# Revised Medical Criteria for Evaluating Cardiovascular Disorders

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2026-13420

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** July 2, 2026
- **Citation:** 91 FR 40804

## Text

SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA-2019-0013]
RIN 0960-AI43
Revised Medical Criteria for Evaluating Cardiovascular Disorders

AGENCY:

Social Security Administration.

ACTION:

Final rule.

SUMMARY:

We are revising the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving cardiovascular disorders in adults and children under titles II and XVI of the Social Security Act (Act). The revisions reflect our adjudicative experience, advances in medical knowledge, and comments we received from the public in response to a notice of proposed rulemaking (NPRM).

DATES:

This rule is effective October 30, 2026.

FOR FURTHER INFORMATION CONTACT:

Michael J. Goldstein, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020.

For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our internet site, Social Security Online, at
http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Background

The listings describe medical conditions that are so severe that we presume any adult who has a medical condition(s) that satisfies the criteria of a listing is unable to perform any gainful activity regardless of their age, education, or work experience and, therefore, is disabled.
1

For children, the listings describe impairments we consider severe enough to cause marked and severe functional limitations.
2

We use the listings at step 3 of the sequential evaluation process to identify claims that we should clearly allow.
3

We do not deny any claim solely because a person's medical condition(s) does not satisfy the criteria of a listing.

1
20 CFR 404.1525(a) and 416.925(a).

2
20 CFR 416.925(a).

3
20 CFR 404.1520, 404.1525(a), 416.920, 416.924, and 416.925(a).

We last published final rules that comprehensively revised the cardiovascular disorders listings on January 13, 2006.
4

We published an Advance Notice of Proposed Rulemaking (ANPRM) for cardiovascular disorders in the
Federal Register
on April 16, 2008.
5

4
71 FR 2312 (2006).

5
73 FR 20564 (2008).

We are making final the rule for evaluating cardiovascular disorders that we proposed in the NPRM published in the
Federal Register
on June 29, 2022.
6

The preamble to the NPRM provides the background and rationale for these revisions. As explained in the NPRM, the revisions were informed by recommendations from the Institute of Medicine (IOM)
7

contained in their report titled “
Cardiovascular Disability: Updating the Social Security Listings
” (IOM report).
8

The IOM report provides an important foundation because it was prepared within the context of the statutory definition of disability and the cardiovascular listings. The considerations under our disability program may be different than those found in a clinical or research setting. For example, the medical listings account for the most severe impairments that limit a person's function and ability to engage in any gainful activity, while clinical or research settings may seek to address all those affected by a condition or impairment and focus on decision-making regarding diagnosis and treatment of the medical problem; their focus is not necessarily on the ability to engage in any gainful activity. The IOM report specifically discusses these differences: for example, the IOM notes that generally, clinical guidelines do not address patient disability or employability as a major topic of discussion and rarely indicate the relationship of impairment severity to functional limitations that might affect work capacity.
9

6
87 FR 38838 (2022).

7
Institute of Medicine (IOM). (2010).
Cardiovascular Disability: Updating the Social Security Listings.
Washington, DC: The National Academies Press. Note: We did not adopt all of the IOM report's recommendations. In some instances, certain recommendations were already addressed in another listing, or they conflicted with existing SSA policy. However, we did adopt multiple IOM recommendations. See IOM Adoption Chart in Supporting and Related Materials to this Docket for more details (see also 87 FR 38838).

8
On April 28, 2015, the membership of the National Academy of Science voted to change the name of the IOM to the National Academy of Medicine. At that time, reports and studies of the IOM continued as activities of the Health and Medicine Division, a program unit operating under the direction of the National Academies of Sciences, Engineering, and Medicine. We will continue to use “IOM” and “Institute of Medicine” throughout this rule, as this is the name reflected in the cited report.

9
IOM. (2010), 274.

However, the revisions to our listings are not based solely on the IOM report. We have additionally reviewed a comprehensive body of relevant and reliable medical research, consulted with agency medical experts, and reviewed disability claims involving cardiovascular disorders to ensure that the revised criteria still reflect listing-level severity based on current medical practice. You can view the preamble to the NPRM by visiting
http://www.regulations.gov
and searching for document “SSA-2019-0013.” There are some differences in the introductory text and listing text from the NPRM to this final rule, which we explain below. Those differences reflect, in large part, our response to public comments we received about our proposed rule.

Why are we revising the listings for evaluating cardiovascular disorders?

We developed this final rule as part of our ongoing review of the listings. We are revising the listings for evaluating cardiovascular disorders to update their medical criteria, and to clarify how we evaluate cardiovascular disorders.

When will we begin to use this final rule?

As we noted in the dates section of this preamble, this final rule will be effective on October 30, 2026.

We delayed the effective date of the rule to give us time to update our systems and to provide training and guidance to all of our adjudicators before we implement the final rule. The current rules will continue to apply until the effective date of the final rule. When the final rule becomes effective, we will apply it to new applications filed on or after the effective date of the rule, and to claims that are pending on or after the effective date.
10

10
This means that we will use this final rule on and after the effective date in any case in which we make a determination or decision, including new applications, pending claims, and continuing disability reviews (CDRs), as applicable. See 20 CFR 404.901, 404.1590, 416.990, and 416.1401. We expect that Federal courts will review our final decisions using the rules that were in effect at the time we issued the decisions. If a court reverses our final decision and remands a case for further administrative proceedings after the effective date of this final rule, we will apply this final rule to the entire period at issue in the decision we make after the court's remand.

We present a series of tables below. These tables summarize the revisions we are making to the cardiovascular disorders introductory text and listings. Following the tables, we discuss the changes in detail.

The following table summarizes the current and revised sections of the adult cardiovascular disorders introductory text and listings:

BILLING CODE 4191-02-P

ER02JY26.000

The following table summarizes the current and revised sections of the childhood cardiovascular disorders introductory text and listings:

ER02JY26.001

Listings 4.07 (
Aortic valvular disease
), 4.08 (
Cardiomyopathy
), and 4.16/104.16 (
Cardiac allograft vasculopathy
) are new listings. We added these listings to more directly address very serious conditions that can progress quickly and significantly limit an adult's ability to perform gainful activity or cause marked and severe limitations in a child's function. The impairments in these listings were previously evaluated under listings 4.02, 4.04, 4.05, 4.06, 4.09, 11.00, and 104.09.

The following tables show the revisions to the cardiovascular disorders listings criteria that involve changes to healthcare utilization and condition/episode requirements, along with the rationale for each change, and supporting resources.
11

A version of this table was in the Notice of Proposed Rulemaking; this updated version includes current resources and changes in the criteria which were made in the final rule. Following this table, we discuss all of the changes to the cardiovascular disorders listings in more detail.

11

Note:
We made several additions and changes to the tables based on feedback from public comments described later in this document, including updating listing criteria and terminology, adding more detailed rationales for our changes, and replacing or supplementing some of the older resources with newer references and guidelines.

Please be advised that the tables below contain only the changes that we are finalizing that relate to healthcare utilization, and not all revised listing criteria contain changes that relate to healthcare utilization.

ER02JY26.002

ER02JY26.003

ER02JY26.004

ER02JY26.005

ER02JY26.006

ER02JY26.007

ER02JY26.008

ER02JY26.009

ER02JY26.010

ER02JY26.011

ER02JY26.012

ER02JY26.013

ER02JY26.014

ER02JY26.015

ER02JY26.016

BILLING CODE 4191-02-C
We are making several changes from the NPRM to this final rule for cardiovascular disorders:

The following is a high-level summary of the major changes from the NPRM to this final rule. Below, in the section titled
Public Comments on the NPRM,
we describe in greater detail our responses to public comments, including the changes we made from the NPRM as a result of the comments. We also made minor, editorial changes from the NPRM for clarity and readability.

•
Chronic heart failure (chronic HF):
We changed the acronym we use for chronic heart failure from “CHF” to “chronic HF.” We revised the terminology we use to describe the types of heart failure in paragraph 4.00D1 (
What is chronic HF?
) and listing 4.02 (
Chronic heart failure
) to align with current medical terminology. In the introductory text, we expanded the list of appropriate medically acceptable imaging (paragraph 4.00D2 (
What evidence of chronic HF do we need?
)), expanded the discussion of symptoms of chronic HF (paragraph 104.00C2b (Your medical history and physical examination)), and included increased ventricular volume in our discussion of cardiomegaly (paragraph 104.00C2a (Cardiomegaly or ventricular dysfunction)). In 4.02A1a (Left ventricular end diastolic dimension), we changed the threshold criterion for left ventricular end diastolic dimension (LVEDD) and provided different cutoffs for males and females. We also made a minor corresponding revision to the language describing a “period of stability” in paragraph 4.02A1b to replace the term “acute heart failure” with the term “exacerbation of heart failure,” which was our original intent and aligns with the language used in the description of a “period of stability” in paragraphs 4.02A1, 4.02A2, and 4.02C and ensures consistency of this description throughout listing 4.02.

•
Ischemic heart disease:
We revised the introductory text in paragraphs 4.00E1 (
What is ischemic heart disease (IHD)?
) and 4.00E2 (
What causes chest discomfort of myocardial origin?
) to fully capture the causes of IHD. We also added language about non-obstructive coronary artery disease (paragraph 4.00E6 (
What is variant angina?
)) and instantaneous wave-free ratio (iFR) (paragraph 4.00E9f (In 4.04D2, instantaneous wave-free ratio (iFR)). We added a new listing 4.04D2 (Instantaneous wave-free ratio) to provide another measure of listing-level IHD.

•
Peripheral vascular disease:
We replaced the term “peripheral arterial disease” with “peripheral artery disease” throughout section 4.00G (
How do we evaluate peripheral vascular disease?
) and listing 4.12 (
Peripheral artery disease
) to reflect current medical terminology. In the introductory text, we clarified the symptoms associated with peripheral artery disease (PAD) (paragraph 4.00G1 (
What is peripheral vascular disease (PVD)?)
) and lymphedema (paragraphs 4.00G4 and 104.00F9 (
What is lymphedema and how do we evaluate it?
)). We also updated terminology describing ankle-brachial measurements and toe-brachial measurements we use to evaluate PAD to be consistent with modern medical practice (paragraphs 4.00G5 (
When will we purchase exercise Doppler studies for peripheral artery disease (PAD)?),
4.00G6
(Are there any other studies that are helpful in evaluating PAD?),
4.00G7
(How do we evaluate PAD under 4.12?),
and 4.12 (
Peripheral artery disease
)).

•
Congenital heart disease:
In the introductory text, we added “pulmonary atresia” as an example of congenital valvular defects in paragraph 104.00D1c (
Valvular defects or obstructions to ventricular outflow
). We also added “pulmonary atresia with intact ventricular septum” to the list of single ventricle anomalies in paragraphs 4.00H3 and 104.00D4 (
What is single ventricle?
).

•
Cardiomyopathy:
We added functional criteria to listing 4.08A.

•
Other Changes:
We revised paragraph 4.00C15b (
Cardiac catheterization reports
) to incorporate language that further describes the type of information typically provided in cardiac catheterization reports. We also added language that discusses the evaluation of genetic connective tissue disorders to paragraphs 4.00I8 and 104.00F10 (
What is Marfan syndrome and how do we evaluate it?
).

•
References to the cardiovascular disorders listings in other body systems:
As we finalize revisions to the cardiovascular disorders listings, we are revising references in the introductory text for other body systems to mirror changes made in the cardiovascular listings. Specifically, we made a revision to the term “peripheral arterial disease” in paragraph 1.00B5 and to the term “Cardiovascular system” in paragraph 114.00J2m.

Public Comments on the NPRM

In the NPRM, we provided the public with a 60-day comment period, which was scheduled to end on August 29, 2022. During the comment period we received multiple comments requesting that SSA extend the comment period to give commenters more time to evaluate and respond to the proposed rule. In response to those requests, we extended the comment period until September 30, 2022.
12

We received 14 public comments.
13

Those comments came from advocacy groups, legal services organizations, medical organizations, and individual commenters.

12
87 FR 51933 (2022).

13
Three of the comment letters were requests from the public for an extension of the comment period.

We carefully considered all of the public comments related to this rulemaking. Below, we respond to all of the significant issues raised by the commenters that were within the scope of this rulemaking. We have not summarized or responded to comments that were outside the scope of the proposed rule. Some commenters noted provisions with which they agreed. We did not summarize or respond to those comments.

