[Federal Register Volume 69, Number 179 (Thursday, September 16, 2004)]
[Proposed Rules]
[Pages 55874-55894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20709]



[[Page 55873]]

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Part II





Social Security Administration





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20 CFR Part 404



Revised Medical Criteria for Evaluating Cardiovascular Impairments; 
Proposed Rule

  Federal Register / Vol. 69, No. 179 / Thursday, September 16, 2004 / 
Proposed Rules  

[[Page 55874]]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulation No. 4]
RIN 0960-AF48


Revised Medical Criteria for Evaluating Cardiovascular 
Impairments

AGENCY: Social Security Administration.

ACTION: Proposed rules.

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SUMMARY: We propose to revise the criteria in the Listing of 
Impairments (the listings) that we use to evaluate claims involving 
cardiovascular impairments. We apply these criteria when you claim 
benefits based on disability under title II and title XVI of the Social 
Security Act (the Act). The proposed revisions reflect our program 
experience and advances in medical knowledge, treatment, and methods of 
evaluating cardiovascular disorders.

DATES: To be sure your comments are considered, we must receive them by 
November 15, 2004.

ADDRESSES: You may give us your comments by: using our Internet site 
facility (i.e., Social Security Online) at: http://policy.ssa.gov/pnpublic.nsf/LawsRegs or the Federal eRulemaking Portal at: http://www.regulations.gov; e-mail to [email protected]; telefax to (410) 
966-2830; or letter to the Commissioner of Social Security, P.O. Box 
17703, Baltimore, Maryland 21235-7703. You may also deliver them to the 
Office of Regulations, Social Security Administration, 100 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, 
between 8 a.m. and 4:30 p.m. on regular business days. Comments are 
posted on our Internet site at http://policy.ssa.gov/pnpublic.nsf/LawsRegs or you may inspect them on regular business days by making 
arrangements with the contact person shown in this preamble.
    Electronic Version: The electronic file of this document is 
available on the date of publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html. It is also available on the Internet 
site for SSA (i.e., Social Security Online): http://policy.ssa.gov/pnpublic.nsf/LawsRegs.

FOR FURTHER INFORMATION CONTACT: Fran O. Thomas, Social Insurance 
Specialist, Office of Disability and Income Security Programs, Social 
Security Administration, 100 Altmeyer, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, (410) 966-9822 or TTY (410) 966-5609. 
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 Web site, Social Security Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

What Programs Would These Proposed Regulations Affect?

    These proposed regulations would affect disability determinations 
and decisions that we make under title II and title XVI of the Act. In 
addition, to the extent that Medicare entitlement and Medicaid 
eligibility are based on whether you qualify for disability benefits 
under title II or title XVI, these proposed regulations would also 
affect the Medicare and Medicaid programs.

Who Can Get Disability Benefits?

    Under title II of the Act, we provide for the payment of disability 
benefits if you are disabled and belong to one of the following three 
groups:
     Workers insured under the Act,
     Children of insured workers, and
     Widows, widowers, and surviving divorced spouses (see 20 
CFR 404.336) of insured workers.
    Under title XVI of the Act, we provide for Supplemental Security 
Income (SSI) payments on the basis of disability if you are disabled 
and have limited income and resources.

How Do We Define Disability?

    Under both the title II and title XVI programs, disability must be 
the result of any medically determinable physical or mental impairment 
or combination of impairments that is expected to result in death or 
which has lasted or is expected to last for a continuous period of at 
least 12 months. Our definitions of disability are shown in the 
following table:

------------------------------------------------------------------------
                                                    Disability means you
                                                      have a medically
 If you file a claim under . .  And you are . . .       determinable
               .                                      impairment(s) as
                                                    described above and
                                                   that results in . . .
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Title II......................  An adult or a      The inability to do
                                 child.             any substantial
                                                    gainful activity
                                                    (SGA).
-------------------------------
Title XVI.....................  a person age 18    The inability to do
                                 or older.          any SGA.
-------------------------------
Title XVI.....................  A person under     Marked and severe
                                 age 18.            functional
                                                    limitations.
------------------------------------------------------------------------

What Are the Listings?

    The listings are examples of impairments that we consider severe 
enough to prevent an individual from doing any gainful activity or that 
result in ``marked and severe functional limitations'' in children 
seeking SSI payments under title XVI of the Act. Although we publish 
the listings only in appendix 1 to subpart P of part 404 of our rules, 
we incorporate them by reference in the SSI program in Sec.  416.925 of 
our regulations, and apply them to claims under both title II and title 
XVI of the Act.

How Do We Use the Listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we never 
use the listings in part B.
    If you are an individual under age 18, we first use the criteria in 
part B of the listings. If the listings in part B do not apply, and the 
specific disease process(es) has a similar effect on adults and 
children, we then use the criteria in part A. (See Sec. Sec.  404.1525 
and 416.925.) If your impairment(s) does not meet any listing, we will 
also consider whether it medically equals any listing; that is, whether 
it is as medically severe. (See Sec. Sec.  404.1526 and 416.926.)
    We use the listings only to decide that individuals are disabled or 
that they are still disabled. We will never deny your claim or decide 
that you no longer qualify for benefits because your impairment(s) does 
not meet or medically equal a listing. If you have a severe 
impairment(s) that does not meet or medically equal any listing, we may 
still find you disabled based on other rules in the ``sequential 
evaluation process'' that we use to evaluate all disability claims. 
(See Sec. Sec.  404.1520, 416.920, and 416.924.)
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended based only 
on any changes in the listings. Our regulations explain that, when we 
change our listings, we continue to use our prior

[[Page 55875]]

listings when we review your case, if you qualified for disability 
benefits or SSI payments based on our determination or decision that 
your impairment(s) met or medically equaled the listings. In these 
cases, we determine whether you have experienced medical improvement 
and, if so, whether the medical improvement is related to the ability 
to work. If your condition(s) has medically improved so that you no 
longer meet or medically equal the prior listing, we evaluate your case 
further to determine whether you are currently disabled. We may find 
that you are currently disabled, depending on the full circumstances of 
your case. See Sec. Sec.  404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). 
If you are a child who is eligible for SSI payments, we follow a 
similar rule after we decide that you have experienced medical 
improvement in your condition(s). See Sec.  416.994a(b)(2).

Why Are We Proposing To Revise the Listings for Cardiovascular 
Impairments?

    We last published final rules revising the listings for the 
cardiovascular body system in the Federal Register on February 10, 1994 
(59 FR 6468). In that notice, we said that those rules would be 
effective for 4 years unless we extended them, or revised and issued 
them again. The current listings for the cardiovascular system will no 
longer be effective on July 1, 2005, unless we extend them, or revise 
and issue them again.
    We are proposing these revisions because we decided to update the 
medical criteria and provide more information about how we evaluate 
cardiovascular impairments.

When Will We Start To Use These Rules?

    We will not use these rules until we evaluate the public comments 
we receive on them, determine whether to issue them as final rules, and 
issue final rules in the Federal Register. If we publish final rules, 
we will explain in the preamble how we will apply them, and summarize 
and respond to the major public comments. Until the effective date of 
any final rules, we will continue to use our current rules.

How Long Would These Proposed Rules Be Effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 5 years after the date they become effective, unless we 
extend them, or revise and issue them again.

How Are We Proposing To Change the Introductory Text to the Adult 
Cardiovascular Listings?

    We propose to expand and reorganize the introductory material in 
current section 4.00 to provide additional guidance and to reflect the 
new listings. Because of the extensive information and guidance 
included in the introductory text to the listings, we propose to 
provide separate sections that are devoted to specific issues. The 
following is an explanation of the proposed material.

Proposed 4.00A--General

    In this proposed section, we provide general information on what we 
mean by a cardiovascular impairment and what we consider when we 
evaluate cardiovascular impairments. Proposed section 4.00A1 
incorporates the information found in current 4.00B, with some minor 
editing. Proposed section 4.00A2 is taken from the first paragraph of 
current 4.00A. Proposed section 4.00A3 is a new section containing 
definitions of some terms we use in these proposed listings.

Proposed 4.00B--Documenting Cardiovascular Impairments

    In 4.00B1, we propose to provide information on the basic 
documentation that we need to evaluate cardiovascular impairments under 
the listings. In proposed sections 4.00B2-4.00B3, we include a 
discussion of the importance of longitudinal records and what we will 
do when a longitudinal record is not available because you have not 
received ongoing medical treatment. In proposed sections 4.00B4-4.00B6, 
we explain when we will wait for your condition to become stable before 
we ask for more evidence to help us evaluate the severity and duration 
of your impairment, explain when we may decide to order studies, and 
specify what studies we will not order. Much of this information is 
taken from the current sections 4.00A and 4.00C, with some rephrasing 
to clarify our meaning.

Proposed 4.00C--Using Cardiovascular Test Results

    In this proposed section, we discuss various specialized 
cardiovascular tests and how we evaluate their results. In 4.00C1, we 
explain what an electrocardiogram (ECG) is. Our specifications for ECG 
tracings from current section 4.00C1 are given in proposed section 
4.00C2. In proposed section 4.00C3, we explain what the different kinds 
of exercise tests are and discuss their uses. Exercise testing is the 
most widely used testing for identifying the presence of myocardial 
ischemia and for estimating maximal aerobic capacity if you have heart 
disease. However, as we state throughout the introductory text, we will 
consider all the relevant evidence and will not rely solely on the 
results of one type of test. In proposed section 4.00C4, we discuss 
what limitations exercise tolerance tests (ETTs) have. We also explain, 
in proposed section 4.00C5, what ETTs with measurement of maximal or 
peak oxygen uptake are and how they differ from other ETTs.
    In proposed sections 4.00C6-4.00C7, we explain when we will 
consider ordering an exercise test for case evaluation and what we must 
do before ordering one. We will continue to require that a medical 
consultant (MC), preferably one with experience in the care of patients 
with cardiovascular disease, review the evidence to determine whether 
performing an exercise test would put you at significant risk, or if 
there is some other medical reason not to do the test. (When an 
administrative law judge or an administrative appeals judge at the 
Appeals Council decides that a consultative examination is appropriate, 
the administrative law judge or the administrative appeals judge will 
ask the State agency to arrange for the examination. In this situation, 
an MC will still assess whether a consultative examination that 
includes exercise testing would involve a significant risk to you. This 
is the same procedure that we follow under our current rules.) We also 
send copies of your records to the physician conducting the exercise 
test for us, if he or she does not already have them, as the examining 
physician has the ultimate responsibility for determining whether you 
would be at risk. We also propose, in section 4.00C8, to reorganize and 
modify the information on ``significant risk'' in current section 
4.00C2c. We are doing this because some of the so-called risk factors 
identified in the current section are not risks per se, but are factors 
that affect proper interpretation of the tracings or are situations 
that only temporarily preclude exercise testing. We propose to identify 
several different categories that explain the various circumstances 
under which we will not order an ETT or will defer ordering one. We 
propose to base much of these provisions on the list of 
contraindications to exercise testing in the Guidelines for Exercise 
Testing published jointly by the American College of Cardiology (ACC) 
and the American Heart Association (AHA) in 1997 and updated in 2002. 
(See citations at the end of this preamble.)

[[Page 55876]]

    In proposed section 4.00C9, we explain when we consider exercise 
test results to be timely. In proposed sections 4.00C10-4.00C11, we 
outline the criteria for evaluating how ETTs we order should be 
performed (taken from current section 4.00C2b) and explain how we 
evaluate ETT results (taken from current section 4.00C2e). We explain 
when ETTs are done with imaging and when we will consider ordering such 
tests in proposed sections 4.00C12-4.00C13, which are based on the 
guidance given in current section 4.00C3. We provide new guidance on 
drug-induced stress tests, what they are, and how they are used, in 
proposed section 4.00C14.
    In proposed section 4.00C15, we placed the information found in 
current section 4.00C4 on two types of cardiac catheterization reports 
and the details that the reports should contain and what we consider 
when evaluating these reports. In proposed sections 4.00C16-4.00C17, we 
placed the information found in current section 4.00E4 on the details 
that exercise Doppler studies should contain and how any such studies 
we order should be performed. We propose to change the requirement in 
the third paragraph of current section 4.00E4 for walking on a 10 or 12 
percent grade to a 12 percent grade. This proposed change would make 
our rules consistent with how the test is generally done. Because this 
is an exercise test, we must evaluate whether such testing would put 
you at significant risk, in accordance with the guidance found in 
proposed 4.00C7 and 4.00C8. We also specify that the tracings should be 
included with the report and that they should be annotated with the 
standardization used by the testing facility.
    In proposed sections 4.00D-4.00H, we would provide general medical 
information on the various cardiovascular impairments and information 
on how we evaluate each of them using the proposed listing criteria. We 
propose to incorporate information currently found in section 4.00E and 
guidance we have provided to our adjudicators that is not in the 
current listings. We also propose to add some new information, as 
described below.

Proposed 4.00D--Evaluating Chronic Heart Failure

    In proposed section 4.00D1, for chronic heart failure, we explain 
what chronic heart failure is and the differences between the two main 
types of chronic heart failure. We also propose to evaluate cor 
pulmonale under the respiratory system listing 3.09, rather than 
listing 4.02, as it is a heart condition resulting from a respiratory 
disorder. In proposed 4.00D2 and 4.00D3, we describe the evidence of 
chronic heart failure that we need and explain how ETTs are used to 
evaluate individuals with known chronic heart failure. We also explain, 
in proposed 4.00D4, the phrase ``periods of stabilization,'' which we 
use in proposed listing 4.02B2.

Proposed 4.00E--Evaluating Ischemic Heart Disease

    In proposed section 4.00E, for ischemic heart disease (IHD), we 
would incorporate most of the information in current section 4.00E3. We 
explain what IHD is and what causes chest discomfort of myocardial 
origin in proposed sections 4.00E1 and 4.00E2. We propose to move 
unchanged the material on chest discomfort of myocardial ischemic 
origin from current section 4.00E3e to proposed section 4.00E2 and to 
explain that individuals with IHD may experience manifestations other 
than typical angina pectoris. We discuss the characteristics of typical 
angina pectoris in proposed section 4.00E3. This section is based on 
and incorporates material from current section 4.00E3a. In proposed 
section 4.00E4, we include a definition of, and information on, 
atypical angina, which we include in our discussion of anginal 
equivalent in current section 4.00E3b. We discuss anginal equivalent in 
proposed section 4.00E5. The material on anginal equivalent is based on 
current section 4.00E3b, but we explain that it is essential to 
establish objective evidence of myocardial ischemia in order to 
differentiate anginal equivalent shortness of breath (dyspnea) that 
results from myocardial ischemia from dyspnea that results from non-
ischemic or non-cardiac causes. Proposed section 4.00E6 on variant 
angina is based on current section 4.00E3c, but we discuss in greater 
detail what variant angina is, how it is diagnosed and treated, and how 
we will evaluate it. We also state that vasospasm that is catheter-
induced during coronary angiography is not variant angina.
    In proposed section 4.00E7, we would expand the discussion of 
silent ischemia that appears in current section 4.00E3d. We explain 
what silent ischemia is and why it may occur. We describe the 
situations in which it most often occurs, how it may be documented 
using ambulatory monitoring (Holter) equipment, and how we evaluate it. 
We propose to move the material on chest discomfort of non-ischemic 
origin from current section 4.00E3f to proposed section 4.00E8. We 
propose to add acute anxiety or panic attacks to the examples of 
noncardiac conditions that may produce symptoms mimicking myocardial 
ischemia, since we recognize that mental disorders may produce physical 
symptoms. In proposed section 4.00E9, we explain how we evaluate IHD 
using the criteria in proposed listing 4.04.

Proposed 4.00F--Evaluating Arrhythmias

    In proposed section 4.00F, we provide information on evaluating 
arrhythmias. We explain what arrhythmias are and discuss the different 
types in proposed sections 4.00F1-4.00F2. In proposed section 4.00F3, 
we explain what we mean by ``near syncope'' in listing 4.05. In 
proposed sections 4.00F4 and 4.00F5, we would add information on 
implantable cardiac defibrillators and how we will evaluate arrhythmias 
if you have a defibrillator implanted.

Proposed 4.00G--Evaluating Peripheral Vascular Disease

    In the proposed section on peripheral vascular disease (PVD), 
4.00G, we would incorporate the information in current 4.00E4 and 
provide additional information and guidance on the evaluation of PVD, 
based on questions we have received in the past. Proposed section 
4.00G1 explains what we mean by PVD and describes its usual effects. In 
proposed section 4.00G2, we explain how we assess the limitations 
resulting from PVD. This section is based on current section 4.00E4, 
and explains that we will evaluate limitations based on your symptoms, 
together with physical findings, Doppler studies, other appropriate 
non-invasive studies, or angiographic findings. We also explain that we 
will evaluate amputations resulting from PVD under the musculoskeletal 
body system listings.
    We explain in proposed section 4.00G3 what brawny edema is to 
distinguish it from pitting edema and clarify that pitting edema does 
not satisfy the requirements of listing 4.11. We also propose to 
explain what lymphedema is and what causes it in proposed section 
4.00G4. We also add guidance on the evaluation of lymphedema in section 
4.00G5. We propose to evaluate lymphedema either under the listing for 
the underlying cause, or to consider whether the condition medically 
equals a cardiovascular listing, such as listing 4.11, or a 
musculoskeletal listing in 1.00. We also explain how we evaluate the 
condition in cases in which the listings are not met or medically 
equaled.

