[Federal Register Volume 67, Number 246 (Monday, December 23, 2002)]
[Proposed Rules]
[Pages 78196-78202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32217]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Regulation Nos. 4 and 16]
RIN 0960-AF32


Revised Medical Criteria for Evaluating Impairments That Affect 
Multiple Body Systems

AGENCY: Social Security Administration.

ACTION: Proposed rules.

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SUMMARY: We propose to revise the criteria in the Listing of 
Impairments (the listings) that we use to evaluate claims involving 
impairments that affect multiple body systems. 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 proposed revisions 
reflect current medical knowledge, treatment, and methods of evaluating 
impairments that affect multiple body systems.

DATES: To be sure your comments are considered, we must receive them by 
February 21, 2003.

ADDRESSES: You may give us your comments by using: our Internet site 
facility (i.e., Social Security Online) at http://www.ssa.gov/regulations/; e-mail to [email protected]; by telefax to (410) 966-
2830, or, by letter to the Commissioner of Social Security, PO Box 
17703, Baltimore, Maryland 21235-7703. You may also deliver them to the 
Office of Process and Innovation Management, Social Security 
Administration, 2109 West Low Rise Building, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, between 8 a.m. and 4:30 p.m. on regular 
business days. Comments are posted on our Internet site, at http://policy.ssa.gov/pnpublic.nsf/LawsRegs or you may inspect them on regular 
business days by making arrangements with the contact person shown in 
this preamble.
    Electronic Version: The electronic file of this document is 
available on the date of publication in the Federal Register at http://www.access.gpo.gov/su_docs/aces/aces140.html. It is also available on 
the Internet site for SSA (i.e., Social Security Online): http://www.ssa.gov/regulations/.

FOR FURTHER INFORMATION CONTACT: Suzanne DiMarino, Social Insurance 
Specialist, Office of Process and Innovation Management, Social 
Security Administration, 2109 West Low Rise, 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.ssa.gov.

SUPPLEMENTARY INFORMATION: 

What Programs Would These Proposed Regulations Affect?

    These proposed regulations would 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 proposed regulations would 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:
    [sbull] Workers insured under the Act,
    [sbull] Children of insured workers, and
    [sbull] Widows, widowers, and surviving divorced spouses (see 20 
CFR 404.336) of insured workers.

[[Page 78197]]

    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 meets the statutory duration 
requirement; that is, it must be expected to result in death or must 
have lasted or 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
                                                         determinable
 If you file a claim under * * *   And you are * * *  impairment(s) that
                                                           meets the
                                                      statutory duration
                                                        requirement and
                                                       results in * * *
------------------------------------------------------------------------
Title II........................  An adult or a       The inability to
                                   child.              do any
                                                       substantial
                                                       gainful activity
                                                       (SGA).
Title XVI.......................  A person age 18 or  The inability to
                                   older.              do any SGA.
Title XVI.......................  A person under age  Marked and severe
                                   18.                 functional
                                                       limitations.
------------------------------------------------------------------------

What Are The Listings?

    The listings are examples of impairments that we consider severe 
enough to prevent a person from doing any gainful activity or that 
result in ``marked and severe functional limitations'' in children 
seeking SSI payments under title XVI of the Act. Although we publish 
the listings only in appendix 1 to subpart P of part 404 of our rules, 
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 a person 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 a person 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.)
    We use the listings only to decide that people are disabled or that 
they are still disabled. We will never deny your claim or decide that 
you no longer qualify for benefits because your impairment(s) does not 
meet or medically equal a listing. If 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'' that we use to evaluate all disability claims. (See 
Sec. Sec.  404.1520, 416.920, and 416.924.)
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended based only 
on any changes in the listings. 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 the listings. 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 after 
we decide that you have experienced medical improvement in your 
condition(s). See Sec.  416.994a(b)(2).

Why Are We Proposing To Revise the Listings for Impairments That Affect 
Multiple Body Systems?

