Revised Medical Criteria for Evaluating Cardiovascular Impairments, 2312-2340 [06-195]

Agencies

• Social Security Administration

[Federal Register Volume 71, Number 9 (Friday, January 13, 2006)]
[Rules and Regulations]
[Pages 2312-2340]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-195]



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Part II





Social Security Administration





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20 CFR Part 404



Revised Medical Criteria for Evaluating Cardiovascular Impairments; 
Final Rule

Federal Register / Vol. 71, No. 9 / Friday, January 13, 2006 / Rules 
and Regulations

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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

RIN 0960-AD48


Revised Medical Criteria for Evaluating Cardiovascular 
Impairments

AGENCY: Social Security Administration.

ACTION: Final rules.

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

DATES: These rules are effective April 13, 2006.

Electronic Version

    The electronic file of this document is available on the date of 
publication in the Federal Register at https://www.gpoaccess.gov/fr/
index.html.

FOR FURTHER INFORMATION CONTACT: Fran O. Thomas, Social Insurance 
Specialist, Office of Regulations, Social Security Administration, 100 
Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235-
6401, (410) 966-9822 or TTY (410) 966-5609. For information on 
eligibility or filing for benefits, call our national toll-free number, 
1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet Web site, 
Social Security Online, at https://www.socialsecurity.gov/.

SUPPLEMENTARY INFORMATION: We are revising and making final the rules 
we proposed for evaluating cardiovascular impairments in the Notice of 
Proposed Rulemaking (NPRM) published in the Federal Register on 
September 16, 2004 (69 FR 55874).
    We provide a summary of the provisions of the final rules below, 
with an explanation of the changes we have made from the text in the 
NPRM. We then provide summaries of the public comments and our reasons 
for adopting or not adopting the recommendations in those comments in 
the section ``Public Comments.'' The final rule language follows the 
Public Comments section.

What Programs Do These Final Regulations Affect?

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

Who Can Get Disability Benefits?

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

How Do We Define Disability?

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

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

How Do We Decide Whether You Are Disabled?

    If you are seeking benefits under title II of the Act, or if you 
are an adult seeking benefits under title XVI of the Act, we use a 
five-step ``sequential evaluation process'' to decide whether you are 
disabled. We describe this five-step process in our regulations at 
Sec. Sec.  404.1520 and 416.920. We follow the five steps in order and 
stop as soon as we can make a determination or decision. The steps are:
    1. Are you working and is the work you are doing substantial 
gainful activity? If you are working and the work you are doing is 
substantial gainful activity, we will find that you are not disabled, 
regardless of your medical condition or your age, education, and work 
experience. If you are not, we will go on to step 2.
    2. Do you have a ``severe'' impairment? If you do not have an 
impairment or combination of impairments that significantly limits your 
physical or mental ability to do basic work activities, we will find 
that you are not disabled. If you do, we will go on to step 3.
    3. Do you have an impairment(s) that meets or medically equals the 
severity of an impairment in the listings? If you do, and the 
impairment(s) meets the duration requirement, we will find that you are 
disabled. If you do not, we will go on to step 4.
    4. Do you have the residual functional capacity to do your past 
relevant work? If you do, we will find that you are not disabled. If 
you do not, we will go on to step 5.
    5. Does your impairment(s) prevent you from doing any other work 
that exists in significant numbers in the national economy, considering 
your residual functional capacity, age, education, and work experience? 
If it does, and it meets the duration requirement, we will find that 
you are disabled. If it does not, we will find that you are not 
disabled.
    We use a different sequential evaluation process for children who 
apply for payments based on disability under title XVI of the Act. We 
describe that sequential evaluation process in Sec.  416.924 of our 
regulations. If you are already receiving benefits, we also use a 
different sequential evaluation process when we decide whether your 
disability continues. See Sec. Sec.  404.1594, 416.994, and 416.994a of 
our regulations. However, all of these processes include steps at which 
we consider whether your impairment meets or medically equals one of 
our listings.

What Are the Listings?

    The listings are examples of impairments that we consider severe 
enough to prevent you as an adult from doing any gainful activity. If 
you are a child seeking SSI benefits based on disability, the listings 
describe impairments that we consider severe

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enough to result in marked and severe functional limitations. Although 
the listings are contained only in appendix 1 to subpart P of part 404 
of our regulations we incorporate them by reference in the SSI program 
in Sec.  416.925 of our regulations, and apply them to claims under 
both title II and title XVI of the Act.

How Do We Use the Listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we do 
not use the listings in part B.
    If you are an individual under age 18, we first use the criteria in 
part B of the listings. If the listings in part B do not apply, and the 
specific disease process(es) has a similar effect on adults and 
children, we then use the criteria in part A. (See Sec. Sec.  404.1525 
and 416.925.)
    If your impairment(s) does not meet any listing, we will also 
consider whether it medically equals any listing; that is, whether it 
is as medically severe as an impairment in the listings. (See 
Sec. Sec.  404.1526 and 416.926.)

What If You Do Not Have an Impairment(s) That Meets or Medically Equals 
a Listing?

    We use the listings only to decide that individuals are disabled or 
that they are still disabled. We will not deny your claim because your 
impairment(s) does not meet or medically equal a listing. If you are 
not doing work that is substantial gainful activity, and you have a 
severe impairment(s) that does not meet or medically equal any listing, 
we may still find you disabled based on other rules in the ``sequential 
evaluation process'' described above. Likewise, we will not decide that 
your disability has ended only because your impairment(s) does not meet 
or medically equal a listing.
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended because we 
have changed a listing. Our regulations explain that, when we change 
our listings, we continue to use our prior listings when we review your 
case, if you had qualified for disability benefits or SSI payments 
based on our determination or decision that your impairment(s) met or 
medically equaled a listing. In these cases, we determine whether you 
have experienced medical improvement, and if so, whether the medical 
improvement is related to the ability to work. If your condition(s) has 
medically improved so that you no longer meet or medically equal the 
prior listing, we evaluate your case further to determine whether you 
are currently disabled. We may find that you are currently disabled, 
depending on the full circumstances of your case. See Sec. Sec.  
404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is 
eligible for SSI payments, we follow a similar rule when we decide 
whether you have experienced medical improvement in your condition(s). 
See Sec.  416.994a(b)(2).