Cardiovascular Disorders

Chronic Heart Failure

Comment:
One commenter noted that throughout the child and adult listings, “chronic heart failure” is abbreviated as “CHF.” They noted that CHF is commonly used in the medical community to refer to congestive heart failure. The commenter recommended using the abbreviation “chronic HF” instead.

Response:
We adopted this comment.

Comment:
Two commenters recommended that we revise the terminology in paragraph 4.00D1 (SSA Note: In the NPRM we identified this section as
What is chronic heart failure (CHF)?
) and listing 4.02A (Medically documented presence of 4.02A1 or A2) to align with current terminology reflecting the two types of chronic HF: heart failure with reduced EF (HFrEF) (EF<40%) and heart failure with preserved EF (HFpEF) (EF>50%). One of these commenters suggested including heart failure with mid-range EF (HFmrEF) (EF 40-49%). Another commenter provided proposed text to describe chronic HF in 4.00D1. The same commenter recommended changing the description of heart failure in paragraph 104.00C1a (
Heart failure
) to match their suggested description in 4.00D1, and recommended replacing the term diastolic heart failure and systolic heart failure in 4.02A with the preferred terminology.

Response:
We partially adopted these comments. We revised the terminology in final paragraphs 4.00D1a(i)
(Heart failure with reduced EF (HFrEF)
) and 4.00D1a(ii)
(Heart failure with preserved EF (HFpEF)
) to add HFrEF and HFpEF

to describe the two types of HF.
14

We also replaced systolic failure with HFrEF in revised listing 4.02A1 (Heart failure with reduced ejection fraction) and diastolic failure with HFpEF in revised listing 4.02A2 (Heart failure with preserved ejection fraction). We did not include HFmrEF in our revisions; although the terminology and identification as a distinct category of HF has been accepted by the clinical community, the available research does not provide a clear picture of the clinical significance of HFmrEF and its impact on a person's functioning. Further, there is a lack of consensus as to whether the addition of HFmrEF can be uniformly applied in practice and clinical trials.
15

Therefore, we did not include HFmrEF in our revisions.

14

Types of heart failure.
(n.d.). American Heart Association. (
https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/types-of-heart-failure#:~:text=This%20is%20also%20known%20as%20heart%20failure%20with%20preserved%20ejection,41%25%20and%2049%25%20EF
).

15
Heidenreich, P.A., Bozkurt, B., Aguilar, D., Allen, L.A., Byun, J.J., Colvin, M.M., Deswal, A., Drazner, M.H., Dunlay, S.M., Evers, L.R., Fang, J.C., Fedson, S.E., Fonarow, G.C., Hayek, S.S., Hernandez, A.F., Khazanie, P., Kittleson, M.M., Lee, C.S., Link, M.S., Milano, C.A., . . . ACC/AHA Joint Committee Members (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Circulation, 145
(18), e895-e1032. (
https://doi.org/10.1161/CIR.0000000000001063
).

Although the commenter suggested matching the description of chronic HF in paragraph 104.00C1 to their proposed description of chronic HF in 4.00D1, they also provided proposed text that did not align with their suggested revisions for 4.00D1. We adopted portions of their proposed text rather than fully matching the proposed text with the description of chronic HF in 4.00D1 to account for the discrepancy.

Comment:
One commenter recommended that we add right ventricular failure as an important refractory cause of heart failure to the definition of chronic HF in paragraph 4.00D1 (SSA Note: In the NPRM we identified this section as
What is chronic heart failure (CHF)
). The same commenter recommended that we add infection and coronary artery insufficiency as possible causes of heart failure to paragraph 104.00C1b (Chronic HF is considered in these listings).

Response:
We did not adopt these comments. The introductory text is intended to provide information generally about chronic HF for the public. It is not intended to provide an exhaustive discussion of the underlying causes of heart failure. Specifically, in paragraphs 4.00D1b and 104.00C1b (Chronic HF is considered in these listings), we explain that chronic HF is considered in these listings as a single category regardless of the underlying cause(s).

Comment:
A commenter recommended that we expand the list of appropriate medically acceptable imaging in paragraph 4.00D2 (
What evidence of chronic HF do we need?
) to include cardiac magnetic resonance imaging (MRI).

Response:
We adopted this comment. A cardiac MRI is a noninvasive test that provides important information in evaluating chronic HF and meets the definition of appropriate medical imaging in paragraph 4.00A3d.
16

16
Heidenreich, P.A., Bozkurt, B., Aguilar, D., Allen, L.A., Byun, J.J., Colvin, M.M., Deswal, A., Drazner, M.H., Dunlay, S.M., Evers, L.R., Fang, J.C., Fedson, S.E., Fonarow, G.C., Hayek, S.S., Hernandez, A.F., Khazanie, P., Kittleson, M.M., Lee, C.S., Link, M.S., Milano, C.A., . . . ACC/AHA Joint Committee Members (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Circulation, 145
(18), e895-e1032. (
https://doi.org/10.1161/CIR.0000000000001063
).

Comment:
We received comments recommending that we revise paragraph 4.00D2a(ii) (SSA Note: In the NPRM we identified an EF of 30 percent or less during a period of stability) and listing 4.02A1 (Heart failure with reduced ejection fraction) to require an EF of less than or equal to 40 percent, rather than our current requirement of an EF of 30 percent or less.

Response:
We did not adopt these comments. The American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI) considers an EF in the range of 30 percent to 40 percent as moderately abnormal and less than 30 percent as severely abnormal.
17

While ASE and EACVI do not describe how “severe” or “moderate” abnormalities relate to a patient's ability to engage in substantial gainful activity, the 2022 ACC/AHA guidelines referenced by commenters only distinguishes between “mildly reduced” EF (41-49 percent) and “reduced” EF as 40 percent or below. There is a difference between being diagnosed with a heart impairment and having an impairment severe enough to meet a listing. The 40 percent suggested by the commenters is a threshold for a diagnosis of heart failure, but is not indicative of the severity required to meet the listings. For example, for some individuals with an EF of 40 percent, the ACC/AHA guidelines recommend simply treating the impairment with beta blockers, which is not indicative of a level of medical severity necessary to meet a medical listing. We further note that although the ACC/AHA guidelines do not include a formal conclusion or distinction differentiating the severity of EF values below 40 percent, the guidelines do include multiple references to an EF less than 30 percent as a sign of severity, which is consistent with our criteria.
18

An EF between 30 percent and 40 percent does not indicate an impairment that would prevent a person from performing any gainful activity.

17
See Supplemental Table 3 in. Lang, R.M., Badano, L.P., Mor-Avi, V., Afilalo, J., Armstrong, A., Ernande, L., Flachskampf, F.A., Foster, E., Goldstein, S.A., Kuznetsova, T., Lancellotti, P., Muraru, D., Picard, M.H., Rietzschel, E.R., Rudski, L., Spencer, K.T., Tsang, W., & Voigt, J.-U. (2015). Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.
Journal of the American Society of Echocardiography, 28
(1), 1-39.e14, p. 39.e8. (
https://doi.org/10.1016/j.echo.2014.10.003).

18
Heidenreich, P.A., Bozkurt, B., Aguilar, D., Allen, L.A., Byun, J.J., Colvin, M.M., Deswal, A., Drazner, M.H., Dunlay, S.M., Evers, L.R., Fang, J.C., Fedson, S.E., Fonarow, G.C., Hayek, S.S., Hernandez, A.F., Khazanie, P., Kittleson, M.M., Lee, C.S., Link, M.S., Milano, C.A., . . . ACC/AHA Joint Committee Members (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Circulation, 145
(18), e895-e1032. (
https://doi.org/10.1161/CIR.0000000000001063
). See specifically Table 16 (e955) and discussion of “severely depressed” EF (e978).

Comment:
One commenter suggested defining mechanical circulatory support device (MCSD), the type of MCSD utilized, and length of time required to establish severity for listing criterion. The commenter questioned the use of “Impella devices.”

Response:
We partially adopted this comment. We added a discussion of devices using the Impella technology to paragraphs 4.00D4e and 104.00C4 (
How do we evaluate chronic HF treated with a mechanical circulatory support device?
) to clarify that such devices do not satisfy the requirements of listing 4.02D1 (An implanted mechanical circulatory support device except extracorporeal membrane oxygenation (ECMO)) because they are intended for short-term usage only. We did not revise the text to specify a time period for an implanted MCSD to meet the criterion in this listing. The clinical conditions for which an implanted MCSD would be used reflect the underlying severity of chronic HF and the potential complications. Furthermore, the use of an implanted device carries additional risks, such as infections, blood clots, and renal failure. As a result of this comment, we realized that we inadvertently did not include

“implanted” in proposed listings 4.02D1 or 104.02D (Mechanical circulatory support device), as we intended, and we added this term to revised 4.02D1 and 104.02D (An implanted mechanical circulatory support device except extracorporeal membrane oxygenation (ECMO)). We note that adding “implanted” to listings 4.02D1 and 104.02D provides additional clarity but does not change the substance of those listings because the acceptable MCSDs described by the listings are always implanted.

Comment:
Two commenters suggested that we use a left ventricular end-diastolic dimension (LVEDD) indexed to body size. One of the commenters suggested that we provide separate LVEDD cutoffs for men and women, rather than specifying an absolute cutoff for LVEDD in listing 4.02A1 (Heart failure with reduced ejection fraction).

Response:
We partially adopted these comments. We did not include an LVEDD dimension indexed to body size, but we did provide separate cutoffs for men and women. While indexing LVEDD to body size can be useful in clinical practice, uncorrected measurements are generally available in the medical record and sufficient for determining the most severe forms of heart failure.
19

Requiring an indexed LVEDD is not practical for disability evaluation purposes because indexed LVEDD measurements are unavailable in many cases. LVEDD is not a stand-alone criterion for establishing disability; it must be considered in combination with the impact of chronic HF on the functional limitations we describe in listing 4.02B (Resulting in 4.02B1, B2, or B3). After consultation with agency medical experts and reviewing pertinent research, we did not include indexed LVEDD measurements in the listings. In cases where an indexed LVEDD measurement is available in the medical record, adjudicators will evaluate the indexed LVEDD measurement along with all other evidence in the record when evaluating disability.

19
See Hayward, C., Perez, C., Patel, H., Mouyis, K., Patel, K., Akhtar, M., Harding, D., Adasuriya, G., Gillott, H., Harvey, G., Sotto, I., & Bhattacharyya, S. (2019). The impact of misclassifying left ventricular size if indexing to body surface area is not performed.
Imaging,
A11.1-A11. (
https://doi.org/10.1136/heartjnl-2019-bcs.11
). In this study, the uncorrected LVEDD and the indexed LVEDD led to the same clinical classification 89.2 percent of the time. (
See also
Daimon, M., Watanabe, H., Nakanishi, K., Abe, Y., Hirata, K., Ishii, K., Iwakura, K., Izumi, C., Abe, H., Negishi, K., Ito, H., Tanabe, K., Tanaka, N., & Nakatani, S. (2024). Is left ventricular diameter indexed for body surface area appropriate for assessing left ventricular dilation?
Journal of cardiology, 84
(1), 67-69. (
https://doi.org/10.1016/j.jjcc.2024.03.004
)). This study showed that indexing left ventricle (LV) diameters for body surface area (BSA) might overestimate LV dilation, particularly in subjects with a small body size.

We agree with the commenter that different LVEDD cutoffs for men and women are appropriate and we have changed the LVEDD threshold to greater than 6.8 cm for men and 6.1 cm for women during a period of stability. Clinical guidelines from the ASE and the EACVI provide these separate cutoffs for identifying severe dilation for males and females, and these cutoffs are easy to apply and are used by practitioners and researchers.
20

Additionally, studies have shown that they correlate with severity.
21

We also made a minor corresponding revision to the language describing a “period of stability” in paragraph 4.02A1b to replace the term “acute heart failure” with the term “exacerbation of heart failure,” which was our original intent, aligns with the language used in the description of a “period of stability” in paragraphs 4.02A1, 4.02A2, and 4.02C, and ensures consistency of this description throughout listing 4.02.

