[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
[[Page 58010]]
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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
[[Page 58014]]
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