ 

apta_covid19_report2023.pdf. 

31Cottrill, A. & Cubanski, J. & Neuman, T., (2024, 

October 2). What to Know about Medicare Coverage 

of Telehealth. The Kaiser Family Foundation. 

https://www.kff.org/medicare/issue-brief/what-toknow-about-medicare-coverage-of-telehealth/. 

32Shaver J. (2022). The State of Telehealth Before 

and After the COVID–19 Pandemic. Primary care, 

49(4), 517–530. https://doi.org/10.1016/j.pop.

2022.04.002. 

33Bartelt, K., Piff, A., Allen, S., & Barkley, E. 

(2023, November 21). Telehealth Utilization Higher 

Than Pre-Pandemic Levels, but Down from 

Pandemic Highs. Epic Research. https://

epicresearch.org/articles/telehealth-utilizationhigher-than-pre-pandemic-levels-but-down-frompandemic-highs. Accessed on November 27, 2024. 

34Lee, A.C., Deutsch, J.E., Holdsworth, L., 

Kaplan, S.L., Kosakowski, H., Latz, R., McNeary, 

L.L., O’Neil, J., Ronzio, O., Sanders, K., SigmundGaines, M., Wiley, M., & Russell, T. (2024). 

Telerehabilitation in Physical Therapist Practice: A 

Clinical Practice Guideline From the American 

Physical Therapy Association. Physical therapy, 

104(5), pzae045. https://doi.org/10.1093/ptj/ 

pzae045. 

35Standaert, Christopher, M.D. COVID 

Disruptions and their Impact on Musculoskeletal 

Care. Presentation to the Standing Committee of the 

National Academies of Science and Medicine 

Health and Medicine Division, on June 20, 2024. 

36Ferguson, J.M., Wray, C.M., Van Campen, J., & 

Zulman, D.M. (2024). A New Equilibrium for 

Telemedicine: Prevalence of In-Person, VideoBased, and Telephone-Based Care in the Veterans 

Health Administration, 2019–2023. Annals of 

internal medicine, 177(2), 262–264. https://doi.org/ 

10.7326/M23-2644; see also Centers for Medicare & 

Medicaid Services (2022, December). Medicare 

Telehealth Trends Report. Centers for Medicare & 

Medicaid Services, HHS. https://data.cms.gov/sites/ 

default/files/2022-12/a7c3a319-5ded-4baf-ad7c9aa2a897263a/MedicareTelehealthTrends

Snapshot20221201.pdf. 

37Ferguson, J.M., Wray, C.M., Van Campen, J., & 

Zulman, D.M. (2024). A New Equilibrium for 

Telemedicine: Prevalence of In-Person, VideoBased, and Telephone-Based Care in the Veterans 

Health Administration, 2019–2023. Annals of 

internal medicine, 177(2), 262–264. https://doi.org/ 

10.7326/M23-2644. 

38Centers for Medicare & Medicaid Services 

(2024, November). Medicare Telehealth Trends 

Report. Centers for Medicare & Medicaid Services, 

HHS https://data.cms.gov/sites/default/files/2024- 

12/f5b35fbf-002a-425d-924d-f99aa362a63f/ 

Medicare%20Telehealth%20Trends%20Snapshot

%2020241127_508.pdf; see also Centers for 

Medicare & Medicaid Services (2024, May). 

Medicare Telehealth Trends Report. Centers for 

Medicare & Medicaid Services, HHS https://

data.cms.gov/sites/default/files/2024-05/ 

Medicare%20Telehealth%20Trends%20Snapshot

%2020240528_508.pdf. 

39Standaert, Christopher, M.D. COVID 

Disruptions and their Impact on Musculoskeletal 

Care. Presentation to the Standing Committee of the 

National Academies of Science and Medicine 

Health and Medicine Division, on June 20, 2024; 

see also Escorpizo, Reuben, P.T., M.Sc., D.P.T. 

Musculoskeletal Health, and Telehealth—Rapid 

Overview. Presentation to the Standing Committee 

Continued 

to deferment of care and long wait times 

to see providers. These issues are 

projected to get worse over the next 

decade,29 which could result in further 

delays in accessing in-person 

examinations, which provide the 

evidence we need to evaluate 

musculoskeletal disorders. We need 

further data to establish a permanent 

definition for ‘‘close proximity of time.’’ 

Available research and data on postPHE healthcare provides an uncertain 

picture of the long-term impact of the 

COVID–19 pandemic. Although the PHE 

ended on May 11, 2023, several 

flexibilities provided during the PHE to 

increase telehealth access have been 

extended through March 31, 2025 (e.g., 

Medicare coverage of audio-only 

telehealth, telehealth originating at a 

patient’s home, and 

telerehabilitation).30 Additionally, 

Congress is considering permanent 

changes to provide additional 

flexibilities for telehealth.31 In addition 

to the evolving nature of telehealth, 

there are also significant delays in care 

provision due to healthcare workforce 

shortages and access issues that have 

persisted and, in many cases, worsened 

after the PHE. 

