[Federal Register Volume 71, Number 9 (Friday, January 13, 2006)]
[Rules and Regulations]
[Pages 2312-2340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-195]
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Part II
Social Security Administration
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20 CFR Part 404
Revised Medical Criteria for Evaluating Cardiovascular Impairments;
Final Rule
Federal Register / Vol. 71, No. 9 / Friday, January 13, 2006 / Rules
and Regulations
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SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
RIN 0960-AD48
Revised Medical Criteria for Evaluating Cardiovascular
Impairments
AGENCY: Social Security Administration.
ACTION: Final rules.
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SUMMARY: We are revising 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 revisions reflect advances in medical knowledge, treatment,
and methods of evaluating cardiovascular impairments.
DATES: These rules are effective April 13, 2006.
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.
FOR FURTHER INFORMATION CONTACT: Fran O. Thomas, Social Insurance
Specialist, Office of Regulations, Social Security Administration, 100
Altmeyer Building, 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: We are revising and making final the rules
we proposed for evaluating cardiovascular impairments in the Notice of
Proposed Rulemaking (NPRM) published in the Federal Register on
September 16, 2004 (69 FR 55874).
We provide a summary of the provisions of the final rules below,
with an explanation of the changes we have made from the text in the
NPRM. We then provide summaries of the public comments and our reasons
for adopting or not adopting the recommendations in those comments in
the section ``Public Comments.'' The final rule language follows the
Public Comments section.
What Programs Do These Final Regulations Affect?
These final regulations 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 and title XVI, these final regulations 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.
Widows, widowers, and surviving divorced spouses (see
Sec. 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 can be expected to last for a continuous period of
at least 12 months. Our definitions of disability are shown in the
following table:
------------------------------------------------------------------------
Disability means you
have a medically
If you file a claim under . . And you are . . . determinable
. impairment(s) as
described above 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..................... an individual age the inability to do
18 or older. any SGA.
title XVI..................... an individual marked and severe
under age 18. functional
limitations.
------------------------------------------------------------------------
How Do We Decide Whether You Are Disabled?
If you are seeking benefits under title II of the Act, or if you
are an adult seeking benefits under title XVI of the Act, we use a
five-step ``sequential evaluation process'' to decide whether you are
disabled. We describe this five-step process in our regulations at
Sec. Sec. 404.1520 and 416.920. We follow the five steps in order and
stop as soon as we can make a determination or decision. The steps are:
1. Are you working and is the work you are doing substantial
gainful activity? If you are working and the work you are doing is
substantial gainful activity, we will find that you are not disabled,
regardless of your medical condition or your age, education, and work
experience. If you are not, we will go on to step 2.
2. Do you have a ``severe'' impairment? If you do not have an
impairment or combination of impairments that significantly limits your
physical or mental ability to do basic work activities, we will find
that you are not disabled. If you do, we will go on to step 3.
3. Do you have an impairment(s) that meets or medically equals the
severity of an impairment in the listings? If you do, and the
impairment(s) meets the duration requirement, we will find that you are
disabled. If you do not, we will go on to step 4.
4. Do you have the residual functional capacity to do your past
relevant work? If you do, we will find that you are not disabled. If
you do not, we will go on to step 5.
5. Does your impairment(s) prevent you from doing any other work
that exists in significant numbers in the national economy, considering
your residual functional capacity, age, education, and work experience?
If it does, and it meets the duration requirement, we will find that
you are disabled. If it does not, we will find that you are not
disabled.
We use a different sequential evaluation process for children who
apply for payments based on disability under title XVI of the Act. We
describe that sequential evaluation process in Sec. 416.924 of our
regulations. If you are already receiving benefits, we also use a
different sequential evaluation process when we decide whether your
disability continues. See Sec. Sec. 404.1594, 416.994, and 416.994a of
our regulations. However, all of these processes include steps at which
we consider whether your impairment meets or medically equals one of
our listings.
What Are the Listings?
The listings are examples of impairments that we consider severe
enough to prevent you as an adult from doing any gainful activity. If
you are a child seeking SSI benefits based on disability, the listings
describe impairments that we consider severe
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enough to result in marked and severe functional limitations. Although
the listings are contained only in appendix 1 to subpart P of part 404
of our regulations 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 do
not 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 as an impairment in the listings. (See
Sec. Sec. 404.1526 and 416.926.)
What If You Do Not Have an Impairment(s) That Meets or Medically Equals
a Listing?
We use the listings only to decide that individuals are disabled or
that they are still disabled. We will not deny your claim because your
impairment(s) does not meet or medically equal a listing. If you are
not doing work that is substantial gainful activity, and 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'' described above. Likewise, we will not decide that
your disability has ended only because your impairment(s) does not meet
or medically equal a listing.
Also, when we conduct reviews to determine whether your disability
continues, we will not find that your disability has ended because we
have changed a listing. Our regulations explain that, when we change
our listings, we continue to use our prior listings when we review your
case, if you had qualified for disability benefits or SSI payments
based on our determination or decision that your impairment(s) met or
medically equaled a listing. 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 when we decide
whether you have experienced medical improvement in your condition(s).
See Sec. 416.994a(b)(2).
Why Are We Revising the Listings for Cardiovascular Impairments?
We are revising these listings to update our medical criteria for
evaluating cardiovascular impairments and to provide more information
about how we evaluate them. On April 24, 2002, we published final rules
in the Federal Register (67 FR 20018) that included technical revisions
to some of the listings for cardiovascular impairments. Prior to this,
we last published final rules making comprehensive revisions to the
listings for cardiovascular impairments in the Federal Register on
February 10, 1994 (59 FR 6468). Because we have not comprehensively
revised the listings for this body system since 1994, we believe that
we need to update the rules.
What Do We Mean by ``Final Rules'' and ``Prior Rules''?
Even though these rules will not go into effect until 90 days after
publication of this notice, for clarity, we refer to the changes we are
making here as the ``final rules'' and to the rules that will be
changed by these final rules as the ``prior rules.''
When Will We Start To Use These Final Rules?
We will start to use these final rules on their effective date. We
will continue to use our prior rules until the effective date of these
final rules. When these final rules become effective, we will apply
them to new applications filed on or after the effective date of these
rules and to claims pending before us, as we describe below.
As is our usual practice when we make changes to our regulations,
we will apply these final rules on or after their effective date when
we make a determination or decision, including those claims in which we
make a determination or decision after remand to us from a Federal
court. With respect to claims in which we have made a final decision,
and that are pending judicial review in Federal court, we expect that
the court's review of the Commissioner's final decision would be made
in accordance with the rules in effect at the time of the
administrative law judge's (ALJ) decision, if the ALJ's decision is the
final decision of the Commissioner. If the court determines that the
Commissioner's final decision is not supported by substantial evidence,
or contains an error of law, we would expect that the court would
reverse the final decision, and remand the case for further
administrative proceedings pursuant to the fourth sentence of section
205(g) of the Act, except in those few instances in which the court
determines that it is appropriate to reverse the final decision and
award benefits without remanding the case for further administrative
proceedings. In those cases decided by a court after the effective date
of the rules, where the court reverses the Commissioner's final
decision and remands the case for further administrative proceedings,
on remand, we will apply the provisions of these final rules to the
entire period at issue in the claim.
How Long Will These Final Rules Be Effective?
These rules will no longer be effective 5 years after the date on
which they become effective, unless we extend them or revise and issue
them again.
What General Changes Are We Making That Affect Both the Adult and
Childhood Listings for Cardiovascular Impairments?
We are reorganizing and expanding the evaluation guidance we
provide in the introductory text and improving its logical
presentation. We are also removing reference listings from this body
system. Reference listings are listings that are met by satisfying the
criteria of another listing. For example, prior listing 4.08, for
cardiomyopathies, was a reference listing that required evaluation
under listings 4.02, Chronic heart failure, 4.04, Ischemic heart
disease, 4.05, Recurrent arrhythmias, or 11.04, Central nervous system
vascular accident. Instead of using reference listings, we are
providing guidance in the introductory text stating that these
impairments should be evaluated under the criteria for the affected
body system. Where appropriate, we also provide references to specific
listings. For example, in final section 104.00F4, we indicate that
valvular heart disease should be evaluated under the criteria in 4.04
in part A, 104.02, 104.05, 104.06, or an appropriate neurological
listing under 111.00ff.
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How Are We Changing the Introductory Text to the Listings for
Evaluating Cardiovascular Impairments in Adults?
4.00 Cardiovascular Impairments
We are expanding and reorganizing the introductory text to these
listings to present the information in a more logical order, to provide
additional guidance, and to reflect the new listings. The following is
a detailed explanation of this material.
4.00A--General
In this section, we provide general information on what we mean by
the term ``a cardiovascular impairment'' and what we consider when we
evaluate cardiovascular impairments. Final section 4.00A1 incorporates
the information found in prior 4.00B, with some minor editing. Final
section 4.00A2 is taken from the first sentence of the first paragraph
of prior 4.00A.
Final section 4.00A3 is a new section containing definitions of
major terms we use in these final listings. In a nonsubstantive
editorial revision to the NPRM text, we clarified the definition of a
``consecutive 12-month period'' to explain better when the 12-month
period must occur.
4.00B--Documenting Cardiovascular Impairment
Final section 4.00B1 is based on the first sentence of prior
section 4.00C and the second sentence of prior section 4.00A. In it, we
provide information on the basic documentation that we need to evaluate
cardiovascular impairments under the listings. Final sections 4.00B2-
4.00B3 are based on the second and third paragraphs of prior section
4.00A. They 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 final
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 purchase studies, and specify what studies we will not
purchase. Much of this information is taken from prior sections 4.00C
and 4.00D, with some rephrasing to clarify our meaning. For example:
Final section 4.00B4a is based on prior section 4.00D1,
and the examples in final sections 4.00B4a(i) and 4.00B4a(ii) are based
on the first sentence of prior section 4.00D2.
Final section 4.00B5 is based on the second sentence of
prior section 4.00C2a and the third and sixth sentences of prior
section 4.00C3.
Final section 4.00B6 is based on information in prior
section 4.00C4.
4.00C--Using Cardiovascular Test Results
In this section, we discuss various specialized cardiovascular
tests and how we evaluate their results. In final section 4.00C1, we
explain what an electrocardiogram (ECG) is. Our specifications for ECG
tracings from prior section 4.00C1 are given in final section 4.00C2.
In final section 4.00C3, we explain what the different kinds of
exercise tests are and discuss their uses; the section includes
information from various provisions throughout prior sections 4.00C and
E, but we have also included additional guidance and definitions.
Exercise testing is the most widely used testing for identifying the
presence of myocardial ischemia and for estimating maximal aerobic
capacity. 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 final section 4.00C4, we discuss the
limitations of exercise tolerance tests (ETTs) as evidence for
disability evaluation. We repeat our longstanding policy that ETTs
estimate your ability to walk on a grade, bicycle, or move your arms in
an environmentally controlled setting, so they do not correlate with
the ability to perform other types of exertional activities and do not
provide an estimate of your ability to perform activities required for
work in all possible work environments or throughout a workday. Final
section 4.00C5 is based on the second paragraph of prior section
4.00C3. In it, we explain what ETTs with measurement of maximal or peak
oxygen uptake are and how they differ from other ETTs. We also explain
what METs (metabolic equivalents) are and how they are calculated when
not given in the report of an ETT with measurement of maximal or peak
oxygen uptake.
In final section 4.00C6, we explain when we will consider
purchasing an exercise test for case evaluation. Like final section
4.00B5, it is based on the second sentence of prior section 4.00C2a. As
a result of a comment we describe below, we revised the language we
proposed to clarify that we purchase an exercise test only when we need
one to make a determination or decision.
In final section 4.00C7, we explain what we must do before we
purchase an exercise test. The final rule combines a number of related
provisions that were not grouped together in our prior rules and also
adds a provision that provides additional safeguards for individuals
that we ask to go for stress testing that we purchase.
In final section 4.00C7a, as in the third sentence of prior section
4.00C2a and the second sentence of prior section 4.00C2c, we 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 followed
under our prior rules.)
Final section 4.00C7b corresponds to the fourth sentence of prior
section 4.00C2e(1). In it, we explain that if you are under the care of
a treating source for your cardiovascular impairment, this source has
not performed an exercise test, and there are no reported significant
risks to testing, we will request a statement from the source
explaining why an exercise test was not done.
