[Federal Register Volume 59, Number 28 (Thursday, February 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2844]
[[Page Unknown]]
[Federal Register: February 10, 1994]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Social Security Administration
_______________________________________________________________________
20 CFR Part 404
Revised Medical Criteria for Determination of Disability,
Cardiovascular System; Final Rules
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Social Security Administration
20 CFR Part 404
[Regulations No. 4]
RIN 0960-AA99
Revised Medical Criteria for Determination of Disability,
Cardiovascular System
AGENCY: Social Security Administration, HHS.
ACTION: Final rules.
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SUMMARY: These amendments revise the criteria in the Listing of
Impairments (the listings) that we use to evaluate cardiovascular
impairments for adults and children who claim Social Security or
Supplemental Security Income (SSI) 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.
EFFECTIVE DATE: These rules are effective February 10, 1994.
FOR FURTHER INFORMATION CONTACT: Irving Darrow, Esq., Legal Assistant,
Office of Regulations, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, (410) 966-0512.
SUPPLEMENTARY INFORMATION: The Act provides, in title II, for the
payment of disability benefits to workers insured under the Act. Title
II also provides child's insurance benefits for persons who became
disabled before age 22 and widow's and widower's insurance benefits
based on disability for widows/widowers and surviving divorced spouses
of insured individuals. In addition, the Act provides, in title XVI,
for SSI payments to persons who are disabled and have limited income
and resources. For workers insured under title II, for children of
workers insured under title II who become disabled before age 22, for
widows/widowers and surviving divorced spouses claiming widow's or
widower's insurance benefits based on disability under title II, and
for adults claiming SSI benefits based on disability, ``disability''
means inability to engage in any substantial gainful activity. For
eligibility for SSI benefits as a disabled child under age 18,
``disability'' means that the impairment substantially reduces the
child's ability to function independently, appropriately, and
effectively in an age-appropriate manner. Under both the title II and
title XVI programs, disability must be due to a medically determinable
physical or mental impairment or combination of impairments which can
be expected to result in death or which has lasted or can be expected
to last for a continuous period of at least 12 months.
The listings contained in appendix 1 to subpart P of part 404 are
incorporated by reference in subpart I of part 416. The listings are
divided into part A and part B. The medical criteria in part A are
applied in evaluating impairments of persons age 18 or over. The
criteria in part A may also be applied in evaluating impairments in
persons under age 18 if the disease processes have a similar effect on
adults and younger persons. Part B contains medical criteria for
evaluating impairments of persons under age 18 when the criteria in
part A do not give appropriate consideration to the particular effects
of the disease processes in childhood. In evaluating disability for a
person under age 18, we first use the criteria in part B and, if the
criteria in part B do not apply, we use the criteria in part A. (See
Secs. 404.1525 and 416.925.)
When parts of the listings were last revised and published in the
Federal Register on December 6, 1985 (50 FR 50068), we indicated in the
preamble that medical advancements in disability evaluation and
treatment and program experience would require that the listings be
periodically reviewed and updated. Accordingly, we published
termination dates ranging from 4 to 8 years for each of the specific
body system listings. These dates currently appear in the introductory
paragraphs of the listings; the latest extension for the expiration
date for part A of the cardiovascular regulation appeared in the
Federal Register of July 6, 1993 (58 FR 36133). We are now updating the
cardiovascular system listings in 4.00 (part A) and 104.00 (part B) and
extending the effective date of these revised listings for 4 years from
the date of their publication. Therefore, 4 years after publication of
the final rules, these regulations will no longer be effective unless
extended by the Secretary or revised and promulgated again.
We published these regulations in the Federal Register on July 9,
1991 (56 FR 31266) as a Notice of Proposed Rulemaking (NPRM).
Interested persons, organizations, Government agencies, and other
groups were given 60 days to comment. The comment period ended
September 8, 1991. Twenty-four commenters provided comments on the
NPRM. Below we discuss the significant differences between the final
rule and the proposed rule, and we also respond to the substantive
public comments we received on the NPRM.
Explanation of the Final Rules
We have updated these final rules to provide criteria reflecting
state-of-the-art medical science and technology. The basic approach
underlying the final listings is to place less emphasis on the
diagnosis of disease, and to emphasize the impact of the impairment(s)
on a person's ability to perform gainful activity or, in the case of a
child under the SSI program, on the child's ability to perform age-
appropriate activities.
The listings contain examples of some of the most frequently
encountered impairments in the disability program. The criteria include
specific symptoms, signs, and laboratory findings that are considered
to characterize impairments severe enough to prevent a person from
doing work-related activities, or in the case of a child claiming SSI
benefits under title XVI of the Act, an impairment severe enough to
prevent the child from functioning independently, appropriately, and
effectively in an age-appropriate manner. The listings help to ensure
that determinations of disability have a sound medical basis, that
claimants receive equal treatment through the use of specific criteria,
and that people who are disabled can be readily identified and awarded
benefits if all other factors of entitlement or eligibility are met.
Claimants may be found disabled based on medical factors alone if
their impairment(s) meets or equals one of the sets of medical
criteria. If the severity of a claimant's impairment(s) does not meet
or equal the severity in the medical listings, we then assess the
claimant's residual functional capacity to determine what he or she can
still do; or in the case of a child claiming SSI benefits under title
XVI of the Act, we perform an individualized functional assessment.
Using the residual functional capacity assessment, we determine whether
the person retains the capacity to perform past relevant work; if not,
we determine his or her capacity to do any other work that exists in
the national economy, considering the individual's age, education, and
work experience. If the person is a child claiming SSI benefits under
title XVI of the Act, we use the individualized functional assessment
to determine whether he or she has an impairment(s) of comparable
severity to one that would disable an adult. Thus, we do not deny any
claim of disability on the sole basis that the individual's
impairment(s) does not meet or equal in severity the criteria of a
listing.
As in the NPRM, the final rules contain some criteria in the
listings for chronic heart failure (4.02) and ischemic heart disease
(4.04) based on exercise test results; however, in response to
comments, we have removed the general rules requiring the purchase of
exercise testing in all cases in which exercise testing poses no
significant risk to the individual. A number of commenters, nearly all
of whom were not physicians, were concerned with our proposal to expand
the use of the exercise test and expressed the view that other
evidence, particularly angiography, should be afforded as much
consideration. Although we agree with the commenters that cardiac
angiography is the best diagnostic test for the presence of coronary
atherosclerosis, the angiogram provides only confirmatory anatomic
information supporting the diagnosis of coronary atherosclerosis and
does not help in any way to quantify functional performance. Moreover,
even angiography has some limitations because of inter-observer
variability.
In these listings, we do not use the exercise test for diagnostic
purposes. The purpose of these listings is to subordinate the
diagnostic use of the exercise test and to recognize its usefulness as
a functional test of aerobic capacity. When viewed in this light,
exercise testing is useful for defining the safe limits of exercise,
the aerobic exertional threshold of angina pectoris, or left
ventricular failure. If a person can exercise to greater than 5 METS
without evidence of overt failure, ischemic discomfort, or hypotension,
it can be reasonably inferred that this is a safe level of aerobic
exertion. Even at less than 5 METS, an exercise test is some evidence
of an individual's capacity--or lack of capacity--for aerobic exertion.
However, we agree with the commenters that one should not rely solely
on the results of an exercise test; as with any evidence, exercise test
results must be considered in the context of the entire record.
Even though we have retained in the final rules some criteria for
exercise testing, we want to emphasize that we do not deny any
individual's claim solely because his or her impairment(s) does not
meet or equal in severity any listing. Under the sequential evaluation
processes set out in Secs. 404.1520, 416.920, and 416.924 of our
regulations, we provide every claimant whose severe impairment or
combination of impairments does not meet or equal in severity a listing
with an individualized assessment of his or her functioning and an
opportunity to establish that he or she is disabled. This assessment of
functioning considers all relevant evidence.
In response to public comments, we have also deleted all of the
references in the listings to the New York Heart Association (NYHA)
Functional Criteria, which we had proposed to use in several listings
under 4.02, 4.04, and 4.06. Instead, under final listings 4.02 and
4.04, we have replaced the references with narrative criteria that
describe the functional classes; in final listing 4.06, we deleted the
references to functioning entirely because they were unnecessary. We
describe the criteria and our reasons for making these changes later in
this preamble.
We made a number of other changes in response to the public
comments, which are all described below or in the public comments
section of this preamble. In addition, it was apparent to us from some
of the comments that it would be helpful and clearer if we used the
same or similar language in Parts A and B of the listings when we
intended the provisions to be analogous. We have, therefore, made a
number of conforming revisions in Parts A and B. In the majority of
cases, these changes are not substantive; we describe all of them below
in the summary of provisions or in the public comments section of this
preamble.
Finally, we have made a number of minor editorial changes
throughout the rules to correct errors in the NPRM, to make the rules
internally consistent, and to conform the style of these listings to
our other listings. For instance, we deleted the word ``listing''
before all references to specific listings because that is the style
throughout appendix 1. We also revised the opening paragraphs of
several of the listings in Parts A and B so that they use the same or
similar language to introduce the subparagraphs.
The following is a summary of the provisions of the final rules and
the changes we have made from both the text of the NPRM and the text of
our former rules.
Revisions to Part A (Adult Portion) of Appendix 1
4.00 Preface
4.00A Introduction
We have reorganized the introductory portions of the cardiovascular
listings to facilitate their use. Final 4.00A, ``Introduction,'' is a
new paragraph that explains the basic approach used in evaluating
cardiovascular impairments. It includes general information about the
kinds and extent of documentation we generally require, and stresses
the importance of a longitudinal clinical record to the assessment of
severity and duration, when such a record is available.
We made a number of changes from the NPRM in response to public
comments. There are now four paragraphs in the final 4.00A. The first
paragraph is a general paragraph based on the first two sentences of
the NPRM. We revised the first sentence from the NPRM to make it more
listings-specific; that is, to state that the ``listings in this
section describe impairments resulting from cardiovascular disease.''
We also changed the word ``heart'' to ``cardiovascular'' because it
more accurately describes the content of the listings. In the second
sentence, we added a clause which says that a longitudinal record of 3
months is not necessary if the claim can be decided favorably based on
the current evidence. The third sentence is new. It reaffirms our
general policy that all relevant evidence must be considered in
assessing disability.
The second and third paragraphs of final 4.00A address issues of
treatment. They reorganize and revise the third and fourth sentences
from the NPRM, and expand their discussion. The first sentence of the
second paragraph, which corresponds to the fourth sentence in the NPRM,
now states that many individuals with listing-level impairments will
have received the benefit of a medically prescribed therapeutic
program; this is in contrast to the NPRM statement that ``most''
individuals with cardiovascular disease have ``usually'' received such
treatment. In response to comments that asked whether we would consider
treating source opinions in our determinations, we added the clause,
``in addition to information about the nature and severity of the
impairment,'' to the end of the second sentence, which includes
language from our rules on the evaluation of treating source opinions.
We expanded the provisions at the end of the second paragraph to state
more clearly the reasons why it is important to establish a
longitudinal record and document treatment and response.
We added the third paragraph in response to comments which pointed
out that some people do not receive treatment, and that some do not
have an ongoing relationship with the medical community. The new
paragraph provides that it is still important to establish a
longitudinal record in these cases unless the case can be decided
favorably based on the available evidence. It also explains that, even
though individuals who do not receive treatment cannot be found to have
impairments that ``meet'' the criteria of several of the listings, they
may still have impairments that are equivalent in severity to listed
impairments, or that are disabling at the last step of the sequential
evaluation process. To be consistent with the adult rules, we also
added a fifth paragraph to final 104.00A of the preface to the
childhood listings; the paragraph contains the same provisions as the
adult rules.
The fourth paragraph is a new paragraph that emphasizes the
importance of the last point in all cases in which impairments do not
meet the criteria of a listing. We added this paragraph in response to
many commenters who thought that we would deny claimants whose
impairments did not meet the requirements in the listings, or who
thought that the listings criteria were the only criteria we considered
in the steps of sequential evaluation beyond the listings step. It is a
reminder that claimants whose impairments do not ``meet'' any listing
may still be found to have impairments that ``equal'' a listing, and
that the listings can only be used to find a person disabled, never
``not disabled.'' The new paragraph stresses the importance of an
individualized residual functional capacity assessment, which may or
may not result in a finding of disability, whenever a person's severe
impairment(s) does not meet or equal the severity of a listing. To be
consistent with the adult rules, we also added a sixth paragraph to
104.00A of the preface to the childhood listings emphasizing the
importance of equivalence determinations and individualized functional
assessments when childhood impairments do not meet a listing.
We edited slightly and have moved the fifth sentence from proposed
4.00A to final 4.00C2d because it is guidance relevant to the purchase
of exercise testing.
4.00B Cardiovascular Impairment
We moved the discussion that was in 4.00A of our former rules to
final 4.00B, which we have retitled ``Cardiovascular Impairment.'' We
changed the title from ``Cardiac Impairment'' to ``Cardiovascular
Impairment'' because the section in fact addresses both kinds of
impairments. We revised and expanded this discussion of the
consequences of heart disease to increase its scope and to conform to
current clinical concepts. The discussion now also includes congenital
heart disease, because more individuals with this condition are living
into adulthood.
The final rule is the same as that proposed in the NPRM except that
we added ``near syncope'' in 4.00B3 in response to a comment and, in a
technical correction, we deleted the reference to ``extremities (4.11-
4.12)'' in the paragraph after paragraph 4. Impairment of the
extremities does not result in cardiac impairment.
4.00C Documentation
Final 4.00C, ``Documentation,'' consolidates and augments the
guides formerly in 4.00F, G, H, and I. We have expanded the discussion
in 4.00Clb on the needed descriptions of protocols for various types of
exercise tests, including treadmill, bicycle, and arm ergometry.
The final rules in 4.00C1a are the same as those in the NPRM. In
4.00C1b, we made three changes in response to public comments: In final
4.00C1b(1), we changed the word ``should'' to ``must'' to state the
rule more straightforwardly; in final 4.00C1b(5), we updated the
reference to the American Heart Association standards; and in final
4.00C1b(6) we added text which recognizes that information will not
always be available in the existing medical evidence about whether an
individual supported himself or herself on the handrails or about the
Borg scale.
In responding to a comment, we also made a technical correction in
4.00C1b(4), which had inadvertently misstated how hyperventilation
studies are performed. The NPRM stated that the posthyperventilation
electrocardiogram (ECG)--that is, the ECG taken to assess the effects
of hyperventilation--should be deferred until at least 10 minutes after
exercise; because hyperventilation is performed before exercise, this
would have made the instruction meaningless. We revised the criterion
to explain that it is the exercise that should be deferred for 10
minutes after hyperventilation, which is what we intended to state.
Finally, we made minor editorial changes in the section, such as
substituting ``ECG'' for the word ``electrocardiogram'' in 4.00C1b(1)
and changing the word ``references'' to ``reference'' in the last
sentence of the paragraph.
We substantially revised 4.00C2 from the language of the NPRM in
response to comments. We changed the heading of the section to
``Purchasing exercise tests'' in order to narrow the focus of the
section. We revised the first sentence of final 4.00C2a to state more
accurately that it is well recognized that exercise testing is the best
tool currently available for estimating maximal aerobic capacity,
instead of the more general statement about the assessment of
functional capacity we had proposed. We did this because we agreed with
those commenters who pointed out that exercise testing does not assess
all kinds of functional capacities, only certain functions. We deleted
without replacement the proposed second and third sentences of the
paragraph. The proposed second sentence was the sentence which stated
that exercise tests are the primary basis for evaluating functional
capacity under this listing, which was an inaccurate statement. The
third sentence was an absolute requirement to include existing exercise
test results in the evidence. Aside from the fact that it was not a
rule having to do with the purchase of exercise testing, it also left
no leeway for the possibility that we would be unable to obtain the
evidence despite diligent efforts; we deleted the sentence (instead of
moving it) because inherent in our rules for gathering evidence is the
need to make every reasonable effort to obtain any relevant evidence,
including exercise test results.
We then revised the remainder of the paragraph to better explain
our rules on the purchase of exercise testing and when such purchase
could be appropriate. We explain these revisions in more detail, and
our reasons for making them, in the public comments section of this
preamble. The final rule provides that before purchasing any tests when
exercise is involved, a program physician, preferably one experienced
in the care of patients with cardiovascular disease, should review the
clinical record to determine whether the test presents a significant
risk to the individual. This requirement recognizes that technically
sophisticated medical reports of record need to be reviewed by a
physician to assess potential risk of exercise testing.
Final 4.00C2b replaces former 4.00G2. We have removed the
requirement that the targeted heart rate should not be less than 85
percent of maximum predicted heart rate during exercise testing because
the listings do not use the exercise test for diagnosis but for
functional evaluation.
In a technical change for consistency with final 4.00C1b, we
revised final 4.00C2b(1) to state that a purchased exercise test must
be performed using a generally accepted protocol, that the protocol
that was followed must be reported, and that the test must meet the
requirements of 4.00C1b and 4.00C2b. As in final 4.00C1b(6), we deleted
the requirement for information about whether an individual supported
himself or herself on the handrails and about the Borg scale. We also
deleted the proposed requirement for a description of whether the
individual was allowed to support himself or herself on the handrails
for the reasons we explained in the comments and responses. In response
to a comment, we added a sentence about the significance of isolated
systolic hypertension at the end of 4.00C2b(4); and we deleted proposed
4.00C2(5) and renumbered proposed 4.00C2b(6) as final 4.00C2(5). In
4.00C2b(5), we made conforming changes to permit the use of generally
accepted standards for the exercise laboratory.
Final 4.00C2c discusses risk factors that will preclude the
purchase of exercise testing; it replaces the first paragraph of former
4.00G3. In response to comments, we have expanded the list of risk
factors in final 4.00C2c to include several conditions from the prior
rules that were not in the NPRM; we have also added cardiomyopathies to
the list, and made clear that the risk factors listed are only
examples; we changed the word ``should'' to ``will'' in the opening
clause to make it clear that we will not purchase exercise tests in the
situations listed. We removed the example of arterial dissection after
coronary angioplasty because it was medically inappropriate. We explain
our reason for this change in the public comments section of this
preamble. When the risk factors in 4.00C2c are not present, a claimant
may still be at risk for exercise testing, and the program physician
retains the authority to decide whether a claimant would be at risk.
However, we revised and expanded the section to state more plainly that
it should be a rare case in which the opinion of a treating physician
that a claimant would be at risk to exercise would be overridden and,
if it is, that the program physician's reasons for overriding the
opinion must be documented. We also expanded the section to indicate
that we will purchase an exercise test only if it poses no risk to the
individual and the claim cannot otherwise be favorably decided.
The NPRM language of 4.00C2d, which provided guidance for deferral
of exercise testing following surgery, is unchanged in the final rule.
We did, however, add a cross-reference to 4.00D for clarity. We also
edited slightly and moved the fifth sentence of proposed 4.00A into
this section, as previously described.
In a technical correction, we moved proposed 4.00C2e and
redesignated it as final 4.00C2e(2). The paragraph discusses factors
that limit the interpretation of exercise tests. Therefore, we believe
that it more logically belongs under the heading of ``Evaluation,''
rather than ``Purchasing exercise tests.'' We describe other changes to
the paragraph below, under its new designation of 4.00C2e(2).
Because of the redesignation of proposed 4.00C2e as 4.00C2e(2), we
redesignated proposed 4.00C2f as final 4.00C2e(1). Final 4.00C2e(1)
provides rules on the evaluation of exercise testing. We made a number
of revisions and additions from the NPRM in response to comments. We
deleted the parenthetical statement in the first sentence that
characterized the work level at which the test becomes abnormal as an
``ischemic threshold.'' We added a new second sentence which provides
that the ability or inability to complete an exercise test is not, by
itself, evidence that a person is free from ischemic heart disease and
that the results of exercise testing must be considered in the context
of all of the other evidence in the individual's case record. We also
revised the last sentence of the NPRM to place the focus squarely on
individuals who are under the care of treating physicians. We now state
more clearly the rule from the NPRM that, if the person has a treating
physician who has not ordered an exercise test, and there is no
apparent reason why the person would be at risk, contact must be made
with the source to determine the source's opinion whether exercise
testing involves significant risk, or whether there is some other
reason why the treating physician did not have the test performed, such
as a financial bar. We also deleted references to the ``examining
physician'' in response to a comment that pointed out that the rule was
unclear; moreover, after we had published the NPRM, we published final
rules entitled, ``Standards for Consultative Examinations and Existing
Medical Evidence'' (56 FR 36932, August 1, 1991), in which we do not
include the term ``examining physician'' in our definitions of
``medical sources.'' We have also added a new sentence that underscores
the need to follow the rules in 4.00C2c in those rare situations in
which a treating source's opinion is overridden. Finally, we added a
sentence setting forth the responsibility of the program physician when
an individual does not have a treating physician. We explain all of
these changes and additions in the public comments section of this
preamble.
Final 4.00C2e(2) (proposed 4.00C2e), which discusses factors that
may limit exercise test interpretation, replaces the second and third
paragraphs of 4.00G3 of the former listings. In addition to the
redesignation of the paragraph, there are two changes from the NPRM. We
added a parenthetical example, ``(e.g., 2 weeks of bedrest),'' to
illustrate ``prolonged periods of physical inactivity''; this was in
response to a comment that asked us to define the term and is an
example we use elsewhere in the preface. We also deleted the example of
Wolff-Parkinson-White syndrome, which we have instead restored to final
4.00C2c as an example of a risk factor that precludes the purchase of
exercise testing.
We have moved the discussion on other studies in former 4.00I to
4.00C3 and have expanded the discussion on the use of echocardiograms
and radionuclide studies. Our former criteria stated that the results
of these tests are considered but are not determinative. The new final
criteria explain that there are several imaging techniques, including
two-dimensional echocardiography, which can provide a reliable estimate
of ejection fraction. Purchase of these tests is now permitted in
selected cases; for example, when the available evidence is not
adequate to assess the severity of ventricular dysfunction or
myocardial ischemia. In response to a comment, however, we have added a
clause to the last sentence of the first paragraph of the section
reminding adjudicators that purchase of these tests is permitted only
when the claim cannot be favorably decided on any other basis.
In addition to the foregoing new clause, there are two other
changes in final 4.00C3 from the NPRM. We added a new second paragraph
in response to comments about the value of the measurement of aerobic
capacity by oxygen uptake during maximal exercise rather than
estimation of aerobic capacity from the level of exercise attained
(i.e., speed and grade of treadmill exercise test) without measurement
of oxygen consumption. In the third paragraph of the final rule (the
second paragraph in the NPRM), we added a reference to ``silent''
ischemia at the end of the first sentence. We explain our reasons for
these revisions in the public comments section of this preamble.
Final 4.00C4, on cardiac catheterization, replaces and updates the
rules that were in 4.00H1 of the former listings. There are two
technical changes in the final rules from the NPRM. We deleted the
parenthetical statement ``(by catheter)'' from the heading in 4.00C4a
because coronary arteriography is always performed by catheter;
therefore, the parenthetical statement was redundant and could have
been confusing. In the heading of 4.00C4b, we changed the parenthetical
statement to ``(by angiography).'' The language means the same thing as
``by catheter'' but is more current.
4.00D Treatment and Relationship to Functional Status
We have revised the heading of final 4.00D to, ``Treatment and
relationship to functional status,'' so that it has the same title as
the corresponding section in part B, 104.00C. The change is
nonsubstantive, and it is made only for consistency. This is also true
of the deletion of the parenthetical phrase, ``medical, surgical, or
prescribed program of progressive physical activity,'' from the
heading; the language still appears in the body of 4.00D1 and was,
therefore, merely redundant in the heading. As part of our response to
several comments that led us to focus the discussions more on the
listing level and the need to consider all relevant evidence, we have
also incorporated into final 4.00D1 the guidance we proposed in 104.00C
of part B.
Final 4.00D also continues to state, as in the NPRM, that
evaluation should usually be deferred for a period of up to 3 months to
assess the effect of treatment. We added that the 3 months will be from
the date of treatment to clarify when the deferral period begins.
However, in response to public comments, we have clarified final 4.00D1
to state that evaluation need not be deferred if the claim can be
favorably decided based on the available evidence. We deleted the
4.00D2 we had proposed in the NPRM in response to public comments that
asked us to remove the absolute requirement for exercise test evidence.
In final 4.00D2 (which was designated as 4.00D3 in the NPRM), we expand
the criteria formerly in 4.00J for evaluation 3 months after cardiac
surgery and provide guides for evaluation postangioplasty.
For the above reasons, we renumbered proposed 4.00D4 as final
4.00D3. In final 4.00D3, which addresses cardiac transplantation, we
deleted the second sentence, which would have required us to obtain
records of endocardial biopsies performed during the first few months
after the transplant. We agreed with commenters who pointed out that,
inasmuch as an individual is considered disabled under listing 4.09 for
1 year following transplant, these early records are unnecessary. We
have also corrected the cross-reference at the end of the section,
which was to Sec. 416.994(c)(1)(i) in the NPRM, to
Sec. 416.994(b)(1)(i); there is no longer a Sec. 416.994(c)(1)(i) in
our rules.
4.00E Clinical Syndromes
In final 4.00E, we address the clinical syndromes formerly
discussed in 4.00B, C, D, E and K. In 4.00E1, we have added a
discussion on chronic heart failure with and without congestion.
Because congestion (fluid retention) is now often controlled by potent
diuretic medications, we eliminated the requirement for the presence of
congestion at the time of adjudication. We now clarify that either
there is or has been congestion, but it need not be present at the time
of adjudication. We also moved the material on ``hypertensive vascular
disease'' formerly in 4.00C to 4.00E2 and updated the terminology to
the more comprehensive term, ``hypertensive cardiovascular disease.''
In response to a comment from a physician, we expanded the guidance in
final 4.00E1a to indicate that chronic heart failure may be manifested
by pulmonary congestion, systemic congestion, or both. There are no
other changes from the NPRM in either final 4.00E1 or 4.00E2.
Final 4.00E3, on ischemic heart disease, combines and expands the
guides in 4.00D and E of the former listings. The terminology ``chest
pain of cardiac origin'' has been reworded, for clarity, to
``discomfort of myocardial ischemic origin.'' This revision also
recognizes that the discomfort may be precipitated by emotion as well
as exertion. Descriptions of noncoronary conditions that may cause
ischemic discomfort and noncardiac chest conditions that may produce
symptoms mimicking that of myocardial ischemia have been added to help
in the evaluation of chest discomfort. The final section also indicates
that chest discomfort of nonischemic origin may result from other
cardiac conditions, such as pericarditis and mitral valve prolapse.