Although the research is still 

developing and most professional 

organizations still have yet to update 

their clinical practice guidelines for 

post-pandemic healthcare, the emerging 

research and data suggest that the 

increased use of telehealth (including in 

place of some in-person visits) is 

generally appreciated by patients and 

providers and expected to continue for 

some time, but at a lower level than at 

the height of the pandemic.32 This 

appears true for both audio-only and 

audio-visual telehealth modalities, and 

for specialties that previously only 

sparingly used telehealth, such as 

orthopedic surgery, spine surgery, and 

rehabilitation.33 In the field of 

rehabilitation, the American Physical 

Therapy Association recently published 

clinical practice guidelines supporting 

telerehabilitation as a mode of 

delivering physical therapist services to 

patients who would benefit from 

services and whose barriers can be 

accommodated. At the same time, they 

noted that additional telerehabilitation 

research is needed for all ages, digital 

health applications, physical therapist 

measures, and interventions.34

Nevertheless, there is a yearslong 

research lag that limits availability of 

post-PHE data, making it difficult to 

fully quantify the post-PHE utilization 

of telehealth and in-person care in 

practice.35

The initial data from CMS and the 

Department of Veterans Affairs (VA) 

appears to show that rates of telehealth 

use for the first few months after the end 

of the PHE remained steady and 

generally consistent with utilization 

rates in late 2021 and 2022.36 VA data 

showed an overall increase in the 

proportion of telehealth visits from 20 

percent prior to the pandemic to about 

35 percent leading up to and for the first 

few months after the end of the PHE. 

Researchers analyzing the VA data 

through August 2023 indicated that 

telehealth rates stabilized around May 

2021 and that ‘‘although primary care 

and subspecialty telemedicine is often 

limited by the need for in-person 

evaluations (for example, physical 

examinations), about 10% of in-person 

primary and subspecialty care has 

converted to telemedicine.’’ 37

Additionally, Medicare data trends 

through the second quarter of 2024 

showed rates of telehealth stabilizing 

between 12 and 15 percent of Medicare 

users in 2022 through June 2024, 

compared to 7 percent of users prior to 

the pandemic. They also showed 

differences in telehealth use by race, 

ethnicity, age, disability status, and dual 

enrollment status with Medicaid. The 

data shows that Medicare users who 

were disabled or who were dually 

eligible for Medicare and Medicaid 

tended to use telehealth more both 

during and after the PHE.38

Anecdotal evidence supports that 

telehealth is still being used at higher 

rates than prior to the pandemic, but 

that additional research is needed to 

describe the role of telehealth in 

healthcare after the PHE. At their 

presentation to the National Academies 

of Science, Engineering, and Medicine 

(NASEM) Standing Committee of 

Medical and Vocational Experts for the 

Social Security Administration’s 

Disability Programs, two experts in 

musculoskeletal care affirmed that 

although telehealth is more common 

now than prior to the pandemic and 

provides benefits for those who use it, 

there is no currently available data that 

provides a picture of telehealth use 

following the PHE. They concluded that 

there is not an industry standard for 

telehealth utilization at this time, with 

more research, consensus, and 

standardization needed in the field.39


KHAMMOND on DSK9W7S144PROD with RULES
5586 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

of the National Academies of Science and Medicine 

Health and Medicine Division, on June 20, 2024. 40Connolly, S.L., Sherman, S.E., Dardashti, N., 

Duran, E., Bosworth, H.B., Charness, M.E., Newton, 

T.J., Reddy, A., Wong, E.S., Zullig, L.L., & Gutierrez, 

J. (2024). Defining and Improving Outcomes 

Measurement for Virtual Care: Report from the VHA 

State-of-the-Art Conference on Virtual Care. Journal 

of general internal medicine, 39(Suppl 1), 29–35. 

https://doi.org/10.1007/s11606-023-08464-1. 

41Tanaka, M.J., Oh, L.S., Martin, S.D., & Berkson, 

E.M. (2020). Telemedicine in the Era of COVID–19: 

The Virtual Orthopaedic Examination. The Journal 

of Bone and Joint Surgery, American volume, 

102(12), e57. http://dx.doi.org/10.2106/

JBJS.20.00609. 

42Laskowski, E.R., Johnson, S.E., Shelerud, R.A., 

Lee, J.A., Rabatin, A.E., Driscoll, S.W., Moore, B.J., 

Wainberg, M.C., & Terzic, C.M. (2020). The 

Telemedicine Musculoskeletal Examination. Mayo 

Clinic Proc. 95(8). doi: https://doi.org/10.1016/ 

j.mayocp.2020.05.026. 

43Baus, Shanna, PA–C. Telehealth & Disability 

Items: Veterans Health Administration. Presentation 

to the Standing Committee of the National 

Academies of Science and Medicine Health and 

Medicine Division, on December 1, 2020; see also 

Cannedy, S., Leung, L., Wyte-Lake, T., Balut, M.D., 

Dobalian, A., Heyworth, L., Paige, N.M., & DerMartirosian, C. (2023). Primary Care Team 

Perspectives on the Suitability of Telehealth 

Modality (Phone vs Video) at the Veterans Health 

Administration. Journal of primary care & 

community health, 14, 21501319231172897. 

https://doi.org/10.1177/21501319231172897. 

