[Federal Register Volume 68, Number 167 (Thursday, August 28, 2003)]
[Rules and Regulations]
[Pages 51689-51693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22016]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Regulations No. 4 and 16]
RIN 0960-AF95


Revised Medical Criteria for Evaluating Amyotrophic Lateral 
Sclerosis

AGENCY: Social Security Administration

ACTION: Final rules.

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SUMMARY: We are revising the criteria in the Listing of Impairments 
(the listings) that we use to evaluate Amyotrophic Lateral Sclerosis 
(ALS). We apply these criteria when you claim benefits based on 
disability under title II or title XVI of the Social Security Act (the 
Act). The revision provides that we will find you disabled if you have 
medical evidence showing that you have ALS.
    Because of this change, we are also adding guidance about ALS to 
our listings. We are also adding ALS to the list of specific impairment 
categories in our regulation that provides for presumptive disability 
payments under title XVI.

DATES: These rules are effective August 28, 2003.

FOR FURTHER INFORMATION CONTACT: Martin Sussman, Regulations Officer, 
Social Security Administration, 100 Altmeyer Building, 6401 Security 
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1767 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.
    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://www.socialsecurity.gov/regulations.

SUPPLEMENTARY INFORMATION: For the reasons we explain below, we are 
revising listing 11.10, our listing for ALS, in our neurological body 
system listings. The new listing provides that we will find you 
disabled if you have medical evidence that shows that you have ALS. 
Because of this change, we are also making two additional changes:
    [sbull] We are adding a new section 11.00G to the introductory 
material to the neurological listings to provide information about ALS 
and the evidence we need so that we can evaluate ALS under the new 
listing.
    [sbull] We are amending Sec.  416.934 of our regulations to include 
ALS on the list of ``specific impairment categories'' our field offices 
and State agencies use to make findings of presumptive disability under 
the Supplemental Security Income (SSI) program. This change will allow 
us to make findings of presumptive disability in claims involving 
allegations of ALS, without obtaining any medical evidence. We are also 
making a nonsubstantive technical change to the specific impairment 
category for Down syndrome in Sec.  416.934, so that the category 
reflects the current terminology for the condition.

[[Page 51690]]

What Programs Do These Final Regulations Affect?

    These final regulations 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 regulations 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 Sec.  
404.336) of insured workers.
    Under title XVI of the Act, we provide for 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, the Act says that 
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 is 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  the inability to do
                                 18 or older.       any SGA.
title XVI.....................  an individual      marked and severe
                                 under age 18.      functional
                                                    limitations.
------------------------------------------------------------------------

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. Does your impairment(s) prevent you from doing your past 
relevant work? If it does not, we will find that you are not disabled. 
If it does, we will go on to step 5.
    5. Does your impairment(s) prevent you from doing any other work, 
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 different sequential evaluation processes for children who 
apply for disability payments under SSI and, if you are already 
receiving benefits, when we are deciding whether your disability 
continues. See Sec. Sec.  404.1594, 416.424, 416.994, and 416.994a of 
our regulations. However, all of these different processes also include 
steps that 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 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 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 criteria 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 that we use to 
evaluate all disability claims. Likewise, we will never decide that you 
no longer qualify for benefits 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 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

[[Page 51691]]

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).

What Is ALS?

    ALS, sometimes called Lou Gehrig's disease, is a progressive, 
invariably fatal neurological disease that attacks the nerve cells 
(motor neurons) responsible for controlling voluntary muscles.
    ALS most commonly strikes people between 40 and 60 years of age. 
The diagnosis of ALS is based on history, clinical findings, and 
electrophysiological and neuroimaging studies. It is also arrived at by 
ruling out the existence of other neurological disorders that may have 
similar effects, such as neuropathy.
    Eventually, all muscles under voluntary control are affected and 
individuals with ALS ultimately lose the ability to move their arms and 
legs, and the capacity to effectively swallow, speak, and breathe. Most 
people with ALS die from respiratory failure, usually within 3 to 5 
years from the onset of symptoms. There is currently no cure for ALS.