[[Page 55877]]

    In proposed section 4.00G6, we clarify how we consider blood 
pressures taken at the ankle. We will use the higher of the posterior 
tibial or dorsalis pedis systolic blood pressures measured at the 
ankle, because the higher pressure is the more reliable. In proposed 
section 4.00G7, we take information from the third paragraph of current 
section 4.00E4 on how the ankle/brachial ratio is determined for 
purposes of evaluating a claim under listing 4.12. We also explain that 
the ankle and brachial pressures do not have to be taken on the same 
side of the body because we will use the higher brachial pressure 
measured, and we provide information on the various techniques used for 
obtaining ankle systolic blood pressures. We also specify that we will 
request any available tracings from those techniques, so that we can 
review them.
    We would move and rephrase somewhat for clarity the information on 
when we will obtain exercise Doppler studies for the evaluation of 
peripheral arterial disease from current section 4.00E4 to proposed 
section 4.00G8, but make no substantive changes. We add guidance in 
proposed section 4.00G9 on the use of toe pressures for evaluating 
intermittent claudication in individuals with abnormal arterial 
calcification or small vessel disease, as may happen if you have 
diabetes mellitus or certain other diseases. In the presence of 
abnormal arterial calcification or small vessel disease, the blood 
pressure at the ankle may be misleadingly high, but the toe pressure is 
seldom affected by these vascular changes. We are also proposing two 
new criteria in listing 4.12 using toe pressure and toe/brachial 
pressure ratio. Then, in proposed section 4.00G10, we explain how toe 
pressures are measured. In proposed section 4.00G11, we describe other 
studies helpful in evaluating PVD, particularly the recording 
ultrasonic Doppler unit, and the value of reviewing pulse wave tracings 
from these studies when evaluating individuals with diabetes mellitus 
or other diseases with similar vascular changes. We close our 
discussion of the evaluation of PVD with section 4.00G12, which 
discusses the similarities between peripheral grafting and coronary 
grafting and explains how we will evaluate cases involving peripheral 
grafting.

Proposed 4.00H--Evaluating Other Cardiovascular Impairments

    In proposed section 4.00H, we provide guidance on evaluating other 
cardiovascular impairments. In proposed section 4.00H1, we discuss the 
evaluation of hypertension, rephrasing material found in current 
section 4.00E2. We explain what congenital heart disease is in proposed 
section 4.00H2 and provide guidance on how we will evaluate symptomatic 
congenital heart disease in proposed 4.00H3. In proposed 4.00H4, we 
provide guidance on what cardiomyopathy is and how we will evaluate it. 
We provide guidance on the evaluation of valvular heart disease in 
proposed 4.00H5. We discuss the evaluation of heart transplant 
recipients in proposed section 4.00H6. Finally, we explain when an 
aneurysm has ``dissection not controlled by prescribed treatment'' as 
required under listing 4.10, in proposed section 4.00H7. We propose to 
add guidance on what hyperlipidemia is and how we will evaluate it in 
proposed section 4.00H8.

Proposed 4.00I--Other Evaluation Issues

    In this section, we would provide guidance on a variety of issues. 
In proposed section 4.00I1, we explain the evaluation of obesity's 
effect on the cardiovascular system. The guidance in this section is 
taken from current section 4.00F and incorporates additional guidance 
we included in Social Security Ruling 02-1p (``Titles II and XVI: 
Evaluation of Obesity,'' 67 FR 57859 (2002)). Proposed section 4.00I2 
explains how we relate treatment to functional status. This section is 
based on current section 4.00D; we have deleted some language that 
dealt with listing-level impairment from the current section and made 
non-substantive editorial changes. If the anticipated improvement might 
affect the determination or decision on the case, we will wait an 
appropriate length of time in order to evaluate the results of the 
treatment. Finally, in proposed section 4.00I3, we explain how we 
evaluate cardiovascular impairments that do not meet a cardiovascular 
listing. This section is based on the fourth paragraph of current 
section 4.00A. We propose to make non-substantive editorial changes in 
the current language.

How Are We Proposing To Change the Criteria in the Listings for 
Evaluating Cardiovascular Impairments in Adults?

Proposed 4.01--Category of Impairments, Cardiovascular System

    We propose to delete the following current cardiovascular listings 
because they are reference listings that direct adjudicators to 
evaluate these impairments and their effects under other listings: 
4.02C, Cor pulmonale; 4.03, Hypertensive cardiovascular disease; 4.06C, 
Symptomatic congenital heart disease with chronic heart failure; 4.06D, 
Symptomatic congenital heart disease with recurrent arrhythmias; 4.07, 
Valvular heart disease or other stenotic defects, or valvular 
regurgitation; 4.08, Cardiomyopathies; 4.10B, Aneurysm of aorta or 
major branches with chronic heart failure; 4.10C, Aneurysm of aorta or 
major branches with renal failure; and 4.10D, Aneurysm of aorta or 
major branches with neurological complications. As we have done with 
other body system listings, we propose to delete these reference 
listings from our listings because they are redundant. However, we 
provide guidance in the introductory text of the listing on how we will 
evaluate these impairments using other listings.
    The following is a detailed explanation of the proposed listing 
criteria.

Proposed 4.02--Chronic Heart Failure

    We propose to change the format of current listing 4.02, creating 
two new sections, 4.02A and 4.02B, with subsections. For the listing to 
be met, both the 4.02A and 4.02B requirements must be satisfied. We 
propose to move the required imaging findings that are generally 
associated with the clinical diagnosis of heart failure from current 
subsections 4.02A and 4.02B to new subsections 4.02A1 and 4.02A2 and to 
revise them to reflect the anatomical changes associated with systolic 
and diastolic dysfunction, respectively. The current listing has 
different criteria for heart failure in sections 4.02A and 4.02B and 
does not provide criteria for both systolic and diastolic failure. 
Additionally, because the criteria in current listing 4.02A of 5.5 cm 
is generally considered the high end of normal for heart size, we 
propose to change the left ventricular diastolic diameter to left 
ventricular end diastolic dimensions greater than 6.0 cm. This change 
would more clearly establish an enlarged heart that would result in the 
signs and symptoms associated with listing-level severity.
    We also propose to redesignate current listing 4.02A as 4.02B1 and 
revise the criteria language. The current listing includes a 
description of heart failure and refers to the ``inability to carry on 
any physical activity,'' which implies that the individual must be 
bedridden. Our program experience shows that this listing is set at too 
high a level of severity and is little used. We have removed the 
description of heart failure and rephrased the proposed criteria in 
listing 4.02B1 to describe an extreme limitation in that you have an 
impairment that very seriously limits

[[Page 55878]]

your ability to independently initiate, sustain, or complete activities 
of daily living. This is modeled after the definition of ``inability to 
ambulate effectively'' in the musculoskeletal listings, section 
1.00A2b(1). We believe this reflects the proper listing level of 
severity. This listing may only be used if exercise testing presents a 
significant risk to you.
    We propose to add a new criterion in listing 4.02B2 to include 
individuals who have frequent acute attacks of heart failure, showing 
that the heart failure is not well-controlled by the prescribed 
treatment. This also would provide another avenue that would allow us 
to make favorable determinations or decisions in certain cases without 
exercise tolerance test documentation.
    We propose to redesignate current 4.02B1 as listing 4.02B3. We also 
propose to revise it, by specifying in proposed listing 4.02B3a the 
symptoms of chronic heart failure that might cause termination of an 
ETT. This proposed change makes it clear that the inability to exercise 
at a workload equivalent to 5 METs could be due to symptoms, as well as 
the signs listed in proposed 4.02B3b through 4.02B3d. We propose to 
change the ``three or more multiform beats'' in the current listing 
4.02B1a to ``increasing frequency of ventricular ectopy with at least 6 
premature ventricular contractions per minute'' in proposed listing 
4.02B3b. This provides broader criteria for terminating the test on 
account of exercise-induced (and potentially dangerous) ventricular 
ectopy (an arrhythmia in which the heartbeat is being triggered 
inappropriately by the ventricle, causing premature ventricular 
contraction).
    In proposed listing 4.02B3c, we propose to eliminate the criterion 
for ``[f]ailure to increase systolic blood pressure by 10 mmHg,'' from 
current listing 4.02B1b because your blood pressure might be 
temporarily elevated at ``baseline'' due to anxiety, and the blood 
pressure response could be blunted by medications. Instead, we propose 
to specify only an amount of decrease from the ``baseline'' systolic 
blood pressure due to left ventricular dysfunction or the preceding 
systolic pressure measured during exercise at which the test should be 
terminated. We would redesignate current listing 4.02B1c, for signs 
attributable to inadequate cerebral perfusion, as proposed listing 
4.02B3d, but would make no other changes to it. We would remove current 
listing 4.02B2, the functional criterion that calls for ``marked 
limitation of physical activity,'' because it is unnecessary. If you 
satisfy one of the proposed 4.02A criteria and one of the proposed 
4.02B3 criteria, a very seriously limited level of physical activity is 
implied, so it is not necessary to have a criterion describing this 
limitation.

Proposed 4.04--Ischemic Heart Disease

    In the header text, we propose to change ``chest discomfort'' to 
``symptoms'' because some individuals have discomfort in other parts of 
their body, such as an arm, back, or neck, or have other symptoms, such 
as shortness of breath (dyspnea), associated with ischemia. In proposed 
listing 4.04A1, we would remove the phrase ``and that have a typical 
ischemic time course of development and resolution (progression of 
horizontal or downsloping ST depression with exercise)'' which appears 
in current listing 4.04A1 because we believe it is unnecessary. We also 
propose to eliminate the current listing 4.04A2 criterion. The ACC/AHA 
Guidelines for Exercise Testing indicated that an upsloping ST junction 
depression, as described in the current criterion, has less specificity 
(more false-positive results) and they favored the more commonly used 
horizontal or downsloping ST depression. We would redesignate the 
subsequent criteria.
    In proposed listing 4.04A2 (current listing 4.04A3), we would 
specify that the ST elevation must occur in ``non-infarct'' leads; that 
is, leads that do not reflect previous injury due to an infarction. 
This is because ST elevation during exercise commonly occurs with a 
ventricular aneurysm resulting from an infarction, without ischemia 
being present. We also propose to reduce the requirement for the ST 
elevation during recovery from 3 or more minutes to 1 or more minutes. 
This ST elevation in non-infarct leads is of such significance, we 
believe persistence of the ST elevation for 1 or more minutes of 
recovery to be sufficient for listing-level severity. In proposed 
listing 4.04A3 (current listing 4.04A4), we would eliminate the phrase 
``failure to increase systolic pressure by 10 mmHg'' for the reasons 
previously discussed under the explanation of proposed listing 4.02B3c. 
We also would specify a decrease of 10 mmHg below baseline due to left 
ventricular dysfunction, or the preceding systolic pressure measured 
during exercise, despite an increase in workload, because exercise 
normally raises blood pressure and a decrease during exercise reflects 
the presence of ischemia.
    We propose to revise current listing 4.04A5, but would make no 
substantive changes to it, to make clear that the ``perfusion defect'' 
represents ischemia and to provide for use of imaging techniques other 
than radionuclide perfusion scans. We would also redesignate it as 
listing 4.04A4.
    We propose a new listing 4.04B criterion. The new criterion would 
provide that you would meet the listing if you have three separate 
ischemic episodes, each requiring revascularization (angioplasty or 
bypass surgery) or be not amenable to revascularization, within a 
consecutive 12-month period. This will permit us to decide some cases 
more quickly.
    In the header text for listing 4.04C, we propose to change the 
phrase ``evaluating program physician'' to ``MC'' to be consistent with 
our terminology throughout these proposed rules and in other 
regulations. Because not everyone who has the cited findings has 
ischemia, we propose to add that this criterion can be used only ``in 
the absence of a timely exercise tolerance test or a timely normal 
drug-induced stress test.''
    We also propose to revise the current listing 4.04C1e criterion, 
``[t]otal obstruction of a bypass graft vessel,'' to change it from 
``total obstruction'' to ``70 percent or more narrowing.'' This would 
conform to the criterion in current listing 4.04C1b for a nonbypassed 
coronary artery, which we are not proposing to change. When we 
originally published the current rule, it was not possible to tell how 
obstructed bypass graft vessels were. Imaging techniques have improved, 
making it possible to identify lesser degrees of obstruction of a 
bypass graft vessel. We propose to revise the 4.04C2 criterion, using 
substantively the same language that appears in proposed 4.02B1.

Proposed 4.05--Recurrent Arrhythmias

    We propose to change the requirement for ``uncontrolled repeated 
episodes of cardiac syncope or near syncope'' to ``uncontrolled 
recurrent episodes'' using the same definitions for the terms 
``uncontrolled'' and ``recurrent'' in proposed 4.00A3 that we use 
throughout these proposed rules. We propose to remove the phrase ``and 
arrhythmia'' that follows near syncope in current 4.05, because it is 
redundant. Listing 4.05 is for ``recurrent arrhythmias.'' We also 
propose to add language that allows documentation ``by other 
appropriate medically acceptable testing coincident with the occurrence 
of syncope or near syncope'' to provide for the use of 
electrophysiological studies or any appropriate medical tests developed 
for arrhythmia in the future.

[[Page 55879]]

Proposed 4.06--Symptomatic Congenital Heart Disease

    Because we propose to eliminate current reference listings 4.06C 
and 4.06D, we would redesignate current listing 4.06E as 4.06C. In 
proposed listing 4.06C, we would no longer refer to ``mean'' pulmonary 
artery pressure, as it is the relationship between the pulmonary artery 
pressure and the systemic arterial pressure that is important. We also 
clarify that the systolic pressures are to be used.

Proposed 4.09--Heart Transplant

    We propose to change the name from ``Cardiac transplantation'' to 
``Heart transplant'' consistent with terminology in our other listings. 
We also propose to change the phrase ``reevaluate residual impairment'' 
to ``evaluate residual impairment,'' as more accurate, since we would 
not have evaluated the residual impairment earlier than the end of the 
12-month period following the transplant. In addition, we propose to 
remove the cross-reference to listings 4.02 to 4.08, which we explain 
we may use when we reevaluate an individual a year after the 
transplant, and to substitute the phrase ``the appropriate listing.'' 
This will clarify that other listings besides listings 4.02 through 
4.08 may apply, including listings in other body systems.

Proposed 4.10--Aneurysm of Aorta or Major Branches

    As we have already noted, we propose to remove listings 4.10B 
through 4.10D because they are reference listings. We would incorporate 
the criteria from current listing 4.10A into the header text, because 
it would be the sole remaining criterion. Because dissection of an 
aorta must be either acute or chronic, we propose to remove those 
descriptors as unnecessary in this context. We also propose to change 
the description of treatment to ``prescribed treatment,'' which 
includes both medical and surgical methods, and to include a cross-
reference to proposed section 4.00H7. That paragraph explains what a 
dissecting aneurysm is and when we consider that it is not controlled 
for purposes of this listing.

Proposed 4.11--Chronic Venous Insufficiency

    In listing 4.11A, we propose to add language to clarify what we 
mean by ``extensive'' brawny edema. We provide that, for purposes of 
this proposed listing, the brawny edema is ``extensive'' if it involves 
approximately two-thirds of the leg between the ankle and knee. In 
listing 4.11B, we propose to refer only to ``prescribed treatment,'' 
which includes both medical and surgical methods. This is a non-
substantive change from the current listing, which uses the phrase 
``prescribed medical or surgical therapy.'' We have also clarified that 
the phrase ``that has not healed following at least 3 months of 
prescribed treatment'' applies only to ``persistent'' ulceration.

Proposed 4.12--Peripheral Arterial Disease

    In listing 4.12, we propose to remove current listing 4.12A because 
arteriograms are generally used to determine when and where surgical 
intervention is needed and, if surgery is performed, it is unlikely 
that the duration requirement would be met. Following surgery, if 
intermittent claudication continued, it would be evaluated under the 
remaining criteria. We would redesignate current listings 4.12B1 and 
4.12B2 as 4.12A and 4.12B. (Note: We removed prior 4.12C, amputation, 
when we published the final musculoskeletal rules, which were effective 
February 19, 2002. See 66 FR 58010.)
    We also propose to revise the criteria on the methods for 
establishing peripheral arterial disease by substituting the phrase 
``appropriate medically acceptable imaging'' for the current reference 
to ``Doppler studies.'' In proposed listing 4.12B (current listing 
4.12B2), we propose to eliminate the phrase ``at the ankle'' following 
``pre-exercise level'' because it is redundant.
    We also propose two new listings, 4.12C and 4.12D, for the use of 
resting toe systolic blood pressures and resting toe/brachial systolic 
blood pressure ratios. As we explained under the discussion of proposed 
4.00G8, ankle pressures can be misleadingly high when you have a 
disease that results in abnormal arterial calcification or small vessel 
disease.

How Are We Proposing To Change the Introductory Text to the Listings 
for Evaluating Cardiovascular Impairments in Children?