44Leyendecker, J., Prasse, T., Bieler, E., Yap, N., 

Eysel, P., Bredow, J., Hofstetter, C.P., & Members of 

the Endoscopic Spine Research Group (ESRG) 

(2024). Smartphone applications for remote patient 

monitoring reduces clinic utilization after fullendoscopic spine surgery. Journal of telemedicine 

and telecare, 1357633X241229466. Advance online 

publication. https://doi.org/10.1177/13576

33X241229466.; see also Murhekar, S., Relwani, S., 

Lau, S., & Virani, S. (2024). Evaluation of the 

Effectiveness of Virtual Telephone Consultations 

Against Traditional Face-to-Face Consultations in 

Spine Surgery Using an Objective Metric. Cureus, 

16(9), e69433. https://doi.org/10.7759/cureus.

69433. 

45 Gammel, J., Rivas, G., Horn, R., Munford, J., 

Reid, K., & Harstock, L. (2024, September 4). A 

survey of telehealth and its role in orthopaedic 

trauma during and after COVID–19. Journal of 

Public Health (Berl.) https://doi.org/10.1007/ 

s10389-024-02347-3. 

46Tolbert, J., & Corallo, B. (2024, September 18). 

An examination of Medicaid Renewal Outcomes 

and enrollment changes at the end of the 

Unwinding. The Kaiser Family Foundation. https:// 

www.kff.org/medicaid/issue-brief/an-examinationof-medicaid-renewal-outcomes-and-enrollmentchanges-at-the-end-of-the-unwinding/; See also 

Minicozzi, A., & Masi, S. (2024, June 18). CBO 

Publishes New Projections Related to Health 

Insurance for 2024 to 2034, CBO. https://

www.cbo.gov/publication/60383. 

47Tolbert, J., & Corallo, B. (2024, September 18). 

An examination of Medicaid Renewal Outcomes 

and enrollment changes at the end of the 

Unwinding. The Kaiser Family Foundation. https:// 

www.kff.org/medicaid/issue-brief/an-examinationof-medicaid-renewal-outcomes-and-enrollmentchanges-at-the-end-of-the-unwinding/. 

48Hale, J., Hong, N., Hopkins, B., Lyons, S., 

Molloy, E., & The Congressional Budget Office 

Coverage Team (2024). Health Insurance Coverage 

Projections for the US Population and Sources Of 

Coverage, By Age, 2024–34. Health affairs (Project 

Hope), 43(7), 922–932. https://doi.org/10.1377/ 

hlthaff.2024.00460. 

49Tolbert, J., & Corallo, B. (2024, September 18). 

An examination of Medicaid Renewal Outcomes 

and enrollment changes at the end of the 

Unwinding. The Kaiser Family Foundation. https:// 

www.kff.org/medicaid/issue-brief/an-examinationof-medicaid-renewal-outcomes-and-enrollmentchanges-at-the-end-of-the-unwinding/. 

50Blumenthal, D., Gumas, E., & Shah, A. (2024). 

The Failing U.S. Health System. The New England 

journal of medicine, 391(17), 1566–1568. https://

doi.org/10.1056/NEJMp2410855. 

The conclusions of the experts are 

supported by a report from the 

Outcomes Planning Committee of the 

VHA Office of Health Services Research 

and Development’s State-of-the-Art 

Conference on Virtual Care. The report 

concluded that there is a need for 

additional research to identify the 

specific scenarios in which virtual care 

can be leveraged to improve patient 

outcomes, and that additional research 

regarding the use of hybrid models ‘‘will 

be critical in determining whether 

virtual visits should function primarily 

as periodic check-ins before patients can 

receive certain examinations or 

procedures in-person, or whether virtual 

care can fully replace in-person care in 

specific clinical scenarios.’’ 40

Although many individuals access 

telehealth visits successfully, the 

clinical signs and findings required by 

some of the musculoskeletal disorders 

listings may not be present in the 

telehealth record due to the limitations 

of telemedicine. While testing by the 

patient is possible through telehealth, 

there are limits in provocative testing 

(testing that manipulates the areas 

where an individual has pain in order 

to reproduce the pain), discrete 

palpation (a technique that uses targeted 

pressure to identify and quantify the 

abnormalities of the musculoskeletal 

system, such as warmth, swelling, pain, 

tenderness, and trigger points), and 

strength or stability testing.41 During the 

beginning of the COVID–19 pandemic, 

orthopedists created guidelines for 

virtual examinations of patients through 

telemedicine, and found that while the 

patient could perform many tests, there 

are inherent limitations to testing in this 

manner. For example, the authors 

recommend using another person to 

hold the camera during gait examination 

to get a better view of the patient’s gait 

mechanics, which is not always 

possible.42 Further, the VHA has found 

that although patients appreciate 

telehealth, many are unable to complete 

exams that require precise 

measurements, such as range of motion 

or reflexes.43 While it appears that since 

the end of the PHE there have been 

some post-surgical innovations to 

conduct follow-up spine care virtually, 

such as applications that can be used on 

a smartphone,44 a recent survey of 

orthopedic trauma care providers shows 

that concerns still exist about the 

generalizability of telemedicine to the 

field of orthopedic trauma care, as a 

majority of orthopedic physicians felt 

that virtual physical examinations 

allowed for only limited information.45

Thus, the utility of telehealth 

examination in the specific context of 

surgical and/or orthopedic trauma care 

remains uncertain. 