20
Lang, R.M., Badano, L.P., Mor-Avi, V., Afilalo, J., Armstrong, A., Ernande, L., Flachskampf, F.A., Foster, E., Goldstein, S.A., Kuznetsova, T., Lancellotti, P., Muraru, D., Picard, M.H., Rietzschel, E.R., Rudski, L., Spencer, K.T., Tsang, W., & Voigt, J.-U. (2015). Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.
Journal of the American Society of Echocardiography, 28
(1), 1-39.e14. (
https://doi.org/10.1016/j.echo.2014.10.003
); See page 18 in
The American Society of Echocardiography Recommendations for Cardiac Chamber Quantification In Adults: A Quick Reference Guide From The ASE Workflow And Lab Management Task Force.
(n.d.). (
https://www.asecho.org/wp-content/uploads/2018/08/WFTF-Chamber-Quantification-Summary-Doc-Final-July-18.pdf
).

21
Narayanan, K., Reinier, K., Teodorescu, C., Uy-Evanado, A., Aleong, R., Chugh, H., Nichols, G.A., Gunson, K., London, B., Jui, J., & Chugh, S.S. (2014). Left Ventricular Diameter and Risk Stratification for Sudden Cardiac Death.
Journal of the American Heart Association, 3
(5), e001193. (
https://doi.org/10.1161/JAHA.114.001193
).

Comment:
One commenter suggested that we retain the requirement for an LVEDD of greater than 6 cm in listing 4.02A1 (Heart failure with reduced ejection fraction) rather than changing it to a value of equal to or greater than 7 cm. The commenter noted that only patients with the most severe forms of heart failure would be captured under the 7 cm criterion and that 6 cm is likely an appropriate threshold to delineate those patients who will benefit from some advanced cardiovascular therapies. The same commenter recommended that we include an LV volume index in addition to or instead of LVEDD.

Response:
We did not adopt these comments, but we did revise the LVEDD criterion to better reflect the cutoffs for males and females used in clinical practice, as discussed in our response to the previous comment. An LVEDD of 6 cm reflects a mildly to moderately abnormal enlargement of the heart.
22

While 6 cm may be an appropriate threshold to delineate patients who will benefit from some advanced cardiovascular therapies, this is not the purpose of our Listing of Impairments. Rather, our listing for chronic HF is meant to capture more severe forms of the condition that represent an inability to perform any gainful activity. An LVEDD threshold of greater than 6.8 cm for males and greater than 6.1 cm for females more clearly establishes a severely enlarged heart with signs and symptoms associated with the functional limitations we require in listing 4.02B (Resulting in 4.02B1, B2, or B3).
23

22
Lang, R.M., Badano, L.P., Mor-Avi, V., Afilalo, J., Armstrong, A., Ernande, L., Flachskampf, F.A., Foster, E., Goldstein, S.A., Kuznetsova, T., Lancellotti, P., Muraru, D., Picard, M.H., Rietzschel, E.R., Rudski, L., Spencer, K.T., Tsang, W., & Voigt, J.-U. (2015). Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.
Journal of the American Society of Echocardiography, 28
(1), 1-39.e14. (
https://doi.org/10.1016/j.echo.2014.10.003
).

23
Institute of Medicine (IOM). (2010).
Cardiovascular Disability: Updating the Social Security Listings
(pg. 89). Washington, DC: The National Academies Press; Narayanan, K., Reinier, K., Teodorescu, C., Uy-Evanado, A., Aleong, R., Chugh, H., Nichols, G.A., Gunson, K., London, B., Jui, J., & Chugh, S.S. (2014). Left Ventricular Diameter and Risk Stratification for Sudden Cardiac Death.
Journal of the American Heart Association, 3
(5), e001193. (
https://doi.org/10.1161/JAHA.114.001193
).

In clinical practice, left ventricular volume index scores are most helpful in evaluating ventricular function in the early stages of heart failure with normal or mildly reduced EF. At present, reliable left ventricle volume index scores are time-consuming and not always feasible. Consequently, left ventricle volume index scores are seldomly included in echocardiogram reports, whereas LVEDD are routinely included in echocardiogram reports.

24

After consulting with agency medical experts and reviewing pertinent research, we did not include left ventricular volume index scores in the listings.

24
Ito, K., Li, S., Homma, S., Thompson, J.L.P., Buchsbaum, R., Matsumoto, K., Anker, S.D., Qian, M., Di Tullio, M.R., & WARCEF Investigators (2021). Left ventricular dimensions and cardiovascular outcomes in systolic heart failure: the WARCEF trial.
ESC heart failure, 8
(6), 4997-5009.
https://doi.org/10.1002/ehf2.13560.
(
See also
Lang, R.M., Badano, L.P., Mor-Avi, V., Afilalo, J., Armstrong, A., Ernande, L., Flachskampf, F.A., Foster, E., Goldstein, S.A., Kuznetsova, T., Lancellotti, P., Muraru, D., Picard, M.H., Rietzschel, E.R., Rudski, L., Spencer, K.T., Tsang, W., & Voigt, J.-U. (2015). Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.

Journal of the American

Society of Echocardiography, 28

(1), 1-39.e14. (
https://doi.org/10.1016/j.echo.2014.10.003
)). These guidelines indicate that there are limitations with each method of measuring and calculating LV end diastolic volume, and that indexing to BSA, and 3D measurement and reporting of LV volumes are recommended when feasible depending on image quality.

Comment:
Several commenters suggested that we revise the proposed requirements in listing 4.02A2 (Heart failure with preserved ejection fraction), including revising the required left atrial volume index (LAVI) score and adding alternative criteria. One commenter suggested that an LAVI of greater than 34 ml/m
2
should be the required cutoff, while another commenter suggested the cutoff should be an LAVI of 34 ml/m
2
. Another commenter suggested that the cutoff should be greater than or equal to 30 ml/m
2
. One of the commenters also suggested that we add diastolic function requirements as an alternative, while another specifically suggested that we include a tricuspid regurgitant jet velocity greater than 2.8 m/s and abnormal tissue dopplers over the mitral valve as a requirement. One of the commenters also suggested that we include a left ventricular EF (LVEF) of greater than or equal to 50 percent, a tissue velocity septal E/e ratio on echocardiography greater than 9, or a lateral E/e ratio greater than 13.

Response:
We did not adopt these comments. An LAVI of 34 ml/m
2
, as suggested by some commenters, falls within the normal range and serves as a cutoff measurement to identify a heart abnormality. Generally, higher LAVI measurements indicate greater severity of the condition. While an LAVI value between 34 and 40 ml/m
2
may support a diagnosis of heart failure, as indicated in one public commenter's reference to a 2016 article from the Journal of American Society of Echocardiography, such scores are consistent with only mild enlargement.
25

By contrast, an LAVI value of 40 ml/m
2
or greater identifies people with more severe forms of heart failure and more clearly establishes an inability to perform any gainful activity than the other suggested thresholds.
26

25
See Table 3 in Nagueh SF, Smiseth OA, Appleton CP, et al. (2016). Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging
Journal of the American Society of Echocardiography, 29
(4), 277-314, p. 288. (
https://doi.org/10.1016/j.echo.2016.01.011
).

26
See page 18 in
The American Society of Echocardiography Recommendations for Cardiac Chamber Quantification In Adults: A Quick Reference Guide From The ASE Workflow And Lab Management Task Force.
(n.d.). (
https://www.asecho.org/wp-content/uploads/2018/08/WFTF-Chamber-Quantification-Summary-Doc-Final-July-18.pdf
).

We did not include additional criteria to evaluate diastolic function because we already provide criteria, including the LAVI, to evaluate diastolic function. We did not add the suggested LVEF criterion because the suggested EF is implicit in the HFpEF category (
i.e.,
a normal EF). Furthermore, we did not add criteria to include tricuspid regurgitant jet velocity, abnormal tissue dopplers, or tissue velocity septal E/e ratios. These measurements may provide value in the overall evaluation of one's cardiovascular condition; however, they are not consistently contained in echocardiogram reports. The measurements we include in listing 4.02A (Medically documented presence of 4.02A1 or A2) are meant to capture the most severe conditions that prevent a person from being able to engage in any gainful activity. The criteria we include in 4.02A2 are not a comprehensive list of every measurement used to diagnose and assess heart failure. Alternative measures that are not included in the listing criteria may be evaluated under our rules for medical equivalence.
27

27
20 CFR 404.1526 and 416.926.

Comment:
One commenter noted that the proposed criterion in listing 4.02A2 (Heart failure with preserved ejection fraction) may not be standard criterion, and questioned whether the proposed criterion captures diastolic failure of a non-hypertrophic etiology. They noted it was unclear which criteria were needed to establish a diagnosis.

Response:
We disagree with the commenter's concern that the criteria are not standard. The measurements in 4.02A2 are commonly included in echocardiogram reports and used to identify left atrial enlargement, which leads to chronic HF. We use the criteria in 4.02A2 to identify people with diastolic failure that may prevent a person from engaging in any gainful activity. Satisfying the criteria in 4.02A2 is insufficient to find a person disabled at the listing level; the person's limitations caused by the heart failure must also satisfy the criteria in listing 4.02B (Resulting in 4.02B1, B2, or B3). There are many non-hypertrophic causes of diastolic dysfunction, including, but not limited to, coronary artery disease, arrythmias (such as atrial fibrillation), and non-hypertrophic cardiomyopathy. These and other non-hypertrophic causes of diastolic dysfunction may be evaluated under other listings, such as 4.04 (
Ischemic heart disease
), 4.05 (
Recurrent arrythmias
), and 4.08 (
Cardiomyopathy
).

Comment:
Several commenters suggested that we add elevated b-type natriuretic peptide (BNP) levels as another way to assess chronic HF at listing 4.02A2 (Heart failure with preserved ejection fraction).

Response:
We did not adopt this comment. BNP (and Immunoreactive amino terminal pro-brain natriuretic peptide (NT-proBNP)) measurements alone are insufficient for determining listing-level severity. These levels vary in relation to heart failure severity and may be influenced by other factors such as age, sex, body mass index, and other medical conditions. Further, these measurements are most often obtained during periods of instability, while the listings contemplate functional ability during periods of stability. We discuss how we use BNP and NT-proBNP in paragraph 4.00D1b (Chronic HF is considered in these listings).

Comment:
One commenter suggested that we remove the requirement of an EF of 20 percent or less from listing 4.02C (Heart failure with left ventricular ejection fraction of 20 percent or less), noting the cutoff is too low and arbitrary.

Response:
We did not adopt this comment. The IOM recommended a criterion for chronic HF with an EF on a sustained basis of 20 percent or less.
28

An EF of only 20 percent means the heart's pumping action is less than a third of normal, and therefore critically affects a person's ability to perform gainful activity.
29

Most people with heart disease this advanced have a greater risk of mortality and major functional limitations, such as shortness of breath or fatigue, even during mild exertion. In addition to consulting with the IOM and reviewing the medical research supporting this criterion, we reviewed disability claims involving chronic HF to ensure that the revised

criteria reflect listing-level severity based on medical practice. This criterion is an administrative expedient to quickly identify people whose chronic HF is at a listing-level of severity.

28
IOM. (2010), 84, 89.

29

Content—Health Encyclopedia—University of Rochester Medical Center.
(n.d.). (
https://www.urmc.rochester.edu/encyclopedia/content?contenttypeid=56&contentid=DM14
); IOM. (2010), 84, 89; Runge, M.S., Patterson, C., Stouffer, G.A., & Netter, F.H. (2010). Netter's Cardiology (2nd ed.). Philadelphia, PA: Saunders Elsevier; Fukunaga, N., Ribeiro, R. V.P., Lafreniere-Roula, M., Manlhiot, C., Badiwala, M.V., & Rao, V. (2020). Left Ventricular Size and Outcomes in Patients With Left Ventricular Ejection Fraction Less Than 20%.
The Annals of Thoracic Surgery, 110
(3), 863-869. (
https://doi.org/10.1016/j.athoracsur.2020.01.005
).

Ischemic Heart Disease

Comment:
One commenter suggested several revisions to more fully capture the causes of ischemic heart disease in paragraphs 4.00E1 (
What is ischemic heart disease (IHD)?)
and 4.00E2 (
What causes chest discomfort of myocardial origin?
). The same commenter also suggested revisions to paragraph 4.00E6 (
What is variant angina?
) to include non-obstructive coronary artery disease in our discussion of variant angina.

Response:
We partially adopted the commenter's suggestion to revise 4.00E1, 4.00E2, and 4.00E6. Although we did not propose changes to these sections in the NPRM, we agree that it is appropriate to include language addressing non-obstructive coronary artery disease to more fully explain potential sources of chest discomfort. These changes do not affect the substantive criteria of the listings, as they describe other possible origins of chest discomfort as background information but do not contain additional requirements to meet any listing.

