[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Proposed Rules]
[Pages 10636-10654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02659]



[[Page 10635]]

Vol. 79

Tuesday,

No. 37

February 25, 2014

Part II





 Social Security Administration





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20 CFR Parts 404





 Revised Medical Criteria for Evaluating Neurological Disorders; 
Proposed Rule

  Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / 
Proposed Rules  

[[Page 10636]]


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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: Notice of proposed rulemaking.

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SUMMARY: We propose to revise 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). The proposed 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; and responses to an advance notice of proposed rulemaking 
(ANPRM).

DATES: To ensure that your comments are considered, we must receive 
them no later than April 28, 2014.

ADDRESSES: You may submit comments by any one of three methods--
Internet, fax, or mail. Do not submit the same comments multiple times 
or by more than one method. Regardless of which method you choose, 
please state that your comments refer to Docket No. SSA-2006-0140 so 
that we may associate your comments with the correct regulation.
    CAUTION: You should be careful to include in your comments only 
information that you wish to make publicly available. We strongly urge 
you not to include in your comments any personal information, such as 
Social Security numbers or medical information.
    1. Internet: We strongly recommend that you submit your comments 
via the Internet. Please visit the Federal eRulemaking portal at http://www.regulations.gov. Use the Search function to find docket number 
SSA-2006-0140. The system will issue you a tracking number to confirm 
your submission. You will not be able to view your comment immediately 
because we must post each comment manually. It may take up to a week 
for your comment to be viewable.
    2. Fax: Fax comments to (410) 966-2830.
    3. Mail: Address your comments to the Office of Regulations and 
Reports Clearance, Social Security Administration, 107 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
    Comments are available for public viewing on the Federal 
eRulemaking portal at http://www.regulations.gov or in person, during 
regular business hours, by arranging with the contact person identified 
below.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Medical 
Listings Improvement, 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 http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

What revisions are we proposing

    We propose to:
     Change the name of the body system from Neurological to 
Neurological Disorders;
     Revise and expand the introductory text to the 
neurological disorders body system for both adults (section 11.00) and 
children (section 111.00);
     Add criteria to the adult and the childhood listings to 
evaluate the effects of neurological disorders;
     Add criteria to the adult listings based on functional 
limitations associated with neurological disorders; and
     Make conforming changes in the mental disorders body 
system in sections 12.00 and 112.00.

Why are we proposing to revise the listings for this body system?

    We propose these revisions to reflect our program experience and 
advances in medical knowledge, treatment, and methods of evaluating 
neurological disorders. We last published final rules making 
comprehensive revisions to section 11.00--the neurological listings for 
adults (people who are at least 18 years old)--and section 111.00--the 
neurological listings for children (people under age 18)--on December 
6, 1985.\1\ Although we have made some changes since then, we have not 
comprehensively revised the rules since 1985.\2\
---------------------------------------------------------------------------

    \1\ 50 FR 50068.
    \2\ We published final rules 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, 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).
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How did we develop these proposed rules?

    In developing these proposed rules, we considered the public 
comments we received in response to an ANPRM that we published in the 
Federal Register on April 13, 2005.\3\ In the ANPRM, we announced our 
plans to update and revise this body system, and we invited the public 
to send us written comments and suggestions. We also considered the 
public comments we received at an outreach policy conference on 
``Neurological Disorders in the Disability Programs'' that we hosted in 
New York, New York, on July 28, 2005.\4\ In addition, we considered 
comments about neuropathy that we received when we revised the medical 
criteria for evaluating endocrine disorders.\5\
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    \3\ 70 FR 19356.
    \4\ Although we indicated in the ANPRM that we would not 
summarize or respond to the comments, we read and considered them 
carefully. You can read the ANPRM, the comments we received in 
response to the ANPRM, and a transcript of the policy conference 
at--http://www.regulations.gov/#!documentDetail;D=SSA-2006-0140-0002 
and http://www.regulations.gov/#!documentDetail;D=SSA-2006-0140-
0003.
    \5\ 76 FR 19692.
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    We also used information from other sources, including:
     Medical experts in the field of neurology and other 
related fields, advocacy groups for people with neurological disorders, 
and people with neurological disorders and their families;
     People who make and review disability determinations and 
decisions for us in state agencies, in our Office of Quality 
Performance, and in our Office of Disability Adjudication and Review; 
and
     The published sources we list in the References section at 
the end of this preamble.
    We describe in more detail below the revisions we propose to make 
to the introductory text of the adult listings, the adult listings, the 
introductory text of the childhood listings, and the childhood 
listings.

Why are we proposing to change the name of this body system?

    We propose to change the name of this body system from Neurological 
to Neurological Disorders to make it consistent with our naming of 
other body systems. We have been renaming all of the other body systems 
to include the word ``disorders'' as we revise them, and the name 
change we are proposing in this notice of proposed rulemaking (NPRM) is 
consistent with that approach.

[[Page 10637]]

What changes are we proposing to the introductory text of the 
neurological disorders listings for adults?