Additionally, an increasing number of 

people are unable to access needed 

healthcare due to cost as the PHE 

flexibilities are phased out. Medicaid 

redeterminations restarted at the end of 

the PHE, leading to an increase in the 

uninsured, and the enhanced health 

insurance marketplace subsidies will 

expire in 2025.46 According to data from 

the Kaiser Family Foundation (KFF), 

over 25 million people have been 

disenrolled from Medicaid since April 

2023, when the ‘‘unwinding’’ of the 

continuous enrollment provision began, 

leading to an increase in the uninsured 

population.47

The Congressional Budget Office 

predicts an increase in the share and 

number of people without insurance 

over the next decade, with a predicted 

increase in the uninsured population 

from 24 million in 2023 to 32 million 

in 2027, primarily driven by changes in 

Medicaid and Children’s Health 

Insurance Program (CHIP) enrollment 

over the next few years resulting from 

the expiration of PHE-era programs.48

National surveys from KFF and the 

Federal Reserve in 2022 and 2023 

showed that a large percentage of people 

(25 to 28 percent) postponed or went 

without needed medical care due to cost 

regardless of insurance status, and that 

the uninsured population was 

significantly more likely to forego or 

postpone care (42 to 60 percent) than 

the insured population.49

The Commonwealth Fund’s 2024 

report, which compared the 

performance of health systems of 10 

high-income countries using data from 

2020 or later and is the first such report 

to account for the effects of the COVID– 

19 pandemic, found that the United 

States ranked last on several measures, 

including access to care, and this was 

attributed largely to cost-related 

barriers, such as the percentage of 

uninsured residents as well as 

inadequate coverage and high 

deductibles and copayments.50 The 

Commonwealth Fund’s 2023 survey 

noted that nearly half of adults with 

lower or average incomes in the U.S., 

and nearly one of three with higher 

incomes, reported at least one costrelated problem accessing health care in 

the prior year. The problems included 


KHAMMOND on DSK9W7S144PROD with RULES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 5587 

51 Gunja MZ, Gumas ED, Williams RD II, Doty 

MM, Shah A, Fields K. The cost of not getting care: 

income disparities in the affordability of health 

services across high-income countries. New York: 

Commonwealth Fund, November 16, 2023 (https:// 

www.commonwealthfund.org/publications/surveys/ 

2023/nov/cost-not-getting-care-income-disparitiesaffordability-health). 

52Tolbert, J, Drake, P., & Damic, A., (2023, 

December 18). Key Facts about the Uninsured 

Population. The Kaiser Family Foundation. https:// 

www.kff.org/report-section/key-facts-about-theuninsured-population-issue-brief/#endnote_link_

607642-9. 

53Lopes, L., Montero, A., Presiado, M., & Hamel, 

L. (2024, March 01). Americans’ Challenges with 

Health Care Costs. The Kaiser Family Foundation. 

https://www.kff.org/health-costs/issue-brief/ 

americans-challenges-with-health-care-costs/ 

54National Center for Health Statistics, National 

Health Interview Survey. See Sources and 

Definitions, National Health Interview Survey 

(NHIS) and Health, United States, 2020–2021 Table 

UnmtNd. 

55For example, a 2009 study found that recent 

SSDI recipients were uninsured at substantially 

higher rates than the general population. See, 

Livermore, G., Stapleton, D., & Claypool, H. Health 

Insurance and Health Care Access Before and After 

SSDI Entry. New York: Commonwealth Fund, May 

20, 2009. https://www.commonwealthfund.org/ 

publications/fund-reports/2009/may/healthinsurance-and-health-care-access-and-after-ssdientry. 

56 GlobalData Plc. (2024, March). The 

Complexities of Physician Supply and Demand: 

Projections From 2021 to 2036. AAMC; https://

www.aamc.org/media/75236/download?

attachment. 

57Martin, B., Kaminski-Ozturk, N., O’Hara, C., & 

Smiley, R. (2023). Examining the Impact of the 

COVID–19 Pandemic on Burnout and Stress Among 

U.S. Nurses. Journal of nursing regulation, 14(1), 4– 

12. https://doi.org/10.1016/S2155-8256(23)00063-7. 

58 GlobalData Plc. (2024, March). The 

Complexities of Physician Supply and Demand: 

Projections From 2021 to 2036. AAMC; https://

www.aamc.org/media/75236/download?

attachment. 

59Standaert, Christopher, M.D. COVID 

Disruptions and their Impact on Musculoskeletal 

Care. Presentation to the Standing Committee of the 

National Academies of Science and Medicine 

Health and Medicine Division, on June 20, 2024; 

see also Escorpizo, Reuben, P.T., M.Sc., D.P.T. 

Musculoskeletal Health, and Telehealth—Rapid 

Overview. Presentation to the Standing Committee 

of the National Academies of Science and Medicine 

Health and Medicine Division, on June 20, 2024. 

60Blumenthal, D., Gumas, E., & Shah, A. (2024). 

The Failing U.S. Health System. The New England 

journal of medicine, 391(17), 1566–1568. https://

doi.org/10.1056/NEJMp2410855. 

61National Center for Health Workforce Analysis 

(2024, May). State of the U.S. Health Care 

Workforce, 2023 HRSA; https://bhw.hrsa.gov/sites/ 

default/files/bureau-health-workforce/dataresearch/state-of-the-health-workforce-report2023.pdf. 

