38838 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 

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

2 20 CFR 416.925(a). 

3 20 CFR 404.1520, 20 CFR 416.920, and 20 CFR 

416.924. 

4 71 FR 2312 (2006). 

5 73 FR 20564 (2008). 

6 In current listing 4.02B1 (Chronic heart failure), 

we require persistent symptoms of heart failure 

‘‘which very seriously limit the person’s ability to 

independently initiate, sustain or complete 

activities of daily living.’’ Consistent with the 

commenter’s suggestion and how we assess 

functional limitations in the adult mental disorders 

listings (12.00), in proposed 4.02B1, we require ‘‘a 

very serious limitation in the ability to perform 

activities of daily living independently, 

appropriately, effectively, and on a sustained 

basis.’’ 

7On April 28, 2015, the membership of the 

National Academy of Sciences 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. 

8 Institute of Medicine (IOM). (2010). 

Cardiovascular Disability: Updating the Social 

Security Listings. Washington, DC: The National 

Academies Press. 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

[Docket No. SSA–2019–0013] 

RIN 0960–AI43 

Revised Medical Criteria for Evaluating 

Cardiovascular Disorders 

AGENCY: Social Security Administration. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to revise some of 

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 

proposed revisions reflect advances in 

medical knowledge, our adjudicative 

experience, and comments we received 

from experts and the public in response 

to an advance notice of proposed 

rulemaking (ANPRM), and at an 

outreach policy conference. 

DATES: To ensure that your comments 

are considered, we must receive them 

by no later than August 29, 2022. 

ADDRESSES: You may submit comments 

by any one of three methods—internet, 

fax, or mail. Do not submit the same 

comments multiple times or by more 

than one method. Regardless of which 

method you choose, please state that 

your comments refer to Docket No. 

SSA–2019–0013, so that we may 

associate your comments with the 

correct regulation. 

Caution: You should be careful to 

include in your comments only 

information that you wish to make 

publicly available. We strongly urge you 

not to include in your comments any 

personal information, such as Social 

Security numbers or medical 

information. 

1. Internet: We strongly recommend 

that you submit your comments via the 

internet. Please visit the Federal 

eRulemaking portal at http://

www.regulations.gov. Use the search 

function to find docket number SSA– 

2019–0013. The system will issue a 

tracking number to confirm your 

submission. You will not be able to 

view your comment immediately 

because we must post each comment 

manually. It may take up to a week for 

your comment to be viewable. 

2. Fax: Fax comments to (410) 966– 

2830. 

3. Mail: Address your comments to 

the Office of Regulations and Reports 

Clearance, Social Security 

Administration, 3100 West High Rise, 

6401 Security Boulevard, Baltimore, 

Maryland 21235–6401. 

Comments are available for public 

viewing on the Federal eRulemaking 

portal at http://www.regulations.gov or 

in person, during regular business 

hours, by arranging with the contact 

person identified below. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Goldstein, Office of Disability 

Policy, Social Security Administration, 

6401 Security Boulevard, Baltimore, 

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 

For adults, the listings describe, for 

each of the major body systems, 

impairments that we consider to be 

severe enough to prevent an individual 

from doing any gainful activity 

regardless of his or her age, education, 

or work experience.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 in which the individual is clearly 

disabled under our rules.3 However, we 

do not deny any claim solely because a 

person’s medical impairment(s) does 

not satisfy the criteria of a listing. 

Why are we proposing to revise the 

listings for cardiovascular disorders? 

We last published final rules that 

comprehensively revised the 

cardiovascular disorders listings on 

January 13, 2006, and the rules became 

effective on April 13, 2006.4 We are now 

proposing targeted revisions to the 

cardiovascular disorders listings, as 

previously mentioned, to reflect 

advances in medical knowledge, our 

adjudicative experience, and comments 

we received from experts and the public 

in response to an ANPRM, and at an 

outreach policy conference. 

How did we develop this proposed rule? 

In developing this proposed rule: 

• We published an ANPRM for 

cardiovascular disorders in the Federal 

Register on April 16, 2008.5 We invited 

the public to send us written comments 

and suggestions about whether and how 

we should revise the cardiovascular 

disorders listings. We received five 

comments on the ANPRM. The 

commenters made several suggestions 

that we incorporated into the proposals, 

such as consideration for people with a 

single ventricle; clarifying in proposed 

4.00D(4)(c)(ii) (How do we evaluate CHF 

using 4.02?) and 4.02B1 (Chronic heart 

failure) that when we evaluate a 

person’s ability to perform activities of 

daily living, we will also consider the 

person’s ability to perform them 

effectively; 6 and providing more 

examples of skin examination findings 

that might accompany venous 

insufficiency. Two commenters asked 

us to base our proposals on the 

American College of Cardiology/ 

American Heart Association (ACC/ 

AHA) clinical practice guidelines and 

one suggested we review and 

incorporate the American Society of 

Echocardiography (ASE) guidelines. As 

a result, we tasked a committee of 

medical experts with reviewing and 

analyzing the ACC/AHA and ASE 

guidelines to inform the 

recommendations in the Institute of 

Medicine (IOM) 7 report titled, 

‘‘Cardiovascular Disability: Updating 

the Social Security Listings.’’ 8 This 

report, which is discussed in more 

detail below, informed some of the 

proposed changes in this NPRM. 

• On September 24 and 25, 2008, we 

hosted a policy conference titled 

‘‘Cardiovascular Disorders in the 

Disability Programs’’ in Baltimore, 

Maryland. At this conference, we 

received public comments and 

suggestions from physicians and 

advocacy groups for updating and 

revising our criteria for evaluating 

cardiovascular disorders. Physicians 

and advocacy groups specifically 

discussed the evaluation of chronic 

heart failure, ischemic heart disease, 

peripheral artery disease, and chronic 


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9 IOM. (2010). 

10SSA’s Office of Medical Assistance (OMA) 

provides medical and analytical support to ensure 

accurate and consistent disability policy and 

procedure application. In addition to a full 

complement of subject matter experts who are 

permanent SSA staff, OMA contracts with medical 

and psychological consultants to provide medical 

expertise in the development and evaluation of 

policy. 

11 82 FR 5844 (2017). 

venous insufficiency. Participants made 

several suggestions that we researched 

and incorporated into the proposals, 

such as distinguishing cardiovascular 

disorders from pulmonary disorders by 

using biomarkers such as B-type 

natriuretic peptide (BNP). 

• In 2009, we commissioned a study 

by an ad hoc committee of medical 

experts appointed by the Institute of 

Medicine (IOM). The committee: (1) 

conducted a comprehensive review of 

the relevant research literature and 

current professional practice guidelines 

developed jointly by the ACC/AHA; (2) 

assessed the current criteria in light of 

current research knowledge and 

evidence-based medical practice; and 

(3) produced a report with specific 

recommendations for revision of the 

criteria based on evidence and 

professional judgment. The committee 

provided its recommendations in a 2010 

report titled, ‘‘Cardiovascular Disability: 

Updating the Social Security Listings.’’ 9

We recently sought guidance from our 

cardiologists and other medical experts, 

reviewed disability claims involving 

cardiovascular disorders, and reviewed 

current research to ensure the IOM 

recommendations are still relevant. 

Recommendations we received from 

the IOM report, responses to the 

ANPRM, and the ‘‘Cardiovascular 

Disorders in the Disability Programs’’ 

policy conference informed the 

proposed changes in this NPRM. As 

with the IOM report, we have conducted 

independent medical research, 

consulted with agency cardiologists, 

and reviewed disability claims 

involving cardiovascular disorders to 

ensure the accuracy and relevance of 

these stated resources. In developing 

this proposed rule, we also considered 

information from several other sources, 

including: 

• Medical experts in cardiology from 

SSA’s Office of Medical Assistance 10

who assist in the development and 

evaluation of policy and whom we 

regularly consulted with in drafting 

these proposals; 

• Advocacy groups for people with 

cardiovascular disorders and 

individuals with cardiovascular 

disorders and their families who 

submitted comments on the ANPRM or 

participated in the 2008 

‘‘Cardiovascular Disorders in the 

Disability Program’’ policy conference; 

• Individuals who make and review 

disability determinations and decisions 

for us in State agencies; in our Office of 

Hearings Operations; and in our Office 

of Analytics, Review, and Oversight; 

and 

• The published sources of medical 

literature and research we list in the 

references section at the end of this 

preamble. 

What revisions are we proposing for 

cardiovascular disorders? 

We propose to: 

• Change the name of the body 

system from ‘‘Cardiovascular System’’ to 

‘‘Cardiovascular Disorders’’ to be 

consistent with the nomenclature of all 

body systems in our listings; 

• Reorganize and revise the 

introductory text (section 4.00 for adults 

and 104.00 for children) to provide 

guidance for using the revised criteria in 

the listings; 

• Revise the adult and childhood 

listings for chronic heart failure (4.02 

and 104.02), recurrent arrhythmias (4.05 

and 104.05), symptomatic congenital 

heart disease (4.06) and congenital heart 

disease (104.06), and heart transplant 

(4.09 and 104.09); 

• Revise the adult listings for 

ischemic heart disease (IHD) (4.04), 

chronic venous insufficiency (4.11), and 

peripheral arterial disease (4.12); 

• Add adult listings for aortic 

valvular disease (4.07) and 

cardiomyopathy (4.08); 

• Add adult and childhood listings 

for cardiac allograft vasculopathy (4.16 

and 104.16); 

• Remove childhood listing for 

rheumatic heart disease (104.13) and 

reserve listing number 104.13; and 

• Make minor editorial revisions, 

including changes to conform to revised 

rules for evaluating medical evidence,11

to the introductory text and to the 

listings for clarity. 

Proposed Changes to the Adult 

Cardiovascular Disorders Introductory 

Text 

The following table shows the 

heading of the current and proposed 

sections of the adult introductory text 

for cardiovascular disorders: 

INTRODUCTORY TEXT 4.00 

Current Sections of the Adult Introductory Text for Cardiovascular System.Proposed Sections of the Adult Introductory Text for Cardiovascular 

Disorders. 

4.00 Cardiovascular System .................................................................... 4.00 Cardiovascular Disorders. 

A. General ................................................................................................ A. How do we define cardiovascular disorders and cardiovascular 

terms? 

B. Documenting Cardiovascular Impairment ............................................ B. What documentation do we need to evaluate cardiovascular disorders? 

C. Using Cardiovascular Test Results ..................................................... C. How do we use cardiovascular test results? 

D. Evaluating Chronic Heart Failure ........................................................ D. How do we evaluate chronic heart failure? 

E. Evaluating Ischemic Heart Disease ..................................................... E. How do we evaluate ischemic heart disease? 

F. Evaluating Arrhythmias ........................................................................ F. How do we evaluate arrhythmias? 

G. Evaluating Peripheral Vascular Disease ............................................. G. How do we evaluate peripheral vascular disease? 

H. Evaluating Other Cardiovascular Impairments .................................... H. How do we evaluate congenital heart disease? 

I. Other Evaluation Issues ........................................................................ I. How do we evaluate other cardiovascular disorders? 

J. How do we evaluate issues that affect the cardiovascular system? 

K. How do we evaluate cardiovascular disorders that do not meet one 

of these listings? 


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12 Id. 

13 IOM. (2010), 109. 

14Cohen-Solal, A., Laribi, S., Ishihara, S., 

Vergaro, G., Baudet, M., Logeart, D., . . . Seronde, 

M.-F. (2015). Prognostic markers of acute 

decompensated heart failure: The emerging roles of 

cardiac biomarkers and prognostic scores. Archives 

of Cardiovascular Disease, 108(1), 64–74. 

doi:10.1016/j.acvd.2014.10.002. 

15 Desai, A.S. (2013). Are serial BNP 

measurements useful in heart failure management? 

Serial natriuretic peptide measurements are not 

useful in heart failure management: The art of 

medicine remains long. Circulation, 127(4), 509– 

516. doi:10.1161/CIRCULATIONAHA.112.120493. 

16Patterson, C.C., Blankenberg, S., Ben-Shlomo, 

Y., Heslop, L., Bayer, A., Lowe, G., . . . Yarnell, J. 

(2015). Which biomarkers are predictive 

specifically for cardiovascular or for noncardiovascular mortality in men? Evidence from the 

Caerphilly Prospective Study (CaPS). International 

Journal of Cardiology, 201, 113–118. doi:10.1016/ 

j.ijcard.2015.07.106. 

17Uszko-Lencer, N.H., Frankenstein, L., Spruit, 

M.A., Maeder, M.T., Gutmann, M., Muzzarelli, S., 

. . . Brunner-La Rocca, H.-P. (2017). Predicting 

hospitalization and mortality in patients with heart 

failure: The BARDICHE-index. International Journal 

of Cardiology, 227, 901–907. doi:10.1016/ 

j.ijcard.2016.11.122. 

18We define an exercise tolerance test at 4.00C3b 

(What are exercise tests and what are they used 

for?) as ‘‘a sign-or symptom-limited test in which 

you exercise while connected to an ECG until you 

develop a sign or symptom that indicates that you 

have exercised as much as is considered safe for 

you.’’ This is an existing definition coming from 

existing regulation. 

19Ciarka, A., Edwards, L., Nilsson, J., Stehlik, J., 

& Lund, L.H. (2017). Trends in the use of 

mechanical circulatory support as a bridge to heart 

transplantation across different age groups. 

International Journal of Cardiology, 231, 225–227. 

doi:10.1016/j.ijcard.2016.10.049. 

20 20 CFR 404.1502(a) and 416.902(a). 

21 20 CFR 404.1521 and 416.921. 

22As we explain in 4.00E9c, revascularization 

means angioplasty (with or without stent 

placement) or bypass surgery. 

Proposed 4.00—Introductory Text to the 

Adult Cardiovascular Disorders Listings 

The following is a detailed 

description of the primary changes we 

are proposing to the introductory text. 

In addition to the changes we describe 

below, we are proposing minor changes 

to the introductory text to clarify how 

we use the proposed listings to evaluate 

cardiovascular disorders, changes to be 

consistent with current medical 

terminology, the language we use in 

other body system listings, and the 

revised rules for evaluating medical 

evidence.12 We repeat much of the 

introductory text of proposed 4.00 in the 

introductory text of proposed 104.00 

(the introductory text to the childhood 

cardiovascular disorders listings), 

making distinctions where needed. This 

is necessary because the same basic 

criteria for evaluating cardiovascular 

disorders apply to both adults and 

children. 

Proposed 4.00A—How do we define 

cardiovascular disorders and 

cardiovascular terms? 

To improve clarity and promote 

consistent understanding of the terms 

we use in these listings, we propose: 

• In 4.00A3b (Persistent), to clarify 

that ‘‘exceptions’’ means brief periods 

when the required finding(s) is greatly 

reduced or gone. These periods are so 

brief or inconsequential, the required 

finding(s) remains a factor in the 

person’s condition; 

• In 4.00A3c (Recurrent), to clarify in 

our definition of ‘‘recurrent’’ that the 

term ‘‘improvement of sufficient 

duration’’ means the finding is greatly 

reduced (for example, treatment 

reduced a grade 3 chronic venous 

insufficiency (CVI) skin ulcer to a grade 

1 CVI skin ulcer) or not present for long 

enough that the required finding(s) is no 

longer a factor in the person’s condition. 

• In 4.00A3f (Uncontrolled) we 

would remove the definition for the 

term ‘‘uncontrolled’’ because we 

propose to eliminate the term as a 

descriptor for recurrent episodes of 

cardiac syncope. The definition of 

‘‘uncontrolled’’ was redundant after 

describing reoccurring episodes of 

cardiac syncope despite treatment. 

Proposed 4.00C—How do we use 

cardiovascular test results? 

We propose: 

• In 4.00C8d(iv) (When will we not 

purchase an exercise test or wait before 

we purchase an exercise test?), to 

include the procedure percutaneous 

coronary intervention (PCI) to be 

consistent with medical advancements 

that indicate a PCI is a nonsurgical 

procedure to improve blood flow to the 

heart.13

• In 4.00C15 (How do we evaluate 

cardiac catheterization evidence?), to 

remove 4.00C15b and 4.00C15c and 

create a new 4.00C15b to simplify our 

explanation of cardiac catheterization 

reports and to include information 

about fractional flow reserve (FFR), 

which we use in the proposed 4.04D1 

(Ischemic heart disease). 

Proposed 4.00D—How do we evaluate 

chronic heart failure? 

We propose: 

• In 4.00D1a (What is chronic heart 

failure (CHF)?), to provide a more 

descriptive definition of ‘‘ejection 

fraction’’ for clarity; 

• In 4.00D1b (What is chronic heart 

failure (CHF)?), to explain that high 

blood levels of the proteins B-type 

natriuretic peptide (BNP) and Nterminal pro-BNP (NT-pro-BNP) may 

help identify chronic heart failure as the 

cause of a person’s symptoms (for 

example, shortness of breath);§ 14 15 16 17

• In 4.00D2a(i) (What evidence of 

CHF do we need?) and 4.00D2a(iii) 

(What evidence of CHF do we need?), to 

explain left atrial volume index (LAVi) 

and how it is calculated. LAVi is a new 

measurement used in criterion A2 of 

proposed listing 4.02 (Chronic heart 

failure) to provide a more precise 

representation of increased left atrial 

pressure; 

• In 4.00D4c (How do we evaluate 

CHF using 4.02? ),to describe in more 

detail the two-part process we use in 

criteria B1 of proposed listing 4.02 

(Chronic heart failure) to evaluate 

chronic heart failure if a person cannot 

perform an exercise tolerance test 

(ETT);18; and 

• Add 4.00D4e (How do we evaluate 

CHF treated with a mechanical 

circulatory support device?) to explain 

mechanical circulatory support devices 

(MCSD) and clarify how we would 

evaluate individuals treated for heart 

failure with a MCSD.19 We propose to 

evaluate MCSDs under proposed 4.02D1 

(Chronic heart failure )to account for 

cardiac bridge treatment which we 

currently evaluate under listing 4.09 

(Heart transplantation). 

Proposed 4.00E—How do we evaluate 

ischemic heart disease? 

We propose: 

• In 4.00E9b (How do we evaluate 

IHD using 4.04?), to consolidate and 

revise the guidance that is currently in 

4.00E9b, c, d, and e for ease of reference; 

• In 4.00E9b (How do we evaluate 

IHD using 4.04?), to explain that we will 

use an interpretation of 

electrocardiogram (ECG) findings by an 

acceptable medical source (AMS) 20 if 

the interpretation concludes that the 

ECG findings are positive for IHD. 

Interpreting ECG results requires a 

systematic review and analysis of 

several components, including relevant 

clinical details and raw data. Relying on 

an interpretation by an AMS is 

consistent with our rules for 

establishing a medically determinable 

impairment (MDI) and will ensure the 

accuracy of adjudication for claims 

involving IHD because interpretation of 

ECG findings requires medical 

judgment; 21

• In 4.00E9c (How do we evaluate 

IHD using 4.04?), to clarify that 

revascularizations that result from 

unplanned hospitalizations must be an 

emergency and unplanned; 22

• To redesignate current 4.00E9f, g, 

and h (How do we evaluate IHD using 

4.04?) as proposed new sections 

4.00E9c, d, and f, respectively; and 

• In 4.00E9e ( How do we evaluate 

IHD using 4.04?), to add a definition for 


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23Fearon, W.F. (2014). Percutaneous coronary 

intervention should be guided by fractional flow 

reserve measurement. Circulation, 129(18), 1860– 

1870. doi:10.1161/CIRCULATIONAHA.113.004300. 

24 IOM. (2010), 151. 

the term ‘‘fractional flow reserve (FFR),’’ 

which is an objective measure of flow 

access across an obstruction that we use 

in criterion D1 of proposed listing 4.04 

(Ischemic heart disease).23

Proposed 4.00G—How do we evaluate 

peripheral vascular disease? 

In 4.00G6 (Are there any other studies 

that are helpful in evaluating PAD?), as 

IOM advised, we propose to provide 

more information about imaging and 

other tests used to diagnose peripheral 

arterial disease (PAD) to clearly convey 

our intent of the listing, which is to tie 

PAD to mobility.24

Proposed 4.00H—How do we evaluate 

congenital heart disease? 

We propose: 

• To redesignate and rename some 

paragraphs for ease of reference; 

• In 4.00H (How do we evaluate 

congenital heart disease?), to add a 

definition for the term ‘‘single 

ventricle,’’ and include more detailed 

guidance on how we evaluate congenital 

heart disease as recommended by the 

IOM; and 

• To add 4.00H1 (What is congenital 

heart disease?), 4.00H2 (What is 

Eisenmenger syndrome?), 4.00H3 (What 

is single ventricle?), and 4.004H4 (How 

do we evaluate conditions associated 

with congenital heart disease?). 

Proposed 4.00I—How do we evaluate 

other cardiovascular disorders? 

We propose: 

• To rename and rearrange the 

content of 4.00I (How do we evaluate 

other cardiovascular disorders?), 

including redesignating some 

paragraphs, for ease of reference; 

• In 4.00I2 (What is cardiomyopathy 

and how will we evaluate it?), to explain 

how we would evaluate 

cardiomyopathy under proposed new 

4.08 (Cardiomyopathy); 

• In 4.00I3 (How do we evaluate 

valvular heart disease?), to explain that 

we would evaluate valvular heart 

disease under the proposed new 4.07 

(Aortic valvular disease); 

• In 4.00I4 (What do we consider 

when we evaluate heart transplant 

recipients?), to explain that we would 

evaluate cardiac allograft vasculopathy 

under proposed new 4.16 (Cardiac 

allograft vasculopathy); and 

• To add 4.00I5 (What is cardiac 

allograft vasculopathy and how do we 

evaluate it?), to explain proposed new 

4.16 (Cardiac allograft vasculopathy). 

Proposed 4.00J—How do we evaluate 

issues that affect the cardiovascular 

system? 

We propose: 

• To redesignate and rename some 

paragraphs for ease of reference; 

• In 4.00J1 (How do we consider the 

effects of obesity when we evaluate your 

cardiovascular disorder?), to simplify 

and refocus our discussion of how we 

consider the effects of obesity more 

specifically on cardiovascular disorders; 

• To add 4.00J3 (How do we consider 

hospitalizations?) to explain how we 

would evaluate hospitalizations for 

repeated exacerbations and 

complications of cardiovascular 

disorders under proposed 4.02B3 

(Chronic heart failure), 4.04E (Ischemic 

heart disease), 4.06E (Congenital heart 

disease), and 4.08D (Cardiomyopathy). 

Proposed 4.00K—How do we evaluate 

cardiovascular disorders that do not 

meet one of these listings? 

• We propose to rename and 

redesignate 4.00I3 (How do we evaluate 

impairments that do not meet one of the 

cardiovascular listings?) as 4.00K and 

redesignate 4.00I3a and 4.00I3b as 

4.00K1 and 4.00K2 for ease of reference. 