    We propose to expand, revise, and clarify the introductory text to 
the listings to provide more guidance for our adjudicators, to update 
it, and to reflect the revised listings. The following chart shows the 
headings of the current and proposed sections of the introductory text:

------------------------------------------------------------------------
       Current introductory text            Proposed introductory text
------------------------------------------------------------------------
11.00A Epilepsy........................  11.00A Which neurological
                                          disorders do we evaluate under
                                          these listings?
11.00B Brain tumors....................  11.00B What evidence do we need
                                          to document your neurological
                                          disorder?
11.00C Persistent disorganization of     11.00C How do we consider
 motor function.                          adherence to prescribed
                                          treatment in neurological
                                          disorders?
11.00D In conditions which are episodic  11.00D What do we mean by
 in character.                            disorganization of motor
                                          function?
11.00E Multiple sclerosis..............  11.00E How do we evaluate
                                          communication impairments
                                          under these listings?
11.00F Traumatic brain injury (TBI)....  11.00F What do we mean by
                                          bulbar and neuromuscular
                                          dysfunction?
11.00G Amyotrophic Lateral Sclerosis     11.00G How do we evaluate a
 (ALS).                                   combination of functional
                                          limitations under these
                                          listings?
                                         11.00H What is epilepsy, and
                                          how do we evaluate it under
                                          11.02?
                                         11.00I What is vascular insult
                                          to the brain, and how do we
                                          evaluate it under 11.04?
                                         11.00J What are benign brain
                                          tumors, and how do we evaluate
                                          them under 11.05?
                                         11.00K What is Parkinsonian
                                          syndrome, and how do we
                                          evaluate it under 11.06?
                                         11.00L What is cerebral palsy,
                                          and how do we evaluate it
                                          under 11.07?
                                         11.00M What are spinal cord
                                          insults, and how do we
                                          evaluate them under 11.08?
                                         11.00N What is multiple
                                          sclerosis, and how do we
                                          evaluate it under 11.09?
                                         11.00O What is amyotrophic
                                          lateral sclerosis, and how do
                                          we evaluate it under 11.10?
                                         11.00P What are
                                          neurodegenerative disorders of
                                          the central nervous system,
                                          such as Huntington disease,
                                          Friedreich ataxia, and
                                          spinocerebellar degeneration,
                                          and how do we evaluate them
                                          under 11.17?
                                         11.00Q What is traumatic brain
                                          injury, and how do we evaluate
                                          it under 11.18?
                                         11.00R What are coma and
                                          persistent vegetative state,
                                          and how do we evaluate them
                                          under 11.20?
                                         11.00S What are motor neuron
                                          disorders, other than ALS, and
                                          how do we evaluate them under
                                          11.22?
                                         11.00T How do we consider your
                                          symptom of fatigue in these
                                          listings?
                                         11.00U How do we evaluate your
                                          neurological disorder when it
                                          does not meet one of these
                                          listings?
------------------------------------------------------------------------

    The following is a detailed explanation of the proposed changes to 
the introductory text:

Proposed Section 11.00A--Which neurological disorders do we evaluate 
under these listings?

    In this new section, we explain which neurological disorders we 
evaluate under these listings and how we evaluate their effects.

Proposed Section 11.00B--What evidence do we need to document your 
neurological disorder?

    In this new section, we describe the kinds of information that we 
use to establish the existence and severity of your neurological 
disorder. We also clarify our policy that we will not purchase imaging 
or laboratory tests that are complex, costly, or invasive.\6\
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    \6\ DI 39545.175 states, ``DDS examiners, supervisors, medical 
consultants and psychological consultants will ensure that only 
necessary and appropriate CEs are purchased.'' In the same POMS, as 
well as DI 22510.006, we explain when not to purchase an exam.
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Proposed Section 11.00C--How do we consider adherence to prescribed 
treatment in neurological disorders?

    We define the phrase ``despite adherence to prescribed treatment'' 
that is in proposed listings 11.02 Epilepsy, 11.06 Parkinsonian 
syndrome, and 11.12 Myasthenia gravis. Medical research shows that 
these neurological conditions may improve after a period of treatment. 
This criterion is used for conditions that do not improve despite a 
regular regimen of medication or other treatment that has been 
prescribed by a physician for 3 consecutive months.

Proposed Section 11.00D--What do we mean by disorganization of motor 
function?

    In this new section, we define the phrase ``disorganization of 
motor function''. In proposed 11.00D2, we explain the addition of a 
severity standard for disorganized motor function, which we refer to as 
``extreme limitation.'' We propose to define an extreme limitation as 
the inability to stand up from a seated position, or the inability to 
maintain balance in a standing position and while walking, or the 
inability to use your upper extremities. We then explain what each of 
these limitations means.

[[Page 10638]]

Proposed Section 11.00E--How do we evaluate communication impairments 
under these listings?

    In this section, we propose to provide guidance about how to 
document communication impairments associated with neurological 
disorders evaluated under listings 11.04A, 11.07C, and 11.11B. We also 
explain that communication impairments caused by non-neurological 
disorders be evaluated under listing 2.09 in the special senses and 
speech body system.
    Although we do not propose to revise the requirements for 
evaluating communication impairments that are currently in listings 
11.04A, 11.07C, and 11.11B, we propose to define the terms 
``ineffective speech or communication'' and ``significant 
interference'' in 11.00E1 and 11.00E2. Guidance for evaluating speech 
and language impairments will be addressed in future regulations, as 
discussed in ANPRMs published in the Federal Register on April 13, 
2005, and February 6, 2012.\7\
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    \7\ 70 FR 19351 published on April 13, 2005; 77 FR 5734 
published on February 6, 2012.
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Proposed Section 11.00F--What do we mean by bulbar and neuromuscular 
dysfunction?

    In this new section, we propose criteria for evaluating bulbar and 
neuromuscular dysfunction and explain what characterizes it.

Proposed Section 11.00G--How do we evaluate a combination of functional 
limitations under these listings?