    We last published final rules revising the adult listings for 
impairments that affect multiple body systems in the Federal Register 
on May 19, 2000 (65 FR 31800); the rules were effective on June 19, 
2000. In that document, we said that those rules would be effective for 
8 years unless we extended them, or revised and issued them again. The 
current adult (Part A) listings for impairments that affect multiple 
body systems will no longer be effective on June 19, 2008 unless we 
extend them, or revise and issue them again.
    We last published final rules revising the childhood listings for 
impairments that affect multiple body systems in the Federal Register 
on December 12, 1990 (55 FR 51204). The current childhood (Part B) 
listings for impairments that affect multiple body systems will no 
longer be effective on July 2, 2003 (66 FR 34361).
    We are proposing these revisions because we decided to update the 
medical criteria in the listings and to provide more information about 
how we evaluate impairments that affect multiple body systems.

When Will We Start To Use These Rules?

    We will not use these rules until we evaluate the public comments 
we receive on them, determine whether they should be issued as final 
rules, and issue final rules in the Federal Register. If we publish 
final rules, we will explain in the preamble how we will apply them, 
and summarize and respond to the public comments. Until the effective 
date of any final rules, we will continue to use our current rules.

How Long Would These Proposed Rules Be Effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 8 years after the date they become effective, unless we 
extend them, or revise and issue them again.

What Revisions Are We Proposing To Make?

    We are proposing to:
    [sbull] Change the name of this body system listing from ``Multiple 
Body Systems'' to ``Impairments That Affect Multiple Body Systems,''
    [sbull] Expand, update, and reorganize the introductory text,
    [sbull] Remove current listing 110.07,
    [sbull] Make conforming changes, when applicable, in related 
regulations, and
    [sbull] Make nonsubstantive editorial changes.

Why Are We Proposing To Change the Name of This Body System Listing?

    We are proposing to change the name of this body system listing 
from ``Multiple Body Systems'' to ``Impairments That Affect Multiple 
Body Systems'' to more accurately

[[Page 78198]]

reflect that we use this listing to evaluate single impairments that 
affect two or more body systems.

How Are We Proposing to Change the Introductory Text to the Adult 
Multiple Body Systems Listing?

10.00 Impairments That Affect Multiple Body Systems

    To provide additional guidance, we propose to expand, update, and 
reorganize the introductory text to the listing of impairments that 
affect multiple body systems. A detailed description of the proposed 
introductory text follows.

Proposed 10.00A--What Impairment Do We Evaluate Under This Body System 
Listing?

    This section expands and clarifies current 10.00A, ``Down syndrome 
(except for mosaic Down syndrome)'' and provides a description of Down 
syndrome:
    [sbull] Proposed 10.00A1 explains that we evaluate non-mosaic Down 
syndrome under this body system listing.
    [sbull] Proposed 10.00A2 is a new paragraph that describes Down 
syndrome and explains that it exists in ``non-mosaic'' and ``mosaic'' 
forms.
    [sbull] Proposed 10.00A3a describes non-mosaic Down syndrome. 
Proposed 10.00A3b explains that we evaluate non-mosaic Down syndrome 
under proposed listing 10.06. It also explains that, if you have 
confirmed non-mosaic Down syndrome, we consider you disabled from 
birth. This provision is currently part of listing 10.06, but we 
propose to move it here, because it is a criterion for establishing 
when the person is first disabled under our rules, which belongs in the 
introductory text.
    [sbull] Proposed 10.00A4a describes mosaic Down syndrome. Proposed 
10.00A4b explains that we evaluate adults with confirmed mosaic Down 
syndrome under the listing criteria for the affected body system(s) on 
an individual case basis and refers to 10.00C for an explanation of how 
we adjudicate claims involving mosaic Down syndrome.

Proposed 10.00B--What Documentation Do We Need To Establish That You 
Have An Impairment That Affects Multiple Body Systems?