Final section 4.00C7c explains that an MC will generally give
``great weight'' to your treating source's opinion about the risk of
exercise testing to you and will generally not override such an
opinion; this policy was in the third sentence of prior section
4.00C2c. As in the NPRM, we are also including the provision that was
in the fourth sentence of prior section 4.00C2c to require that in the
rare situation in which the MC does override a treating source's
opinion the MC must provide a written rationale documenting the reasons
for overriding the opinion.
Final section 4.00C7d corresponds to the last sentence of prior
section 4.00C2e(1). It explains that 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 of exercise testing to you.
Final section 4.00C7e is new in our cardiovascular listings. It
explains that, when we purchase an exercise test, we must send copies
of your records to the medical source who conducts the test for us if
he or she does not already have them. We also provide that this
individual has the ultimate
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responsibility for determining whether you would be at risk if you take
the test.
In final section 4.00C8, we reorganize and modify the information
on ``significant risk'' from the first sentence of prior section
4.00C2c. We are doing this because some of the so-called risk factors
identified in the prior rule were not risks per se, but factors that
affect proper interpretation of the tracings or situations that only
temporarily preclude exercise testing. We identify several different
categories that explain the various circumstances under which we will
not purchase an ETT or will defer purchasing one. We 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 in the NPRM, 69 FR 55874,
55881-55882.) In response to a comment discussed in the public comments
section of this preamble below, we have added a provision in the final
rules, final section 4.00C8c, explaining that we will not purchase an
ETT to document the presence of a cardiac arrhythmia. Final section
4.00C8d (proposed section 4.00C8c) is based on the first and second
sentences of prior section 4.00C2d, the paragraph that explained when
we will wait following specific cardiac events before we purchase an
exercise test. Final section 4.00C8e corresponds to the last sentence
of prior paragraph 4.00C2d; it explains that we will wait an
appropriate period of time before we purchase an exercise test if you
are deconditioned after an extended period of bedrest or inactivity. As
in the NPRM, we removed the example of ``2 weeks'' from the prior rule
to avoid any suggestion that a 2-week recovery period will generally be
sufficient. The amount of time we may need to wait will depend on the
particular facts of your case.
In final section 4.00C9, we explain when we consider exercise test
results to be ``timely.'' Final section 4.00C9a corresponds to the last
sentence of prior section 4.00C2a, explaining that 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. In final
4.00C9b and 4.00C9c, we are expanding this topic to explain how we
consider tests that are not timely.
Final section 4.00C10 discusses the performance requirements of
tests that we purchase, while final section 4.00C11 discusses how we
evaluate all ETT results. We retained these provisions from prior
sections 4.00C2b and the first three sentences of prior section
4.00C2e(1). In final section 4.00C10a, we added a sentence that we did
not include in the NPRM. The sentence explains that exercise tests may
also be performed using echocardiography to detect stress-induced
ischemia and left ventricular dysfunction. This additional guidance
will make more complete our explanation of the types of ETTs we may
purchase in appropriate cases.
We explain when ETTs are done with imaging and when we will
consider purchasing such tests in final sections 4.00C12-4.00C13; the
provisions are based on prior section 4.00C3. We provide new guidance
on drug-induced stress tests, what they are, how they are used, and
when we may purchase them, in final section 4.00C14.
Final section 4.00C15 includes the information found in prior
section 4.00C4 on two types of cardiac catheterization reports, the
details that these reports should contain, and what we consider when
evaluating these reports. Final sections 4.00C16 and 4.00C17 describe
Doppler exercise tests and when we will purchase them. In response to a
comment described below, we revised final section 4.00C16 to clarify
which details are required in reports of exercise Doppler studies and
what information should be obtained. We specify that the tracings
should be included with the report and that they must be annotated with
the standardization used by the testing facility. In final section
4.00C17, as in the NPRM, we changed the requirement in the third
paragraph of prior section 4.00E4 for walking on a ``10 or 12 percent
grade'' to a ``12 percent grade.'' This change makes our rules
consistent with how the test is generally done. In a nonsubstantive
editorial revision to the NPRM text, we have also clarified that you
must exercise for ``up to 5 minutes'' to recognize that some
individuals will be unable to exercise for a full 5 minutes. The
language we proposed in the NPRM could have been misread to mean that
we require everyone to exercise for 5 minutes even if they are unable
to do so. We also provide that, 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 4.00C6, 4.00C7, and 4.00C8.
Finally, in a technical clarification, we revised the heading of final
section 4.00C17 from the proposed heading to change the word ``should''
to ``must.'' This is because the final rule (like the NPRM) specifies
what we require in any exercise Doppler test we purchase.
In final sections 4.00D-4.00H, we provide general medical
information on the various cardiovascular impairments and information
on how we evaluate each of them using the final listing criteria. We
incorporate information found in prior section 4.00E and guidance we
have provided to our adjudicators in instructions that were not in the
prior listings. We also add some new information, as described below.
4.00D--Evaluating Chronic Heart Failure
In final 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--systolic and diastolic. Final section 4.00D1b
is based on prior section 4.00E1. We explain that we will now evaluate
cor pulmonale under respiratory system listing 3.09, rather than
listing 4.02, as it is a heart condition resulting from a respiratory
disorder. (In a related change, described later in this preamble, we
are also removing a cross-reference to the cardiovascular listings from
listing 3.09.)
In final sections 4.00D2 and 4.00D3, we describe the evidence that
we need for evaluating chronic heart failure and explain how ETTs may
be used to evaluate individuals with known chronic heart failure. We
added a reference in final section 4.00D3 to the section on when we
will consider the purchase of an ETT (final section 4.00C6). In
response to a comment on the last sentence of proposed section 4.00D3,
we revised the sentence to clarify our intent, that ST segment changes
from digitalis use in the treatment of chronic heart failure do not
preclude the purchase of an ETT in cases involving chronic heart
failure.
In the NPRM, proposed section 4.00D4 was a single paragraph that
explained what we mean by ``periods of stabilization'' in listing
4.02B2. In the final rules, we have changed the heading of the section
to ``How do we evaluate CHF using 4.02?'' and expanded the section to
include four subparagraphs. The changes are not substantive, but only
clarify generally how we use listing 4.02. They also explain how we use
a criterion that is common to listings 4.02B3c and 4.04A3: In the NPRM,
we explained how the criterion applies in listing 4.04A3 but
inadvertently did not include the same explanation for listing 4.02B3c.
In final section 4.00D4a, and consistent with the provisions of
final
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section 4.00D2, we explain that we need objective evidence of chronic
heart failure. In final section 4.00D4b, we repeat the requirement of
final listing 4.02 that your impairment must satisfy one of the
criteria in both A and B of that listing to meet the listing. Neither
of these new sections provides any additional substantive guidance that
was not already inherent in the proposed rules; however, they do
explain more clearly how to use final listing 4.02.
Final section 4.00D4c corresponds to proposed section 4.00D4. Based
on a suggestion from a commenter, we changed the duration of the
periods of stabilization from 5 days to 2 weeks to allow for
variability during medication titrations. We discuss the comment and
our reasons for making the change in the public comments section later
in this preamble.
Final section 4.00D4d addresses the criterion that is common to
final listings sections 4.02B3c and 4.04A3: a requirement for a 10 mmHg
decrease in systolic blood pressure below the baseline systolic blood
pressure. We provided a detailed explanation of this provision in
proposed section 4.00E9e, which addressed ischemic heart disease, but
inadvertently omitted the same explanation for the virtually identical
provision for CHF. Therefore, in these final rules, we moved the text
of proposed section 4.00E9e to final section 4.00D4d because it comes
first in the introductory text. In final section 4.00E9e, we now
include only a cross-reference to the provisions we moved to final
4.00D4d instead of repeating the entire paragraph.
4.00E--Evaluating Ischemic Heart Disease
In final section 4.00E, for ischemic heart disease (IHD), we
incorporate most of the information in prior section 4.00E3. We explain
what IHD is and what causes chest discomfort of myocardial origin in
final sections 4.00E1 and 4.00E2. We move and revise slightly the
material on chest discomfort of myocardial ischemic origin from prior
section 4.00E3e to final section 4.00E2 and explain that individuals
with IHD may experience manifestations other than typical angina
pectoris. We also deleted the final sentence in prior section 4.00E3e
as it was not useful adjudicative guidance. We discuss the
characteristics of typical angina pectoris in final section 4.00E3.
This section is based on and incorporates material from prior section
4.00E3a. In final section 4.00E4, we include a definition of, and
information on, atypical angina, which we included in our discussion of
anginal equivalent in prior section 4.00E3b. We discuss anginal
equivalent in final section 4.00E5. The material on anginal equivalent
is based on prior 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. Final section 4.00E6, on variant
angina, is based on prior 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 final section 4.00E7, we expand the discussion of silent
ischemia that appeared in prior 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 ECG
monitoring (Holter) equipment, and how we evaluate it. We move the
material on chest discomfort of non-ischemic origin from prior section
4.00E3f to final section 4.00E8. We 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 final section 4.00E9, we explain how we evaluate IHD using the
criteria in listing 4.04. In a nonsubstantive editorial change from the
NPRM text, we specify in final section 4.00E9b how ischemia is
confirmed in possible false-positive test situations, to conform to the
language in final section 4.00E9d. We changed the reference to
``appropriate medically acceptable imaging techniques'' to
``radionuclide or echocardiogram confirmation'' because these are the
appropriate medically acceptable imaging techniques for diagnosing
ischemia in possible false-positive situations. We also added a
reference to final sections 4.00C12 and 4.00C13, which discuss ETTs
done with imaging.
In the next-to-last sentence of the final section 4.00E9d, we also
added a reference to echocardiography in addition to the reference to
radionuclide testing we had already included in the NPRM. Again,
radionuclide and echocardiogram confirmation are the appropriate
medically acceptable imaging techniques for diagnosing ischemia in
possible false-positive situations. We also added a reference to final
sections 4.00C12 and 4.00C13; this will make final sections 4.00D4b and
4.00D4d consistent with each other. As already noted, we moved the text
we included in proposed section 4.00E9e to final section 4.00D4d
because final listing sections 4.02B3c and 4.04A3 are identical.
Instead of repeating the same provisions in final sections 4.00D4d and
4.00E9e, we abbreviate the explanation of the 10 mmHg decrease in
systolic blood pressure required in final listing 4.04A3 and add a
reference to the detailed discussion in final section 4.00D4d.
We also clarified and moved the explanation of what we mean by
``nonbypassed'' from proposed section 4.00E9g into a new section, final
section 4.00E9h, because it is a different subject from what is
addressed in final section 4.00E9g.
4.00F--Evaluating Arrhythmias
In final section 4.00F, we provide information on evaluating
arrhythmias. We explain what arrhythmias are and discuss the different
types in final sections 4.00F1-4.00F2. We made a nonsubstantive
editorial revision, rearranging the NPRM material by combining the
provisions of proposed sections 4.00F3 and 4.00F4 in final section
4.00F3 under the heading ``How do we evaluate arrhythmias under 4.05?''
Thus, final section 4.00F3a corresponds to proposed section 4.00F4, on
the use of listing 4.05 when there is an implanted cardiac
defibrillator, and final sections 4.00F3b and 4.00F3c correspond to
proposed section 4.00F3. In final section 4.00F3b, we explain what we
mean by ``near syncope'' in final listing 4.05. In final section
4.00F3c, we add information on the evidence we need to document the
required association between your syncope or near syncope and your
cardiac arrhythmia. Because of a comment that tilt-table testing is
frequently used to establish the presence of arrhythmia, we reexamined
our position on tilt-table testing. In the final rules, we removed the
proposed prohibition for the use of tilt-table testing as acceptable
documentation of arrhythmia and included new guidance for using such
testing. We specify that the tilt-table testing must be done
concurrently with an ECG, and that the symptom of syncope or near
syncope must be associated with the arrhythmia.
We redesignated proposed section 4.00F5 as final section 4.00F4, in
which we provide information on implantable cardiac defibrillators and
how we will evaluate arrhythmias if you have an implanted cardiac
defibrillator, to
[[Page 2317]]
reflect the foregoing reorganization of the proposed provisions.
