Revised Medical Criteria for Evaluating Neurological Disorders, 43048-43061 [2016-15306]
Download as PDF
43048
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
and attaching Inline XBRL documents to
EDGAR submissions are described in a
new subsection 5.2.5 of EDGAR Filer
Manual, Volume II.
Along with the adoption of the Filer
Manual, we are amending Rule 301 of
Regulation S–T to provide for the
incorporation by reference into the Code
of Federal Regulations of today’s
revisions. This incorporation by
reference was approved by the Director
of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51.
The updated EDGAR Filer Manual
will be available for Web site viewing
and printing; the address for the Filer
Manual is https://www.sec.gov/info/
edgar.shtml. You may also obtain paper
copies of the EDGAR Filer Manual from
the following address: Public Reference
Room, U.S. Securities and Exchange
Commission, 100 F Street NE.,
Washington, DC 20549, on official
business days between the hours of
10:00 a.m. and 3:00 p.m.
Since the Filer Manual and the
corresponding rule changes relate solely
to agency procedures or practice,
publication for notice and comment is
not required under the Administrative
Procedure Act (APA).4 It follows that
the requirements of the Regulatory
Flexibility Act 5 do not apply.
The effective date for the updated
Filer Manual and the rule amendments
is July 1, 2016. In accordance with the
APA,6 we find that there is good cause
to establish an effective date less than
30 days after publication of these rules.
The EDGAR system upgrade to Release
16.2 is scheduled to become available
on June 13, 2016. The Commission
believes that establishing an effective
date less than 30 days after publication
of these rules is necessary to coordinate
the effectiveness of the updated Filer
Manual with these system upgrades.
asabaliauskas on DSK3SPTVN1PROD with RULES
Statutory Basis
We are adopting the amendments to
Regulation S–T under Sections 6, 7, 8,
10, and 19(a) of the Securities Act of
1933,7 Sections 3, 12, 13, 14, 15, 23, and
35A of the Securities Exchange Act of
1934,8 Section 319 of the Trust
Indenture Act of 1939,9 and Sections 8,
30, 31, and 38 of the Investment
Company Act of 1940.10
45
U.S.C. 553(b).
U.S.C. 601–612.
6 5 U.S.C. 553(d)(3).
7 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a).
8 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll.
9 15 U.S.C. 77sss.
10 15 U.S.C. 80a–8, 80a–29, 80a–30, and 80a–37.
55
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
List of Subjects in 17 CFR Part 232
Incorporation by reference, Reporting
and recordkeeping requirements,
Securities.
Text of the Amendment
In accordance with the foregoing, title
17, chapter II of the Code of Federal
Regulations is amended as follows:
PART 232—REGULATION S–T—
GENERAL RULES AND REGULATIONS
FOR ELECTRONIC FILINGS
availability of this material at NARA,
call 202–741–6030, or go to: https://
www.archives.gov/federal_register/
code_of_federal_regulations/ibr_
locations.html.
By the Commission.
Dated: June 13, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016–15510 Filed 6–30–16; 8:45 am]
BILLING CODE 8011–01–P
■
1. The authority citation for part 232
continues to read in part as follows:
SOCIAL SECURITY ADMINISTRATION
Authority: 15 U.S.C. 77f, 77g, 77h, 77j,
77s(a), 77z–3, 77sss(a), 78c(b), 78l, 78m, 78n,
78o(d), 78w(a), 78ll, 80a–6(c), 80a–8, 80a–29,
80a–30, 80a–37, and 7201 et seq.; and 18
U.S.C. 1350, unless otherwise noted.
20 CFR Part 404
*
*
*
*
*
2. Section 232.301 is revised to read
as follows:
Revised Medical Criteria for Evaluating
Neurological Disorders
§ 232.301
ACTION:
■
EDGAR Filer Manual.
Filers must prepare electronic filings
in the manner prescribed by the EDGAR
Filer Manual, promulgated by the
Commission, which sets out the
technical formatting requirements for
electronic submissions. The
requirements for becoming an EDGAR
Filer and updating company data are set
forth in the updated EDGAR Filer
Manual, Volume I: ‘‘General
Information,’’ Version 24 (December
2015). The requirements for filing on
EDGAR are set forth in the updated
EDGAR Filer Manual, Volume II:
‘‘EDGAR Filing,’’ Version 37 (June
2016). Additional provisions applicable
to Form N–SAR filers are set forth in the
EDGAR Filer Manual, Volume III: ‘‘N–
SAR Supplement,’’ Version 5
(September 2015). All of these
provisions have been incorporated by
reference into the Code of Federal
Regulations, which action was approved
by the Director of the Federal Register
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You must comply with
these requirements in order for
documents to be timely received and
accepted. The EDGAR Filer Manual is
available for Web site viewing and
printing; the address for the Filer
Manual is https://www.sec.gov/info/
edgar.shtml. You can obtain paper
copies of the EDGAR Filer Manual from
the following address: Public Reference
Room, U.S. Securities and Exchange
Commission, 100 F Street NE.,
Washington, DC 20549, on official
business days between the hours of
10:00 a.m. and 3:00 p.m. You can also
inspect the document at the National
Archives and Records Administration
(NARA). For information on the
PO 00000
Frm 00066
Fmt 4700
Sfmt 4700
[Docket No. SSA–2006–0140]
RIN 0960–AF35
Social Security Administration.
Final rule.
AGENCY:
We are revising the criteria in
the Listing of Impairments (listings) that
we use to evaluate disability claims
involving neurological disorders in
adults and children under titles II and
XVI of the Social Security Act (Act).
These revisions reflect our program
experience; advances in medical
knowledge, treatment, and methods of
evaluating neurological disorders;
comments we received from medical
experts and the public at an outreach
policy conference; responses to an
advance notice of proposed rulemaking
(ANPRM); and public comments we
received in response to a Notice of
Proposed Rulemaking (NPRM) and a
Federal Register notice that reopened
the NPRM comment period.
DATES: This rule is effective September
29, 2016.
FOR FURTHER INFORMATION CONTACT:
Cheryl A. Williams, Office of Disability
Policy, Social Security Administration,
6401 Security Boulevard, Baltimore,
Maryland 21235–6401, (410) 965–1020.
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 site,
Social Security Online, at https://
www.socialsecurity.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Background
We are making final the rule for
evaluating neurological disorders that
we proposed in an NPRM published in
the Federal Register on February 25,
2014 (79 FR 10636). In the preamble to
the NPRM, we discussed the revisions
to our current rule for the neurological
E:\FR\FM\01JYR1.SGM
01JYR1
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
body system and our reasons for
proposing those revisions. To the extent
that we are adopting the proposed rule
as published, we are not repeating that
information here; interested readers may
refer to the NPRM preamble. We
incorporated into the final rule the
portions of Social Security Ruling (SSR)
87–6, ‘‘Titles II and XVI: The Role of
Prescribed Treatment in the Evaluation
of Epilepsy’’ that continue to be relevant
to the treatment of epilepsy. As part of
the publication of this final rule, we are
rescinding SSR 87–6. We also respond
to public comments on the NPRM and
explain what changes we are making
based on those comments in the ‘‘Public
Comments on the NPRM’’ section of the
preamble.
Why are we revising the listings for
evaluating neurological disorders?
We are comprehensively revising the
listings for evaluating neurological
disorders to update the medical criteria,
provide additional methods of
evaluating neurological disorders,
provide more information on how we
evaluate neurological disorders, make
other changes that reflect our program
experience, and address adjudicator
questions. We last comprehensively
revised the listings for the neurological
disorders body system in a final rule
published on December 6, 1985.1 We
have made only a few changes since
then to meet program purposes.2
Summary of Public Comments on the
NPRM
In the NPRM, we provided the public
with a 60-day comment period that
ended on April 28, 2014. We reopened
the comment period for 30 days on May
1, 2014 (70 FR 24634). The last of the
two comment periods closed on June 2,
2014. We received and posted 2,103
public comments during the initial
period for public comments on the
NPRM, and received and posted an
additional 921 when we extended the
NPRM comment period. We also
received and posted 55 comments when
we initially made the public aware of
our efforts to update this rule, when we
1 50
FR 50068.
December 12, 1990, we raised the IQ limit
in 11.07A, 111.02B1, 111.07B1, and 111.08B2 from
69 to 70 (55 FR 51204). We published a final rule
adding section 11.00F for traumatic brain injury on
August 21, 2000 (65 FR 50746); made technical
revisions to most of the body systems on April 24,
2002 (67 FR 20018), which included some changes
to the neurological body system; revised listing
11.10 for Amyotrophic lateral sclerosis (ALS) on
August 82, 2003 (68 FR 51689); moved the listings
for malignant brain tumors to the body system for
malignant neoplastic diseases on November 15,
2004 (69 FR 67018); and made a technical
correction in listing 111.09 on March 24, 2011 (76
FR 16531).
asabaliauskas on DSK3SPTVN1PROD with RULES
2 On
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
published the ANPRM. The comments
came from members of the public,
medical professionals, national medical
organizations, advocacy groups,
disability examiners and other
adjudicators, and a national association
representing disability examiners in the
State agencies that make disability
determinations for us.
The majority of the comments was
repetitive and expressed support of or
agreement with identical
recommendations submitted by a few
national organizations. For example, we
received just over 1,100 comments that
repeated, or were in support of
recommendations submitted by a few
Huntington’s disease organizations;
approximately 800 comments that
repeated, or were in support of
recommendations submitted by various
headache organizations; and
approximately 350 repeat comments
that were in support of
recommendations from various
Parkinson’s disease organizations.
In general, the recommendations and
concerns raised by the majority of
public commenters were very similar or
identical. We received several
comments suggesting that we create
separate listings for various neurological
disorders that we address in one
comment below. Some commenters
noted provisions with which they
agreed and did not make suggestions for
changes in those provisions. For
example, over 300 comments were
testimonials from commenters sharing
their personal experience with various
neurological disorders. Approximately
300 comments were outside the scope of
the neurological NPRM, several of those
were relevant to other body system
disorders; we shared those comments
with the appropriate body systems
policy teams for consideration. We did
not summarize or respond to comments
that were in agreement with, or outside
the scope of the neurological NPRM. We
addressed repetitive comments that
raised identical issues as one comment.
We carefully considered all of the
relevant comments we received and we
responded to all of the significant issues
raised by the commenters that were
within the scope of this rule. We
provide our reasons for adopting or not
adopting the comment
recommendations in our responses
below.
General Comments
Comment: Several commenters
suggested that we create separate
listings for various neurological
disorders, such as migraine, cluster
headaches and other severe headache
disorders, fetal alcohol syndrome,
PO 00000
Frm 00067
Fmt 4700
Sfmt 4700
43049
cervical dystonias, atypical facial pain,
and trigeminal neuralgia. One
commenter expressed opposition to
creating a separate listing for migraine
headaches because the symptoms are
too subjective. Other commenters
suggested adding several neurological
disorders to specific listings.
Response: We did not adopt these
comments. While we do not have
listings for every neurological condition,
we are able to evaluate unlisted
neurological disorders in several ways
under our sequential evaluation process.
We will determine whether your
impairment medically equals a listing. If
your impairment does not medically
equal the criteria of a listing, you may
or may not have the residual functional
capacity to perform your past relevant
work or adjust to other work that exists
in significant numbers in the national
economy, which we determine at the
fourth and, if necessary, the fifth steps
of the sequential evaluation process. As
we work on the next iteration of
revisions to the neurological rule, we
will consider the suggestions for adding
new listings and will consider
comments expressing opposition to
adding certain new listings.
Comment: We received a number of
comments related to how we evaluate
migraines and other chronic headache
disorders. As we mentioned in the
previous comment, several commenters
asked that we recognize migraines as a
disabling impairment and suggested we
create a specific listing. Other
commenters suggested listing criteria for
us to consider. One commenter raised
concerns about evaluating chronic
headache disorders because of the
subjective nature of the disorders.
Response: We acknowledge the
commenters’ concerns. We realize it is
appropriate to provide impairmentspecific guidance on how we evaluate
migraines and other chronic headache
disorders. We will address these
concerns in training to ensure all
adjudicators know how to establish
migraine and other chronic headache
disorders as medically determinable
impairments (MDIs). Once we establish
the existence of an MDI(s), we follow
the remaining steps in the sequential
evaluation process (See §§ 404.1520,
416.920, and 416.924). As noted in the
response above to the comments about
creating additional listings, we are able
to evaluate unlisted neurological
disorders in several ways under our
sequential evaluation process.
Comment: We received several
comments expressing concern that the
proposed functional criteria for
determining disability in individuals
with Huntington’s disease (HD) and
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
43050
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
Parkinson’s disease still rely on the
presence of physical limitations and do
not adequately address the common
non-physical manifestations of these
diseases. The commenters suggested we
include the mental criteria from the
mental body system in the neurological
disorders body system to evaluate the
mental aspects of neurological disorders
in the absence of physical limitations
commonly seen in HD and in
Parkinson’s disease. They indicated the
proposed criteria should include criteria
specific to mental functioning in order
to address the full range of symptoms
often experienced by people who suffer
with HD and Parkinson’s disease. The
commenters also suggested that the
proposed introductory text sections
where we discuss HD and Parkinson’s
disease direct adjudicators beyond
listing 12.02 to expand to the entire
mental body system, as appropriate,
when they need to evaluate mental
symptoms associated with neurological
disorders.
Response: We partially adopted this
comment. For program purposes, we
consider all impairments under all
applicable body systems as part of our
disability evaluation. In the listings, we
describe each of the major body systems
impairments we consider severe enough
to be disabling, and we list requirements
that demonstrate a level of severity and
duration consistent with the definition
of disability set by Congress under the
Act. We evaluate the person’s
impairment(s) under the most
appropriate body system(s). We
recognize that neurological disorders
may co-occur with impairments we
evaluate in other body systems;
however, we intend the listings in this
final rule to address only neurological
disorders and the complications from
those disorders. When only mental
aspects of neurological disorders are
present in the absence of physical
limitations commonly seen in HD and
Parkinson’s disease, we evaluate those
limitations under the appropriate
mental disorders body system listings.
However, when mental aspects of
neurological disorders are present and
co-occur with the physical limitations of
these disorders, we evaluate limitations
in physical and mental functioning
under the neurological listings. In
response to this and similar comments,
we provided additional guidance in the
introductory text explaining how we
evaluate mental disorders under these
listings.
We modified our functional criteria
and severity rating scale to address the
common mental aspects of neurological
disorders. Our intent in the new
functional criteria for adults is to
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
provide a way to evaluate impairments
and determine disability appropriately,
even when those impairments are
difficult to evaluate based on medical
criteria alone. With functional criteria,
we can evaluate the functional impact
associated with any neurological
impairment in broad areas of physical
and mental functioning. The four areas
of mental functioning are
understanding, remembering, or
applying information; interacting with
others; concentrating, persisting, or
maintaining pace; and adapting or
managing oneself. For example, a
person with a neurological disorder may
demonstrate a limitation in the ability to
walk (as addressed under the physical
functioning criterion). He or she may
also have a mental impairment resulting
from the neurological disorder, which is
demonstrated by a limitation in the
ability to concentrate.
Comment: A commenter stated that
the definition of social functioning in
proposed section 11.00G3 should not
focus solely on limitations caused by
physical ailments. The commenter
suggested that the social functioning
criteria should include interpersonal
interactions, as well as non-physical
symptoms such as irritability,
aggression, and perseveration.
Response: We adopted this comment.
We mentioned in the previous comment
we modified our functional criteria to
focus on the common mental aspects of
neurological disorders. We also changed
the criterion from ‘‘social functioning’’
to ‘‘interacting with others’’ to be
consistent with the way mental
functions are described in the
Diagnostic and Statistical Manual of
Mental Disorders, Fifth Edition.3
Comment: Several commenters noted
that proposed section 11.00C states,
‘‘Medical research shows that these
neurological conditions may improve
after a period of treatment.’’ The
commenters pointed out this statement
is false and we should correct it because
Parkinson’s disease never improves.
Response: We adopted this comment.
It was not our intent to indicate in
listing 11.06 that Parkinson’s disease
itself may improve with treatment, as
the disease is progressive. We removed
the statement.
Comment: Several commenters asked
that we revise proposed section 11.00K
to clarify that motor and non-motor
symptoms can be equally disabling in
Parkinsonian syndromes, and to reflect
that symptoms can fluctuate
3 American Psychiatric Association: Diagnostic
and Statistical Manual of Mental Disorders, Fifth
Edition, Arlington, VA, American Psychiatric
Association, 2013.
PO 00000
Frm 00068
Fmt 4700
Sfmt 4700
significantly from hour to hour and
minute to minute, often making job
performance in a professional
environment very difficult.
Response: We partially adopted this
comment. We agree that non-motor
symptoms can be as disabling as motor
symptoms in Parkinsonian syndromes.
However, limitations resulting from
non-motor symptoms are highly variable
and we evaluate them on a case-by-case
basis. The new functional criteria enable
adjudicators to evaluate non-motor
symptoms associated with Parkinsonian
syndromes under listing 11.06B. We
mention that neurological disorders may
manifest in a combination of limitations
in physical and mental functioning in
the adult section, 11.00G. We will also
provide guidance in training to
adjudicators about the variable
manifestations of neurological
disorders, such as Parkinsonian
syndrome.
Comment: One commenter expressed
disappointment that the revised
epilepsy listing does not include any
discussion of how to ‘‘deal with
claimants who suffer from a mix of
tonic-clonic and dyscognitive seizures.’’
The commenter stated that ‘‘although
the revised listing explicitly
acknowledges that individuals may
suffer from a mix of tonic-clonic and
dyscognitive seizures,4 there is no
guidance as to how to evaluate a
claimant experiencing both types of
seizures.’’
Response: We do not agree with the
commenter. In section 11.00H4c, we
provide guidance on how to count
dyscognitive seizures that progress into
generalized tonic-clonic seizures.
However, we do not believe that it is
possible to address every permutation of
the dyscognitive and tonic-clonic mixed
seizure types. The signs and symptoms
of such seizure types will vary from
person to person. Adjudicators evaluate
limitations caused by mixed seizures on
a case-by-case basis.
Comment: One commenter was
pleased that we included a more
detailed explanation for the term
‘‘marked’’ in 11.00G2 but was
concerned that this definition relied on
the term ‘‘seriously,’’ as in ‘‘interfere
seriously’’ and ‘‘seriously limit,’’ which
we did not define. This commenter
believed that not defining the term
‘‘seriously,’’ while repeatedly relying on
it to define the term ‘‘marked,’’ creates
a significant ambiguity in the listings.
The commenter was concerned that
adjudicators will apply the term
‘‘marked’’ inconsistently unless we
4 See
E:\FR\FM\01JYR1.SGM
NPRM 11.00H(4)(c).
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
include a definition for the term
‘‘seriously.’’
Response: We partially adopted this
comment. In the modified final section
11.00D of the introductory text, we
include criteria for how to establish
disorganization of motor function,
descriptions for how to evaluate those
criteria, and a definition of an extreme
limitation in disorganization of motor
function. If we do not find that a person
is disabled on the basis of
disorganization of motor function alone,
as explained in 11.00D, we will find
that the person’s neurological disorder
is incompatible with the ability to do
any gainful activity if it results in
marked limitation in physical
functioning and marked limitation in
one of four areas of mental functioning.
In the modified final section 11.00G of
the introductory text, we provide
definitions for marked limitations
drawn from our currently used
definitions in section 7.00G4 of the
listing of impairments for hematological
disorders and section 1.00B of the
listing of impairments for
musculoskeletal disorders. We also
provide descriptions of the
considerations for physical and mental
functioning in 11.00G2 and 11.00G3.
Comment: One commenter suggested
that we not remove the intelligence
quotient (IQ) requirement from the
neurological listings, as the commenter
believes it is the best indicator of mental
capability.
Response: We did not adopt this
comment. As we explained in the
preamble to the NPRM, we are removing
the criterion of an IQ score from our
neurological listings because advances
in medical knowledge of cerebral palsy
(for adults and children), epilepsy (for
children), spinal cord insults (for
children), and our program experience
indicate that an IQ score does not
provide the best measure of limitations
in cognitive functioning associated with
these disorders. Therefore, it may not
indicate listing-level severity under the
neurological listings and would be more
appropriately used to evaluate mental
disorders under our mental disorders
body system.
Comment: One commenter expressed
that scales rating function into
categories such as ‘‘mild,’’ ‘‘moderate,’’
and ‘‘severe,’’ are clearly subjective on
the part of the rater and their
meaningfulness is questionable.
