[Federal Register Volume 66, Number 223 (Monday, November 19, 2001)]
[Rules and Regulations]
[Pages 58010-58046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28456]



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Part II





Social Security Administration





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20 CFR Parts 404 and 416



Revised Medical Criteria for Determination of Disability, 
Musculoskeletal System and Related Criteria; Final Rule,



Rescission of Social Security Acquiescence Ruling 97-2(9); Notice

  Federal Register / Vol. 66 , No. 223 / Monday, November 19, 2001 / 
Rules and Regulations  

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SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Regulations Nos. 4 and 16]
RIN 0960-AB01


Revised Medical Criteria for Determination of Disability, 
Musculoskeletal System and Related Criteria

AGENCY: Social Security Administration (SSA).

ACTION: Final rules with request for comments.

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SUMMARY: We are revising the criteria in the Listing of Impairments 
(the listings) that we use to evaluate musculoskeletal impairments in 
adults and children who claim Social Security or Supplemental Security 
Income (SSI) benefits based on disability under titles II and XVI of 
the Social Security Act (the Act). The revisions reflect advances in 
medical knowledge, treatment, and methods of evaluating musculoskeletal 
impairments.
    When the final rules become effective, we will apply them to new 
applications filed on or after the effective date of the rules and to 
other claims described in the preamble. Individuals who currently 
receive benefits will not lose eligibility as a result of these final 
rules.
    Also, although some individuals with musculoskeletal impairments 
will not meet the requirements of these final listings, they may still 
be found disabled at a later step in the sequential evaluation process 
based on their functional limitations.

DATES: These regulations are effective February 19, 2002. Comments must 
be received on or before January 18, 2002.

ADDRESSES: You may give us your comments via: our Internet site 
facility (i.e., Social Security Online) at http://www.ssa.gov/regulations/index.htm; e-mail to [email protected]; telefax to (410) 
966-2830; or, letter to the Commissioner of Social Security, P.O. Box 
17703, Baltimore, Maryland 21235-7703. You may also deliver them to the 
Office of Process and Innovation Management, Social Security 
Administration, L2109 West Low Rise Building, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, between 8:00 a.m. and 4:30 p.m. on 
regular business days. Comments are posted on our Internet site, or you 
may inspect them on regular business days by making arrangements with 
the contact person shown in this preamble.

FOR FURTHER INFORMATION CONTACT: Suzanne DiMarino, Social Insurance 
Specialist, Office of Process and Innovation Management, 2109 West Low 
Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 
965-1769 or TTY (410) 966-5609 for information about these rules. For 
information on eligibility, claiming benefits, or coverage of earnings, 
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 
www.ssa.gov.

SUPPLEMENTARY INFORMATION: We are revising and making final the rules 
we proposed in the Notice of Proposed Rulemaking (NPRM) published in 
the Federal Register on December 21, 1993 (58 FR 67574). Although we 
are publishing these regulations as final rules, we also are providing 
the public with the opportunity to provide us with comments on the 
changes we have made in these final rules. Although this is not our 
usual practice when we issue final rules, we are providing an 
opportunity to comment on these changes for two reasons. First, we 
recognize that there is significant public interest in the listings 
that we use to adjudicate musculoskeletal impairments, since 
impairments of the musculoskeletal system represent a high percentage 
of cases that we adjudicate under the listings. Second, we are 
committed to ensuring that the listings for the musculoskeletal body 
system continue to reflect appropriate advances in medical knowledge, 
treatment and methods of evaluating musculoskeletal impairments. In 
light of the advances in medical knowledge with respect to the 
treatment and evaluation of musculoskeletal impairments, we have 
determined that the most appropriate way to ensure that the 
requirements of these listings continue to reflect current medical 
knowledge is to request public comments on the changes we are making in 
these final rules.
    We provide a summary of the provisions of the final rules below. A 
more detailed explanation of the provisions of the final rules and the 
changes we have made from the text in the NPRM follows in the section, 
``Revisions to Appendix 1.'' We then provide a summary of the public 
comments and our reasons for adopting or not adopting the 
recommendations in the summaries of the comments in the section, 
``Public Comments.'' The final rule language follows the comment 
section.

Background

    The Act provides, in title II, for the payment of disability 
benefits to individuals insured under the Act. Title II also provides 
child's insurance benefits based on disability and widow's and 
widower's insurance benefits for disabled 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 adults under both the title 
II and title XVI programs and for persons claiming child's insurance 
benefits based on disability under the title II program, ``disability'' 
means that an impairment(s) results in an inability to engage in any 
substantial gainful activity. For a child claiming SSI benefits based 
on disability, ``disability'' means that an impairment(s) causes marked 
and severe functional limitations. Under both title II and title XVI, 
disability must be the result of a medically determinable physical or 
mental impairment(s) 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 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 any gainful activity, or in the case of a child claiming SSI 
benefits under title XVI of the Act, an impairment that causes marked 
and severe functional limitations. The listings help to ensure that 
determinations and decisions regarding 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.
    The listings contained in appendix 1 to subpart P of part 404 are 
referenced in subpart I of part 416. The listings are divided into part 
A and part B. The 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 children (persons under age 18) 
if the disease processes have a similar effect on adults and children. 
In evaluating disability for children using the listings, 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. We use the 
criteria in the listings only to make favorable determinations or 
decisions regarding disability. We never deny a claim or find that an 
individual's disability has ceased because an impairment(s) does not 
meet or medically equal a listing. When an

[[Page 58011]]

individual has a severe impairment(s) that does not meet or medically 
equal a listing, we may still find him or her disabled (or still 
disabled) based on other rules. For more information about our 
sequential evaluation processes for adults and children, see 
Secs. 404.1520, 416.920, and 416.924 of our regulations regarding 
initial claims and Secs. 404.1594, 416.994, and 416.994a of our 
regulations regarding continuing disability reviews.
    When the musculoskeletal listings were revised and published in the 
Federal Register on December 6, 1985 (50 FR 50068), we indicated that 
medical advances in disability evaluation and treatment and program 
experience would require that we periodically review and update the 
medical criteria in the listings. 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 text of the 
listings. We published the latest extension for part A and part B of 
the musculoskeletal listings, until July 2, 2003, in the Federal 
Register on June 28, 2001 at 66 FR 34361. We are now updating the 
listings for the musculoskeletal system in 1.00 (part A) and 101.00 
(part B). These regulations will expire 7 years after the effective 
date unless revised and issued again or extended.
    We published these regulations in the Federal Register on December 
21, 1993 (58 FR 67574) as an NPRM. We gave members of the public a 
period of 60 days in which to comment. The comment period ended on 
February 22, 1994. Thirty-four commenters provided comments on the 
NPRM. We have carefully considered all the comments submitted and we 
respond below to those comments that were substantive. In addition, we 
discuss the significant differences between the final rules and the 
proposed rules and the changes we have made in response to the public 
comments.

Explanation of the Effective Date

    As we noted in the ``Date'' section of this preamble, these final 
rules will be effective February 19, 2002. Under the provisions of 5 
U.S.C. 801ff, for certain rules, we must provide an effective date of 
no less than 60 days after the later of the date the rule is published 
in the Federal Register or the date on which we sent them to Congress 
for review. There are also extensive changes in these final rules, and 
we need additional time to provide training and instructions to all of 
our adjudicators. For these reasons, we have provided that the rules 
will not be effective until 90 days after the date on which we 
published them. In addition, we will carefully consider any comments we 
receive in order to determine whether any changes in these rules are 
necessary. We will then respond to the comments we receive and publish 
any necessary revisions as final rules.
    We will continue to apply the current rules until the effective 
date of these final rules. When the final rules become effective, we 
will apply them to new applications filed on or after the effective 
date of the rules. Individuals who currently receive benefits will not 
lose eligibility solely as a result of these listings going into 
effect.
    When we conduct reviews to determine whether an individual's 
disability continues, we do not find that disability has ended based 
only on these changes in the listings. Our regulations explain that we 
continue to use our prior listings when we review the cases of people 
who receive disability benefits or SSI payments because we found that 
their impairments met or equaled those listings. In these cases, we 
determine whether the individual has experienced medical improvement, 
and if so, whether the medical improvement is related to the ability to 
work. If the individual's impairment still meets or equals the same 
listing section that we used to make our most recent favorable 
determination or decision, we will find the medical improvement is not 
related to the ability to work. If the individual's condition has 
medically improved so that he or she no longer meets or equals the 
prior listing, we engage in further evaluation to determine whether the 
individual is currently disabled. We may find that such an individual 
is currently disabled, depending on the full circumstances of his or 
her case. See 20 CFR 404.1594(c)(3)(i), 416.994(b)(2)(iv)(A). We follow 
a similar rule when we decide whether a child who is eligible for SSI 
payments has experienced medical improvement in his or her condition. 
20 CFR 416.994a(b)(2).
    As is our usual practice when we make changes to our regulations, 
we will apply these final rules to the claims of applicants for 
benefits that are pending at any stage of our administrative review 
process, including those claims that are pending administrative review 
after remand 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 final decision. 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 vacates 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.

Explanation of the Final Rules

    For clarity, we refer to the changes we are making here as 
``final'' rules and to the rules that will be changed by these final 
rules as the ``current'' rules. These final rules update our 
regulations to reflect advances in the medical treatment and methods of 
evaluating musculoskeletal impairments since we published the current 
rules. We explain the reasons for these changes in more detail below. 
Because these final rules provide listing-level criteria that reflect 
advances in medical science and technology, some individuals with 
musculoskeletal impairments who would meet the criteria of the current 
listings will not meet the requirements of these final listings. 
Although these individuals may not have their claims allowed at the 
third step of our sequential evaluation process, depending on their 
residual functional capacity and age, education and past work 
experience, they may be found disabled at a later step in the 
sequential evaluation process.
    It must be remembered that these final rules do not go into effect 
until February 19, 2002. Therefore, the current rules remain in effect 
until that date.
    A claimant with a musculoskeletal impairment, as a claimant with 
any other impairment(s), may be found disabled without considering age, 
education, and work experience, if his or her impairment(s) meets or 
equals one of the sets of medical criteria in the listings. We do not 
deny any adult's claim solely because his or her impairment(s) does not 
meet or equal in severity the requirements of any listing. Under the 
sequential evaluation process set out in Secs. 404.1520 and 416.920 of 
our regulations, for every adult claimant whose severe impairment or 
combination of impairments does not

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meet or equal in severity a listing, we assess his or her residual 
functional capacity to determine what he or she can still do despite 
his or her limitations. This individualized assessment of the 
individual's functioning considers all relevant evidence. Using the 
residual functional capacity assessment, we determine whether the 
person retains the capacity to perform his or her past relevant work; 
if not, we determine if any other work exists in significant numbers in 
the national economy, considering the individual's residual functional 
capacity, age, education, and work experience. Thus, we do not deny any 
adult's claim of disability on the sole basis that the individual's 
musculoskeletal impairment or any other impairment(s) does not meet or 
equal in severity the criteria of a listing.
    For children claiming SSI benefits based on disability, the 
impairment(s) must cause marked and severe functional limitations as 
defined in Sec. 416.906 following a sequential evaluation process for 
children set out in Sec. 416.924. If the child has a severe impairment 
that does not meet or medically equal the requirements of a listed 
impairment, we will determine if the child's impairment(s) functionally 
equals listing-level severity (see Sec. 416.926a.) If the child's 
impairment(s) does not meet or medically or functionally equal the 
requirements of the listings, we will find that he or she is not 
disabled.
    The final rules stress a finding of disability under the 
musculoskeletal listings on the basis of how the individual is 
functioning. This factor, especially as it relates to the individual's 
ability to ambulate and perform fine and gross movements effectively on 
a sustained basis, drew the greatest number of comments, both positive 
and negative. For reasons that we will explain in detail below, we have 
kept with some minor modifications the sections on ability to ambulate 
and perform fine and gross movements effectively, because we continue 
to believe that these represent appropriate benchmarks for deciding 
whether the majority of musculoskeletal impairments are of listing-
level severity. We believe these functional criteria represent an 
appropriate method to evaluate listing-level severity in individuals 
with musculoskeletal impairments. We will carefully monitor these 
musculoskeletal listings to ensure that they continue to meet program 
intent as part of our ongoing review of our criteria in the Listing of 
Impairments for evaluating musculoskeletal impairments.
    As we stated earlier, current beneficiaries will not lose 
eligibility solely as a result of these listings going into effect. If 
the beneficiary's impairment(s) does not meet or medically equal the 
requirements of a listing, we may still find him or her disabled based 
on other rules. For more information about our sequential evaluation 
processes for adults and children, see Secs. 404.1520, 416.920, and 
416.924 of our regulations regarding initial claims, and 
Secs. 404.1594, 416.994, and 416.994a of our regulations regarding 
continuing disability reviews.
    The following is a summary of the provisions of the final rules and 
the changes we have made from the text of the NPRM published on 
December 21, 1993 (58 FR 67574) and the comments we received on it. A 
more detailed discussion of the changes made and why we made them 
follows in the section discussing public comments. The changes in the 
proposed rules ``Technical Revisions to Medical Criteria for 
Determinations of Disability'' that we published in the Federal 
Register on February 11, 2000 (65 FR 6929), and the comments we 
received in response to that NPRM are not addressed here.

Revisions to Appendix 1

    We revised item 2 in the second paragraph of the introductory text 
to Appendix 1 to show that the part A and part B musculoskeletal system 
listings will expire 7 years after the effective date of the final 
regulations.

Revisions to Part A of Appendix 1

1.00  Musculoskeletal System

    We reorganized and revised 1.00, the introductory section of the 
musculoskeletal listings, to bring it up to date and to reflect the new 
listings. To facilitate use of the new listings, we have provided sub-
section headings for the text in this section.
1.00A  Disorders of the Musculoskeletal System
    This is a new, brief introductory section which describes the 
pathologic processes that may cause musculoskeletal impairments.
1.00B  Loss of Function
    We redesignated the section on loss of function from 1.00A in the 
current rules to 1.00B and have expanded the section to provide more 
information about the causes of, and ways to evaluate, loss of function 
resulting from musculoskeletal impairments. The opening section (final 
1.00B1) expands the first sentence of current 1.00A to include a wider 
range of causes for musculoskeletal dysfunction than in the current 
rule, which mentions only amputation and deformity. The final rules 
include the following impairments that have been in the listings for 
some time: Bone or joint deformity or destruction due to any cause, 
miscellaneous disorders of the spine with or without radiculopathy or 
other neurological deficits, amputation, and fractures or soft tissue 
injuries, including burns, requiring prolonged periods of immobility or 
convalescence. The additions make the list of possible causes of 
functional loss due to musculoskeletal impairments correspond to the 
listed impairments.
    We expanded the guidance about musculoskeletal ``deformity'' to 
clarify that the term refers to joint deformity due to any cause. In a 
nonsubstantive editorial change, we clarified the second sentence of 
the first paragraph of proposed 1.00B to cross-refer to final 14.00B6 
instead of final listing 14.09. We also clarified the language to 
better express our intent. This will clarify in the final rules that 
individuals with inflammatory arthritis that does not meet the 
requirements of final listing 14.09 are to be evaluated under final 
listing 1.02 or under any other body system listing that is 
appropriate. In response to a comment, we added a new sentence at the 
end of final 1.00B1 to make it clear that impairments with neurological 
causes are to be evaluated under the appropriate neurological listings 
(11.00ff).
    The second section (final 1.00B2) is based in part on current 
1.00A, but it also contains new material. It explains that, regardless 
of the cause(s) of a musculoskeletal impairment, the functional loss 
that must result from certain listed impairments is defined in terms of 
``the inability to ambulate effectively on a sustained basis for any 
reason, including pain associated with the underlying musculoskeletal 
impairment, or the inability to perform fine and gross movements 
effectively on a sustained basis for any reason, including pain 
associated with the underlying musculoskeletal impairment.'' The terms 
represent new criteria we use to measure loss of function in several of 
the listings. Because we intend these listings to emphasize the impact 
of the impairment(s) on a person's ability to function, and thereby to 
perform gainful activity, these criteria clarify the degree of 
musculoskeletal functional limitations required to establish listing-
level severity in adults and make clear that the inability to ambulate 
effectively or the inability to perform fine and gross movements 
effectively must have lasted, or be expected to last for at least 12

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months. We use the same basic standards in part B, because they 
establish an appropriate benchmark for determining whether a child has 
``marked and severe functional limitations'' necessary to establish 
disability under the SSI program; i.e., an ``extreme'' limitation in 
functioning. We also clarified in these sections that we will determine 
whether an individual can ambulate effectively or can perform fine and 
gross movements effectively based on the medical and other evidence in 
the case record, generally without developing additional evidence about 
the individual's ability to perform the specific activities that we 
list as examples in this section.
    These criteria are measurements to be considered from a physical 
standpoint alone. The functional limitations resulting from a mental 
impairment(s) are to be considered under the mental disorders criteria 
in 12.00ff.
    Sections 1.00B2b and 1.00B2c (B1, paragraph 2, and B2 in the NPRM) 
define what we mean by ``inability to ambulate effectively'' and 
``inability to perform fine and gross movements effectively.'' Both 
sections describe ``extreme'' functional loss. In response to a public 
comment, we expanded the first sentence in each section to better 
explain what we mean by an ``extreme'' loss of function when we talk 
about an inability to ambulate effectively and an inability to perform 
fine and gross movements effectively. In final 1.00B2b and 1.00B2c we 
define an ``extreme'' loss in terms of the individual's ability to 
independently initiate, sustain, or complete activities. We believe 
that this phrase better describes what we mean later on in 1.00B2b(1) 
and 1.00B2c when we explain that the individual must have an extreme 
limitation in ``the ability to carry out activities of daily living.'' 
It clarifies that an individual may have an ``extreme'' limitation when 
he or she has a very serious limitation in any one of these abilities: 
the ability to independently initiate activities (e.g., because of 
frequent need for assistance from somebody else), or sustain activities 
(e.g., because of pain), or complete activities (e.g., because of 
muscle fatigue).
    The phrase also helps to clarify that an individual does not have 
to be completely unable to walk or to use his or her upper extremities. 
We recognize that, even though individuals may have functional 
limitations of such severity that they are unable to engage in any 
gainful activity, they may still have some residual ability to function 
in their daily activities.
    The phrase is also consistent with the definition of ``extreme'' in 
our rules for assessing ``functional equivalence'' in SSI childhood 
cases (Sec. 416.926a(e)(3)). In this way, the term will have the same 
meaning throughout our rules. For this reason, we made the same changes 
in part B of these final listings.
    Final 1.00B2b addresses only an individual's ability to walk, not 
the ability to stand. This is because standing as a functional measure 
is a presupposed condition for walking; that is, before a person can 
walk, he or she must be able to stand. Furthermore, standing is not an 
accurate gauge of functioning for purposes of assessing listing-level 
severity. Even profoundly impaired individuals can often stand for a 
period of time, although they may not be able to walk effectively.
    In response to public comments, we added ``the inability to walk 
without the use of a walker, two crutches or two canes'' as one example 
of an inability to ambulate effectively. For reasons explained in the 
section that deals with public comments, we do not consider required 
use of one cane or crutch to automatically exclude all gainful 
activity. However, if someone who uses one cane or crutch is otherwise 
unable to effectively ambulate, the impairment(s) might still meet or 
equal a listing. In addition, if an adult's impaired ability to 
ambulate does not meet or equal any listing, this does not mean that, 
upon further consideration at later steps in the sequential evaluation 
process, the claim could not be allowed.
    We also made several other changes in final 1.00B2c (1.00B2 in the 
NPRM) in response to public comments. We revised the second sentence to 
clarify that loss of function of one arm (including amputation of the 
arm), but continued excellent use of the other arm would not satisfy 
the definition. We also deleted the example of ``intermittent 
assistance'' in buttoning and tying shoes in the last sentence of the 
proposed rule because of public comments that indicated it was not 
clear.
    Finally, we made two minor editorial changes to sections 1.00B2b 
and 1.00B2c in the final rules (1.00B1 and B2 in the NPRM) to make the 
sentences read less awkwardly and to make them more ``user-friendly.'' 
The phrase, ``to afford them the ability to,'' which appeared in both 
paragraphs of the NPRM, now reads, ``to be able to.''
    In final 1.00B2d (1.00B3 in the NPRM), we clarified the statement 
about pain in the second sentence of current 1.00A. Our intention is to 
make sure that no one has the erroneous impression that there must be 
objective medical findings that directly support the severity of a 
person's pain. The new language, which is consistent with our rules for 
the evaluation of symptoms, including pain, in Secs. 404.1525(f), 
404.1529 and Secs. 416.925(f) and 416.929, clarifies that there need 
only be medical signs or laboratory findings that show the existence of 
a medically determinable impairment which could reasonably be expected 
to cause pain or other symptoms for these symptoms to be found to 
affect an individual's ability to perform basic work activities. It 
also explains the importance of evaluating the intensity and 
persistence of an individual's pain or other symptoms to determine 
their impact on functioning in the new musculoskeletal listings, 
whenever appropriate.
1.00C  Diagnosis and Evaluation
    As in the NPRM, final 1.00C expands the guidance in the third 
sentence of current 1.00A. In response to comments and to make the 
provisions easier to read, we divided the proposed section into three 
numbered paragraphs.
    The first sentence of final 1.00C1 (the first paragraph of proposed 
1.00C) corresponds to the current rule. We expanded the section to say 
that both the evaluation and the diagnosis of musculoskeletal 
impairments should be supported, as applicable, by detailed clinical 
and laboratory findings. Although the severity level of the new 
listings is generally met with functional limitations, diagnosis may be 
important for predicting the duration of the impairment, including 
expected response to any treatment an individual may be receiving. 
Chronic conditions must be differentiated from short-term, reversible 
disorders, and it is sometimes necessary to be able to predict response 
to current treatment.
    We also revised the references to x-ray evidence to include other, 
modern imaging. Requirements for x-ray evidence appear in numerous 
places in the current listings. Because there have been significant 
medical advances in imaging techniques, such as computerized axial 
tomography (CAT scan) and magnetic resonance imaging (MRI), we expanded 
the criteria in final 1.00C1 and throughout the introductory text and 
listings to include all medically acceptable imaging. In these final 
rules we added language to make clear that not only must the imaging be 
medically acceptable, but that it must also be ``appropriate'' to 
ensure that the technique used is the proper one to support the 
evaluation and diagnosis of the impairment. In response to public 
comments, we added myelography to the list of examples of appropriate 
medically acceptable imaging.
    Final 1.00C2 and 1.00C3 correspond to the second paragraph of 
proposed

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1.00C. Both the proposed and final language are based on the seventh 
paragraph in current 1.00B, but the final rules are expanded to respond 
to public comments. We added final 1.00C2 to address CAT scans, MRIs, 
myelography, and similar tests. The final rule clarifies that we will 
not routinely purchase expensive tests such as CAT scans and MRIs, and 
that we will not order myelograms and other invasive tests that may 
involve significant risk to the claimant. However, we also include a 
reminder of our longstanding policy that we will consider the results 
of these tests when they are part of the existing evidence we have in 
the case record.
    Final 1.00C3 now addresses only electrodiagnostic procedures. It is 
otherwise substantially the same as the current and proposed rules. We 
included the paragraph in this section because it fits more 
appropriately with the discussion of evaluation techniques in 1.00C.
    We made one other minor change from the NPRM in final 1.00C1. The 
parenthetical examples of condition of the musculature in the first 
sentence of this section are just that, examples. Thus, the correct 
term to use is ``e.g.,'' not ``i.e.,'' as shown in the NPRM.
1.00D  The Physical Examination
    Final 1.00D draws extensively from the fourth and fifth paragraphs 
of current 1.00B. These paragraphs are included in current 1.00B under 
the heading, ``Disorders of the spine,'' even though much of the 
information they contain is relevant to examinations for any 
musculoskeletal impairment. We created a new section headed, ``The 
physical examination,'' to make clear that these criteria are not 
confined to disorders of the spine. We moved parts of the fourth 
paragraph of current 1.00B that are relevant only to examinations of 
the spine to what is now 1.00E, ``Examination of the spine.'' In 
addition, we made a number of nonsubstantive editorial changes for 
clarity and precision.
    In the next-to-the-last sentence of 1.00D in the final rules, which 
corresponds to the third sentence of the fifth paragraph of current 
1.00B, we changed the reference from ``a record of ongoing treatment'' 
to ``a record of ongoing management and evaluation.'' Not all 
individuals with musculoskeletal impairments receive treatment even 
though they may be seen by a medical source. In some cases, the 
abnormalities may temporarily, or even permanently, improve with the 
passage of time, even if the individual is not receiving treatment; in 
others, there may not be any formal treatment, only such conservative 
measures as bed rest, curtailed activities, or over-the-counter 
medications. The provision is also meant to underscore the need for a 
longitudinal record because musculoskeletal impairments are often 
characterized by exacerbations and remissions, whether there is 
treatment or not.
    We also included the last sentence from the third paragraph of 
current 1.00B as the last sentence of final 1.00D. We believe that a 
correlation of examination findings with an individual's daily 
activities is important not only for evaluation of pain, as the current 
rule may suggest, but also for the assessment of the individual's 
overall ability to function.
1.00E  Examination of the Spine
    As pointed out in the explanation for 1.00D, we retained the 
portions of the sentences from the fourth paragraph of current 1.00B 
that pertain only to examinations of the spine in the new section that 
describes examinations for disorders of the spine, now 1.00E. In 1.00E1 
we also defined more precisely how measurements of motion of the spine 
and straight-leg raising are to be made, based on guidance in the 
``Guides to the Evaluation of Permanent Impairment'' published by the 
American Medical Association. Since publishing the NPRM, we added that 
straight-leg raising should be reported together with any other 
appropriate tension signs. In response to public comments, we added 
that muscle spasm should be reported when present. We also added 
guidance for measuring muscle strength in conjunction with findings of 
atrophy in response to comments that pointed out that atrophy in itself 
may not provide sufficient information about functioning of the muscle.
    The last sentence of final 1.00E2 (the second paragraph of 1.00E in 
the NPRM) is based on the last sentence of the second paragraph of 
current 1.00B, which explains that neurological impairments are to be 
evaluated under the neurological listings in 11.00ff. The reference to 
``neurological abnormalities'' in the old paragraph is not a general 
reference to all neurological abnormalities that may not completely 
subside after treatment or with the passage of time. Rather, it is a 
reference to neurological abnormalities of such severity that they 
could be considered to meet or equal the severity of a neurological 
listing. We, therefore, clarified the statement and have indicated in 
parentheses the two types of neurological conditions that would be 
evaluated under the neurological listings. We removed the second and 
third sentences of the second paragraph of current 1.00B because they 
would be redundant in the context of the new rules.
Final 1.00F  (Proposed 1.00N) Major Joints
    We redesignated this section from 1.00N, as it appeared in the 
NPRM, to final 1.00F. It corresponds to current 1.00D. Current 1.00D 
explains that the wrist and hand are considered together as one major 
joint, but there was no provision for the ankle and foot. Instead, it 
referred only to the ankle and did not mention the foot. The new 
section corrects this inadvertent omission.
    Although we do not use the term ``major joint'' in these final 
rules, we are defining it in final 1.00F to point out a difference 
between our rules and the ordinary use of the term. In the final rule, 
we make explicit that we are referring to major peripheral joints, as 
opposed to other peripheral joints (e.g., the joints of the hand or 
forefoot) or axial joints (i.e., the joints of the spine.) Further, and 
in response to comments, we explain that we consider the ankle and foot 
separately for evaluation of weight bearing under final listings 1.02A 
and 1.03.
Final 1.00G  (Proposed 1.00O) Measurements of Joint Motion
    Final 1.00G was proposed 1.00O in the NPRM and it corresponds to 
current 1.00E. We revised this section to bring it up-to-date and to 
broaden its scope. We removed the reference in the current rules to the 
``Joint Motion Method of Measuring and Recording'' published by the 
American Academy of Orthopedic Surgeons because it has not been revised 
or updated since 1965. For the measurement of joint motion, therefore, 
the final rule refers only to the ``Guides to the Evaluation of 
Permanent Impairment,'' which is used throughout the country by 
physicians and surgeons. The final rule does not include a date of 
publication but instead refers to the ``current edition'' in order to 
ensure that only the most current standards are used in the future.
Final 1.00H  (Proposed 1.00F) Documentation
    We added a new 1.00H, based on 1.00F of the NPRM, ``Duration of 
Impairment.'' The final section explains that musculoskeletal 
impairments frequently improve with time or treatment and provides 
guidance on the evidence we need to establish a longitudinal record. In 
the final rules, we revised the heading to better reflect