4.00G--Evaluating Peripheral Vascular Disease
In final section 4.00G, the section on peripheral vascular disease
(PVD), we incorporate the information in prior section 4.00E4 and
provide additional information and guidance on the evaluation of PVD
based on questions we have received in the past. Final section 4.00G1
explains what we mean by PVD and describes its usual effects. In a
nonsubstantive editorial revision, we rearranged the third sentence and
added a description of the effects of advanced PVD. In final section
4.00G2, we explain how we assess the limitations resulting from PVD.
This section is based on prior 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.
In final section 4.00G3, we define ``brawny edema'' and explain how
it is different from pitting edema, adding to the NPRM language a brief
explanation of the term ``pit.'' As in the NPRM, we also clarify that
pitting edema does not satisfy the requirements of listing 4.11A. In a
nonsubstantive editorial revision, we combined proposed sections 4.00G4
and 4.00G5, on what lymphedema is and what causes it, and the guidance
on the evaluation of lymphedema into one section devoted to lymphedema,
final section 4.00G4. The final rules provide that we will evaluate
lymphedema under the listing for the underlying cause or 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.
In the final rules, we rearranged proposed sections 4.00G6-4.00G12
to present the information more logically and to follow the order of
final listings 4.11 and 4.12 more closely. We moved proposed section
4.00G8, on when we will obtain exercise Doppler studies for the
evaluation of peripheral arterial disease (PAD), which we took from
prior section 4.00E4, to final section 4.00G5. We moved proposed
section 4.00G11 to final section 4.00G6. That section describes other
studies that are helpful in evaluating PAD, 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 the potential for similar vascular changes.
In final section 4.00G7, we combine proposed sections 4.00G6,
4.00G7, and 4.00G9 to describe how we evaluate PAD under final listing
4.12. In final section 4.00G7a (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 more
significant in assessing the extent of arterial insufficiency.
In final section 4.00G7b (proposed section 4.00G7), we take
information from the third paragraph of prior section 4.00E4 on how the
ankle/brachial ratio is determined for purposes of evaluating a claim
under final 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. For medical accuracy, we removed ``duplex scanning
with color imaging'' from the NPRM's list of techniques for obtaining
ankle systolic blood pressures because, although it is done in
conjunction with testing, it does not measure pressures. We also
specify that we will request any available tracings from those listed
techniques, so that we can review them.
In final section 4.00G7c (proposed section 4.00G9), we add guidance
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 also add two new criteria in final listing 4.12 using toe
pressure and toe/brachial pressure ratio.
We redesignated the remaining sections of proposed 4.00G because of
the foregoing reorganization. In final section 4.00G8 (proposed section
4.00G10), we explain how toe pressures are measured. In final section
4.00G9 (proposed section 4.00G12), we discuss the similarities between
peripheral grafting and coronary grafting and explain how we will
evaluate cases involving peripheral grafting.
4.00H--Evaluating Other Cardiovascular Impairments
In final section 4.00H, we provide guidance on evaluating other
cardiovascular impairments. In final section 4.00H1, we discuss the
evaluation of hypertension, rephrasing material found in prior section
4.00E2. We explain what congenital heart disease is and provide
guidance on how we will evaluate symptomatic congenital heart disease
in final section 4.00H2, combining proposed sections 4.00H2 and 4.00H3
in a nonsubstantive editorial revision. In final section 4.00H3
(proposed section 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 final section 4.00H4 (proposed section
4.00H5). We discuss the evaluation of heart transplant recipients in
final section 4.00H5 (proposed section 4.00H6). In final section 4.00H6
(proposed section 4.00H7), we explain when an aneurysm has ``dissection
not controlled by prescribed treatment'' as required under final
listing 4.10. We add guidance on what hyperlipidemia is and how we will
evaluate it in final section 4.00H7 (proposed section 4.00H8).
Because of a comment described below in the public comments section
of this preamble, we added a new section, final section 4.00H8, to
discuss Marfan syndrome and how we evaluate its manifestations.
4.00I--Other Evaluation Issues
In this section, we provide guidance on a variety of issues. In
final section 4.00I1, we explain the evaluation of obesity's effect on
the cardiovascular system. The guidance in this section is taken from
prior section 4.00F, with minor edits, and incorporates additional
guidance we included in Social Security Ruling 02-1p (``Titles II and
XVI: Evaluation of Obesity,'' 67 FR 57859 (2002)). Final section 4.00I2
explains how we relate treatment to functional status. This section is
based on prior section 4.00D; we have deleted some language that dealt
with listing-level impairment from the prior section and made
nonsubstantive editorial changes. If the anticipated improvement might
affect the determination or decision in the case, we will wait an
appropriate length of time in order to evaluate the results of the
treatment. Finally, in final 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 prior section 4.00A.
[[Page 2318]]
How Are We Changing the Listings for Evaluating Cardiovascular
Impairments in Adults?
4.01--Category of Impairments, Cardiovascular System
We are deleting 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 are deleting these reference 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 final listing
criteria.
4.02--Chronic heart failure
We change the format of prior listing 4.02, creating two new
sections, 4.02A and 4.02B. For the listing to be met, both the 4.02A
and 4.02B requirements must be satisfied. We move the required imaging
findings that are generally associated with the clinical diagnosis of
heart failure from prior listings 4.02A and 4.02B to final listings
4.02A1 and 4.02A2 and revise them to reflect the anatomical changes
associated with systolic and diastolic dysfunction, respectively; in a
minor edit, we replaced the reference we included in proposed sections
4.02A1 and 4.02A2 with a brief explanation of what we mean by ``a
period of stability.'' The prior listing had different criteria for
heart failure in sections 4.02A and 4.02B and did not provide criteria
for both systolic and diastolic failure. Additionally, because the
criterion in prior listing 4.02A of 5.5 cm is generally considered the
high end of normal for heart size, we change the left ventricular
diastolic diameter to left ventricular end diastolic dimensions greater
than 6.0 cm. This change more clearly establishes an enlarged heart
that would result in the signs and symptoms associated with listing-
level severity.
We also redesignate prior listing 4.02A as final listing 4.02B1 and
revise the criteria. The prior listing included a description of heart
failure and referred to the ``inability to carry on any physical
activity,'' which implied that the individual must be bedridden. Our
program experience shows that this listing was set at too high a level
of severity and was little used. We have removed the description of
heart failure and rephrased the criteria in final listing 4.02B1 to
describe an ``extreme'' limitation; that is, an impairment that very
seriously limits your ability to independently initiate, sustain, or
complete activities of daily living. This is modeled after our other
rules that define listing-level severity in terms of an ``extreme''
limitation; for example, the definition of ``inability to ambulate
effectively'' in the musculoskeletal listings, section 1.00A2b(1). This
listing may be used only if the performance of an exercise test would
present a significant risk to you.
We add a new criterion in final listing 4.02B2 to include
individuals who have frequent acute episodes of heart failure, showing
that the heart failure is not well-controlled by the prescribed
treatment. This also provides another avenue that allows us to make
favorable determinations or decisions in certain cases without ETTs.
We redesignate prior listing 4.02B1 as final listing 4.02B3. We
also revise it by specifying in final listing 4.02B3a the symptoms of
chronic heart failure that might cause termination of an ETT. This
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 final 4.02B3b through 4.02B3d. We change the ``three or more
multiform beats'' in prior listing 4.02B1a to ``increasing frequency of
ventricular ectopy with at least 6 premature ventricular contractions
per minute'' in final 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 final listing 4.02B3c, we eliminate the criterion for
``[f]ailure to increase systolic blood pressure by 10 mmHg,'' from
prior 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 specify only an
amount of decrease from the baseline systolic blood pressure or the
preceding systolic pressure measured during exercise, due to left
ventricular dysfunction, despite an increase in workload, at which the
test should be terminated. In the final rule, we made minor revisions
to the language of listings 4.02B3c and 4.04A3, which were slightly
different from each other, to make them match exactly as we originally
intended. These revisions do not substantively change either of the
criteria, but are only for language consistency. We redesignate prior
listing 4.02B1c, for signs attributable to inadequate cerebral
perfusion, as final listing 4.02B3d, but make no other changes to it.
We remove prior listing 4.02B2, the functional criterion that calls for
``marked limitation of physical activity,'' because it is unnecessary.
If you satisfy one of the final listing 4.02A criteria and one of the
final listing 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.
4.04--Ischemic Heart Disease
In the header text, we change ``chest discomfort'' to ``symptoms''
because some individuals have discomfort in other parts of their body,
such as an arm, their back, or their neck, or have other symptoms, such
as shortness of breath (dyspnea), associated with ischemia. In final
listing 4.04A1, we 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 appeared in prior
listing 4.04A1 because we believe it is unnecessary. We also eliminate
the prior listing 4.04A2 criterion. The ACC/AHA Guidelines for Exercise
Testing indicate that an upsloping ST junction depression, as described
in the prior criterion, has less specificity (more false-positive
results) and favors the more commonly used horizontal or downsloping ST
depression. We redesignate the subsequent criteria.
In final listing 4.04A2 (prior listing 4.04A3), we 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
reduce the requirement for the ST elevation during recovery from ``3 or
more minutes'' to ``1 or more minutes.'' We believe that this ST
elevation in non-infarct leads is of such significance that ST
elevation for 1 minute or more during recovery is sufficient to show an
impairment of listing-level severity. In listing 4.04A3
[[Page 2319]]
(prior listing 4.04A4), we eliminate the phrase ``[f]ailure to increase
systolic pressure by 10 mmHg'' for the reasons previously discussed
under the explanation of listing 4.02B3c. We also specify that there
must be a decrease of 10 mmHg below baseline or the preceding systolic
pressure measured during exercise due to left ventricular dysfunction,
despite an increase in workload, because exercise normally raises blood
pressure and a decrease during exercise reflects the presence of
ischemia. As already noted, we made minor revisions to the language of
final listing 4.04A3 to make it the same as final listing 4.02B3c.
We revise prior listing 4.04A5, but 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 also redesignate it as final listing 4.04A4.
We are adding a new listing 4.04B criterion. The new criterion
provides that your impairment meets the listing if you have three
separate ischemic episodes, each requiring revascularization
(angioplasty or bypass surgery) or not amenable to revascularization,
within a consecutive 12-month period. Because this is a new, additional
listing criterion, it will permit us to allow some cases more quickly.
In the header text for final listing 4.04C, we added the phrase
``or other appropriate medically acceptable imaging'' because this area
of technology is rapidly improving. Thus, we are providing for the
likelihood that imaging other than angiography will soon be able to
identify the extent of blockage resulting from coronary artery disease.
We also change the phrase ``evaluating program physician'' from the
prior listing to ``MC'' to be consistent with our terminology
throughout these final rules and in other regulations. Because not
everyone who has the cited findings has ischemia, we add that this
listing can be used only ``in the absence of a timely exercise
tolerance test or a timely normal drug-induced stress test.''
We also revise the prior 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 conforms to the
criterion in prior listing 4.04C1b for a nonbypassed coronary artery,
which we are not changing. When we originally published the prior 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. In the final rules, we
revise the prior listing 4.04C2 criterion for functional limitations
using substantively the same language as in final listing section
4.02B1.
4.05--Recurrent Arrhythmias
We 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 final section 4.00A3 that we use throughout these
final rules. We remove the phrase ``and arrhythmia'' that followed
``near syncope'' in prior listing 4.05, because it was redundant;
listing 4.05 is for ``[r]ecurrent arrhythmias.'' We also 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 any appropriate medically acceptable tests
developed for arrhythmia in the future, and refer to final section
4.00F3c, the paragraph that describes how we consider test findings in
cases of arrhythmia.
4.06--Symptomatic Congenital Heart Disease
Because we are eliminating prior reference listings 4.06C and
4.06D, we redesignate prior listing 4.06E as final listing 4.06C. In
final listing 4.06C, we 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.
4.09--Heart Transplant
We change the name from ``Cardiac transplantation'' to ``Heart
transplant'' consistent with terminology in our other listings. We also
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 remove the guidance in
the prior listing to evaluate the residual impairment under listings
``4.02 to 4.08,'' and substitute the phrase ``the appropriate
listing.'' This clarifies that other listings besides listings 4.02
through 4.08 may apply, including listings in other body systems.
4.10--Aneurysm of Aorta or Major Branches
As we have already noted, we remove listings 4.10B through 4.10D
because they are reference listings. We incorporate prior listing 4.10A
into the header text, because it was the sole remaining listing.