Response: The word ‘‘severe’’ in the
disability program separates step 2 from
step 3 in the sequential evaluation
process that we use to evaluate a
person’s physical or mental impairment
or combination of impairments. If we
find at step 2 that a person does not
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
have a ‘‘severe’’ medically determinable
impairment (MDI) or combination of
MDIs that meet the duration
requirement, we will find the person is
not disabled. If we find at step 2 that the
person has a ‘‘severe’’ MDI or
combination of MDIs, we will continue
evaluating the impairment(s) at step 3 of
the sequential evaluation process. (See
§§ 404.1520(a), 416.920(a) and
416.924(a).) With respect to the terms,
‘‘mild’’ and ‘‘moderate,’’ we have used
those terms in a five-point rating scale
in the mental disorders body system
(consisting of none, mild, moderate,
marked, and extreme) since 1985
(§§ 404.1520a and 416.920a). We have
also used the terms ‘‘marked’’ and
‘‘extreme’’ limitation in childhood
functional equivalence policy
(§§ 416.926a). Such scales and ratings
continue to be standard medical
practice, and continue to be effective for
evaluating degrees of impairmentrelated limitation(s). Moreover, in the
modified final introductory text
(11.00D2, 11.00G2, and 11.02D2), we
include guidance for our adjudicators
on the meaning and use of these terms.
Comment: One commenter said a
significant feature of the proposed new
criteria is that we will presume
individuals (with many different
neurological disorders) are disabled if
they are unable to stand from a sitting
position and are not presently working.
The commenter noted that it appears
obvious from casual observation that
many individuals successfully work in
a wide variety of different sedentary
positions, such as Wal-Mart greeter,
office worker, and physician. Because
significant numbers of these individuals
work on a regular basis in the national
economy, it is quite easy for a lay
observer to think it inappropriate for the
Social Security Administration to
presume that all individuals unable to
stand are also unable to work.
Response: We did not adopt this
comment. As we explain in 11.00D2a,
an inability to stand up from a seated
position means that, once seated, you
are unable to stand and maintain an
upright position without the risk of
falling unless you have the assistance of
another person or the use of an assistive
device, such as a walker, two crutches,
or two canes. The severity of such a
limitation is set at a standard much
higher than that applicable to a person
who is able to do sedentary work; it
thereby constitutes an inability to do
any gainful activity in the national
economy.
Comment: One commenter suggested
that when referring to spinal cord
insults we use the term ‘‘spinal cord
PO 00000
Frm 00069
Fmt 4700
Sfmt 4700
43051
disorders’’ instead of ‘‘spinal cord
insults.’’
Response: We agree with the
commenter and adopted this comment.
Comment: Some commenters asked
how we would evaluate adherence to
prescribed treatment for epilepsy
patients when we removed the
requirement for serum drug levels,
particularly for patients prescribed
newer antiepileptic drugs.
Response: We describe how we
consider adherence to prescribed
treatment under 11.00C. We consider
whether you have taken medications or
followed other treatment procedures as
prescribed by a physician for three
consecutive months. We no longer
require serum drug levels. When we last
revised the listings in 1985, blood drug
levels were strong indicators for
prescribed treatment compliance
because therapeutic ranges had been
established for antiepileptic drugs
(AEDs) and the ranges were often noted
on laboratory results. Many newer AEDs
do not have established therapeutic
levels, which makes lab results difficult
for our adjudicators to interpret. We
removed the requirement for obtaining
blood drug levels to address this
adjudicative issue and to simplify
evaluation of seizures that satisfy the
listing criteria. However, we will
continue to consider blood drug levels
available in the evidence in the context
of all evidence in the case record.
What is our authority to make rules
and set procedures for determining
whether a person is disabled under the
statutory definition?
The Act authorizes us to make rules
and regulations and to establish
necessary and appropriate procedures to
implement them.5
When will we begin to use this final
rule?
We will begin to use this final rule on
its effective date. We will continue to
use the current listings until the date the
final rule becomes effective. We will
apply the final rule to new applications
filed on or after the effective date of the
final rule and to claims that are pending
on or after the effective date.6
5 42
U.S.C. 405(a), 902(a)(5), and 1383(d)(1).
means that we will use the final rule on
and after their effective date in any case in which
we make a determination or decision. We expect
that Federal courts will review the Commissioner’s
final decisions using the rule that were in effect at
the time we issued the decisions. If a court reverses
the Commissioner’s final decision and remands a
case for further administrative proceedings after the
effective date of the final rule, we will apply the
final rule to the entire period at issue in the
decision we make after the court’s remand.
6 This
E:\FR\FM\01JYR1.SGM
01JYR1
43052
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
How long will this final rule be
effective?
This final rule will remain in effect
for 5 years after the date it becomes
effective, unless we extend it, or revise
and issue it again.
Regulatory Procedures
Executive Order 12866, as
Supplemented by Executive Order
13563
We consulted with the Office of
Management and Budget (OMB) and
determined that this final rule meets the
criteria for a significant regulatory
action under Executive Order 12866, as
supplemented by Executive Order
13563. Therefore, OMB reviewed it.
Regulatory Flexibility Act
We certify that this final rule will not
have a significant economic impact on
a substantial number of small entities
because it affects only individuals.
Therefore, the Regulatory Flexibility
Act, as amended, does not require us to
prepare a regulatory flexibility analysis.
Paperwork Reduction Act
These rules do not create any new or
affect any existing collections and,
therefore, do not require OMB approval
under the Paperwork Reduction Act.
Carolyn W. Colvin,
Acting Commissioner of Social Security.
For the reasons set out in the
preamble, we are amending 20 CFR part
404, subpart P as set forth below:
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950–)
Subpart P—Determining Disability and
Blindness
1. The authority citation for subpart P
of part 404 continues to read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
■
Authority: Secs. 202, 205(a)–(b) and (d)–
(h), 216(i), 221(a), (i), and (j), 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), (i), and (j), 422(c), 423, 425, and
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108–203,
118 Stat. 509 (42 U.S.C. 902 note).
Jkt 238001
*
*
*
*
*
12. Neurological Disorders (11.00 and
111.00): September 29, 2021.
*
*
*
*
*
*
*
*
Part A
*
*
11.00
*
*
*
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.
16:44 Jun 30, 2016
APPENDIX 1 TO SUBPART P OF PART
404—LISTING OF IMPAIRMENTS
1.00
(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).
VerDate Sep<11>2014
2. Amend appendix 1 to subpart P of
part 404 as follows:
■ a. Revise item 12 of the introductory
text before part A;
■ b. Amend part A by revising the body
system name for section 11.00 in the
table of contents;
■ c. In section 1.00 of part A, revise the
introduction to paragraph K;
■ d. Revise section 11.00 of part A;
■ e. In section 12.00 of part A, revise
paragraph D10, listing 12.01, listing
12.09E, and listing 12.09I;
■ f. Amend part B by revising the body
system name for section 111.00 in the
table of contents;
■ g. In section 101.00 of part B, revise
the last sentence of paragraph B1;
■ h. In section 101.00 of part B, revise
the last sentence of paragraph B1 and
paragraph K; and
■ i. Revise section 111.00 of part B to
read as follows:
■
*
Neurological Disorders
*
*
*
Musculoskeletal System
*
*
*
K. Disorders of the spine, listed in 1.04,
result in limitations because of distortion of
the bony and ligamentous architecture of the
spine and associated impingement on nerve
roots (including the cauda equina) or spinal
cord. Such impingement on nerve tissue may
result from a herniated nucleus pulposus,
spinal stenosis, arachnoiditis, or other
miscellaneous conditions.
*
*
*
*
*
11.00 NEUROLOGICAL DISORDERS
A. Which neurological disorders do we
evaluate under these listings? We evaluate
epilepsy, amyotrophic lateral sclerosis, coma
or persistent vegetative state (PVS), and
neurological disorders that cause
disorganization of motor function, bulbar and
neuromuscular dysfunction, communication
impairment, or a combination of limitations
in physical and mental functioning. We
evaluate neurological disorders that may
manifest in a combination of limitations in
physical and mental functioning. For
example, if you have a neurological disorder
that causes mental limitations, such as
Huntington’s disease or early-onset
Alzheimer’s disease, which may limit
executive functioning (e.g., regulating
attention, planning, inhibiting responses,
decision-making), we evaluate your
limitations using the functional criteria
under these listings (see 11.00G). Under this
body system, we evaluate the limitations
resulting from the impact of the neurological
disease process itself. If your neurological
disorder results in only mental impairment
PO 00000
Frm 00070
Fmt 4700
Sfmt 4700
or if you have a co-occurring mental
condition that is not caused by your
neurological disorder (for example,
dementia), we will evaluate your mental
impairment under the mental disorders body
system, 12.00.
B. What evidence do we need to document
your neurological disorder?
1. We need both medical and non-medical
evidence (signs, symptoms, and laboratory
findings) to assess the effects of your
neurological disorder. Medical evidence
should include your medical history,
examination findings, relevant laboratory
tests, and the results of imaging. Imaging
refers to medical imaging techniques, such as
x-ray, computerized tomography (CT),
magnetic resonance imaging (MRI), and
electroencephalography (EEG). The imaging
must be consistent with the prevailing state
of medical knowledge and clinical practice as
the proper technique to support the
evaluation of the disorder. In addition, the
medical evidence may include descriptions
of any prescribed treatment and your
response to it. We consider non-medical
evidence such as statements you or others
make about your impairments, your
restrictions, your daily activities, or your
efforts to work.
2. We will make every reasonable effort to
obtain the results of your laboratory and
imaging evidence. When the results of any of
these tests are part of the existing evidence
in your case record, we will evaluate the test
results and all other relevant evidence. We
will not purchase imaging, or other
diagnostic tests, or laboratory tests that are
complex, may involve significant risk, or that
are invasive. We will not routinely purchase
tests that are expensive or not readily
available.
C. How do we consider adherence to
prescribed treatment in neurological
disorders? In 11.02 (Epilepsy), 11.06
(Parkinsonian syndrome), and 11.12
(Myasthenia gravis), we require that
limitations from these neurological disorders
exist despite adherence to prescribed
treatment. ‘‘Despite adherence to prescribed
treatment’’ means that you have taken
medication(s) or followed other treatment
procedures for your neurological disorder(s)
as prescribed by a physician for three
consecutive months but your impairment
continues to meet the other listing
requirements despite this treatment. You may
receive your treatment at a health care
facility that you visit regularly, even if you
do not see the same physician on each visit.
D. What do we mean by disorganization of
motor function?
1. Disorganization of motor function means
interference, due to your neurological
disorder, with movement of two extremities;
i.e., the lower extremities, or upper
extremities (including fingers, wrists, hands,
arms, and shoulders). By two extremities we
mean both lower extremities, or both upper
extremities, or one upper extremity and one
lower extremity. All listings in this body
system, except for 11.02 (Epilepsy), 11.10
(Amyotrophic lateral sclerosis), and 11.20
(Coma and persistent vegetative state),
include criteria for disorganization of motor
function that results in an extreme limitation
in your ability to:
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
a. Stand up from a seated position; or
b. Balance while standing or walking; or
c. Use the upper extremities (including
fingers, wrists, hands, arms, and shoulders).
2. Extreme limitation means the inability to
stand up from a seated position, maintain
balance in a standing position and while
walking, or use your upper extremities to
independently initiate, sustain, and complete
work-related activities. The assessment of
motor function depends on the degree of
interference with standing up; balancing
while standing or walking; or using the upper
extremities (including fingers, hands, arms,
and shoulders).
a. Inability to stand up from a seated
position means that once seated you are
unable to stand and maintain an upright
position without the assistance of another
person or the use of an assistive device, such
as a walker, two crutches, or two canes.
b. Inability to maintain balance in a
standing position means that you are unable
to maintain an upright position while
standing or walking without the assistance of
another person or an assistive device, such as
a walker, two crutches, or two canes.
c. Inability to use your upper extremities
means that you have a loss of function of
both upper extremities (including fingers,
wrists, hands, arms, and shoulders) that very
seriously limits your ability to independently
initiate, sustain, and complete work-related
activities involving fine and gross motor
movements. Inability to perform fine and
gross motor movements could include not
being able to pinch, manipulate, and use
your fingers; or not being able to use your
hands, arms, and shoulders to perform gross
motor movements, such as handling,
gripping, grasping, holding, turning, and
reaching; or not being able to engage in
exertional movements such a lifting,
carrying, pushing, and pulling.
E. How do we evaluate communication
impairments under these listings? We must
have a description of a recent comprehensive
evaluation including all areas of
communication, performed by an acceptable
medical source, to document a
communication impairment associated with
a neurological disorder. A communication
impairment may occur when a medically
determinable neurological impairment
results in dysfunction in the parts of the
brain responsible for speech and language.
We evaluate communication impairments
associated with neurological disorders under
11.04A, 11.07C, or 11.11B. We evaluate
communication impairments due to nonneurological disorders under 2.09.
1. Under 11.04A, we need evidence
documenting that your central nervous
system vascular accident or insult (CVA) and
sensory or motor aphasia have resulted in
ineffective speech or communication.
Ineffective speech or communication means
there is an extreme limitation in your ability
to understand or convey your message in
simple spoken language resulting in your
inability to demonstrate basic
communication skills, such as following onestep commands or telling someone about
your basic personal needs without assistance.
2. Under 11.07C, we need evidence
documenting that your cerebral palsy has
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
resulted in significant interference in your
ability to speak, hear, or see. We will find
you have ‘‘significant interference’’ in your
ability to speak, hear, or see if your signs,
such as aphasia, strabismus, or sensorineural
hearing loss, seriously limit your ability to
communicate on a sustained basis.
3. Under 11.11B, we need evidence
documenting that your post-polio syndrome
has resulted in the inability to produce
intelligible speech.
F. What do we mean by bulbar and
neuromuscular dysfunction? The bulbar
region of the brain is responsible for
controlling the bulbar muscles in the throat,
tongue, jaw, and face. Bulbar and
neuromuscular dysfunction refers to
weakness in these muscles, resulting in
breathing, swallowing, and speaking
impairments. Listings 11.11 (Post-polio
syndrome), 11.12 (Myasthenia gravis), and
11.22 (Motor neuron disorders other than
ALS) include criteria for evaluating bulbar
and neuromuscular dysfunction. If your
neurological disorder has resulted in a
breathing disorder, we may evaluate that
condition under the respiratory system, 3.00.
G. How do we evaluate limitations in
physical and mental functioning under these
listings?
1. Neurological disorders may manifest in
a combination of limitations in physical and
mental functioning. We consider all relevant
information in your case record to determine
the effects of your neurological disorder on
your physical and mental functioning. To
satisfy the requirement described under
11.00G, your neurological disorder must
result in a marked limitation in physical
functioning and a marked limitation in at
least one of four areas of mental functioning:
Understanding, remembering, or applying
information; interacting with others;
concentrating, persisting, or maintaining
pace; or adapting or managing oneself. If your
neurological disorder results in an extreme
limitation in at least one of the four areas of
mental functioning, or results in marked
limitation in at least two of the four areas of
mental functioning, but you do not have at
least a marked limitation in your physical
functioning, we will consider whether your
condition meets or medically equals one of
the mental disorders body system listings,
12.00.
2. Marked Limitation. To satisfy the
requirements of the functional criteria, your
neurological disorder must result in a marked
limitation in physical functioning and a
marked limitation in one of the four areas of
mental functioning (see 11.00G3). Although
we do not require the use of such a scale,
‘‘marked’’ would be the fourth point on a
five-point scale consisting of no limitation,
mild limitation, moderate limitation, marked
limitation, and extreme limitation. We
consider the nature and overall degree of
interference with your functioning. The term
‘‘marked’’ does not require that you must be
confined to bed, hospitalized, or in a nursing
home.
a. Marked limitation and physical
functioning. For this criterion, a marked
limitation means that, due to the signs and
symptoms of your neurological disorder, you
are seriously limited in the ability to
PO 00000
Frm 00071
Fmt 4700
Sfmt 4700
43053
independently initiate, sustain, and complete
work-related physical activities (see
11.00G3). You may have a marked limitation
in your physical functioning when your
neurological disease process causes
persistent or intermittent symptoms that
affect your abilities to independently initiate,
sustain, and complete work-related activities,
such as standing, balancing, walking, using
both upper extremities for fine and gross
movements, or results in limitations in using
one upper and one lower extremity. The
persistent and intermittent symptoms must
result in a serious limitation in your ability
to do a task or activity on a sustained basis.
We do not define ‘‘marked’’ by a specific
number of different physical activities or
tasks that demonstrate your ability, but by
the overall effects of your neurological
symptoms on your ability to perform such
physical activities on a consistent and
sustained basis. You need not be totally
precluded from performing a function or
activity to have a marked limitation, as long
as the degree of limitation seriously limits
your ability to independently initiate,
sustain, and complete work-related physical
activities.
b. Marked limitation and mental
functioning. For this criterion, a marked
limitation means that, due to the signs and
symptoms of your neurological disorder, you
are seriously limited in the ability to function
independently, appropriately, effectively,
and on a sustained basis in work settings (see
11.03G3). We do not define ‘‘marked’’ by a
specific number of mental activities, such as:
The number of activities that demonstrate
your ability to understand, remember, and
apply information; the number of tasks that
demonstrate your ability to interact with
others; a specific number of tasks that
demonstrate you are able to concentrate,
persist or maintain pace; or a specific number
of tasks that demonstrate you are able to
manage yourself. You may have a marked
limitation in your mental functioning when
several activities or functions are impaired,
or even when only one is impaired. You need
not be totally precluded from performing an
activity to have a marked limitation, as long
as the degree of limitation seriously limits
your ability to function independently,
appropriately, and effectively on a sustained
basis, and complete work-related mental
activities.
3. Areas of physical and mental
functioning.
a. Physical functioning. Examples of this
criterion include specific motor abilities,
such as independently initiating, sustaining,
and completing the following activities:
Standing up from a seated position,
balancing while standing or walking, or using
both your upper extremities for fine and
gross movements (see 11.00D). Physical
functioning may also include functions of the
body that support motor abilities, such as the
abilities to see, breathe, and swallow (see
11.00E and 11.00F). Examples of when your
limitation in seeing, breathing, or swallowing
may, on its own, rise to a ‘‘marked’’
limitation include: Prolonged and
uncorrectable double vision causing
difficulty with balance; prolonged difficulty
breathing requiring the use of a prescribed
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
43054
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
assistive breathing device, such as a portable
continuous positive airway pressure
machine; or repeated instances, occurring at
least weekly, of aspiration without causing
aspiration pneumonia. Alternatively, you
may have a combination of limitations due to
your neurological disorder that together rise
to a ‘‘marked’’ limitation in physical
functioning. We may also find that you have
a ‘‘marked’’ limitation in this area if, for
example, your symptoms, such as pain or
fatigue (see 11.00T), as documented in your
medical record, and caused by your
neurological disorder or its treatment,
seriously limit your ability to independently
initiate, sustain, and complete these workrelated motor functions, or the other physical
functions or physiological processes that
support those motor functions. We may also
find you seriously limited in an area if, while
you retain some ability to perform the
function, you are unable to do so consistently
and on a sustained basis. The limitation in
your physical functioning must last or be
expected to last at least 12 months. These
examples illustrate the nature of physical
functioning. We do not require
documentation of all of the examples.
b. Mental functioning.
(i) Understanding, remembering, or
applying information. This area of mental
functioning refers to the abilities to learn,
recall, and use information to perform work
activities. Examples include: Understanding
and learning terms, instructions, procedures;
following one- or two-step oral instructions
to carry out a task; describing work activity
to someone else; asking and answering
questions and providing explanations;
recognizing a mistake and correcting it;
identifying and solving problems; sequencing
multi-step activities; and using reason and
judgment to make work-related decisions.
These examples illustrate the nature of this
area of mental functioning. We do not require
documentation of all of the examples.
(ii) Interacting with others. This area of
mental functioning refers to the abilities to
relate to and work with supervisors, coworkers, and the public. Examples include:
Cooperating with others; asking for help
when needed; handling conflicts with others;
stating your own point of view; initiating or
sustaining conversation; understanding and
responding to social cues (physical, verbal,
emotional); responding to requests,
suggestions, criticism, correction, and
challenges; and keeping social interactions
free of excessive irritability, sensitivity,
argumentativeness, or suspiciousness. These
examples illustrate the nature of this area of
mental functioning. We do not require
documentation of all of the examples.
(iii) Concentrating, persisting, or
maintaining pace. This area of mental
functioning refers to the abilities to focus
attention on work activities and to stay ontask at a sustained rate. Examples include:
Initiating and performing a task that you
understand and know how to do; working at
an appropriate and consistent pace;
completing tasks in a timely manner;
ignoring or avoiding distractions while
working; changing activities or work settings
without being disruptive; working close to or
with others without interrupting or
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
distracting them; sustaining an ordinary
routine and regular attendance at work; and
working a full day without needing more
than the allotted number or length of rest
periods during the day. These examples
illustrate the nature of this area of mental
functioning. We do not require
documentation of all of the examples.
(iv) Adapting or managing oneself. This
area of mental functioning refers to the
abilities to regulate emotions, control
behavior, and maintain well-being in a work
setting. Examples include: Responding to
demands; adapting to changes; managing
your psychologically based symptoms;
distinguishing between acceptable and
unacceptable work performance; setting
realistic goals; making plans for yourself
independently of others; maintaining
personal hygiene and attire appropriate to a
work setting; and being aware of normal
hazards and taking appropriate precautions.
These examples illustrate the nature of this
area of mental functioning. We do not require
documentation of all of the examples.