In response to comments, we have made two changes to final 4.00E3
from the NPRM. We added a new 4.00E3d, which consists of a single
sentence reminding adjudicators to be alert to the possibility of so-
called silent ischemia or that the individual may be symptom-free
because of the avoidance of activities that bring on symptoms. In final
4.00E3f, we added ``chest wall syndrome'' to the list of noncardiac
conditions that may produce symptoms mimicking that of myocardial
ischemia. Aside from these changes, we made a few minor editorial
changes (such as the insertion of commas, combining paragraphs into one
paragraph, and the addition of the missing word ``and'' in the second
sentence of 4.00E3f) that do not substantively affect the final rules.
We have moved the discussion of peripheral arterial disease
formerly in 4.00K to final 4.00E4. The final rule is the same as the
NPRM except that, in response to a public comment, we added a phrase in
the second paragraph clarifying that the ankle and brachial blood
pressures are taken in the supine position. We also expanded the
criteria for the Doppler treadmill exercise test in the third paragraph
to permit a 10 percent grade as well as a 12 percent grade. We made a
nonsubstantive change in the last sentence of the third paragraph to
change the term ``contraindicated'' to ``significant risk'' to be
consistent with terminology used in these regulations in Secs. 404.1519
and 416.919. We explain our reasons for adopting these comments in the
public comments section of this preamble.
4.02 Chronic Heart Failure
This listing provides criteria for individuals with chronic heart
failure resulting in functional restrictions that equate with NYHA
class III or IV despite a regimen of prescribed treatment. Because
heart enlargement is a major component of these listings, we have
defined cardiac enlargement. We have also changed the word
``congestive,'' which was in the title of former listing 4.02, to
``chronic'' heart failure because the conditions covered under this
listing are not necessarily required to be associated with congestion.
The final rule, unlike the former rule, also requires that the
individual be on a treatment regimen prescribed by a treating source.
Because overt fluid retention is now often medically controlled at
rest, even in the presence of chronic failure, we have removed the
requirement that peripheral or pulmonary edema be present on physical
or laboratory examination. We have also added a listing (final listing
4.02B) that may be met with marked exercise intolerance, as
demonstrated by inability to exercise on a treadmill at a workload
equivalent of 5 METS or less due to symptoms of chronic heart failure,
or the need to terminate exercise because of certain clinical findings,
together with functional restrictions equivalent to the NYHA class III
level.
We have revised final listing 4.02, largely in response to public
comments on the NPRM. In the opening paragraph of final listing 4.02,
we have deleted the phrase, ``any specified etiology,'' in order to
include idiopathic chronic heart failure under the listing. We also
added a cross-reference to 4.00A for those individuals who do not have
a regimen of prescribed treatment. As we have stated above, we removed
the references to the NYHA functional classifications in listings 4.02A
and B and replaced them with narrative descriptions of the criteria. We
also reorganized the listings so that the objective medical criteria
are presented first, followed by the functional criteria, consistent
with other listings in appendix 1; this does not change the content of
the listings, only their order of presentation. In listing 4.02A, we
replaced the cross-reference to 4.00C3, which does not define
cardiomegaly but only discusses appropriate imaging techniques, with
more explicit examples of how cardiomegaly can be demonstrated on x-ray
or two-dimensional echocardiography.
In the opening paragraph of final listing 4.02B, we replaced the
phrase, ``reduced global ejection fraction,'' with the phrase, ``left
ventricular ejection fraction of 30 percent or less.'' The phrase
``global ejection fraction'' is outdated medical terminology which
means the same thing as ``left ventricular ejection fraction.'' The
requirement of 30 percent or less removes any uncertainty about the
criterion and is the same criterion as in listing 4.04B. In final
listing 4.02B1, we revised the language that was in listing 4.02B2 of
the NPRM in response to comments that demonstrated to us that it was
unclear; the revisions are not a substantive change, but a
clarification of the proposed rules. This includes the replacement of
the phrase ``markedly symptomatic exercise intolerance'' with a clearer
statement explicitly requiring the inability to exercise at the 5-MET
level or less on an exercise test because of symptoms or specific
clinical findings. We also added a criterion for three or more
multiform beats in final listing 4.02B1a in response to a comment.
Final listing 4.02C is the same as in the NPRM, except that we
redesignated it as paragraph C of the listing. The designation as
paragraph D in the NPRM was an error, inasmuch as there were only three
paragraphs in the listing.
4.03 Hypertensive Cardiovascular Disease
We have changed the title of this listing from the former,
``Hypertensive vascular disease,'' but have made no change in the
content. There is no change from the NPRM.
4.04 Ischemic Heart Disease
The listing 4.04A criteria on evaluating ischemic heart disease
when there is a recent exercise test of record have been amended to
exclude nonspecific rhythm/conduction disturbance and expanded to
include blood pressure response and imaging techniques in current use.
When an exercise test has not been performed and cannot be purchased
because performance of the test would present a significant risk to the
individual, final listings 4.04B and C may apply. Listings 4.04B and C
are also descriptive of individuals who may be too impaired to perform
exercise, but who are symptomatic on normal activity. The new listing
4.04B and C criteria require demonstration of cardiac functional loss
resulting from heart disease.
In response to comments, we have made a number of changes from the
NPRM in the final listing. In the opening paragraph of the listing, we
deleted the phrase, ``occurring repeatedly,'' because we agreed with a
commenter who pointed out that the frequency of chest discomfort should
not be a decisive issue inasmuch as many people structure their lives
so as to avoid chest discomfort. The relevant issue is their functional
limitations; that is, the level of exertion at which they would have
chest discomfort if they were to make the attempt. We also added a
cross-reference to 4.00A for those individuals who do not have a
regimen of prescribed treatment.
As in final listing 4.02, we removed the references to the NYHA
functional classifications in listings 4.04B and C and replaced them
with narrative descriptions of the criteria. We also reorganized these
listings so that the objective medical criteria are presented first,
followed by the functional criteria, consistent with the changes in
final listing 4.02 and other listings in appendix 1.
There are no substantive changes in final listing 4.04A from the
NPRM. The only change is that we corrected the word ``unsloping'' in
listing 4.04A2, to ``upsloping.'' This was only a typographical error.
In addition to the changes already noted, we have revised final
listing 4.04B so that its functional criterion is at the level of NYHA
functional class III instead of the proposed class IV. In addition, we
revised final listing 4.04C so that its objective medical criterion is
now only angiography, instead of the proposed angiography and an
ejection fraction. We agreed with those commenters who pointed out that
proposed listing 4.04C described an unusual fact pattern that would
rarely be met and that, for individuals who are at risk for exercise
testing, the restrictions associated with NYHA functional class III
together with documented chest discomfort and the required objective
medical findings should be enough to establish disability at the
listing level. There are no other changes from the NPRM in final
listings 4.04B and C.
4.05 Recurrent Arrhythmias
Listing 4.05 has been expanded. The new criteria specify that
arrhythmias related to reversible causes are excluded from the listing
and add a requirement that resting or ambulatory (Holter)
electrocardiography demonstrating the arrhythmia be coincident with the
occurrence of syncope or near syncope. The only change from the
proposed rule is that, in response to a comment, we added ``near
syncope'' to the symptoms that may satisfy the criteria of the listing.
4.06 Symptomatic Congenital Heart Disease
We have added a new listing 4.06 on congenital heart disease
because more individuals with this condition are living into adulthood.
In response to comments, and for technical reasons described in the
public comments section of this preamble, we deleted all specific
references to functioning from the final listing. As we explain later,
the final criteria are sufficiently severe that the functional
limitations are implicit in the listing and need not be stated as
separate criteria.
Other changes from the NPRM are in final listings 4.06A2 and 4.06B.
To make these listings consistent with the final (and proposed)
childhood listing 104.06A1, we have added the criterion in listing
4.06A2 of arterial O2 saturation of less than 90 percent in room
air. In 4.06A2 and 4.06B, we have revised the arterial PO2 to 60
Torr or less and deleted the altitude adjustments. These criteria are
also relevant to the evaluation of cyanotic heart disease in adults.
Finally for consistency with the language of part B and for clarity, we
added the word ``Secondary'' to final listing 4.06E to make it the same
as final listing 104.06D.
4.07 Valvular Heart Disease or Other Stenotic Defects, or Valvular
Regurgitation
The new listing provides references to other listings to be used to
evaluate valvular heart disease or other stenotic defects or valvular
regurgitation. It replaces former listing 4.09. We expanded the scope
of this listing in response to a comment about proposed listing 104.06F
in part B (final listing 104.06E) which was also relevant to the adult
rules. We explain our reasons for this revision in the public comments
section of this preamble.
4.08 Cardiomyopathies
This listing provides references to other listings to be used to
evaluate cardiomyopathies. It replaces former listing 4.09. The final
rule is the same as the NPRM.
4.09 Cardiac Transplantation
This is a new listing providing for a finding of disability for 1
year following a heart transplant. We made minor editorial revisions to
the NPRM to conform final listings 4.09 and 104.09. These revisions do
not substantively change the final rule from the proposed rule but only
provide consistency between part A and part B.
4.10 Aneurysm of Aorta or Major Branches
This listing replaces former listing 4.11, and has been broadened
to encompass all neurological complications from aneurysm, not just
syncopal episodes. We have also added a list of common causes of
aneurysms. Except for a minor editorial change, the listing is
substantively the same as the proposed rule.
4.11 Chronic Venous Insufficiency
This final listing replaces former listing 4.12 for chronic venous
insufficiency of a lower extremity. In response to a comment, we
revised the final rule to provide for a finding of ``meets'' when the
individual has chronic venous insufficiency of a lower extremity with
incompetency or obstruction of the deep venous system, resulting in
either extensive brawny edema (final listing 4.11A), or a combination
of superficial varicosities, stasis dermatitis, and recurrent or
persistent ulceration which has not healed following at least 3 months
of prescribed medical or surgical therapy (final listing 4.11B). We
explain our reasons for this revision in the public comments section of
this preamble.
4.12 Peripheral Arterial Disease
This final listing replaces former listing 4.13. The final listing
describes listing-level disability from peripheral arterial disease as
a result of intermittent claudication or amputation at or above the
tarsal region. The final rule is the same as the proposed rule except
that we added the phrase ``at the ankle'' in final listing 4.12B2
before the word ``and'' to clarify the distinction between the tests in
listings 4.12B1 and B2. The systolic blood pressure ratio in listing
4.12B1 is based on a comparison of blood pressures taken at the ankle
and the arm, whereas the ratio in listing 4.12B2 is based on two ankle
readings. This is not a change from the NPRM but a clarification of the
meaning of a rule that has been in our listings for many years.
Revisions to Part B (Childhood Portion) of Appendix 1
104.00 Preface
We have revised and expanded the introductory material to improve
and facilitate its use. In response to comments, we have made a number
of changes in this section, detailed below. Because one general comment
expressed a concern that we had not explained our reasons for proposing
the changes to this section of the listings, we now provide these
explanations. In some instances, while providing these explanations in
response to the comments, we realized that the information in 104.00
could be more clearly and comprehensively presented and, in a few
instances, that it could be made more consistent with statements in
4.00 of the adult rules; we, therefore, made appropriate revisions. We
explain all of these revisions below or in the public comments section.
104.00A Introduction
We have made a number of revisions from the NPRM in final 104.00A
in response to comments and to maintain consistency with the adult
rules. In the first paragraph, we continue to emphasize that
cardiovascular disorders and impairments must be substantiated on the
basis of medical evidence. However, we have revised the paragraph to
mirror more closely the first paragraph of final 4.00A of the adult
rules, primarily by incorporating into the first paragraph statements
that were in subsequent paragraphs of the NPRM. The new paragraph
incorporates the statement that was in the second sentence of the third
paragraph of 104.00A in the NPRM, that the criteria in the listings are
based on medical evidence consisting of signs, symptoms, and laboratory
test abnormalities, but that it is also important to consider the
child's response to treatment. It also includes the second sentence of
the fourth paragraph of the NPRM, which requires a longitudinal record
of at least 3 months; however, as in the final adult rules, we have
added a statement in the final rules that this is unnecessary if the
claim can be decided favorably on the basis of the existing evidence.
In addition, because of the importance of specialization in childhood
cardiovascular disease, we have added a statement that reasonable
efforts should be made to ensure review by a program physician
specializing in the evaluation of childhood cardiovascular disease or
by a qualified pediatrician; this language is adapted from section 5036
of Public Law 101-508, the Omnibus Budget Reconciliation Act of 1990
(now incorporated at section 1614(a)(3)(H) of the Act), and merely
reflects our current policy.
Because not all forms of cardiac disease are necessarily disabling,
the second paragraph provides examples of congenital and acquired heart
conditions that can frequently be associated with disabling impairments
during childhood. The second paragraph of final 104.00A is the same as
in the NPRM, except that we corrected typographical errors. We deleted
the third paragraph of the NPRM because we moved its sentences to other
paragraphs: We moved the first sentence, on evidence, to the first
paragraph of 104.00B, the section on documentation; as we have already
stated, we moved the second sentence, describing the medical basis of
the listings, to the first paragraph of 104.00A.
We revised, expanded, and clarified the fourth paragraph of the
NPRM (the third paragraph of final 104.00A). We moved the second
sentence of the NPRM to the first paragraph. We also expanded the
discussion in this paragraph about the adverse effects of
cardiovascular impairments on other body systems because it could have
been misleading. The paragraph we proposed could have suggested that
cardiovascular impairments may affect only growth and development in
children or cause mental retardation, when in fact they can have other
adverse effects involving other body systems. Our intent in providing
this paragraph was to highlight the fact that mental retardation and
impairments of growth and development can result from cardiovascular
impairments to ensure that these particular manifestations are not
overlooked. However, because we are also concerned that other
conditions should not be overlooked, we have expanded the paragraph to
state that cardiovascular impairments, especially chronic heart failure
and congenital heart disease, may result in impairments in other body
systems including, but not limited to, growth, neurological, and
mental; therefore, evaluation should include a consideration of the
adverse effects of cardiovascular impairment in all relevant body
systems. We then continue to highlight the importance of considering
the effects on a child's growth and development or mental functioning,
as described under the growth impairment (100.00), neurological
(111.00), and mental retardation (112.05) listings.
In the final rules, we have also added three paragraphs to make the
preface to the childhood listings consistent with the preface to the
adult listings, and to minimize the need to cross-refer to the adult
rules. The fourth and fifth paragraphs of final 104.00A emphasize the
importance of establishing a longitudinal treatment record when
possible, or of creating a longitudinal record when there has not been
any treatment. In the fourth paragraph, we have used much of the same
language that is in the second paragraph of final 4.00A of the adult
rules, but have not included discussions of factors (such as cardiac
insult) that are generally not relevant to children. The new final
sixth paragraph emphasizes the importance of considering equivalence
and, if necessary when there is a claim for SSI benefits under title
XVI, performing an individualized functional assessment whenever a
child does not have an impairment that meets or equals a listing. This
paragraph replaces the fifth paragraph of the NPRM, which we deleted in
response to a public comment.
104.00B Documentation
Final 104.00B addresses documentation requirements, with emphasis
on obtaining medical evidence from sources experienced in providing
pediatric cardiac services. Reference is made to obtaining results of
studies which may have been performed using technologies, e.g., two-
dimensional and Doppler echocardiography, exercise testing, and
radionuclide ventriculograms, for evaluating the presence and severity
of cardiovascular disorders. We also state explicitly that we will not
purchase cardiac catheterization studies; this is because such
procedures involve risk to the claimant. However, we emphasize the
importance of requesting data and reports of cardiac catheterization
and other tests, when they are available.
We revised the heading of this section from the NPRM (which said,
``Documentation and Evaluation'') so that it is the same as the
corresponding heading in the adult rules and because this section does
not, in fact, discuss evaluation. For consistency with the adult rules,
we also deleted the proposed first sentence and replaced it with the
sentence we had proposed as the first sentence of the third paragraph
of 104.00A, slightly revised for context and to be consistent with the
language of the adult rules. We also added a cross-reference to part A,
4.00C1 at the end of the first paragraph to indicate that the same
basic evidentiary requirements apply to ECG tracings for children as
for adults. We had inadvertently omitted this cross-reference in the
NPRM, and its addition merely makes the paragraph consistent with the
format we follow in the second paragraph of the section.
In response to a comment, we have also added a new second sentence
to the second paragraph of final 104.00B, ``Documentation,'' providing
procedural guidance on when the purchase of an ambulatory ECG may be
appropriate. Also in response to a comment, we have added a third
paragraph that discusses generally when exercise testing may be useful
in evaluating children with arrhythmias or chronic heart failure. The
new paragraph provides that exercise testing for children, while
increasingly used, is still less frequently indicated in children than
in adults and can rarely be performed on children who are under 6 years
of age. It may only be purchased if the case cannot be decided based on
the available evidence and, if it is purchased, must be performed at a
specialty center for pediatric cardiology or other facility qualified
to perform exercise testing for children. We also included a paragraph
for consistency with the adult rules that indicates that purchased
exercise tests should be performed using a generally accepted protocol
consistent with the prevailing state of medical knowledge and clinical
practice; that risk should be assessed for children; and that the same
general guidelines on risk factors for adults in 4.00C2c apply to
children.
104.00C Treatment and Relationship to Functional Status; 104.00D
Congenital Heart Disease
Final 104.00 C and D provide guidelines to be used in the
evaluation of infants and children with congenital heart disease under
final listing 104.06H, as well as general guidance on the relationship
of treatment to functional status. Final listing 104.06H was proposed
listing 104.06A. We explain our reasons for moving it to the end of the
listing under the summary of provisions to listing 104.06, below. For
the same reasons given under the summary of provisions for 4.00D of
part A, we revised the heading of final 104.00C from that in the NPRM
so that it is identical to 4.00D of the adult rules. We also
incorporated the provisions of 4.00D1 into the first paragraph of final
104.00C to make clear that this important information about the need to
establish a longitudinal record also applies to children, unless a
favorable decision is possible based on the available evidence. Because
we added the exception for decisions favorable to the claimant, we
deleted the word, ``however,'' from the beginning of the first sentence
of the second paragraph for context.
In response to comments we have received, we also expanded the
discussions in final 104.00C and D to clarify their meaning. In the
second paragraph of final 104.00C, we state our original intent that
``the most life-threatening forms of congenital heart disease and
cardiac impairment'' are exemplified by the conditions named in
104.00D; therefore, these conditions, or conditions of equivalent
severity, are the kinds of conditions contemplated by final listing
104.06H. We also make clear that these are conditions for which life-
saving surgery must be performed within the first year of life. We then
provide more detail about why these conditions are disabling under the
listing. This is because they are so severe that, even with surgery, we
would expect them to continue to be disabling for a period of at least
12 months, as required by the Act, because of residual impairment after
surgery, the recovery time after surgery, or a combination of both
factors. We do not intend any of these revisions to be a substantive
change from the rules we proposed.
In the third paragraph of final 104.00C, we replaced the ambiguous
references to the ``specified period'' of time, with the actual time
periods set forth in final listings 104.06H and 104.09. We also revised
the last sentence of the paragraph because it contained inaccurate and
incorrect information. We revised the general statement about
continuing disability evaluation because it was an inaccurate statement
of our medical improvement review standard in Sec. 416.994a, which
requires a finding of medical improvement based on symptoms, signs, and
laboratory findings, and a finding whether any medical improvement is
``related to the ability to work'' before consideration of whether the
residual impairment is still disabling. The revised language now more
closely follows the statement in final 4.00D4 of the adult rules that,
``continuing disability evaluation will be based upon residual
impairment as shown by symptoms, signs, and laboratory findings,'' and
then cross-refers to the appropriate rules for continuing disability
review.
We also revised the cross-references at the end of 104.00C because
they were incorrect. The appropriate rule for evaluating continuing
disability in children will usually be Sec. 416.994a; moreover, there
is no longer a Sec. 416.994(c)(1)(i) in our current rules. We have,
therefore, revised the cross-references to refer more generally to the
three rules that might apply: Secs. 416.994a, 404.1594, and 416.994.
The last two rules usually apply to adults, but there will be cases in
which our continuing disability review occurs when the person is over
age 18. Also, even though these listings apply to all people under age
18, the continuing disability review process in Sec. 404.1594 applies
to children seeking child's insurance benefits based on disability
under title II.
We deleted the first paragraph of proposed 104.00D because it was
redundant of the discussions in 104.00C. In the first and second
paragraphs of final 104.00D (which were the second and third paragraphs
in the NPRM), we made minor editorial changes to clarify that the named
conditions are only examples of the kinds of conditions discussed in
final 104.00C and final listing 104.06H. We also added the modifier
``listing-level'' before the word ``impairment'' in the opening clause
of the first paragraph. Clearly, there are less severe impairments than
the life-threatening conditions named in 104.00D which would cause
impairment; therefore, the addition of the phrase only corrects an
ambiguous use of the word ``impairment.'' For the same reason, we added
the same modifier before the word ``impairment'' in the second and
third sentences of the third paragraph of final 104.00D (the fifth
paragraph in the NPRM). We also broadened the scope of the final second
paragraph of the section to encompass up-to-date treatment modalities.
We now indicate that the conditions named may require multiple surgical
interventions (as in the NPRM), but that they may also involve only one
surgery but require other significant treatments after surgery, such as
multiple cardiac catheterization procedures, which are now being used
more frequently in infants.
We deleted the proposed fourth paragraph, regarding patent ductus
arteriosus, in response to a comment which pointed out that the
condition is not of the level of severity contemplated by final listing
104.06H; this comment also led us to clarify final 104.00C and D to
indicate more clearly the kinds of conditions that are contemplated.
Finally, in the third sentence of the third paragraph of the final rule
(the fifth paragraph of the NPRM) we added a parenthetical statement
clarifying that the guidance about lower levels of pulmonary artery
pressure ``in the absence of such a defect'' refers to primary
pulmonary hypertension, or to some connective tissue disorders with
cardiopulmonary involvement and pulmonary vascular destruction, such as
systemic lupus erythematosus.
104.00E Chronic Heart Failure
Final 104.00E, ``Chronic heart failure,'' emphasizes the clinical
and laboratory findings that document the existence of chronic heart
failure, and describes symptoms of the impairment in infants and
children. The use of imaging techniques is cited in demonstrating the
presence of cardiomegaly or ventricular dysfunction.
We made a number of changes and additions in response to public
comments. We expanded the first paragraph of the section to restore
mention of some of the symptoms from former listing 104.02 and to
include some of the guidance we had originally proposed for inclusion
in listing 104.02. In the second paragraph, we also deleted our
reference to radionuclide studies (formerly in the last sentence of the
proposed rule), which are rarely performed on children, and replaced
the examples with references to two-dimensional or Doppler
echocardiography, two common imaging techniques, and added a reference
to standards for measuring cardiomegaly using echocardiography. We also
restored the rule that was in former 104.00C regarding the use of
roentgenography (x-rays) to determine cardiomegaly, which we had
proposed to delete because it is now an uncommon practice for this
purpose and below the modern standard of care for children with chronic
heart failure. For this reason, we also now require that findings of
cardiomegaly on chest x-ray also be accompanied by other findings
demonstrating chronic heart failure; we have also provided a reference
for the evaluation of enlargement using appropriate imaging techniques
and have made minor revisions to update the rules. We explain our
reasons for these changes in more detail in the public comments section
of this preamble.
In addition, we made two nonsubstantive, editorial revisions in the
section for clarity. In the first sentence of the section, we added the
phrase ``in infants and children'' to make clear that the guidance in
that sentence applies to all children, not just infants. Inasmuch as
the other two sentences in the paragraph are about infants, we were
concerned that people understand that we had not overlooked older
children. In the first sentence of the second paragraph (which was the
last sentence of the proposed section in the NPRM), we deleted the
phrase, ``can be,'' because it was ambiguous. Our intent was to give
examples of kinds of imaging techniques that could be used to
demonstrate manifestations of chronic heart failure, not to state that
imaging techniques were only one alternative for demonstrating the
manifestations.
104.00F Valvular Heart Disease
Final 104.00F, ``Valvular heart disease,'' describes the
circumstances under which a listing-level impairment is likely to be
present and the necessary documentation requirements. In the first
sentence, we added the phrase ``or other source of record,'' after
``treating source.'' This is a technical correction that is required
because of final rules we published after we published this NPRM
(``Standards for Consultative Examinations and Existing Medical
Evidence,'' 56 FR 36932, August 1, 1991). Under Secs. 404.1502 and
416.902, the term ``source of record'' is a more inclusive term that
includes both treating sources and other sources, such as hospitals,
clinics, or other medical sources that have provided an individual with
treatment or evaluation. If the results of angiography are available
from such sources, we will, of course, try to get them.
As in final 104.00C and D, we added the phrase ``listing-level''
before the word ``impairment'' in the second sentence of the section.
We also added ``arrhythmias'' to the list of possible outcomes of
valvular heart disease that could result in listing-level impairments.
This, too, is a technical correction, inasmuch as arrhythmias are
included in the listing that corresponds to this section, final listing
104.07. For clarity, we deleted the qualifying reference to
``prepubertal children, age 16 years or less'' that was at the end of
the proposed paragraph. In fact, this guidance applies to all children,
up to age 18. Finally, for consistency with the adult rules, we have
added the same guidance that appears in the first sentence of final
4.00D2, that the usual time for adequate assessment of the results of
treatment after valvular surgery is 3 months.
104.00G Rheumatic Heart Disease
This section renumbers and retitles former 104.00E on rheumatic
fever. We made two changes from the NPRM language. We deleted the
phrase ``as used in this section,'' because it is superfluous; the
deletion does not change the meaning of the sentence at all, and is,
therefore, only editorial. We also deleted the specific reference to
the 1965 Jones criteria for guidance in the diagnosis of rheumatic
fever. This is because we have recently become aware that a new
revision is forthcoming and we want the listings to be as up-to-date as
possible. We replaced the reference with a general requirement to use
the ``current'' Jones criteria.
104.01 Category of Impairments, Cardiovascular
The revisions to the part B cardiovascular listings maintain
structural and content comparability with part A to the extent
applicable. As in the sections of 104.00, there were a few instances in
which we were able to incorporate language from the adult rules into
the listings language we proposed in the NPRM or to make the same or
similar revisions in both parts for even greater consistency between
parts A and B.
104.02 Chronic Heart Failure
As in the adult rules, we have removed the term ``congestive'' from
the heading of listing 104.02 and replaced it with ``chronic.'' Because
of pharmacological and clinical advances in the control of overt
pulmonary and systemic congestion (fluid retention), heart failure can
be present despite the absence of congestive signs.
The criteria under final listing 104.02 stress the importance of
demonstrating functional impairment. However, we also require the
presence of either cardiomegaly or ventricular dysfunction, as
described in 104.00E, to demonstrate the presence of chronic heart
failure.