    We propose to expand and reorganize the introductory material in 
104.00 to provide additional guidance and reflect the new listings. As 
with the adult listings, because of the extensive information and 
guidance included in the introductory text for the listings, we propose 
to group information on various subjects and related issues together in 
separate sections. Except for minor changes to refer to children, we 
have repeated much of the introductory text of proposed 4.00 in the 
introductory text to proposed 104.00. This is because the same basic 
rules for establishing and evaluating the existence and severity of 
cardiovascular impairments in adults also apply to children. Because we 
have already described these provisions under the explanation of 
proposed 4.00, the following discussions describe only those provisions 
that are unique to the childhood rules or that require further 
explanation.

Proposed 104.00A--General

    In proposed section 104.00A3, we explain the same terms and phrases 
as in proposed 4.00A4, but also include an explanation of the phrase 
``currently present,'' which appears only in the childhood listings for 
reasons we explain below.

Proposed 104.00B--Documenting Cardiovascular Impairments

    In proposed 104.00B5, we specify that ``We will make a reasonable 
effort to obtain any additional studies from a qualified medical source 
in an office or center experienced in pediatric cardiac assessment.'' 
In proposed section 104.00B7a and 104.00B7b, we include the discussion, 
with some non-substantive editorial changes, on the use of exercise 
testing in children found in the third and fourth paragraphs of current 
section 104.00B. In proposed section 104.00B7c, we include a cross-
reference to the guidance on ETT requirements and usage found in 
proposed section 4.00C. We did not repeat that section in the childhood 
listing because it addresses cardiovascular tests used mainly for the 
diagnosis and evaluation of ischemia, which is rare in children, but if 
present, the documentation and evaluation are the same as for adults.

Proposed 104.00C--Evaluating Chronic Heart Failure

    In proposed section 104.00C1, we do not differentiate between 
systolic and diastolic dysfunction, as we do with adults in proposed 
section 4.00D1a, because in children, it is unlikely that we will have 
a specific type of dysfunction clearly identified. For children, 
certain laboratory findings of cardiac functional and structural 
abnormality in support of the diagnosis of chronic heart failure are 
sufficient. In proposed section 104.00C2a, we also update the findings 
that represent cardiomegaly or ventricular dysfunction in children. We 
use the phrase ``fractional shortening'' rather than ``shortening 
fraction'' in the discussion of left ventricular dysfunction and 
explain what it is. We retain in proposed 104.00C2a(1)(c) the chest x-
ray findings cited in the second paragraph of current section 104.00E. 
In

[[Page 55880]]

proposed section 104.00C2b, we include the information found in the 
first and third paragraphs of current 104.00E, with some rephrasing for 
clarity, but no substantive changes.

Proposed 104.00D--Evaluating Congenital Heart Disease

    In the proposed congenital heart disease section, we would move the 
list of examples of congenital heart defects from the second paragraph 
of current section 104.00A to proposed section 104.00D1. In proposed 
section 104.00D2, we state that we will accept pulse oximetry 
measurements instead of arterial O2 values when evaluating 
children under proposed listing 104.06A2. However, if the arterial 
O2 values are available, they are preferred because they are 
the most accurate. Proposed section 104.00D3 lists examples of 
congenital heart defects that we would evaluate under proposed listing 
104.06D. This material was taken from the first and second paragraphs 
of current section 104.00D. The discussion of symptomatic congenital 
heart disease found in proposed section 4.00H3 is repeated in proposed 
104.00D4, with minor changes to address children. We propose to delete 
the information contained in the third paragraph of current section 
104.00D, which discusses pulmonary vascular obstructive disease, 
because it is rarely seen due to the improved diagnosis and treatment 
of congenital heart disease.

Proposed 104.00E--Evaluating Arrhythmias

    This section is substantively identical to the corresponding 
section in the adult listing, 4.00F, with minor editorial changes that 
refer specifically to children.

Proposed 104.00F--Evaluating Other Cardiovascular Impairments

    In proposed section 104.00F, we address cardiovascular impairments 
that are most likely to affect children and that are not already 
discussed in previous sections, omitting those that are more often seen 
in adults, such as peripheral vascular disease. If necessary, the 
effects of any such cardiovascular impairment on a child can be 
evaluated using the adult listings. We include discussions of 
cardiovascular impairments that are more likely to be seen in children, 
such as chronic rheumatic fever or rheumatic heart disease. This 
proposed section contains much of the same information found in the 
proposed section 4.00H, with the following differences.
    We address ischemia in proposed section 104.00F1 instead of a 
separate section (like in the adult rules) because it is rare in 
children. Because the documentation and evaluation are the same as for 
adults, we refer to the adult sections 4.00E and listing 4.04 for the 
evaluation of ischemic heart disease in children. Proposed section 
104.00F2, on how we will evaluate hypertension, is similar to proposed 
section 4.00H1, but has been modified to reflect its effects on 
children. In proposed section 104.00F5, we include the information on 
chronic rheumatic fever and rheumatic heart disease found in current 
section 104.00G. We refer to the appropriate cardiovascular listings 
for the evaluation of chronic heart failure and arrhythmias associated 
with rheumatic heart disease. In proposed section 104.00F7, we discuss 
how we will evaluate Kawasaki Disease (formerly called Kawasaki 
syndrome), which usually develops before you are 5 years old.

Proposed 104.00G--Other Evaluation Issues

    This proposed section corresponds to the proposed adult section 
4.00I, with minor editorial changes to refer to children.

How Are We Proposing To Change the Criteria in the Listings for 
Evaluating Cardiovascular Impairments in Children?

Proposed 104.01--Category of Impairments, Cardiovascular System

    We propose to delete the following current listings: 104.02C, 
Chronic heart failure with recurrent arrhythmias; 104.02D3, Chronic 
heart failure with growth disturbance as described under the criteria 
in 100.00; 104.03, Hypertensive cardiovascular disease; 104.06B, 
Congenital heart disease with chronic heart failure with evidence of 
ventricular dysfunction; 104.06C, Congenital heart disease with 
recurrent arrhythmias; 104.06E, Congenital heart disease with 
congenital valvular or other stenotic defects, or valvular 
regurgitation; 104.06G, Congenital heart disease with growth failure; 
104.07, Valvular heart disease or other stenotic defects, or valvular 
regurgitation; 104.08, Cardiomyopathies; 104.13B, Chronic rheumatic 
fever or rheumatic heart disease with evidence of chronic heart 
failure; 104.13C, Chronic rheumatic fever or rheumatic heart disease 
with recurrent arrhythmias; 104.14, Hyperlipidemia; and 104.15, 
Kawasaki syndrome. With the exception of listings 104.07B, 104.14B, 
104.14C, 104.14D and 104.15A, these are reference listings that we 
propose to delete because they are redundant. However, we provide 
guidance in the introductory text of the listing on how we will 
evaluate these impairments using other listings.
    We propose to delete current listing 104.07B, Critical aortic 
stenosis in newborn, because treatment has improved such that this 
condition would not usually be expected to result in limitations of 
listing-level severity for 12 months. When necessary, this impairment 
can be evaluated using proposed listing 104.06D. We also propose to 
delete the current Hyperlipidemia listings that are not reference 
listings, 104.14B, 104.14C, and 104.14D. We propose to delete these 
listings because there is better treatment now available for 
hyperlipidemia, making it less likely to result in limitations of 
listing-level severity. If necessary, hyperlipidemia's effect on a 
child can be evaluated under a listing for the affected body system. We 
propose to delete current listing 104.15A, Kawasaki syndrome with major 
coronary artery aneurysm, because generally such an aneurysm would be 
producing symptoms of heart failure or ischemia, which can be evaluated 
under the appropriate listings.
    The following is a detailed explanation of the proposed listing 
criteria.

Proposed 104.02--Chronic Heart Failure

    We propose to add language to the header text to clarify that the 
heart failure must occur ``while on a regimen of prescribed 
treatment.'' Listings 104.02A and 104.02B and their associated tables 
will remain the same. Because we propose to delete current listing 
104.02C, Recurrent arrhythmias, which refers the adjudicator to listing 
104.05, we would redesignate the current listing 104.02D, Growth 
disturbance, as 104.02C. We also propose to add language to the first 
two growth disturbance criteria to clarify that the weight loss must be 
currently present and have persisted for 2 months or longer. This is to 
clarify that we will not find that a child is disabled simply because 
of a short-term growth disturbance that occurred sometime in the past. 
We also specify that we will use the current growth charts issued by 
the National Center for Health Statistics in the Centers for Disease 
Control and Prevention. This is consistent with the Growth Impairment 
listings at 100.00. The current growth charts are available on-line at: 
www.cdc.gov/growthcharts/.

Proposed 104.05--Recurrent Arrhythmias

    We propose to use the same language as in proposed listing 4.05.

[[Page 55881]]

Proposed 104.06--Congenital Heart Disease

    In the header text of this section, we propose to add language on 
documentation by appropriate medically acceptable imaging or cardiac 
catheterization, to make it parallel with the adult listing. In listing 
104.06A1, we propose to revise the language on the frequency of the 
hematocrit finding to better capture persistence of the finding. 
Because we propose to remove current listings 104.06B and 104.06C, 
which refer the adjudicator to other listings, we would redesignate 
current listing 104.06D as 104.06B. In proposed listing 104.06B, we 
would no longer refer to ``mean'' pulmonary artery pressure, for the 
reason discussed under proposed listing 4.06. We also clarify that we 
will use the systolic pressures for purposes of this listing. We 
propose to remove current listing 104.06E, because it is a reference 
listing, and redesignate current listing 104.06F as 104.06C. We also 
propose to revise the language of proposed listing 104.06C to reflect 
the definition of an ``extreme'' limitation, found in section 
416.926a(e)(3) of our regulations.
    Finally, we propose to remove the current reference listing 
104.06G, redesignate current listing 104.06H as 104.06D and to remove 
the references to specific listings from it. Also in proposed listing 
104.06D, we would change the language that currently directs that a 
child should be considered disabled until the later of 1 year of age or 
12 months after surgery for a life-threatening congenital heart 
impairment. Instead, we would specify that the child should be 
considered disabled until at least 1 year of age. This is because, if 
the condition is truly life threatening, the surgical treatment would 
generally be done within the first few months after birth and, at the 
age of 1 year, an assessment of the child's residual impairment would 
generally be possible. We would further specify that the listing 
applies only when the impairment is expected to be disabling (because 
of residual impairment following surgery, the recovery time required, 
or both) until the attainment of at least 1 year of age. The listing 
would not apply to surgery for congenital heart impairments that 
routinely result in prompt recovery or less severe residual impairment.

Proposed Listing 104.09--Heart Transplant

    We propose to use the same language as in proposed listing 4.09.

Proposed Listing 104.13--Rheumatic Heart Disease

    We propose to change the name by removing ``Chronic rheumatic 
fever'' because the impairment is related to the resulting heart 
disease, rather than the fever activity. We also propose to include 
current listing 104.13A with the current header text, with some 
reorganization of the material. We would remove listings 104.13B and 
104.13C because they are reference listings.

What Other Revision Are We Proposing?

    We propose that Cor pulmonale be evaluated under the respiratory 
listings, as it is a heart condition resulting from a respiratory 
disorder. Thus, we also propose to revise current listing 3.09 by 
removing the reference listing 3.09C, which refers to listing 4.02.

Clarity of These Proposed Rules

    Executive Order 12866 requires each agency to write all rules in 
plain language. In addition to your substantive comments on these 
proposed rules, we invite your comments on how to make these proposed 
rules easier to understand. For example:
     Have we organized the material to suit your needs?
     Are the requirements in the rules clearly stated?
     Do the rules contain technical language or jargon that is 
not clear?
     Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rules easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?

Regulatory Procedures

Executive Order (E.O.) 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these proposed rules meet the requirements for a 
significant regulatory action under E.O. 12866, as amended by E.O. 
13258. Thus, they were subject to OMB review.

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
would affect only individuals. Thus, a regulatory flexibility analysis 
as provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    These proposed rules contain reporting requirements at 4.00B, 
4.00C, 4.00D, 4.00E, 4.00F, 4.00G, 4.02A, 104.00B, 104.00C, 104.00E, 
and 104.06. The public reporting burden is accounted for in the 
Information Collection Requests for the various forms that the public 
uses to submit the information to SSA. Consequently, a 1-hour 
placeholder burden is being assigned to the specific reporting 
requirement(s) contained in these rules. We are seeking clearance of 
the burden referenced in these rules because the rules were not 
considered during the clearance of the forms. An Information Collection 
Request has been submitted to OMB. We are soliciting comments on the 
burden estimate; the need for the information; its practical utility; 
ways to enhance its quality, utility and clarity; and on ways to 
minimize the burden on respondents, including the use of automated 
collection techniques or other forms of information technology. 
Comments should be submitted and/or faxed to the Office of Management 
and Budget and to the Social Security Administration at the following 
addresses/numbers:
    Office of Management and Budget, Attn: Desk Officer for SSA, Fax 
Number: (202) 395-6974.
    Social Security Administration, Attn: SSA Reports Clearance 
Officer, Rm: 1338 Annex Building, 6401 Security Boulevard, Baltimore, 
MD 21235-6401, (410) 965-6400.
    Comments can be received for up to 60 days after publication of 
this notice and will be most useful if received within 30 days of 
publication. To receive a copy of the OMB clearance package, you may 
call the SSA Reports Clearance Officer on (410) 965-0454.

References

    A list of the sources we consulted when developing these proposed 
rules include the following:

    1. Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WFC, 
Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD, 
Winters WL Jr, Yanowitz FG. ACC/AHA guidelines for exercise testing: 
a report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines (Committee on Exercise 
Testing). J Am Coll Cardiol. 1997; 30:260-315.
    2. Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, 
Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, 
Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a 
report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines (Committee on Exercise 
Testing). 2002. American College of

[[Page 55882]]

Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex.htm.
    3. Braddom, RL, ed., Physical Medicine and Rehabilitation, 2nd 
ed., Philadelphia: W.B. Saunders Co., 2000, pp. 665-686.
    4. Canto, JG, et al., ``Prevalence, Clinical Characteristics, 
and Mortality Among Patients With Myocardial Infarction Presenting 
Without Chest Pain.'' Journal of the American Medical Association, 
June 28, 2000, Vol. 283, No. 24, pp. 3223-3229.
    5. ``Diastolic Heart Failure--No Time to Relax.'' The New 
England Journal of Medicine, January 4, 2001, Vol. 344, No. 1, pp. 
56-58.
    6. National Heart, Lung, and Blood Institute, National 
Institutes of Health. ``Facts About Heart Failure.'' NIH Publication 
No. 97-923, Reprinted May 1997. Available on-line at: 
www.nhlbi.nih.gov/health/public/heart/other/hrtfail.htm.
    7. Pinkowish, MD, ``Revascularization in the 21st century.'' 
Patient Care, January 15, 2001, pp. 82-98.
    8. ``Syncope.'' The New England Journal of Medicine, December 
21, 2000, Vol. 343, No. 25, pp. 1856-1862.
    9. ``Guidelines for the Diagnosis of Rheumatic Fever, Jones 
Criteria, 1992 Update.'' The Journal of the American Medical 
Association, October 21, 1992, Vol. 268, No. 15, pp. 2069-2073.
    10. National Heart, Lung, and Blood Institute, National 
Institutes of Health. ``Facts About Arrhythmias/Rhythm Disorders.'' 
NIH Publication No. 95-2264, Reprinted September 1995. Available on-
line at: www.nhlbi.nih.gov/health/public/heart/other/arrhyth.htm.
    11. Anthony S. Fauci, et al., eds., Harrison's Principles of 
Internal Medicine, 14th ed., New York: McGraw-Hill, 1998, pp.1405-
1406.
    12. P. J. Palumbo, MD, and L. Joseph Melton III, MD, 
``Peripheral Vascular Disease and Diabetes,'' Diabetes in America, 
2nd ed., National Diabetes Data Group, National Institute of 
Diabetes and Digestive and Kidney Diseases, National Institutes of 
Health, NIH Publication No. 95-1468, 1995, chapter 17, pp. 401-408. 
Available on-line at: www.niddk.nih.gov/health/diabetes/dia/chpt17.pdf.
    13. Jamie D. Santilli, MD, and Steven M. Santilli, MD, PhD, 
``Chronic Critical Limb Ischemia: Diagnosis, Treatment and 
Prognosis,'' American Family Physician, April 1, 1999, pp. 1899-
1910. Available on-line at: www.aafp.org/afp/990401ap/1899.html.
    14. Jeffrey W. Olin, DO, ``Clinical Evaluation and Office-Based 
Detection of Peripheral Arterial Disease,'' Monograph from 
Continuing Medical Education, Part I: The Epidemiology and Practical 
Detection of PAD, Society of Vascular Medicine and Biology.
    15. Michael R. Jaff, DO, FACP, FACC, ``Severe Peripheral 
Arterial Disease and Critical Limb Ischemia: Incidence, 
Pathophysiology, Presentation, Methods of Diagnosis,'' Monograph 
from Continuing Medical Education, Part III: Severe PAD: Limb 
Salvage and Revascularization Failure, Society of Vascular Medicine 
and Biology.
    16. National Heart, Lung, and Blood Institute, National 
Institutes of Health. ``Facts About Cardiomyopathy.'' NIH 
Publication No. 97-3082, Revised July 1997. Available on-line at: 
www.nhlbi.nih.gov/health/public/heart/other/cardiomy.htm.