Proposed Changes to the Adult 

Cardiovascular Disorders Listings 

The following table shows the 

heading of the current and proposed 

sections of the adult listings for 

cardiovascular disorders: 

ADULT CARDIOVASCULAR DISORDERS LISTINGS

Current Proposed 

4.02 Chronic heart failure ......................................................................... 4.02 Chronic heart failure. 

4.04 Ischemic heart disease .................................................................... 4.03 [Reserved]. 

4.05 Recurrent arrhythmias ...................................................................... 4.04 Ischemic heart disease. 

4.06 Symptomatic congenital heart disease ............................................ 4.05 Recurrent arrhythmias. 

4.09 Heart transplant ................................................................................ 4.06 Congenital heart disease. 

4.10 Aneurysm of aorta or major branches ............................................. 4.07 Aortic valvular disease. 

4.11 Chronic venous insufficiency ............................................................ 4.08 Cardiomyopathy. 

4.12 Peripheral arterial disease ............................................................... 4.09 Heart transplantation. 

4.10 Dissecting aneurysm of the aorta or major branches. 

4.11 Chronic venous insufficiency. 

4.12 Peripheral arterial disease. 

4.13 [Reserved]. 

4.14 [Reserved]. 

4.15 [Reserved]. 

4.16 Cardiac allograft vasculopathy. 


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The following table shows our 

proposed changes to the adult 

cardiovascular disorders listings criteria 

that involve changes to healthcare 

utilization and condition/episode 

requirements, the rationale for each 

change, and supporting resource. 

Following this table, we discuss all of 

our proposed changes to the adult 

cardiovascular disorders listings in 

more detail. 

ADULT CARDIOVASCULAR DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ 

EPISODE REQUIREMENTS

Current listing criterion Proposed listing criterion Rationale Resources 

Listing 4.02 Chronic heart failure 

4.02 A1—A. Medically documented presence of one of 

the following: 

1. Systolic failure (see 

4.00D1a(i)), with left ventricular end diastolic dimensions 

greater than 6.0 cm or ejection fraction of 30 percent or 

less during a period of stability 

(not during an episode of 

acute heart failure); or.

A. Medically documented 

presence of one of the 

following: 

1. Systolic failure documented by appropriate 

medically acceptable 

imaging during a period of stability (not 

during an episode of 

exacerbation of heart 

failure), with left ventricular end diastolic 

dimension equal to or 

greater than 7.0 cm; or 

ejection fraction of 30 

percent or less during 

a period of stability 

(not during an episode 

of acute heart failure).

Proposed criterion 4.02A1 requires an increased 

left ventricular end diastolic dimension (LVEDD) 

equal to or greater than 7.0 centimeters (cm) instead of the current criterion of an LVEDD 

greater than 6.0 cm. We followed the IOM’s recommendation in determining that an increased 

LVEDD of greater than 6.0 cm but less than 7.0 

cm indicates only a moderately enlarged heart, 

and an increased LVEDD of at least 7.0 cm 

more clearly establishes an enlarged heart with 

signs and symptoms indicating listing-level 

heart failure.

IOM. (2010), 88, 89. 

4.02B2—Three or more separate episodes of acute congestive heart failure within a 

consecutive 12-month period 

(see 4.00A3e), with evidence 

of fluid retention (see 

4.00D2b(ii)) from clinical and 

imaging assessments at the 

time of the episodes, requiring 

acute extended physician 

intervention such as hospitalization or emergency 

room treatment for 12 hours 

or more, separated by periods 

of stabilization (see 4.00D4c); 

B.3. Exacerbations or 

complications of 

chronic heart failure 

(see 4.00D1b) requiring three hospitalizations within a consecutive 12-month period 

(see 4.00A3e) and at 

least 30 days apart. 

Each hospitalization 

must last at least 48 

hours, including hours 

in a hospital emergency department immediately before the 

hospitalization (see 

4.00J3).

We propose to remove current 4.02B2 ‘‘three or 

more separate episodes of acute congestive 

heart failure’’ because we would evaluate these 

episodes under proposed 4.02B3. As recommended by the IOM, proposed 4.02B3 would 

evaluate exacerbations or complications of 

CHF, requiring three hospitalizations within a 

consecutive 12-month period and at least 30 

days apart. An impairment resulting in exacerbations or complications that require this many 

hospitalizations in 12 months is a very severe 

impairment. We would require these hospitalizations to be at least 30 days apart to ensure we 

are evaluating separate episodes of exacerbations or complications.

IOM. (2010), 89, 91. 

No current listing criteria ............ C. Heart failure with left 

ventricular ejection 

fraction of 20 percent 

or less while on a regimen of prescribed 

therapy, on two evaluations at least 90 

days apart within a 

consecutive 12-month 

period (see 4.00A3e) 

during a period of stability (not during an 

episode of exacerbation of heart failure); 

The IOM recommended a criterion for chronic 

heart failure with an EF on a sustained basis of 

20 percent or less. An EF of only 20 percent 

means the heart’s pumping action is less than a 

third of normal, and critically affects a person’s 

ability to perform gainful activity.

IOM. (2010), 84, 89. 

Desai, R.V., Guichard, J.L., Mujib, M., Ahmed, 

M.I., Feller, M.A., Fonarow, G.C., . . . Ahmed, 

A. (2013). Reduced right ventricular ejection 

fraction and increased mortality in chronic systolic heart failure patients receiving betablockers: Insights from the BEST trial. International Journal of Cardiology, 163(1), 61–67. 

doi:10.1016/j.ijcard.2011.05.051. 

Runge, M.S., Patterson, C., Stouffer, G.A., & Netter, F.H. (2010). Netter’s Cardiology (2nd ed.). 

Philadelphia, PA: Saunders Elsevier. 


lotter on DSK11XQN23PROD with PROPOSALS2
Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 38843 

ADULT CARDIOVASCULAR DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ 

EPISODE REQUIREMENTS—Continued 

Current listing criterion Proposed listing criterion Rationale Resources 

No current listing criteria ............ D. One of the following 

while hospitalized, at 

home, or both: 

1. Mechanical circulatory 

support device except 

extracorporeal membrane oxygenation 

(ECMO) (see 

4.00D4e). Consider 

under a disability for 1 

year from the date of 

implantation; after that, 

evaluate any residual 

impairment(s) under 

the criteria for the affected body system.

2. Continuous intravenous administration 

of inotropic medication 

(for example, 

milrinone) for at least 

30 consecutive days. 

Consider under a disability for 1 year from 

the date of initiation of 

the treatment; after 

that, evaluate any residual impairment(s) 

under the criteria for 

the affected body system.

Implanted MCSDs help the heart pump blood and 

may be used as a ‘‘bridge’’ while a person waits 

for a heart transplant. We currently use our 

medical equivalence rules to find someone with 

heart failure and an implanted MCSD disabled 

under listing 4.09 (Heart transplantation). Adding this new criterion will ensure that people 

with heart failure treated with MCSD are consistently identified.

People who require continuous intravenous administration of inotropic medication (for example, milrinone) have very serious heart failure, 

and the length of this treatment can be an accurate predictor of impairment severity. Accordingly, proposed 4.02D2 would find people disabled if they require continuous intravenous 

inotropic medications for 30 or more consecutive days.

Malotte, K., Saguros, A., & Groninger, H. (2018). 

Continuous cardiac inotropes in patients with 

end-stage heart failure: An evolving experience. 

Journal of Pain Symptom Management, 55(1), 

159–163. doi:10.1016/j.jpainsymman.2017.09.

026. 

Bistola, V., Arfaras-Melainis, A., Polyzogopoulou, 

E., Ikonomidis, I., & Parissis, J. (2019). 

Inotropes in acute heart failure: From guidelines 

to practical use: Therapeutic options and clinical 

practice. Cardiac Failure Review, 5(3), 133– 

139. doi:10.15420/cfr.2019.11.2. 

Listing 4.04 Ischemic heart disease 

4.04B—Three separate ischemic 

episodes, each requiring 

revascularization or not amenable to revascularization (see 

4.00E9f), within a consecutive 

12-month period (see 

4.00A3e).

4.04C—Documentation 

of three separate 

ischemic episodes 

(see 4.00E9c) requiring unplanned hospitalization (inpatient 

or observation status) 

within a consecutive 

12-month period (see 

4.00A3e).

We would evaluate unplanned hospitalizations 

under this section to ensure we are only evaluating urgent ischemic episodes. Individuals who 

have ischemic episodes that result in unplanned 

hospitalizations may need intensive care, can 

have long hospital stays, may require multiple 

procedures, and can be at high risk for post-discharge morbidity and mortality.

Hua, M., Gong, M.N., Brady, J., & Wunsch, H. 

(2015). Early and late unplanned rehospitalizations for survivors of critical illness. Critical Care 

Medicine, 43(2), 430–438. doi:10.1097/

CCM.0000000000000717. 

No current criterion for repeated 

exacerbations or complications ischemic heart disease, 

4.04B (above) only considers 

episodes requiring 

revascularization or that are 

not amenable to 

revascularization.

4.04E—Exacerbations or 

complications of 

ischemic heart disease 

(see 4.00E2–4.00E7) 

requiring three hospitalizations within a 

consecutive 12-month 

period (see 4.00A3e) 

and at least 30 days 

apart. Each hospitalization must last at 

least 48 hours, including hours in a hospital 

emergency department 

immediately before the 

hospitalization (see 

4.00E9c).

An impairment resulting in exacerbations or complications that require three or more hospitalizations in 12 months is a very severe impairment. 

We would require these hospitalizations to be at 

least 30 days apart to ensure we are evaluating 

separate episodes of exacerbations or complications of ischemic heart disease.

Hua, M., Gong, M.N., Brady, J., & Wunsch, H. 

(2015). Early and late unplanned rehospitalizations for survivors of critical illness. Critical Care 

Medicine, 43(2), 430–438. doi:10.1097/CCM.

0000000000000717. 


lotter on DSK11XQN23PROD with PROPOSALS2
38844 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 

ADULT CARDIOVASCULAR DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ 

EPISODE REQUIREMENTS—Continued 

Current listing criterion Proposed listing criterion Rationale Resources 

Listing 4.06 Congenital heart disease 

4.06A—A. Cyanosis at rest, and: 

1. Hematocrit of 55 percent or 

greater; or.

2. Arterial O2 saturation of less 

than 90 percent in room air or 

resting arterial PO2 of 60 Torr 

or less.

A. Chronic hypoxemia, 

and 1, 2, or 3: 

1. Hematocrit of 55 percent or greater on two 

evaluations at least 90 

days apart within a 

consecutive 12-month 

period (see 4.00A3e); 

or.

2. Arterial blood gas test 

measurement obtained 

at rest while breathing 

room air, as described 

in either a or b: 

a. SaO2 (arterial oxygen 

saturation) less than or 

equal to 89 percent; or.

b. PO2 or PaO2 (partial 

pressure of oxygen) 

less than or equal to 

60 mmHg; 

3. SpO2 (percentage of 

oxygen saturation of 

blood hemoglobin) 

measured by pulse 

oximetry either at rest, 

during a 6-minute walk 

test (6MWT), or after a 

6MWT, while breathing 

room air, less than or 

equal to 87 percent on 

three evaluations at 

least 30 days apart 

within a consecutive 

12-month period (see 

4.00A3e).

We propose to revise current 4.06A to require 

‘‘hypoxemia’’ rather than ‘‘cyanosis or 

acyanosis’’. Cyanosis is a more subjective assessment subject to misinterpretation due to by 

many factors, including skin complexion. Thus, 

the term ‘‘hypoxemia’’ relates more to the laboratory and pulse oximetry findings than the 

term ‘‘cyanosis.

We would require two hematocrit measurements 

instead of the current listing’s single measurement. Two measurements, at least 90 days 

apart within a consecutive 12-month period will 

help ensure the person’s hematocrit level is associated with chronic hypoxemia and not the result of a reversible condition.

Proposed 4.06A3 would require three SpO2 

measurements 30 days apart within a consecutive 12-month period showing hypoxemia. This 

will document that the condition is chronic and 

persistent, and the measurements are not related to a reversible condition or an inaccurate 

reading.

We would add a criterion for SpO2 (percentage of 

oxygen saturation of blood hemoglobin) measured by pulse oximetry, including measurements taken while the person is at rest or while 

doing a six-minute walk test (6MWT). Pulse 

oximetry measurements are a non-invasive alternative to invasive testing. A person’s medical 

evidence often provides SpO2 findings, and 

SpO2 measured by pulse oximetry reflects an 

advance in medical technology that provides 

another way to establish listing-level severity.

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. doi:10.1016/j.jacc.2018.

08.1029. 

Stack, S.W, . . . & Berger, S.A. (2009). The effects of high hematocrit arterial flow—A phenomenological study of health risk implications. 

Chemical Engineering Science, 64(22), 4701– 

4706. doi:10/1016/j.ces.2009.07.017. 

IOM. (2010), 178. 

Oster, M.E, . . . & Kochilas, L.K. (2016). Screening for critical congenital heart disease. Clinics 

in Perinatology, 43(1), 73–80. doi:10.1016/

j.clp.2015.11.005. 

Mechem, C.C. (2014). Pulse oximetry. In P.E. 

Parsons (Ed.), UpToDate (Jan. 2014). Retrieved from https://www.uptodate.com/contents/ 

pulse-oximetry. 

No current criteria ...................... 4.06E—Exacerbations or 

complications of congenital heart disease 

(see 4.00J3) requiring 

three hospitalizations 

within a consecutive 

12-month period (see 

4.00A3e) and at least 

30 days apart. Each 

hospitalization must 

last at least 48 hours, 

including hours in a 

hospital emergency 

department immediately before the hospitalization (see 

4.00J3).

An impairment resulting in exacerbations or complications that require three or more hospitalizations in 12 months is a very severe impairment. 

We would require these hospitalizations to be at 

least 30 days apart to ensure we are evaluating 

separate episodes of exacerbations or complications.

Hua, M., Gong, M.N., Brady, J., & Wunsch, H. 

(2015). Early and late unplanned rehospitalizations for survivors of critical illness. Critical Care 

Medicine, 43(2), 430–438. doi:10.1097/CCM.

0000000000000717. 

Listing 4.08 Cardiomyopathy 

No current listing ........................ 4.08D—D. Exacerbations 

or complications of 

cardiomyopathy requiring three hospitalizations within a consecutive 12-month period 

(see 4.00A3e) and at 

least 30 days apart. 

Each hospitalization 

must last at least 48 

hours, including hours 

in a hospital emergency department immediately before the 

hospitalization (see 

4.00J3).

Consistent with IOM recommendations, we created this new cardiomyopathy listing to specifically address hypertrophic cardiomyopathy, 

endomyocardial fibrosis, and cardiac amyloidosis AL type, which are more serious types of 

cardiomyopathy.

IOM. (2010), 80. 

In addition, SSA has designated endomyocardial 

fibrosis and cardiac amyloidosis AL type as 

Compassionate Allowance (CAL) conditions. 

See Compassionate Allowances Website Home 

Page (ssa.gov). 


lotter on DSK11XQN23PROD with PROPOSALS2
Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 38845 

25 IOM. (2010), 88, 89. 

26Cacciapuoti, Fu., Scognamiglio, A., Paoli, V.D., 

Romano, C., & Cacciapuoti, Fe. (2012). Left atrial 

volume index as indicator of left ventricular 

diastolic dysfunction: Comparation between left 

atrial volume index and tissue myocardial 

performance index. Journal of Cardiovascular 

Ultrasound, 20(1), 25–29. doi:10.4250/ 

jcu.2012.20.1.25. 27 IOM. (2010), 85, 93. 

ADULT CARDIOVASCULAR DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ 

EPISODE REQUIREMENTS—Continued 

Current listing criterion Proposed listing criterion Rationale Resources 

Listing 4.11 Chronic venous insufficiency 

4.11—Chronic venous insufficiency of a lower extremity 

with incompetency or obstruction of the deep venous system and one of the following: 

4.11—Chronic venous 

insufficiency (see 

4.00G) of a lower extremity with reflux or 

obstruction of the venous system documented by duplex 

ultrasound or other appropriate diagnostic 

technique, with A or B: 

As recommended by IOM, we would require confirmation of CVI by duplex ultrasound or other 

appropriate diagnostic technique. The medical 

community considers the use of duplex 

ultrasound to be the best method for detecting 

reflux or obstruction.

IOM. (2010), 161. 

4.11A—A. Extensive brawny 

edema (see 4.00G3) involving 

at least two-thirds of the leg 

between the ankle and knee 

or the distal one-third of the 

lower extremity between the 

ankle and hip.

A. Extensive trophic 

changes of skin (for 

example, 

hyperpigmentation, 

lipodermatosclerosis, 

brawny edema) involving at least two-thirds 

of the leg below the 

knee, on two evaluations at least 90 days 

apart within a consecutive 12-month period (see 4.00A3e), 

with both 1 and 2: 

We would adopt IOM recommendations and 

broaden the listing criteria we apply to trophic 

changes of the skin. For example, in addition to 

brawny edema, trophic changes evaluated 

under the proposed listing would include 

hyperpigmentation and lipodermatosclerosis 

We would revise the current requirement that 

these skin changes involve ‘‘at least two-thirds 

of the leg between the ankle and knee or the 

distal one-third of the lower extremity between 

the ankle and hip.’’ Instead, we would require 

extensive skin changes involving at least twothirds of the leg below the knee, to make the requirement simpler to understand and apply. 

This revision is consistent with IOM’s recommendation to require skin changes below the 

knee.

We would require the skin changes under proposed 4.11A to be consistent with CVI, and we 

would document the skin changes over a period 

of at least 90 days to ensure they are chronic.

IOM. (2010), 157–161. 

4.11B—Superficial varicosities, 

stasis dermatitis, and either 

recurrent ulceration or persistent ulceration that has not 

healed following at least 3 

months of prescribed treatment.

4.11B—Two or more episodes of ulceration 

that has not healed 

following at least 6 

months of prescribed 

treatment.

This requirement is more conclusive than the current requirement of 3 months of unsuccessful 

prescribed treatment as it demonstrates the 

condition has persisted despite treatment for a 

longer period of time. The CVI must be unresponsive to compression therapy, because this 

therapy usually enables people to return to a 

good level of functioning.

IOM. (2010), 161. 

Proposed Listing 4.02—Chronic Heart 

Failure 

We propose to revise the listing 

criteria for chronic heart failure (CHF) 

in 4.02A and 4.02B and add new listing 

criteria 4.02C and 4.02D. Proposed 

listing-level severity for CHF would be 

met when the person’s CHF satisfies the 

criteria in 4.02A and 4.02B. Listing-level 

severity for CHF would also be met 

when the person’s CHF satisfies either 

proposed 4.02C or 4.02D. 

Proposed criterion 4.02A1 requires an 

increased left ventricular end diastolic 

dimension (LVEDD) equal to or greater 

than 7.0 centimeters (cm) instead of the 

current criterion of an LVEDD greater 

than 6.0 cm, because an LVEDD less 

than 5.6 cm is normal. We followed the 

IOM’s recommendation in determining 

that an increased LVEDD of greater than 

6.0 cm but less than 7.0 cm indicates 

only a moderately enlarged heart, and 

an increased LVEDD of at least 7.0 cm 

more clearly establishes an enlarged 

heart with signs and symptoms 

indicating listing-level heart failure and 

is comparable to an ejection fraction 

(EF) of 30 percent or less.25

In proposed 4.02A2, we would 

consider an elevated left atrial volume 

index (LAVi) measurement. An LAVi 

measurement provides a precise 

representation of increased left atrial 

pressure, making it a more accurate 

indicator of heart failure than 

considering left atrium size alone.26

To establish listing-level severity for 

CHF, in addition to satisfying the 

criteria in proposed 4.02A, a person’s 

CHF must satisfy the criteria in 

proposed 4.02B. The criteria in 

proposed 4.02B are similar to the 

criteria in current 4.02B1 and 4.02B3, 

respectively, with some important 

changes. For proposed 4.02B1a, we can 

use a conclusion by a medical source 

that an exercise tolerance test (ETT) 

presents a significant risk to a person; 

for example, the person’s cardiologist 

stating that an ETT would cause cardiac 

instability or injury. For proposed 

4.02B1b, we would require findings 

showing that a person is very seriously 

limited in his or her ability to perform 

an ETT, similar to current 4.02B3. 

Consistent with the IOM’s 

recommendations, proposed 4.02B2 

would also include findings showing 

the inability to perform on an ETT at 15 

milliliters/kilograms/minute (ml/kg/ 

min) peak VO2 (oxygen consumption).27

Peak VO2 at this level is comparable to 

the requirement in current 4.02B3 for an 

inability to perform on an ETT at a 

workload equivalent to 5 metabolic 

equivalents (METs) of task. 

We propose to remove current 4.02B2 

‘‘three or more separate episodes of 

acute congestive heart failure’’ because 

we would evaluate these episodes under 

proposed 4.02B3. As recommended by 

the IOM, proposed 4.02B3 would 

evaluate exacerbations or complications 


lotter on DSK11XQN23PROD with PROPOSALS2
38846 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 

28 IOM. (2010), 89, 91. 

29Cha, Y.-M., Lee, G.K., Klarich, K.W., & Grogan, 

M. (2012). Premature ventricular contractioninduced cardiomyopathy: A treatable condition. 

Circulation: Arrhythmia and Electrophysiology, 

5(1), 229–236. doi:10.1161/CIRCEP.111.963348. 

30 Dukes, J.W., Dewland, T.A., Vittinghoff, E., 

Mandyam, M.C., Heckbert, S.R., Siscovick, D.S., 

. . . Marcus, G.M. (2015). Ventricular ectopy as a 

predictor of heart failure and death. Journal of the 

American College of Cardiology, 66(2), 101–109. 

doi:10.1016/j.jacc.2015.04.062. 

31 IOM. (2010), 87. 

32 IOM. (2010), 87, 88. 

33 Desai, R.V., Guichard, J.L., Mujib, M., Ahmed, 

M.I., Feller, M.A., Fonarow, G.C., . . . Ahmed, A. 

(2013). Reduced right ventricular ejection fraction 

and increased mortality in chronic systolic heart 

failure patients receiving beta-blockers: Insights 

from the BEST trial. International Journal of 

Cardiology, 163(1), 61–67. doi:10.1016/ 

j.ijcard.2011.05.051. 

34 IOM. (2010), 84, 89. 

35Runge, M.S., Patterson, C., Stouffer, G.A., & 

Netter, F.H. (2010). Netter’s Cardiology (2nd ed.). 

Philadelphia, PA: Saunders Elsevier. 

36 IOM. (2010), 78, 81, 82, 94. 

37 20 CFR 404.1526 and 416.926. 

38Malotte, K., Saguros, A., & Groninger, H. (2018). 

Continuous cardiac inotropes in patients with endstage heart failure: An evolving experience. Journal 

of Pain Symptom Management, 55(1), 159–163. 

doi:10.1016/j.jpainsymman.2017.09.026. 