We have revised listing 104.02 of the proposed rules in response to
public comments. Final listing 104.02A is now a criterion for
persistent tachycardia at rest, and final listing 104.02B includes
persistent tachypnea at rest or markedly decreased exercise tolerance,
as defined in 104.00E of the preface; in response to the comments, we
also included the tables for resting tachycardia and tachypnea from the
prior rules. Final listing 104.02C now lists recurrent arrhythmias
under listing 104.02 in lieu of the cross-reference to listing 104.02
we had proposed to provide in the listing for arrhythmias, 104.05. The
addition of these three rules also required us to redesignate the
paragraphs we had proposed in the NPRM.
In addition, in response to comments which demonstrated that the
rules could be made clearer for lay readers, we moved some of the
requirements of proposed listing 104.02A, which discussed
symptomatology and severity, into the prefatory discussion in 104.00E
and expanded that discussion. We explain all of these changes and our
reasons for them in the public comments section of the preamble.
Final listing 104.02D (proposed listings 104.02B and 104.02C)
provides for the evaluation of the infant and young child whose major
manifestation of chronic heart failure is a growth disturbance. In a
technical correction, we revised final listings 104.02D1 and D2 because
proposed listing 104.02B was unclear and illustrated a level of
severity that was above listing-level. We revised final listings
104.02D2 and D3 to provide criteria for the evaluation of involuntary
weight loss or failure to gain weight at an appropriate rate. In this
way, we not only include children who have stopped gaining weight or
lose weight, but also children who do not gain enough weight. We also
explicitly provide for the possibility that a child will actually lose
weight. Final listing 104.02D3 (proposed listing 104.02C) provides a
reference to the listing on growth impairment. It has been included to
permit evaluation of height and growth failure under the cardiovascular
listing. In a technical clarification, we changed the reference in
final listing 104.02D3 from a specific reference to listings 100.02A
and B, to a general reference to the listings in section 100.00. In
this way, listing 104.02D3 will remain current when we revise the
growth impairment listings in the future.
104.03 Hypertensive Cardiovascular Disease
The final listing is essentially the same as the former listing
except that we have updated final Table III, ``Elevated Blood
Pressure,'' using values currently recommended by the American Academy
of Pediatrics (see the definition of ``Significant Hypertension'' in
Table 5 of the ``Guidelines of the American Academy of Pediatrics;
Report of the 2d Task Force on Blood Pressure Control in Children--
1987,'' ``Pediatrics,'' 1987; 79:1-25). The table was unnumbered in the
NPRM because it was the only table in the proposed rules. Now that we
have restored the tables for tachycardia at rest and tachypnea at rest
to final listing 104.02, we have restored the designation ``Table III''
in the final rules. In response to a comment, we have also added a
statement in the opening paragraph of the listing clarifying that the
values in the table are equal to or greater than the 95th percentile
for age.
104.05 Recurrent Arrhythmias
We have dropped the criteria in former listing 104.05C for exercise
intolerance because, if present, such intolerance would most likely be
manifested in association with chronic heart failure as described under
final listing 104.02. In response to comments, we have revised the
final rule to state more clearly our original intent and to be more
consistent with final listing 4.05, the corresponding adult rule. Final
listing 104.05 is now a single paragraph which provides that recurrent
arrhythmias resulting in uncontrolled repeated episodes of cardiac
syncope or near syncope and arrhythmia despite prescribed treatment,
including electronic pacemaker, and documented by resting or ambulatory
(Holter) electrocardiography coincident with the occurrence of syncope
or near syncope will meet the criteria of the listing. As in the adult
rule, we now include near syncope among the symptoms that will satisfy
the requirements of the listing.
As we explain in more detail in the public comments section of this
preamble, we removed the proposed criterion in listing 104.05B for
chronic heart failure that meets the requirements of listing 104.02 and
instead added a criterion of arrhythmia in final listing 104.02C by
which that listing can be met. We also moved the proposed criterion in
listing 104.05C, for electronic pacemaker therapy, into the text of the
rule; electronic pacemaker therapy is merely a kind of treatment and,
therefore, is now included as an example of treatment that must be
ineffectual instead of as a separate criterion. Our intent in making
this revision from the NPRM is not to raise the severity of the listing
but to clarify our original meaning and to ensure that the rule is
medically correct.
104.06 Congenital Heart Disease
Final listing 104.06 (former listing 104.04) is renamed
``Congenital heart disease'' because it is to be used for both cyanotic
and acyanotic congenital conditions. The term ``palliative'' as applied
to cardiac impairment or surgical procedures is no longer particularly
meaningful in evaluating impairment severity. For this reason, the
former listing 104.04A criterion, which referred to palliative surgery,
has been omitted from the final listing.
In a nonsubstantive, editorial change from the NPRM, we reorganized
the paragraphs of final listing 104.06 to move proposed listing 104.06A
to the end of the listing, as final listing 104.06H. We did this
because proposed listing 104.06A specifies that it is confined to
infants under age 1, but the subsequent listings in the proposed rules
did not state that they apply to children of all ages. Therefore, if
the listing for infants under age 1 came first, it would not be clear
that the subsequent listings (i.e., proposed listings 104.06B through
H) were applicable to all children, regardless of their age. By
redesignating proposed listings 104.06B through H as final listings
104.06A through G in the final rules and placing the infant listing
last, there will be no possibility of ambiguity or misunderstanding
about the applicability of the first seven criteria in the listing.
The criteria under final listing 104.06A (proposed listing 104.06B)
represent criteria that were previously included under listings 104.04B
and C. Cardiac syncope, formerly in listing 104.07, is in final
listings 104.06A3 and 104.05. In keeping with our revisions to ensure
comparability between the adult and childhood listings, we revised the
NPRM nonsubstantively, to reflect more closely listing 4.06A in part A.
We now clarify that final listing 104.06A is for the evaluation of
cyanotic heart disease. We also reversed the order of subparagraphs 1
and 2 so that they are in the same order as the corresponding rules in
adult listing 4.06A. Because we now include reference to cyanosis in
the opening statement of final listing 104.06A, and because this
listing includes both cyanotic and noncyanotic heart disease, we
replaced the word ``cyanosis'' with the more medically accurate
``hypoxemia'' in final listing 104.06A4. Also, in response to a comment
about our omission of the former listing 104.08 criterion for
hemoptysis in proposed listing 104.06D, we have deleted the criterion
for recurrent hemoptysis in final listing 104.06A3. We explain our
reasons for this deletion in the public comments section of this
preamble.
Final listings 104.06B, C, D, and E are included to maintain
content comparability with part A, listing 4.06. In final listing
104.06B (proposed listing 104.06C), we added the phrase, ``with
evidence of ventricular dysfunction,'' as in the corresponding adult
rule, final listing 4.06C. The former listing for hemoptysis (104.08)
has been deleted for reasons we explain in the public comments section
of this preamble; this very severe manifestation will be evaluated
under final listing 104.06D or other appropriate listings. We also
explain why we no longer include the finding of bronchial collaterals
in the listing in the public comments section. In response to a
comment, we revised final listing 104.06E (proposed listing 104.06F) to
include other stenotic defects as well as valvular stenosis and to make
the listing consistent with the corresponding adult listing, final
listing 4.07. Final listing 104.06F is a new criterion that has been
included to evaluate manifestations of symptomatic acyanotic congenital
heart disease with ventricular dysfunction; we did not make any changes
from the NPRM. In final listing 104.06G, we revised the reference to
growth impairment in listing 100.02 to a more general reference to the
listings in 100.00 in anticipation of future revisions to those
listings.
The revised surgical criterion in final listing 104.06H permits
more appropriate evaluation of life-threatening cardiac impairment. In
response to a public comment, we have revised the criteria in this
section to better express our original intent and to make the listing
more equitable. The final rule provides that a child who meets this
listing will be considered under a disability for 12 months after
surgery; children with impairments that were expected to result in
death before age 1, who have not had surgery, and who have, in fact,
survived to age 1 will be considered for review at age 1. The rule is
confined to infants under 12 months of age because the majority of
congenital conditions described are known to result in life-threatening
cardiac impairment or death within that time period. Twelve months is
an appropriate period of time at which to consider continuing
disability review because it allows most infants the necessary
postoperative time for stabilization and resumption of expected growth
and development patterns for age. Because of this response to the
comment, we also made a similar change in listing 104.09, ``Cardiac
transplantation.'' We provide a more in-depth explanation of our
reasons for these revisions of the proposed rules in the public
comments section of this preamble.
104.07 Valvular Heart Disease or Other Stenotic Defects, or Valvular
Regurgitation
This new listing provides cross-reference listings for the
evaluation of valvular or other stenotic defects, or valvular
regurgitation, and a criterion for critical aortic stenosis in infants.
The criteria of former listing 104.07 have been moved to final listings
104.05 and 104.06A3. In response to a comment about final listing
104.06E, we expanded the scope of the proposed listing by making it
consistent with the revisions to final listings 4.06 and 104.06E.
104.08 Cardiomyopathies
This new category provides criteria for use of the results of
imaging techniques and provides references to other relevant listings
for evaluating function in cardiomyopathy. The final listing is
unchanged from the NPRM.
104.09 Cardiac Transplantation
Children who have had heart transplants will be considered disabled
for 1 year after surgery. We deleted the proposed criterion ``or until
age 24 months, whichever is the later event,'' for the same reason we
revised final 104.06H; i.e., because of the comment which pointed out
that the proposed rule was inequitable. We explain our reasons for
making this revision in more detail in the public comments section of
this preamble. We also made slight revisions to this section in order
to parallel the adult rules. These revisions are only editorial.
104.13 Chronic Rheumatic Fever or Rheumatic Heart Disease
This listing was former listing 104.09. We have added a provision
for finding a child disabled for 18 months after established onset of
the impairment when the specified medical findings are present.
We made two revisions to proposed listing 104.13A. In response to a
comment, we restored the example of ECG findings to the listing. We
also added a cross-reference to the example of cardiomegaly in 104.00E.
The former listing had included such a cross-reference, but it was to
the section of the preface that discussed cardiomegaly on x-ray. The
NPRM, therefore, did not include the cross-reference because we had
proposed to delete that section of the preface. Because we have
restored the guidance in 104.00E, we also restored the cross-reference.
104.14 Hyperlipidemia
We have added this new listing because there are forms of this
disorder that can result in major organ complications and cause
disabling impairment or early death. The final rule is the same as the
proposed rule.
104.15 Kawasaki Syndrome
In response to a comment from a major medical organization, we have
added a listing for Kawasaki syndrome. The final listing includes
major, listing-level cardiovascular manifestations of the disorder.
Public Comments
Following the publication of the NPRM in the Federal Register, we
received 24 letters containing comments pertaining to the changes we
proposed. Ten of these letters came from individuals and Government
agencies, both State and Federal, whose responsibilities require them
to make disability determinations involving cardiovascular impairments
under titles II and XVI of the Act. Eight of the letters were from
legal services organizations or advocacy groups, State and city legal
departments, and individual lawyers. The remaining six letters came
from medical associations, a hospital, and other medical professionals.
We carefully considered all of the comments and have adopted many
of the recommendations made by the commenters. These changes are
identified in the following discussion of issues that were raised in
the comments.
A number of the comments were quite long and detailed. Of
necessity, therefore, we have condensed, summarized, or paraphrased
them. However, we have tried to respond adequately to the substantive
comments we received.
For ease of reference, we have organized the comments and responses
as follows. We first address general comments, i.e., comments that are
either about the rules as a whole or that apply to more than one
section of the rules. We then address the remaining comments, which
pertain to specific sections of the rules. The section references in
the headings below refer to the final rules. In those instances in
which we changed the section numbers or headings in the final rules, we
provide both the NPRM and final references in the text of the comment
and response.
General Comments
3-Month Guideline
Comment: We received seven comments about the 3-month guidelines in
proposed 4.00A, 4.00C2d, and 4.00D. Four of the commenters thought that
this was a ``blanket rule'' which would require delay in the
adjudication of a class of claims or unnecessary delay of many claims.
Three of the commenters pointed out that the deferral would have no
practical effect in many SSI claims because many SSI claimants will
receive little or no treatment; therefore, there will be little or no
additional evidence even if we were to wait 3 months. One commenter
said that delay in some cases would be unwarranted because 3 months
will have already elapsed before the date of adjudication. The same
commenter pointed out that deferral would not be necessary in some of
the most serious cases because it will be clear that the claimant is
disabled. This commenter suggested that we revise the rules to provide
that deferral of adjudication is never appropriate without a specific
reason particular to the individual's case. One medical organization
supported this guideline, stating that it was welcome to ``those of us
in the field of cardiac rehabilitation.''
Response: We have not deleted the 3-month guidelines, but we have
clarified the rules in response to the comments. We never intended to
create a ``class'' of claimants who would be treated differently from
other claimants. The requirement for a longitudinal record in
cardiovascular cases is consistent with our rules for evaluating all
types of impairments, not only cardiovascular impairments. We need a
longitudinal record to establish the severity and duration of most
impairments, especially those that may be amenable to treatment.
We provided a specific time guideline in the cardiovascular rules
because many individuals with cardiovascular impairments have sudden
onset of their impairments, have undergone surgery, or have impairments
that will improve with treatment; in all three instances, they may
recover in a relatively short time. We, therefore, must have some
indication that the individual will be disabled for 12 months, and we
believe that a 3-month recovery period is the minimum amount of time
needed to demonstrate whether there will be a significant recovery. We
also did not intend to have the 3-month guideline be an invariable rule
and accordingly we used qualifying phrases, such as ``usually'' and
``whenever there is such evidence,'' in the proposed rules.
However, in response to the comments we have clarified 4.00A and
104.00A by stating specifically that the reason we require 3 months of
evidence is to establish a longitudinal picture of the individual's
impairment(s), in terms of medical severity, functioning, and
symptomatology. We also explain that, for the same reasons, a
longitudinal record is important even when the individual has not
received ongoing treatment. We have also added explicit statements to
final 4.00A, 4.00C, and 4.00D in part A, and 104.00A and 104.00C in
part B, that it is not necessary to defer issuing a determination or
decision on a claim when the available evidence establishes that the
claimant is disabled.
The fact that an individual may have no treating source does not
mean that we cannot establish a longitudinal clinical record. If
necessary, we may purchase a consultative examination for comparison
with earlier evidence. However, in response to the comments, we have
added a new third paragraph in final 4.00A to address this concern.
Finally, the commenter who noted that many claimants will have
already established a 3-month history was correct. For exactly that
reason, we do not believe that the 3-month guideline is especially
onerous or that it will result in many delays in adjudication. The
final rules do not say (nor did the NPRM) that adjudicators should
defer claims for an additional 3 months, only that they should
establish a 3-month record. Indeed, we expect that even when deferral
is necessary, we will rarely have to defer the claim for a full 3
months because some time will necessarily have passed by the time of
adjudication.
New York Heart Association Functional Classification
Comment: We received several comments about our use of the New York
Heart Association (NYHA) functional criteria in proposed adult listings
4.02, 4.04, and 4.06. One commenter said that the criteria are vague
and believed that we would misapply them to the detriment of claimants.
Another commenter said that, in the majority of cases, treating sources
do not use the NYHA classifications. Another commenter was concerned
about how to use the classifications when the individual's impairment
fluctuates, saying that it is unrealistic to presume that some patients
will remain in one classification. Two commenters were concerned about
how we would develop evidence and weigh treating source opinions about
the classification.
One commenter said that the criteria were in a publication that has
long been out-of-print. This commenter, and several others, thought
that, at a minimum, we should include the definitions of the NYHA
classification levels in the listings. One commenter, however, pointed
out that if the NYHA alters its classification standards in the future,
it may become necessary for us to revise the listings that employ those
standards.
Finally, two commenters were concerned that the proposed rules
failed to include the NYHA ``therapeutic classifications.'' One of
these commenters said that the final regulations must at least
recognize the concept behind the therapeutic classifications, which is
that some individuals must restrict their activities for reasons of
medical safety, even though they are technically capable of performing
more exercise than is safe or medically appropriate.
Response: We adopted the comments by removing the references to the
NYHA functional classifications from final listings 4.02 and 4.04 and
replacing them with explicit, descriptive functional criteria based on
the NYHA criteria, and by removing all functional criteria from final
listing 4.06. In this way, we have avoided the pitfalls pointed out by
the commenters, although we do not believe that our proposed use of the
classifications was as problematic as the commenters did.
Cardiologists have used the NYHA functional classifications for
many years, and the criteria are well understood by people in the
profession; this undoubtedly accounts for the fact that we did not
receive any comments from physicians or medical organizations about our
proposal to use the criteria. Nevertheless, we agree with the
commenters that there are a number of real problems that could arise in
an adjudicatory context and, on balance, believe that the most
straightforward solution is to simply state exactly what we require in
the listings themselves.
As we have explained in the first section of this preamble, the
deletion of the references to the NYHA functional criteria also
necessitated a reorganization of the rules in final listings 4.02 and
4.04. This is not a substantive change; we merely reorganized the
criteria of the proposed rules to place the medical criteria describing
the listed medically determinable impairments first--as in all other
listings--followed by the explicit functional criteria. This
organization is also consistent with the organization of the mental
listings in 12.00 and 112.00, as well as several other listings that
include disabling functional consequences among their criteria.
We decided to delete the proposed functional criteria from final
listing 4.06 for several reasons, chiefly because they were
unnecessary. Individuals whose impairments demonstrate the findings in
final listings 4.06A, 4.06B, and 4.06E have impairments that will cause
at least NYHA functional class III limitations. Individuals whose
impairments satisfy the criteria in the reference listings, final
listings 4.06C and 4.06D, already have impairments that meet the
requirements of other listings. Therefore, the proposed functional
requirement for listing 4.06 was at best redundant. Also, the proposed
requirement for functional class III ``or class IV'' was unnecessary
for logical reasons: Since functional class III would have been
sufficient to establish disability under proposed listing 4.06, a
person who had functional limitations equivalent to class IV (i.e.,
symptoms at rest) would have had an impairment that was more severe
than was necessary to meet the requirements of this listing. Finally,
some of the provisions of final listing 4.06 are the same as provisions
in final childhood listing 104.06, which does not include functional
criteria; deletion of the functional criteria in the adult listing
makes the corresponding part A and part B listings consistent with each
other.
We did not include the NYHA therapeutic classifications in the
listings, or explicit criteria based on the therapeutic
classifications, because we believe that such considerations are
generally more suitable to the assessment of residual functional
capacity. However, we want to assure the commenters that the principle
illustrated by the therapeutic classifications is a basic principle in
all of our disability evaluations. It has long been our policy that
valid medical reasons for limiting an individual's level of exertion
(or any functioning, including mental functioning) can be sufficient to
establish that the individual is in fact limited in that capacity; the
individual need not demonstrate this limitation by putting himself or
herself at risk in order to demonstrate that there is a limitation.
As to the comment about individuals whose functional status changes
and who, thus, might properly be classified in more than one of the
NYHA classes at different times, it is our policy that an individual
need not be continuously limited to the degree specified in order to be
found disabled. This is one of the reasons we repeatedly stress the
need for longitudinal evidence, which will permit our adjudicators to
draw conclusions about how the individual generally functions, over
time. Practically speaking, the fact that an individual's ability to
function may briefly improve, only to worsen again, is immaterial to
the determination that the individual is unable to work.
Although we have deleted all references to the NYHA classifications
as listings criteria, we have retained one reference in the preface to
the listings. This is in final 4.00C2c of the preface, in which we list
NYHA class IV heart failure as a risk factor militating against the
purchase of an exercise test. We believe that in this narrow context
the use of the term is sufficiently clear.
Exercise Testing
Comment: Ten commenters strongly opposed our proposals in the NPRM
for using exercise testing. In particular, the commenters opposed
proposed 4.00D2, which would have required treadmill exercise testing
in all cases in which such testing was not medically contraindicated,
and proposed in 4.00C2a, which stated that valid exercise tests,
although not the exclusive means for assessing the severity of heart
disease, should be the ``primary basis'' for evaluating functional
capacity under the listing. One commenter said that the proposed rules
would result in exercise testing that was unnecessary, expensive, and
dangerous. One commenter said that our statement in proposed 4.00C2a
that the utility of exercise testing is ``well recognized'' would
further improperly underscore the importance of exercise testing.
Response: We adopted the comments asking us to delete the reference
to the primacy of exercise testing in 4.00C2a and all of proposed
4.00D2. As we have explained above in the explanation of the final
rules, final 4.00C2a is now confined to a discussion of when to
purchase exercise testing, and limits the circumstances in which
purchase will be appropriate.
The commenters offered many arguments for removing the above-
mentioned references in proposed 4.00C2a and 4.00D2. Because we have
adopted the comments, we have not summarized all of the comments and
arguments here. Most of those who commented on this aspect of the final
rule pointed out that our statement in proposed 4.00C2c could have been
misunderstood, as indeed it was by most of these commenters. The
commenters assumed that our statement that treadmill exercise testing
would be the ``primary basis for evaluating functional capacity under
this listing'' meant that treadmill testing would be the primary basis
for assessing functioning at all steps of the sequential evaluation
process. The plain language of the proposed rule, of course, did not
say this, but was confined to a discussion of whether a claim could be
allowed at the listings step. Nevertheless, the comments do demonstrate
that there were misunderstandings, especially because we also proposed
to require the purchase of exercise testing in most cases.
We were also persuaded by the arguments that there will be many
cases in which it will be evident that the claimant is disabled,
obviating the need for--and expense of--exercise testing. We also
agreed with the commenter who pointed out that, even though we require
consideration of exercise testing in the context of the entire record,
the use of the word ``primary'' in the proposed rules could have been
interpreted as an instruction to our adjudicators to automatically give
more weight to the results of such testing than to any other evidence;
such an instruction would be contrary to our policy.
In related comments, several commenters suggested that we emphasize
in the final rules that exercise testing is merely one tool that
physicians use to evaluate the severity of cardiac disease, and that
the proper evaluation of a claim for Social Security or SSI benefits
based on disability requires consideration of the test results in the
context of all the relevant evidence. As we have explained above in the
explanation of the final rules, we have adopted the comment by adding a
statement to this effect in 4.00A and 4.00C2e(1) of the final rules.
Final 4.00A emphasizes the need to consider all of the evidence; the
fact that no claim may be denied solely because the claimant's
impairment(s) does not meet or equal in severity the requirements of a
listing; and the need to provide an individualized assessment in every
case. Final 4.00C2e(1) emphasizes the need to consider exercise test
results in the context of all of the relevant evidence. We did not add
similar statements in 4.00C2a because we revised it to change its focus
to the purchase of exercise testing, and there was no longer a context
for such a discussion in that section.
We did not agree with the commenter who said that our purchase of
exercise tests would be dangerous. We have many safeguards to ensure
proper review by an expert physician before we will purchase such
testing. We have also provided a detailed methodology for performing
the tests safely and in approved facilities, including a requirement
for supervision of the test by a physician.
We also did not agree with the comment about our statement of the
utility of exercise testing in the first sentence of proposed 4.00C2a;
although, we did revise the statement. We agreed with those commenters
who referred to the information supplied by the American Medical
Association and the American College of Cardiology in the joint amicus
curiae brief these organizations filed with the U.S. Court of Appeals
in New York in the case of the State of New York v. Sullivan, 906 F.2d
910 (2d Cir. 1990), that treadmill exercise testing does not assess all
types of functioning or functioning in different environments. We,
therefore, revised 4.00C2a to state more accurately that it is well
recognized by medical experts that exercise testing is the best tool
currently available for estimating aerobic capacity.
Comment: Four commenters, quoting or paraphrasing the district
court's decision in 1989 in the State of New York case, stated that the
exercise test is not a valuable tool for assessing disability because
the exercise test results in a misdiagnosis of ischemic heart disease
more than one-third of the time. They also cited the part of the
court's decision that noted that, in certain circumstances, other
widely used procedures (e.g., the exercise thallium test, the
equilibrium radionuclide angiogram, and angiography) are more reliable
in measuring the severity of ischemic heart disease.
Three of these commenters, in identical or similar language, also
asserted that the proposed listings authorized adjudicators to deny
benefits based on the results of suboptimal exercise tests. Another
commenter stated that many exercise tests purchased on a consultative
basis are terminated due to detoning or hyperventilation before
cardiovascular challenge can occur, thus rendering the exercise test
useless for evaluation of cardiac functioning.
Response: We do not use treadmill exercise tests to diagnose the
existence of impairments; we use them to estimate the aerobic capacity
of individuals and, hence, as a test of a certain kind of functional
capacity. Indeed, in the preamble in the NPRM, we stated that we
proposed to remove the requirement for a targeted heart rate because
``the proposed listings do not use the exercise test for diagnosis but
rather for functional evaluation.'' We made this statement in part
because we agree with the commenters that the failure to demonstrate
ischemia on an ECG does not by itself establish that the individual's
heart is normal; however, it is evidence of the exercise test level
that can be safely performed without triggering ischemic ST changes
and, hence, is some evidence of aerobic capacity. Even when an exercise
test is negative, it still provides some information about the
individual's ability to exercise to the level achieved on the test.
Although we agree with the commenters' opinion that the exercise
thallium test is the best method for diagnosing the existence of
ischemic heart disease, we repeat that the issue in these listings is
not one of diagnosis but of functioning. We also agree that the other
tests may be useful for evaluating the severity of ischemic heart
disease in some circumstances; however, they are not generally more
reliable than the exercise test for this purpose. For this reason, we
do not agree that they belong in our listings as alternative criteria.
The listings are only examples. We do not attempt to state every
possible fact pattern in the listings; that is the province of our
findings that claimants may have an impairment that is equal in
severity to a listed impairment.
In response to the three commenters who asserted that the proposed
rules would permit adjudicators to deny benefits based on suboptimal
exercise tests, we have stated above that the failure to meet or equal
the requirements of a listing is never a basis for denying a claim. We
can find nothing in the proposed rules, or in the preamble to the
proposed rules, that could have led the commenters to draw this
conclusion. The results of suboptimal exercise testing are only one
piece of evidence that we must consider in the context of the entire
record.
Comment: Another commenter was concerned that the proposed rules
would ``no longer prohibit adjudicators from relying upon suboptimal
exercise tests in determining that the listing for ischemic heart
disease is not met.'' The commenter asserted that the use of suboptimal
tests would allow adjudicators to conclude ``erroneously'' that a
listing was not met, and that our statement in the preamble that
suboptimal tests are a useful measure of function (56 FR 31267) is
contradicted by listing 4.04, which does not permit adjudicators to
consider the test as a sign of the claimant's limitations. The
commenter said that the listings should be changed to specifically
allow adjudicators to consider the inability to complete a test as a
ground for establishing that an impairment is of listing-level
severity, as is done in listing 4.02, which recognizes that markedly
symptomatic exercise intolerance may meet that listing. Alternatively,
the commenter recommended that the listing should explicitly state that
the inability to complete a test is not evidence that a person is free
from ischemic heart disease. A similar comment added that our assurance
that those cases that do not meet the listings could be allowed under
the rules for equivalence was not persuasive because the commenter had
seen many cases in which this had not occurred.