[[Page 58015]]

these provisions, which were not only about duration.
    We made several revisions in the final rule in response to 
comments. The final rule now contains four numbered paragraphs. In 
final 1.00H1, we clarified what we mean by a ``longitudinal clinical 
record.'' We deleted the requirement that there must usually be a 
longitudinal clinical record covering at least 3 months of management 
and evaluation in response to public comments. However, we continue to 
stress in final 1.00H1 that a longitudinal clinical record is important 
for the assessment of severity and expected duration of an impairment 
unless the claim can be decided favorably on the basis of current 
evidence.
    In final 1.00H2, we provide a reminder that we will consider 
evidence of treatment when it is available. In final 1.00H3, we added 
guidance to explain what we will do when an individual does not have a 
record of ongoing treatment. The guidance is identical to guidance we 
provide in the introductory text in some of the other body system 
listings.
    In final 1.00H4, we added a reminder that individuals whose 
impairments do not meet the listings may still be found disabled based 
on a finding of medical equivalence or an assessment of residual 
functional capacity, age, education, and work experience. This language 
is also identical to provisions in the introductory text to other body 
system listings.
Final 1.00I  (Proposed 1.00G) Effects of Treatment
    Final 1.00I (1.00G in the NPRM) discusses the effects of treatment, 
including surgery. It explains the importance of considering a person's 
treatment because treatment can have beneficial effects or adverse side 
effects that in themselves can cause limitations. The section explains 
that some people can experience full or partial improvement of their 
conditions with a given treatment, while others may experience little 
or no improvement with the same treatment. Even though some treatments 
may result in improvement in a condition, their beneficial effects may 
be counterbalanced by adverse side effects, such as in the case of pain 
medication that relieves the symptom of pain but causes symptoms of 
drowsiness, dizziness, or disorientation that compromises the 
individual's ability to function.
    In response to a public comment, we added the phrase, ``or judgment 
about future functioning,'' to the end of the last sentence of final 
1.00I3 to make clear our concern with how treatment affects or will 
affect the individual's ability to function.
Final 1.00J  (Proposed 1.00H) Orthotic, Prosthetic, or Assistive 
Devices
    Another new section, 1.00J (1.00H in the NPRM), discusses how 
orthotic, prosthetic, or assistive devices are to be considered in 
evaluating musculoskeletal impairments.
    In response to comments, we revised and clarified this section and 
removed the phrase ``medically necessary.'' In final 1.00J2 (orthotics) 
and 1.00J3 (prosthetics) we explain that it is unnecessary to routinely 
evaluate an individual's ability to function without the orthotic or 
prosthetic device in place. In 1.00J2 (orthotics) we explain that we 
would not expect an examination without an orthotic device unless the 
individual with a lower extremity impairment has difficulty with, or 
cannot use, the device. In this situation, the examination should 
include information on how the individual ambulates without the device. 
However, we do not expect a physician to examine the individual without 
the device if contraindicated by medical judgment.
    In final 1.00J3 (prosthetics) we explain that it is necessary to 
evaluate an individual's medical ability to use a prosthetic device to 
ambulate effectively. However, it is unnecessary to evaluate an 
individual's ability to walk without the device. This is because we 
recognize that individuals with the type of lower extremity amputation 
described in final listing 1.05B, will have an inability to ambulate 
effectively, as defined in 1.00B2b, when they are not using a 
prosthesis. This would be true whether they do not use a prosthesis 
because they cannot afford one, because a prosthesis has not been 
prescribed for them, or for other reasons. However, the condition of 
the stump should be evaluated without the prosthesis in place.
    Also, in final 1.00J4 (hand-held assistive devices) we explain the 
importance of an evaluation with and without a hand-held assistive 
device. We explain that it is important to document the medical basis 
for the hand-held assistive device.
    We expect that the medical basis for an orthotic, prosthetic or 
hand-held assistive device will be confirmed by a physician who has 
treated or examined the individual.
Final 1.00K  (Proposed 1.00I) Disorders of the Spine
    Final 1.00K (1.00I in the NPRM) revises current 1.00B. We 
reorganized and expanded the current rules.
    The first sentence of final 1.00K corresponds to the first sentence 
of current 1.00B. In this sentence of the final rules and in the next 
sentence, we explain that various abnormalities may result in nerve 
root impingement (including impingement on those in the cauda equina) 
or impingement on the spinal cord, from a herniated nucleus pulposus 
(1.00K1), spinal arachnoiditis (1.00K2), or lumbar spinal stenosis 
resulting in pseudoclaudication (1.00K3). We expanded the second 
sentence of 1.00K to include other causes of limitations that should be 
evaluated under final listing 1.04. However, we do not describe every 
possible impairment that can cause neurological involvement because the 
effects of some of the impairments are identical to those we have 
described.
    The third sentence of 1.00K corresponds to the last sentence of the 
second paragraph in current 1.00B, and is a brief restatement of 
current 1.00B and 1.00E. We clarified the language in the third 
sentence of final 1.00K from the way it appeared in the NPRM, because 
the original language was possibly ambiguous. It also is consistent 
with the statements added to final 1.00B1 about how to evaluate 
neurological impairments. No substantive change is intended from the 
current rule or the NPRM.
    Final sections 1.00K1 through 1.00K4 describe the various 
impairments we refer to in 1.00K: herniated nucleus pulposus (1.00K1), 
spinal arachnoiditis (1.00K2), lumbar spinal stenosis (1.00K3), and 
other miscellaneous conditions (1.00K4). In these sections, we provide 
information about the causes of the conditions, the findings one should 
look for on clinical and laboratory examination, and the functional 
effects of the impairments. We also provide guidance about certain 
conditions, such as spinal dysrhaphism (e.g., spinal bifida), 
diastematomyelia, and tethered cord syndrome, that are more 
appropriately evaluated under the neurological listings.
    We made a minor revision to the first sentence of 1.00K1 to make it 
clear that herniated nucleus pulposus is a common disorder 
``frequently'' associated with the impingement of a nerve root since 
this is not an absolute; that is, the two are not always associated. We 
have made a very minor syntactical change to the final sentence of 
1.00K3 because the original language

[[Page 58016]]

was awkward and possibly unclear. We have deleted the word ``obvious'' 
in the penultimate sentence of 1.00K4 and have combined this sentence 
with the last sentence, revising the syntax to be more compatible with 
the statement added to final 1.00B1 about where to evaluate 
neurological impairments.
Final 1.00L  (Proposed 1.00J) Abnormal Curvatures of the Spine
    We designated a new section as 1.00L (1.00J in the NPRM) to discuss 
evaluation of abnormal curvatures of the spine. We revised the language 
of the NPRM in response to comments, the first revision being to the 
first sentence. We no longer cite scoliosis, kyphosis, and 
kyphoscoliosis as examples of spinal curvature. Rather, we specify that 
these are the types of curvature we are considering under this section. 
The new section focuses on the impact of the abnormal curvature on the 
individual's ability to function, in keeping with our approach in 
revising the current listings. Thus, we explain in the final rule that 
abnormal curvatures may impair a number of functions and we cite as 
examples impaired ability to ambulate, restricted breathing, cardiac 
difficulties, and disfigurement resulting in withdrawal or isolation. 
When abnormal curvature of the spine results in impaired ambulation, 
evaluation of equivalence should be done by reference to final listing 
14.09A, which describes impaired ambulation resulting from a deformed 
spine. When abnormal curvature of the spine results in symptoms related 
to fixation of the dorsolumbar or cervical spine, evaluation of 
equivalence should be done by reference to final listing 14.09B. When 
there is respiratory or cardiac involvement, or an associated mental 
disorder, evaluation should be done by reference to the respiratory 
listings, the cardiovascular listings, or the mental disorder listings, 
as appropriate.
Final 1.00M  (Proposed 1.00K) Under Continuing Surgical Management
    We added final 1.00M (1.00K in the NPRM) to explain what we mean by 
the term ``under continuing surgical management,'' which is a term we 
use in final listings 1.07 and 1.08 and in current listing 1.12. The 
new provision explains that ``surgical management'' includes more than 
the surgery itself. It includes various post-surgical procedures, 
complications of surgery, infections, or other medical complications, 
and other factors associated with surgery that delay the individual's 
attainment of maximum benefits from surgery.
Final 1.00N  (Proposed 1.00L) After Maximum Benefit From Therapy Has 
Been Achieved
    Final 1.00N (1.00L in the NPRM), which discusses evaluation after 
the achievement of maximum benefit from surgery or other medical 
therapy in certain situations, corresponds to current 1.00C. We revised 
and expanded the current provision to clarify our policy that an 
individual can have an impairment that meets the criteria of current 
listings 1.12 and 1.13 (final listings 1.07 and 1.08) because of 
functional limitations resulting from the impairment itself and because 
of the effects of the surgery or other medical management, including 
recovery time following intervention and any complications from the 
intervention. In response to comments, we revised the language from 
that in the NPRM, as discussed in more detail in the discussion of 
public comments that follows.
Final 1.00O  Major Function of the Face and Head
    As the result of public comments, we added a new section describing 
what we mean by major function of the face and head for purposes of 
listing 1.08. We also added a cross-reference to this new section in 
final listing 1.08.
Final 1.00P  (Proposed 1.00M) When Surgical Procedures Have Been 
Performed
    Final 1.00P (1.00M in the NPRM) is substantively the same as the 
sixth paragraph of current 1.00B. It states that the documentation 
should include a copy of operative notes and available pathology 
reports when surgery has been performed.
Final 1.00Q  Effects of Obesity
    Final 1.00Q (current 1.00F) is a new section that was not in the 
NPRM. On August 24, 1999, we published in the Federal Register (64 FR 
46122) final rules to remove prior listing 9.09, ``Obesity.'' The rules 
became effective October 25, 1999. At that time, we added a paragraph 
(1.00F) to the introductory text of the musculoskeletal body system 
listing to provide guidance about the evaluation of claims for benefits 
involving obesity. Final 1.00Q is the same as current 1.00F.
1.01  Category of Impairments, Musculoskeletal
    We removed the criteria for rheumatoid arthritis previously in 
listing 1.02 and have established new listing 14.09 in the Immune 
System listings. Rheumatoid arthritis is a connective tissue disorder 
that should be grouped with other connective tissue disorders. Final 
listing 14.09 will cover all the inflammatory arthritides, including 
rheumatoid arthritis. In addition to moving current listing 1.02 to 
14.09, we removed two other listings. We removed the criteria in 
current listing 1.05B, which would be met if an individual had 
generalized osteoporosis with pain, limitation of motion, paravertebral 
muscle spasm, and vertebral fracture. As we stated in the NPRM, our 
experience showed that the listing was unclear. Moreover, our 
experience has shown that the number of applicants alleging disability 
on the basis of osteoporosis is small and no longer justifies a 
specific listing.
    The final listings include criteria to evaluate individuals who 
have osteoporosis of listing-level severity by adding ``vertebral 
fractures'' in the list of examples of conditions that are included 
under final listing 1.04, for disorders of the spine resulting in 
compromise of a nerve root or the spinal cord.
    Final listing 1.02A will cover the situations in which there is hip 
involvement resulting in inability to ambulate effectively, a situation 
that is not included in the current listing.
    We also removed current listing 1.08, ``Osteomyelitis or septic 
arthritis.'' Again, as we explained in the NPRM, advances in treatment 
have made both osteomyelitis and septic arthritis much rarer than they 
were when we last issued these listings. More importantly, fundamental 
advances in antibiotic therapy have meant that, when they do occur, 
these conditions are not usually expected to last for 1 year. 
Therefore, we believe that cases of osteomyelitis and septic arthritis 
must be evaluated on a case-by-case basis to determine whether they are 
equivalent in severity to a listed impairment or result in a finding of 
disability at later steps in the sequential evaluation process for 
adults, and will meet the 12-month duration requirement. Residuals of 
these impairments may also result in disability. Any residuals (such as 
a fused hip or knee joint in a poor anatomic position) may be evaluated 
under the appropriate listings, or later in the sequential evaluation 
process for adults. As we stated earlier, current beneficiaries will 
not lose eligibility solely as a result of the removal of this listing. 
We may find these individuals disabled based on this listing section or 
other rules.
    Septic arthritis that is associated with human immunodeficiency 
virus (HIV) infection is listed separately in our existing rules, under 
listing 14.08M.

[[Page 58017]]

1.02  Major Dysfunction of a Joint(s) (due to any cause)
    As the result of a public comment, we changed the title of this 
listing from the proposed ``Deficit of musculoskeletal function of a 
major joint(s) (due to any cause)'' to ``Major dysfunction of a 
joint(s) (due to any cause).''
    This final listing consolidates into one listing current listing 
1.03A, ``Arthritis of a major weight-bearing joint (due to any 
cause),'' and current listing 1.04, ``Arthritis of one major joint in 
each of the upper extremities (due to any cause),'' because both 
listings describe gross anatomical deformities. We also have expanded 
the scope of the listing to include deficits of musculoskeletal 
function from residual deformity due to any cause, not just arthritis. 
Current listing 1.03B, for reconstructive surgery or surgical 
arthrodesis of a major weight-bearing joint, has been retained as a 
separate listing 1.03, described below.
    In keeping with the overall functional approach in our listings, 
the final listing encompasses any musculoskeletal condition that 
involves a major peripheral joint in one lower extremity and results in 
an inability to ambulate effectively (listing 1.02A), or that involves 
a major peripheral joint in each of the upper extremities, and results 
in an inability to perform fine and gross movements effectively 
(listing 1.02B). As in the current rules, the listing requires gross 
anatomical deformity, such as subluxation, contracture, bony or fibrous 
ankylosis, or instability, and chronic joint pain and stiffness with 
signs of limitation of motion of the affected joints. We removed the 
example of ``ulnar deviation'' because it is no longer germane in this 
context.
    We broadened the criteria used to evaluate disability under final 
listing 1.02, for reasons similar to those that apply to the evaluation 
of disability under final listing 14.09, explained below. Diagnosis may 
be necessary to resolve duration issues, but the basis for finding that 
the listing is met or equaled is whether the medical condition causes 
functional limitations that are of listing-level severity.
    Because final listing 1.02 is based on a criterion for gross 
anatomical deformity, it would also replace some of the criteria of 
current listing 1.09. Current listing 1.09 is met with amputation ``or 
anatomical deformity'' of both hands (current listing 1.09A), both feet 
(current listing 1.09B), or one hand and one foot (current listing 
1.09C). In current listings 1.09B and 1.09C, the anatomic reference to 
the foot means the entire foot, to include the hindfoot which, as part 
of the ankle joint, is weight bearing. Final listing 1.02A requires 
gross anatomical deformity of one major peripheral weight-bearing joint 
and, therefore, replaces the requirement for deformity of two feet now 
in listing 1.09B with a less anatomically based, more functionally 
based criterion. The final criterion does not require involvement of 
both lower extremities or even specifically of the feet.
    Final listing 1.02B replaces the requirement for involvement of 
both hands with a requirement for involvement of any major joint in 
each upper extremity and, again, is a functionally based criterion. 
There is no provision to correspond to current listing 1.09C, however, 
because we believe that individuals who have deformities of one hand 
and one foot should have their claims evaluated on a case-by-case 
basis. Such individuals do not always have impairments that would 
preclude the ability to do any gainful activity, and to determine if 
they are disabled, we may have to assess their residual functional 
capacity and consider their age, education, and work experience.
    As already noted, under final 1.00F (proposed 1.00N in the NPRM), 
we clarified that major joints refers to the major peripheral joints. 
We also further defined the ankle-foot as a major peripheral joint and 
stated that the ankle is a major weight-bearing joint for purposes of 
final listing 1.02A. As throughout these listings, we updated the 
criterion for x-ray evidence by replacing it with a reference to 
``appropriate medically acceptable imaging.'' Throughout the final 
rules we have added that the medically acceptable imaging must be 
``appropriate.''
    We also removed the term ``significant,'' used to describe the 
amount of joint space narrowing or bony destruction caused by the 
arthritis in current listings 1.03A and 1.04A, because there is a 
relative lack of correlation between findings on imaging and function 
of the joint. Furthermore, since final listing 1.02 would ultimately be 
met because of functional limitations resulting from the arthritis or 
any other condition, the term ``significant'' is unnecessary in the 
revised rule. We believe that the objective requirement for gross 
anatomical deformity and the other requirements in the listing are 
sufficient in themselves.
1.03  Reconstructive Surgery or Surgical Arthrodesis of a Major Weight-
Bearing Joint
    Final listing 1.03 corresponds to current listing 1.03B. The 
current listing describes individuals who have undergone reconstructive 
surgery or surgical arthrodesis of a major peripheral weight-bearing 
joint, and return to full weight-bearing status did not occur, or is 
not expected to occur within 12 months of onset. The final listing 
would change the criterion for failure to return to ``full weight-
bearing status'' to the criterion for inability to ambulate effectively 
used in final listing 1.02 and other final listings. As we explained in 
the NPRM, with advances in surgical techniques and post-surgical 
treatment, some individuals who are not able to bear full weight on a 
lower extremity nevertheless have sufficient ability to ambulate to be 
able to work.
1.04  Disorders of the Spine
    This final listing corresponds to current listing 1.05C, which we 
use for evaluating impairments like herniated nucleus pulposus and 
lumbar spinal stenosis. We have expanded the list of examples in the 
opening sentence to show that other conditions are also included, such 
as spinal arachnoiditis, osteoarthritis, degenerative disc disease, 
facet arthritis and vertebral fractures, which are all examples of 
conditions that may compromise nerve roots (including the cauda equina) 
or the spinal cord. As already stated, we also describe several--though 
not all--of these conditions and their effects in final 1.00K (1.00I in 
the NPRM). We have not described every possible impairment that can 
cause neurological involvement because the effects of some of the 
impairments are identical to those we have described.
    Consistent with the discussions in final 1.00K, we have named three 
separate sets of criteria under listing 1.04, for nerve root 
compression (final listing 1.04A), spinal arachnoiditis (final listing 
1.04B), and lumbar spinal stenosis resulting in pseudoclaudication 
(final listing 1.04C). Spinal arachnoiditis and lumbar spinal stenosis 
with pseudoclaudication are listed separately because they present 
different signs and symptoms than nerve root compression (which has 
many causes, including spinal stenosis) and neither condition is 
adequately covered by the current rules.
    Final listing 1.04A corresponds most closely to current listing 
1.05C. We replaced the examples in the current rule with the examples 
in final listing 1.04 and the discussions in final 1.00K.

[[Page 58018]]

We also added a criterion for positive straight-leg raising in the 
sitting and supine positions when there is involvement of the lower 
back. We also removed the requirement for muscle spasm in current 
listing 1.05C because the finding usually reflects an acute condition 
that will not persist for a year. Moreover, because spasm is often an 
intermittent finding, it may not be present on a given examination even 
though an individual might otherwise be significantly limited.
    We also removed the requirement in current listing 1.05C that 
limitation of motion of the spine be ``significant.'' The requirement 
is imprecise. More importantly, we would consider any limitation of 
motion to be significant if it were accompanied by the other 
requirements of the final listing. Under the final listing, we no 
longer require anatomic or radicular distribution of both sensory and 
reflex abnormalities as required under the current listing, but require 
only that one or the other be present. This is because sensory and 
reflex abnormalities are not concurrent in all cases of nerve root 
compression that would nonetheless be disabling at the listing level. 
Depending on the level of the compression, both sensory and reflex 
abnormalities may not occur anatomically. However, the final listing 
does require a ``neuro-anatomic distribution'' of pain to make clear 
that the nerve root compression would have to be reasonably expected to 
cause the pain. This final requirement is consistent with our 
evaluation of pain and other symptoms pursuant to Secs. 404.1529 and 
416.929 of our rules. We also clarified in final 1.00E1 what we mean by 
``motor loss''--that is, atrophy with associated muscle weakness, or 
muscle weakness alone. Atrophy in the absence of muscle weakness is not 
evidence of motor loss. We explain in final 1.00E, discussed earlier, 
what we require to show atrophy.
    Final listing 1.04A does not contain the criteria in current 
listing 1.05C for persistence of signs and symptoms ``for at least 3 
months despite prescribed therapy'' and that they be ``expected to last 
12 months.'' This is because we no longer require that there must 
invariably be a record of at least 3 months. Instead we require that 
there be a longitudinal clinical record sufficient to assess the 
severity and expected duration of an impairment, as explained in final 
1.00H. In final 1.00H we explain that when there is no longitudinal 
clinical record the evaluation will be based on all the available 
evidence.
    Final listings 1.04B, for spinal arachnoiditis, and 1.04C, for 
lumbar spinal stenosis resulting in pseudoclaudication, list the 
characteristic signs and symptoms of their respective impairments and 
require appropriate limitations of function. Thus, final listing 1.04B 
describes severe burning or painful dysesthesia resulting in the need 
for frequent changes in position or posture, and final listing 1.04C 
describes chronic nonradicular pain and weakness resulting in an 
inability to ambulate effectively. In response to a public comment, 
final listing 1.04B contains a more precise description of what we mean 
by frequent changes in position or posture. The final rule states that 
the changes in position or posture must be more than once every 2 
hours.
1.05  Amputation (due to any cause)
    As the result of a public comment, we changed the title of this 
listing from ``Amputation,'' to ``Amputation (due to any cause),'' to 
make clear that impairments due to amputations, including amputations 
due to vascular disease, diabetes mellitus, or any other cause, may be 
evaluated under final listing 1.05.
    We combined the two current listings that deal with amputations, 
1.09 and 1.10, into a single listing 1.05. As stated earlier, the 
``anatomical deformity'' criterion of current listing 1.09 will be 
evaluated under final listing 1.02.
    Final listing 1.05A, amputation of both hands, corresponds to 
current listing 1.09A, and is unchanged.
    We replaced the listings that previously included a criterion for 
amputation of the foot (current listings 1.09B and 1.09C) with listings 
based on inability to ambulate effectively. We also removed one listing 
that provides a criterion for amputation ``at or above the tarsal 
region'' as a result of peripheral vascular disease or diabetes 
mellitus (current listing 1.10B). Since we last published these 
listings, significant refinements in surgical techniques (e.g., 
development of improved soft tissue flaps) to cover the bone stump have 
been made. This has resulted in more durable stumps. Engineering 
advances have produced prosthetic devices which minimize and distribute 
stress so that some individuals wearing artificial limbs after 
amputation above the tarsal level for any reason (including diabetes 
mellitus, and vascular and arterial disease) are able to work. Although 
some individuals with these impairments will, of course, be disabled, 
the final revisions recognize that this is not a certainty and that we 
must assess the impairments of such individuals and how well these 
individuals are able to adapt to their impairments on a case-by-case 
basis.
    Accordingly, final listing 1.05B replaces current listings 1.09B 
(amputation of both feet) and 1.10B and 1.10C (amputation of one lower 
extremity at or above the tarsal region due to peripheral vascular 
disease or diabetes mellitus, or inability to use a prosthesis 
effectively) with a requirement for stump complications resulting in 
medical inability to use a prosthetic device to ambulate effectively, 
regardless of the cause of the amputation, the level of the amputation 
(at or above the tarsal region,) or whether there is amputation of one 
or both limbs. In the final rule we removed the phrase ``from onset'' 
which appeared in the NPRM and is in current listing 1.10C3 to make 
clear that for purposes of final listing 1.05B, the stump complications 
resulting in medical inability to use a prosthetic device to ambulate 
effectively have to last or be expected to last for at least 12 months. 
Similarly, final listing 1.05C replaces current listing 1.09C 
(amputation of one hand and one foot) with a requirement for amputation 
of one hand and one lower extremity at or above the tarsal region 
resulting in an inability to ambulate effectively without an obligatory 
hand-held assistive device. (We also added an exception to the 
definition of ``inability to ambulate effectively'' in final 1.00B2b to 
take this listing into account since individuals with amputation of a 
hand will not generally use bilateral upper limb assistance.)
    Final listing 1.05C corresponds to current listing 1.09C 
(amputation of one hand and one foot) with a requirement for amputation 
of one hand and one lower extremity at or above the tarsal region 
resulting in an inability to ambulate effectively. In final listing 
1.05C we deleted the phrase ``without an obligatory hand-held assistive 
device,'' which we had included in the NPRM. The change is not 
substantive, but only for clarity. The phrase was unnecessary since 
section 1.00B2b(1) defines ``ineffective ambulation'' as the inability 
to ambulate independently without the use of a hand-held assistive 
device(s).
    In the NPRM, proposed listing 1.05D, hemipelvectomy or hip 
disarticulation also required that there be an amputation of the other 
lower extremity at or above the tarsal region. In response to public 
comment, we agree that, despite advances in treatment and technology, a 
hemipelvectomy or hip disarticulation is still, in itself, sufficient 
to establish the existence of an impairment of listing-level severity.