Because dissection of an aorta must be either acute or chronic, we
remove those descriptors as unnecessary in this context. We also change
the description of treatment to ``prescribed treatment,'' which
includes both medical and surgical methods, and include a cross-
reference to final section 4.00H6, the section that explains what a
dissecting aneurysm is and when we consider that it is not controlled
by prescribed treatment.
4.11--Chronic Venous Insufficiency
In final listing 4.11A, we add language to clarify what we mean by
``extensive'' brawny edema. We provide that brawny edema is
``extensive'' if it involves at least two-thirds of the leg between the
ankle and knee. In response to a comment, we removed the word
``approximately'' from this criterion and added an additional
descriptor, ``or the distal one-third of the lower extremity between
the ankle and hip'' for further clarity. In final listing 4.11B, as in
the NPRM, we refer only to ``prescribed treatment,'' which includes
both medical and surgical methods. This is a clarification of the prior
listing, which used the phrase ``prescribed medical or surgical
therapy.'' These changes also help to clarify that the phrase ``that
has not healed following at least 3 months of prescribed treatment''
applies only to ``persistent'' ulceration.
4.12--Peripheral Arterial Disease
In final listing 4.12, we remove prior 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. If intermittent
claudication continues following surgery, we will evaluate it under the
remaining criteria of this listing. We redesignate prior listings
4.12B1 and 4.12B2 as final listings 4.12A and 4.12B. (Note: We removed
prior listing 4.12C, amputation, when we published the final
musculoskeletal rules, which were effective February 19, 2002. See 66
FR 58010.)
We also revise the criteria on the methods for establishing
peripheral arterial disease by substituting the phrase ``appropriate
medically acceptable imaging'' for the prior reference to ``Doppler
studies.'' In final listing 4.12B (prior listing 4.12B2), we eliminate
the phrase ``at the ankle'' following ``pre-exercise level'' because it
is redundant.
We also add two new listings, final listings 4.12C and 4.12D, for
the use of resting toe systolic blood pressures and
[[Page 2320]]
resting toe/brachial systolic blood pressure ratios. As we explained
under the discussion of final section 4.00G7c, ankle pressures can be
misleadingly high when you have a disease that results in abnormal
arterial calcification or small vessel disease, but the toe pressure is
seldom affected by these vascular changes.
How Are We Changing the Introductory Text to the Listings for
Evaluating Cardiovascular Impairments in Children?
We expand and reorganize the introductory material in 104.00 to
provide additional guidance and to reflect the final listings. Because
of the extensive information and guidance included in the introductory
text for the listings, and as in the adult listings in part A, we 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 final 4.00 in the
introductory text to final 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 and revisions under the
explanation of 4.00, the following discussions describe only those
provisions or revisions that are unique to the childhood rules or that
require further explanation.
104.00A--General
In final section 104.00A3, we explain the same terms and phrases as
in final section 4.00A4, but also include an explanation of the phrase
``currently present,'' which appears only in the childhood listings for
reasons we explain below.
104.00B--Documenting Cardiovascular Impairments
In final section 104.00B5, we specify that ``[w]e 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 final sections 104.00B7a and 104.00B7b, we include the
discussion, with some nonsubstantive editorial changes, on the use of
exercise testing in children that was found in the third and fourth
paragraphs of prior section 104.00B. In final section 104.00B7c, we
include a cross-reference to the guidance on ETT requirements and usage
found in final section 4.00C in part A. We did not repeat that section
in part B because it addresses cardiovascular tests used mainly for the
diagnosis and evaluation of ischemia, which is rare in children.
However, if a child has IHD, documentation and evaluation are the same
as for an adult. (See 20 CFR 416.925(b)(1).)
104.00C--Evaluating Chronic Heart Failure
In final section 104.00C1, we do not differentiate between systolic
and diastolic dysfunction, as we do with adults in final section
4.00D1a, because in children it is unlikely that a specific type of
dysfunction will be clearly identified. For children, certain
laboratory findings of cardiac functional and structural abnormality in
support of the diagnosis of CHF are sufficient. In final 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 final
section 104.00C2a(i)(C) the chest x-ray findings cited in the second
paragraph of prior section 104.00E. In final section 104.00C2b, we
include the information found in the first and third paragraphs of
prior section 104.00E with some rephrasing for clarity but no
substantive changes.
104.00D--Evaluating Congenital Heart Disease
In final section 104.00D, we move the list of examples of
congenital heart defects from the second paragraph of prior section
104.00A to final section 104.00D1, with some minor edits. We make a
nonsubstantive editorial revision in final section 104.00D2, combining
proposed sections 104.00D2, 104.00D3, and 104.00D4 into a discussion of
how we will evaluate symptomatic congenital heart disease. In final
section 104.00D2a (proposed section 104.00D4), we repeat the discussion
of symptomatic congenital heart disease in final section 4.00H3 with
minor changes to address children. We delete the information contained
in the third paragraph of prior 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. In
final section 104.00D2b (proposed section 104.00D2), we state that we
will accept pulse oximetry measurements instead of arterial
O2 values when evaluating children under final listing
104.06A2. However, if the arterial O2 values are available,
they are preferred because they are the most accurate. In final section
104.00D2c (proposed section 104.00D3) we list examples of congenital
heart defects that we will evaluate under final listing 104.06D. We
took this material from the first and second paragraphs of prior
section 104.00D.
104.00E--Evaluating Arrhythmias
This section is substantively identical to the corresponding
section in the final adult listing, 4.00F, with minor editorial changes
that refer specifically to children.
104.00F--Evaluating Other Cardiovascular Impairments
In final section 104.00F, we address other cardiovascular
impairments that may affect children and that are not already discussed
in previous sections, such as chronic rheumatic fever or rheumatic
heart disease, omitting some 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 part A
listings, as we explain in Sec. 416.925(b) of our regulations and in
the introductory paragraph to the table of contents in part A of the
listings.
Final section 104.00F contains much of the same information found
in final section 4.00H, with the following differences.
We address ischemia only briefly in section 104.00F1, instead of
discussing it in detail as in the adult rules, because it is rare in
children. Because the documentation and evaluation are the same as for
adults, we refer to final section 4.00E and final listing 4.04 in part
A. As we have already noted, these provisions are also applicable to
ischemia in children. Final section 104.00F2, on how we will evaluate
hypertension, is similar to final section 4.00H1, but we have modified
it to reflect the particular effects of hypertension in children.
In the preamble to the NPRM, we listed the reference listings that
we proposed to remove as redundant and said that we were including
guidance on how to evaluate the affected impairments in the
introductory text. See 69 FR 55880. However, we inadvertently omitted a
discussion of cardiomyopathies (included in prior listing 104.08) from
the proposed introductory text. To correct this oversight, we have
added a section on cardiomyopathy, final section 104.00F3. The final
rule is the same as the corresponding adult section, final section
4.00H3, with minor changes to refer to children.
In final section 104.00F6, we include the information on chronic
rheumatic fever and rheumatic heart disease found in prior section
104.00G. We refer to the
[[Page 2321]]
appropriate cardiovascular listings for the evaluation of chronic heart
failure and arrhythmias associated with rheumatic heart disease. In
section 104.00F8, we discuss how we will evaluate Kawasaki disease
(formerly called Kawasaki syndrome), which usually develops before age
5. We have also added a section on Marfan syndrome in final section
104.00F10; it is the same as final section 4.00H8 in part A.
How Are We Changing the Listings for Evaluating Cardiovascular
Impairments in Children?
104.01 Category of Impairments, Cardiovascular System
We are deleting the following prior 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 are
deleting 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 are deleting prior 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 final listing 104.06D. We also are deleting the prior
hyperlipidemia listings that are not reference listings, prior listings
104.14B, 104.14C, and 104.14D, because there is better treatment now
available for hyperlipidemia making it less likely to result in
limitations of listing-level severity. We will evaluate
hyperlipidemia's effect on a child under a listing for the affected
body system when appropriate. We also delete prior 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 for
those effects.
The following is a detailed explanation of the final listing
criteria.
104.02--Chronic Heart Failure
We add language to the header text to clarify that the heart
failure must occur ``while on a regimen of prescribed treatment.''
Final listings 104.02A and 104.02B and their associated tables are the
same as the prior listings. Because we deleted prior reference listing
104.02C, Recurrent arrhythmias, which refers the adjudicator to listing
104.05, we are redesignating prior listing 104.02D, Growth disturbance,
as final listing 104.02C. We also 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 under this listing
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 in 100.00. The current growth charts are
available online at: http://www.cdc.gov/growthcharts/.
104.05--Recurrent Arrhythmias
We use the same language as in final listing 4.05.
104.06--Congenital Heart Disease
In the header text of this section, we add language on
documentation by appropriate medically acceptable imaging or cardiac
catheterization, to make it parallel to the adult listing. In final
listing 104.06A1, we revise the language on the frequency of the
hematocrit finding to better capture persistence of the finding.
Because we remove prior reference listings 104.06B and 104.06C, we
redesignate prior listing 104.06D as final listing 104.06B. In this
listing, we no longer refer to ``mean'' pulmonary artery pressure, for
the reason discussed under the explanation of final listing 4.06. We
also clarify that we will use the systolic pressures for purposes of
this listing. We remove prior listing 104.06E, because it was a
reference listing, and redesignate prior listing 104.06F as final
listing 104.06C. We also revise the language of prior listing 104.06C
to reflect the definition of an ``extreme'' limitation, found in Sec.
416.926a(e)(3) of our regulations.
Finally, we remove prior reference listing 104.06G, redesignate
prior listing 104.06H as final listing 104.06D and remove the
references to two specific cardiovascular listings to allow for
reference to any appropriate listing in any body system. Also in final
listing 104.06D, we change the language that previously directed 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 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 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 will not
apply to surgery for congenital heart impairments that routinely result
in prompt recovery or less severe residual impairment.
104.09--Heart Transplant
We use the same language as in final listing 4.09.
104.13--Rheumatic Heart Disease
We change the heading by removing the reference to ``[c]hronic
rheumatic fever'' because the impairment is related to the resulting
heart disease, not the ``fever.'' We also include prior listing 104.13A
with the prior header text, with some reorganization of the material.
We remove listings 104.13B and 104.13C because they are reference
listings.
What Other Revisions Are We Making?
As we have already noted in our explanation of final section
4.00D1, cor pulmonale will be evaluated under the respiratory listings,
as it is a heart condition resulting from a respiratory disorder. Thus,
we also revise prior listing 3.09 by removing reference listing 3.09C,
which referred to listing 4.02.
Throughout these final rules, we are also making nonsubstantive
editorial changes to language we proposed in the NPRM for clarity,
consistency, medical accuracy, and readability. For example:
[[Page 2322]]
In the NPRM, we used ``order'' and ``purchase''
interchangeably in referring to consultative examinations or special
testing we need to purchase to complete our evaluation of your case. To
make it clear that we are paying for these examinations, we have
changed ``order'' to ``purchase'' throughout these final listings.
In final sections 4.00B3b and 104.00B3b, we added a
reference to ``duration'' to the second sentence to clarify that we may
need to purchase a consultative examination to help us establish
severity and duration of your impairment.
We have also simplified the language of several of the provisions
we proposed, corrected unintentional inconsistencies between part A and
part B, and corrected other minor errors in the NPRM. As we have
already explained, we also reorganized some of the paragraphs we
proposed in the introductory text of both part A and part B to group
them more logically. In some cases, this necessitated redesignation of
subsequent paragraphs. Throughout, we also made minor editorial changes
to simplify and clarify the language we proposed. We do not intend any
of these revisions to change the meaning of the proposed rules.
Public Comments
In the NPRM we published in the Federal Register on September 16,
2004 (69 FR 55874), we provided the public with a 60-day comment period
that ended on November 15, 2004.
In response to the notice, we received comments from six
commenters. These commenters included a legal services organization, an
advocacy organization for people with Marfan syndrome, State agencies
that make disability determinations for us, an organization
representing individuals who make disability determinations for us, and
a private individual. Most of the commenters raised more than one
issue. We carefully considered all of the comments.
A number of the comments were quite long and detailed, requiring us
to condense, summarize, or paraphrase them. We believe we have
accurately presented the views of the commenters, and we are responding
to all of the significant issues within the scope of the proposed
rulemaking raised by the commenters. Some comments simply agreed with
specific proposed changes and do not require a response, and we did not
summarize them here. We provide our reasons for adopting or not
adopting the comments in our responses below.