    These references are included in the rulemaking record for these 
proposed rules and are available for inspection by interested 
individuals by making arrangements with the contact person shown in 
this preamble.

(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.

    Dated: June 10, 2004.
Jo Anne B. Barnhart,
Commissioner of Social Security.
    For the reasons set out in the preamble, we propose to amend 
subpart P of part 404 of chapter III of title 20 of the Code of Federal 
Regulations as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

Subpart P--[Amended]

    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 (i), 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 (i), 
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 
Stat. 2105, 2189.

Appendix 1 to Subpart P of Part 404--[Amended]

    2. Appendix 1 to subpart P of part 404 is amended as follows:
    a. Item 5 of the introductory text before part A of appendix 1 is 
revised as set forth below.
    b. Listing 3.09 of part A of appendix 1 is amended by removing ``; 
Or'' at the end of paragraph B, replacing it with a period, and 
removing paragraph C.
    c. Sections 4.00 and 104.00 of appendix 1 to subpart P of part 404 
are revised to read as follows:

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

* * * * *
    5. Cardiovascular System (4.00 and 104.00): (Insert date 5 years 
from the date of publication of the final rules in the Federal 
Register.)
* * * * *
Part A
* * * * *

Sec.  4.00 Cardiovascular System

A. General

    1. What do we mean by a cardiovascular impairment?
    a. We mean any disorder that affects the proper functioning of 
either the heart or the circulatory system (arteries, veins, 
capillaries, and the lymphatic drainage). The disorder can be 
congenital or acquired.
    b. Cardiovascular impairment results from one or more of four 
consequences of heart disease:
    (1) Chronic heart failure or ventricular dysfunction.
    (2) Discomfort or pain due to myocardial ischemia, with or 
without necrosis of heart muscle.
    (3) Syncope, or near syncope, due to inadequate cerebral 
perfusion from any cardiac cause, such as obstruction of flow or 
disturbance in rhythm or conduction resulting in inadequate cardiac 
output.
    (4) Central cyanosis due to right-to-left shunt, reduced oxygen 
concentration in the arterial blood, or pulmonary vascular disease.
    c. Disorders of the veins or arteries (for example, obstruction, 
rupture, or aneurysm) may cause impairments of the lower extremities 
(peripheral vascular disease), the central nervous system, eyes, 
kidneys, and other organs. We will evaluate peripheral vascular 
disease under this body system and impairments of another body 
system(s) under the listings for that body system(s).
    2. What do we consider in evaluating cardiovascular impairments? 
The listings in this section describe impairments of the 
cardiovascular system based on symptoms, signs, laboratory findings, 
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 an individual defined in Sec. Sec.  
404.1616(a) and 416.1016(a). This term does not include medical 
sources who provide consultative examinations for us. We use the 
abbreviation ``MC'' throughout this section to designate a medical 
consultant.
    b. Persistent means that the longitudinal clinical record shows 
that, with few exceptions, the required finding(s) has been present, 
or is expected to be present, for a continuous period of at least 12 
months, such that a pattern of continuing severity is established.
    c. Recurrent means that the longitudinal clinical record shows 
that, within a consecutive 12-month period, the finding(s) occurs at 
least three times, with intervening periods of improvement of 
sufficient duration that it is clear that separate events are 
involved.
    d. Appropriate medically acceptable imaging means that the 
technique used is the proper one to evaluate and diagnose the 
impairment and is commonly recognized as accurate for assessing the 
cited finding.

[[Page 55883]]

    e. A consecutive 12-month period must occur within the period we 
are considering in connection with an application or continuing 
disability review.
    f. Uncontrolled means the condition does not adequately respond 
to standard prescribed medical treatment.

B. Documenting Cardiovascular Impairment

    1. What basic documentation do we need? We need sufficiently 
detailed reports on history, physical examinations, laboratory 
studies, and any prescribed treatment and response to allow us to 
assess the severity and duration of your cardiovascular impairment. 
A longitudinal clinical record covering a period of not less than 3 
months of observations and treatment is usually necessary, unless we 
can make a determination or decision based on the current evidence.
    2. Why is a longitudinal clinical record important? We will 
usually need a longitudinal clinical record to assess the severity 
and expected duration of your impairment(s). If you have a listing-
level impairment, you probably will have received medically 
prescribed treatment. Whenever there is evidence of such treatment, 
your longitudinal clinical record should include a description of 
the ongoing management and evaluation provided by your treating or 
other medical source. It should also include your response to this 
medical management, as well as information about the nature and 
severity of your impairment. The record will provide us with 
information on your functional status over an extended period of 
time and show whether your ability to function is improving, 
worsening, or unchanging.
    3. What if there is no longitudinal record because you have not 
received ongoing medical treatment?
    a. You may not have received ongoing treatment or have an 
ongoing relationship with the medical community, despite the 
existence of a severe impairment(s). In such cases, we will base our 
evaluation on the current objective medical evidence and the other 
evidence we have. If you do not receive treatment, you cannot show 
an impairment that meets the criteria of most of these listings. 
However, you may have another impairment(s) that, in combination 
with your cardiovascular impairment, medically equals a listed 
impairment, or you may be found disabled based on consideration of 
your residual functional capacity and age, education, and work 
experience.
    b. Unless your claim can be decided favorably on the basis of 
the current evidence, a longitudinal record is still important. In 
rare instances where there is no or insufficient longitudinal 
evidence, we may purchase any necessary examination(s) to establish 
the severity of your impairment.
    4. When will we wait before we ask for more evidence?
    a. We will wait when we have information showing that your 
impairment is not yet stable and the expected change in your 
condition might affect our determination or decision. In these 
cases, we need to wait to properly evaluate the severity and 
duration of your impairment during a stable period. Examples of when 
we might wait are:
    (1) If you have had a recent acute event; for example, a 
myocardial infarction (heart attack).
    (2) If you have recently had a corrective cardiac procedure; for 
example, coronary artery bypass grafting.
    (3) If you have started new drug therapy and your response to 
this treatment has not yet been established; for example, beta-
blocker therapy for dilated congestive cardiomyopathy.
    b. In these situations, we will obtain more evidence 3 months 
following the event before we evaluate your impairment. However, we 
will not wait if we have enough information to make a determination 
or decision based on all of the relevant evidence in your case.
    5. Will we order any studies? In appropriate cases, we will 
order additional studies necessary to substantiate the diagnosis or 
to document the severity of your impairment after we have evaluated 
the medical and other evidence we already have. We will order 
studies involving exercise testing only if there is no significant 
risk involved or if there is no other medical reason not to perform 
the test. We will follow sections 4.00C7 and 4.00C8 when we decide 
whether to order these studies.
    6. What studies will we not order? We will not order any studies 
involving cardiac catheterization, such as coronary angiography, 
arteriograms, or electrophysiological studies. However, if the 
results of catheterization are part of the existing evidence we 
have, we will consider them together with the other relevant 
evidence.

C. Using Cardiovascular Test Results

    1. What is an ECG?
    a. ECG stands for electrocardiograph or electrocardiogram. An 
electrocardiograph is a machine that records electrical impulses of 
your heart on a strip of paper called an electrocardiogram or a 
tracing. To record the ECG, a technician positions a number of small 
contacts (or ``leads'') on your arms, legs, and across your chest to 
connect them to the ECG machine. An ECG may be done while you are 
resting or exercising.
    b. The ECG tracing may indicate that you have a heart 
abnormality. It may indicate that your heart muscle is not getting 
as much oxygen as it needs (ischemia), that your heart rhythm is 
abnormal (arrhythmia), or that there are other abnormalities of your 
heart, such as left ventricular enlargement.
    2. How do we evaluate ECG evidence? We consider a number of 
factors when we evaluate ECG evidence:
    a. An original or legible copy of the 12-lead ECG obtained at 
rest must be appropriately dated and labeled, with the 
standardization inscribed on the tracing. Alteration in 
standardization of specific leads (such as to accommodate large QRS 
amplitudes) must be identified on those leads.
    (1) Detailed descriptions or computer-averaged signals without 
original or legible copies of the ECG as described in subsection 
4.00C2a are not acceptable.
    (2) The effects of drugs or electrolyte abnormalities must be 
considered as possible noncardiac causes of ECG abnormalities of 
ventricular repolarization; that is, those involving the ST segment 
and T wave. If available, the predrug (especially digitalis 
glycosides) ECG should be submitted.
    b. ECGs obtained in conjunction with treadmill, bicycle, or arm 
exercise tests (see 4.00C4-4.00C14) should meet the following 
specifications:
    (1) ECG reports must include the original calibrated ECG 
tracings or a legible copy.
    (2) A 12-lead baseline ECG must be recorded in the upright 
position before exercise.
    (3) A 12-lead ECG should be recorded at the end of each minute 
of exercise.
    (4) If ECG documentation of the effects of hyperventilation is 
obtained, the exercise test should be deferred for at least 10 
minutes because metabolic changes of hyperventilation may alter the 
physiologic and ECG-recorded response to exercise.
    (5) Post-exercise ECGs should be recorded using a generally 
accepted protocol consistent with the prevailing state of medical 
knowledge and clinical practice.
    (6) All resting, exercise, and recovery ECG strips must have the 
standardization inscribed on the tracing. The ECG strips should be 
labeled to indicate the date, the times recorded and the 
relationship to the stage of the exercise protocol. The speed and 
grade (treadmill test) or work rate (bicycle or arm ergometric test) 
should be recorded. The highest level of exercise achieved, heart 
rate and blood pressure levels during testing, and the reason(s) for 
terminating the test (including limiting signs or symptoms) must be 
recorded.
    3. What are exercise tests and what are they used for?
    a. Exercise tests have you perform physical activity and record 
how your cardiovascular system responds. Exercise tests usually 
involve walking on a treadmill, but other forms of exercise, such as 
an exercise bicycle or an arm exercise machine, may be used. 
Exercise testing may be done for various reasons; such as, to 
evaluate the severity of your coronary artery disease or peripheral 
vascular disease or to evaluate your progress after a cardiac 
procedure or an acute event, like a myocardial infarction (heart 
attack). Exercise testing is the most widely used testing for 
identifying the presence of myocardial ischemia and for estimating 
maximal aerobic capacity if you have heart disease.
    b. We include exercise tolerance test (ETT) criteria in 4.02B3 
(chronic heart failure) and 4.04A (ischemic heart disease). To meet 
the ETT criteria in these listings, the ETT must be a sign-or 
symptom-limited test in which you exercise while connected to an ECG 
until you develop a sign or symptom that indicates you have 
exercised as much as is considered safe for you.
    c. In 4.12B, we also refer to exercise testing for peripheral 
vascular disease. In this test, you walk on a treadmill, usually for 
a specified period of time, and the individual who administers the 
test measures the effect of exercise on the flow of blood in your 
legs, usually by using ultrasound. The test is also called exercise 
Doppler testing. Even though this test is intended to evaluate 
peripheral vascular disease, if you develop abnormal signs or 
symptoms because of heart disease, it will be stopped for your 
safety.

[[Page 55884]]

    d. Each type of test is done in a certain way following specific 
criteria, called a protocol. For our program, we also specify 
certain aspects of how any exercise test we purchase is to be done. 
See 4.00C10 and 4.00C17.
    4. Do ETTs have limitations? An ETT provides an estimate of 
aerobic capacity for walking on a grade, bicycling, or moving one's 
arms in an environmentally controlled setting. Therefore, ETT 
results do not correlate with the ability to perform other types of 
exertional activities, such as lifting and carrying heavy loads, and 
do not provide an estimate of the ability to perform, throughout a 
workday, activities required for work in all possible work 
environments. Also, certain medications (such as beta blockers) and 
conduction disorders (such as left or right bundle branch blocks) 
can result in false negatives or false positives. Therefore, we must 
consider the results of an ETT together with all the other relevant 
evidence.
    5. How does an ETT with measurement of maximal or peak oxygen 
uptake (VO2) differ from other ETTs? Occasionally, 
medical evidence will include the results of an ETT with 
VO2. While ETTs without measurement of VO2 
provide only an estimate of aerobic capacity, measured maximal or 
peak oxygen uptake provides an accurate measurement of aerobic 
capacity, which is often expressed in METs (metabolic equivalents). 
The MET level may not be indicated in the report of attained maximal 
or peak VO2 testing, but can be calculated as follows: 1 
MET = 3.5 milliliter (ml) of oxygen uptake per kilogram (kg) of body 
weight per minute. For example, a 70 kg (154 lb.) individual who 
achieves a maximal or peak VO2 of 1225 ml in 1 minute has 
attained 5 METs (1225 ml/70 kg/1 min = 17.5 ml/kg/min. 17.5/3.5 = 5 
METs.)
    6. When will we consider ordering an exercise test for case 
evaluation? We will consider ordering an exercise test when:
    a. We cannot find you disabled on some other basis; and
    b. There is no timely test in the evidence we have (see 4.00C9); 
and
    c. There is a question whether a cardiovascular impairment meets 
or medically equals the severity of one of the listings; or
    d. We need to assess your residual functional capacity and there 
is insufficient evidence in the record to evaluate your aerobic 
capacity or the effect of exercise on blood flow in your legs.
    7. What must we do before ordering an exercise test?
    a. Before we order an exercise test, an MC, preferably one with 
experience in the care of patients with cardiovascular disease, must 
review the pertinent history, physical examinations, and laboratory 
tests that we have to determine whether the test would present a 
significant risk to you or if there is some other medical reason not 
to order the test (see 4.00C8).
    b. If you are under the care of a treating source (see Sec.  
404.1502) for a cardiac impairment, 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 order the test.
    c. In defining risk, the MC, in accordance with the regulations 
and other instructions on consultative examinations, will generally 
give great weight to the treating source's opinions and will 
generally not override them. In the rare situation in which the MC 
does override the treating source's opinion, the MC must prepare a 
written rationale documenting the reasons for overriding the 
opinion.
    d. If you do not have a treating source or we cannot obtain a 
statement from your treating source, the MC is responsible for 
assessing the risk to exercise testing based on a review of the 
records we have before ordering an exercise test for you.
    e. We must also provide your records to the medical source who 
performs the exercise test for review prior to conducting the test 
if the source does not already have them. The medical source who 
performs the exercise test has the ultimate responsibility for 
deciding whether you would be at risk.
    8. When will we not order or wait before we order an exercise 
test?
    a. We will not order an exercise test when an MC finds that you 
have one of the following significant risk factors:
    (1) Unstable angina not previously stabilized by medical 
treatment.
    (2) Uncontrolled cardiac arrhythmias causing symptoms or 
hemodynamic compromise.
    (3) An implantable cardiac defibrillator.
    (4) Symptomatic severe aortic stenosis.
    (5) Uncontrolled symptomatic heart failure.
    (6) Aortic dissection.
    (7) Severe pulmonary hypertension (pulmonary artery systolic 
pressure greater than 60 mm Hg).
    (8) Left main coronary stenosis of 50 percent or greater that 
has not been bypassed.
    (9) Moderate stenotic valvular disease with a systolic gradient 
across the aortic valve of 50 mm Hg or greater.
    (10) Severe arterial hypertension (systolic greater than 200 mm 
Hg or diastolic greater than 110 mm Hg).
    (11) Hypertrophic cardiomyopathy with a systolic gradient of 50 
mm Hg or greater; or
    b. We will also not order an exercise test when you are 
prevented from performing exercise testing due to another impairment 
affecting your ability to use your arms and legs; or
    c. We will wait to order an exercise test when you have had one 
of the following within the last 3 months. In these situations, we 
will defer ordering the ETT until 3 months after the event to allow 
for maximal, attainable restoration of functional capacity:
    (1) Acute myocardial infarction.
    (2) Surgical myocardial revascularization (bypass surgery).
    (3) Other open-heart surgical procedures.
    (4) Percutaneous transluminal coronary angioplasty with or 
without stenting; or
    d. 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 for you to recuperate before we 
order an exercise test.
    9. What do we mean by a ``timely'' test?
    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 impairment.
    b. However, an exercise test that is older than 12 months, 
especially an abnormal one, can still provide information important 
to our adjudication. For example, a test that is more than 12 months 
old can provide evidence of ischemic heart disease or peripheral 
vascular disease, information on decreased aerobic capacity, or 
information about the duration or onset of your impairment. Such 
tests can be an important component of the longitudinal record.
    c. When we evaluate a test that is more than 12 months old, we 
must consider the results in the context of all the relevant 
evidence, whether there has been an intervening event or improvement 
or worsening of your condition. We will also consider the purpose of 
the test.
    d. We will order a new exercise test only if we cannot make a 
determination or decision based on the evidence we have.
    10. How should ETTs we order be performed?
    a. The ETT should be a ``sign- or symptom-limited'' test 
characterized by a progressive multistage regimen. It must be 
performed using a generally accepted protocol consistent with the 
prevailing state of medical knowledge and clinical practice. A 
description of the protocol that was followed must be provided, and 
the test must meet the requirements of 4.00C2b and this section. A 
radionuclide perfusion scan may be useful for detecting or 
confirming ischemia when resting ECG abnormalities, medications, or 
other factors may decrease the accuracy of ECG interpretation of 
ischemia. (The perfusion imaging is done at the termination of 
exercise, which may be at a higher MET level than that at which 
ischemia first occurs. If the imaging confirms the presence of 
reversible ischemia, the exercise ECG may be useful for detecting 
the MET level at which ischemia initially appeared.)
    b. The exercise test should be paced to your capabilities and be 
performed following the generally accepted standards for adult 
exercise test laboratories. With a treadmill test, the speed, grade 
(incline), and duration of exercise must be recorded for each 
exercise test stage performed. Other exercise test protocols or 
techniques should use similar workloads. The exercise protocol may 
need to be modified in individual cases to allow for a lower initial 
workload with more slowly graded increments than the standard Bruce 
protocol.
    c. Levels of exercise should be described in terms of workload 
and duration of each stage; for example, treadmill speed and grade, 
or bicycle ergometer work rate in kpm/min or watts.
    d. The exercise laboratory's physical environment, staffing, and 
equipment should meet the generally accepted standards for adult 
exercise test laboratories.
    11. How do we evaluate ETT results? We evaluate ETT results on 
the basis of the work level at which the test becomes abnormal, as 
documented by onset of signs or symptoms and any ECG or imaging 
abnormalities. The absence of an ischemic response on an ETT