62Bureau of Health Workforce. (2024, November). 

Health Workforce Projections. HRSA; Retrieved 

November 22, 2024, from https://bhw.hrsa.gov/ 

data-research/projecting-health-workforce-supplydemand. 

63 GlobalData Plc. (2024, March) The 

Complexities of Physician Supply and Demand: 

Projections From 2021 to 2036. AAMC; https://

www.aamc.org/media/75236/download?

attachment. 

having a medical issue but not visiting 

a doctor, skipping a medical test, 

treatment, or follow-up that was 

recommended by a doctor, not filling a 

prescription, or skipping medication 

doses.51 Given the projected increases in 

the uninsured population and the 

impact of cost and insurance status on 

access to care, postponed and foregone 

health care is expected to remain an 

issue for the foreseeable future, 

potentially limiting the frequency of 

visits. 

Additional research suggests that 

certain individuals, such as those who 

are uninsured or low-income, may face 

barriers to regular or recommended 

health care treatment, and that these 

barriers appear to have increased after 

the pandemic, which may warrant a 

longer standard to allow for developing 

the necessary evidence. In a separate 

publication, summarizing recent 

research, KFF notes that studies 

repeatedly demonstrate that uninsured 

individuals are less likely than those 

with insurance to receive preventive 

care and services for major health 

conditions and chronic diseases.52 For 

example, a 2023 KFF survey found that 

61 percent of uninsured adults skipped 

or postponed getting treatment due to 

cost compared to 21 percent for insured 

adults.53 Similarly, a 2019 National 

Center for Health Statistics survey found 

that 36.5 percent of uninsured adults 

delayed or did not receive needed 

medical care due to cost as compared to 

eight percent of insured individuals.54

That same study found that over 20 

percent of individuals living at or below 

200 percent of the federal poverty 

threshold delayed or did not receive 

medical care due to cost as compared to 

8.5 percent of all individuals. Notably, 

the 2019 study showed fewer people 

missing care than the 2023 KFF survey, 

again suggesting that problems 

accessing care have been exacerbated by 

the pandemic. Given that individuals 

who apply for disability benefits are 

disproportionately uninsured 55 or lowincome, a standard which helps to 

accommodate cost barriers to healthcare 

access may be appropriate. 

Healthcare workforce analyses have 

also shown significant healthcare 

workforce shortages and delays in care, 

exacerbated by the pandemic, and have 

projected ongoing healthcare workforce 

shortages for at least a decade, further 

impacting access to care, with disparate 

access to care for different 

communities.56 Preliminary data from 

the pandemic shows that stress during 

the pandemic led to burnout and 

retirement earlier than projected for 

many physicians and nurses, 

exacerbating workforce shortages that 

were already increasing due to an aging 

healthcare workforce.57 At the same 

time, healthcare demand has increased 

and is expected to continue to increase 

due to population growth, the increase 

in individuals with multiple chronic 

conditions, and the aging population.58

Experts in musculoskeletal care 

presenting to the NASEM Standing 

Committee reported significant 

persisting delays in specialty care 

appointments compared to prepandemic norms.59 The Commonwealth 

Fund’s 2024 report also noted that 

timely access to care in the United 

States is limited by a worsening 

shortage of primary care clinicians and 

the time spent by healthcare providers 

on administrative issues related to 

billing.60

The Health Resources and Services 

Administration (HRSA) reported in 

November 2023 that approximately 102 

million Americans live in a primary 

care health professional shortage area 

and that maldistribution of the 

healthcare workforce results in severe 

shortages in rural communities.61

Additionally, a 2024 HRSA report 

projects average physician shortages of 

56 percent in non-metro areas by 

2036.62 Similarly, the Association of 

American Medical Colleges recently 

projected a shortage of up to 139,000 

physicians by 2033 and concluded that 

if communities historically underserved 

by our health care system had fewer 

access barriers and comparable access 

was provided for all, the shortfall would 

be three to six times the magnitude of 

current estimates.63

Any ongoing decrease in the 

frequency of, or increase in wait times 

for, in-person medical visits could lead 

to additional barriers or delays in 

documenting certain findings in the 

medical record that are needed to meet 

or equal the musculoskeletal disorders 

listings. This is true even if the decrease 

in in-person visits is offset with 

telehealth visits that make healthcare 

more accessible for some, because 

telehealth visits cannot reliably provide 

all the findings provided during inperson visits. The anecdotal evidence 

we have suggests the possibility of 

ongoing changes in healthcare related to 

the pandemic, including significant 

post-PHE delays in in-person care and 

ongoing telehealth utilization at a higher 

rate than prior to the pandemic. 

Although this evidence may support 

additional flexibility in the proximity 

standard, there is also an overall lack of 

published and available data on 

healthcare access and utilization 

following the PHE on which to rely. 

Therefore, an extension until May 11, 


KHAMMOND on DSK9W7S144PROD with RULES
5588 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

64Standaert, Christopher, M.D. COVID 

Disruptions and their Impact on Musculoskeletal 

Care. Presentation to the Standing Committee of the 

National Academies of Science and Medicine 

Health and Medicine Division, on June 20, 2024. 

