[Federal Register Volume 64, Number 196 (Tuesday, October 12, 1999)]
[Proposed Rules]
[Pages 55215-55217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26459]



20 CFR Part 404

[Regulations No. 4]
RIN 0960-AF03

Federal Old-Age, Survivors, and Disability Insurance; Determining 
Disability and Blindness; Addition of Medical Criteria for Evaluating 
Down Syndrome in Adults

AGENCY: Social Security Administration (SSA).

ACTION: Proposed rule.


SUMMARY: We are proposing to add a new listing to provide for the 
evaluation of Down syndrome for adults. Our current regulations only 
include a listing for evaluating Down syndrome in children; we evaluate 
claims filed by adults with Down syndrome under other listings. We 
believe that establishing a separate listing for this disorder in the 
adult listings will acknowledge the lifelong impact and severity of 
this disorder, and will simplify our adjudication of claims filed by 
adults with Down syndrome.

DATES: To be sure that your comments are considered, we must receive 
them no later than December 13, 1999.

ADDRESSES: Comments should be submitted in writing to the Commissioner 
of Social Security, PO Box 17703, Baltimore, MD 21235-7703, sent by 
telefax to (410) 966-2830, sent by E-mail to [email protected], or 
delivered to the Office of Process and Innovation Management, Social 
Security Administration, L2109 West Low Rise Building, 6401 Security 
Boulevard, Baltimore, MD 21235-6401, between 8 a.m. and 4:30 p.m. on 
regular business days. Comments received may be inspected during these 
hours by making arrangements with the contact person shown below.

FOR FURTHER INFORMATION CONTACT: Michelle Hungerman, Social Insurance 
Specialist, Office of Disability, Social Security Administration, 3-A-9 
Operations Building, 6401 Security Boulevard, Baltimore, Maryland, 
21235-6401, (410) 965-2289 or TTY (410) 966-5609.



    We pay disability benefits under title II of the Social Security 
Act (the Act) to disabled individuals who are insured under the Act. We 
also pay child's insurance benefits based on disability and widow's and 
widower's insurance benefits for disabled widows, widowers, and 
surviving divorced spouses of insured individuals. In addition, we pay 
Supplemental Security Income (SSI) payments under title XVI of the Act 
to persons who are disabled and who have limited income and resources. 
For adults under both the title II and title XVI programs, and for 
persons claiming child's insurance benefits based on disability under 
title II, ``disability'' means that an impairment(s) results in an 
inability to engage in any substantial gainful activity. Disability 
must also be the result of medically determinable physical or mental 
impairment(s) that can be expected to result in death or that has 
lasted or can be expected to last for a continuous period of at least 
12 months.
    Our longstanding regulations at Secs. 404.1520 and 416.920 provide 
for a five-step sequential evaluation process to determine if someone 
is disabled. At step 3 of this process, we decide whether an individual 
who is not engaging in substantial gainful activity and who has an 
impairment(s) that is severe (steps 1 and 2), has an impairment(s) that 
meets or is medically equivalent in severity to the criteria of an 
impairment in the listings. The listings describe, for each of several 
major body systems, impairments that are considered severe enough to 
prevent a person from doing any gainful activity. Although the listings 
are contained only in part 404, they are incorporated by reference in 
the SSI program by Sec. 416.925 of our regulations.

[[Page 55216]]

    The listings are divided into part A and part B. The criteria in 
part A are applied in evaluating impairments of persons age 18 or over. 
The criteria in part B are applied in evaluating impairments of persons 
under age 18. (See Secs. 404.1525 and 416.925.)

Explanation of Proposed Regulation

    We propose to add a new listing to evaluate claims filed by 
individuals age 18 or older who have non-mosaic Down syndrome. Since 
1990, we have evaluated claims for individuals under age 18 who have 
non-mosaic Down syndrome under listing 110.06, but we do not have a 
Down syndrome listing for adults. Instead, we evaluate most of these 
claims under listing 12.05-Mental Retardation--which requires 
measurement of intellectual functioning. Almost all adults with Down 
syndrome also have moderate to severe musculoskeletal abnormalities, 
and many have other impairments, including cardiac, gastrointestinal, 
oral/facial and skeletal abnormalities. Therefore, we may also evaluate 
the physical impairments that such individuals may have under the 
appropriate body system listings.
    For individuals under age 18, current listing 110.06 represents 
what we have known for some time: That when we obtain appropriate 
evidence, virtually all individuals who have non-mosaic Down syndrome 
will be found disabled under our rules. Therefore, the listing is met 
by showing that the individual has Down syndrome (excluding mosaic Down 
syndrome) that has been established by clinical findings, including the 
characteristic physical features, and laboratory evidence, including 
chromosomal analysis.
    When listing 110.06 is met, disability is established from birth. 
In recognition of the fact that Down syndrome rarely, if ever, improves 
to the point that an individual would not meet our definition of 
disability, we now propose to simplify our adjudication of cases of all 
individuals with non-mosaic Down syndrome by providing a corresponding 
listing in part A. For example, the addition of this listing will 
simplify the process of performing disability redeterminations at age 
18 for individuals who are eligible for SSI as children on the basis of 
non-mosaic Down syndrome. Even though it would be the only listing in 
section 10.00, we propose to number the new listing as listing 10.06, 
to correspond to listing 110.06 in part B.
    As in the childhood listing, proposed listing 10.06 would provide 
that an individual age 18 or older who has non-mosaic Down syndrome 
established by clinical and laboratory findings, including chromosomal 
analysis, is disabled. We also propose new sections 10.00A and 10.00B 
in the preface to the listing to provide rules for documenting non-
mosaic Down syndrome. The proposed rules are similar to those in the 
corresponding sections of part B, 110.00A and 110.00B. Proposed 10.00A 
includes a provision similar to one in current 110.00A.2 that an 
individual with Down syndrome is considered disabled since birth. We 
included this in the proposed rule for adults to establish that the 12-
month duration requirement has been met.
    As in part B, we are proposing to exclude mosaic Down syndrome from 
the listing. Mosaic Down syndrome is a rare form of the condition that 
is manifested in a wide range of impairment severity. The condition can 
be profound and disabling, but it can also be so slight as to go 
undetected. Therefore, it would not be appropriate to conclude that the 
impairment is always disabling. However, we will still find individuals 
with mosaic Down syndrome disabled if their impairments meet or are 
medically equivalent in severity to the requirements of other listings, 
or, if their impairments are severe, at the fifth step of the 
sequential evaluation process based on a residual functional capacity 
assessment and consideration of their age, education, and work 
    Finally, we are proposing a new section 10.00C. This paragraph 
provides guidance for evaluating other chromosomal abnormalities.