Why Are We Revising the Listings for Cardiovascular Impairments?

    We are revising these listings to update our medical criteria for 
evaluating cardiovascular impairments and to provide more information 
about how we evaluate them. On April 24, 2002, we published final rules 
in the Federal Register (67 FR 20018) that included technical revisions 
to some of the listings for cardiovascular impairments. Prior to this, 
we last published final rules making comprehensive revisions to the 
listings for cardiovascular impairments in the Federal Register on 
February 10, 1994 (59 FR 6468). Because we have not comprehensively 
revised the listings for this body system since 1994, we believe that 
we need to update the rules.

What Do We Mean by ``Final Rules'' and ``Prior Rules''?

    Even though these rules will not go into effect until 90 days after 
publication of this notice, for clarity, we refer to the changes we are 
making here as the ``final rules'' and to the rules that will be 
changed by these final rules as the ``prior rules.''

When Will We Start To Use These Final Rules?

    We will start to use these final rules on their effective date. We 
will continue to use our prior rules until the effective date of these 
final rules. When these final rules become effective, we will apply 
them to new applications filed on or after the effective date of these 
rules and to claims pending before us, as we describe below.
    As is our usual practice when we make changes to our regulations, 
we will apply these final rules on or after their effective date when 
we make a determination or decision, including those claims in which we 
make a determination or decision after remand to us from a Federal 
court. With respect to claims in which we have made a final decision, 
and that are pending judicial review in Federal court, we expect that 
the court's review of the Commissioner's final decision would be made 
in accordance with the rules in effect at the time of the 
administrative law judge's (ALJ) decision, if the ALJ's decision is the 
final decision of the Commissioner. If the court determines that the 
Commissioner's final decision is not supported by substantial evidence, 
or contains an error of law, we would expect that the court would 
reverse the final decision, and remand the case for further 
administrative proceedings pursuant to the fourth sentence of section 
205(g) of the Act, except in those few instances in which the court 
determines that it is appropriate to reverse the final decision and 
award benefits without remanding the case for further administrative 
proceedings. In those cases decided by a court after the effective date 
of the rules, where the court reverses the Commissioner's final 
decision and remands the case for further administrative proceedings, 
on remand, we will apply the provisions of these final rules to the 
entire period at issue in the claim.

How Long Will These Final Rules Be Effective?

    These rules will no longer be effective 5 years after the date on 
which they become effective, unless we extend them or revise and issue 
them again.

What General Changes Are We Making That Affect Both the Adult and 
Childhood Listings for Cardiovascular Impairments?

    We are reorganizing and expanding the evaluation guidance we 
provide in the introductory text and improving its logical 
presentation. We are also removing reference listings from this body 
system. Reference listings are listings that are met by satisfying the 
criteria of another listing. For example, prior listing 4.08, for 
cardiomyopathies, was a reference listing that required evaluation 
under listings 4.02, Chronic heart failure, 4.04, Ischemic heart 
disease, 4.05, Recurrent arrhythmias, or 11.04, Central nervous system 
vascular accident. Instead of using reference listings, we are 
providing guidance in the introductory text stating that these 
impairments should be evaluated under the criteria for the affected 
body system. Where appropriate, we also provide references to specific 
listings. For example, in final section 104.00F4, we indicate that 
valvular heart disease should be evaluated under the criteria in 4.04 
in part A, 104.02, 104.05, 104.06, or an appropriate neurological 
listing under 111.00ff.

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How Are We Changing the Introductory Text to the Listings for 
Evaluating Cardiovascular Impairments in Adults?

4.00 Cardiovascular Impairments

    We are expanding and reorganizing the introductory text to these 
listings to present the information in a more logical order, to provide 
additional guidance, and to reflect the new listings. The following is 
a detailed explanation of this material.

4.00A--General

    In this section, we provide general information on what we mean by 
the term ``a cardiovascular impairment'' and what we consider when we 
evaluate cardiovascular impairments. Final section 4.00A1 incorporates 
the information found in prior 4.00B, with some minor editing. Final 
section 4.00A2 is taken from the first sentence of the first paragraph 
of prior 4.00A.
    Final section 4.00A3 is a new section containing definitions of 
major terms we use in these final listings. In a nonsubstantive 
editorial revision to the NPRM text, we clarified the definition of a 
``consecutive 12-month period'' to explain better when the 12-month 
period must occur.

4.00B--Documenting Cardiovascular Impairment

    Final section 4.00B1 is based on the first sentence of prior 
section 4.00C and the second sentence of prior section 4.00A. In it, we 
provide information on the basic documentation that we need to evaluate 
cardiovascular impairments under the listings. Final sections 4.00B2-
4.00B3 are based on the second and third paragraphs of prior section 
4.00A. They include a discussion of the importance of longitudinal 
records and what we will do when a longitudinal record is not available 
because you have not received ongoing medical treatment. In final 
sections 4.00B4-4.00B6, we explain when we will wait for your condition 
to become stable before we ask for more evidence to help us evaluate 
the severity and duration of your impairment, explain when we may 
decide to purchase studies, and specify what studies we will not 
purchase. Much of this information is taken from prior sections 4.00C 
and 4.00D, with some rephrasing to clarify our meaning. For example:
     Final section 4.00B4a is based on prior section 4.00D1, 
and the examples in final sections 4.00B4a(i) and 4.00B4a(ii) are based 
on the first sentence of prior section 4.00D2.
     Final section 4.00B5 is based on the second sentence of 
prior section 4.00C2a and the third and sixth sentences of prior 
section 4.00C3.
     Final section 4.00B6 is based on information in prior 
section 4.00C4.