    We propose new functional criteria for evaluating neurological 
disorders in all listings except proposed 11.20, coma and persistent 
vegetative state (PVS). These criteria would give adjudicators another 
way to evaluate neurological disorders. A person must have marked 
limitation in physical functioning and marked limitation in at least 
one of three broad areas of functioning: Activities of daily living; 
maintaining social functioning; or completing tasks in a timely manner 
due to deficiencies in concentration, persistence, or pace. We explain 
each part of this listing in detail in proposed 11.00G.
    In proposed 11.00G2, we use essentially the same definition of 
``marked'' as in 14.00I5, but we would not include the description of 
``marked'' as ``more than moderate but less than extreme.'' Instead, we 
include an explanation based on the language describing the rating 
scale for mental disorders in current Sec. Sec.  404.1520a(c)(4) and 
416.920a(c)(4). This rating scale describes ``marked'' as the fourth 
point on a five-point rating scale. We explain that we would not 
require our adjudicators to use such a scale, but that ``marked'' would 
be the fourth point on a scale of ``no limitation, mild limitation, 
moderate limitation, marked limitation, and extreme limitation.'' With 
this guideline, we would not need to state that ``marked'' falls 
between ``moderate'' and ``extreme.''
    In proposed 11.00G3, we explain what we mean by ``physical 
functioning,'' ``activities of daily living,'' ``social functioning,'' 
and ``completing tasks in a timely manner.'' We based this proposed 
section, in part, on current 14.00I6, 14.00I7, and 14.00I8 in our 
immune system disorders listings.

Proposed Section 11.00H--What is epilepsy, and how do we evaluate it 
under 11.02?

    In proposed 11.00H1, we define epilepsy and acknowledge the various 
types. We include information about evaluating the most severe types of 
epilepsy, generalized tonic-clonic and dyscognitive seizures (formerly 
complex partial seizures), and dyscognitive seizures that may develop 
into generalized tonic-clonic seizures. In proposed 11.00H2, we clarify 
the requirement for a detailed description of seizures.
    In proposed 11.00H3, we explain that we no longer require serum 
drug levels and we will therefore not purchase them. 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 believe that removing the requirement for 
obtaining blood drug levels for adjudicative purposes address this 
issue and simplify evaluation of seizures that satisfy the listing 
criteria. We continue to consider blood drug levels available in the 
evidence in the context of all evidence in the case record.
    We propose 11.00H4 in response to requests from our adjudicators 
for guidance about how to count seizures to satisfy the listing 
requirements. In proposed 11.00H5, we clarify our longstanding policy 
that we will not purchase electroencephalography (EEG) and explain when 
we use EEG test results in making a disability determination or 
decision.

Proposed Section 11.00I--What is vascular insult to the brain, and how 
do we evaluate it under 11.04?

    In proposed 11.00I1, we describe vascular insult to the brain. In 
proposed 11.00I3, we clarify the 3-month requirement for evaluating 
disorganization of motor function in combination with functional 
limitations resulting from a vascular insult.

Proposed Section 11.00J--What are benign brain tumors, and how do we 
evaluate them under 11.05?

    In proposed 11.00J, we describe benign brain tumors and explain 
that we evaluate them under the proposed criteria of disorganized motor 
functioning, oral communication, or a combination of functional 
limitations.

Proposed Section 11.00K--What is Parkinsonian syndrome, and how do we 
evaluate it under 11.06?

    In proposed 11.00K, we describe Parkinsonian syndrome and explain 
that we evaluate this disorder using our requirement for adherence to 
prescribed treatment.

Proposed Section 11.00L--What is cerebral palsy, and how do we evaluate 
it under 11.07?

    In proposed 11.00L, we describe cerebral palsy (CP) and the various 
signs and symptoms of the disorder. We explain how we consider the 
signs and symptoms of this disorder when we decide a claim.

Proposed Section 11.00M--What are spinal cord insults, and how do we 
evaluate them under 11.08?

    In this proposed 11.00M, we define spinal cord insults and describe 
their signs and symptoms. We describe spinal cord insults with complete 
loss of function of the affected part(s) of the body in proposed 
11.00M2, and spinal cord insults with less than complete loss of 
function of the affected part(s) of the body in proposed 11.00M3. In 
proposed 11.00M4, we clarify the 3-month requirement for evaluating 
disorganization of motor function resulting from spinal cord insults.

Proposed Section 11.00N--What is multiple sclerosis, and how do we 
evaluate it under 11.09?

    We propose to expand guidance to our adjudicators on evaluating 
multiple sclerosis (MS) by explaining that the disorder affects several 
aspects of functioning. In proposed 11.00N2, we explain how we evaluate 
the effects of MS using proposed criteria for disorganization of motor 
functioning or a combination of functional limitations.

[[Page 10639]]

Proposed Section 11.00O--What is amyotrophic lateral sclerosis, and how 
do we evaluate it under 11.10?

    We explain that amyotrophic lateral sclerosis (ALS) is one type of 
motor neuron disorder, and we describe our documentation requirements 
for it. We propose to remove some of the discussion about ALS that is 
currently in 11.00G. Based on our program experience, we no longer need 
this guidance on evaluating ALS.

Proposed Section 11.00P--What are neurodegenerative disorders of the 
central nervous system, such as Huntington disease, Friedreich ataxia, 
and spinocerebellar degeneration, and how do we evaluate them under 
11.17?