What Did the Prior Listing for ALS Require?

    The prior listing for ALS, listing 11.10, required that you have 
ALS with either:
    [sbull] ``Significant bulbar signs'' (listing 11.10A) or
    [sbull] ``Disorganization of motor function as described in 
11.04B'' (listing 11.10B).

``Significant bulbar signs'' include difficulty in the ability to chew, 
swallow, and speak. Listing 11.04B requires ``[s]ignificant and 
persistent disorganization of motor function in two extremities, 
resulting in sustained disturbance of gross and dexterous movements, or 
gait and station''; in other words, inability to use both of your upper 
extremities effectively or to walk effectively.

Why Are We Revising the Listing for ALS?

    We are revising listing 11.10 because we have determined that it is 
not necessary to include the requirements in paragraphs A and B of 
prior listing 11.10. We expect that these final rules will simplify and 
expedite our adjudication of claims filed by individuals with ALS.
    We receive very few applications based on ALS, and we approve 
almost all of them at the first level of our decisionmaking process. 
For example, in calendar year 2002 we received a total of only 1,384 
claims based on ALS under titles II and XVI, and the State agencies 
that review disability claims for us allowed 1,324, or almost 96 
percent of them, at the initial level of our administrative review 
process. The vast majority of the people who appealed their initial 
determinations denying their claims were also found disabled. In 2002, 
the State agencies found disabled about 80 percent of the people with 
claims based on ALS who asked for a reconsideration of their initial 
determinations. There were similar approval rates for every year since 
1999.
    There has also been significant Congressional action to help people 
with ALS qualify for benefits and services as quickly as possible. For 
example, in 2000, Congress amended the Act to provide that people who 
are disabled with ALS do not have to wait until they have received 
benefit payments under title II for 24 months before they can qualify 
for Medicare, as do all other people who are entitled to disability 
benefits under title II. See section 226(h) of the Act. These rules 
will help some people who are disabled with ALS to qualify for Medicare 
sooner.
    We have decided that the simplest and fastest way to process claims 
of individuals with ALS without sacrificing the quality of our 
disability determinations and decisions is to revise the listing to 
provide that anyone who shows that he or she has ALS, established by 
clinical and laboratory findings, will be found disabled.

Why Are We Adding ALS to Sec.  416.934 of Our Regulations?

    The Act and our regulations provide that we may make SSI payments 
to you for up to 6 months on the basis of presumptive disability before 
we make a formal determination about whether you are disabled. You must 
also meet all other eligibility requirements before we may make 
presumptive disability payments. See section 1631(a)(4) of the Act and 
Sec.  416.932 of our regulations. (There are no provisions in the Act 
that would allow us to make presumptive disability payments under title 
II.) Under Sec.  416.933 of our regulations, we explain that we make 
these payments if there is a high degree of probability that we will 
find that you are disabled when we make our formal determination. If 
our formal determination is that you are not disabled, the Act provides 
that you do not have to pay us back.
    We may make findings of presumptive disability with or without 
medical evidence. Section 416.934 of our regulations provides a list of 
``specific impairment categories'' that we use to find presumptive 
disability without medical evidence. For example, we may make a finding 
of presumptive disability without medical evidence based on an 
allegation of Down syndrome. A person meets a listing for Down syndrome 
(10.06 or 110.06) simply by showing medical evidence establishing that 
he or she has non-mosaic Down syndrome. Therefore, there is a high 
degree of probability that we will find people who allege Down syndrome 
disabled. The new rules for ALS are similar. There is a high degree of 
probability that we will find people who have ALS disabled when we make 
our formal determination because everyone who applies for SSI and who 
has medical evidence showing that they have ALS will be found disabled 
under revised listing 11.10.

When Will We Start To Use These Final Rules?

