[Federal Register: September 16, 2004 (Volume 69, Number 179)]
[Proposed Rules]
[Page 55873-55894]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se04-25]
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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
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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 regulations@ssa.gov; 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:
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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.
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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.)
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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:
http://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: http://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:
http://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: http://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: http://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: http://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:
http://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
[[Page 55894]]
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