Exercise Tolerance Tests (ETTs)
Comment: One commenter had several concerns about the ETT
provisions in the proposed rules. The commenter believed that the
proposed listings would require many more claimants to get SSA-
purchased testing. The commenter believed that the proposed rules took
a much more aggressive approach to testing than the prior rules and
``actually established a protocol for testing claimants using stress
tests and exercise tolerance tests.'' The commenter also noted the
requirement for review by a State agency medical consultant to
determine whether there was risk before we purchased an ETT. Finally,
the commenter said that the proposed rules did not allow for a
consulting physician to examine a claimant or to talk to either the
claimant or the claimant's treating physician in determining whether
there was risk. The commenter said that this was ``a marked departure
from previous policy.''
Another commenter believed that proposed section 4.00C6d would have
required the purchase of an ETT to evaluate aerobic capacity even when
there was sufficient information in the record to adequately assess
residual functional capacity.
Response: Except for a few minor technical changes, the testing
requirements in section 4.00C of the proposed listings and these final
rules are the same as the requirements in section 4.00C of the prior
rules; we primarily reorganized and clarified those provisions. For
example, the provisions about what we need to evaluate
electrocardiogram (ECG) reports in proposed and final section 4.00C2
were in prior section 4.00C1.
Likewise, the final rules for MC review and treating physician
contact are based on the prior rules, although we expanded them
somewhat to provide even more protection for claimants. We took the
rules in final (and proposed) section 4.00C7a, which describe how an MC
will review the evidence to determine whether an ETT would pose a
significant risk to you, from section 4.00C2 of the prior rules. As in
the fourth sentence of prior section 4.00C2e(1), we continue to require
in final section 4.00C7b that our adjudicators ask for a statement from
the treating source for your cardiac impairment why an ETT was not done
or should not be done when we believe that we need to purchase an ETT.
In final section 4.00C7c, as in the NPRM, we include the provision from
the last sentence of prior section 4.00C2c and the fifth sentence of
prior section 4.00C2e(1) that it will be a ``rare situation'' in which
an MC will override a treating source's opinion that an ETT should not
be performed. We also include the provision from the last sentence of
prior section 4.00C2c that requires the MC to provide a written
rationale documenting the reasons for overriding the opinion in those
rare circumstances. In addition, we added a new provision in final
section 4.00C7e explaining that the physician who conducts the ETT (and
therefore who examines the claimant) must be provided with the
background medical evidence and is ultimately responsible for assessing
risk before performing a test we purchase.
In response to the second commenter, it was not our intent to
require the purchase of ETTs under the circumstances described in the
comment letter, but we are clarifying the final rule in response to
this comment. Our intent in proposed section 4.00C6d was to clarify the
statement in section 4.00C2a of our prior rules that ``[p]urchase of an
exercise test may be appropriate when * * * there is insufficient
evidence in the record to evaluate aerobic capacity, and the claim
cannot otherwise be favorably decided.'' Like prior section 4.00C2a,
final section 4.00C6 provides that we will purchase an ETT only when we
need one to make a determination or decision. If we have sufficient
evidence to evaluate your residual functional capacity, we will not
purchase an ETT. We do not expect an increase in the number of
purchased exercise tests.
Comment: One commenter agreed with our statement in proposed
section 4.00D3 that digitalis would not prevent application of listing
4.02B3. However, the commenter said that digitalis raises the risk of
performing an ETT and that the clinical findings of jugular venous
distention, rales, S3 gallop, and peripheral edema in a claimant with
chronic heart failure on digitalis should be adequate to assess these
cases without the risk of an ETT.
Response: We clarified the rule in response to this comment. We
believe that the commenter was referring to our statement in the NPRM
that digitalis use ``is not a factor'' when considering ETT purchase in
cases involving chronic heart failure. Although it is true that
digitalis alone does not increase the risk of performing an ETT, it is
certainly an indication that the individual is being treated for a
heart condition and is one piece of information, along with the other
factors presented in the commenter's remarks, that we would consider
when we determine whether to purchase an ETT. As we have already
[[Page 2323]]
noted, and as we explain in final section 4.00C6, we do not require
ETTs in any case in which there is already sufficient evidence to make
a determination or decision.
In the final rules, we are clarifying what we originally intended;
only that digitalis use by itself does not preclude the purchase of an
ETT in cases involving CHF. We are also adding a cross-reference in
section 4.00D3 to section 4.00C6 as a reminder that we do not need to
purchase ETTs in all cases.
Other Cardiovascular Tests
Comment: A commenter was concerned that in proposed section 4.00C16
we seemed to require our adjudicators to obtain a copy of the
plethysmographic tracings that support a report of a Doppler study in
every case, including when we obtain the report from your treating
source or another existing medical source. The commenter pointed out
that these tracings are not always available and asked whether the
proposed rule would require the purchase of new studies just so that we
could get tracings.
Response: We clarified the final rule in response to this comment.
To distinguish what we must have from what we would like to have in
evidence we receive from treating sources and other existing medical
sources, we indicate in final section 4.00C16 that we ``should'' have
the tracings but that we ``must'' have the other information we include
in the final rule. Although we prefer to get the tracings when they are
available, we do not require them in reports from treating sources or
other existing medical sources for the reasons given by the commenter
and we would not always require retesting just to obtain the tracings.
We do require the other information we note in the paragraph because we
need it to properly evaluate the results of the Doppler study. We also
require plethysmographic tracings when we purchase a Doppler study as
part of a consultative examination.
Comment: One commenter objected to our exclusion of tilt-table
testing for evaluating arrhythmias and syncope/near syncope.
Response: As noted in the summary of the changes above, we
rethought our position on this and have decided to accept tilt-table
testing for establishing arrhythmias as the cause for syncope/near
syncope in appropriate circumstances. Final sections 4.00F3c and
104.00E3 require that the testing be done concurrently with an ECG and
that the arrhythmias are coincident with the occurrence of syncope/near
syncope, similar to the Holter requirements.
The Listing Criteria
Comment: We received extensive comments from an organization that
provides support, advocacy, and education for and about people who have
Marfan syndrome. The commenter noted that Marfan syndrome is rare and
that, with improvements in diagnosis and treatment, people with Marfan
syndrome are living longer. However, these individuals are experiencing
more medical problems that affect other body systems in addition to the
cardiovascular system. These other medical problems were not seen as
frequently when people with Marfan syndrome did not live as long. The
commenter noted that we did include Marfan syndrome under proposed
listing 4.10. However, the commenter requested that we also add a
separate listing for Marfan syndrome that would recognize the multiple
body system effects of the syndrome, and suggested criteria for such a
listing. The commenter also asked us to include Marfan syndrome under
prior listing 4.07, Valvular heart disease. Finally, the commenter
expressed concern about the difficulty that some individuals with
Marfan syndrome have in obtaining disability benefits from us.
Response: We did not adopt the specific comments, but we added a
section to the introductory text of part A and part B to address the
commenter's concern. We did not add a new listing specifically for
Marfan syndrome in these final rules because, as the commenter noted,
Marfan syndrome is a genetic connective tissue disorder that affects
multiple body systems; therefore, we do not believe it is appropriate
to add a listing for this disorder in the cardiovascular listings.
Also, we did not adopt the comment regarding prior listing 4.07,
because we have removed it. We explained in the preamble to the NPRM
(69 FR 55877) that we were removing all reference listings--listings
that cross-refer to other listings--from the cardiovascular system.
However, in response to this comment we have added final sections
4.00H8 and 104.00F10. The new sections briefly describe Marfan syndrome
and explain that we will evaluate your Marfan syndrome manifestations
under the appropriate body system criteria.
Comment: One commenter provided several comments about the
functional criteria in the proposed rules. The commenter said that the
proposed listings did not mention the New York Heart Association (NYHA)
standards for assessing functional loss in cardiovascular impairments.
The commenter also said that, while the immune system and mental
disorders listings put a great deal of emphasis on functional loss, the
proposed cardiovascular listings made ``relatively little mention of
function.''
The commenter also believed that when the proposed listings did
mention functional loss, the standard of ``a very serious limit on
ability to initiate or sustain activities of daily living'' appeared
too high. Another commenter thought this standard was vague and hard to
apply and preferred the prior terms, ``normal activities'' and ``at
rest.''
A third commenter considered ``the changes to the requirements for
heart failure to be more consistent with NYHA'' classifications.
Response: In the 1991 NPRM for the prior rules, we proposed to
include NYHA functional criteria in the cardiovascular listings. (See
56 FR 31266, July 9, 1991.) We received several comments opposing this
proposal, and because we agreed with the comments, we removed those
references when we promulgated the prior rules in 1994. Among other
concerns, commenters pointed out that the NYHA criteria are too vague
for our purposes, that treating sources do not use the classifications,
that the definitions of the NYHA classifications may be changed, and
that the classifications are not useful when the level of an
individual's functional limitations fluctuates over time. In responding
to these comments, we said that we agreed with the commenters that
there were a number of real problems in using the NYHA classifications
in an adjudicatory context, and that the most straightforward approach
would be simply to state exactly what we require in the listings. (See
59 FR 6468, at 6479-6480, February 10, 1994.) We believe that this
explanation still holds true, especially since the final rules are not
significantly different from the prior rules.
The phrase ``very serious limitations in the ability to
independently initiate, sustain, or complete activities of daily
living'' and similar phrases in these final rules convey our standard
for an ``extreme'' limitation; that is, a limitation of listing-level
severity. We use this standard for functional loss in other listings;
for example, sections 1.00B2b and 1.00B2c in the musculoskeletal body
system and section 8.00C in the skin body system in part A of our
listings. We also use it in other regulations; see Sec.
416.926a(e)(3). The standard describes limitations in all of an
individual's day-to-day activities, so it includes limitations from
[[Page 2324]]
cardiovascular symptoms both during normal activities and at rest.
Comment: One commenter said that the proposed listings referred to
medical procedures that are not ``fully embraced,'' that may become
out-of-date in the near future, and that are not necessarily widely
available, especially to people with low incomes. As an example, the
commenter pointed to proposed new listing 4.04B for ischemic heart
disease with three ischemic episodes requiring revascularization
procedures within a 12-month period. The commenter said that it would
be highly unlikely that a Medicaid patient could be scheduled for three
procedures in such a short period of time.
Response: The medical procedures we include in the final rules are
generally well-established and widely used. Therefore, we do not agree
with the commenter that they are likely to become out-of-date in the
near future. Also, we provide in these final rules that these rules
will no longer be effective 5 years after the date on which they become
effective, unless we extend them or revise and issue them again. This
will allow us to update the medical procedures cited, if appropriate.
Individuals with the very serious cardiovascular impairments described
in these listings generally receive the kinds of tests and treatments
described in these final rules because of urgent medical need.
Moreover, as we explained in the preamble to the proposed rules,
final listing 4.04B is a new, additional listing criterion that ``will
permit us to decide some cases more quickly.'' (69 FR 55878) In other
words, it does not add any additional requirement that must be met, but
provides another way in which a person can be found disabled under the
listing.
Comment: One commenter approved of our addition of recurrent bouts
of decompensation to the evaluation of chronic heart failure in
proposed section 4.00D4, but suggested that we change the definition of
``periods of stabilization'' from at least 5 days between episodes to
30 days between episodes to avoid variability during medication
titrations. This commenter also suggested that we include a reference
to left ventricular ``fractional shortening'' on echocardiograms, as
the fractional shortening parameter is being used with increasing
frequency to assess left ventricular function.
Response: We partially adopted the comment on the number of days
between episodes of decompensation by extending the required length of
the ``periods of stabilization'' from the proposed 5 days to 2 weeks.
Our intent is to set the minimum number of days that would denote
separate episodes. We believe that 30 days is too long and that 2 weeks
is sufficient for this purpose.
We use fractional shortening in the childhood listing as evidence
of chronic heart failure, but cannot add fractional shortening to the
adult listing. Ejection fraction, which we use in the adult listing,
represents the mean of the fractional shortening of the left ventricle;
therefore, it is more accurate than fractional shortening measured at a
single point. This is especially important if there is a segmental wall
motion abnormality, which is often seen in claimants with coronary
artery disease, a more common condition in adults than in children.