Comment:
One commenter stated that the term “fractional flow reserve” (FFR) at listing 4.04D1 (Fractional flow reserve) was too restrictive and would exclude other similarly effective measures of coronary physiology that are commonly used (including other non-hyperemic pressure ratios such as diastolic hyperemia-free ratio (DFR), resting full-cycle ratio (RFR), diastolic pressure ratio (DPR), and/or instantaneous wave-free ratio (iFR)). The commenter suggested we use the term “coronary artery physiology” instead. Another commenter suggested adding iFR as another method to measure stenosis severity in section 4.00E (
How do we evaluate ischemic heart disease?
) and 4.04D1.

Response:
We partially adopted these comments. We added iFR as a second method to measure the severity of stenosis in 4.00E and 4.04D2 because iFR and FFR are two of the most commonly used physiological methods of assessment and have been thoroughly validated for clinical use.
30

However, we did not add the term “coronary artery physiology” to 4.04D1 because it does not align with specific measures of stenosis severity that are required in the listing.

30
Lawton, J.S., Tamis-Holland, J., Bangalore, S., Bates, E., Beckie, T., Bischoff, J., Bittl, J., Cohen, M., DiMaio, J.M., Don, C., Fremes, S., Gaudine, M., Goldberger, Z., Grant, M., Jaswal, J., Kurlansky, P., Mehran, R., Metkus, Jr., T., Nnacheta, L., Rao, S., C.A, . . . 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cariology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Circulation, 145
(3), e18-e114. (
https://doi.org/10.1161/CIR.0000000000001038
).

Comment:
One commenter suggested we replace the term “irregular heartbeat” in listing 4.04C (Documentation of three separate ischemic episodes) with “arrythmia thought to be due to ischemic cause” because the term is nonspecific.

Response:
We did not adopt this suggestion. We do not use the term “irregular heartbeat” in 4.04C. We used that term in the Supplementary Information section of the NPRM and in paragraph 4.00I2 (
What is cardiomyopathy and how do we evaluate it?
). We did not use the language suggested by the commenter for any listing criteria because the listing criteria must identify specific evidence required to meet the listing, and the phrase “thought to be due to ischemic cause” is not specific.

Comment:
Listing 4.04E (Exacerbations or complications of ischemic heart disease) includes both planned and unplanned hospital admissions for ischemic heart disease. One commenter questioned whether this included planned staged interventions of coronary artery disease.

Response:
Planned staged interventions are not exacerbations nor would they be separate events showing symptoms requiring hospitalization with improvement in the meantime to show it is an exacerbation. The staged surgical treatment plan, which may be in response to a complication or exacerbation, would be a single event and would not, by itself, satisfy the criterion in 4.04E.

Congenital Heart Disease

Comment:
One commenter expressed concerns that section 4.00H (
How do we evaluate congenital heart disease?
) does not adequately cover all forms of congenital heart disease. Specifically, their concern was that we do not include congenital heart diseases that can progress to heart failure, including right-sided heart failure. The commenter recommended that we allow exceptions for congenital heart disease that are not characterized in the listings.

Response:
We did not adopt these comments. Section 4.00H1 (
What is congenital heart disease?
) states that congenital heart disease is any abnormality of the heart or the major blood vessels that is present at birth. When congenital heart disease results in chronic HF, we evaluate it under listing 4.02 (
Chronic heart failure
), regardless of the underlying cause. As we have explained elsewhere, we do not intend to provide exhaustive discussions of congenital heart conditions that may be disabling or provide listing criteria for each condition. Notably, our rules for medical equivalence provide flexibility in determining whether an impairment is disabling by allowing us to consider whether the person's impairment is at least equal in severity and duration to the criteria of any listed impairment.
31

Moreover, if we are unable to find a person's cardiovascular disorder disabling based on meeting or equaling a listed impairment, we will continue the sequential evaluation and may find the person disabled at the final step of the process.
32

31
20 CFR 404.1520 and 416.920.

32
20 CFR 404.1520(a)(4) and (g) and 416.920(a)(4) and (g).

Comment:
One commenter proposed that we change the heading at paragraph 4.00H3 (
What is single ventricle?
) to read “What is unrepaired congenital heart disease” to “include definitions of single ventricle.” Another commenter urged us to include “unrepaired cyanotic congenital heart disease” in listing 4.06D (Single ventricle (with or without Fontan procedures)), as they broadly interpret Fontan circulation as “unrepaired.”

Response:
We did not adopt these comments. Paragraph 4.00H3 states that the term “single ventricle” (also known as single ventricle physiology or functional single ventricle) describes a diverse group of congenital cardiac anomalies sharing the common feature that only one of the two heart ventricles is adequately developed.
33

This applies whether the single ventricle has been repaired or not. Furthermore, we note in 4.06D that the criterion applies whether or not Fontan procedures have been performed.

33
Of note, the AHA guidelines use the term “single ventricle.” Stout, K.K., Daniels, C.J., Aboulhosn, J.A., Bozkurt, B., Broberg, C.S., Colman, J.M., . . . Van Hare, G.F. (2019). 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
Journal of the American College of Cardiology, 73
(12), e81-e192. (
https://doi.org/10.1016/j.jacc.2018.08.1029
).

Comment:
A commenter suggested that while there is a theoretical value in linking hypoxia to hematocrit in listing 4.06A1(Hematocrit of 55 percent or greater), there may be more variables that affect hematocrit. The commenter provided specific variables they indicated affect hematocrit in addition

to hypoxia. They noted that unless the criterion accounts for all such variables, there may be no value in linking hypoxia to hematocrit. They included specific variables that are not discussed in proposed 4.06A1.

Response:
We did not make changes based on this comment. Listing 4.06A1 discusses chronic hypoxemia, not hypoxia. We agree there may be variables other than hypoxemia that affect hematocrit, including the examples the commenter provided. Although the comment specifically referenced 4.06A1, which applies to adults, some of the commenter's examples relate to conditions in children. The criterion in 4.06A1 is only one of several alternatives for evaluating hypoxemia in congenital heart disease. We also use arterial blood gas measurements and pulse oximetry for evaluating hypoxemia when considering congenital heart disease. Other causes of elevated hematocrit levels would not be evaluated under this listing.

Comment:
We received several comments related to use of pulse oximetry in the adult and childhood listings related to hypoxemia. One commenter noted that the 87 percent oxygen saturation rate under listings 4.06A and 104.06A (Chronic hypoxemia) seemed low and added that people can be limited when resting saturation is 90 percent. Another commenter suggested the saturation cut-off should be set at less than or equal to 89 percent.

Response:
We did not adopt these comments. We use a threshold of 89 percent or below when oxygen saturation is obtained through arterial blood gas (ABG) measurements. Pulse oximeter measurements may be between 2 and 4 percent higher or lower than ABG measurements.
34

The 87 percent measurement in listings 4.06A3 (S
p
O
2
) and 104.06A3 (S
p
O
2
) accounts for this known discrepancy between pulse oximeter and ABG measurements. In addition to consulting with the IOM and reviewing the medical research supporting this criterion, we reviewed disability claims involving congenital heart disease to ensure that the revised criteria reflect listing-level severity based on medical practice.

34
Torp KD, Modi P, Pollard EJ, et al. Pulse Oximetry. 2023 Jul 30. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. PMID: 29262014;
Yale Medicine. (2023, January 3). Pulse Oximetry.
(
https://www.yalemedicine.org/conditions/pulse-oximetry
). See also MedlinePlus. (2025, November 28).
Pulse Oximetry.
(
https://medlineplus.gov/lab-tests/pulse-oximetry/
).

Comment:
One commenter noted that the proposal in listing 4.06A (Chronic hypoxemia) to require three separate S
p
O
2
measurements 30 days apart within a 12-month period to show chronic hypoxemia may be onerous, unnecessary, and would delay appropriate diagnosis.

Response:
We do not agree that the requirements in 4.06A would delay appropriate diagnosis. The requirements in our listings are intended to evaluate the severity of a person's congenital heart disease, not to establish a diagnosis. The criteria for three separate measurements 30 days apart within a 12-month period demonstrates chronicity of a person's hypoxemia. Although we indicate that the evaluations must occur within a 12-month period, people may have the requisite findings in a shorter time period. Further, gathering three separate S
p
O
2
measurements is one alternative for documenting chronic hypoxemia in our listings.

Comment:
One commenter noted that proposed listing 4.06 (
Congenital heart disease
) includes no specific mention of target threshold stats after the 6-minute walk test (6MWT) and encouraged more specificity towards a cardiac versus chronic pulmonary issue. The same commenter suggested we revise listing 4.06A3 (S
p
O
2
) to include people who are unable to perform the 6MWT.

Response:
We did not adopt these comments. The criterion in listing 4.06A3 requires a target threshold amount of less than or equal to 87 percent of oxygen saturation of blood hemoglobin on three evaluations at least 30 days apart within a consecutive 12-month period, during a 6MWT or after a 6MWT. We do not need to differentiate between cardiac and pulmonary conditions in listing 4.06 because the listing requires a diagnosis of congenital heart disease documented by appropriate medically acceptable imaging or cardiac catheterization. The listing criteria cannot be met without first fulfilling one of these requirements, which relate directly to cardiac conditions, not pulmonary conditions.

If a person is unable to perform the 6MWT, we provide other criteria for evaluating congenital heart disease under listing 4.06A (Chronic hypoxemia), including hematocrit, arterial blood gas levels, and oxygen saturation levels measured by pulse oximetry at rest.

Comment:
Under their comments identified as pertaining to listing criteria 4.06A (Chronic hypoxemia), one commenter indicated that criteria should also exist for those patients who are not cyanotic or hypoxic.

Response:
We did not adopt this comment. In listing 4.06 (
Congenital heart disease
), we provide several alternatives for evaluating congenital heart disease that do not require hypoxemia or cyanosis, including hypertension (4.06C) and exacerbations or complications requiring three hospitalizations in a 12-month period (4.06E). While listing 4.06A requires a diagnosis of chronic hypoxemia, a person with congenital heart disease who is not cyanotic or hypoxic may still be found disabled under one of the other criteria in listing 4.06, other cardiovascular listings, our rules for functional equivalence in children,
35

or at step 5 of the adult sequential evaluation process.
36

35
20 CFR 416.926a.

36
20 CFR 404 1520(g) and 416.920(g).

Comment:
One commenter suggested that we include criterion pertaining to cardiac surgery and complications from cardiac intervention in listing 4.06A1 (Hematocrit of 55 percent or greater).

Response:
We did not adopt this comment. The occurrence of a surgery does not necessarily mean a person will have limitations that prevent them from performing substantial gainful activity and meet the durational requirement. If the person has complications resulting from a surgery, we will evaluate them under listing 4.06E (Exacerbations or complications of congenital heart disease).

Comment:
One commenter encouraged SSA to consider the duration of a hospitalization as a marker for complexity, not just the need for readmission under listing 4.06E (Exacerbations or complications of congenital heart disease). The same commenter similarly encouraged SSA to consider prolonged hospitalizations under listing 104.06E (Exacerbations or complications of congenital heart disease). They noted concerns that a person who is chronically hospitalized, which they defined as more than 90 days, would not qualify for disability under 104.06E but likely should.

Response:
We did not make any changes based on these comments. We consider the duration of a person's hospitalization as a marker of complexity; both 4.06E and 104.06E require that each hospitalization last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization. A person with prolonged hospitalization as described by the commenter is likely to have medical findings that satisfy another criterion. The condition(s) leading to the prolonged hospitalization may also medically equal another cardiac listing under our equivalence

policy.
37

Furthermore, satisfying the hospitalization criteria is only one way that we may find a person disabled under the adult and childhood listings for congenital heart disease.

37
20 CFR 404.1526 and 416.926.

Vascular Disease

Comment:
We received comments suggesting that we use the term “peripheral artery disease” in place of “peripheral arterial disease” throughout section 4.00G (
How do we evaluate peripheral vascular disease?)
and listing 4.12 (SSA Note: In the NPRM we titled this section “
Peripheral arterial disease
”), and replace the term “ankle-brachial systolic blood pressure ratio” with “ankle-brachial index,” which is the common term used for the test.