[[Page 58019]]

Therefore, we are not changing the criteria. Final listing 1.05D, for 
hemipelvectomy or hip disarticulation, corresponds to current listing 
1.10A.
1.06  Fracture of the Femur, Tibia, Pelvis or One or More of the Tarsal 
Bones
    Final listing 1.06 corresponds to current listing 1.11. We have 
revised the criterion requiring an inability to return to full weight-
bearing status within 12 months of onset to a criterion requiring an 
inability to ambulate effectively for an expected 12 months or longer. 
This is essentially the same requirement as for final listing 1.03 
(current listing 1.03B). Internal fixation devices (such as 
intramedullary rods) and external fixators can in some cases return an 
individual to effective ambulation even though the lower extremity is 
not fully weight bearing.
    Because of the above revision, we restructured the listing for 
clarity. We are also changing the reference to the ``tarsal bone'' in 
the heading of the listing to ``one or more tarsal bones'' for 
technical reasons. There are a number of tarsal bones.
    In final listing 1.06A we deleted the phrase ``when such 
determination is feasible,'' which we had included in the NPRM. The 
change is not substantive, but only for clarity. The phrase was clearly 
unnecessary since we would not make any determination or decision that 
was not ``feasible.''
1.07  Fracture of an Upper Extremity
    Final listing 1.07 is identical to current listing 1.12 except for 
minor editorial changes.
1.08  Soft Tissue Injury (e.g., Burns) of an Upper or Lower Extremity, 
Trunk, or Face and Head
    Final listing 1.08 corresponds to current listing 1.13. We revised 
the heading to make clear that the listing is appropriate for the 
evaluation of burns. We expanded the scope of the rule to include soft 
tissue injuries to the trunk or to the face and head. The criteria for 
``surgical management'' are the same as in final listing 1.07. 
Therefore, we would no longer require surgical procedures to be 
``staged.'' The surgical procedures required to restore function in 
injuries of the type covered by this listing are not always planned in 
advance and are, therefore, not necessarily ``staged.'' For further 
clarity, a reference to final listing 1.08, has been added to final 
1.00M.
14.00  Immune System
    For reasons explained above, we moved the criteria in current 1.00 
that address rheumatoid arthritis and other inflammatory arthritides to 
the immune system listings so that these conditions can be grouped 
together with the other connective tissue disorders. We, therefore, 
established new sections in the introductory text to 14.00 and a new 
listing 14.09 which corresponds to current listing 1.02. We are also 
revising and broadening our criteria, as explained below.
14.00B  
    The fourth paragraph of final 14.00B is changed to include the 
inflammatory arthritides in the impairments mentioned therein.
    We changed final 14.09D as the result of public comments.
    We changed the term ``severe'' in the first sentence of the 
paragraph to ``serious.'' We also took the opportunity to correct a 
preexisting syntactical error in the same sentence. The phrase, ``loss 
of function in,'' as it appeared in two places in the sentence has been 
changed to ``loss of function because of disease affecting'' because an 
organ(s) of the body does not lose function in the manner we intended 
by our narrow definition of the term. It is the individual's ability to 
function about which we are concerned in the listings, and not whether 
an organ(s) is functioning from a medical standpoint.
14.00B6  Inflammatory Arthritis
    Final 14.00B6 is a new section we added to address the inflammatory 
arthritides; it has no counterpart in current 1.00. Even though the 
primary feature of these disorders is joint involvement, they are 
connective tissue disorders, like systemic lupus erythematosus and 
scleroderma, and they cause extra-articular manifestations that may be 
disabling, just as the other connective tissue disorders do.
    Final 14.00B6 provides examples of some of the disorders that 
affect the spine (inflammatory spondyloarthropathies). It also provides 
examples of disorders that affect the peripheral joints. The first 
group of disorders includes ankylosing spondylitis, Reiter's syndrome, 
Behiet's disease and other conditions. The second group includes 
rheumatoid arthritis, Sjgren's syndrome, psoriatic arthritis and other 
conditions.
    We made a number of changes in this section in response to comments 
that asked us to clarify the provisions of proposed listing 14.09. The 
changes in final 14.00B6 respond to those comments as well. We provide 
a description of some of the factors that can cause functional deficits 
and clarify that their combined effects may produce serious functional 
limitations. In addition, we clarified the reminder in the rule that, 
when the conditions are quiescent but have caused persistent 
musculoskeletal deformity, it is still appropriate to use final listing 
1.02, which describes gross anatomical deformity due to any cause, or 
final listing 1.03, which describes reconstructive surgery or surgical 
arthrodesis of a major peripheral weight-bearing joint, when such 
deformities are the dominant feature.
    We added the word ``persistent'' to the last sentence in the 
opening paragraph to further emphasize this point.
    We also deleted the fourth sentence of this paragraph from the 
NPRM. That sentence discussed chronic forms of the diseases and is no 
longer necessary because of the other clarifications we made in the 
paragraph and in final listing 14.09.
    In the subsections of final 14.00B6, we provide explanations to 
make clear that the provisions in listing 14.09 use the same terms and 
definitions that are in the final musculoskeletal listings. Thus, the 
terms ``major joints,'' ``inability to ambulate effectively,'' and 
``inability to perform fine and gross movements effectively'' have the 
same meaning as they do in final 1.00. Accordingly, we indicated in 
final 14.00B6a that the term ``major joints'' refers to major 
peripheral joints and have explained that because only the ankle joint 
is crucial to weight-bearing, the ankle and foot are considered 
separately for evaluation of weight-bearing. In final 14.00B6b we make 
clear that the inability to ambulate effectively or the inability to 
perform fine and gross movements effectively must have lasted, or be 
expected to last for at least 12 months. In final 14.00B6c, we do not 
provide a functional criterion for ankylosing spondylitis and other 
ankylosing spondyloarthropathies (final listing 14.09B), because the 
medical findings in that listing would invariably cause such functional 
limitations. Thus, once the requisite objective medical findings are 
established, we expect the individual will have functional limitations 
that result in an impairment of listing-level severity.
    In final 14.00B6d, we provide guidance about establishing the 
existence of an impairment of listing-level severity based upon extra-
articular features. We also provide examples of kinds of extra-
articular features that may be seen with the inflammatory arthritides 
in the different body systems. Although many of the extra-articular 
features are the same as those that may be seen in other medical 
disorders, some (such as keratoconjunctivitis sicca,

[[Page 58020]]

which is seen in Sjogren's syndrome, and amyloidosis of the kidney, 
which is seen in rheumatoid arthritis) are specific to the disorders in 
listing 14.09. The term ``extra-articular features'' has replaced 
``extra-articular findings'' in the NPRM. We also made syntactical 
changes to final 14.00B6d to clarify the listings as requested by 
commenters.
    Final 14.00B6e is a new section added for consistency between the 
adult and childhood rules. The section, which corresponds to final rule 
114.00E6, explains why steroid dependence in and of itself is 
insufficient to establish an impairment of listing-level severity.
14.09  Inflammatory Arthritis
    For reasons explained above, we redesignated current listing 1.02 
as final listing 14.09. We also changed its heading from ``Active 
rheumatoid arthritis and other inflammatory arthritis'' to 
``Inflammatory arthritis'' to emphasize that we include a host of 
syndromes characterized by joint inflammation, not just rheumatoid 
arthritis. The final change also emphasizes the functional consequences 
of joint inflammation as a determinant of a disabling impairment rather 
than focusing on specific etiologic diagnoses. The final change 
recognizes that, although etiologic diagnosis is needed to distinguish 
chronic disorders from short-term disorders, as well as from other 
connective tissue disorders that are listed elsewhere, it is joint 
inflammation and its sequelae, and other symptoms and signs of these 
disorders, not etiologic diagnosis, that result in work-related 
functional limitations.
    The final rule provides several methods for determining whether an 
impairment is of listing-level severity. It advances the concept of 
graded levels of severity of the diseased joint (i.e., articular 
process), which can result in disability because of the severity of the 
joint involvement itself, or because of joint involvement coupled with 
major signs and symptoms produced by the extra-articular features which 
together impair an individual's functioning to the degree described in 
these final listings. Thus, final listings 14.09A and 14.09B would be 
met with articular findings that are of such severity that they alone 
result in inability to ambulate effectively or to perform fine and 
gross movements effectively. Final listings 14.09C, 14.09D, and 14.09E 
would be met with less severe joint involvement than in final listings 
14.09A and 14.09B, but with extra-articular features that establish the 
existence of an impairment of listing-level severity.
    Final listing 14.09A replaces current listing 1.02A. It describes 
inflammatory arthritis of the major peripheral joints (i.e., the hip, 
knee, shoulder, elbow, wrist-hand, and ankle-foot) which is of such 
severity that in itself it results in disability. We clarified and 
simplified the current provisions and replaced the requirement in 
current listing 1.02A for involvement of ``multiple'' major joints with 
the more precise requirement for ``two or more'' major joints. 
Consistent with other final listings, we replaced the current criterion 
for ``significant restriction of function of the affected joints'' with 
the more precise standard of inability to ambulate effectively or 
inability to perform fine and gross movements effectively. We removed 
the requirement for the listed findings despite prescribed therapy for 
at least 3 months and clinical activity expected to last at least 12 
months from final listing 14.09A. This is because the third paragraph 
of current 14.00B already provides a general requirement for these 
findings, applicable to all of the connective tissue disorder listings.
    In final listings 14.09A, C, and D, we removed the requirements in 
current listing 1.02B for corroboration of the existence of the 
impairment by specific laboratory tests. We retained the requirement 
for appropriate medically acceptable imaging in final listings 14.09B 
and E, as the imaging is necessary to document the impairment.
    We made these changes because inflammatory arthritis with the 
findings described in final listing 14.09 is sufficient to establish 
the existence of an impairment of listing-level severity. Moreover, the 
laboratory findings described under current listing 1.02B are neither 
specific for diagnosis nor indicators of a level of functional 
limitation.
    Ankylosing spondylitis, currently evaluated under listing 1.05A, 
will be evaluated under final listing 14.09B, which lists ``ankylosing 
spondylitis or other spondyloarthropathy.'' In the NPRM (proposed 
listing 14.09B) we inadvertently required fixation of both the 
dorsolumbar and cervical spine. In the final rule we corrected this. 
Consistent with the current rules, final listing 14.09B requires 
fixation of either the dorsolumbar or cervical spine. Because the 
emphasis in these final listings is on function, the final listing does 
not require the extensive x-ray evidence of calcification of spinal 
ligaments and abnormal apophyseal articulations, and bilateral 
ankylosis of the sacroiliac joints required in current listing 1.05A. 
Rather, the final listing provides for a degree of ankylosis of the 
cervical or dorsolumbar spines that correlates with an inability to 
ambulate effectively. We also broadened the current criterion for a 
finding of bilateral sacroiliac ankylosis to include those disorders 
that are characterized by either unilateral or bilateral sacroiliitis.
    Final listing 14.09C is based on the other connective tissue 
disorders listings in 14.00, and provides for a finding of disability 
when an extra-articular feature of any inflammatory arthritis is 
disabling, as shown by reference to listings in other body systems. The 
final listing is similar to current listing 14.06, ``Undifferentiated 
connective tissue disorder,'' which cross-refers to the list of body 
systems established in current listing 14.02A so that repetition of 
that long list is unnecessary.
    Final listing 14.09D is a listing for the inflammatory arthritides 
that affect the peripheral joints which would be met with less severe 
joint findings than in listing 14.09A and less severe extra-articular 
features than in listing 14.09C. It provides criteria similar to those 
in listings 14.02B, 14.03B, 14.04B, and 14.06; that is, significant, 
documented constitutional symptoms and signs with involvement of at 
least two other organs/body systems. To reflect the symptoms and signs 
of these particular disorders, the final rule calls for a history of 
joint pain, swelling, tenderness, and inflammation, which we included 
in 14.09D. As a result of public comments, in the final rule we removed 
the requirement in the NPRM for morning stiffness of at least 2 hours' 
duration, as we recognize that there is no reliable way to document a 
claimant's allegation of morning stiffness.
    Similarly, final listing 14.09E is a listing for inflammatory 
spondyloarthropathies that do not meet the deformity requirements of 
final listing 14.09B or the extra-articular requirements of final 
listing 14.09C. The final rule calls for the extra-articular features 
described in 14.09D, which is more appropriate than the NPRM 
requirements for ``the extra-articular findings described in 14.09D.''

Revisions to Part B of Appendix 1

101.00  Musculoskeletal System
    We reorganized, revised, and expanded 101.00, the introductory text 
to part B of the musculoskeletal listings, to be consistent with the 
final revisions in part A. When changes have been made from the NPRM 
for adults and parallel criteria existed in the NPRM for children, we 
have made the same changes in final part B for the same reasons as in 
final part A. However, we

[[Page 58021]]

also established additional criteria in final 101.00 to give 
appropriate consideration to the particular effects of the disease 
processes in children. For example, in 101.00B2b and 101.00B2c, we 
created specific definitions of the terms ``inability to ambulate 
effectively'' and ``inability to perform fine and gross movements 
effectively'' for infants and young children in terms that are 
appropriate to these children. Thus, final 101.00B2b(2) defines 
ineffective ambulation for children who would not yet be expected to 
walk in terms of a failure to achieve skills or performance involving 
the lower extremities at no greater than one-half of age-appropriate 
expectations based on an overall developmental assessment. Extreme 
limitations on use of the upper extremities is defined by reference to 
the descriptions of motor dysfunction in the listing for multiple body 
dysfunction, listing 110.07A.
    In other instances, we altered in part B the criteria in final part 
A to address children, in order to underscore the importance of the 
criteria in childhood cases and to eliminate any question about their 
applicability to children.
    As in part A, we moved current listing 101.02, for juvenile 
rheumatoid arthritis, to the immune system listings in 114.00. For this 
reason, we removed current 101.00A, which addresses the documentation 
of juvenile rheumatoid arthritis. We have not moved it into the 
introductory text of 114.00 because it explains that the documentation 
of the diagnosis of juvenile rheumatoid arthritis should be made 
according to an established protocol, such as that published by the 
Arthritis Foundation, and we have expanded the listings to address all 
forms of inflammatory arthritis in children. As in the final adult 
rules, final listing 114.09A includes the findings of joint pain, 
swelling, tenderness, and inflammation noted in current 101.00A, but 
goes on to address the functional impact of any form of severe 
inflammatory arthritis by acknowledging that it may result in the 
inability to ambulate effectively or the inability to perform fine and 
gross movements effectively with the upper extremities.
    We also removed the discussion currently in 101.00C. This section 
of the current rules explained that degenerative arthritis may be the 
end stage of many skeletal diseases and conditions. The discussion, 
though correct, has no special relevance to the final rules, which are 
functionally based.
101.01  Category of Impairments, Musculoskeletal
    We removed current listings 101.05B, 101.05C, and 101.08 for the 
reasons set forth below.
    We removed listing 101.05B, ``Scoliosis,'' and listing 101.05C, 
``Kyphosis or lordosis,'' and added to the introductory text a new 
101.00L, ``Abnormal curvatures of the spine,'' which corresponds to 
final 1.00L in the adult rules. We have removed the criteria for a 
spinal curve measuring 60 deg. or greater in current listing 101.05B1 
and for kyphosis or lordosis measuring 90 deg. or greater in current 
listing 101.05C because these measurements do not focus on the 
functional impact of the abnormal curvature. We instead included a 
provision which parallels the provision for the adult listings, and 
focuses evaluation on the functional impact of abnormal curvatures; 
i.e., impaired ambulation, ventilatory restriction, cardiac 
difficulties, or disfigurement resulting in withdrawal or isolation. As 
in the final adult rules, we now make reference to listing 114.09A when 
the spinal deformity is so severe that it results in ineffective 
ambulation; the reference is to the respiratory listings in 103.00ff 
when there is restricted breathing because of the deformity, to the 
cardiovascular listings in 104.00ff when there is cardiac involvement 
and to the mental disorder listings in 112.00ff when there is an 
associated mental disorder.
    We removed current listing 101.05B2, which provides that a child 
will be considered disabled for 1 year from the time of surgery based 
on a spinal fusion of six or more levels, because improvements in 
medical technology have shortened the period of recuperation following 
spinal fusion to less than a year. As a result, it is no longer 
possible to assume that the duration requirement will be met in all 
cases. Improved techniques with internal fixation devices (e.g., 
Harrington rods, Cotrel-Dubousset, and other fixation devices) have 
eliminated the need for turnbuckle casts and lengthy immobilization in 
plaster following spinal fusion. With the use of these improved 
techniques, a return to age-appropriate activities can now be expected 
in less than 1 year following spinal fusion.
    The removal of current listing 101.05B will also correct a printing 
error. The current listing provided for ``FEV (vital capacity)'' of 50 
percent or less of predicted normal. The abbreviation ``FEV,'' however, 
does not stand for ``vital capacity,'' but for ``forced expiratory 
volume,'' a measurement of obstructive lung disease, not of restrictive 
dysfunction. Our intent has always been to measure the restrictive 
breathing dysfunction that may be caused by the musculoskeletal 
deformity, the vital capacity or VC.
    Finally, consistent with the revisions to the listings in part A, 
we also removed listing 101.08, ``Chronic osteomyelitis.'' We provide 
our reasons for this in the explanation under part A for the removal of 
current listing 1.08.
    Final listings 101.02 through 101.08 are in most instances the same 
as the corresponding final adult rules explained above. Final listings 
101.03 and 101.05 through 101.08 are new, and are the same as the 
corresponding final adult listings, 1.03 and 1.05 through 1.08. These 
listings will maintain structural and content consistency with the 
adult listings. The following is an explanation of final listings 
101.02 and 101.04, which have revised current listings 101.03 and 
101.05.
101.02  Major Dysfunction of a Joint(s) (Due to Any Cause)
    This final listing corresponds to current listing 101.03, ``Deficit 
of musculoskeletal function.'' The final rule is the same as the 
corresponding adult rule. As in the adult rule, the proposal would 
broaden the listing to include deficit of functioning due to any cause, 
with involvement of either one major peripheral weight-bearing joint or 
one major peripheral joint in each upper extremity.
    The functional limitations in the final listing encompass the 
criteria of current listings 101.03A, 101.03B, and 101.03C, and provide 
a uniform functional measure which applies to all children within their 
respective age-appropriate functional expectations. We believe the 
listing will be easier to use with the better-defined term ``inability 
to ambulate effectively.'' Current listing 101.03A (``Walking is 
markedly reduced in speed or distance despite orthotic or prosthetic 
devices'') and current listing 101.03B (``Ambulation is possible only 
with obligatory bilateral upper limb assistance * * *'') have been 
subsumed under the definition of ``inability to ambulate effectively.'' 
Current listing 101.03C (``Inability to perform age-related personal 
self-care activities * * *'') has been subsumed under the definition of 
``inability to perform fine and gross movements effectively.''
101.04  Disorders of the Spine
    This final listing corresponds to current listing 101.05. Final 
listing 101.04 focuses on disorders that involve compromise of a nerve 
root(s)

[[Page 58022]]

(including the cauda equina) or the spinal cord. Although the listing 
is consistent with the final adult listing, it does not include 
criteria for spinal arachnoiditis or lumbar spinal stenosis resulting 
in pseudoclaudication. These conditions generally develop over time and 
with age and are rarely seen in children. Should a child need to be 
evaluated for spinal arachnoiditis or lumbar spinal stenosis, the part 
A listings should be used.
    We removed current listing 101.05A, for fracture of a vertebra with 
spinal cord involvement, because it describes a spinal cord injury and 
is more appropriately a neurological disorder than a musculoskeletal 
disorder. Current listing 111.06 describes the limitations resulting 
from such an injury.
114.00  Immune System
    For reasons we have given under the explanation of the 
corresponding adult rules, 14.00 of the introductory text to the immune 
system listings in part A and final listing 14.09, we changed the 
heading of listing 114.09 (formerly 101.02) from ``Juvenile rheumatoid 
arthritis'' to ``Inflammatory arthritis.'' This revision provides a 
more comprehensive consideration of the features and functional impact 
of any of the inflammatory arthritides and moves all of the criteria 
for juvenile rheumatoid arthritis and the inflammatory arthritides into 
114.00. In final 114.00E, we provide essentially the same provision for 
children that we provide for the inflammatory arthritides for adults, 
with appropriate changes to address the particular presentation and 
effects of the disorders in children. The difference in numbering of 
the sections in part A and part B reflects the differences between the 
current part A and part B sections. Final 114.00E1, however, has no 
counterpart in final part A. Final 114.00E1 explains the importance of 
differentiating the inflammatory arthritides from other connective 
tissue disorders in children and of determining whether the disorder is 
chronic or short-term, because children may have more limited antigenic 
exposure and immune reactivity than adults.
    For reasons we explain below, we removed current listing 101.02B, 
which provides that a child with rheumatoid arthritis who is dependent 
on steroids meets the listing. In final 114.00E6, we explain why 
steroid dependence in and of itself is insufficient to establish an 
impairment of listing-level severity.
    We revised 114.00B, which currently refers to the descriptions of 
the connective tissue disorders in 14.00B, to add a cross-reference to 
final 114.00E. We made technical revisions to 114.00B so that it will 
parallel 14.00B. The changes bring conformity to the two sections, but 
do not substantively change the rules. Rather, they remove any question 
that might arise from our using slightly different language in two 
sections that are intended to say the same thing.
    We added a new second sentence in 114.00C2, which describes growth 
impairments resulting from connective tissue disorders. The new 
provision explains that children with inflammatory arthritides have 
growth impairments because of the diseases' effects on the immature 
skeleton, open epiphyses, and young cartilage and bone. In the final 
rule, we deleted the ``many'' as a modifier as we are not certain that 
this is a true reflection of the incidence of growth impairment as a 
result of the inflammatory arthritides.
    The final listing criteria in 114.09 are the same as the 
corresponding adult listing in part A and replace the criteria in 
current listing 101.02A. Again, changes we made to final 114.00E and 
114.09 that are identical to changes made in the corresponding part A 
sections that were not in the NPRM have been made for the same reasons.
    As noted above, we removed current listing 101.02B, which provided 
that a child with rheumatoid arthritis who is dependent on steroids 
meets the listing. Although this was an appropriate listing when we 
first published it, advances in treatment have made the listing 
obsolete. Advances in the administration of steroids have corrected 
some of the previously disabling consequences of continuous steroid 
use, and it is no longer appropriate to assume that every child who is 
dependent on steroids will have an impairment of listing-level 
severity. Moreover, there are few instances when systemic 
corticosteroids are used in the long-term management of children with 
inflammatory arthritis. When steroid treatment is indicated, it is 
usually given only on a short-term basis, with the drug dosage being 
gradually reduced and discontinued within a few weeks or months.

Other Changes

    Because current listing 1.10B in part A (amputation at or above the 
tarsal region due to peripheral vascular disease or diabetes mellitus) 
has been removed, we also removed the listings with similar criteria in 
other body systems, listing 4.12C (``Amputation at or above the tarsal 
region due to peripheral vascular disease'') and listing 9.08C 
(``Amputation at, or above, the tarsal region due to diabetic necrosis 
or peripheral arterial disease'') to be consistent with our approach 
that assesses disability on the basis of how the individual is 
functioning. Our experience has shown that many individuals who have 
undergone amputation at or above the tarsal level for vascular disease 
or diabetes mellitus are able to return successfully to gainful work. 
Those individuals who are unable to ambulate effectively due to stump 
complications may still have their impairments evaluated under final 
listing 1.05B. Current listing 9.08D has become listing 9.08C. We 
believe that these cases must be evaluated on a case-by-case basis to 
determine whether they are equivalent in severity to a listed 
impairment or result in a finding of disability at later steps in the 
sequential evaluation process for adults, and will meet the 12-month 
duration requirement. As we stated earlier, current beneficiaries will 
not lose eligibility solely as a result of this listing being removed. 
We may find these individuals disabled based on this listing section or 
other rules.
    In addition, we made a technical change to the current listing for 
systemic lupus erythematosus. Current listing 14.02A provides cross-
references to ten body systems in which impairments of listing-level 
severity that result from the primary condition are described. We 
inadvertently omitted from this list an eleventh possibility, 
hematologic disorders, which would be evaluated under the listings in 
7.00ff.
    As we explain in current 14.00B1, systemic lupus erythematosus 
frequently results in anemia, leukopenia, and thrombocytopenia, and it 
is, therefore, possible that an individual would have an impairment of 
listing-level severity based on a hematologic disorder. We added a 
reference to the hemic and lymphatic body system. In keeping with the 
format of listing 14.02A, which lists the body systems in their order 
of appearance in appendix 1, the new provision has become listing 
14.02A8. For this reason, we redesignated current listings 14.02A8 
through 14.02A10 as listings 14.02A9 through 14.02A11.
    No similar change is required in part B. Current listing 114.02A 
includes a reference to the hemic and lymphatic listings.
    For consistency, in the final rules, we also made changes in two of 
the examples in Sec. 416.926a(m), ``Examples of impairments that 
functionally equal the listings.'' In the second example, the 
requirement for ``a series of staged surgical procedures,'' has been 
changed to a requirement for ``continuing

[[Page 58023]]

surgical management.'' As explained above, we no longer require 
surgical procedures to be ``staged.'' We have also made a small change 
in the fourth example to make clear that it is the inability to 
maintain effective ambulation that makes a condition functionally 
equivalent to a listed impairment.
    Also for consistency, in the final rules we made technical changes 
in Secs. 416.933, ``How we make a finding of presumptive disability or 
presumptive blindness,'' and 416.934, ``Impairments which may warrant a 
finding of presumptive disability or presumptive blindness,'' based on 
our change in assessing disability on how the individual is 
functioning. In Sec. 416.933 we have amended the second sentence by 
removing ``amputation of extremities'' as an example of a readily 
observable impairment upon which we can find an individual disabled 
without medical or other evidence. In Sec. 416.934 we have removed 
current impairment categories (a) and (h). Our experience has shown 
that we can no longer presume that an individual who has undergone 
amputation of two limbs (impairment category (a)) or an individual with 
diabetes who has undergone amputation of a foot (impairment category 
(h)) would be unable to successfully perform gainful work.
    Throughout the final rules, we made nonsubstantive editorial 
changes from the NPRM. For example, in several places in final 101.00, 
we deleted the words, ``given age ranges'' from the phrase ``given 
normal developmental expectations for given age ranges'' because 
``developmental expectations'' already implies consideration of age. 
Deleting the words does not change the meaning of the statement. In the 
NPRM, we used ``motor deficit'' and ``motor loss'' interchangeably. For 
consistency, throughout the final rules we use ``motor loss.''

Public Comments

    Subsequent to the publication of the NPRM in the Federal Register 
(58 FR 67574) on December 21, 1993, we mailed copies to national 
medical organizations and professionals whose responsibilities and 
interests provide them with some expertise in the evaluation of 
musculoskeletal impairments. We also sent copies to Federal and State 
agencies (including the State agencies that make disability 
determinations for us) interested in the administration of the title II 
and title XVI disability programs. As part of our outreach efforts, we 
invited comments from advocacy groups, as well as from legal service 
organizations.
    We received 34 letters and telefaxes containing comments pertaining 
to the changes we proposed. We carefully considered all of the comments 
and adopted many of the recommendations. A number of the comments were 
quite long and detailed. Of necessity, we have had to condense, 
summarize, or paraphrase them. Nevertheless, we have tried to present 
all views adequately and to respond to all of the relevant issues 
raised by the commenters. We provide our reasons for adopting or not 
adopting the recommendations in the summaries of the comments and our 
responses below.

General Comments

Emphasis on Function

    Comment: A number of commenters expressed general approval of the 
proposed listings. One commenter stated that the changes are reasonable 
and probably necessary in light of the fact that there have been 
advances in medical knowledge and diagnoses since changes were last 
considered several years ago. Other commenters specifically praised the 
emphasis on function, on the results of physical examination rather 
than on diagnosis, and on a longitudinal picture of the claimant's 
impairment in the proposed listings. These commenters were impressed 
generally with the expansion of the introductory text to the proposed 
listings to include definitions of terms and examples. One of these 
commenters stated that the definitions of ambiguous terms and examples 
would promote uniformity of decisionmaking. These commenters had no 
specific suggestions.
    Response: We agree with the commenter who stated that the changes 
are reasonable and necessary in light of the fact that there have been 
advances in medical knowledge, diagnosis, and treatment. In the past, 
it may have been reasonable to assume that individuals with particular 
diagnoses were disabled once the diagnoses were objectively 
established. However, with state-of-the-art medicine, we can no longer 
reach the same conclusions. It is more important now to determine how 
an individual is functioning with treatment and use of technological 
advances in such devices as prostheses than it is to know the diagnosis 
of the individual.

Proposed Listings More Restrictive Than Past Listings

    Comment: Some commenters, however, expressed concerns about the 
functional aspects of the proposals. Several commenters noted that the 
proposed revisions reflect the trend to write listings which rely on 
the assessment of function, rather than on diagnosis, to determine if a 
listing is met. While all of these commenters did not necessarily 
disagree with this trend, there were various concerns, such as that the 
proposed listings are possibly more restrictive than past listings and 
that with an emphasis on function comes the potential need for detailed 
development of activities of daily living on a larger number of cases. 
In the view of some commenters, the proposed listings require or at 
least imply the need for a more extreme level of functional loss to 
meet the listings than did prior listings.
    Response: The proposed and final listings describe a level of 
impairment severity that represents the inability to perform any 
gainful activity. We believe the new listings describe this level of 
impairment severity more clearly and will therefore promote greater 
consistency in decisionmaking. Furthermore, if an individual does not 
have an impairment that meets a listing, this does not mean that the 
claim will be denied. This is because we do not make a determination or 
decision regarding disability based solely on whether or not an 
individual's impairment(s) meets a listing. The impairment(s)also could 
be found to equal a listing. If the severity of an adult claimant's 
impairment(s) does not meet or medically equal the severity of an 
impairment in the medical listings, the claimant can be found disabled 
at a later step in the sequential evaluation process. (In the case of a 
child claiming benefits under title XVI of the Act, the impairment(s) 
must cause marked and severe functional limitations as defined in 
Sec. 416.906.)

Proposed Listings May Result In More Documentation and Delays

    Comment: Some commenters stated that the listing changes could lead 
to more decisions at steps four and five of the sequential evaluation 
process for adults than at step three. Based on a premise that more 
documentation is required at these later steps of the sequential 
evaluation process, these commenters also thought the proposed listings 
may require more development and longer case processing time.
    One commenter also stated that the proposed listings will require 
more documentation because they emphasize the need for and reliance on 
existing medical evidence, and the course of an impairment must be 
documented with a longitudinal clinical record covering at least 3 
months of management and

[[Page 58024]]

evaluation. This commenter pointed out that the expanded criteria 
included the need to look at ``surgical management,'' not just ``staged 
surgical treatment,'' which, in the commenter's view, also will require 
more documentation of such things as information regarding various 
procedures post-surgery, complications of surgery, infections, and 
other factors associated with surgery, which adjudicators will need in 
order to determine functional limitations.
    Response: We are not convinced that, even if there are more 
decisions at steps four and five of the sequential evaluation process, 
this will result in more development and increased processing time. The 
intent of the listings is to identify impairments that preclude the 
ability to perform any gainful activity (or, in the case of a child 
applying for SSI benefits based on disability, results in marked and 
severe functional limitations). Several of the current listings already 
include criteria based on functioning, and a degree of functioning has 
always been implicit in the other listings. Furthermore, we believe 
that if there are any increases in required documentation or processing 
time, they will be counterbalanced by the positive impact of the 
clarifications made in the new listings and the resulting uniformity of 
determinations and decisions. This will help ensure that the correct 
decision is made as early in the adjudicative process as possible, 
thereby reducing the number of appeals. However, in response to these 
comments, we added language in final 1.00B2a and 101.00B2a to make 
clear that we are not requiring additional documentation about the 
individual's ability to perform the specific activities that we list as 
examples in this section.
    Although we disagree with the comment that the requirement for a 
longitudinal clinical history of management and evaluation for at least 
3 months after alleged onset of the impairment in many cases would have 
resulted in more documentation and delays, we adopted the comment and 
deleted the 3-month requirement in favor of more general language on 
the need to establish a longitudinal history. In final 1.00H we make 
clear that, while a longitudinal clinical record is generally important 
for the assessment of severity and expected duration of an impairment, 
it is not always required.