4.00C--Using Cardiovascular Test Results

    In this section, we discuss various specialized cardiovascular 
tests and how we evaluate their results. In final section 4.00C1, we 
explain what an electrocardiogram (ECG) is. Our specifications for ECG 
tracings from prior section 4.00C1 are given in final section 4.00C2. 
In final section 4.00C3, we explain what the different kinds of 
exercise tests are and discuss their uses; the section includes 
information from various provisions throughout prior sections 4.00C and 
E, but we have also included additional guidance and definitions. 
Exercise testing is the most widely used testing for identifying the 
presence of myocardial ischemia and for estimating maximal aerobic 
capacity. However, as we state throughout the introductory text, we 
will consider all the relevant evidence and will not rely solely on the 
results of one type of test. In final section 4.00C4, we discuss the 
limitations of exercise tolerance tests (ETTs) as evidence for 
disability evaluation. We repeat our longstanding policy that ETTs 
estimate your ability to walk on a grade, bicycle, or move your arms in 
an environmentally controlled setting, so they do not correlate with 
the ability to perform other types of exertional activities and do not 
provide an estimate of your ability to perform activities required for 
work in all possible work environments or throughout a workday. Final 
section 4.00C5 is based on the second paragraph of prior section 
4.00C3. In it, we explain what ETTs with measurement of maximal or peak 
oxygen uptake are and how they differ from other ETTs. We also explain 
what METs (metabolic equivalents) are and how they are calculated when 
not given in the report of an ETT with measurement of maximal or peak 
oxygen uptake.
    In final section 4.00C6, we explain when we will consider 
purchasing an exercise test for case evaluation. Like final section 
4.00B5, it is based on the second sentence of prior section 4.00C2a. As 
a result of a comment we describe below, we revised the language we 
proposed to clarify that we purchase an exercise test only when we need 
one to make a determination or decision.
    In final section 4.00C7, we explain what we must do before we 
purchase an exercise test. The final rule combines a number of related 
provisions that were not grouped together in our prior rules and also 
adds a provision that provides additional safeguards for individuals 
that we ask to go for stress testing that we purchase.
    In final section 4.00C7a, as in the third sentence of prior section 
4.00C2a and the second sentence of prior section 4.00C2c, we continue 
to require that a medical consultant (MC), preferably one with 
experience in the care of patients with cardiovascular disease, review 
the evidence to determine whether performing an exercise test would put 
you at significant risk, or if there is some other medical reason not 
to do the test. (When an administrative law judge or an administrative 
appeals judge at the Appeals Council decides that a consultative 
examination is appropriate, the administrative law judge or the 
administrative appeals judge will ask the State agency to arrange for 
the examination. In this situation, an MC will still assess whether a 
consultative examination that includes exercise testing would involve a 
significant risk to you. This is the same procedure that we followed 
under our prior rules.)
    Final section 4.00C7b corresponds to the fourth sentence of prior 
section 4.00C2e(1). In it, we explain that if you are under the care of 
a treating source for your cardiovascular impairment, this source has 
not performed an exercise test, and there are no reported significant 
risks to testing, we will request a statement from the source 
explaining why an exercise test was not done.
    Final section 4.00C7c explains that an MC will generally give 
``great weight'' to your treating source's opinion about the risk of 
exercise testing to you and will generally not override such an 
opinion; this policy was in the third sentence of prior section 
4.00C2c. As in the NPRM, we are also including the provision that was 
in the fourth sentence of prior section 4.00C2c to require that in the 
rare situation in which the MC does override a treating source's 
opinion the MC must provide a written rationale documenting the reasons 
for overriding the opinion.
    Final section 4.00C7d corresponds to the last sentence of prior 
section 4.00C2e(1). It explains that if you do not have a treating 
source or we cannot obtain a statement from your treating source, the 
MC is responsible for assessing the risk of exercise testing to you.
    Final section 4.00C7e is new in our cardiovascular listings. It 
explains that, when we purchase an exercise test, we must send copies 
of your records to the medical source who conducts the test for us if 
he or she does not already have them. We also provide that this 
individual has the ultimate

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responsibility for determining whether you would be at risk if you take 
the test.
    In final section 4.00C8, we reorganize and modify the information 
on ``significant risk'' from the first sentence of prior section 
4.00C2c. We are doing this because some of the so-called risk factors 
identified in the prior rule were not risks per se, but factors that 
affect proper interpretation of the tracings or situations that only 
temporarily preclude exercise testing. We identify several different 
categories that explain the various circumstances under which we will 
not purchase an ETT or will defer purchasing one. We base much of these 
provisions on the list of contraindications to exercise testing in the 
Guidelines for Exercise Testing published jointly by the American 
College of Cardiology (ACC) and the American Heart Association (AHA) in 
1997 and updated in 2002. (See citations in the NPRM, 69 FR 55874, 
55881-55882.) In response to a comment discussed in the public comments 
section of this preamble below, we have added a provision in the final 
rules, final section 4.00C8c, explaining that we will not purchase an 
ETT to document the presence of a cardiac arrhythmia. Final section 
4.00C8d (proposed section 4.00C8c) is based on the first and second 
sentences of prior section 4.00C2d, the paragraph that explained when 
we will wait following specific cardiac events before we purchase an 
exercise test. Final section 4.00C8e corresponds to the last sentence 
of prior paragraph 4.00C2d; it explains that we will wait an 
appropriate period of time before we purchase an exercise test if you 
are deconditioned after an extended period of bedrest or inactivity. As 
in the NPRM, we removed the example of ``2 weeks'' from the prior rule 
to avoid any suggestion that a 2-week recovery period will generally be 
sufficient. The amount of time we may need to wait will depend on the 
particular facts of your case.
    In final section 4.00C9, we explain when we consider exercise test 
results to be ``timely.'' Final section 4.00C9a corresponds to the last 
sentence of prior section 4.00C2a, explaining that we consider exercise 
test results to be timely for 12 months after the date they are 
performed, provided there has been no change in your clinical status 
that may alter the severity of your cardiovascular impairment. In final 
4.00C9b and 4.00C9c, we are expanding this topic to explain how we 
consider tests that are not timely.
    Final section 4.00C10 discusses the performance requirements of 
tests that we purchase, while final section 4.00C11 discusses how we 
evaluate all ETT results. We retained these provisions from prior 
sections 4.00C2b and the first three sentences of prior section 
4.00C2e(1). In final section 4.00C10a, we added a sentence that we did 
not include in the NPRM. The sentence explains that exercise tests may 
also be performed using echocardiography to detect stress-induced 
ischemia and left ventricular dysfunction. This additional guidance 
will make more complete our explanation of the types of ETTs we may 
purchase in appropriate cases.
    We explain when ETTs are done with imaging and when we will 
consider purchasing such tests in final sections 4.00C12-4.00C13; the 
provisions are based on prior section 4.00C3. We provide new guidance 
on drug-induced stress tests, what they are, how they are used, and 
when we may purchase them, in final section 4.00C14.
    Final section 4.00C15 includes the information found in prior 
section 4.00C4 on two types of cardiac catheterization reports, the 
details that these reports should contain, and what we consider when 
evaluating these reports. Final sections 4.00C16 and 4.00C17 describe 
Doppler exercise tests and when we will purchase them. In response to a 
comment described below, we revised final section 4.00C16 to clarify 
which details are required in reports of exercise Doppler studies and 
what information should be obtained. We specify that the tracings 
should be included with the report and that they must be annotated with 
the standardization used by the testing facility. In final section 
4.00C17, as in the NPRM, we changed the requirement in the third 
paragraph of prior section 4.00E4 for walking on a ``10 or 12 percent 
grade'' to a ``12 percent grade.'' This change makes our rules 
consistent with how the test is generally done. In a nonsubstantive 
editorial revision to the NPRM text, we have also clarified that you 
must exercise for ``up to 5 minutes'' to recognize that some 
individuals will be unable to exercise for a full 5 minutes. The 
language we proposed in the NPRM could have been misread to mean that 
we require everyone to exercise for 5 minutes even if they are unable 
to do so. We also provide that, because this is an exercise test, we 
must evaluate whether such testing would put you at significant risk, 
in accordance with the guidance found in 4.00C6, 4.00C7, and 4.00C8. 
Finally, in a technical clarification, we revised the heading of final 
section 4.00C17 from the proposed heading to change the word ``should'' 
to ``must.'' This is because the final rule (like the NPRM) specifies 
what we require in any exercise Doppler test we purchase.
    In final sections 4.00D-4.00H, we provide general medical 
information on the various cardiovascular impairments and information 
on how we evaluate each of them using the final listing criteria. We 
incorporate information found in prior section 4.00E and guidance we 
have provided to our adjudicators in instructions that were not in the 
prior listings. We also add some new information, as described below.