[[Page 55885]]

alone does not exclude the diagnosis of ischemic heart disease. We 
must consider the results of an ETT in the context of all of the 
other evidence in your case record.
    12. When are ETTs done with imaging? When resting ECG 
abnormalities preclude interpretation of ETT tracings relative to 
ischemia, a radionuclide (for example, thallium-201 or technetium-
99m) perfusion scan or echocardiography in conjunction with an ETT 
provides better results. Examples of such resting ECG abnormalities 
include conduction defects--Wolff-Parkinson-White syndrome, left 
bundle branch block, left ventricular hypertrophy--or you are taking 
digitalis or other antiarrhythmic drugs or resting ST changes are 
present. Also, these techniques can provide a reliable estimate of 
ejection fraction.
    13. Will we order ETTs with imaging? We may order an ETT with 
imaging in your case after an MC, preferably one with experience in 
the care of patients with cardiovascular disease, has reviewed your 
medical history and physical examination, any report(s) of 
appropriate medically acceptable imaging, ECGs, and other 
appropriate tests. We will consider ordering an ETT with imaging 
when other information we have is not adequate for us to assess 
whether you have severe ventricular dysfunction or myocardial 
ischemia, there is no significant risk involved (see 4.00C8a), and 
we cannot decide your claim in your favor on another basis.
    14. What are drug-induced stress tests? These are tests designed 
primarily to provide evidence about myocardial ischemia or prior 
myocardial infarction, but do not require you to exercise. These 
tests are used when you cannot exercise or cannot exercise enough to 
achieve the desired cardiac stress. Drug-induced stress tests can 
also provide evidence about heart chamber dimensions and function; 
however, these tests do not provide information about your aerobic 
capacity and cannot be used to help us assess your ability to 
function. Some of these tests use agents, such as Persantine or 
adenosine, that dilate the coronary arteries and are used in 
combination with nuclear agents, such as thallium or technetium (for 
example, Cardiolyte or Myoview), and a myocardial scan. Other tests 
use agents, such as dobutamine, that stimulate the heart to contract 
more forcefully and faster (simulating exercise) and are used in 
combination with a 2-dimensional echocardiogram. We may, when 
necessary, order a drug-induced stress test to confirm the presence 
of myocardial ischemia after a review of the evidence in your file 
by an MC, preferably one with experience in the care of patients 
with cardiovascular disease.
    15. How do we evaluate cardiac catheterization evidence?
    a. Although we will not purchase cardiac catheterization, if you 
have had catheterization, we will make a reasonable effort to obtain 
the report and any ancillary studies. We will consider the quality 
and type of data provided and its relevance to the evaluation of 
your impairment. For adults, we generally see two types of 
catheterization reports, coronary arteriography and left 
ventriculography.
    b. For coronary arteriography, the report should provide 
information citing the method of assessing coronary arterial lumen 
diameter and the nature and location of obstructive lesions. Drug 
treatment at baseline and during the procedure should be reported. 
Some individuals with significant coronary atherosclerotic 
obstruction have collateral vessels that supply the myocardium 
distal to the arterial obstruction so that there is no evidence of 
myocardial damage or ischemia, even with exercise. When available, 
we will consider quantitative computer measurements and analyses in 
interpreting the severity of stenotic lesions.
    c. For left ventriculography, the report should describe the 
wall motion of the myocardium with regard to any areas of 
hypokinesis (abnormally decreased motion), akinesis (lack of 
motion), or dyskinesis (distortion of motion), and the overall 
contraction of the ventricle as measured by the ejection fraction. 
Measurement of chamber volumes and pressures may be useful. When 
available, quantitative computer analysis provides precise 
measurement of segmental left ventricular wall thickness and motion. 
There is often a poor correlation between left ventricular function 
at rest and functional capacity for physical activity.
    16. What details should exercise Doppler test reports contain? 
The reports of exercise Doppler tests should describe the level of 
exercise; for example, the speed and grade of the treadmill 
settings, the duration of exercise, symptoms during exercise, and 
the reasons for stopping exercise if the expected level of exercise 
was not attained. They should also include the blood pressures at 
the ankle and other pertinent sites measured after exercise and the 
time required for the systolic blood pressure to return toward or to 
the pre-exercise level. The graphic tracings should also be included 
with the report. All tracings should be annotated with the 
standardization used by the testing facility.
    17. How should exercise Doppler tests we order be performed? 
When we order an exercise Doppler test, you must exercise on a 
treadmill at 2 mph on a 12 percent grade for 5 minutes. The reports 
must include the information specified in 4.00C16. Because this is 
an exercise test, we must evaluate whether such testing would put 
you at significant risk, in accordance with the guidance found in 
4.00C7 and 4.00C8.

D. Evaluating Chronic Heart Failure

    1. What is chronic heart failure (CHF)?
    a. CHF is the inability of the heart to pump enough oxygenated 
blood to body tissues. This syndrome is characterized by symptoms 
and signs of pulmonary or systemic congestion (fluid retention) or 
limited cardiac output. Certain laboratory findings of cardiac 
functional and structural abnormality support the diagnosis of CHF. 
There are two main types of CHF:
    (1) Predominant systolic dysfunction (the inability of the heart 
to contract normally and expel sufficient blood), which is 
characterized by a dilated, poorly contracting left ventricle and 
reduced ejection fraction (abbreviated EF, it represents the 
percentage of the blood in the ventricle actually pumped out with 
each contraction), and
    (2) Predominant diastolic dysfunction (the inability to relax 
and fill normally), which is characterized by a thickened 
ventricular muscle, poor ability of the left ventricle to distend, 
increased ventricular filling pressure, and a normal or increased 
EF.
    b. CHF is considered in these listings as a single category 
whether due to atherosclerosis (narrowing of the arteries), 
cardiomyopathy, hypertension, or rheumatic, congenital, or other 
heart disease. However, if the CHF is the result of primary 
pulmonary hypertension secondary to disease of the lung (cor 
pulmonale), we will use 3.09 under the respiratory system listings.
    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 (M-Mode, 2-dimensional, and Doppler), 
radionuclide studies, or cardiac catheterization.
    (1) Abnormal cardiac imaging showing increased left ventricular 
end diastolic diameter (LVEDD), decreased EF, increased left atrial 
chamber size, increased ventricular filling pressures measured at 
cardiac catheterization, or increased left ventricular wall or 
septum thickness, provides objective measures of both left 
ventricular function and structural abnormality in heart failure.
    (2) An LVEDD greater than 6.0 cm or an EF of 30 percent or less 
measured during a period of stability (that is, not during an 
episode of acute heart failure) may be associated clinically with 
systolic failure.
    (3) Left ventricular posterior wall thickness added to septal 
thickness totaling 2.5 cm or greater with left atrium enlarged to 
4.5 cm or greater may be associated clinically with diastolic 
failure.
    (4) However, these measurements do not in themselves reflect 
your functional capacity, which we evaluate by considering all of 
the relevant evidence. In some situations, we may need to order an 
ETT to help us assess your functional capacity.
    (5) Other findings on appropriate medically acceptable imaging 
may include increased pulmonary vascular markings, pleural effusion, 
and pulmonary edema. These findings need not be present on each 
report, since CHF may be controlled by prescribed treatment.
    b. To establish that you have chronic heart failure, there 
should also be characteristic symptoms and signs of pulmonary or 
systemic congestion, or limited cardiac output described in the 
medical history and on physical examinations, 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.
    (1) Symptoms of congestion or of limited cardiac output include 
easy fatigue, weakness, shortness of breath (dyspnea), cough, or 
chest discomfort at rest or with activity. Individuals with CHF may 
also experience shortness of breath on lying flat

[[Page 55886]]

(orthopnea) or episodes of shortness of breath waking them from 
sleep (paroxysmal nocturnal dyspnea). They may also experience 
cardiac arrhythmias resulting in palpitations, lightheadedness, or 
fainting.
    (2) Signs of congestion may include hepatomegaly, ascites, 
increased jugular venous distention or pressure, rales, peripheral 
edema, or rapid weight gain. However, these signs need not be found 
on all examinations, because fluid retention may be controlled by 
prescribed treatment.
    3. Is it safe for you to perform an ETT, if you have CHF? The 
presence of CHF is not necessarily a contraindication to an ETT, 
unless you are having an acute episode of heart failure. Measures of 
cardiac performance are valuable in helping us to evaluate your 
ability to do work-related activities. Exercise testing has been 
safely used in individuals with CHF, and we may order an ETT for 
evaluation under 4.02B3 if an MC, preferably one experienced in the 
care of patients with cardiovascular disease, determines that there 
is no significant risk to you. (See 4.00C7-4.00C8 for what we must 
do before we order an ETT and when we will not order one.) Since the 
presence of possible ischemic ST segment abnormality on exercise is 
not critical for application of 4.02B3, digitalis use is not a 
factor when considering ETT purchase in cases involving CHF.
    4. What do we mean by ``periods of stabilization'' in 4.02B2? We 
mean that, for at least 5 days between episodes of acute heart 
failure, there must be some objective evidence of clearing of the 
pulmonary edema or pleural effusions and that you returned to or you 
were medically considered able to return to your prior level of 
activity.

E. Evaluating Ischemic Heart Disease

    1. What is ischemic heart disease (IHD)? IHD results when one or 
more of the coronary arteries is narrowed or obstructed or, in rare 
cases, constricted due to vasospasm, interfering with the normal 
flow of blood to the heart muscle (ischemia). The obstruction may be 
the result of an embolus, a thrombus, or plaque. When heart muscle 
tissue dies as a result of the reduced blood supply, it is called a 
myocardial infarction (heart attack).
    2. What causes chest discomfort of myocardial origin?
    a. Chest discomfort of myocardial ischemic origin, commonly 
known as angina pectoris, is usually caused by coronary artery 
disease (often abbreviated CAD). However, ischemic discomfort may be 
caused by a noncoronary artery condition, such as critical aortic 
stenosis, hypertrophic cardiomyopathy, pulmonary hypertension, or 
anemia.
    b. Instead of typical angina pectoris, some individuals with IHD 
may experience atypical angina, anginal equivalent, variant angina, 
or even silent ischemia, all of which we may evaluate using 4.04. We 
discuss the various manifestations of ischemia in 4.00E3-4.00E7.
    3. What are the characteristics of typical angina pectoris? 
Discomfort of myocardial ischemic origin (angina pectoris) is 
discomfort that is precipitated by effort or emotion and promptly 
relieved by rest, sublingual nitroglycerin (that is, nitroglycerin 
tablets that are placed under the tongue), or other rapidly acting 
nitrates. Typically, the discomfort is located in the chest (usually 
substernal) and described as pressing, crushing, squeezing, burning, 
aching, or oppressive. Sharp, sticking, or cramping discomfort is 
less common. Discomfort occurring with activity or emotion should be 
described specifically as to timing and usual inciting factors (type 
and intensity), character, location, radiation, duration, and 
response to nitrate treatment or rest.
    4. What is atypical angina? Atypical angina describes discomfort 
or pain from myocardial ischemia that is felt in places other than 
the chest. The common sites of cardiac pain are the inner aspect of 
the left arm, neck, jaw(s), upper abdomen, and back, but the 
discomfort or pain can be elsewhere. When pain of cardiac ischemic 
origin presents in an atypical site in the absence of chest 
discomfort, the source of the pain may be difficult to diagnose. To 
establish that this symptom represents atypical angina, the 
discomfort or pain should have similar precipitating and relieving 
factors as with typical chest discomfort and we must have objective 
medical evidence of myocardial ischemia; for example, ECG or ETT 
evidence or appropriate medically acceptable imaging.
    5. What is anginal equivalent? Often, individuals with cardiac 
disease will complain of shortness of breath (dyspnea) on exertion 
without chest pain or discomfort. In a minority of such cases, the 
shortness of breath is due to myocardial ischemia and this is called 
anginal equivalent. To establish that this symptom represents 
anginal equivalent, the shortness of breath should have similar 
precipitating and relieving factors as with typical chest discomfort 
and we must have objective medical evidence of myocardial ischemia; 
such as, ECG or ETT evidence or appropriate medically acceptable 
imaging. It is essential to establish objective evidence of 
myocardial ischemia in order to differentiate these cases from those 
presenting with effort dyspnea due to non-ischemic or non-cardiac 
causes.
    6. What is variant angina?
    a. Variant angina (Prinzmetal's, vasospastic angina) refers to 
the occurrence of anginal episodes at rest, accompanied by 
transitory ST segment elevation (or, at times, ST depression) on 
ECG. It is due to severe spasm of a coronary artery, causing 
ischemia of the heart wall, and is often accompanied by major 
ventricular arrhythmias, such as ventricular tachycardia, which we 
may evaluate using 4.05. Spasm of a coronary artery may occur in 
relation to an obstructive lesion of the vessel of varying degree 
and is the only situation in which we will consider variant angina 
under 4.04.
    b. Variant angina may also occur in the absence of obstructive 
coronary disease. In this situation, the ETT will not demonstrate 
ischemia, and diagnosis will depend on documenting the typical 
transitory ST segment changes during attacks of pain, and the 
absence of obstructive lesions at catheterization. Treatment in 
cases where there is no obstructive coronary disease is limited to 
medications that reduce coronary vasospasm, such as calcium channel 
blockers and nitrates. In such cases, we will consider the frequency 
of anginal episodes despite prescribed treatment.
    c. Vasospasm that is catheter-induced during coronary 
angiography is not variant angina.
    7. What is silent ischemia?
    a. Myocardial ischemia, and even myocardial infarction, can 
occur without perception of pain or any other symptoms; when this 
happens, we call it ``silent'' ischemia. Pain sensitivity may be 
altered by a variety of diseases, most notably diabetes mellitus and 
other neuropathic disorders. Individuals also vary in their 
threshold for pain.
    b. Silent ischemia occurs most often in:
    (1) Individuals 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 or perfusion imaging.
    (2) Individuals 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. The ambulatory recording may show ST depression that should 
not be interpreted as positive for ischemia unless similar 
depression is also seen during chest pain episodes annotated in the 
diary that the individual keeps while wearing the Holter monitor.
    c. ST depression can result from a variety of factors such as 
postural changes and variations in cardiac sympathetic tone. In 
addition, there are differences in how different Holter monitors 
record the electrical responses. Therefore, we do not consider the 
Holter monitor reliable for the diagnosis of silent ischemia except 
in the situation described in 4.00E7b(2).
    8. What other sources of chest discomfort are there? Chest 
discomfort of nonischemic origin may result from other cardiac 
conditions such as pericarditis. Noncardiac conditions may also 
produce symptoms mimicking that of myocardial ischemia. These 
conditions 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. 
Hyperventilation may also mimic ischemic discomfort. Thus, in the 
absence of documented myocardial ischemia, such disorders should be 
considered as possible causes of chest discomfort.
    9. How do we evaluate IHD using 4.04?
    a. We must have objective evidence, as described under 4.00C, 
that your symptoms are due to myocardial ischemia.
    b. Listing-level changes on the ECG in 4.04A1 are the 
classically accepted changes of horizontal or downsloping ST 
depression occurring during both exercise and recovery. Although we 
recognize that ischemic changes may at times be confined only to 
exercise or only to recovery, and may at times be upsloping with 
only junctional ST depression, such changes can also occur in the 
absence of ischemia; that is, a ``false positive'' ECG response. 
Such situations may

[[Page 55887]]

require appropriate medically acceptable imaging for clarification.
    c. Also in 4.04A1, we require that the depression of the ST 
segment last for at least 1 minute of recovery because ST depression 
occurring during exercise that rapidly normalizes in recovery is a 
common ``false positive'' response.
    d. In 4.04A2, we specify that the ST elevation must be in non-
infarct leads during both exercise and recovery. This is because, in 
the absence of ECG signs of prior infarction, ST elevation during 
exercise denotes ischemia, usually severe, requiring immediate 
termination of exercise. However, if there is baseline ST elevation 
in association with a prior infarction or ventricular aneurysm, 
further ST elevation during exercise does not necessarily denote 
ischemia and could be a ``false positive'' ECG response. Diagnosis 
of ischemia in this situation requires radionuclide confirmation.
    e. Listing 4.04A3 requires a decrease in systolic blood pressure 
below the baseline level (taken in the standing position immediately 
prior to exercise) or below any systolic pressure reading recorded 
during exercise. This is because, normally, systolic blood pressure 
and heart rate increase gradually with exercise. Decreases in 
systolic blood pressure below the baseline level that occur during 
exercise are often associated with ischemia-induced left ventricular 
dysfunction resulting in decreased cardiac output. However, a 
blunted response (that is, failure of the systolic blood pressure to 
rise 10 mm Hg or more) particularly in the first 3 minutes of 
exercise, may be drug-related and is not necessarily associated with 
left ventricular dysfunction. Also, some individuals (because of 
deconditioning or apprehension) with increased sympathetic responses 
may increase their systolic blood pressure and heart rate above 
their baseline level just before and early into exercise. This can 
be associated with a drop in systolic pressure in early exercise 
that is not due to left ventricular dysfunction. Therefore, an early 
decrease in systolic blood pressure must be interpreted within the 
total context of the test; that is, the presence or absence of 
symptoms such as lightheadedness, ischemic changes, or arrhythmias 
on the ECG.
    f. In 4.04B, each of the three ischemic episodes must require 
revascularization or be not amenable to treatment. Revascularization 
means angioplasty, with or without stent placement, or bypass 
surgery. However, reocclusion that occurs after a revascularization 
procedure but during the same hospitalization, requiring a second 
procedure during the same hospitalization, will not be counted as 
another ischemic episode. ``Not amenable'' means that the 
revascularization procedure could not be done because of another 
health condition or the vessel was not suitable for 
revascularization.
    g. For 4.04C to apply, you must be at risk for exercise testing 
(see 4.00C9) and we must not have a timely ETT or timely normal 
drug-induced stress test for you. For purposes of 4.04C, 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 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 is considered a nonbypassed vessel for purposes of this 
listing. When you have had revascularization, we will not use the 
pre-operative findings to assess the current severity of your 
coronary artery disease under 4.04C, although we will consider the 
severity and duration of your impairment prior to your surgery in 
making our determination or decision.