``Level of Proof'' Needed To Show Loss of Function

    Comment: One commenter suggested that we should define the ``level 
of proof'' needed in order for a physician to reach a conclusion 
regarding a condition and its effect on function. Physicians generally 
are asked if something is ``possible,'' ``probable,'' (more likely than 
not) or beyond a reasonable doubt. The commenter stated that there are 
a variety of references throughout this text which need this 
clarification. The same commenter was concerned that the proposed 
listings may not clearly show how physicians should determine 
functional ability. This commenter voiced the opinion that there is no 
more difficult determination that physicians have to make than to 
objectively evaluate functional capacity. Another commenter stated, 
``If the intent is to make a more functional evaluation, then a more 
objective standard should be utilized.''
    Response: We believe the ``level of proof'' issue, that is a better 
definition of how physicians will determine functional loss, is 
comprehensively discussed in our existing regulations at 
Secs. 404.1512(b)(2) through (6), 404.1513(b)(1), (4), and (5), 
404.1528(b) and (c), 404.1529, 416.912(b)(2) through (6), 
416.913(b)(1), (4), and (5), 416.928(b) and (c), and 416.929. These 
sections stress that there must be objective medical evidence of a 
medically determinable impairment, and what is meant by objective 
medical evidence and other evidence. They also emphasize how we will 
consider all such evidence in determining how an impairment and related 
symptoms will be considered in determining their impact on an 
individual's ability to function. Regarding the concern that the 
listings do not teach physicians how to determine functional ability, 
the listings are not intended as a vehicle for training physicians. 
Rather, the listings provide guidelines for evaluating disability 
claims and provide an administrative means for screening in obviously 
disabled individuals. However, we do provide information on functional 
assessments as part of our professional relations outreach at medical 
conventions, forums, etc. We believe this is a more appropriate and 
effective approach to educating doctors and other medical professionals 
than using the regulatory process.
    We agree that it is difficult for physicians to reach conclusions 
about an individual's functional ability. As we stress in 
Secs. 404.1527 and 416.927, a physician's medical opinion on an 
individual's functional ability should be based on the medical signs 
and laboratory findings, the individual's symptoms, diagnosis and 
prognosis and the physician's own observations of the individual. 
However, the ultimate decision about a claimant's residual functional 
capacity (RFC) and whether the individual is disabled is reserved to 
the Commissioner of Social Security.

Muscle Spasm as an Indication of Impairment

    Comment: One commenter suggested that the regulations should still 
require that muscle spasm be reported when it is present in back 
impairments, even if the finding may not be constantly present, because 
it helps to establish a severe impairment.
    Response: We agree and have added language to final 1.00E and 
101.00E that muscle spasm, when present, should be reported. We trust 
it is clear that, because muscle spasm is not always present in severe 
back impairments and is often a transient finding when it occurs, it 
need not be present to support a finding of disability. This is stated 
in our policy on pain and other symptoms at Secs. 404.1529(c)(2) and 
416.929(c)(2). This is also why sections 1.00D and 101.00D discuss the 
need for establishing a record of such intermittent findings as muscle 
spasm over a period of time, whenever possible.

Medical History

    Comment: One commenter stated that the introductory text to the 
listings contains no guidance or requirement that a standard medical 
history be taken, nor does it include a description of the elements 
that should be included in the history. The commenter would add a 
section that discusses specific elements that the history should 
contain. The commenter suggested that the introduction should discuss 
acceptable methods of obtaining information regarding functioning, and 
that it should clarify that information regarding function should be 
obtained through a medical history, which may be supplemented by 
information obtained directly from claimants or third parties by 
adjudicators. The commenter also suggested that, when appropriate, the 
history should specify why treatment is not commensurate with the 
claimant's alleged level of symptoms to better address issues of 
credibility.
    Response: We have not adopted this comment because most of the 
suggested revisions are covered adequately in other sections of the 
existing regulations and Social Security Rulings (SSRs), which are 
better vehicles for issues such as relating claimants' medical 
histories to their levels of functioning and addressing credibility. 
Current Secs. 404.1512(d), 404.1513(b), 416.912(d), and 416.913(b) 
stress the need for a medical history in all medical reports, 
regardless of the nature of the

[[Page 58025]]

impairment, and state that we will make every reasonable effort to 
obtain this history. The suggestion that information regarding 
functioning should be obtained through a medical history supplemented 
by non-medical evidence need not be included in these rules because 
this is already required by Secs. 404.1545(a) and 416.945(a).
    We believe the suggestion that adjudicators should obtain 
information that explains why a claimant has not sought treatment 
commensurate with his or her allegations is already required in the 
regulations at Secs. 404.1529 and 416.929. These regulations require 
adjudicators to consider, among other things, the type, dosage, 
effectiveness, and side effects of any medication the claimant takes or 
has taken to alleviate pain or other symptoms; treatment other than 
medication that the claimant receives or has received to relieve 
symptoms; any other measures used to relieve symptoms; and other 
factors concerning the claimant's functional limitations and 
restrictions due to symptoms. The regulations go on to state that in 
determining the extent to which symptoms affect the claimant's ability 
to perform basic work activities, we will evaluate the claimant's 
statements in relation to the objective medical evidence and other 
evidence in reaching a conclusion concerning disability. Further, we 
will consider whether there are any inconsistencies in the evidence and 
the extent to which there are any conflicts between the claimant's 
statements and the rest of the evidence. To make sure that adjudicators 
fully understand how to consider the level of a claimant's treatment in 
assessing his or her credibility, we published SSR 96-7p, ``Titles II 
and XVI: Evaluation of Symptoms in Disability Claims: Assessing the 
Credibility of an Individual's Statements,'' on July 2, 1996 (61 FR 
34483), to further clarify the intent of these regulations.
    We do not see further need to specify what goes into a history 
taken by an examining physician. Sections 1.00B2d-1.00E2 and 101.00B2d-
101.00E2 include statements about what is needed to evaluate an 
impairment under these listings, and this includes the elements of a 
complete musculoskeletal history.

Proposed Obsolescence of Listing for Osteomyelitis

    Comment: Another commenter stated that the listing for 
osteomyelitis and septic arthritis should be retained because she 
indicated that she knows of some individuals who continue to meet this 
listing.
    Response: As we stated above and in the NPRM, advances in 
antibiotic therapy and in treatment have made osteomyelitis and septic 
arthritis rare occurrences, and cases that would last or be expected to 
last 12 months are even rarer. This does not mean that we would never 
find an individual disabled based on these conditions. It simply means 
that their occurrence is sufficiently rare that we can no longer 
justify a specific listing just for the occasional case we may 
encounter. As we stated in the NPRM, individual occurrences should be 
handled on a case-by-case basis to determine if they are equivalent in 
severity to a listed impairment or if they reduce RFC sufficiently to 
result in an allowance at a later step of the sequential evaluation 
process.
    An individual who has been found disabled because of a listing for 
osteomyelitis or septic arthritis would not be disadvantaged because we 
later removed the listing. We do conduct periodic ``continuing 
disability reviews'' of individuals on the rolls to determine whether 
they are still disabled. However, when we conduct continuing disability 
reviews, we do not find that disability has ended solely based on a 
change in the listing. In most cases, we must show that an individual's 
impairment(s) has medically improved and that any medical improvement 
is ``related to the ability to work.'' If an individual's impairment(s) 
has not medically improved, we will generally find that the individual 
is still disabled. Even if the impairment has medically improved, our 
regulations provide that the improvement is not ``related to the 
ability to work,'' if the impairment(s) continues to meet or equal the 
``same listing section used to make our most recent favorable 
decision.'' This is true even if, as in these final rules, we have 
removed the listing section that we used to make the most recent 
favorable decision. See Secs. 404.1594(c)(3)(i) and 
416.994(b)(2)(iv)(A) of our regulations. (A similar provision for 
continuing disability reviews for children eligible for SSI based on 
disability appears in Sec. 416.994a(b)(2).) In a case where we find 
that medical improvement is not related to the ability to work (or the 
impairment still meets or equals the prior listing, in the case of an 
individual under age 18), we will find that disability continues, 
unless an exception to medical improvement applies.

Need for Training/Education

    Comment: Some commenters thought that any change in listings such 
as these will require re-education of the medical community and 
disability adjudicators. As one commenter noted, there may be an 
initial slowing of adjudication because of requests for clarification 
of the doctors' reports. This should be only temporary, however, and 
should be resolved in a relatively short time. Another commenter 
strongly recommended that SSA involve itself in the process of 
educating the medical community and motivating them to provide timely, 
complete information.
    Response: Any changes in policy raise some issues during 
transition, but as always, we will train our adjudicators on the final 
regulations so that they will be familiar with the new criteria. We 
would expect physicians in the community who are involved with the 
program to learn about the changes through the usual channels provided 
under our auspices (e.g., public relations forums and meetings with 
professional relations officers).

1.00A  Disorders of the Musculoskeletal System

    Comment: A commenter asked (apparently for informational purposes) 
if hemophilic arthritides are also included under this section of the 
listings, but did not ask for any changes to the listings.
    Response: Joint problems in people with hemophilia are caused by 
either acute bleeding into the joints or chronic changes related to 
prior joint bleeding. Because this is not a true inflammatory or 
infectious process, the term ``arthrosis'' rather than ``arthritis'' is 
actually more technically correct. Children, as well as adults, are 
affected by this condition, although children more frequently present 
with acute problems and adults more frequently present with chronic 
problems. Thus, hemophilic arthrosis would be included in the general 
conditions considered under 1.00A and 101.00A, and the effects of this 
condition generally would be considered under the listings that follow. 
Occasionally, chronic septic arthritis can occur in a hemophiliac with 
joint bleeding from frequent needle withdrawal of fluid from the 
joints. If this occurs, then the resulting impairment would be 
evaluated under listings 14.09 or 114.09.

1.00B  Loss of Function

    Comment: One commenter asked, ``Since these functional criteria are 
similar to 11.04B, shouldn't there be a referral to Listing 11.00ff if 
the restriction is due to a neurological problem?''
    Response: We agree with this suggestion and have added statements

[[Page 58026]]

to this effect to final 1.00B1 and 101.00B1.

Terminology Used in 1.00B

    Comment: One commenter called the term ``sustained basis'' an open-
ended term that could use further definition. Several other commenters 
believed that the terms ``inability to ambulate effectively'' and 
``inability to perform fine and gross movements effectively'' need 
clarification because they are open to interpretation and may make 
consistency of decisionmaking and review difficult. In addition, a 
commenter suggested that we need to provide some guidance on how to 
verify the degree to which a claimant's ability to ambulate is 
diminished. Another commenter suggested that the ``term `extreme' is 
nonspecific and will not provide appropriate guidance to decision 
makers.'' Still another commenter suggested that the criteria for 
inability to ambulate provide more specific examples than the inability 
to perform fine and gross movements, and an explanation of how much or 
to what extent the ability or inability to reach, push and/or pull has 
in determining severity is needed. The commenter also stated that 
further explanation about intermittent assistance in buttoning and 
tying should be included. Similarly, another commenter suggested that 
we need to define exactly what we mean by intermittent assistance.
    Response: We disagree, but we clarified the rules in response to 
these comments. We believe that it is clear from the examples cited in 
1.00B2b, 1.00B2c, 101.00B2b, and 101.00B2c what we mean by ``the 
inability to ambulate effectively on a sustained basis or the inability 
to perform fine and gross movements effectively on a sustained basis.'' 
Further, we do not believe that assessing a claimant's ability to 
ambulate will be any different from any other assessment of the 
individual's ability to function. Thus, no further ``verification'' 
should be necessary.
    The term ``extreme'' is not a new one to our disability 
adjudicators and is, in fact, defined, as it relates to children, in 
Sec. 416.926a(e)(3) of our regulations. We disagree that the examples 
for inability to ambulate are any more specific than the examples for 
inability to perform fine and gross movements.
    However, in response to these and other comments, we made several 
changes in final 1.00B2 and 101.00B2 that we believe will help clarify 
our intent. In 1.00B2b, 1.00B2c, 101.00B2b, and 101.00B2c we expanded 
the first sentence to better explain what we mean by an ``extreme'' 
loss of function when we talk about the ``inability to ambulate 
effectively'' and the ``inability to perform fine and gross movements 
effectively.'' In response to the comments indicating that the example 
of ``intermittent assistance'' in buttoning and tying shoes was not 
clear, we deleted this example.
    In final 101.00B2b(2) we have made an additional modification of 
the first sentence to make it clear that consideration of function in 
children too young to walk independently must be based on assessment of 
the limitations in the ability to perform comparable age-appropriate 
activities with the lower extremities, given normal developmental 
expectations. This makes it clear that ``extreme'' levels of limitation 
will not necessarily mean a complete inability to do age-appropriate 
activities. We made a similar change in final 101.00B2c(2) regarding 
limitations in the ability to perform fine and gross movements for very 
young children.
    Comment: Without making a specific recommendation, two commenters 
asked for clarification of the second sentence of 1.00B1 in the NPRM 
(final 1.00B2b). They wondered why the definition would require 
limitations to both upper extremities if a hand-held assistive device 
were required for adequate ambulation. They also asked if a cane would 
qualify under this section. Furthermore, would holding a device in one 
hand with only minimal assistance of the other hand constitute 
functional limitations of both upper extremities, or must the hand-held 
device require limitations of both hands (i.e., crutches, walker, 
etc.).
    Response: We believe that the sentence is clear in its intent that 
an individual with one hand free while using an assistive device in 
walking would not meet the definition if he or she were otherwise 
ambulating effectively as defined in final 1.00B2b. As we repeatedly 
stress, the criteria expressed in the listings are intended to define 
limitations that prevent any gainful activity. A claimant requiring a 
cane or other device in only one hand to effectively ambulate might be 
severely impaired and could possibly be allowed at a later step of the 
sequential evaluation process, but he or she would not necessarily be 
unable to perform any gainful activity.
    Comment: In related comments, two respondents implied that the 
required limitations to both upper extremities if a hand-held assistive 
device is required for adequate ambulation is a restatement of our 
policy. One of the two indicated that the proposed criteria are too 
restrictive, while the other believed the change is a good idea but 
would require training of adjudicators.
    Response: We believe that the change is consistent with the intent 
of all listings regardless of the body system (i.e., as stated in the 
previous response, the listings are intended to define limitations that 
they would prevent any gainful activity.) Some individuals who walk 
reasonably well with a cane might be capable of some jobs and would 
need to be evaluated at later steps of the sequential evaluation 
process. To the degree that these changes require training for our 
adjudicators, we will provide such training just as we do with all new 
listings. Furthermore, the change is consistent with SSR 96-9p, 
``Titles II and XVI: Determining Capability to Do Other Work--
Implications of a Residual Functional Capacity for Less Than a Full 
Range of Sedentary Work'' (61 FR 34478 (1996)), which deals with 
evaluating the vocational impact of using a hand-held assistive device.
    Comment: Three commenters were opposed to the new criteria because 
they were apparently of the impression that we will now require 
individuals to use an assistive device with both hands to meet the 
criteria, which they, in turn, seem to equate with disability. One 
commenter stated, ``It has been my experience in working with 
disability claimants who have musculoskeletal impairments that would 
require the use of a hand held assistive device for ambulation, that 
even in the most extreme cases, an individual does not necessarily use 
a hand held assistive device that limits the functioning of both upper 
extremities.'' Another stated, ``The new proposal requiring the use of 
an ambulatory aid which uses both hands to be classified as the 
`inability to ambulate effectively' is unjustified and absurd. By this 
proposal you are saying that a person who needs a cane to safely and 
effectively get around is not disabled.'' This individual also wanted 
to know how a case would be handled ``if a person has no use of an 
upper extremity because of C[erebral] V[ascular] A[ccident] or 
amputation.'' The third commenter suggested that, unless a claimant 
were in a wheelchair, he or she would not meet the ambulatory criteria, 
and that ``the slightest ability to ambulate would, in effect, rule out 
your meeting and/or equalling [sic]'' the musculoskeletal listings.
    Response: We believe that these comments stem from a 
misinterpretation of the criteria. The criteria do not require an 
individual to use an assistive device of any kind. The first sentence 
of final 1.00B2b stresses that ``[i]nability to

[[Page 58027]]

ambulate effectively means an extreme limitation of the ability to 
walk.'' The ensuing explanation and examples should make it clear that 
this applies to anyone who cannot walk adequately. The explanation is 
intended to mean that individuals who can only walk with the aid of 
hand-held assistive devices requiring the use of both upper extremities 
would meet the definition of inability to ambulate effectively. In 
addition, anyone with an ineffective gait who cannot use assistive 
devices would also meet the definition of inability to ambulate 
effectively. An individual who can walk adequately with a cane or other 
device that affects only one upper extremity cannot be considered as 
incapable of any gainful activity, but such an individual might well be 
found disabled at later steps of the sequential evaluation process.
    Thus, we recognize that individuals with extreme inability to 
ambulate do not necessarily use assistive devices. Furthermore, we 
recognize that an individual who uses a cane may be disabled. In 
addition, we state in the explanations at 1.00B2b and 101.00B2b(1) that 
listings 1.05C and 101.05C are exceptions to the general rule because 
an individual evaluated under these listings would have only one upper 
extremity. If an individual, for any reason, could only use a cane and 
no other assistive device and could not effectively ambulate, he or she 
would meet the criteria. Furthermore, we hope it is clear that the 
criteria are not intended to exclude all but those confined to 
wheelchairs. We believe that the language in final 1.00B2b and 
101.00B2b(1) clarifies confusing language in the current listings.
    Comment: One commenter stated that proposed 1.00B (final 1.00B2b) 
``is contrary to the intent of the S[ocial] S[ecurity] Act, which 
defines a listed impairment as any impairment in which medical factors 
alone are presumed to preclude substantial gainful activity.'' The 
commenter suggested that we change the language to reflect that an 
individual would be disabled with the ``ability to walk only short 
distances (e.g., a city block) before resting,'' or the ``ability to 
walk only with the use of any ambulatory aid (e.g., one cane or 
crutch), as long as the other criteria of the Listings (e.g., joint 
pain, swelling, tenderness, and signs of inflammation or deformity on 
current physical examination in 14.09) are met.''
    Response: We do not believe that the criteria in any way conflict 
with the Act. The Act does not, in fact, make any provision for the 
listings at all. The listings are an administrative convenience 
established by regulation to identify obviously disabled individuals. 
Furthermore, we believe the final criteria better identify obviously 
disabled individuals than would the suggested criteria. The suggestion 
might result in erroneous awards of benefits to individuals who could 
perform substantial gainful activity.
    Comment: Another two commenters indicated that the introductory 
text should provide a definition and or example of what constitutes 
``reasonable pace.'' One of the two wanted to know if it is having the 
ability to walk for one block on uneven surfaces in 5 minutes.
    Response: We do not believe that ``reasonable pace'' can be easily 
limited to a particular distance in a specific amount of time. 
Disability determinations and decisions require a certain amount of 
judgment, no matter how specifically we define our terminology. The 
total medical and other evidence, including, but not limited to, what 
is learned about the individual's activities of daily living, and third 
party observations, must be utilized. By providing specific examples, 
we believe that we are providing adjudicators with sufficiently defined 
terms to make reasonable and consistent determinations and decisions.
    Comment: One commenter disagreed with our decision not to consider 
the ability to stand in the definition for ambulation. The commenter 
stated, ``This section addresses only an ability to walk, not the 
ability to stand because standing is `not an accurate gauge of 
functioning.' Standing is often a frequent function of many jobs, 
whereas, walking may only be occasional. For example, most assembly 
line workers stand a majority of the day in one spot, with minimal 
walking.'' The commenter further stated that standard SSA vocational 
documentation forms ``list walking and standing as separate physical 
activities when describing job duties.''
    Response: The commenter has taken issue with the explanatory 
section of the draft regulations, and we agree that this explanation 
may have been confusing. We did not mean to imply that standing is not 
considered in an individual's ability to function. The primary 
intention for not including standing as a measure of function in final 
1.00B2b (1.00B1 in the NPRM) is because, as we state in the 
explanation, ``profoundly impaired individuals can often stand for a 
period of time, although they may not be able to walk effectively.'' By 
including standing as a criterion, we might have incorrectly denied 
some claims by individuals who are disabled. A focus on ambulation 
rather than on standing does not mean that an individual who cannot 
stand for a period of time would not be disabled. Such an individual 
could quite possibly be unable to ambulate effectively. If an adult's 
impairment(s) did not meet or equal the requirements of the listings 
because the individual could walk without much difficulty but was 
unable to stand for long periods of time, as in the case of an 
individual with a back impairment who must alternate standing and 
sitting, the claim would be evaluated at the later steps of the 
sequential evaluation process.
    Comment: Another commenter stated that in proposed 1.00B1, 
inability to ambulate effectively is defined as needing a hand-held 
assistive device that limits the functioning of both upper extremities, 
i.e., the claimant cannot walk without two canes or crutches, but the 
second paragraph of this section appears to describe a severe 
impairment, but less severe than the need for two assistive devices. 
The commenter suggested that either we change the first paragraph or we 
state that ineffective ambulation means the claimant needs two hand-
held assistive devices and omit the rest of the description. Another 
commenter suggested that the regulations should include one other 
example of inability to ambulate effectively, the inability to walk 
without the use of a walker or two canes.
    Response: We do not want to say that a claimant needs two hand-held 
assistive devices in order to exhibit inability to ambulate effectively 
because this would mean that people who cannot walk at all or who do 
not use any device but still cannot ambulate effectively would not meet 
the definition. The definition requires only that the claimant not be 
able to ambulate effectively and that effective ambulation would not 
occur if the only way an individual could get around would be with an 
assistive device that requires use of both upper extremities. 
Nonetheless, we have adopted the second suggestion, which may also 
satisfy the first commenter's concerns.
    Comment: Two commenters believed there were additional 
inconsistencies within the definitions themselves. One commenter 
suggested that the first example listed in proposed 1.00B1 and 
101.00B1, ``inability to climb,'' seems to be significantly more 
stringent than a later example, ``inability to use standard public 
transportation.'' Because most commuter trains and subways involve 
climbing up/down one or more flights of stairs, the commenter reasoned 
that inability to use public transit will

[[Page 58028]]

include many more people than those who are unable to climb ``a few 
steps.'' Asking if these examples are to be considered ``comparable'' 
in the level of severity, the commenter suggested that perhaps 
additional examples would help illustrate the level intended.
    The other commenter believed that the second sentences of proposed 
1.00B2 and 101.00B2, which stated, in part, that ``to use their upper 
extremities effectively, individuals must be capable of sustaining 
reasonable use of both upper extremities,'' could be interpreted to 
mean that individuals who can use only one upper extremity for pushing, 
pulling, grasping and fingering would have an impairment of listing-
level severity because they do not have reasonable use of both upper 
extremities. The commenter believed this interpretation is inconsistent 
with a finding that an individual with a total amputation of one arm 
but no restriction in the use of the other arm would not meet any 
listing. The commenter recommended that the section be revised to 
indicate that individuals who are unable to perform such functions as 
reaching, pushing, and pulling with either upper extremity are not 
capable of sustaining reasonable use of the upper extremities.
    Response: We added one example in connection with the previous 
comment, which may also help to clear up any concerns about inequities 
in final 1.00B2b and 101.00B2b. Nevertheless, we do not believe there 
is a problem with these sections. We do not intend the examples to be 
equivalent to each other, but to illustrate that even ``extreme'' 
limitation represents a range of severity. We list other examples and 
we make clear in final 1.00B2b and 101.00B2b that inability to ambulate 
effectively is not limited to these examples. For this reason, we did 
not change the example of inability to use ``standard public 
transportation.''
    We did not agree with the commenter's suggestion that any 
individual who has lost, or lost the use of, an upper extremity should 
be found to meet a listing even if he or she has no other functional 
limitation. However, the comment made us realize that proposed 1.00B2 
and 101.00B2 could have been misinterpreted. Therefore, in response to 
this comment we revised final 1.00B2c and 101.00B2c to make it clear 
that an individual must be unable to sustain such functions as 
reaching, pushing, pulling, grasping and fingering, regardless of 
whether he or she has the use of one or both upper extremities.
    Comment: One commenter wanted to know how the examples in proposed 
1.00B1 and 2 are to be developed and applied. The commenter wanted to 
know if some examples are ``critical'' to a decision of disability and 
how a claim would be decided if the claimant met some of the criteria 
but not others.
    Response: Because the criteria mentioned are intended as examples 
of what would be extreme loss of function and not as individual 
requirements of a listing, it is not intended that some are more 
``critical'' to a decision than others, any more than that some should 
be construed as more ``stringent'' than others. A claimant's loss of 
function may be evident through some other description than is found in 
any of the examples. This is why we are careful to state that these are 
examples and inability to ambulate or use the upper extremities is not 
limited to these examples.

Documentation Issues

    Comment: Some commenters questioned how adjudicators should obtain 
the documentation required to meet the proposed 1.00B or 101.00B 
criteria, specifically inquiring whether adjudicators should attempt to 
get the evidence from physicians who treat or examine the individual or 
from lay sources, such as spouses, relatives, neighbors, or claimants, 
themselves. This led to the concern that getting the documentation 
might necessitate purchasing more examinations. One commenter stated 
that the ``emphasis on `effective ambulation' will be very difficult to 
document objectively, since it will depend on the claimant's 
description of their activities.''
    Response: As we noted in response to a prior comment, we added 
language in final 1.00B2a and 101.00B2a to explain that we are not 
requiring additional documentation about the individual's ability to 
perform the specific activities that we list as examples in final 
1.00B2 and 101.00B2. In obtaining the evidence necessary to determine 
whether a claimant has an extreme loss of ability to ambulate or to use 
the upper extremities, adjudicators should follow the rules of evidence 
in Secs. 404.1512 through 404.1513 and 416.912 through 416.913. Thus, 
we do not see this as an ``either/or'' question. Rather, we would 
consider statements from both medical sources and lay sources to assess 
the claimant's ability to do these things, ascribing appropriate weight 
to the statements as explained in these rules. We do not believe that 
the new rules will result in the purchase of more examinations or in 
the need for increased documentation. Even when documentation is 
insufficient to establish listing-level severity, many adults' claims 
may be allowed at a succeeding step in the sequential evaluation 
process.
    We do not see lack of objectivity as an issue. A claimant's own 
statements about his or her functioning have always been factored into 
a decision, because symptoms are the claimant's statements about how an 
impairment affects the individual. We base disability determinations 
and decisions on all of the evidence in file, objective and subjective, 
and we consider whether there are any conflicts between the objective 
evidence and the claimant's own statements.

Pain or Other Symptoms

    Comment: One commenter considered it problematic to include pain as 
a reason for loss of function, stating that with regard to the 
definitions of inability to ambulate and inability to perform fine and 
gross movements, including pain could create problems. The commenter 
indicated that this language might blur the lines between assessing the 
impairment severity based on objective findings, and then subsequently 
evaluating symptoms to see if there is a further reduction in function. 
Another commenter suggested we clarify the pain standard in this 
section. Still another commenter was concerned that this section will 
require the purchase of more consultative examinations.
    Response: Under final 1.00B2d and 101.00B2d, we stress that in 
order for pain or other symptoms to be found to affect an individual's 
ability to perform work activities, there must first be objective 
medical evidence to support the existence of a medically determinable 
impairment that could reasonably be expected to produce the symptom. 
Considering pain as a factor in an individual's loss of function is 
consistent with Secs. 404.1529 and 416.929 on evaluation of symptoms, 
including pain. Because the language in these final regulations is 
consistent with the current regulatory language regarding pain and 
other symptoms, it should not affect documentation requirements or 
practices, nor do we see any need for further clarification of the pain 
standard.

