[Federal Register: June 9, 2004 (Volume 69, Number 111)]
[Rules and Regulations]
[Page 32260-32272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn04-14]
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
[Regulation No. 4]
RIN 0960-AF29
Revised Medical Criteria for Evaluating Skin Disorders
AGENCY: Social Security Administration.
ACTION: Final rules.
-----------------------------------------------------------------------
SUMMARY: We are revising the criteria in the Listing of Impairments
(the listings) that we use to evaluate claims involving skin disorders.
We apply these criteria when you claim benefits based on disability
under title II and title XVI of the Social Security Act (the Act). The
revisions reflect advances in medical knowledge, treatment, and methods
of evaluating skin disorders.
DATES: These rules are effective July 9, 2004.
ADDRESSES: Electronic Version: The electronic file of this document is
available on the date of publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html.
It is also available on the Internet
site for SSA (i.e., Social Security Online): http://policy.ssa.gov/pnpublic.nsf/LawsRegs
.
FOR FURTHER INFORMATION CONTACT: Suzanne DiMarino, Social Insurance
Specialist, Office of Regulations, Social Security Administration, 100
Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235-
6401, (410) 965-1769 or TTY (410) 966-5609. For information on
eligibility or filing for benefits, call our national toll-free number,
1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet Web site,
Social Security Online, at http://www.socialsecurity.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 10, 2001
[[Page 32261]]
(66 FR 63634). We provide a summary of the provisions of the final
rules below, with an explanation of the changes we have made from the
text in the NPRM. We then provide 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.
What Programs Do These Final Rules Affect?
These final rules affect disability determinations and decisions
that we make under title II and title XVI of the Act. In addition, to
the extent that Medicare entitlement and Medicaid eligibility are based
on whether you qualify for disability benefits under title II or title
XVI, these final rules also affect the Medicare and Medicaid programs.
Who Can Get Disability Benefits?
Under title II of the Act, we provide for the payment of disability
benefits if you are disabled and belong to one of the following three
groups:
Workers insured under the Act,
Children of insured workers, and
Widows, widowers, and surviving divorced spouses (see
Sec. 404.336) of insured workers.
Under title XVI of the Act, we provide for Supplemental Security
Income (SSI) payments on the basis of disability if you are disabled
and have limited income and resources.
How Do We Define Disability?
Under both the title II and title XVI programs, disability must be
the result of any medically determinable physical or mental impairment
or combination of impairments that is expected to result in death or
which has lasted or can be expected to last for a continuous period of
at least 12 months. Our definitions of disability are shown in the
following table:
----------------------------------------------------------------------------------------------------------------
Disability means you have a medically
If you file a claim under . . . . And you are . . . . determinable impairment(s) as described above and
that results in . . . .
----------------------------------------------------------------------------------------------------------------
Title II............................ An adult or child...... The inability to do any substantial gainful
activity (SGA).
Title XVI........................... An individual age 18 or The inability to do any SGA.
older.
Title XVI........................... An individual under age Marked and severe functional limitations.
18.
----------------------------------------------------------------------------------------------------------------
How Do We Decide Whether You Are Disabled?
To decide whether you are disabled under the Act, we use a five-
step ``sequential evaluation process,'' which we describe in our
regulations at Sec. Sec. 404.1520 and 416.920. We follow the five
steps in order and stop as soon as we can make a determination or
decision. The steps are:
1. Are you working, and is the work you are doing substantial
gainful activity? If you are working and the work you are doing is
substantial gainful activity, we will find that you are not disabled,
regardless of your medical condition or your age, education, and work
experience. If you are not, we will go on to step 2.
2. Do you have a ``severe'' impairment? If you do not have an
impairment or combination of impairments that significantly limits your
physical or mental ability to do basic work activities, we will find
that you are not disabled. If you do, we will go on to step 3.
3. Do you have an impairment(s) that meets or equals the severity
of an impairment in the listings? If you do, and the impairment(s)
meets the duration requirement, we will find that you are disabled. If
you do not, we will go on to step 4.
4. Do you have the residual functional capacity to do your past
relevant work? If you do, we will find that you are not disabled. If
you do not, we will go on to step 5.
5. Does your impairment(s) prevent you from doing any other work
that exists in significant numbers in the national economy, considering
your residual functional capacity, age, education, and work experience?
If it does, and it meets the duration requirement, we will find that
you are disabled. If it does not, we will find that you are not
disabled.
We use a different sequential evaluation process for children who
apply for payments based on disability under SSI. If you are already
receiving benefits, we also use a different sequential evaluation
process when we decide whether your disability continues. See
Sec. Sec. 404.1594, 416.924, 416.994, and 416.994a of our regulations.
However, all of these processes include steps at which we consider
whether your impairment meets or medically equals one of our listings.
What Are the Listings?
The listings are examples of impairments that we consider severe
enough to prevent you as an adult from doing any gainful activity. If
you are a child seeking SSI benefits based on disability, the listings
describe impairments that we consider severe enough to result in marked
and severe functional limitations. Although the listings are contained
only in appendix 1 to subpart P of part 404 of our regulations, we
incorporate them by reference in the SSI program in Sec. 416.925 of
our regulations, and apply them to claims under both title II and title
XVI of the Act.
How Do We Use the Listings?
The listings are in two parts. There are listings for adults (part
A) and for children (part B). If you are an individual age 18 or over,
we apply the listings in part A when we assess your claim, and we never
use the listings in part B.
If you are an individual under age 18, we first use the criteria in
part B of the listings. If the listings in part B do not apply, and the
specific disease process(es) has a similar effect on adults and
children, we then use the criteria in part A. (See Sec. Sec. 404.1525
and 416.925.)
If your impairment(s) does not meet any listing, we will also
consider whether it medically equals any listing; that is, whether it
is as medically severe. (See Sec. Sec. 404.1526 and 416.926.)
What If You Do Not Have an Impairment That Meets or Medically Equals a
Listing?
We use the listings only to decide that individuals are disabled or
that they are still disabled. We will never deny your claim because
your impairment(s) does not meet or medically equal a listing. If you
are not working and you have a severe impairment(s) that does not meet
or medically equal any listing, we may still find you disabled based on
other rules in the ``sequential evaluation process.'' Likewise, we will
never
[[Page 32262]]
decide that your disability has ended only because your impairment(s)
does not meet or medically equal a listing.
Also, when we conduct reviews to determine whether your disability
continues, we will not find that your disability has ended because we
have changed a listing. Our regulations explain that, when we change
our listings, we continue to use our prior listings when we review your
case, if you qualified for disability benefits or SSI payments based on
our determination or decision that your impairment(s) met or medically
equaled a listing. In these cases, we determine whether you have
experienced medical improvement, and if so, whether the medical
improvement is related to the ability to work. If your condition(s) has
medically improved so that you no longer meet or medically equal the
prior listing, we evaluate your case further to determine whether you
are currently disabled. We may find that you are currently disabled,
depending on the full circumstances of your case. See Sec. Sec.
404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is
eligible for SSI payments, we follow a similar rule when we decide
whether you have experienced medical improvement in your condition(s).
See Sec. 416.994a(b)(2).
Why Are We Revising the Listings for Skin Disorders?
We are revising the listings to update their medical criteria and
to provide more information about how we evaluate skin disorders. We
last published final rules containing comprehensive revisions to the
skin disorder listings in the Federal Register on March 27, 1979 (44 FR
18170). In subsequent rules published on December 6, 1985 (50 FR
50068), we indicated that due to advances in medical treatment,
technology, and program experience we would periodically review and
update the listings. We published the latest extension for part A of
the skin disorders listings, until July 1, 2005, in the Federal
Register on June 20, 2003 (68 FR 36911).
When Will We Start To Use These Final Rules?
We will start to use these final rules on their effective date. We
will continue to apply the prior 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 these
rules.
As is our usual practice when we make changes to our regulations,
we will apply these final rules on or after their effective date when
we make a determination or decision in claims for benefits that are
pending in our administrative review process, including those claims
that are pending administrative review after remand to us from a
Federal court. With respect to claims in which we have made a final
decision, and that are pending judicial review in Federal court, we
expect that the court's review of the Commissioner's final decision
would be made in accordance with the rules in effect at the time of the
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 reverses
the Commissioner's final decision and remands the case for further
administrative proceedings, on remand, we will apply the provisions of
these final rules to the entire period at issue in the claim.
What Do We Mean by ``Final Rules'' and ``Prior Rules''?
Even though these rules will not go into effect until 30 days after
publication of this notice, for clarity we refer to the changes we are
making here as the ``final rules'' and to the rules that will be
changed by these final rules as the ``prior rules.''
How Long Will These Final Rules Be Effective?
These final rules will no longer be effective 8 years after the
date on which they become effective, unless we extend them, or revise
and issue them again.
What Revisions Are We Making With These Final Rules?