F. Evaluating Arrhythmias

    1. What is an arrhythmia? An arrhythmia is a change in the 
regular beat of the heart. Your heart may seem to skip a beat, beat 
irregularly, very quickly (tachycardia), or very slowly 
(bradycardia).
    2. What are the different types of arrhythmias?
    a. There are many types of arrhythmias. Arrhythmias are 
identified by where they occur in the heart (atria or ventricles) 
and by what happens to the heart's rhythm when they occur.
    b. Arrhythmias arising in the atria (upper chambers of the 
heart) are called atrial or supraventricular arrhythmias. 
Ventricular arrhythmias begin in the ventricles (lower chambers). In 
general, ventricular arrhythmias caused by heart disease are the 
most serious.
    3. What do we mean by ``near syncope'' in 4.05? We consider 
``near syncope'' to be a period of altered consciousness, since 
syncope is a loss of consciousness or a faint. It is not merely a 
feeling of light-headedness, momentary weakness, or dizziness. For 
purposes of 4.05, there has to be a documented association between 
the symptom and the medically determinable arrhythmia to satisfy the 
requirements of the listing and it must be recurrent arrhythmia 
causing the recurrent episodes of syncope or near syncope. The 
arrhythmia, not some other cardiac or non-cardiac disorder, must be 
established as the cause of the symptom. Thus, for purposes of this 
listing, tilt table findings are not acceptable, as they may provoke 
syncope or near syncope not related to a cardiac condition.
    4. Will we evaluate arrhythmias under 4.05 when an implantable 
cardiac defibrillator is present? If you have arrhythmias that are 
not fully controlled by drug or implantable cardiac defibrillator 
treatment such that you have uncontrolled recurrent episodes of 
syncope or near syncope, we will evaluate the arrhythmias under 
4.05. If your arrhythmias are controlled, we will evaluate your 
underlying heart disease using the appropriate listing. For other 
considerations when we evaluate arrhythmias in the presence of an 
implantable cardiac defibrillator, see 4.00F5.
    5. What will we consider when we evaluate arrhythmias that do 
not meet 4.05 and an implantable cardiac defibrillator is present?
    a. Implantable cardiac defibrillators are used to prevent sudden 
cardiac death in individuals 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 
individuals with cardiomyopathy (ischemic or non-ischemic) and 
reduced ventricular function. However, life-threatening ventricular 
arrhythmias can also occur in individuals with little or no 
ventricular dysfunction. The shock from the implantable cardiac 
defibrillator is a unique form of treatment; it rescues an 
individual from what may have been cardiac arrest. As a consequence 
of the shock(s), individuals may experience psychological distress, 
which we may evaluate under the mental disorders listings.
    b. Most implantable cardiac defibrillators have rhythm-
correcting and pacemaker capabilities. In some individuals, these 
functions may result in the termination of ventricular arrhythmias 
without an otherwise painful shock. (The shock is like being kicked 
in the chest.) Implantable cardiac defibrillators may deliver 
inappropriate shocks, often repeatedly, in response to benign 
arrhythmias or electrical malfunction. Also, exposure to strong 
electrical or magnetic fields, such as an MRI (magnetic resonance 
imaging), can trigger or reprogram an implantable cardiac 
defibrillator, resulting in inappropriate shocks. We must consider 
the frequency of and the reason(s) for the shocks when evaluating 
the severity and duration of your impairment.
    c. In general, the exercise limitations imposed on individuals 
with an implantable cardiac defibrillator are those dictated by the 
underlying heart condition. However, the exercise limitations may be 
lowered further when the implantable cardiac defibrillator delivers 
an inappropriate shock in response to the increase in heart rate 
with exercise, or when there is exercise-induced ventricular 
arrhythmia.

G. Evaluating Peripheral Vascular Disease

    1. What is peripheral vascular disease (PVD)? Generally, for our 
purposes, PVD is any condition that affects either the arteries 
(peripheral arterial disease) or the veins (venous insufficiency) in 
the extremities, particularly the lower extremities. The usual 
effect is blockage of the flow of blood either from the heart 
(arterial) or back to the heart (venous). You may have pain in the 
calf of your leg after walking a distance (intermittent 
claudication) if you have peripheral arterial disease. If you have 
venous insufficiency, you may have swelling, varicose veins, or skin 
changes.
    2. How do we assess limitations resulting from PVD? We will 
assess your limitations based on your symptoms, together with 
physical findings, Doppler studies, other appropriate non-invasive 
studies, or angiographic findings. However, if the PVD has resulted 
in amputation, we will evaluate any limitations related to the 
amputation under the musculoskeletal listings, 1.00ff.
    3. What is brawny edema? ``Brawny'' edema (4.11A) is usually 
dense and feels firm, due to the presence of increased connective 
tissue, and is associated with characteristic skin pigmentation 
changes. It is not the same thing as ``pitting edema.'' Brawny edema 
generally does not ``pit,'' and the terms are not interchangeable. 
Pitting edema does not satisfy the requirements of 4.11A.

[[Page 55888]]

    4. What is lymphedema? Edema of the extremities due to a 
disorder of the lymph circulation is called lymphedema or, at its 
worst, elephantiasis. Primary lymphedema is caused by abnormal 
development of lymph vessels and may be present at birth (congenital 
lymphedema), but more often develops during the teens (lymphedema 
praecox). It may also appear later, usually after age 35 (lymphedema 
tarda). Secondary lymphedema is due to obstruction or destruction of 
normal lymphatic channels due to tumor, surgery, repeated 
infections, or parasitic infection such as filariasis. Lymphedema 
most commonly affects one extremity.
    5. How do we evaluate lymphedema? We will evaluate lymphedema by 
considering whether the underlying cause meets or medically equals 
any listing or whether the lymphedema medically equals a 
cardiovascular listing, such as 4.11, or a musculoskeletal listing. 
If no listing is met or medically equaled, we will evaluate any 
functional limitations imposed by the lymphedema when we assess your 
residual functional capacity.
    6. Which ankle blood pressure is referred to in 4.12, the 
posterior tibial or the dorsalis pedis? The ankle blood pressure 
referred to in 4.12 is the higher recorded pressure, either from the 
posterior tibial or dorsalis pedis. The higher pressure recorded 
from either site is the more reliable measurement.
    7. What is an ankle/brachial ratio and how do we use it under 
4.12A? The requirements for evaluating peripheral arterial disease 
in 4.12A are based on the ratio of the systolic blood pressure at 
the ankle to the systolic blood pressure at the brachial artery; 
both taken at the same time while you are lying on your back. We do 
not require that the ankle and brachial pressures be taken on the 
same side of your body. This is because, as with the ankle pressure, 
we will use the higher brachial systolic pressure measured. 
Techniques for obtaining ankle systolic blood pressures include 
Doppler, plethysmographic studies, duplex scanning with color 
imaging, or other techniques. We will request any available tracings 
generated by these studies so that we can review them. (See 4.00C16 
and 4.00C17.) Listing 4.12A is met when your resting ankle/brachial 
systolic blood pressure ratio is less than 0.50. If your resting 
ankle/brachial systolic blood pressure ratio is 0.50 or above, we 
will use 4.12B to evaluate the severity of your peripheral arterial 
disease, unless you also have a disease causing abnormal arterial 
calcification or small vessel disease. See 4.00G9 and 4.00G10.
    8. When will we purchase exercise Doppler studies for evaluating 
peripheral arterial disease? We will decide whether to purchase 
exercise Doppler studies by evaluating the existing clinical 
evidence. If we need additional evidence of your peripheral arterial 
disease, we will generally order exercise studies (see 4.00C16 and 
4.00C17) when your resting ankle/brachial systolic blood pressure 
ratio is at least 0.50 or above, but less than 0.80, and only rarely 
when it is 0.80 or above. We will not order exercise Doppler testing 
if you have a disease that results in abnormal arterial 
calcification or small vessel disease, but will use your resting toe 
systolic blood pressure or resting toe/brachial systolic blood 
pressure ratio. (See 4.00G9.) There are no current medical standards 
for evaluating exercise toe pressures. Because any exercise test 
stresses your entire cardiovascular system, we will order exercise 
Doppler studies only after an MC, preferably one with experience in 
the care of patients with cardiovascular disease, has determined 
that none of the situations listed in 4.00C8 apply to you.
    9. When will we use toe systolic blood pressures for evaluating 
peripheral arterial disease under 4.12? We will use resting toe 
systolic blood pressures or resting toe/brachial systolic blood 
pressure ratios (determined the same way as ankle/brachial ratios, 
see 4.00G7) when you have a disease that results in abnormal 
arterial calcification (for example, Monckeberg's sclerosis or 
diabetes mellitus) or small vessel disease (for example, diabetes 
mellitus). These diseases may result in misleadingly high blood 
pressure readings at the ankle. However, high blood pressures due to 
vascular changes related to these diseases seldom occur at the toe 
level. Therefore, if you have intermittent claudication and arterial 
calcification or small vessel disease, we will use your resting toe 
systolic blood pressure or resting toe/brachial systolic blood 
pressure ratio when we evaluate your impairment. While the criteria 
in 4.12C and 4.12D are intended primarily for use when you have a 
disease causing abnormal arterial calcification or small vessel 
disease, we may also use them for evaluating anyone with peripheral 
arterial disease.
    10. How are toe pressures measured? Toe pressures are measured 
routinely in most vascular laboratories through one of three 
methods: Doppler ultrasound; plethysmography using strain gauge 
cuffs; and photoplethysmography. Toe pressure can also be measured 
by using any blood pressure cuff that fits snugly around the big toe 
and is neither too tight nor too loose. A neonatal cuff or a cuff 
designed for use on fingers or toes (digicuffs) can be used in the 
measurement of toe pressure.
    11. Are there any other studies that are helpful in evaluating 
PVD? Doppler studies done using a recording ultrasonic Doppler unit 
and strain-gauge plethysmography are other useful tools for 
evaluating PVD. A recording Doppler, which prints a tracing of the 
arterial pulse wave in the femoral, popliteal, dorsalis pedis, and 
posterior tibial arteries, is an excellent evaluation tool to 
compare wave forms in normal and compromised peripheral blood flow. 
Qualitative analysis of the pulse wave is very helpful in the 
overall assessment of the severity of the occlusive disease. 
Tracings are especially helpful 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.
    12. How do we use the PVD listings if you have had a peripheral 
graft? Peripheral grafting serves the same purpose as coronary 
grafting; that is, to bypass a narrow or obstructed arterial 
segment. If intermittent claudication recurs or persists after 
peripheral grafting, we may purchase Doppler studies to assess the 
flow of blood through the bypassed vessel and to establish the 
current severity of the peripheral vascular impairment. However, if 
you have had peripheral grafting done for your PVD, we will not use 
the findings from before the surgery to assess the current severity 
of your impairment, although we will consider the severity and 
duration of your impairment prior to your surgery in making our 
determination or decision.

H. Evaluating Other Cardiovascular Impairments

    1. How will we evaluate hypertension? Because hypertension (high 
blood pressure) generally causes disability through its effects on 
other body systems, we will evaluate it by reference to the specific 
body system(s) affected (heart, brain, kidneys, or eyes) when we 
consider the effects of hypertension under the listings. We will 
also consider any limitations imposed by your hypertension when we 
assess your residual functional capacity.
    2. What is congenital heart disease? Congenital heart disease is 
any abnormality of the heart or the major blood vessels that is 
present at birth.
    3. How will we evaluate symptomatic congenital heart disease? 
Because of improved treatment methods, more individuals with 
congenital heart disease are living longer. Although some types of 
congenital heart disease may be corrected through surgery, many 
individuals with treated congenital heart disease continue to have 
problems throughout their lives (symptomatic congenital heart 
disease). If you have congenital heart disease that results in 
chronic heart failure with evidence of ventricular dysfunction or in 
recurrent arrhythmias, we will evaluate your impairment under 4.02 
or 4.05. Otherwise, we will evaluate your impairment under 4.06.
    4. 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). 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, hypertrophic, and restrictive. We 
will evaluate cardiomyopathy under 4.02, 4.04, 4.05, or 11.04, 
depending on its effects on you.
    5. How will we evaluate valvular heart disease? We will evaluate 
valvular heart disease under the listing appropriate for its effect 
on you. Thus, we may use 4.02, 4.04, 4.05, or the appropriate 
neurological listing in 11.00ff.
    6. What do we consider when we evaluate heart transplant 
recipients?

[[Page 55889]]

    a. After your heart transplant, we will consider you disabled 
for 1 year following the surgery because there is a greater 
likelihood of rejection of the organ and infection during the first 
year.
    b. However, heart transplant patients generally meet our 
definition of disability before they undergo transplantation. We 
will determine the actual onset of your disability based on the 
facts in your case.
    c. We will not assume that you became disabled when your name 
was placed on a transplant waiting list. This is because you may be 
placed on a waiting list soon after diagnosis of the cardiac 
disorder that may eventually require a transplant. Physicians 
recognize that candidates for transplantation often have to wait 
months or even years before a suitable donor heart is found, so they 
place their patients on the list as soon as permitted.
    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 symptoms, signs, and laboratory findings, 
including any side-effects of medication. We will consider any 
remaining symptoms, signs, and laboratory findings indicative of 
cardiac dysfunction in deciding whether medical improvement (as 
defined in Sec. Sec.  404.1579(b)(1) and 404.1579(c)(1), 
404.1594(b)(1) and 404.1594(c)(1), or 416.994(b)(1)(i) and 
416.994(b)(2)(i), as appropriate) has occurred.
    7. When does an aneurysm have ``dissection not controlled by 
prescribed treatment,'' as required under 4.10? An aneurysm (or 
bulge in the aorta or one of its major branches) is dissecting when 
the inner lining of the artery begins to separate from the arterial 
wall. We consider the dissection not controlled when you have 
persistence of chest pain due to progression of the dissection, an 
increase in the size of the aneurysm, or compression of one or more 
branches of the aorta supplying the heart, kidneys, brain, or other 
organs. An aneurysm with associated dissection can cause heart 
failure, renal (kidney) failure, or neurological complications. We 
will evaluate these conditions using the appropriate listing.
    8. What is hyperlipidemia and how will we evaluate it? 
Hyperlipidemia is the general term for an elevation of any or all of 
the lipids (fats/cholesterol) in the blood; for example, 
hypertriglyceridemia, hypercholesterolemia, and 
hyperlipoproteinemia. These disorders of lipoprotein metabolism and 
transport can cause defects in various organs. The effects most 
likely to interfere with function are those produced by 
atherosclerosis (narrowing of the arteries) and coronary artery 
disease. Treatment of all of these disorders has improved, which 
lessens or delays the resulting functional limitations. We will 
evaluate all of these lipoprotein disorders under the listing 
appropriate to its effects on you, which may include myocardial 
ischemia, arterial stenosis, liver transplant (as a form of 
treatment), pancreatitis, or joint effusions.