    We propose to list examples of the types of disorders we evaluate 
under 11.17. We explain the instances in which we evaluate these 
disorders under the mental body disorders system (12.00).

Proposed Section 11.00Q--What is traumatic brain injury, and how do we 
evaluate it under 11.18?

    In proposed 11.00Q1, we define traumatic brain injury (TBI) and 
explain that we evaluate an injury that results in coma or PVS under 
proposed listing 11.20. In proposed 11.00Q2, we clarify the 3-month 
requirement for evaluating disorganization of motor function and a 
combination of functional limitations resulting from a TBI.

Proposed Section 11.00R--What are coma and persistent vegetative state, 
and how do we evaluate them under 11.20?

    In this new section, we explain the differences between coma and 
PVS. We also describe the common symptoms and signs of these 
conditions.

Proposed Section 11.00S--What are motor neuron disorders, other than 
ALS, and how do we evaluate them under 11.22?

    In this new section, we provide a general explanation of these 
disorders and explain how we evaluate them.

Proposed Section 11.00T--How do we consider your symptom of fatigue in 
these listings?

    In this new section, we propose to expand our guidance on how to 
consider fatigue so that it applies to more neurological disorders. We 
explain how we evaluate the intensity, persistence, and effects of 
fatigue. We also provide general guidance for all neurological 
disorders that may cause or be associated with fatigue, including 
multiple sclerosis, post-polio syndrome, and myasthenia gravis. In 
response to the ANPRM comments, we explain how we evaluate the effects 
of both physical fatigue and mental fatigue.

Proposed Section 11.00U--How do we evaluate your neurological disorder 
when it does not meet one of these listings?

    In this new section, we propose to provide guidance on how to 
evaluate neurological disorders that do not meet the proposed listings. 
We explain the steps in our evaluation process that we use in 
determining whether your disorder is disabling when it does not meet 
one of the listings.

What changes are we proposing to the neurological disorders listings 
for adults?

    We propose to revise the headings of eight listings, remove two 
listings, add two listings, and replace reference listings with 
appropriate criteria to evaluate neurological disorders, except in 
situations when the neurological disorder has resulted in a 
communication impairment. The following chart provides a comparison of 
the current adult listings and the proposed adult listings.

------------------------------------------------------------------------
                Current                              Proposed
------------------------------------------------------------------------
11.02 Epilepsy--convulsive epilepsy....  11.02 Epilepsy.
11.03 Epilepsy--nonconvulsive epilepsy.  11.03 [Reserved].
11.04 Central nervous system vascular    11.04 Vascular insult to the
 accident.                                brain.
11.05 Benign brain tumors..............  11.05 Benign brain tumors.
11.06 Parkinsonian syndrome............  11.06 Parkinsonian syndrome.
11.07 Cerebral palsy...................  11.07 Cerebral palsy.
11.08 Spinal cord or nerve root          11.08 Spinal cord insults.
 lesions, due to any cause.
11.09 Multiple sclerosis...............  11.09 Multiple sclerosis.
11.10 Amyotrophic lateral sclerosis....  11.10 Amyotrophic lateral
                                          sclerosis.
11.11 Anterior poliomyelitis...........  11.11 Post-polio syndrome.
11.12 Myasthenia gravis................  11.12 Myasthenia gravis.
11.13 Muscular dystrophy...............  11.13 Muscular dystrophy.
11.14 Peripheral neuropathies..........  11.14 Peripheral neuropathy.
11.15 [Reserved].......................  11.15 [Reserved].
11.16 Subacute combined cord             11.16 [Reserved]
 degeneration (pernicious anemia).
11.17 Degenerative disease not listed    11.17 Neurodegenerative
 elsewhere, such as Huntington's          disorders of the central
 chorea, Friedreich's ataxia, and spino-  nervous system, such as
 cerebellar degeneration.                 Huntington disease, Friedreich
                                          ataxia, and spinocerebellar
                                          degeneration.
11.18 Cerebral trauma..................  11.18 Traumatic brain injury.
11.19 Syringomyelia....................  11.19 [Reserved].
                                         11.20 Coma or persistent
                                          vegetative state.
                                         11.21 [Reserved].
                                         11.22 Motor neuron disorders
                                          other than ALS.
------------------------------------------------------------------------

What general criteria are we proposing to add to the neurological 
disorders listings for adults?

    We propose to use the following criteria, as appropriate, to 
establish the severity of a person's neurological disorder: 
Disorganization of motor function, bulbar and neuromuscular 
dysfunction, and a combination of functional limitations. We describe 
the three criteria below.
    We propose to use the criterion disorganization of motor function 
in all listings, except proposed 11.02 for Epilepsy and 11.20 for coma 
or PVS. This criterion is analogous to the ``disorganization of motor 
function'' criterion that we have in most of the current neurological 
disorders listings. Our proposed criterion focuses on specific 
limitations in the ability to stand up, balance, walk, and use fingers, 
hands, and arms to perform fine and gross motor movements, rather than 
on

[[Page 10640]]

specific neurological signs and the measureable degree of limitation 
demonstrated by those signs. This clarification to disorganization of 
motor function provides more consistency to our determinations of 
disorganization of motor function under the listings.
    We propose to use the criterion bulbar and neuromuscular 
dysfunction in proposed listings 11.11 for Post-polio syndrome, 11.12 
for Myasthenia gravis, and 11.22 for Motor neuron disorders to evaluate 
neurologically-based problems with speaking, swallowing, or breathing. 
This criterion replaces the bulbar and neuromuscular dysfunction 
criteria currently used in listings 11.11 and 11.12.
    We propose to use the criterion a combination of functional 
limitations in all of the proposed listings except 11.20 for coma or 
PVS. We describe the four broad areas of functioning that we use to 
establish the severity of a person's neurological disorder in proposed 
paragraph 11.00G. With the exception of epilepsy, a neurological 
disorder is of listing-level severity if it results in marked 
limitation in physical functioning and marked limitation in one of 
three other broad areas of functioning.