Response: We believe that the commenter who made the first comment
misunderstood our prior rules and the statement we made in the preamble
to the proposed rules about why we deleted the requirement for
attainment of a targeted heart rate. An impairment meets a listing in
only one way: by matching exactly the criteria in that listing. Because
the results of suboptimal exercise tests have never been criteria in
our listings, they cannot be--and never could have been--a per se
reason for finding whether a person's impairment met or did not meet a
listing. Thus, the listings did not ``prohibit'' us from using the
results of suboptimal exercise tests to find that an impairment did not
meet a listing. The only question in any ``meets'' finding is whether
the person has presented evidence that satisfies the specific criteria
of the listing.
As we have explained in the preceding response, the failure of a
suboptimal test to diagnose coronary disease does not mean that the
test results are without use; and it is not a ``false negative'' in the
scientific sense, because we are not using the exercise test for
diagnosis. This is not a new policy. We have always required our
adjudicators to consider at all steps in the sequential evaluation
process all relevant evidence of an individual's functioning, which
includes failure to complete an exercise test.
Nor does listing 4.04 prohibit adjudicators from using the results
of suboptimal or negative exercise tests as evidence of a person's
aerobic functional capacity. It is faulty reasoning to conclude that we
do not consider the implications of a person's ability to function on a
suboptimal or negative exercise test because we do not include a
criterion within the listing for a test that is not ``positive.'' All
this means is that a claimant with a suboptimal or negative exercise
test cannot have, on the basis of that test, an impairment that
``meets'' the requirements of those listings that include exercise
tests among their criteria.
We did not adopt the suggestion to add a criterion to final listing
4.04 which would permit a finding of ``meets'' the listing based on
markedly symptomatic exercise intolerance. The commenter's comparison
with listing 4.02 was inapt. In proposed listing 4.02B, the requirement
for ``markedly symptomatic exercise intolerance'' (the language of
which we have now deleted in our clarification of the final rule) had
to be associated with objective, demonstrable chronic heart failure,
with cardiac enlargement or ventricular dysfunction. In final listing
4.04A, the listing for angina demonstrated by exercise testing, the
objective requirement is the ECG abnormality or inability to maintain
adequate blood pressure on exercise to support the inference that
symptoms alleged at a low level of exercise may be attributed to
ischemia; if we were to replace it with an allegation of exercise
intolerance, the listing would not have any objective criteria. Again,
this does not mean that an individual who is actually limited by his or
her ischemic heart disease despite inability to ``meet'' this listing
cannot be found disabled. The person may present evidence demonstrating
equivalence to a listing, or by establishing a residual functional
capacity which prevents him or her from working at past work and other
work. Also, exercise intolerance may be indicative of a noncardiac
condition that may alone or in conjunction with a cardiac impairment
render a person disabled.
Nevertheless, we find reasonable and helpful the commenter's
suggestion that we add a statement to the listing that the ability or
inability to complete an exercise test is not evidence that a person is
free from ischemic heart disease. We believe, however, that the
statement is more appropriate in 4.00C2e(1) of the preface, where we
discuss evaluation of the results of exercise testing. We have,
therefore, added the statement as a new second sentence in final
4.00C2e.
Comment: Four commenters referred to the amicus curiae brief filed
in the case of State of New York v. Sullivan by the American Medical
Association and the American College of Cardiology, in which it was
argued that the treadmill exercise test is not a fair measure of stress
from heat, cold, humidity, pollution, altitude, psychological
pressures, or other work-related stresses in the workplace. The brief
also pointed out that in the workplace a person may, for example, be
required to perform tasks that require substantial use of the arms,
isometric exertion and physical effort that is sudden or prolonged, and
these things are not measured by the treadmill exercise test. In
identical language, two of the commenters said that the proposed rules
demonstrated that we ``continue to ignore this medical reality.''
Response: These final rules are consistent with the facts presented
in the amicus curiae brief. As the commenters noted in their quotes
from the brief, the argument presented by the two medical associations
discussed the efficacy of the treadmill stress test as the sole or
primary basis for establishing a person's ability to work, not the
propriety of our use of the treadmill exercise test in our listings.
Indeed, we received comments on the NPRM from both medical
organizations, and neither of them objected to the proposed rules in
this regard--in fact, no physician advised us that he or she objected
to this aspect of the proposed rules.
However, as we have explained above, we have revised the final
rules to lessen further the likelihood that they can be misinterpreted
to mean that the treadmill exercise test is the ``primary'' basis for
assessing ``functioning'' throughout the sequential evaluation process.
We have also revised the final rules to underscore our longstanding
policy that when an individual's impairment does not meet a listing,
all relevant evidence must be considered to determine whether the
individual is disabled. It is in the residual functional capacity
assessment that factors are considered such as the effect of heat,
cold, humidity, pollution, altitude, psychological pressures, and other
work-related stresses.
Comment: Four commenters also opposed the rule that listing 4.04,
for cardiac ischemia, could not be ``met'' without the results of
exercise testing unless the individual was at risk for exercise. The
commenters said that this rule prevents consideration of other test
results, such as echocardiograms and angiograms, under the listings.
One of the commenters said that the listings must state that the
criteria in listings 4.04B and C (the listings that include
echocardiography and angiography among their criteria) can be met even
if the claimant can exercise on a treadmill or even if an exercise
treadmill test is negative. The same commenter said that 4.00A
``instructs adjudicators to disregard'' evidence of other tests, the
opinions of treating physicians and the claimant's pain, and that the
listings do not permit signs or symptoms (such as pain) to be
considered as the basis for proving that an impairment actually meets a
listing.
Response: We did not adopt the comments, except to the extent that
we included language in the new fourth paragraph of final 4.00A which
reminds adjudicators that the listings are only examples of common
cardiovascular disorders that are disabling. The listings are intended
to be a screening device by which we can identify and allow claims
filed by the most obviously disabled individuals; they are not an all-
inclusive list of disabilities under which all individuals must be
found disabled. Even though echocardiography can demonstrate
abnormality of cardiac functioning, and coronary angiography is the
``gold standard'' for ascertaining the presence of coronary
atherosclerosis, neither of these tests provides information about
whether any discovered disease is directly related to or predictive of
functional status in the way that a positive exercise test does.
This does not mean, however, that individuals who are unable to
exercise for the requisite time on a treadmill, or individuals who have
negative exercise tests will be found not disabled. All it means is
that we cannot find that they have impairments that ``meet'' the
listings. We believe that our revisions to the preface have clarified
that such individuals will always receive the benefit of an
individualized assessment that considers all of the evidence--including
the results of any other tests they may have undergone, their symptoms,
and their treating sources' opinions.
With respect to the last comment, we could not find any text in the
NPRM in which we instructed our adjudicators to disregard any evidence,
nor would we have intentionally written such a rule because it would
have been contrary to our policy. Indeed, subsequent to the publication
of the NPRM, we published final rules that explicitly address the
importance of the role of pain and treating source opinions in our
adjudications (see ``Standards for Consultative Examinations and
Existing Medical Evidence,'' 56 FR 36932, August 1, 1991; and
``Evaluation of Symptoms, Including Pain,'' 56 FR 57928, November 14,
1991). Again, if the evidence of record, including evidence from a
treating physician, and including evidence of pain or other symptoms,
establishes that an individual is disabled, the fact that the evidence
fails to show that a listing is met or equaled will not prevent a
favorable determination. Moreover, listing 4.04 is a listing for
cardiac ischemia, which ordinarily describes a kind of chest pain; we
do not even consider using this listing unless the individual has the
symptom of ``chest discomfort,'' as we state in the opening sentence of
the listing.
Comment: One commenter criticized the example of equivalence we had
provided in the preamble to the proposed rules (56 FR 31267). The
commenter also said that the listings as proposed did not set forth any
substantive method for considering nonexercise test evidence in
determining equivalence, and the general language in the preface about
equaling any listing was insufficient.
Response: We disagree. We did not include the example in the final
rules because it is virtually impossible to devise a single example, or
even two or three examples, that would illustrate such complex concepts
as, for instance, equivalence. Moreover, any example we devised would
have to be so clear and unambiguous that it would not provide useful
guidance; indeed, this could be a valid criticism of the example we
provided in the preamble to the NPRM.
We do not provide methods for determining equivalence in any of the
listings sections in part A or part B. We have separate rules in
Secs. 404.1526, 416.926, and 416.926a for that purpose.
Comment: In addition to those commenters who mentioned that an
evaluation of pain should be included as part of the listings, two
commenters thought that the proposed rules allowed exercise testing to
be used to overcome an individual's allegations of pain. One commenter
said that lack of adequate consideration of the limitations imposed by
pain associated with ischemia will result in unrealistic functional
assessments. The commenter referred to the decision in Avery v.
Secretary of HHS, 797 F.2d 19 (1st Cir., 1987), which requires an
individualized assessment of pain in the event of a medically
determinable impairment that could cause pain.
Response: We did not intend to give the impression that a single
exercise test in and of itself would be sufficient evidence to overcome
an allegation of pain. As noted above, in November 1991, we published
final rules regarding the evaluation of pain (56 FR 57928). Among other
things, these rules require consideration of all relevant evidence,
including a number of specific factors that must be considered whenever
we consider an allegation of a symptom, such as pain. Our rules also
require an individualized assessment of each person's allegations of
pain, consistent with the Avery decision.
Comment: Several commenters raised issues of treating physician
opinion and its relationship to the rules on exercise testing. A number
of the commenters questioned the proposed rule in 4.00C2c that
permitted a program physician to override a treating physician's
opinion as to the advisability of conducting an exercise test under
some circumstances. Most stated that we should never permit a program
physician to require a claimant to submit to an exercise test against
the recommendation of a treating physician. Several commenters thought
that the program physician's decision to override a treating source's
opinion would be limited to a review of the medical evidence in the
claim file without giving proper weight to the treating source's
opinion. Three commenters, citing the proposed rule in 4.00C2f (final
4.00C2e(1)) that required us to obtain statements from treating sources
before we would decide whether to override their opinions, felt that
the rule would create professional relations problems which will be
magnified when the treating physician's opinion is overridden. One
person suggested that the rules should require the program physician to
ask the treating physician his or her opinion on whether the exercise
test should be performed and to ask whether an exercise test had been
performed in the past year. One commenter felt this policy could
interfere with patient/doctor relationships. Another questioned if a
statement should be made in the regulations that the facility
performing the test should decide whether the test is contraindicated
prior to its performance. Three commenters wanted to know what we would
do if there is no treating source. One commenter asked whether our use
of the term ``examining source'' meant that we would contact every
physician who had examined the claimant, even if the physician was not
a treating physician.
Several commenters stated that we were not giving proper weight to
the opinion of treating physicians because proposed 4.00D2 required the
purchase of an exercise test if a timely exercise test was not
available and posed no significant risk to the individual.
Response: In response to the comments, we have made a number of
revisions in the preface; however, we did not adopt the comments that
asked us to prohibit program physicians from ever overriding the
opinions of treating sources. In 4.00C2c of the NPRM we stated that we
``will generally give great weight to the treating physicians' opinions
and will generally not override them.'' We also characterized as
``limited'' the situations in which we would override such an opinion
and require a written statement of explanation whenever a source's
opinion was overridden. Clearly, therefore, we did not expect program
physicians to override the opinions of treating sources except in the
rarest of cases.
To make clear what those cases are, and in response to the
comments, we first deleted proposed 4.00D2, which required exercise
tests in all cases in which such testing posed no significant risk to
the individual, thereby sharply limiting the number of cases in which
the issue of whether to purchase an exercise test will even arise.
Second, we revised final 4.00C2a to provide guidance for when purchase
of an exercise test may be appropriate: when there is a question
whether an impairment meets or is equivalent in severity to one of the
listings, or when there is insufficient evidence in the record to
evaluate aerobic capacity, and the claim cannot otherwise be favorably
decided. Third, we revised 4.00C2c to state plainly that it will be a
rare case in which the program physician would override the opinion of
a treating source with respect to the purchase of an exercise test. If
the treating source's opinion is overridden, the program physician must
document the file with a rationale setting forth his or her reasons for
doing so. We also expanded final 4.00C2c to indicate that an exercise
test will only be purchased if it poses no significant risk to the
individual and the claim cannot otherwise be favorably decided. Fourth,
we revised final 4.00C2e(1) to state even more clearly the rule from
the NPRM that, if purchase of an exercise test is contemplated, and the
claimant has a treating physician who has not ordered an exercise test,
and there is no apparent reason why the person would be at risk,
contact must be made with the source to determine the source's opinion
whether exercise testing poses a significant risk, or whether there is
some other reason why the treating physician did not have the test
performed, such as because of a financial bar.
We do not believe that there will be significant professional
relations problems from these rules. We believe that physicians will
understand that we are contacting them out of concern for their
patients' well-being, inasmuch as we will have to contact them when we
need to purchase an exercise test and it is not clear why they have not
ordered one, or why they think an exercise test poses a significant
risk. Also, again, it should be a rare instance when the treating
physician's opinion will be overridden.
It has always been the responsibility of the provider performing
the exercise test to determine whether there is any risk to the
claimant. Also, if there is no treating source, the program physician
will be responsible for assessing the risk of exercise to the claimant,
as has always been the case in the past. Neither of these policies is
new, nor are they unique to the cardiovascular listings. However, in
response to the comment that asked whether all ``examining'' but
nontreating sources should be contacted, we have revised the section by
deleting the phrase ``examining physician.'' Under the aforementioned
``Standards for Consultative Examinations and Existing Medical
Evidence,'' we no longer use the term ``examining physician,'' and our
rules requiring recontact with physicians are clearly set out. Whether
it will be necessary to contact other sources who may have examined the
claimant but who are not treating sources will vary from case to case.
Comment: With regard to general policy on treating source opinions,
several commenters said that the rules demonstrated that we do not give
appropriate weight to such opinions. One commenter said that we did not
provide any instruction in the listings on how to evaluate treating
physician opinions about the nature and severity of the claimant's
impairment, or which demonstrate that particular exercise test results
are questionable, or provide some other basis for establishing
disability. Another commenter said that the final rule must make clear
that the results of an exercise test do not constitute substantial
evidence to override a treating physician's opinion on the severity of
the claimant's impairment. One commenter from a State located within
the Second Circuit said that an exercise test should not be purchased
if the treating physician can determine disability without it. The
commenter said that, by purchasing an exercise test, we would not be
according proper weight to the opinion of the claimant's treating
physician if the treating physician has determined that the test is not
necessary to evaluate disability.
Response: We added the clause, ``in addition to information about
the nature and severity of the impairment,'' to the end of the second
sentence of the second paragraph of final 4.00A (which was the third
sentence in proposed 4.00A). This revision reflects Secs. 404.1527 and
416.927 of our rules. Otherwise, we did not adopt the comments. We
would not provide rules for evaluating treating source opinions in this
listing or any other because there are separate rules (Secs. 404.1527
and 416.927) for considering the opinions of treating physicians. (See
56 FR 36932, ``Standards for Consultative Examinations and Existing
Medical Evidence,'' August 1, 1991.) The rules apply to all
impairments.
When a treating physician provides us with evidence that
demonstrates that the results of a particular exercise test are
questionable, or a treating source provides evidence upon which we
could base an allowance, our general rules provide that we will have to
determine whether there is a conflict in the evidence. If there is a
conflict in the evidence, we are required to resolve it, giving more
weight to the treating source's opinion than we would if the opinion
had come from a source who was not a treating physician (see
Secs. 404.1527(d) and 416.927(d)). If necessary to resolve the
conflict, we may recontact the treating physician for additional
information. Of course, we may be able to resolve the conflict based on
the existing evidence, such as when we agree with the treating source
that the results of a test are questionable or that the claimant is
disabled. Our rules also explain how we decide whether there is
substantial evidence to overcome a treating source's opinion. If the
treating physician's opinion that a claimant is disabled is well
supported by the evidence of record and is not contradicted by the
other substantial evidence, we will give it controlling weight.
In response to the last comment, the Act provides that we must
determine whether a claimant is disabled, not the treating physician.
We are not aware of any decision of the Second Circuit, or any other
Federal court, that holds that a treating source may make the
determination of disability or decide the sufficiency of the evidence
for SSA under the Act.
Comment: Several attorneys opposed the proposed rules, asserting
that they were in conflict with the Social Security Act and the
decision in the State of New York case in which the United States Court
of Appeals for the Second Circuit ruled that all relevant evidence must
be considered in determining disability and that the results of
exercise tests cannot be used to the exclusion of other evidence to
deny disability benefits. The commenters offered a number of arguments
addressing the proposed policies both in general and as they pertained
specifically to the ``meets,'' ``equals,'' and residual functional
capacity aspects of our decisions. Two of the commenters cited the
United States Supreme Court's decision in Sullivan v. Zebley, 493 U.S.
521 (1990), in support of the notion that all disability determinations
must be based on an individualized consideration of each claim and
reflect all relevant medical evidence.
Response: We believe that the revisions we have already described
address most of the commenters' concerns, and that these rules are not
contrary to the Second Circuit's holding in State of New York. We also
believe that we have the statutory authority under section 205(a) of
the Act (made applicable to title XVI by section 1631(d)(1)) to issue
these rules, which have national applicability and which the Second
Circuit (or any other court) has not reviewed or found to be invalid.
We also want to emphasize that we consider all of the medical
evidence of record at step 3 of the sequential evaluation process,
i.e., the listings step. We do this to be certain that the evidence is
consistent, to resolve any apparent conflicts in the record, and, if we
ultimately rely on a treadmill exercise test to find a claimant
disabled under the listings, to be certain that it is a valid test and
not a ``false-positive'' test. Our policy does not permit a finding of
``meets'' or ``equals'' in the face of a record that casts doubt on the
validity of the test results; plainly, we must consider the entire
record to determine whether the test raises such a doubt. Moreover, at
the equivalence stage of step 3, evidence that may not play a role in a
finding of ``meets'' may be decisive in our determination that the
claimant is disabled; and, as we have repeatedly stated throughout this
preamble, if a claimant is unable to establish that he or she has an
impairment that meets or equals the severity of a listing, we will
continue the sequential evaluation to determine whether, based on all
the evidence of record, the claimant is disabled.
Beyond that, we believe that the Supreme Court ruled in Zebley that
it is not possible to provide individualized assessments to all
claimants under the listings, and that the listings could never be
revised to adequately provide for such assessments. For example, in its
detailed analysis of the listings as a sole test of disability for
children claiming benefits under the SSI program, the Court stated that
``the listings obviously do not cover all illnesses and abnormalities
that actually can be disabling,'' that ``the listings * * * exclude any
claimant whose impairment would not prevent any and all persons from
doing any kind of work, but which actually precludes the particular
claimant from working, given its actual effects on him--such as pain,
consequences of medication, and other symptoms that vary greatly with
the individual,'' that ``the equivalence analysis excludes'' many
claimants, and that ``there are several obvious categories of claimants
who would not qualify under the listings but who nonetheless would meet
the statutory standard.'' 493 U.S. at 533-34. Even more to the point,
the Court stated:
Even if the listings were set at the same level of severity as
the statute, and expanded to cover many more * * * impairments, no
set of listings could ensure that * * * claimants would receive
benefits * * * under the individualized, functional analysis
contemplated by the statute * * *. No decision process restricted to
comparing claimants' medical evidence to a fixed, finite set of
medical criteria can respond adequately to the infinite variety of
medical conditions and combinations thereof, the varying impact of
such conditions due to the claimant's individual characteristics and
the constant evolution of medical diagnostic techniques.
Id. at 539, emphasis in original. The Court's holding in Zebley,
therefore, was to require an additional step beyond the listings step,
at which we would be required to satisfy the statutory criterion in
title XVI of the Act of providing an individualized analysis for
children based on all the evidence on a case-by-case basis; it was not
that we must expand the listings to provide individualized assessments
at the listings step. Therefore, we believe that, far from supporting
the commenters' contentions, the Zebley decision refutes them.
Again, all claimants who are not found disabled at the listings
step receive the kind of individualized assessment which considers the
effects of pain, the side effects of medication, and the myriad other
factors that describe their particular responses to their particular
impairments, as required by the law. Much of the new text we have added
to the prefaces to Parts A and B of these final rules is intended to
underscore these important, longstanding policy principles.
Moreover, the listings step, which is only an allowance mechanism,
is not required by the Social Security Act. If we did not have a
listings step or if we were precluded from using our listings, it would
only work to the detriment of claimants in terms of delaying some
allowances, not to their advantage.
Information in the Preamble
Comment: One commenter expressed the view that in a number of
instances, and especially in the childhood listings, we had proposed
significant changes to our rules that were not mentioned or explained
in the preamble. The commenter suggested that this would preclude the
public from having a meaningful opportunity to comment on proposed rule
changes.
Response: We believe the NPRM did give the public a meaningful
opportunity to comment on the proposed rules, and that the detailed
nature of the comments we received, which are discussed in this
preamble to our final rules, attests to this fact.
The New Listings Will Result in More Denials
Comment: Three commenters thought that the proposed listings would
result in our denying more claims for benefits. One commenter said that
the new listings would result in denials of benefits to ``tens of
thousands of seriously impaired adult cardiac disease claimants.'' The
other two commenters said that the proposed listings would result in
more denials by the State agencies, and that this would result in more
requests for hearings before an administrative law judge. One of these
commenters also thought that the proposed listings provided less
discretion to the State agencies than the former listings did.
Response: We use the listings only to find people disabled. Failure
to have an impairment that meets or equals in severity a listing is
never a basis for denying any claim, whether the claim is filed for an
adult or a child.
However, it is true that some people whose impairments would have
met the criteria of our prior listings will not be found to have
impairments that meet these final listings. It is also true that some
of these people will not be found disabled. For example, under 4.04B of
the prior listings, individuals with chest pain of cardiac origin and
an ejection fraction of 30 percent had impairments that met the
listing. We now know that an ejection fraction of 30 percent does not
reliably establish the severity or functional effects of an impairment;
indeed, many people with ejection fractions of 30 percent function
normally.
It is, of course, not true that the listings will result in the
denial of individuals who are seriously impaired, nor was that our
intent. Our only aim in these revisions was to fairly and accurately
update the listings consistent with current medical knowledge.
Nevertheless, in response to these and several other comments
discussed below, we have revised 4.00A and 104.00A to clarify that the
guidance in the prefaces to the listings is primarily for the purpose
of deciding whether an impairment meets one of the listings. We have
also added new paragraphs to 4.00A and 104.00A (already described
above, in the summary of provisions) which remind adjudicators that
individuals whose impairments do not meet any listing may still have
impairments that are equivalent in severity to a listed impairment, or
that may result in a finding of disability as a result of the adult or
child sequential evaluation processes based on an individualized
assessment of their functioning. We have also added language in several
places in the prefaces to state that all evidence in the case must be
considered, and that, if the evidence already obtained establishes a
favorable decision, the adjudicator should not continue development
just to determine whether an impairment meets a listing.
Finally, we do not agree that the rules provide less discretion to
the State agencies than the former listings. As the former listings
were based almost exclusively on objective, diagnostic medical
findings, the revised listings which provide functional criteria as
well as medical criteria arguably provide the decisionmaker with more
discretion.
4.00 Preface to Part A
4.00A Introduction
Comment: A number of commenters were concerned about the statement
in the NPRM that ``most individuals usually have received the benefit
of a medically prescribed program of progressive physical activity
accompanied by relevant educational and psychological support.'' They
said that many of the people who file for title II and SSI disability
benefits are outside the mainstream of health care and cannot afford
such treatment or do not live where it is available. Three commenters
thought that we would deny claims in which the claimants did not
undergo treatment; one of these commenters said that the listings
indicated that a claimant who did not undergo treatment should be
denied. Two commenters were concerned that the rules were related to
the rules on failure to follow prescribed treatment. One medical
association suggested that the language in 4.00A should be, ``Whenever
there is such evidence, the clinical record must include a description
of the therapy and positive evidence of rehabilitation measures
prescribed by the treating source and response.'' One attorney
commenter pointed out that listing 4.04 requires a regimen of
prescribed treatment as a prerequisite under that listing, so that a
claimant whose impairment satisfies the criteria in listing 4.04A but
does not receive treatment still could not be found disabled under that
listing.
Response: We adopted the comments by clarifying the final rules. In
the second paragraph of final 4.00A, we now indicate that ``many''
individuals who have ``listing-level'' impairments will have received
the benefit of such treatment. Although we agree that people with
impairments of lesser severity than those in the listings may not
necessarily receive this kind of therapy, we believe that the listing-
level impairments are so severe that many, if not most, individuals
with such serious--and in the case of cardiovascular impairments,
potentially life-threatening--impairments will be placed on some sort
of rehabilitative and supportive program.
However, we also state that, ``[w]henever there is such evidence *
* *, [i]t is important to document any prescribed therapy and response
because this medical management may have improved the individual's
functional status,'' recognizing that there will be cases in which no
such treatment was prescribed or instituted. This does not mean that we
will find individuals who have not received treatment to be not
disabled, only that we cannot find them to have impairments that
``meet'' the requirements of those listings that require a regimen of
therapy, as noted by the last commenter. For instance, an individual
whose impairment meets the requirements of final listing 4.04A but does
not have any treatment available to him or her, and who can establish
duration of 12 months (prospectively or retrospectively) could be found
to have an impairment that is equivalent in severity to the listing.
To underscore our policy that we never deny claims because of
failure to meet the listings, we added new paragraphs in final 4.00A
and 104.00A which stress the necessity for making an equivalence
determination when a claimant's impairment(s) does not meet a listing,
and for assessing residual functional capacity (or performing an
individualized functional assessment) when a claimant's severe
impairment(s) neither meets nor equals in severity any listing. We have
also added reminders in final 4.00A and 104.00A to consider all
relevant evidence whenever there is no evidence of therapy.
Finally, the rules on failure to follow prescribed treatment are
quite complex, but have one simple underpinning: They do not come into
play unless an individual's treating source has prescribed treatment
for the individual which the individual is not following. If the
individual's treating source has not prescribed treatment, or the
individual does not have a treating source, the principle does not
apply.