39Bistola, V., Arfaras-Melainis, A., 

Polyzogopoulou, E., Ikonomidis, I., & Parissis, J. 

(2019). Inotropes in acute heart failure: From 

guidelines to practical use: Therapeutic options and 

clinical practice. Cardiac Failure Review, 5(3), 133– 

139. doi:10.15420/cfr.2019.11.2. 

40 IOM. (2010), 120. 

41Hua, M., Gong, M.N., Brady, J., & Wunsch, H. 

(2015). Early and late unplanned rehospitalizations 

for survivors of critical illness. Critical Care 

Medicine, 43(2), 430–438. doi:10.1097/ 

CCM.0000000000000717. 

42 Kim, Y., Gani, F., Canner, J.K., Margonis G.A., 

Makary, M.A., Schneider, E.B., & Pawlik, T.M. 

(2016). Hospital readmission after multiple major 

operative procedures among patients with employer 

provided health insurance. Surgery, 160(1), 178– 

190. doi:10.1016/j.surg.2016.01.025. 

43Reynolds, K., Butler, M.G., Kimes, T.M., 

Rosales, A.G., Chan, W., & Nichols, G.A. (2015). 

Relation of acute heart failure hospital length of 

stay to subsequent readmission and all-cause 

mortality. American Journal of Cardiology, 116(3), 

400–405. doi:10.1016/j.amjcard.2015.04.052. 

44 Yu, P.-J., Cassiere, H.A., Fishbein, J., Esposito, 

R.A., & Hartman, A.R. (2016). Outcomes of patients 

with prolonged intensive care unit length of stay 

after cardiac surgery. Journal of Cardiothoracic and 

Vascular Anesthesia, 30(6), 1550–1554. 

doi:10.1053/j.jvca.2016.03.145. 

45Frigola-Capell, E., Comin-Colet, J., DavinsMiralles, J., Gich-Saladich, I., Wensing, M., & 

Verdu ́-Rotellar, J.M. (2012). Trends and predictors 

of hospitalization, readmissions and length of stay 

in ambulatory patients with heart failure. Revista 

Clinica Espanola, 213(1), 1–7. doi:10.1016/ 

j.rce.2012.10.006. 

46Nombela-Franco, L., del Trigo, M., MorrisonPolo, G., Veiga, G., Jimenez-Quevedo, P., Altisent, 

O.A.-J., . . . Rode ́s-Cabau, J. (2015). Incidence, 

causes, and predictors of early (<30 days) and late 

unplanned hospital readmissions after transcatheter 

aortic valve replacement. Journal of the American 

College of Cardiology: Cardiovascular Interventions, 

8(13), 1748–1757. doi:10.1016/j.jcin.2015.07.022. 

47 Versteeg, H., Hoogwegt, M.T., Hansen, T.B., 

Pedersen, S.S., Zwisler, A.-D., & Thygesen, L.C. 

(2013). Depression, not anxiety, is independently 

associated with 5-year hospitalizations and 

mortality in patients with ischemic heart disease. 

Journal of Psychosomatic Research, 75(6), 518–525. 

doi:10.1016/j.jpsychores.2013.10.005. 

of CHF, requiring three hospitalizations 

within a consecutive 12-month period 

and at least 30 days apart.28

Additionally, proposed 4.02B2 would 

not include the requirement in current 

4.02B3b of frequent premature 

ventricular contractions (PVCs). 

Frequent PVCs do not necessarily reflect 

an inability to perform an ETT.29 30 31

The proposed listing also would no 

longer include the criterion in current 

4.02B3d requiring signs attributable to 

inadequate cerebral perfusion, such as 

ataxic gait or mental confusion. Such 

manifestations rarely occur during an 

ETT, even if the person has very serious 

CHF.32

The IOM recommended a criterion for 

chronic heart failure in people who are 

stable and receiving treatment but have 

an EF on a sustained basis of 20 percent 

or less. An EF of only 20 percent means 

the heart’s pumping action is less than 

a third of normal, and critically affects 

a person’s ability to perform gainful 

activity.33 34 35 Most individuals with 

disease this advanced have greater risk 

of mortality and major functional 

limitations, such as shortness of breath 

or fatigue, even during mild exertion.36

We propose 4.02C consistent with the 

IOM’s recommendation. We would 

require at least two EF measurements 

equal to or less than 20 percent at least 

90 days apart within a consecutive 12- 

month period to document chronic 

disease and to exclude heart failure 

resulting from reversible causes. 

Under proposed 4.02D1, we would 

include a new criterion for heart failure 

treated with a mechanical circulatory 

support device (MCSD). Implanted 

MCSDs, such as a left ventricle assistive 

device (LVAD) or a right ventricle 

assistive device (RVAD), help the heart 

pump blood and may be used as a 

‘‘bridge’’ while a person waits for a 

heart transplant. We currently use our 

medical equivalence rules 37 to find 

someone with heart failure and an 

implanted MCSD disabled under listing 

4.09 (Heart transplantation). Adding 

this new criterion will ensure that 

people with heart failure treated with 

MCSD are consistently identified. 

People who require continuous 

intravenous administration of inotropic 

medication (for example, milrinone) 

have very serious heart failure, and the 

length of this treatment can be an 

accurate predictor of impairment 

severity.38 39 Accordingly, proposed 

4.02D2 would find people disabled if 

they require continuous intravenous 

inotropic medications for 30 or more 

consecutive days. 

Proposed Listing 4.04—Ischemic Heart 

Disease 

As noted earlier in this preamble, we 

propose to use reports from AMSs under 

proposed 4.04A to determine whether 

ECG findings are positive for IHD. We 

would also rely on such reports to 

determine whether systolic blood 

pressure measurements during ETTs are 

positive for IHD. Based on our program 

experience and consultation with 

agency medical experts, we expect that 

relying on these reports from AMSs will 

ensure the accuracy of disability claims 

adjudication. 

We would replace current 4.04A4 

with proposed 4.04A. Proposed 4.04B 

adds the requirement to consider 

imaging results derived from 

pharmacologic stress testing. The new 

proposed requirement will provide 

more specific findings than the current 

criterion, which generally requires only 

‘‘documented ischemia.’’ 40 Because of 

these changes, we would redesignate 

current 4.04B as proposed 4.04C and 

revise the introductory text accordingly. 

Proposed 4.04C (current 4.04B) would 

require three separate ischemic episodes 

that result in unplanned 

hospitalizations within a consecutive 

12-month period (see 4.00A3e (What do 

the following terms or phrases mean in 

these listings?), including episodes 

requiring unplanned revascularization 

or treatment for myocardial infarction 

(heart attack), unstable angina, or an 

irregular heartbeat. We would evaluate 

unplanned hospitalizations under this 

section to ensure we are only evaluating 

urgent ischemic episodes. Individuals 

who have ischemic episodes that result 

in unplanned hospitalizations may need 

intensive care, can have long hospital 

stays, may require multiple procedures, 

and can be at high risk for postdischarge morbidity and 

mortality.41 42 43 44 Many also have 

serious co-occurring medical conditions 

(for example, heart failure, chronic 

kidney disease, and chronic obstructive 

pulmonary disease).45 46 47

We would redesignate current 4.04C 

as proposed 4.04D. We would 

reorganize the criteria in current 4.04C 

and follow IOM’s recommendation to 

add new criteria to evaluate the severity 

of a person’s IHD regardless of whether 

he or she has had a timely ETT or 

pharmacologic stress test or whether 

such tests are contraindicated. ETTs and 

pharmacologic stress test are commonly 

performed for diagnostic and prognostic 

purposes, and applicable to determine 


lotter on DSK11XQN23PROD with PROPOSALS2
Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 38847 

48 IOM. (2010), 70. 

49Shlofmitz, E., and Jeremias, A. (2017). FFR in 

2017: Current Status in PCI Management— 

American College of Cardiology. Available online 

at: https://www.acc.org/latest-in-cardiology/ 

articles/2017/05/25/08/34/ffr-in-2017-currentstatus-in-pci-management (accessed September 17, 

2021). 

50Fearon, W.F. (2014). Percutaneous coronary 

intervention should be guided by fractional flow 

reserve measurement. Circulation, 129(18), 1860– 

1870. doi:10.1161/CIRCULATIONAHA.113.004300. 

51Fearon, W.F., De Bruyne, B., & Pijlis, N.H. 

(2016). Fractional flow reserve in acute coronary 

syndromes. Journal of the American College of 

Cardiology, 68(11), 1192–1194. doi:10.1016/ 

j.jacc.2016.07.713. 

52Tebaldi, M., Biscaglia, S., Pecoraro, A., 

Fineschi, M., & Campo, G. (2016). Fractional flow 

reserve implementation in daily clinical practice: A 

European survey. International Journal of 

Cardiology, 207, 206–207. doi:10.1016/ 

j.ijcard.2016.01.097. 

53 Koene, R.J., Adkisson, W.O., & Benditt, D.G. 

(2017). Syncope and the risk of sudden cardiac 

death: Evaluation, management, and prevention. 

Journal of arrhythmia, 33(6), 533–544. https://

doi.org/10.1016/j.joa.2017.07.005. 

54Stout, K.K. (2019). 

55Stack, S.W. . . ., & Berger, S.A. (2009). The 

effects of high hematocrit arterial flow—A 

phenomenological study of health risk implications. 

Chemical Engineering Science, 64(22), 4701–4706. 

doi:10/1016/j.ces.2009.07.017. 

56Bavafa, H., Savin, S., & Terwiesch, C. (2019). 

Redesigning Primary Care Delivery: Customized 

Office Revisit Intervals and E-Visits. https://

dx.doi.org/10.21con39/ssrn.2363685. 

Paper referenced by Bavafa: Schectman, G., G. 

Barnas, P. Laud, L. Cantwell, M. Horton, E.J. 

Zarling. 2005. Prolonging the return visit interval in 

primary care. The American Journal of Medicine, 

118(4) 393–39. 

57According to the University of Washington’s 

Adult Congenital Heart Disease Clinic’s Information 

for Patients and Families (2016), most people with 

congenital heart disease require regular check-ups 

with their cardiologist ‘‘at intervals ranging from 

Continued 

functional capacity in persons with 

IHD.48

We would create proposed new 

4.04D1 based upon blood flow in the 

coronary arteries expressed as fractional 

flow reserve (FFR). Updated medical 

science has shown FFR is a more 

objective and medically updated 

measure of the severity of stenosis.49 A 

clinician may measure FFR in a stenotic 

(obstructed) artery to determine whether 

it requires revascularization. A normal 

(patent) artery has an FFR equal to 1.0. 

If a stenotic artery has an FFR equal to 

or less than 0.80, and the artery is 

amenable to revascularization, the 

clinician will use revascularization to 

restore the vessel, because the 

obstructed artery is causing significant 

ischemia. Accordingly, an FFR 

measurement less than or equal to 0.80 

in the proximal or mid segment of an 

artery that is not amenable to 

revascularization is consistent with the 

requirements of proposed 4.04D1.50 51 52

In proposed 4.04D2 we would 

evaluate IHD by taking into 

consideration a person’s history of 

coronary artery bypass graft surgery. In 

proposed 4.04D3, we would evaluate 

IHD by taking into consideration that a 

person has a decreased EF (i.e., EF of 

less than 50 percent while medically 

stable and on a regimen of prescribed 

treatment). 

In both proposed 4.04D2 and 4.04D3, 

we would require the person to have 

symptoms of myocardial ischemia, as 

described in current 4.00E3 through 

4.00E7 and be on a regimen of 

prescribed treatment. Proposed 4.04D2 

and 4.04D3 would include the criteria 

in current 4.04C1a, b, and d with minor 

editorial changes. Proposed 4.04D2 

includes criteria in current 4.04C1e. We 

would not include the criteria in current 

4.04C1c in the proposed listings 4.04D2 

and 4.04D3 because based on our 

program experience, we determined that 

these criteria do not consistently 

correlate with listing-level severity. 

We would remove current 4.04C2 

with its requirement that a person’s IHD 

result in very serious limitations in his 

or her ability to independently initiate, 

sustain, or complete activities of daily 

living. The criteria in proposed listings 

4.04D1, 4.04D2, and 4.04D3 alone 

provide a description of listing-level 

IHD. 

We are proposing new 4.04E to 

evaluate exacerbations or complications 

of IHD requiring three hospitalizations 

within a consecutive 12-month period 

and at least 30 days apart. These 

hospitalizations may be planned or 

unplanned. The hospitalizations 

required under 4.04E differ from those 

required in proposed 4.04C, which 

requires that hospitalizations be 

unplanned. 

Proposed Listing 4.05—Recurrent 

Arrhythmias 

We propose to reorganize the basic 

structure and presentation of current 

4.05 (Recurrent arrhythmias) to improve 

its clarity and ease of reference. We 

would breakdown the current criteria 

into two parts: recurrent episodes of 

syncope (or near syncope) and findings 

and documentation by a medically 

acceptable test, to demonstrate that both 

parts must be satisfied to document 

listing-level severity. We would also 

remove ‘‘uncontrolled’’ as a descriptor 

for recurrent episodes of cardiac 

syncope because, inherently, these 

episodes are uncontrolled if they recur 

while a person is on a regimen of 

prescribed treatment. Because we would 

remove ‘‘uncontrolled’’ as a descriptor 

in the listing, we would also remove the 

definition for this term from current 

4.00A3 in the introductory text. 

Symptoms associated with arrhythmia 

include: anxiety, chest pain, fatigue, 

sweating, near-syncope, and fainting 

(syncope). Syncope and near-syncope 

are two of the more serious symptoms; 

individuals with arrhythmias and 

recurrent episodes of syncope have a 

higher risk of mortality and sudden 

cardiac death. Furthermore, syncope 

and near-syncope are more quantifiable 

and objective than other symptoms like 

anxiety and fatigue. For these reasons, 

recurrent episodes of syncope and near 

syncope continue to be an appropriate 

indicator of listing-level severity for 

individuals with recurrent 

arrhythmias.53

Proposed Listing 4.06—Congenital Heart 

Disease 

For the reason discussed below, we 

propose to remove the parenthetical 

reference to ‘‘cyanotic or acyanotic’’ 

congenital heart disease from the 

heading in current 4.06 in order to focus 

on hypoxemia. 

Accordingly, we propose to revise 

current 4.06A to require ‘‘hypoxemia’’ 

rather than ‘‘cyanosis or acyanosis.’’ 

‘‘Hypoxemia’’ reflects abnormalities in 

the blood, such as an increased 

hematocrit level or a low blood oxygen 

level, which are detected through 

laboratory analysis or pulse oximetry. 

On the other hand, the term ‘‘cyanosis’’ 

refers to skin discoloration observed 

during a physical examination. Cyanosis 

is a more subjective assessment subject 

to misinterpretation due to by many 

factors, including skin complexion. 

Thus, the term ‘‘hypoxemia’’ relates 

more to the laboratory and pulse 

oximetry findings than the term 

‘‘cyanosis.’’ 54

To establish listing-level severity for 

individuals with congenital heart 

disease, IOM recommended 

documentation of chronic and persistent 

hypoxemia. Therefore to demonstrate 

the chronic and persistent nature, in 

proposed 4.06A1, we would require two 

hematocrit measurements instead of the 

current listing’s single measurement. 

Two measurements, at least 90 days 

apart within a consecutive 12-month 

period will help ensure the person’s 

hematocrit level is associated with 

chronic hypoxemia and not the result of 

a reversible condition, such as 

dehydration.55 The proposed 

requirement that the two measurements 

be 90 days apart is consistent with the 

time period requirement used in our 

other body system listings, and 

consistent with instructions providers 

receive for scheduling patients 56 and 

established check-up intervals for adults 

with congenital heart disease.57


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38848 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 

every several months to every several years.’’ 

Accessed May 4, 2022, from HeartInstitute_

AdultCongenitalHeartDiseaseClinic.pdf 

(uwmedicine.org). 

People with listing-level congenital heart disease 

are expected to require more frequent checkups 

than those who are asymptomatic or have less 

severe disease. 

58See 20 CFR 404.1505(a) and 416.905(a). The 

law defines disability as the inability to do any 

substantial gainful activity by reason of any 

medically determinable physical or mental 

impairment which can be expected to result in 

death or which has lasted or can be expected to last 

for a continuous period of not less than 12 months. 

59Castro D, Patil SM, Keenaghan M. Arterial 

Blood Gas. 2021 Jan 27. In: StatPearls [internet]. 

Treasure Island (FL): StatPearls Publishing; 2021 

Jan–. PMID: 30725604. 

60 IOM. (2010), 178. 

61Oster, M. E. . . ., & Kochilas, L.K. (2016). 

Screening for critical congenital heart disease. 

Clinics in Perinatology, 43(1), 73–80. doi:10.1016/ 

j.clp.2015.11.005. 

62Mechem, C.C. (2014). Pulse oximetry. In P.E. 

Parsons (Ed.), UpToDate (Jan. 2014). Retrieved from 

https://www.uptodate.com/contents/pulseoximetry. 

63 IOM. (2010), 178. 

64A review of the website for the Journal of the 

American Medical Association (JAMA), a peerreviewed medical journal published 48 times a year 

by the American Medical Association, found that 

the exact term ‘‘pulmonary hypertension’’ came 

back with more than 800 results. A search for the 

exact term ‘‘pulmonary vascular obstructive 

disease’’ came back with zero results. The search 

was conducted on September 8, 2021. 

65People with single ventricle will generally 

undergo staged reconstructive ‘‘Fontan 

procedures,’’ ultimately resulting in a ‘‘Fontan 

circulation.’’ Fontan circulation describes the state 

in which virtually all systemic venous return-blood 

passively flows directly into the pulmonary arteries 

via surgical or catheter-placed shunts, without the 

blood passing through a ventricle. 

66Cohen, S., & Marelli, A. (2016). Evolving heart 

transplantation across the lifespan: A growing 

population of adults with congenital heart disease. 

Archives of Cardiovascular Disease, 109(10), 511– 

513. doi:10.1016/j.acvd.2016.05.001. 

67 IOM. (2010), 169, 178. 

68 IOM. (2010), 195. 

69 IOM. (2010), 194, 195. 

Furthermore, requiring two 

measurements at least 90 days apart is 

consistent with the current (and 

proposed) childhood congenital heart 

disease criterion (104.06A1) and will 

assist with documenting duration and 

establishing that the persistent nature of 

the person’s condition.58

We would include the medical 

abbreviation ‘‘SaO2’’ in 4.06A2. This 

abbreviation frequently appears in the 

medical evidence to indicate arterial 

oxygen (O2) saturation determined by 

arterial blood gas testing. We would also 

include the medical abbreviation ‘‘PaO2’’ 

(partial pressure of O2), because medical 

reports may use it interchangeably with 

the abbreviation ‘‘PO2’’ that we use in 

current 4.06A for arterial partial 

pressure of oxygen. Additionally, we 

would express PaO2 and PO2 in 

millimeters of mercury (mmHg) instead 

of Torr units to make the listing 

consistent with current medical practice 

and terminology.59

In proposed 4.06A3, we would add a 

criterion for SpO2 (percentage of oxygen 

saturation of blood hemoglobin) 

measured by pulse oximetry, including 

measurements taken while the person is 

at rest or while doing a six-minute walk 

test (6MWT). Pulse oximetry 

measurements are a non-invasive 

alternative to invasive testing. A 

person’s medical evidence often 

provides SpO2 findings, and SpO2

measured by pulse oximetry reflects an 

advance in medical technology that 

provides another way to establish 

listing-level severity.60 61 62

Proposed 4.06A3 would require three 

SpO2 measurements 30 days apart 

within a consecutive 12-month period 

showing hypoxemia. We explain in the 

introductory text of proposed 4.00H4c 

that these measurements must be 

documented by a medical source using 

methods consistent with the prevailing 

state of medical knowledge and clinical 

practice, and also must be consistent 

with the other evidence in the person’s 

case record. We would require an SpO2

of 87 percent or less because this 

finding is comparable in severity to an 

SaO2 of less than 90 percent in current 

4.06A2.63 By requiring several 

measurements at least 30 days apart, we 

ensure that the required findings span a 

period of at least 90 days. Similar to the 

requirement for repeated hematocrit 

measurements under 4.06A1, this will 

document that the condition is chronic 

and persistent, and the measurements 

are not related to a reversible condition 

or an inaccurate reading. 

In proposed 4.06B, we would include 

an additional option of taking an SaO2

measurement for determining the level 

of hypoxemia during exertion. This 

change would provide an additional 

way of evaluating hypoxemia. Similarly, 

we would include an oxygen uptake 

measurement as another option. 

We are proposing several changes to 

current 4.06C. We would use the term 

‘‘pulmonary hypertension’’ to describe 

the impairment instead of the term 

‘‘pulmonary vascular obstructive 

disease.’’ ‘‘Pulmonary hypertension’’ is 

the term more commonly used by 

clinicians and, therefore, the most likely 

to appear in the medical evidence.64 We 

are also proposing to delete ‘‘secondary’’ 

from the listing’s heading, because 

pulmonary hypertension can be 

disabling regardless of whether it is a 

‘‘primary’’ or ‘‘secondary’’ condition. 

We would include medical findings 

in proposed 4.06C that are expressed in 

millimeters of mercury (mmHg). 

Findings of pulmonary artery pressure 

are expressed in mmHg more often than 

they are expressed as a percentage of 

‘‘systemic arterial systolic pressure,’’ as 

in current 4.06C. Pulmonary 

hypertension may be reported in the 

medical evidence as either pulmonary 

artery pressure or mean pulmonary 

artery pressure, so we would include 

both types of findings in the proposed 

listing. 

We would add a new criterion— 

proposed 4.06D—to evaluate adults 

with ‘‘single ventricle,’’ which is also 

known as ‘‘single ventricle physiology’’ 

or ‘‘functional single ventricle.’’ 

Children born with single ventricle have 

a severe, medically determinable 

impairment (MDI) that will usually need 

to be corrected by staged surgery called 

‘‘Fontan procedures.’’ 65 These 

procedures enable an increasing 

percentage of affected children to 

survive into adulthood. As adults, they 

have significantly reduced functional 

capacities that steadily decline. We 

would find adults disabled under 

proposed 4.06D if objective medical 

evidence shows the person has single 

ventricle, regardless of whether or not 

they had Fontan or other surgical 

procedures.66 67 We provide information 

in the introductory text in proposed 

4.00H3 (What is single ventricle?) about 

single ventricle and these surgical 

procedures. 