    This section, which expands and modifies current 10.00B, explains 
the documentation we need to establish that you have an impairment(s) 
that affects multiple body systems. There are two subsections:
    [sbull] Proposed 10.00B1 explains that the documentation we need to 
establish the existence of a medically determinable impairment must 
come from an acceptable medical source. We require such documentation 
for any impairment. The documentation must include a clinical 
description of the abnormal physical findings and definitive laboratory 
tests, including chromosomal analysis, where appropriate.
    [sbull] Proposed 10.00B2 explains that, in lieu of a copy of the 
actual laboratory report, we will accept medical evidence that is 
persuasive that a positive diagnosis has been confirmed by appropriate 
laboratory testing at some time prior to our evaluation. This section 
includes the guidance in current 10.00B on what we mean by medical 
evidence that is ``persuasive.''

Proposed 10.00C--How Do We Evaluate Impairments That Affect Multiple 
Body Systems That Do Not Meet the Criteria of the Listing In This Body 
System?

    [sbull] Proposed 10.00C1 explains that if your severe impairment(s) 
that affects multiple body systems does not meet the listing in this 
body system, we must consider whether you have another impairment(s) 
that meets the criteria of a listing in another body system.
    [sbull] Proposed 10.00C2 gives some examples of the many other 
impairments that can affect multiple body systems, such as trisomy X 
syndrome, fragile X syndrome, phenylketonuria (PKU), caudal regression 
syndrome, and fetal alcohol syndrome. We also explain that, because the 
body systems that these impairments can affect vary, and the effects on 
each body system can differ in severity and progression, we would 
evaluate these impairments under the listing criteria of the affected 
body system on an individual case basis. Proposed 10.00C2 generally 
corresponds to current 10.00C.
    [sbull] Proposed 10.00C3 explains that, if you have a severe 
medically determinable impairment(s) that does not meet a listing, we 
will consider whether your impairment(s) medically equals a listing. If 
not, we will proceed to the fourth and, if necessary, fifth steps of 
the sequential evaluation process in Sec. Sec.  404.1520 and 416.920. 
We explain that we follow the rules in Sec. Sec.  404.1594 and 416.994, 
as appropriate, when we decide whether you continue to be disabled.

Proposed 10.01--Category of Impairments, Impairments That Affect 
Multiple Body Systems

    The following is an explanation of the proposed changes to the 
listing.

Proposed Listing 10.06--Non-Mosaic Down Syndrome

    We propose to simplify the heading to make it clear that we 
evaluate only non-mosaic Down syndrome under this listing. We also 
propose to move the last sentence of current 10.06 to proposed 10.00A3b 
because it is a criterion for establishing when the person is first 
disabled under our rules, which belongs in the introductory text.

What Changes Do We Propose for Children?

    If the same criteria exist in both the adult and childhood rules, 
we propose to make the same changes in the childhood rules that we 
propose for the adult rules for the same reasons we made the changes in 
the adult rules.
    To provide additional guidance, we propose to expand, update, and 
reorganize the introductory text to the listing of impairments that 
affect multiple body systems. A description of the proposed 
introductory text follows.

Proposed 110.00A--What kinds of Impairments Do We Evaluate Under This 
Body System Listing?

    This section describes the kinds of impairments that we evaluate 
under these listings.
    [sbull] Proposed 110.00A1 explains that we use these listings when 
a single impairment affects two or more body systems, and describes 
what kinds of impairments we evaluate under these listings. We also 
provide a brief description of the effects that these impairments 
generally have on a child's ability to perform age-appropriate 
activities and explain how we use the term ``very seriously.''
    [sbull] Proposed 110.00A2 describes Down syndrome.
    [sbull] Proposed 110.00A3a describes non-mosaic Down syndrome. 
Proposed 110.00A3b explains that we evaluate children with confirmed 
non-mosaic Down syndrome under proposed listing 110.06.
    [sbull] Proposed 110.00A4a describes mosaic Down syndrome. Proposed 
110.00A4b explains that we evaluate children with confirmed mosaic Down 
syndrome under the listing criteria for the affected body system(s) on 
an individual case basis.
    [sbull] Proposed 110.00A5a describes what we mean by ``catastrophic 
congenital abnormalities or diseases.'' We explain that it is 
reasonably certain that these abnormalities and diseases result in 
early death or interfere very seriously with development. ``Very 
seriously'' is consistent with our definition of ``extreme'' limitation 
in Sec.  416.926a(e)(3).