We are:
Revising the headings of the listings to put them in plain
language;
Revising the order of the listings and updating the
diagnostic groupings to more logically group skin disorders;
Adding listings for xeroderma pigmentosum and other
genetic photosensitivity disorders;
Adding a new listing for burns that do not meet the
requirements of listing 1.08;
Providing a more uniform and clearly defined statement of
severity required for a listing-level skin disorder;
Expanding the guidance in the introductory text to the
listings;
Making nonsubstantive editorial changes to the prior
listings and introductory text; and
Adding a skin disorders body system in part B of appendix
1 to provide a set of childhood skin disorder listings.
How Are We Changing the Introductory Text to the Adult Skin Disorder
Listings?
We are changing the heading from 8.00 Skin to 8.00 Skin Disorders.
We are expanding and reorganizing the introductory text to the skin
disorders listings in prior 8.00A and 8.00B to provide additional
guidance in applying the skin disorders listings. In doing so, we are:
Expanding and supplementing the first sentence of prior
8.00A and moving it into final 8.00C;
Expanding and supplementing the second sentence of prior
8.00A and moving it into final 8.00C2 and 8.00G;
Expanding the third sentence of prior 8.00A and moving it
into final 8.00C4; and
Expanding the material in 8.00B and moving it into final
8.00D.
8.00A--What Skin Disorders Do We Evaluate With These Listings?
This new section describes the kinds of skin disorders we evaluate
under these listings.
8.00B--What Documentation Do We Need?
We are adding a new section that discusses the documentation we
require when we evaluate the existence and severity of skin disorders.
The section explains the information we expect to find in a complete
dermatologic case record in order to assess the existence and severity
of your impairment. It also explains that we may need laboratory
findings or evidence from other medically acceptable methods consistent
with the prevailing state of medical knowledge and clinical practice to
confirm your diagnosis. In a nonsubstantive editorial revision, we
clarified the language of the NPRM to explain that these are
considerations we make whenever we assess the severity of skin
disorders.
8.00C--How Do We Assess the Severity of Your Skin Disorder(s)?
This section, which is partially new and partially based on the
first sentence of prior 8.00A, explains four factors that
[[Page 32263]]
we consider whenever we evaluate the severity of skin disorders. The
section consists of four subsections.
Final section 8.00C1 defines extensive skin lesions. ``Extensive''
is a term we use in most of the final listings. We explain that the
term ``extensive'' means lesions that involve multiple body sites or
critical body areas and that result in ``a very serious limitation,'' a
term we use to define an extreme limitation for purposes of determining
listing-level severity in other regulations. Because extensive skin
lesions result in a very serious limitation, we will often be able to
determine whether your lesions meet the requirement of these listings
based on the medical evidence in your case record, without the need to
develop additional evidence about your ability to perform the specific
activities in the examples set out in final sections 8.00C1a, C1b, and
C1c.
We changed the phrase ``very serious limitations'' from the NPRM to
``a very serious limitation'' in response to a comment we describe
below. We also made a number of editorial changes from the language of
the NPRM to clarify our intent. For example, we removed the phrase
``sufficient surface area'' which we proposed in section 8.00C1 of the
NPRM, because it was not specific and was unnecessary to the meaning of
the sentence. Lesions that result in a very serious limitation are by
definition of sufficient surface area to do so. In the examples, we
also added the word ``both'' in front of the words ``hands,'' ``feet,''
and ``inguinal areas'' to be even clearer about our intent.
Final section 8.00C2 is a new section we added in response to
comments that asked us to explain how we evaluate skin conditions that
produce lesions that do not persist for at least 3 months but are
subject to frequent flareups.
Final section 8.00C3, which was section 8.00C2 in the NPRM,
explains that we evaluate symptoms (including pain) consistent with our
rules in Sec. Sec. 404.1528, 404.1529, 416.928, and 416.929. We
revised this section to correct a technical error in the cross-
references we used in the NPRM.
Final section 8.00C4, which was proposed section 8.00C3 in the
NPRM, explains that while skin disorders frequently respond to
treatment, there is a wide variation in how people respond to
treatment, and that some impairments become resistant to treatment. We
also note that treatment can have side effects that in themselves
result in limitations. Therefore, we consider each case on an
individual basis. In response to a comment, we added a reference to
final section 8.00H in final section 8.00C4b to remind our adjudicators
how to assess situations in which there is no treatment or in which
treatment has not lasted for 3 months.
8.00D--How Do We Assess Impairments That May Affect the Skin and Other
Body Systems?
This section revises prior section 8.00B. We are clarifying that
other impairments besides the systemic ones we included in prior
section 8.00B can involve the skin, and we explain how we evaluate such
impairments under the listings. We are also expanding the list of
examples of impairments that may affect the skin and other body
systems.
In the final rules, we revised the heading of this section and
reorganized its text for clarity. For example, we combined proposed
sections 8.00D3 and 8.00D4 in final section 8.00D3 because both
proposed sections addressed connective tissue and other immune system
disorders. In response to a comment, we added a reference to Sjogren's
syndrome in the examples of connective tissue disorders and other
immune disorders we include in parentheses in the heading of final
section 8.00D3. We redesignated section 8.00D5 and 108.00D5 in the
NPRM, which addressed disfigurement and deformity, to 8.00D4 and
108.00D4 in the final rules.
8.00E--How Do We Evaluate Genetic Photosensitivity Disorders?
Final section 8.00E is another new section. It explains how we
evaluate xeroderma pigmentosum (XP) and other genetic photosensitivity
disorders. We added it in response to comments that said the proposed
listings did not make allowance for individuals with XP who do not have
extensive skin lesions because they live an extremely restricted
lifestyle in order to avoid or minimize serious consequences of the
impairment. Because we agreed with the commenters, we added a new
listing 8.07A, which provides that we will consider disabled any person
who has a diagnosis of XP confirmed by clinical and laboratory
findings. We also added a separate listing 8.07B for individuals who
have other kinds of genetic photosensitivity disorders. We describe
these listings in more detail later in this preamble.
Final section 8.00E provides more information about XP and other
genetic photosensitivity disorders. It also explains how we apply the
new listings and includes a definition of the term, ``inability to
function outside of a highly protective environment,'' the severity
criterion we use in final listing 8.07B2. In final section 8.00E3, we
explain our criteria for the clinical and laboratory findings we need
to establish the existence of XP or another genetic photosensitivity
disorder. Final section 8.00E3 is based on section 10.00B of our
listings, a provision that explains the evidence we need to confirm a
diagnosis of Down syndrome, another kind of genetic disorder. Like that
section, final section 8.00E3 explains that we need both clinical
evidence and evidence of definitive genetic laboratory testing.
However, in recognition of the fact that in many cases laboratory
testing may have been conducted years in the past, we provide that we
do not need a copy of the actual laboratory report if we have medical
evidence that is persuasive that a positive diagnosis has been
confirmed by laboratory testing in the past.
Because we added this new section 8.00E, we redesignated proposed
section 8.00E as final section 8.00F.
8.00F--How Do We Evaluate Burns?
Final section 8.00F was proposed section 8.00E in the NPRM. We
include this new section on burns in the introductory text to the skin
disorder listings in response to many inquiries we have received over
the years about how to evaluate these injuries.
In response to a comment, we added a new listing 8.08 for
evaluating burns that do not meet the criteria of listing 1.08. As a
consequence, we revised the language we proposed for this section of
the introductory text to reflect this change. We also revised the
language of this section to explain more clearly that we evaluate burns
the way we evaluate other disorders that can affect both the skin and
other body systems; that is, by referring first to the listing for the
predominant feature of the impairment.
For consistency, we are also adding a sentence to section 1.00M in
the musculoskeletal body system that cross-refers to final section
8.00F. This paragraph in the musculoskeletal listings defines the term
``under continuing surgical management'' for purposes of listing 1.08.
The sentence we are adding explains that when burns are not under
continuing surgical management, our adjudicators should refer to
section 8.00F.
8.00G--How Do We Determine if Your Skin Disorder(s) Will Continue at a
Disabling Level of Severity in Order To Meet the Duration Requirement?
We are adding this section to explain how we determine if your
impairment(s) meets the duration requirement. This section is partially
new and partially based on the second sentence of prior section 8.00A.
We revised the language from the NPRM to more clearly state our
[[Page 32264]]
intent. This is not a substantive change from the NPRM, only a
clarification of the proposed language.
In the final rules, we explain that in most of these final listings
we will find that your impairment meets the duration requirement if you
have a skin disorder with extensive skin lesions that persist for at
least 3 months despite continuing treatment as prescribed. We explain
that by ``persist,'' we mean that the longitudinal clinical record
shows that, with few exceptions, the lesions have been at the level of
severity specified in the listing.