Proposed Listing 4.07—Aortic Valvular 

Disease 

We currently evaluate aortic valvular 

disease under other cardiovascular 

disorders listings, which include 

requirements for ETT or repeated 

hospitalization. According to the IOM 

report, due to the risk associated with 

exercise testing for individuals with 

symptomatic aortic stenosis, ETT is not 

advised.68 Furthermore, very serious 

symptomatic aortic stenosis is 

‘‘universally fatal’’ if left untreated and 

there are few effective, long-term 

medical therapies for individuals with 

this level of disease.69 Therefore, we 

followed IOM recommendations to 

provide evaluation criteria for aortic 

valvular disease and propose to add 

new listing 4.07 to evaluate aortic 

valvular disease. The medical 

community considers an aortic valve 

area equal to or less than 1.0 cm2

indicative of advanced stenotic disease 

associated with significant dyspnea, 

fatigue, angina, and other serious 


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70Berthelot-Richer, M., Pibarot, P., Capoulade, R., 

Dumesnil, J.G., Dahou, A., Thebault, C., . . . Clavel, 

M.-A. (2016). Discordant grading of aortic stenosis 

severity: Echocardiographic predictors of survival 

benefit associated with aortic valve replacement. 

Journal of the American College of Cardiology: 

Cardiovascular Imaging, 9(7), 797–805. doi:10.1016/ 

j.jcmg.2015.09.026. 

71 IOM. (2010), 195. 

72Nombela-Franco, L. (2015). 

73Ziberszac, R., Gabriel, H., Schemper, M., 

Laufer, G., Maurer, G., & Rosenhek, R. (2017). 

Asymptomatic severe aortic stenosis in the elderly. 

Journal of the American College of Cardiology: 

Cardiovascular Imaging, 10(1), 43–50. doi:10.1016/ 

j.jcmg.2016.05.015. 

74SSA has designated endomyocardial fibrosis 

and cardiac amyloidosis AL type as Compassionate 

Allowance (CAL) conditions. See Compassionate 

Allowances website Home Page (ssa.gov). 

75 IOM. (2010), 80. 

76 IOM. (2010), 217. 

77 IOM. (2010), 160. 

78 IOM. (2010), 161. 

79 Id. 

80 IOM. (2010), 157–161. 

81 IOM. (2010), 159. 

82 IOM. (2010), 161. 

83 IOM. (2010), 161. 

84Poredosˇ P, Jezovnik M, Kalodiki E. Medical 

management of patients with peripheral arterial 

Continued 

symptoms.70 71 72 73 Proposed 4.07 would 

require appropriate testing that 

documents the aortic valve area. 

Proposed Listing 4.08—Cardiomyopathy 

Consistent with IOM 

recommendations, we would add 4.08 

to evaluate cardiomyopathies, such as 

hypertrophic cardiomyopathy (HCM). 

We currently evaluate cardiomyopathy 

under 4.02 (Chronic heart failure), 4.04 

(Ischemic heart disease), 4.05 (Recurrent 

arrhythmias), or 11.04 (Vascular insult 

to the brain), depending on its effects. 

Depending on the underlying cause of 

the person’s cardiomyopathy or its 

effects, we may continue to evaluate 

cardiomyopathy under 4.02, 4.04, 4.05, 

and 11.04. We created this new 

cardiomyopathy listing to specifically 

address HCM, endomyocardial fibrosis, 

and cardiac amyloidosis AL type, which 

are more serious types of 

cardiomyopathy.74

HCM with severe left ventricular or 

septal wall thickness can cause serious 

problems, including chest pain, 

dyspnea, syncope, and arrhythmias.75

As recommended by IOM, we would 

evaluate HCM under proposed 4.08A by 

requiring the heart to have a left 

ventricular or septal wall thickness 

equal to or greater than 20 millimeters. 

Proposed 4.08 also requires the 

individual to be seriously limited in the 

ability to perform an ETT, or a medical 

source has concluded that the 

performance of an ETT would present a 

significant risk. 

Proposed 4.08B would evaluate 

endomyocardial fibrosis, a form of 

cardiomyopathy with a generally poor 

prognosis despite treatment. Under 

proposed 4.08B, we would require 

endomyocardial fibrosis resulting in a 

loss of heart chamber volume, atrial 

dilatation, and mitral or tricuspid valve 

regurgitation. 

Proposed 4.08C would evaluate 

cardiac amyloidosis AL (light-chain) 

type, another form of cardiomyopathy 

with a poor prognosis. We would need 

objective medical evidence, such as 

biopsy findings, echocardiogram, 

cardiac MRI, and PET scan to establish 

listing-level severity. 

Proposed 4.08D would evaluate 

exacerbations or complications of 

cardiomyopathy, requiring three 

hospitalizations within a consecutive 

12-month period and at least 30 days 

apart. 

Proposed Listing 4.09—Heart 

Transplantation 

We are proposing editorial changes in 

the heading and text of current 4.09, 

which would not be substantive but 

would clarify the guidance. We have 

changed from ‘‘1 year following 

surgery’’ to ‘‘1 year from the date of the 

transplant’’ consistent with 

transplantation listings in other body 

systems such as 6.04 (Chronic kidney 

disease) and 7.17 (Hematological 

disorders treated by bone marrow or 

stem cell transplantation). 

Proposed Listing 4.10—Dissecting 

Aneurysm of the Aorta or Major 

Branches 

We propose to revise the heading for 

listing 4.10 to specify that we evaluate 

only ‘‘dissecting’’ aneurysms under the 

listing consistent with IOM 

recommendations.76

Proposed Listing 4.11—Chronic Venous 

Insufficiency 

We propose to revise the heading in 

current listing 4.11 by replacing the 

outdated term ‘‘incompetency’’ with the 

term ‘‘reflux’’—the term the medical 

community currently uses to describe 

decrease blood flow and pooling of 

blood in the veins.77 We would delete 

the word ‘‘deep’’ in the heading so that 

the listing covers reflux or obstruction 

associated with superficial and 

perforating veins. Reflux or obstruction 

in these veins may result in the required 

level of CVI.78 Additionally, as 

recommended by IOM, we would 

require confirmation of CVI by duplex 

ultrasound or other appropriate 

diagnostic technique. The medical 

community considers the use of duplex 

ultrasound to be the best method for 

detecting reflux or obstruction.79

In proposed 4.11A, we would adopt 

IOM recommendations and broaden the 

listing criteria we apply to trophic 

changes (changes resulting from 

interruption of nerve supply) of the 

skin. For example, in addition to 

brawny edema, trophic changes 

evaluated under the proposed listing 

would include hyperpigmentation and 

lipodermatosclerosis. 

We would revise the current 

requirement that these skin changes 

involve ‘‘at least two-thirds of the leg 

between the ankle and knee or the distal 

one-third of the lower extremity 

between the ankle and hip.’’ Instead, we 

would require extensive skin changes 

involving at least two-thirds of the leg 

below the knee, to make the 

requirement simpler to understand and 

apply. This revision is consistent with 

IOM’s recommendation to require skin 

changes below the knee.80

We would require the skin changes 

under proposed 4.11A to be consistent 

with CVI, and we would document the 

skin changes over a period of at least 90 

days to ensure they are chronic. 

Additionally, the CVI must be 

unresponsive to compression therapy, 

because this therapy usually enables 

people to return to a good level of 

functioning.81

In proposed 4.11B, we would remove 

findings in the current listing that no 

longer demonstrate required severity. 

For example, we would remove 

superficial varicosities, which indicate 

venous disease but not necessarily CVI. 

We would follow IOM’s 

recommendation and also remove stasis 

dermatitis, because it is ‘‘a generic term 

referring to the trophic changes,’’ and it 

is unreliable because it may be a sign of 

other unrelated conditions including 

aging.82

Proposed 4.11B would require 

recurrent or persistent skin ulceration 

that has not healed after 6 or more 

months of prescribed treatment. In 

regard to documenting duration and 

severity of CVI, this requirement is more 

conclusive than the current requirement 

of 3 months of unsuccessful prescribed 

treatment as it demonstrates the 

condition has persisted despite 

treatment for a longer period of time.83

Proposed Listing 4.12—Peripheral 

Arterial Disease 

We propose to revise the heading of 

the current listing to evaluate peripheral 

arterial disease (PAD) while the person 

is on a regimen of prescribed treatment. 

PAD often improves with angioplasty, 

supervised physical rehabilitation, and 

other prescribed therapies.84


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38850 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 

disease. Int Angiol. 2015 Feb;34(1):75–93. Epub 

2014 Jun 11. PMID: 24916346. 

85 IOM. (2010), 151. 

86 Id. 

87The International Society of Heart and Lung 

Transplantation’s grading classification defines 

mild cardiac allograft vasculopathy (CAV1) as 

having left main artery stenosis of less than 50 

percent, primary vessel stenosis greater than 70 

percent (including the right coronary artery), or any 

branch stenosis greater than 70 percent (see Mehra, 

M.R., Crespo-Leiro, M.G., Dipchand, A., Ensminger, 

S.M., Hiemann, N.E., Kobashigawa, J.A., . . . Uber, 

P.A. (2010). International Society of Heart and Lung 

Transplantation working formulation of a 

standardized nomenclature for cardiac allograft 

vasculopathy—2010. Journal of Heart and Lung 

Transplantation, 29(7), 717–727. doi:10.1016/ 

j.healun.2010.05.017). 

88 Kindel, S.J., & Pahl, E. (2011). Cardiac allograft 

vasculopathy in children—treatment challenges. 

Progress in Pediatric Cardiology, 32(1), 37–42. 

doi:10.1016/j.ppedcard.2011.06.008. 89 Kobashingawa, J.A. (2015). The changing face 

of first-year intravascular ultrasonography in heart 

transplantation. Journal of the American College of 

Cardiology: Heart Failure, 3(12), 954–955. 

doi:10.1016/j.jchf.2015.09.004. 

90Mehra, M.R. (2010). 

91Okada, K., Kitahara, H., Yang, H., Tanaka, S., 

Kobayashi, Y., Kimura, T., . . . Fearon, W.F. (2015). 

Paradoxical vessel remodeling of the proximal 

segment of the left anterior descending artery 

predicts long-term mortality after heart 

transplantation. Journal of the American College of 

Cardiology: Heart Failure, 3(12), 945–952. 

doi:10.1016/j.jchf.2015.07.013. 

92 IOM. (2010), 89, 172. 

93 Id. 

94Hua, M. (2015). 

95 IOM. (2010), 30, 90, 196. 

96 Kim, Y. (2016). 

97 Kyriakou, M., & Kiff, P.F. (2016). Prognosis of 

the comorbid heart failure and anemia: A 

systematic review and meta-analysis. Clinical Trials 

and Regulatory Science in Cardiology, 16, 12–21. 

doi:10.1016/j.ctrsc.2016.01.008. 

98Reynolds, K. (2015). 

99 Versteeg, H. (2013). 

100 Yu, P.-J. (2016). 

101 Jackson SL, Tong X, King RJ, et al. National 

Burden of Heart Failure Events in the United States, 

2006 to 2014. Circulation. Heart Failure. 2018 

Dec;11(12):e004873. DOI: 10.1161/ 

circheartfailure.117.004873. PMID: 30562099; 

PMCID: PMC6424109. 

102Cedars, A., Benjamin, L., Burns, S.V., Novak, 

E., & Amin, A. (2017). Clinical predictors of length 

of stay in adults with congenital heart disease. 

Heart (British Cardiac Society), 103(16), 1258–1263. 

https://doi.org/10.1136/heartjnl-2016-310841. 

103 IOM. (2010), 161. 

We would add leg pain in the heading 

as a serious and potentially debilitating 

symptom of PAD. People who have PAD 

with intermittent leg pain may be 

impaired to a similar extent as a person 

with PAD with intermittent 

claudication.85

Consistent with IOM 

recommendations, we would require a 

person’s intermittent leg pain or 

claudication to interfere with his or her 

mobility. This proposed change clarifies 

our original intent in the listing, which 

is to tie PAD to functioning. Finally, we 

would replace the term ‘‘appropriate 

medically acceptable imaging’’ in the 

listing heading with ‘‘appropriate 

test(s)’’ (4.00G6—Are there any other 

studies that are helpful in evaluating 

PAD?) to acknowledge that non-imaging 

procedures such as physical 

examination and blood tests may also 

help detect PAD.86

Proposed Listing 4.16—Cardiac 

Allograft Vasculopathy 

We propose to add new listing 4.16 to 

evaluate a person who received a heart 

transplant (allograft) and subsequently 

developed cardiac allograft 

vasculopathy (CAV). Currently, we 

evaluate CAV through medical 

equivalence to listing 4.09 (Heart 

transplant). CAV results in stenosis of 

the heart’s blood vessels that may 

progress quickly and cause significant 

heart dysfunction. CAV with moderate 

stenosis, as defined in the medical 

literature,87 may also result in a listinglevel impairment, depending on the 

extent and seriousness of dysfunction. 

To establish the required level of CAV, 

we would require a cardiac index 

(cardiac output) of less than 2 liters/ 

minute/meter square (L/min/m2), an 

ejection fraction equal to or less than 45 

percent, right atrial pressure greater 

than 12 mmHg, or pulmonary capillary 

wedge pressure greater than 15 mmHg. 

Individuals who have any of these 

findings have a poor prognosis and are 

limited in their activities and ability to 

work.88 89 90 91

Other Proposed Changes 

As mentioned, we are proposing new 

criteria to evaluate exacerbations or 

complications of several categories of 

cardiovascular disorders. These new 

criteria include proposed 4.02B3 for 

evaluating chronic heart failure, 

proposed 4.04E for evaluating ischemic 

heart disease, proposed 4.06E for 

evaluating congenital heart disease, and 

proposed 4.08D for evaluating 

cardiomyopathies. Consistent with IOM 

recommendations, we are proposing 

these new criteria for evaluating chronic 

heart failure and cardiomyopathies.92 In 

addition, we are proposing these new 

criteria for evaluating ischemic heart 

disease (4.04) and congenital heart 

disease (4.06). Our adjudicative 

experience shows that these 

cardiovascular disorders are prone to 

exacerbations and serious 

complications. These proposed criteria 

would require exacerbations or 

complications causing a person to be 

hospitalized three or more times within 

a consecutive 12-month period.93 An 

impairment resulting in exacerbations 

or complications that require this many 

hospitalizations in 12 months will 

prevent a person from engaging in any 

gainful activity.94 95 96 97 98 99 100 We 

would require these hospitalizations to 

be at least 30 days apart and to last at 

least 48 hours, including hours in a 

hospital emergency department 

immediately before the hospitalization, 

to ensure we are evaluating separate 

listing-level episodes of exacerbations or 

complications. Our proposal to require 

that each hospitalization last at least 48 

hours is generally consistent with data 

showing that the average length of 

hospital stays for serious cardiac 

conditions like primary heart failure 

and adult congenital heart disease is at 

least 48 hours.101 102

Another revision we are proposing 

would affect chronic venous 

insufficiency evaluated under 4.11. 

Under our proposed changes, we would 

follow IOM’s recommendations and 

require documentation that certain 

manifestations of chronic venous 

insufficiency (for example, trophic 

changes of the skin) occurred at least 

twice within a consecutive 12-month 

period, instead of only once under the 

current listings.103 This change is based 

on the IOM recommendation that two 

occurrences per year more accurately 

and consistently demonstrates listinglevel severity. We would also require 

documentation that these manifestations 

occurred at least 90 days apart. These 

requirements ensure we are 

appropriately documenting the 

chronicity and persistence of these 

conditions and evaluating people who 

have very serious chronic conditions. 

Proposed Changes to the Childhood 

Cardiovascular Disorders Introductory 

Text 

Proposed 104.00—Introductory Text to 

the Childhood Cardiovascular Disorders 

Listings 

We repeat much of the introductory 

text of proposed 4.00 in the introductory 

text of proposed 104.00, because the 

same basic criteria for evaluating 

cardiovascular disorders apply to both 

adults and children. Because we have 

already described these proposed 

criteria above, the following discussion 

describes only those criteria that are 

unique to children or that require 

further explanation in how they will be 

applied to children. 

The following table shows the 

heading of the current and proposed 

sections of the childhood introductory 

text for cardiovascular disorders: 


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Current sections of the childhood introductory text and listings for 

cardiovascular system 

Proposed sections of the childhood introductory text and listings for 

cardiovascular disorders 

104.00 Cardiovascular System ................................................................ 104.00 Cardiovascular Disorders. 

A. General ................................................................................................ A. How do we define cardiovascular disorder and cardiovascular 

terms? 

B. Documenting Cardiovascular Impairment ............................................ B. What documentation do we need to evaluate cardiovascular disorders? 

C. Evaluating Chronic Heart Failure ........................................................ C. How do we evaluate chronic heart failure? 

D. Evaluating Congenital Heart Disease .................................................. D. How do we evaluate congenital heart disease? 

E. Evaluating Arrhythmias ........................................................................ E. How do we evaluate arrhythmias? 

F. Evaluating Other Cardiovascular Impairments .................................... F. How do we evaluate other cardiovascular disorders? 

G. Other Evaluation Issues ...................................................................... G. How do we evaluate issues that affect the cardiovascular system? 

H. How do we evaluate cardiovascular disorders that do not meet one 

of these listings? 

Proposed 104.00C—How do we evaluate 

chronic heart failure? 

We are proposing changes in current 

104.00C consistent with changes we are 

proposing in the adult listings for 

chronic heart failure. We would 

extensively revise current 104.00C2 by 

removing specific findings for 

documenting cardiomegaly. These 

findings are often not provided in a 

child’s case record and, therefore, have 

presented difficulty in adjudication. 

Proposed 104.00C2a would describe the 

types of imaging provided in a child’s 

case record for documenting 

cardiomegaly. We explain at 

104.00C2b(iii) that signs of congestion 

need not be found on all examinations 

because congestion may be controlled 

by prescribed treatment or may not be 

present at the time of evaluation. We 

have added 104.00C4 to explain how we 

propose to evaluate chronic heart failure 

treated with a mechanical circulatory 

support device under proposed 104.02D 

(Chronic heart failure). 

Proposed 104.00D—How do we evaluate 

congenital heart disease? 

We plan to significantly expand the 

information in current 104.00D. In 

proposed 104.00D2 (How do we 

evaluate conditions associated with 

congenital heart disease?), we would 

explain how we evaluate conditions 

associated with congenital heart disease. 

Proposed 104.00D2 includes additional 

means of measuring oxygen saturation 

in 104.06 (Congenital heart disease), 

because these measurements are readily 

found in the medical evidence. We are 

proposing new 104.00D3 (What is 

Eisenmenger syndrome?) to explain 

Eisenmenger syndrome in children, and 

we propose new 104.00D4 (What is a 

single ventricle?) to include a definition 

for the term ‘‘single ventricle.’’ 

Proposed 104.00F—How do we evaluate 

other cardiovascular disorders? 

We propose revisions to 104.00F6 

(How will we evaluate chronic 

rheumatic fever or rheumatic heart 

disease?) consistent with the removal of 

current listing 104.13, rheumatic heart 

disease. These revisions would explain 

that we evaluate rheumatic heart disease 

under 104.02 (Chronic heart failure) or 

104.05 (Recurrent arrhythmias). We 

propose adding 104.00F11 (What is 

cardiac allograft vasculopathy and how 

do we evaluate it?) consistent with 

proposed 104.16 (Cardiac allograft 

vasculopathy). 

Proposed 104.00G—How do we evaluate 

issues that affect the cardiovascular 

system? 

We propose revisions to 104.00G 

consistent with those proposed to the 

adult listings. We propose to revise 

104.00G1 (How do we consider the 

effects of obesity when we evaluate your 

cardiovascular disorder?) to simplify 

and refocus our discussion of how we 

consider the effects of obesity more 

specifically on cardiovascular disorders. 

We propose adding 104.00G3 (How do 

we consider hospitalizations?), 

consistent with new 104.02E (Chronic 

heart failure) and 104.06E (Congenital 

heart disease). We propose to 

redesignate current 104.00G3 (How do 

we evaluate impairments that do not 

meet one of the cardiovascular listings?) 

as 104.00H (How do we evaluate 

cardiovascular disorders that do not 

meet one of these listings?). 

Proposed Changes to the Childhood 

Cardiovascular Disorders Listings 

We are proposing some changes to the 

childhood listings that correspond with 

changes we are proposing to the adult 

listings. Other changes are specific to 

how we evaluate cardiovascular 

disorders in children. The reasons 

provided above for changing or 

removing current criteria for adults also 

apply to the criteria for children. 

Because we have already described 

these proposed criteria above, the 

following discussion describes only 

those criteria that are unique to children 

or that require further explanation in 

how we will specifically apply them to 

children. Additionally, the numbering 

of the childhood listings would conform 

to that of the adult listings. 

The following table shows the 

heading of the current and proposed 

sections of the childhood listings for 

cardiovascular disorders: 

CHILDHOOD CARDIOVASCULAR DISORDERS LISTINGS

Current Proposed 

104.02 Chronic heart failure ..................................................................... 104.02 Chronic heart failure. 

104.05 Recurrent arrhythmias .................................................................. 104.03 [Reserved]. 

104.06 Congenital heart disease ............................................................. 104.04 [Reserved]. 

104.09 Heart transplant ............................................................................ 104.05 Recurrent arrhythmias. 

104.13 Rheumatic heart disease ............................................................. 104.06 Congenital heart disease. 

104.07 [Reserved]. 

104.08 [Reserved]. 

104.09 Heart transplantation. 

104.10 [Reserved]. 

104.11 [Reserved]. 

104.12 [Reserved]. 


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CHILDHOOD CARDIOVASCULAR DISORDERS LISTINGS—Continued 

Current Proposed 

104.13 [Reserved]. 

104.14 [Reserved]. 

104.15 [Reserved]. 

104.16 Cardiac allograft vasculopathy. 

The following table shows our 

proposed changes to the childhood 

cardiovascular disorders listings criteria 

that involve changes to healthcare 

utilization and condition/episode 

requirements, the rationale for each 

change, and supporting resource. 

Following this table, we discuss all of 

our proposed changes to the childhood 

cardiovascular disorders listings in 

more detail. 

CHILDHOOD CARDIOVASCULAR DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ 

EPISODE REQUIREMENTS

Current listing criterion Proposed listing criterion Rationale Resources 

Listing 104.02 Chronic heart failure 

104.02A Persistent tachycardia at 

rest (see Table I); 

A. Persistent tachycardia at rest 

measured at least twice within a 

consecutive 12-month period 

and at least 90 days apart documented by apical heart rate 

greater than or equal to the 

value in Table I. 

We would clarify that to satisfy 

104.02A, we would require two 

or more tachycardia measurements in a consecutive 12- 

month period. Our intent is to 

ensure that the child has persistent tachycardia despite 

treatment. We would also require that readings of tachycardia occur at least 90 days 

apart to further document 

chronic disease. 

IOM. (2010), 171,173, 176. 

104.02B ..........................................

Persistent tachypnea at rest (see 

Table II) or markedly decreased 

exercise tolerance (see 

104.00C2b); 

B. Persistent tachypnea at rest 

measured at least twice within a 

consecutive12-month period 

and at least 90 days apart documented by respiratory rate 

greater than or equal to the 

value in Table II or markedly 

decreased exercise tolerance 

(see 104.00C2b). 

To satisfy 104.02B, we would require two or more tachypnea 

measurements in a consecutive 

12-month period. Our intent is 

to ensure that the child has persistent tachypnea, despite treatment. We would also require 

that readings of tachypnea 

occur at least 90 days apart to 

further document chronic disease. 