4. Signs and symptoms of your disorder
and the effects of treatment.
a. We will consider your signs and
symptoms and how they affect your ability to
function in the work place. When we
evaluate your functioning, we will consider
whether your signs and symptoms are
persistent or intermittent, how frequently
they occur and how long they last, their
intensity, and whether you have periods of
exacerbation and remission.
b. We will consider the effectiveness of
treatment in improving the signs, symptoms,
and laboratory findings related to your
neurological disorder, as well as any aspects
of treatment that may interfere with your
ability to function. We will consider, for
example: The effects of medications you take
(including side effects); the time-limited
efficacy of some medications; the
intrusiveness, complexity, and duration of
your treatment (for example, the dosing
schedule or need for injections); the effects
of treatment, including medications, therapy,
and surgery, on your functioning; the
variability of your response to treatment; and
any drug interactions.
H. What is epilepsy, and how do we
evaluate it under 11.02?
1. Epilepsy is a pattern of recurrent and
unprovoked seizures that are manifestations
of abnormal electrical activity in the brain.
There are various types of generalized and
‘‘focal’’ or partial seizures. However,
psychogenic nonepileptic seizures and
pseudoseizures are not epileptic seizures for
the purpose of 11.02. We evaluate
psychogenic seizures and pseudoseizures
under the mental disorders body system,
12.00. In adults, the most common
potentially disabling seizure types are
generalized tonic-clonic seizures and
dyscognitive seizures (formerly complex
partial seizures).
a. Generalized tonic-clonic seizures are
characterized by loss of consciousness
accompanied by a tonic phase (sudden
muscle tensing causing the person to lose
postural control) followed by a clonic phase
(rapid cycles of muscle contraction and
relaxation, also called convulsions). Tongue
PO 00000
Frm 00072
Fmt 4700
Sfmt 4700
biting and incontinence may occur during
generalized tonic-clonic seizures, and
injuries may result from falling.
b. Dyscognitive seizures are characterized
by alteration of consciousness without
convulsions or loss of muscle control. During
the seizure, blank staring, change of facial
expression, and automatisms (such as lip
smacking, chewing or swallowing, or
repetitive simple actions, such as gestures or
verbal utterances) may occur. During its
course, a dyscognitive seizure may progress
into a generalized tonic-clonic seizure (see
11.00H1a).
2. Description of seizure. We require at
least one detailed description of your
seizures from someone, preferably a medical
professional, who has observed at least one
of your typical seizures. If you experience
more than one type of seizure, we require a
description of each type.
3. Serum drug levels. We do not require
serum drug levels; therefore, we will not
purchase them. However, if serum drug
levels are available in your medical records,
we will evaluate them in the context of the
other evidence in your case record.
4. Counting seizures. The period specified
in 11.02A, B, or C cannot begin earlier than
one month after you began prescribed
treatment. The required number of seizures
must occur within the period we are
considering in connection with your
application or continuing disability review.
When we evaluate the frequency of your
seizures, we also consider your adherence to
prescribed treatment (see 11.00C). When we
determine the number of seizures you have
had in the specified period, we will:
a. Count multiple seizures occurring in a
24-hour period as one seizure.
b. Count status epilepticus (a continuous
series of seizures without return to
consciousness between seizures) as one
seizure.
c. Count a dyscognitive seizure that
progresses into a generalized tonic-clonic
seizure as one generalized tonic-clonic
seizure.
d. We do not count seizures that occur
during a period when you are not adhering
to prescribed treatment without good reason.
When we determine that you had good
reason for not adhering to prescribed
treatment, we will consider your physical,
mental, educational, and communicative
limitations (including any language barriers).
We will consider you to have good reason for
not following prescribed treatment if, for
example, the treatment is very risky for you
due to its consequences or unusual nature, or
if you are unable to afford prescribed
treatment that you are willing to accept, but
for which no free community resources are
available. We will follow guidelines found in
our policy, such as §§ 404.1530(c) and
416.930(c) of this chapter, when we
determine whether you have a good reason
for not adhering to prescribed treatment.
e. We do not count psychogenic
nonepileptic seizures or pseudoseizures
under 11.02. We evaluate these seizures
under the mental disorders body system,
12.00.
5. Electroencephalography (EEG) testing.
We do not require EEG test results; therefore,
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
we will not purchase them. However, if EEG
test results are available in your medical
records, we will evaluate them in the context
of the other evidence in your case record.
I. What is vascular insult to the brain, and
how do we evaluate it under 11.04?
1. Vascular insult to the brain (cerebrum,
cerebellum, or brainstem), commonly
referred to as stroke or cerebrovascular
accident (CVA), is brain cell death caused by
an interruption of blood flow within or
leading to the brain, or by a hemorrhage from
a ruptured blood vessel or aneurysm in the
brain. If you have a vision impairment
resulting from your vascular insult, we may
evaluate that impairment under the special
senses body system, 2.00.
2. We need evidence of sensory or motor
aphasia that results in ineffective speech or
communication under 11.04A (see 11.00E).
We may evaluate your communication
impairment under listing 11.04C if you have
marked limitation in physical functioning
and marked limitation in one of the four
areas of mental functioning.
3. We generally need evidence from at least
3 months after the vascular insult to evaluate
whether you have disorganization of motor
functioning under 11.04B, or the impact that
your disorder has on your physical and
mental functioning under 11.04C. In some
cases, evidence of your vascular insult is
sufficient to allow your claim within 3
months post-vascular insult. If we are unable
to allow your claim within 3 months after
your vascular insult, we will defer
adjudication of the claim until we obtain
evidence of your neurological disorder at
least 3 months post-vascular insult.
J. What are benign brain tumors, and how
do we evaluate them under 11.05? Benign
brain tumors are noncancerous
(nonmalignant) abnormal growths of tissue in
or on the brain that invade healthy brain
tissue or apply pressure on the brain or
cranial nerves. We evaluate their effects on
your functioning as discussed in 11.00D and
11.00G. We evaluate malignant brain tumors
under the cancer body system in 13.00. If you
have a vision impairment resulting from your
benign brain tumor, we may evaluate that
impairment under the special senses body
system, 2.00.
K. What is Parkinsonian syndrome, and
how do we evaluate it under 11.06?
Parkinsonian syndrome is a term that
describes a group of chronic, progressive
movement disorders resulting from loss or
decline in the function of dopamineproducing brain cells. Dopamine is a
neurotransmitter that regulates muscle
movement throughout the body. When we
evaluate your Parkinsonian syndrome, we
will consider your adherence to prescribed
treatment (see 11.00C).
L. What is cerebral palsy, and how do we
evaluate it under 11.07?
1. Cerebral palsy (CP) is a term that
describes a group of static, nonprogressive
disorders caused by abnormalities within the
brain that disrupt the brain’s ability to
control movement, muscle coordination, and
posture. The resulting motor deficits manifest
very early in a person’s development, with
delayed or abnormal progress in attaining
developmental milestones. Deficits may
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
become more obvious as the person grows
and matures over time.
2. We evaluate your signs and symptoms,
such as ataxia, spasticity, flaccidity,
athetosis, chorea, and difficulty with precise
movements when we determine your ability
to stand up, balance, walk, or perform fine
and gross motor movements. We will also
evaluate your signs, such as dysarthria and
apraxia of speech, and receptive and
expressive language problems when we
determine your ability to communicate.
3. We will consider your other
impairments or signs and symptoms that
develop secondary to the disorder, such as
post-impairment syndrome (a combination of
pain, fatigue, and weakness due to muscle
abnormalities); overuse syndromes (repetitive
motion injuries); arthritis; abnormalities of
proprioception (perception of the movements
and position of the body); abnormalities of
stereognosis (perception and identification of
objects by touch); learning problems; anxiety;
and depression.
M. What are spinal cord disorders, and
how do we evaluate them under 11.08?
1. Spinal cord disorders may be congenital
or caused by injury to the spinal cord. Motor
signs and symptoms of spinal cord disorders
include paralysis, flaccidity, spasticity, and
weakness.
2. Spinal cord disorders with complete loss
of function (11.08A) addresses spinal cord
disorders that result in a complete lack of
motor, sensory, and autonomic function of
the affected part(s) of the body.
3. Spinal cord disorders with
disorganization of motor function (11.08B)
addresses spinal cord disorders that result in
less than a complete loss of function of the
affected part(s) of the body, reducing, but not
eliminating, motor, sensory, and autonomic
function.
4. When we evaluate your spinal cord
disorder, we generally need evidence from at
least 3 months after your symptoms began in
order to evaluate your disorganization of
motor function. In some cases, evidence of
your spinal cord disorder may be sufficient
to allow your claim within 3 months after the
spinal cord disorder. If the medical evidence
demonstrates total cord transection causing a
loss of motor and sensory functions below
the level of injury, we will not wait 3 months
but will make the allowance decision
immediately.
N. What is multiple sclerosis, and how do
we evaluate it under 11.09?
1. Multiple sclerosis (MS) is a chronic,
inflammatory, degenerative disorder that
damages the myelin sheath surrounding the
nerve fibers in the brain and spinal cord. The
damage disrupts the normal transmission of
nerve impulses within the brain and between
the brain and other parts of the body, causing
impairment in muscle coordination, strength,
balance, sensation, and vision. There are
several forms of MS, ranging from mildly to
highly aggressive. Milder forms generally
involve acute attacks (exacerbations) with
partial or complete recovery from signs and
symptoms (remissions). Aggressive forms
generally exhibit a steady progression of
signs and symptoms with few or no
remissions. The effects of all forms vary from
person to person.
PO 00000
Frm 00073
Fmt 4700
Sfmt 4700
43055
2. We evaluate your signs and symptoms,
such as flaccidity, spasticity, spasms,
incoordination, imbalance, tremor, physical
fatigue, muscle weakness, dizziness, tingling,
and numbness when we determine your
ability to stand up, balance, walk, or perform
fine and gross motor movements. When
determining whether you have limitations of
physical and mental functioning, we will
consider your other impairments or signs and
symptoms that develop secondary to the
disorder, such as fatigue; visual loss; trouble
sleeping; impaired attention, concentration,
memory, or judgment; mood swings; and
depression. If you have a vision impairment
resulting from your MS, we may evaluate that
impairment under the special senses body
system, 2.00.
O. What is amyotrophic lateral sclerosis,
and how do we evaluate it under 11.10?
Amyotrophic lateral sclerosis (ALS) is a type
of motor neuron disorder that rapidly and
progressively attacks the nerve cells
responsible for controlling voluntary
muscles. We establish ALS under 11.10 when
you have a documented diagnosis of ALS.
We require documentation based on
generally accepted methods consistent with
the prevailing state of medical knowledge
and clinical practice. We require laboratory
testing to establish the diagnosis when the
clinical findings of upper and lower motor
neuron disease are not present in three or
more regions. Electrophysiological studies,
such as nerve conduction velocity studies
and electromyography (EMG), may support
your diagnosis of ALS; however, we will not
purchase these studies.
P. What are neurodegenerative disorders of
the central nervous system, such as
Huntington’s disease, Friedreich’s ataxia,
and spinocerebellar degeneration, and how
do we evaluate them under 11.17?
Neurodegenerative disorders of the central
nervous system are disorders characterized
by progressive and irreversible degeneration
of neurons or their supporting cells. Over
time, these disorders impair many of the
body’s motor, cognitive, and other mental
functions. We consider neurodegenerative
disorders of the central nervous system under
11.17 that we do not evaluate elsewhere in
section 11.00, such as Huntington’s disease
(HD), Friedreich’s ataxia, spinocerebellar
degeneration, Creutzfeldt-Jakob disease (CJD),
progressive supranuclear palsy (PSP), earlyonset Alzheimer’s disease, and
frontotemporal dementia (Pick’s disease).
When these disorders result in solely
cognitive and other mental function effects,
we will evaluate the disorder under the
mental disorder listings.
Q. What is traumatic brain injury, and how
do we evaluate it under 11.18?
1. Traumatic brain injury (TBI) is damage
to the brain resulting from skull fracture,
collision with an external force leading to a
closed head injury, or penetration by an
object that enters the skull and makes contact
with brain tissue. We evaluate TBI that
results in coma or persistent vegetative state
(PVS) under 11.20.
2. We generally need evidence from at least
3 months after the TBI to evaluate whether
you have disorganization of motor function
under 11.18A or the impact that your
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
43056
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
disorder has on your physical and mental
functioning under 11.18B. In some cases,
evidence of your TBI is sufficient to
determine disability within 3 months postTBI. If we are unable to allow your claim
within 3 months post-TBI, we will defer
adjudication of the claim until we obtain
evidence of your neurological disorder at
least 3 months post-TBI. If a finding of
disability still is not possible at that time, we
will again defer adjudication of the claim
until we obtain evidence at least 6 months
after your TBI.
R. What are coma and persistent vegetative
state, and how do we evaluate them under
11.20? Coma is a state of unconsciousness in
which a person does not exhibit a sleep/wake
cycle, and is unable to perceive or respond
to external stimuli. People who do not fully
emerge from coma may progress into a
persistent vegetative state (PVS). PVS is a
condition of partial arousal in which a
person may have a low level of
consciousness but is still unable to react to
external stimuli. In contrast to coma, a
person in a PVS retains sleep/wake cycles
and may exhibit some key lower brain
functions, such as spontaneous movement,
opening and moving eyes, and grimacing.
Coma or PVS may result from TBI, a
nontraumatic insult to the brain (such as a
vascular insult, infection, or brain tumor), or
a neurodegenerative or metabolic disorder.
Medically induced comas are not considered
under 11.20 and should be considered under
the section pertaining to the underlying
reason the coma was medically induced and
not under this section.
S. What are motor neuron disorders, other
than ALS, and how do we evaluate them
under 11.22? Motor neuron disorders such as
progressive bulbar palsy, primary lateral
sclerosis (PLS), and spinal muscular atrophy
(SMA) are progressive neurological disorders
that destroy the cells that control voluntary
muscle activity, such as walking, breathing,
swallowing, and speaking. We evaluate the
effects of these disorders on motor
functioning, bulbar and neuromuscular
functioning, oral communication, or
limitations in physical and mental
functioning.
T. How do we consider symptoms of
fatigue in these listings? Fatigue is one of the
most common and limiting symptoms of
some neurological disorders, such as
multiple sclerosis, post-polio syndrome, and
myasthenia gravis. These disorders may
result in physical fatigue (lack of muscle
strength) or mental fatigue (decreased
awareness or attention). When we evaluate
your fatigue, we will consider the intensity,
persistence, and effects of fatigue on your
functioning. This may include information
such as the clinical and laboratory data and
other objective evidence concerning your
neurological deficit, a description of fatigue
considered characteristic of your disorder,
and information about your functioning. We
consider the effects of physical fatigue on
your ability to stand up, balance, walk, or
perform fine and gross motor movements
using the criteria described in 11.00D. We
consider the effects of physical and mental
fatigue when we evaluate your physical and
mental functioning described in 11.00G.
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
U. How do we evaluate your neurological
disorder when it does not meet one of these
listings?
1. If your neurological disorder does not
meet the criteria of any of these listings, we
must also consider whether your
impairment(s) meets the criteria of a listing
in another body system. If you have a severe
medically determinable impairment(s) that
does not meet a listing, we will determine
whether your impairment(s) medically equals
a listing. See §§ 404.1526 and 416.926 of this
chapter.
2. If your impairment(s) does not meet or
medically equal the criteria of a listing, you
may or may not have the residual functional
capacity to perform your past relevant work
or adjust to other work that exists in
significant numbers in the national economy,
which we determine at the fourth and, if
necessary, the fifth steps of the sequential
evaluation process in §§ 404.1520 and
416.920 of this chapter.
3. We use the rules in §§ 404.1594 and
416.994 of this chapter, as appropriate, when
we decide whether you continue to be
disabled.
11.01 Category of Impairments,
Neurological Disorders
11.02 Epilepsy, documented by a detailed
description of a typical seizure and
characterized by A, B, C, or D:
A. Generalized tonic-clonic seizures (see
11.00H1a), occurring at least once a month
for at least 3 consecutive months (see
11.00H4) despite adherence to prescribed
treatment (see 11.00C); or
B. Dyscognitive seizures (see 11.00H1b),
occurring at least once a week for at least 3
consecutive months (see 11.00H4) despite
adherence to prescribed treatment (see
11.00C); or
C. Generalized tonic-clonic seizures (see
11.00H1a), occurring at least once every 2
months for at least 4 consecutive months (see
11.00H4) despite adherence to prescribed
treatment (see 11.00C); and a marked
limitation in one of the following:
1. Physical functioning (see 11.00G3a); or
2. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
3. Interacting with others (see
11.00G3b(ii)); or
4. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
5. Adapting or managing oneself (see
11.00G3b(iv)); or
D. Dyscognitive seizures (see 11.00H1b),
occurring at least once every 2 weeks for at
least 3 consecutive months (see 11.00H4)
despite adherence to prescribed treatment
(see 11.00C); and a marked limitation in one
of the following:
1. Physical functioning (see 11.00G3a); or
2. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
3. Interacting with others (see
11.00G3b(ii)); or
4. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
5. Adapting or managing oneself (see
11.00G3b(iv)).
11.03 [Reserved]
11.04 Vascular insult to the brain,
characterized by A, B, or C:
PO 00000
Frm 00074
Fmt 4700
Sfmt 4700
A. Sensory or motor aphasia resulting in
ineffective speech or communication (see
11.00E1) persisting for at least 3 consecutive
months after the insult; or
B. Disorganization of motor function in two
extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities, persisting for at least 3
consecutive months after the insult; or
C. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a) and in
one of the following areas of mental
functioning, both persisting for at least 3
consecutive months after the insult:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.05 Benign brain tumors, characterized
by A or B:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.06 Parkinsonian syndrome,
characterized by A or B despite adherence to
prescribed treatment for at least 3
consecutive months (see 11.00C):
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.07 Cerebral palsy, characterized by A,
B, or C:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)); or
C. Significant interference in
communication due to speech, hearing, or
visual deficit (see 11.00E2).
11.08 Spinal cord disorders,
characterized by A, B, or C:
A. Complete loss of function, as described
in 11.00M2, persisting for 3 consecutive
months after the disorder (see 11.00M4); or
B. Disorganization of motor function in two
extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities persisting for 3 consecutive
months after the disorder (see 11.00M4); or
C. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a) and in
one of the following areas of mental
functioning, both persisting for 3 consecutive
months after the disorder (see 11.00M4):
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.09 Multiple sclerosis, characterized by
A or B:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.10 Amyotrophic lateral sclerosis (ALS)
established by clinical and laboratory
findings (see 11.00O).
11.11 Post-polio syndrome, characterized
by A, B, C, or D:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Unintelligible speech (see 11.00E3); or
C. Bulbar and neuromuscular dysfunction
(see 11.00F), resulting in:
1. Acute respiratory failure requiring
mechanical ventilation; or
2. Need for supplemental enteral nutrition
via a gastrostomy or parenteral nutrition via
a central venous catheter; or
D. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.12 Myasthenia gravis, characterized by
A, B, or C despite adherence to prescribed
treatment for at least 3 months (see 11.00C):
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Bulbar and neuromuscular dysfunction
(see 11.00F), resulting in:
1. One myasthenic crisis requiring
mechanical ventilation; or
2. Need for supplemental enteral nutrition
via a gastrostomy or parenteral nutrition via
a central venous catheter; or
C. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.13 Muscular dystrophy, characterized
by A or B:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.14 Peripheral neuropathy,
characterized by A or B:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.15 [Reserved]
11.16 [Reserved]
11.17 Neurodegenerative disorders of the
central nervous system, such as Huntington’s
disease, Friedreich’s ataxia, and
PO 00000
Frm 00075
Fmt 4700
Sfmt 4700
43057
spinocerebellar degeneration, characterized
by A or B:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.18 Traumatic brain injury,
characterized by A or B:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities, persisting for at least 3
consecutive months after the injury; or
B. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following areas of mental
functioning, persisting for at least 3
consecutive months after the injury:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
11.19 [Reserved]
11.20 Coma or persistent vegetative state,
persisting for at least 1 month.
11.21 [Reserved]
11.22 Motor neuron disorders other than
ALS, characterized by A, B, or C:
A. Disorganization of motor function in
two extremities (see 11.00D1), resulting in an
extreme limitation (see 11.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Bulbar and neuromuscular dysfunction
(see 11.00F), resulting in:
1. Acute respiratory failure requiring
invasive mechanical ventilation; or
2. Need for supplemental enteral nutrition
via a gastrostomy or parenteral nutrition via
a central venous catheter; or
C. Marked limitation (see 11.00G2) in
physical functioning (see 11.00G3a), and in
one of the following:
1. Understanding, remembering, or
applying information (see 11.00G3b(i)); or
2. Interacting with others (see
11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining
pace (see 11.00G3b(iii)); or
4. Adapting or managing oneself (see
11.00G3b(iv)).
*
*
12.00
*
*
*
*
D. * * *
E:\FR\FM\01JYR1.SGM
*
*
MENTAL DISORDERS
01JYR1
*
*
43058
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
10. Traumatic brain injury (TBI). In cases
involving TBI, follow the documentation and
evaluation guidelines in 11.00Q.
*
*
*
*
*
12.01 Category of Impairments, Mental
Disorders
*
*
*
*
*
12.09 * * *
E. Peripheral neuropathy. Evaluate under
11.14.