Comment: Two legal services organizations commented on the
statement in 4.00A of the NPRM that individuals who are
``deconditioned'' may do poorly on exercise testing. The commenters
thought that this meant our adjudicators would disregard deconditioning
in the determination of disability. One commenter said that the section
should instruct adjudicators to consider the effects of deconditioning
as a basis for a finding of disability because it is a consequence of a
cardiovascular impairment or a side effect of treatment (e.g.,
bedrest). The same commenter also said that we should include
deconditioning as a listing criterion in listing 4.04.
Response: We did not adopt the specific comments, but we have
clarified the rules. By ``deconditioned,'' we meant the reversible
exercise intolerance that comes from a lack of activity, such as from
prolonged hospitalization, but which resolves with therapy. Thus, one
of our reasons for requiring a longitudinal clinical record of at least
3 months was to allow time for the individual to become reconditioned;
in this way our evaluation would consider the individual in the most
stable condition and provide a more accurate picture of expected long-
term functioning. We have, therefore, revised the proposed language
(now in the second paragraph of final 4.00A) to clarify our original
intent that inactivity or bedrest may result in a reversible
deconditioned state, and that individuals in such a deconditioned state
may do poorly on exercise testing if the testing is performed before
they have been reconditioned.
We do not agree that the factor of deconditioning should be added
to listing 4.04. Listing 4.04 already includes functional criteria that
result from the listed impairment.
4.00B Cardiovascular Impairment
Comment: A national medical association noted that we had included
arterial desaturation as one of the consequences of heart disease in
4.00B4. They noted, however, that we had not provided a methodology for
quantifying this condition, and suggested that purchase of exercise
pulse oximetry in conjunction with exercise testing may be an objective
measure of degree of impairment.
Response: We did not adopt the comment. The documentation for
arterial desaturation is found in the criteria in 4.06A or B and the
methodology can be easily inferred from the criteria. We do not provide
for the purchase of pulse oximetry to determine oxygen saturation
because it is not as sensitive a measure as arterial blood oxygen
tension. Of course, if we obtain it from a treating source, we will
consider the results along with all other evidence.
4.00C Documentation
Comment: One commenter thought that the requirement in 4.00C1 for a
12-lead resting ECG rather than a 3-lead test might pose a problem
because the 3-lead test is used in smaller facilities and rural areas.
Another commenter thought that the statement in 4.00C1 that the
tracings of a resting ECG ``must be submitted,'' might be
misinterpreted by adjudicators to mean that a resting ECG must be
purchased even if the documentation is sufficient to meet a listing
that does not require an ECG.
Response: We did not adopt the comments. The provision is
substantively the same as the provision in 4.00F of the prior listings,
and has not been a problem in the past. We will, of course, accept a 3-
lead ECG which is submitted to us by a treating or examining source,
and use it to decide the case if the remaining information in the
record is sufficient. If this information is not sufficient for a
favorable decision, we may purchase the needed evidence. When we
purchase an ECG, it will be a 12-lead test. With regard to the second
commenter's point, inasmuch as the language in the final rule is nearly
identical to the language in former 4.00F and there was no
misunderstanding of that language, we do not believe that these rules
will be misinterpreted either.
Comment: Two attorney commenters said that detailed descriptions of
ECG findings without the original or legible copies of the tracing
should be sufficient documentation, at least in the Second Circuit. The
commenters, in nearly identical language, said that this regulatory
requirement ``frequently results in purchase of a CE with [its]
attendant problems.''
Response: We require ECG tracings to minimize error in adjudication
and to ensure that standardized criteria for interpretation are applied
to all claimants. Having the actual tracings, or a copy, also permits
us to compare the findings with other evidence in the record--such as
ECGs from emergency rooms and other medical sources--which the treating
source might not have seen, and permits us to create a longitudinal
picture through serial tests. Furthermore, our requirement for the
actual tracings or a copy is only consistent with standard medical
practice; it is routine to send the tracings along with other medical
records whenever referring a patient to another physician, and for this
reason it is rare for treating sources to provide the kind of detailed
description of the tracing and the methodology in their narrative
reports needed to understand the interpretation and methodology.
Although it is possible that the physician could provide us with a
narrative showing all of the information we would need to resolve any
questions we might have, we have found it much simpler and more
straightforward to review the tracings.
Under our recently published standards for obtaining consultative
examinations, we do not anticipate the purchase of many consultative
examinations merely because a treating source failed to submit actual
tracings. The rules which are applicable nationwide, including in the
Second Circuit, require us to make every reasonable effort to recontact
the doctor to try to obtain the missing evidence. If the tracing is for
some reason not available, the rules also provide that the treating
source is the preferred source for a consultative examination, and
that, furthermore, we may restrict the examination only to the evidence
we need. Therefore, if it is necessary to complete the record, we may
purchase a new ECG from the treating source, without the need for a
full-blown, independent consultative examination. We will only purchase
examinations from other physicians when we have good reason to do so,
primarily because the treating source has been unable or unwilling to
provide us with adequate information and is unable or unwilling to
perform the consultation for us.
The commenters seemed to have assumed that our rule for obtaining
tracings is one that only works to the detriment of the claimant. In
fact, because we have specialists in cardiovascular disorders working
in our State agencies, and because treating sources are not always
specialists, we often find abnormalities on ECGs that were not noted in
the treating sources' readings. Without review of the actual tracings
by a knowledgeable program physician applying nationally acceptable
standards, erroneous decisions could result which adversely affect
claimants. The rule can, and does, work both ways.
Comment: A national medical association suggested that we should
include a requirement for routine documentation of the effects of
hyperventilation under 4.00C1b(4) because it is a necessary part of the
examination.
Response: We partially adopted the comment. We could not add a rule
requiring documentation of the effects of hyperventilation under
4.00C1b(4) because it is a general section that includes existing
medical evidence. Inasmuch as this existing evidence often will not
include documentation of the effects of hyperventilation, such a
requirement would have little practical effect. However, we can require
such testing when we purchase exercise testing on a consultative basis.
Therefore, we have added this requirement under final 4.00C2b(1), the
methodology section under ``Purchasing Exercise Tests.'' The new
language is an almost exact copy of the third and fourth sentences of
the first paragraph of 4.00F2 of the former rules.
In addition, the comment made us realize that the statement in
proposed 4.00C1b(4) was an inadvertent error. It required
posthyperventilation tracings to be deferred for at least 10 minutes
after hyperventilation, which is manifestly so long a recovery time
that it would defeat the purpose of the hyperventilation study. We
have, therefore, corrected the sentence to state what we originally
intended--that the exercise test should be deferred for at least 10
minutes after hyperventilation.
Comment: A medical association provided an updated reference for
exercise standards to be used in 4.00C1b(5).
Response: Instead of updating the literature citations, we decided
to delete the references entirely in favor of a more general
requirement to use generally accepted protocols for post-exercise
electrocardiograms. In this way, we ensure that the criteria will not
again become out-of-date in the future.
Comment: Several commenters asserted that the use of handrails and
the Borg scale intensity rating of perceived exertion are not usually
reported in the existing medical evidence. The commenters pointed out
that, if this information is required for a program acceptable exercise
test, it will require frequent recontact with the attending physician.
They also said that this information will usually not be available from
hospitals.
Response: In response to the comment, we deleted the language on
the Borg scale and the use of handrails. We agree with the commenters
that these are not usually reported or available.
Comment: One commenter referred to our statement in the third
sentence of proposed 4.00C2a that ``[e]xercise test reports, when
available, must be included in the file.'' The commenter said that
there are occasions when certain exercise tests would not be germane to
a decision, e.g., an exercise test performed only a week after an acute
event or when chest discomfort is clearly not of coronary ischemic
origin.
Response: Although we do not agree with the commenter, we have
deleted the sentence in our clarification of final 4.00C2a. Inasmuch as
we have revised 4.00C2 to focus only on the purchase of exercise tests,
it is no longer relevant to discuss available (i.e., existing)
evidence.
Even though we have not retained the sentence, it is still our
policy that all relevant, existing evidence must be requested. In the
case of a person alleging chest pain, this will include reports of
exercise testing. We do not believe that it would be fair, or accurate,
to automatically conclude that a person's chest pain is ``clearly'' not
of cardiac origin when a physician has seen fit to order a treadmill
test for the individual. Moreover, as we have stated several times in
this preamble, the treadmill test provides valuable information about
an individual's aerobic capacity which will always be relevant to
determining functional capacity.
4.00C2b Methodology
Comment: An attorney said that we had acknowledged in 4.00C2b(1)
that ``there is more than a little uncertainty about what constitutes a
MET or 5 METS'' on an exercise test, and said that there was no
universally accepted guideline in the medical community for how many
METS a person has completed at a given level of a treadmill test. The
commenter suggested, therefore, that we provide a definition in the
listings that would serve as the standard for these listings.
Response: We did not adopt the comment. It is universally
understood by physicians that the metabolic equivalent, or MET, is a
unit of sitting, resting oxygen uptake equal to approximately 3.5 ml of
oxygen per kilogram of body weight per minute. Exercise protocols, such
as the Bruce protocol, are standardized and have been developed so that
each level approximates a workload in multiples of METS; hence, stage I
of the Bruce protocol approximates 5 METS. (See, e.g., The American
Heart Association Special Report, ``Exercise Standards: A Statement for
Health Professionals From the American Heart Association,''
``Circulation,'' Vol. 82, No. 6, December, 1990, p. 2286; and Schlant,
et al., ``Guidelines for Exercise Testing: A Report of the Joint
American College of Cardiology/American Heart Association Task Force on
Assessment of Cardiovascular Procedures (Subcommittee on Exercise
Testing),'' printed in the ``Journal of the American College of
Cardiology,'' Vol. 8, No. 3, September, 1986, p. 725, and
``Circulation,'' Vol. 74, No. 3, September, 1986, p. 653A.) An exact
MET level can be determined only by measuring the volume of oxygen
uptake directly, but this is rarely done in conjunction with the
clinical use of the ECG treadmill exercise test.
We do not believe that there is any reason for us to define the
criteria of these listings beyond what is universally understood by
physicians. Inasmuch as we use the listings only to find people
disabled, the fact that there is some variation from person to person
in the actual workload imposed at a given level of an exercise protocol
will not disadvantage any claimant. Those claimants who demonstrate the
requisite findings of the listings on exercise will be found to have
impairments that meet the listings; those who do not will still have
the opportunity to demonstrate disability by showing equivalence to the
listings or by an individualized assessment of their residual
functional capacities.
Comment: A commenter from a national medical association suggested
the use of measured oxygen consumption to quantify functional capacity
objectively. The commenter said that use of measured oxygen consumption
may enhance objectivity of data obtained during exercise testing and
strengthen interpretation of exercise test results in cases where
effort on the part of the claimant is questionable; while measurement
of oxygen consumption is not frequently used in clinical practice, the
additional data gathered from this relatively simple, noninvasive
technique may allow for more objective interpretation of respiratory or
cardiovascular limitation.
Response: Although we agree that exercise testing with measurement
of maximal oxygen uptake provides an accurate determination of aerobic
capacity, this procedure is not widely utilized and would also increase
the cost of impairment evaluation prohibitively. Therefore, we are
unable to adopt the comment. However, in response to the comment, we
have added a discussion of the efficacy of such testing to final
4.00C3, ``Other studies,'' and the importance of obtaining test results
when the test has been performed by a treating source or other medical
source.
Comment: A national medical association suggested the 5 METS or
less criterion should apply to leg exercise only and that we should
provide a threshold for arm exercises. The commenter recommended that
the arm threshold should be 60 to 70 percent of the leg criterion. The
commenter also said that some work does not require much leg work and,
therefore, thought the treadmill test could be inappropriate. The
commenter said that some people without the use of legs may still be
capable of performing many jobs.
Response: The primary focus of the preface to the listings is on
providing guidance for the evaluation of disability under the listings,
although the guidance may also be applicable for disability evaluation
at other steps of the sequence. The listings are only examples of
impairments that are so severe that they preclude the performance of
gainful activity. We believe that the exercise threshold levels we have
provided in these listings are so limited as to render the issue of arm
exercise at the listing level moot; even sedentary work requires some
ability to walk, stand, lift, and carry, as well as the ability to
travel to and from a job. We also want to make clear that, under our
longstanding rules, people who do not have the use of their legs are
always deemed to be disabled.
We do agree with the commenter that arm exercise testing is less
sensitive than treadmill testing in the detection of myocardial
ischemia because the large muscle groups are not exercised. We believe
that the maximal aerobic capacity is approximately 80 percent of a
treadmill exercise test. A MET level on arm exercise that would be
comparable to the 5-MET level of the treadmill test would be 4 METs,
and in such a circumstance, an equivalence determination would be
appropriate.
Comment: Another commenter wondered whether the increase in
systolic blood pressure before and early into exercise discussed in
4.00C2b(4) and the diastolic rise in blood pressure discussed in
4.00C2b(5) occur with sufficient frequency that they warrant inclusion
in the listings. The commenter also suggested that we add a statement
requiring review by a program physician to ensure the validity of the
test interpretation. Another commenter recommended that we add the
phrase, ``at peak level,'' to the third sentence of proposed
4.00C2b(5), so that the sentence would begin: ``Conversely, an increase
in diastolic blood pressure with low workloads, together with a
decrease in systolic blood pressure at peak level and decrease in pulse
pressure * * *.'' Another commenter also asked if the significance of
severe systolic hypertension during exercise needs to be mentioned.
Response: We believe that the guidance we provide in final
4.00C2b(4) is important and that the phenomenon does occur frequently
enough to warrant inclusion in the methodology section of the preface.
It is well known that there is a degree of apprehension in the patient-
physician encounter which can result in a transient elevation of blood
pressure, and this occurs commonly. As the test progresses, the
transient elevation in blood pressure settles down. This degree of
apprehension must be taken into consideration when blood pressure is
measured early in an exercise test in order to distinguish between
tests that are truly sign-or symptom-limited and those that register
transient elevations in blood pressure early in the test as a result of
apprehension.
We agree with the first commenter that the changes in diastolic
blood pressure discussed in proposed 4.00C2b(5) were not as important;
it is the decrease in systolic blood pressure which is associated with
significant coronary disease and which increases the risk of further
treadmill testing. Moreover, the paragraph could have been misleading;
it is, in fact, not invariably true that an increase in diastolic blood
pressure with low workloads, together with a decrease in systolic blood
pressure and decrease in pulse pressure, indicates a response to
inadequate cardiac output. There are other reasons why this may occur.
Therefore, we have deleted the paragraph and redesignated proposed
4.00C2b(6) (with modifications to delete redundancies and cross-
references not in the final regulation) as final 4.00C2b(5). We did not
adopt the comment to add ``at peak level.''
We did not adopt the comment that asked us to add a sentence
ensuring review by a program physician because the results of an
exercise test must be considered in the context of all of the other
evidence in the individual's case record, and we did not wish to
mandate a physician review of only one specific type of evidence. We
did not single out the issue of blood pressure because we believe that
it is well understood by experienced program physicians that
interpretation of exercise tests takes into account all relevant
factors, including the individual's exercise time, stage of exercise,
electrocardiographic manifestations, and blood pressure changes. Blood
pressure changes as an isolated finding are not the basis of an
exercise test interpretation.
Finally, we adopted the comment that asked us to add information
about the significance of systolic hypertension on exercise. We added a
sentence to the end of final 4.00C2b(4) that states: ``In addition,
isolated systolic hypertension may be a manifestation of
arteriosclerosis.''
Comment: A physician, noting that 4.00C2b(4) discusses the
significance of a decrease in systolic blood pressure during exercise
to below the usual resting level, wondered whether it would be helpful
if we added a discussion of the significance of a decrease in systolic
blood pressure during exercise that did not fall to below the resting
level. The commenter noted similar passages in listings 4.02B2 and
4.04A4.
Response: As the commenter is undoubtedly aware, a decrease in
systolic blood pressure that does not fall below the resting level may
have no special significance. It is merely one of many factors the
doctor must consider when interpreting the test results. Because we do
not, and could not, list all of the factors that must be considered in
exercise test interpretation, we do not believe that it would be
helpful to address this particular one, either in the preface or the
listings.
Comment: We received two general comments about the examples of
risk factors in proposed 4.00C2c. One commenter noted that there were
fewer risk factors named in the proposed rules than in 4.00G3 of the
former rules, and that we had recategorized some of the risk factors
militating against the purchase of exercise testing in the former rules
to factors that would limit interpretation of exercise test results in
the proposed rules. This commenter, who believed that the rules
``contemplate[ ] large numbers of exercise tests purchased by State
agencies notwithstanding the judgments of treating physicians,'' said
that we would also be exposing claimants to additional risk ``by
abandoning many of the factors which have heretofore restrained the
discretion of SSA decisionmakers.'' In a similar vein, the second
commenter indicated a belief that, by changing some of the factors in
the prior rules (such as musculoskeletal and neurological impairments)
from risk factors to factors that would limit the usefulness of
exercise testing, we were indicating that we would purchase exercise
tests in which the results are likely to be of limited or no value
because of the presence of other diseases.
Response: In response to the comments, we have restored to final
4.00C2c several of the examples from the former rules of conditions
that would preclude purchase of exercise testing; specifically, Wolff-
Parkinson-White syndrome (which we have deleted from final 4.00C2e(2)),
marked aortic stenosis, marked pulmonary hypertension, and limiting
musculoskeletal and neurological impairments. We had proposed to delete
the examples of second-and third-degree heart blocks because they are
subsumed under the category of arrhythmias; moreover, second-degree
heart blocks are not always significant risks to exercise testing, as
in the case of Wenckebach periods. However, in response to the
comments, we have included third-degree heart blocks and Mobitz II, a
kind of second degree heart block that would preclude the purchase of
testing, as examples of arrhythmias. We deleted the example of
ventricular aneurysms because we now know that they do not rupture;
therefore, we no longer consider them to be a significant risk to
exercise testing for that reason. Arrhythmias that result from
ventricular aneurysms would already be covered. However, in response to
the comments, we have revised the example of aneurysms that was in the
former rules to include chronic or dissecting aortic aneurysms and have
added it to the list of examples. We deleted the example from the
former rules of recent onset angina because it is too imprecise. Unless
the angina is unstable or progressive, there is no significant risk to
the purchase of testing.
In some cases, the examples in the NPRM were the same as the
examples in the former rules, but with more up-to-date or clearer
language; for instance, ``atrial'' fibrillation instead of
``auricular'' fibrillation and the example of cardiac drug toxicity
instead of the less precise ``individuals on medication where
performance of stress testing may constitute a significant risk.'' In
the final rules, we have also clarified an example we proposed in the
NPRM. Because ``recent'' aortic dissection was unclear, we have revised
the example to ``unrepaired'' aortic dissection; thus, we will not
require recency. The proposed rules contained the example of arterial
dissection after coronary angioplasty; however, we eliminated this
example because it was medically inappropriate. Coronary arterial
dissection usually occurs during coronary angioplasty and is the major
means by which arterial blood flow is reestablished. Therefore, it is
not a risk factor for exercise testing. In addition, we have added
language to 4.00C2c to indicate that the risk factors listed are only
examples, not an all-inclusive list. Based upon the facts of each
individual's case, the program physician can decide if other factors
would pose a risk to the claimant.
With regard to the first commenter's remark that we intend to
purchase many exercise tests despite the judgments of treating
physicians, we believe that the commenter misread the NPRM. As we have
already explained, the proposed rules clearly stated that the program
physician would ``give great weight to the treating physicians'
opinions and will generally not override them,'' in this regard.
Comment: One commenter from a national medical association
recommended that the unstable progressive angina in 4.00C2c should be
well-documented as it could be attributable to anxiety, especially
following coronary artery bypass graft surgery.
Response: We always try to document any impairment as well as
possible. However, we believe that unstable angina due to any cause
raises a sufficient question of risk that we will not purchase exercise
testing.
Comment: One national cardiological association said that our
proposal in 4.00C2d to wait 3 months following an acute myocardial
infarction or angioplasty before purchasing an exercise test was too
long. They indicated an exercise test can be safely done within 1 to 2
months. Conversely, a lay commenter suggested that we might extend the
deferral period to 4 months.
Response: We did not adopt the comments. We chose a 3-month
deferral period not for reasons of safety, but to provide a reasonable
period of time for recovery so that we could realistically evaluate the
benefits achieved from medical management. We also believe that 3
months is long enough to wait before purchasing the test, and that
there is no need to extend the requirement to 4 months.
Comment: One commenter asked whether the factors in proposed
4.00C2e (final 4.00C2e(2)) could be used to rule out exercise testing,
inasmuch as they limit test interpretation.
Response: The factors in this section may, on an individual case
basis, be used for this purpose, although they generally will not
preclude exercise testing. We have included this section to alert
program physicians that these things sometimes make interpretation of
an exercise test more difficult. They do not necessarily pose a risk to
the individual, nor do they make interpretation impossible.
Comment: The same commenter asked us to define ``prolonged periods
of physical inactivity.''
Response: We have added a parenthetical statement indicating that
an example of a prolonged period of physical inactivity could be two
weeks of bedrest.
Comment: Two attorneys, using identical language, said that they
were concerned about the ``requirement'' for an exercise test for
individuals with chronic heart failure, who generally are treated with
digitalis. The commenters said that the medication alters the ECGs and
can result in misinterpretation of the exercise test results, thereby
denying benefits to disabled individuals. Two other attorneys, also
using identical language, said that the rules authorized reliance on
exercise tests where medication conceals the underlying impairment. One
of these commenters said that we should instruct adjudicators to
disregard results of exercise tests that are unfavorable to individuals
when the individuals were on medication at the time of the test.
Another commenter thought that we should not use treadmills or Holter
monitors to evaluate ischemia when the individual takes medication that
controls symptoms because a negative test result does not give a
reliable picture of the person's ability to function on a sustained
basis. This commenter also said that we routinely invalidate positive
test findings when they are supportive of listing criteria because the
claimant is on digitalis.
Response: The final rules do not require exercise testing for
people with chronic heart failure. They provide a listing under which
people who have chronic heart failure can show listing-level severity
through exercise testing, in addition to two other listings for the
impairment that do not include exercise testing among their criteria.
Moreover, the exercise test criteria in listing 4.02 do not include
ischemic findings; they require only an inability to exercise at 5 METS
or less or a need to stop exercising because of certain abnormalities
that require the cessation of the test. Therefore, any effect of
medication on the ECG will have no relevance to whether the person
meets this particular listing. However, because these commenters
misunderstood the language we had proposed, we have revised listing
4.02B1 to make it clearer. We also repeat that the results of exercise
tests alone will not result in denials of benefits.
With regard to the issue of the value of exercise testing when
medication controls symptoms, a so-called medication-affected test in
an asymptomatic individual indicates the effectiveness of the
treatment. The absence of ST changes on an exercise test does not mean
that the person is free of coronary disease; however, the absence of
ischemic ECG changes or symptoms at a given level of exercise indicates
what can safely be done in terms of aerobic capacity. As we have
already stated, we do not use the exercise test to determine the
existence of an impairment, but the aerobic functional limitations
associated with the impairment. If medication sufficiently controls an
impairment, the impairment is not disabling.
With regard to digitalis, we agree with the commenters that the
presence of baseline segment abnormalities makes interpretation of an
abnormal exercise test difficult and reduces the usefulness of such a
piece of medical evidence in the evaluation of ischemic heart disease.
This is because digitalis may induce or accentuate ST segment
displacements on exercise, resulting in a false-positive test; for this
reason, an abnormal exercise test of an individual taking digitalis
could not in itself establish that the individual has met the criteria
of the ischemia listing. However, this is not the case for normal
tests, and a normal exercise test is valid. In any event, inasmuch as
we have deleted the requirement to purchase exercise tests we believe
that we have responded to the commenters' concerns.
4.00C3 Other Studies
Comment: A national medical association suggested that we should
place less reliance on imaging techniques such as echocardiography and
radionuclide tests in determining function. The commenter said that too
much emphasis is placed on ejection fraction when tests must be related
to aerobic capacity, and that the effective cardiac output and
effective stroke volume are more important.
Response: We did not adopt the comment. It was not clear to us what
the commenter meant by ``effective'' cardiac output and stroke volume.
However, both cardiac output and stroke volume are measures of
ventricular function that do not in themselves provide enough
information from which one could infer reduced functional capacity. The
implications of both depend on variables that we could not easily
define in these listings. For instance, cardiac output depends on
stroke volume and heart rate--which can vary through a wide range--as
well as according to the individual's size. Therefore, neither test is
amenable to a simple cutoff for listings purposes as the ejection
fraction is. Moreover, stroke volume is one of the components used to
calculate the ejection fraction. Even if we provide a threshold level
for stroke volume in these listings, it would likely be redundant
because it would also appear as a reduced ejection fraction.
Comment: One commenter felt that stricter guidelines need to be
given as to when studies described in 4.00C3 may be purchased to ensure
that the treating physician's opinion is carefully considered in order
to protect the safety of claimants.
Response: We have clarified section 4.00C3 to indicate that these
tests may only be purchased if the claim cannot be favorably decided on
another basis, and the program physician, preferably one experienced in
the care of patients with cardiovascular disease, has concluded that
the test does not pose a significant risk to the individual.
Comment: One commenter asked us to provide criteria for purchase of
two-dimensional echocardiograms and radionuclide studies in 4.00C3.
Response: We did not adopt the comment. We believe that this is a
procedure that is more appropriate to our operational manual and other
subinstructions than to the regulations.
4.00D Treatment and Relationship to Functional Status
Comment: One commenter suggested that the requirement in proposed
4.00D4 to obtain results of biopsies during the first few months after
transplant was unnecessary because the listing directs an allowance
once we have documented that a transplant has been performed.
Response: We adopted the comment by deleting the sentence. As the
commenter correctly noted, under listing 4.09 there is a presumption of
disability for 1 year following cardiac transplantation so that there
is no need for requiring biopsy results within that period.
4.00E Clinical Syndromes
Comment: A physician noted the statement in proposed 4.00E1a that
chronic heart failure may manifest itself as pulmonary congestion
``or'' systemic congestion could be clarified to indicate that it might
also result in both pulmonary and systemic congestion.
Response: We adopted the comment.
Comment: One national medical association suggested that we add
``chest wall syndrome'' to the list of noncardiac conditions that may
also produce symptoms mimicking myocardial ischemia.
Response: We adopted the comment in final 4.00E3f.
Comment: A national medical organization suggested three clarifying
language additions for the second and third paragraphs of 4.00E4.
Response: We adopted two of the suggestions but not the third. In
the first sentence of the second paragraph of 4.00E4, we added the
phrase, ``in the supine position,'' following the word, ``determined,''
as suggested because this is standard practice for determining the
ankle/brachial blood pressure ratio. Similarly, in the fifth sentence
of the third paragraph of the section, we now indicate that the
treadmill for Doppler exercise may be on a ``10 or 12 percent'' grade,
instead of 12 percent alone, in recognition of variations in standard
practice; for the purposes of this listing, the difference in the
grading is so small as to be immaterial. We did not adopt the third
suggestion, to indicate in the same sentence that the exercise should
be for ``up to'' 5 minutes, because we already include the possibility
that the individual will not complete the test in the fourth sentence
of the paragraph.