4.00D--Evaluating Chronic Heart Failure

    In final section 4.00D1, for chronic heart failure, we explain what 
chronic heart failure is and the differences between the two main types 
of chronic heart failure--systolic and diastolic. Final section 4.00D1b 
is based on prior section 4.00E1. We explain that we will now evaluate 
cor pulmonale under respiratory system listing 3.09, rather than 
listing 4.02, as it is a heart condition resulting from a respiratory 
disorder. (In a related change, described later in this preamble, we 
are also removing a cross-reference to the cardiovascular listings from 
listing 3.09.)
    In final sections 4.00D2 and 4.00D3, we describe the evidence that 
we need for evaluating chronic heart failure and explain how ETTs may 
be used to evaluate individuals with known chronic heart failure. We 
added a reference in final section 4.00D3 to the section on when we 
will consider the purchase of an ETT (final section 4.00C6). In 
response to a comment on the last sentence of proposed section 4.00D3, 
we revised the sentence to clarify our intent, that ST segment changes 
from digitalis use in the treatment of chronic heart failure do not 
preclude the purchase of an ETT in cases involving chronic heart 
failure.
    In the NPRM, proposed section 4.00D4 was a single paragraph that 
explained what we mean by ``periods of stabilization'' in listing 
4.02B2. In the final rules, we have changed the heading of the section 
to ``How do we evaluate CHF using 4.02?'' and expanded the section to 
include four subparagraphs. The changes are not substantive, but only 
clarify generally how we use listing 4.02. They also explain how we use 
a criterion that is common to listings 4.02B3c and 4.04A3: In the NPRM, 
we explained how the criterion applies in listing 4.04A3 but 
inadvertently did not include the same explanation for listing 4.02B3c.
    In final section 4.00D4a, and consistent with the provisions of 
final

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section 4.00D2, we explain that we need objective evidence of chronic 
heart failure. In final section 4.00D4b, we repeat the requirement of 
final listing 4.02 that your impairment must satisfy one of the 
criteria in both A and B of that listing to meet the listing. Neither 
of these new sections provides any additional substantive guidance that 
was not already inherent in the proposed rules; however, they do 
explain more clearly how to use final listing 4.02.
    Final section 4.00D4c corresponds to proposed section 4.00D4. Based 
on a suggestion from a commenter, we changed the duration of the 
periods of stabilization from 5 days to 2 weeks to allow for 
variability during medication titrations. We discuss the comment and 
our reasons for making the change in the public comments section later 
in this preamble.
    Final section 4.00D4d addresses the criterion that is common to 
final listings sections 4.02B3c and 4.04A3: a requirement for a 10 mmHg 
decrease in systolic blood pressure below the baseline systolic blood 
pressure. We provided a detailed explanation of this provision in 
proposed section 4.00E9e, which addressed ischemic heart disease, but 
inadvertently omitted the same explanation for the virtually identical 
provision for CHF. Therefore, in these final rules, we moved the text 
of proposed section 4.00E9e to final section 4.00D4d because it comes 
first in the introductory text. In final section 4.00E9e, we now 
include only a cross-reference to the provisions we moved to final 
4.00D4d instead of repeating the entire paragraph.