*
*
*
*
*
I. Seizures. Evaluate under 11.02.
*
*
*
*
*
*
*
*
Part B
*
*
111.00
*
*
101.00
*
*
Neurological Disorders
*
*
*
MUSCULOSKELETAL SYSTEM
*
*
*
B. Loss of function.
1. General. * * * We evaluate
impairments with neurological causes under
111.00, as appropriate.
*
*
*
*
*
K. Disorders of the spine, listed in 101.04,
result in limitations because of distortion of
the bony and ligamentous architecture of the
spine and associated impingement on nerve
roots (including the cauda equina) or spinal
cord. Such impingement on nerve tissue may
result from a herniated nucleus pulposus,
spinal stenosis, arachnoiditis, or other
miscellaneous conditions.
asabaliauskas on DSK3SPTVN1PROD with RULES
*
*
*
*
*
111.00 NEUROLOGICAL DISORDERS
A. Which neurological disorders do we
evaluate under these listings? We evaluate
epilepsy, coma or persistent vegetative state
(PVS), and neurological disorders that cause
disorganization of motor function, bulbar and
neuromuscular dysfunction, or
communication impairment. Under this body
system, we evaluate the limitations resulting
from the impact of the neurological disease
process itself. If you have a neurological
disorder(s) that affects your physical and
mental functioning, we will evaluate your
impairments under the rules we use to
determine functional equivalence. If your
neurological disorder results in only mental
impairment or if you have a co-occurring
mental condition that is not caused by your
neurological disorder (for example, Autism
spectrum disorder), we will evaluate your
mental impairment under the mental
disorders body system, 112.00.
B. What evidence do we need to document
your neurological disorder?
1. We need both medical and non-medical
evidence (signs, symptoms, and laboratory
findings) to assess the effects of your
neurological disorder. Medical evidence
should include your medical history,
examination findings, relevant laboratory
tests, and the results of imaging. Imaging
refers to medical imaging techniques, such as
x-ray, computerized tomography (CT),
magnetic resonance imaging (MRI), and
electroencephalography (EEG). The imaging
must be consistent with the prevailing state
of medical knowledge and clinical practice as
the proper technique to support the
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
evaluation of the disorder. In addition, the
medical evidence may include descriptions
of any prescribed treatment and your
response to it. We consider non-medical
evidence such as statements you or others
make about your impairments, your
restrictions, your daily activities, or, if you
are an adolescent, your efforts to work.
2. We will make every reasonable effort to
obtain the results of your laboratory and
imaging evidence. When the results of any of
these tests are part of the existing evidence
in your case record, we will evaluate the test
results and all other relevant evidence. We
will not purchase imaging, or other
diagnostic tests or laboratory tests that are
complex, may involve significant risk, or that
are invasive. We will not routinely purchase
tests that are expensive or not readily
available.
C. How do we consider adherence to
prescribed treatment in neurological
disorders? In 111.02 (Epilepsy) and 111.12
(Myasthenia gravis), we require that
limitations from these neurological disorders
exist despite adherence to prescribed
treatment. ‘‘Despite adherence to prescribed
treatment’’ means that you have taken
medication(s) or followed other treatment
procedures for your neurological disorder(s)
as prescribed by a physician for three
consecutive months but your impairment
continues to meet the other listing
requirements despite this treatment. You may
receive your treatment at a health care
facility that you visit regularly, even if you
do not see the same physician on each visit.
D. What do we mean by disorganization of
motor function?
1. Disorganization of motor function means
interference, due to your neurological
disorder, with movement of two extremities;
i.e., the lower extremities, or upper
extremities (including fingers, wrists, hands,
arms, and shoulders). By two extremities we
mean both lower extremities, or both upper
extremities, or one upper extremity and one
lower extremity. All listings in this body
system, except for 111.02 (Epilepsy) and
111.20 (Coma and persistent vegetative state),
include criteria for disorganization of motor
function that results in an extreme limitation
in your ability to:
a. Stand up from a seated position; or
b. Balance while standing or walking; or
c. Use the upper extremities (e.g., fingers,
wrists, hands, arms, and shoulders).
2. Extreme limitation means the inability to
stand up from a seated position, maintain
balance in a standing position and while
walking, or use your upper extremities to
independently initiate, sustain, and complete
age-appropriate activities. The assessment of
motor function depends on the degree of
interference with standing up; balancing
while standing or walking; or using the upper
extremities (including fingers, hands, arms,
and shoulders).
a. Inability to stand up from a seated
position means that once seated you are
unable to stand and maintain an upright
position without the assistance of another
person or the use of an assistive device, such
as a walker, two crutches, or two canes.
b. Inability to maintain balance in a
standing position means that you are unable
PO 00000
Frm 00076
Fmt 4700
Sfmt 4700
to maintain an upright position while
standing or walking without the assistance of
another person or an assistive device, such as
a walker, two crutches, or two canes.
c. Inability to use your upper extremities
means that you have a loss of function of
both upper extremities (e.g., fingers, wrists,
hands, arms, and shoulders) that very
seriously limits your ability to independently
initiate, sustain, and complete ageappropriate activities involving fine and
gross motor movements. Inability to perform
fine and gross motor movements could
include not being able to pinch, manipulate,
and use your fingers; or not being able to use
your hands, arms, and shoulders to perform
gross motor movements, such as handling,
gripping, grasping, holding, turning, and
reaching; or not being able to engage in
exertional movements such a lifting,
carrying, pushing, and pulling.
3. For children who are not yet able to
balance, stand up, or walk independently, we
consider their function based on assessments
of limitations in the ability to perform
comparable age-appropriate activities with
the lower and upper extremities, given
normal developmental milestones. For such
children, an extreme level of limitation
means developmental milestones at less than
one-half of the child’s chronological age.
E. What do we mean by bulbar and
neuromuscular dysfunction? The bulbar
region of the brain is responsible for
controlling the bulbar muscles in the throat,
tongue, jaw, and face. Bulbar and
neuromuscular dysfunction refers to
weakness in these muscles, resulting in
breathing, swallowing, and speaking
impairments. Listings 111.12 (Myasthenia
gravis) and 111.22 (Motor neuron disorders)
include criteria for evaluating bulbar and
neuromuscular dysfunction. If your
neurological disorder has resulted in a
breathing disorder, we may evaluate that
condition under the respiratory system,
103.00.
F. What is epilepsy, and how do we
evaluate it under 111.02?
1. Epilepsy is a pattern of recurrent and
unprovoked seizures that are manifestations
of abnormal electrical activity in the brain.
There are various types of generalized and
‘‘focal’’ or partial seizures. In children, the
most common potentially disabling seizure
types are generalized tonic-clonic seizures,
dyscognitive seizures (formerly complex
partial seizures), and absence seizures.
However, psychogenic nonepileptic seizures
and pseudoseizures are not epileptic seizures
for the purpose of 111.02. We evaluate
psychogenic seizures and pseudoseizures
under the mental disorders body system,
112.00.
a. Generalized tonic-clonic seizures are
characterized by loss of consciousness
accompanied by a tonic phase (sudden
muscle tensing causing the child to lose
postural control) followed by a clonic phase
(rapid cycles of muscle contraction and
relaxation, also called convulsions). Tongue
biting and incontinence may occur during
generalized tonic-clonic seizures, and
injuries may result from falling.
b. Dyscognitive seizures are characterized
by alteration of consciousness without
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
convulsions or loss of muscle control. During
the seizure, blank staring, change of facial
expression, and automatisms (such as lip
smacking, chewing or swallowing, or
repetitive simple actions, such as gestures or
verbal utterances) may occur. During its
course, a dyscognitive seizure may progress
into a generalized tonic-clonic seizure (see
111.00F1a).
c. Absence seizures (petit mal) are also
characterized by an alteration in
consciousness, but are shorter than other
generalized seizures (e.g., tonic-clonic and
dyscognitive) seizures, generally lasting for
only a few seconds rather than minutes. They
may present with blank staring, change of
facial expression, lack of awareness and
responsiveness, and a sense of lost time after
the seizure. An aura never precedes absence
seizures. Although absence seizures are brief,
frequent occurrence may limit functioning.
This type of seizure usually does not occur
after adolescence.
d. Febrile seizures may occur in young
children in association with febrile illnesses.
We will consider seizures occurring during
febrile illnesses. To meet 111.02, we require
documentation of seizures during nonfebrile
periods and epilepsy must be established.
2. Description of seizure. We require at
least one detailed description of your
seizures from someone, preferably a medical
professional, who has observed at least one
of your typical seizures. If you experience
more than one type of seizure, we require a
description of each type.
3. Serum drug levels. We do not require
serum drug levels; therefore, we will not
purchase them. However, if serum drug
levels are available in your medical records,
we will evaluate them in the context of the
other evidence in your case record.
4. Counting seizures. The period specified
in 111.02A or B cannot begin earlier than one
month after you began prescribed treatment.
The required number of seizures must occur
within the period we are considering in
connection with your application or
continuing disability review. When we
evaluate the frequency of your seizures, we
also consider your adherence to prescribed
treatment (see 111.00C). When we determine
the number of seizures you have had in the
specified period, we will:
a. Count multiple seizures occurring in a
24-hour period as one seizure.
b. Count status epilepticus (a continuous
series of seizures without return to
consciousness between seizures) as one
seizure.
c. Count a dyscognitive seizure that
progresses into a generalized tonic-clonic
seizure as one generalized tonic-clonic
seizure.
d. We do not count seizures that occur
during a period when you are not adhering
to prescribed treatment without good reason.
When we determine that you had a good
reason for not adhering to prescribed
treatment, we will consider your physical,
mental, educational, and communicative
limitations (including any language barriers).
We will consider you to have good reason for
not following prescribed treatment if, for
example, the treatment is very risky for you
due to its consequences or unusual nature, or
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
if you are unable to afford prescribed
treatment that you are willing to accept, but
for which no free community resources are
available. We will follow guidelines found in
our policy, such as § 416.930(c) of this
chapter, when we determine whether you
have a good reason for not adhering to
prescribed treatment.
e. We do not count psychogenic
nonepileptic seizures or pseudoseizures
under 111.02.We evaluate these seizures
under the mental disorders body system,
112.00.
5. Electroencephalography (EEG) testing.
We do not require EEG test results; therefore,
we will not purchase them. However, if EEG
test results are available in your medical
records, we will evaluate them in the context
of the other evidence in your case record.
G. What is vascular insult to the brain, and
how do we evaluate it under 111.04?
1. Vascular insult to the brain (cerebrum,
cerebellum, or brainstem), commonly
referred to as stroke or cerebrovascular
accident (CVA), is brain cell death caused by
an interruption of blood flow within or
leading to the brain, or by a hemorrhage from
a ruptured blood vessel or aneurysm in the
brain. If you have a vision impairment
resulting from your vascular insult, we may
evaluate that impairment under the special
senses body system, 102.00.
2. We generally need evidence from at least
3 months after the vascular insult to
determine whether you have disorganization
of motor function under 111.04. In some
cases, evidence of your vascular insult is
sufficient to allow your claim within 3
months post-vascular insult. If we are unable
to allow your claim within 3 months after
your vascular insult, we will defer
adjudication of the claim until we obtain
evidence of your neurological disorder at
least 3 months post-vascular insult.
H. What are benign brain tumors, and how
do we evaluate them under 111.05? Benign
brain tumors are noncancerous
(nonmalignant) abnormal growths of tissue in
or on the brain that invade healthy brain
tissue or apply pressure on the brain or
cranial nerves. We evaluate their effects on
your functioning as discussed in 111.00D.
We evaluate malignant brain tumors under
the cancer body system in 113.00. If you have
a vision impairment resulting from your
benign brain tumor, we may evaluate that
impairment under the special senses body
system, 102.00.
I. What is cerebral palsy, and how do we
evaluate it under 111.07?
1. Cerebral palsy (CP) is a term that
describes a group of static, nonprogressive
disorders caused by abnormalities within the
brain that disrupt the brain’s ability to
control movement, muscle coordination, and
posture. The resulting motor deficits manifest
very early in a child’s development, with
delayed or abnormal progress in attaining
developmental milestones; deficits may
become more obvious as the child grows and
matures over time.
2. We evaluate your signs and symptoms,
such as ataxia, spasticity, flaccidity,
athetosis, chorea, and difficulty with precise
movements when we determine your ability
to stand up, balance, walk, or perform fine
PO 00000
Frm 00077
Fmt 4700
Sfmt 4700
43059
and gross motor movements. We will also
evaluate your signs, such as dysarthria and
apraxia of speech, and receptive and
expressive language problems when we
determine your ability to communicate.
3. We will consider your other
impairments or signs and symptoms that
develop secondary to the disorder, such as
post-impairment syndrome (a combination of
pain, fatigue, and weakness due to muscle
abnormalities); overuse syndromes (repetitive
motion injuries); arthritis; abnormalities of
proprioception (perception of the movements
and position of the body); abnormalities of
stereognosis (perception and identification of
objects by touch); learning problems; anxiety;
and depression.
J. What are spinal cord disorders, and how
do we evaluate them under 111.08?
1. Spinal cord disorders may be congenital
or caused by injury to the spinal cord. Motor
signs and symptoms of spinal cord disorders
include paralysis, flaccidity, spasticity, and
weakness.
2. Spinal cord disorders with complete loss
of function (111.08A) addresses spinal cord
disorders that result in complete lack of
motor, sensory, and autonomic function of
the affected part(s) of the body.
3. Spinal cord disorders with
disorganization of motor function (111.08B)
addresses spinal cord disorders that result in
less than complete loss of function of the
affected part(s) of the body, reducing, but not
eliminating, motor, sensory, and autonomic
function.
4. When we evaluate your spinal cord
disorder, we generally need evidence from at
least 3 months after your symptoms began in
order to evaluate your disorganization of
motor function. In some cases, evidence of
your spinal cord disorder may be sufficient
to allow your claim within 3 months after the
spinal cord disorder. If the medical evidence
demonstrates total cord transection causing a
loss of motor and sensory functions below
the level of injury, we will not wait 3 months
but will make the allowance decision
immediately.
K. What are communication impairments
associated with neurological disorders, and
how do we evaluate them under 111.09?
1. Communication impairments result from
medically determinable neurological
disorders that cause dysfunction in the parts
of the brain responsible for speech and
language. Under 111.09, we must have recent
comprehensive evaluation including all areas
of affective and effective communication,
performed by a qualified professional, to
document a communication impairment
associated with a neurological disorder.
2. Under 111.09A, we need documentation
from a qualified professional that your
neurological disorder has resulted in a
speech deficit that significantly affects your
ability to communicate. Significantly affects
means that you demonstrate a serious
limitation in communicating, and a person
who is unfamiliar with you cannot easily
understand or interpret your speech.
3. Under 111.09B, we need documentation
from a qualified professional that shows that
your neurological disorder has resulted in a
comprehension deficit that results in
ineffective verbal communication for your
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
43060
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
age. For the purposes of 111.09B,
comprehension deficit means a deficit in
receptive language. Ineffective verbal
communication means that you demonstrate
serious limitation in your ability to
communicate orally on the same level as
other children of the same age and level of
development.
4. Under 111.09C, we need documentation
of a neurological disorder that has resulted in
hearing loss. Your hearing loss will be
evaluated under listing 102.10 or 102.11.
5. We evaluate speech deficits due to nonneurological disorders under 2.09.
L. What are neurodegenerative disorders of
the central nervous system, such as Juvenileonset Huntington’s disease and Friedreich’s
ataxia, and how do we evaluate them under
111.17? Neurodegenerative disorders of the
central nervous system are disorders
characterized by progressive and irreversible
degeneration of neurons or their supporting
cells. Over time, these disorders impair many
of the body’s motor or cognitive and other
mental functions. We consider
neurodegenerative disorders of the central
nervous system under 111.17 that we do not
evaluate elsewhere in section 111.00, such as
juvenile-onset Huntington’s disease (HD) and
Friedreich’s ataxia. When these disorders
result in solely cognitive and other mental
functional limitations, we will evaluate the
disorder under the mental disorder listings,
112.00.
M. What is traumatic brain injury, and how
do we evaluate it under 111.18?
1. Traumatic brain injury (TBI) is damage
to the brain resulting from skull fracture,
collision with an external force leading to a
closed head injury, or penetration by an
object that enters the skull and makes contact
with brain tissue. We evaluate a TBI that
results in coma or persistent vegetative state
(PVS) under 111.20.
2. We generally need evidence from at least
3 months after the TBI to evaluate whether
you have disorganization of motor function
under 111.18. In some cases, evidence of
your TBI is sufficient to determine disability.
If we are unable to allow your claim within
3 months post-TBI, we will defer
adjudication of the claim until we obtain
evidence of your neurological disorder at
least 3 months post-TBI. If a finding of
disability still is not possible at that time, we
will again defer adjudication of the claim
until we obtain evidence at least 6 months
after your TBI.
N. What are coma and persistent vegetative
state, and how do we evaluate them under
111.20? Coma is a state of unconsciousness
in which a child does not exhibit a sleep/
wake cycle, and is unable to perceive or
respond to external stimuli. Children who do
not fully emerge from coma may progress
into persistent vegetative state (PVS). PVS is
a condition of partial arousal in which a
child may have a low level of consciousness
but is still unable to react to external stimuli.
In contrast to coma, a child in a PVS retains
sleep/wake cycles and may exhibit some key
lower brain functions, such as spontaneous
movement, opening and moving eyes, and
grimacing. Coma or PVS may result from a
TBI, a nontraumatic insult to the brain (such
as a vascular insult, infection, or brain
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
tumor), or a neurodegenerative or metabolic
disorder. Medically induced comas should be
considered under the section pertaining to
the underlying reason the coma was
medically induced and not under this
section.
O. What is multiple sclerosis, and how do
we evaluate it under 111.21?
1. Multiple sclerosis (MS) is a chronic,
inflammatory, degenerative disorder that
damages the myelin sheath surrounding the
nerve fibers in the brain and spinal cord. The
damage disrupts the normal transmission of
nerve impulses within the brain and between
the brain and other parts of the body causing
impairment in muscle coordination, strength,
balance, sensation, and vision. There are
several forms of MS, ranging from slightly to
highly aggressive. Milder forms generally
involve acute attacks (exacerbations) with
partial or complete recovery from signs and
symptoms (remissions). Aggressive forms
generally exhibit a steady progression of
signs and symptoms with few or no
remissions. The effects of all forms vary from
child to child.
2. We evaluate your signs and symptoms,
such as flaccidity, spasticity, spasms,
incoordination, imbalance, tremor, physical
fatigue, muscle weakness, dizziness, tingling,
and numbness when we determine your
ability to stand up, balance, walk, or perform
fine and gross motor movements, such as
using your arms, hands, and fingers. If you
have a vision impairment resulting from your
MS, we may evaluate that impairment under
the special senses body system, 102.00.
P. What are motor neuron disorders, and
how do we evaluate them under 111.22?
Motor neuron disorders are progressive
neurological disorders that destroy the cells
that control voluntary muscle activity, such
as walking, breathing, swallowing, and
speaking. The most common motor neuron
disorders in children are progressive bulbar
palsy and spinal muscular dystrophy
syndromes. We evaluate the effects of these
disorders on motor functioning or bulbar and
neuromuscular functioning.
Q. How do we consider symptoms of
fatigue in these listings? Fatigue is one of the
most common and limiting symptoms of
some neurological disorders, such as
multiple sclerosis and myasthenia gravis.
These disorders may result in physical
fatigue (lack of muscle strength) or mental
fatigue (decreased awareness or attention).
When we evaluate your fatigue, we will
consider the intensity, persistence, and
effects of fatigue on your functioning. This
may include information such as the clinical
and laboratory data and other objective
evidence concerning your neurological
deficit, a description of fatigue considered
characteristic of your disorder, and
information about your functioning. We
consider the effects of physical fatigue on
your ability to stand up, balance, walk, or
perform fine and gross motor movements
using the criteria described in 111.00D.
R. How do we evaluate your neurological
disorder when it does not meet one of these
listings?
1. If your neurological disorder does not
meet the criteria of any of these listings, we
must also consider whether your
PO 00000
Frm 00078
Fmt 4700
Sfmt 4700
impairment(s) meets the criteria of a listing
in another body system. If you have a severe
medically determinable impairment(s) that
does not meet a listing, we will determine
whether your impairment(s) medically equals
a listing. See § 416.926 of this chapter.
2. If your impairment(s) does not meet or
medically equal a listing, we will consider
whether your impairment(s) functionally
equals the listings. See § 416.926a of this
chapter.
3. We use the rules in § 416.994a of this
chapter when we decide whether you
continue to be disabled.
111.01 Category of Impairments,
Neurological Disorders
111.02 Epilepsy, documented by a
detailed description of a typical seizure and
characterized by A or B:
A. Generalized tonic-clonic seizures (see
111.00F1a), occurring at least once a month
for at least 3 consecutive months (see
111.00F4) despite adherence to prescribed
treatment (see 111.00C); or
B. Dyscognitive seizures (see 111.00F1b) or
absence seizures (see 111.00F1c), occurring
at least once a week for at least 3 consecutive
months (see 111.00F4) despite adherence to
prescribed treatment (see 111.00C).