I. Other Evaluation Issues

    1. What effect does obesity have on the cardiovascular system 
and how will we evaluate it? Obesity is a medically determinable 
impairment that is often associated with disorders of the 
cardiovascular system. Disturbance of this system can be a major 
cause of disability if you have obesity. Obesity may affect the 
cardiovascular system because of the increased workload the 
additional body mass places on the heart. Obesity may make it harder 
for the chest and lungs to expand. This can mean that the 
respiratory system must work harder to provide needed oxygen. This 
in turn would make the heart work harder to pump blood to carry 
oxygen to the body. Because the body would be working harder at 
rest, its ability to perform additional work would be less than 
would otherwise be expected. Thus, the combined effects of obesity 
with cardiovascular impairments can be greater than the effects of 
each of the impairments considered separately. If you have obesity, 
when we determine whether you have a listing-level cardiovascular 
impairment (or a combination of impairments that medically equals 
the severity of a listed impairment), and when assessing your claim 
at other steps of the sequential evaluation process, including when 
assessing your residual functional capacity, we must consider any 
additional and cumulative effects of obesity.
    2. How do we relate treatment to functional status? In general, 
conclusions about the severity of a cardiovascular impairment cannot 
be made on the basis of type of treatment rendered or anticipated. 
The amount of function restored and the time required for 
improvement after treatment (medical, surgical, or a prescribed 
program of progressive physical activity) vary with the nature and 
extent of the disorder, the type of treatment, and other factors. 
Depending upon the timing of this treatment in relation to the 
alleged onset date of disability, we may need to defer evaluation of 
the impairment for a period of up to 3 months from the date 
treatment began to permit consideration of treatment effects, unless 
we can make a determination or decision using the evidence we have. 
See 4.00B4.
    3. How do we evaluate impairments that do not meet one of the 
cardiovascular listings?
    a. These listings are only examples of common cardiovascular 
impairments that we consider severe enough to prevent you from doing 
any gainful activity. If your severe 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.
    b. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether the 
impairments(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926.) 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. In that situation, we 
proceed to the fourth and, if necessary, the fifth steps of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920. If 
you are an adult, we use the rules in Sec. Sec.  404.1594 or 
416.994, as appropriate, when we decide whether you continue to be 
disabled.
    4.01 Category of Impairments, Cardiovascular System.
    4.02 Chronic heart failure 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 
in both A and B are satisfied.
    A. Medically documented presence of one of the following:
    1. Left ventricular end diastolic dimensions greater than 6.0 cm 
or ejection fraction of 30 percent or less during a period of 
stability (see 4.00D2a(2)) (systolic failure); or
    2. Left ventricular posterior wall plus septal thickness 
totaling 2.5 cm or greater on imaging, with an enlarged left atrium 
(greater than or equal to 4.5 cm), with normal or elevated ejection 
fraction during a period of stability (see 4.00D2a(2)) (diastolic 
failure); and
    B. Resulting in one of the following:
    1. Persistent symptoms of heart failure which very seriously 
limit the ability to independently initiate, sustain, or complete 
activities of daily living in an individual for whom an MC, 
preferably one experienced in the care of patients with 
cardiovascular disease, has concluded that the performance of an 
exercise test would present a significant risk to the individual; or
    2. 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(2)) from clinical and 
imaging methods 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 4.00D4); or
    3. Inability to perform on an exercise tolerance test at a 
workload equivalent to 5 METs or less (see 4.00C2b and 4.00C10) due 
to:
    a. Dyspnea, fatigue, palpitations, or chest discomfort; or
    b. Three or more consecutive premature ventricular contractions 
(ventricular tachycardia) or increasing frequency of ventricular 
ectopy with at least 6 premature ventricular contractions per 
minute; or
    c. Decrease of 10 mm Hg or more below the baseline systolic 
blood pressure due to left ventricular dysfunction or the preceding 
systolic pressure measured during exercise; or
    d. Signs attributable to inadequate cerebral perfusion, such as 
ataxic gait or mental confusion.
    4.04 Ischemic heart disease, with symptoms due to myocardial 
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 one of the following:
    A. Sign- or symptom-limited exercise tolerance test 
demonstrating at least one of the following manifestations at a 
workload equivalent to 5 METs or less:
    1. Horizontal or downsloping 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 3 consecutive 
complexes that are on a level

[[Page 55890]]

baseline in any lead (other than aVR), and depression of at least -
0.10 millivolts lasting for at least 1 minute of recovery; or
    2. At least 0.1 millivolt (1 mm) ST elevation above resting 
baseline in non-infarct leads during both exercise and 1 or more 
minutes of recovery; or
    3. Decrease of 10 mm Hg in systolic pressure below the baseline 
blood pressure due to left ventricular dysfunction or the preceding 
systolic pressure measured during exercise (see 4.00E9e) despite an 
increase in workload; or
    4. Documented ischemia at an exercise level equivalent to 5 METs 
or less on appropriate medically acceptable imaging such as 
radionuclide perfusion scans or stress echocardiography; or
    B. Three separate ischemic episodes (see 4.00E9f), each 
requiring revascularization or not amenable (see 4.00E9f) to 
revascularization, within a consecutive 12-month period (see 
4.00A3e); or
    C. Coronary artery disease, demonstrated by angiography 
(obtained independent of Social Security disability evaluation), 
and, in the absence of a timely exercise tolerance test or a timely 
normal drug-induced stress test, an MC, preferably one experienced 
in the care of patients with cardiovascular disease, has concluded 
that performance of exercise tolerance testing would present a 
significant risk to the individual, with both 1 and 2:
    1. Angiographic evidence revealing:
    a. 50 percent or more narrowing of a nonbypassed left main 
coronary artery; or
    b. 70 percent or more narrowing of another nonbypassed coronary 
artery; or
    c. 50 percent or more narrowing involving a long (greater than 1 
cm) segment of a nonbypassed coronary artery; or
    d. 50 percent or more narrowing of at least 2 nonbypassed 
coronary arteries; or
    e. 70 percent or more narrowing of a bypass graft vessel; and
    2. Resulting in very serious limitations in the ability to 
independently initiate, sustain, or complete activities of daily 
living.
    4.05 Recurrent arrhythmias, not related to reversible causes 
such as electrolyte abnormalities or digitalis glycoside or 
antiarrhythmic drug toxicity, resulting in uncontrolled (see 
4.00A3f), recurrent (see 4.00A3c) episodes of cardiac syncope or 
near syncope (see 4.00F3), despite prescribed treatment (see 4.00B3 
if there is no prescribed treatment), and documented by resting or 
ambulatory (Holter) electrocardiography, or by other appropriate 
medically acceptable testing, coincident with the occurrence of 
syncope or near syncope.
    4.06 Symptomatic congenital heart disease (cyanotic or 
acyanotic), documented by appropriate medically acceptable imaging 
(see 4.00A3d) or cardiac catheterization, with one of the following:
    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; or
    B. Intermittent right-to-left shunting resulting in cyanosis on 
exertion (e.g., Eisenmenger's physiology) and with arterial 
PO2 of 60 Torr or less at a workload equivalent to 5 METs 
or less; or
    C. Secondary pulmonary vascular obstructive disease with 
pulmonary arterial systolic pressure elevated to at least 70 percent 
of the systemic arterial systolic pressure.
    4.09 Heart transplant. Consider under a disability for 1 year 
following surgery; thereafter, evaluate residual impairment under 
the appropriate listing.
    4.10 Aneurysm of aorta or major branches, due to any cause 
(e.g., atherosclerosis, cystic medial necrosis, Marfan syndrome, 
trauma), demonstrated by appropriate medically acceptable imaging, 
with dissection not controlled by prescribed treatment (see 4.00H7).
    4.11 Chronic venous insufficiency of a lower extremity with 
incompetency or obstruction of the deep venous system and one of the 
following:
    A. Extensive brawny edema involving approximately two-thirds of 
the leg between the ankle and knee; or
    B. Superficial varicosities, stasis dermatitis, and either 
recurrent ulceration or persistent ulceration that has not healed 
following at least 3 months of prescribed treatment.
    4.12 Peripheral arterial disease, as determined by appropriate 
medically acceptable imaging (see 4.00A3d, 4.00G2, and 4.00G11), 
causing intermittent claudication (see 4.00G1) and one of the 
following:
    A. Resting ankle/brachial systolic blood pressure ratio of less 
than 0.50; or
    B. Decrease in systolic blood pressure at the ankle on exercise 
(see 4.00G6-4.00G7 and 4.00C13-4.00C14) of 50 percent or more of 
pre-exercise level and requiring 10 minutes or more to return to 
pre-exercise level; or
    C. Resting toe systolic pressure of less than 30 mm Hg (see 
4.00G9); or
    D. Resting toe/brachial systolic blood pressure ratio of less 
than 0.40 (see 4.00G9).
* * * * *
Part B
* * * * *

Sec.  104.00 Cardiovascular System

A. General

    1. What do we mean by a cardiovascular impairment?
    a. We mean any disorder that affects the proper functioning of 
either the heart or the circulatory system (arteries, veins, 
capillaries, and the lymphatic drainage). The disorder can be 
congenital or acquired.
    b. Cardiovascular impairment results from one or more of four 
consequences of heart disease:
    (1) Chronic heart failure or ventricular dysfunction.
    (2) Discomfort or pain due to myocardial ischemia, with or 
without necrosis of heart muscle.
    (3) Syncope, or near syncope, due to inadequate cerebral 
perfusion from any cardiac cause, such as obstruction of flow or 
disturbance in rhythm or conduction resulting in inadequate cardiac 
output.
    (4) Central cyanosis due to right-to-left shunt, reduced oxygen 
concentration in the arterial blood, or pulmonary vascular disease.
    c. Disorders of the veins and arteries (for example, 
obstruction, rupture, or aneurysm) may cause impairments of the 
lower extremities (peripheral vascular disease), the central nervous 
system, eyes, kidneys, and other organs. We will evaluate peripheral 
vascular disease under 4.11 or 4.12 and impairments of another body 
system(s) under the listings for that body system(s).
    2. What do we consider in evaluating cardiovascular impairments? 
The listings in this section describe impairments of the 
cardiovascular system based on symptoms, signs, laboratory findings, 
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 an individual defined in Sec. Sec.  
404.1616(a) and 416.1016(a). This term does not include medical 
sources who provide consultative examinations for us. We use the 
abbreviation ``MC'' throughout this section to designate a medical 
consultant.
    b. Persistent means that the longitudinal clinical record shows 
that, with few exceptions, the required finding(s) has been present, 
or is expected to be present, for a continuous period of at least 12 
months, such that a pattern of continuing severity is established.
    c. Recurrent means that the longitudinal clinical record shows 
that, within a consecutive 12-month period, the finding(s) occurs at 
least three times, with intervening periods of improvement of 
sufficient duration that it is clear that separate events are 
involved.
    d. Appropriate medically acceptable imaging means that the 
technique used is the proper one to evaluate and diagnose the 
impairment and is commonly recognized as accurate for assessing the 
cited finding.
    e. A consecutive 12-month period must occur within the period we 
are considering in connection with an application or continuing 
disability review.
    f. Currently present means that the finding is present at the 
time of adjudication.
    g. Uncontrolled means the condition does not respond adequately 
to standard prescribed medical treatment.

B. Documenting Cardiovascular Impairment

    1. What basic documentation do we need? We need sufficiently 
detailed reports on history, physical examinations, laboratory 
studies, and any prescribed treatment and response to allow us to 
assess the severity and duration of your cardiovascular impairment. 
A longitudinal clinical record covering a period of not less than 3 
months of observations and treatment is usually necessary, unless we 
can make a determination or decision based on the current evidence.
    2. Why is a longitudinal clinical record important? We will 
usually need a longitudinal clinical record to assess the severity 
and expected duration of your impairment(s). If you have a listing-
level impairment, you probably will have received medically 
prescribed treatment. Whenever there is evidence of such treatment, 
your longitudinal clinical record should include a description of 
the ongoing management and evaluation provided by your treating or 
other

[[Page 55891]]

medical source. It should also include your response to this medical 
management, as well as information about the nature and severity of 
your impairment. The record will provide us with information on your 
functional status over an extended period of time and show whether 
your ability to function is improving, worsening, or unchanging.
    3. What if there is no longitudinal record because you have not 
received ongoing medical treatment?
    a. You may not have received ongoing treatment or have an 
ongoing relationship with the medical community, despite the 
existence of a severe impairment(s). In such cases, we will base our 
evaluation on the current objective medical evidence and the other 
evidence we have. If you do not receive treatment, you cannot show 
an impairment that meets the criteria of these listings. However, 
you may have another impairment(s) that, in combination with your 
cardiovascular impairment, medically equals a listed impairment or 
that functionally equals the listings.
    b. Unless your claim can be decided favorably on the basis of 
the current evidence, a longitudinal record is still important. In 
rare instances where there is no or insufficient longitudinal 
evidence, we may purchase any necessary examination(s) to establish 
the severity of your impairment.
    4. When will we wait before we ask for more evidence?
    a. We will wait when we have information showing that your 
impairment is not yet stable and the expected change in your 
condition might affect our determination or decision. In these 
cases, we need to wait to properly evaluate the severity and 
duration of your impairment during a stable period. Examples of when 
we might wait are:
    (1) If you have had a recent acute event; for example, acute 
rheumatic fever.
    (2) If you have recently had a corrective cardiac procedure; for 
example, open-heart surgery.
    (3) If you have started new drug therapy and your response to 
this treatment has not yet been established; for example, beta-
blocker therapy for dilated congestive cardiomyopathy.
    b. In these situations, we will obtain more evidence 3 months 
following the event before we evaluate your impairment. However, we 
will not wait if we have enough information to make a determination 
or decision based on all of the relevant evidence in your case.
    5. Will we order any studies? In appropriate cases, we will 
order additional studies necessary to substantiate the diagnosis or 
to document the severity of your impairment after we have evaluated 
the medical and other evidence we already have. We will order 
studies involving exercise testing only if there is no significant 
risk involved or if there is no other medical reason not to perform 
the test. We will follow sections 4.00C7 and 4.00C8 when we decide 
whether to order these studies. We will make a reasonable effort to 
obtain any additional studies from a qualified medical source in an 
office or center experienced in pediatric cardiac assessment. (See 
Sec. Sec.  404.1519g and 416.919g.)
    6. What studies will we not order? We will not order any studies 
involving cardiac catheterization, such as coronary angiography, 
arteriograms, or electrophysiological studies. However, if the 
results of catheterization are part of the existing evidence we 
have, we will consider them together with the other relevant 
evidence.
    7. Will we use exercise tolerance tests (ETTs) for evaluating 
children with cardiovascular impairment?
    a. ETTs, though increasingly used, are still less frequently 
indicated in children than in adults, and can rarely be successfully 
performed in children under 6 years of age. An ETT may be of value 
in the assessment of some arrhythmias, 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 in a childhood claim 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 impairments, has determined that an ETT 
is needed to evaluate your impairment. We will not purchase an ETT 
if you are less than 6 years of age. If we do purchase an ETT for a 
child age 12 or younger, it must be performed by a qualified medical 
source in a specialty center for pediatric cardiology or other 
facility qualified to perform exercise testing for children.
    c. For full details on ETT requirements and usage, see 4.00C.

C. Evaluating Chronic Heart Failure

    1. What is chronic heart failure (CHF)? CHF is the inability of 
the heart to pump enough oxygenated blood to body tissues. This 
syndrome is characterized by symptoms and signs of pulmonary or 
systemic congestion (fluid retention) or limited cardiac output. 
Certain laboratory findings of cardiac functional and structural 
abnormality support the diagnosis of CHF. CHF is considered in these 
listings as a single category whether due to atherosclerosis 
(narrowing of the arteries), cardiomyopathy, hypertension, or 
rheumatic, congenital, or other heart disease. However, if the CHF 
is the result of primary pulmonary hypertension secondary to disease 
of the lung (cor pulmonale), we will use 3.09 under the respiratory 
system listings.
    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 (M-Mode, 2-dimensional, and Doppler), 
radionuclide studies, or cardiac catheterization.
    (1) Cardiomegaly is present when:
    (a) Left ventricular diastolic dimension or systolic dimension 
is greater than 2 standard deviations above the mean for the child's 
body surface area;
    (b) Left ventricular mass is greater than 2 standard deviations 
above the mean for the child's body surface area; or
    (c) Chest x-ray (6 foot PA film) is indicative of cardiomegaly 
if the cardiothoracic ratio is over 60 percent at 1 year of age or 
less, or 55 percent or greater at more than 1 year of age.
    (2) Ventricular dysfunction is present when indices of left 
ventricular function, such as fractional shortening or ejection 
fraction (the percentage of the blood in the ventricle actually 
pumped out with each contraction), are greater than 2 standard 
deviations below the mean for the child's age. (Fractional 
shortening, also called shortening fraction, reflects the left 
ventricular systolic function in the absence of segmental wall 
motion abnormalities and has a linear correlation with ejection 
fraction. In children, fractional shortening is more commonly used 
than ejection fraction.)
    (3) Other findings on appropriate medically acceptable imaging 
may include increased pulmonary vascular markings, pleural effusion, 
and pulmonary edema. These findings need not be present on each 
report, since CHF may be controlled by prescribed treatment.
    b. To establish that you have chronic heart failure, there 
should also be characteristic symptoms and signs of pulmonary or 
systemic congestion, or limited cardiac output described in the 
medical history and on physical examinations, 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.
    (1) Symptoms of congestion or of limited cardiac output include 
easy fatigue, weakness, shortness of breath (dyspnea), cough, or 
chest discomfort at rest or with activity. Children with CHF may 
also experience shortness of breath on lying flat (orthopnea) or 
episodes of shortness of breath waking them from sleep (paroxysmal 
nocturnal dyspnea). They may also experience cardiac arrhythmias 
resulting in palpitations, lightheadedness, or fainting. Fatigue or 
exercise intolerance in an infant may be manifested by prolonged 
feeding time, often associated with excessive respiratory effort and 
sweating.
    (2) During infancy, other manifestations of chronic heart 
failure may include failure to gain weight or involuntary loss of 
weight and repeated lower respiratory tract infections.
    (3) Signs of congestion may include hepatomegaly, ascites, 
increased jugular venous distention or pressure, rales, peripheral 
edema, quick shallow breathing (tachypnea), or rapid weight gain. 
However, these signs need not be found on all examinations, because 
fluid retention may be controlled by prescribed treatment.