4.00E--Evaluating Ischemic Heart Disease

    In final section 4.00E, for ischemic heart disease (IHD), we 
incorporate most of the information in prior section 4.00E3. We explain 
what IHD is and what causes chest discomfort of myocardial origin in 
final sections 4.00E1 and 4.00E2. We move and revise slightly the 
material on chest discomfort of myocardial ischemic origin from prior 
section 4.00E3e to final section 4.00E2 and explain that individuals 
with IHD may experience manifestations other than typical angina 
pectoris. We also deleted the final sentence in prior section 4.00E3e 
as it was not useful adjudicative guidance. We discuss the 
characteristics of typical angina pectoris in final section 4.00E3. 
This section is based on and incorporates material from prior section 
4.00E3a. In final section 4.00E4, we include a definition of, and 
information on, atypical angina, which we included in our discussion of 
anginal equivalent in prior section 4.00E3b. We discuss anginal 
equivalent in final section 4.00E5. The material on anginal equivalent 
is based on prior section 4.00E3b, but we explain that it is essential 
to establish objective evidence of myocardial ischemia in order to 
differentiate anginal equivalent shortness of breath (dyspnea) that 
results from myocardial ischemia from dyspnea that results from non-
ischemic or non-cardiac causes. Final section 4.00E6, on variant 
angina, is based on prior section 4.00E3c, but we discuss in greater 
detail what variant angina is, how it is diagnosed and treated, and how 
we will evaluate it. We also state that vasospasm that is catheter-
induced during coronary angiography is not variant angina.
    In final section 4.00E7, we expand the discussion of silent 
ischemia that appeared in prior section 4.00E3d. We explain what silent 
ischemia is and why it may occur. We describe the situations in which 
it most often occurs, how it may be documented using ambulatory ECG 
monitoring (Holter) equipment, and how we evaluate it. We move the 
material on chest discomfort of non-ischemic origin from prior section 
4.00E3f to final section 4.00E8. We add acute anxiety or panic attacks 
to the examples of noncardiac conditions that may produce symptoms 
mimicking myocardial ischemia since we recognize that mental disorders 
may produce physical symptoms.
    In final section 4.00E9, we explain how we evaluate IHD using the 
criteria in listing 4.04. In a nonsubstantive editorial change from the 
NPRM text, we specify in final section 4.00E9b how ischemia is 
confirmed in possible false-positive test situations, to conform to the 
language in final section 4.00E9d. We changed the reference to 
``appropriate medically acceptable imaging techniques'' to 
``radionuclide or echocardiogram confirmation'' because these are the 
appropriate medically acceptable imaging techniques for diagnosing 
ischemia in possible false-positive situations. We also added a 
reference to final sections 4.00C12 and 4.00C13, which discuss ETTs 
done with imaging.
    In the next-to-last sentence of the final section 4.00E9d, we also 
added a reference to echocardiography in addition to the reference to 
radionuclide testing we had already included in the NPRM. Again, 
radionuclide and echocardiogram confirmation are the appropriate 
medically acceptable imaging techniques for diagnosing ischemia in 
possible false-positive situations. We also added a reference to final 
sections 4.00C12 and 4.00C13; this will make final sections 4.00D4b and 
4.00D4d consistent with each other. As already noted, we moved the text 
we included in proposed section 4.00E9e to final section 4.00D4d 
because final listing sections 4.02B3c and 4.04A3 are identical. 
Instead of repeating the same provisions in final sections 4.00D4d and 
4.00E9e, we abbreviate the explanation of the 10 mmHg decrease in 
systolic blood pressure required in final listing 4.04A3 and add a 
reference to the detailed discussion in final section 4.00D4d.
    We also clarified and moved the explanation of what we mean by 
``nonbypassed'' from proposed section 4.00E9g into a new section, final 
section 4.00E9h, because it is a different subject from what is 
addressed in final section 4.00E9g.

4.00F--Evaluating Arrhythmias

    In final section 4.00F, we provide information on evaluating 
arrhythmias. We explain what arrhythmias are and discuss the different 
types in final sections 4.00F1-4.00F2. We made a nonsubstantive 
editorial revision, rearranging the NPRM material by combining the 
provisions of proposed sections 4.00F3 and 4.00F4 in final section 
4.00F3 under the heading ``How do we evaluate arrhythmias under 4.05?'' 
Thus, final section 4.00F3a corresponds to proposed section 4.00F4, on 
the use of listing 4.05 when there is an implanted cardiac 
defibrillator, and final sections 4.00F3b and 4.00F3c correspond to 
proposed section 4.00F3. In final section 4.00F3b, we explain what we 
mean by ``near syncope'' in final listing 4.05. In final section 
4.00F3c, we add information on the evidence we need to document the 
required association between your syncope or near syncope and your 
cardiac arrhythmia. Because of a comment that tilt-table testing is 
frequently used to establish the presence of arrhythmia, we reexamined 
our position on tilt-table testing. In the final rules, we removed the 
proposed prohibition for the use of tilt-table testing as acceptable 
documentation of arrhythmia and included new guidance for using such 
testing. We specify that the tilt-table testing must be done 
concurrently with an ECG, and that the symptom of syncope or near 
syncope must be associated with the arrhythmia.
    We redesignated proposed section 4.00F5 as final section 4.00F4, in 
which we provide information on implantable cardiac defibrillators and 
how we will evaluate arrhythmias if you have an implanted cardiac 
defibrillator, to

[[Page 2317]]

reflect the foregoing reorganization of the proposed provisions.