Comment: One commenter suggested that we change the description of
brawny edema in proposed listing 4.11A from ``approximately'' two-
thirds of the leg between the ankle and the knee to ``at least'' two-
thirds or ``above mid-tibia level.''
Response: We adopted the comment. We proposed to say
``approximately'' because physicians generally will estimate the extent
of the edema, rather than actually measure it. However, we agree that
the commenter's suggestion of ``at least'' is clearer and better
expresses our intent. In response to this comment, we also added an
alternate descriptor of ``the distal one-third of the lower extremity
between the ankle and hip'' to provide for those situations where the
amount of brawny edema is given as a fraction of the entire lower
extremity.
Comment: One commenter was reluctant to support the elimination of
all reference listings, citing valvular heart disease as an example of
an impairment unique enough to merit a listing. The commenter conceded
that we discussed the listings we proposed to eliminate in the
introductory text, but felt that it is easier for adjudicators to
identify the need to evaluate these impairments if they are also
included in the listings. It was also this commenter's opinion that
this would offer assurance to the public and to their treating sources
that these specific impairments have been considered.
Response: We did not adopt the comment. We do not agree that any
prior reference listing would be especially helpful to adjudicators.
All people who could qualify under any of the provisions of our prior
reference listings will continue to qualify under other listings or the
rules for medical equivalence or, in children, functional equivalence.
Also, as we have already noted, we are removing reference listings from
all the body systems as we revise them because reference listings are
redundant; therefore, retaining one reference listing in this body
system would be anomalous. Our adjudicators are aware that the listings
do not include all possible disabling impairments, so they review
allegations and the medical evidence obtained from treating or
examining sources to identify all of the impairments we will evaluate.
However, in reviewing the NPRM in connection with this comment, we
realized that we had inadvertently omitted a discussion of
cardiomyopathies (prior listing 104.08) in the introductory text to
part B. As noted above, we have corrected this oversight by adding
final section 104.00F3. The text of the final rule is essentially
identical to the corresponding rule in part A, final section 4.00H3,
with minor changes to refer to children.
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of Management and Budget (OMB)
and determined that these final rules meet the criteria for a
significant regulatory action under Executive Order 12866, as amended
by Executive Order 13258. Thus, they were subject to OMB review.
Regulatory Flexibility Act
We certify that these final rules do not have a significant
economic impact on a substantial number of small entities because they
affect only individuals. Thus, a regulatory flexibility analysis as
provided in the Regulatory Flexibility Act, as amended, is not
required.
Paperwork Reduction Act
The Paperwork Reduction Act (PRA) of 1995 says that no persons are
required to respond to a collection of information unless it displays a
valid OMB control number. In accordance with the PRA, SSA is providing
notice that the Office of Management and Budget has approved the
information collection requirements contained in sections 4.00B, 4.00C,
4.00D, 4.00E, 4.00F, 4.00G, 4.02A, 104.00B, 104.00C, 104.00E, and
104.06 of these final rules. The OMB Control Number for these
collections is 0960-0642, expiring March 31, 2008.
(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, Death benefits, Blind,
[[Page 2325]]
Disability benefits, Old-Age, Survivors, and Disability Insurance,
Reporting and recordkeeping requirements, Social Security.
Dated: October 14, 2005.
Jo Anne B. Barnhart,
Commissioner of Social Security.
0
For the reasons set forth in the preamble, subpart P of part 404 of
chapter III of title 20 of the Code of Federal Regulations is amended
as set forth below:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950- )
0
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--Listings of Impairments [Amended]
0
2. Item 5 of the introductory text before part A of appendix 1 is
revised to read as follows:
* * * * *
5. Cardiovascular System (4.00 and 104.00): January 13, 2011.
* * * * *
0
3. Listing 3.09 of part A of appendix 1 is amended by removing the
semi-colon at the end of B, replacing it with a period, and removing
the remainder of the listing.
0
4. Section 4.00 of appendix 1 to subpart P of part 404 is revised to
read as follows:
* * * * *
Part A
* * * * *
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 the
heart or the circulatory system (that is, 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:
(i) Chronic heart failure or ventricular dysfunction.
(ii) Discomfort or pain due to myocardial ischemia, with or without
necrosis of heart muscle.
(iii) Syncope, or near syncope, due to inadequate cerebral
perfusion from any cardiac cause, such as obstruction of flow or
disturbance in rhythm or conduction resulting in inadequate cardiac
output.
(iv) 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, the eyes,
the kidneys, and other organs. We will evaluate peripheral vascular
disease under 4.11 or 4.12 and impairments of another body system(s)
under the listings for that body system(s).
2. What do we consider in evaluating cardiovascular impairments?
The listings in this section describe cardiovascular impairments 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 means a period of 12 consecutive
months, all or part of which must occur within the period we are
considering in connection with an application or continuing disability
review.
f. Uncontrolled means the impairment 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 of 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 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 this situation, 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, we may find you
disabled because you have another impairment(s) that in combination
with your cardiovascular impairment medically equals the severity of a
listed impairment or based on consideration of your residual functional
capacity and age, education, and work experience.
b. Unless we can decide your claim 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 a consultative examination(s) to help us establish the
severity and duration of your impairment.
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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 impairment
might affect our determination or decision. In these situations, 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:
(i) If you have had a recent acute event; for example, a myocardial
infarction (heart attack).
(ii) If you have recently had a corrective cardiac procedure; for
example, coronary artery bypass grafting.
(iii) 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 purchase any studies? In appropriate situations, we will
purchase studies necessary to substantiate the diagnosis or to document
the severity of your impairment, generally after we have evaluated the
medical and other evidence we already have. We will not purchase
studies involving exercise testing if there is significant risk
involved or if there is another medical reason not to perform the test.
We will follow sections 4.00C6, 4.00C7, and 4.00C8 when we decide
whether to purchase exercise testing.
6. What studies will we not purchase? We will not purchase 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.
See 4.00C15a.
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.
(i) Detailed descriptions or computer-averaged signals without
original or legible copies of the ECG as described in listing 4.00C2a
are not acceptable.
(ii) 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 should meet the following specifications:
(i) ECG reports must include the original calibrated ECG tracings
or a legible copy.
(ii) A 12-lead baseline ECG must be recorded in the upright
position before exercise.
(iii) A 12-lead ECG should be recorded at the end of each minute of
exercise.
(iv) 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.
(v) Post-exercise ECGs should be recorded using a generally
accepted protocol consistent with the prevailing state of medical
knowledge and clinical practice.
(vi) 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 (usually expressed
in METs--metabolic equivalents) 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 that 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 an exercise
Doppler test. Even though this test is intended to evaluate peripheral
vascular disease, it will be stopped for your safety if you develop
abnormal signs or symptoms because of heart disease.
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 activities required for
work in all possible work environments or throughout a workday. Also,
certain medications (such as beta blockers) and
[[Page 2327]]
conduction disorders (such as left or right bundle branch blocks) can
cause false-negative or false-positive results. Therefore, we must
consider the results of an ETT together with all the other relevant
evidence in your case record.
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 milliliters (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 whether to purchase an exercise test?
a. We will consider whether to purchase an exercise test when:
(i) There is a question whether your cardiovascular impairment
meets or medically equals the severity of one of the listings, or there
is no timely test in the evidence we have (see 4.00C9), and we cannot
find you disabled on some other basis; or
(ii) We need to assess your residual functional capacity and there
is insufficient evidence in the record to make a determination or
decision.
b. We will not purchase an exercise test when we can make our
determination or decision based on the evidence we already have.
7. What must we do before purchasing an exercise test?
a. Before we purchase 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
purchase the test (see 4.00C8).
b. If you are under the care of a treating source (see Sec. Sec.
404.1502 and 416.902) for a cardiovascular 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 purchase the test.
c. The MC, in accordance with the regulations and other
instructions on consultative examinations, will generally give great
weight to the treating source's opinion about the risk of exercise
testing to you and will generally not override it. 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 purchasing 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 purchase an exercise test or wait before we
purchase an exercise test?
a. We will not purchase an exercise test when an MC finds that you
have one of the following significant risk factors:
(i) Unstable angina not previously stabilized by medical treatment.
(ii) Uncontrolled cardiac arrhythmias causing symptoms or
hemodynamic compromise.
(iii) An implanted cardiac defibrillator.
(iv) Symptomatic severe aortic stenosis.
(v) Uncontrolled symptomatic heart failure.
(vi) Aortic dissection.
(vii) Severe pulmonary hypertension (pulmonary artery systolic
pressure greater than 60 mm Hg).
(viii) Left main coronary stenosis of 50 percent or greater that
has not been bypassed.
(ix) Moderate stenotic valvular disease with a systolic gradient
across the aortic valve of 50 mm Hg or greater.
(x) Severe arterial hypertension (systolic greater than 200 mm Hg
or diastolic greater than 110 mm Hg).
(xi) Hypertrophic cardiomyopathy with a systolic gradient of 50 mm
Hg or greater.
b. We also will not purchase an exercise test when you are
prevented from performing exercise testing due to another impairment
affecting your ability to use your arms and legs.
c. We will not purchase an ETT to document the presence of a
cardiac arrhythmia.
d. We will wait to purchase an exercise test until 3 months after
you have had one of the following events. This will allow for maximal,
attainable restoration of functional capacity.
(i) Acute myocardial infarction.
(ii) Surgical myocardial revascularization (bypass surgery).
(iii) Other open-heart surgical procedures.
(iv) Percutaneous transluminal coronary angioplasty with or without
stenting.
e. If you are deconditioned after an extended period of bedrest or
inactivity and could improve with activity, or if you are in acute
heart failure and are expected to improve with treatment, we will wait
an appropriate period of time for you to recuperate before we purchase
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,
including why the test was performed and whether there has been an
intervening event or improvement or worsening of your impairment.
d. We will purchase a new exercise test only if we cannot make a
determination or decision based on the evidence we have.
10. How must ETTs we purchase be performed?
a. The ETT must 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
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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.) Exercise
tests may also be performed using echocardiography to detect stress-
induced ischemia and left ventricular dysfunction (see 4.00C12 and
4.00C13).
b. The exercise test must 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 must 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 must 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 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. You may have resting ECG abnormalities when you have a
conduction defect--for example, Wolff-Parkinson-White syndrome, left
bundle branch block, left ventricular hypertrophy--or when you are
taking digitalis or other antiarrhythmic drugs, or when resting ST
changes are present. Also, these techniques can provide a reliable
estimate of ejection fraction.
13. Will we purchase ETTs with imaging? We may purchase 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 purchasing 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 make our determination or
decision based on the evidence we already have.
14. What are drug-induced stress tests? These tests are 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 to simulate
exercise and are used in combination with a 2-dimensional
echocardiogram. We may, when appropriate, purchase 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. We will not purchase cardiac catheterization; however, if you
have had catheterization, we will make every 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 the results of quantitative computer
measurements and analyses are included in your case record, we will
consider them 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. 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 must 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 must 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, if available, should also be included with the
report. All tracings must be annotated with the standardization used by
the testing facility.
17. How must exercise Doppler tests we purchase be performed? When
we purchase an exercise Doppler test, you must exercise on a treadmill
at 2 mph on a 12 percent grade for up to 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 4.00C6,
4.00C7, and 4.00C8.
D. Evaluating Chronic Heart Failure
1. What is chronic heart failure (CHF)?
[[Page 2329]]
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:
(i) 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
(ii) Predominant diastolic dysfunction (the inability of the heart
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 evaluate your
impairment using 3.09, in 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.
(i) 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.
(ii) 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.
(iii) 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.
(iv) However, these measurements alone do not reflect your
functional capacity, which we evaluate by considering all of the
relevant evidence. In some situations, we may need to purchase an ETT
to help us assess your functional capacity.
(v) 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, your medical
history and physical examination should describe characteristic
symptoms and signs of pulmonary or systemic congestion or of limited
cardiac output associated with the abnormal findings on appropriate
medically acceptable imaging. When an acute episode of heart failure is
triggered by a remediable factor, such as an arrhythmia, dietary sodium
overload, or high altitude, cardiac function may be restored and a
chronic impairment may not be present.
(i) 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 (orthopnea) or episodes of
shortness of breath that wake them from sleep (paroxysmal nocturnal
dyspnea). They may also experience cardiac arrhythmias resulting in
palpitations, lightheadedness, or fainting.