We also explain how we consider whether your impairment meets the
duration requirement under listings 8.07 and 8.08, the listings that do
not include the 3-month criterion. As we have already noted, under
listing 8.07A, we presume that you meet the duration requirement if you
have XP, established by the clinical and laboratory findings described
in 8.00E. For listings 8.07B and 8.08, you must show that your
limitations have lasted or can be expected to last for a continuous
period of at least 12 months. Therefore, we explain in final section
8.00G that we will decide whether your skin disorder satisfies the
duration requirement under these listings by considering all of the
relevant medical and other information in your case record.
8.00H--How Do We Assess Your Skin Disorder(s) if Your Impairment Does
Not Meet the Requirements of One of These Listings?
This new section explains how we assess a skin disorder(s) when you
do not have continuing treatment as prescribed, when your treatment has
not lasted for at least 3 months, or when you do not have extensive
skin lesions that have persisted for at least 3 months.
In the final rules, we are making changes in response to public
comments about this section and to reflect other changes we are making
in these final rules. We are also making nonsubstantive editorial
changes for clarity and correcting an error in the NPRM. We explain
that your impairment cannot meet the requirements of most of these
listings unless you have extensive skin lesions that have persisted for
at least 3 months despite continuing treatment as prescribed; however,
we may still find that you are disabled based on our other rules for
determining disability. In the final rules, we indicate that final
listings 8.07 and 8.08 are exceptions to this general rule. In final
listing 8.08, we do require evidence of extensive skin lesions, but do
not require evidence of 3 months of continuing treatment as prescribed
because we believe that it will be evident from the extent of the burns
whether extensive lesions can be expected to last for a continuous
period of at least 12 months.
We also deleted the reference to our policy regarding failure to
follow prescribed treatment, which we had included in proposed section
8.00G1 of the NPRM. The reference was inappropriate in this context and
could have been confusing. Under our policy, failure to follow
prescribed treatment is a basis for denying a claim for benefits and
does not apply when we consider whether you meet the requirements of a
listing.
How Are We Proposing To Change the Criteria in the Listings for
Evaluating Skin Disorders in Adults?
8.01--Category of Impairments, Skin Disorders
Most of the changes we are making in these final skin disorder
listings:
Update medical terminology,
Clarify our criteria,
Include more skin disorders in each category, and
Reorganize the prior listings.
We are also adding final listings 8.07A and B for photosensitivity
disorders and final listing 8.08 for burns. Under the prior listings,
these disorders were not listed and could therefore only be found to
medically equal a listing, such as a skin or musculoskeletal disorder
listing, if they were of listing-level severity. We are also revising
the requirement in most of the prior skin disorders listings for
extensive lesions ``not responding to prescribed treatment'' with the
more specific requirement that there be extensive skin lesions that
persist for at least 3 months despite continuing treatment as
prescribed.
The following is a detailed explanation of the revised listing
criteria.
Listing 8.02--Ichthyosis
We are revising the heading of listing 8.02 to cover the general
group of disorders characterized by noninflammatory scaling of the
skin. The prior listing named three specific kinds of disorders. The
final listing includes all forms of ichthyosis. We are also moving
exfoliative dermatitis from prior listing 8.02 to final listing 8.05,
where it will be evaluated with the other dermatitis disorders.
Listing 8.03--Bullous Disease
We are revising the heading of listing 8.03 so that we can apply it
to all types of bullous diseases. We are citing as examples four
diseases we included in the prior listings and adding epidermolysis
bullosa as a fifth example. We include dermatitis herpetiformis in this
listing instead of listing 8.05 because, despite the word
``dermatitis'' in its name, dermatitis herpetiformis is primarily a
bullous disease.
Listing 8.04--Chronic Infections of the Skin or Mucous Membranes
We are revising the heading of listing 8.04 so that it will include
infections other than deep mycotic (fungal) infections. In this
listing, similarly to the prior listing, we use the words ``fungating''
(to grow exuberantly like a fungus or spongy growth) and ``ulcerating''
(a lesion through the skin or a mucous membrane resulting from loss of
tissue, usually with inflammation) to modify the term ``extensive skin
lesions'' because they are descriptive of the different types of
lesions frequently associated with the more severe types of chronic
skin infections. Listing-level severity is characterized by either
extensive fungating or extensive ulcerating lesions that persist for at
least 3 months despite continuing treatment as prescribed.
Listing 8.05--Dermatitis
We are revising the heading of listing 8.05 so that we can also use
it to evaluate miscellaneous inflammatory conditions of the skin,
rather than just the three conditions the prior listing cited
(psoriasis, atopic dermatitis, and dyshidrosis). We will use the
revised listing to evaluate all dermatitis disorders, including
environmental skin conditions such as allergic contact dermatitis,
which we have added to the list of examples of impairments covered by
this listing. As already noted, we are also including exfoliative
dermatitis under this listing instead of including it under listing
8.02.
Listing 8.06--Hidradenitis Suppurativa
We are removing the reference to acne conglobata from listing 8.06
because it frequently responds well to treatment. Therefore, we cannot
assume that it will meet the duration requirement. We are also
providing the same severity standard for hidradenitis suppurativa as
for most of the other listings in these final rules. The condition must
result in extensive skin lesions, as defined in final section 8.00C1,
that persist despite at least 3 months of continuing treatment as
prescribed. The lesions must involve both axillae, both inguinal areas
or the perineum. We deleted the reference to surgical treatment from
the prior listing because the phrase
[[Page 32265]]
``continuing treatment as prescribed'' includes surgical treatment. As
we did in final section 8.00C1, we added the word ``both'' in front of
the words ``axillae'' and ``inguinal areas'' to be clearer about our
intent.
Listing 8.07--Genetic Photosensitivity Disorders
We are adding a listing for evaluating photosensitivity disorders,
including xeroderma pigmentosum (XP), in adults. Some individuals with
these disorders are now surviving into adulthood, and we believe it is
appropriate to have separate listings for them.
In the NPRM, we proposed a listing for photosensitivity disorders,
such as XP, that used the same criteria as the other proposed listings:
extensive lesions that persist for at least 3 months despite prescribed
treatment. Some commenters pointed out that very few people with XP
could meet the criteria of the proposed listing because many people
with the disorder live very restricted lifestyles to avoid consequences
like extensive lesions. In reviewing these comments and reconsidering
our proposed listing, we determined that XP is such a serious disorder
that we could conclude that any person who has XP would be very
seriously limited, given the likelihood that he or she would need to be
in a highly protective environment to avoid the serious consequences of
the disorder. Indeed, two of the commenters described this precise
situation. Moreover, XP is a lifelong disorder that does not improve,
so we could conclude that any person who has XP would meet the duration
requirement. Therefore, we provide in final listing 8.07A that
individuals who have XP that is confirmed by clinical and laboratory
findings are disabled from birth.
In final listing 8.07B, we provide criteria for evaluating other
genetic photosensitivity disorders. XP is only an example of the kind
of photosensitivity disorders we intended to include in proposed
listing 8.07A; that is, what physicians call ``heritable''
photosensitivity disorders, and what we call ``genetic''
photosensitivity disorders in these listings. In considering other
types of genetic photosensitivity disorders, we determined that these
other disorders can have unpredictable courses where skin lesions
improve and a highly protective environment may not be required.
Therefore, to meet this listing you must show that your genetic
photosensitivity disorder results in extensive lesions or that you are
unable to function outside of a highly protective environment. You must
also show that these limitations have lasted or can be expected to last
for a continuous period of at least 12 months.
Listing 8.08--Burns
In response to a comment, we are adding a listing for evaluating
burns that do not meet the criteria of listing 1.08 in our
musculoskeletal listings. Listing 1.08 applies to individuals who have
soft tissue injuries, including burns, that are under continuing
surgical management (as defined in 1.00M in the introductory text to
the musculoskeletal listings) directed toward the salvage or
restoration of major function of an extremity, the trunk, or the face
and head, and in which such salvage or restoration was not achieved or
expected to be achieved within 12 months of onset. Under the prior
listings, we used our policy of medical equivalence to evaluate
individuals whose burns did not meet listing 1.08. Generally we used
our medical equivalence policy to evaluate claims by individuals who
had achieved maximum benefit from surgical management or whose burns
did not satisfy one of the requirements of the listing.
Your impairment will meet this listing if you have extensive skin
lesions, as defined in final section 8.00C1, that have lasted or that
can be expected to last for a continuous period of at least 12 months.
We explain our reasons for making this change in more detail in the
public comments section of this preamble.
Why Are We Adding Listings for Evaluating Skin Disorders in Children?
We are adding new listings to evaluate claims of individuals under
age 18 who have skin disorders to maintain consistency with the other
body system listings, which have both adult and child criteria.
How Do the Final Skin Disorder Listings for Children Differ From the
Final Adult Listings?
The skin disorder listings for children are essentially identical
to those for adults. Exceptions are in final sections 108.00D5 and D6,
where we include examples of erythropoietic porphyrias and hemangiomas
for children.