Response:
We adopted these comments. We must use appropriate modern medical terminology to specify the medical criteria we use to evaluate cardiovascular disorders. Our research indicates that “ankle-brachial index” is the more commonly used term among professionals in the field of cardiology.
38

For consistency, we also replaced the term “arterial” with “artery” (in this final rule listing 4.12 is now titled “Peripheral artery disease”). Additionally, we replaced “toe/brachial systolic blood pressure ratio” with “toe-brachial index.”

38
A review of the website for the Journal of the American Medical Association (JAMA), a peer-reviewed medical journal published 48 times a year by the American Medical Association, found that the term “ankle-brachial index” was used more than “ankle-brachial systolic blood pressure ratio.”

Comment:
A commenter recommended adding “lymphatics” to the list describing disorders of the veins or arteries at paragraph 4.00A1c (Disorders of the veins or arteries) and adding text that describes the symptoms of lymphedema to paragraph 4.00G1 (
What is peripheral vascular disease (PVD)?
). The same commenter recommended broadening paragraph 104.00F9 (
What is lymphedema and how do we evaluate it?
) to address “lymphatic disorder” or “lymphatic perfusion disorder.”

Response:
We partially adopted these comments. We added language to paragraph 4.00G4a and 104.00F9a (
Lymphedema
) that describes lymphedema. We did not revise paragraphs 4.00A1c or 4.00G1. The lymphatic system is not part of the cardiovascular system. Disorders of lymphatic circulation, such as lymphedema, are related to the immune system of the body. Although the signs and symptoms of lymphatic disease are similar to those associated with peripheral vascular disease, lymphatic disease is not part of the vascular system and is treated in a completely different manner. We believe it is more appropriate to provide general guidance about lymphedema in this section rather than focus on specific lymphatic disorders.

Comment:
One commenter suggested editorial changes to paragraph 4.00G6 (
Are there any other studies that are helpful in evaluating PAD?
) to include brief discussion of Doppler waveforms and plethysmographic tracings. The commenter further suggested that we include “stenting” along with our discussion of peripheral grafting in paragraph 4.00G9 (
How do we use listing 4.12 if you have had a peripheral graft?
) to better reflect current medical technologies and treatment.

Response:
We adopted the suggested editorial changes.

Comment:
One commenter questioned whether venous dopplers are the only method to establish the diagnosis of chronic venous insufficiency.

Response:
Venous dopplers are not the only method to establish a diagnosis of chronic venous insufficiency. In listing 4.11 (
Chronic venous insufficiency
), we allow for a person's chronic venous insufficiency to be documented by duplex ultrasound “or other appropriate diagnostic technique.”

Comment:
One commenter recommended clarifying section 4.00G (
How do we evaluate peripheral vascular disease?
) to include that peripheral artery disease can cause leg or foot pain.

Response:
We adopted this comment. This change better encapsulates symptoms of claudication, which include pain not only in the calf, but also other parts of the lower extremities, such as the thighs or buttocks. This wording is consistent with the language in listing 4.12 (
Peripheral artery disease
), which discusses intermittent claudication or leg pain, as opposed to simply calf pain.

Comment:
One commenter recommended that we add a third option to the criteria in listing 4.11 (
Chronic venous insufficiency
) to account for leg pain that interferes with mobility and provided a specific criterion for consideration.

Response:
We did not adopt this comment. The commenter suggested a standalone criterion that does not include objective medical findings and does not quantify the limitation in mobility. Without specific quantified criteria for limitations in mobility, we would not be able to ensure the consistent application of the proposed criterion. To consider pain as a listing criterion, we would also require medical signs documenting the chronic venous insufficiency. Symptoms such as pain are subjective and difficult to quantify. We will not substitute symptoms such as pain for a medical sign (or diagnostic finding) in the listing criteria. However, if we are unable to find a person's cardiovascular disorder meets or medically equals a listed impairment, we will continue the sequential evaluation process and evaluate the person's symptoms, including pain, as set forth in our regulations.
39

39
20 CFR 404.1529 and 416.929.

Comment:
A commenter had questions pertaining to the duration requirement of listing 4.11B (Two or more episodes of ulceration), specifically whether this listing requires the presence of an ulceration that has not healed following at least 6 months of treatment, or whether it would also need to last for 12 continuous months.

Response:
A temporal requirement such as the requirement described in 4.11B serves as a specific indicator of listing-level severity and does not establish that the medically determinable impairment (MDI) meets the duration requirement. To meet the duration requirement, the MDI(s) must have lasted, or be expected to last, for a continuous period of at least 12 months and the person's resulting inability to perform substantial gainful activity by reason of the MDI(s) must also have lasted, or be expected to last, for not less than 12 months without interruption or stopping.
40

40
20 CFR 404.1509 and 416.909.
See also
SSR 23-1p (2023). Available at:
https://www.ssa.gov/OP_Home/rulings/di/01/SSR2023-01-di-01.html.

Comment:
One commenter inquired as to why we did not include a listing addressing deep venous thromboses (DVT) or pulmonary emboli (PE).

Response:
We understand the commenter's concerns related to DVTs and PEs. When DVTs or PEs are chronic, there are a number of factors we consider in determining the appropriate body system(s) for evaluation. When the chronic DVT or PE has a specific cause, we will evaluate the impairment under the listing related to that cause. For example, an underlying disorder of thrombosis would be evaluated under the hematological body system. In other cases, the chronic DVT or PE may result in another MDI. For example, the chronic DVTs may cause heart failure which would be evaluated under listing 4.02 (
Chronic heart failure
). In many cases, the chronic DVT may result in signs and symptoms similar to those for chronic venous insufficiency. In such cases, we would evaluate the impairment under the medical

equivalence policy for listing 4.11 (
Chronic venous insufficiency
).

Other Cardiovascular Disorders

Comment:
One commenter suggested broadening listing 4.07 (
Aortic valvular disease
) to include all valvular heart diseases, as all valve diseases can cause heart failure symptoms and disability.

Response:
We did not adopt this comment. The introductory text at paragraph 4.00I3 (
How do we evaluate valvular heart disease?
) specifically notes we may evaluate other forms of valvular disease under listings 4.02 (
Chronic heart failure
), 4.04 (
Ischemic heart disease
), 4.05 (
Recurrent arrhythmias
), 4.06 (
Congenital heart disease
), or a listing in 11.00 (
Neurological Disorders
), depending on its effects on the person. The listings are not intended to be an exhaustive compilation of disabling conditions. Rather, they are used to identify cases at an early stage of the sequential evaluation process that meet a strict threshold for the statutory definition of disability. They describe impairments that we consider severe enough to prevent an adult from doing any gainful activity. If an impairment does not meet a listing, this does not mean that we will deny a claim. Rather, we will continue the sequential evaluation.

Comment:
One commenter suggested that listing 4.08 (
Cardiomyopathy
) should include a functional component and should not be dependent on an exercise tolerance test (ETT). The commenter expressed concerns about logistical barriers related to practices of locally available physician's offices that may inhibit access to vendors who can properly perform ETTs for some offices (
e.g.,
Disability Determination Services), and suggested that the listing needs to take this into consideration. The same commenter expressed concerns about the ability to order echocardiograms and the resulting effect on the ability of those offices to evaluate claimants under listings 4.02C and 4.07. Another commenter suggested that functional details would help clarify guidelines regarding the cardiomyopathy listing.

Response:
We adopted the suggestion to add functional criteria to listing 4.08. Although proposed listing 4.08 provided criteria for evaluating cardiomyopathy when ETTs present significant risks to the person, we agree that consideration of a person's functioning is appropriate. This criterion is consistent with the criterion we provide in listing 4.02B1b (Very serious limitation) for evaluating chronic HF when ETTs cannot be performed.

Regarding the commenter's concern about some offices having barriers to ordering ETTs or echocardiograms, the listing criteria are based on a person's medical condition and the types of findings typically present in disability claims. An echocardiogram is a common diagnostic test that is typically included in the medical evidence of record for claimants with these impairments. In addition, we allow other acceptable medical testing. Furthermore, listing 4.08 provides several alternative criteria that do not consider ETTs or echocardiograms for evaluating cardiomyopathy. SSA would follow the existing processes (which are outside of the scope of the listing criteria and this rulemaking) to address any logistical concerns and barriers to acquiring the necessary medical evidence, which may include, when appropriate, ordering an echocardiogram.

Comment:
One commenter suggested we establish sex-specific criteria in evaluating hypertrophic cardiomyopathy in listing 4.08 (
Cardiomyopathy
) to account for differences in body size and heart dimensions.

Response:
We did not adopt this comment. In the clinical guidelines for diagnosing and evaluating hypertrophic cardiomyopathy, the American College of Cardiology, the American Society of Echocardiology, and the American Heart Association do not provide standards for cardiac wall measurements based on sex or body size.
41

Therefore, we think it is inappropriate to incorporate such requirements in our listings.

41
Heidenreich, P.A., Bozkurt, B., Aguilar, D., Allen, L.A., Byun, J.J., Colvin, M.M., Deswal, A., Drazner, M.H., Dunlay, S.M., Evers, L.R., Fang, J.C., Fedson, S.E., Fonarow, G.C., Hayek, S.S., Hernandez, A.F., Khazanie, P., Kittleson, M.M., Lee, C.S., Link, M.S., Milano, C.A., . . . ACC/AHA Joint Committee Members (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Circulation, 145
(18), e895-e1032. (
https://doi.org/10.1161/CIR.0000000000001063
).

Comment:
One commenter suggested adding all etiologic factors to listing 4.10 (
Dissecting aneurysm of the aorta or major branches),
as it currently does not specifically mention other connective tissue disorders or penetrating aortic ulcers as other etiological factors.

Response:
We did not adopt this comment. Under listing 4.10, we evaluate dissecting aneurysm of the aorta or major branches due to any cause. The listing text is not meant to be an exhaustive compilation of the causes of dissecting aneurysms; therefore, it is not necessary to list other etiological factors.

Comment:
One commenter asked if listings 4.16 and 104.16 (
Cardiac allograft vasculopathy)
address issues such as vasculitis, including Kawasaki disease.

Response:
Cardiac allograft vasculopathy is a condition that affects the blood vessels of the heart in people who have had a heart transplant. The condition does not include those who develop narrowing of the arteries due to other conditions. People who develop narrowing or blockage of arteries of the heart in the absence of a heart transplant are evaluated under listing 4.04 (
Ischemic heart disease).
Systemic vasculitis is an immune system disorder which we evaluate under listings 14.03 and 114.03 (
Systematic vasculitis
). We provide information about how we evaluate Kawasaki disease in paragraph 104.00F8 (
How do we evaluate Kawasaki disease?
).

Comment:
One commenter suggested we include other genetic connective tissue disorders with serious cardiovascular effects, such as Loeys-Dietz Syndrome, in paragraphs 4.00I8 and 104.00F10 (
What is Marfan syndrome and how do we evaluate it?
).

Response:
We adopted this comment to explain how genetic connective tissue disorders other than Marfan syndrome are evaluated under the listings. We added a new paragraph to sections 4.00I and 104.00F (
How do we evaluate other cardiovascular disorders?
) that discusses the evaluation of connective tissue disorders with cardiovascular effects, such as Loeys-Dietz syndrome and Ehlers-Danlos syndrome.

Miscellaneous

Comment:
One commenter questioned why “reduced oxygen concentration” is listed as a mechanism for hypoxemia in paragraphs 4.00A1b(iv) and 104.00A1b(iv) (Hypoxemia), when hypoxemia is synonymous with reduced oxygen concentration.

Response:
We agree that including the words “reduced oxygen concentration” is redundant. Therefore, we removed “reduced oxygen concentration in the arterial blood” as a cause of hypoxemia.

Comment:
One commenter noted that in paragraph 4.00C8d (We will wait to purchase an exercise test), “percutaneous transluminal coronary angioplasty” and “percutaneous coronary intervention” are the same procedure, and we should consider using only one term.

Response:
We did not adopt this comment. While these terms are both names for the same procedure, they are each used in medical records. We kept

both terms in 4.00C8d to account for the use of both terms in medical records.

Comment:
One commenter recommended that we revise our language in paragraph 4.00C15 (
How do we evaluate cardiac catheterization evidence?)
to better describe the type of information commonly provided by a cardiac catheterization. The commenter also provided specific language for consideration.

Response:
We partially adopted this comment. As the commenter suggested, we removed the last sentence of paragraph 4.00C15a (We will not purchase) and we revised paragraph 4.00C15b (Cardiac catheterization reports). Specifically, we incorporated additional information into the description of typical cardiac catheterization report content, while retaining other findings commonly seen by adjudicators in medical evidence. We did not include some of the suggested language that only described background information and was less helpful in understanding the requirements to meet any listing.