111.03 [Reserved]
111.04 Vascular insult to the brain,
characterized by disorganization of motor
function in two extremities (see 111.00D1),
resulting in an extreme limitation (see
111.00D2) in the ability to stand up from a
seated position, balance while standing or
walking, or use the upper extremities,
persisting for at least 3 consecutive months
after the insult.
111.05 Benign brain tumors,
characterized by disorganization of motor
function in two extremities (see 111.00D1),
resulting in an extreme limitation (see
111.00D2) in the ability to stand up from a
seated position, balance while standing or
walking, or use the upper extremities.
111.06 [Reserved]
111.07 Cerebral palsy, characterized by
disorganization of motor function in two
extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities.
111.08 Spinal cord disorders,
characterized by A or B:
A. Complete loss of function, as described
in 111.00J2, persisting for 3 consecutive
months after the disorder (see 111.00J4); or
B. Disorganization of motor function in two
extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities persisting for 3 consecutive
months after the disorder (see 111.00J4).
111.09 Communication impairment,
associated with documented neurological
disorder and one of the following:
A. Documented speech deficit that
significantly affects (see 111.00K1) the clarity
and content of the speech; or
B. Documented comprehension deficit
resulting in ineffective verbal communication
(see 111.00K2) for age; or
E:\FR\FM\01JYR1.SGM
01JYR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
C. Impairment of hearing as described
under the criteria in 102.10 or 102.11.
111.10 [Reserved]
111.11 [Reserved]
111.12 Myasthenia gravis, characterized
by A or B despite adherence to prescribed
treatment for at least 3 months (see 111.00C):
A. Disorganization of motor function in
two extremities (see 111.00D1), resulting in
an extreme limitation (see 111.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Bulbar and neuromuscular dysfunction
(see 111.00E), resulting in:
1. One myasthenic crisis requiring
mechanical ventilation; or
2. Need for supplemental enteral nutrition
via a gastrostomy or parenteral nutrition via
a central venous catheter.
111.13 Muscular dystrophy, characterized
by disorganization of motor function in two
extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities.
111.14 Peripheral neuropathy,
characterized by disorganization of motor
function in two extremities (see 111.00D1),
resulting in an extreme limitation (see
111.00D2) in the ability to stand up from a
seated position, balance while standing or
walking, or use the upper extremities.
111.15 [Reserved]
111.16 [Reserved]
111.17 Neurodegenerative disorders of
the central nervous system, such as Juvenileonset Huntington’s disease and Friedreich’s
ataxia, characterized by disorganization of
motor function in two extremities (see
111.00D1), resulting in an extreme limitation
(see 111.00D2) in the ability to stand up from
a seated position, balance while standing or
walking, or use the upper extremities.
111.18 Traumatic brain injury,
characterized by disorganization of motor
function in two extremities (see 111.00D1),
resulting in an extreme limitation (see
111.00D2) in the ability to stand up from a
seated position, balance while standing or
walking, or use the upper extremities,
persisting for at least 3 consecutive months
after the injury.
111.19 [Reserved]
111.20 Coma or persistent vegetative
state, persisting for at least 1 month.
111.21 Multiple sclerosis, characterized
by disorganization of motor function in two
extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities.
111.22 Motor neuron disorders,
characterized by A or B:
A. Disorganization of motor function in
two extremities (see 111.00D1), resulting in
an extreme limitation (see 111.00D2) in the
ability to stand up from a seated position,
balance while standing or walking, or use the
upper extremities; or
B. Bulbar and neuromuscular dysfunction
(see 111.00E), resulting in:
1. Acute respiratory failure requiring
invasive mechanical ventilation; or
VerDate Sep<11>2014
16:44 Jun 30, 2016
Jkt 238001
2. Need for supplemental enteral nutrition
via a gastrostomy or parenteral nutrition via
a central venous catheter.
[FR Doc. 2016–15306 Filed 6–30–16; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2015–D–1839]
The Food and Drug Administration’s
Policy on Declaring Small Amounts of
Nutrients and Dietary Ingredients on
Nutrition Labels; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA, we, or the
Agency) is announcing the availability
of a guidance for industry entitled
‘‘FDA’s Policy on Declaring Small
Amounts of Nutrients and Dietary
Ingredients on Nutrition Labels:
Guidance for Industry.’’ The guidance
explains to manufacturers of
conventional foods and dietary
supplements our policy on determining
the amount to declare on the nutrition
label for certain nutrients and dietary
ingredients that are present in a small
amount.
SUMMARY:
The guidance is available on July
1, 2016. Submit either electronic or
written comments on FDA guidances at
any time.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
PO 00000
Frm 00079
Fmt 4700
Sfmt 4700
43061
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–1839. Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
E:\FR\FM\01JYR1.SGM
01JYR1
Agencies
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Rules and Regulations]
[Pages 43048-43061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15306]
=======================================================================
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
[Docket No. SSA-2006-0140]
RIN 0960-AF35
Revised Medical Criteria for Evaluating Neurological Disorders
AGENCY: Social Security Administration.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are revising the criteria in the Listing of Impairments
(listings) that we use to evaluate disability claims involving
neurological disorders in adults and children under titles II and XVI
of the Social Security Act (Act). These revisions reflect our program
experience; advances in medical knowledge, treatment, and methods of
evaluating neurological disorders; comments we received from medical
experts and the public at an outreach policy conference; responses to
an advance notice of proposed rulemaking (ANPRM); and public comments
we received in response to a Notice of Proposed Rulemaking (NPRM) and a
Federal Register notice that reopened the NPRM comment period.
DATES: This rule is effective September 29, 2016.
FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of
Disability Policy, Social Security Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020. 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 site, Social Security Online, at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
Background
We are making final the rule for evaluating neurological disorders
that we proposed in an NPRM published in the Federal Register on
February 25, 2014 (79 FR 10636). In the preamble to the NPRM, we
discussed the revisions to our current rule for the neurological
[[Page 43049]]
body system and our reasons for proposing those revisions. To the
extent that we are adopting the proposed rule as published, we are not
repeating that information here; interested readers may refer to the
NPRM preamble. We incorporated into the final rule the portions of
Social Security Ruling (SSR) 87-6, ``Titles II and XVI: The Role of
Prescribed Treatment in the Evaluation of Epilepsy'' that continue to
be relevant to the treatment of epilepsy. As part of the publication of
this final rule, we are rescinding SSR 87-6. We also respond to public
comments on the NPRM and explain what changes we are making based on
those comments in the ``Public Comments on the NPRM'' section of the
preamble.
Why are we revising the listings for evaluating neurological disorders?
We are comprehensively revising the listings for evaluating
neurological disorders to update the medical criteria, provide
additional methods of evaluating neurological disorders, provide more
information on how we evaluate neurological disorders, make other
changes that reflect our program experience, and address adjudicator
questions. We last comprehensively revised the listings for the
neurological disorders body system in a final rule published on
December 6, 1985.\1\ We have made only a few changes since then to meet
program purposes.\2\
---------------------------------------------------------------------------
\1\ 50 FR 50068.
\2\ On December 12, 1990, we raised the IQ limit in 11.07A,
111.02B1, 111.07B1, and 111.08B2 from 69 to 70 (55 FR 51204). We
published a final rule adding section 11.00F for traumatic brain
injury on August 21, 2000 (65 FR 50746); made technical revisions to
most of the body systems on April 24, 2002 (67 FR 20018), which
included some changes to the neurological body system; revised
listing 11.10 for Amyotrophic lateral sclerosis (ALS) on August 82,
2003 (68 FR 51689); moved the listings for malignant brain tumors to
the body system for malignant neoplastic diseases on November 15,
2004 (69 FR 67018); and made a technical correction in listing
111.09 on March 24, 2011 (76 FR 16531).
---------------------------------------------------------------------------
Summary of Public Comments on the NPRM
In the NPRM, we provided the public with a 60-day comment period
that ended on April 28, 2014. We reopened the comment period for 30
days on May 1, 2014 (70 FR 24634). The last of the two comment periods
closed on June 2, 2014. We received and posted 2,103 public comments
during the initial period for public comments on the NPRM, and received
and posted an additional 921 when we extended the NPRM comment period.
We also received and posted 55 comments when we initially made the
public aware of our efforts to update this rule, when we published the
ANPRM. The comments came from members of the public, medical
professionals, national medical organizations, advocacy groups,
disability examiners and other adjudicators, and a national association
representing disability examiners in the State agencies that make
disability determinations for us.
The majority of the comments was repetitive and expressed support
of or agreement with identical recommendations submitted by a few
national organizations. For example, we received just over 1,100
comments that repeated, or were in support of recommendations submitted
by a few Huntington's disease organizations; approximately 800 comments
that repeated, or were in support of recommendations submitted by
various headache organizations; and approximately 350 repeat comments
that were in support of recommendations from various Parkinson's
disease organizations.
In general, the recommendations and concerns raised by the majority
of public commenters were very similar or identical. We received
several comments suggesting that we create separate listings for
various neurological disorders that we address in one comment below.
Some commenters noted provisions with which they agreed and did not
make suggestions for changes in those provisions. For example, over 300
comments were testimonials from commenters sharing their personal
experience with various neurological disorders. Approximately 300
comments were outside the scope of the neurological NPRM, several of
those were relevant to other body system disorders; we shared those
comments with the appropriate body systems policy teams for
consideration. We did not summarize or respond to comments that were in
agreement with, or outside the scope of the neurological NPRM. We
addressed repetitive comments that raised identical issues as one
comment.
We carefully considered all of the relevant comments we received
and we responded to all of the significant issues raised by the
commenters that were within the scope of this rule. We provide our
reasons for adopting or not adopting the comment recommendations in our
responses below.
General Comments
Comment: Several commenters suggested that we create separate
listings for various neurological disorders, such as migraine, cluster
headaches and other severe headache disorders, fetal alcohol syndrome,
cervical dystonias, atypical facial pain, and trigeminal neuralgia. One
commenter expressed opposition to creating a separate listing for
migraine headaches because the symptoms are too subjective. Other
commenters suggested adding several neurological disorders to specific
listings.
Response: We did not adopt these comments. While we do not have
listings for every neurological condition, we are able to evaluate
unlisted neurological disorders in several ways under our sequential
evaluation process. We will determine whether your impairment medically
equals a listing. If your impairment does not medically equal the
criteria of a listing, you may or may not have the residual functional
capacity to perform your past relevant work or adjust to other work
that exists in significant numbers in the national economy, which we
determine at the fourth and, if necessary, the fifth steps of the
sequential evaluation process. As we work on the next iteration of
revisions to the neurological rule, we will consider the suggestions
for adding new listings and will consider comments expressing
opposition to adding certain new listings.
Comment: We received a number of comments related to how we
evaluate migraines and other chronic headache disorders. As we
mentioned in the previous comment, several commenters asked that we
recognize migraines as a disabling impairment and suggested we create a
specific listing. Other commenters suggested listing criteria for us to
consider. One commenter raised concerns about evaluating chronic
headache disorders because of the subjective nature of the disorders.
Response: We acknowledge the commenters' concerns. We realize it is
appropriate to provide impairment-specific guidance on how we evaluate
migraines and other chronic headache disorders. We will address these
concerns in training to ensure all adjudicators know how to establish
migraine and other chronic headache disorders as medically determinable
impairments (MDIs). Once we establish the existence of an MDI(s), we
follow the remaining steps in the sequential evaluation process (See
Sec. Sec. 404.1520, 416.920, and 416.924). As noted in the response
above to the comments about creating additional listings, we are able
to evaluate unlisted neurological disorders in several ways under our
sequential evaluation process.
Comment: We received several comments expressing concern that the
proposed functional criteria for determining disability in individuals
with Huntington's disease (HD) and
[[Page 43050]]
Parkinson's disease still rely on the presence of physical limitations
and do not adequately address the common non-physical manifestations of
these diseases. The commenters suggested we include the mental criteria
from the mental body system in the neurological disorders body system
to evaluate the mental aspects of neurological disorders in the absence
of physical limitations commonly seen in HD and in Parkinson's disease.
They indicated the proposed criteria should include criteria specific
to mental functioning in order to address the full range of symptoms
often experienced by people who suffer with HD and Parkinson's disease.
The commenters also suggested that the proposed introductory text
sections where we discuss HD and Parkinson's disease direct
adjudicators beyond listing 12.02 to expand to the entire mental body
system, as appropriate, when they need to evaluate mental symptoms
associated with neurological disorders.
Response: We partially adopted this comment. For program purposes,
we consider all impairments under all applicable body systems as part
of our disability evaluation. In the listings, we describe each of the
major body systems impairments we consider severe enough to be
disabling, and we list requirements that demonstrate a level of
severity and duration consistent with the definition of disability set
by Congress under the Act. We evaluate the person's impairment(s) under
the most appropriate body system(s). We recognize that neurological
disorders may co-occur with impairments we evaluate in other body
systems; however, we intend the listings in this final rule to address
only neurological disorders and the complications from those disorders.
When only mental aspects of neurological disorders are present in the
absence of physical limitations commonly seen in HD and Parkinson's
disease, we evaluate those limitations under the appropriate mental
disorders body system listings. However, when mental aspects of
neurological disorders are present and co-occur with the physical
limitations of these disorders, we evaluate limitations in physical and
mental functioning under the neurological listings. In response to this
and similar comments, we provided additional guidance in the
introductory text explaining how we evaluate mental disorders under
these listings.
We modified our functional criteria and severity rating scale to
address the common mental aspects of neurological disorders. Our intent
in the new functional criteria for adults is to provide a way to
evaluate impairments and determine disability appropriately, even when
those impairments are difficult to evaluate based on medical criteria
alone. With functional criteria, we can evaluate the functional impact
associated with any neurological impairment in broad areas of physical
and mental functioning. The four areas of mental functioning are
understanding, remembering, or applying information; interacting with
others; concentrating, persisting, or maintaining pace; and adapting or
managing oneself. For example, a person with a neurological disorder
may demonstrate a limitation in the ability to walk (as addressed under
the physical functioning criterion). He or she may also have a mental
impairment resulting from the neurological disorder, which is
demonstrated by a limitation in the ability to concentrate.
Comment: A commenter stated that the definition of social
functioning in proposed section 11.00G3 should not focus solely on
limitations caused by physical ailments. The commenter suggested that
the social functioning criteria should include interpersonal
interactions, as well as non-physical symptoms such as irritability,
aggression, and perseveration.
Response: We adopted this comment. We mentioned in the previous
comment we modified our functional criteria to focus on the common
mental aspects of neurological disorders. We also changed the criterion
from ``social functioning'' to ``interacting with others'' to be
consistent with the way mental functions are described in the
Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition.\3\
---------------------------------------------------------------------------
\3\ American Psychiatric Association: Diagnostic and Statistical
Manual of Mental Disorders, Fifth Edition, Arlington, VA, American
Psychiatric Association, 2013.
---------------------------------------------------------------------------
Comment: Several commenters noted that proposed section 11.00C
states, ``Medical research shows that these neurological conditions may
improve after a period of treatment.'' The commenters pointed out this
statement is false and we should correct it because Parkinson's disease
never improves.
Response: We adopted this comment. It was not our intent to
indicate in listing 11.06 that Parkinson's disease itself may improve
with treatment, as the disease is progressive. We removed the
statement.
Comment: Several commenters asked that we revise proposed section
11.00K to clarify that motor and non-motor symptoms can be equally
disabling in Parkinsonian syndromes, and to reflect that symptoms can
fluctuate significantly from hour to hour and minute to minute, often
making job performance in a professional environment very difficult.
Response: We partially adopted this comment. We agree that non-
motor symptoms can be as disabling as motor symptoms in Parkinsonian
syndromes. However, limitations resulting from non-motor symptoms are
highly variable and we evaluate them on a case-by-case basis. The new
functional criteria enable adjudicators to evaluate non-motor symptoms
associated with Parkinsonian syndromes under listing 11.06B. We mention
that neurological disorders may manifest in a combination of
limitations in physical and mental functioning in the adult section,
11.00G. We will also provide guidance in training to adjudicators about
the variable manifestations of neurological disorders, such as
Parkinsonian syndrome.
Comment: One commenter expressed disappointment that the revised
epilepsy listing does not include any discussion of how to ``deal with
claimants who suffer from a mix of tonic-clonic and dyscognitive
seizures.'' The commenter stated that ``although the revised listing
explicitly acknowledges that individuals may suffer from a mix of
tonic-clonic and dyscognitive seizures,\4\ there is no guidance as to
how to evaluate a claimant experiencing both types of seizures.''
---------------------------------------------------------------------------
\4\ See NPRM 11.00H(4)(c).
---------------------------------------------------------------------------
Response: We do not agree with the commenter. In section 11.00H4c,
we provide guidance on how to count dyscognitive seizures that progress
into generalized tonic-clonic seizures. However, we do not believe that
it is possible to address every permutation of the dyscognitive and
tonic-clonic mixed seizure types. The signs and symptoms of such
seizure types will vary from person to person. Adjudicators evaluate
limitations caused by mixed seizures on a case-by-case basis.
Comment: One commenter was pleased that we included a more detailed
explanation for the term ``marked'' in 11.00G2 but was concerned that
this definition relied on the term ``seriously,'' as in ``interfere
seriously'' and ``seriously limit,'' which we did not define. This
commenter believed that not defining the term ``seriously,'' while
repeatedly relying on it to define the term ``marked,'' creates a
significant ambiguity in the listings. The commenter was concerned that
adjudicators will apply the term ``marked'' inconsistently unless we
[[Page 43051]]
include a definition for the term ``seriously.''
Response: We partially adopted this comment. In the modified final
section 11.00D of the introductory text, we include criteria for how to
establish disorganization of motor function, descriptions for how to
evaluate those criteria, and a definition of an extreme limitation in
disorganization of motor function. If we do not find that a person is
disabled on the basis of disorganization of motor function alone, as
explained in 11.00D, we will find that the person's neurological
disorder is incompatible with the ability to do any gainful activity if
it results in marked limitation in physical functioning and marked
limitation in one of four areas of mental functioning. In the modified
final section 11.00G of the introductory text, we provide definitions
for marked limitations drawn from our currently used definitions in
section 7.00G4 of the listing of impairments for hematological
disorders and section 1.00B of the listing of impairments for
musculoskeletal disorders. We also provide descriptions of the
considerations for physical and mental functioning in 11.00G2 and
11.00G3.
Comment: One commenter suggested that we not remove the
intelligence quotient (IQ) requirement from the neurological listings,
as the commenter believes it is the best indicator of mental
capability.
Response: We did not adopt this comment. As we explained in the
preamble to the NPRM, we are removing the criterion of an IQ score from
our neurological listings because advances in medical knowledge of
cerebral palsy (for adults and children), epilepsy (for children),
spinal cord insults (for children), and our program experience indicate
that an IQ score does not provide the best measure of limitations in
cognitive functioning associated with these disorders. Therefore, it
may not indicate listing-level severity under the neurological listings
and would be more appropriately used to evaluate mental disorders under
our mental disorders body system.
Comment: One commenter expressed that scales rating function into
categories such as ``mild,'' ``moderate,'' and ``severe,'' are clearly
subjective on the part of the rater and their meaningfulness is
questionable.
Response: The word ``severe'' in the disability program separates
step 2 from step 3 in the sequential evaluation process that we use to
evaluate a person's physical or mental impairment or combination of
impairments. If we find at step 2 that a person does not have a
``severe'' medically determinable impairment (MDI) or combination of
MDIs that meet the duration requirement, we will find the person is not
disabled. If we find at step 2 that the person has a ``severe'' MDI or
combination of MDIs, we will continue evaluating the impairment(s) at
step 3 of the sequential evaluation process. (See Sec. Sec.
404.1520(a), 416.920(a) and 416.924(a).) With respect to the terms,
``mild'' and ``moderate,'' we have used those terms in a five-point
rating scale in the mental disorders body system (consisting of none,
mild, moderate, marked, and extreme) since 1985 (Sec. Sec. 404.1520a
and 416.920a). We have also used the terms ``marked'' and ``extreme''
limitation in childhood functional equivalence policy (Sec. Sec.
416.926a). Such scales and ratings continue to be standard medical
practice, and continue to be effective for evaluating degrees of
impairment-related limitation(s). Moreover, in the modified final
introductory text (11.00D2, 11.00G2, and 11.02D2), we include guidance
for our adjudicators on the meaning and use of these terms.
Comment: One commenter said a significant feature of the proposed
new criteria is that we will presume individuals (with many different
neurological disorders) are disabled if they are unable to stand from a
sitting position and are not presently working. The commenter noted
that it appears obvious from casual observation that many individuals
successfully work in a wide variety of different sedentary positions,
such as Wal-Mart greeter, office worker, and physician. Because
significant numbers of these individuals work on a regular basis in the
national economy, it is quite easy for a lay observer to think it
inappropriate for the Social Security Administration to presume that
all individuals unable to stand are also unable to work.