We mention these disorders only in the introductory text in part B
because the skin manifestations of these disorders are not likely to be
the primary manifestations in adults. For example, a major symptom in
children who have erythropoietic porphyria, a metabolic disorder
characterized by a deficiency of the enzyme ferrochelatase that is
essential to the synthesis of hemoglobin, is hypersensitivity of skin
to sunlight and some types of artificial light. Generally, by
adulthood, anemia is a prominent manifestation in the more severe
cases, with possible complications related to liver and gallbladder
function. Therefore, we evaluate the impairment in adults under the
appropriate body systems for those manifestations, the hemic and
lymphatic system (7.00) and the digestive system (5.00). Similarly,
most hemangiomas disappear spontaneously or are surgically removed in
childhood. When hemangiomas are associated with Kasabach-Merritt
Syndrome, a condition in which the low number of blood platelets causes
bleeding, the hematologic manifestations are obvious in adults and we
evaluate them under the listings in the hemic and lymphatic system,
sections 7.00.
The rules in part B are also slightly different from the rules in
part A to reflect differences between the rules for evaluating
disability in children under the SSI program and the rules for
evaluating disability in adults. For example, instead of referring to
the ``inability to do any gainful activity,'' we refer to the standard
for childhood disability, ``marked and severe functional limitations.''
Likewise, instead of referring to residual functional capacity
assessments and the last step of the five-step adult sequential
evaluation process, we refer to the policy of functional equivalence.
Other Changes
Throughout these final rules, we are making nonsubstantive
editorial changes from the language we proposed in the NPRM. The
changes:
Make the language clearer and simpler;
Improve the consistency between parts A and B of the skin
disorders listings;
Improve the consistency between the skin disorders
listings and other body system listings; and,
Correct technical errors that were in the NPRM.
For example, in these final rules, we changed the term ``skin
impairments,'' which we used in the introductory text in the NPRM, to
``skin disorders.'' We also changed the phrase ``prescribed treatment''
in the NPRM to ``continuing treatment as prescribed'' wherever it
appeared. In the NPRM we used both phrases inconsistently and now we
are using the same phrase everywhere throughout these final rules. We
have already given examples of several of the other changes in the
explanation of changes above.
[[Page 32266]]
Public Comments
We published these rules in the Federal Register as an NPRM on
December 10, 2001 (66 FR 63634). We gave members of the public a period
of 60 days in which to comment. The comment period ended on February 8,
2002.
We received a total of 12 letters, telefaxes, and e-mails
responding to our request for comments. The comments came from a
professional medical organization, advocacy organizations for specific
types of skin disorders and other disorders that may involve the skin,
legal advocates, parents of children with skin disorders, and a State
agency that makes disability determinations for us. We carefully
considered all of the comments, and we are making a number of changes
in these final rules as a result of the comments.
Some of the comment letters were long and detailed, requiring us to
condense, summarize, or paraphrase them. We have tried to present all
views and to respond to all of the significant issues raised by the
commenters. We provide our reasons for adopting or not adopting the
comments in our responses below.
Final Sections 8.00D and 108.00D--How Do We Assess Impairments That May
Affect the Skin and Other Body Systems?
Comment: We received two comments about facial disfigurement. One
commenter discussed the social difficulties an individual with a facial
disfigurement may encounter in school and in finding a job. Another
commenter mentioned the difficulties that can result if frequent
surgeries or other medical attention is needed to care for or correct
the disfigurement. The first commenter encouraged us to make the
changes needed to help these individuals.
Response: We agree with the commenters that facial disfigurement
can be a cause of significant physical and mental limitations. This is
why we proposed new sections 8.00D5 and 108.00D5 in the NPRM to address
the complications of facial disfigurement and its psychological
effects. (In the final rule, we redesignated these sections as 8.00D4
and 108.00D4.) The final provisions explain that disfigurement may have
specific physical effects, such as loss of sight, hearing, speech, and
the ability to chew, but may also have effects that we evaluate under
the mental disorders listings, such as when they affect mood or social
functioning. We evaluate the physical and mental effects of
disfigurement under the appropriate listings for the manifestations;
for example, special senses and speech, 2.00 and 102.00, the digestive
system, 5.00 and 105.00, and mental disorders, 12.00 and 112.00. In
addition, we explain in final sections 8.00C4 and 108.00C4 (proposed
sections 8.00C3 and 108.00C3) that we consider the effects of surgery
when we evaluate the severity and duration of your impairment. We do
not believe that other changes are needed to respond to these comments.
Final Sections 8.00F and 108.00F--How Do We Evaluate Burns?
Comment: One commenter stated that we should make clear that, when
we evaluate burn victims under the musculoskeletal listings, it is the
functional limitations that are being compared, not the underlying
diagnostic criteria. For example, a burn may leave someone with the
inability to move a joint, but the reason for the immobility will not
be seen on x-ray. Therefore, it may not be clear that an individual
could have an impairment that medically equals listing 1.02 or 101.02
because those listings include a requirement for appropriate medically
acceptable imaging (such as an x-ray) showing joint space narrowing.
Response: We adopted the comment by adding new listings 8.08 and
108.08 for evaluating burns and by revising sections 8.00F and 108.00F.
Final listings 8.08 and 108.08 now include burns that result in
extensive skin lesions and that are not under continuing surgical
management (as defined in 1.00M and 101.00M). With these final rules,
it will no longer be necessary for our adjudicators to consider medical
equivalence to a musculoskeletal listing when there is an extreme
limitation resulting from extensive burn lesions.
We believe that this is a simpler solution to the problem raised by
the commenter than clarifying how to use the musculoskeletal listings
to show medical equivalence for individuals whose burns do not meet the
requirements of listings 1.08 or 101.08. We will also continue to use
listings 1.08 and 101.08 when there are burns that meet their criteria.
We are also adding references to final section 8.00F and 108.00F in
sections 1.00M and 101.00M to remind our adjudicators to consider these
new provisions.
Final Sections 8.00G and 108.00G--How Do We Determine if Your Skin
Disorder(s) Will Continue at a Disabling Level of Severity in Order To
Meet the Duration Requirement?
Comment: Two commenters expressed concern about the requirement in
proposed sections 8.00G and 108.00G, as well as other sections of the
proposed rules, that skin lesions must persist for at least 3 months
despite treatment. One commenter believed that our adjudicators would
not properly consider conditions that go in and out of remission in
periods shorter than 3 months, and said that such conditions might be
disabling even if flareups are shorter than 3 months. The other
commenter pointed out that in proposed sections 8.00B and 108.00B we
indicated that we consider the frequency of flareups when we evaluate
the severity of skin disorders. This commenter noted that we did not go
on to provide any standards for considering flareups, especially when
there are frequent flareups of shorter than 3 months despite treatment.
Response: We revised the rules to address these comments. Although
the prior listings also contained a requirement that the lesions not
respond to treatment, we agree that it is appropriate to provide
guidance in the introductory text to the listings about how to consider
frequent flareups. Therefore, in response to these comments, we are
adding new sections 8.00C2 and 108.00C2, Frequency of flareups, in
these final rules. The new sections explain that, if your skin lesions
do not meet the requirements of one of these listings, your impairment
may still medically equal one of the skin disorder listings. We explain
that we will consider the frequency and seriousness of the flareups
over time, especially if they result in extensive skin lesions, as
described in final section 8.00C1, and even though there are
intervening periods of remission. We must also consider how you
function between flareups, and whether your impairment(s) has met or
will meet the 12-month duration requirement.
We did not provide a specific number of episodes or specific rules
regarding the seriousness or length of episodes because there are too
many possible combinations of circumstances that could result in an
impairment of listing-level severity. We will evaluate each case
individually based on the evidence we have in the case record.
In addition, we added guidance in final sections 8.00H and 108.00H
in response to these comments and the comment we summarize next. The
new
[[Page 32267]]
text reminds our adjudicators that these listings are only examples of
common skin disorders that we consider to be of listing-level severity.
It also explains that we may still find you disabled under other
listings, based on medical equivalence, or based on your residual
functional capacity, age, education, and work experience (or, if you
are a child claiming disability payments under SSI, based on functional
equivalence). When we make these determinations, we will also consider
the frequency of your flareups.
Comment: One commenter stated that, while it is true that most skin
disorders are responsive to treatment, it is also true that not all
claimants have access to health care. The commenter said that we should
make it clear that claimants will not be penalized if they are unable
to obtain state-of-the-art care.
Response: We adopted the comment. We revised sections 8.00H and
108.00H as explained in the preceding response.
As a point of clarification, it should be noted that you are not
required to have ``state-of-the-art'' treatment to meet these listings,
as the commenter assumed. As in all of our other listings that include
requirements for persistence of findings despite treatment (see, for
example, the cardiovascular body system listings in 4.00 and 104.00),
we require only that you receive prescribed treatment in order to meet
this requirement of the listings. We generally do not specify the kind
or level of treatment. The treatment requirements in the listings are
primarily to establish that the impairment is of a particular level of
severity; that is, one that is so serious that it does not respond to
medical treatment. You can still show that you are disabled in other
ways if your impairment does not meet the requirements of a listing.