[[Page 78199]]

Proposed 110.00A5b explains that we evaluate catastrophic congenital 
abnormalities or diseases under proposed listing 110.08.

Proposed 110.00B--What Documentation Do We need To Establish That You 
Have an Impairment That Affects Multiple Body Systems?

    This section, which expands and modifies current 110.00B, explains 
the documentation we need to establish that you have an impairment(s) 
that affects multiple body systems. There are two subsections:
    [sbull] Proposed 110.00B1 explains the documentation we need to 
establish that you have a medically determinable impairment. This 
section is substantively the same as proposed section 10.00B1 of the 
part A listings for adults.
    [sbull] Proposed 110.00B2 explains what medical evidence we will 
accept in lieu of a copy of the actual laboratory report. The medical 
evidence must be persuasive that a positive diagnosis has been 
confirmed by appropriate laboratory testing at some time prior to our 
evaluation. This section is substantively the same as proposed section 
10.00B2 of the part A listings for adults.

Proposed 110.00C--How Do We Evaluate Impairments That Affect Multiple 
Body Systems That Do Not Meet The Criteria of The Listings In This Body 
System?

    Proposed 110.00C is substantively similar to proposed section 
10.00C of the part A listings for adults.
    [sbull] Proposed 110.00C1 explains that if your severe 
impairment(s) that affects multiple body systems does not meet the 
criteria for a listing in this body system, we must also consider 
whether you have an impairment(s) that meets the criteria of a listing 
in another body system.
    [sbull] Proposed 110.00C2 gives some examples of the many other 
impairments that can affect multiple body systems, such as trisomy X 
syndrome, fragile X syndrome, phenylketonuria (PKU), caudal regression 
syndrome, and fetal alcohol syndrome. We also explain that, because the 
body systems that these impairments can affect vary, and the effects on 
each body system can differ in severity and progression, we would 
evaluate these impairments under the listing criteria of any affected 
body system on an individual case basis.
    [sbull] Proposed 110.00C3 explains that, if your severe medically 
determinable impairment(s) does not meet a listing, we will consider 
whether your impairment(s) medically equals a listing or, in the case 
of a claim for SSI payments, functionally equals the listings. Proposed 
110.00C3 also explains that if you are a child receiving SSI payments, 
we use the rules in Sec.  416.994a to decide whether you continue to be 
disabled.

Proposed 110.01 Category of Impairments, Impairments That Affect 
Multiple Body Systems

    The following is an explanation of the proposed changes to the 
listings.

Proposed Listing 110.06--Non-Mosaic Down Syndrome

    We propose to simplify the heading to make it clear that we 
evaluate only non-mosaic Down syndrome under this listing. We also 
propose to move the last sentence of current 110.06 to proposed 
110.00A3b because it is a criterion for establishing when the child is 
first disabled under our rules, which belongs in the introductory text.

Current Listing 110.07--Multiple Body Dysfunction

    We propose to remove current listing 110.07 for two reasons.
    [sbull] First, the A criterion in this listing, published December 
12, 1990, was created to evaluate physical impairments in infants or 
young children. We wrote this listing before we had the policy of 
functional equivalence (Sec.  416.926a) to help adjudicators evaluate 
physical impairments in very young children. Current listing 110.07A is 
now outdated and unnecessary because we have made a number of changes 
in our other listings and regulations, including the implementation of 
the functional equivalence policy more than 10 years ago, that provide 
better rules for evaluating infants and toddlers.
    [sbull] Second, the remaining criteria, 110.07B through F, are 
solely reference listings that refer adjudicators to another listing 
for the affected body system. As we update the listings in each of the 
body systems, we are removing reference listings because they are 
redundant.