(ii) 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 have 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 evaluate your ability to do
work-related activities. Exercise testing has been safely used in
individuals with CHF; therefore, we may purchase 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 4.00C6 for when we will consider the
purchase of an ETT. See 4.00C7-4.00C8 for what we must do before we
purchase an ETT and when we will not purchase one.) ST segment changes
from digitalis use in the treatment of CHF do not preclude the purchase
of an ETT.
4. How do we evaluate CHF using 4.02?
a. We must have objective evidence, as described in 4.00D2, that
you have chronic heart failure.
b. To meet the required level of severity for this listing, your
impairment must satisfy the requirements of one of the criteria in A
and one of the criteria in B.
c. In 4.02B2, the phrase periods of stabilization means that, for
at least 2 weeks between episodes of acute heart failure, there must be
objective evidence of clearing of the pulmonary edema or pleural
effusions and evidence that you returned to, or you were medically
considered able to return to, your prior level of activity.
d. Listing 4.02B3c 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 with increased sympathetic
responses because of deconditioning or apprehension may increase their
systolic blood pressure and heart rate above their baseline level just
before and early into exercise. 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.
E. Evaluating Ischemic Heart Disease
1. What is ischemic heart disease (IHD)? IHD results when one or
more of your coronary arteries is narrowed or obstructed or, in rare
situations, constricted due to vasospasm, interfering with the normal
flow of blood to your heart muscle (ischemia). The obstruction may be
the result of an embolus, a thrombus, or plaque. When
[[Page 2330]]
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 impairment, such as aortic stenosis, hypertrophic
cardiomyopathy, pulmonary hypertension, or anemia.
b. Instead of typical angina pectoris, some individuals with IHD
experience atypical angina, anginal equivalent, variant angina, or
silent ischemia, all of which we may evaluate using 4.04. We discuss
the various manifestations of ischemia in 4.00E3-4.00E7.
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 represent atypical angina, your
discomfort or pain should have precipitating and relieving factors
similar to those of 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 IHD will
complain of shortness of breath (dyspnea) on exertion without chest
pain or discomfort. In a minority of such situations, the shortness of
breath is due to myocardial ischemia; this is called anginal
equivalent. To represent anginal equivalent, your shortness of breath
should have precipitating and relieving factors similar to those of
typical chest discomfort, and we must have objective medical evidence
of myocardial ischemia; for example, ECG or ETT evidence or appropriate
medically acceptable imaging. In these situations, it is essential to
establish objective evidence of myocardial ischemia to ensure that you
do not have effort dyspnea due to non-ischemic or non-cardiac causes.
6. What is variant angina?
a. Variant angina (Prinzmetal's angina, vasospastic angina) refers
to the occurrence of anginal episodes at rest, especially at night,
accompanied by transitory ST segment elevation (or, at times, ST
depression) on an 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. We will
consider variant angina under 4.04 only if you have spasm of a coronary
artery in relation to an obstructive lesion of the vessel. If you have
an arrhythmia as a result of variant angina, we may consider your
impairment under 4.05.
b. Variant angina may also occur in the absence of obstructive
coronary disease. In this situation, an ETT will not demonstrate
ischemia. The diagnosis will be established by showing the typical
transitory ST segment changes during attacks of pain, and the absence
of obstructive lesions shown by 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 situations, we will consider the
frequency of anginal episodes despite prescribed treatment when
evaluating your residual functional capacity.
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:
(i) 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,
perfusion scan, or other appropriate medically acceptable imaging.
(ii) 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. ST depression shown on the ambulatory recording should not be
interpreted as positive for ischemia unless similar depression is also
seen during chest pain episodes annotated in the diary that the
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(ii).
8. What other sources of chest discomfort are there? Chest
discomfort of nonischemic origin may result from other cardiac
impairments, such as pericarditis. Noncardiac impairments may also
produce symptoms mimicking that of myocardial ischemia. These
impairments 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
both during exercise and recovery. Although we recognize that ischemic
changes may at times occur only during exercise or recovery, and may at
times be upsloping with only junctional ST depression, such changes can
be false positive; that is, occur in the absence of ischemia.
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Diagnosis of ischemia in this situation requires radionuclide or
echocardiogram confirmation. See 4.00C12 and 4.00C13.
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 that
occurs during exercise but 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 or echocardiogram confirmation. See
4.00C12 and 4.00C13.
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 the same finding required in 4.02B3c. See
4.00D4d for full details.
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 and that requires 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 medical impairment or
because the vessel was not suitable for revascularization.
g. We will use 4.04C only when you have symptoms due to myocardial
ischemia as described in 4.00E3-4.00E7 while on a regimen of prescribed
treatment, you are at risk for exercise testing (see 4.00C8), and we do
not have a timely ETT or a timely normal drug-induced stress test for
you. See 4.00C9 for what we mean by a timely test.
h. In 4.04C1 the term nonbypassed means that the blockage is in a
vessel that is potentially bypassable; that is, large enough to be
bypassed and considered to be a cause of your ischemia. These vessels
are usually major arteries or one of a major artery's major branches. A
vessel that has become obstructed again after angioplasty or stent
placement and has remained obstructed or is not amenable to another
revascularization is considered a nonbypassed vessel for purposes of
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 or 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 cardiac 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. How do we evaluate arrhythmias using 4.05?
a. We will use 4.05 when you have arrhythmias that are not fully
controlled by medication, an implanted pacemaker, or an implanted
cardiac defibrillator and you have uncontrolled recurrent episodes of
syncope or near syncope. 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 implanted cardiac defibrillator, see 4.00F4.
b. 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.
c. For purposes of 4.05, there must be a documented association
between the syncope or near syncope and the recurrent arrhythmia. The
recurrent arrhythmia, not some other cardiac or non-cardiac disorder,
must be established as the cause of the associated symptom. This
documentation of the association between the symptoms and the
arrhythmia may come from the usual diagnostic methods, including Holter
monitoring (also called ambulatory electrocardiography) and tilt-table
testing with a concurrent ECG. Although an arrhythmia may be a
coincidental finding on an ETT, we will not purchase an ETT to document
the presence of a cardiac arrhythmia.
4. What will we consider when you have an implanted cardiac
defibrillator and you do not have arrhythmias that meet the
requirements of 4.05?
a. Implanted 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 implanted cardiac defibrillator is a unique form of
treatment; it rescues an individual from what may have been cardiac
arrest. However, as a consequence of the shock(s), individuals may
experience psychological distress, which we may evaluate under the
mental disorders listings in 12.00ff.
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.)
Implanted 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 from MRI (magnetic resonance imaging), can trigger or reprogram
an implanted 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 implanted cardiac defibrillator are those dictated by the underlying
heart impairment. However, the exercise limitations may be greater when
the implanted cardiac defibrillator delivers an inappropriate shock in
response to the increase in heart rate with exercise, or when there is
exercise-induced ventricular arrhythmia.
[[Page 2332]]
G. Evaluating Peripheral Vascular Disease
1. What is peripheral vascular disease (PVD)? Generally, PVD is any
impairment 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). If you have peripheral arterial disease, you may have pain in
your calf after walking a distance that goes away when you rest
(intermittent claudication); at more advanced stages, you may have pain
in your calf at rest or you may develop ulceration or gangrene. If you
have venous insufficiency, you may have swelling, varicose veins, skin
pigmentation changes, or skin ulceration.
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 swelling that is
usually dense and feels firm due to the presence of increased
connective tissue; it is also associated with characteristic skin
pigmentation changes. It is not the same thing as pitting edema. Brawny
edema generally does not pit (indent on pressure), and the terms are
not interchangeable. Pitting edema does not satisfy the requirements of
4.11A.
4. What is lymphedema and how will we evaluate it?
a. Lymphedema is edema of the extremities due to a disorder of the
lymphatic circulation; at its worst, it is called 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.
b. Lymphedema does not meet the requirements of 4.11, although it
may medically equal the severity of that listing. We will evaluate
lymphedema by considering whether the underlying cause meets or
medically equals any listing or whether the lymphedema medically equals
a cardiovascular listing, such as 4.11, or a musculoskeletal listing,
such as 1.02A or 1.03. If no listing is met or medically equaled, we
will evaluate any functional limitations imposed by your lymphedema
when we assess your residual functional capacity.
5. When will we purchase exercise Doppler studies for evaluating
peripheral arterial disease (PAD)? If we need additional evidence of
your PAD, we will generally purchase exercise Doppler studies (see
4.00C16 and 4.00C17) when your resting ankle/brachial systolic blood
pressure ratio is at least 0.50 but less than 0.80, and only rarely
when it is 0.80 or above. We will not purchase 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
4.00G7c and 4.00G8.) There are no current medical standards for
evaluating exercise toe pressures. Because any exercise test stresses
your entire cardiovascular system, we will purchase exercise Doppler
studies only after an MC, preferably one with experience in the care of
patients with cardiovascular disease, has determined that the test
would not present a significant risk to you and that there is no other
medical reason not to purchase the test (see 4.00C6, 4.00C7, and
4.00C8).
6. Are there any other studies that are helpful in evaluating PAD?
Doppler studies done using a recording ultrasonic Doppler unit and
strain-gauge plethysmography are other useful tools for evaluating PAD.
A recording Doppler, which prints a tracing of the arterial pulse wave
in the femoral, popliteal, dorsalis pedis, and posterior 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.
7. How do we evaluate PAD under 4.12?
a. The ankle blood pressure referred to in 4.12A and B is the
higher of the pressures recorded from the posterior tibial and dorsalis
pedis arteries in the affected leg. The higher pressure recorded from
the two sites is the more significant measurement in assessing the
extent of arterial insufficiency. Techniques for obtaining ankle
systolic blood pressures include Doppler (See 4.00C16 and 4.00C17),
plethysmographic studies, or other techniques. We will request any
available tracings generated by these studies so that we can review
them.
b. In 4.12A, the ankle/brachial systolic blood pressure ratio is
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. 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 PAD, unless you also
have a disease causing abnormal arterial calcification or small vessel
disease, such as diabetes mellitus. See 4.00G7c and 4.00G8.
c. 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 4.00G7b) when you have intermittent
claudication and 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. While the
criteria in 4.12C and 4.12D are intended primarily for individuals who
have a disease causing abnormal arterial calcification or small vessel
disease, we may also use them for evaluating anyone with PAD.
8. How are toe pressures measured? Toe pressures are measured
routinely in most vascular laboratories through one of three methods:
most frequently, photoplethysmography; less frequently, plethysmography
using strain gauge cuffs; and Doppler ultrasound. 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 can be used in the
measurement of toe pressure.
[[Page 2333]]
9. How do we use listing 4.12 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
arterial impairment. However, if you have had peripheral grafting done
for your PAD, 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 its effects under the listings. We will also consider any
limitations imposed by your hypertension when we assess your residual
functional capacity.
2. How will we evaluate symptomatic congenital heart disease?
Congenital heart disease is any abnormality of the heart or the major
blood vessels that is present at birth. Because of improved treatment
methods, more children with congenital heart disease are living to
adulthood. Although some types of congenital heart disease may be
corrected by 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.
3. 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.
4. 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, 4.06, or an appropriate
neurological listing in 11.00ff.
5. 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 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. 404.1594
and 416.994) has occurred.
6. 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 dissection can cause heart failure, renal (kidney) failure, or
neurological complications. If you have an aneurysm that does not meet
the requirements of 4.10 and you have one or more of these associated
conditions, we will evaluate the condition(s) using the appropriate
listing.
7. 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 or cholesterol) in the blood; for example,
hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia.
These disorders of lipoprotein metabolism and transport can cause
defects throughout the body. The effects most likely to interfere with
function are those produced by atherosclerosis (narrowing of the
arteries) and coronary artery disease. We will evaluate your
lipoprotein disorder by considering its effects on you.
8. What is Marfan syndrome and how will we evaluate it?
a. Marfan syndrome is a genetic connective tissue disorder that
affects multiple body systems, including the skeleton, eyes, heart,
blood vessels, nervous system, skin, and lungs. There is no specific
laboratory test to diagnose Marfan syndrome. The diagnosis is generally
made by medical history, including family history, physical
examination, including an evaluation of the ratio of arm/leg size to
trunk size, a slit lamp eye examination, and a heart test(s), such as
an echocardiogram. In some cases, a genetic analysis may be useful, but
such analyses may not provide any additional helpful information.
b. The effects of Marfan syndrome can range from mild to severe. In
most cases, the disorder progresses as you age. Most individuals with
Marfan syndrome have abnormalities associated with the heart and blood
vessels. Your heart's mitral valve may leak, causing a heart murmur.