Comment:
One commenter recommended clarifying that paragraph 4.00C16 (
What details should exercise Doppler test reports contain?
) applies to Doppler studies of the lower extremities and recommended specific language.

Response:
We partially adopted this comment. While relatively rare, exercise Doppler tests can be performed for conditions other than peripheral vascular disease. We recognize that this distinction was not clear in our proposed language; therefore, while we did not include all of the exact language suggested by the commenter, we revised the language to distinguish between elements of a report common to all exercise Doppler tests and those specific to exercise Doppler tests for peripheral vascular disease.

Comment:
A commenter noted that the 3-month waiting period after treatment begins under paragraph 4.00J2 (
How do we relate treatment to functional status?
) may be unnecessary due to the rapid progression of some peoples' disease and the improbable improvement with treatment.

Response:
We did not adopt this comment. In paragraph 4.00B4 (
When will we wait before we ask for more evidence?
), we explain that we may need to defer evaluation of an impairment for a period of up to 3 months from the date treatment began. We further state in paragraph 4.00B4b (In these situations) that “we will not wait if we have enough information to make a determination or decision based on all of the relevant evidence in your case.”

Comment:
One commenter questioned whether determinations regarding ability to perform an ETT made by “medical sources” in listing 4.02B1a (A medical source has concluded) and listing 4.08 (
Cardiomyopathy
) includes medical consultants.

Response:
We did not make any changes in response to this comment. Paragraph 4.00D4c(i) (Your impairment satisfies the first part) states that if the case record does not include a conclusion from a medical source that an ETT would present a significant risk to you, a medical consultant as defined in paragraph 4.00A3a (
Medical consultant
) may make such a conclusion.

Comment:
A commenter indicated that the term “prescribed treatment” lacked clarity and suggested replacing it with “guideline-recommended treatment” in listing 4.12 (SSA Note: In the NPRM we titled this section “Peripheral arterial disease”).

Response:
We did not adopt this comment. The term “failure to follow prescribed treatment” is a term of art that is described in our regulations at 20 CFR 404.1530 and 416.930. We hold a person responsible to follow treatment prescribed by their medical source if that treatment is expected to restore the ability to work. The term “guideline-recommended treatment” does not adequately convey that requirement.

Comments Specific To Evaluating Cardiovascular Disorders in Children

Comment:
A commenter suggested replacing the word “corrective” with “palliative” in paragraph 104.00B4 (
When will we wait before we ask for more evidence?
).

Response:
We did not adopt this comment. Paragraph 104.00B4 discusses when we will wait before we ask for additional evidence. The term “corrective” covers conditions where improvement may occur post-surgery and is appropriate for a situation when we will wait before asking for more evidence. The term “palliative” implies a likeliness that the person will have significant lifelong impairment in function. This term would not be an appropriate replacement, because the term would apply to situations when we do not wait for additional evidence.

Comment:
One commenter recommended removing the word “congestive” from paragraph 104.00B4a(iii) (If you have started new drug therapy).

Response:
We adopted this comment. Although we did not propose changing the wording in 104.00B4a(iii), we agree removing “congestive” reflects the terminology more commonly used in the medical field.

Comment:
A commenter recommended we add “volume” as a measure of ventricle size as evidence necessary to show cardiomegaly in paragraph 104.00C2b(i) (Symptoms of congestion). The same commenter recommended we remove the requirement for a 6-foot PA film to show cardiomegaly.

Response:
Although the commenter identified the incorrect section for the discussion of cardiomegaly, we adopted the recommendation and added increased ventricular volume in the discussion of cardiomegaly in paragraph 104.00C2a (Cardiomegaly or ventricular dysfunction) because increased ventricular volume is a finding that is helpful in evaluating cardiomegaly and is often documented in medical records. However, we did not make additional changes based on the recommendation to remove the requirement for 6-foot PA film, as we had already proposed removing this requirement in the NPRM and ultimately did so in this final rule.

Comment:
A commenter noted that the absence of tachycardia may no longer be a relevant assessment of the severity of heart failure in discussing listing 104.02A (Persistent tachycardia at rest).

Response:
We did not make changes based on this comment. Assessment of tachycardia is an important and common factor in evaluating heart failure. Even in its absence, listing 104.02 (
Chronic heart failure
) provides several criteria by which a person may be found disabled, including several criteria that do not consider tachycardia.

Comment:
A commenter recommended that we consider revising the criterion under listing 104.02A (Persistent tachycardia at rest) and listing 104.02B (Persistent tachypnea at rest) to define tachycardia and tachypnea as a resting heart rate or respiratory rate (respectively) in excess of the upper limit of normal for that age. The commenter also suggested that we use the criteria on more than one evaluation more than 3 days apart, rather than at least 90 days apart. The same commenter also noted that the 12-month assessment period is too long and would result in delays.

Response:
We did not adopt these comments. The commenter appears to suggest that we use a broad definition of tachycardia and tachypnea rather than providing specific cutoffs for each age range. The definition suggested is overly broad and there does not appear to be consensus among the medical community as to what the “upper limit of normal” is for various age ranges.

Furthermore, the use of a definition without specific cutoffs could lead to inconsistent determinations and decisions because of the underlying variation in the cutoffs used by the medical community.

Regarding the commenter's suggestion to require more than 3 days between evaluations, as we stated in the NPRM, we believe that a longer time period between evaluations is necessary to ensure that the underlying condition is chronic and not acute. We believe that requiring evaluations to occur at least 90 days apart is an appropriate time period for establishing the chronicity of the underlying condition. Although we indicate that the evaluations must occur within a 12-month period, we expect that many people may have the requisite findings in a shorter time period.

Comment:
With respect to listing 104.02A (Persistent tachycardia at rest), a commenter noted that tachycardia and tachypnea are not exclusive to chronic HF and may also be seen in acute or chronic HF or heart failure exacerbation.

Response:
Although we understand the commenter's concern, listing 104.02 (
Chronic heart failure
) is specifically used to evaluate chronic HF, and not other disorders which may present with tachycardia and tachypnea.

Comment:
One commenter noted that persistent tachycardia can also include measurement by palpation of pulse, in addition to the proposed apical heart rate.

Response:
We did not make changes based on this comment. A pulse rate taken by palpation is a measurement of the pressure waves created by contraction of the left ventricle, an indirect measurement, whereas measurement of the apical pulse rate is a direct measurement of the left ventricle's contraction; therefore, this direct measurement is a more accurate measurement of the child's heart rate than the indirect measurement. The apical pulse gives the most accurate reading.
42

42
Zimmerman B., Williams D. Peripheral Pulse. 2025 July 6. In: StatPearls [internet]. Treasure Island (FL): StatPearls publishing; 2025 Jan. PMID: 31194332. (
https://www.ncbi.nlm.nih.gov/books/NBK542175/
).; Cleveland Clinic.
Apical Pulse.
(
https://my.clevelandclinic.org/health/articles/23346-apical-pulse
).

Comment:
One commenter suggested we consider growth failure instead of persistent tachycardia and tachypnea for the pediatric population under listing 104.02 (
Chronic heart failure).
Another commenter expressed concerns that growth failure over the 12-month evaluation period under listing 104.02C (Growth failure) may not be reflected on growth charts as it is generally treated aggressively, with providers not waiting 12 months to initiate treatment. The same commenter also suggested expanding the symptoms of chronic HF in paragraph 104.00C2b (Your medical history and physical examination) to include signs and symptoms related to feeding intolerance and associated complications.

Response:
We did not adopt the first comment because we already provide criteria for evaluating growth failure in chronic HF in 104.02C. It is one of several ways to evaluate chronic HF in children, along with persistent tachycardia and tachypnea. Additionally, although we understand the second commenter's concerns, the criteria for growth failure in 104.02C are intended to establish that the growth failure persists while on a regimen of prescribed treatment, including nutritional support. Furthermore, while we indicate that the evaluations must occur within a 12-month period, many people will have the requisite findings in a shorter time period. We adopted the suggestion to expand the symptoms of chronic HF in 104.00C2b to include signs and symptoms related to feeding intolerance and associated complications.

Comment:
One commenter questioned the requirement in listing 104.02E (Exacerbations or complications of chronic heart failure) that children with chronic heart failure experience three hospitalizations within a consecutive 12-month period. They noted three hospitalizations “seems high” and suggested requiring only two hospitalizations within a consecutive 12-month period. The same commenter similarly suggested that we reconsider the hospitalization criterion in listing 104.06E (Exacerbations or complications of congenital heart disease), which also requires three hospitalizations within a 12-month period.

Response:
We did not make changes based on these comments. For children, the requirement for three hospitalizations within a consecutive 12-month period is grounded in our rules for functional equivalence, specifically how we define “marked” and “extreme” limitations in the “Health and physical well-being” domain.
43

If a child has frequent exacerbations of their impairment (
i.e.,
episodes of illness or exacerbations that occur on average of three times per year, or once every 4 months, each lasting 2 weeks or more) that result in significant, documented signs or symptoms, we may consider that to be a “marked” limitation in this domain.
44

If the frequent exacerbations result in significant, documented symptoms or signs that are substantially in excess of the requirements for showing a “marked” limitation, we may find the child to have an “extreme” limitation in this domain.
45

Although the hospitalization requirement is less than the 2 weeks contemplated in the definition of a “marked” limitation, the 2-week period will also consider the period immediately before the hospitalization and the post-hospitalization recovery. Exacerbations and complications requiring frequent hospitalization demonstrate a level of care beyond the usual course of treatment for cardiovascular disorders and are consistent with listing-level severity.

43
20 CFR 416.926a(e)(2)(iv) and 416.926a(e)(3)(iv).

44
20 CFR 416.926a(e)(2)(iv).

45
20 CFR 416.926a(e)(3)(iv).

Further, the hospitalization criterion in 104.02E and 104.06E is just one of several ways to document listing-level severity under each of these listings. We are also able to evaluate exacerbations or complications of chronic HF and congenital heart disease resulting in fewer than three hospitalizations in a consecutive 12-month period using our rules for medical equivalence,
46

under our rules for functional equivalence,
47

or under other listing criteria.

46
20 CFR 404.1526 and 416.926.

47
20 CFR 416.926a.

Comment:
In response to a question we posed on the consideration of the atrial measurements in listing 4.02A2 (Heart failure with preserved ejection fraction), one commenter noted that the criteria found in listing 4.02A1 (Heart failure with reduced ejection fraction) are not applicable to children. They suggested that eligibility for children should be determined based on z-scores, biomarkers, or clinical findings as opposed to diastolic dimensions and wall thickness. They noted that left atrial enlargement is difficult to use as a criterion in children since there is no normative data for all age groups and the presence of some types of heart disease precludes this measurement. Furthermore, they noted that other end organ failure (renal disease, growth failure, neurodevelopmental disorders) needs to be considered for their impact.

Response:
We did not make any changes in the final rule based on the commenter's concerns. Our final criteria for evaluating chronic HF in children do not include the types of specific measurements we use for adults. As we noted in the NPRM, we proposed to revise paragraph 104.00C2 (
What evidence of chronic HF do we need?
) to

remove “specific findings for documenting cardiomegaly,” because such findings are infrequently included in a child's case record and this absence presents difficulty in case adjudication. We believe that requiring z-scores or biomarkers would also be infrequently present and thus poses similar difficulty in case adjudication. Our rules already provide for evaluating other end organ failure. If the chronic HF results in end organ failure, such as renal disease and neurodevelopmental disorders, we will evaluate the effects under the appropriate body system or under our rules for functional equivalence.
48

We already provide specific guidance for evaluating growth failure in paragraph 104.00C3 (
How do we evaluate growth failure due to chronic HF?
).

48
20 CFR 416.926a.

Comment:
One commenter recommended revisions to paragraph 104.00D1 (
What is congenital heart disease?
) to include additional treatments, such as an interventional catheterization procedure, and examples of congenital heart abnormalities, such as truncus arteriosus, total anomalous pulmonary venous return, and Epstein malformation.

Response:
We adopted the recommended revisions to provide additional examples of congenital heart disease and its treatment.

Comment:
One commenter recommended that we expand the list of impairments that may require life-saving surgery before age 1 in paragraph 104.00D2c (For 104.06D, life-threatening congenital heart disease) to include “pulmonary atresia” and “critical pulmonary stenosis.”