    We will apply the final rules starting today.
    As is our usual practice when we make changes to our regulations, 
we will apply these final rules to the claims of applicants for 
benefits that are pending at any stage of our administrative review 
process, including any claims that are pending administrative review 
after remand from a Federal court.

What Revisions Are We Making?

    We are adding a new section 11.00G to the introductory material in 
the neurological body system section of our listings. The new section 
contains three paragraphs. Section 11.00G1 provides some basic 
information about ALS. Sections 11.00G2 and 11.00G3 provide information 
about how ALS is diagnosed and the information we need to establish 
that you meet the requirements of revised listing 11.10. The language 
of paragraphs 11.00G2 and 11.00G3 is based on language we use in the 
introductory material to the Down syndrome listings (sections 10.00A 
and B, and 110.00A and B) and the introductory material to our immune 
system listings regarding documentation of HIV infection (sections 
14.00D and 114.00D).
    We are revising listing 11.10 to provide that, if you have a 
diagnosis of ALS established by the medical evidence described in 
section 11.00G,

[[Page 51692]]

we will find that you are disabled. We are not adding a corresponding 
listing in part B of our listings, the listings we use to evaluate 
people who are under 18 years old, because ALS is rare in children. We 
will use revised listing 11.10 to evaluate all people with ALS, 
including people who are under age 18, as we did under the prior 
listing.
    As already noted, we are also adding a new paragraph (i) to Sec.  
416.934 to allow us to make findings of presumptive disability without 
medical evidence in cases involving allegations of ALS. Together with 
this addition, we are also making minor editorial changes for context 
and to update one of our rules. We needed to revise paragraph (g) near 
the end of prior Sec.  416.934 to remove the word ``and'' at the end of 
the section because paragraph (h) is no longer the last paragraph in 
the section. In addition, we are changing the language of paragraph (g) 
from ``Allegation of Down's syndrome (Mongolism)'' to ``Allegation of 
Down syndrome.'' This is the current terminology for the condition.

Regulatory Procedures

    Pursuant to section 702(a)(5) of the Act, 42 U.S.C. 902(a)(5), the 
Social Security Administration follows the Administrative Procedure Act 
(APA) rulemaking procedures specified in 5 U.S.C. 553 in the 
development of its regulations. The APA provides exceptions to its 
Notice of Proposed Rulemaking (NPRM) procedures when an agency finds 
that there is good cause for dispensing with such procedures on the 
basis that they are impracticable, unnecessary, or contrary to the 
public interest. In the case of these rules, we have determined that, 
under 5 U.S.C. 553(b)(B), good cause exists for waiving the NPRM 
procedures.
    As we have noted above, we receive very few claims each year based 
on ALS. In light of the nature of ALS, we find disabled at the initial 
level of our administrative review process about 96 percent of people 
who apply for disability benefits under title II and title XVI based on 
the condition. Many of the remaining few people whose claims are denied 
initially are found disabled on appeal. Ultimately, we find that almost 
all people who apply based on ALS are disabled. We expect that the 
changes we are making in these rules will simplify and expedite our 
processing of claims based on ALS. The main differences between these 
rules and our prior rules are that a small number of people who would 
be required to appeal an unfavorable determination under our prior 
rules will no longer have to do so, and a very small number of people 
whose claims were denied incorrectly under our prior rules will now 
properly be found to be disabled. Consequently, we find that prior 
notice and comment is unnecessary with respect to these rules.
    We also find that good cause exists for waiving the APA's notice-
and-comment rulemaking procedures because use of notice-and-comment 
rulemaking procedures would be contrary to the public interest. In 
light of the serious consequences caused by ALS, ultimately, we find 
that almost all people who apply for disability benefits based on the 
condition are disabled. The serious consequences caused by ALS are also 
reflected in Congress' judgment, set out in section 226(h) of the Act, 
to eliminate for individuals who are disabled with ALS the normal 24-
month Medicare waiting period that applies to people who are found 
disabled under title II of the Act. The changes we are making in these 
rules will allow us to make more timely determinations of disability 
for individuals with a progressive and invariably fatal disorder. The 
changes we are making in these rules will also help to implement 
Congress' judgment that individuals who are disabled under title II of 
the Act based on ALS should also receive immediate entitlement to 
Medicare rather than having to wait 24 months. It is critical that we 
issue these rules as soon as possible so that more people can qualify 
as quickly as possible for Medicare benefits and other services. 
Likewise, the small number of individuals who file applications for SSI 
will be able to benefit from the presumptive eligibility provisions of 
these rules. For these reasons, we find that use of the APA's notice-
and-comment rulemaking procedures is contrary to the public interest in 
this instance.
    In addition, we find good cause for dispensing with the 30-day 
delay in the effective date of a substantive rule, as provided for by 5 
U.S.C. 553(d)(3). For the reasons that we have discussed above, we find 
that it is in the public interest to make these rules effective upon 
publication.