What changes are we proposing to the neurological disorders listings?

    We describe the significant changes to the neurological listings 
for adults below, following the order of the proposed listings.

Proposed Listing 11.02, Epilepsy

    We propose to revise the heading of current 11.02, Epilepsy--
convulsive epilepsy, to Epilepsy, and remove current 11.03, Epilepsy--
nonconvulsive epilepsy. The current classifications of seizures are 
``generalized'' and ``focal'' or partial, which are based upon which 
part and how much of the brain is affected. We describe the most severe 
types of epilepsy that we propose to evaluate, generalized tonic-clonic 
seizures and dyscognitive seizures (formerly complex partial seizures). 
We use terms that are consistent with current medical terminology.
    We propose to revise the current epilepsy listing criteria 
requirement for seizures to occur more frequently than once a month by 
requiring generalized tonic-clonic seizures to occur at least once a 
month for at least 3 consecutive months despite adherence to prescribed 
treatment. We also revise the current epilepsy listing criteria 
requirement for seizures to occur more frequently than once a week by 
requiring dyscognitive seizures to occur at least once a week for at 
least 3 consecutive months despite adherence to prescribed treatment. 
We also propose new criteria for generalized tonic-clonic seizures and 
for dyscognitive seizures that occur less frequently in combination 
with functional criteria.
    In order to simplify and clarify our frequency of seizure 
requirement, we provide guidance in proposed 11.00H4 on how to count 
seizures to satisfy the proposed listing criteria.

Listing 11.04, Vascular Insult to the Brain

    We propose to revise the heading of current 11.04, Central nervous 
system vascular accident, to Vascular insult to the brain. In proposed 
11.04B, we add the general criteria for evaluating disorganization of 
motor function as described above.

Listing 11.05, Benign Brain Tumors

    We propose to add the general criteria described above for 
evaluating disorganization of motor function and a combination of 
functional limitations. We remove references to current listings 11.02, 
11.03, and 11.04.

Listing 11.06, Parkinsonian Syndrome

    We propose to add a criterion for adherence to prescribed 
treatment. Medical research shows that Parkinsonian syndrome may be 
responsive to treatment. We believe that a specific period of time 
needs to pass during which you are adhering to prescribed treatment 
before considering the severity of the condition.

Listing 11.07, Cerebral Palsy

    We propose to remove the current intelligence quotient (IQ) score 
criterion because advances in medical knowledge of cerebral palsy and 
our program experience indicate that an IQ score does not provide us 
the best measure of a person's cognitive limitations and may not 
indicate listing-level severity.
    We propose to update the remaining criteria by replacing them with 
the general criteria described above for evaluating disorganization of 
motor function and a combination of functional limitations.

Listing 11.08, Spinal Cord Insults

    We propose to revise the heading of current 11.08, Spinal cord or 
nerve root lesions, due to any cause, to Spinal cord insults, to more 
accurately reflect the disorders we evaluate under this listing. We 
evaluate insults that primarily affect the spinal cord, such as 
infections, tumors, hemorrhages and vascular lesions, and anatomical 
abnormalities, under proposed 11.08. This change clarifies for our 
adjudicators that we evaluate disorders of the spine, such as nerve 
root impingement that is primarily a result of bony spine disorders, 
under the musculoskeletal body system, 1.00, rather than under the 
neurological listings.
    We add the general criteria described above for evaluating a 
combination of functional limitations, and we remove the reference to 
current listing 11.04.

Listing 11.09, Multiple Sclerosis

    We propose to replace the disorganization of motor function 
criteria in current 11.09 with the proposed disorganization of motor 
function criteria. Under the proposed listing, we assess the severity 
of a visual or mental impairment related to multiple sclerosis using 
the proposed combination of functional limitations criteria or under a 
special senses and speech listing in 2.00, or under a mental disorders 
listing in 12.00, respectively. We also replace the requirement for 
significant reproducible fatigue with the general criteria described 
above for evaluating disorganization of motor function and a 
combination of functional limitations.

Listing 11.11, Post-Polio Syndrome

    We propose to revise the heading of current 11.11, Anterior 
poliomyelitis, to Post-polio syndrome, because modern medicine has 
mostly eradicated anterior poliomyelitis. We update the current listing 
criteria by replacing it with the general criteria described above for 
evaluating disorganization of motor function and a combination of 
functional limitations. In proposed listing 11.11C, we also propose 
criteria for evaluating bulbar and neuromuscular dysfunction.

Listing 11.12, Myasthenia Gravis

    We propose to update the current listing criteria for significant 
difficulty with speaking, swallowing, or breathing by replacing it with 
the general criteria described above for evaluating bulbar and 
neuromuscular dysfunction. We also add the general criteria described 
above for a combination of functional limitations. Our program 
experience shows that it is difficult to evaluate motor weakness under 
the current listing. We propose to clarify the criteria for evaluating 
motor weakness by using the general criteria described above for 
evaluating disorganization of motor function.
    We propose to add a criterion for adherence to prescribed 
treatment. We believe that a specific period of time needs to pass 
during which you are adhering to prescribed treatment before

[[Page 10641]]

considering the severity of the condition.
    We replace the current criteria for bulbar dysfunction and 
significant motor weakness of muscles of extremities with the proposed 
bulbar and neuromuscular dysfunction criteria in proposed 11.12.