Other Changes

    Section 10.00 of part A of the listings is currently reserved for 
future use. We are now proposing to add a new preface (10.00A, 10.00B, 
and 10.00C) and new listing 10.06 in this section. For this reason, and 
because Down syndrome often has physical as well as mental effects, we 
propose the heading ``Multiple body systems'' for this section. We are 
also proposing to make minor editorial changes to the introductory text 
and table of contents to part A of appendix 1, to reflect the 
provisions of the proposed rule.

Clarity of This Proposed Rule

    Executive Order 12866 and the President's memorandum of June 1, 
1998 (63 FR 31885), require each agency to write all rules in plain 
language. In addition to your substantive comments on this proposed 
rule, we invite your comments on how to make this proposed rule easier 
to understand.
    For example:
     Have we organized the material to suit your needs?
     Are the requirements in the rule clearly stated?
     Does the rule contain technical language or jargon that is 
not clear?
     Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rule easier to understand?
     What else could we do to make the rule easier to 

Electronic Versions

    The electronic file of this document is available on the internet 
at <http://www.access.gpo.gov/su__docs/aces/aces140.html>. It is also 
available on the internet site for SSA (i.e., ``SSA Online'') at http:/

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that this proposed rule does not meet the criteria for a 
significant regulatory action under Executive Order 12866. Thus, it was 
not subject to OMB review.

Regulatory Flexibility Act

    We certify that the proposed rule, if promulgated, will not have a 
significant economic impact on a substantial number of small entities 
because it only affects individuals. Therefore, a regulatory 
flexibility analysis as provided in the Regulatory Flexibility Act, as 
amended, is not required.

Paperwork Reduction Act

    This proposed regulation imposes no reporting/recordkeeping 
requirements necessitating clearance by OMB.

(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; 96.006, 
Supplemental Security Income)

List of Subjects in 20 CFR Part 404

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

    Dated: September 14, 1999.
Kenneth S. Apfel,
Commissioner of Social Security.

    For the reasons set out in the preamble, we propose to amend part 
404, subpart P, of chapter III of title 20 of the Code of Federal 
Regulations to read as follow:

[[Page 55217]]

(1950-    )

    1. The authority citation for subpart P of part 404 continues to 
read as follow:

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

Appendix 1 to Subpart P of Part 404--[Amended]

    2. Appendix 1 to subpart P of part 404 is amended as follows:
    a. Item 11 of the introductory text before Part A of appendix 1 is 
    b. The Table of Contents for part A of appendix 1 is amended by 
adding section 10.00.
    c. Section 10.00 is added to Part A of appendix 1.
    The added and revised text reads as follows:

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

* * * * *
    11. Multiple Body Systems (10.00 and 110.00): July 2, 2001.
* * * * *
    Part A
* * * * *

10.00  Multiple Body Systems

* * * * *


    A. Down syndrome (except for mosaic Down syndrome (see 10.00C)) 
established by clinical findings, including the characteristic 
physical features, and laboratory evidence is considered to meet the 
requirement of listing 10.06, commencing at birth.
    B. Documentation must include confirmation of a positive 
diagnosis by a clinical description of the usual abnormal physical 
findings associated with the condition and definitive laboratory 
tests, including chromosomal analysis. Medical evidence that is 
persuasive that a positive diagnosis has been confirmed by 
appropriate laboratory testing, at some time prior to evaluation, is 
acceptable in lieu of a copy of the actual laboratory report.
    C. Other chromosomal abnormalities, e.g., mosaic Down syndrome, 
fragile X syndrome, phenylketonuria, and fetal alcohol syndrome, 
produce a pattern of multiple impairments but manifest in a wide 
range of impairment severity. Therefore, the effects of these 
impairments should be evaluated under the affected body system.

10.01  Category of Impairments, Multiple Body Systems

    10.06  Down syndrome (excluding mosaic Down syndrome) 
established by clinical and laboratory findings, as described in 
10.00B. Consider the individual disabled from birth.
* * * * *
[FR Doc. 99-26459 Filed 10-8-99; 8:45 am]