65 In our first TFR, we provided notice that we 

would consider extending the expiration date of the 

rule, and we invited public comments on the 

expiration date. 86 FR at 38920, 38924. As 

discussed above, we received a public comment 

from NOSSCR that encouraged us to make the 

temporary 12-month standard permanent or, if we 

chose not to make the 12-month standard 

permanent, to extend the period covered by the first 

TFR to one year after the end of the PHE. Similarly, 

in our second TFR we provided notice that we 

would consider extending the expiration date of the 

rule, and we invited public comments on the 

expiration date. 88 FR at 67081, 67088. As 

discussed above, we received a public comment 

from The Connected Health Initiative which 

supported our decision to extend the original TFR 

to continue to study the impacts of the PHE and 

barriers to healthcare. 

66 Individuals who are eligible for disability 

benefits are, by definition, not able to engage in 

substantial gainful activity, which means they may 

experience immediate and severe financial 

hardship. 

67 42 U.S.C. 1382(a); 20 CFR 416.202. 

2029, is necessary to ensure a sufficient 

research base for a permanent standard. 

We are extending the flexibility until 

May 11, 2029, to provide time for 

published research to demonstrate 

utilization data after the PHE. Experts in 

musculoskeletal care presenting to the 

NASEM Standing Committee in June 

2024 noted that there was almost no 

published research about 

musculoskeletal health care utilization 

in 2022 and beyond. One expert 

explained that this is largely due to the 

logistics of scientific research, where 

data is collected in large databases on a 

delay, and researchers must obtain 

funding and access to the database, 

analyze the data, and seek peer review 

and publication, which typically takes 

several years.64 Therefore, in order to 

provide time for development of the 

evidence base and for full notice-andcomment rulemaking, we are extending 

the flexibility in the proximity standard 

until May 11, 2029. However, we will 

begin the rulemaking process for a 

permanent proximity standard as soon 

as the evidence base is available. 

Evidence to Review 

We will continue to use the extension 

period to study the changes in 

healthcare access and provision after the 

expiration of the PHE. During the 

extension period, we will also continue 

to review information about disparities 

in access to care or modalities of care. 

We expect this additional period will 

allow us to consider whether we should 

revert to the 4-month ‘‘close proximity 

of time’’ standard, adopt a permanent 

change to the consecutive 12-month 

‘‘close proximity of time’’ period, or use 

a different timeframe, to account for 

ongoing changes in healthcare access 

and delivery. 

We will also continue to study the 

application of the ‘‘close proximity of 

time’’ rule in our programs. In addition, 

we will continue to monitor the quality 

of our determinations and decisions to 

inform our policy decision and ensure 

the appropriate adjudication of claims 

for people with musculoskeletal 

disorders. 

Solicitation for Public Comment 

Although we are publishing a 

temporary final rule, we invite public 

comment on all aspects of the rule, 

including: 

• The appropriate standard for ‘‘close 

proximity of time’’ to account for 

barriers to access to care or changes in 

healthcare delivery, and the justification 

or evidence for the standard the 

commenter identifies as appropriate; 

• Research, evidence, or information 

about barriers to access to care, changes 

in healthcare delivery, and 

disproportionate burdens faced by any 

subset of the population and how that 

impacts an individual’s ability to 

provide the required evidence for a 

medical listing; and 

• The expiration date of this rule. 

Please share any supporting 

information that you might have. We 

will consider any substantive comments 

we receive within 60 days of the 

publication of this TFR. 

Summary of the Changes 

This rule revises sections 1.00C7a and 

101.00C7a of the musculoskeletal 

disorders listings to define a new term, 

‘‘post-pandemic evaluation period,’’ to 

mean ‘‘the period beginning on May 12, 

2025, and ending on May 11, 2029.’’ We 

are adding this new term because we are 

extending the more flexible ‘‘close 

proximity of time’’ standard to six years 

after the end of the PHE. This rule also 

revises sections 1.00C7c and 101.00C7c 

to indicate that, for claims determined 

or decided during the pandemic period 

or the post-pandemic evaluation period, 

‘‘within a close proximity of time’’ 

means that all the relevant criteria must 

appear in the medical record within a 

consecutive 12-month period. 

We are making changes based on the 

Commissioner of Social Security’s 

rulemaking authority specified in 

sections 205(a), 702(a)(5), 1631(d)(1), 

1631(e)(1)(A), and 1633(a) of the Social 

Security Act. Under those sections, the 

Commissioner may adopt rules 

regarding, among other things, the 

nature and extent of evidence needed to 

establish benefit eligibility, as well as 

methods of taking and furnishing such 

evidence. 

Justification for Foregoing Notice and 

Comment Rulemaking 

We follow the Administrative 

Procedure Act’s (APA) rulemaking 

procedures specified in 5 U.S.C. 553 

when we develop regulations. 

Generally, the APA requires that an 

agency provide prior notice and 

opportunity for public comment before 

issuing a final rule. However, the APA 

provides exceptions to its notice and 

public comment procedures when an 

agency finds there is good cause for 

dispensing with such procedures 

because they are impracticable, 

unnecessary, or contrary to the public 

interest (5 U.S.C. 553(b)(B)). 