Also, we use the listings only to find that people are disabled. We
will never deny your claim or find that your disability has ended only
because your impairment does not meet or medically equal the
requirements of a listing.
Listings 8.03 and 108.03--Bullous Disease
Comment: One commenter asked us to rename this listing
``immunobullous disease.'' The commenter believed that this is a
broader category and would allow for the inclusion of newly recognized
diseases. The commenter also suggested that we add epidermolysis
bullosa acquisita to the listing.
Response: We did not adopt the comment. We use the term ``bullous
disease'' generically in our listings to include any disease that is
characterized by bullae, including immunobullous diseases. The
parenthetical examples of the kinds of impairments we intend to cover
should make this clear because they include examples of immunobullous
diseases. The fact that we list only some examples of bullous diseases
should also make clear that we will evaluate epidermolysis bullosa
acquisita under these listings and that they will include any newly
discovered diseases that are characterized by bullae.
Listings 8.05 and 108.05--Dermatitis
Comment: One commenter suggested that we give psoriasis its own
category instead of listing it with dermatitis, because psoriasis can
affect the joints and other body systems in addition to the skin.
Response: We did not adopt the comment because we have other
listings that address the effects of psoriasis in other body systems.
See, for example, listings 14.09 and 114.09, which include psoriatic
arthritis, as explained in 14.00B6 and 114.00E of the introductory text
to those listings.
Comment: One commenter suggested that we address the role of
temperature in listing 8.05 because extensive skin lesions from
dermatitis can be, and often are, exacerbated by a lack of temperature
control.
Response: We did not adopt the comment. We consider the role of
temperature extremes when we evaluate your ability to do work-related
activities. Therefore, we consider it when we determine whether you
have a ``severe'' impairment and when we assess your residual
functional capacity to determine whether you can do your past relevant
work or any other work that exists in significant numbers in the
national economy. See, generally, Sec. Sec. 404.1520 and 416.920. We
also consider the role of temperature extremes when we make findings
about functional equivalence in children.
Comment: Another commenter asked us to add ``or other inflammation
caused by rheumatic autoimmune conditions, such as Sjogren's syndrome''
to the examples of dermatitis in proposed listing 108.05.
Response: We did not adopt the specific suggestion, but we did add
a reference to Sj[ouml]gren's syndrome in final sections 8.00D3 and
108.00D3 in response to this comment. We refer specifically to
Sj[ouml]gren's syndrome in our instructions for applying listings 14.03
and 14.09 for adults and listing 114.09 for children in our immune
system listings. See sections 14.00B2 and B6 and 114.00E of the
introductory text to those body system listings. We can also use any
other appropriate listing in the immune system. While Sj[ouml]gren's
syndrome can result in inflammation of the skin, we believe that it is
most appropriate to consider it under the immune system listings.
The introductory text in the proposed rules included two paragraphs
that explained how we evaluate individuals who have autoimmune
disorders that can have effects on the skin. In the final rules, we
combined the two paragraphs in final sections 8.00D3 and 108.00D3, and
in response to these comments, we added Sj[ouml]gren's syndrome to the
list of examples of connective tissue disorders and other immune system
disorders in those sections. We also included a reminder that we
evaluate Sj[ouml]gren's syndrome under listing 14.03, 14.09, 114.09, or
any other appropriate immune system listing.
Listings 8.06 and 108.06--Hidradenitis Suppurativa
Comment: One commenter opposed our proposal to remove acne
conglobata from this listing, stating that the debilitating state
resulting from this disease can last for at least 3 months in some
cases. The commenter believed that the most severely impaired acne
conglobata patients should be considered eligible for disability
benefits.
Response: We did not adopt the comment. To meet the statutory
duration requirement, you must have a medically determinable impairment
that has lasted or can be expected to last at a disabling level for a
continuous period of at least 12 months. We require documentation of at
least 3 months of persistent, extensive skin lesions in most of these
listings because, for those listings that include this requirement, it
is reasonable to assume that the disabling level of severity will
continue for at least 12 months. Although we agree that some people
with acne conglobata can be seriously limited for at least 3 months, we
believe that it would be extremely rare for the condition to persist at
a listing level of severity for a continuous period of at least 12
months. Therefore, we cannot presume that the duration requirement will
be met after 3 months. We may still find individuals with the most
serious cases of acne conglobata to be disabled using our other rules
for determining disability based on medical equivalence or at later
steps of the sequential evaluation processes for adults and children.
Comment: One commenter stated that the 3-month duration of
treatment for hidradenitis suppurativa is too
[[Page 32268]]
restrictive and not realistic where antimicrobial treatment may be
offered as part of a staged procedure that ends with surgical
treatment.
Response: As we stated earlier, the 3-month duration of extensive
skin lesions despite continuing treatment as prescribed (which includes
both medical and surgical treatment) is only a criterion for meeting
the listing. If your impairment does not meet this criterion, we may
still find you disabled based on medical equivalence or at later steps
of the sequential evaluation process.
Comment: One commenter noted that proposed section 108.00C1 used
the phrase ``very serious limitations,'' instead of ``very serious
limitation.'' He pointed out that, when read in the context of our
definition of the term ``extreme'' in our functional equivalence
regulation for children (Sec. 416.926a(e)(3)), the plural
``limitations'' might be misinterpreted as an even stricter standard
than in the functional equivalence rule, which uses the singular form
of the word.
Response: We adopted the comment. We now use the phrase ``a very
serious limitation'' in both part A and part B of these final rules.
Our intent in the NPRM was to describe an ``extreme'' limitation in the
same way we use the term in the musculoskeletal listings for adults and
children and in our functional equivalence rules. We also provide
equivalent severity criteria in other listings, such as the
neurological listings, that do not use the term ``extreme.''
Listings 8.07 and 108.07--Genetic Photosensitivity Disorders
Comment: We received comments from three commenters about the
proposed listings for photosensitivity disorders, including xeroderma
pigmentosum (XP). One commenter stated that proposed listings 8.07 and
108.07 did not make allowance for people with XP who may have not
developed extensive skin lesions because they live extremely restricted
lifestyles by totally avoiding sunlight. The commenter added that the
listings should not require that one get sick in order to establish
disability. Similarly, a second commenter described her personal
experience with a child with XP. She explained that her son had had
many surgeries for skin cancer and must stay in a specially protected
home so he can avoid exposure to sunlight and any other ultraviolet
light. She expressed concern that he would not meet proposed listing
108.07 because he did not have the extensive skin lesions required. The
third commenter asked us to give more funding for research of XP, and
to provide more assistance for the parents of children with XP and more
education to the public about this disease.
Response: We adopted most of these comments. As we have already
noted, we are adding listings 8.07A and 108.07A for adults and children
with documented XP in response to these comments.
We are also adding new sections 8.00E and 108.00E to explain the
criteria of the final listings and the documentation required to
satisfy the listings. We also define the phrase ``inability to function
outside of a highly protective environment,'' the severity criterion we
use in final listings 8.07B and 108.07B. By adding these final rules,
we will assist individuals with XP and other genetic photosensitivity
disorders, and families who have children with these disorders, by
providing them better access to disability benefits and, in many cases,
access to health care through Medicare or Medicaid. The new rules also
provide some information to the public about XP and how we consider it.
However, we are unable to provide funding for research into XP or to
provide training for the public about XP beyond what is required by our
rules. These activities are not within our purview.
Other Comment
Comment: One commenter suggested that, instead of changing the body
system name to ``Skin disorders,'' we change it to ``Skin, hair, nails,
and mucous membranes'' because these denote the full range of body
systems treated by dermatologists. The commenter noted that proposed
listing 8.04 included a reference to the mucous membranes.
Response: We did not adopt the comment. The headings of our body
systems explain the kinds of disorders we list within the body systems,
not the range of conditions treated by particular medical specialties.
Since these listings include primarily disorders of the skin, we are
not changing the heading. Although we refer to mucous membranes in
final listings 8.04 and 108.04, Chronic infections of the skin or
mucous membranes, it is only to recognize that infections of the skin
often involve the mucous membranes.
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of Management and Budget (OMB)
and determined that these final rules meet the criteria for a
significant regulatory action under Executive Order 12866, as amended
by Executive Order 13258. Thus, they were subject to OMB review.
Regulatory Flexibility Act
We certify that these final rules do not have a significant
economic impact on a substantial number of small entities because they
affect only individuals. Thus, a regulatory flexibility analysis as
provided in the Regulatory Flexibility Act, as amended, is not
required.
Paperwork Reduction Act
The Paperwork Reduction Act (PRA) of 1995 says that no persons are
required to respond to a collection of information unless it displays a
valid OMB control number. In accordance with the PRA, SSA is providing
notice that OMB has approved the information collection requirements
contained in sections 8.00C, 8.00D, 108.00B, 108.00C and 108.00D of
these final rules. The OMB Control Number for this collection is 0960-
0642 expiring 12/31/2004.