Listing 11.13, Muscular Dystrophy

    We propose to add the general criteria described above for 
evaluating disorganization of motor function and a combination of 
functional limitations. We remove references to current listing 11.04B.

Listing 11.14, Peripheral Neuropathy

    We propose to revise the heading of current 11.14, Peripheral 
neuropathies, to Peripheral neuropathy, because the medical community 
uses the singular form to refer to the various types of this disorder. 
Current 11.14 is a reference listing that cross-refers to the 
disorganization of motor function criteria in current 11.04B and 
requires that the motor dysfunction occur despite prescribed treatment. 
We update the current listing criteria for disorganization of motor 
function by replacing it with the general criteria described above for 
evaluating disorganization of motor function. We provide an alternative 
means for evaluating peripheral neuropathy by adding the general 
criteria described above for evaluating a combination of functional 
limitations. We remove the prescribed treatment requirement because a 
person's response to treatment is variable depending on the underlying 
cause.

Listing 11.17, Neurodegenerative Disorders of the Central Nervous 
System, Such as Huntington Disease, Friedreich Ataxia, and 
Spinocerebellar Degeneration

    We propose to revise the heading of current 11.17, Degenerative 
disease not listed elsewhere, such as Huntington's chorea, Friedreich's 
ataxia, and spino-cerebellar degeneration, to Neurodegenerative 
disorders of the central nervous system, such as Huntington disease, 
Friedreich ataxia, and spinocerebellar degeneration, to reflect the 
disorders we evaluate under this listing and current medical 
terminology. Current 11.17 is a reference listing that cross-refers to 
the disorganization of motor function criteria in 11.04B and the mental 
criteria in 12.02. We update the criteria for disorganization of motor 
function by replacing it with the general criteria described above for 
evaluating disorganization of motor function. When these disorders 
result in solely cognitive and other mental function effects, we 
evaluate the disorder under 12.02.

Listing 11.18, Traumatic Brain Injury

    We propose to revise the heading of current 11.18, Cerebral trauma, 
to Traumatic brain injury. We add the general criteria described above 
for evaluating disorganization of motor function and a combination of 
functional limitations. We remove references to current listings 11.02, 
11.03, 11.04, and 12.02. We also move the 3-month requirement for 
resulting limitations from the current introductory text to the 
proposed listing.

Listing 11.20, Coma or PVS.

    In response to questions from our adjudicators, we propose to add 
11.20, coma or PVS, to evaluate neurological disorders that result in 
coma or persistent vegetative state.

Listing 11.22, Motor Neuron Disorders Other Than ALS

    We propose to add 11.22 Motor neuron disorders for evaluating all 
such disorders except for ALS. We add the general criteria described 
above for evaluating disorganization of motor function, bulbar and 
neuromuscular dysfunction, and a combination of functional limitations.

Other Revisions

    We propose to remove current 11.16, Subacute combined cord 
degeneration (pernicious anemia) and current 11.19, Syringomyelia. 
These disorders generally respond to medical treatment and do not reach 
listing-level severity because they do not become sufficiently severe 
or do not remain at a sufficient level of severity long enough to meet 
our 12-month duration requirement. We evaluate these disorders under 
proposed 11.08 if they result in severe impairment despite medical 
treatment and intervention.

What changes are we proposing to the introductory text of the 
neurological disorders listings for children?

    The proposed childhood introductory text and listings are similar 
to the proposed adult rules and only have minor differences, such as 
referring to children instead of adults.
    To clarify the guidance that we provide on evaluating communication 
disorders in children, we propose to provide definitions and severity 
criteria for the terms ``significantly affects'' and ``ineffective 
verbal communication'' in 111.00K.
    We are not proposing to include criteria for evaluating a 
combination of functional limitations in the childhood listings because 
we already evaluate functioning in children using the rules for 
determining the functional equivalence of an impairment(s) to the 
listings.\8\ Except for minor editorial changes to make the text 
specific to children, we propose to repeat most of the introductory 
text of proposed 11.00 in the introductory text of proposed 111.00. 
Since we have already described these proposed revisions in the 
explanation to the introductory text of proposed 11.00, we describe 
here only sections of the proposed rules that are unique to children or 
that require further explanation.
---------------------------------------------------------------------------

    \8\ See Sec.  416.926(a) of this chapter.
---------------------------------------------------------------------------

What changes are we proposing to the neurological disorders listings 
for children?

    We propose to remove one childhood listing and revise the heading 
of another. We propose to add nine childhood listings to parallel the 
adult listings because many neurological disorders that affect adults 
also affect children. We are not proposing corresponding childhood 
listings to proposed adult listings 11.06 for Parkinsonian syndrome, 
11.10 for Amyotrophic lateral sclerosis, and 11.11 for Post-polio 
syndrome because these disorders rarely occur in children. When these 
disorders do occur in children, we evaluate them under the adult 
listings, when appropriate, or determine whether they functionally 
equal the listings. Although we are proposing corresponding childhood 
listings to most of the proposed adult listings, we propose to add a 
childhood Multiple Sclerosis listing, 111.21, and maintain current 
childhood neurological communication listing, 111.09, as is. We are 
also proposing to remove the current intelligence quotient (IQ) score 
criterion in listing 111.02 and 111.08 because advances in medical 
knowledge of epilepsy and spinal cord insults, and our program 
experience indicate that an IQ score does not provide us the best 
measure of a child's cognitive limitations and may not indicate 
listing-level severity
    The following chart provides a comparison of the current childhood 
listings and the proposed childhood listings.