Proposed Listing 110.08--A Catastrophic Congenital Abnormality or 
Disease

    In proposed 110.08, we explain that such abnormalities and diseases 
are generally regarded as being incompatible with prolonged life 
outside the uterus (110.08A) or interfere very seriously with 
development (110.08B). In proposed 110.08A, we are changing the phrase 
``incompatible with extrauterine life'' in current listing 110.08A to 
``incompatible with prolonged life outside the uterus'' to recognize 
that children with some catastrophic congenital abnormalities or 
diseases may live for many months or even a few years. In proposed 
110.08B, we are changing the phrase ``attainment of the growth and 
development of 2 years is not expected to occur'' in the current 
listing to ``interfere very seriously with development.'' The new 
language takes into consideration advances in evaluation and management 
of these abnormalities and diseases, and is consistent with our 
definition of ``extreme'' limitation in Sec.  416.926a(e)(3). We also 
propose to make listing 110.08 clearer and easier to understand by:
    [sbull] Changing the word ``abnormalities'' in current listing 
110.08 to ``abnormality'' to emphasize that there need be only a single 
abnormality or disease involved; and
    [sbull] Moving the requirement for ``a positive diagnosis'' from 
current listings 110.08A and B to the opening statement in proposed 
listing 110.08.

What Other Rules Are We Proposing to Change?

    We propose to remove the last sentence of 101.00B2c(2), ``How we 
assess inability to perform fine and gross movements in very young 
children,'' in the introductory text of the childhood musculoskeletal 
listings, because it refers adjudicators to current 110.07A, which we 
propose to remove from the multiple body listings. We propose to 
replace the reference to 110.07A with the following statement: ``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.'' This statement provides clearer guidance for 
assessing extreme limitation of fine and gross movements in very young 
children, and is the same guidance we provide in 101.00B2b(2).
    We propose to change the presumptive disability citation for Down 
syndrome in Sec.  416.934, ``Impairments which may warrant a finding of 
presumptive disability or presumptive blindness'' (Sec.  416.934(g)) 
from ``Allegation of Down's syndrome (Mongolism)'' to ``Allegation of 
Down Syndrome.'' This will update the language of our rules to reflect 
current terminology.

Clarity of These Proposed Rules

    Executive Order (E.O.) 12866, as amended by E.O. 13258, requires 
each agency to write all rules in plain language. In addition to your

[[Page 78200]]

substantive comments on these proposed rules, we invite your comments 
on how to make these proposed rules easier to understand.
    For example:
    [sbull] Have we organized the material to suit your needs?
    [sbull] Are the requirements in the rules clearly stated?
    [sbull] Do the rules contain technical language or jargon that 
isn't clear?
    [sbull] Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rules easier to understand?
    [sbull] Would more (but shorter) sections be better?
    [sbull] Could we improve clarity by adding tables, lists, or 
diagrams?
    [sbull] What else could we do to make the rules easier to 
understand?

Regulatory Procedures

Executive Order (E.O.) 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these proposed rules meet the criteria for a 
significant regulatory action under E.O. 12866, as amended by E.O. 
13258. Thus, they were subject to OMB review.

Regulatory Flexibility Act

    We certify that these proposed rules would 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

    These proposed rules contain reporting requirements at 10.00B, 
10.00C, 110.00B, and 110.00C. 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 these rules. We are seeking clearance of 
the burdens referenced in these rules because they were not considered 
during the clearance of the forms. An Information Collection request 
has been submitted to 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. Comments should be 
submitted to the Social Security Administration at the following 
address: Social Security Administration, Attn: SSA Reports Clearance 
Officer, Rm. 1338 Annex Building, 6401 Security Boulevard, Baltimore, 
MD 21235-6401.
    Comments can be received between 30 and 60 days after publication 
of this notice and will be most useful if received by SSA within 30 
days of publication.

References

    We consulted the following sources when developing these proposed 
rules:

Goldman, L. & Bennett, J.C. (Eds.). (2000). Cecil Textbook of Medicine, 
(21st ed.). (126-129). Philadelphia: W. B. Saunders Company.
Fauci, A.S., et al. (Eds.). (1998). Harrison's Principles of Internal 
Medicine, (14th ed.). (365-403, 2087-2131). New York: McGraw-Hill.
Behrman, R.E., Kliegman, R.M. & Jenson, H.B. (Eds.). (2000). Nelson's 
Textbook of Pediatrics (16th ed.). (313-342). Philadelphia: W.B. 
Saunders Company.

    These references are included in the rulemaking record for these 
proposed rules and are available for inspection by interested persons 
by making arrangements with the contact person shown in this preamble.