(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social
Security-Disability Insurance; 96.002, Social Security-Retirement
Insurance; 96.004, Social Security-Survivors Insurance; and 96.006,
Supplemental Security Income)
List of Subjects in 20 CFR Part 404
Administrative practice and procedure, Death benefits, Blind,
Disability benefits, Old-Age, Survivors, and Disability Insurance,
Reporting and record keeping requirements, Social Security.
Dated: March 12, 2004.
Jo Anne B. Barnhart,
Commissioner of Social Security.
0
For the reasons set forth in the preamble, subpart P of part 404 of
chapter III of title 20 of the Code of Federal Regulations is amended
as set forth below:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950- )
Subpart P--Determining Disability and Blindness
0
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.
[[Page 32269]]
Appendix 1 to Subpart P of Part 404--[Amended]
0
2. Appendix 1 to subpart P of part 404 is amended as follows:
0
a. Item 9 of the introductory text before part A of appendix 1 is
amended by revising the body system name, revising the expiration date
for section 8.00, and adding section 108.00 and its expiration date.
0
b. The list of sections for part A of appendix 1 is amended by revising
the body system name for section 8.00.
0
c. Section 1.00M of part A of appendix 1 is amended by adding a new
last sentence to the paragraph.
0
d. Section 8.00 of part A of appendix 1 is revised.
0
e. The list of sections for part B of appendix 1 is amended by revising
section 108.00 to read ``108.00 Skin Disorders''.
0
f. Section 101.00M of part B of appendix 1 is amended by adding a new
last sentence to the paragraph.
0
g. Section 108.00 of part B of appendix 1 is added.
The new and revised text is set forth as follows:
Appendix 1 To Subpart P of Part 404--Listing of Impairments
* * * * *
9. Skin Disorders (8.00 and 108.00): July 9, 2012.
* * * * *
Part A
* * * * *
8.00 Skin Disorders
* * * * *
1.00 Musculoskeletal System
* * * * *
M. * * * When burns are not under continuing surgical
management, see 8.00F.
* * * * *
8.00 Skin Disorders
A. What skin disorders do we evaluate with these listings? We
use these listings to evaluate skin disorders that may result from
hereditary, congenital, or acquired pathological processes. The
kinds of impairments covered by these listings are: Ichthyosis,
bullous diseases, chronic infections of the skin or mucous
membranes, dermatitis, hidradenitis suppurativa, genetic
photosensitivity disorders, and burns.
B. What documentation do we need? When we evaluate the existence
and severity of your skin disorder, we generally need information
about the onset, duration, frequency of flareups, and prognosis of
your skin disorder; the location, size, and appearance of lesions;
and, when applicable, history of exposure to toxins, allergens, or
irritants, familial incidence, seasonal variation, stress factors,
and your ability to function outside of a highly protective
environment. To confirm the diagnosis, we may need laboratory
findings (for example, results of a biopsy obtained independently of
Social Security disability evaluation or blood tests) or evidence
from other medically acceptable methods consistent with the
prevailing state of medical knowledge and clinical practice.
C. How do we assess the severity of your skin disorder(s)? We
generally base our assessment of severity on the extent of your skin
lesions, the frequency of flareups of your skin lesions, how your
symptoms (including pain) limit you, the extent of your treatment,
and how your treatment affects you.
1. Extensive skin lesions. Extensive skin lesions are those that
involve multiple body sites or critical body areas, and result in a
very serious limitation. Examples of extensive skin lesions that
result in a very serious limitation include but are not limited to:
a. Skin lesions that interfere with the motion of your joints
and that very seriously limit your use of more than one extremity;
that is, two upper extremities, two lower extremities, or one upper
and one lower extremity.
b. Skin lesions on the palms of both hands that very seriously
limit your ability to do fine and gross motor movements.
c. Skin lesions on the soles of both feet, the perineum, or both
inguinal areas that very seriously limit your ability to ambulate.
2. Frequency of flareups. If you have skin lesions, but they do
not meet the requirements of any of the listings in this body
system, you may still have an impairment that prevents you from
doing any gainful activity when we consider your condition over
time, especially if your flareups result in extensive skin lesions,
as defined in C1 of this section. Therefore, if you have frequent
flareups, we may find that your impairment(s) is medically equal to
one of these listings even though you have some periods during which
your condition is in remission. We will consider how frequent and
serious your flareups are, how quickly they resolve, and how you
function between flareups to determine whether you have been unable
to do any gainful activity for a continuous period of at least 12
months or can be expected to be unable to do any gainful activity
for a continuous period of at least 12 months. We will also consider
the frequency of your flareups when we determine whether you have a
severe impairment and when we need to assess your residual
functional capacity.
3. Symptoms (including pain). Symptoms (including pain) may be
important factors contributing to the severity of your skin
disorder(s). We assess the impact of symptoms as explained in
Sec. Sec. 404.1528, 404.1529, 416.928, and 416.929 of this chapter.
4. Treatment. We assess the effects of medication, therapy,
surgery, and any other form of treatment you receive when we
determine the severity and duration of your impairment(s). Skin
disorders frequently respond to treatment; however, response to
treatment can vary widely, with some impairments becoming resistant
to treatment. Some treatments can have side effects that can in
themselves result in limitations.
a. We assess the effects of continuing treatment as prescribed
by determining if there is improvement in the symptoms, signs, and
laboratory findings of your disorder, and if you experience side
effects that result in functional limitations. To assess the effects
of your treatment, we may need information about:
i. The treatment you have been prescribed (for example, the
type, dosage, method, and frequency of administration of medication
or therapy);
ii. Your response to the treatment;
iii. Any adverse effects of the treatment; and
iv. The expected duration of the treatment.
b. Because treatment itself or the effects of treatment may be
temporary, in most cases sufficient time must elapse to allow us to
evaluate the impact and expected duration of treatment and its side
effects. Except under 8.07 and 8.08, you must follow continuing
treatment as prescribed for at least 3 months before your impairment
can be determined to meet the requirements of a skin disorder
listing. (See 8.00H if you are not undergoing treatment or did not
have treatment for 3 months.) We consider your specific response to
treatment when we evaluate the overall severity of your impairment.
D. How do we assess impairments that may affect the skin and
other body systems? When your impairment affects your skin and has
effects in other body systems, we first evaluate the predominant
feature of your impairment under the appropriate body system.
Examples include, but are not limited to the following.
1. Tuberous sclerosis primarily affects the brain. The
predominant features are seizures, which we evaluate under the
neurological listings in 11.00, and developmental delays or other
mental disorders, which we evaluate under the mental disorders
listings in 12.00.
2. Malignant tumors of the skin (for example, malignant
melanomas) are cancers, or neoplastic diseases, which we evaluate
under the listings in 13.00.
3. Connective tissue disorders and other immune system disorders
(for example, systemic lupus erythematosus, scleroderma, human
immunodeficiency virus (HIV) infection, and Sjogren's syndrome)
often involve more than one body system. We first evaluate these
disorders under the immune system listings in 14.00. We evaluate
lupus erythematosus under 14.02, scleroderma under 14.04,
symptomatic HIV infection under 14.08, and Sjogren's syndrome under
14.03, 14.09, or any other appropriate listing in section 14.00.
4. Disfigurement or deformity resulting from skin lesions may
result in loss of sight, hearing, speech, and the ability to chew
(mastication). We evaluate these impairments and their effects under
the special senses and speech listings in 2.00 and the digestive
system listings in 5.00. Facial disfigurement or other physical
deformities may also have effects we evaluate under the mental
disorders listings in 12.00, such as when they affect mood or social
functioning.
E. How do we evaluate genetic photosensitivity disorders?
1. Xeroderma pigmentosum (XP). When you have XP, your impairment
meets the
[[Page 32270]]
requirements of 8.07A if you have clinical and laboratory findings
showing that you have the disorder. (See 8.00E3.) People who have XP
have a lifelong hypersensitivity to all forms of ultraviolet light
and generally lead extremely restricted lives in highly protective
environments in order to prevent skin cancers from developing. Some
people with XP also experience problems with their eyes,
neurological problems, mental disorders, and problems in other body
systems.
2. Other genetic photosensitivity disorders. Other genetic
photosensitivity disorders may vary in their effects on different
people, and may not result in an inability to engage in any gainful
activity for a continuous period of at least 12 months. Therefore,
if you have a genetic photosensitivity disorder other than XP
(established by clinical and laboratory findings as described in
8.00E3), you must show that you have either extensive skin lesions
or an inability to function outside of a highly protective
environment to meet the requirements of 8.07B. You must also show
that your impairment meets the duration requirement. By inability to
function outside of a highly protective environment we mean that you
must avoid exposure to ultraviolet light (including sunlight passing
through windows and light from unshielded fluorescent bulbs), wear
protective clothing and eyeglasses, and use opaque broad-spectrum
sunscreens in order to avoid skin cancer or other serious effects.