IOM. (2010), 171,173, 176. 

Listing 104.06 Congenital heart disease 

104.06 ............................................

A. 2. Arterial O2 saturation of less 

than 90 percent in room air, or 

resting arterial PO2 of 60 Torr or 

less; or 

3. Hypercyanotic spells, syncope, 

characteristic squatting, or other 

incapacitating symptoms directly 

related to documented cyanotic 

heart disease; or 

4. Exercise intolerance with increased hypoxemia on exertion. 

104.06 ...........................................

A. 2. Arterial blood gas test measurement obtained at rest while 

breathing room air, as described in either a or b: 

a. SaO2 (arterial oxygen saturation) less than or equal to 89 

percent; or 

b. PO2 or PaO2 (partial pressure 

of oxygen) less than or equal to 

60 mmHg; or 

3. SpO2 (percentage of oxygen 

saturation of blood hemoglobin) 

measured by pulse oximetry either at rest, or after activity, 

while breathing room air, less 

than or equal to 87 percent on 

three evaluations at least 30 

days apart within a consecutive 

12-month period (see 

104.00A3e). 

In 104.06A2, we would use the 

measurement of millimeters of 

mercury, ‘‘mmHg,’’ instead of 

the measurement of ‘‘Torr’’ that 

is used in current 104.06A2, 

and we would note that arterial 

PO2 is normally measured in 

room air. 

We would remove current 

104.06A3 and 104.06A4, because Agency medical experts 

indicated they are less objective 

and more difficult to document 

than the other criteria and they 

are used infrequently. 

We would add another criterion to 

104.06A by adding SpO2 (percentage of oxygen saturation of 

blood hemoglobin), measured 

by pulse oximetry equal to or 

less than 87 percent. Consistent with the proposed adult 

listing (4.06), this criterion 

would become the new 

104.06A3. 

Based on SSA administrative data 

from FY 2019–2021, of all 

childhood claims with a primary 

impairment of congenital heart 

disease that met or medically 

equaled listing 104.06, approximately .2 percent cited 

104.06A3 or 104.06A4 criteria. 

See Table A and B in supporting and related materials to 

this Docket for more information. 


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104 IOM. (2010), 171, 176. 

105 IOM. (2010), 173. 

106 80 FR 19522 (2015). 

107Based on SSA administrative data from FY 

2019–2021, of all childhood claims with a primary 

impairment of congenital heart disease that met or 

medically equaled listing 104.06, approximately .2 

percent cited these criteria. See Table A and B in 

supporting and related materials to this Docket for 

more information. 

108 IOM. (2010), 179. 

109Beaudoin, A., Edison, L., Introcaso, C.E., Goh, 

L., Marrone, J., Mejia, A. . . ., & Van Beneden, C. 

(2015). Acute rheumatic fever and rheumatic heart 

disease among children—America Samoa, 2011– 

2012. Morbidity and Mortality Weekly Report, 

64(20), 555–558. Retrieved from https:// 

www.cdc.gov/mmwr/pdf/wk/mm6420.pdf. 

110 Yandrapalli, S., Tariq, S., Vuddanda, V.L.K., 

Sanaani, A., Solangi, Z., Anugu, V.R., . . . Aronow, 

W. (2017). In-hospital outcomes and 

hospitalizations for acute rheumatic heart disease: 

A United States national study. Journal of the 

American College of Cardiology, 69(11)(Suppl.), 

1742. doi:10.1016/S0735–1097(17)35131–8. 

CHILDHOOD CARDIOVASCULAR DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ 

EPISODE REQUIREMENTS—Continued 

Current listing criterion Proposed listing criterion Rationale Resources 

No current criteria .......................... E. Exacerbations or complications 

of congenital heart disease (see 

104.00D) requiring three hospitalizations within a consecutive 12-month period (see 

104.00A3e) and at least 30 

days apart. Each hospitalization 

must last at least 48 hours, including hours in a hospital 

emergency department immediately before the hospitalization (see 104.00G3). 

We would add 104.06E to evaluate exacerbations or complications of congenital heart disease occurring at least 30 days 

apart and resulting in at least 

three hospitalizations within a 

consecutive 12-month period. 

An impairment resulting in exacerbations or complications 

that require this many hospitalizations in 12 months will 

result in marked and severe 

functional limitations for children. We would require these 

hospitalizations to be at least 

30 days apart to ensure we are 

evaluating separate episodes of 

exacerbations or complications. 

IOM. (2010), 179. 

Proposed Listing 104.02—Chronic Heart 

Failure 

We would clarify that to satisfy 

104.02A, we would require two or more 

tachycardia measurements in a 

consecutive 12-month period, and to 

satisfy 104.02B, we would require two 

or more tachypnea measurements in a 

consecutive 12-month period.104 Our 

intent is to ensure that the child has 

persistent tachycardia or persistent 

tachypnea, despite treatment. We would 

also require that readings of tachycardia 

or tachypnea occur at least 90 days apart 

to further document chronic disease.105

When we last published final rules for 

growth disorders and weight loss in 

children,106 we inadvertently removed 

Table I for tachycardia at rest and Table 

II for tachypnea at rest in listing 104.02. 

We would restore these tables to the 

proposed 104.02. 

We would add new 104.02D to 

describe how we will evaluate chronic 

heart failure treated with a mechanical 

circulatory support device. 

We would add new 104.02E(), to 

describe how we will evaluate 

exacerbations and complications of 

heart failure requiring extended medical 

intervention in the hospital or 

emergency department, as explained 

above. 

Proposed Listing 104.06—Congenital 

Heart Disease 

In 104.06A2, we would use the 

measurement of millimeters of mercury, 

‘‘mmHg,’’ instead of the measurement of 

‘‘Torr’’ that is used in current 104.06A2, 

and we would note that arterial PO2 is 

normally measured in room air. 

We would add another criterion to 

104.06A by adding SpO2 (percentage of 

oxygen saturation of blood hemoglobin), 

measured by pulse oximetry equal to or 

less than 87 percent. This criterion 

would become the new criterion 

104.06A3. As we are proposing in the 

adult criteria, we would explain in the 

introductory text to the childhood 

listings that we need pulse oximetry 

measurements documented by medical 

sources using methods consistent with 

the prevailing state of medical 

knowledge and clinical practice. These 

measurements must be consistent with 

the other evidence in the case record. 

We would remove current 104.06A3 

and 104.06A4, because they are used 

infrequently.107 Our adjudicative 

experience shows that children with 

impairments meeting these listings 

would be evaluated under current and 

proposed 104.06. 

We would add multiple medical 

readings for pulmonary hypertension in 

104.06B. We propose adding laboratory 

findings expressed in millimeters of 

mercury (mmHG) in 104.06B2, and we 

would add mean pulmonary artery 

pressure readings in 104.06B3. 

We are proposing 104.06C, similar to 

the adult criterion 4.06D (Congenital 

heart disease), to evaluate children born 

with a single ventricle. Adding 

consideration of single ventricle to 

listing 104.06 enables seriously limited 

children to be identified earlier in the 

sequential evaluation process. 

We would add 104.06E to evaluate 

exacerbations or complications of 

congenital heart disease occurring at 

least 30 days apart and resulting in at 

least three hospitalizations within a 

consecutive 12-month period. An 

impairment resulting in exacerbations 

or complications that require this many 

hospitalizations in 12 months will result 

in marked and severe functional 

limitations for children.108 We would 

require these hospitalizations to be at 

least 30 days apart to ensure we are 

evaluating separate episodes of 

exacerbations or complications. 

Proposed Removal of Listing 104.13— 

Rheumatic Heart Disease 

We would remove and reserve listing 

104.13 because rheumatic heart disease 

is a complication of rheumatic fever, 

which is rare in the United States due 

to widely available treatment with 

antibiotics.109 110 When complications of 

rheumatic fever result in rheumatic 

heart disease, and these complications 

last for 12 months or more, we would 

evaluate the complications under other 

cardiovascular listings, such as 104.02 

(Chronic heart failure) or 104.05 


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111 Kindel, S.J. (2011). 

112 IOM. (2010), 195. 

113Sections 205(a), 702(a)(5), and 1631(d)(1) of 

the Social Security Act. 

(Recurrent arrhythmias). Rheumatic 

heart disease will still be addressed in 

the introductory text under 104.00F6 

(How will we evaluate chronic 

rheumatic fever or rheumatic heart 

disease?). 

Proposed Listing 104.16—Cardiac 

Allograft Vasculopathy 

We propose to add listing 104.16 

(Cardiac allograft vasculopathy) to 

evaluate a child who received a heart 

transplant and developed cardiac 

allograft vasculopathy (CAV). CAV may 

develop after heart transplantation and 

progress to a very serious condition 

with significant functional effects. The 

medical literature indicates that CAV is 

a leading cause of graft failure and 

mortality in pediatric heart transplant 

recipients.111 To establish listing-level 

CAV for children, we would require 

only CAV documented by appropriate 

medically acceptable imaging, because 

pediatric CAV alone is disabling enough 

to result in marked and severe 

functional limitations for children 

Specific Questions for the Public 

While the public is welcome to 

comment on any aspect of this proposed 

rule, we are also seeking input on the 

following topics: 

• Should any of the proposed listings 

for cardiovascular disorders be 

combined into one listing, or divided 

into multiple listings, to enable our 

adjudicators to more easily identify 

adults or children with impairments 

that are of listing-level severity? If you 

believe our listing categories create 

unnecessary administrative barriers for 

impairments that meet listing level 

severity, please tell us by submitting 

your comments and any supporting 

research or data. 

• Are there changes in the medical 

terminology related to cardiovascular 

disorders that we should consider 

incorporating or clarifying in future 

revisions to the cardiovascular disorders 

listings? If you believe we should 

consider updating the medical 

terminology we use in our 

cardiovascular disorders listings, please 

tell us by submitting your comments 

and any supporting research or data. 

• Do the frequencies and durations of 

exacerbations of cardiovascular 

disorders in this proposed rule 

adequately represent listing level 

severity for cardiovascular disorders? 

Are there other treatments and evidence 

we should consider when assessing 

listing-level severity including 

additional objective medical tests, for 

any of the proposed cardiovascular 

disorders listings? We encourage you to 

cite relevant research or data to support 

your comments. 

• Are the proposed functional criteria 

for cardiovascular disorders sufficient 

for assessing listing level severity? 

Please provide specific suggestions 

along with supporting research and data 

for different criteria you would like SSA 

to consider. 

• Did we not include any valuable 

information that should be included in 

the introductory text of the 

cardiovascular disorders listings? This 

text is intended to ease administrative 

burden for adjudicators, claimants, 

claimant representatives, and the 

public. Please submit specific 

comments, along with supporting 

research or data, about additional 

information to include in the 

introductory text. 

• In proposed 4.02A1 (Chronic heart 

failure), we require systolic failure 

documented by appropriate medically 

acceptable imaging during a period of 

stability (not during an episode of 

exacerbation of heart failure), with left 

ventricular end diastolic dimension 

equal to or greater than 7.0 cm; or 

ejection fraction of 30 percent or less. If 

you believe we should require more 

than one evaluation to document the 

duration of an individual’s chronic 

heart failure, please tell us by 

submitting your comments and any 

supporting research or data. 

• In proposed 4.02A2 (Chronic heart 

failure), we require diastolic failure 

documented by appropriate medically 

acceptable imaging during a period of 

stability (not during an episode of 

exacerbation of heart failure), with left 

ventricular posterior wall plus septal 

thickness totaling 2.5 cm or greater, 

with an enlarged left atrium greater than 

or equal to 4.5 cm, OR left atrial volume 

index (LAVi) greater than or equal to 40 

ml, BSA/m2 (milliliters to body surface 

area in squared meters). If you believe 

we should consider other measurements 

of chronic heart failure, please tell us by 

submitting your comments and any 

supporting research or data. 

• In proposed 104.02A (Chronic heart 

failure), we require persistent 

tachycardia at rest measured twice 

within a consecutive 12-month period 

and at least 90 days apart documented 

by apical heart rate greater than or equal 

to the value in Table I. In proposed 

104.02B, we require persistent 

tachypnea measured at least twice 

within a consecutive 12-month period 

and at least 90 days apart documented 

by respiratory rate greater than or equal 

to the value in Table II or markedly 

decreased exercise tolerance. If you 

believe our proposed requirement for at 

least two measurements of apical heart 

rate and respiratory rate under this 

listing is inconsistent with current 

medical practice or standards of care 

(i.e., medical providers do not routinely 

repeat these measurements), please tell 

us by submitting your comments and 

any supporting research or data. 

• In proposed 4.06A1 (Congenital 

heart disease), we require two 

measurements of hematocrit at least 90 

days apart within a consecutive 12- 

month period instead of the current 

requirement for one measurement. If 

you would like to propose a different 

time frame during which these measures 

should occur, please submit comments 

and any supporting research or data. 

• Are there alternatives to pulse 

oximetry testing that are reliable, noninvasive, and commonly used to 

measure chronic hypoxemia that we 

should consider incorporating into 

proposed listing criterion 4.06A3 

(Congenital heart disease) and 104.06A3 

(Congenital heart disease)? If you 

believe there are tests that fit into this 

category, please tell us by submitting 

your comments and any supporting 

research or data. 

• At IOM’s recommendation, we are 

proposing to add listing 4.07 (Aortic 

valvular disease) to provide evaluation 

criteria for symptomatic adult 

individuals with aortic valvular 

disease.112 We currently evaluate aortic 

valvular disease under other 

cardiovascular disorders listings, which 

include requirements for exercise 

testing or repeated hospitalizations. If 

you disagree with proposed 4.07 (Aortic 

valvular disease), please tell us by 

submitting your comments and any 

supporting research or data. 

What is our authority to make rules 

and set procedures for determining 

whether a person is disabled under the 

statutory definition? 

The Act authorizes us to make rules 

and regulations and to establish 

necessary and appropriate procedures to 

implement them.113

How long would this proposed rule be 

effective? 

If we publish this proposed rule as a 

final rule, it will remain in effect for five 

years after the date it becomes effective, 

unless we extend it, or revise and issue 

it again. 

Rulemaking Analyses and Notices 

We will consider all comments we 

receive on or before the close of 


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business on the comment closing date 

indicated above. The comments will be 

available for examination in the 

rulemaking docket for this rule at the 

above address. We will file comments 

received after the comment closing date 

in the docket and will consider those 

comments to the extent practicable. 

However, we will not address untimely 

comments. We may publish a final rule 

at any time after close of the comment 

period. 

Clarity of This Proposed Rule 

Executive Order 12866, as 

supplemented by Executive Order 

13563, requires each agency to write all 

rules in plain language. In addition to 

your substantive comments on this 

proposed rule, we invite your comments 

on how to make them easier to 

understand. 

For example: 

• Would more, but shorter, sections 

be better? 

• Are the requirements in the rule 

clearly stated? 

• Have we organized the material to 

suit your needs? 

• Could we improve clarity by adding 

tables, lists, or diagrams? 

• What else could we do to make the 

rule easier to understand? 

• Does the rule contain technical 

language or jargon that is not clear? 

• Would a different format make the 

rule easier to understand such as using 

different groupings and order of 

sections, headings, or paragraphing? 

When will we start to use this rule? 

We will not use this proposed rule 

until we evaluate public comments and 

publish a final rule in the Federal 

Register. All final rules we issue 

include an effective date. We will 

continue to use our current rule until 

that date. If we publish a final rule, we 

will include a summary of the relevant 

comments we received and an 

explanation of how we will apply the 

new rule. 

Regulatory Procedures 

Executive Order 12866, as 

Supplemented by Executive Order 

13563 

We consulted with the Office of 

Management and Budget (OMB) and 

determined that this proposed rule 

meets the criteria for a significant 

regulatory action under Executive Order 

12866, as supplemented by Executive 

Order 13563. Therefore, OMB reviewed 

the rule. 

We also determined that this 

proposed rule meets the plain language 

requirement of Executive Order 12866. 

Executive Order 13132 (Federalism) 

We analyzed this proposed rule in 

accordance with the principles and 

criteria established by Executive Order 

13132 and determined that this 

proposed rule will not have sufficient 

federalism implications to warrant the 

preparation of a federalism assessment. 

We also determined that this proposed 

rule will not preempt any State law or 

State regulation or affect the States’ 

abilities to discharge traditional State 

governmental functions. 

Regulatory Flexibility Act 

We certify that this proposed rule 

would not have a significant economic 

impact on a substantial number of small 

entities because it affects individuals 

only. Therefore, a regulatory flexibility 

analysis is not required under the 

Regulatory Flexibility Act, as amended. 

Executive Order 13771 

Based upon the criteria established in 

Executive Order 13771 and M–17–21 

(Guidance Implementing E.O. 13771), 

we consider this rule a transfer rule 

with no more than de minimis costs. As 

such, it is exempt from requirements 

under E.O. 13771. 

Anticipated Accounting Costs of This 

Proposed Rule 

Anticipated Costs to Our Programs 

Our Office of the Chief Actuary has 

developed estimates of the effects of 

implementing this proposed rule, which 

are presented in a memorandum 

attached to this NPRM as a 

supplementary document. The 

memorandum indicates the estimated 

annual changes in Old-Age, Survivors 

and Disability Insurance (OASDI) 

benefit payments and Federal 

Supplemental Security Income (SSI) 

payments over the 10-year period of 

fiscal years (FY) 2022–2031. The 

memorandum also provides details 

about the case study developed for the 

purpose of making these estimates, as 

well as changes since the time the case 

study was originally developed and 

conducted, that may have impacted the 

case study results. 

In summary, based on the best 

available data, our Office of the Chief 

Actuary estimates that this proposed 

rule, assuming it is finalized and 

implemented for all disability decisions 

completed on or after April 1, 2023, 

would result in net increases of $308 

million in scheduled OASDI benefit 

payments and $71 million in Federal 

SSI payments over the 10-year period of 

fiscal years (FY) 2022–2031. 

Anticipated Administrative Costs to the 

Social Security Administration 

The Office of Budget, Finance, and 

Management estimates a net 

administrative savings of less than 15 

work years and $2 million annually. 

Paperwork Reduction Act 

This rule does not create any new or 

affect any existing collections and, 

therefore, does not require OMB 

approval under the Paperwork 

Reduction Act. 

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like to review any reference materials. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; and 

96.006, Supplemental Security Income). 

List of Subjects in 20 CFR Part 404 

Administrative practice and 

procedure; Blind, Disability benefits; 

Old-age, survivors, and disability 

insurance; Reporting and recordkeeping 

requirements; Social Security. 

The Acting Commissioner of Social 

Security, Kilolo Kijakazi, Ph.D., M.S.W., 

having reviewed and approved this 

document, is delegating the authority to 

electronically sign this document to 

Faye I. Lipsky, who is the primary 

Federal Register Liaison for the Social 

Security Administration, for purposes of 

publication in the Federal Register. 

Faye I. Lipsky, 

Federal Register Liaison, Office of Legislation 

and Congressional Affairs, Social Security 

Administration. 

For the reasons set forth in the 

preamble, we propose to amend subpart 

P of part 404 of title 20 of the Code of 

Federal Regulations as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

Authority: Secs. 202, 205(a)–(b), and (d)– 

(h), 216(i), 221(a) and (h)–(j), 222(c), 223, 

225, and 702(a)(5) of the Social Security Act 

(42 U.S.C. 402, 405(a)–(b), and (d)–(h), 416(i), 

421(a) and (h)–(j), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. Amend appendix 1 to subpart P of 

part 404 by: 

■ a. Revising item 5 of the introductory 

text before part A; 

■ b. Revising the body system name for 

section 4.00 in the table of contents; 

■ c. Revising the heading of 4.00A, the 

heading of 4.00A1, the introductory text 

of 4.00A1b, and 4.00A1b(iv), 4.00A2, 

and the first sentence of 4.00A3a; and 

adding two sentences to 4.00A3b, and 

two sentences to 4.00A3c; and removing 

4.00A3f; 

■ d. Revising the heading of 4.00B, the 

first sentence of 4.00B1, the third 

sentence of 4.00B2, the second and 

fourth sentences of 4.00B3(a), the 

second sentence of 4.00B3(b), and the 

first sentence of 4.00B5; 

■ e. Revising the heading of 4.00C, the 

second sentence of 4.00C3(c), 

4.00C6(a)(i), 4.00C7(b) through (d), 

4.00C8(d)(iv), 4.00C8(e), and 4.00C9(a); 

removing the third sentence of 

4.00C15(a), revising 4.00C15(b), 

removing 4.00C15(c); and revising the 

first two sentences of 4.00C16; 

■ f. Revising the heading of 4.00D; 

adding new fourth and fifth sentences to 

4.00D1a; revising the second sentence of 

4.00D1b; adding a third sentence to 

4.00D1b; revising 4.00D2(a)(i) through 

(iii), the first sentence of 4.00D2(b), the 

second sentence of 4.00D2(b)(i), the 

second sentence of 4.00D2(b)(ii), the 

third sentence of 4.00D3, 4.00D4(b) and 

4.00D4(c) and the first, second, and fifth 

sentences of 4.00D4(d); and adding 

4.00D4(e); 

■ g. Revising the heading of 4.00E, 

4.00E2b; the first sentence of 4.00E5, 

4.00E7(b)(i)–(ii); and adding 

4.00E7(b)(iii); 

■ h. Revising the first three sentences of 

4.00E8, and4.00E9(b) through (f), and 

removing 4.00E9(g) and (h); 

■ i. Revising the heading of 4.00F; 

adding a new sentence to 4.00F1, 

revising the first sentence of 4.00F3(a), 

4.00F4(a), and the second and fourth 

sentences of 4.00F4(b); 

■ j. Revising the heading of 4.00G; 

adding a fourth sentence to 4.00G1, 

revising 4.00G2, the first two sentences 

of 4.00G4(b), 4.00G6, and the fourth 

sentence of 4.00G7(b); 

■ k. Redesignating 4.00H and I as 4.00I 

and J, respectively 

■ l. Adding a new 4.00H; 

■ m. Revising the heading of 4.00I; 

4.00I1, removing 4.00I2, and 

redesignating 4.00I3 through 5 as 4.00I2 

through 4; 

■ n. Revising 4.00I2, 4.00I3, 4.00I4(a) 

and (d), adding a new 4.00I5, and 

revising the third sentence of 4.00I8b; 

■ o. Revising the heading of 4.00J, 

4.00J1, the first sentence of 4.00J2, 

redesignating 4.00J3 as 4.00K, and 

adding new 4.00J3; 

■ p. Revising 4.00K; 

■ q. Revising listings 4.01 and 4.02, 

adding and reserving listing 4.03, 

revising listings 4.05 and 4.06, adding 

listing 4.07, adding listing 4.08, revising 

4.09 through 4.12, adding and reserving 

listings 4.13 through 4.15, and adding 

listing 4.16. 

