[Federal Register Volume 65, Number 98 (Friday, May 19, 2000)]
[Rules and Regulations]
[Pages 31800-31802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12593]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulations No. 4]
RIN 0960-AF03


Addition of Medical Criteria for Evaluating Down Syndrome in 
Adults

AGENCY: Social Security Administration (SSA).

ACTION: Final rule.

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SUMMARY: We are adding a new listing to evaluate non-mosaic Down 
syndrome in 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 are establishing a 
separate adult listing for this disorder to acknowledge its lifelong 
impact and severity. We expect that these final rules will simplify and 
expedite our adjudication of claims filed by adults with non-mosaic 
Down syndrome.

DATES: These rules are effective June 19, 2000.

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, TTY (410) 966-5609. For information on 
eligibility, claiming benefits, or coverage of earnings, call our 
national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778.

SUPPLEMENTARY INFORMATION:

Background

    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 make 
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 be the result of any 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.
    Although the listings are contained only in part 404, we 
incorporate them by reference in the SSI program by Sec. 416.925 of our 
regulations. The listings are divided into part A and part B. We apply 
the criteria in part A when we evaluate impairments in adults, that is, 
persons age 18 or over. The listings in part A describe, for each of 
several major body systems, impairments that are considered severe 
enough to prevent a person from doing any gainful activity.
    As a result of medical advances in disability evaluation and 
treatment, and program experience, we are required to periodically 
review and update the listings. In the Notice of Proposed Rulemaking 
(NPRM) we published in the Federal Register (64 FR 55215) on October 
12, 1999, we indicated that we would review these rules on July 2, 
2001. However, based on our experience adjudicating claims filed by 
adults with non-mosaic Down syndrome, we believe that these rules will 
continue to be valid for our program purposes after that date. 
Therefore, these rules will be in effect for 8 years after the 
effective date, unless we extend them, or revise and issue them again.

Explanation of Final Rules

    Aside from the change in the date on which these rules will no 
longer be effective, which we discussed above, we have made no changes 
from the proposed rules. We are adding a new listing to evaluate claims 
filed by adults who have non-mosaic Down syndrome. Since 1990, we have 
evaluated claims filed on behalf of children who have

[[Page 31801]]

non-mosaic Down syndrome under listing 110.06, but we have not had 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. We also evaluate the physical 
impairments that such individuals may have under the appropriate body 
system listings.
    For children, 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, listing 110.06 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 non-mosaic Down syndrome rarely, if 
ever, improves to the point that an individual would not meet our 
definition of disability, we are adding a corresponding listing in part 
A. We expect that this listing will simplify and expedite our 
adjudication of cases filed by adults with non-mosaic Down syndrome. We 
also expect that these rules will simplify and expedite 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. Although it is the only listing in section 10.00, we are 
numbering the new listing as listing 10.06, to correspond to listing 
110.06 in part B.
    As in the childhood listing, final listing 10.06 provides that an 
individual age 18 or older who has non-mosaic Down syndrome established 
by clinical and laboratory findings, including chromosomal analysis, is 
considered disabled from birth. The new sections 10.00A and 10.00B in 
the preface to the listing provide rules for documenting non-mosaic 
Down syndrome. These rules are similar to those in the corresponding 
sections of the part B listing, 110.00A and 110.00B. Final 10.00A 
includes a provision similar to one in current 110.00A.2, which states 
that an individual with Down syndrome is considered disabled from 
birth. We included this provision in the final rules for adults to 
establish that the 12-month duration requirement has been met.
    As we have done in part B of our listings, we are excluding 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 mosaic Down syndrome 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. An individual whose 
mosaic Down syndrome is ``severe'' but whose impairment(s) do not meet 
or medically equal the requirements of a listing may also be found 
disabled at the fifth step of the sequential evaluation process, based 
on an assessment of his or her residual functional capacity and 
consideration of his or her age, education, and work experience.
    Finally, we are adding 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 was reserved for future 
use. We are now adding 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 are adding 
the heading ``Multiple body systems'' for this section. We are also 
making minor editorial changes to the introductory text and table of 
contents to part A of appendix 1, to reflect the provisions of the 
final rules.