Small leaks may not cause symptoms, but larger ones may cause shortness
of breath, fatigue, and palpitations. Another effect is that the wall
of the aorta may be weakened and abnormally stretch (aortic dilation).
This aortic dilation may tear, dissect, or rupture, causing serious
heart problems or sometimes sudden death. We will evaluate the
manifestations of your Marfan syndrome under the appropriate body
system criteria, such as 4.10, or if necessary, consider the functional
limitations imposed by your impairment.
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
[[Page 2334]]
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. We must consider any additional and cumulative
effects of 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 the severity of
a listed impairment), and when we assess your residual functional
capacity.
2. How do we relate treatment to functional status? In general,
conclusions about the severity of a cardiovascular 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 your impairments(s)
medically equals a listing. (See Sec. Sec. 404.1526 and 416.926.) If
you have a severe impairment(s) that does not meet or medically equal
the criteria of a listing, you may or may not have the residual
functional capacity to engage in substantial gainful activity.
Therefore, 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. Systolic failure (see 4.00D1a(i)), with left ventricular end
diastolic dimensions greater than 6.0 cm or ejection fraction of 30
percent or less during a period of stability (not during an episode of
acute heart failure); or
2. Diastolic failure (see 4.00D1a(ii)), with 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
(not during an episode of acute heart 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(ii)) from clinical and imaging
assessments at the time of the episodes, requiring acute extended
physician intervention such as hospitalization or emergency room
treatment for 12 hours or more, separated by periods of stabilization
(see 4.00D4c); or
3. Inability to perform on an exercise tolerance test at a workload
equivalent to 5 METs or less 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 in systolic pressure below the
baseline systolic blood pressure or the preceding systolic pressure
measured during exercise (see 4.00D4d) due to left ventricular
dysfunction, despite an increase in workload; or
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 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 or more in systolic pressure below the
baseline blood pressure or the preceding systolic pressure measured
during exercise (see 4.00E9e) due to left ventricular dysfunction,
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, each requiring
revascularization or not amenable to revascularization (see 4.00E9f),
within a consecutive 12-month period (see 4.00A3e).
OR
C. Coronary artery disease, demonstrated by angiography (obtained
independent of Social Security disability evaluation) or other
appropriate medically acceptable imaging, and in the absence of a
timely exercise tolerance test or a timely
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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 showing:
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 two 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 4.00F3b),
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 (see
4.00F3c).
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 4.00H6).
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 (see 4.00G3) involving at least two-
thirds of the leg between the ankle and knee or the distal one-third of
the lower extremity between the ankle and hip.
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, 4.00G5, and 4.00G6),
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 4.00G7a and 4.00C16-4.00C17) 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 4.00G7c
and 4.00G8).
OR
D. Resting toe/brachial systolic blood pressure ratio of less than
0.40 (see 4.00G7c).
* * * * *
0
5. Section 104.00 of appendix 1 to subpart P of part 404 is revised to
read as follows:
Part B
* * * * *
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 the
heart or the circulatory system (that is, 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:
(i) Chronic heart failure or ventricular dysfunction.
(ii) Discomfort or pain due to myocardial ischemia, with or without
necrosis of heart muscle.
(iii) Syncope, or near syncope, due to inadequate cerebral
perfusion from any cardiac cause, such as obstruction of flow or
disturbance in rhythm or conduction resulting in inadequate cardiac
output.
(iv) 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, the eyes,
the kidneys, and other organs. We will evaluate peripheral vascular
disease under 4.11 or 4.12 in part A, 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 cardiovascular impairments 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.
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e. A consecutive 12-month period means a period of 12 consecutive
months, all or part of which 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 impairment 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 of 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 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 this situation, 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, we may find you disabled
because you have another impairment(s) that in combination with your
cardiovascular impairment medically equals the severity of a listed
impairment or that functionally equals the listings.
b. Unless we can decide your claim 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 a consultative examination(s) to help us establish the
severity and duration 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 impairment
might affect our determination or decision. In these situations, 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:
(i) If you have had a recent acute event; for example, acute
rheumatic fever.
(ii) If you have recently had a corrective cardiac procedure; for
example, open-heart surgery.
(iii) 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 purchase any studies? In appropriate situations, we will
purchase studies necessary to substantiate the diagnosis or to document
the severity of your impairment, generally after we have evaluated the
medical and other evidence we already have. We will not purchase
studies involving exercise testing if there is significant risk
involved or if there is another medical reason not to perform the test.
We will follow sections 4.00C6, 4.00C7, 4.00C8, and 104.00B7 when we
decide whether to purchase exercise testing. 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. 416.919g.)
6. What studies will we not purchase? We will not purchase 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.
See 4.00C15a in part A.
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 performed
successfully by 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 tests of children.
c. For full details on ETT requirements and usage, see 4.00C in
part A.
C. 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.
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 evaluate your
impairment using 3.09 in the respiratory system listings in part A.
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.
(i) Cardiomegaly is present when:
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(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.
(ii) 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.)
(iii) However, these measurements alone do not reflect your
functional capacity, which we evaluate by considering all of the
relevant evidence.
(iv) 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, your medical
history and physical examination should describe characteristic
symptoms and signs of pulmonary or systemic congestion or of limited
cardiac output associated with the abnormal findings on appropriate
medically acceptable imaging. When an acute episode of heart failure is
triggered by a remediable factor, such as an arrhythmia, dietary sodium
overload, or high altitude, cardiac function may be restored and a
chronic impairment may not be present.
(i) 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 that wake 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.
(ii) 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.
(iii) Signs of congestion may include hepatomegaly, ascites,
increased jugular venous distention or pressure, rales, peripheral
edema, rapid 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, including ventricular septal
defect or atrioventricular canal;
b. Abnormalities resulting in cyanotic heart disease, including
tetralogy of Fallot or transposition of the great arteries;
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. How will we evaluate symptomatic congenital heart disease?
a. Because of improved treatment methods, more children with
congenital heart disease are living longer. Although some types of
congenital heart disease may be corrected by 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 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.
b. For 104.06A2, we will accept pulse oximetry measurements instead
of arterial O2, but the arterial O2 values are
preferred, if available.
c. For 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:
(i) Hypoplastic left heart syndrome,
(ii) Critical aortic stenosis with neonatal heart failure,
(iii) Critical coarctation of the aorta, with or without associated
anomalies,
(iv) Complete atrioventricular canal defects,
(v) Transposition of the great arteries,
(vi) Tetralogy of Fallot,
(vii) Pulmonary atresia with intact ventricular septum,
(viii) Single ventricle,
(ix) Tricuspid atresia, and
(x) Multiple ventricular septal defects.
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 or 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 cardiac 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. How do we evaluate arrhythmias using 104.05?
a. We will use 104.05 when you have arrhythmias that are not fully
controlled by medication, an implanted pacemaker, or an implanted
cardiac defibrillator and you have uncontrolled recurrent episodes of
syncope or near syncope. 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 implanted cardiac defibrillator, see 104.00E4.
b. 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.
c. For purposes of 104.05, there must be a documented association
between the syncope or near syncope and the recurrent arrhythmia. The
recurrent arrhythmia, not some other cardiac or non-cardiac disorder,
must be established as the cause of the associated symptom. This
documentation of the association between the symptoms and the
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arrhythmia may come from the usual diagnostic methods, including Holter
monitoring (also called ambulatory electrocardiography) and tilt-table
testing with a concurrent ECG. Although an arrhythmia may be a
coincidental finding on an ETT, we will not purchase an ETT to document
the presence of a cardiac arrhythmia.
4. What will we consider when you have an implanted cardiac
defibrillator and you do not have arrhythmias that meet the
requirements of 104.05?
a. Implanted 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 implanted cardiac defibrillator is a unique form of
treatment; it rescues a child from what may have been cardiac arrest.
However, as a consequence of the shock(s), children may experience
psychological distress, which we may evaluate under the mental
disorders listings in 112.00ff.
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.)
Implanted 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 from MRI (magnetic resonance imaging), can trigger or reprogram
an implanted 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
implanted cardiac defibrillator are those dictated by the underlying
heart impairment. However, the exercise limitations may be greater when
the implanted 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 (IHD) and how will we evaluate it
in children? IHD results when one or more of your coronary arteries is
narrowed or obstructed or, in rare situations, constricted due to
vasospasm, interfering with the normal flow of blood to your 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, but when it occurs, its effects
on children are the same as on adults. If you have IHD, we will
evaluate it under 4.00E and 4.04 in part A.
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 its effects under the listings. We will also consider any
limitations imposed by your hypertension when we consider whether you
have an impairment that functionally equals the listings.
3. 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 4.04 in part A, 104.02, 104.05, or 111.06, depending on its
effects on you.
4. 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 4.04 in part A, 104.02, 104.05, 104.06, or an
appropriate neurological listing in 111.00ff.
5. 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 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) has
occurred.
6. How will we evaluate chronic rheumatic fever or rheumatic heart
disease? The diagnosis should be made in accordance with 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.
7. 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 or cholesterol) in the blood; for example,
hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia.
These disorders of lipoprotein metabolism and transport can cause
defects throughout the body. The effects most likely to interfere with
function are those produced by atherosclerosis (narrowing of the
arteries) and coronary artery disease. We will evaluate your
lipoprotein disorder by considering its effects on you.
8. 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 in part A or 104.05. We will
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evaluate chronic heart failure under 104.02.
9. What is lymphedema and how will we evaluate it?
a. Lymphedema is edema of the extremities due to a disorder of the
lymphatic circulation; at its worst, it is called 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.
b. Lymphedema does not meet the requirements of 4.11 in part A,
although it may medically equal the severity of that listing. We will
evaluate lymphedema by considering whether the underlying cause meets
or medically equals any listing or whether the lymphedema medically
equals a cardiovascular listing, such as 4.11, or a musculoskeletal
listing, such as 101.02A or 101.03. If no listing is met or medically
equaled, we will evaluate any functional limitations imposed by your
lymphedema when we consider whether you have an impairment that
functionally equals the listings.
10. What is Marfan syndrome and how will we evaluate it?
a. Marfan syndrome is a genetic connective tissue disorder that
affects multiple body systems, including the skeleton, eyes, heart,
blood vessels, nervous system, skin, and lungs. There is no specific
laboratory test to diagnose Marfan syndrome. The diagnosis is generally
made by medical history, including family history, physical
examination, including an evaluation of the ratio of arm/leg size to
trunk size, a slit lamp eye examination, and a heart test(s), such as
an echocardiogram. In some cases, a genetic analysis may be useful, but
such analyses may not provide any additional helpful information.
b. The effects of Marfan syndrome can range from mild to severe. In
most cases, the disorder progresses as you age. Most individuals with
Marfan syndrome have abnormalities associated with the heart and blood
vessels. Your heart's mitral valve may leak, causing a heart murmur.
Small leaks may not cause symptoms, but larger ones may cause shortness
of breath, fatigue, and palpitations. Another effect is that the wall
of the aorta may be weakened and stretch (aortic dilation). This aortic
dilation may tear, dissect, or rupture, causing serious heart problems
or sometimes sudden death. We will evaluate the manifestations of your
Marfan syndrome under the appropriate body system criteria, such as
4.10 in part A, or if necessary consider the functional limitations
imposed by your impairment.
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. We must consider any
additional and cumulative effects of 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), and when we determine whether your
impairment(s) functionally equals the listings.
2. How do we relate treatment to functional status? In general,
conclusions about the severity of a cardiovascular 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. (See Sec. 416.926.) If you have a severe
impairment(s) that does not meet or medically equal the criteria of a
listing, we will consider whether it functionally equals the listings.
(See Sec. 416.926a.) 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 rate
Age (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
------------------------------------------------------------------------
[[Page 2340]]
Table II.--Tachypnea at rest
------------------------------------------------------------------------
Respiratory rate
Age 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
104.00E3b), despite prescribed treatment (see 104.00B3 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 (see
104.00E3c).
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
C. Symptomatic acyanotic heart disease, with ventricular
dysfunction interfering very seriously with the ability to
independently initiate, sustain, or complete activities.
OR
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. 06-195 Filed 1-12-06; 8:45 am]
BILLING CODE 4191-02-P