Response:
We did not adopt this comment. The examples of life-saving surgeries in 104.00D2c are not meant to be an exhaustive list of every life-saving surgery before age 1. However, we did make a related change to introductory text paragraph 104.00D1 (
What is congenital heart disease?)
as a result of the comment. We added pulmonary atresia as an example of congenital valvular defects in paragraph 104.00D1c (
Valvular defects or obstructions to ventricular outflow
).

Comment:
A commenter suggested revising the text in paragraph 104.00D4 (
What is single ventricle?
) and adding “pulmonary atresia with intact ventricular septum” to the list of single ventricle anomalies.

Response:
We partially adopted this comment. We added “pulmonary atresia with intact ventricular septum” to the list of single ventricle anomalies. We did not make the suggested minor edits to the text, because this paragraph describes background information, and the minor edits had unnecessary detail that is not informative for adjudication. However, we did include the additional discussion of Fontan circulation in 104.00D4. We made parallel changes to paragraph 4.00H3 (
What is single ventricle?
).

Comment:
We received a comment related to the use of arterial saturation in listing 104.06 (
Congenital heart disease
). A commenter recommended we consider replacing the proposed emphasis on arterial saturation with oximetry and imaging diagnosis at listing 104.06A (Chronic hypoxemia), but if arterial saturation were to be used, the commenter recommended that the threshold should be set to less than 95 percent in room air. The commenter noted that the current threshold would not be appropriate for children considering that the adult threshold is set to 89 percent. The commenter also suggested a better alternative would be an echocardiographic diagnosis of anatomic abnormality.

Response:
We did not adopt this comment. As we previously stated, the criterion for ABG measurements is only one alternative for establishing disability under the listing for congenital heart disease. Although ABGs may be infrequently done on children, these tests may be found in the medical evidence for some children. A threshold of less than 95 percent on room air is not appropriate because it does not reflect a level of hypoxemia that would result in marked and severe limitations (
i.e.,
that threshold does not reflect a disabling impairment).

Echocardiography is appropriate medically acceptable imaging that we use to establish congenital heart disease as an MDI. However, an anatomical abnormality established by echocardiography does not necessarily establish a degree of limitation that a child would experience. To establish the degree of limitations, we consider chronic hypoxemia or other medical findings.

Comment:
One commenter suggested revising the description of congenital heart disease in listing 104.06C (Single ventricle) to account for those with single ventricle congenital heart disease. The commenter provided specific language they suggested we include in the listing, including specific functional limitations.

Response:
We did not adopt this comment. The criterion in 104.06C is sufficient to establish a disabling impairment and it is not necessary to include the functional component suggested by the commenter. In addition to consulting with the IOM and reviewing the medical research supporting this criterion, we reviewed disability claims involving single ventricle congenital heart disease to ensure that the revised criteria reflect listing-level severity based on medical practice.

Comment:
One commenter suggested we consider additional assessments to evaluate chronic HF and congenital heart disease in children. They specifically recommended including poor feeding, poor weight gain, frequent respiratory infections, irritability, and hepatomegaly.

Response:
We did not adopt this comment. We provide a criterion for evaluating poor weight gain in listing 104.02C (Growth failure). We also provide a criterion for considering frequent respiratory infections in listings 104.02E (Exacerbations or complications of chronic heart failure) and 104.06E (Exacerbations or complications of congenital heart disease). Furthermore, the listings are not meant to be an exhaustive list of all signs, symptoms, and complications of cardiac impairments. They are meant to identify the common medical findings that cause marked and severe limitation in most children. Signs and symptoms not found in the listings may still be evaluated under the functional equivalence rules.
49

Some conditions may also be evaluated under their related body system, such as evaluating hepatomegaly under the Digestive Disorders listings.

49
20 CFR 416.926a.

Comment:
One commenter recommended that we revise the text in paragraph 104.00E4a (Implanted cardiac defibrillators), describing children at risk for sudden cardiac arrest due to arrhythmias, including adding “hypertrophic cardiomyopathy” and “rare forms of ischemic cardiomyopathy” to the description.

Response:
We did not adopt this comment. This section addresses the evaluation of children with implanted cardiac defibrillators who do not meet the listing requirements. The information about cardiomyopathy merely identifies the largest group of children at risk for sudden cardiac death and is not intended to provide information about the evaluation of cardiomyopathy. We provide more specific information about cardiomyopathy in paragraph 104.00F3 (
What is cardiomyopathy and how do we evaluate it?
).

Comment:
One commenter suggested adding specific language to paragraph 104.00F1 (

What is ischemic heart disease (IHD) and how do we evaluate

it in children?

) to address the causes of IHD in children.

Response:
We did not adopt the commenter's suggested language. Our evaluation of IHD in children focuses on the functional limitations resulting from IHD and thus addressing specific causes of IHD is not required for adjudication of these cases.

Comment:
One commenter suggested revising the description of cardiomyopathy we proposed in paragraph 104.00F3a (There are various types of cardiomyopathy) to include subtypes of dilated, hypertrophic, restrictive, noncompaction, and arrhythmogenic.

Response:
We partially adopted this comment. We included the suggested “arrhythmogenic” as it is a more common type of cardiomyopathy and removed “hypertensive,” because it is less commonly used to categorize cardiomyopathies. However, we did not include all the suggested types because there is lack of consensus as to what constitutes a separate type of cardiomyopathy. We also made these changes in the introductory text for consistency. Although the final text does not enumerate all five subtypes listed by the commenter, our text already refers to several of them. These are included for illustrative purposes and are not meant to be an exhaustive list of every type or subtype of cardiomyopathy.
50

The specific subtype of cardiomyopathy is not a consideration under our childhood listings. We will evaluate cardiomyopathy in children under listing 4.04 (
Ischemic heart disease
) in part A, listing 104.02 (
Chronic heart failure
), or listing 104.05 (
Recurrent arrhythmias
), depending on its effects on the child.

50
National Heart, Lung, and Blood Institute (2024, December 6).
Cardiomyopathy Types.
(
https://www.nhlbi.nih.gov/health/cardiomyopathy/types
); Brieler, J., Breeden, M., Tucker, J. (2017). Cardiomyopathy: An Overview.
American Family Physician,
96 (10), 640-646, (
https://www.aafp.org/pubs/afp/issues/2017/1115/p640.html
). These articles illustrate the diversity of classifications of cardiomyopathy.

Comment:
One commenter noted that we should consider the person's status classification when evaluating children listed for a transplant under paragraph 104.00F5c (We will not assume). They noted that children placed on the transplant list as category “1A” are most certainly disabled as they require extensive medical intervention including intensive care hospitalization, life support measures, and certain cardiac supporting intravenous medications with a Swan-Ganz catheter, or mechanical-assist devices.

Response:
We did not adopt this comment. Although we do not consider a child's status on the transplant waiting list, we will consider the evidence that resulted in that classification. For children who are in classification 1A, we expect that the evidence supporting 1A will, in most cases, result in a finding of disability based on meeting or medically equaling a cardiovascular disorder listing or functionally equaling the listings.
51

51
20 CFR 416.924.

Comment:
One commenter suggested we retain the listing for rheumatic heart disease (current listing 104.13).

Response:
We did not adopt this suggestion. As we state in final paragraph 104.00F6 (
How do we evaluate chronic rheumatic fever or rheumatic heart disease?
), we evaluate the manifestations of rheumatic heart disease under other criteria, such as listing 104.02 (
Chronic heart failure
) or listing 104.05 (
Recurrent arrhythmias
). If a child's rheumatic heart disease does not meet or medically equal a listing, we will evaluate it under our functional equivalence rules.
52

52
20 CFR 416.924.

Other Concerns Raised by Commenters

Comment:
We received several comments expressing concerns with the age of the IOM report and that our updates to the listings are based on outdated science. One commenter noted our changes to the listings may not make the listings more scientifically accurate and may result in some people no longer qualifying for benefits through the listings.

Response:
The IOM report is one of several sources that informed these revisions to the cardiovascular disorders listings. Despite the age of the IOM report, it remains relevant because it was drafted within the context of the statutory definition of disability and the cardiovascular listings. These considerations may be different than those found in a strictly clinical setting. However, in drafting the NPRM and this final rule, we additionally reviewed current research, consulted with agency cardiologists and other medical experts, and reviewed disability claims involving cardiovascular disorders to ensure the IOM recommendations are still relevant. We are confident the policy changes we are finalizing reflect relevant and current medical practice, and the impact of cardiovascular impairments on the person's ability to sustain gainful activity, or ability to perform age-appropriate activities (for children).

We recognize the importance of clinical practice in formulating policy. In drafting this final rule, we reviewed and considered information more recently released, including the joint guidelines promulgated by the American Heart Association, the American College of Cardiologists, and the Heart Failure Society of America.
53

However, the clinical guidelines focus on the diagnosis and treatment of people with cardiac conditions and do not necessarily consider a person's level of impairment or functioning as it relates to the definition of disability in the Act.
54

In addition, we considered recent information from other sources, including the comments we received from the public in response to the NPRM and the published sources of medical literature and research we list in the references section of the NPRM and those cited in this final rule.

53
Heidenreich, P.A., Bozkurt, B., Aguilar, D., Allen, L.A., Byun, J.J., Colvin, M.M., Deswal, A., Drazner, M.H., Dunlay, S.M., Evers, L.R., Fang, J.C., Fedson, S.E., Fonarow, G.C., Hayek, S.S., Hernandez, A.F., Khazanie, P., Kittleson, M.M., Lee, C.S., Link, M.S., Milano, C.A., . . . ACC/AHA Joint Committee Members (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Circulation, 145
(18), e895-e1032. (
https://doi.org/10.1161/CIR.0000000000001063
).

54
See sections 216(i)(1), 223(d), and 1614(a)(3) of the Act (42 U.S.C. 416(i)(1), 423(d), 1382c(a)(3)).

Comment:
One commenter suggested that we consider whether reliance on healthcare use as a proxy for severity raises concerns regarding racial equity.

Response:
We appreciate the commenter's suggestion. However, to be disabled under the Act, a person must have one or more medically determinable impairments—impairments that result from anatomical, physiological, or psychological abnormalities shown by medically acceptable clinical and laboratory diagnostic techniques.
55

If there is insufficient medical evidence for us to determine whether a person is disabled, we may ask the person to attend one or more examinations or tests at our expense.
56

Once we have evidence that shows a medically determinable impairment, we consider all the available evidence from all sources, medical and non-medical, when we make a disability determination.

55
See sections 216(i)(1), 223(d)(1) and 1614(a)(3) of the Act (42 U.S.C. 416(i)(1), 423(d)(1), and 1382c(a)(3)). 20 CFR 404.1521 and 416.921.

56
20 CFR 404.1517 and 416.917.

The listings describe impairments that are so severe they prevent people from doing any substantial gainful activity regardless of their age, education, or

work experience.
57

People with very serious cardiovascular disorders, such as those described in these listings, often receive the kinds of diagnostic treatments and tests discussed in the listings because of urgent medical need.

57
20 CFR 404.1525(a) and 416.925(a).

However, we do not penalize those who do not have access to the kinds of medical evidence that we describe in these listings. Furthermore, we provide several alternative criteria for people with cardiovascular impairments to establish that their impairment is of listing-level severity. If a person's cardiovascular disorder does not meet the requirements of any listing, we can still find that person disabled based on a finding of medical equivalence or functional equivalence in child claims or at a later step in our adjudication process.
58

58
20 CFR 404.1520, 416.920, and 416.924.

Comment:
We received several comments expressing concerns with the hospitalization criteria in our listings for cardiovascular disorders. Several commenters noted our listings do not account for current medical practice or updated research on the role of healthcare utilization as a proxy for severity. They noted that SSA does not provide compelling evidence to explain why hospitalizations are an appropriate metric by which to measure severity. Another commenter noted that many procedures that used to require inpatient hospitalization are now routinely performed on an outpatient basis, and that using hospitalizations as a predictor of disability would exclude people who are getting the exact same treatment as those in 2010. Another commenter suggested that severity and prognosis should be classified based on trajectory of symptoms rather than frequencies of exacerbations or number of hospitalizations. Several commenters expressed concerns that using hospitalization as a proxy for disability would disproportionately disadvantage low-income people in rural areas.