4.00G--Evaluating Peripheral Vascular Disease

    In final section 4.00G, the section on peripheral vascular disease 
(PVD), we incorporate the information in prior section 4.00E4 and 
provide additional information and guidance on the evaluation of PVD 
based on questions we have received in the past. Final section 4.00G1 
explains what we mean by PVD and describes its usual effects. In a 
nonsubstantive editorial revision, we rearranged the third sentence and 
added a description of the effects of advanced PVD. In final section 
4.00G2, we explain how we assess the limitations resulting from PVD. 
This section is based on prior section 4.00E4, and explains that we 
will evaluate limitations based on your symptoms, together with 
physical findings, Doppler studies, other appropriate non-invasive 
studies, or angiographic findings. We also explain that we will 
evaluate amputations resulting from PVD under the musculoskeletal body 
system listings.
    In final section 4.00G3, we define ``brawny edema'' and explain how 
it is different from pitting edema, adding to the NPRM language a brief 
explanation of the term ``pit.'' As in the NPRM, we also clarify that 
pitting edema does not satisfy the requirements of listing 4.11A. In a 
nonsubstantive editorial revision, we combined proposed sections 4.00G4 
and 4.00G5, on what lymphedema is and what causes it, and the guidance 
on the evaluation of lymphedema into one section devoted to lymphedema, 
final section 4.00G4. The final rules provide that we will evaluate 
lymphedema under the listing for the underlying cause or consider 
whether the condition medically equals a cardiovascular listing, such 
as listing 4.11, or a musculoskeletal listing in 1.00. We also explain 
how we evaluate the condition in cases in which the listings are not 
met or medically equaled.
    In the final rules, we rearranged proposed sections 4.00G6-4.00G12 
to present the information more logically and to follow the order of 
final listings 4.11 and 4.12 more closely. We moved proposed section 
4.00G8, on when we will obtain exercise Doppler studies for the 
evaluation of peripheral arterial disease (PAD), which we took from 
prior section 4.00E4, to final section 4.00G5. We moved proposed 
section 4.00G11 to final section 4.00G6. That section describes other 
studies that are helpful in evaluating PAD, particularly the recording 
ultrasonic Doppler unit, and the value of reviewing pulse wave tracings 
from these studies when evaluating individuals with diabetes mellitus 
or other diseases with the potential for similar vascular changes.
    In final section 4.00G7, we combine proposed sections 4.00G6, 
4.00G7, and 4.00G9 to describe how we evaluate PAD under final listing 
4.12. In final section 4.00G7a (proposed section 4.00G6), we clarify 
how we consider blood pressures taken at the ankle. We will use the 
higher of the posterior tibial or dorsalis pedis systolic blood 
pressures measured at the ankle, because the higher pressure is more 
significant in assessing the extent of arterial insufficiency.
    In final section 4.00G7b (proposed section 4.00G7), we take 
information from the third paragraph of prior section 4.00E4 on how the 
ankle/brachial ratio is determined for purposes of evaluating a claim 
under final listing 4.12. We also explain that the ankle and brachial 
pressures do not have to be taken on the same side of the body because 
we will use the higher brachial pressure measured, and we provide 
information on the various techniques used for obtaining ankle systolic 
blood pressures. For medical accuracy, we removed ``duplex scanning 
with color imaging'' from the NPRM's list of techniques for obtaining 
ankle systolic blood pressures because, although it is done in 
conjunction with testing, it does not measure pressures. We also 
specify that we will request any available tracings from those listed 
techniques, so that we can review them.
    In final section 4.00G7c (proposed section 4.00G9), we add guidance 
on the use of toe pressures for evaluating intermittent claudication in 
individuals with abnormal arterial calcification or small vessel 
disease, as may happen if you have diabetes mellitus or certain other 
diseases. In the presence of abnormal arterial calcification or small 
vessel disease, the blood pressure at the ankle may be misleadingly 
high, but the toe pressure is seldom affected by these vascular 
changes. We also add two new criteria in final listing 4.12 using toe 
pressure and toe/brachial pressure ratio.
    We redesignated the remaining sections of proposed 4.00G because of 
the foregoing reorganization. In final section 4.00G8 (proposed section 
4.00G10), we explain how toe pressures are measured. In final section 
4.00G9 (proposed section 4.00G12), we discuss the similarities between 
peripheral grafting and coronary grafting and explain how we will 
evaluate cases involving peripheral grafting.

4.00H--Evaluating Other Cardiovascular Impairments

    In final section 4.00H, we provide guidance on evaluating other 
cardiovascular impairments. In final section 4.00H1, we discuss the 
evaluation of hypertension, rephrasing material found in prior section 
4.00E2. We explain what congenital heart disease is and provide 
guidance on how we will evaluate symptomatic congenital heart disease 
in final section 4.00H2, combining proposed sections 4.00H2 and 4.00H3 
in a nonsubstantive editorial revision. In final section 4.00H3 
(proposed section 4.00H4), we provide guidance on what cardiomyopathy 
is and how we will evaluate it. We provide guidance on the evaluation 
of valvular heart disease in final section 4.00H4 (proposed section 
4.00H5). We discuss the evaluation of heart transplant recipients in 
final section 4.00H5 (proposed section 4.00H6). In final section 4.00H6 
(proposed section 4.00H7), we explain when an aneurysm has ``dissection 
not controlled by prescribed treatment'' as required under final 
listing 4.10. We add guidance on what hyperlipidemia is and how we will 
evaluate it in final section 4.00H7 (proposed section 4.00H8).
    Because of a comment described below in the public comments section 
of this preamble, we added a new section, final section 4.00H8, to 
discuss Marfan syndrome and how we evaluate its manifestations.

4.00I--Other Evaluation Issues

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

[[Page 2318]]

How Are We Changing the Listings for Evaluating Cardiovascular 
Impairments in Adults?

4.01--Category of Impairments, Cardiovascular System

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

4.02--Chronic heart failure

    We change the format of prior listing 4.02, creating two new 
sections, 4.02A and 4.02B. For the listing to be met, both the 4.02A 
and 4.02B requirements must be satisfied. We move the required imaging 
findings that are generally associated with the clinical diagnosis of 
heart failure from prior listings 4.02A and 4.02B to final listings 
4.02A1 and 4.02A2 and revise them to reflect the anatomical changes 
associated with systolic and diastolic dysfunction, respectively; in a 
minor edit, we replaced the reference we included in proposed sections 
4.02A1 and 4.02A2 with a brief explanation of what we mean by ``a 
period of stability.'' The prior listing had different criteria for 
heart failure in sections 4.02A and 4.02B and did not provide criteria 
for both systolic and diastolic failure. Additionally, because the 
criterion in prior listing 4.02A of 5.5 cm is generally considered the 
high end of normal for heart size, we change the left ventricular 
diastolic diameter to left ventricular end diastolic dimensions greater 
than 6.0 cm. This change more clearly establishes an enlarged heart 
that would result in the signs and symptoms associated with listing-
level severity.
    We also redesignate prior listing 4.02A as final listing 4.02B1 and 
revise the criteria. The prior listing included a description of heart 
failure and referred to the ``inability to carry on any physical 
activity,'' which implied that the individual must be bedridden. Our 
program experience shows that this listing was set at too high a level 
of severity and was little used. We have removed the description of 
heart failure and rephrased the criteria in final listing 4.02B1 to 
describe an ``extreme'' limitation; that is, an impairment that very 
seriously limits your ability to independently initiate, sustain, or 
complete activities of daily living. This is modeled after our other 
rules that define listing-level severity in terms of an ``extreme'' 
limitation; for example, the definition of ``inability to ambulate 
effectively'' in the musculoskeletal listings, section 1.00A2b(1). This 
listing may be used only if the performance of an exercise test would 
present a significant risk to you.
    We add a new criterion in final listing 4.02B2 to include 
individuals who have frequent acute episodes of heart failure, showing 
that the heart failure is not well-controlled by the prescribed 
treatment. This also provides another avenue that allows us to make 
favorable determinations or decisions in certain cases without ETTs.
    We redesignate prior listing 4.02B1 as final listing 4.02B3. We 
also revise it by specifying in final listing 4.02B3a the symptoms of 
chronic heart failure that might cause termination of an ETT. This 
change makes it clear that the inability to exercise at a workload 
equivalent to 5 METs could be due to symptoms, as well as the signs 
listed in final 4.02B3b through 4.02B3d. We change the ``three or more 
multiform beats'' in prior listing 4.02B1a to ``increasing frequency of 
ventricular ectopy with at least 6 premature ventricular contractions 
per minute'' in final listing 4.02B3b. This provides broader criteria 
for terminating the test on account of exercise-induced (and 
potentially dangerous) ventricular ectopy (an arrhythmia in which the 
heartbeat is being triggered inappropriately by the ventricle, causing 
premature ventricular contraction).
    In final listing 4.02B3c, we eliminate the criterion for 
``[f]ailure to increase systolic blood pressure by 10 mmHg,'' from 
prior listing 4.02B1b because your blood pressure might be temporarily 
elevated at ``baseline'' due to anxiety, and the blood pressure 
response could be blunted by medications. Instead, we specify only an 
amount of decrease from the baseline systolic blood pressure or the 
preceding systolic pressure measured during exercise, due to left 
ventricular dysfunction, despite an increase in workload, at which the 
test should be terminated. In the final rule, we made minor revisions 
to the language of listings 4.02B3c and 4.04A3, which were slightly 
different from each other, to make them match exactly as we originally 
intended. These revisions do not substantively change either of the 
criteria, but are only for language consistency. We redesignate prior 
listing 4.02B1c, for signs attributable to inadequate cerebral 
perfusion, as final listing 4.02B3d, but make no other changes to it. 
We remove prior listing 4.02B2, the functional criterion that calls for 
``marked limitation of physical activity,'' because it is unnecessary. 
If you satisfy one of the final listing 4.02A criteria and one of the 
final listing 4.02B3 criteria, a very seriously limited level of 
physical activity is implied, so it is not necessary to have a 
criterion describing this limitation.