Response: We did not adopt this comment. As we explain in 11.00D2a,
an inability to stand up from a seated position means that, once
seated, you are unable to stand and maintain an upright position
without the risk of falling unless you have the assistance of another
person or the use of an assistive device, such as a walker, two
crutches, or two canes. The severity of such a limitation is set at a
standard much higher than that applicable to a person who is able to do
sedentary work; it thereby constitutes an inability to do any gainful
activity in the national economy.
Comment: One commenter suggested that when referring to spinal cord
insults we use the term ``spinal cord disorders'' instead of ``spinal
cord insults.''
Response: We agree with the commenter and adopted this comment.
Comment: Some commenters asked how we would evaluate adherence to
prescribed treatment for epilepsy patients when we removed the
requirement for serum drug levels, particularly for patients prescribed
newer antiepileptic drugs.
Response: We describe how we consider adherence to prescribed
treatment under 11.00C. We consider whether you have taken medications
or followed other treatment procedures as prescribed by a physician for
three consecutive months. We no longer require serum drug levels. When
we last revised the listings in 1985, blood drug levels were strong
indicators for prescribed treatment compliance because therapeutic
ranges had been established for antiepileptic drugs (AEDs) and the
ranges were often noted on laboratory results. Many newer AEDs do not
have established therapeutic levels, which makes lab results difficult
for our adjudicators to interpret. We removed the requirement for
obtaining blood drug levels to address this adjudicative issue and to
simplify evaluation of seizures that satisfy the listing criteria.
However, we will continue to consider blood drug levels available in
the evidence in the context of all evidence in the case record.
What is our authority to make rules and set procedures for determining
whether a person is disabled under the statutory definition?
The Act authorizes us to make rules and regulations and to
establish necessary and appropriate procedures to implement them.\5\
---------------------------------------------------------------------------
\5\ 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1).
---------------------------------------------------------------------------
When will we begin to use this final rule?
We will begin to use this final rule on its effective date. We will
continue to use the current listings until the date the final rule
becomes effective. We will apply the final rule to new applications
filed on or after the effective date of the final rule and to claims
that are pending on or after the effective date.\6\
---------------------------------------------------------------------------
\6\ This means that we will use the final rule on and after
their effective date in any case in which we make a determination or
decision. We expect that Federal courts will review the
Commissioner's final decisions using the rule that were in effect at
the time we issued the decisions. If a court reverses the
Commissioner's final decision and remands a case for further
administrative proceedings after the effective date of the final
rule, we will apply the final rule to the entire period at issue in
the decision we make after the court's remand.
---------------------------------------------------------------------------
[[Page 43052]]
How long will this final rule be effective?
This final rule will remain in effect for 5 years after the date it
becomes effective, unless we extend it, or revise and issue it again.
Regulatory Procedures
Executive Order 12866, as Supplemented by Executive Order 13563
We consulted with the Office of Management and Budget (OMB) and
determined that this final rule meets the criteria for a significant
regulatory action under Executive Order 12866, as supplemented by
Executive Order 13563. Therefore, OMB reviewed it.
Regulatory Flexibility Act
We certify that this final rule will not have a significant
economic impact on a substantial number of small entities because it
affects only individuals. Therefore, the Regulatory Flexibility Act, as
amended, does not require us to prepare a regulatory flexibility
analysis.
Paperwork Reduction Act
These rules do not create any new or affect any existing
collections and, therefore, do not require OMB approval under the
Paperwork Reduction Act.
(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 in 20 CFR Part 404
Administrative practice and procedure, Blind, Disability benefits,
Old-age, Survivors, and Disability Insurance, Reporting and
recordkeeping requirements, Social Security.
Carolyn W. Colvin,
Acting Commissioner of Social Security.
For the reasons set out in the preamble, we are amending 20 CFR
part 404, subpart P as set forth below:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950-)
Subpart P--Determining Disability and Blindness
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),
(i), and (j), 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), (i), and
(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193,
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42
U.S.C. 902 note).
0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 12 of the introductory text before part A;
0
b. Amend part A by revising the body system name for section 11.00 in
the table of contents;
0
c. In section 1.00 of part A, revise the introduction to paragraph K;
0
d. Revise section 11.00 of part A;
0
e. In section 12.00 of part A, revise paragraph D10, listing 12.01,
listing 12.09E, and listing 12.09I;
0
f. Amend part B by revising the body system name for section 111.00 in
the table of contents;
0
g. In section 101.00 of part B, revise the last sentence of paragraph
B1;
0
h. In section 101.00 of part B, revise the last sentence of paragraph
B1 and paragraph K; and
0
i. Revise section 111.00 of part B to read as follows:
APPENDIX 1 TO SUBPART P OF PART 404--LISTING OF IMPAIRMENTS
* * * * *
12. Neurological Disorders (11.00 and 111.00): September 29,
2021.
* * * * *
Part A
* * * * *
11.00 Neurological Disorders
* * * * *
1.00 Musculoskeletal System
* * * * *
K. Disorders of the spine, listed in 1.04, result in limitations
because of distortion of the bony and ligamentous architecture of
the spine and associated impingement on nerve roots (including the
cauda equina) or spinal cord. Such impingement on nerve tissue may
result from a herniated nucleus pulposus, spinal stenosis,
arachnoiditis, or other miscellaneous conditions.
* * * * *
11.00 NEUROLOGICAL DISORDERS
A. Which neurological disorders do we evaluate under these
listings? We evaluate epilepsy, amyotrophic lateral sclerosis, coma
or persistent vegetative state (PVS), and neurological disorders
that cause disorganization of motor function, bulbar and
neuromuscular dysfunction, communication impairment, or a
combination of limitations in physical and mental functioning. We
evaluate neurological disorders that may manifest in a combination
of limitations in physical and mental functioning. For example, if
you have a neurological disorder that causes mental limitations,
such as Huntington's disease or early-onset Alzheimer's disease,
which may limit executive functioning (e.g., regulating attention,
planning, inhibiting responses, decision-making), we evaluate your
limitations using the functional criteria under these listings (see
11.00G). Under this body system, we evaluate the limitations
resulting from the impact of the neurological disease process
itself. If your neurological disorder results in only mental
impairment or if you have a co-occurring mental condition that is
not caused by your neurological disorder (for example, dementia), we
will evaluate your mental impairment under the mental disorders body
system, 12.00.
B. What evidence do we need to document your neurological
disorder?
1. We need both medical and non-medical evidence (signs,
symptoms, and laboratory findings) to assess the effects of your
neurological disorder. Medical evidence should include your medical
history, examination findings, relevant laboratory tests, and the
results of imaging. Imaging refers to medical imaging techniques,
such as x-ray, computerized tomography (CT), magnetic resonance
imaging (MRI), and electroencephalography (EEG). The imaging must be
consistent with the prevailing state of medical knowledge and
clinical practice as the proper technique to support the evaluation
of the disorder. In addition, the medical evidence may include
descriptions of any prescribed treatment and your response to it. We
consider non-medical evidence such as statements you or others make
about your impairments, your restrictions, your daily activities, or
your efforts to work.
2. We will make every reasonable effort to obtain the results of
your laboratory and imaging evidence. When the results of any of
these tests are part of the existing evidence in your case record,
we will evaluate the test results and all other relevant evidence.
We will not purchase imaging, or other diagnostic tests, or
laboratory tests that are complex, may involve significant risk, or
that are invasive. We will not routinely purchase tests that are
expensive or not readily available.
C. How do we consider adherence to prescribed treatment in
neurological disorders? In 11.02 (Epilepsy), 11.06 (Parkinsonian
syndrome), and 11.12 (Myasthenia gravis), we require that
limitations from these neurological disorders exist despite
adherence to prescribed treatment. ``Despite adherence to prescribed
treatment'' means that you have taken medication(s) or followed
other treatment procedures for your neurological disorder(s) as
prescribed by a physician for three consecutive months but your
impairment continues to meet the other listing requirements despite
this treatment. You may receive your treatment at a health care
facility that you visit regularly, even if you do not see the same
physician on each visit.
D. What do we mean by disorganization of motor function?
1. Disorganization of motor function means interference, due to
your neurological disorder, with movement of two extremities; i.e.,
the lower extremities, or upper extremities (including fingers,
wrists, hands, arms, and shoulders). By two extremities we mean both
lower extremities, or both upper extremities, or one upper extremity
and one lower extremity. All listings in this body system, except
for 11.02 (Epilepsy), 11.10 (Amyotrophic lateral sclerosis), and
11.20 (Coma and persistent vegetative state), include criteria for
disorganization of motor function that results in an extreme
limitation in your ability to:
[[Page 43053]]
a. Stand up from a seated position; or
b. Balance while standing or walking; or
c. Use the upper extremities (including fingers, wrists, hands,
arms, and shoulders).
2. Extreme limitation means the inability to stand up from a
seated position, maintain balance in a standing position and while
walking, or use your upper extremities to independently initiate,
sustain, and complete work-related activities. The assessment of
motor function depends on the degree of interference with standing
up; balancing while standing or walking; or using the upper
extremities (including fingers, hands, arms, and shoulders).
a. Inability to stand up from a seated position means that once
seated you are unable to stand and maintain an upright position
without the assistance of another person or the use of an assistive
device, such as a walker, two crutches, or two canes.
b. Inability to maintain balance in a standing position means
that you are unable to maintain an upright position while standing
or walking without the assistance of another person or an assistive
device, such as a walker, two crutches, or two canes.
c. Inability to use your upper extremities means that you have a
loss of function of both upper extremities (including fingers,
wrists, hands, arms, and shoulders) that very seriously limits your
ability to independently initiate, sustain, and complete work-
related activities involving fine and gross motor movements.
Inability to perform fine and gross motor movements could include
not being able to pinch, manipulate, and use your fingers; or not
being able to use your hands, arms, and shoulders to perform gross
motor movements, such as handling, gripping, grasping, holding,
turning, and reaching; or not being able to engage in exertional
movements such a lifting, carrying, pushing, and pulling.
E. How do we evaluate communication impairments under these
listings? We must have a description of a recent comprehensive
evaluation including all areas of communication, performed by an
acceptable medical source, to document a communication impairment
associated with a neurological disorder. A communication impairment
may occur when a medically determinable neurological impairment
results in dysfunction in the parts of the brain responsible for
speech and language. We evaluate communication impairments
associated with neurological disorders under 11.04A, 11.07C, or
11.11B. We evaluate communication impairments due to non-
neurological disorders under 2.09.
1. Under 11.04A, we need evidence documenting that your central
nervous system vascular accident or insult (CVA) and sensory or
motor aphasia have resulted in ineffective speech or communication.
Ineffective speech or communication means there is an extreme
limitation in your ability to understand or convey your message in
simple spoken language resulting in your inability to demonstrate
basic communication skills, such as following one-step commands or
telling someone about your basic personal needs without assistance.
2. Under 11.07C, we need evidence documenting that your cerebral
palsy has resulted in significant interference in your ability to
speak, hear, or see. We will find you have ``significant
interference'' in your ability to speak, hear, or see if your signs,
such as aphasia, strabismus, or sensorineural hearing loss,
seriously limit your ability to communicate on a sustained basis.
3. Under 11.11B, we need evidence documenting that your post-
polio syndrome has resulted in the inability to produce intelligible
speech.
F. What do we mean by bulbar and neuromuscular dysfunction? The
bulbar region of the brain is responsible for controlling the bulbar
muscles in the throat, tongue, jaw, and face. Bulbar and
neuromuscular dysfunction refers to weakness in these muscles,
resulting in breathing, swallowing, and speaking impairments.
Listings 11.11 (Post-polio syndrome), 11.12 (Myasthenia gravis), and
11.22 (Motor neuron disorders other than ALS) include criteria for
evaluating bulbar and neuromuscular dysfunction. If your
neurological disorder has resulted in a breathing disorder, we may
evaluate that condition under the respiratory system, 3.00.
G. How do we evaluate limitations in physical and mental
functioning under these listings?
1. Neurological disorders may manifest in a combination of
limitations in physical and mental functioning. We consider all
relevant information in your case record to determine the effects of
your neurological disorder on your physical and mental functioning.
To satisfy the requirement described under 11.00G, your neurological
disorder must result in a marked limitation in physical functioning
and a marked limitation in at least one of four areas of mental
functioning: Understanding, remembering, or applying information;
interacting with others; concentrating, persisting, or maintaining
pace; or adapting or managing oneself. If your neurological disorder
results in an extreme limitation in at least one of the four areas
of mental functioning, or results in marked limitation in at least
two of the four areas of mental functioning, but you do not have at
least a marked limitation in your physical functioning, we will
consider whether your condition meets or medically equals one of the
mental disorders body system listings, 12.00.
2. Marked Limitation. To satisfy the requirements of the
functional criteria, your neurological disorder must result in a
marked limitation in physical functioning and a marked limitation in
one of the four areas of mental functioning (see 11.00G3). Although
we do not require the use of such a scale, ``marked'' would be the
fourth point on a five-point scale consisting of no limitation, mild
limitation, moderate limitation, marked limitation, and extreme
limitation. We consider the nature and overall degree of
interference with your functioning. The term ``marked'' does not
require that you must be confined to bed, hospitalized, or in a
nursing home.
a. Marked limitation and physical functioning. For this
criterion, a marked limitation means that, due to the signs and
symptoms of your neurological disorder, you are seriously limited in
the ability to independently initiate, sustain, and complete work-
related physical activities (see 11.00G3). You may have a marked
limitation in your physical functioning when your neurological
disease process causes persistent or intermittent symptoms that
affect your abilities to independently initiate, sustain, and
complete work-related activities, such as standing, balancing,
walking, using both upper extremities for fine and gross movements,
or results in limitations in using one upper and one lower
extremity. The persistent and intermittent symptoms must result in a
serious limitation in your ability to do a task or activity on a
sustained basis. We do not define ``marked'' by a specific number of
different physical activities or tasks that demonstrate your
ability, but by the overall effects of your neurological symptoms on
your ability to perform such physical activities on a consistent and
sustained basis. You need not be totally precluded from performing a
function or activity to have a marked limitation, as long as the
degree of limitation seriously limits your ability to independently
initiate, sustain, and complete work-related physical activities.
b. Marked limitation and mental functioning. For this criterion,
a marked limitation means that, due to the signs and symptoms of
your neurological disorder, you are seriously limited in the ability
to function independently, appropriately, effectively, and on a
sustained basis in work settings (see 11.03G3). We do not define
``marked'' by a specific number of mental activities, such as: The
number of activities that demonstrate your ability to understand,
remember, and apply information; the number of tasks that
demonstrate your ability to interact with others; a specific number
of tasks that demonstrate you are able to concentrate, persist or
maintain pace; or a specific number of tasks that demonstrate you
are able to manage yourself. You may have a marked limitation in
your mental functioning when several activities or functions are
impaired, or even when only one is impaired. You need not be totally
precluded from performing an activity to have a marked limitation,
as long as the degree of limitation seriously limits your ability to
function independently, appropriately, and effectively on a
sustained basis, and complete work-related mental activities.
3. Areas of physical and mental functioning.
a. Physical functioning. Examples of this criterion include
specific motor abilities, such as independently initiating,
sustaining, and completing the following activities: Standing up
from a seated position, balancing while standing or walking, or
using both your upper extremities for fine and gross movements (see
11.00D). Physical functioning may also include functions of the body
that support motor abilities, such as the abilities to see, breathe,
and swallow (see 11.00E and 11.00F). Examples of when your
limitation in seeing, breathing, or swallowing may, on its own, rise
to a ``marked'' limitation include: Prolonged and uncorrectable
double vision causing difficulty with balance; prolonged difficulty
breathing requiring the use of a prescribed
[[Page 43054]]
assistive breathing device, such as a portable continuous positive
airway pressure machine; or repeated instances, occurring at least
weekly, of aspiration without causing aspiration pneumonia.
Alternatively, you may have a combination of limitations due to your
neurological disorder that together rise to a ``marked'' limitation
in physical functioning. We may also find that you have a ``marked''
limitation in this area if, for example, your symptoms, such as pain
or fatigue (see 11.00T), as documented in your medical record, and
caused by your neurological disorder or its treatment, seriously
limit your ability to independently initiate, sustain, and complete
these work-related motor functions, or the other physical functions
or physiological processes that support those motor functions. We
may also find you seriously limited in an area if, while you retain
some ability to perform the function, you are unable to do so
consistently and on a sustained basis. The limitation in your
physical functioning must last or be expected to last at least 12
months. These examples illustrate the nature of physical
functioning. We do not require documentation of all of the examples.
b. Mental functioning.
(i) Understanding, remembering, or applying information. This
area of mental functioning refers to the abilities to learn, recall,
and use information to perform work activities. Examples include:
Understanding and learning terms, instructions, procedures;
following one- or two-step oral instructions to carry out a task;
describing work activity to someone else; asking and answering
questions and providing explanations; recognizing a mistake and
correcting it; identifying and solving problems; sequencing multi-
step activities; and using reason and judgment to make work-related
decisions. These examples illustrate the nature of this area of
mental functioning. We do not require documentation of all of the
examples.
(ii) Interacting with others. This area of mental functioning
refers to the abilities to relate to and work with supervisors, co-
workers, and the public. Examples include: Cooperating with others;
asking for help when needed; handling conflicts with others; stating
your own point of view; initiating or sustaining conversation;
understanding and responding to social cues (physical, verbal,
emotional); responding to requests, suggestions, criticism,
correction, and challenges; and keeping social interactions free of
excessive irritability, sensitivity, argumentativeness, or
suspiciousness. These examples illustrate the nature of this area of
mental functioning. We do not require documentation of all of the
examples.
(iii) Concentrating, persisting, or maintaining pace. This area
of mental functioning refers to the abilities to focus attention on
work activities and to stay on-task at a sustained rate. Examples
include: Initiating and performing a task that you understand and
know how to do; working at an appropriate and consistent pace;
completing tasks in a timely manner; ignoring or avoiding
distractions while working; changing activities or work settings
without being disruptive; working close to or with others without
interrupting or distracting them; sustaining an ordinary routine and
regular attendance at work; and working a full day without needing
more than the allotted number or length of rest periods during the
day. These examples illustrate the nature of this area of mental
functioning. We do not require documentation of all of the examples.
(iv) Adapting or managing oneself. This area of mental
functioning refers to the abilities to regulate emotions, control
behavior, and maintain well-being in a work setting. Examples
include: Responding to demands; adapting to changes; managing your
psychologically based symptoms; distinguishing between acceptable
and unacceptable work performance; setting realistic goals; making
plans for yourself independently of others; maintaining personal
hygiene and attire appropriate to a work setting; and being aware of
normal hazards and taking appropriate precautions. These examples
illustrate the nature of this area of mental functioning. We do not
require documentation of all of the examples.
4. Signs and symptoms of your disorder and the effects of
treatment.
a. We will consider your signs and symptoms and how they affect
your ability to function in the work place. When we evaluate your
functioning, we will consider whether your signs and symptoms are
persistent or intermittent, how frequently they occur and how long
they last, their intensity, and whether you have periods of
exacerbation and remission.
b. We will consider the effectiveness of treatment in improving
the signs, symptoms, and laboratory findings related to your
neurological disorder, as well as any aspects of treatment that may
interfere with your ability to function. We will consider, for
example: The effects of medications you take (including side
effects); the time-limited efficacy of some medications; the
intrusiveness, complexity, and duration of your treatment (for
example, the dosing schedule or need for injections); the effects of
treatment, including medications, therapy, and surgery, on your
functioning; the variability of your response to treatment; and any
drug interactions.
H. What is epilepsy, and how do we evaluate it under 11.02?
1. Epilepsy is a pattern of recurrent and unprovoked seizures
that are manifestations of abnormal electrical activity in the
brain. There are various types of generalized and ``focal'' or
partial seizures. However, psychogenic nonepileptic seizures and
pseudoseizures are not epileptic seizures for the purpose of 11.02.
We evaluate psychogenic seizures and pseudoseizures under the mental
disorders body system, 12.00. In adults, the most common potentially
disabling seizure types are generalized tonic-clonic seizures and
dyscognitive seizures (formerly complex partial seizures).
a. Generalized tonic-clonic seizures are characterized by loss
of consciousness accompanied by a tonic phase (sudden muscle tensing
causing the person to lose postural control) followed by a clonic
phase (rapid cycles of muscle contraction and relaxation, also
called convulsions). Tongue biting and incontinence may occur during
generalized tonic-clonic seizures, and injuries may result from
falling.
b. Dyscognitive seizures are characterized by alteration of
consciousness without convulsions or loss of muscle control. During
the seizure, blank staring, change of facial expression, and
automatisms (such as lip smacking, chewing or swallowing, or
repetitive simple actions, such as gestures or verbal utterances)
may occur. During its course, a dyscognitive seizure may progress
into a generalized tonic-clonic seizure (see 11.00H1a).
2. Description of seizure. We require at least one detailed
description of your seizures from someone, preferably a medical
professional, who has observed at least one of your typical
seizures. If you experience more than one type of seizure, we
require a description of each type.
3. Serum drug levels. We do not require serum drug levels;
therefore, we will not purchase them. However, if serum drug levels
are available in your medical records, we will evaluate them in the
context of the other evidence in your case record.