■ r. Revising the heading of 104.00A; 

the heading of 104.00A1; the 

introductory text of 104.00A1(b), 

104.00A1(b)(iv), and 104.00A2; and the 

first sentence of 104.00A3(a), and 

adding two sentences to 104.00A3(b), 

adding two sentences to 104.00A3(c), 

and removing 104.00A3(f) and (g); 

■ s. Revising the heading of 104.00B; the 

first sentence of 104.00B1; the third 

sentence of 104.00B2; the second and 

fourth sentences of 104.00B3(a); the 

second sentence of 104.00B3(b); 

104.00B4(a)(i); the first and third 

sentences of 104.00B5; the heading of 

100.04B7; the second sentence of 

100.04B7(a); and the first sentence of 

104.00B7(b); 

■ t. Revising the heading of 104.00C; the 

heading of 104.00C1, and the first 

sentence of 104.00C1a; adding two 

sentences to 104.00C1a; revising 

104.00C1b; 104.00C2(a);.00C2(b), and 

the second sentence of 104.00C2(b)(iii); 

and adding 104.00C4; 

■ u. Revising the heading of 104.00D; 

104.00D1, 104.00D1d, and 104.00D2; 

and adding 104.00D3 and 104.00D4; 

■ v. Revising the heading of 104.00E; 

adding a new sentence to the end of 

104.00E1; revising the fourth and fifth 

sentences of 104.00E4(a), and the fourth 

sentence of 104.00E4(b); 


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Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Proposed Rules 38859 

■ w. Revising the heading of 104.00F; 

the last sentence of 104.00F1, the first 

sentence of 104.00F2; removing the 

fourth through seventh sentences of 

104.00F3; adding a new 104.00F3a and 

104.00F3b; revising 104.00F4, 

104.00F5(a), 104.00F5(d), 104.00F6, and 

104.00F9b; and adding 104.00F11; 

■ x. Revising the heading of 104.00G; 

104.00G1, the first sentence of 

104.00G2; redesignating 104.00G3 as 

104.00H, 104.00G3(a) as 104.00H1, and 

104.00G3(b) as 104.00H2; and adding a 

new 104.00G3; 

■ y. Revising 104.00H; and 

■ z. Revising listings 104.01,104.02; 

adding and reserving 104.03 and 104.04; 

revising 104.05 and 104.06; adding and 

reserving 104.07 and 104.08; revising 

104.09; adding and reserving listings 

104.10 through 104.12; removing and 

reserving listing 104.13; adding and 

reserving listings 104.14 and 104.15: 

and adding listing 104.16. 

The additions and revision to read as 

follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

5. Cardiovascular Disorders (4.00 and 

104.00) [DATE 5 YEARS FROM THE 

EFFECTIVE DATE OF THE FINAL RULE]. 

* * * * * 

Part A 

* * * * * 

4.00 Cardiovascular Disorders. 

* * * * * 

4.00 Cardiovascular Disorders 

A. How do we define cardiovascular 

disorders and cardiovascular terms? 

1. What do we mean by a cardiovascular 

disorder? 

a. * * * 

b. Cardiovascular disorders result from one 

or more of four consequences of heart 

disease: 

(i) * * * 

(ii) * * * 

(iii) * * * 

(iv) Hypoxemia due to right-to-left shunt, 

reduced oxygen concentration in the arterial 

blood, or pulmonary vascular disease. 

c. * * * 

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. * * * 

a. Medical consultant is a person defined 

in §§ 404.1616(a) and 416.1016(a) of this 

chapter. * * * 

b. * * * By ‘‘exceptions,’’ we mean brief 

periods when the required finding(s) is 

greatly reduced or gone. These periods are so 

brief or inconsequential, the required 

finding(s) remains a factor in the person’s 

condition. 

c. * * * By ‘‘improvement of sufficient 

duration,’’ we mean the finding is greatly 

reduced or not present for long enough that 

the required finding(s) is no longer a factor 

in the person’s condition. 

* * * * * 

f. [Removed] 

B. What documentation do we need to 

evaluate cardiovascular disorders? 

1. What basic documentation do we need? 

We need sufficiently detailed reports of 

history, physical examinations, laboratory 

studies, and any prescribed treatment and 

response to allow us to assess the severity 

and duration of your cardiovascular disorder. 

* * * * * 

2. Why is a longitudinal clinical record 

important? * * * Whenever there is 

evidence of such treatment, your longitudinal 

clinical record should include a description 

of the ongoing management and evaluation 

provided by your medical source(s). * * * 

3. * * * 

a. * * * In this situation, we will base our 

evaluation on the current evidence we have. 

* * * However, we may find you disabled 

because you have another impairment(s) that, 

in combination with your cardiovascular 

disorder, medically equals a listing or based 

on consideration of your residual functional 

capacity and age, education, and work 

experience. 

b. * * * In rare instances when there is no 

or insufficient longitudinal evidence, we may 

purchase a consultative examination(s) to 

help us establish the existence, severity, and 

duration of your impairment. 

* * * * * 

5. Will we purchase any studies? In 

appropriate situations, we may purchase 

studies necessary to substantiate the 

existence of a medically determinable 

impairment or to document the severity of 

your impairment, generally after we have 

evaluated the evidence we already have. 

* * * 

* * * * * 

C. How do we use cardiovascular test 

results? 

* * * * * 

3. * * * 

c. * * * In this test, you walk on a 

treadmill, usually for a specified period of 

time, and the person who administers the test 

measures the effect of exercise on the flow of 

blood in your legs, usually by using 

ultrasound. * * * 

* * * * * 

6. * * * 

a. * * * 

(i) There is a question whether your 

cardiovascular disorder meets or medically 

equals the severity of one of the listings, or 

there is no timely test in the evidence we 

have (see 4.00C9), and we cannot find you 

disabled on some other basis; or 

* * * * * 

7. * * * 

a. * * * 

b. If you are under the care of a medical 

source (see §§ 404.1502 and 416.902 of this 

chapter) for a cardiovascular disorder, this 

source has not performed an exercise test, 

and there are no reported significant risks to 

testing, we will request a statement from that 

source explaining why it was not done or 

should not be done before we decide whether 

we will purchase the test. 

c. The MC, in accordance with the 

regulations and other instructions on 

consultative examinations, will generally not 

override the medical source’s conclusion 

about the risk of exercise testing to you. In 

the rare situation in which the MC does 

override the medical source’s conclusion, the 

MC must prepare a written rationale 

documenting the reasons for overriding the 

conclusion. 

d. If you do not have a medical source or 

we cannot obtain a statement from your 

medical source, the MC is responsible for 

assessing the risk of exercise testing based on 

a review of the records we have before 

purchasing an exercise test for you. 

* * * * * 

8. * * * 

d. * * * 

(iv) Percutaneous transluminal coronary 

angioplasty (PTCA) or percutaneous coronary 

intervention (PCI) with or without stenting. 

e. If you are deconditioned after an 

extended period of bedrest or inactivity and 

could improve with activity, or if you are in 

acute heart failure and are expected to 

improve with treatment, we will wait an 

appropriate period of time until you are 

ready and there are no medical reasons that 

prevent us from purchasing an exercise test. 

9. * * * 

a. We consider exercise test results to be 

timely for 12 months after the date they are 

performed, provided there has been no 

change in your clinical status that may alter 

the severity of your cardiovascular disorder. 

* * * * * 

15. * * * 

a. * * * 

b. Cardiac catheterization reports 

commonly include evaluation of coronary 

artery size and flow patterns, pressures in the 

left and right side of the heart, and evaluation 

of wall motion and ejection fraction, as well 

as chamber size. Also more routinely 

included in the catheterization report is 

fractional flow reserve (FFR), which is an 

objective measure of flow access across an 

obstruction. FFR also helps define the 

adequacy of collateral flow that directly 

affects function in ischemic heart disease. 

16. What details should exercise Doppler 

test reports contain? The reports of exercise 

Doppler tests must describe the level of 

exercise; for example, the speed and grade of 

the treadmill settings, the duration of 

exercise, changes in the person’s condition 

during exercise, and the reasons for stopping 

exercise if the expected level of exercise was 

not attained. These reports must also provide 

the blood pressures at the ankle and other 

pertinent sites measured after exercise, and 

also provide the time required for the systolic 

blood pressure to return toward or to the preexercise level. * * * 

* * * * * 

D. How do we evaluate chronic heart 

failure? 

1. * * * 

a. * * * Ejection fraction in heart failure 

is a continuum ranging from low ejection 


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fraction due to muscle dysfunction to 

preserved ejection fraction resulting from 

high intracardiac pressures. We consider 

heart failure to be chronic when the 

condition persists or recurs over time despite 

treatment. * * * 

b. * * * If the CHF is the result of primary 

pulmonary hypertension secondary to 

disease of the lung, we evaluate your 

impairment under the listings in 3.00 (for 

example, 3.09) or 4.00, as appropriate. For 

the purposes of 4.02B3, a finding of elevated 

B-type natriuretic peptide (BNP) or Nterminal pro-B-type natriuretic peptide (NTpro-BNP) in the blood assists in 

differentiating chronic heart failure from 

non-heart failure symptoms. 

2. * * * 

a. * * * 

(i) Abnormal cardiac imaging provides 

objective measures of both left ventricular 

function and structural abnormality in heart 

failure. Examples of abnormal findings 

include increased left ventricular end 

diastolic dimension (LVEDD), decreased EF, 

increased left atrial chamber size, increased 

left atrial volume index (LAVi), increased 

ventricular filling pressures measured at 

cardiac catheterization, or increased left 

ventricular wall or septum thickness. 

(ii) An LVEDD equal to or greater than 7.0 

cm, or an EF of 30 percent or less during a 

period of stability (that is, not during an 

episode of acute heart failure) may be 

associated clinically with systolic 

dysfunction. 

(iii) LAVi is measured in milliliters (ml) 

indexed to body surface area (BSA) measured 

in squared meters (m2). Indexing is a method 

of standardizing measurements to different 

body sizes. Diastolic dysfunction may be 

clinically associated with LAVi of 40 ml, 

BSA/m2 or greater. The imaging report will 

contain a measurement for the left atrium 

volume. The index is calculated by dividing 

the left atrium volume by BSA. 

* * * * * 

b. Your medical history and physical 

examination should describe characteristic 

symptoms and signs of pulmonary or 

systemic congestion (fluid retention) or of 

limited cardiac output associated with the 

abnormal findings on appropriate medically 

acceptable imaging. * * * 

(i) * * * People with CHF may also 

experience shortness of breath upon lying flat 

(orthopnea) or episodes of shortness of breath 

that wake them from sleep (paroxysmal 

nocturnal dyspnea). * * * 

(ii) * * * However, these signs need not be 

found on all examinations because 

congestion may be controlled by prescribed 

treatment or may not be present at the time 

of evaluation. 

3. Is it safe for you to have an ETT if you 

have CHF? * * * ETT has been used safely 

in people with CHF. Therefore, we may 

purchase an ETT for evaluation under 4.02B2 

if an MC, preferably one experienced in the 

care of patients with cardiovascular disease, 

determines that the test poses no significant 

risk to you. * * * 

4. * * * 

a. * * * 

b. To meet the required level of severity for 

this listing, your impairment must satisfy the 

requirements of the criteria in A and B or 

satisfy either C or D. 

c. In 4.02B1, we follow a two-part process 

to evaluate your impairment. Your 

impairment must satisfy the requirements in 

the first part of this process before we will 

move to the second part. 

(i) Your impairment satisfies the first part 

if a medical source has concluded that the 

performance of an ETT would present a 

significant risk to you. This medical source, 

such as a cardiologist, may be providing your 

care. If your case record does not include a 

conclusion from a medical source that an 

ETT would present a significant risk to you, 

an MC as defined in 4.00A3a may make such 

a conclusion if evidence in your case record 

supports it. 

(ii) In the second part of the process, we 

will evaluate activities of daily living (ADL). 

ADLs include, but are not limited to, such 

activities as doing household chores, 

grooming and hygiene, shopping at a grocery 

store, taking public transportation, or paying 

bills. We will assess whether you have 

persistent symptoms of chronic heart failure 

(for example, easy fatigue, weakness, 

shortness of breath, or chest discomfort) at 

rest or with activity that very seriously limit 

your ability to perform ADLs independently, 

appropriately, effectively, and on a sustained 

basis. Even if you are able to perform some 

ADLs, we may find your ability is very 

seriously limited and that your impairment 

satisfies the second part of the evaluation. 

d. Listing 4.02B2b requires a decrease in 

systolic blood pressure below the baseline 

level or below any systolic pressure reading 

recorded during exercise. We have this 

requirement because, normally, systolic 

blood pressure and heart rate increase 

gradually with exercise. * * * Also, some 

people with increased sympathetic responses 

because of deconditioning or apprehension 

may increase their systolic blood pressure 

and heart rate above their baseline level just 

before and early into exercise. * * * 

e. How do we evaluate CHF treated with a 

mechanical circulatory support device? We 

use 4.02D1 to evaluate CHF treated with an 

implanted mechanical circulatory support 

device (MCSD), such as a left ventricle 

assistive device (LVAD) or a right ventricle 

assistive device (RVAD). Implanted MCSDs 

are intended for long-term circulatory 

support in helping the heart pump blood. For 

the purposes of 4.02D1, an MCSD does not 

include extracorporeal membrane 

oxygenation (ECMO). Although ECMO is a 

form of mechanical circulatory support, we 

do not include it in 4.02D1 because ECMO 

is intended only for short-term circulatory 

support (maximum 30 days), used in a setting 

of imminent or actual cardiac arrest. 

E. How do we evaluate ischemic heart 

disease? 

1. * * * 

2. * * * 

a. * * * 

b. Instead of typical angina pectoris, some 

people with IHD experience atypical angina, 

anginal equivalent, variant angina, or silent 

ischemia, all of which we may evaluate using 

4.04. We discuss the various manifestations 

of ischemia in 4.00E3–4.00E7. 

* * * * * 

5. What is anginal equivalent? Often, 

people with IHD will complain of shortness 

of breath (dyspnea) on exertion without chest 

pain or discomfort. * * * 

* * * * * 

7. * * * 

a. * * * 

b. * * * 

(i) People with documented past 

myocardial infarction or established angina 

without prior infarction who do not have 

chest pain on ETT, but have a positive test 

with ischemic abnormality on ECG, perfusion 

scan, or other appropriate medically 

acceptable imaging. 

(ii) People with documented past 

myocardial infarction or angina who have ST 

segment changes on ambulatory monitoring 

(Holter monitoring) that are similar to those 

that occur during episodes of angina. ST 

depression shown on the ambulatory 

recording should not be interpreted as 

positive for ischemia unless similar 

depression is also seen during chest pain 

episodes annotated in the diary that the 

person keeps while wearing the Holter 

monitor. 

(iii) People who have diabetes mellitus 

with neuropathy. People with diabetes 

mellitus can have a higher threshold for pain 

because of the neuropathy and may not feel 

chest pain or discomfort from cardiac 

ischemia. 

* * * * * 

8. What other sources of chest discomfort 

are there? Chest discomfort of nonischemic 

origin may result from other cardiovascular 

disorders, such as pericarditis. Noncardiac 

disorders may also produce symptoms 

mimicking that of myocardial ischemia. 

These disorders include acute anxiety or 

panic attacks, gastrointestinal tract disorders, 

such as esophageal spasm, esophagitis, hiatal 

hernia, biliary tract disease, gastritis, peptic 

ulcer, and pancreatitis, and musculoskeletal 

syndromes, such as chest wall muscle spasm, 

chest wall syndrome (especially after 

coronary bypass surgery), costochondritis, 

and cervical or dorsal spine arthritis. * * * 

9. * * * 

a. * * * 

b. In 4.04A, we need evidence, such as an 

ECG interpretation, from an acceptable 

medical source who reviewed your ETT 

findings and found them positive for 

ischemia. These ETT findings may include 

ECG tracings or systolic blood pressure 

measurements. If your case record does not 

have such an interpretation from an 

acceptable medical source, an MC, as defined 

in 4.00A3a, may review your ETT findings 

and interpret them as being positive for 

ischemia if evidence in your case record 

supports it. 

(i) ETT findings may show the classically 

accepted changes in ECG tracings of 

horizontal or down sloping ST depression or 

of ST elevation. For example, ECG tracings 

may show horizontal or down sloping 

depression, in the absence of digitalis 

glycoside treatment or hypokalemia, of the 

ST segment of at least –0.10 millivolts (-1.0 

mm) in at least three consecutive complexes 

that are on a level baseline in any lead other 

than a VR, and depression of at least –0.10 

millivolts last for at least 1 minute of 


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recovery. Alternatively, the ECG tracings may 

show at least 0.10 millivolt (1 mm) ST 

elevation above resting baseline in noninfarct leads during both exercise and 1 or 

more minutes of recovery. 

(ii) ETT findings may also show a decrease 

of 10 mmHg or more in systolic pressure 

below the baseline systolic blood pressure or 

the preceding systolic pressure measured 

during exercise due to left ventricular 

dysfunction, despite an increase in workload. 

This finding is the same finding required in 

4.02B2b. See 4.00D4d for full details. 

c. In 4.04C, each ischemic episode must 

result in an unplanned hospitalization. 

Examples of ischemic episodes that may 

result in unplanned hospitalizations include 

unplanned revascularizations, myocardial 

infarctions, unstable angina, or 

dysrhythmias. Revascularization means 

angioplasty (with or without stent placement) 

or bypass surgery. 

(i) How do we calculate separate ischemic 

episodes? Reocclusion that occurs after a 

revascularization procedure but during the 

same hospitalization and that requires a 

second procedure during the same 

hospitalization will not be counted as 

another ischemic episode. If you are 

hospitalized for documented myocardial 

infarction and have a revascularization 

procedure during the same hospitalization, 

this event will be counted as one ischemic 

episode. 

(ii) How do we evaluate ischemic episodes 

not amenable to revascularizations? If your 

ischemic episodes are not amenable to 

revascularization, we will evaluate them 

using the appropriate listing (for example, 

4.04D). Not amenable means that the 

revascularization procedure could not be 

done because of another medical impairment 

or because the vessel was not suitable for 

revascularization. 

d. We will use 4.04D only when you have 

symptoms due to myocardial ischemia as 

described in 4.00E3–4.00E7 while on a 

regimen of prescribed treatment, you are at 

risk for ETT (see 4.00C8), and we do not have 

a timely ETT or a timely normal druginduced stress test for you. See 4.00C9 for 

what we mean by a timely test. 

e. In 4.04D1, the term fractional flow 

reserve (FFR) is a measurement of the 

pressure differences across an obstructive 

lesion, giving an estimate of the severity of 

stenosis. An FFR measurement of 1.0 

indicates normal blood flow. An FFR 

measurement equal to or less than 0.80 

indicates stenosis capable of producing 

serious myocardial ischemia in an artery 

appropriate for revascularization. An FFR 

measurement that is greater than 0.80 

indicates stenosis not likely to produce 

significant ischemia. 

f. In 4.04D2 and 4.04D3, the term 

nonbypassed means that the blockage is in a 

vessel that is potentially bypassable; that is, 

large enough to be bypassed and considered 

to be a cause of your ischemia. These vessels 

are usually major arteries or one of a major 

artery’s major branches. A vessel that has 

become obstructed again after angioplasty or 

stent placement and has remained obstructed 

or is not amenable to another 

revascularization is considered a 

nonbypassed vessel for purposes of the 

listings. When you have had 

revascularization, we will not use the preoperative findings to assess the current 

severity of your coronary artery disease 

under 4.04D, although we will consider the 

severity and duration of your impairment 

before your surgery in making our 

determination or decision. 

F. How do we evaluate arrhythmias? 

1. What is an arrhythmia? * * * Although 

we use the term ‘‘arrhythmia’’ in the listings, 

the term ‘‘dysrhythmia’’ may also be used in 

the medical evidence to describe this 

condition. 

* * * * * 

3. * * * 

a. We will use 4.05 when you have 

arrhythmias that are not fully controlled by 

medication, an implanted pacemaker, or an 

implanted cardiac defibrillator, and you have 

recurrent episodes of syncope or near 

syncope. * * * 

* * * * * 

4. * * * 

a. Implanted cardiac defibrillators are used 

to prevent sudden cardiac death in people 

who have had, or are at high risk for, cardiac 

arrest from life-threatening ventricular 

arrhythmias. The largest group at risk for 

sudden cardiac death consists of people with 

cardiomyopathy (ischemic or non-ischemic) 

and reduced ventricular function. However, 

life-threatening ventricular arrhythmias can 

also occur in people with little or no 

ventricular dysfunction. The shock from the 

implanted cardiac defibrillator rescues a 

person from what may have been cardiac 

arrest. However, as a consequence of the 

shock(s), similar to the effects of treatments 

for other cardiovascular disease, a person 

may experience psychological distress, 

which we may evaluate under the listings in 

12.00. 

b. * * * In some people, these functions 

may result in the termination of ventricular 

arrhythmias without an otherwise painful 

shock. * * * Also, exposure to strong 

electrical or magnetic fields, such as from 

magnetic resonance imaging, can trigger or 

reprogram an implanted cardiac defibrillator, 

resulting in inappropriate shocks. * * * 

* * * * * 

G. How do we evaluate peripheral vascular 

disease? 

1. What is peripheral vascular disease 

(PVD)? * * * Neuropathy may mask these 

typical symptoms. * * * 

2. How do we assess limitations resulting 

from PVD? We will assess your limitations 

based on your symptoms together with 

physical findings and Doppler studies or 

other appropriate diagnostic techniques. 

However, if the PVD has resulted in 

amputation, we will evaluate any limitations 

related to the amputation under the listings 

in 1.00. 

* * * * * 

4. * * * 

a. * * * 

b. Lymphedema does not meet the 

requirements of 4.11, although it may 

medically equal the listing. We will evaluate 

lymphedema by considering whether the 

underlying cause meets or medically equals 

any listing, or whether the lymphedema 

medically equals a cardiovascular disorders 

listing such as 4.11 or a listing in 1.00. * * * 

5. * * * 

6. Are there any other studies that are 

helpful in evaluating PAD? Doppler studies 

done using a recording ultrasonic Doppler 

unit and strain-gauge plethysmography are 

other useful tools for evaluating PAD. A 

recording Doppler, which prints a tracing of 

the arterial pulse wave in the femoral, 

popliteal, dorsalis pedis, and posterior tibia 

arteries, is an evaluation tool that compares 

waveforms in normal and compromised 

peripheral blood flow. Qualitative analysis of 

the pulse wave is helpful in the overall 

assessment of the severity of the occlusive 

disease. Tracings help in assessing severity if 

you have small vessel disease related to 

diabetes mellitus or other diseases with 

similar vascular changes, or diseases causing 

medial calcifications when ankle pressure is 

either normal or falsely high. When there is 

evidence of medial calcification of the ankle 

arteries or the ankle-brachial index is 0.50 or 

greater, other appropriate tests for PAD 

include magnetic resonance angiography, 

computed tomography angiography, contrast 

angiography, and graded treadmill tests. 