4.04--Ischemic Heart Disease

    In the header text, we change ``chest discomfort'' to ``symptoms'' 
because some individuals have discomfort in other parts of their body, 
such as an arm, their back, or their neck, or have other symptoms, such 
as shortness of breath (dyspnea), associated with ischemia. In final 
listing 4.04A1, we remove the phrase ``and that have a typical ischemic 
time course of development and resolution (progression of horizontal or 
downsloping ST depression with exercise)'' which appeared in prior 
listing 4.04A1 because we believe it is unnecessary. We also eliminate 
the prior listing 4.04A2 criterion. The ACC/AHA Guidelines for Exercise 
Testing indicate that an upsloping ST junction depression, as described 
in the prior criterion, has less specificity (more false-positive 
results) and favors the more commonly used horizontal or downsloping ST 
depression. We redesignate the subsequent criteria.
    In final listing 4.04A2 (prior listing 4.04A3), we specify that the 
ST elevation must occur in ``non-infarct'' leads; that is, leads that 
do not reflect previous injury due to an infarction. This is because ST 
elevation during exercise commonly occurs with a ventricular aneurysm 
resulting from an infarction, without ischemia being present. We also 
reduce the requirement for the ST elevation during recovery from ``3 or 
more minutes'' to ``1 or more minutes.'' We believe that this ST 
elevation in non-infarct leads is of such significance that ST 
elevation for 1 minute or more during recovery is sufficient to show an 
impairment of listing-level severity. In listing 4.04A3

[[Page 2319]]

(prior listing 4.04A4), we eliminate the phrase ``[f]ailure to increase 
systolic pressure by 10 mmHg'' for the reasons previously discussed 
under the explanation of listing 4.02B3c. We also specify that there 
must be a decrease of 10 mmHg below baseline or the preceding systolic 
pressure measured during exercise due to left ventricular dysfunction, 
despite an increase in workload, because exercise normally raises blood 
pressure and a decrease during exercise reflects the presence of 
ischemia. As already noted, we made minor revisions to the language of 
final listing 4.04A3 to make it the same as final listing 4.02B3c.
    We revise prior listing 4.04A5, but make no substantive changes to 
it, to make clear that the ``perfusion defect'' represents ischemia and 
to provide for use of imaging techniques other than radionuclide 
perfusion scans. We also redesignate it as final listing 4.04A4.
    We are adding a new listing 4.04B criterion. The new criterion 
provides that your impairment meets the listing if you have three 
separate ischemic episodes, each requiring revascularization 
(angioplasty or bypass surgery) or not amenable to revascularization, 
within a consecutive 12-month period. Because this is a new, additional 
listing criterion, it will permit us to allow some cases more quickly.
    In the header text for final listing 4.04C, we added the phrase 
``or other appropriate medically acceptable imaging'' because this area 
of technology is rapidly improving. Thus, we are providing for the 
likelihood that imaging other than angiography will soon be able to 
identify the extent of blockage resulting from coronary artery disease. 
We also change the phrase ``evaluating program physician'' from the 
prior listing to ``MC'' to be consistent with our terminology 
throughout these final rules and in other regulations. Because not 
everyone who has the cited findings has ischemia, we add that this 
listing can be used only ``in the absence of a timely exercise 
tolerance test or a timely normal drug-induced stress test.''
    We also revise the prior listing 4.04C1e criterion, ``[t]otal 
obstruction of a bypass graft vessel,'' to change it from ``total 
obstruction'' to ``70 percent or more narrowing.'' This conforms to the 
criterion in prior listing 4.04C1b for a nonbypassed coronary artery, 
which we are not changing. When we originally published the prior rule, 
it was not possible to tell how obstructed bypass graft vessels were. 
Imaging techniques have improved, making it possible to identify lesser 
degrees of obstruction of a bypass graft vessel. In the final rules, we 
revise the prior listing 4.04C2 criterion for functional limitations 
using substantively the same language as in final listing section 
4.02B1.

4.05--Recurrent Arrhythmias

    We change the requirement for ``uncontrolled repeated episodes of 
cardiac syncope or near syncope'' to ``uncontrolled recurrent 
episodes'' using the same definitions for the terms ``uncontrolled'' 
and ``recurrent'' in final section 4.00A3 that we use throughout these 
final rules. We remove the phrase ``and arrhythmia'' that followed 
``near syncope'' in prior listing 4.05, because it was redundant; 
listing 4.05 is for ``[r]ecurrent arrhythmias.'' We also add language 
that allows documentation ``by other appropriate medically acceptable 
testing, coincident with the occurrence of syncope or near syncope'' to 
provide for the use of any appropriate medically acceptable tests 
developed for arrhythmia in the future, and refer to final section 
4.00F3c, the paragraph that describes how we consider test findings in 
cases of arrhythmia.