We find that there is good cause to 

issue this TFR without prior notice and 

public comment.65 We have been 

following the more flexible 12-month 

‘‘close proximity of time’’ standard for 

over three years, and it would be 

impracticable and contrary to the public 

interest to disrupt our claims 

adjudications by delaying 

implementation of this TFR. Delayed 

implementation of this TFR would 

require us to either delay adjudicating 

affected claims, potentially resulting in 

delayed benefits to vulnerable 

individuals,66 or apply the 4-month 

‘‘close proximity of time’’ standard, 

which does not consider changes in 

healthcare access and delivery related to 

the PHE, as discussed in the preamble. 

If we applied the 4-month standard, 

individuals might be unable to show 

that they meet a listing under the 4- 

month ‘‘close proximity of time’’ 

standard merely due to changes in how 

the healthcare system works. 

Implementing this TFR, without prior 

notice and public comment, will allow 

us to maintain this more flexible 

standard while we review and adapt to 

new clinical practices and healthcare 

data that emerge in a post-PHE 

landscape. 

Delay in implementing this TFR 

would be impracticable and contrary to 

the public interest because it may cause 

some applicants to experience 

immediate and severe financial 

hardship, placing them at risk of losing 

their homes, means of transportation, 

access to health care, and other 

important resources, in addition to 

experiencing increased stress as they 

await the outcome of their case and 

their award of benefits. This is 

particularly true for the population that 

is eligible for Supplemental Security 

Income (SSI), which has, by definition, 

severely limited income and financial 

resources.67 An unnecessary delay 


KHAMMOND on DSK9W7S144PROD with RULES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 5589 

68 5 U.S.C. 801 et seq. 

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. 

Delaying implementation of this final 

rule to provide an opportunity for prior 

notice and public comment is also 

unnecessary. As noted above, we have 

applied the more flexible 12-month 

‘‘close proximity of time’’ standard for 

over three years, and its effects have 

been negligible, merely resulting in 

more streamlined, faster disability 

determinations for a very small number 

of claimants. 

Moreover, we have given interested 

parties an opportunity to provide public 

comment on the 12-month standard— 

including soliciting comments about a 

possible extension—on two prior 

occasions: first when we published the 

2021 TFR and then, when we extended 

the flexibility in September 2023. 

Altogether, we received two public 

comments. The first commenter 

supported making the 12-month 

standard permanent or, alternatively, 

extending it, and the second commenter 

supported an extension of the 12-month 

standard. Accordingly, delaying 

implementation of this rule to obtain 

further public comment is unnecessary. 

For good cause shown, to avoid 

delaying benefits to vulnerable 

individuals while providing appropriate 

flexibility to account for COVID–19- 

related healthcare changes, we are 

dispensing with prior notice and public 

comment on this rule pursuant to 5 

U.S.C. 553(b)(B). 

Regulatory Procedures 

Clarity of This Rule 

Executive Order 12866, as 

supplemented by Executive Orders 

13563 and 14094, requires each agency 

to write all rules in plain language. In 

addition to your substantive comments 

on this rule, we invite your comments 

on how to make the rule easier to 

understand. 

For example: 

• 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 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: 

• Providing a more flexible 12-month 

‘‘close proximity of time’’ standard in 

the musculoskeletal disorders listings 

will potentially result in streamlined, 

faster disability determinations for a 

small number of claimants. Absent this 

policy, a small number of 

determinations might be delayed due to 

a need for additional medical or 

vocational development. 

Anticipated Costs 

We do not believe there are more than 

de minimis costs to the public 

associated with this rule. The 

requirements in this rule will not 

impose new additional costs outside of 

the normal course of business for 

applicants or change how the public 

interacts with our disability programs. 

Congressional Review Act 

This final rule is not a major rule as 

defined by the Congressional Review 

Act.68

Executive Order 13132 (Federalism) 

We analyzed this temporary final rule 

in accordance with the principles and 

criteria established by Executive Order 

13132 and determined that the rule will 

not have sufficient Federalism 

implications to warrant the preparation 

of a Federalism assessment. We also 

determined that this rule will not 

preempt any State law or State 

regulation or affect the States’ abilities 

to discharge traditional State 

governmental functions. 

Regulatory Flexibility Act 

We certify that this temporary final 

rule will not have a significant 

economic impact on a substantial 

number of small entities because it 

affects individuals only. Therefore, a 

regulatory flexibility analysis is not 

required under the Regulatory 

Flexibility Act, as amended. 

Paperwork Reduction Act 

These rules do not create any new or 

affect any existing collections and, 

therefore, do not require Office of 

Management and Budget approval 

under the Paperwork Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; and 

96.006, Supplemental Security Income) 

List of Subjects 

20 CFR Part 404 

Administrative practice and 

procedure; Blind, Disability benefits; 

Old-age, survivors, and disability 

insurance; Reporting and recordkeeping 

requirements; Social Security. 

20 CFR Part 416 

Administrative practice and 

procedure; Aged, Blind, Disability cash 

payments; Public assistance programs; 

Reporting and recordkeeping 

requirements; Supplemental Security 

Income (SSI). 

The Acting Commissioner of Social 

Security, Carolyn W. Colvin, having 

reviewed and approved this document, 

is delegating the authority to 

electronically sign this document to Erik 

Hansen, who is a Federal Register 

Liaison for the Social Security 

Administration, for purposes of 

publication in the Federal Register. 

Erik Hansen, 

Associate Commissioner, Office of Legislative 

Development and Operations, Social Security 

Administration. 