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, Supplemental Security Income 
(SSI), Reporting and recordkeeping requirements.

    Dated: September 25, 2002.
Jo Anne B. Barnhart,
Commissioner of Social Security.
    For the reasons set out in the preamble, we propose to amend 
subpart P of part 404 and subpart I of part 416 of chapter III of title 
20 of the Code of Federal Regulations as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

Subpart P--[Amended]

    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.

    2. Item 11 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

* * * * *

    11. Impairments That Affect Multiple Body Systems (10.00 and 
110.00): [Date 8 years after effective date of final regulations.]

* * * * *
    3. The list of sections for part A is amended by revising the 
heading for section 10.00 to read as follows:

Part A

* * * * *

10.00 Impairments That Affect Multiple Body Systems

* * * * *

    4. Listing 10.00, Multiple Body Systems, of part A of appendix 1 of 
subpart P of part 404 is revised to read as follows:

* * * * *

10.00 Impairments That Affect Multiple Body Systems

A. What impairment do we evaluate under this body system listing?

    1. General. We evaluate non-mosaic Down syndrome under this body 
system listing.
    2. What is Down syndrome? Down syndrome is a chromosomal 
condition, present before birth, in which there are three 
chromosomes 21 instead of two. The three chromosomes may be separate 
(trisomy) or one chromosome may be attached to another 
(translocation). The extra chromosomal material changes the orderly 
development of the body and brain. Down syndrome is characterized by 
a complex of physical characteristics, delayed physical development, 
and mental retardation. It is often accompanied by heart disease, 
vision defects, chronic respiratory infections, and other 
conditions. It exists in non-mosaic and mosaic forms.
    3. What is non-mosaic Down syndrome?
    a. Non-mosaic Down syndrome occurs when the extra chromosome is 
replicated in every cell of the body. This form of Down syndrome is 
responsible for 95 percent of all cases. Virtually all cases of non-
mosaic Down syndrome affect the mental, neurological, and skeletal 
systems, and often other body systems such as cardiac, endocrine, 
and gastrointestinal.
    b. We evaluate adults with confirmed non-mosaic Down syndrome 
under 10.06. If you have confirmed non-mosaic Down syndrome, we 
consider you disabled from birth.
    4. What is mosaic Down syndrome?

[[Page 78201]]

    a. Mosaic Down syndrome occurs when you have some cells with 
normal chromosomes and some cells with extra chromosomal material. 
When this occurs, there is a mixture of two types of cells. Some of 
the cells contain 46 chromosomes and some of the cells contain 47 
chromosomes. Mosaic Down syndrome occurs far less frequently than 
non-mosaic Down syndrome and can have features that manifest in a 
wide range of severity. Mosaic Down syndrome can be profound and 
disabling, but it also can be so slight as to be undetected 
clinically.
    b. We evaluate adults with confirmed mosaic Down syndrome under 
the listing criteria for the affected body system(s) on an 
individual case basis, as described in 10.00C.

B. What Documentation Do We Need To Establish That You Have an 
Impairment That Affects Multiple Body Systems?

    1. General. We need documentation from an acceptable medical 
source as defined in Sec. Sec.  404.1513(a) and 416.913(a) to 
establish that you have a medically determinable impairment. The 
documentation must include a clinical description of the abnormal 
physical findings and definitive laboratory tests, including 
chromosomal analysis, where appropriate.
    2. What will we accept as medical evidence in lieu of the actual 
laboratory report? When the actual laboratory report is unavailable, 
we will accept medical evidence that is persuasive that a positive 
diagnosis has been confirmed by appropriate laboratory testing at 
some time prior to our evaluation. To be persuasive, a report from 
an acceptable medical source must state that appropriate testing was 
conducted and the results confirmed the diagnosis. The report must 
be consistent with other evidence in your case record, for example, 
the description of abnormal physical findings, your educational 
history, or, if available, the results of psychological testing.

C. How Do We Evaluate Impairments That Affect Multiple Body Systems 
That Do Not Meet the Criteria of the Listing in This Body System?