4.06--Symptomatic Congenital Heart Disease

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

4.09--Heart Transplant

    We change the name from ``Cardiac transplantation'' to ``Heart 
transplant'' consistent with terminology in our other listings. We also 
change the phrase ``reevaluate residual impairment'' to ``evaluate 
residual impairment,'' as more accurate, since we would not have 
evaluated the residual impairment earlier than the end of the 12-month 
period following the transplant. In addition, we remove the guidance in 
the prior listing to evaluate the residual impairment under listings 
``4.02 to 4.08,'' and substitute the phrase ``the appropriate 
listing.'' This clarifies that other listings besides listings 4.02 
through 4.08 may apply, including listings in other body systems.

4.10--Aneurysm of Aorta or Major Branches

    As we have already noted, we remove listings 4.10B through 4.10D 
because they are reference listings. We incorporate prior listing 4.10A 
into the header text, because it was the sole remaining listing. 
Because dissection of an aorta must be either acute or chronic, we 
remove those descriptors as unnecessary in this context. We also change 
the description of treatment to ``prescribed treatment,'' which 
includes both medical and surgical methods, and include a cross-
reference to final section 4.00H6, the section that explains what a 
dissecting aneurysm is and when we consider that it is not controlled 
by prescribed treatment.

4.11--Chronic Venous Insufficiency

    In final listing 4.11A, we add language to clarify what we mean by 
``extensive'' brawny edema. We provide that brawny edema is 
``extensive'' if it involves at least two-thirds of the leg between the 
ankle and knee. In response to a comment, we removed the word 
``approximately'' from this criterion and added an additional 
descriptor, ``or the distal one-third of the lower extremity between 
the ankle and hip'' for further clarity. In final listing 4.11B, as in 
the NPRM, we refer only to ``prescribed treatment,'' which includes 
both medical and surgical methods. This is a clarification of the prior 
listing, which used the phrase ``prescribed medical or surgical 
therapy.'' These changes also help to clarify that the phrase ``that 
has not healed following at least 3 months of prescribed treatment'' 
applies only to ``persistent'' ulceration.

4.12--Peripheral Arterial Disease

    In final listing 4.12, we remove prior listing 4.12A because 
arteriograms are generally used to determine when and where surgical 
intervention is needed and, if surgery is performed, it is unlikely 
that the duration requirement would be met. If intermittent 
claudication continues following surgery, we will evaluate it under the 
remaining criteria of this listing. We redesignate prior listings 
4.12B1 and 4.12B2 as final listings 4.12A and 4.12B. (Note: We removed 
prior listing 4.12C, amputation, when we published the final 
musculoskeletal rules, which were effective February 19, 2002. See 66 
FR 58010.)
    We also revise the criteria on the methods for establishing 
peripheral arterial disease by substituting the phrase ``appropriate 
medically acceptable imaging'' for the prior reference to ``Doppler 
studies.'' In final listing 4.12B (prior listing 4.12B2), we eliminate 
the phrase ``at the ankle'' following ``pre-exercise level'' because it 
is redundant.
    We also add two new listings, final listings 4.12C and 4.12D, for 
the use of resting toe systolic blood pressures and

[[Page 2320]]

resting toe/brachial systolic blood pressure ratios. As we explained 
under the discussion of final section 4.00G7c, ankle pressures can be 
misleadingly high when you have a disease that results in abnormal 
arterial calcification or small vessel disease, but the toe pressure is 
seldom affected by these vascular changes.

How Are We Changing the Introductory Text to the Listings for 
Evaluating Cardiovascular Impairments in Children?

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

104.00A--General

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

104.00B--Documenting Cardiovascular Impairments

    In final section 104.00B5, we specify that ``[w]e will make a 
reasonable effort to obtain any additional studies from a qualified 
medical source in an office or center experienced in pediatric cardiac 
assessment.'' In final sections 104.00B7a and 104.00B7b, we include the 
discussion, with some nonsubstantive editorial changes, on the use of 
exercise testing in children that was found in the third and fourth 
paragraphs of prior section 104.00B. In final section 104.00B7c, we 
include a cross-reference to the guidance on ETT requirements and usage 
found in final section 4.00C in part A. We did not repeat that section 
in part B because it addresses cardiovascular tests used mainly for the 
diagnosis and evaluation of ischemia, which is rare in children. 
However, if a child has IHD, documentation and evaluation are the same 
as for an adult. (See 20 CFR 416.925(b)(1).)

104.00C--Evaluating Chronic Heart Failure

    In final section 104.00C1, we do not differentiate between systolic 
and diastolic dysfunction, as we do with adults in final section 
4.00D1a, because in children it is unlikely that a specific type of 
dysfunction will be clearly identified. For children, certain 
laboratory findings of cardiac functional and structural abnormality in 
support of the diagnosis of CHF are sufficient. In final section 
104.00C2a, we also update the findings that represent cardiomegaly or 
ventricular dysfunction in children. We use the phrase ``fractional 
shortening'' rather than ``shortening fraction'' in the discussion of 
left ventricular dysfunction and explain what it is. We retain in final 
section 104.00C2a(i)(C) the chest x-ray findings cited in the second 
paragraph of prior section 104.00E. In final section 104.00C2b, we 
include the information found in the first and third paragraphs of 
prior section 104.00E with some rephrasing for clarity but no 
substantive changes.

104.00D--Evaluating Congenital Heart Disease

    In final section 104.00D, we move the list of examples of 
congenital heart defects from the second paragraph of prior section 
104.00A to final section 104.00D1, with some minor edits. We make a 
nonsubstantive editorial revision in final section 104.00D2, combining 
proposed sections 104.00D2, 104.00D3, and 104.00D4 into a discussion of 
how we will evaluate symptomatic congenital heart disease. In final 
section 104.00D2a (proposed section 104.00D4), we repeat the discussion 
of symptomatic congenital heart disease in final section 4.00H3 with 
minor changes to address children. We delete the information contained 
in the third paragraph of prior section 104.00D, which discusses 
pulmonary vascular obstructive d