1.00C  Diagnosis and Evaluation

    Comment: Two commenters questioned whether this section might lead 
to purchase of extremely expensive tests. To avoid unnecessary purchase 
of such tests, one suggested it might be useful to include an 
explanation of the limitations inherent in using electromyography to 
assess impairment severity or functional limitations, and

[[Page 58029]]

that the section should specifically state that tests such as 
computerized axial tomography (CAT) scan or magnetic resonance imaging 
(MRI) should be reserved for difficult cases. Also, the commenter 
wanted to know if it would be possible to address the role of such 
newer testing as thermography. The other commenter asked, ``Since 
diagnosis and evaluation will be supported by medically acceptable 
imaging techniques such as CAT scan, MRI and radionuclear bone scans, 
will SSA be considering purchase of these techniques, if not part of 
the medical evidence of record?''
    Response: SSA has never routinely purchased the types of tests 
mentioned in proposed 1.00C and 101.00C, nor do we see these sections 
as endorsing such a purchase. Rather, we will consider the results of 
such tests when they are part of the existing evidence in the case 
record. Such evidence normally would not be necessary because of the 
functional aspects of the revised listings. The ultimate degree of 
impairment severity is determined by how the claimant is functioning. 
Thus, although the types of tests mentioned are useful, they are 
usually not required for establishing a diagnosis and are rarely 
required for evaluating function. Nevertheless, in order to avoid 
unnecessary purchase of expensive tests, we have provided clarification 
in final 1.00C2 and 101.00C2 that we do not routinely purchase certain 
types of tests which are expensive and do not order other tests, such 
as myelograms, which are invasive and may pose significant risk to the 
claimant. In final 1.00C1 and 101.00C1 we have also explained that the 
medically acceptable imaging must be ``appropriate'' to ensure that the 
technique is one which can support the evaluation and diagnosis of an 
impairment.
    A discussion of such newer techniques as thermography is not 
necessary since the tests mentioned are examples and not an exhaustive 
list. Tests such as electromyography, which are generally accepted by 
health care professionals as useful in establishing a diagnosis, would 
be acceptable to SSA. We state in final 1.00C3, with a minor 
clarification of the NPRM, that electrodiagnostic procedures may be 
useful in establishing the clinical diagnosis, but do not provide 
evidence which can be used to assess function for purposes of listing 
1.04.
    Comment: One commenter asked, ``Why is myelography (with or without 
post-myelographic CAT) not considered an acceptable imaging study? Are 
not the `acceptable' imaging studies diagnostic procedures in the same 
vein and only helpful in establishing (supporting) the history of 
symptoms and physical signs?''
    Response: This commenter seems to have misinterpreted the intent of 
the section. We do not state that these tests are not ``acceptable.'' 
We state that they may be ``useful'' in establishing diagnosis. 
However, because they do not, in and of themselves, measure functional 
ability they are not a substitute for the other requirements of the 
listings. The commenter is correct in noting that myelography is a form 
of medically acceptable imaging. We have added myelography to the list 
of examples in final 1.00C1 and 101.00C1. However, as explained above, 
this is an invasive procedure which may involve significant risk to the 
claimant. Therefore, we will consider the results of this testing when 
it is in the evidence in the case record, but we will never order the 
test.

1.00D  The Physical Examination

    Comment: One commenter suggested that ``[t]his section requires 
`alternative' testing methods'' be used to verify abnormal findings'' 
and wanted to know, if alternate methods are not reported, would 
additional development be required to obtain them. Another commenter 
stated that use of alternative testing methods could result in apparent 
conflicts and delays in claims processing to resolve these conflicts. 
However, the commenter added that the provision recognizing that 
musculoskeletal impairments may be intermittent is a positive one.
    Response: In response to the first commenter's concern, 1.00D does 
not require alternative testing methods in all cases. In some cases 
disability might be so obvious that alternative tests would not be 
needed. An adjudicator would only delay adjudication of a case if 
alternative methods were specifically required. Such a decision would 
be made on a case-by-case basis. We do not see such a need as a 
frequent occurrence because alternative tests are routinely performed 
in a general examination. The main reason why we included straight-leg 
raising in both the supine and the sitting positions as an example in 
this section is that these two versions of this test are routinely done 
to verify findings on examination. We should add that the language 
about which the commenters have expressed concern was not new to the 
NPRM. Rather, it is longstanding policy, having been part of current 
1.00B.
    We agree with the second commenter that in the event of a conflict, 
further investigation may be necessary. This, too, is consistent with 
longstanding policy. We believe that the type of thorough examination 
in which such cross-checks are performed will help ensure sound 
determinations and decisions and will in no way disadvantage disabled 
individuals. The statement that recognizes the intermittent nature of 
the presenting signs and symptoms of some impairments has been in the 
introduction to the musculoskeletal listings for some time and is there 
to safeguard the rights of disabled individuals. Current 1.00B contains 
an almost identical statement to the one in the proposed and final 
rule.

1.00E  Examination of the Spine

    Comment: Several commenters presented suggestions and concerns 
regarding the specificity needed for findings of muscle atrophy, motor 
abnormalities, and ranges of motion. One commenter suggested that a 
straight-leg raising test is meaningless if simply reported as 
``positive,'' and that if pain is produced during straight-leg raising, 
it is necessary to know the location, pattern, and character of the 
pain. Another commenter suggested the listings should request that 
examining and treating physicians provide the Lasegue's sign. Some 
commenters also questioned the value of physicians merely reporting 
atrophy. One commenter suggested that a slight asymmetry of comparative 
circumference measurements may be unrelated to strength and could even 
be the result of errors in methods of measurement. Similarly, other 
commenters suggested that general statements regarding loss of muscle 
strength are of limited value and suggested the need for standard 
guidelines for measuring muscle strength. One commenter suggested the 
commonly used ratings of 0-5 with 5 representing normal muscle 
strength. Concerning ranges of motion, one commenter asked whether they 
should be given quantitatively, while another asked if anything less 
than the normal values listed in the ``Guides to the Evaluation of 
Permanent Impairment'' (the Guides) be considered a limitation of 
motion. He stated, ``For example the normal range of motion for flexion 
of the shoulder is listed as 180o. The rule should clarify what degree 
of flexion of the shoulder, e.g., 175o or 179o, is to be considered as 
a limitation of motion.''
    Response: We agree that a statement of positive straight-leg 
raising alone is insufficient, which is why we request that it be 
reported in degrees and why we prefer that it be reported from both the 
supine and sitting positions (cf. 1.00D). We agree that the Lasegue's 
sign,

[[Page 58030]]

or any other appropriate tension signs, be provided, and we have added 
a phrase to this effect to final 1.00E1. We believe that this addition, 
together with the statement that observations of the individual during 
the examination should be reported, will be adequate to determine the 
significance of pain on straight-leg raising, especially because we 
already consider the location, pattern, and character of any pain under 
our regulations at Secs. 404.1529(c)(3) and 416.929(c)(3). Furthermore, 
listing 1.04A, to which this discussion of straight-leg raising refers, 
calls for a ``neuro-anatomic distribution of pain.''
    We also agree that measurement of muscle strength via the 5-point 
scale would be useful in conjunction with reports of atrophy for 
assessing motor function. Therefore, we have added language to final 
1.00E1 and 101.00E1 that a report of atrophy should be accompanied by 
some form of measurement of the strength of the muscle(s) in question, 
and that we suggest that the 0 to 5 scale be used.
    Concerning ranges of motion, experience in the past has shown that 
the criteria in the Guides have been sufficient for proper adjudication 
of musculoskeletal impairments. No further descriptions are really 
needed. Anything less than normal range of motion is clearly defined in 
the Guides and should be considered a limitation of motion.
    Comment: One commenter thought that residual neurological deficit 
after surgery or other resolution of the underlying problem should be 
able to satisfy listing 1.04.
    Response: As we stated in the explanation of the proposed rules in 
the NPRM, the second paragraph of proposed 1.00E (final 1.00E2), which 
is the section in question, is a clarification of the language in the 
current listings. As such, it represents a longstanding policy. Because 
the listing presupposes certain complications, such as significant 
disability due to pain, caused by active compromise of a nerve root, it 
is sound and logical from a medical standpoint to evaluate residual 
impairment under the more appropriate neurological listings once the 
compromise has been alleviated.

Proposed 1.00F (Final 1.00H)  Documentation

    Comment: Two commenters indicated that the section on Duration of 
Impairment (1.00F in the NPRM) needed clarification because it implied 
that 3 months of treatment history is needed in all cases. One 
commenter suggested that ``[t]here are many musculoskeletal impairments 
in which we do not need to have a record of at least 3 months of 
management and evaluation,'' while the other was concerned that ``the 
impression is that musculoskeletal conditions all improve with time.'' 
The latter suggested rewording the phrase, ``musculoskeletal 
impairments frequently improve with time or respond to treatment'' to 
``musculoskeletal impairments frequently improve or respond to 
treatment within a three-month period after onset; degree of 
improvement can vary, and some impairments ultimately result in 
progressive disability.'' Two additional commenters were concerned that 
the 3-month requirement could result in delays and increased expense, 
and one of the two asked for clarification of what we mean by a 
favorable decision because if ``favorable'' means ``fully favorable'' 
and all other cases require a 3-month history, this would delay 
development of the majority of cases. Another commenter asked for 
clarifying language on how to handle this requirement when there is no 
treating source.
    Response: As already noted, we deleted the requirement for a 3-
month history in response to these and other comments, although we 
continue to stress the importance of a longitudinal history. In final 
1.00H, we explain that, in the absence of a longitudinal clinical 
record, we will make a determination based on all the available 
evidence.
    In responding to these comments, we also realized that the heading 
of the section was inaccurate because the section was not exclusively 
about ``Duration.'' In final 1.00H (and final 101.00H) we have changed 
the title to ``Documentation,'' which better describes the provisions 
in this section.
    The fact that an individual may not have a treating or other 
medical 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. Also, we made several 
changes in response to this and other comments. We clarified final 
1.00H and 101.00H by stating that a longitudinal picture of the 
individual's impairment(s) in terms of medical severity, functioning, 
and symptomatology is important even when the individual has not 
received ongoing treatment. We also added final 1.00H3 and 101.00H3, 
``When there is no record of ongoing treatment.'' The language is taken 
from the introductory texts to other body systems; see, e.g., 4.00A, 
third paragraph, in the cardiovascular system. It only repeats our 
longstanding policy. In both the NPRM and final 1.00H and 101.00H, we 
state that it is not necessary to defer a determination or decision 
when the evidence establishes that the claimant is disabled.

Proposed 1.00G (Final 1.00I)  Effects of Treatment

    Comment: One commenter wanted to know how the issue of duration 
figures into the positive or negative effects of pain medication, while 
another asked how the impact of adverse side effects should be 
documented or evaluated.
    Response: We believe that these issues are adequately addressed in 
the regulations on pain and other symptoms found in Secs. 404.1529 and 
416.929. The effects of any medications used for symptoms are 
considered together with all medical and other evidence in determining 
the severity and expected duration of an impairment. Findings that 
medication relieves pain only sporadically or that side effects are 
long lasting and particularly debilitating would impact adversely on 
the claimant's overall ability to function for extended periods, while 
extended periods of relief with few side effects might improve ability 
to function. However, the regulations do not intend that the effects of 
medication be considered alone. Rather, these effects should be 
considered with a number of factors outlined in Secs. 404.1529(c)(3) 
and 416.929(c)(3), as well as the objective medical evidence and all 
other available evidence, in measuring the total impact of symptoms on 
the ability to function. Nevertheless, we added the phrase, ``or 
judgment about future functioning,'' to the end of the last sentence of 
final 1.00I3 and 101.00I3 to make clear that we are ultimately 
concerned with how treatment, be it medication, surgery, or any other 
measures, affects or will affect the individual's ability to function.

Proposed 1.00H (Final 1.00J)  Orthotic, Prosthetic, or Assistive 
Devices

    Comment: One commenter questioned the logic for assessing an 
individual without the aid of a hand-held device, especially because it 
has already been deemed ``medically'' necessary. Another commenter 
liked the concept, but together with a third commenter, foresaw 
practical difficulties with getting the information. The former 
suggested that it is unlikely that claimants will voluntarily 
relinquish their devices, and he doubted that consulting physicians 
will remove them forcibly. The other commenter stated, ``The new 
listings require information as to exactly what function a person has 
without the device if one is usually used, including how far he/she can 
ambulate without it, and on what kind

[[Page 58031]]

of surfaces. Not all claimants are treated by specialists prepared to 
provide such details.''
    Response: In response to these comments we have removed the phrase, 
``medically necessary'' and have restructured the section to clarify 
when an examination with or without an orthotic, prosthetic, or 
assistive device is important.
    We explain in final 1.00J4 (hand-held assistive devices), the 
importance of an evaluation with and without a hand-held assistive 
device, and why it is important to document the need for the device. We 
would not require an examination without the assistive device if such 
an examination is contraindicated by the medical judgment of a 
physician who has treated or examined the individual.
    In final 1.00J2 (orthotics) we explain that it is unnecessary to 
routinely evaluate an individual's ability to function without the 
orthosis in place. If an individual with an impairment of a lower 
extremity or extremities cannot use an orthotic device, the examination 
should include information on how the individual ambulates without the 
device. However, we do not expect a physician to examine the individual 
without the device if contraindicated by medical judgment.
    In final 1.00J3 (prosthetics) we explain that the examination 
should be with the prosthetic device in place. We make clear that where 
an amputation involves a lower extremity or extremities, we do not 
require an evaluation of an individual's ability to walk without the 
prosthesis, but we do require an evaluation of the individual's medical 
ability to use a prosthetic device to ambulate effectively as defined 
in 1.00B2b. We also explain that the condition of the stump should be 
evaluated without the prosthesis in place.
    We expect that the appropriate medical need for an orthotic, 
prosthetic, or hand-held assistive device will be confirmed by a 
physician who has treated or examined the individual.

Proposed 1.00I (Final 1.00K)  Disorders of the Spine

    Comment: One commenter suggested that arachnoiditis can be 
determined through CAT and MRI scans, rather than only through surgery 
and subsequent pathology report. Another was concerned that this 
section does not mention scarring from surgery, which is one of the 
most common causes of arachnoiditis. A third commenter indicated that 
the listings for impairments such as spinal arachnoiditis and lumbar 
stenosis call for a description of pain sufficiently detailed to 
determine whether or not it follows the required anatomical 
distribution and persists despite prescribed therapy. By implication, 
the commenter seemed to be suggesting that this would lead to increased 
documentation of claims.
    Response: We agree with the first commenter and believe this is 
adequately covered by our statement in final 1.00K2b that arachnoiditis 
can be confirmed by ``appropriate medically acceptable imaging.'' 
Concerning the second comment, we do not list any causes of 
arachnoiditis but only that it may be related to certain factors. In 
fact, we specifically stated in 1.00K2 of the NPRM that ``the cause of 
spinal arachnoiditis often remains obscure.'' In the event that this 
language may have been ambiguous, we have revised the sentence to 
indicate that ``[a]lthough the cause of spinal arachnoiditis is not 
always clear, it may be associated with chronic compression or 
irritation of nerve roots (including the cauda equina) or the spinal 
cord.'' We have also revised the last sentence of 1.00K2b to make it 
clear that it is particularly arachnoiditis of the lumbosacral spine 
that generally makes it difficult for an individual to sustain a given 
position or posture for more than a short period of time due to pain.
    We do not believe that the description of pain required to document 
either spinal arachnoiditis or lumbar stenosis deviates in any way from 
longstanding policy set forth in the regulations at Secs. 404.1529 and 
416.929. The regulations require that any symptom(s) must be reasonably 
expected to be produced by the impairment. Generally, if a symptom is a 
criterion of a listing, the symptom need only be present along with the 
other requisite criteria. It is usually not necessary to determine 
whether there is functional loss associated with the symptom. It is the 
interrelationship of the set of medical findings, not the individual 
criteria, that establishes listing-level severity. Information about 
the nature of the pain, its intensity, persistence or limiting effects 
is appropriate in certain listings to establish the required level of 
severity. Thus, we do not believe that the requirements under proposed 
1.00I and final 1.00K will affect the way claims are documented.

Proposed 1.00J (Final 1.00L)  Abnormal Curvatures of the Spine

    Comment: One commenter suggested that we include ``outside 
parameters'' of degrees of curvature, even though the primary focus of 
the listings is on functioning.
    Response: We did not adopt the comment. As the commenter noted, the 
emphasis of this section is on functioning, and we do not think it 
would be practical to set a level of curvature beyond which we would 
presume the appropriate degree of functional limitation.
    Comment: One commenter referred to our statement in the NPRM that 
marked disfigurement may result in emotional withdrawal and isolation. 
This commenter asked whether such a mental impairment should be 
evaluated separately since any marked deformity could have a similar 
impact. Another commenter suggested that we expand our list of examples 
to include ``cardiac, gastrointestinal, neurologic, and immune system 
compromise'' in addition to ``pulmonary complications'' and 
``disfigurement with emotional withdrawal or isolation.''
    Response: We revised the rules to address these comments, although 
the first comment was not entirely clear to us. We expanded the section 
to provide guidance about other impairments an individual with abnormal 
curvature of the spine may have.
    We provide guidance in this section about the potential emotional 
effects of disfigurement to remind our adjudicators to be alert to this 
possibility when they evaluate the effects of the impairment on each 
individual. However, as in the NPRM, we also provide that associated 
mental disorders may be evaluated separately under the mental disorders 
listings, consistent with the suggestion in the first comment.

Proposed 1.00K (Final 1.00M)  Under Continuing Surgical Management

    Comment: One commenter asked us to clarify this section. 
Essentially, the inquirer wanted to know if ``continuing surgical 
management'' meant only surgery or if other treatment modalities, such 
as closed reduction, casting, bracing, bone stimulation, etc., with 
nonunion of the radius or ulna lasting more than 12 months, would 
satisfy the criteria for listing 1.07.
    Response: The types of alternatives to surgery mentioned in the 
question would satisfy the requirements of the listings, as we believe 
is made clear by the language in 1.00M. This is why we use such terms 
as ``surgical procedures and any other associated treatments,'' ``other 
medical complications,'' and ``related treatments'' in our discussion 
of what we mean by surgical management. In our explanation of changes 
we did state that ``surgical management'' means more than surgery 
itself.

[[Page 58032]]

Proposed 1.00L (Final 1.00N)  After Maximum Benefit From Therapy Has 
Been Achieved

    Comment: There were three separate suggestions for clarification of 
this section. One suggestion was that the section should make some 
mention of how to apply the guides when the 12-month duration period 
has already been met, not merely when there has been no surgical 
intervention for 6 months. Another commenter was concerned that ``[a]s 
written, this section would require multiple surgical procedures. Is 
this the intent or could the listing be met with more conservative 
treatment without surgical intervention?'' The third commenter was 
concerned about how to apply the medical improvement review standard in 
Secs. 404.1594 and 416.994 when surgeries ``appeared to be in progress 
at the time of the initial allowance'' but no further surgery was done 
and no ``substantial increase in function has occurred.'' This 
commenter recommended adding language to proposed 1.00L to address this 
situation.
    Response: We do not see the need to discuss how to address duration 
if a condition has lasted at listing-level for at least 12 months and 
then stabilized following surgical or medical intervention during this 
period. If this were the situation, we believe it is obvious that the 
claimant's impairment would be disabling for at least a closed period, 
and any further finding of disability would depend on how the 
individual's demonstrable residuals affect him or her, using the 
guidelines set forth in proposed 1.00L (final 1.00N).
    We did not intend for 1.00L (final 1.00N) to exclude more 
conservative treatment, as evidenced by our phrase approximately midway 
through the proposed and final sections, ``surgical or medical 
intervention.'' To clarify our intent, we have added a similar phrase 
to the first sentence of final 1.00N. What once read, ``last definitive 
surgical procedure,'' in this sentence, now reads ``last definitive 
surgical procedure or other medical intervention.''
    We revised the language of the last two sentences in final 1.00N 
and 101.00N to attempt to clear up any ambiguities that might have 
arisen. We believe the revised text addresses the third commenter's 
concern.

Proposed 1.00M (Final 1.00P)  When Surgical Procedures Have Been 
Performed

    Comment: A commenter wanted to know if we really mean to state that 
a copy of operative notes and available pathology reports ``should'' be 
included or do we mean that they ``must'' be included. If it is not 
imperative that they be included, the commenter suggested that a 
summary of the surgery, usually included in hospitalization summaries, 
would be sufficient and that a statement to this effect should be 
added.
    Response: In most cases, the operative notes and pathology reports 
would be preferred, but we recognize that they are not always 
available. If a summary is sufficiently detailed and the actual report 
is either not provided or unavailable, we would not require the actual 
report. The proposed language is nearly identical to the statement in 
1.00B it has replaced, and there have been no adjudicative problems 
associated with this language in the past. We believe that our 
adjudicators can use sound judgment in applying this guideline in case 
situations.

Proposed 1.00N (Final 1.00F)  Major Joints

    Comment: One commenter suggested that this section and 1.00O be 
placed more logically after 1.00E and that 101.00N and 101.00O be 
placed after 101.00E. Another suggested that the ``ankle'' joint is so 
crucial to the ability to ambulate, it should be considered a major 
weight-bearing joint without being combined with the foot. A third 
inquirer wanted to know if the fact that we consider the wrist and hand 
to be a major joint requires impairment of both the wrist and hand and 
whether an impairment of the fingers alone can be considered a major 
joint.
    Response: We agree with the first suggestion and have redesignated 
all affected sections accordingly. We also agree that for purposes of 
weight bearing, the ankle and foot should be considered separately for 
the reasons stated by the commenter, and we have reworded this section 
and listing 1.02A to reflect this change. In the final rules we 
clarified that ``major joints'' as used in 1.00F and 101.00F and in 
listings 1.02 and 101.02 refers to major peripheral joints as opposed 
to other peripheral joints, (e.g., the joints of the hand or forefoot) 
or axial joints (i.e., the joints of the spine). For purposes of 
meeting the ``listings test'' for disability, we must consider the hand 
and wrist as a major joint. Impairment of either the hand (including 
fingers) or wrist, alone, would not be of listing-level severity. 
However, this does not mean that an adult could not be disabled at a 
later step of the sequential evaluation process with only impairment to 
the fingers, hand, or wrist.

1.02  Major Dysfunction of a Joint(s) (Due to Any Cause)

    Comment: One commenter wanted to know if any degree of limitation 
of motion will satisfy the requirements of the listing.
    Response: Yes. As we stated in our response to a similar inquiry 
involving 1.00E, anything less than normal range of motion is clearly 
defined in the ``Guides to the Evaluation of Permanent Impairment'' and 
should be considered a limitation of motion.
    Comment: Another commenter proposed adding another subsection to 
the listing requiring involvement of one hand and one foot, with less 
severe restrictions than are required in A and B.
    Response: As we stated in other responses, the listings are 
intended to define such extreme limitations that they would prevent any 
gainful activity. Although we agree with the commenter that the 
suggested impairment would likely be severe, and might prevent many 
types of gainful activity, we do not think that such an impairment with 
fewer limitations than are contemplated by either listing 1.02A or B 
would necessarily prevent any gainful activity. Therefore, we have not 
added the suggested listing. Rather, in adult claims, we would continue 
to evaluate any severe impairment that falls short of listing-level 
severity at later steps of the sequential evaluation process.
    Comment: A physician commented that the title of this listing is 
confusing and should be changed to ``Major Joint Dysfunction.'' He also 
stated that the listing is too rigid and requires too many physical 
findings. Because the A and B sections of the listing require extreme 
loss of function, the commenter suggested that requiring such extensive 
physical findings could result in delays of decisions and unnecessary 
development to attempt to obtain missing findings, when all that is 
really required is that an individual have a medically determinable 
impairment that has resulted in the functional loss required by section 
A or B. He suggested language for revising the listing.
    Response: We have partially accepted the suggestion in that we have 
changed the title of the listing to ``Major dysfunction of a joint(s) 
(due to any cause).'' We disagree with the suggested language revisions 
to the listing, however. Findings such as subluxation or fixation of a 
joint can be due to a wide variety of causes, and some cases are 
amenable to treatment. Therefore, we believe that the findings on 
appropriate medically acceptable imaging, which aid both in determining

[[Page 58033]]

the cause and in defining the chronicity of an impairment, are vital to 
fulfilling the requirements of this listing.

1.03  Reconstructive Surgery or Surgical Arthrodesis of a Major Weight-
Bearing Joint

    Comment: One commenter stated that return of effective ambulation 
within 12 months is subjective and may cause difficulties from an 
adjudicative standpoint. Another commenter suggested that the new 
listing is too restrictive because it replaces the return to full 
weight bearing with the more restrictive ``inability to ambulate 
effectively.''
    Response: These concerns stem from the same issues raised by other 
commenters under 1.00B. We believe we have already explained, in both 
the NPRM and in final 1.00B, that the need for the new functional 
criteria and for revising this listing is to place more emphasis on the 
functional impact of impairments on a person's ability to work. We 
agree with the second commenter that many individuals might be 
prevented from working under the current criteria. But with advances in 
surgical techniques and post-surgical treatment, some individuals who 
are not considered fully weight bearing on a lower extremity have 
sufficient ability to ambulate to be able to work. Individuals who 
cannot return to past relevant work because return to full weight-
bearing status has not occurred will be evaluated at the appropriate 
steps in the sequential evaluation process.

1.04  Disorders of the Spine

    Comment: At least two commenters specifically indicated that this 
listing would be helpful and an improvement over previous listings. 
Three others asked for clarification of some of the terminology in this 
listing. One commenter pointed out that proposed listing 1.04A requires 
evidence of a ``motor deficit (atrophy or muscle weakness)'' while 
proposed listing 1.04C requires evidence of ``weakness'' alone. The 
commenter asked whether we intend that motor deficit, which would 
include either weakness or atrophy, be a requirement for proposed 
listing 1.04C. A second commenter asked what would be positive for 
straight-leg raising and how the need for frequent changes in position 
or posture would be documented. The third commenter suggested that the 
meaning of ``frequent'' in proposed listing 1.04B needs to be more 
clearly defined.
    Response: We made some changes in final listing 1.04A to make clear 
that we are referring to neuro-anatomic distribution of pain. The terms 
``motor loss'' and ``motor deficit'' were used interchangeably in the 
NPRM. For consistency in the final rules, we refer to ``motor loss'' in 
listing 1.04A. We further clarified that atrophy as evidence of motor 
loss must be associated with muscle weakness. However, we purposely did 
not require atrophy as a requisite for meeting listing 1.04C. As we 
stated in the explanation of the revisions in the NPRM, we list both 
spinal arachnoiditis and lumbar spinal stenosis with pseudoclaudication 
separately from nerve root compression because they present different 
signs and symptoms. While atrophy can often be an outcome of nerve root 
compression, this usually will not be the case with spinal stenosis. In 
addition, in order to meet final listing 1.04C, an individual must be 
unable to ambulate effectively, as defined in 1.00B1 in the NPRM (final 
1.00B2b,) which is not a requirement to meet final listing 1.04A. Such 
inability to ambulate would be indicative of ``motor loss'' associated 
with extreme spinal stenosis.
    We presume that the second questioner is asking what would be 
positive for purposes of our program. We have provided the answer to 
this question in our response to comments at 1.00E. The need for 
frequent changes in position or posture would be documented from 
observations by treating or examining physicians, to be supplemented by 
appropriate lay testimony, as needed. We do not see this as a new 
requirement, as we have historically sought to obtain such evidence in 
support of any condition that causes pain or discomfort. However, we 
agree with the third commenter that we need to more clearly define 
``frequent'' as used in proposed listing 1.04B. In final listing 1.04 
we have clarified that the changes in position or posture must be more 
than once every 2 hours. We believe that a longitudinal record of the 
effects of arachnoiditis on an individual will provide sufficient data 
for adjudicators to determine whether the listing is met.