Response:
We decided to retain the hospitalization criteria as one of several alternative criteria in the affected listings because our intent is to reflect impairments that are so severe they result in an inability to perform any gainful activity. The hospitalization criteria reflect a need for a level of care beyond conventional outpatient treatments or isolated or brief hospitalizations for cardiovascular disorders. We understand the concerns regarding the decrease in hospitalizations due to the use of outpatient procedures and other advances in treatment. For people who are able to access these outpatient procedures and other advances in treatment, our other listing criteria specify the documentation required to evaluate cardiovascular disorders. However, in many locations, especially rural settings, people do not have access to preventative care, regular treatment, or more advanced treatment. As such, their only recourse for treating and managing severe cardiovascular disease is hospitalization.
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None of the cardiovascular listings require a specific number of hospitalizations as the only way to meet the listing. The hospitalization criterion in the listings for chronic heart failure (4.02 and 104.02), ischemic heart disease (4.04), congenital heart disease (4.06 and 104.06), and cardiomyopathy (4.08) gives people another avenue of establishing a listing-level impairment.

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National Academies of Sciences, Engineering, and Medicine. 2018.
Health-Care Utilization as a Proxy in Disability Determination.
Washington, DC: The National Academies Press. (
https://doi.org/10.17226/24969
).

Although some of our listings include criteria for repeated hospitalizations, our rules for medical equivalence
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and functional equivalence in children
61

provide a means for adjudicators to consider the clinical care that emphasizes quality of, rather than quantity of, medical treatment. These rules consider all findings and other evidence in the record, including those impacted by a person's level of access to medical care (as well as the preference of some medical providers to reduce the use of emergency department and hospital-level medical interventions). The medical equivalence rules provide some flexibility in determining whether a person is disabled at step 3 of the sequential evaluation process by considering whether the person's impairment is at least equal in severity and duration to the criteria of any listed impairment. If we are unable to find a person's cardiovascular disorder meets or medically equals a listing, we may still find the person disabled at the final step of the sequential evaluation process.
62

In children, we may still find the person disabled under our rules for functional equivalence.
63

60
20 CFR 404.1526 and 416.926.

61
20 CFR 416.926a.

62
20 CFR 404.1520(g) and 416.920(g).

63
20 CFR 416.926a.

Comment:
We received several comments expressing concerns with our proposed listings that require at least 30-days elapse between hospitalizations to constitute a separate event. One commenter called the requirement “arbitrary.”

Response:
We decided to retain the requirement that at least 30 days elapse between hospitalizations to ensure that we are evaluating separate listing-level episodes of exacerbations or complications. We disagree that the 30-day requirement is arbitrary in defining separate events. The Centers for Medicare and Medicaid Services (CMS) uses 30 days between hospitalizations as a benchmark in their regulations. For example, the CMS defines “readmission” as the admission of a person to the same or another applicable hospital within a time period of 30 days from the date of a previous discharge.
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CMS determined that 30 days is a “clinically meaningful period” for hospitals to work with their communities to reduce readmissions by ensuring patients are clinically ready at discharge and they receive appropriate planning for follow-up care after discharge.
65

Further, clinical research often uses 30 days as a benchmark in studying readmission rates.
66

While admission rates may trend lower in the future, the current 30-day benchmark is an appropriate period to delineate separate events in evaluating the severity of cardiovascular disorders. In some instances, hospitalizations that are less than 30 days apart may be evaluated using our rules for medical equivalence
67

or our rules for functional equivalence in children.
68

64
42 CFR 412.152.

65
77 FR 53258, 53377 (2012).

66
Jiang, H.J., & Hensche, M. (2023).
Characteristics of 30-Day All-Cause Hospital Readmissions, 2016-2020
(Healthcare Cost and Utilization Project Statistical Brief #304). Agency for Healthcare Research and Quality. (
www.hcup-us.ahrq.gov/reports/statbriefs/sb304-readmissions-2016-2020.pdf
); James, J., Tan, S., Stretton, B., Kovoor, J.G., Gupta, A.K., Gluck, S., Gilbert, T., Sharma, Y. and Bacchi, S. (2023). Why do we evaluate 30-day readmissions in general medicine? A historical perspective and contemporary data.
Internal Medicine Journal, 53
(6), 1070-1075. (
https://doi.org/10.1111/imj.16115
).

67
20 CFR 404.1526 and 416.926.

68
20 CFR 416.926a.

What is our authority to make rules and set procedures for determining whether a person is disabled under our statutory definition?

Under the Act, we have authority to make rules and regulations and to establish necessary and appropriate procedures to carry out such provisions.
69

Furthermore, the Act directs us to adopt rules and regulations that “provide for the nature and extent of the proofs and evidence” needed to establish the right to benefits.
70

69
See sections 205(a), 702(a)(5), and 1631(d)(1) of the Act (42 U.S.C. 405(a), 902(a)(5), 1383(d)(1)).

70
See sections 205(a) and 1631(d)(1) of the Act (42 U.S.C. 205(a), 1383(d)(1)).

How long will this final rule be in effect?

This final rule will remain in effect for 5 years after the date it becomes effective, unless we extend, revise, or issue it again. We will continue to monitor this rule to ensure that it continues to meet program purposes, and we may revise it before the end of the 5-year period if warranted.

How will we implement this final rule?

We will begin to apply this final rule to new applications, pending claims, and continuing disability reviews (CDR), as applicable, as of the effective date of this final rule.
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We will use the final rule beginning on its effective date. We will apply the final rule to new applications filed on or after the effective date, and to claims that are pending on and after the effective date. This means that we will use the final rule on and after its effective date in any case in which we make a determination or decision, including CDRs, as applicable. See 20 CFR 404.901, 404.1590, 416.990, and 416.1401.

Regulatory Procedures

Executive Order 12866

We consulted with the Office of Management and Budget (OMB) and determined that this final rule meets the criteria for a significant regulatory action under section 3(f) of Executive Order (E.O.) 12866, and is subject to OMB review. Therefore, OMB reviewed the rule. Details about the economic impacts of this rule follow.

Anticipated Accounting Costs of This Final Rule

Anticipated Costs to Our Programs

Our Actuarial Services currently estimate that implementation of the final rule will result in net increases of $446 million in scheduled Old-Age, Survivors, and Disability Insurance (OASDI) benefit payments and $94 million in Federal Supplemental Security Income (SSI) payments for the 10-year period covering fiscal years (FYs) 2026-2035. This estimate assumes the final rule will be implemented and effective for all disability determinations made on or after February 1, 2026. At the time of NPRM publication, Actuarial Services estimated net increases of $308 million in scheduled OASDI benefits and $71 million in Federal SSI payments for the 10-year period covering FYs 2022-2031, and assumed the rule would be effective for all disability determinations made on or after April 1, 2023.

We note that the 10-year projection period used for all of Actuarial Services' regulatory estimates is not arbitrarily selected. The period over which estimates are provided corresponds precisely to the 10-year projection period in the President's Budget used as the baseline for the estimates. Therefore, if the assumed effective date of a regulatory action provided to Actuarial Services is not the beginning of that 10-year period, then the estimates will cover less than 10 years.

The current estimates are higher than those included in the NPRM for three primary reasons: (1) the 10-year estimate in the NPRM covered 8 years and 6 months in which the rule was effective, while the 10-year estimate for this final rule covers 9 years and 8 months in which the rule is effective, so the estimate for this final rule effectively includes more than one year of additional OASDI and SSI payments; (2) the Cost-of-Living Adjustment (COLA) effective for benefits paid in 2023 was 8.7 percent, which was significantly larger than the 2023 COLA of 2.5 percent that was assumed in the NPRM estimate; and (3) the estimation window has shifted from 2022-2031 to 2026-2035, so the average monthly benefits assumed for this final rule are higher than in the NPRM because of assumed benefit increases over time. The changes we made from the proposed to the final rule did not cause any estimated change in allowances.

Anticipated Net Administrative Costs to the Social Security Administration

SSA's Finance, and Management division estimates a net administrative savings of less than 15 work years and $2 million annually.

Anticipated Costs to the Public

We do not believe there are any more than de minimis costs to the public associated with this rulemaking. As discussed earlier in our responses to comments on the Notice of Proposed Rulemaking as well as in the Paperwork Reduction Action section below, the requirements contained in this rulemaking 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. We do not anticipate that the requirements contained in the new cardiovascular listings will impose additional costs or documentation requirements on applicants or cause the affected applicants to pursue a different course of treatment than they otherwise would have done under our existing rules.

Anticipated Benefits to the Public

The revisions to the cardiovascular listings update the medical criteria and clarify how we evaluate cardiovascular disorders. The revisions also improve the clarity, readability, and application of the listings as well as consistency across the listings as a whole. The revisions also help promote uniform national disability policy and can simplify claims adjudication.

Congressional Review Act

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act, 5 U.S.C. 801
et seq.
), the Office of Information and Regulatory Affairs designated this final rule as not meeting the criteria in 5 U.S.C. 804(2), and it is therefore not a major rule as defined by the Congressional Review Act.

Executive Order 13132 (Federalism)

We analyzed this final rule in accordance with the principles and criteria established by E.O. 13132 and determined that it will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. We also determined that the final rule will not preempt any State law or State regulations or affect the States' abilities to discharge traditional State governmental functions.

Executive Order 14192

As previously discussed in the NPRM, we consider this rule a transfer rule with no more than
de minimis
costs.
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As such, it is not a regulatory action under E.O. 14192.

72
Based upon the criteria established in E.O. 13771, now superseded by E.O. 14192. For further information
see
OMB M- Memo 25-20 (“Guidance Implementing Section 3 of Executive Order 14192, Titled `Unleashing Prosperity Through Deregulation' ”).

Regulatory Flexibility Act

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Paperwork Reduction Act

This final rule only updates the criteria in the Listing of Impairments that we use to evaluate disability claims involving cardiovascular disorders under titles II and XVI of the Social Security Act. It does not create any new or affect any existing collections. Accordingly, this final rule does not impose any burdens under the Paperwork Reduction Act and does not require further OMB approval.

(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).

Mark Steffensen,
General Counsel, Social Security Administration.

For the reasons set out in the preamble, we are amending subpart P of 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, 902(a)(5), and 1320e-3; 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. Amend appendix 1 to subpart P of part 404 as follows:
a. Revise item 5 of the introductory text before part A;
b. Revise the body system name for section 4.00 in the table of contents in part A;
c. Amend section 1.00 by revising paragraph 1.00B5;
d. Revise and republish section 4.00;
e. Revise the body system name for section 104.00 in the table of contents in part B;
f. Revise and republish section 104.00;
g. Amend section 114.00 by revising paragraph 114.00J2m.
The revisions read as follows:

Appendix 1 to Subpart P of Part 404—Listing of Impairments

5. Cardiovascular Disorders (4.00 and 104.00): October 30, 2031.

Part A

Sec.

4.00 Cardiovascular Disorders

1.00 Musculoskeletal Disorders

B. * * *

5. We evaluate leg pain associated with peripheral vascular claudication and foot ulceration associated with peripheral artery disease under the listings in 4.00.

4.00 Cardiovascular Disorders

A. How do we define cardiovascular disorders and cardiovascular terms?

1.
What do we mean by a cardiovascular disorder?

a. We mean any disorder that affects the proper functioning of the heart or the circulatory system (that is, arteries, veins, capillaries, and the lymphatic drainage). The disorder can be congenital or acquired.

b. Cardiovascular disorders result from one or more of four consequences of heart disease:

(i) Chronic heart failure (chronic HF) or ventricular dysfunction.

(ii) Discomfort or pain due to myocardial ischemia, with or without necrosis of the heart muscle.

(iii) Syncope, or near syncope, due to inadequate cerebral perfusion from any cardiac cause, such as obstruction of flow or disturbance in rhythm or conduction resulting in inadequate cardiac output.

(iv) Hypoxemia (reduced oxygen concentration in the blood) due to right-to-left shunt or pulmonary vascular disease.

c. Disorders of the veins or arteries (for example, obstruction, rupture, or aneurysm) may cause impairments of the lower extremities (peripheral vascular disease), the central nervous system, the eyes, the kidneys, and other organs. We will evaluate peripheral vascular disease under 4.11 or 4.12 and impairments of another body system(s) under the listings for that body system(s).

2.
What do we consider in evaluating cardiovascular disorders?
The listings in this section describe cardiovascular disorders based on the medical and other evidence, including response to a regimen of prescribed treatment and functional limitations.

3.
What do the following terms or phrases mean in these listings?

a.
Medical con

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2026-13420. Public record. Not legal advice.