D. Evaluating 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. Examples include:
    a. Abnormalities of cardiac septation, such as ventricular 
septal defect or atrioventricular canal;
    b. Abnormalities resulting in cyanotic heart disease, such as 
tetralogy of Fallot or transposition of the vessels;

[[Page 55892]]

    c. Valvular defects or obstructions to ventricular outflow, 
including pulmonary or aortic stenosis or coarctation of the aorta; 
and
    d. Major abnormalities of ventricular development, including 
hypoplastic left heart syndrome or pulmonary tricuspid atresia with 
hypoplastic right ventricle.
    2. Will we accept pulse oximetry measurements for use under 
104.06A2? We will accept pulse oximetry measurements instead of 
arterial O2, but if the arterial O2 values are 
available, they are preferred.
    3. What congenital heart defects will we evaluate under 104.06D? 
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:
    a. Hypoplastic left heart syndrome;
    b. Critical aortic stenosis with neonatal heart failure;
    c. Critical coarctation of the aorta, with or without associated 
anomalies;
    d. Complete atrioventricular canal defects;
    e. Transposition of the great arteries;
    f. Tetralogy of Fallot;
    g. Pulmonary atresia with intact ventricular septum;
    h. Single ventricle;
    i. Tricuspid atresia, and
    j. Multiple ventricular septal defects.
    4. How will we evaluate symptomatic congenital heart disease? 
Because of improved treatment methods, more children with congenital 
heart disease are living longer. Although some types of congenital 
heart disease may be corrected through surgery, many children with 
treated congenital heart disease continue to have problems 
throughout their lives (symptomatic congenital heart disease). If 
you have congenital heart disease that results either in chronic 
heart failure with evidence of ventricular dysfunction or in 
recurrent arrhythmias, we will evaluate your impairment under 104.02 
or 104.05. Otherwise, we will evaluate your impairment under 104.06.

E. Evaluating Arrhythmias

    1. What is an arrhythmia? An arrhythmia is a change in the 
regular beat of the heart. Your heart may seem to skip a beat, beat 
irregularly, very quickly (tachycardia) or very slowly 
(bradycardia).
    2. What are the different types of arrhythmias?
    a. There are many types of arrhythmias. Arrhythmias are 
identified by where they occur in the heart (atria or ventricles) 
and by what happens to the heart's rhythm when they occur.
    b. Arrhythmias arising in the atria (upper chambers of the 
heart) are called atrial or supraventricular arrhythmias. 
Ventricular arrhythmias begin in the ventricles (lower chambers). In 
general, ventricular arrhythmias caused by heart disease are the 
most serious.
    3. What do we mean by ``near syncope'' in 104.05? We consider 
``near syncope'' to be a period of altered consciousness, since 
syncope is a loss of consciousness or a faint. It is not merely a 
feeling of light-headedness, momentary weakness, or dizziness. For 
purposes of 104.05, there has to be a documented association between 
the symptom and the medically determinable arrhythmia to satisfy the 
requirements of the listing and it must be recurrent arrhythmia 
causing the recurrent episodes of syncope or near syncope. The 
arrhythmia, not some other cardiac or non-cardiac disorder, must be 
established as the cause of the symptom. Thus, for purposes of this 
listing, tilt table findings are not acceptable, as they may provoke 
syncope or near syncope not related to a cardiac condition.
    4. Will we evaluate arrhythmias under 104.05 when an implantable 
cardiac defibrillator is present? If you have arrhythmias that are 
not fully controlled by drug or implantable cardiac defibrillator 
treatment such that you have uncontrolled recurrent episodes of 
syncope or near syncope, we will evaluate the arrhythmias under 
104.05. If your arrhythmias are controlled, we will evaluate your 
underlying heart disease using the appropriate listing. For other 
considerations when we evaluate arrhythmias in the presence of an 
implantable cardiac defibrillator, see 104.00E5.
    5. What will we consider when we evaluate arrhythmias that do 
not meet 104.05 and an implantable cardiac defibrillator is present?
    a. Implantable cardiac defibrillators are used to prevent sudden 
cardiac death in children who have had, or are at high risk for, 
cardiac arrest from life-threatening ventricular arrhythmias. The 
largest group of children at risk for sudden cardiac death consists 
of children with cardiomyopathy (ischemic or non-ischemic) and 
reduced ventricular function. However, life-threatening ventricular 
arrhythmias can also occur in children with little or no ventricular 
dysfunction. The shock from the implantable cardiac defibrillator is 
a unique form of treatment; it rescues a child from what may have 
been cardiac arrest. As a consequence of the shock(s), children may 
experience psychological distress, which we may evaluate under the 
mental disorders listings.
    b. Most implantable cardiac defibrillators have rhythm-
correcting and pacemaker capabilities. In some children, these 
functions may result in the termination of ventricular arrhythmias 
without an otherwise painful shock. (The shock is like being kicked 
in the chest.) Implantable cardiac defibrillators may deliver 
inappropriate shocks, often repeatedly, in response to benign 
arrhythmias or electrical malfunction. Also, exposure to strong 
electrical or magnetic fields, such as an MRI (magnetic resonance 
imaging), can trigger or reprogram an implantable cardiac 
defibrillator, resulting in inappropriate shocks. We must consider 
the frequency of and the reason(s) for the shocks when evaluating 
the severity and duration of your impairment.
    c. In general, the exercise limitations imposed on children with 
an implantable cardiac defibrillator are those dictated by the 
underlying heart condition. However, the exercise limitations may be 
lowered further when the implantable cardiac defibrillator delivers 
an inappropriate shock in response to the increase in heart rate 
with exercise, or when there is exercise-induced ventricular 
arrhythmia.

F. Evaluating Other Cardiovascular Impairments

    1. What is ischemic heart disease and how will we evaluate it in 
children? Ischemic heart disease results when one or more of the 
coronary arteries is narrowed or obstructed or, in rare cases, 
constricted due to vasospasm, interfering with the normal flow of 
blood to the heart muscle (ischemia). The obstruction may be the 
result of an embolus, a thrombus, or plaque. When heart muscle 
tissue dies as a result of the reduced blood supply, it is called a 
myocardial infarction (heart attack). Ischemia is rare in children 
and its effects on children and adults are the same. We will 
evaluate it in children using the guidance and criteria found in 
4.00E and 4.04.
    2. How will we evaluate hypertension? Because hypertension (high 
blood pressure) generally causes disability through its effects on 
other body systems, we will evaluate it by reference to the specific 
body system(s) affected (heart, brain, kidneys, or eyes) when we 
consider the effects of hypertension under the listings. If you are 
a child seeking supplemental security income payments based on 
disability, we will also consider your hypertension when we consider 
whether you have an impairment that functionally equals the 
listings.
    3. How will we evaluate valvular heart disease? We will evaluate 
valvular heart disease under the listing appropriate for its effect 
on you. Thus, we may use 104.02, 104.05, 104.06, 4.04, or the 
appropriate neurological listing under 111.00ff or 11.00ff.
    4. What do we consider when we evaluate heart transplant 
recipients?
    a. After your heart transplant, we will consider you disabled 
for 1 year following the surgery because there is a greater 
likelihood of rejection of the organ and infection during the first 
year.
    b. However, heart transplant patients generally meet our 
definition of disability before they undergo transplantation. We 
will determine the actual onset of your disability based on the 
facts in your case.
    c. We will not assume that you became disabled when your name 
was placed on a transplant waiting list. This is because you may be 
placed on a waiting list soon after diagnosis of the cardiac 
disorder that may eventually require a transplant. Physicians 
recognize that candidates for transplantation often have to wait 
months or even years before a suitable donor heart is found, so they 
place their patients on the list as soon as permitted.
    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 symptoms, signs, and laboratory findings, 
including any side-effects of medication. We will consider any 
remaining symptoms, signs, and laboratory findings indicative of 
cardiac dysfunction in deciding whether medical improvement (as 
defined in Sec.  416.994a(c)) has occurred.
    5. How will we evaluate chronic rheumatic fever or rheumatic 
heart disease? The diagnosis should be made in accordance with

[[Page 55893]]

the current revised Jones criteria for guidance in the diagnosis of 
rheumatic fever. We will evaluate persistence of rheumatic fever 
activity under 104.13. If you have evidence of chronic heart failure 
or recurrent arrhythmias associated with rheumatic heart disease, we 
will use 104.02 or 104.05.
    6. What is hyperlipidemia and how will we evaluate it? 
Hyperlipidemia is the general term for an elevation of any or all of 
the lipids (fats/cholesterol) in the blood; for example, 
hypertriglyceridemia, hypercholesterolemia, and 
hyperlipoproteinemia. These disorders of lipoprotein metabolism and 
transport can cause defects in various organs. The effects most 
likely to interfere with function are those produced by 
atherosclerosis (narrowing of the arteries) and coronary artery 
disease. Treatment of all of these disorders has improved, which 
lessens or delays the resulting functional limitations. We will 
evaluate all of these lipoprotein disorders under the listing 
appropriate to its effects on you, which may include myocardial 
ischemia, arterial stenosis, liver transplant (as a form of 
treatment), pancreatitis, or joint effusions.
    7. How will we evaluate Kawasaki disease? We will evaluate 
Kawasaki disease under the listing appropriate to its effects on 
you, which may include major coronary artery aneurysm or heart 
failure. A major coronary artery aneurysm may cause ischemia or 
arrhythmia, which we will evaluate under 4.04 or 104.05. We will 
evaluate heart failure under 104.02.
    8. What is lymphedema? Edema of the extremities due to a 
disorder of the lymph circulation is called lymphedema or, at its 
worst, elephantiasis. Primary lymphedema is caused by abnormal 
development of lymph vessels and may be present at birth (congenital 
lymphedema), but more often develops during the teens (lymphedema 
praecox). Secondary lymphedema is due to obstruction or destruction 
of normal lymphatic channels due to tumor, surgery, repeated 
infections, or parasitic infection such as filariasis. Lymphedema 
most commonly affects one extremity.
    9. How do we evaluate lymphedema? We will evaluate lymphedema by 
considering whether the underlying cause meets or medically equals 
any listing or whether the lymphedema medically equals a 
cardiovascular listing, such as 4.11, or a musculoskeletal listing. 
If you are a child seeking supplemental security income payments 
based on disability, we will also consider your lymphedema when we 
consider whether you have an impairment that functionally equals the 
listings.

G. Other Evaluation Issues

    1. What effect does obesity have on the cardiovascular system 
and how will we evaluate it? Obesity is a medically determinable 
impairment that is often associated with disorders of the 
cardiovascular system. Disturbance of this system can be a major 
cause of disability in children with obesity. Obesity may affect the 
cardiovascular system because of the increased workload the 
additional body mass places on the heart. Obesity may make it harder 
for the chest and lungs to expand. This can mean that the 
respiratory system must work harder to provide needed oxygen. This 
in turn would make the heart work harder to pump blood to carry 
oxygen to the body. Because the body would be working harder at 
rest, its ability to perform additional work would be less than 
would otherwise be expected. Thus, the combined effects of obesity 
with cardiovascular impairments can be greater than the effects of 
each of the impairments considered separately. If you have obesity, 
when we determine whether you have a severe cardiovascular 
impairment or a listing-level cardiovascular impairment (or a 
combination of impairments that medically equals a listing or, as 
appropriate, functionally equals the listings), we must consider any 
additional and cumulative effects of obesity.
    2. How do we relate treatment to functional status? In general, 
conclusions about the severity of a cardiovascular impairment cannot 
be made on the basis of type of treatment rendered or anticipated. 
The amount of function restored and the time required for 
improvement after treatment (medical, surgical, or a prescribed 
program of progressive physical activity) vary with the nature and 
extent of the disorder, the type of treatment, and other factors. 
Depending upon the timing of this treatment in relation to the 
alleged onset date of disability, we may need to defer evaluation of 
the impairment for a period of up to 3 months from the date 
treatment began to permit consideration of treatment effects, unless 
we can make a determination or decision using the evidence we have. 
See 104.00B4.
    3. How do we evaluate impairments that do not meet one of the 
cardiovascular listings?
    a. These listings are only examples of common cardiovascular 
disorders that we consider severe enough to result in marked and 
severe functional limitations. If your severe 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.
    b. 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. In the case of a claim for 
SSI payments, if your impairment(s) does not meet or medically equal 
a listing, we will consider whether it functionally equals the 
listings. (See Sec. Sec.  404.1526, 416.926, and 416.926a.) If you 
are receiving SSI payments, when we decide whether you continue to 
be disabled, we use the rules in Sec.  416.994a.
    104.01 Category of Impairments, Cardiovascular System
    104.02 Chronic heart failure while on a regimen of prescribed 
treatment with symptoms and signs described in 104.00C2 and with one 
of the following:
    A. Persistent tachycardia at rest (see Table I); or
    B. Persistent tachypnea at rest (see Table II) or markedly 
decreased exercise tolerance (see 104.00C2b); or
    C. Growth disturbance with:
    1. An involuntary weight loss or failure to gain weight at an 
appropriate rate for age, resulting in a fall of 15 percentiles from 
an established growth curve (on current NCHS/CDC growth chart) which 
is currently present (see 104.00A3f) and has persisted for 2 months 
or longer; or
    2. An involuntary weight loss or failure to gain weight at an 
appropriate rate for age, resulting in a fall to below the third 
percentile from an established growth curve (on current NCHS/CDC 
growth chart) which is currently present (see 104.00A3f) and has 
persisted for 2 months or longer.

                      Table I.--Tachycardia at Rest
------------------------------------------------------------------------
                                                           Apical heart
                           Age                             rate  (beats
                                                            per minute)
------------------------------------------------------------------------
Under 1 yr..............................................             150
1 through 3 yrs.........................................             130
4 through 9 yrs.........................................             120
10 through 15 yrs.......................................             110
Over 15 yrs.............................................             100
------------------------------------------------------------------------


                      Table II.--Tachypnea at Rest
------------------------------------------------------------------------
                                                            Respiratory
                           Age                               rate over
                                                           (per minute)
------------------------------------------------------------------------
Under 1 yr..............................................              40
1 through 5 yrs.........................................              35
6 through 9 yrs.........................................              30
Over 9 yrs..............................................              25
------------------------------------------------------------------------

    104.05 Recurrent arrhythmias, not related to reversible causes 
such as electrolyte abnormalities or digitalis glycoside or 
antiarrhythmic drug toxicity, resulting in uncontrolled (see 
104.00A3g), recurrent (see 104.00A3c) episodes of cardiac syncope or 
near syncope (see 104.00E3), despite prescribed treatment (see 
104.00B3 if there is no prescribed treatment), and documented by 
resting or ambulatory (Holter) electrocardiography, or by other 
appropriate medical testing, coincident with the occurrence of 
syncope or near syncope.
    104.06 Congenital heart disease, documented by appropriate 
medically acceptable imaging (see 104.00A3d) or cardiac 
catheterization, with one of the following:
    A. Cyanotic heart disease, with persistent, chronic hypoxemia as 
manifested by:
    1. Hematocrit of 55 percent or greater on two evaluations 3 
months or more apart within a consecutive 12-month period (see 
104.00A3e); or
    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; or
    B. Secondary pulmonary vascular obstructive disease with 
pulmonary arterial systolic pressure elevated to at least 70 percent 
of the systemic arterial systolic pressure; or

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    C. Symptomatic acyanotic heart disease, with ventricular 
dysfunction interfering very seriously with the ability to 
independently initiate, sustain, or complete activities.
    D. For infants under 12 months of age at the time of filing, 
with life-threatening congenital heart impairment 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 the infant to be under disability until the attainment of 
at least age 1; thereafter, evaluate impairment severity with 
reference to the appropriate listing.
    104.09 Heart transplant. Consider under a disability for 1 year 
following surgery; thereafter, evaluate residual impairment under 
the appropriate listing.
    104.13 Rheumatic heart disease, with persistence of rheumatic 
fever activity manifested by significant murmurs(s), cardiac 
enlargement or ventricular dysfunction (see 104.00C2a), and other 
associated abnormal laboratory findings; for example, an elevated 
sedimentation rate or ECG findings, for 6 months or more in a 
consecutive 12-month period (see 104.00A3e). Consider under a 
disability for 18 months from the established onset of impairment, 
then evaluate any residual impairment(s).
* * * * *
[FR Doc. 04-20709 Filed 9-15-04; 8:45 am]
BILLING CODE 4191-02-P