1.05  Amputation (Due to Any Cause)

    Comment: One commenter indicated that listing 1.05C is redundant, 
because both listings 1.05B and C involve amputation of a leg at or 
above the tarsal region with ineffective ambulation as defined in 
1.00B1 in the NPRM (final 1.00B2b.)
    Response: We do not agree that the listings are redundant because 
they are based on different circumstances stemming from different 
impairment mechanics. Under final listing 1.05B, an individual would be 
disabled if he or she has stump complications which result in the 
medical inability to use a prosthetic device to ambulate effectively. 
If there are no stump complications, modern surgery and advances in 
prosthetic devices should enable an individual to ambulate effectively. 
Final listing 1.05C would apply to someone who has had an amputation of 
the leg at or above the tarsal region but can only walk with a hand-
held assistive device, and given that the other hand is absent, such an 
individual would have effectively lost the use of both upper 
extremities.
    Comment: Two commenters suggested that listing 1.05, in general, is 
punitive in nature. One stated that the proposed listing presumes that 
individuals will have benefited from the latest in surgical techniques 
and prosthetic devices. This commenter stated that individuals who have 
not, including those who had their surgery prior to the advances in 
surgical and engineering techniques or those who could not afford to 
replace an older prosthesis with a newly perfected type, would be 
penalized by the new listing. The other commenter simply stated that 
the impairments described by the existing listings would be severe 
enough to be disabling and should stand. Several other commenters also 
disagreed with the decision to revise the existing listing for a 
hemipelvectomy or hip disarticulation. While one commenter agreed with 
this decision, the commenter and a number of others disagreed with the 
decision to remove the listings for amputations due to peripheral 
vascular disease or diabetes mellitus. In addition, one commenter 
suggested retaining both listings for amputations of both feet and for 
one hand and one foot, while another recommended retention of the 
listing for one hand and one foot.
    Response: We already made clear our reasons for revising the 
listings in our explanation of revisions in the NPRM.
    Overall, we believe that the level of concern expressed by the 
commenters results from a misunderstanding of our intent. We are not 
proposing that individuals who would have met the current listings will 
never be found disabled. Nor do we believe that these rules will 
disadvantage individuals who had their surgery or were fitted with a 
prosthesis before recent advances in surgical and engineering 
techniques, or individuals who could not afford a newer prosthesis. 
Rather, these rules reflect our judgment that surgical and engineering 
techniques have progressed to the point where it is no longer a 
relative certainty that individuals with the level of impairment 
described in the

[[Page 58034]]

current listings can automatically be deemed disabled.
    Some individuals who have not benefited from recent surgical and 
engineering techniques can still be found to have an impairment of 
listing-level severity if they have insufficient lower extremity 
functioning to permit independent ambulation without the use of a hand-
held assistive device(s) that limits the functioning of both upper 
extremities. As with some of our other listings, other individuals may 
well be found disabled at later steps in the sequential evaluation 
process and, we believe, at relatively little cost in time or resources 
to adjudicators.
    The inability to afford the cost of a replacement prosthesis was an 
issue in the application of current listing 1.10C in Gamble v. Chater, 
68 F.3d 319 (9th Cir. 1995). We issued a Social Security Acquiescence 
Ruling (AR) 97-2(9) (62 FR 1791) to explain our policies and how we 
apply the holding of the United States Court of Appeals for the Ninth 
Circuit in this case. In these final rules we replaced current listing 
1.10C with final listing 1.05B and expanded the guidance in final 
1.00J. Final listing 1.05B requires that an individual with an 
amputation of a lower extremity or extremities at or above the tarsal 
region be medically unable to use a prosthetic device to ambulate 
effectively as defined in 1.00B2b. In final 1.00J3 we explain that it 
is unnecessary to evaluate the individual's ability to walk without the 
prosthesis in place. We added this explanation because we recognize 
that individuals with the type of lower extremity amputation described 
in final listing 1.05B, will have an inability to ambulate effectively, 
as defined in 1.00B2b, when they are not using a prosthesis. This would 
be true whether they do not use a prosthesis because they cannot afford 
one, because a prosthesis has not been prescribed for them, or for 
other reasons. For that reason, it would be unnecessary to evaluate the 
individual's ability to walk without the prosthesis in place. However, 
we do require an evaluation of the individual's medical ability to use 
a prosthetic device to ambulate effectively. As the final rules 
sufficiently clarify the issue in Gamble, we are rescinding AR 97-2(9) 
under the authority of Secs. 404.985(e)(4) and 416.1485(e)(4) of our 
regulations concurrently with these final rules.
    As we already noted, medical advances in disability evaluation and 
treatment and program experience require that we periodically review 
and update the medical criteria in the listings. This is an ongoing 
process which we will continue. However, as indicated above, after 
reviewing the comments and the literature, we agree with those 
commenters who felt that a hemipelvectomy or hip disarticulation is 
still in itself sufficient to establish the existence of an impairment 
of listing-level severity. Therefore, final listing 1.05D has been 
revised to reflect the same criteria as current listing 1.10A.
    Comment: One commenter noted that on page 67583 of the NPRM we 
state that individuals who are unable to ambulate effectively due to 
stump complications resulting from diabetes or other disease, may have 
their impairments evaluated under listing 1.05B. The commenter 
suggested we add a statement to this effect to the introduction to the 
listings.
    Response: In final listing 1.05B, ``stump complications,'' means 
any stump complications regardless of the cause. However, to clarify 
that an individual with an amputation(s) due to any cause, including 
diabetes mellitus or other disease, will have his or her impairment 
evaluated under listing 1.05, we changed the title of the listing from 
``Amputation,'' to ``Amputation (due to any cause).''

1.06  Fracture of the Femur, Tibia, Pelvis, or One or More of the 
Tarsal Bones

    Comment: One commenter suggested that the listings should provide 
for individuals who may have achieved a solid union of their fractures 
in fewer than 12 months but who will take 12 months or longer, in 
total, to return to work.
    Response: Individuals with solid union of their fractures occurring 
in fewer than 12 months, but with residual soft tissue damage or soft 
tissue complications (e.g., of muscle or connective tissue) requiring 
surgical or medical intervention for 12 months or longer related to the 
efforts directed toward the salvage or restoration of major function of 
the affected part could equal listing 1.08. An adult whose residual 
impairment is either not of listing-level severity or not expected to 
be of listing-level severity at 12 months after the fracture would 
still be evaluated at steps 4 and 5 of the sequential evaluation 
process.
    Comment: Another commenter suggested that this listing is punitive 
and open to subjective interpretation, apparently because it is linked 
to the requirement for independent ambulation. The commenter suggested 
that this term needs a uniform definition.
    Response: We already answered this concern, at least indirectly, 
under our responses to comments on proposed 1.00B1. We believe that the 
term is clearly defined by way of the examples provided as ways in 
which ambulation would be considered as ineffective.

1.08  Soft Tissue Injury (e.g., Burns) of an Upper or Lower Extremity, 
Trunk or Face and Head

    Comment: Two commenters sought clarification of what we mean by 
``major function'' of the face and head.
    Response: In policy memoranda and manuals, we have generally 
considered such function to be related to sight, hearing, speech, 
mastication, and the initiation of the digestive process. In the final 
rules we have added new sections 1.00O and 101.00O to describe what we 
mean by major function of the face and head for purposes of listing 
1.08. (1.00O in the NPRM will now be final 1.00G.)
    Comment: One commenter questioned the role of pain for this 
listing, while hypothesizing that chronic lumbago and fibromyalgia 
might be considered under this listing, and seemed to want more 
objective criteria for evaluation of this listing.
    Response: We do not see how fibromyalgia or lumbago would be 
evaluated under this listing because the listing involves surgical 
management of the affected soft tissue areas. To the degree that pain 
factors into this listing or any other musculoskeletal listing, we 
believe the statements provided in 1.00B2d of the introductory text to 
these listings, as well as in Secs. 404.1529 and 416.929 of the 
regulations adequately describe how we consider pain and the factors 
used to determine how it affects an individual's ability to function.

4.12  Peripheral Arterial Disease

    Comment: One commenter stated that this listing appears to have 
been assigned the wrong number and that it should remain 4.13, unless 
our intent is to eliminate current listing 4.12 for chronic venous 
insufficiency.
    Response: The revised regulations on cardiovascular impairments 
published at 59 FR 6468 on February 10, 1994, renumbered chronic venous 
insufficiency as listing 4.11 and peripheral arterial disease as 
listing 4.12.

14.00B

    Comment: One commenter remarked, ``The discussion of the use of the 
term `severe' in the listings to describe medical severity is 
ambiguous. The statement that it does not have the same meaning as it 
does when we use it in connection with a finding at the second step of 
the sequential evaluation process does not adequately address the 
differences in the use of the term in the

[[Page 58035]]

listing and at step two of sequential evaluation.''
    Response: The language in this section regarding how we use the 
term ``severe'' was not new but was in the existing Immune System 
listings. It describes how we use the term in a number of existing 
listings, not in any of the new listings introduced by the final 
revisions to the musculoskeletal listings. The overall severe loss of 
function would result in an impairment that would be profoundly 
disabling and not merely ``severe'' for program purposes as defined in 
Secs. 404.1520, 416.920, and 416.924 of existing regulations. 
Therefore, we are not changing it.
    However, we agree that the first use of ``severe'' in the paragraph 
to describe loss of function might be somewhat confusing, so we have 
changed the phrase to read, ``serious loss of function.'' Also, it is 
not function of the body's organs with which we are concerned in 
disability evaluation, but with function of the whole individual. 
Therefore, we have further revised this first sentence in two places to 
read that functional loss is ``because of disease affecting'' an 
organ(s) and not because of functional loss ``in'' the organ(s).

14.09  Inflammatory Arthritis

    Comment: One commenter suggested rewriting this listing to avoid 
the potential difficulty of the listing inadequately specifying 
diagnostic criteria for the long list of disorders named in the 
introductory text to the listings. The commenter suggested that 
inflammatory arthritis be documented as described in 14.00B6 and that 
14.09A would be met if the inflammatory arthritis were diagnosed in 
accordance with the criteria of a current widely accepted medical text 
or journal, and it resulted in inability to ambulate effectively or 
inability to perform fine and gross movements effectively as defined in 
proposed 14.00B6b and 1.00B1 and B2.
    Response: The suggested revision would actually change the intent 
of 14.09A. The intent is that the inflammatory process itself is still 
active and has involved or affected two or more major joints. The 
suggested revision would raise the possibility that disability could be 
established solely on allegations of pain in an individual with a prior 
diagnosis of an inflammatory arthritis. Also, to suggest that 
inflammatory arthritis be ``diagnosed in accord with the criteria of a 
current widely accepted medical text or journal'' leaves the issue open 
to very broad interpretation and judgment.
    Comment: Another commenter suggested that listing 14.09A should 
refer back to 1.00G (final 1.00I) on effects of treatment.
    Response: Although we recognize that an individual with 
inflammatory arthritis likely will be under active therapy for the 
condition, we do not think that the effects need to be expressly 
considered herein. Whether effects are positive or negative is 
immaterial, given the degree of limitation needed to meet the criteria 
of listing 14.09A. According to these criteria, an individual's disease 
would be active and would result in inability to ambulate effectively 
or to perform fine and gross movements effectively.

14.09B  Ankylosing Spondylitis

    Comment: One commenter interpreted proposed listing 14.09B as not 
requiring x-ray evidence and believed this was a good decision.
    Response: We believe this commenter misinterpreted our intent. We 
removed the requirement for corroboration of the existence of the 
impairment by specific laboratory tests, to include x-ray or other 
appropriate medically acceptable imaging, in both proposed and final 
listings 14.09A, C, and D. However, we have retained the requirement 
for appropriate medically acceptable imaging in listings 14.09B and 
14.09E as the imaging is necessary to document the impairments 
evaluated under these listings.
    Comment: Several commenters stated the new range of motion 
restrictions required to meet this listing and others in this section 
are too stringent, suggesting that fixation of the spine be left at 30  
deg. rather than 45 deg.. One of these commenters also objected to the 
requirement that fixation be of the dorsolumbar and cervical spines, 
stating that fixation of either be considered severe enough to be 
presumed disabling.
    Response: As with other listings, we recognize that an individual 
might be unable to perform many forms of gainful activity with the 
level of impairment contemplated in the current listings, but we do not 
agree that the impairment would preclude any gainful activity. However, 
we realize that the NPRM incorrectly required fixation of both the 
dorsolumbar and the cervical spines. We agree with the commenter that 
the required fixation of either the dorsolumbar or cervical spine is 
sufficiently severe to be considered disabling and we changed final 
14.09B accordingly. Lesser degrees of involvement will be evaluated at 
later steps of the sequential evaluation process.
    Comment: One commenter recommended an additional listing for 
individuals who are developing ankylosing spondylitis, but whose spines 
have not yet ankylosed. The reasoning was that in these cases the 
disability produced by ankylosing spondylitis is actually less once the 
spine has ankylosed. Before that time, the individual is in severe 
pain, and on the basis of this severe pain, disability should be 
established.
    Response: Because pain is variable and some individuals might 
function fairly well while the process is occurring, while others might 
be more incapacitated by the pain, we cannot create a listing that 
would rely so exclusively on a symptom alone. We believe that the 
regulations on pain and other symptoms at Secs. 404.1529 and 416.929 
provide sufficient guidance on how to handle the types of situations 
described in the recommendation.

14.09D and E

    Comment: One commenter called listing 14.09D too complicated and 
stated that it will be difficult for adjudicators to apply, while 
others considered it and 14.09E vague. One suggested that the many 
cross-references to other listings and the nonspecific criteria in D2 
make these listings difficult to use. Three others called for more 
precise wording and definition of terms, particularly the term 
``moderate.'' Another commenter asked what ``lesser deformity than in 
B'' and ``lesser articular findings'' called for in 14.09E mean and 
suggested these terms be defined. Still another commenter suggested 
that these same three terms as used in the childhood listing, 114.09, 
need clarification. The same commenter asked how duration of morning 
stiffness can be documented.
    Response: We did not adopt all of these comments, but we did 
clarify the rules somewhat, as explained above in the summary of the 
changes. Listing 14.09D (and 114.09D) is based on, and uses the same 
criteria as, listings 14.02B, 14.03B, 14.04B, 14.05B and their 
counterparts in part B of the listings. As such, the new listing for 
inflammatory arthritides is consistent with our other existing listings 
for connective tissue disorders.

101.00B  Loss of Function

    Comment: One commenter noted, ``This section discusses functioning, 
but not sequential evaluation. We feel there should be a stronger 
reference to `age appropriate activities.'' `
    Response: The listings are not intended as a vehicle for describing 
the full sequential evaluation process.

[[Page 58036]]

Rather, this complex process is discussed throughout our regulations. 
Nevertheless, we recognize that musculoskeletal impairments impact 
differently on children depending on their ages, and we consider our 
references to ``age-appropriate activities'' to adequately detail this 
point. In final 101.00B2b(2), we explicitly state that, for children 
who are too young to walk independently, assessment of inability to 
ambulate effectively must be in terms of age-appropriate activities and 
normal developmental expectations, and we specifically define ``an 
extreme level of limitation'' for such children in terms of age-
appropriate activities. In final 101.00B2c(2), we provide similar 
language concerning inability to perform fine and gross movements 
effectively, and we cross-refer to listing 110.07A which describes 
motor dysfunction in infants and young children.
    Comment: One commenter found the criteria for evaluation of 
ineffective ambulation for children who are too young to be expected to 
walk independently ``a valuable addition to the listing as is the 
discussion of evaluation of the inability to perform fine and gross 
movements of the upper extremities for very young children in section 
B.2.'' However, another commenter suggested that listing-level 
disability for young children could be served by one set of criteria. 
The commenter suggested utilizing the criteria in listing 112.02B1a for 
gross and fine motor development for children 1-3 and 112.12B for motor 
development for infants up to age 1 year as an appropriate description 
of functional loss for ambulation, as well as fine and gross movement. 
These listings require motor development of no more than one-half of 
the child's chronological age. The commenter suggested that if the 
paragraphs are not changed, the examples given should be more specific 
for each age group.
    Response: We made a minor clarifying revision to the language in 
the sections in question, although we have not made the changes 
suggested. The language in the NPRM and the final sections already 
utilizes the concepts and, to a degree, the language of listings 
112.02B1a and 112.12B, as recommended, and we consider what we mean by 
loss of function for different aged children to be well-explained as 
written.

101.04  Disorders of the Spine

    Comment: One commenter stated that current listing 101.05B should 
be retained, because the commenter did not consider proposed listing 
114.09B to adequately apply to cases of scoliosis. However, another 
commenter agreed with the changes, stating that the new language in 
proposed 101.00J (final 101.00L) brings the listings up to basis would 
be evaluated under the criteria in date. A third commenter stated that 
if spina bifida and related impairments should be evaluated under this 
listing, we should spell it out.
    Response: Concerning scoliosis, we agree with the second commenter, 
which is why we are removing the current listing. Not only does this 
bring the listings up to date, but it enables the adult and childhood 
listings to more closely parallel each other. In paragraph 101.00K2, we 
indicate that with disorders such as spinal dysrhaphism there may be 
the types of difficulties evaluated under listing 101.04. Difficulties 
caused by dysrhaphism on a neurogenic 111.00ff. Although we believe 
this is sufficiently clear to explain how and where any form of 
dysrhaphism, including spina bifida would be evaluated, we have added 
the parenthetical remark, ``(e.g., spina bifida)'' after the words, 
``spinal dysrhaphism,'' to both 1.00K4, and 101.00K2 for further 
clarification.

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and have determined that these final regulations meet the criteria for 
an economically significant regulatory action under Executive Order 
(E.O.) 12866. They are also a ``major'' rule under 5 U.S.C. 801 ff. The 
following is a discussion of the potential costs and benefits of this 
regulatory action. This assessment also contains an analysis of 
alternatives we considered and chose not to adopt.
    These final rules benefit society by updating the current listings 
to provide criteria that reflect state-of-the-art medical science and 
technology. The final rules 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.
    We are projecting savings in program expenditures and increases in 
administrative costs as a result of these actions, described in more 
detail below.

Program Savings

1. Title II
    We estimate that these rules will result in reduced program outlays 
resulting in the following savings (in millions of dollars) to the 
title II program ($305 million total in a 5-year period beginning FY 
2001).

Fiscal year:
    2001.......................................................      $10
    2002.......................................................       35
    2003.......................................................       60
    2004.......................................................       85
    2005.......................................................      110
                                                                --------
      Total \1\................................................      305
 
\1\ 5-year total may not be equal to the sum of the annual totals due to
  rounding-out.

2. Title XVI
    We estimate that these rules will result in reduced program outlays 
resulting in the following savings (in millions of dollars) to the SSI 
program ($55 million total in a 5-year period beginning FY 2001).

Fiscal year:
    2001.......................................................       5$
    2002.......................................................        5
    2003.......................................................       10
    2004.......................................................       15
    2005.......................................................       20
                                                                --------
      Total \1\................................................       55
 
\1\ 5-year total may not be equal to the sum of the annual totals due to
  rounding-out.

3. Title XVIII
    We estimate that these rules will result in reduced program outlays 
resulting in the following savings (in millions of dollars) to the 
title XVIII program ($60 million total in a 5-year period beginning FY 
2001).

Fiscal year:
    2001.......................................................       $0
    2002.......................................................        0
    2003.......................................................       10
    2004.......................................................       20
    2005.......................................................       30
                                                                --------
      Total \1\................................................      60
 
\1\ 5-year total may not be equal to the sum of the annual totals due to
  rounding-out.

4. Title XIX
    We estimate that these rules will result in reduced program outlays 
resulting in the following savings (in millions of dollars) to the XIX 
program ($117 million total in a 5-year period beginning FY 2001).

Fiscal year:
    2001.......................................................       $4
    2002.......................................................       13
    2003.......................................................       23
    2004.......................................................       33
    2005.......................................................       44
                                                                --------
      Total \1\................................................     117
 
\1\ 5-year total may not be equal to the sum of the annual totals due to
  rounding-out.

Program Costs

    We do not expect any program costs to result from these 
regulations.

[[Page 58037]]

Administrative Savings

    We do not expect any administrative savings to result from these 
regulations.

Administrative Costs

    We expect there will be some administrative costs associated with 
these final rules. The final rules are expected to result in 
administrative costs of about 18WYs or about $1.5 million per year.

Policy Alternatives

    We considered keeping the current listing criteria with only minor 
technical changes. When the musculoskeletal listings were last revised 
and published in the Federal Register we indicated that medical 
advances in disability evaluationa nd treatment and program experience 
would require that we periodically review and update the medical 
criteria in the listings. The current listings are now over 15 years 
old. Medical advances in disability evaluation and treatment and our 
program experience make clear that the current listings are not an 
accurate reflection of state-of-the-art medical science and technology. 
A simple technical change would not be sufficient to provide state-of-
the-art criteria for deciding listing-level severity in musculoskeletal 
impairments. Therefore, we rejected this alternative.
    If we kept the current listing criteria and made only minor 
technical changes, the program and administrative costs would be the 
same as under the current rules.

Regulatory Flexibility Act

    We certify that these final regulations will not have a significant 
economic impact on a substantial number of small entities because they 
affect only individuals. Therefore, a regulatory flexibility analysis 
as provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    This final rules contain reporting requirements at: 1.00B; 1.00C; 
1.00D; 1.00E; 1.00H; 1.00I; 1.00J; 1.00K; 1.00P; 14.09A; 101.00B; 
101.00C; 101.00D; 101.00E; 101.00H; 101.00I; 101.00J; 101.00P; and 
114.09A. The public reporting burden is accounted for in the 
Information Collection Requests for the various forms that the public 
uses to submit the information to SSA. Consequently, a 1-hour 
placeholder burden is being assigned to the specific reporting 
requirement(s) contained in the rule. We are seeking clearance of the 
burden referenced in the rules because these rules were not considered 
during the clearance of the forms. An Information Collection Request 
has been submitted to OMB. While these rules will be effective 90 days 
from publication, these burdens will not be effective until cleared by 
OMB. We are soliciting comments on the burden estimate; the need for 
the information; its practical utility; ways to enhance its quality, 
utility and clarity; and on ways to minimize the burden on respondents, 
including the use of automated collection techniques or other forms of 
information technology. We will publish a notice in the Federal 
Register upon OMB approval of the informational collection 
requirement(s). Comments should be submitted to the OMB Desk Officer 
for SSA within 30 days of publication of this final rule at the 
following address:

Office of Management and Budget, Attn: Desk Officer for SSA, New 
Executive Office Building, Room 10230, 725 17th St., NW, Washington, DC 
20530.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security-Disability Insurance; 96.006, Supplemental Security Income)

List of Subjects

20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-Age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

20 CFR Part 416

    Administrative practice and procedure, Aged, Blind, Disability 
benefits, Public assistance programs, Reporting and recordkeeping 
requirements, Supplemental Security Income (SSI).

    Dated: October 16, 2001.
Larry G. Massanari,
Acting Commissioner of Social Security.

    For the reasons set out in the preamble, subpart P of part 404 and 
subpart I of part 416 of chapter III of title 20 of the Code of Federal 
Regulations are amended as set forth below:
    1. The authority citation for subpart P of part 404 continues to 
read as follows:

    Authority:  Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) 
and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act 
(42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i), 
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 
Stat. 2105, 2189.
    Appendix 1 to Subpart P of Part 404--[Amended]

    2. Item 2 in the introductory text before part A of appendix 1 to 
subpart P of part 404 is revised to read as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    2. Musculoskeletal System (1.00 and 101.00): February 19, 2009.
* * * * *
    3. Listing 1.00, Musculoskeletal System, of part A of appendix 1 of 
subpart P of part 404 is revised to read as follows:

1.00  MUSCULOSKELETAL SYSTEM

    A. Disorders of the musculoskeletal system may result from 
hereditary, congenital, or acquired pathologic processes. 
Impairments may result from infectious, inflammatory, or 
degenerative processes, traumatic or developmental events, or 
neoplastic, vascular, or toxic/metabolic diseases.
    B. Loss of function.
    1. General. Under this section, loss of function may be due to 
bone or joint deformity or destruction from any cause; miscellaneous 
disorders of the spine with or without radiculopathy or other 
neurological deficits; amputation; or fractures or soft tissue 
injuries, including burns, requiring prolonged periods of immobility 
or convalescence. For inflammatory arthritides that may result in 
loss of function because of inflammatory peripheral joint or axial 
arthritis or sequelae, or because of extra-articular features, see 
14.00B6. Impairments with neurological causes are to be evaluated 
under 11.00ff.

2. How We Define Loss of Function in These Listings

    a. General. Regardless of the cause(s) of a musculoskeletal 
impairment, functional loss for purposes of these listings is 
defined as the inability to ambulate effectively on a sustained 
basis for any reason, including pain associated with the underlying 
musculoskeletal impairment, or the inability to perform fine and 
gross movements effectively on a sustained basis for any reason, 
including pain associated with the underlying musculoskeletal 
impairment. The inability to ambulate effectively or the inability 
to perform fine and gross movements effectively must have lasted, or 
be expected to last, for at least 12 months. For the purposes of 
these criteria, consideration of the ability to perform these 
activities must be from a physical standpoint alone. When there is 
an inability to perform these activities due to a mental impairment, 
the criteria in 12.00ff are to be used. We will determine whether an 
individual can ambulate effectively or can perform fine and gross 
movements effectively based on the medical and other evidence in the 
case record, generally without developing additional evidence about 
the individual's ability to perform the specific activities listed 
as examples in 1.00B2b(2) and 1.00B2c.

b. What We Mean by Inability to Ambulate Effectively

    (1) Definition. Inability to ambulate effectively means an 
extreme limitation of

[[Page 58038]]

the ability to walk; i.e., an impairment(s) that interferes very 
seriously with the individual's ability to independently initiate, 
sustain, or complete activities. Ineffective ambulation is defined 
generally as having insufficient lower extremity functioning (see 
1.00J) to permit independent ambulation without the use of a hand-
held assistive device(s) that limits the functioning of both upper 
extremities. (Listing 1.05C is an exception to this general 
definition because the individual has the use of only one upper 
extremity due to amputation of a hand.)
    (2) To ambulate effectively, individuals must be capable of 
sustaining a reasonable walking pace over a sufficient distance to 
be able to carry out activities of daily living. They must have the 
ability to travel without companion assistance to and from a place 
of employment or school. Therefore, examples of ineffective 
ambulation include, but are not limited to, the inability to walk 
without the use of a walker, two crutches or two canes, the 
inability to walk a block at a reasonable pace on rough or uneven 
surfaces, the inability to use standard public transportation, the 
inability to carry out routine ambulatory activities, such as 
shopping and banking, and the inability to climb a few steps at a 
reasonable pace with the use of a single hand rail. The ability to 
walk independently about one's home without the use of assistive 
devices does not, in and of itself, constitute effective ambulation.
    c. What we mean by inability to perform fine and gross movements 
effectively. Inability to perform fine and gross movements 
effectively means an extreme loss of function of both upper 
extremities; i.e., an impairment(s) that interferes very seriously 
with the individual's ability to independently initiate, sustain, or 
complete activities. To use their upper extremities effectively, 
individuals must be capable of sustaining such functions as 
reaching, pushing, pulling, grasping, and fingering to be able to 
carry out activities of daily living. Therefore, examples of 
inability to perform fine and gross movements effectively include, 
but are not limited to, the inability to prepare a simple meal and 
feed oneself, the inability to take care of personal hygiene, the 
inability to sort and handle papers or files, and the inability to 
place files in a file cabinet at or above waist level.
    d. Pain or other symptoms. Pain or other symptoms may be an 
important factor contributing to functional loss. In order for pain 
or other symptoms to be found to affect an individual's ability to 
perform basic work activities, medical signs or laboratory findings 
must show the existence of a medically determinable impairment(s) 
that could reasonably be expected to produce the pain or other 
symptoms. The musculoskeletal listings that include pain or other 
symptoms among their criteria also include criteria for limitations 
in functioning as a result of the listed impairment, including 
limitations caused by pain. It is, therefore, important to evaluate 
the intensity and persistence of such pain or other symptoms 
carefully in order to determine their impact on the individual's 
functioning under these listings. See also Secs. 404.1525(f) and 
404.1529 of this part, and Secs. 416.925(f) and 416.929 of part 416 
of this chapter.

C. Diagnosis and Evaluation

    1. General. Diagnosis and evaluation of musculoskeletal 
impairments should be supported, as applicable, by detailed 
descriptions of the joints, including ranges of motion, condition of 
the musculature (e.g., weakness, atrophy), sensory or reflex 
changes, circulatory deficits, and laboratory findings, including 
findings on x-ray or other appropriate medically acceptable imaging. 
Medically acceptable imaging includes, but is not limited to, x-ray 
imaging, computerized axial tomography (CAT scan) or magnetic 
resonance imaging (MRI), with or without contrast material, 
myelography, and radionuclear bone scans. ``Appropriate'' means that 
the technique used is the proper one to support the evaluation and 
diagnosis of the impairment.
    2. Purchase of certain medically acceptable imaging. While any 
appropriate medically acceptable imaging is useful in establishing 
the diagnosis of musculoskeletal impairments, some tests, such as 
CAT scans and MRIs, are quite expensive, and we will not routinely 
purchase them. Some, such as myelograms, are invasive and may 
involve significant risk. We will not order such tests. However, 
when the results of any of these tests are part of the existing 
evidence in the case record we will consider them together with the 
other relevant evidence.
    3. Consideration of electrodiagnostic procedures. 
Electrodiagnostic procedures may be useful in establishing the 
clinical diagnosis, but do not constitute alternative criteria to 
the requirements of 1.04.
    D. The physical examination must include a detailed description 
of the rheumatological, orthopedic, neurological, and other findings 
appropriate to the specific impairment being evaluated. These 
physical findings must be determined on the basis of objective 
observation during the examination and not simply a report of the 
individual's allegation; e.g., ``He says his leg is weak, numb.'' 
Alternative testing methods should be used to verify the abnormal 
findings; e.g., a seated straight-leg raising test in addition to a 
supine straight-leg raising test. Because abnormal physical findings 
may be intermittent, their presence over a period of time must be 
established by a record of ongoing management and evaluation. Care 
must be taken to ascertain that the reported examination findings 
are consistent with the individual's daily activities.