4. Counting seizures. The period specified in 11.02A, B, or C
cannot begin earlier than one month after you began prescribed
treatment. The required number of seizures must occur within the
period we are considering in connection with your application or
continuing disability review. When we evaluate the frequency of your
seizures, we also consider your adherence to prescribed treatment
(see 11.00C). When we determine the number of seizures you have had
in the specified period, we will:
a. Count multiple seizures occurring in a 24-hour period as one
seizure.
b. Count status epilepticus (a continuous series of seizures
without return to consciousness between seizures) as one seizure.
c. Count a dyscognitive seizure that progresses into a
generalized tonic-clonic seizure as one generalized tonic-clonic
seizure.
d. We do not count seizures that occur during a period when you
are not adhering to prescribed treatment without good reason. When
we determine that you had good reason for not adhering to prescribed
treatment, we will consider your physical, mental, educational, and
communicative limitations (including any language barriers). We will
consider you to have good reason for not following prescribed
treatment if, for example, the treatment is very risky for you due
to its consequences or unusual nature, or if you are unable to
afford prescribed treatment that you are willing to accept, but for
which no free community resources are available. We will follow
guidelines found in our policy, such as Sec. Sec. 404.1530(c) and
416.930(c) of this chapter, when we determine whether you have a
good reason for not adhering to prescribed treatment.
e. We do not count psychogenic nonepileptic seizures or
pseudoseizures under 11.02. We evaluate these seizures under the
mental disorders body system, 12.00.
5. Electroencephalography (EEG) testing. We do not require EEG
test results; therefore,
[[Page 43055]]
we will not purchase them. However, if EEG test results are
available in your medical records, we will evaluate them in the
context of the other evidence in your case record.
I. What is vascular insult to the brain, and how do we evaluate
it under 11.04?
1. Vascular insult to the brain (cerebrum, cerebellum, or
brainstem), commonly referred to as stroke or cerebrovascular
accident (CVA), is brain cell death caused by an interruption of
blood flow within or leading to the brain, or by a hemorrhage from a
ruptured blood vessel or aneurysm in the brain. If you have a vision
impairment resulting from your vascular insult, we may evaluate that
impairment under the special senses body system, 2.00.
2. We need evidence of sensory or motor aphasia that results in
ineffective speech or communication under 11.04A (see 11.00E). We
may evaluate your communication impairment under listing 11.04C if
you have marked limitation in physical functioning and marked
limitation in one of the four areas of mental functioning.
3. We generally need evidence from at least 3 months after the
vascular insult to evaluate whether you have disorganization of
motor functioning under 11.04B, or the impact that your disorder has
on your physical and mental functioning under 11.04C. In some cases,
evidence of your vascular insult is sufficient to allow your claim
within 3 months post-vascular insult. If we are unable to allow your
claim within 3 months after your vascular insult, we will defer
adjudication of the claim until we obtain evidence of your
neurological disorder at least 3 months post-vascular insult.
J. What are benign brain tumors, and how do we evaluate them
under 11.05? Benign brain tumors are noncancerous (nonmalignant)
abnormal growths of tissue in or on the brain that invade healthy
brain tissue or apply pressure on the brain or cranial nerves. We
evaluate their effects on your functioning as discussed in 11.00D
and 11.00G. We evaluate malignant brain tumors under the cancer body
system in 13.00. If you have a vision impairment resulting from your
benign brain tumor, we may evaluate that impairment under the
special senses body system, 2.00.
K. What is Parkinsonian syndrome, and how do we evaluate it
under 11.06? Parkinsonian syndrome is a term that describes a group
of chronic, progressive movement disorders resulting from loss or
decline in the function of dopamine-producing brain cells. Dopamine
is a neurotransmitter that regulates muscle movement throughout the
body. When we evaluate your Parkinsonian syndrome, we will consider
your adherence to prescribed treatment (see 11.00C).
L. What is cerebral palsy, and how do we evaluate it under
11.07?
1. Cerebral palsy (CP) is a term that describes a group of
static, nonprogressive disorders caused by abnormalities within the
brain that disrupt the brain's ability to control movement, muscle
coordination, and posture. The resulting motor deficits manifest
very early in a person's development, with delayed or abnormal
progress in attaining developmental milestones. Deficits may become
more obvious as the person grows and matures over time.
2. We evaluate your signs and symptoms, such as ataxia,
spasticity, flaccidity, athetosis, chorea, and difficulty with
precise movements when we determine your ability to stand up,
balance, walk, or perform fine and gross motor movements. We will
also evaluate your signs, such as dysarthria and apraxia of speech,
and receptive and expressive language problems when we determine
your ability to communicate.
3. We will consider your other impairments or signs and symptoms
that develop secondary to the disorder, such as post-impairment
syndrome (a combination of pain, fatigue, and weakness due to muscle
abnormalities); overuse syndromes (repetitive motion injuries);
arthritis; abnormalities of proprioception (perception of the
movements and position of the body); abnormalities of stereognosis
(perception and identification of objects by touch); learning
problems; anxiety; and depression.
M. What are spinal cord disorders, and how do we evaluate them
under 11.08?
1. Spinal cord disorders may be congenital or caused by injury
to the spinal cord. Motor signs and symptoms of spinal cord
disorders include paralysis, flaccidity, spasticity, and weakness.
2. Spinal cord disorders with complete loss of function (11.08A)
addresses spinal cord disorders that result in a complete lack of
motor, sensory, and autonomic function of the affected part(s) of
the body.
3. Spinal cord disorders with disorganization of motor function
(11.08B) addresses spinal cord disorders that result in less than a
complete loss of function of the affected part(s) of the body,
reducing, but not eliminating, motor, sensory, and autonomic
function.
4. When we evaluate your spinal cord disorder, we generally need
evidence from at least 3 months after your symptoms began in order
to evaluate your disorganization of motor function. In some cases,
evidence of your spinal cord disorder may be sufficient to allow
your claim within 3 months after the spinal cord disorder. If the
medical evidence demonstrates total cord transection causing a loss
of motor and sensory functions below the level of injury, we will
not wait 3 months but will make the allowance decision immediately.
N. What is multiple sclerosis, and how do we evaluate it under
11.09?
1. Multiple sclerosis (MS) is a chronic, inflammatory,
degenerative disorder that damages the myelin sheath surrounding the
nerve fibers in the brain and spinal cord. The damage disrupts the
normal transmission of nerve impulses within the brain and between
the brain and other parts of the body, causing impairment in muscle
coordination, strength, balance, sensation, and vision. There are
several forms of MS, ranging from mildly to highly aggressive.
Milder forms generally involve acute attacks (exacerbations) with
partial or complete recovery from signs and symptoms (remissions).
Aggressive forms generally exhibit a steady progression of signs and
symptoms with few or no remissions. The effects of all forms vary
from person to person.
2. We evaluate your signs and symptoms, such as flaccidity,
spasticity, spasms, incoordination, imbalance, tremor, physical
fatigue, muscle weakness, dizziness, tingling, and numbness when we
determine your ability to stand up, balance, walk, or perform fine
and gross motor movements. When determining whether you have
limitations of physical and mental functioning, we will consider
your other impairments or signs and symptoms that develop secondary
to the disorder, such as fatigue; visual loss; trouble sleeping;
impaired attention, concentration, memory, or judgment; mood swings;
and depression. If you have a vision impairment resulting from your
MS, we may evaluate that impairment under the special senses body
system, 2.00.
O. What is amyotrophic lateral sclerosis, and how do we evaluate
it under 11.10? Amyotrophic lateral sclerosis (ALS) is a type of
motor neuron disorder that rapidly and progressively attacks the
nerve cells responsible for controlling voluntary muscles. We
establish ALS under 11.10 when you have a documented diagnosis of
ALS. We require documentation based on generally accepted methods
consistent with the prevailing state of medical knowledge and
clinical practice. We require laboratory testing to establish the
diagnosis when the clinical findings of upper and lower motor neuron
disease are not present in three or more regions.
Electrophysiological studies, such as nerve conduction velocity
studies and electromyography (EMG), may support your diagnosis of
ALS; however, we will not purchase these studies.
P. What are neurodegenerative disorders of the central nervous
system, such as Huntington's disease, Friedreich's ataxia, and
spinocerebellar degeneration, and how do we evaluate them under
11.17? Neurodegenerative disorders of the central nervous system are
disorders characterized by progressive and irreversible degeneration
of neurons or their supporting cells. Over time, these disorders
impair many of the body's motor, cognitive, and other mental
functions. We consider neurodegenerative disorders of the central
nervous system under 11.17 that we do not evaluate elsewhere in
section 11.00, such as Huntington's disease (HD), Friedreich's
ataxia, spinocerebellar degeneration, Creutzfeldt-Jakob disease
(CJD), progressive supranuclear palsy (PSP), early-onset Alzheimer's
disease, and frontotemporal dementia (Pick's disease). When these
disorders result in solely cognitive and other mental function
effects, we will evaluate the disorder under the mental disorder
listings.
Q. What is traumatic brain injury, and how do we evaluate it
under 11.18?
1. Traumatic brain injury (TBI) is damage to the brain resulting
from skull fracture, collision with an external force leading to a
closed head injury, or penetration by an object that enters the
skull and makes contact with brain tissue. We evaluate TBI that
results in coma or persistent vegetative state (PVS) under 11.20.
2. We generally need evidence from at least 3 months after the
TBI to evaluate whether you have disorganization of motor function
under 11.18A or the impact that your
[[Page 43056]]
disorder has on your physical and mental functioning under 11.18B.
In some cases, evidence of your TBI is sufficient to determine
disability within 3 months post-TBI. If we are unable to allow your
claim within 3 months post-TBI, we will defer adjudication of the
claim until we obtain evidence of your neurological disorder at
least 3 months post-TBI. If a finding of disability still is not
possible at that time, we will again defer adjudication of the claim
until we obtain evidence at least 6 months after your TBI.
R. What are coma and persistent vegetative state, and how do we
evaluate them under 11.20? Coma is a state of unconsciousness in
which a person does not exhibit a sleep/wake cycle, and is unable to
perceive or respond to external stimuli. People who do not fully
emerge from coma may progress into a persistent vegetative state
(PVS). PVS is a condition of partial arousal in which a person may
have a low level of consciousness but is still unable to react to
external stimuli. In contrast to coma, a person in a PVS retains
sleep/wake cycles and may exhibit some key lower brain functions,
such as spontaneous movement, opening and moving eyes, and
grimacing. Coma or PVS may result from TBI, a nontraumatic insult to
the brain (such as a vascular insult, infection, or brain tumor), or
a neurodegenerative or metabolic disorder. Medically induced comas
are not considered under 11.20 and should be considered under the
section pertaining to the underlying reason the coma was medically
induced and not under this section.
S. What are motor neuron disorders, other than ALS, and how do
we evaluate them under 11.22? Motor neuron disorders such as
progressive bulbar palsy, primary lateral sclerosis (PLS), and
spinal muscular atrophy (SMA) are progressive neurological disorders
that destroy the cells that control voluntary muscle activity, such
as walking, breathing, swallowing, and speaking. We evaluate the
effects of these disorders on motor functioning, bulbar and
neuromuscular functioning, oral communication, or limitations in
physical and mental functioning.
T. How do we consider symptoms of fatigue in these listings?
Fatigue is one of the most common and limiting symptoms of some
neurological disorders, such as multiple sclerosis, post-polio
syndrome, and myasthenia gravis. These disorders may result in
physical fatigue (lack of muscle strength) or mental fatigue
(decreased awareness or attention). When we evaluate your fatigue,
we will consider the intensity, persistence, and effects of fatigue
on your functioning. This may include information such as the
clinical and laboratory data and other objective evidence concerning
your neurological deficit, a description of fatigue considered
characteristic of your disorder, and information about your
functioning. We consider the effects of physical fatigue on your
ability to stand up, balance, walk, or perform fine and gross motor
movements using the criteria described in 11.00D. We consider the
effects of physical and mental fatigue when we evaluate your
physical and mental functioning described in 11.00G.
U. How do we evaluate your neurological disorder when it does
not meet one of these listings?
1. If your neurological disorder does not meet the criteria of
any of these listings, we must also consider whether your
impairment(s) meets the criteria of a listing in another body
system. If you have a severe medically determinable impairment(s)
that does not meet a listing, we will determine whether your
impairment(s) medically equals a listing. See Sec. Sec. 404.1526
and 416.926 of this chapter.
2. If your impairment(s) does not meet or medically equal the
criteria of a listing, you may or may not have the residual
functional capacity to perform your past relevant work or adjust to
other work that exists in significant numbers in the national
economy, which we determine at the fourth and, if necessary, the
fifth steps of the sequential evaluation process in Sec. Sec.
404.1520 and 416.920 of this chapter.
3. We use the rules in Sec. Sec. 404.1594 and 416.994 of this
chapter, as appropriate, when we decide whether you continue to be
disabled.
11.01 Category of Impairments, Neurological Disorders
11.02 Epilepsy, documented by a detailed description of a
typical seizure and characterized by A, B, C, or D:
A. Generalized tonic-clonic seizures (see 11.00H1a), occurring
at least once a month for at least 3 consecutive months (see
11.00H4) despite adherence to prescribed treatment (see 11.00C); or
B. Dyscognitive seizures (see 11.00H1b), occurring at least once
a week for at least 3 consecutive months (see 11.00H4) despite
adherence to prescribed treatment (see 11.00C); or
C. Generalized tonic-clonic seizures (see 11.00H1a), occurring
at least once every 2 months for at least 4 consecutive months (see
11.00H4) despite adherence to prescribed treatment (see 11.00C); and
a marked limitation in one of the following:
1. Physical functioning (see 11.00G3a); or
2. Understanding, remembering, or applying information (see
11.00G3b(i)); or
3. Interacting with others (see 11.00G3b(ii)); or
4. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
5. Adapting or managing oneself (see 11.00G3b(iv)); or
D. Dyscognitive seizures (see 11.00H1b), occurring at least once
every 2 weeks for at least 3 consecutive months (see 11.00H4)
despite adherence to prescribed treatment (see 11.00C); and a marked
limitation in one of the following:
1. Physical functioning (see 11.00G3a); or
2. Understanding, remembering, or applying information (see
11.00G3b(i)); or
3. Interacting with others (see 11.00G3b(ii)); or
4. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
5. Adapting or managing oneself (see 11.00G3b(iv)).
11.03 [Reserved]
11.04 Vascular insult to the brain, characterized by A, B, or C:
A. Sensory or motor aphasia resulting in ineffective speech or
communication (see 11.00E1) persisting for at least 3 consecutive
months after the insult; or
B. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities, persisting for at least 3
consecutive months after the insult; or
C. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a) and in one of the following areas of mental functioning,
both persisting for at least 3 consecutive months after the insult:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.05 Benign brain tumors, characterized by A or B:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.06 Parkinsonian syndrome, characterized by A or B despite
adherence to prescribed treatment for at least 3 consecutive months
(see 11.00C):
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.07 Cerebral palsy, characterized by A, B, or C:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
[[Page 43057]]
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)); or
C. Significant interference in communication due to speech,
hearing, or visual deficit (see 11.00E2).
11.08 Spinal cord disorders, characterized by A, B, or C:
A. Complete loss of function, as described in 11.00M2,
persisting for 3 consecutive months after the disorder (see
11.00M4); or
B. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities persisting for 3
consecutive months after the disorder (see 11.00M4); or
C. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a) and in one of the following areas of mental functioning,
both persisting for 3 consecutive months after the disorder (see
11.00M4):
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.09 Multiple sclerosis, characterized by A or B:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.10 Amyotrophic lateral sclerosis (ALS) established by
clinical and laboratory findings (see 11.00O).
11.11 Post-polio syndrome, characterized by A, B, C, or D:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Unintelligible speech (see 11.00E3); or
C. Bulbar and neuromuscular dysfunction (see 11.00F), resulting
in:
1. Acute respiratory failure requiring mechanical ventilation;
or
2. Need for supplemental enteral nutrition via a gastrostomy or
parenteral nutrition via a central venous catheter; or
D. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.12 Myasthenia gravis, characterized by A, B, or C despite
adherence to prescribed treatment for at least 3 months (see
11.00C):
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Bulbar and neuromuscular dysfunction (see 11.00F), resulting
in:
1. One myasthenic crisis requiring mechanical ventilation; or
2. Need for supplemental enteral nutrition via a gastrostomy or
parenteral nutrition via a central venous catheter; or
C. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.13 Muscular dystrophy, characterized by A or B:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.14 Peripheral neuropathy, characterized by A or B:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.15 [Reserved]
11.16 [Reserved]
11.17 Neurodegenerative disorders of the central nervous system,
such as Huntington's disease, Friedreich's ataxia, and
spinocerebellar degeneration, characterized by A or B:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.18 Traumatic brain injury, characterized by A or B:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities, persisting for at least 3
consecutive months after the injury; or
B. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following areas of mental functioning,
persisting for at least 3 consecutive months after the injury:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
11.19 [Reserved]
11.20 Coma or persistent vegetative state, persisting for at
least 1 month.
11.21 [Reserved]
11.22 Motor neuron disorders other than ALS, characterized by A,
B, or C:
A. Disorganization of motor function in two extremities (see
11.00D1), resulting in an extreme limitation (see 11.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Bulbar and neuromuscular dysfunction (see 11.00F), resulting
in:
1. Acute respiratory failure requiring invasive mechanical
ventilation; or
2. Need for supplemental enteral nutrition via a gastrostomy or
parenteral nutrition via a central venous catheter; or
C. Marked limitation (see 11.00G2) in physical functioning (see
11.00G3a), and in one of the following:
1. Understanding, remembering, or applying information (see
11.00G3b(i)); or
2. Interacting with others (see 11.00G3b(ii)); or
3. Concentrating, persisting, or maintaining pace (see
11.00G3b(iii)); or
4. Adapting or managing oneself (see 11.00G3b(iv)).
* * * * *
12.00 MENTAL DISORDERS
* * * * *
D. * * *
[[Page 43058]]
10. Traumatic brain injury (TBI). In cases involving TBI, follow
the documentation and evaluation guidelines in 11.00Q.
* * * * *
12.01 Category of Impairments, Mental Disorders
* * * * *
12.09 * * *
E. Peripheral neuropathy. Evaluate under 11.14.
* * * * *
I. Seizures. Evaluate under 11.02.
* * * * *
Part B
* * * * *
111.00 Neurological Disorders
* * * * *
101.00 MUSCULOSKELETAL SYSTEM
* * * * *
B. Loss of function.
1. General. * * * We evaluate impairments with neurological
causes under 111.00, as appropriate.
* * * * *
K. Disorders of the spine, listed in 101.04, result in
limitations because of distortion of the bony and ligamentous
architecture of the spine and associated impingement on nerve roots
(including the cauda equina) or spinal cord. Such impingement on
nerve tissue may result from a herniated nucleus pulposus, spinal
stenosis, arachnoiditis, or other miscellaneous conditions.
* * * * *
111.00 NEUROLOGICAL DISORDERS
A. Which neurological disorders do we evaluate under these
listings? We evaluate epilepsy, coma or persistent vegetative state
(PVS), and neurological disorders that cause disorganization of
motor function, bulbar and neuromuscular dysfunction, or
communication impairment. Under this body system, we evaluate the
limitations resulting from the impact of the neurological disease
process itself. If you have a neurological disorder(s) that affects
your physical and mental functioning, we will evaluate your
impairments under the rules we use to determine functional
equivalence. If your neurological disorder results in only mental
impairment or if you have a co-occurring mental condition that is
not caused by your neurological disorder (for example, Autism
spectrum disorder), we will evaluate your mental impairment under
the mental disorders body system, 112.00.
B. What evidence do we need to document your neurological
disorder?
1. We need both medical and non-medical evidence (signs,
symptoms, and laboratory findings) to assess the effects of your
neurological disorder. Medical evidence should include your medical
history, examination findings, relevant laboratory tests, and the
results of imaging. Imaging refers to medical imaging techniques,
such as x-ray, computerized tomography (CT), magnetic resonance
imaging (MRI), and electroencephalography (EEG). The imaging must be
consistent with the prevailing state of medical knowledge and
clinical practice as the proper technique to support the evaluation
of the disorder. In addition, the medical evidence may include
descriptions of any prescribed treatment and your response to it. We
consider non-medical evidence such as statements you or others make
about your impairments, your restrictions, your daily activities,
or, if you are an adolescent, your efforts to work.
2. We will make every reasonable effort to obtain the results of
your laboratory and imaging evidence. When the results of any of
these tests are part of the existing evidence in your case record,
we will evaluate the test results and all other relevant evidence.
We will not purchase imaging, or other diagnostic tests or
laboratory tests that are complex, may involve significant risk, or
that are invasive. We will not routinely purchase tests that are
expensive or not readily available.
C. How do we consider adherence to prescribed treatment in
neurological disorders? In 111.02 (Epilepsy) and 111.12 (Myasthenia
gravis), we require that limitations from these neurological
disorders exist despite adherence to prescribed treatment. ``Despite
adherence to prescribed treatment'' means that you have taken
medication(s) or followed other treatment procedures for your
neurological disorder(s) as prescribed by a physician for three
consecutive months but your impairment continues to meet the other
listing requirements despite this treatment. You may receive your
treatment at a health care facility that you visit regularly, even
if you do not see the same physician on each visit.