Some genetic photosensitivity disorders can have very serious
effects in other body systems, especially special senses and speech
(2.00), neurological (11.00), mental (12.00), and neoplastic
(13.00). We will evaluate the predominant feature of your impairment
under the appropriate body system, as explained in 8.00D.
3. Clinical and laboratory findings. We need evidence confirming
the diagnosis of your XP or other genetic photosensitivity disorder.
The evidence must include a clinical description of abnormal
physical findings associated with the condition. There must also be
definitive genetic laboratory studies documenting appropriate
chromosomal damage, abnormal DNA repair, or other DNA or genetic
abnormality specific to your type of photosensitivity disorder.
However, we do not need a copy of the actual laboratory report if we
have medical evidence that is persuasive that a positive diagnosis
has been confirmed by laboratory testing.
F. How do we evaluate burns? Electrical, chemical, or thermal
burns frequently affect other body systems; for example,
musculoskeletal, special senses and speech, respiratory,
cardiovascular, renal, neurological, or mental. Consequently, we
evaluate burns the way we evaluate other disorders that can affect
the skin and other body systems, using the listing for the
predominant feature of your impairment. For example, if your soft
tissue injuries are under continuing surgical management (as defined
in 1.00M), we will evaluate your impairment under 1.08. However, if
your burns do not meet the requirements of 1.08 and you have
extensive skin lesions that result in a very serious limitation (as
defined in 8.00C1) that has lasted or can be expected to last for a
continuous period of at least 12 months, we will evaluate them under
8.08.
G. How do we determine if your skin disorder(s) will continue at
a disabling level of severity in order to meet the duration
requirement? For all of these skin disorder listings except 8.07 and
8.08, we will find that your impairment meets the duration
requirement if your skin disorder results in extensive skin lesions
that persist for at least 3 months despite continuing treatment as
prescribed. By persist, we mean that the longitudinal clinical
record shows that, with few exceptions, your lesions have been at
the level of severity specified in the listing. For 8.07A, we will
presume that you meet the duration requirement. For 8.07B and 8.08,
we will consider all of the relevant medical and other information
in your case record to determine whether your skin disorder meets
the duration requirement.
H. How do we assess your skin disorder(s) if your impairment
does not meet the requirements of one of these listings?
1. These listings are only examples of common skin disorders
that we consider severe enough to prevent you from engaging in any
gainful activity. For most of these listings, if you do not have
continuing treatment as prescribed, if your treatment has not lasted
for at least 3 months, or if you do not have extensive skin lesions
that have persisted for at least 3 months, your impairment cannot
meet the requirements of these skin disorder listings. (This
provision does not apply to 8.07 and 8.08.) However, we may still
find that you are disabled because your impairment(s) meets the
requirements of a listing in another body system or medically equals
the severity of a listing. (See Sec. Sec. 404.1526 and 416.926 of
this chapter.) We may also find you disabled at the last step of the
sequential evaluation process.
2. If you have not received ongoing treatment or do not have an
ongoing relationship with the medical community despite the
existence of a severe impairment(s), or if your skin lesions have
not persisted for at least 3 months but you are undergoing
continuing treatment as prescribed, you may still have an
impairment(s) that meets a listing in another body system or that
medically equals a listing. If you do not have an impairment(s) that
meets or medically equals a listing, we will assess your residual
functional capacity and proceed to the fourth and, if necessary, the
fifth step of the sequential evaluation process in Sec. Sec.
404.1520 and 416.920 of this chapter. When we decide whether you
continue to be disabled, we use the rules in Sec. Sec. 404.1594 and
416.994 of this chapter.
8.01 Category of Impairments, Skin Disorders
8.02 Ichthyosis, with extensive skin lesions that persist for at
least 3 months despite continuing treatment as prescribed.
8.03 Bullous disease (for example, pemphigus, erythema
multiforme bullosum, epidermolysis bullosa, bullous pemphigoid,
dermatitis herpetiformis), with extensive skin lesions that persist
for at least 3 months despite continuing treatment as prescribed.
8.04 Chronic infections of the skin or mucous membranes, with
extensive fungating or extensive ulcerating skin lesions that
persist for at least 3 months despite continuing treatment as
prescribed.
8.05 Dermatitis (for example, psoriasis, dyshidrosis, atopic
dermatitis, exfoliative dermatitis, allergic contact dermatitis),
with extensive skin lesions that persist for at least 3 months
despite continuing treatment as prescribed.
8.06 Hidradenitis suppurativa, with extensive skin lesions
involving both axillae, both inguinal areas or the perineum that
persist for at least 3 months despite continuing treatment as
prescribed.
8.07 Genetic photosensitivity disorders, established by clinical
and laboratory findings as described in 8.00E.
A. Xeroderma pigmentosum. Consider the individual disabled from
birth.
B. Other genetic photosensitivity disorders, with:
1. Extensive skin lesions that have lasted or can be expected to
last for a continuous period of at least 12 months, or
2. Inability to function outside of a highly protective
environment for a continuous period of at least 12 months (see
8.00E2).
8.08 Burns, with extensive skin lesions that have lasted or can
be expected to last for a continuous period of at least 12 months
(see 8.00F).
* * * * *
Part B
* * * * *
108.00 Skin Disorders
* * * * *
101.00 Musculoskeletal System
* * * * *
M. * * * When burns are not under continuing surgical
management, see 108.00F.
* * * * *
108.00 Skin Disorders
A. What skin disorders do we evaluate with these listings? We
use these listings to evaluate skin disorders that may result from
hereditary, congenital, or acquired pathological processes. The
kinds of impairments covered by these listings are: Ichthyosis,
bullous diseases, chronic infections of the skin or mucous
membranes, dermatitis, hidradenitis suppurativa, genetic
photosensitivity disorders, and burns.
B. What documentation do we need? When we evaluate the existence
and severity of your skin disorder, we generally need information
about the onset, duration, frequency of flareups, and prognosis of
your skin disorder; the location, size, and appearance of lesions;
and, when applicable, history of exposure to toxins, allergens, or
irritants, familial incidence, seasonal variation, stress factors,
and your ability to function outside of a highly protective
environment. To confirm the diagnosis, we may need laboratory
findings (for example, results of a biopsy obtained independently of
Social Security disability evaluation or blood tests) or evidence
from other medically acceptable methods consistent with the
[[Page 32271]]
prevailing state of medical knowledge and clinical practice.
C. How do we assess the severity of your skin disorders(s)? We
generally base our assessment of severity on the extent of your skin
lesions, the frequency of flareups of your skin lesions, how your
symptoms (including pain) limit you, the extent of your treatment,
and how your treatment affects you.
1. Extensive skin lesions. Extensive skin lesions are those that
involve multiple body sites or critical body areas, and result in a
very serious limitation. Examples of extensive skin lesions that
result in a very serious limitation include but are not limited to:
a. Skin lesions that interfere with the motion of your joints
and that very seriously limit your use of more than one extremity;
that is, two upper extremities, two lower extremities, or one upper
and one lower extremity.
b. Skin lesions on the palms of both hands that very seriously
limit your ability to do fine and gross motor movements.
c. Skin lesions on the soles of both feet, the perineum, or both
inguinal areas that very seriously limit your ability to ambulate.
2. Frequency of flareups. If you have skin lesions, but they do
not meet the requirements of any of the listings in this body
system, you may still have an impairment that results in marked and
severe functional limitations when we consider your condition over
time, especially if your flareups result in extensive skin lesions,
as defined in C1 of this section. Therefore, if you have frequent
flareups, we may find that your impairment(s) is medically equal to
one of these listings even though you have some periods during which
your condition is in remission. We will consider how frequent and
serious your flareups are, how quickly they resolve, and how you
function between flareups to determine whether you have marked and
severe functional limitations that have lasted for a continuous
period of at least 12 months or that can be expected to last for a
continuous period of at least 12 months. We will also consider the
frequency of your flareups when we determine whether you have a
severe impairment and when we need to assess functional equivalence.
3. Symptoms (including pain). Symptoms (including pain) may be
important factors contributing to the severity of your skin
disorder(s). We assess the impact of symptoms as explained in
Sec. Sec. 404.1528, 404.1529, 416.928, and 416.929 of this chapter.
4. Treatment. We assess the effects of medication, therapy,
surgery, and any other form of treatment you receive when we
determine the severity and duration of your impairment(s). Skin
disorders frequently respond to treatment; however, response to
treatment can vary widely, with some impairments becoming resistant
to treatment. Some treatments can have side effects that can in
themselves result in limitations.
a. We assess the effects of continuing treatment as prescribed
by determining if there is improvement in the symptoms, signs, and
laboratory findings of your disorder, and if you experience side
effects that result in functional limitations. To assess the effects
of your treatment, we may need information about:
i. The treatment you have been prescribed (for example, the
type, dosage, method and frequency of administration of medication
or therapy);
ii. Your response to the treatment;
iii. Any adverse effects of the treatment; and
iv. The expected duration of the treatment.
b. Because treatment itself or the effects of treatment may be
temporary, in most cases sufficient time must elapse to allow us to
evaluate the impact and expected duration of treatment and its side
effects. Except under 108.07 and 108.08, you must follow continuing
treatment as prescribed for at least 3 months before your impairment
can be determined to meet the requirements of a skin disorder
listing. (See 108.00H if you are not undergoing treatment or did not
have treatment for 3 months.) We consider your specific response to
treatment when we evaluate the overall severity of your impairment.