E. Examination of the Spine

    1. General. Examination of the spine should include a detailed 
description of gait, range of motion of the spine given 
quantitatively in degrees from the vertical position (zero degrees) 
or, for straight-leg raising from the sitting and supine position 
(zero degrees), any other appropriate tension signs, motor and 
sensory abnormalities, muscle spasm, when present, and deep tendon 
reflexes. Observations of the individual during the examination 
should be reported; e.g., how he or she gets on and off the 
examination table. Inability to walk on the heels or toes, to squat, 
or to arise from a squatting position, when appropriate, may be 
considered evidence of significant motor loss. However, a report of 
atrophy is not acceptable as evidence of significant motor loss 
without circumferential measurements of both thighs and lower legs, 
or both upper and lower arms, as appropriate, at a stated point 
above and below the knee or elbow given in inches or centimeters. 
Additionally, a report of atrophy should be accompanied by 
measurement of the strength of the muscle(s) in question generally 
based on a grading system of 0 to 5, with 0 being complete loss of 
strength and 5 being maximum strength. A specific description of 
atrophy of hand muscles is acceptable without measurements of 
atrophy but should include measurements of grip and pinch strength.
    2. When neurological abnormalities persist. Neurological 
abnormalities may not completely subside after treatment or with the 
passage of time. Therefore, residual neurological abnormalities that 
persist after it has been determined clinically or by direct 
surgical or other observation that the ongoing or progressive 
condition is no longer present will not satisfy the required 
findings in 1.04. More serious neurological deficits (paraparesis, 
paraplegia) are to be evaluated under the criteria in 11.00ff.
    F. Major joints refers to the major peripheral joints, which are 
the hip, knee, shoulder, elbow, wrist-hand, and ankle-foot, as 
opposed to other peripheral joints (e.g., the joints of the hand or 
forefoot) or axial joints (i.e., the joints of the spine.) The wrist 
and hand are considered together as one major joint, as are the 
ankle and foot. Since only the ankle joint, which consists of the 
juncture of the bones of the lower leg (tibia and fibula) with the 
hindfoot (tarsal bones), but not the forefoot, is crucial to weight 
bearing, the ankle and foot are considered separately in evaluating 
weight bearing.
    G. Measurements of joint motion are based on the techniques 
described in the chapter on the extremities, spine, and pelvis in 
the current edition of the ``Guides to the Evaluation of Permanent 
Impairment'' published by the American Medical Association.

H. Documentation

    1. General. Musculoskeletal impairments frequently improve with 
time or respond to treatment. Therefore, a longitudinal clinical 
record is generally important for the assessment of severity and 
expected duration of an impairment unless the claim can be decided 
favorably on the basis of the current evidence.
    2. Documentation of medically prescribed treatment and response. 
Many individuals, especially those who have listing-level 
impairments, will have received the benefit of medically prescribed 
treatment. Whenever evidence of such treatment is available it must 
be considered.
    3. When there is no record of ongoing treatment. Some 
individuals will not have received ongoing treatment or have an 
ongoing relationship with the medical community despite the 
existence of a severe impairment(s). In such cases, evaluation will 
be made on the basis of the current objective

[[Page 58039]]

medical evidence and other available evidence, taking into 
consideration the individual's medical history, symptoms, and 
medical source opinions. Even though an individual who does not 
receive treatment may not be able to show an impairment that meets 
the criteria of one of the musculoskeletal listings, the individual 
may have an impairment(s) equivalent in severity to one of the 
listed impairments or be disabled based on consideration of his or 
her residual functional capacity (RFC) and age, education and work 
experience.
    4. Evaluation when the criteria of a musculoskeletal listing are 
not met. These listings are only examples of common musculoskeletal 
disorders that are severe enough to prevent a person from engaging 
in gainful activity. Therefore, in any case in which an individual 
has a medically determinable impairment that is not listed, an 
impairment that does not meet the requirements of a listing, or a 
combination of impairments no one of which meets the requirements of 
a listing, we will consider medical equivalence. (See Secs. 404.1526 
and 416.926.) Individuals who have an impairment(s) with a level of 
severity that does not meet or equal the criteria of the 
musculoskeletal listings may or may not have the RFC that would 
enable them to engage in substantial gainful activity. Evaluation of 
the impairment(s) of these individuals should proceed through the 
final steps of the sequential evaluation process in Secs. 404.1520 
and 416.920 (or, as appropriate, the steps in the medical 
improvement review standard in Secs. 404.1594 and 416.994).

I. Effects of Treatment

    1. General. Treatments for musculoskeletal disorders may have 
beneficial effects or adverse side effects. Therefore, medical 
treatment (including surgical treatment) must be considered in terms 
of its effectiveness in ameliorating the signs, symptoms, and 
laboratory abnormalities of the disorder, and in terms of any side 
effects that may further limit the individual.
    2. Response to treatment. Response to treatment and adverse 
consequences of treatment may vary widely. For example, a pain 
medication may relieve an individual's pain completely, partially, 
or not at all. It may also result in adverse effects, e.g., 
drowsiness, dizziness, or disorientation, that compromise the 
individual's ability to function. Therefore, each case must be 
considered on an individual basis, and include consideration of the 
effects of treatment on the individual's ability to function.
    3. Documentation. A specific description of the drugs or 
treatment given (including surgery), dosage, frequency of 
administration, and a description of the complications or response 
to treatment should be obtained. The effects of treatment may be 
temporary or long-term. As such, the finding regarding the impact of 
treatment must be based on a sufficient period of treatment to 
permit proper consideration or judgment about future functioning.

J. Orthotic, Prosthetic, or Assistive Devices

    1. General. Consistent with clinical practice, individuals with 
musculoskeletal impairments may be examined with and without the use 
of any orthotic, prosthetic, or assistive devices as explained in 
this section.
    2. Orthotic devices. Examination should be with the orthotic 
device in place and should include an evaluation of the individual's 
maximum ability to function effectively with the orthosis. It is 
unnecessary to routinely evaluate the individual's ability to 
function without the orthosis in place. If the individual has 
difficulty with, or is unable to use, the orthotic device, the 
medical basis for the difficulty should be documented. In such 
cases, if the impairment involves a lower extremity or extremities, 
the examination should include information on the individual's 
ability to ambulate effectively without the device in place unless 
contraindicated by the medical judgment of a physician who has 
treated or examined the individual.
    3. Prosthetic devices. Examination should be with the prosthetic 
device in place. In amputations involving a lower extremity or 
extremities, it is unnecessary to evaluate the individual's ability 
to walk without the prosthesis in place. However, the individual's 
medical ability to use a prosthesis to ambulate effectively, as 
defined in 1.00B2b, should be evaluated. The condition of the stump 
should be evaluated without the prosthesis in place.
    4. Hand-held assistive devices. When an individual with an 
impairment involving a lower extremity or extremities uses a hand-
held assistive device, such as a cane, crutch or walker, examination 
should be with and without the use of the assistive device unless 
contraindicated by the medical judgment of a physician who has 
treated or examined the individual. The individual's ability to 
ambulate with and without the device provides information as to 
whether, or the extent to which, the individual is able to ambulate 
without assistance. The medical basis for the use of any assistive 
device (e.g., instability, weakness) should be documented. The 
requirement to use a hand-held assistive device may also impact on 
the individual's functional capacity by virtue of the fact that one 
or both upper extremities are not available for such activities as 
lifting, carrying, pushing, and pulling.
    K. Disorders of the spine, listed in 1.04, result in limitations 
because of distortion of the bony and ligamentous architecture of 
the spine and associated impingement on nerve roots (including the 
cauda equina) or spinal cord. Such impingement on nerve tissue may 
result from a herniated nucleus pulposus, spinal stenosis, 
arachnoiditis, or other miscellaneous conditions. Neurological 
abnormalities resulting from these disorders are to be evaluated by 
referral to the neurological listings in 11.00ff, as appropriate. 
(See also 1.00B and E.)
    1. Herniated nucleus pulposus is a disorder frequently 
associated with the impingement of a nerve root. Nerve root 
compression results in a specific neuro-anatomic distribution of 
symptoms and signs depending upon the nerve root(s) compromised.

2. Spinal Arachnoiditis

    a. General. Spinal arachnoiditis is a condition characterized by 
adhesive thickening of the arachnoid which may cause intermittent 
ill-defined burning pain and sensory dysesthesia, and may cause 
neurogenic bladder or bowel incontinence when the cauda equina is 
involved.
    b. Documentation. Although the cause of spinal arachnoiditis is 
not always clear, it may be associated with chronic compression or 
irritation of nerve roots (including the cauda equina) or the spinal 
cord. For example, there may be evidence of spinal stenosis, or a 
history of spinal trauma or meningitis. Diagnosis must be confirmed 
at the time of surgery by gross description, microscopic examination 
of biopsied tissue, or by findings on appropriate medically 
acceptable imaging. Arachnoiditis is sometimes used as a diagnosis 
when such a diagnosis is unsupported by clinical or laboratory 
findings. Therefore, care must be taken to ensure that the diagnosis 
is documented as described in 1.04B. Individuals with arachnoiditis, 
particularly when it involves the lumbosacral spine, are generally 
unable to sustain any given position or posture for more than a 
short period of time due to pain.
    3. Lumbar spinal stenosis is a condition that may occur in 
association with degenerative processes, or as a result of a 
congenital anomaly or trauma, or in association with Paget's disease 
of the bone. Pseudoclaudication, which may result from lumbar spinal 
stenosis, is manifested as pain and weakness, and may impair 
ambulation. Symptoms are usually bilateral, in the low back, 
buttocks, or thighs, although some individuals may experience only 
leg pain and, in a few cases, the leg pain may be unilateral. The 
pain generally does not follow a particular neuro-anatomical 
distribution, i.e., it is distinctly different from the radicular 
type of pain seen with a herniated intervertebral disc, is often of 
a dull, aching quality, which may be described as ``discomfort'' or 
an ``unpleasant sensation,'' or may be of even greater severity, 
usually in the low back and radiating into the buttocks region 
bilaterally. The pain is provoked by extension of the spine, as in 
walking or merely standing, but is reduced by leaning forward. The 
distance the individual has to walk before the pain comes on may 
vary. Pseudoclaudication differs from peripheral vascular 
claudication in several ways. Pedal pulses and Doppler examinations 
are unaffected by pseudoclaudication. Leg pain resulting from 
peripheral vascular claudication involves the calves, and the leg 
pain in vascular claudication is ordinarily more severe than any 
back pain that may also be present. An individual with vascular 
claudication will experience pain after walking the same distance 
time after time, and the pain will be relieved quickly when walking 
stops.
    4. Other miscellaneous conditions that may cause weakness of the 
lower extremities, sensory changes, areflexia, trophic ulceration, 
bladder or bowel incontinence, and that should be evaluated under 
1.04 include, but are not limited to, osteoarthritis, degenerative 
disc disease, facet arthritis, and vertebral fracture. Disorders 
such as spinal dysrhaphism (e.g., spina bifida), diastematomyelia, 
and tethered cord

[[Page 58040]]

syndrome may also cause such abnormalities. In these cases, there 
may be gait difficulty and deformity of the lower extremities based 
on neurological abnormalities, and the neurological effects are to 
be evaluated under the criteria in 11.00ff.
    L. Abnormal curvatures of the spine. Abnormal curvatures of the 
spine (specifically, scoliosis, kyphosis and kyphoscoliosis) can 
result in impaired ambulation, but may also adversely affect 
functioning in body systems other than the musculoskeletal system. 
For example, an individual's ability to breathe may be affected; 
there may be cardiac difficulties (e.g., impaired myocardial 
function); or there may be disfigurement resulting in withdrawal or 
isolation. When there is impaired ambulation, evaluation of 
equivalence may be made by reference to 14.09A. When the abnormal 
curvature of the spine results in symptoms related to fixation of 
the dorsolumbar or cervical spine, evaluation of equivalence may be 
made by reference to 14.09B. When there is respiratory or cardiac 
involvement or an associated mental disorder, evaluation may be made 
under 3.00ff, 4.00ff, or 12.00ff, as appropriate. Other consequences 
should be evaluated according to the listing for the affected body 
system.
    M. Under continuing surgical management, as used in 1.07 and 
1.08, refers to surgical procedures and any other associated 
treatments related to the efforts directed toward the salvage or 
restoration of functional use of the affected part. It may include 
such factors as post-surgical procedures, surgical complications, 
infections, or other medical complications, related illnesses, or 
related treatments that delay the individual's attainment of maximum 
benefit from therapy.
    N. After maximum benefit from therapy has been achieved in 
situations involving fractures of an upper extremity (1.07), or soft 
tissue injuries (1.08), i.e., there have been no significant changes 
in physical findings or on appropriate medically acceptable imaging 
for any 6-month period after the last definitive surgical procedure 
or other medical intervention, evaluation must be made on the basis 
of the demonstrable residuals, if any. A finding that 1.07 or 1.08 
is met must be based on a consideration of the symptoms, signs, and 
laboratory findings associated with recent or anticipated surgical 
procedures and the resulting recuperative periods, including any 
related medical complications, such as infections, illnesses, and 
therapies which impede or delay the efforts toward restoration of 
function. Generally, when there has been no surgical or medical 
intervention for 6 months after the last definitive surgical 
procedure, it can be concluded that maximum therapeutic benefit has 
been reached. Evaluation at this point must be made on the basis of 
the demonstrable residual limitations, if any, considering the 
individual's impairment-related symptoms, signs, and laboratory 
findings, any residual symptoms, signs, and laboratory findings 
associated with such surgeries, complications, and recuperative 
periods, and other relevant evidence.
    O. Major function of the face and head, for purposes of listing 
1.08, relates to impact on any or all of the activities involving 
vision, hearing, speech, mastication, and the initiation of the 
digestive process.
    P. When surgical procedures have been performed, documentation 
should include a copy of the operative notes and available pathology 
reports.
    Q. Effects of obesity. Obesity is a medically determinable 
impairment that is often associated with disturbance of the 
musculoskeletal system, and disturbance of this system can be a 
major cause of disability in individuals with obesity. The combined 
effects of obesity with musculoskeletal impairments can be greater 
than the effects of each of the impairments considered separately. 
Therefore, when determining whether an individual with obesity has a 
listing-level impairment or combination of impairments, and when 
assessing a claim at other steps of the sequential evaluation 
process, including when assessing an individual's residual 
functional capacity, adjudicators must consider any additional and 
cumulative effects of obesity.

1.01  Category of Impairments, Musculoskeletal

    1.02 Major dysfunction of a joint(s) (due to any cause): 
Characterized by gross anatomical deformity (e.g., subluxation, 
contracture, bony or fibrous ankylosis, instability) and chronic 
joint pain and stiffness with signs of limitation of motion or other 
abnormal motion of the affected joint(s), and findings on 
appropriate medically acceptable imaging of joint space narrowing, 
bony destruction, or ankylosis of the affected joint(s). With:
    A. Involvement of one major peripheral weight-bearing joint 
(i.e., hip, knee, or ankle), resulting in inability to ambulate 
effectively, as defined in 1.00B2b;

or

    B. Involvement of one major peripheral joint in each upper 
extremity (i.e., shoulder, elbow, or wrist-hand), resulting in 
inability to perform fine and gross movements effectively, as 
defined in 1.00B2c.
    1.03 Reconstructive surgery or surgical arthrodesis of a major 
weight-bearing joint, with inability to ambulate effectively, as 
defined in 1.00B2b, and return to effective ambulation did not 
occur, or is not expected to occur, within 12 months of onset.
    1.04  Disorders of the spine (e.g., herniated nucleus pulposus, 
spinal arachnoiditis, spinal stenosis, osteoarthritis, degenerative 
disc disease, facet arthritis, vertebral fracture), resulting in 
compromise of a nerve root (including the cauda equina) or the 
spinal cord. With:
    A. Evidence of nerve root compression characterized by neuro-
anatomic distribution of pain, limitation of motion of the spine, 
motor loss (atrophy with associated muscle weakness or muscle 
weakness) accompanied by sensory or reflex loss and, if there is 
involvement of the lower back, positive straight-leg raising test 
(sitting and supine);

or

    B. Spinal arachnoiditis, confirmed by an operative note or 
pathology report of tissue biopsy, or by appropriate medically 
acceptable imaging, manifested by severe burning or painful 
dysesthesia, resulting in the need for changes in position or 
posture more than once every 2 hours;
or

    C. Lumbar spinal stenosis resulting in pseudoclaudication, 
established by findings on appropriate medically acceptable imaging, 
manifested by chronic nonradicular pain and weakness, and resulting 
in inability to ambulate effectively, as defined in 1.00B2b.
    1.05 Amputation (due to any cause).
    A. Both hands; or

or

    B. One or both lower extremities at or above the tarsal region, 
with stump complications resulting in medical inability to use a 
prosthetic device to ambulate effectively, as defined in 1.00B2b, 
which have lasted or are expected to last for at least 12 months;
or

    C. One hand and one lower extremity at or above the tarsal 
region, with inability to ambulate effectively, as defined in 
1.00B2b; OR
    D. Hemipelvectomy or hip disarticulation.

    1.06 Fracture of the femur, tibia, pelvis, or one or more of the 
tarsal bones. With:
    A. Solid union not evident on appropriate medically acceptable 
imaging and not clinically solid;
and

    B. Inability to ambulate effectively, as defined in 1.00B2b, and 
return to effective ambulation did not occur or is not expected to 
occur within 12 months of onset.
    1.07 Fracture of an upper extremity with nonunion of a fracture 
of the shaft of the humerus, radius, or ulna, under continuing 
surgical management, as defined in 1.00M, directed toward 
restoration of functional use of the extremity, and such function 
was not restored or expected to be restored within 12 months of 
onset.
    1.08 Soft tissue injury (e.g., burns) of an upper or lower 
extremity, trunk, or face and head, under continuing surgical 
management, as defined in 1.00M, directed toward the salvage or 
restoration of major function, and such major function was not 
restored or expected to be restored within 12 months of onset. Major 
function of the face and head is described in 1.000.


    4. Under listing 4.00, Cadiovascular System, listing 4.12, 
Peripheral arterial disease, of part A of appendix 1 of subpart P of 
part 404 is revised to read as follows:

4.00  CARDIOVASCULAR SYSTEM

* * * * *
    4.12 Peripheral arterial disease. With one of the following:
    A. Intermittent claudication with failure to visualize (on 
arteriogram obtained independent of Social Security disability 
evaluation) the common femoral or deep femoral artery in one 
extremity;

or

    B. Intermittent claudication with marked impairment of 
peripheral arterial circulation as determined by Doppler studies 
showing:
    1. Resting ankle/brachial systolic blood pressure ratio of less 
than 0.50; or

[[Page 58041]]

    2. Decrease in systolic blood pressure at the ankle on exercise 
(see 4.00E4) of 50 percent or more of pre-exercise level at the 
ankle, and requiring 10 minutes or more to return to pre-exercise 
level.

    5. Under listing 9.00, Endocrine System, listing 9.08, Diabetes 
mellitus of part A of appendix 1 of subpart P of part 404 is amended by 
removing listing 9.08C and redesignating listing 9.08D as listing 
9.08C.

    6. Listing 14.00, Immune System, of part A of appendix 1 of subpart 
P of part 404 is amended by revising the fourth and sixth paragraphs 
within 14.00 B and by adding a new section 14.00B6 to read as follows:

14.00  IMMUNE SYSTEM

* * * * *
    B. * * *
    To permit appropriate application of a listing, the specific 
diagnostic features that should be documented in the clinical record 
for each of the disorders are summarized for systemic lupus 
erythematosus (SLE), systemic vasculitis, systemic sclerosis and 
scleroderma, polymyositis or dermatomyositis, undifferentiated 
connective tissue disorders, and the inflammatory arthritides.
* * * * *
    These disorders may preclude performance of any gainful activity 
by reason of serious loss of function because of disease affecting a 
single organ or body system, or lesser degrees of functional loss 
because of disease affecting two or more organs/body systems 
associated with significant constitutional symptoms and signs of 
severe fatigue, fever, malaise, weight loss, and joint pain and 
stiffness. We use the term ``severe'' in these listings to describe 
medical severity; the term does not have the same meaning as it does 
when we use it in connection with a finding at the second step of 
the sequential evaluation processes in Secs. 404.1520, 416.920, and 
416.924.
* * * * *
    6. Inflammatory arthritis (14.09) includes a vast array of 
disorders that differ in cause, course, and outcome. For example, 
inflammatory spondyloarthropathies include ankylosing spondylitis, 
Reiter's syndrome and other reactive arthropathies, psoriatic 
arthropathy, Behcet's disease, and Whipple's disease, as well as 
undifferentiated spondylitis. Inflammatory arthritis of peripheral 
joints likewise comprises many disorders, including rheumatoid 
arthritis, Sjogren's syndrome, psoriatic arthritis, crystal 
deposition disorders, and Lyme disease. Clinically, inflammation of 
major joints may be the dominant problem causing difficulties with 
ambulation or fine and gross movements, or the arthritis may involve 
other joints or cause less restriction of ambulation or other 
movements but be complicated by extra-articular features that 
cumulatively result in serious functional deficit. When persistent 
deformity without ongoing inflammation is the dominant feature of 
the impairment, it should be evaluated under 1.02, or, if there has 
been surgical reconstruction, 1.03.
    a. In 14.09A, the term major joints refers to the major 
peripheral joints, which are the hip, knee, shoulder, elbow, wrist-
hand, and ankle-foot, as opposed to other peripheral joints (e.g., 
the joints of the hand or forefoot) or axial joints (i.e., the 
joints of the spine.) The wrist and hand are considered together as 
one major joint, as are the ankle and foot. Since only the ankle 
joint, which consists of the juncture of the bones of the lower leg 
(tibia and fibula) with the hindfoot (tarsal bones), but not the 
forefoot, is crucial to weight bearing, the ankle and foot are 
considered separately in evaluating weight bearing.
    b. The terms inability to ambulate effectively and inability to 
perform fine and gross movements effectively in 14.09A have the same 
meaning as in 1.00B2b and 1.00B2c and must have lasted, or be 
expected to last, for at least 12 months.
    c. Inability to ambulate effectively is implicit in 14.09B. Even 
though individuals who demonstrate the findings of 14.09B will not 
ordinarily require bilateral upper limb assistance, the required 
ankylosis of the cervical or dorsolumbar spine will result in an 
extreme loss of the ability to see ahead, above, and to the side.
    d. As in 14.02 through 14.06, extra-articular features of an 
inflammatory arthritis may satisfy the criteria for a listing in an 
involved extra-articular body system. Such impairments may be found 
to meet a criterion of 14.09C. Extra-articular impairments of lesser 
severity should be evaluated under 14.09D and 14.09E. Commonly 
occurring extra-articular impairments include keratoconjunctivitis 
sicca, uveitis, iridocyclitis, pleuritis, pulmonary fibrosis or 
nodules, restrictive lung disease, pericarditis, myocarditis, 
cardiac arrhythmias, aortic valve insufficiency, coronary arteritis, 
Raynaud's phenomena, systemic vasculitis, amyloidosis of the kidney, 
chronic anemia, thrombocytopenia, hypersplenism with compromised 
immune competence (Felty's syndrome), peripheral neuropathy, 
radiculopathy, spinal cord or cauda equina compression with sensory 
and motor loss, and heel enthesopathy with functionally limiting 
pain.
    e. The fact that an individual is dependent on steroids, or any 
other drug, for the control of inflammatory arthritis is, in and of 
itself, insufficient to find disability. Advances in the treatment 
of inflammatory connective tissue disease and in the administration 
of steroids for its treatment have corrected some of the previously 
disabling consequences of continuous steroid use. Therefore, each 
case must be evaluated on its own merits, taking into consideration 
the severity of the underlying impairment and any adverse effects of 
treatment.

* * * * *

    7. In listing 14.02A, listings 14.02A8 through 14.02A10 are 
redesignated as listings 14.02A9 through 14.02A11, respectively and a 
new listing 14.02A8 is added reading as follows:
    14.02  Systemic lupus erythematosus. * * *
    A. One of the following:
* * * * *
    8. Hematologic involvement, as described under the criteria in 
7.00ff; or
* * * * *

    8. A new listing 14.09 is added to read as follows:

    14.09  Inflammatory arthritis. Documented as described in 
14.00B6, with one of the following:
    A. History of joint pain, swelling, and tenderness, and signs on 
current physical examination of joint inflammation or deformity in 
two or more major joints resulting in inability to ambulate 
effectively or inability to perform fine and gross movements 
effectively, as defined in 14.00B6b and 1.00B2b and B2c;

or

    B. Ankylosing spondylitis or other spondyloarthropathy, with 
diagnosis established by findings of unilateral or bilateral 
sacroiliitis (e.g., erosions or fusions), shown by appropriate 
medically acceptable imaging, with both:
    1. History of back pain, tenderness, and stiffness, and
    2. Findings on physical examination of ankylosis (fixation) of 
the dorsolumbar or cervical spine at 45 deg. or more of flexion 
measured from the vertical position (zero degrees);

or

    C. An impairment as described under the criteria in 14.02A.

or

    D. Inflammatory arthritis, with signs of peripheral joint 
inflammation on current examination, but with lesser joint 
involvement than in A and lesser extra-articular features than in C, 
and:
    1. Significant, documented constitutional symptoms and signs 
(e.g., fatigue, fever, malaise, weight loss), and
    2. Involvement of two or more organs/body systems (see 
14.00B6d). At least one of the organs/body systems must be involved 
to at least a moderate level of severity.

or

    E. Inflammatory spondylitis or other inflammatory 
spondyloarthropathies, with lesser deformity than in B and lesser 
extra-articular features than in C, with signs of unilateral or 
bilateral sacroiliitis on appropriate medically acceptable imaging; 
and with the extra-articular features described in 14.09D.


    9. Listing 101.00, Musculoskeletal System, of part B of appendix 1 
of subpart P of part 404 is revised to read as follows:

101.00  Musculoskeletal System

    A. Disorders of the musculoskeletal system may result from 
hereditary, congenital, or acquired pathologic processes. 
Impairments may result from infectious, inflammatory, or 
degenerative processes, traumatic or developmental events, or 
neoplastic, vascular, or toxic/metabolic diseases.

[[Page 58042]]

B. Loss of Function

    1. General. Under this section, loss of function may be due to 
bone or joint deformity or destruction from any cause; miscellaneous 
disorders of the spine with or without radiculopathy or other 
neurological deficits; amputation; or fractures or soft tissue 
injuries, including burns, requiring prolonged periods of immobility 
or convalescence. For inflammatory arthritides that result in loss 
of function because of inflammatory peripheral joint or axial 
arthritis or sequelae, or because of extra-articular features, see 
114.00E. Impairments with neurological causes are to be evaluated 
under 111.00ff.

2. How We Define Loss of Function in These Listings

    a. General. Regardless of the cause(s) of a musculoskeletal 
impairment, functional loss for purposes of these listings is 
defined as the inability to ambulate effectively on a sustained 
basis for any reason, including pain associated with the underlying 
musculoskeletal impairment, or the inability to perform fine and 
gross movements effectively on a sustained basis for any reason, 
including pain associated with the underlying musculoskeletal 
impairment. The inability to ambulate effectively or the inability 
to perform fine and gross movements effectively must have lasted, or 
be expected to last, for at least 12 months. For the purposes of 
these criteria, consideration of the ability to perform these 
activities must be from a physical standpoint alone. When there is 
an inability to perform these activities due to a mental impairment, 
the criteria in 112.00ff are to be used. We will determine whether a 
child can ambulate effectively or can perform fine and gross 
movements effectively based on the medical and other evidence in the 
case record, generally without developing additional evidence about 
the child's ability to perform the specific activities listed as 
examples in 101.00B2b(2) and (3) and 101.00B2c(2) and (3).

b. What We Mean by Inability to Ambulate Effectively

    (1) Definition. Inability to ambulate effectively means an 
extreme limitation of the ability to walk; i.e., an impairment that 
interferes very seriously with the child's ability to independently 
initiate, sustain, or complete activities. Ineffective ambulation is 
defined generally as having insufficient lower extremity functioning 
(see 101.00J) to permit independent ambulation without the use of a 
hand-held assistive device(s) that limits the functioning of both 
upper extremities. (Listing 101.05C is an exception to this general 
definition because the child has the use of only one upper extremity 
due to amputation of a hand.)