7. * * * 

a. * * * 

b. * * * The criterion in 4.12A is met 

when your resting ankle/brachial systolic 

blood pressure ratio is less than 0.50. * * * 

* * * * * 

H. How do we evaluate congenital heart 

disease? 

1. What is congenital heart disease? 

Congenital heart disease is any abnormality 

of the heart or the major blood vessels that 

is present at birth. Congenital heart disease 

includes abnormal structure of the individual 

heart chambers, valves, and blood vessels, 

and abnormal relative relationship of the 

chambers to each other that alters the normal 

pattern of blood flow. Surgery in childhood 

is the usual treatment, and with improving 

surgical techniques and medical 

management, more children with congenital 

heart disease are surviving into adulthood. 

Rarely, a person with congenital heart 

disease may not have received the usual 

surgery in childhood, and later, as an adult, 

he or she is no longer a surgical candidate, 

as for example, in Eisenmenger syndrome. 

2. What is Eisenmenger syndrome? 

Eisenmenger syndrome refers to any 

surgically untreated congenital heart defect 

with intracardiac communication that over 

time leads to pulmonary hypertension, 

reversal of blood flow, and hypoxemia. 

a. Lesions in Eisenmenger syndrome, such 

as large septal defects, are characterized by 

elevated pulmonary pressures or a high 

pulmonary flow rate. In response, the 

pulmonary blood vessels pathologically 

change, leading eventually to pulmonary 

hypertension. Development of Eisenmenger 

syndrome represents a point at which 

pulmonary hypertension is irreversible and 

the cardiac lesion is likely inoperable. 

b. Examples of congenital heart disease 

that if untreated may cause pulmonary 

vascular disease leading to Eisenmenger 

syndrome include atrial septal defect (ASD), 

ventricular septal defect (VSD), and large 

patent ductus arteriosus (PDA). 


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3. What is single ventricle? 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. At 

birth, one ventricle must functionally do the 

work of two, pumping blood for both the 

body (systemic) and the lungs (pulmonary). 

Because of this feature, the ultimate plan for 

cardiac reconstruction is similar for most of 

these anomalies. People with single ventricle 

will generally undergo staged reconstructive 

‘‘Fontan procedures,’’ ultimately resulting in 

a ‘‘Fontan circulation.’’ Fontan circulation 

describes the hemodynamic state in which 

virtually all systemic venous return-blood 

passively flows directly into the pulmonary 

arteries via surgical or catheter-placed 

shunts, without the blood passing through a 

ventricle. Some of the anomalies described as 

single ventricle include the following: 

(a) Hypoplastic left heart syndrome; 

(b) Hypoplastic right ventricle; 

(c) Tricuspid valve atresia; 

(d) Double inlet left ventricle; and 

(e) Some variations of double outlet right 

ventricle. 

4. How do we evaluate conditions 

associated with congenital heart disease? 

a. We evaluate congenital heart disease that 

results in chronic heart failure with evidence 

of ventricular dysfunction or in recurrent 

arrhythmias under 4.02 or 4.05, respectively. 

Otherwise, we evaluate your impairment 

under 4.06. 

b. We evaluate pulmonary hypertension 

due to congenital heart disease under 4.06B 

or 4.06C. We evaluate pulmonary 

hypertension not due to congenital heart 

disease under the listings in 3.00 (for 

example, 3.09). 

c. We need pulse oximetry measurements 

documented by medical sources using 

methods consistent with the prevailing state 

of medical knowledge and clinical practice to 

evaluate chronic hypoxemia in congenital 

heart disease under 4.06A3. These pulse 

oximetry measurements also must be 

consistent with the other evidence in the case 

record. 

d. We evaluate single ventricle physiology 

under 4.06D and will consider you disabled 

if your medical evidence documents that you 

have any congenital heart disorder that 

results in single ventricle physiology 

(functional single ventricle). In addition to 

the above congenital heart disorders, 

examples of palliative surgical procedures 

that indicate single ventricle physiology 

include the Glenn, Fontan, and Norwood 

procedures. 

* * * * * 

I. How do we evaluate other cardiovascular 

disorders? 

1. How do we evaluate hypertension? 

Hypertension (high blood pressure) over time 

may significantly raise the pressures in the 

heart to the point of ineffective heart muscle 

function known generally as hypertensive 

heart disease that we can evaluate under 

4.02. Other body systems, such as the brain, 

kidneys, or eyes may also be affected. We 

evaluate these impairments by reference to 

the specific body system(s) that is affected. 

We will also consider any limitations 

imposed by your hypertension when we 

assess your residual functional capacity. 

2. What is cardiomyopathy and how will 

we evaluate it? Cardiomyopathy is a disease 

of the heart muscle. The heart loses its ability 

to pump blood (heart failure), and in some 

instances, heart rhythm is disturbed, leading 

to irregular heartbeats (arrhythmias). Usually, 

the exact cause of the muscle damage is 

never found (idiopathic cardiomyopathy). 

a. There are various types of 

cardiomyopathy, which fall into two major 

categories: ischemic and nonischemic 

cardiomyopathy. Ischemic cardiomyopathy 

typically refers to heart muscle damage that 

results from coronary artery disease, 

including heart attacks. Nonischemic 

cardiomyopathy includes several types: 

dilated, hypertensive, hypertrophic, and 

restrictive. Cardiomyopathy includes 

hypertrophic cardiomyopathy, 

endomyocardial fibrosis, or cardiac 

amyloidosis AL type. 

b. We evaluate cardiomyopathy under 4.08. 

Depending on the underlying cause of the 

cardiomyopathy or its effects on you, we may 

also evaluate your cardiomyopathy under 

4.02, 4.04, or 4.05. If your cardiomyopathy 

results in vascular insult to the brain, we may 

also evaluate it under 11.04. 

c. Under 4.08A2, we need a conclusion 

from a medical source that the performance 

of an exercise test would present a significant 

risk to you. If your case record does not have 

a conclusion from a medical source that an 

exercise test would present a significant risk 

to you, an MC defined in 4.00A3a may make 

such a conclusion if evidence in your case 

record supports it. 

3. How do we evaluate valvular heart 

disease? We evaluate aortic valvular disease 

under 4.07. We may also evaluate aortic 

valvular disease, as well as other forms of 

valvular disease, under 4.02, 4.04, 4.05, 4.06, 

or a listing in 11.00, depending on its effects 

on you. 

4. What do we consider when we evaluate 

heart transplant recipients? a. After your 

heart transplant, we will consider you 

disabled under 4.09 for 1 year following the 

surgery because there is a greater likelihood 

of rejection of the organ and infection during 

the first year. If you develop cardiac allograft 

vasculopathy after your transplant, we will 

evaluate this impairment under 4.16. 

b. * * * 

c. * * * 

d. When we do a continuing disability 

review to determine whether you are still 

disabled, we will evaluate your residual 

impairment(s), as shown by the evidence in 

your case record, including any side effects 

of medication. We will consider all evidence 

indicative of cardiac dysfunction in deciding 

whether medical improvement (as defined in 

§§ 404.1594 and 416.994 of this chapter) has 

occurred. 

5. What is cardiac allograft vasculopathy 

and how do we evaluate it? Cardiac allograft 

vasculopathy (CAV) may affect a person who 

has received a heart transplant and involves 

thickening in the walls of the coronary 

arteries that may progress quickly into 

serious vascular stenosis and heart 

dysfunction. Stenosis in CAV is caused by a 

pathological process different from classic 

atherosclerosis and treatment often is only 

palliative. We evaluate CAV under 4.16. 

* * * * * 

8. * * * 

a. * * * 

b. * * * Most people with Marfan 

syndrome have abnormalities associated with 

the heart and blood vessels. * * * * * 

J. How do we evaluate issues that affect the 

cardiovascular system? 1. How do we 

consider the effects of obesity when we 

evaluate your cardiovascular disorder? 

Obesity is a medically determinable 

impairment that may be associated with 

cardiovascular disorders. The additional 

body mass may make it harder for the chest 

and lungs to expand or may cause the heart 

to work harder to pump blood to carry 

oxygen to the body. The combined effects of 

obesity with a cardiovascular disorder can be 

greater than the effects of each of the 

impairments considered separately. We 

consider the additional and cumulative 

effects of obesity when we determine 

whether you have a severe cardiovascular 

disorder, a listing-level cardiovascular 

disorder, a combination of impairments that 

medically equals the severity of a listed 

impairment, and when we assess your 

residual functional capacity. 

2. How do we relate treatment to functional 

status? In general, conclusions about the 

severity of a cardiovascular disorder cannot 

be made on the basis of the type of treatment 

rendered or anticipated. * * * 

3. How do we consider hospitalizations? 

When we evaluate hospitalizations for 

chronic heart failure (4.02B3), ischemic heart 

disease (4.04E), congenital heart disease 

(4.06E), and cardiomyopathy (4.08D), the 

hospitalizations do not all have to be for the 

same cardiovascular disorder(s). They may be 

for three different exacerbations or 

complications resulting from your 

cardiovascular disorder. The hospitalizations 

must be at least 30 days apart, and each one 

must last at least 48 hours, including hours 

in a hospital emergency department 

immediately before the hospitalization. 

K. How do we evaluate cardiovascular 

disorders that do not meet one of these 

listings? 

1. These listings are only examples of 

common cardiovascular disorders that we 

consider severe enough to prevent you from 

doing any gainful activity. If your 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether you have an impairment(s) that 

satisfies the criteria of a listing in another 

body system. 

2. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will determine whether 

your impairment(s) medically equals a 

listing. See §§ 404.1526 and 416.926 of this 

chapter. If your impairment(s) does not meet 

or medically equal a listing, you may or may 

not have the residual functional capacity to 

engage in substantial gainful activity. We will 

proceed to the fourth step and, if necessary, 

the fifth step of the sequential evaluation 

process in §§ 404.1520 and 416.920 of this 

chapter. We will use the rules in §§ 404.1594 

or 416.994 of this chapter, as appropriate, 


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when we decide whether you continue to be 

disabled. 

4.01 Category of Impairments, 

Cardiovascular Disorders 

4.02 Chronic heart failure (see 4.00D) 

while on a regimen of prescribed treatment, 

with symptoms and signs described in 

4.00D2. The required level of severity for this 

impairment is met when the requirements are 

satisfied by A and B; or C alone; or D alone. 

A. Medically documented presence of one 

of the following: 

1. Systolic failure documented by 

appropriate medically acceptable imaging 

during a period of stability (not during an 

episode of exacerbation of heart failure), with 

left ventricular end diastolic dimension equal 

to or greater than 7.0 cm; or ejection fraction 

of 30 percent or less during a period of 

stability (not during an episode of acute heart 

failure); OR 

2. Diastolic failure documented by 

appropriate medically acceptable imaging 

during a period of stability (not during an 

episode of exacerbation of heart failure), with 

left ventricular posterior wall plus septal 

thickness totaling 2.5 cm or greater, with an 

enlarged left atrium greater than or equal to 

4.5 cm, OR left atrial volume index (LAVi) 

greater than or equal to 40 ml, BSA/m2 

(milliliters to body surface area in squared 

meters). 

AND 

B. Resulting in one of the following: 

1. Recurrent (see 4.00A3c) symptoms of 

heart failure, resulting in both a and b: 

a. A medical source (see 4.00D4c(i)) has 

concluded that the performance of an 

exercise test would present a significant risk 

to the person; and 

b. Very serious limitation in the ability to 

perform activities of daily living 

independently, appropriately, effectively, 

and on a sustained basis; or 

2. Inability to perform on an exercise 

tolerance test at a workload equivalent to 5 

METs or less if using a standard treadmill (or 

bicycle) test without gas exchange, or at 15 

ml/kg/min peak VO2 (oxygen consumption) 

on a cardiopulmonary exercise test, due to 

either a or b: 

a. Dyspnea, fatigue, palpitations, or chest 

discomfort; or 

b. Decrease of 10 mmHg or more in systolic 

pressure below the baseline systolic blood 

pressure or the preceding systolic pressure 

measured during exercise (see 4.00D4d) due 

to left ventricular dysfunction, despite an 

increase in workload; or 

3. Exacerbations or complications of 

chronic heart failure (see 4.00D1b) requiring 

three hospitalizations within a consecutive 

12-month period (see 4.00A3e) and at least 

30 days apart. Each hospitalization must last 

at least 48 hours, including hours in a 

hospital emergency department immediately 

before the hospitalization (see 4.00J3); 

OR 

C. Heart failure with left ventricular 

ejection fraction of 20 percent or less while 

on a regimen of prescribed therapy, on two 

evaluations at least 90 days apart within a 

consecutive 12-month period (see 4.00A3e) 

during a period of stability (not during an 

episode of exacerbation of heart failure); 

OR 

D. One of the following while hospitalized, 

at home, or both: 

1. Mechanical circulatory support device 

except extracorporeal membrane oxygenation 

(ECMO) (see 4.00D4e). Consider under a 

disability for 1 year from the date of 

implantation; after that, evaluate any residual 

impairment(s) under the criteria for the 

affected body system. 

2. Continuous intravenous administration 

of inotropic medication (for example, 

milrinone) for at least 30 consecutive days. 

Consider under a disability for 1 year from 

the date of initiation of the treatment; after 

that, evaluate any residual impairment(s) 

under the criteria for the affected body 

system. 

4.03 [Reserved] 

4.04 Ischemic heart disease (see 4.00E), 

with symptoms due to myocardial ischemia, 

while on a regimen of prescribed treatment 

(see 4.00B3 if there is no regimen of 

prescribed treatment), with A, B, C, D, or E: 

A. Inability to perform on an exercise 

tolerance test at a workload equivalent to 5 

METs or less with findings interpreted by an 

acceptable medical source as positive for 

ischemia (see 4.00E9b). 

OR 

B. Ischemic response with exercise or 

pharmacological (drug-induced) stress testing 

(see 4.00C14) on medically appropriate 

imaging, with either 1 or 2: 

1. At least two reversible or fixed regional 

myocardial perfusion defects and either a or 

b: 

a. Transient ischemic dilatation; or 

b. Resting left ventricular ejection fraction 

of less than 50 percent; or 

2. At least two reversible or fixed regional 

wall motion abnormalities and either a or b: 

a. Decrease in left ventricular ejection 

fraction during testing; or 

b. Resting left ventricular ejection fraction 

of less than 50 percent. 

OR 

C. Documentation of three separate 

ischemic episodes (see 4.00E9c) requiring 

unplanned hospitalization (inpatient or 

observation status) within a consecutive 12- 

month period (see 4.00A3e). 

OR 

D. Coronary artery disease, documented by 

coronary angiography (obtained 

independently of Social Security disability 

evaluation) with 1, 2, or 3: 

1. Fractional flow reserve (see 4.00E9e) 

measurement of less than or equal to 0.80 of 

a proximal segment or mid segment coronary 

artery not amenable to revascularization (see 

4.00E9c(ii)). 

2. History of coronary artery bypass graft 

surgery with manifestations of ischemia, as 

described in 4.00E3–4.00E7, while on a 

regimen of prescribed treatment (see 4.00B3 

if there is no regimen of prescribed 

treatment) with a, b, c, or d: 

a. 50 percent or more stenosis of a 

nonbypassed left main coronary artery; or 

b. 70 percent or more stenosis in the 

proximal segment or mid segment of another 

nonbypassed coronary artery; or 

c. 50 percent or more stenosis in the 

proximal segment or mid segment of at least 

two nonbypassed coronary arteries; or 

d. 70 percent or more stenosis of a bypass 

graft vessel. 

3. Resting left ventricular ejection fraction 

of less than 50 percent while medically stable 

(see 4.00B4) with manifestations of ischemia, 

as described in 4.00E3–4.00E7, while on a 

regimen of prescribed treatment (see 4.00B3 

if there is no regimen of prescribed 

treatment) with a, b, or c: 

a. 50 percent or more stenosis of a 

nonbypassed left main coronary artery; or 

b. 70 percent stenosis in the proximal 

segment or mid segment of another 

nonbypassed coronary artery; or 

c. 50 percent or more stenosis in the 

proximal segment or mid segment of at least 

two nonbypassed coronary arteries. 

OR 

E. Exacerbations or complications of 

ischemic heart disease (see 4.00E2–4.00E7) 

requiring three hospitalizations within a 

consecutive 12-month period (see 4.00A3e) 

and at least 30 days apart. Each 

hospitalization must last at least 48 hours, 

including hours in a hospital emergency 

department immediately before the 

hospitalization (see 4.00J3). 

4.05 Recurrent arrhythmias (see 4.00F), not 

related to reversible causes such as 

electrolyte abnormalities or digitalis 

glycoside or antiarrhythmic drug toxicity, 

while on a regimen of prescribed treatment 

(see 4.00B3 if there is no prescribed 

treatment), demonstrated by both A and B: 

A. Coincident with recurrent (see 4.00A3c) 

episodes of cardiac syncope or near syncope 

(see 4.00F3b). 

AND 

B. Documented by either 1 or 2: 

1. Resting or ambulatory (Holter) 

electrocardiography; or 

2. Other appropriate medically acceptable 

testing. 

4.06 Congenital heart disease (see 4.00H), 

documented by appropriate medically 

acceptable imaging (see 4.00A3d) or cardiac 

catheterization, with A, B, C, D, or E: 

A. Chronic hypoxemia, and 1, 2, or 3: 

1. Hematocrit of 55 percent or greater on 

two evaluations at least 90 days apart within 

a consecutive 12-month period (see 4.00A3e); 

or 

2. Arterial blood gas test measurement 

obtained at rest while breathing room air, as 

described in either a or b: 

a. SaO2 (arterial oxygen saturation) less 

than or equal to 89 percent; or 

b. PO2 or PaO2 (partial pressure of oxygen) 

less than or equal to 60 mmHg; 

3. SpO2 (percentage of oxygen saturation of 

blood hemoglobin) measured by pulse 

oximetry either at rest, during a 6-minute 

walk test (6MWT), or after a 6MWT, while 

breathing room air, less than or equal to 87 

percent on three evaluations at least 30 days 

apart within a consecutive 12-month period 

(see 4.00A3e). 

OR 

B. Intermittent right-to-left shunting (for 

example, Eisenmenger syndrome; see 

4.00H2) during cardiopulmonary exercise 

testing while breathing room air, resulting in 

oxygen desaturation on exertion at a 

workload equivalent to 5 METs or less, or 

peak VO2 (oxygen uptake) of 15.0 ml/kg/min 

or less, and arterial blood gas test 

measurement, with either 1 or 2: 


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1. SaO2 less than or equal to 89 percent; or 

2. PO2 or PaO2 less than or equal to 60 

mmHg. 

OR 

C. Pulmonary hypertension documented by 

cardiac catheterization while medically 

stable, as described in 1, 2, or 3: 

1. Pulmonary arterial systolic pressure 

elevated to at least 70 percent of the systemic 

arterial systolic pressure; or 

2. Pulmonary arterial systolic pressure 

equal to or greater than 70 mmHg; or 

3. Mean pulmonary artery pressure equal 

to or greater than 40mmHg. 

OR 

D. Single ventricle (with or without Fontan 

procedures) (see 4.00H4). 

OR 

E. Exacerbations or complications of 

congenital heart disease (see 4.00J3) requiring 

three hospitalizations within a consecutive 

12-month period (see 4.00A3e) and at least 

30 days apart. Each hospitalization must last 

at least 48 hours, including hours in a 

hospital emergency department immediately 

before the hospitalization (see 4.00J3). 

4.07 Aortic valvular disease (see 4.00I3), 

with symptoms due to stenosis, determined 

by appropriate test or tests showing an aortic 

valve area of less than 1.0 cm2. 

4.08 Cardiomyopathy (see 4.00I2) while on 

a regimen of prescribed treatment, with A, B, 

C, or D: 

A. Hypertrophic cardiomyopathy 

documented by appropriate medically 

acceptable imaging, with left ventricular or 

septal wall thickness equal to or greater than 

20 mm in the absence of other causes of left 

ventricular hypertrophy (for example, 

hypertension or aortic valvular disease) and 

either 1 or 2: 

1. Inability to perform on an exercise 

tolerance test at a workload equivalent to 5 

METs or less if using a standard treadmill (or 

bicycle) test without gas exchange, or at 15 

ml/kg/min peak VO2 (oxygen consumption) 

on a cardiopulmonary exercise test; or 

2. A medical source (see 4.00I2c) has 

concluded that the performance of an 

exercise tolerance test would present a 

significant risk to the person. 

OR 

B. Endomyocardial fibrosis documented by 

appropriate medically acceptable imaging, 

with 1, 2, and 3: 

1. Loss of chamber volume due to fibrosis 

of the endocardium of at least one ventricle; 

and 

2. Right or left atrial dilatation (chamber 

enlargement); and 

3. Regurgitant (backward) blood flow 

through the mitral or tricuspid valve. 

OR 

C. Cardiac amyloidosis AL (light-chain) 

type documented by biopsy. 

OR 

D. Exacerbations or complications of 

cardiomyopathy requiring three 

hospitalizations within a consecutive 12- 

month period (see 4.00A3e) and at least 30 

days apart. Each hospitalization must last at 

least 48 hours, including hours in a hospital 

emergency department immediately before 

the hospitalization (see 4.00J3). 

4.09 Heart transplantation (see 4.00I4). 

Consider under a disability for 1 year from 

the date of the transplant; after that, evaluate 

the residual impairment(s). 

4.10 Dissecting aneurysm of the aorta or 

major branches (see 4.00I6), due to any cause 

(for example, atherosclerosis, cystic medical 

necrosis Marfan syndrome, or trauma), 

demonstrated by appropriate medically 

acceptable imaging, with dissection not 

controlled by prescribed treatment. 

4.11 Chronic venous insufficiency (see 

4.00G) of a lower extremity with reflux or 

obstruction of the venous system 

documented by duplex ultrasound or other 

appropriate diagnostic technique, with A or 

B: 

A. Extensive trophic changes of skin (for 

example, hyperpigmentation, 

lipodermatosclerosis, brawny edema) 

involving at least two-thirds of the leg below 

the knee, on two evaluations at least 90 days 

apart within a consecutive 12-month period 

(see 4.00A3e), with both 1 and 2: 

1. Consistent with chronic venous 

insufficiency; and 

2. Unresponsive to compression therapy. 

OR 

B. Two or more episodes of ulceration that 

has not healed following at least 6 months of 

prescribed treatment. 

4.12 Peripheral arterial disease (see 

4.00G7) while on a regimen of prescribed 

treatment resulting in intermittent 

claudication or leg pain that interferes with 

mobility (see 4.00G1), with A, B, C, or D, as 

determined by an appropriate test(s) (see 

4.00G5–4.00G6): 

A. Resting ankle/brachial systolic blood 

pressure ratio of less than 0.50 (see 4.00G7a). 

OR 

B. Decrease in systolic blood pressure at 

the ankle on exercise test (see 4.00G7a) of 50 

percent or more of the pre-exercise level and 

requiring 10 minutes or more to return to preexercise level. 