Public Comments

    In the NPRM, we provided the public with a 60-day comment period. 
In response to the NPRM, we received comments from 20 commenters. Most 
of the comments came from individuals, many of whom have family members 
with Down syndrome. These commenters supported the proposed rules, 
without any suggested changes. Several comments came from interested 
organizations, including the National Down Syndrome Congress, the 
National Down Syndrome Society, the Arc of the United States, and the 
Joseph P. Kennedy, Jr., Foundation. Other comments came from the State 
agencies that make disability determinations for us.
    All of the commenters supported the addition of an adult listing 
for evaluating non-mosaic Down syndrome. The summaries of the 
significant comments we received and our responses to them follow. We 
have tried to summarize the commenters' views accurately, and have 
responded to all of the significant issues raised that are within the 
scope of the proposed rules.
    Comment: Commenters from a State agency that makes disability 
determinations for us agreed that including a separate listing for 
evaluating non-mosaic Down syndrome in adults was a good idea that 
would help simplify the adjudication of these cases. Two commenters 
from a State agency asked us to consider additional revisions to the 
listings to include other genetic disorders. One of these commenters 
specifically suggested we add a listing for evaluating Lowe's syndrome.
    Response: We have not adopted the comment. Lowe's syndrome is a 
genetic disorder that primarily affects the eyes, brain, and kidneys. 
As with most genetic disorders, the physical stigmas and the degree of 
mental retardation associated with Lowe's syndrome vary widely. 
Therefore, we cannot conclude that the impairment is always of listing-
level severity. Section 10.00C of these final rules provides that 
genetic disorders other than non-mosaic Down syndrome should be 
evaluated under the listings for the affected body system. We believe 
that this section will allow us to evaluate appropriately the effects 
of other genetic disorders, including Lowe's syndrome.
    Comment: One commenter indicated that laboratory testing for Down 
syndrome is generally done at birth or soon thereafter. This commenter 
stated that, since the listing would apply to individuals who are at 
least 18 years old, the result of any laboratory testing might be 
difficult to obtain due to the passage of time. The commenter 
questioned what type of medical evidence could be used to establish the 
diagnosis under the provisions of section 10.00B of these final rules. 
The commenter also asked if SSA would pay for chromosomal analysis if 
needed.
    Response: Section 10.00B of the final rules provides that, in lieu 
of a copy of the actual laboratory report, medical evidence that is 
persuasive that a positive diagnosis has been confirmed by an 
appropriate laboratory testing, at some time prior to evaluation, is 
acceptable documentation of the existence of non-mosaic Down syndrome. 
Under this provision, the file must contain an acceptable reference to 
the fact that testing was conducted and the results of that testing. 
The referenced results must be consistent

[[Page 31802]]

with other evidence in file, e.g., the description of the usual 
abnormal physical findings, the individual's educational history, or 
the results of psychological testing, if performed. Generally, this 
information will give us sufficient evidence to establish the 
diagnosis. However, in the unusual case in which it becomes necessary, 
SSA can purchase the appropriate blood test.
    Comment: Another commenter from a State agency that makes 
disability determinations for us agreed that this listing will assist 
in the adjudication of adult cases, age-18 redetermination cases, and 
continuing disability review (CDR) cases. This commenter asked whether 
we could revise the listing to indicate that medical improvement is not 
expected and that the cases adjudicated under listing 10.06 be diaried 
for 7 years.
    Response: After we find that an individual is disabled, we must 
evaluate his or her continued eligibility for benefits from time to 
time. SSA issues guidelines on how to schedule these reviews through 
internal operating instructions in our Program Operations Manual System 
(POMS). We will consider the guidelines recommended by the commenter 
when we issue POMS instructions on how to schedule CDR diaries for 
adults found disabled based on non-mosaic Down syndrome.
    Comment: One commenter representing an interested organization 
expressed support for adding a new listing to provide for the 
evaluation of Down syndrome for adults. This commenter urged SSA to 
provide training to all adjudicators when these rules become final.
    Response: We agree with the commenter's recommendation. In 
accordance with our usual practice, we will conduct training for all 
adjudicators after the final rules are published.
    For the reasons given in our responses to the comments on the 
proposed rules, we have not made further changes to the text of the 
proposed rules. Other than the one change discussed above, we are 
publishing the proposed regulations as final regulations.

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these final rules do not meet the criteria for a 
significant regulatory action under Executive Order 12866. Thus, the 
final rules were not subject to OMB review. We have also determined 
that these final rules meet the plain language requirement of Executive 
Order 12866 and the President's memorandum of June 1, 1998 (63 FR 
31885).

Regulatory Flexibility Act

    We certify that these final rules will not have a significant 
economic impact on a substantial number of small entities because they 
only affect individuals. Therefore, a regulatory flexibility analysis, 
as provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    These final rules impose 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: May 3, 2000.
Kenneth S. Apfel,
Commissioner of Social Security.

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

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(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 
revised.
    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): June 19, 2008, and (10.00): July 
2, 2001.
* * * * *
Part A
* * * * *
10.00  Multiple Body Systems
* * * * *
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. 00-12593 Filed 5-18-00; 8:45 am]
BILLING CODE 4191-02-U