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 will 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 final rules contain reporting requirements at sections 11.00G 
and 11.10. 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 burden referenced in these rules because the rules 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 Office of Management and Budget at 
the following fax number and to the Social Security Administration at 
the following address or fax number:

Office of Management and Budget, Attn: Desk Officer for SSA, Fax 
Number: 202-395-6974.
Social Security Administration, Attn: SSA Reports Clearance Officer, 
1338 Annex Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, 
Fax Number: 410-965-6400.

Comments can be received for between 30 and 60 days after publication 
of this notice and will be most useful if received by SSA within 30 
days of publication.

(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

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, Reporting and recordkeeping

[[Page 51693]]

requirements, Supplemental Security Income.

    Dated: July 22, 2003.
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- )

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.

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

0
2. Add new section 11.00G to section 11.00 in part A of appendix 1 and 
revise section 11.10 to read as follows:

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

* * * * *

11.00 Neurological

* * * * *
    G. Amyotrophic Lateral Sclerosis (ALS). 1. Amyotrophic lateral 
sclerosis (ALS), sometimes called Lou Gehrig's disease, is a 
progressive, invariably fatal neurological disease that attacks the 
nerve cells (motor neurons) responsible for controlling voluntary 
muscles. Eventually, all muscles under voluntary control are 
affected, and individuals with ALS ultimately lose their ability to 
move their arms and legs, and their capacity to swallow, speak, and 
breath. Most people with ALS die from respiratory failure. There is 
currently no cure for ALS, and most treatments are designed only to 
relieve symptoms and improve the quality of life.
    2. Diagnosis of ALS is based on history, neurological findings 
consistent with the diagnosis of ALS, and electrophysiological and 
neuroimaging testing to rule out other impairments that may cause 
similar signs and symptoms. The diagnosis may also be supported by 
electrophysiological studies (electromyography or nerve conduction 
studies), but these tests may be negative or only suggestive of the 
diagnosis. There is no single test that establishes the existence of 
ALS.
    3. For purposes of 11.10, documentation of the diagnosis must be 
by generally accepted methods consistent with the prevailing state 
of medical knowledge and clinical practice. The evidence should 
include documentation of a clinically appropriate medical history, 
neurological findings consistent with the diagnosis of ALS, and the 
results of any electrophysiological and neuroimaging testing.
* * * * *
    11.10 Amyotrophic lateral sclerosis established by clinical and 
laboratory findings, as described in 11.00G.
* * * * *

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

0
3. 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).

0
4. In Sec.  416.934, revise paragraph (g) and add new paragraph (i) to 
read as follows:


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

* * * * *
    (g) Allegation of Down syndrome.
* * * * *
    (i) Allegation of amyotrophic lateral sclerosis (ALS, Lou Gehrig's 
disease).

[FR Doc. 03-22016 Filed 8-27-03; 8:45 am]
BILLING CODE 4191-02-P