D. What do we mean by disorganization of motor function?
1. Disorganization of motor function means interference, due to
your neurological disorder, with movement of two extremities; i.e.,
the lower extremities, or upper extremities (including fingers,
wrists, hands, arms, and shoulders). By two extremities we mean both
lower extremities, or both upper extremities, or one upper extremity
and one lower extremity. All listings in this body system, except
for 111.02 (Epilepsy) and 111.20 (Coma and persistent vegetative
state), include criteria for disorganization of motor function that
results in an extreme limitation in your ability to:
a. Stand up from a seated position; or
b. Balance while standing or walking; or
c. Use the upper extremities (e.g., fingers, wrists, hands,
arms, and shoulders).
2. Extreme limitation means the inability to stand up from a
seated position, maintain balance in a standing position and while
walking, or use your upper extremities to independently initiate,
sustain, and complete age-appropriate activities. The assessment of
motor function depends on the degree of interference with standing
up; balancing while standing or walking; or using the upper
extremities (including fingers, hands, arms, and shoulders).
a. Inability to stand up from a seated position means that once
seated you are unable to stand and maintain an upright position
without the assistance of another person or the use of an assistive
device, such as a walker, two crutches, or two canes.
b. Inability to maintain balance in a standing position means
that you are unable to maintain an upright position while standing
or walking without the assistance of another person or an assistive
device, such as a walker, two crutches, or two canes.
c. Inability to use your upper extremities means that you have a
loss of function of both upper extremities (e.g., fingers, wrists,
hands, arms, and shoulders) that very seriously limits your ability
to independently initiate, sustain, and complete age- appropriate
activities involving fine and gross motor movements. Inability to
perform fine and gross motor movements could include not being able
to pinch, manipulate, and use your fingers; or not being able to use
your hands, arms, and shoulders to perform gross motor movements,
such as handling, gripping, grasping, holding, turning, and
reaching; or not being able to engage in exertional movements such a
lifting, carrying, pushing, and pulling.
3. For children who are not yet able to balance, stand up, or
walk independently, we consider their function based on assessments
of limitations in the ability to perform comparable age-appropriate
activities with the lower and upper extremities, given normal
developmental milestones. For such children, an extreme level of
limitation means developmental milestones at less than one-half of
the child's chronological age.
E. What do we mean by bulbar and neuromuscular dysfunction? The
bulbar region of the brain is responsible for controlling the bulbar
muscles in the throat, tongue, jaw, and face. Bulbar and
neuromuscular dysfunction refers to weakness in these muscles,
resulting in breathing, swallowing, and speaking impairments.
Listings 111.12 (Myasthenia gravis) and 111.22 (Motor neuron
disorders) include criteria for evaluating bulbar and neuromuscular
dysfunction. If your neurological disorder has resulted in a
breathing disorder, we may evaluate that condition under the
respiratory system, 103.00.
F. What is epilepsy, and how do we evaluate it under 111.02?
1. Epilepsy is a pattern of recurrent and unprovoked seizures
that are manifestations of abnormal electrical activity in the
brain. There are various types of generalized and ``focal'' or
partial seizures. In children, the most common potentially disabling
seizure types are generalized tonic-clonic seizures, dyscognitive
seizures (formerly complex partial seizures), and absence seizures.
However, psychogenic nonepileptic seizures and pseudoseizures are
not epileptic seizures for the purpose of 111.02. We evaluate
psychogenic seizures and pseudoseizures under the mental disorders
body system, 112.00.
a. Generalized tonic-clonic seizures are characterized by loss
of consciousness accompanied by a tonic phase (sudden muscle tensing
causing the child to lose postural control) followed by a clonic
phase (rapid cycles of muscle contraction and relaxation, also
called convulsions). Tongue biting and incontinence may occur during
generalized tonic-clonic seizures, and injuries may result from
falling.
b. Dyscognitive seizures are characterized by alteration of
consciousness without
[[Page 43059]]
convulsions or loss of muscle control. During the seizure, blank
staring, change of facial expression, and automatisms (such as lip
smacking, chewing or swallowing, or repetitive simple actions, such
as gestures or verbal utterances) may occur. During its course, a
dyscognitive seizure may progress into a generalized tonic-clonic
seizure (see 111.00F1a).
c. Absence seizures (petit mal) are also characterized by an
alteration in consciousness, but are shorter than other generalized
seizures (e.g., tonic-clonic and dyscognitive) seizures, generally
lasting for only a few seconds rather than minutes. They may present
with blank staring, change of facial expression, lack of awareness
and responsiveness, and a sense of lost time after the seizure. An
aura never precedes absence seizures. Although absence seizures are
brief, frequent occurrence may limit functioning. This type of
seizure usually does not occur after adolescence.
d. Febrile seizures may occur in young children in association
with febrile illnesses. We will consider seizures occurring during
febrile illnesses. To meet 111.02, we require documentation of
seizures during nonfebrile periods and epilepsy must be established.
2. Description of seizure. We require at least one detailed
description of your seizures from someone, preferably a medical
professional, who has observed at least one of your typical
seizures. If you experience more than one type of seizure, we
require a description of each type.
3. Serum drug levels. We do not require serum drug levels;
therefore, we will not purchase them. However, if serum drug levels
are available in your medical records, we will evaluate them in the
context of the other evidence in your case record.
4. Counting seizures. The period specified in 111.02A or B
cannot begin earlier than one month after you began prescribed
treatment. The required number of seizures must occur within the
period we are considering in connection with your application or
continuing disability review. When we evaluate the frequency of your
seizures, we also consider your adherence to prescribed treatment
(see 111.00C). When we determine the number of seizures you have had
in the specified period, we will:
a. Count multiple seizures occurring in a 24-hour period as one
seizure.
b. Count status epilepticus (a continuous series of seizures
without return to consciousness between seizures) as one seizure.
c. Count a dyscognitive seizure that progresses into a
generalized tonic-clonic seizure as one generalized tonic-clonic
seizure.
d. We do not count seizures that occur during a period when you
are not adhering to prescribed treatment without good reason. When
we determine that you had a good reason for not adhering to
prescribed treatment, we will consider your physical, mental,
educational, and communicative limitations (including any language
barriers). We will consider you to have good reason for not
following prescribed treatment if, for example, the treatment is
very risky for you due to its consequences or unusual nature, or if
you are unable to afford prescribed treatment that you are willing
to accept, but for which no free community resources are available.
We will follow guidelines found in our policy, such as Sec.
416.930(c) of this chapter, when we determine whether you have a
good reason for not adhering to prescribed treatment.
e. We do not count psychogenic nonepileptic seizures or
pseudoseizures under 111.02.We evaluate these seizures under the
mental disorders body system, 112.00.
5. Electroencephalography (EEG) testing. We do not require EEG
test results; therefore, we will not purchase them. However, if EEG
test results are available in your medical records, we will evaluate
them in the context of the other evidence in your case record.
G. What is vascular insult to the brain, and how do we evaluate
it under 111.04?
1. Vascular insult to the brain (cerebrum, cerebellum, or
brainstem), commonly referred to as stroke or cerebrovascular
accident (CVA), is brain cell death caused by an interruption of
blood flow within or leading to the brain, or by a hemorrhage from a
ruptured blood vessel or aneurysm in the brain. If you have a vision
impairment resulting from your vascular insult, we may evaluate that
impairment under the special senses body system, 102.00.
2. We generally need evidence from at least 3 months after the
vascular insult to determine whether you have disorganization of
motor function under 111.04. In some cases, evidence of your
vascular insult is sufficient to allow your claim within 3 months
post-vascular insult. If we are unable to allow your claim within 3
months after your vascular insult, we will defer adjudication of the
claim until we obtain evidence of your neurological disorder at
least 3 months post-vascular insult.
H. What are benign brain tumors, and how do we evaluate them
under 111.05? Benign brain tumors are noncancerous (nonmalignant)
abnormal growths of tissue in or on the brain that invade healthy
brain tissue or apply pressure on the brain or cranial nerves. We
evaluate their effects on your functioning as discussed in 111.00D.
We evaluate malignant brain tumors under the cancer body system in
113.00. If you have a vision impairment resulting from your benign
brain tumor, we may evaluate that impairment under the special
senses body system, 102.00.
I. What is cerebral palsy, and how do we evaluate it under
111.07?
1. Cerebral palsy (CP) is a term that describes a group of
static, nonprogressive disorders caused by abnormalities within the
brain that disrupt the brain's ability to control movement, muscle
coordination, and posture. The resulting motor deficits manifest
very early in a child's development, with delayed or abnormal
progress in attaining developmental milestones; deficits may become
more obvious as the child grows and matures over time.
2. We evaluate your signs and symptoms, such as ataxia,
spasticity, flaccidity, athetosis, chorea, and difficulty with
precise movements when we determine your ability to stand up,
balance, walk, or perform fine and gross motor movements. We will
also evaluate your signs, such as dysarthria and apraxia of speech,
and receptive and expressive language problems when we determine
your ability to communicate.
3. We will consider your other impairments or signs and symptoms
that develop secondary to the disorder, such as post-impairment
syndrome (a combination of pain, fatigue, and weakness due to muscle
abnormalities); overuse syndromes (repetitive motion injuries);
arthritis; abnormalities of proprioception (perception of the
movements and position of the body); abnormalities of stereognosis
(perception and identification of objects by touch); learning
problems; anxiety; and depression.
J. What are spinal cord disorders, and how do we evaluate them
under 111.08?
1. Spinal cord disorders may be congenital or caused by injury
to the spinal cord. Motor signs and symptoms of spinal cord
disorders include paralysis, flaccidity, spasticity, and weakness.
2. Spinal cord disorders with complete loss of function
(111.08A) addresses spinal cord disorders that result in complete
lack of motor, sensory, and autonomic function of the affected
part(s) of the body.
3. Spinal cord disorders with disorganization of motor function
(111.08B) addresses spinal cord disorders that result in less than
complete loss of function of the affected part(s) of the body,
reducing, but not eliminating, motor, sensory, and autonomic
function.
4. When we evaluate your spinal cord disorder, we generally need
evidence from at least 3 months after your symptoms began in order
to evaluate your disorganization of motor function. In some cases,
evidence of your spinal cord disorder may be sufficient to allow
your claim within 3 months after the spinal cord disorder. If the
medical evidence demonstrates total cord transection causing a loss
of motor and sensory functions below the level of injury, we will
not wait 3 months but will make the allowance decision immediately.
K. What are communication impairments associated with
neurological disorders, and how do we evaluate them under 111.09?
1. Communication impairments result from medically determinable
neurological disorders that cause dysfunction in the parts of the
brain responsible for speech and language. Under 111.09, we must
have recent comprehensive evaluation including all areas of
affective and effective communication, performed by a qualified
professional, to document a communication impairment associated with
a neurological disorder.
2. Under 111.09A, we need documentation from a qualified
professional that your neurological disorder has resulted in a
speech deficit that significantly affects your ability to
communicate. Significantly affects means that you demonstrate a
serious limitation in communicating, and a person who is unfamiliar
with you cannot easily understand or interpret your speech.
3. Under 111.09B, we need documentation from a qualified
professional that shows that your neurological disorder has resulted
in a comprehension deficit that results in ineffective verbal
communication for your
[[Page 43060]]
age. For the purposes of 111.09B, comprehension deficit means a
deficit in receptive language. Ineffective verbal communication
means that you demonstrate serious limitation in your ability to
communicate orally on the same level as other children of the same
age and level of development.
4. Under 111.09C, we need documentation of a neurological
disorder that has resulted in hearing loss. Your hearing loss will
be evaluated under listing 102.10 or 102.11.
5. We evaluate speech deficits due to non-neurological disorders
under 2.09.
L. What are neurodegenerative disorders of the central nervous
system, such as Juvenile-onset Huntington's disease and Friedreich's
ataxia, and how do we evaluate them under 111.17? Neurodegenerative
disorders of the central nervous system are disorders characterized
by progressive and irreversible degeneration of neurons or their
supporting cells. Over time, these disorders impair many of the
body's motor or cognitive and other mental functions. We consider
neurodegenerative disorders of the central nervous system under
111.17 that we do not evaluate elsewhere in section 111.00, such as
juvenile-onset Huntington's disease (HD) and Friedreich's ataxia.
When these disorders result in solely cognitive and other mental
functional limitations, we will evaluate the disorder under the
mental disorder listings, 112.00.
M. What is traumatic brain injury, and how do we evaluate it
under 111.18?
1. Traumatic brain injury (TBI) is damage to the brain resulting
from skull fracture, collision with an external force leading to a
closed head injury, or penetration by an object that enters the
skull and makes contact with brain tissue. We evaluate a TBI that
results in coma or persistent vegetative state (PVS) under 111.20.
2. We generally need evidence from at least 3 months after the
TBI to evaluate whether you have disorganization of motor function
under 111.18. In some cases, evidence of your TBI is sufficient to
determine disability. If we are unable to allow your claim within 3
months post-TBI, we will defer adjudication of the claim until we
obtain evidence of your neurological disorder at least 3 months
post-TBI. If a finding of disability still is not possible at that
time, we will again defer adjudication of the claim until we obtain
evidence at least 6 months after your TBI.
N. What are coma and persistent vegetative state, and how do we
evaluate them under 111.20? Coma is a state of unconsciousness in
which a child does not exhibit a sleep/wake cycle, and is unable to
perceive or respond to external stimuli. Children who do not fully
emerge from coma may progress into persistent vegetative state
(PVS). PVS is a condition of partial arousal in which a child may
have a low level of consciousness but is still unable to react to
external stimuli. In contrast to coma, a child in a PVS retains
sleep/wake cycles and may exhibit some key lower brain functions,
such as spontaneous movement, opening and moving eyes, and
grimacing. Coma or PVS may result from a TBI, a nontraumatic insult
to the brain (such as a vascular insult, infection, or brain tumor),
or a neurodegenerative or metabolic disorder. Medically induced
comas should be considered under the section pertaining to the
underlying reason the coma was medically induced and not under this
section.
O. What is multiple sclerosis, and how do we evaluate it under
111.21?
1. Multiple sclerosis (MS) is a chronic, inflammatory,
degenerative disorder that damages the myelin sheath surrounding the
nerve fibers in the brain and spinal cord. The damage disrupts the
normal transmission of nerve impulses within the brain and between
the brain and other parts of the body causing impairment in muscle
coordination, strength, balance, sensation, and vision. There are
several forms of MS, ranging from slightly to highly aggressive.
Milder forms generally involve acute attacks (exacerbations) with
partial or complete recovery from signs and symptoms (remissions).
Aggressive forms generally exhibit a steady progression of signs and
symptoms with few or no remissions. The effects of all forms vary
from child to child.
2. We evaluate your signs and symptoms, such as flaccidity,
spasticity, spasms, incoordination, imbalance, tremor, physical
fatigue, muscle weakness, dizziness, tingling, and numbness when we
determine your ability to stand up, balance, walk, or perform fine
and gross motor movements, such as using your arms, hands, and
fingers. If you have a vision impairment resulting from your MS, we
may evaluate that impairment under the special senses body system,
102.00.
P. What are motor neuron disorders, and how do we evaluate them
under 111.22? Motor neuron disorders are progressive neurological
disorders that destroy the cells that control voluntary muscle
activity, such as walking, breathing, swallowing, and speaking. The
most common motor neuron disorders in children are progressive
bulbar palsy and spinal muscular dystrophy syndromes. We evaluate
the effects of these disorders on motor functioning or bulbar and
neuromuscular functioning.
Q. How do we consider symptoms of fatigue in these listings?
Fatigue is one of the most common and limiting symptoms of some
neurological disorders, such as multiple sclerosis and myasthenia
gravis. These disorders may result in physical fatigue (lack of
muscle strength) or mental fatigue (decreased awareness or
attention). When we evaluate your fatigue, we will consider the
intensity, persistence, and effects of fatigue on your functioning.
This may include information such as the clinical and laboratory
data and other objective evidence concerning your neurological
deficit, a description of fatigue considered characteristic of your
disorder, and information about your functioning. We consider the
effects of physical fatigue on your ability to stand up, balance,
walk, or perform fine and gross motor movements using the criteria
described in 111.00D.
R. How do we evaluate your neurological disorder when it does
not meet one of these listings?
1. If your neurological disorder does not meet the criteria of
any of these listings, we must also consider whether your
impairment(s) meets the criteria of a listing in another body
system. If you have a severe medically determinable impairment(s)
that does not meet a listing, we will determine whether your
impairment(s) medically equals a listing. See Sec. 416.926 of this
chapter.
2. If your impairment(s) does not meet or medically equal a
listing, we will consider whether your impairment(s) functionally
equals the listings. See Sec. 416.926a of this chapter.
3. We use the rules in Sec. 416.994a of this chapter when we
decide whether you continue to be disabled.
111.01 Category of Impairments, Neurological Disorders
111.02 Epilepsy, documented by a detailed description of a
typical seizure and characterized by A or B:
A. Generalized tonic-clonic seizures (see 111.00F1a), occurring
at least once a month for at least 3 consecutive months (see
111.00F4) despite adherence to prescribed treatment (see 111.00C);
or
B. Dyscognitive seizures (see 111.00F1b) or absence seizures
(see 111.00F1c), occurring at least once a week for at least 3
consecutive months (see 111.00F4) despite adherence to prescribed
treatment (see 111.00C).
111.03 [Reserved]
111.04 Vascular insult to the brain, characterized by
disorganization of motor function in two extremities (see 111.00D1),
resulting in an extreme limitation (see 111.00D2) in the ability to
stand up from a seated position, balance while standing or walking,
or use the upper extremities, persisting for at least 3 consecutive
months after the insult.
111.05 Benign brain tumors, characterized by disorganization of
motor function in two extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the ability to stand up from a
seated position, balance while standing or walking, or use the upper
extremities.
111.06 [Reserved]
111.07 Cerebral palsy, characterized by disorganization of motor
function in two extremities (see 111.00D1), resulting in an extreme
limitation (see 111.00D2) in the ability to stand up from a seated
position, balance while standing or walking, or use the upper
extremities.
111.08 Spinal cord disorders, characterized by A or B:
A. Complete loss of function, as described in 111.00J2,
persisting for 3 consecutive months after the disorder (see
111.00J4); or
B. Disorganization of motor function in two extremities (see
111.00D1), resulting in an extreme limitation (see 111.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities persisting for 3
consecutive months after the disorder (see 111.00J4).
111.09 Communication impairment, associated with documented
neurological disorder and one of the following:
A. Documented speech deficit that significantly affects (see
111.00K1) the clarity and content of the speech; or
B. Documented comprehension deficit resulting in ineffective
verbal communication (see 111.00K2) for age; or
[[Page 43061]]
C. Impairment of hearing as described under the criteria in
102.10 or 102.11.
111.10 [Reserved]
111.11 [Reserved]
111.12 Myasthenia gravis, characterized by A or B despite
adherence to prescribed treatment for at least 3 months (see
111.00C):
A. Disorganization of motor function in two extremities (see
111.00D1), resulting in an extreme limitation (see 111.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting
in:
1. One myasthenic crisis requiring mechanical ventilation; or
2. Need for supplemental enteral nutrition via a gastrostomy or
parenteral nutrition via a central venous catheter.
111.13 Muscular dystrophy, characterized by disorganization of
motor function in two extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the ability to stand up from a
seated position, balance while standing or walking, or use the upper
extremities.
111.14 Peripheral neuropathy, characterized by disorganization
of motor function in two extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the ability to stand up from a
seated position, balance while standing or walking, or use the upper
extremities.
111.15 [Reserved]
111.16 [Reserved]
111.17 Neurodegenerative disorders of the central nervous
system, such as Juvenile-onset Huntington's disease and Friedreich's
ataxia, characterized by disorganization of motor function in two
extremities (see 111.00D1), resulting in an extreme limitation (see
111.00D2) in the ability to stand up from a seated position, balance
while standing or walking, or use the upper extremities.
111.18 Traumatic brain injury, characterized by disorganization
of motor function in two extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the ability to stand up from a
seated position, balance while standing or walking, or use the upper
extremities, persisting for at least 3 consecutive months after the
injury.
111.19 [Reserved]
111.20 Coma or persistent vegetative state, persisting for at
least 1 month.
111.21 Multiple sclerosis, characterized by disorganization of
motor function in two extremities (see 111.00D1), resulting in an
extreme limitation (see 111.00D2) in the ability to stand up from a
seated position, balance while standing or walking, or use the upper
extremities.
111.22 Motor neuron disorders, characterized by A or B:
A. Disorganization of motor function in two extremities (see
111.00D1), resulting in an extreme limitation (see 111.00D2) in the
ability to stand up from a seated position, balance while standing
or walking, or use the upper extremities; or
B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting
in:
1. Acute respiratory failure requiring invasive mechanical
ventilation; or
2. Need for supplemental enteral nutrition via a gastrostomy or
parenteral nutrition via a central venous catheter.
[FR Doc. 2016-15306 Filed 6-30-16; 8:45 am]
BILLING CODE 4191-02-P