OR 

C. Resting toe systolic pressure of less than 

30 mmHg (see 4.00G7c and 4.00G8). 

OR 

D. Resting toe/brachial systolic blood 

pressure ratio of less than 0.40 (see 4.00G7c). 

4.13–4.15 [Reserved] 

4.16 Cardiac allograft vasculopathy (see 

4.00I5), documented by appropriate 

medically acceptable imaging (for example, 

intravascular ultrasonography or coronary 

angiography) (see 4.00A3d), with A, B, C, or 

D: 

A. Cardiac index (CI) or cardiac output 

(CO) less than 2 l/min/m2. 

OR 

B. Left ventricular ejection fraction equal to 

or less than 45 percent. 

OR 

C. Right atrial pressure (RAP) greater than 

12 mmHg. 

OR 

D. Pulmonary capillary wedge pressure 

(PCWP) greater than 15 mmHg. 

* * * * * 

5. Amend part B of appendix 1 to subpart 

P of part 404 by revising the body system 

name for section 104.00 in the table of 

contents to read as follows: 

* * * * * 

Part B 

* * * * * 

104.00 Cardiovascular Disorders 

* * * * * 

104.00 Cardiovascular Disorders 

A. How do we define cardiovascular 

disorders and cardiovascular terms? 

1. What do we mean by a cardiovascular 

disorder? 

a. * * * 

b. Cardiovascular disorders result from one 

or more of four consequences of heart 

disease: * * * 

(iv) Hypoxemia due to right-to-left shunt, 

reduced oxygen concentration in the arterial 

blood, or pulmonary vascular disease. 

* * * * * 

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 consultant is a person defined 

in § 416.1016(a) of this chapter. * * * 

b. * * * By ‘‘exceptions,’’ we mean brief 

periods when the required finding(s) is 

greatly reduced or gone. These periods are so 

brief or inconsequential, the required 

finding(s) remains a factor in the person’s 

condition. 

c. * * * By ‘‘improvement of sufficient 

duration,’’ we mean the finding is greatly 

reduced or not present for long enough that 

the required finding(s) is no longer a factor 

in the person’s condition. 

* * * * * 

B. What documentation do we need to 

evaluate cardiovascular disorders? 

1. What basic documentation do we need? 

We need sufficiently detailed reports of 

history, physical examinations, laboratory 

studies, and any prescribed treatment and 

response to allow us to assess the severity 

and duration of your cardiovascular disorder. 

* * * * * 

2. Why is a longitudinal clinical record 

important? * * * Whenever there is 

evidence of such treatment, your longitudinal 

clinical record should include a description 

of the ongoing management and evaluation 

provided by your medical source(s). * * * 

3. What if you have not received ongoing 

medical treatment? 

a. * * * In this situation, we will base our 

evaluation on the current evidence we have. 

* * * However, we may find you disabled 

because you have another impairment(s) that, 

in combination with your cardiovascular 

disorder, medically equals a listing or 

functionally equals the listings. 

b. * * * In rare instances when there is no 

or insufficient longitudinal evidence, we may 

purchase a consultative examination(s) to 

help us establish the existence, severity, and 

duration of your impairment. 

4. When will we wait before we ask for 

more evidence? 

a. * * * 

(i) If you have had a recent acute event; for 

example, acute heart failure. 

* * * * * 


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5. Will we purchase any studies? In 

appropriate situations, we may purchase 

studies necessary to substantiate the 

existence of a medically determinable 

impairment or to document the severity of 

your impairment, generally after we have 

evaluated the evidence we already have. 

* * * We will follow sections 4.00C6, 

4.00C7, 4.00C8 in part A, and 104.00B7, 

when we decide whether to purchase 

exercise testing. * * * 

* * * * * 

7. Will we use exercise tolerance tests 

(ETT) for evaluating children with 

cardiovascular disorders? 

a. * * * An ETT may be of value in the 

assessment of some arrhythmias, as indicated 

in 104.05B2. ETTs may also be used in the 

assessment of the severity of chronic heart 

failure and in the assessment of recovery of 

function following cardiac surgery or other 

treatment. 

b. We will purchase an ETT only if we 

cannot make a determination or decision 

based on the evidence we have and an MC, 

preferably one with experience in the care of 

children with cardiovascular disorders, has 

determined that an ETT is needed to evaluate 

your impairment. * * * 

c. For full details on ETT requirements and 

usage, see 4.00C3 in part A. 

C. How do we evaluate chronic heart 

failure? 

1. What is chronic heart failure (CHF)? 

a. Heart failure is the inability of the heart 

to pump enough oxygenated blood to body 

tissues. * * * Ejection fraction in heart 

failure is a continuum ranging from low 

ejection fraction due to muscle dysfunction 

to preserved ejection fraction resulting from 

high intracardiac pressures. We consider 

heart failure to be chronic when the 

condition persists or recurs over time despite 

treatment. 

b. CHF is considered in these listings as a 

single category whether due to 

atherosclerosis (narrowing of the arteries), 

cardiomyopathy, hypertension, congenital, or 

other heart disease. If the CHF is the result 

of primary pulmonary hypertension 

secondary to disease of the lung, we will 

evaluate your impairment under the listings 

in 3.00 (for example, 3.09) or 4.00, as 

appropriate. 

2. What evidence of CHF do we need? 

a. Cardiomegaly or ventricular dysfunction 

must be present and demonstrated by 

appropriate medically acceptable imaging, 

such as chest x-ray, echocardiography (MMode, 2-dimensional, and Doppler), 

radionuclide studies, or cardiac 

catheterization. Other findings on 

appropriate medically acceptable imaging 

may include increased pulmonary vascular 

markings, pleural effusion, and pulmonary 

edema. 

b. Your medical history and physical 

examination should describe characteristic 

symptoms and signs of pulmonary or 

systemic congestion (fluid retention) or of 

limited cardiac output associated with the 

abnormal findings on appropriate medically 

acceptable imaging. When an acute episode 

of heart failure is triggered by a remediable 

factor, such as an arrhythmia, dietary sodium 

overload, or high altitude, cardiac function 

may be restored and a chronic impairment 

may not be present. 

(i) * * * 

(ii) * * * 

(iii) * * * However, these signs need not 

be found on all examinations because 

congestion may be controlled by prescribed 

treatment or may not be present at the time 

of evaluation. 

* * * * * 

4. How do we evaluate CHF treated with a 

mechanical circulatory support device? We 

use 104.02D to evaluate CHF treated with an 

implanted mechanical circulatory support 

device (MCSD), such as a left ventricle 

assistive device (LVAD) or a right ventricle 

assistive device (RVAD). Implanted MCSDs 

are intended for long-term circulatory 

support in helping the heart pump blood. For 

the purposes of 104.02D, an MCSD does not 

include extracorporeal membrane 

oxygenation (ECMO). Although ECMO is a 

form of mechanical circulatory support, we 

do not include it in 104.02D because ECMO 

is intended only for short-term circulatory 

support (maximum 30 days), used in a setting 

of imminent or actual cardiac arrest. 

D. How do we evaluate congenital heart 

disease? 

1. What is congenital heart disease? 

Congenital heart disease is any abnormality 

of the heart or the major blood vessels that 

is present at birth. Congenital heart disease 

includes abnormal structure of the individual 

heart chambers, valves, and blood vessels, 

and abnormal relative relationship of the 

chambers to each other that alters the normal 

pattern of blood flow. Surgery is the usual 

treatment, and with improving surgical 

techniques and medical management, more 

children with congenital heart disease are 

surviving into adulthood. Examples of 

congenital heart disease include: 

a. * * * 

b. * * * 

c. * * * 

d. Major abnormalities of ventricular 

development, including hypoplastic left 

heart syndrome or tricuspid atresia with 

hypoplastic right ventricle. 

2. How do we evaluate conditions 

associated with congenital heart disease? 

a. We will evaluate congenital heart 

disease that results in chronic heart failure 

with evidence of ventricular dysfunction or 

in recurrent arrhythmias under 104.02 or 

104.05, respectively. Otherwise, we will 

evaluate your impairment under 104.06. 

b. We need pulse oximetry measurements 

documented by medical sources using 

methods consistent with the prevailing state 

of medical knowledge and clinical practice to 

evaluate chronic hypoxemia in congenital 

heart disease under 104.06A3. These pulse 

oximetry measurements also must be 

consistent with the other evidence in the case 

record. 

c. 104.06D, life-threatening congenital 

heart disease does not include single 

ventricle; we evaluate single ventricle 

physiology separately under 104.06C. When 

we evaluate life-threatening congenital heart 

disease under 104.06D, we consider whether 

it responds to surgical treatment and, 

therefore, may not meet the 12-month 

duration requirement. Examples of 

impairments that in most instances will 

require life-saving surgery or a combination 

of surgery and other major interventional 

procedures (for example, multiple ‘‘balloon’’ 

catheter procedures) before age 1 include, but 

are not limited to, the following: 

(i) Critical aortic stenosis with neonatal 

heart failure, 

(ii) Critical coarctation of the aorta, with 

associated anomalies, 

(iii) Complete atrioventricular canal 

defects, 

(iv) Transposition of the great arteries, 

(v) Tetralogy of Fallot, and 

(vi) Multiple ventricular septal defects. 

3. What is Eisenmenger syndrome? 

Eisenmenger syndrome refers to any 

surgically untreated congenital heart defect 

with intracardiac communication that over 

time leads to pulmonary hypertension, 

reversal of blood flow, and hypoxemia. 

a. Lesions in Eisenmenger syndrome, such 

as large septal defects, are characterized by 

elevated pulmonary pressures or a high 

pulmonary flow rate. In response, the 

pulmonary blood vessels pathologically 

change, leading eventually to pulmonary 

hypertension. Development of Eisenmenger 

syndrome represents a point at which 

pulmonary hypertension is irreversible and 

the cardiac lesion is likely inoperable. 

b. Examples of congenital heart disease 

that if untreated may cause pulmonary 

vascular disease leading to Eisenmenger 

syndrome include atrial septal defect (ASD), 

ventricular septal defect (VSD), and large 

patent ductus arteriosus (PDA). We evaluate 

Eisenmenger syndrome under 104.06A or 

104.06B. 

4. What is single ventricle? 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. At 

birth, one ventricle must functionally do the 

work of two, pumping blood for both the 

body (systemic) and the lungs (pulmonary). 

Because of this feature, the ultimate plan for 

cardiac reconstruction is similar for most of 

these anomalies. People with single ventricle 

will generally undergo staged reconstructive 

‘‘Fontan procedures,’’ ultimately resulting in 

a ‘‘Fontan circulation.’’ Fontan circulation 

describes the hemodynamic state in which 

virtually all systemic venous return-blood 

passively flows directly into the pulmonary 

arteries via surgical or catheter-placed 

shunts, without (the blood) passing through 

a ventricle. Some of the anomalies described 

as single ventricle include the following: 

(i) Hypoplastic left heart syndrome; 

(ii) Hypoplastic right ventricle; 

(iii) Tricuspid valve atresia; 

(iv) Double inlet left ventricle; and 

(v) Some variations of double outlet right 

ventricle. 

E. How do we evaluate arrhythmias? 

1. What is an arrhythmia? * * * Although 

we use the term ‘‘arrhythmia’’ in the listings, 

the term ‘‘dysrhythmia’’ may also be used in 

the medical evidence to describe this 

condition. 

* * * * * 

4. What will we consider when you have an 

implanted cardiac defibrillator and you do 


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not have arrhythmias that meet the 

requirements of 104.05? 

a. * * * The shock from the implanted 

cardiac defibrillator rescues a child from 

what may have been cardiac arrest. However, 

as a consequence of the shock(s), similar to 

the effects of treatments for other 

cardiovascular disease, a child may 

experience psychological distress, which we 

may evaluate under the listings in 112.00. 

b. * * * Also, exposure to strong electrical 

or magnetic fields, such as from magnetic 

resonance imaging, can trigger or reprogram 

an implanted cardiac defibrillator, resulting 

in inappropriate shocks. * * * 

* * * * * 

F. How do we evaluate other 

cardiovascular disorders? 

1. What is ischemic heart disease (IHD) 

and how will we evaluate it in children? 

* * * If you have IHD, we will evaluate it 

under 4.04 in part A. 

2. How will we evaluate hypertension? 

Hypertension (high blood pressure) generally 

causes disability in children through its 

effects on other body systems, such as the 

brain, kidneys, or eyes, and we will evaluate 

these impairments by reference to the 

specific body system(s) that is affected. * * * 

3. What is cardiomyopathy and how will 

we evaluate it? 

a. There are various types of 

cardiomyopathy, which fall into two major 

categories: ischemic and nonischemic 

cardiomyopathy. Ischemic cardiomyopathy 

typically refers to heart muscle damage that 

results from coronary artery disease, 

including heart attacks. Nonischemic 

cardiomyopathy includes several types: 

dilated, hypertensive, hypertrophic, and 

restrictive. 

b. We will evaluate cardiomyopathy under 

4.04 in part A, 104.02, or 104.05, depending 

on its effects on you. 

4. How will we evaluate valvular heart 

disease? We will evaluate aortic valvular 

disease under 4.07 in part A. We may also 

evaluate aortic valvular disease, as well as 

other forms of valvular disease, under 4.04 in 

part A, 104.02, 104.05, 104.06, or a listing in 

111.00, depending on its effects on you. 

5. * * * 

a. After your heart transplant, we will 

consider you disabled under 104.09 for 1 

year following the surgery because there is a 

greater likelihood of rejection of the organ 

and infection during the first year. If you 

develop cardiac allograft vasculopathy after 

your transplant, we will evaluate this 

impairment under 104.16. 

* * * * * 

d. When we do a continuing disability 

review to determine whether you are still 

disabled, we will evaluate your residual 

impairment(s), as shown by the evidence in 

your case record, including any side effects 

of medication. We will consider all evidence 

indicative of cardiac dysfunction in deciding 

whether medical improvement (as defined in 

§ 416.994a of this chapter) has occurred. 

6. How will we evaluate chronic rheumatic 

fever or rheumatic heart disease? We will 

evaluate rheumatic fever or rheumatic heart 

disease under the listing appropriate to its 

effects on you, which may include heart 

failure or recurrent arrhythmias. If you have 

evidence of chronic heart failure or recurrent 

arrhythmias associated with rheumatic heart 

disease, we will evaluate these disorders 

under 104.02 or 104.05, respectively. 

* * * * * 

9. * * * 

a. * * * 

b. Lymphedema does not meet the 

requirements of 4.11 in part A, although it 

may medically equal the listing. We evaluate 

lymphedema by considering whether the 

underlying cause meets or medically equals 

any listing or whether the lymphedema 

medically equals a cardiovascular disorders 

listing, such as 4.11 in part A, or a listing in 

101.00. If no listing is met or medically 

equaled, we will evaluate any functional 

limitations imposed by your lymphedema 

when we consider whether you have an 

impairment(s) that functionally equals the 

listings. 

* * * * * 

11. What is cardiac allograft vasculopathy 

and how do we evaluate it? Cardiac allograft 

vasculopathy (CAV) may affect a person who 

has received a heart transplant and involves 

thickening in the walls of the coronary 

arteries that may progress quickly into 

serious vascular stenosis and heart 

dysfunction. Stenosis in CAV is caused by a 

pathological process different from classic 

atherosclerosis and treatment often is only 

palliative. We evaluate CAV under 104.16. 

G. How do we evaluate issues that affect 

the cardiovascular system? 

1. How do we consider the effects of obesity 

when we evaluate your cardiovascular 

disorder? Obesity is a medically 

determinable impairment that may be 

associated with cardiovascular disorders. The 

additional body mass may make it harder for 

the chest and lungs to expand or may cause 

the heart to work harder to pump blood to 

carry oxygen to the body. The combined 

effects of obesity with a cardiovascular 

disorder can be greater than the effects of 

each of the impairments considered 

separately. We consider the additional and 

cumulative effects of obesity when we 

determine whether you have a severe 

cardiovascular disorder, a listing-level 

cardiovascular disorder, a combination of 

impairments that medically equals the 

severity of a listed impairment, and when we 

determine whether your impairment(s) 

functionally equals the listings. 

2. How do we relate treatment to functional 

status? In general, conclusions about the 

severity of a cardiovascular disorder cannot 

be made on the basis of the type of treatment 

rendered or anticipated. * * * 

3. How do we consider hospitalizations? 

The hospitalizations in 104.02E and 104.06E 

do not all have to be for the same 

exacerbation or complication of your 

cardiovascular disorder(s). They may be for 

three different exacerbations or 

complications resulting from your 

cardiovascular disorder. The hospitalizations 

must be at least 30 days apart, and each one 

must last at least 48 hours, including hours 

in a hospital emergency department 

immediately before the hospitalization. 

H. How do we evaluate cardiovascular 

disorders that do not meet one of these 

listings? 

1. These listings are only examples of 

common cardiovascular disorders that we 

consider severe enough to result in marked 

and severe functional limitations. If your 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether you have an impairment(s) that 

satisfies the criteria of a listing in another 

body system. 

2. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will determine whether 

your impairment(s) medically equals a 

listing. See § 416.926 of this chapter. If your 

impairment(s) does not meet or medically 

equal a listing, we will also consider whether 

it functionally equals the listings. See 

§ 416.926a of this chapter. We will use the 

rules in § 416.994a of this chapter when we 

decide whether you continue to be disabled. 

104.01 Category of Impairments, 

Cardiovascular Disorders 

104.02 Chronic heart failure (see 104.00C) 

while on a regimen of prescribed treatment 

with symptoms and signs described in 

104.00C2, and with A, B, C, D, or E: 

A. Persistent tachycardia at rest measured 

at least twice within a consecutive 12-month 

period and at least 90 days apart documented 

by apical heart rate greater than or equal to 

the value in Table I. 

TABLE I—TACHYCARDIA AT REST

Age 

Apical 

heart rate 

(beats per 

minute) 

Under 1 year ......................... 150 

1 through 3 years ................. 130 

4 through 9 years ................. 120 

10 through 15 years ............. 110 

Over 15 years ....................... 100 

OR 

B. Persistent tachypnea at rest measured at 

least twice within a consecutive 12-month 

period and at least 90 days apart documented 

by respiratory rate greater than or equal to the 

value in Table II or markedly decreased 

exercise tolerance (see 104.00C2b). 

TABLE II—TACHYPNEA AT REST

Age 

Respiratory 

rate (per 

minute) 

Under 1 year ......................... 40 

1 through 5 years ................. 35 

6 through 9 years ................. 30 

Over 9 years ......................... 25 

OR 

C. Growth failure as required in 1 or 2: 

1. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate weight-for-length table under 

105.08B1; or 


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2. For children age 2 to attainment of age 

18, three BMI-for-age measurements that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate BMI-for-age table under 

105.08B2. 

OR 

D. Mechanical circulatory support device 

(except an extracorporeal membrane 

oxygenation (ECMO) while hospitalized, at 

home, or both (see 104.00C4). Consider under 

a disability for 12 months from the date of 

implantation; after that, evaluate any residual 

impairment(s) under the criteria for the 

affected body system. 

OR 

E. Exacerbations or complications of 

chronic heart failure (see 104.00C1b) 

requiring three hospitalizations within a 

consecutive 12-month period and at least 30 

days apart. Each hospitalization must last at 

least 48 hours, including hours in a hospital 

emergency department immediately before 

the hospitalization (see 104.00G3). 

104.03–104.04 [Reserved] 

104.05 Recurrent arrhythmias (see 

104.00E), not related to reversible causes 

such as electrolyte abnormalities or digitalis 

glycoside or antiarrhythmic drug toxicity, 

while on a regimen of prescribed treatment 

(see 104.00B3 if there is no prescribed 

treatment), demonstrated by both A and B: 

A. Coincident with recurrent (see 

104.00A3c) episodes of cardiac syncope or 

near syncope (see 104.00E3b). 

AND 

B. Documented by either 1 or 2: 

1. Resting or ambulatory (Holter) 

electrocardiography; or 

2. Other appropriate medically acceptable 

testing. 

104.06 Congenital heart disease (see 

104.00D), documented by appropriate 

medically acceptable imaging (see 

104.00A3d) or cardiac catheterization, with 

A, B, C, D, or E: 

A. Chronic hypoxemia, and 1, 2, or 3: 

1. Hematocrit of 55 percent or greater on 

two evaluations at least 90 days apart within 

a consecutive 12-month period (see 

104.00A3e); or 

2. Arterial blood gas test measurement 

obtained at rest while breathing room air, as 

described in either a or b: 

a. SaO2 (arterial oxygen saturation) less 

than or equal to 89 percent; or 

b. PO2 or PaO2 (partial pressure of oxygen) 

less than or equal to 60 mmHg; or 

3. SpO2 (percentage of oxygen saturation of 

blood hemoglobin) measured by pulse 

oximetry either at rest, or after activity, while 

breathing room air, less than or equal to 87 

percent on three evaluations at least 30 days 

apart within a consecutive 12-month period 

(see 104.00A3e). 

OR 

B. Pulmonary hypertension documented by 

cardiac catheterization while medically 

stable, as described in 1, 2, or 3: 

1. Pulmonary arterial systolic pressure 

elevated to at least 70 percent of the systemic 

arterial systolic pressure; or 

2. Pulmonary arterial systolic pressure 

equal to or greater than 70 mmHg; or 

3. Mean pulmonary artery pressure equal 

to or greater than 40 mmHg. 

OR 

C. Single ventricle (for example, 

hypoplastic left or right ventricle) that has or 

will require Fontan procedures (see 

104.00D5). 

OR 

D. For infants under 1 year of age at the 

time of filing, with life-threatening congenital 

heart disease (see 104.00D3c) that will 

require or already has required surgical 

treatment in the first year of life, and the 

impairment is expected to be disabling 

(because of residual impairment following 

surgery, or the recovery time required, or 

both) until the attainment of at least 1 year 

of age, consider under a disability until the 

attainment of at least age 1; after that, 

evaluate impairment severity with the 

appropriate listing. 

OR 

E. Exacerbations or complications of 

congenital heart disease (see 104.00D) 

requiring three hospitalizations within a 

consecutive 12-month period (see 104.00A3e) 

and at least 30 days apart. Each 

hospitalization must last at least 48 hours, 

including hours in a hospital emergency 

department immediately before the 

hospitalization (see 104.00G3). 

104.07–104.08 [Reserved] 

104.09 Heart transplantation (see 

104.00F5). Consider under a disability for 1 

year from the date of the transplant; after 

that, evaluate the residual impairment(s). 

104.10–104.15 [Reserved] 

104.16 Cardiac allograft vasculopathy (see 

104.00F11), documented by appropriate 

medically acceptable imaging (for example, 

intravascular ultrasonography or coronary 

angiography). 

[FR Doc. 2022–12980 Filed 6–28–22; 8:45 am] 

BILLING CODE 4191–02–P 


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