[[Page 10642]]



------------------------------------------------------------------------
                Current                              Proposed
------------------------------------------------------------------------
111.02 Major motor seizure disorder....  111.02 Epilepsy.
111.03 Nonconvulsive epilepsy..........  111.03 [Reserved].
                                         111.04 Vascular insult to the
                                          brain.
111.05 Benign brain tumors.............  111.05 Benign brain tumors.
111.06 Motor dysfunction (due to any     111.06 [Reserved].
 neurological disorder).
111.07 Cerebral Palsy..................  111.07 Cerebral palsy.
111.08 Meningomyelocele (and related     111.08 Spinal cord insults.
 disorders).
111.09 Communication impairment,         111.09 Communication
 associated with documented               impairments, associated with
 neurological disorder.                   documented neurological
                                          disorder.
                                         111.12 Myasthenia gravis.
                                         111.13 Muscular dystrophy.
                                         111.14 Peripheral neuropathy.
                                         111.17 Neurodegenerative
                                          disorders of the central
                                          nervous system, such as
                                          Juvenile Huntington disease
                                          and Friedreich ataxia.
                                         111.18 Traumatic brain injury.
                                         111.20 Coma or persistent
                                          vegetative state.
                                         111.21 Multiple sclerosis.
                                         111.22 Motor neuron disorders
                                          other than ALS.
------------------------------------------------------------------------

Why are we removing current 111.06, motor dysfunction (due to any 
neurological disorder)?

    Current 111.06 lists the criteria we use to evaluate motor 
dysfunction due to any neurological disorder in children. We propose to 
remove current 111.06 because we include disorganization of motor 
function criteria in each of the proposed childhood neurological 
listings, as appropriate.

Listing 111.08, Spinal Cord Insults

    We propose to revise the heading of current 111.08, 
Meningomyelocele (and related disorders), to Spinal cord insults, to 
match the proposed adult heading and to reflect which disorders we 
evaluate in children, including meningomyelocele, a severe form of 
spina bifida.

Other Changes

    We propose minor conforming changes to the musculoskeletal system 
listings (1.00).

How should we consider genetic testing when evaluating neurological 
disorders?

    We are requesting information regarding how we could consider 
genetic testing and/or analysis to document, identify, and evaluate 
specific medically determinable neurological disorder(s).
    Under our current, long-standing policy, we do not require or 
purchase genetic testing to evaluate disability; however, we do 
consider all evidence in the record, including genetic testing, when we 
make a determination or decision of whether you are disabled (See, 
Sec. Sec.  404.1520 and 416.920).

What is our authority to make rules and set procedures for determining 
whether a person is disabled under the statutory definition?

    Under the Act, we have full power and authority to make rules and 
regulations and to establish necessary and appropriate procedures to 
carry out such provisions. Sections 205(a), 702(a)(5), and 1631(d)(1).

How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they would 
remain in effect for 5 years after the date they become effective, 
unless we extend them, or revise and issue them again.

Clarity of These Proposed Rules

    Executive Order 12866, as supplemented by Executive Order 13563, 
requires each agency to write all rules in plain language. In addition 
to your substantive comments on these proposed rules, we invite your 
comments on how to make them easier to understand.
    For example:
     Would more, but shorter sections be better?
     Are the requirements in the rules clearly stated?
     Have we organized the material to suit your needs?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?
     Do the rules contain technical language or jargon that is 
not clear?
     Would a different format make the rules easier to 
understand, such as grouping and order of sections, use of headings, 
paragraphing?

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 NPRM 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 NPRM would not have a significant economic 
impact on a substantial number of small entities because it would 
affect individuals only. Therefore, the Regulatory Flexibility Act, as 
amended, does not require us to prepare a regulatory flexibility 
analysis.

Paperwork Reduction Act

    This NPRM does not create any new or affect any existing 
collections and, therefore, does not require OMB approval under the 
Paperwork Reduction Act.

References

    We consulted the following references when we developed these 
proposed rules:

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Barry, J.J. (2003). The recognition and management of mood disorders 
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    We will make these references available to you for inspection if 
you are interested in reading them. Please make arrangements with the 
contact person shown in this preamble if you would like to review any 
reference materials.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002--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.