For the reasons stated in the 

preamble, we are amending subpart P of 


KHAMMOND on DSK9W7S144PROD with RULES
5590 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

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 continues to read as follows: 

Authority: 42 U.S.C. 402, 405(a)–(b) and 

(d)–(h), 416(i), 421(a) and (h)–(j), 422(c), 423, 

425, and 902(a)(5)); sec. 211(b), Pub. L. 104– 

193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 

108–203, 118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. In appendix 1 to subpart P of part 

404: 

■ a. In part A, amend section 1.00C7 by 

revising paragraphs a and c; and 

■ b. In part B, amend section 101.00C7 

by revising paragraphs a and c. 

The revisions read as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

Part A 

* * * * * 

1.00 Musculoskeletal Disorders 

* * * * * 

C. * * * 

7. * * * 

a. The term pandemic period as used in 

1.00C7c means the period beginning on April 

2, 2021, and ending on May 11, 2025. The 

term post-pandemic evaluation period as 

used in 1.00C7c means the period beginning 

on May 12, 2025, and ending on May 11, 

2029. 

* * * * * 

c. For 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 

1.22, and 1.23, all of the required criteria 

must be present simultaneously, or within a 

close proximity of time, to satisfy the level 

of severity needed to meet the listing. The 

phrase ‘‘within a close proximity of time’’ 

means that all of the relevant criteria must 

appear in the medical record within a 

consecutive 4-month period, except for 

claims determined or decided during the 

pandemic period or post-pandemic 

evaluation period. For claims determined or 

decided during the pandemic period or postpandemic evaluation period, all of the 

relevant criteria must appear in the medical 

record within a consecutive 12-month 

period. When the criterion is imaging, we 

mean that we could reasonably expect the 

findings on imaging to have been present at 

the date of impairment or date of onset. For 

listings that use the word ‘‘and’’ to link the 

elements of the required criteria, the medical 

record must establish the simultaneous 

presence, or presence within a close 

proximity of time, of all the required medical 

criteria. Once this level of severity is 

established, the medical record must also 

show that this level of severity has 

continued, or is expected to continue, for a 

continuous period of at least 12 months. 

* * * * * 

Part B 

* * * * * 

101.00 Musculoskeletal Disorders. 

* * * * * 

C. * * * 

7. * * * 

a. The term pandemic period as used in 

101.00C7c means the period beginning on 

April 2, 2021, and ending on May 11, 2025. 

The term post-pandemic evaluation period as 

used in 101.00C7c means the period 

beginning on May 12, 2025, and ending on 

May 11, 2029. 

* * * * * 

c. For 101.15, 101.16, 101.17, 101.18, 

101.20C, 101.20D, 101.22, and 101.23, all of 

the required criteria must be present 

simultaneously, or within a close proximity 

of time, to satisfy the level of severity needed 

to meet the listing. The phrase ‘‘within a 

close proximity of time’’ means that all of the 

relevant criteria must appear in the medical 

record within a consecutive 4-month period, 

except for claims determined or decided 

during the pandemic period or postpandemic evaluation period. For claims 

determined or decided during the pandemic 

period or post-pandemic evaluation period, 

all of the relevant criteria must appear in the 

medical record within a consecutive 12- 

month period. When the criterion is imaging, 

we mean that we could reasonably expect the 

findings on imaging to have been present at 

the date of impairment or date of onset. For 

listings that use the word ‘‘and’’ to link the 

elements of the required criteria, the medical 

record must establish the simultaneous 

presence, or presence within a close 

proximity of time, of all the required medical 

criteria. Once this level of severity is 

established, the medical record must also 

show that this level of severity has 

continued, or is expected to continue, for a 

continuous period of at least 12 months. 

* * * * * 

[FR Doc. 2025–01283 Filed 1–16–25; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 16 

[Docket No. FDA–2024–N–3654] 

RIN 0910–AI97 

Regulatory Hearing Before the Food 

and Drug Administration; General 

Provisions; Amendments; Withdrawal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

published in the Federal Register of 

September 20, 2024, a direct final rule 

amending the Scope section of our 

regulation that provides for a regulatory 

hearing before the Agency. The 

comment period closed December 4, 

2024. FDA is withdrawing the direct 

final rule because the Agency received 

significant adverse comment. 

DATES: The direct final rule published at 

September 20, 2024, 89 FR 77019, is 

withdrawn effective January 17, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Robert Schwartz, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 1– 

877–287–1373, CTPRegulations@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Therefore, 

under the Federal Food, Drug, and 

Cosmetic Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, the direct final rule 

published on September 20, 2024, 89 FR 

77019 is withdrawn. 

Dated: January 13, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01145 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2022–C–0098] 

Listing of Color Additives Exempt 

From Certification; Myoglobin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the color additive regulations 

to provide for the safe use of myoglobin 

as a color additive in ground meat and 

ground poultry analogue products. We 

are taking this action in response to a 

color additive petition (CAP) submitted 

by Motif FoodWorks, Inc. (Motif 

FoodWorks or petitioner). 

DATES: This order is effective February 

19, 2025. See section X for further 

information on the filing of objections. 

Either electronic or written objections 

and requests for a hearing on the order 

must be submitted by February 18, 

2025. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 


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