(2) How We Assess inability to ambulate effectively for children 
too young to be expected to walk independently. For children who 
are too young to be expected to walk independently, consideration 
of function must be based on assessment of limitations in the 
ability to perform comparable age-appropriate activities with the 
lower extremities, given normal developmental expectations. For 
such children, an extreme level of limitation means skills or 
performance at no greater than one-half of age-appropriate 
expectations based on an overall developmental assessment rather 
than on one or two isolated skills.

    (3) How we assess inability to ambulate effectively for older 
children. Older children, who would be expected to be able to walk 
when compared to other children the same age who do not have 
impairments, must be capable of sustaining a reasonable walking pace 
over a sufficient distance to be able to carry out age-appropriate 
activities. They must have the ability to travel age-appropriately 
without extraordinary assistance to and from school or a place of 
employment. Therefore, examples of ineffective ambulation for older 
children include, but are not limited to, the inability to walk 
without the use of a walker, two crutches or two canes, the 
inability to walk a block at a reasonable pace on rough or uneven 
surfaces, the inability to use standard public transportation, the 
inability to carry out age-appropriate school activities 
independently, and the inability to climb a few steps at a 
reasonable pace with the use of a single hand rail. The ability to 
walk independently about the child's home or a short distance at 
school without the use of assistive devices does not, in and of 
itself, constitute effective ambulation.

c. What We Mean by Inability To Perform Fine and Gross Movements 
Effectively

    (1) Definition. Inability to perform fine and gross movements 
effectively means an extreme loss of function of both upper 
extremities; i.e., an impairment that interferes very seriously with 
the child's ability to independently initiate, sustain, or complete 
activities. To use their upper extremities effectively, a child must 
be capable of sustaining such functions as reaching, pushing, 
pulling, grasping, and fingering in an age-appropriate manner to be 
able to carry out age-appropriate activities.
    (2) How we assess inability to perform fine and gross movements 
in very young children. For very young children, the consideration 
is limitations in the ability to perform comparable age-appropriate 
activities involving the upper extremities given normal 
developmental expectations. Determinations of extreme limitation in 
such children should be made by comparison with the limitations for 
persistent motor dysfunction for infants and young children 
described in 110.07A.
    (3) How we assess inability to perform fine and gross movements 
in older children. For older children, examples of inability to 
perform fine and gross movements effectively include, but are not 
limited to, the inability to prepare a simple meal and feed oneself, 
the inability to take care of personal hygiene, or the inability to 
sort and handle papers or files, depending upon which activities are 
age-appropriate.
    d. Pain or other symptoms. Pain or other symptoms may be an 
important factor contributing to functional loss. In order for pain 
or other symptoms to be found to affect a child's ability to 
function in an age-appropriate manner or to perform basic work 
activities, medical signs or laboratory findings must show the 
existence of a medically determinable impairment(s) that could 
reasonably be expected to produce the pain or other symptoms. The 
musculoskeletal listings that include pain or other symptoms among 
their criteria also include criteria for limitations in functioning 
as a result of the listed impairment, including limitations caused 
by pain. It is, therefore, important to evaluate the intensity and 
persistence of such pain or other symptoms carefully in order to 
determine their impact on the child's functioning under these 
listings. See also Secs. 404.1525(f) and 404.1529 of this part, and 
Secs. 416.925(f) and 416.929 of part 416 of this chapter.

C. Diagnosis and Evaluation

    1. General. Diagnosis and evaluation of musculoskeletal 
impairments should be supported, as applicable, by detailed 
descriptions of the joints, including ranges of motion, condition of 
the musculature (e.g., weakness, atrophy), sensory or reflex 
changes, circulatory deficits, and laboratory findings, including 
findings on x-ray or other appropriate medically acceptable imaging. 
Medically acceptable imaging includes, but is not limited to, x-ray 
imaging, computerized axial tomography (CAT scan) or magnetic 
resonance imaging (MRI), with or without contrast material, 
myelography, and radionuclear bone scans. ``Appropriate'' means that 
the technique used is the proper one to support the evaluation and 
diagnosis of the impairment.
    2. Purchase of certain medically acceptable imaging. While any 
appropriate medically acceptable imaging is useful in establishing 
the diagnosis of musculoskeletal impairments, some tests, such as 
CAT scans and MRIs, are quite expensive, and we will not routinely 
purchase them. Some, such as myelograms, are invasive and may 
involve significant risk. We will not order such tests. However, 
when the results of any of these tests are part of the existing 
evidence in the case record we will consider them together with the 
other relevant evidence.
    3. Consideration of electrodiagnostic procedures. 
Electrodiagnostic procedures may be useful in establishing the 
clinical diagnosis, but do not constitute alternative criteria to 
the requirements of 101.04.
    D. The physical examination must include a detailed description 
of the rheumatological, orthopedic, neurological, and other findings 
appropriate to the specific impairment being evaluated. These 
physical findings must be determined on the basis of objective 
observation during the examination and not simply a report of the 
child's allegation; e.g., ``He says his leg is weak, numb.'' 
Alternative testing methods should be used to verify the abnormal 
findings; e.g., a seated straight-leg raising test in addition to a 
supine straight-leg raising test. Because abnormal physical

[[Page 58043]]

findings may be intermittent, their presence over a period of time 
must be established by a record of ongoing management and 
evaluation. Care must be taken to ascertain that the reported 
examination findings are consistent with the child's age and 
activities.

E. Examination of the Spine

    1. General. Examination of the spine should include a detailed 
description of gait, range of motion of the spine given 
quantitatively in degrees from the vertical position (zero degrees) 
or, for straight-leg raising from the sitting and supine position 
(zero degrees), any other appropriate tension signs, motor and 
sensory abnormalities, muscle spasm, when present, and deep tendon 
reflexes. Observations of the child during the examination should be 
reported; e.g., how he or she gets on and off the examination table. 
Inability to walk on the heels or toes, to squat, or to arise from a 
squatting position, when appropriate, may be considered evidence of 
significant motor loss. However, a report of atrophy is not 
acceptable as evidence of significant motor loss without 
circumferential measurements of both thighs and lower legs, or both 
upper and lower arms, as appropriate, at a stated point above and 
below the knee or elbow given in inches or centimeters. 
Additionally, a report of atrophy should be accompanied by 
measurement of the strength of the muscle(s) in question generally 
based on a grading system of 0 to 5, with 0 being complete loss of 
strength and 5 being maximum strength. A specific description of 
atrophy of hand muscles is acceptable without measurements of 
atrophy but should include measurements of grip and pinch strength. 
However, because of the unreliability of such measurement in younger 
children, these data are not applicable to children under 5 years of 
age.
    2. When neurological abnormalities persist. Neurological 
abnormalities may not completely subside after treatment or with the 
passage of time. Therefore, residual neurological abnormalities that 
persist after it has been determined clinically or by direct 
surgical or other observation that the ongoing or progressive 
condition is no longer present will not satisfy the required 
findings in 101.04. More serious neurological deficits (paraparesis, 
paraplegia) are to be evaluated under the criteria in 111.00ff.
    F. Major joints refers to the major peripheral joints, which are 
the hip, knee, shoulder, elbow, wrist-hand, and ankle-foot, as 
opposed to other peripheral joints (e.g., the joints of the hand or 
forefoot) or axial joints (i.e., the joints of the spine.) The wrist 
and hand are considered together as one major joint, as are the 
ankle and foot. Since only the ankle joint, which consists of the 
juncture of the bones of the lower leg (tibia and fibula) with the 
hindfoot (tarsal bones), but not the forefoot, is crucial to weight 
bearing, the ankle and foot are considered separately in evaluating 
weight bearing.
    G. Measurements of joint motion are based on the techniques 
described in the chapter on the extremities, spine, and pelvis in 
the current edition of the ``Guides to the Evaluation of Permanent 
Impairment'' published by the American Medical Association.

H. Documentation.

    1. General. Musculoskeletal impairments frequently improve with 
time or respond to treatment. Therefore, a longitudinal clinical 
record is generally important for the assessment of severity and 
expected duration of an impairment unless the child is a newborn or 
the claim can be decided favorably on the basis of the current 
evidence.
    2. Documentation of medically prescribed treatment and response. 
Many children, especially those who have listing-level impairments, 
will have received the benefit of medically prescribed treatment. 
Whenever evidence of such treatment is available it must be 
considered.
    3. When there is no record of ongoing treatment. Some children 
will not have received ongoing treatment or have an ongoing 
relationship with the medical community despite the existence of a 
severe impairment(s). In such cases, evaluation will be made on the 
basis of the current objective medical evidence and other available 
evidence, taking into consideration the child's medical history, 
symptoms, and medical source opinions. Even though a child who does 
not receive treatment may not be able to show an impairment that 
meets the criteria of one of the musculoskeletal listings, the child 
may have an impairment(s) that is either medically or, in the case 
of a claim for benefits under part 416 of this chapter, functionally 
equivalent in severity to one of the listed impairments.
    4. Evaluation when the criteria of a musculoskeletal listing are 
not met. These listings are only examples of common musculoskeletal 
disorders that are severe enough to find a child disabled. 
Therefore, in any case in which a child has a medically determinable 
impairment that is not listed, an impairment that does not meet the 
requirements of a listing, or a combination of impairments no one of 
which meets the requirements of a listing, we will consider whether 
the child's impairment(s) is medically or, in the case of a claim 
for benefits under part 416 of this chapter, functionally equivalent 
in severity to the criteria of a listing. (See Secs. 404.1526, 
416.926, and 416.926a.) Individuals with claims for benefits under 
part 404, who have an impairment(s) with a level of severity that 
does not meet or equal the criteria of the musculoskeletal listings 
may or may not have the RFC that would enable them to engage in 
substantial gainful activity. Evaluation of the impairment(s) of 
these individuals should proceed through the final steps of the 
sequential evaluation process in Sec. 404.1520 (or, as appropriate, 
the steps in the medical improvement review standard in 
Sec. 404.1594).

I. Effects of Treatment

    1. General. Treatments for musculoskeletal disorders may have 
beneficial effects or adverse side effects. Therefore, medical 
treatment (including surgical treatment) must be considered in terms 
of its effectiveness in ameliorating the signs, symptoms, and 
laboratory abnormalities of the disorder, and in terms of any side 
effects that may further limit the child.
    2. Response to treatment. Response to treatment and adverse 
consequences of treatment may vary widely. For example, a pain 
medication may relieve a child's pain completely, partially, or not 
at all. It may also result in adverse effects, e.g., drowsiness, 
dizziness, or disorientation, that compromise the child's ability to 
function. Therefore, each case must be considered on an individual 
basis, and include consideration of the effects of treatment on the 
child's ability to function.
    3. Documentation. A specific description of the drugs or 
treatment given (including surgery), dosage, frequency of 
administration, and a description of the complications or response 
to treatment should be obtained. The effects of treatment may be 
temporary or long-term. As such, the finding regarding the impact of 
treatment must be based on a sufficient period of treatment to 
permit proper consideration or judgment about future functioning.

J. Orthotic, Prosthetic, or Assistive Devices

    1. General. Consistent with clinical practice, children with 
musculoskeletal impairments may be examined with and without the use 
of any orthotic, prosthetic, or assistive devices as explained in 
this section.
    2. Orthotic devices. Examination should be with the orthotic 
device in place and should include an evaluation of the child's 
maximum ability to function effectively with the orthosis. It is 
unnecessary to routinely evaluate the child's ability to function 
without the orthosis in place. If the child has difficulty with, or 
is unable to use, the orthotic device, the medical basis for the 
difficulty should be documented. In such cases, if the impairment 
involves a lower extremity or extremities, the examination should 
include information on the child's ability to ambulate effectively 
without the device in place unless contraindicated by the medical 
judgment of a physician who has treated or examined the child.
    3. Prosthetic devices. Examination should be with the prosthetic 
device in place. In amputations involving a lower extremity or 
extremities, it is unnecessary to evaluate the child's ability to 
walk without the prosthesis in place. However, the child's medical 
ability to use a prosthesis to ambulate effectively, as defined in 
101.00B2b, should be evaluated. The condition of the stump should be 
evaluated without the prosthesis in place.
    4. Hand-held assistive devices. When a child with an impairment 
involving a lower extremity or extremities uses a hand-held 
assistive device, such as a cane, crutch or walker, examination 
should be with and without the use of the assistive device unless 
contraindicated by the medical judgment of a physician who has 
treated or examined the child. The child's ability to ambulate with 
and without the device provides information as to whether, or the 
extent to which, the child is able to ambulate without assistance. 
The medical basis for the use of any assistive device (e.g., 
instability, weakness) should be documented. The requirement to use 
a hand-held assistive device may also impact on the child's 
functional capacity by virtue of the fact that one or both upper 
extremities are not available for such activities as lifting, 
carrying, pushing, and pulling.
    K. Disorders of the spine, listed in 101.04, result in 
limitations because of distortion of

[[Page 58044]]

the bony and ligamentous architecture of the spine and associated 
impingement on nerve roots (including the cauda equina) or spinal 
cord. Such impingement on nerve tissue may result from a herniated 
nucleus pulposus or other miscellaneous conditions. Neurological 
abnormalities resulting from these disorders are to be evaluated by 
referral to the neurological listings in 111.00ff, as appropriate. 
(See also 101.00B and E.)
    1. Herniated nucleus pulposus is a disorder frequently 
associated with the impingement of a nerve root, but occurs 
infrequently in children. Nerve root compression results in a 
specific neuro-anatomic distribution of symptoms and signs depending 
upon the nerve root(s) compromised.
    2. Other miscellaneous conditions that may cause weakness of the 
lower extremities, sensory changes, areflexia, trophic ulceration, 
bladder or bowel incontinence, and that should be evaluated under 
101.04 include, but are not limited to, lysosomal disorders, 
metabolic disorders, vertebral osteomyelitis, vertebral fractures 
and achondroplasia. Disorders such as spinal dysrhaphism, (e.g., 
spina bifida) diastematomyelia, and tethered cord syndrome may also 
cause such abnormalities. In these cases, there may be gait 
difficulty and deformity of the lower extremities based on 
neurological abnormalities, and the neurological effects are to be 
evaluated under the criteria in 111.00ff.
    L. Abnormal curvatures of the spine. Abnormal curvatures of the 
spine (specifically, scoliosis, kyphosis and kyphoscoliosis) can 
result in impaired ambulation, but may also adversely affect 
functioning in body systems other than the musculoskeletal system. 
For example, a child's ability to breathe may be affected; there may 
be cardiac difficulties (e.g., impaired myocardial function); or 
there may be disfigurement resulting in withdrawal or isolation. 
When there is impaired ambulation, evaluation of equivalence may be 
made by reference to 114.09A. When the abnormal curvature of the 
spine results in symptoms related to fixation of the dorsolumbar or 
cervical spine, evaluation of equivalence may be made by reference 
to 114.09B. When there is respiratory or cardiac involvement or an 
associated mental disorder, evaluation may be made under 103.00ff, 
104.00ff, or 112.00ff, as appropriate. Other consequences should be 
evaluated according to the listing for the affected body system.
    M. Under continuing surgical management, as used in 101.07 and 
101.08, refers to surgical procedures and any other associated 
treatments related to the efforts directed toward the salvage or 
restoration of functional use of the affected part. It may include 
such factors as post-surgical procedures, surgical complications, 
infections, or other medical complications, related illnesses, or 
related treatments that delay the child's attainment of maximum 
benefit from therapy.
    N. After maximum benefit from therapy has been achieved in 
situations involving fractures of an upper extremity (101.07), or 
soft tissue injuries (101.08), i.e., there have been no significant 
changes in physical findings or on appropriate medically acceptable 
imaging for any 6-month period after the last definitive surgical 
procedure or other medical intervention, evaluation must be made on 
the basis of the demonstrable residuals, if any. A finding that 
101.07 or 101.08 is met must be based on a consideration of the 
symptoms, signs, and laboratory findings associated with recent or 
anticipated surgical procedures and the resulting recuperative 
periods, including any related medical complications, such as 
infections, illnesses, and therapies which impede or delay the 
efforts toward restoration of function. Generally, when there has 
been no surgical or medical intervention for 6 months after the last 
definitive surgical procedure, it can be concluded that maximum 
therapeutic benefit has been reached. Evaluation at this point must 
be made on the basis of the demonstrable residual limitations, if 
any, considering the child's impairment-related symptoms, signs, and 
laboratory findings, any residual symptoms, signs, and laboratory 
findings associated with such surgeries, complications, and 
recuperative periods, and other relevant evidence.
    O. Major function of the face and head, for purposes of listing 
101.08, relates to impact on any or all of the activities involving 
vision, hearing, speech, mastication, and the initiation of the 
digestive process.
    P. When surgical procedures have been performed, documentation 
should include a copy of the operative notes and available pathology 
reports.

101.01  Category of Impairments, Musculoskeletal

    101.02   Major dysfunction of a joint(s) (due to any cause): 
Characterized by gross anatomical deformity (e.g., subluxation, 
contracture, bony or fibrous ankylosis, instability) and chronic 
joint pain and stiffness with signs of limitation of motion or other 
abnormal motion of the affected joint(s), and findings on 
appropriate medically acceptable imaging of joint space narrowing, 
bony destruction, or ankylosis of the affected joint(s). With:
    A. Involvement of one major peripheral weight-bearing joint 
(i.e., hip, knee, or ankle), resulting in inability to ambulate 
effectively, as defined in 101.00B2b;

or

    B. Involvement of one major peripheral joint in each upper 
extremity (i.e., shoulder, elbow, or wrist-hand), resulting in 
inability to perform fine and gross movements effectively, as 
defined in 101.00B2c.
    101.03   Reconstructive surgery or surgical arthrodesis of a 
major weight-bearing joint, with inability to ambulate effectively, 
as defined in 101.00B2b, and return to effective ambulation did not 
occur, or is not expected to occur, within 12 months of onset.
    101.04   Disorders of the spine (e.g., lysosomal disorders, 
metabolic disorders, vertebral osteomyelitis, vertebral fracture, 
achondroplasia) resulting in compromise of a nerve root (including 
the cauda equina) or the spinal cord, with evidence of nerve root 
compression characterized by neuro-anatomic distribution of pain, 
limitation of motion of the spine, motor loss (atrophy with 
associated muscle weakness or muscle weakness) accompanied by 
sensory or reflex loss and, if there is involvement of the lower 
back, positive straight-leg raising test (sitting and supine).
    101.05   Amputation (due to any cause).
    A. Both hands;

or

    B. One or both lower extremities at or above the tarsal region, 
with stump complications resulting in medical inability to use a 
prosthetic device to ambulate effectively, as defined in 101.00B2b, 
which have lasted or are expected to last for at least 12 months;

or

    C. One hand and one lower extremity at or above the tarsal 
region, with inability to ambulate effectively, as defined in 
101.00B2b;

or

    D. Hemipelvectomy or hip disarticulation.
    101.06   Fracture of the femur, tibia, pelvis, or one or more of 
the tarsal bones. With:
    A. Solid union not evident on appropriate medically acceptable 
imaging, and not clinically solid;

and

    B. Inability to ambulate effectively, as defined in 101.00B2b, 
and return to effective ambulation did not occur or is not expected 
to occur within 12 months of onset.
    101.07   Fracture of an upper extremity with nonunion of a 
fracture of the shaft of the humerus, radius, or ulna, under 
continuing surgical management, as defined in 101.00M, directed 
toward restoration of functional use of the extremity, and such 
function was not restored or expected to be restored within 12 
months of onset.
    101.08  Soft tissue injury (e.g., burns) of an upper or lower 
extremity, trunk, or face and head, under continuing surgical 
management, as defined in 101.00M, directed toward the salvage or 
restoration of major function, and such major function was not 
restored or expected to be restored within 12 months of onset. Major 
function of the face and head is described in 101.00O.


    10. Listing 114.00, Immune System, of part B of appendix 1 of 
subpart P of part 404 is amended by revising the first and sixth 
paragraphs of 114.00B, by revising 114.00C2, and by adding a new 
section 114.00E to read as follows:

114.00  IMMUNE SYSTEM

* * * * *
    B. Dysregulation of the immune system may result in the 
development of a connective tissue disorder. Connective tissue 
disorders include several chronic multisystem disorders that differ 
in their clinical manifestation, course, and outcome. These 
disorders are described in part A, 14.00B; inflammatory arthritis is 
also described in 114.00E.
* * * * *
    In children the impairment may affect growth, development, 
attainment of age-appropriate skills, and performance of age-
appropriate activities. The limitations may be

[[Page 58045]]

the result of serious loss of function because of disease affecting 
a single organ or body system, or lesser degrees of functional loss 
because of disease affecting two or more organs/body systems 
associated with significant constitutional symptoms and signs of 
severe fatigue, fever, malaise, weight loss, and joint pain and 
stiffness. We use the term ``severe'' in these listings to describe 
medical severity; the term does not have the same meaning as it does 
when we use it in connection with a finding at the second step of 
the sequential evaluation processes in Secs. 404.1520, 416.920, and 
416.924.

C. Allergies, Growth Impairments and Kawasaki Disease

* * * * *
    2. If growth is affected by the disorder or its treatment by 
immunosuppressive drugs, 100.00, Growth impairment, may apply. 
Children may have growth impairment as a result of the inflammatory 
arthritides because of the diseases' potential effects on the 
immature skeleton, open epiphyses, and young cartilage and bone. In 
such situations, the growth impairment should be evaluated under 
100.00ff.
* * * * *
    E. Inflammatory arthritis (114.09) includes a vast array of 
disorders that differ in cause, course, and outcome. For example, in 
children inflammatory spondyloarthropathies include juvenile 
ankylosing spondylitis, reactive arthropathies, psoriatic 
arthropathy, and Behcet's disease, as well as undifferentiated 
spondylitis. Inflammatory arthritis of peripheral joints likewise 
comprises many disorders, including juvenile rheumatoid arthritis, 
Sjogren's syndrome, psoriatic arthritis, crystal deposition 
disorders, and Lyme disease. Clinically, inflammation of major 
joints may be the dominant problem causing difficulties with 
ambulation or fine and gross movements, or the arthritis may involve 
other joints or cause less restriction of age-appropriate ambulation 
or other movements but be complicated by extra-articular features 
that cumulatively result in serious functional deficit. When 
persistent deformity without ongoing inflammation is the dominant 
feature of the impairment, it should be evaluated under 101.02, or, 
if there has been surgical reconstruction, 101.03.
    1. Because the features of inflammatory connective tissue 
diseases in children are modified by such factors as the child's 
limited antigenic exposure and immune reactivity, the acute 
inflammatory connective tissue diseases must be differentiated from 
each other in order to evaluate duration factors and responses to 
specific treatments. Chronic conditions must be differentiated from 
short-term reversible disorders, and also from other connective 
tissue diseases.
    2. In 114.09A, the term major joints refers to the major 
peripheral joints, which are the hip, knee, shoulder, elbow, wrist-
hand, and ankle-foot, as opposed to other peripheral joints (e.g., 
the joints of the hand or forefoot) or axial joints (i.e., the 
joints of the spine.) The wrist and hand are considered together as 
one major joint, as are the ankle and foot. Since only the ankle 
joint, which consists of the juncture of the bones of the lower leg 
(tibia and fibula) with the hindfoot (tarsal bones), but not the 
forefoot, is crucial to weight bearing, the ankle and foot are 
considered separately in evaluating weight bearing.
    3. The terms inability to ambulate effectively and inability to 
perform fine and gross movements effectively in 114.09A have the 
same meaning as in 101.00B2b and 101.00B2c and must have lasted, or 
be expected to last, for at least 12 months.
    4. Inability to ambulate effectively is implicit in 114.09B. 
Even though children who demonstrate the findings of 114.09B will 
not ordinarily require bilateral upper limb assistance, the required 
ankylosis of the cervical or dorsolumbar spine will result in an 
extreme loss of the ability to see ahead, above, and to the side.
    5. As in 114.02 through 114.06, extra-articular features of an 
inflammatory arthritis may satisfy the criteria for a listing in an 
involved extra-articular body system. Such impairments may be found 
to meet a criterion of 114.09C. Extra-articular impairments of 
lesser severity should be evaluated under 114.09D and 114.09E. 
Commonly occurring extra-articular impairments include 
keratoconjunctivitis sicca, uveitis, iridocyclitis, pleuritis, 
pulmonary fibrosis or nodules, restrictive lung disease, 
pericarditis, myocarditis, cardiac arrhythmias, aortic valve 
insufficiency, coronary arteritis, Raynaud's phenomena, systemic 
vasculitis, amyloidosis of the kidney, chronic anemia, 
thrombocytopenia, hypersplenism with compromised immune competence 
(Felty's syndrome), peripheral neuropathy, radiculopathy, spinal 
cord or cauda equina compression with sensory and motor loss, and 
heel enthesopathy with functionally limiting pain.
    6. The fact that a child is dependent on steroids, or any other 
drug, for the control of inflammatory arthritis is, in and of 
itself, insufficient to find disability. Advances in the treatment 
of inflammatory connective tissue disease and in the administration 
of steroids for its treatment have corrected some of the previously 
disabling consequences of continuous steroid use. Therefore, each 
case must be evaluated on its own merits, taking into consideration 
the severity of the underlying impairment and any adverse effects of 
treatment.


    11. A new listing 114.09 is added to read as follows:

    114.09  Inflammatory arthritis. Documented as described in 
114.00E, with one of the following:
    A. History of joint pain, swelling, and tenderness, and signs on 
current physical examination of joint inflammation or deformity in 
two or more major joints resulting in inability to ambulate 
effectively or inability to perform fine and gross movements 
effectively, as defined in 114.00E3 and 101.00B2b and B2c;

or

    B. Ankylosing spondylitis or other spondyloarthropathy, with 
diagnosis established by findings of unilateral or bilateral 
sacroiliitis (e.g., erosions or fusions), shown by appropriate 
medically acceptable imaging, with both:
    1. History of back pain, tenderness, and stiffness, and
    2. Findings on physical examination of ankylosis (fixation) of 
the dorsolumbar or cervical spine at 45 deg. or more of flexion 
measured from the vertical position (zero degrees);

or

    C. An impairment as described under the criteria in 114.02A.

or

    D. Inflammatory arthritis, with signs of peripheral joint 
inflammation on current examination, but with lesser joint 
involvement than in A and lesser extra-articular features than in C, 
and:
    1. Significant, documented constitutional symptoms and signs 
(e.g., fatigue, fever, malaise, weight loss), and
    2. Involvement of two or more organs/body systems (see 
114.00E5). At least one of the organs/body systems must be involved 
to at least a moderate level of severity.

or

    E. Inflammatory spondylitis or other inflammatory 
spondyloarthropathies, with lesser deformity than in B and lesser 
extra-articular features than in C, with signs of unilateral or 
bilateral sacroiliitis on appropriate medically acceptable imaging; 
and with the extra-articular features described in 114.09D.

PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND 
DISABLED

Subpart I--[Amended]

    12. The authority citation for subpart I of part 416 continues to 
read as follows:

    Authority: Secs. 702(a)(5), 1611, 1614, 1619, 1631(a), (c), and 
(d)(1), and 1633 of the Social Security Act (42 U.S.C. 902(a)(5), 
1382, 1382c, 1382h, 1383(a), (c), and (d)(1), and 1383b); secs. 4(c) 
and 5, 6(c)-(e), 14(a) and 15, Pub. L. 98-460, 98 Stat. 1794, 1801, 
1802, and 1808 (42 U.S.C. 421 note, 423 note, 1382h note).

    13. Section 416.926a is amended by revising paragraphs (m)(2) and 
(m)(4) to read as follows:


Sec. 416.926a  Functional equivalence for children.

* * * * *
    (m) * * *
    (2) Any condition that is disabling at the time of onset, requiring 
continuing surgical management within 12 months after onset as a life-
saving measure or for salvage or restoration of function, and such 
major function is not restored or is not expected to be restored within 
12 months after onset of this condition.
* * * * *

[[Page 58046]]

    (4) Effective ambulation possible only with obligatory bilateral 
upper limb assistance.
* * * * *

    14. Section 416.933 is amended by revising the second sentence to 
read as follows:


Sec. 416.933  How we make a finding of presumptive disability or 
presumptive blindness.

    * * * In the case of readily observable impairments (e.g., total 
blindness), we will find that you are disabled or blind for purposes of 
this section without medical or other evidence. * * *

    15. Section 416.934 is amended by removing paragraphs (a) and (h) 
and redesignating paragraphs (b) through (g) as paragraphs (a) through 
(f) and paragraphs (i) through (j) as paragraphs (g) through (h).

[FR Doc. 01-28456 Filed 11-16-01; 8:45 am]
BILLING CODE 4191-02-U