Comment: Under 4.00E4 there is a requirement for a resting ankle/
brachial systolic blood pressure ratio of less than 0.50. A national
medical association commented that this is an arbitrary ratio and that
pain and pallor must also be taken into account, even though the
individual may register 0.45.
Response: We disagree. The requirement for a resting ankle/brachial
systolic blood pressure ratio of less than 0.50 is not arbitrary, but
is confirmed by the literature and clinical experience. (See, e.g.,
Carter, S.A., ``Rate of Pressure Measurements in Vascular Disease,'' in
Bernstein, E.F., ``Non-invasive Diagnostic Techniques in Valvular
Disease,'' The C.B. Mosby Company, Saint Louis, 1987.)
Furthermore, the existence of pain and pallor is implicit in the
requirements. Listing 4.12 requires ``intermittent claudication,''
which is a description of a kind of pain. People with the severely
reduced ankle/brachial systolic pressure of 0.50 will have both pallor
and rubor, among other clinical findings, and the symptom of pain
associated with the degree of marked peripheral arterial disease
described in the listings. We do not believe that it would be helpful
to mention only one such common finding.
Comment: One commenter suggested that we add text to 4.00E4
explaining that varicose veins by themselves do not generally cause
disability at the listing level, and that the listing concerns chronic
venous insufficiency, not isolated varicosities.
Response: Although the commenter was correct, we do not believe
that it is necessary to add this much detail to the listings, since it
is evident from the listed criteria that a mere finding of varicose
veins could not meet or equal the criteria of the listing.
Listings
4.02 Chronic Heart Failure
Comment: Several commenters believed a definition of cardiac
enlargement should be provided.
Response: We agree and have added two common examples of cardiac
enlargement to listing 4.02A.
Comment: Two attorney commenters noted that proposed listing 4.02
introduced an exercise test criterion. One of these commenters said
that we had presented no justification to support our conclusion that
exercise testing is an appropriate measure of disability arising from
chronic heart disease. The other commenter noted that in our former
rules (in 4.00G3), we had listed congestive heart failure as a reason
for not purchasing exercise tests. A third commenter asked us to define
``markedly symptomatic exercise intolerance'' as used in proposed
listing 4.02B1.
Response: Experts in the field of cardiology indicate that exercise
testing of individuals with chronic cardiac failure that is compensated
is both safe and useful. Among the objectives for subjecting these
individuals to exercise testing are the sensitive and specific
detection of impaired cardiac performance, a gradation of the severity
of chronic cardiac failure, the assessment of aerobic capacity of the
patient, and the monitoring of the therapeutic response (see, e.g.,
``Cardiopulmonary Exercise Testing,'' Karl T. Weber, Joseph S. Janicki,
1986, W. B. Saunders Company, Philadelphia). Nevertheless, we still
exclude individuals who have chronic heart failure resulting in NYHA
functional class IV limitations in 4.00C2c.
Our proposal to use the term ``markedly symptomatic exercise
intolerance'' was unclear. We have, therefore, clarified final listing
4.02B1 by deleting the phrase and revising the final clause to state
clearly what we intended; i.e., that the person is unable to exercise
in an exercise test at a workload equivalent to 5 METS or less because
of symptoms of chronic heart failure. In this way, the criteria for
symptoms will be evaluated only under B2 of final listing 4.02.
Comment: One commenter asked if in listing 4.02B the ``recurrent
fatigue and dyspnea'' must occur at rest or with exercise, or either.
Response: NYHA functional class III connotes that the individual is
comfortable at rest but symptomatic on ordinary physical activity.
Similarly, NYHA functional class IV connotes that the individual is
symptomatic at rest. We believe that we have clarified these principles
by deleting the references to the functional classes and instead
incorporating into the listings narrative descriptions of the
functional criteria.
Comment: One commenter suggested that we include multiform
ventricular premature contractions in listing 4.02B2a.
Response: We adopted the comment. We have rephrased this listing
section to indicate, ``Three or more consecutive ventricular premature
beats or three or more multiform beats * * *.''
4.04 Ischemic Heart Disease
Comment: Three commenters addressed the requirement in the opening
sentence of proposed listing 4.04 for chest discomfort ``occurring
repeatedly.'' One commenter asked us to define the phrase. Two
commenters pointed out that individuals may restrict their activities
so as to avoid discomfort or lessen its frequency. One of the
commenters said that we should delete the phrase, arguing that the
issue is not how often chest discomfort of ischemic origin occurs, but
whether it occurs consistently with exertion.
Response: We adopted the comment that asked us to delete the
phrase. We agree with the last commenter that the issue is not how
often the chest pain occurs, because the individual may have structured
his or her activities so as to avoid chest pain, but whether the
individual would have symptoms with a given level of exertion.
Moreover, the specific listings criteria in the subparagraphs establish
the level of functional severity for the listings.
Comment: One commenter thought that the requirement in listing
4.04A1 for findings in at least 3 consecutive complexes would make it
too difficult to meet this listing. Another commenter asked if the
requirement in listing 4.04A1 for depression in 3 complexes rather than
2 is correct.
Response: The requirement for findings in at least 3 consecutive
complexes is correct. We changed the requirement from the prior
listing's 2 complexes to bring these listings into line with standard
medical practice. We do not intend to raise the severity level of the
listing, but to make it more accurate and up-to-date by minimizing the
effect of wandering baseline or artifacts.
Comment: One commenter requested that we consider expanding
proposed listing 4.04A5 to include abnormal findings on stress
echocardiogram and IV Persantine tests. The commenter said that these
tests could improve sensitivity in assessing claimants with coronary
artery disease who have negative routine exercise tests.
Response: We did not accept the comment because these are new
technologies that are still being developed. Moreover, they are not
widely available and there is currently no correlation indicating the
sensitivity or specificity of these tests relative to more accepted
technologies, such as thallium stress testing. For these reasons, it
would not be appropriate at this time to include such modalities in our
listings.
Comment: Two attorney commenters thought that proposed listings
4.04B and C tightened the criteria in the nonexercise test listings for
ischemic heart disease and could not be met. One of these commenters
said that this constriction of the listings was unfair and unwarranted,
and that the former listing did not have these requirements. Another
commenter asked why listing 4.04C requires both angiographic evidence
of severe vessel occlusion and an ejection fraction of 30 percent or
less.
Response: In response to the comments, we revised the rules so that
final listing 4.04C requires only angiographic evidence instead of both
angiographic evidence and a decreased ejection fraction. We also
revised final listing 4.04B so that it has the same functional severity
level as listing 4.04C, i.e., the condition must result in symptoms on
ordinary physical activity even though the individual is comfortable at
rest; this equates with NYHA functional class III. Proposed listing
4.04B had required NYHA functional class IV, which requires symptoms at
rest.
We revised the listings employing ejection fraction criteria from
the prior rules, which permitted a finding of ``meets'' based on the
ejection fraction alone, because it is well supported in the medical
literature that individuals with even markedly decreased ejection
fractions can functionally live perfectly normal lives; the ejection
fraction alone does not indicate functional capacity. This is also the
reason we require functional limitations associated with angiographic
evidence of coronary atherosclerosis; as we have already explained,
this test does not provide information about whether any discovered
disease is directly related to or predictive of functional status.
Comment: Two commenters noted that we deleted the criteria of
former listings 4.04B1 through B5, which provided criteria for
evaluating chest pain following myocardial infarctions based on resting
ECG findings. One commenter said that resting ECGs should not be
entirely omitted; another said that we should retain the prior
listings.
Response: We did not adopt the comments. We deleted the criteria
because the presence of a previous myocardial infarction does not, of
itself, guarantee that subsequent chest pain is of cardiac origin.
Therefore, we need other information to establish that the individual
is experiencing ischemia resulting in chest discomfort. An exercise
test may be useful for this purpose. Additionally, a resting and
exercise two-dimensional echocardiogram or radionuclide ventriculogram
may also demonstrate cardiac dysfunction, including ischemia. Again,
the fact that we have deleted the criteria does not mean that
individuals who demonstrate these findings will be found not disabled.
It only means that they do not have impairments that ``meet'' the
criteria of the listing.
Comment: Two commenters asked whether we deliberately deleted the
word ``proximal'' in proposed listing 4.04C2b (final listing 4.04C1b),
``70 percent or more narrowing of another nonbypassed coronary
artery''; former listing 4.04B7b, the corresponding listing that was in
effect at the time of the NPRM, had specified that the artery must be a
proximal artery.
Response: We did delete the word intentionally to recognize that
lesions in other than a proximal portion of the major arteries may
result in significant impairment.
Comment: One commenter noted that we had deleted the criterion in
former listing 4.04A5 for development of second-or third-degree heart
block. The commenter thought that heart blocks and conductive defects
with exercise are an important part of the ischemic heart disease
listings and asked us to consider reinstating the criterion.
Response: We did not adopt the comment. We deleted the criterion
because it is unnecessary. Individuals with significant heart block or
conductive defects will have either blood pressure changes or exercise
intolerance and would be considered under the standards for those
consequences of the impairment.
4.05 Recurrent Arrhythmias
Comment: Four commenters believed that the requirement in listing
4.05 that cardiac syncope be coincident with findings on a Holter
monitor is an unduly restrictive requirement. They said that medical
care is unavailable to many claimants, particularly in the SSI claimant
population, who may only have the benefit of a Holter evaluation
because of a consultative examination. The commenters also said that it
was unreasonable to require that the claimant sustain an episode during
an isolated twenty-four hour period.
Response: We did not adopt the comments. There are many causes for
syncope, including noncardiac causes and, except for the use of a
Holter monitor with the individual lying on a tilt table or by
ambulatory monitoring there is no other way to determine whether there
is true cardiac syncope. There has to be an association between the
symptom and medically determinable arrhythmia to satisfy the
requirements of this listing.
Even though we agree with the commenters that there will be some
individuals who have true cardiac syncope but who have not been
appropriately tested by treating sources, we do not believe that this
will occur as often as the commenters do. Cardiac syncope is such a
severe symptom that it is unlikely that many people who experience it
will not be appropriately tested. In any case, and as we have stated
throughout this preamble, those individuals who cannot present evidence
showing that their impairments meet this listing may still establish
disability in other ways.
Comment: A national medical association suggested that the addition
of the phrase ``near syncope'' would make the listing description of
symptoms associated with uncontrolled arrhythmias more accurate.
Response: We agree, and have added the phrase in final 4.00B3 and
listings 4.05 and 104.05.
4.06 Symptomatic Congenital Heart Disease
Comment: One commenter noted that the vast majority of claimants
suffering from symptomatic congenital heart disease who suffer cyanosis
at rest will meet either the requirements of listing 4.06A1 or A2.
However, the commenter was concerned that we might deny claimants whose
impairments do not quite meet the requirements of those listings. The
commenter believed that cyanosis at rest should in itself be sufficient
to meet listing-level severity.
Response: We did not adopt the comment. The commenter was correct
that the vast majority of people who are cyanotic at rest will have
impairments that meet this listing. However, we did not list cyanosis
by itself because it can be too subjective a finding on which to base a
listing. The listings are not intended to be all-inclusive. Those
individuals who have cyanosis at rest but who do not demonstrate the
criteria of the listing may still demonstrate disability through the
equivalence concept and, if necessary, through an individualized
assessment of their residual functional capacities. However, as we
explained earlier in this preamble, and in response to this comment, we
deleted the proposed functional criteria from final listing 4.06 partly
in recognition of the fact that individuals who are cyanotic at rest
will necessarily have functional limitations of at least NYHA
functional class III.
Comment: One commenter suggested that we provide specific
guidelines in the listings regarding when to purchase blood gas studies
because these types of tests constitute an increased risk for
claimants.
Response: We did not adopt the comment. It would be very unusual
for a person with congenital cyanotic heart disease not to have at
least one blood gas test available; therefore, we do not expect to
purchase many of these tests. We also believe that the guidelines for
the purchase of such tests more appropriately belong in our operational
manual instructions. These tests do not pose a risk to the claimant.
4.08 Cardiomyopathies
Comment: One commenter was apparently concerned about the
references to listings 4.02 and 4.04 in listing 4.08. The commenter
noted that individuals with hypertrophic cardiomyopathy are high risk
individuals and should not be subjected to exercise tests.
Response: Listing 4.08 refers to criteria in other listings for the
evaluation of cardiomyopathy because the consequences of this
impairment are so varied (e.g., heart failure, ischemia, arrhythmia)
that it is more efficient to refer to other listings to evaluate the
consequences rather than repeating all the criteria under listing 4.08.
We agree that individuals with hypertrophic cardiomyopathy are at risk
for sudden death due to arrhythmias and physical exertion and they
should not be required to do an exercise test. We have added this
condition to the risk factors in final 4.00C2c to make it clear that we
will not purchase exercise tests in these cases. We did not revise the
cross-references in final listing 4.08 because some individuals may
have undergone exercise testing and may be able to show that their
impairments meet final listings 4.02B or 4.04A. Those who have not may
still be evaluated under final listings 4.02A and C, and 4.04B and C,
the listings that do not include exercise tests among their criteria.
4.09 Cardiac Transplantation
Comment: One national medical association indicated that some
individuals undergoing cardiac transplantation have recurring
disability beyond 1 year. The commenter pointed out that serial
observations and retesting must be continued.
Response: Final listing 4.09 does not conflict with these facts.
The listing provides that, after the year of disability, the individual
must be reevaluated under whatever listing is appropriate to his or her
residual cardiac impairment, where a finding of ``meets'' or ``equals''
may be possible.
Moreover, under the medical improvement disability review standard
that we are required to follow under Secs. 404.1594 and 416.994 (and
Sec. 416.994a for children) we may not find that an individual's
disability has ended ``automatically'' after a certain period of time.
We are generally required to show that there has been medical
improvement in the individual's disabling impairment, that the
improvement is related to the ability to work, and that the individual
is not currently under a disability. This means that, even if the
individual's impairment has improved, we may still find that the
individual continues to be disabled based on an assessment of residual
functional capacity and consideration of vocational factors.
4.11 Chronic Venous Insufficiency
Comment: One commenter thought that there were too many criteria
required to meet listing 4.11. The commenter said that it should be
unnecessary to require all five of the listed criteria in order to find
a claimant disabled and that brawny edema alone should be sufficient
for a finding of disability. Conversely, another commenter questioned
whether this listing is too liberal, but did not say why.
Response: We adopted the first comment. Extensive brawny edema is
the most severe, end-stage manifestation of chronic venous
insufficiency. However, we believe that because there can be
variability in the severity of each of the other findings we proposed
in listing 4.11, they must all be present together in order to
establish listing-level severity based on chronic venous insufficiency
that has not resulted in extensive brawny edema. We have, therefore,
divided final listing 4.11 into two paragraphs. Final listing 4.11A
will be met when there is extensive brawny edema resulting from deep
venous insufficiency, while final listing 4.11B will be met with deep
venous insufficiency with associated superficial varicosities, stasis
dermatitis, and recurrent or persistent ulceration which has not healed
following at least 3 months of prescribed medical or surgical therapy.
We did not include a 3-month treatment requirement in final listing
4.11A because extensive brawny edema is a sufficiently severe finding
in itself that treatment is not an issue in establishing duration.
We also reiterate for the first commenter that an individual does
not have to demonstrate an impairment that ``meets'' a listing to be
found disabled.
Comment: One commenter suggested that we consider adding a
statement about the evaluation of lower extremity pain without evidence
of chronic venous insufficiency.
Response: We did not adopt the comment. It was not clear to us from
the comment what information the commenter was suggesting we provide.
However, we have regulations for the evaluation of pain that we believe
adequately cover the issue for all impairments.
4.12 Peripheral Arterial Disease
Comment: One commenter suggested that we also require failure to
visualize superficial arteries in listing 4.12A.
Response: We did not adopt the comment. When the common femoral or
deep femoral artery cannot be visualized, superficial arteries will not
be visualized either. Therefore, such a requirement would be
superfluous.
Comment: Another commenter suggested that we add a third criterion,
``ischemic pain at rest,'' to listing 4.12B.
Response: We did not adopt the comment. Individuals with peripheral
vascular disease who have ischemic pain at rest will have more severe
impairments than are already described in final listing 4.12B1. Such
individuals have resting ankle/brachial systolic blood pressures in the
range of 0.30 to 0.40, which is even more severe than the listing
requirement of 0.50.
104.00 Preface to Part B
104.00A Introduction
Comment: One commenter pointed out that the statement in the fifth
paragraph of proposed 104.00A about age-appropriate activities for
individuals age 14\1/2\ to 18 (i.e., that they ``are not unlike those
of young adults'') was inconsistent with the interim final rules for
evaluating childhood disability we had issued on February 11, 1991
(``Determining Disability for a Child Under Age 18,'' 56 FR 5534).
Response: We have deleted the entire paragraph. The rules for
evaluating childhood function in Secs. 416.924 through 416.924e provide
information on the evaluation of age-appropriate activities for
children of all ages irrespective of the nature of their impairments.
They are, therefore, also applicable to children with cardiovascular
impairments.
104.00B Documentation
Comment: One commenter thought that the requirement in the second
sentence of proposed 104.00B, which provided in part that a copy of
relevant echocardiographic views ``must'' be included in the record,
was unrealistic. The commenter pointed out that the State agency is not
always able to obtain these copies. Therefore, the commenter
recommended that we change the word ``must'' to ``should.''
Response: We adopted the comment.
104.00D Congenital Heart Disease
Comment: A physician recommended that we eliminate the reference to
patent ductus arteriosus in the fourth paragraph of proposed 104.00D
because this condition is almost always amenable to surgical or medical
therapy with very low morbidity.
Response: We adopted the comment. Because of advances in the
medical and surgical treatment of patent ductus arteriosus, infants
born with this condition would not ordinarily be expected to experience
chronic cardiopulmonary impairment. We have, therefore, deleted the
paragraph. We have also clarified final 104.00 C and D so that they
clearly indicate the kinds of conditions and the level of severity
intended by the discussion. In addition, we have included guidance in
final 104.00D for those conditions which, even though not named,
nevertheless result in listing-level impairment in individual cases.
104.00E Chronic Heart Failure
Comment: A national medical association, noting our reference to
``imaging techniques such as echocardiography and radionuclide
studies'' in the last sentence of proposed 104.00E, pointed out that
pediatric cardiologists almost never do radionuclide studies. The
commenter suggested that we revise the last sentence to refer to other
tests, such as two-dimensional and Doppler echocardiography.
Response: We adopted the comment.
Listings
104.02 Chronic Heart Failure
Comment: One attorney was concerned that our proposal to remove the
tables for tachycardia and tachypnea from listing 104.02 would increase
the severity level of the listing. The commenter thought that the
exercise intolerance criterion was more restrictive in proposed listing
104.02 than in former listing 104.02G. The commenter also thought that
there was no justification for removal of chest x-ray evidence
demonstrating cardiomegaly. The commenter was also concerned that
hepatomegaly and edema were not included as criteria for this listing,
even though they were in the prior listing. This commenter and another
commenter noted that there were no criteria for fatigue and dyspnea in
proposed listing 104.02.
Response: Although the commenter was not correct in the belief that
we had proposed to make the listing more stringent, we adopted most of
the comments. Final listing 104.02A is now a criterion for persistent
tachycardia at rest; final listing 104.02B is now a criterion for
persistent tachypnea at rest or markedly decreased exercise tolerance;
and we have included the corresponding tables from our former listings
as Tables I and II at the end of the section. We moved the other
criteria we had proposed in listing 104.02A into final 104.00E of the
preface, and also added chronic dyspnea, tachypnea, and orthopnea to
the list of symptoms (including fatigue and weakness) we had already
included; we did not specifically mention all of them in the proposed
listings because they are symptoms of chronic heart failure with which
all physicians are familiar. Our proposed addition of the phrase
``markedly reduced'' (now ``markedly decreased'' in the final rules) to
modify the requirement for exercise tolerance was only a clarification;
infants with labored respiration on mild exertion have markedly
decreased exercise tolerance.
The opinion of the commenter that there was no justification for
our deletion of the rule for cardiomegaly demonstrated by x-ray was not
correct. Our prior listing could be met only with the demonstration of
two criteria associated with chronic heart failure. The proposed (and
final) listing is the same, in that it requires as an initial matter
the demonstration of findings--such as cardiomegaly--that confirm the
existence of the impairment, and one other of the criteria in the
subparagraphs. Our proposal to delete the requirement that cardiomegaly
be demonstrated by x-ray was consistent with contemporary standards of
care for infants and children with chronic heart failure, in which
other, more accurate, imaging techniques, including echocardiography
and other radionuclide studies, are generally used. Heart failure in
children must be properly assessed; like cancer, it is not a diagnosis
to be lightly entertained, and should not be based on an x-ray in a
physician's office.
However, we concede that not all claimants receive the proper care
and that there will still occasionally be x-rays in the evidence
without appropriate imaging techniques. Therefore, in response to the
comment, we have restored our prior rules on x-ray evidence of heart
enlargement demonstrated by cardiothoracic ratio in final 104.00E, with
the provision that the findings must also be accompanied by other signs
of chronic heart failure or ventricular dysfunction. Because we
restored these provisions, we were also required to clarify how
enlargement is evaluated using appropriate imaging techniques, such as
echocardiography. We have not included the former requirements for
enlargement on serial x-rays or for measurement of chamber size based
on x-rays because these are outdated methods of assessment.
The foregoing also explains why we removed the listing criteria for
hepatomegaly and dependent edema. Like cardiomegaly, these are examples
of medical findings that are used to confirm the existence of chronic
heart failure, as described in 4.00E.
With regard to the comments on dyspnea, we also added two new
paragraphs to final 104.00B providing for the possibility of exercise
testing in children. Exercise testing has been increasingly used in
children age 6 and older for the assessment of some arrhythmias, for
the assessment of the severity of chronic heart failure, and for the
assessment of recovery of function following cardiac surgery or other
therapy; however, it is still less frequently indicated for children
than for adults and can rarely be successfully performed on children
under age 6. We do not expect to purchase many such tests for children,
but they may be useful in those few cases in which we are unable to
obtain sufficient evidence about a child's functioning (for instance,
from treating sources and schools) to make a decision. The first
paragraph, therefore, provides that we may purchase the test only if we
cannot decide the case based on the available evidence; therefore, it
cannot be used to disadvantage any child claimant. The paragraph also
requires that the testing must be performed in a specialty center for
pediatric cardiology or other facility qualified to perform exercise
testing for children.
The second paragraph parallels the adult rules by requiring that
such testing be performed using a generally accepted protocol
consistent with the prevailing state of medical knowledge and clinical
practice. In addition, it prohibits the purchase of the test for a
child for whom the performance of the test constitutes a significant
risk and adopts by reference the risk provisions in the adult rules,
which are also applicable to children.
104.03 Hypertensive Cardiovascular Disease
Comment: The same attorney commenter thought that the table for
elevated blood pressure in listing 104.03 established a higher level of
severity in the listings for children. The commenter also noted that we
had not provided any explanation in the preamble to the NPRM of our
reasons for making the change.
Response: As we explained in the preamble to the NPRM, Table III in
final listing 104.03 comprises up-to-date values that are recommended
by the American Academy of Pediatrics (56 FR 31269). The table is taken
from the definition of ``Significant Hypertension'' in Table 5 of the
``Guidelines of the American Academy of Pediatrics; Report of the 2d
Task Force on Blood Pressure Control in Children--1987,''
``Pediatrics,'' 1987; 79:1-25. These guidelines should be in every
pediatrician's office.
The levels in Table III are equal to or greater than the 95th
percentile for age. In response to the comment, we have added this
explanation to the opening of the final listing.
In most instances, the readings in final Table III are not more
severe than those on the former table. We also provide more refined age
category breaks. In any event, no child will be disadvantaged by our
updating of the rule inasmuch as, to meet this listing, a child must
also show another, consequent listing-level impairment, as in the
former listing. Children whose blood pressures do not rise to the
levels on the table but who have listing-level kidney, cerebrovascular,
or heart impairment will still be found disabled at the listing level
by virtue of their secondary impairments.
104.05 Recurrent Arrhythmias
Comment: The same commenter thought that our proposal in 104.05A to
require that any episode of cardiac syncope be coincident with the
documented arrhythmia, was a new requirement.
Response: As we explained under the comments about the
corresponding adult rule, listing 4.05, the proposed language merely
clarified what is standard medical practice. In order for cardiac
syncope to be related to the arrhythmia, it must be coincident with the
arrhythmia. In response to the comment, we have also added a new second
sentence to the second paragraph of final 4.00B, ``Documentation,''
providing procedural guidance on when the purchase of an ambulatory ECG
may be appropriate.
Comment: The same commenter thought that by cross-referencing the
chronic heart failure listing in proposed listing 104.05B while
omitting the exercise intolerance criteria in former listing 104.05C,
we were suggesting that even a claimant meeting the more exacting
stricture of the listing 104.02A exercise intolerance test would still
be found not to meet the arrhythmia listing unless he or she also
suffered from chronic heart failure. The commenter felt that an
explicit exercise criterion should be included in the arrhythmia
listing.
Response: We do not believe it is necessary to add the explicit
exercise criterion to 104.05. Cardiac arrhythmias are common in
children, and most childhood arrhythmias are essentially benign. When a
child with a cardiac arrhythmia develops exercise intolerance with
labored respirations on mild exertion, this is usually indicative of
chronic heart failure. This is why we provided the cross-reference to
listing 104.02 instead of incorporating the criteria from listing
104.02 into the listing on arrhythmia, which is what the prior listing
essentially did. In addition, there are other criteria associated with
arrhythmias in childhood, such as syncope or near syncope, which are
more frequent manifestations of severe cardiac arrhythmias and which
may not be necessarily associated with congestive heart failure.
However, in response to the comment, and because we have tried in
these final rules to maintain consistency between part A and part B
wherever possible and appropriate, we have revised listings 104.02 and
104.05. We have removed the reference to listing 104.02 from the
arrhythmia listing and have instead added a criterion for arrhythmia
under final listing 104.02C, by which that listing can now be met; this
better describes our original intent than did proposed listing 104.05B.
In addition, we revised the remaining language in final listing 104.05
into a single paragraph that is more consistent with the adult rules,
as explained in the summary of provisions.
Comment: A medical association recommended that we add nonsyncopal
arrhythmia to listing 104.05. Another commenter questioned why we did
not mention A-V dissociation in the proposed listing; it was a
criterion in the heading of the former listing.