    1. Non-mosaic Down syndrome (10.06) is an example of a common 
impairment that affects multiple body systems that we consider 
severe enough to prevent you from doing any gainful activity. If 
your severe impairment(s) does not meet the criteria of this 
listing, we must also consider whether you have an impairment(s) 
that meets the criteria of a listing in another body system.
    2. There are many other impairments that cause deviation from, 
or interruption of, the normal function of the body, but the degree 
of deviation may vary widely from person to person. Therefore, the 
resulting functional limitations and the progression of those 
limitations also vary widely. For these reasons, we will evaluate 
these impairments on an individual case basis under the listing 
criteria in any affected body system. Examples of such impairments 
include trisomy X syndrome, fragile X syndrome, phenylketonuria 
(PKU), caudal regression syndrome, and fetal alcohol syndrome.
    3. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will consider whether your 
impairment(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926.) If your impairment(s) does not meet or medically equal 
a listing, you may or may not have the residual functional capacity 
to engage in substantial gainful activity. In that situation, we 
proceed to the fourth and, if necessary, the fifth steps of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920. If 
you are an adult, we use the rules in Sec. Sec.  404.1594 and 
416.994, as appropriate, when we decide whether you continue to be 
disabled.

10.01 Category of Impairments, Impairments That Affect Multiple Body 
Systems

    10.06 Non-mosaic Down syndrome, established by clinical and 
laboratory findings, as described in 10.00B.
* * * * *

    5. The list of sections for part B is amended by revising the 
heading title for section 110.00 to read as follows:

Part B

* * * * *
    110.00 Impairments That Affect Multiple Body Systems.
* * * * *
    6. Section B.2.c.(2) of the introductory text of 101.00, 
Musculoskeletal System, of Part B of appendix 1 of Subpart P of part 
404 is revised to read as follows:
* * * * *
    B. * * *
    2. * * *
* * * * *
    c. * * *
* * * * *
    (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. 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.
* * * * *

    7. Listing 110.00, Multiple Body Systems, of part B of appendix 1 
of subpart P of part 404 is revised to read as follows:

* * * * *

110.00 Impairments That Affect Multiple Body Systems

A. What Kinds of Impairments Do We Evaluate Under This Body System 
listing?

    1. General. We use these listings when a single impairment 
affects two or more body systems. Under these listings, we evaluate 
impairments that affect multiple body systems due to non-mosaic and 
mosaic Down syndrome or a catastrophic congenital abnormality or 
disease. These kinds of impairments generally produce long-term, if 
not lifelong, interference with age-appropriate activities. Some of 
them result in early death or interfere very seriously with 
development. We use the term ``very seriously'' in these listings to 
describe an ``extreme'' limitation of functioning as defined in 
Sec.  416.926a(e)(3).
    2. What is Down syndrome? Down syndrome is a chromosomal 
condition, present before birth, in which there are three 
chromosomes 21 instead of two. The three chromosomes may be separate 
(trisomy) or one chromosome may be attached to another 
(translocation). This extra chromosomal material changes the orderly 
development of the body and brain. Down syndrome is characterized by 
a complex of physical characteristics, delayed physical development, 
and mental retardation. It is often accompanied by heart disease, 
vision defects, chronic respiratory infections, and other 
conditions. It exists in non-mosaic and mosaic forms.
    3. What is non-mosaic Down syndrome?
    a. Non-mosaic Down syndrome occurs when the extra chromosome is 
replicated in every cell of the body. This form of Down syndrome is 
responsible for 95 percent of all cases. Virtually all cases of non-
mosaic Down syndrome affect the mental, neurological, and skeletal 
systems, and often other body systems such as cardiac, endocrine, 
and gastrointestinal.
    b. We evaluate children with confirmed non-mosaic Down syndrome 
under listing 110.06. If you have confirmed non-mosaic Down 
syndrome, we consider you disabled from birth.
    4. What is mosaic Down syndrome?
    a. Mosaic Down syndrome occurs when you have some cells with 
normal chromosomes and some cells with extra chromosomal material. 
When this occurs, there is a mixture of two types of cells. Some of 
the cells contain 46 chromosomes and some of the cells contain 47 
chromosomes. Mosaic Down syndrome occurs far less frequently than 
non-mosaic Down syndrome and can have features that manifest in a 
wide range of severity. Mosaic Down syndrome can be profound and 
disabling, but it also can be so slight as to be undetected 
clinically.
    b. We evaluate children with confirmed mosaic Down syndrome 
under the listing criteria for the affected body system(s) on an 
individual case basis.
    5. What are catastrophic congenital abnormalities or diseases?
    a. Catastrophic congenital abnormalities or diseases are present 
at birth although they may not be apparent immediately. They cause 
deviation from, or interruption of, the normal function of the body 
and are reasonably certain to result in early death or interfere 
very seriously with development.
    b. We evaluate catastrophic congenital abnormalities or diseases 
under listing 110.08.

