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

SOCIAL SECURITY ADMINISTRATION

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.

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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.

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 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

experience.

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

understand?

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:/

/www.ssa.gov/.

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]]

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 and 110.00): 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. 99-26459 Filed 10-8-99; 8:45 am]

BILLING CODE 4190-29-P