Response: In response to the comment, we have revised final listing
104.05 to include near syncopal episodes clearly documented to be
associated with arrhythmia. This is also consistent with our addition
of the term to final listing 4.05.
We did not actually delete A-V dissociation from the listing. A-V
dissociation is a kind of heart block and is, therefore, implicit in
the term ``heart block.'' We, therefore, proposed to delete the term
because the prior listing language was ambiguous: The use of the
conjunctive, ``or,'' in the former rules did not mean that A-V
dissociation was a separate medical entity from heart block; it meant
that A-V dissociation was another way of describing a heart block.
However, so that there is no misunderstanding, we have restored the
term parenthetically after ``heart block'' in the final listing.
104.06 Congenital Heart Disease
Comment: A physician questioned our approach in proposed listing
104.06A (final listing 104.06H). The commenter pointed out that the
proposed rule to consider all children who meet the requirements of the
listing to be disabled until age 24 months would result in inequitable
outcomes. For instance, a child who had life-saving surgery at age 3
months would in effect be found disabled for at least 21 months,
whereas a child who was found disabled under this listing at age 11
months would be found disabled for only 13 months. The commenter
suggested that a more equitable approach would be to provide a recovery
time period instead of an age cutoff.
Response: We adopted the comment, which actually conveyed our
original intent. We have revised the final rule to state that we will
consider an infant who meets the requirements of the listing to be
disabled until the attainment of age 1, or for 12 months after surgery,
whichever is later, and then reevaluate. We believe that 12 months is a
sufficient period for stabilization and developmental recovery and, in
this manner, all infants will be treated in the same way under the
listing. We tied the recovery time period to surgery because the
listing is for children who are expected to die within the first year
of life without surgical intervention. If by age 1 an infant has not
had surgery and has survived, the child should be reevaluated because
the impairment may no longer be as severe as it originally appeared.
Even if it is of listing-level severity at age 1, we should be able to
evaluate it under one of the other listings; if it is less severe than
listing-level, we will perform an individualized functional assessment
and determine whether the child is still disabled.
In addition, we believe that the comment also required us to revise
the period described in proposed listing 104.09, ``Cardiac
transplantation,'' because it used the same language. Indeed, proposed
listing 104.09 could have been viewed as being even more inequitable.
This is because, under the proposed rule, all children over age 1 would
have received a period of 12 months (because a 12-month period for a
child over 12 months old would always end later than age 24 months),
whereas all children under age 1 would always receive a period of more
than 12 months, some for nearly 2 years, others for closer to 1 year.
In sum, we believe that the revisions to final listings 104.06H and
104.09 are simply fairer.
Comment: A commenter indicated that squatting, which was a
criterion in former listing 104.04B, was not included in listing
104.06, the corresponding listing in these rules, and questioned its
absence.
Response: We proposed to delete squatting because it is now a rare
finding. In the past, squatting was usually seen in older surviving
children with uncorrected cardiac defects associated with dyspnea and
cyanosis at rest. Because the majority of children with cyanotic forms
of congenital heart disease are now undergoing corrective surgery
within the first year of life to restore oxygenation at more
physiological levels, squatting is rarely seen. Nonetheless, to
encompass the rare situation in which squatting may be present, we have
restored it as a criterion under final listing 104.06A3.
Comment: A national medical association thought that the four
manifestations of persistent, chronic hypoxemia we proposed in listing
104.06B might be too rigid. As an example, it said that a hematocrit of
55 percent or greater could create a problem for children who are
anemic, and suggested that the qualifier ``in the absence of documented
anemia'' should be added to the criterion. An attorney noted that
former listing 104.04C required a ``chronic'' hematocrit of 55 percent
or greater, whereas proposed listing 104.06B2 specified a hematocrit of
55 percent or greater ``on two or more evaluations within a 3-month
period.'' The commenter thought that this was a more stringent
requirement than the one in the former listings, called it a ``hidden''
change in the listings, and strongly objected to it.
Response: We did not adopt the comments. Other than providing the
example of anemia, the first commenter did not provide any other
explanation for the belief that the four criteria in final listing
104.06A are too rigid. We believe that anemic and hypoxic children will
be covered by final listing 104.06A1 because the arterial oxygen
saturation should be significantly reduced as a result of anemia. The
requirement that hematocrit results at 55 percent or greater be
obtained twice or more within a 3-month period is consistent with
medical practice in children, is manifestly a more precise programmatic
definition of what is meant by the term ``chronic'' hematocrit of 55
percent or greater, and is not intended as a change in severity level.
Moreover, we proposed the change through proper notice-and-comment
rulemaking procedures and received no negative comments about the
proposal aside from this lay comment.
Comment: The same attorney commenter from the preceding comment
noted our statement in the preamble of the NPRM that we proposed to
delete former listing 104.08, ``Recurrent hemoptysis,'' because the
condition could be evaluated under proposed listing 104.06E (56 FR
31269). The commenter said that, in fact, we had not mentioned
hemoptysis (or bronchial collaterals, another criterion in the former
listing) in proposed listing 104.06E. Another commenter asked whether
nonvalvular stenosis should have been included in proposed listing
104.06F.
Response: We did not adopt the first comment. Hemoptysis is an
uncommon manifestation of cardiovascular disease which occurs only in
the presence of cyanotic heart disease or pulmonary hypertension of
such seriousness that the primary condition would already have met or
equaled the listings. Under final listing 104.06D, a child does not
have to have an impairment so severe that it results in hemoptysis.
Because of this fact, we have also deleted the criterion for recurrent
hemoptysis in final listing 104.06A3; this, too, describes an
impairment that exceeds listing-level severity.
We deleted the reference to bronchial collaterals for the same
reason. Major collaterals (which generally are shown by cardiac
catheterization) are only present in infants and children with severe
cyanosis, occasionally combined with congestive failure, and such
children will already have evidence that their impairments meet or are
equivalent to one of the listings.
We adopted the second comment because we did intend to include
nonvalvular stenotic lesions under this listing. We, therefore, revised
final listing 104.06E (which was proposed listing 104.06F) to include
congenital valvular or other stenotic defects, or valvular
regurgitation. For consistency, we made similar revisions in final
listings 4.07 and 104.07.
104.13 Chronic Rheumatic Fever or Rheumatic Heart Disease
Comment: Another commenter noted that proposed listing 104.13 was
essentially the same as prior listing 104.09A but that we had not
included ECG findings as an example of an abnormal laboratory finding,
as in the former listing.
Response: We have restored the example of abnormal ECG findings to
final listing 104.13A. We had proposed to delete the example only
because it is a minor criterion; it is not a specific requirement that
abnormal ECG findings be provided in order to meet or equal the
listing. The elevated sedimentation rate and abnormal ECG findings are
only two of several minor criteria that can be used in establishing the
diagnosis of continuing rheumatic activity. The use of elevated
sedimentation rate to the exclusion of the ECG and other minor criteria
was not intended to preclude the use or substitution of these other
criteria for meeting the requirement that rheumatic activity be
manifested by abnormal laboratory findings.
104.15 Kawasaki Syndrome
Comment: A national medical association suggested that we include a
separate listing for Kawasaki syndrome. The commenter said that we
should mention specifically the anatomical and arterial findings
associated with the disorder and the chronic sequelae, including
coronary lesions or valvular involvement.
Response: We have added a new listing 104.15 for Kawasaki syndrome.
The listing will be met with Kawasaki syndrome associated with a major
coronary artery aneurysm or with chronic heart failure of the level
described in listing 104.02. The current treatment of Kawasaki syndrome
with immunoglobulin therapy is thought to reduce the risk of the two
major cardiac sequelae, coronary artery aneurysms and ventricular
dysfunction. Listing-level impairment from either of these causes is
rare, probably on the order of less than 5 percent of all infants
affected, and it is unusual for the syndrome to be a cause of chronic
cardiovascular impairment. However, in those instances in which such
sequelae occur, other listings (such as listing 104.07, for valvular
and other stenotic lesions) may be used for evaluation.
Accordingly, with the aforementioned revisions, the regulations are
adopted.
Regulatory Procedures
Executive Order 12291
The Secretary has determined that this is not a major rule under
Executive Order 12291 because implementation will not result in
additional costs of $100 million and other threshold criteria for a
major rule are not met. Therefore, a regulatory impact analysis is not
required.
Paperwork Reduction Act
These final regulations will impose no new reporting or
recordkeeping requirements subject to clearance by the Office of
Management and Budget.
Regulatory Flexibility Act
We certify that these final regulations, if promulgated, will not
have a significant economic impact on a substantial number of small
entities because they primarily affect only disability claimants and
beneficiaries under title II and title XVI of the Social Security Act.
(Catalog of Federal Domestic Assistance Program No. 93.802,
Disability Insurance; No. 93.807)
List of Subjects in 20 CFR Part 404
Administrative practice and procedure, Blind, Disability benefits,
Old-Age, Survivors and Disability Insurance, Reporting and
recordkeeping requirements, Social Security.
Dated: April 8, 1993.
Louis D. Enoff,
Principal Deputy Commissioner of Social Security.
Approved: October 22, 1993.
Donna E. Shalala,
Secretary of Health and Human Services.
For the reasons set out in the preamble, part 404 of Chapter III of
title 20 of the Code of Federal Regulations is amended as follows:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950-________)
Subpart P--[Amended]
1. The authority citation for subpart P continues to read as
follows:
Authority: Secs. 202, 205 (a), (b), and (d) through (h), 216(i),
221 (a) and (i), 222(c), 223, 225, and 1102 of the Social Security
Act; 42 U.S.C. 402, 405 (a), (b), and (d) through (h), 416(i), 421
(a) and (i), 422(c), 423, 425, and 1302.
2. Appendix 1 to subpart P is amended by revising item 5 of the
introductory text before part A to read as follows:
Appendix 1 to Subpart P--Listing of Impairments
* * * * *
5. The cardiovascular system listings (4.00 and 104.00) within 4
years. Consequently, the listings in this body system will no longer be
effective on February 10, 1994.
* * * * *
3. Listing 4.00, Cardiovascular System, of part A of appendix 1 to
subpart P of part 404 is revised to read as follows:
4.00 Cardiovascular System
A. Introduction. The listings in this section describe
impairments resulting from cardiovascular disease based on symptoms,
physical signs, laboratory test abnormalities, and response to a
regimen of therapy prescribed by a treating source. A longitudinal
clinical record covering a period of not less than 3 months of
observations and therapy is usually necessary for the assessment of
severity and expected duration of cardiovascular impairment, unless
the claim can be decided favorably on the basis of the current
evidence. All relevant evidence must be considered in assessing
disability.
Many individuals, especially those who have listing-level
impairments, will have received the benefit of medically prescribed
treatment. Whenever there is evidence of such treatment, the
longitudinal clinical record must include a description of the
therapy prescribed by the treating source and response, in addition
to information about the nature and severity of the impairment. It
is important to document any prescribed therapy and response because
this medical management may have improved the individual's
functional status. The longitudinal record should provide
information regarding functional recovery, if any.
Some individuals will not have received ongoing treatment or
have an ongoing relationship with the medical community despite the
existence of a severe impairment(s). Unless the claim can be decided
favorably on the basis of the current evidence, a longitudinal
record is still important because it will provide information about
such things as the ongoing medical severity of the impairment, the
degree of recovery from cardiac insult, the level of the
individual's functioning, and the frequency, severity, and duration
of symptoms. Also, several listings include a requirement for
continuing signs and symptoms despite a regimen of prescribed
treatment. Even though an individual who does not receive treatment
may not be able to show an impairment that meets the criteria of
these listings, the individual may have an impairment(s) equivalent
in severity to one of the listed impairments or be disabled because
of a limited residual functional capacity.
Indeed, it must be remembered that these listings are only
examples of common cardiovascular disorders that are severe enough
to prevent a person from engaging in gainful activity. Therefore, in
any case in which an individual has a medically determinable
impairment that is not listed, or a combination of impairments no
one of which meets a listing, we will make a medical equivalence
determination. Individuals who have an impairment(s) with a level of
severity which does not meet or equal the criteria of the
cardiovascular listings may or may not have the residual functional
capacity (RFC) which would enable them to engage in substantial
gainful activity. Evaluation of the impairment(s) of these
individuals should proceed through the final steps of the sequential
evaluation process (or, as appropriate, the steps in the medical
improvement review standard).
B. Cardiovascular impairment results from one or more of four
consequences of heart disease:
1. Chronic heart failure or ventricular dysfunction.
2. Discomfort or pain due to myocardial ischemia, with or
without necrosis of heart muscle.
3. Syncope, or near syncope, due to inadequate cerebral
perfusion from any cardiac cause such as obstruction of flow or
disturbance in rhythm or conduction resulting in inadequate cardiac
output.
4. Central cyanosis due to right-to-left shunt, arterial
desaturation, or pulmonary vascular disease.
Impairment from diseases of arteries and veins may result from
disorders of the vasculature in the central nervous system (11.04A,
B), eyes (2.02-2.04), kidney (6.02), and other organs.
C. Documentation. Each individual's file must include
sufficiently detailed reports on history, physical examinations,
laboratory studies, and any prescribed therapy and response to allow
an independent reviewer to assess the severity and duration of the
cardiovascular impairment.
1. Electrocardiography
a. An original or legible copy of the 12-lead electrocardiogram
(ECG) obtained at rest must be submitted, appropriately dated and
labeled, with the standardization inscribed on the tracing.
Alteration in standardization of specific leads (such as to
accommodate large QRS amplitudes) must be identified on those leads.
(1) Detailed descriptions or computer-averaged signals without
original or legible copies of the ECG as described in subsection
4.00Cla are not acceptable.
(2) The effects of drugs or electrolyte abnormalities must be
considered as possible noncoronary causes of ECG abnormalities of
ventricular repolarization, i.e., those involving the ST segment and
T wave. If available, the predrug (especially digitalis glycoside)
ECG should be submitted.
(3) The term ``ischemic'' is used in 4.04A to describe an
abnormal ST segment deviation. Nonspecific repolarization
abnormalities should not be confused with ``ischemic'' changes.
b. ECGs obtained in conjunction with treadmill, bicycle, or arm
exercise tests should meet the following specifications:
(1) ECGs must include the original calibrated ECG tracings or a
legible copy.
(2) A 12-lead baseline ECG must be recorded in the upright
position before exercise.
(3) A 12-lead ECG should be recorded at the end of each minute
of exercise, including at the time the ST segment abnormalities
reach or exceed the criteria for abnormality described in 4.04A or
the individual experiences chest discomfort or other abnormalities,
and also when the exercise test is terminated.
(4) If ECG documentation of the effects of hyperventilation is
obtained, the exercise test should be deferred for at least 10
minutes because metabolic changes of hyperventilation may alter the
physiologic and ECG response to exercise.
(5) Post-exercise ECGs should be recorded using a generally
accepted protocol consistent with the prevailing state of medical
knowledge and clinical practice.
(6) All resting, exercise, and recovery ECG strips must have a
standardization inscribed on the tracing. The ECG strips should be
labeled to indicate 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, blood pressure levels during
testing, and the reason(s) for terminating the test (including
limiting signs or symptoms) must be recorded.
2. Purchasing Exercise Tests
a. It is well recognized by medical experts that exercise
testing is the best tool currently available for estimating maximal
aerobic capacity in individuals with cardiovascular impairments.
Purchase of an exercise test may be appropriate when there is a
question whether an impairment meets or is equivalent in severity to
one of the listings, or when there is insufficient evidence in the
record to evaluate aerobic capacity, and the claim cannot otherwise
be favorably decided. Before purchasing an exercise test, a program
physician, preferably one with experience in the care of patients
with cardiovascular disease, must review the pertinent history,
physical examinations, and laboratory tests to determine whether
obtaining the test would present a significant risk to the
individual (see 4.00C2c). Purchase may be indicated when there is no
significant risk to exercise testing and there is no timely test of
record. An exercise test is generally considered timely for 12
months after the date performed, provided there has been no change
in clinical status that may alter the severity of the cardiac
impairment.
b. Methodology.
(1) When an exercise test is purchased, it should be a ``sign-or
symptom-limited'' test characterized by a progressive multistage
regimen. A purchased exercise test 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 4.00C1b and this section. A pre-exercise
posthyperventilation tracing may be essential for the proper
evaluation of an ``abnormal'' test in certain circumstances, such as
in women with evidence of mitral valve prolapse.
(2) The exercise test should be paced to the capabilities of the
individual and be supervised by a physician. 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 that are used should utilize similar
workloads.
(3) Levels of exercise should be described in terms of workload
and duration of each stage, e.g., treadmill speed and grade, or
bicycle ergometer work rate in kpm/min or watts.
(4) Normally, systolic blood pressure and heart rate increase
gradually with exercise. A decrease in systolic blood pressure
during exercise below the usual resting level is often associated
with ischemia-induced left ventricular dysfunction resulting in
decreased cardiac output. Some individuals (because of
deconditioning or apprehension) with increased sympathetic responses
may increase their systolic blood pressure and heart rate above
their usual resting level just before and early into exercise. This
occurrence may limit the ability to assess the significance of an
early decrease in systolic blood pressure and heart rate if exercise
is discontinued shortly after initiation. In addition, isolated
systolic hypertension may be a manifestation of arteriosclerosis.
(5) The exercise laboratory's physical environment, staffing,
and equipment should meet the generally accepted standards for adult
exercise test laboratories.
c. Risk factors in exercise testing. The following are examples
of situations in which exercise testing will not be purchased:
unstable progressive angina pectoris, a history of acute myocardial
infarction within the past 3 months, New York Heart Association
(NYHA) class IV heart failure, cardiac drug toxicity, uncontrolled
serious arrhythmia (including uncontrolled atrial fibrillation,
Mobitz II, and third-degree block), Wolff-Parkinson-White syndrome,
uncontrolled severe systemic arterial hypertension, marked pulmonary
hypertension, unrepaired aortic dissection, left main stenosis of 50
percent or greater, marked aortic stenosis, chronic or dissecting
aortic aneurysm, recent pulmonary embolism, hypertrophic
cardiomyopathy, limiting neurological or musculoskeletal
impairments, or an acute illness. In addition, an exercise test
should not be purchased for individuals for whom the performance of
the test is considered to constitute a significant risk by a program
physician, preferably one experienced in the care of patients with
cardiovascular disease, even in the absence of any of the above risk
factors. In defining risk, the program physician, in accordance with
the regulations and other instructions on consultative examinations,
will generally give great weight to the treating physicians'
opinions and will generally not override them. In the rare situation
in which the program physician does override the treating source's
opinion, a written rationale must be prepared documenting the
reasons for overriding the opinion.
d. In order to permit maximal, attainable restoration of
functional capacity, exercise testing should not be purchased until
3 months after an acute myocardial infarction, surgical myocardial
revascularization, or other open-heart surgical procedures. Purchase
of an exercise test should also be deferred for 3 months after
percutaneous transluminal coronary angioplasty because restenosis
with ischemic symptoms may occur within a few months of angioplasty
(see 4.00D). Also, individuals who have had a period of bedrest or
inactivity (e.g., 2 weeks) that results in a reversible
deconditioned state may do poorly if exercise testing is performed
at that time.
e. Evaluation.
(1) Exercise testing is evaluated on the basis of the work level
at which the test becomes abnormal, as documented by onset of signs
and symptoms and any ECG abnormalities listed in 4.04A. The ability
or inability to complete an exercise test is not, by itself,
evidence that a person is free from ischemic heart disease. The
results of an exercise test must be considered in the context of all
of the other evidence in the individual's case record. If the
individual is under the care of a treating physician for a cardiac
impairment, and this physician has not performed an exercise test
and there are no reported significant risks to testing (see
4.00C2c), a statement should be requested from the treating
physician explaining why it was not done or should not be done
before deciding whether an exercise test should be purchased. In
those rare situations in which the treating source's opinion is
overridden, follow 4.00C2c. If there is no treating physician, the
program physician will be responsible for assessing the risk to
exercise testing.
(2) Limitations to exercise test interpretation include the
presence of noncoronary or nonischemic factors that may influence
the hemodynamic and ECG response to exercise, such as hypokalemia or
other electrolyte abnormality, hyperventilation, vasoregulatory
deconditioning, prolonged periods of physical inactivity (e.g., 2
weeks of bedrest), significant anemia, left bundle branch block
pattern on the ECG (and other conduction abnormalities that do not
preclude the purchase of exercise testing), and other heart diseases
or abnormalities (particularly valvular heart disease). Digitalis
glycosides may cause ST segment abnormalities at rest, during, and
after exercise. Digitalis or other drug-related ST segment
displacement, present at rest, may become accentuated with exercise
and make ECG interpretation difficult, but such drugs do not
invalidate an otherwise normal exercise test. Diuretic-induced
hypokalemia and left ventricular hypertrophy may also be associated
with repolarization changes and behave similarly. Finally, treatment
with beta blockers slows the heart rate more at near-maximal
exertion than at rest; this limits apparent chronotropic capacity.
3. Other Studies
Information from two-dimensional and Doppler echocardiographic
studies of ventricular size and function as well as radionuclide
(thallium201) myocardial ``perfusion'' or radionuclide
(technetium 99m) ventriculograms (RVG or MUGA) may be useful. These
techniques can provide a reliable estimate of ejection fraction. In
selected cases, these tests may be purchased after a medical history
and physical examination, report of chest x-rays, ECGs, and other
appropriate tests have been evaluated, preferably by a program
physician with experience in the care of patients with
cardiovascular disease. Purchase should be considered when other
information available is not adequate to assess whether the
individual may have severe ventricular dysfunction or myocardial
ischemia and there is no significant risk involved (follow 4.00C2a
guides), and the claim cannot be favorably decided on any other
basis.
Exercise testing with measurement of maximal oxygen uptake
(VO2) provides an accurate determination of aerobic capacity.
An exercise test without measurement of oxygen uptake provides an
estimate of aerobic capacity. When the results of tests with
measurement of oxygen uptake are available, every reasonable effort
should be made to obtain them.
The recording of properly calibrated ambulatory ECGs for
analysis of ST segment signals with a concomitantly recorded symptom
and treatment log may permit more adequate evaluation of chest
discomfort during activities of daily living, but the significance
of these data for disability evaluation has not been established in
the absence of symptoms (e.g., silent ischemia). This information
(including selected segments of both the ECG recording and summary
report of the patient diary) may be submitted for the record.
4. Cardiac catheterization will not be purchased by the Social
Security Administration.
a. Coronary arteriography. If results of such testing are
available, the report should be obtained and considered as to the
quality and type of data provided and its relevance to the
evaluation of the impairment. A copy of the report of the cardiac
catheterization and ancillary studies should also be obtained. 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. Coronary artery spasm induced by
intracoronary catheterization is not to be considered evidence of
ischemic disease. Some individuals with significant coronary
atherosclerotic obstruction have collateral vessels that supply the
myocardium distal to the arterial obstruction so that there is no
evidence of myocardial damage or ischemia, even with exercise. When
available, quantitative computer measurements and analyses should be
considered in the interpretation of severity of stenotic lesions.
b. Left ventriculography (by angiography). The report should
describe the wall motion of the myocardium with regard to any areas
of hypokinesis, akinesis, or dyskinesis, and the overall contraction
of the ventricle as measured by the ejection fraction. Measurement
of chamber volumes and pressures may be useful. When available,
quantitative computer analysis provides precise measurement of
segmental left ventricular wall thickness and motion. There is often
a poor correlation between left ventricular function at rest and
functional capacity for physical activity.
D. Treatment and relationship to functional status.
1. In general, conclusions about the severity of a
cardiovascular impairment cannot be made on the basis of type of
treatment rendered or anticipated. The overall clinical and
laboratory evidence, including the treatment plan(s) or results,
should be persuasive that a listing-level impairment exists. 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, impairment evaluation may need to be deferred
for a period of up to 3 months from the date of treatment to permit
consideration of treatment effects. Evaluation should not be
deferred if the claim can be favorably decided based upon the
available evidence.
2. The usual time after myocardial infarction, valvular and/or
revascularization surgery for adequate assessment of the results of
treatment is considered to be 3 months. If an exercise test is
performed by a treating source within a week or two after
angioplasty, and there is no significant change in clinical status
during the 3-month period after the angioplasty that would
invalidate the implications of the exercise test results, the
exercise test results may be used to reflect functional capacity
during the period in question. However, if the test was done
immediately following an acute myocardial infarction or during a
period of protracted inactivity, the results should not be projected
to 3 months even if there is no change in clinical status.
3. An individual who has undergone cardiac transplantation will
be considered under a disability for 1 year following the surgery
because, during the first year, there is a greater likelihood of
rejection of the organ and recurrent infection. After the first year
posttransplantation, continuing disability evaluation will be based
upon residual impairment as shown by symptoms, signs, and laboratory
findings. Absence of symptoms, signs, and laboratory findings
indicative of cardiac dysfunction will be included in the
consideration of whether medical improvement (as defined in
Secs. 404.1579(b)(1) and (c)(1), 404.1594(b)(1) and (c)(1), or
416.994(b)(1)(i) and (b)(2)(i), as appropriate) has occurred.
E. Clinical syndromes.
1. Chronic heart failure (ventricular dysfunction) is considered
in these listings as one category whatever its etiology, i.e.,
atherosclerotic, hypertensive, rheumatic, pulmonary, congenital or
other organic heart disease. Chronic heart failure may manifest
itself by:
a. Pulmonary or systemic congestion, or both; or
b. Symptoms of limited cardiac output, such as weakness,
fatigue, or intolerance of physical activity.
For the purpose of 4.02A, pulmonary and systemic congestion are
not considered to have been established unless there is or has been
evidence of fluid retention, such as hepatomegaly or ascites, or
peripheral or pulmonary edema of cardiac origin. The findings of
fluid retention need not be present at the time of adjudication
because congestion may be controlled with medication. Chronic heart
failure due to limited cardiac output is not considered to have been
established for the purpose of 4.02B unless symptoms occur with
ordinary daily activities, i.e., activity restriction as manifested
by a need to decrease activity or pace, or to rest intermittently,
and are associated with one or more physical signs or abnormal
laboratory studies listed in 4.02B. These studies include exercise
testing with ECG and blood pressure recording and/or appropriate
imaging techniques, such as two-dimensional echocardiography or
radionuclide or contrast ventriculography. The exercise criteria are
outlined in 4.02B1. In addition, other abnormal symptoms, signs, or
laboratory test results that lend credence to the impression of
ventricular dysfunction should be considered.
2. For the purposes of 4.03, hypertensive cardiovascular disease
is evaluated by reference to the specific organ system involved
(heart, brain, kidneys, or eyes). The presence of organic impairment
must be established by appropriate physical signs and laboratory
test abnormalities as specified in 4.02 or 4.04, or for the body
system involved.
