Revised Medical Criteria for Determination of Disability, Cardiovascular System; Final Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 r

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