[Federal Register: August 28, 2003 (Volume 68, Number 167)]
[Rules and Regulations]
[Page 51689-51693]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au03-8]
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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 . . .
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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.
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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