3. Ischemic (coronary) heart disease may result in an impairment
due to myocardial ischemia and/or ventricular dysfunction or
infarction. For the purposes of 4.04, the clinical determination
that discomfort of myocardial ischemic origin (angina pectoris) is
present must be supported by objective evidence as described under
4.00Cl, 2, 3, or 4.
a. Discomfort of myocardial ischemic origin (angina pectoris) is
discomfort that is precipitated by effort and/or emotion and
promptly relieved by sublingual nitroglycerin, other rapidly acting
nitrates, or rest. Typically the discomfort is located in the chest
(usually substernal) and described as crushing, squeezing, burning,
aching, or oppressive. Sharp, sticking, or cramping discomfort is
considered less common or atypical. 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 therapy or
rest.
b. So-called anginal equivalent may be localized to the neck,
jaw(s), or hand(s) and has the same precipitating and relieving
factors as typical chest discomfort. Isolated shortness of breath
(dyspnea) is not considered an anginal equivalent for purposes of
adjudication.
c. Variant angina of the Prinzmetal type, i.e., rest angina with
transitory ST segment elevation on ECG, may have the same
significance as typical angina, described in 4.00E3a.
d. If there is documented evidence of silent ischemia or
restricted activity to prevent chest discomfort, this information
must be considered along with all available evidence to determine if
an equivalence decision is appropriate.
e. Chest discomfort of myocardial ischemic origin is usually
caused by coronary artery disease. However, ischemic discomfort may
be caused by noncoronary artery conditions, such as critical aortic
stenosis, hypertrophic cardiomyopathy, pulmonary hypertension, or
anemia. These conditions should be distinguished from coronary
artery disease, because the evaluation criteria, management, and
prognosis (duration) may differ from that of coronary artery
disease.
f. Chest discomfort of nonischemic origin may result from other
cardiac conditions such as pericarditis and mitral valve prolapse.
Noncardiac conditions may also produce symptoms mimicking that of
myocardial ischemia. These conditions include 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 arthritis. Hyperventilation
may also mimic ischemic discomfort. Such disorders should be
considered before concluding that chest discomfort is of myocardial
ischemic origin.
4. Peripheral Arterial Disease
The level of impairment is based on the symptomatology, physical
findings, Doppler studies before and after a standard exercise test,
or angiographic findings.
The requirements for evaluating peripheral arterial disease in
4.12B are based on the ratio of the systolic blood pressure at the
ankle to the systolic blood pressure at the brachial artery,
determined in the supine position at the same time. Techniques for
obtaining ankle systolic blood pressures include Doppler,
plethysmographic studies, or other techniques.
Listing 4.12B1 is met when the resting ankle/brachial systolic
blood pressure ratio is less than 0.50. Listing 4.12B2 provides
additional criteria for evaluating peripheral arterial impairment on
the basis of exercise studies when the resting ankle/brachial
systolic blood pressure ratio is 0.50 or above. The decision to
obtain exercise studies should be based on an evaluation of the
existing clinical evidence, but exercise studies are rarely
warranted when the resting ankle-over-brachial systolic blood
pressure ratio is 0.80 or above. The results of exercise studies
should describe the level of exercise, e.g., speed and grade of the
treadmill settings, the duration of exercise, symptoms during
exercise, the reasons for stopping exercise if the expected level of
exercise was not attained, blood pressures at the ankle and other
pertinent sites measured after exercise, and the time required to
return the systolic blood pressure toward or to the pre-exercise
level. When an exercise Doppler study is purchased by the Social
Security Administration, the requested exercise must be on a
treadmill at 2 mph on a 10 or 12 percent grade for 5 minutes.
Exercise studies should not be performed on individuals for whom
exercise poses a significant risk.
Application of the criteria in 4.12B may be limited in
individuals who have marked calcific (Monckeberg's) sclerosis of the
peripheral arteries or marked small vessel disease associated with
diabetes mellitus.
4.01 Category of Impairments, Cardiovascular System
4.02 Chronic heart failure while on a regimen of prescribed
treatment (see 4.00A if there is no regimen of prescribed
treatment). With one of the following:
A. Documented cardiac enlargement by appropriate imaging
techniques (e.g., a cardiothoracic ratio of greater than 0.50 on a
PA chest x-ray with good inspiratory effort or left ventricular
diastolic diameter of greater than 5.5 cm on two-dimensional
echocardiography), resulting in inability to carry on any physical
activity, and with symptoms of inadequate cardiac output, pulmonary
congestion, systemic congestion, or anginal syndrome at rest (e.g.,
recurrent or persistent fatigue, dyspnea, orthopnea, anginal
discomfort);
OR
B. Documented cardiac enlargement by appropriate imaging
techniques (see 4.02A) or ventricular dysfunction manifested by S3,
abnormal wall motion, or left ventricular ejection fraction of 30
percent or less by appropriate imaging techniques; and
1. Inability to perform on an exercise test at a workload
equivalent to 5 METs or less due to symptoms of chronic heart
failure, or, in rare instances, a need to stop exercise testing at
less than this level of work because of:
a. Three or more consecutive ventricular premature beats or
three or more multiform beats; or
b. Failure to increase systolic blood pressure by 10 mmHg, or
decrease in systolic pressure below the usual resting level (see
4.00C2b); or
c. Signs attributable to inadequate cerebral perfusion, such as
ataxic gait or mental confusion; and
2. Resulting in marked limitation of physical activity, as
demonstrated by fatigue, palpitation, dyspnea, or anginal discomfort
on ordinary physical activity, even though the individual is
comfortable at rest;
OR
C. Cor pulmonale fulfilling the criteria in 4.02A or B.
4.03 Hypertensive cardiovascular disease. Evaluate under 4.02
or 4.04, or under the criteria for the affected body system (2.02
through 2.04, 6.02, or 11.04A or B).
4.04 Ischemic heart disease, with chest discomfort associated
with myocardial ischemia, as described in 4.00E3, while on a regimen
of prescribed treatment (see 4.00A if there is no regimen of
prescribed treatment). With one of the following:
A. Symptom-and sign-limited exercise 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 therapy and/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 that have a typical ischemic time course of development and
resolution (progression of horizontal or downsloping ST depression
with exercise, and persistence of depression of at least -0.10
millivolts for at least 1 minute of recovery); or
2. An upsloping ST junction depression, in the absence of
digitalis glycoside therapy and/or hypokalemia, in any lead (except
aVR) of at least -0.2 millivolts or more for at least 0.08 seconds
after the J junction and persisting for at least 1 minute of
recovery; or
3. At least 0.1 millivolt (1 mm) ST elevation above resting
baseline during both exercise and 3 or more minutes of recovery in
ECG leads with low R and T waves in the leads demonstrating the ST
segment displacement; or
4. Failure to increase systolic pressure by 10 mmHg, or decrease
in systolic pressure below usual clinical resting level (see
4.00C2b); or
5. Documented reversible radionuclide ``perfusion''
(thallium201) defect at an exercise level equivalent to 5 METs
or less;
OR
B. Impaired myocardial function, documented by evidence (as
outlined under 4.00C3 or 4.00C4b) of hypokinetic, akinetic, or
dyskinetic myocardial free wall or septal wall motion with left
ventricular ejection fraction of 30 percent or less, and an
evaluating program physician, preferably one experienced in the care
of patients with cardiovascular disease, has concluded that
performance of exercise testing would present a significant risk to
the individual, and resulting in marked limitation of physical
activity, as demonstrated by fatigue, palpitation, dyspnea, or
anginal discomfort on ordinary physical activity, even though the
individual is comfortable at rest;
OR
C. Coronary artery disease, demonstrated by angiography
(obtained independent of Social Security disability evaluation), and
an evaluating program physician, preferably one experienced in the
care of patients with cardiovascular disease, has concluded that
performance of exercise testing would present a significant risk to
the individual, with both 1 and 2:
1. Angiographic evidence revealing:
a. 50 percent or more narrowing of a nonbypassed left main
coronary artery; or
b. 70 percent or more narrowing of another nonbypassed coronary
artery; or
c. 50 percent or more narrowing involving a long (greater than 1
cm) segment of a nonbypassed coronary artery; or
d. 50 percent or more narrowing of at least 2 nonbypassed
coronary arteries; or
e. Total obstruction of a bypass graft vessel; and
2. Resulting in marked limitation of physical activity, as
demonstrated by fatigue, palpitation, dyspnea, or anginal discomfort
on ordinary physical activity, even though the individual is
comfortable at rest.
4.05 Recurrent arrhythmias, not related to reversible causes
such as electrolyte abnormalities or digitalis glycoside or
antiarrhythmic drug toxicity, resulting in uncontrolled repeated
episodes of cardiac syncope or near syncope and arrhythmia despite
prescribed treatment (see 4.00A if there is no prescribed
treatment), documented by resting or ambulatory (Holter)
electrocardiography coincident with the occurrence of syncope or
near syncope.
4.06 Symptomatic congenital heart disease (cyanotic or
acyanotic), documented by appropriate imaging techniques (as
outlined under 4.00C3) 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. Chronic heart failure with evidence of ventricular
dysfunction, as described in 4.02;
OR
D. Recurrent arrhythmias as described in 4.05;
OR
E. Secondary pulmonary vascular obstructive disease with a mean
pulmonary arterial pressure elevated to at least 70 percent of the
mean systemic arterial pressure.
4.07 Valvular heart disease or other stenotic defects, or
valvular regurgitation, documented by appropriate imaging techniques
or cardiac catheterization. Evaluate under the criteria in 4.02,
4.04, 4.05, or 11.04.
4.08 Cardiomyopathies, documented by appropriate imaging
techniques or cardiac catheterization. Evaluate under the criteria
in 4.02, 4.04, 4.05, or 11.04.
4.09 Cardiac transplantation. Consider under a disability for 1
year following surgery; thereafter, reevaluate residual impairment
under 4.02 to 4.08.
4.10 Aneurysm of aorta or major branches, due to any cause
(e.g., atherosclerosis, cystic medial necrosis, Marfan syndrome,
trauma), demonstrated by an appropriate imaging technique. With one
of the following:
A. Acute or chronic dissection not controlled by prescribed
medical or surgical treatment;
OR
B. Chronic heart failure as described under 4.02;
OR
C. Renal failure as described under 6.02;
OR
D. Neurological complications as described under 11.04.
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;
OR
B. Superficial varicosities, stasis dermatitis, and recurrent or
persistent ulceration which has not healed following at least 3
months of prescribed medical or surgical therapy.
4.12 Peripheral arterial disease. With one of the following:
A. Intermittent claudication with failure to visualize (on
arteriogram obtained independent of Social Security disability
evaluation) the common femoral or deep femoral artery in one
extremity;
OR
B. Intermittent claudication with marked impairment of
peripheral arterial circulation as determined by Doppler studies
showing:
1. Resting ankle/brachial systolic blood pressure ratio of less
than 0.50; or
2. Decrease in systolic blood pressure at the ankle on exercise
(see 4.00E4) of 50 percent or more of pre-exercise level at the
ankle, and requiring 10 minutes or more to return to pre-exercise
level;
OR
C. Amputation at or above the tarsal region due to peripheral
vascular disease.
4. Listing 104.00, Cardiovascular System, of part B of appendix 1
to subpart P of part 404 is revised to read as follows:
104.00 Cardiovascular System
A. Introduction
The listings in this section describe childhood impairments
resulting from congenital or acquired cardiovascular disease based
on symptoms, physical signs, laboratory test abnormalities, and
response to a regimen of therapy prescribed by a treating source. A
longitudinal clinical record covering a period of not less than 3
months of observations and therapy is usually necessary for the
assessment of severity and expected duration unless the child is a
neonate or the claim can be decided favorably on the basis of the
current evidence. All relevant evidence must be considered in
assessing a child's disability. Reasonable efforts should be made to
ensure evaluation by a program physician specializing in childhood
cardiovascular impairments or a qualified pediatrician.
Examples of congenital defects include: abnormalities of cardiac
septation, such as ventricular septal defect or atrioventricular
(AV) canal; abnormalities resulting in cyanotic heart disease, such
as tetralogy of Fallot or transposition of the vessels; valvular
defects or obstructions to ventricular outflow, including pulmonary
or aortic stenosis and/or coarctation of the aorta; and major
abnormalities of ventricular development, including hypoplastic left
heart syndrome or pulmonary tricuspid atresia with hypoplastic right
ventricle. Acquired heart disease may be due to cardiomyopathy,
rheumatic heart disease, Kawasaki syndrome, or other etiologies.
Recurrent arrhythmias, severe enough to cause functional impairment,
may be seen with congenital or acquired heart disease or, more
rarely, in children with structurally normal hearts.
Cardiovascular impairments, especially chronic heart failure and
congenital heart disease, may result in impairments in other body
systems including, but not limited to, growth, neurological, and
mental. Therefore, evaluation should include consideration of the
adverse effects of cardiovascular impairment in all relevant body
systems, and especially on the child's growth and development, or
mental functioning, as described under the Growth impairment
(100.00), Neurological (111.00), and Mental retardation (112.05)
listings.
Many children, especially those who have listing-level
impairments, will have received the benefit of medically prescribed
treatment. Whenever there is evidence of such treatment, the
longitudinal clinical record must include a description of the
therapy prescribed by the treating source and response, in addition
to information about the nature and severity of the impairment. It
is important to document any prescribed therapy and response because
this medical management may have improved the child's functional
status. The longitudinal record should provide information regarding
functional recovery, if any.
Some children will not have received ongoing treatment or have
an ongoing relationship with the medical community despite the
existence of a severe impairment(s). Unless the claim can be decided
favorably on the basis of the current evidence, a longitudinal
record is still important because it will provide information about
such things as the ongoing medical severity of the impairment, the
level of the child's functioning, and the frequency, severity, and
duration of symptoms. Also, several listings include a requirement
for continuing signs and symptoms despite a regimen of prescribed
treatment. Even though a child who does not receive treatment may
not be able to show an impairment that meets the criteria of these
listings, the child may have an impairment(s) equivalent in severity
to one of the listed impairments or be disabled because of a
substantial reduction in the ability to function independently,
appropriately, and effectively in an age-appropriate manner.
Indeed, it must be remembered that these listings are only
examples of common cardiovascular disorders that are severe enough
to prevent a child from functioning independently, appropriately,
and effectively in an age-appropriate manner. When a child has a
medically determinable impairment that is not listed, or a
combination of impairments no one of which meets a listing, we will
make an equivalence determination. Also, with respect to children
claiming SSI benefits under title XVI of the Act who have an
impairment(s) with a level of severity which does not meet or equal
the criteria of the cardiovascular listings, we will determine
whether the impairment(s) is of comparable severity to one that
would disable an adult. In these cases, an individualized functional
assessment is crucial to the evaluation of a child's ability to
function independently, appropriately, and effectively in an age-
appropriate manner when the impairment(s) is severe but the criteria
of these listings are not met or equaled.
B. Documentation
Each child's file must include sufficiently detailed reports on
history, physical examinations, laboratory studies, and any
prescribed therapy and response to allow an independent reviewer to
assess the severity and duration of the cardiovascular impairment.
Data should be obtained preferably from an office or center
experienced in pediatric cardiac assessment. The actual
electrocardiographic tracing (or adequately marked photocopy) and
echocardiogram report with a copy of relevant echocardiographic
views should be included (see part A, 4.00C1).
Results of additional studies necessary to substantiate the
diagnosis or to document the severity of the impairment, including
two-dimensional and Doppler echocardiography, and radionuclide
ventriculograms, should be obtained as appropriate according to part
A, 4.00C3. Ambulatory electrocardiographic monitoring may also be
obtained if necessary to document the presence or severity of an
arrhythmia.
Exercise testing, though increasingly used, is still less
frequently indicated in children than in adults, and can rarely be
successfully performed in children under 6 years of age. It 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 therapy. It
will only be purchased by the Social Security Administration if the
case cannot be decided based on the available evidence and, if
purchased, must be performed in a specialty center for pediatric
cardiology or other facility qualified to perform exercise testing
for children.
Purchased exercise tests should be performed using a generally
accepted protocol consistent with the prevailing state of medical
knowledge and clinical practice. An exercise test should not be
purchased for a child for whom the performance of the test is
considered to constitute a significant risk by a program physician.
See 4.00C2c.
Cardiac catheterization will not be purchased by the Social
Security Administration. If the results of catheterization are
otherwise available, they should be obtained.
C. Treatment and Relationship 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 overall clinical and laboratory evidence,
including the treatment plan(s) or results, should be persuasive
that a listing-level impairment exists. 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,
impairment evaluation may need to be deferred for a period of up to
3 months from the date of treatment to permit consideration of
treatment effects.
Evaluation should not be deferred if the claim can be favorably
decided based upon the available evidence.
The most life-threatening forms of congenital heart disease and
cardiac impairments, such as those listed in 104.00D, almost always
require surgical treatment within the first year of life to prevent
early death. Even with surgery, these impairments are so severe that
it is likely that the impairment will continue to be disabling long
enough to meet the duration requirement because of significant
residual impairment post-surgery, or the recovery time from surgery,
or a combination of both factors. Therefore, when the impairment is
one of those named in 104.00D, or is as severe as one of those
impairments, the presence of a listing-level impairment can usually
be found on the basis of planned or actual cardiac surgery.
A child who has undergone surgical treatment for life-
threatening heart disease will be found under a disability for 12
months following the date of surgery under 104.06H (for infants with
life-threatening cardiac disease) or 104.09 (for a child of any age
who undergoes cardiac transplantation) because of the uncertainty
during that period concerning outcome or long-term results. After 12
months, continuing disability evaluation will be based upon residual
impairment, which will consider the clinical course following
treatment and comparison of symptoms, signs, and laboratory findings
preoperatively and after the specified period. (See Secs. 416.994a,
404.1594, or 416.994, as appropriate, for our rules on medical
improvement and whether an individual is no longer disabled.)
D. Congenital Heart Disease
Some congenital defects usually lead to listing-level impairment
in the first year of life and require surgery within the first year
as a life-saving measure. Examples of impairments that in most
instances will require life-saving surgery before age 1, include,
but are not limited to, the following: hypoplastic left heart
syndrome; critical aortic stenosis with neonatal heart failure;
critical coarctation of the aorta, with or without associated
anomalies; complete AV canal defects; transposition of the great
arteries; tetralogy of Fallot; and pulmonary atresia with intact
ventricular septum.
In addition, there are rarer defects which may lead to early
mortality and that may require multiple surgical interventions or a
combination of surgery and other major interventional procedures
(e.g., multiple ``balloon'' catheter procedures). Examples of such
defects include single ventricle, tricuspid atresia, and multiple
ventricular septal defects.
Pulmonary vascular obstructive disease can cause cardiac
impairment in young children. When a large or nonrestrictive septal
defect or ductus is present, pulmonary artery mean pressures of at
least 70 percent of mean systemic levels are used as a criterion of
listing-level impairment. In the absence of such a defect (i.e.,
with primary pulmonary hypertension, or in some connective tissue
disorders with cardiopulmonary involvement and pulmonary vascular
destruction), listing-level impairment may be present at lower
levels of pulmonary artery pressure, in the range of at least 50
percent of mean systemic levels.
E. Chronic Heart Failure
Chronic heart failure in infants and children may manifest
itself by pulmonary or systemic venous congestion, including
cardiomegaly, chronic dyspnea, tachypnea, orthopnea, or
hepatomegaly; or symptoms of limited cardiac output, such as
weakness or fatigue; or a need for cardiotonic drugs. Fatigue or
exercise intolerance in an infant may be manifested by prolonged
feeding time associated with signs of cardiac impairment, including
excessive respiratory effort and sweating. Other manifestations of
chronic heart failure during infancy may include failure to gain
weight or involuntary loss of weight and repeated lower respiratory
tract infections.
Cardiomegaly or ventricular dysfunction must be present and
demonstrated by imaging techniques, such as two-dimensional and
Doppler echocardiography. (Reference: Feigenbaum, Harvey,
``Echocardiography,'' 4th Edition, Lea and Febiger, 1986, Appendix,
pp. 621-639.) Chest x-ray (6 ft. PA film) will be considered
indicative of cardiomegaly if the cardiothoracic ratio is over 60
percent at age 1 year or less, or 55 percent at more than 1 year of
age.
Findings of cardiomegaly on chest x-ray must be accompanied by
other evidence of chronic heart failure or ventricular dysfunction.
This evidence may include clinical evidence, such as hepatomegaly,
edema, or pulmonary venous congestion; or echocardiographic
evidence, such as marked ventricular dilatation above established
normals for age, or markedly reduced ejection fraction or shortening
fraction.
F. Valvular Heart Disease
Valvular heart disease requires documentation by appropriate
imaging techniques, including Doppler echocardiogram studies or
cardiac catheterization if catheterization results are available
from a treating source or other source of record. Listing-level
impairment is usually associated with critical aortic stenosis in a
newborn child, persistent heart failure, arrhythmias, or valve
replacement and ongoing anticoagulant therapy. The usual time after
valvular surgery for adequate assessment of the results of treatment
is considered to be 3 months.
G. Rheumatic Heart Disease
The diagnosis should be made in accordance with the current
revised Jones criteria for guidance in the diagnosis of rheumatic
fever.
104.01 Category of Impairments, Cardiovascular System
104.02 Chronic heart failure. Documented by clinical and
laboratory findings as described in 104.00E, 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 104.00E);
OR
C. Recurrent arrhythmias, as described in 104.05;
OR
D. 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
established growth curve (on standard growth charts) which persists
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 established growth curve (on standard growth charts)
which persists for 2 months or longer; or
3. Growth impairment as described under the criteria in 100.00.
Table I--Tachycardia at Rest
------------------------------------------------------------------------
Apical
heart
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
------------------------------------------------------------------------
Table II--Tachypnea at Rest
------------------------------------------------------------------------
Respiratory
rate over
Age (per
minute)
------------------------------------------------------------------------
Under 1 yr................................................. 40
1 through 5 yrs............................................ 35
6 through 9 yrs............................................ 30
Over 9 yrs................................................. 25
------------------------------------------------------------------------
104.03 Hypertensive cardiovascular disease. With persistently
elevated blood pressure equal to or greater than the 95th percentile
for age (see Table III), and one of the following:
A. Impaired renal function, as described in 106.02;
OR
B. Cerebrovascular damage, as described in 111.06;
OR
C. Chronic heart failure as described in 104.02.
Table III--Elevated Blood Pressure
------------------------------------------------------------------------
Systolic over Diastolic over
Age (mmHg) OR (mmHg)
------------------------------------------------------------------------
Under 1 month...................... 95 --
1 month through 2 yrs.............. 112 74
3 through 5 yrs.................... 116 76
6 through 9 yrs.................... 122 78
10 through 12 yrs.................. 126 82
13 through 15 yrs.................. 136 86
16 to 18 yrs....................... 142 92
------------------------------------------------------------------------
104.05 Recurrent arrhythmias, such as persistent or recurrent
heart block (A-V dissociation), repeated symptomatic
tachyarrhythmias or bradyarrhythmias or long QT syndrome
arrhythmias, not related to reversible causes such as electrolyte
abnormalities or digitalis glycoside or antiarrhythmic drug
toxicity, resulting in uncontrolled repeated episodes of cardiac
syncope or near syncope and arrhythmia despite prescribed treatment,
including electronic pacemaker (see 104.00A if there is no
prescribed treatment), and documented by resting or ambulatory
(Holter) electrocardiography coincident with the occurrence of
syncope or near syncope.
104.06 Congenital heart disease. 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 or more
evaluations within a 3-month period; or
2. Arterial O2 saturation of less than 90 percent in room
air, or resting 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. Chronic heart failure with evidence of ventricular
dysfunction, as described in 104.02;
OR
C. Recurrent arrhythmias as described in 104.05;
OR
D. Secondary pulmonary vascular obstructive disease with a mean
pulmonary arterial pressure elevated to at least 70 percent of the
mean systemic arterial pressure;
OR
E. Congenital valvular or other stenotic defects, or valvular
regurgitation, as described in 104.00F and 104.07;
OR
F. Symptomatic acyanotic heart disease, with ventricular
dysfunction resulting in significant restriction of age-appropriate
activities or inability to complete age-appropriate tasks (see
104.00A);
OR
G. Growth failure, as described in 100.00;
OR
H. For infants under 12 months of age at the time of filing,
with life-threatening congenital heart impairment that will or has
required surgical treatment in the first year of life, consider the
infant to be under a disability until the attainment of age 1 or for
12 months after surgery, whichever is the later event; thereafter,
evaluate impairment severity with reference to 104.02 to 104.08.
104.07 Valvular heart disease or other stenotic defects, or
valvular regurgitation, documented by appropriate imaging techniques
or cardiac catheterization.
A. Evaluate according to criteria in 104.02, 104.05, 111.06, or
11.04;
OR
B. Critical aortic stenosis in newborn.
104.08 Cardiomyopathies, documented by appropriate imaging
techniques, including echocardiography or cardiac catheterization,
if catheterization results are available from a treating source.
Impairment must be associated with an ejection fraction of 50
percent or less and significant left ventricular dilatation using
standardized age-appropriate echocardiographic ventricular cavity
measurements. Evaluate under the criteria in 104.02, 104.05, or
111.06.
104.09 Cardiac transplantation. Consider under a disability for
1 year following surgery; thereafter, evaluate residual impairment
under 104.02 to 104.08.
104.13 Chronic rheumatic fever or rheumatic heart disease.
Consider under a disability for 18 months from the established onset
of impairment with one of the following:
A. Persistence of rheumatic fever activity for 6 months or more
which is manifested by significant murmur(s), cardiac enlargement
(see 104.00E) or ventricular dysfunction, and other abnormal
laboratory findings, as for example, an elevated sedimentation rate
or ECG findings;
OR
B. Evidence of chronic heart failure, as described under 104.02;
OR
C. Recurrent arrhythmias, as described under 104.05.
104.14 Hyperlipidemia. Documented Type II homozygous
hyperlipidemia with repeated plasma cholesterol levels of 500 mg/ml
or greater, with one of the following:
A. Myocardial ischemia, as described in 4.04B or 4.04C;
OR
B. Significant aortic stenosis documented by Doppler
echocardiographic techniques or cardiac catheterization;
OR
C. Major disruption of normal life activities by repeated
hospitalizations for plasmapheresis or other prescribed therapies,
including liver transplant;
OR
D. Recurrent pancreatitis complicating hyperlipidemia.
104.15 Kawasaki syndrome. With one of the following:
A. Major coronary artery aneurysm;
OR
B. Chronic heart failure, as described in 104.02.
[FR Doc. 94-2844 Filed 2-9-94; 8:45 am]
BILLING CODE 4190-11-P