D. How do we assess impairments that may affect the skin and
other body systems? When your impairment affects your skin and has
effects in other body systems, we first evaluate the predominant
feature of your impairment under the appropriate body system.
Examples include, but are not limited to the following.
1. Tuberous sclerosis primarily affects the brain. The
predominant features are seizures, which we evaluate under the
neurological listings in 111.00, and developmental delays or other
mental disorders, which we evaluate under the mental disorders
listings in 112.00.
2. Malignant tumors of the skin (for example, malignant
melanoma) are cancers, or neoplastic diseases, which we evaluate
under the listings in 113.00.
3. Connective tissue disorders and other immune system disorders
(for example, systemic lupus erythematosus, scleroderma, human
immunodeficiency virus (HIV) infection, and Sj[ouml]gren's syndrome)
often involve more than one body system. We first evaluate these
disorders under the immune system listings in 114.00. We evaluate
lupus erythematosus under 114.02, scleroderma under 114.04,
symptomatic HIV infection under 114.08, and Sj[ouml]gren's syndrome
under 114.03, 114.09, or any other appropriate listing in section
114.00.
4. Disfigurement or deformity resulting from skin lesions may
result in loss of sight, hearing, speech, and the ability to chew
(mastication). We evaluate these impairments and their effects under
the special senses and speech listings in 102.00 and the digestive
system listings in 105.00. Facial disfigurement or other physical
deformities may also have effects we evaluate under the mental
disorders listings in 112.00, such as when they affect mood or
social functioning.
5. We evaluate erythropoietic porphyrias under the hemic and
lymphatic listings in 107.00.
6. We evaluate hemangiomas associated with thrombocytopenia and
hemorrhage (for example, Kasabach-Merritt syndrome) involving
coagulation defects, under the hemic and lymphatic listings in
107.00. But, when hemangiomas impinge on vital structures or
interfere with function, we evaluate their primary effects under the
appropriate body system.
E. How do we evaluate genetic photosensitivity disorders?
1. Xeroderma pigmentosum (XP). When you have XP, your impairment
meets the requirements of 108.07A if you have clinical and
laboratory findings showing that you have the disorder. (See
108.00E3.) People who have XP have a lifelong hypersensitivity to
all forms of ultraviolet light and generally lead extremely
restricted lives in highly protective environments in order to
prevent skin cancers from developing. Some people with XP also
experience problems with their eyes, neurological problems, mental
disorders, and problems in other body systems.
2. Other genetic photosensitivity disorders. Other genetic
photosensitivity disorders may vary in their effects on different
people, and may not result in marked and severe functional
limitations for a continuous period of at least 12 months.
Therefore, if you have a genetic photosensitivity disorder other
than XP (established by clinical and laboratory findings as
described in 108.00E3), you must show that you have either extensive
skin lesions or an inability to function outside of a highly
protective environment to meet the requirements of 108.07B. You must
also show that your impairment meets the duration requirement. By
inability to function outside of a highly protective environment we
mean that you must avoid exposure to ultraviolet light (including
sunlight passing through windows and light from unshielded
fluorescent bulbs), wear protective clothing and eyeglasses, and use
opaque broad-spectrum sunscreens in order to avoid skin cancer or
other serious effects. Some genetic photosensitivity disorders can
have very serious effects in other body systems, especially special
senses and speech (102.00), neurological (111.00), mental (112.00),
and neoplastic (113.00). We will evaluate the predominant feature of
your impairment under the appropriate body system, as explained in
108.00D.
3. Clinical and laboratory findings. We need evidence confirming
the diagnosis of your XP or other genetic photosensitivity disorder.
The evidence must include a clinical description of abnormal
physical findings associated with the condition. There must also be
definitive genetic laboratory studies documenting appropriate
chromosomal damage, abnormal DNA repair, or other DNA or genetic
abnormality specific to your type of photosensitivity disorder.
However, we do not need a copy of the actual laboratory report if we
have medical evidence that is persuasive that a positive diagnosis
has been confirmed by laboratory testing.
F. How do we evaluate burns? Electrical, chemical, or thermal
burns frequently affect other body systems; for example,
musculoskeletal, special senses and speech, respiratory,
cardiovascular, renal, neurological, or mental. Consequently, we
evaluate burns the way we evaluate other disorders that can affect
the skin and other body systems, using the listing for the
predominant feature of your impairment. For
[[Page 32272]]
example, if your soft tissue injuries are under continuing surgical
management (as defined in 101.00M), we will evaluate your impairment
under 101.08. However, if your burns do not meet the requirements of
101.08 and you have extensive skin lesions that result in a very
serious limitation (as defined in 108.00C1) that has lasted or can
be expected to last for a continuous period of at least 12 months,
we will evaluate them under 108.08.
G. How do we determine if your skin disorder(s) will continue at
a disabling level of severity in order to meet the duration
requirement? For all of these skin disorder listings except 108.07
and 108.08, we will find that your impairment meets the duration
requirement if your skin disorder results in extensive skin lesions
that persist for at least 3 months despite continuing treatment as
prescribed. By persist, we mean that the longitudinal clinical
record shows that, with few exceptions, your lesions have been at
the level of severity specified in the listing. For 108.07A, we will
presume that you meet the duration requirement. For 108.07B and
108.08, we will consider all of the relevant medical and other
information in your case record to determine whether your skin
disorder meets the duration requirement.
H. How do we assess your skin disorder(s) if your impairment
does not meet the requirements of one of these listings?
1. These listings are only examples of common skin disorders
that we consider severe enough to result in marked and severe
functional limitations. For most of these listings, if you do not
have continuing treatment as prescribed, if your treatment has not
lasted for at least 3 months, or if you do not have extensive skin
lesions that have persisted for at least 3 months, your impairment
cannot meet the requirements of these skin disorder listings. (This
provision does not apply to 108.07 and 108.08.) However, we may
still find that you are disabled because your impairment(s) meets
the requirements of a listing in another body system, medically
equals (see Sec. Sec. 404.1526 and 416.926 of this chapter) the
severity of a listing, or functionally equals the severity of the
listings.
2. If you have not received ongoing treatment or do not have an
ongoing relationship with the medical community despite the
existence of a severe impairment(s), or if your skin lesions have
not persisted for at least 3 months but you are undergoing
continuing treatment as prescribed, you may still have an
impairment(s) that meets a listing in another body system or that
medically equals a listing. If you do not have an impairment(s) that
meets or medically equals a listing, we will consider whether your
impairment(s) functionally equals the listings. (See Sec. 416.924
of this chapter.) When we decide whether you continue to be
disabled, we use the rules in Sec. 416.994a of this chapter.
108.01 Category of Impairments, Skin Disorders
108.02 Ichthyosis, with extensive skin lesions that persist for
at least 3 months despite continuing treatment as prescribed.
108.03 Bullous disease (for example, pemphigus, erythema
multiforme bullosum, epidermolysis bullosa, bullous pemphigoid,
dermatitis herpetiformis), with extensive skin lesions that persist
for at least 3 months despite continuing treatment as prescribed.
108.04 Chronic infections of the skin or mucous membranes, with
extensive fungating or extensive ulcerating skin lesions that
persist for at least 3 months despite continuing treatment as
prescribed.
108.05 Dermatitis (for example, psoriasis, dyshidrosis, atopic
dermatitis, exfoliative dermatitis, allergic contact dermatitis),
with extensive skin lesions that persist for at least 3 months
despite continuing treatment as prescribed.
108.06 Hidradenitis suppurativa, with extensive skin lesions
involving both axillae, both inguinal areas, or the perineum that
persist for at least 3 months despite continuing treatment as
prescribed.
108.07 Genetic photosensitivity disorders, established by
clinical and laboratory findings as described in 108.00E.
A. Xeroderma pigmentosum. Consider the individual disabled from
birth.
B. Other genetic photosensitivity disorders, with:
1. Extensive skin lesions that have lasted or can be expected to
last for a continuous period of at least 12 months, or
2. Inability to function outside of a highly protective
environment for a continuous period of at least 12 months (see
108.00E2).
108.08 Burns, with extensive skin lesions that have lasted or
can be expected to last for a continuous period of at least 12
months. (See 108.00F).
* * * * *
[FR Doc. 04-12895 Filed 6-8-04; 8:45 am]
BILLING CODE 4191-02-P