Revised Medical Criteria for Determination of Disability
Musculoskeletal System and Related Criteria
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[Federal Register: November 19, 2001 (Volume 66, Number 223)] [Rules and
Regulations]
[Page 58009-58046] From the Federal Register Online via GPO Access
[wais.access.gpo.gov] [DOCID:fr19no01-27]
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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
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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 regulations@ssa.gov; 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
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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
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
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 XI
x 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
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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
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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
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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
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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
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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
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David F. Traver
Mary Traver
Social Security
Disability
Traver Law
Offices
135 W. Wells St.
Suite 340
Milwaukee, WI
53203
(866) 747-1700
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2003, David F. Traver, Milwaukee, Wisconsin
Last updated: July 29, 2003