B. What Documentation Do We Need to Establish That You Have an 
Impairment That Affects Multiple Body Systems?

    1. General. We need documentation from an acceptable medical 
source as defined in Sec. Sec.  404.1513(a) and 416.913(a) to 
establish

[[Page 78202]]

that you have a medically determinable impairment. The documentation 
must include a clinical description of the abnormal physical 
findings and definitive laboratory tests, including chromosomal 
analysis, where appropriate.
    2. What will we accept as medical evidence in lieu of the actual 
laboratory report? When the actual laboratory report is unavailable, 
we will accept medical evidence that is persuasive that a positive 
diagnosis has been confirmed by appropriate laboratory testing at 
some time prior to our evaluation. To be persuasive, a report from 
an acceptable medical source must state that appropriate testing was 
conducted and that the results confirmed the diagnosis. The report 
must be consistent with other evidence in your case record, for 
example, the description of abnormal physical findings, your 
educational history, or, if available, the results of psychological 
testing.

C. How Do We Evaluate Impairments That Affect Multiple Body Systems 
That Do Not Meet the Criteria of the Listings in This Body System?

    1. These listings are examples of common impairments that affect 
multiple body systems that we consider severe enough to result in 
marked and severe functional limitations. If your severe 
impairment(s) does not meet the criteria of any of these listings, 
we must also consider whether you have an impairment(s) that meets 
the criteria of a listing in another body system.
    2. There are many other impairments that cause deviation from, 
or interruption of, the normal function of the body, but the degree 
of deviation may vary widely from child to child. Therefore, the 
resulting functional limitations and the progression of those 
limitations are more variable than with catastrophic congenital 
abnormalities or diseases described in 110.00A5. For these reasons, 
we evaluate these impairments on an individual case basis under the 
listing criteria in any affected body system. Examples of such 
impairments include trisomy X syndrome, fragile X syndrome, 
phenylketonuria (PKU), caudal regression syndrome, and fetal alcohol 
syndrome.
    3. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will consider whether your 
impairment(s) medically equals a listing, and, in the case of a 
claim for SSI payments, functionally equals the listings. (See 
Sec. Sec.  404.1526, 416.926, and 416.926a.) If you are receiving 
SSI payments, when we decide whether you continue to be disabled, we 
use the rules in Sec.  416.994a.

110.01 Category of Impairments, Impairments That Affect Multiple Body 
Systems

    110.06 Non-mosaic Down syndrome, established by clinical and 
laboratory findings, as described in 110.00B.
    110.08 A catastrophic congenital abnormality or disease. With a 
positive diagnosis as described in 110.00B, AND THAT:
    A. Is generally regarded as being incompatible with prolonged 
life outside the uterus (for example, anencephaly, trisomy D or E, 
cyclopia);
    OR
    B. Interferes very seriously with development; for example, 5p-
syndrome (cri du chat) or Tay-Sachs disease.
* * * * *

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

Subpart I--[Amended]

    7. 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).

    8. Section 416.934(g) is revised to read as follows:


Sec.  416.934  Impairments which may warrant a finding of presumptive 
disability or presumptive blindness.

* * * * *
    (g) Allegation of Down syndrome; and
* * * * *
[FR Doc. 02-32217 Filed 12-20-02; 8:45 am]
BILLING CODE 4191-02-P