    Dated: January 31, 2014.
Carolyn W. Colvin,
Acting Commissioner of Social Security.
    For the reasons set out in the preamble, we propose to amend 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 by:
0
a. Revising item 12 of the introductory text before part A;
0
b. In part A table of contents, revising the body system name for 
section 11.00;
0
c. In section 1.00 of part A, revising the introduction to paragraph K;
0
d. Revising section 11.00 of part A;
0
e. In section 12.00 of part A, revising paragraph D10, heading of 
listing 12.01, and listing 12.09I;
0
f. In part B table of contents, revising the body system name for 
section 111.00;
0
g. In section 101.00 of part B, revising the last sentence of paragraph 
B1 and paragraph K;
0
h. In section 101.00 of part B, revising the last sentence of paragraph 
B1 and paragraph K; and
0
i. Revising 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): [DATE 5 YEARS FROM 
EFFECTIVE DATE OF FINAL RULES].
* * * * *
11.00 Neurological Disorders.
* * * * *
    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 
PVS, and neurological disorders that cause disorganization of motor 
function, bulbar and neuromuscular dysfunction, or a combination of 
functional limitations.
    B. What evidence do we need to document your neurological disorder?
    1. We need medical evidence 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 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. We will not purchase imaging or 
laboratory tests that are complex, costly, or invasive.
    C. How do we consider adherence to prescribed treatment in 
neurological disorders? In 11.02, 11.06, and 11.12, we require that 
findings occur 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 3 consecutive 
months. 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 with 
movement of the trunk or lower extremities, or upper extremities 
(including arms, hands, and fingers). All listings in this body system, 
except for 11.02, 11.10, and 11.20, include a requirement for 
disorganization of motor function that results in an extreme limitation 
in your ability to:
     Stand up; or
     Balance; or
     Walk; or
     Use arms, hands, and fingers to perform fine and gross 
motor movements.
    2. Extreme limitation is the inability to stand up from a seated 
position, or the inability to maintain balance in a standing position 
and while walking, or the inability to use your upper extremities.
    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, a crutch, or a cane.
    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 an 
extreme loss of function of both upper extremities that interferes very 
seriously with your ability to perform fine and gross motor movements. 
Inability to perform fine and gross motor

[[Page 10645]]

movements could include inability to feed oneself, inability to take 
care of personal hygiene, inability to sort and handle papers or files, 
or the inability to lift and carry items at or above waist level.
    3. We will find you disabled under these listings if you have 
disorganization of motor function that limits both lower extremities, 
or both upper extremities, or the trunk and one upper or lower 
extremity, or one upper extremity and one lower extremity. Examples of 
extreme limitation that meet this criterion include, but are not 
limited to, very serious limitation in the ability to:
    a. Stand upright without the risk of falling;
    b. Balance in a seated position without the risk of falling;
    c. Walk without the assistance of a device or person without the 
risk of falling; and
    d. Use your fingers, hands, and arms to manipulate, grasp, lift, 
and carry objects.
    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 that there is an extreme 
limitation in your ability to understand or convey your message in 
simple spoken language resulting in the 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 that you have ``significant 
interference'' in your ability to speak, hear, or see if your symptoms, 
such as aphasia, strabismus, or sensorineural hearing loss, seriously 
limit your ability to function 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 most 
neuromuscular dysfunction refer to weakness in these muscles resulting 
in breathing, swallowing, and speaking impairments. Listings 11.11, 
11.12, and 11.22 include criteria for evaluating bulbar and 
neuromuscular dysfunction.
    G. How do we evaluate a combination of functional limitations under 
these listings?
    1. We consider all relevant information in your case record to 
determine the effects of your neurological disorder on your ability to 
function in these four areas: Physical functioning, activities of daily 
living, social functioning, and completing tasks in a timely manner. To 
satisfy the combination of functional limitations requirement in these 
listings, your neurological disorder must result marked limitation in 
physical functioning and in at least one of three broad areas of 
functioning: Activities of daily living; maintaining social 
functioning; or completing tasks in a timely manner due to deficiencies 
in concentration, persistence, or pace.
    2. Marked limitation means that the signs and symptoms of your 
neurological disorder interfere seriously with your ability to function 
independently, appropriately, effectively, and on a sustained basis in 
work-related activities.
    a. Although we do not require the use of such a scale, marked would 
be the fourth point on a five-point rating scale consisting of no 
limitation, slight limitation, moderate limitation, marked limitation, 
and extreme limitation.
    b. We do not define marked in terms of specific physical functions, 
or a specific number of different activities of daily living, or 
different behaviors in which your social functioning is impaired, or a 
specific number of tasks that you are able to complete, but by the 
nature and overall degree of interference with your functioning.
    c. Marked limitation also reflects the kind and extent of help you 
receive and the characteristics of any special supports that may reduce 
your symptoms and signs and enable you to function as you do. Examples 
include help you receive from other people, special appliances or 
equipment, assistive devices, or medications that enable you to 
function. The more extensive the help or supports that you need to 
function, the more limited we will find you to be.
    3. Areas of functioning and marked limitation
    a. Physical functioning includes specific motor abilities, such as 
the ability to stand up, balance, walk, climb, bend, push, pull, lift, 
carry, reach, grasp, and manipulate. Physical functioning may also 
include functions of the body that support motor abilities, such as the 
ability to see, breathe, swallow, and physiological processes that 
sustain energy level, output, and physical pace. We will find that you 
have ``marked'' limitation in this area if your symptoms, such as pain 
or physical or mental fatigue (see 11.00T) caused by your neurological 
disorder or its treatment, seriously limit your motor abilities, or the 
physical functions or physiological processes that support those 
abilities.
    b. Activities of daily living include, but are not limited to, such 
activities as doing household chores, grooming and hygiene, using a 
post office, taking public transportation, or paying bills. We will 
find that you have ``marked'' limitation in this area if your symptoms, 
such as pain or physical or mental fatigue, caused by your neurological 
disorder or its treatment, seriously limit your ability to perform 
activities of daily living.
    c. Social functioning includes the ability to interact with others 
independently, appropriately, effectively, and on a sustained basis. It 
includes the ability to communicate effectively with others. We will 
find that you have ``marked'' limitation in this area if your symptoms, 
such as pain, physical or mental fatigue, or communication deficits, 
caused by your neurological disorder or its treatment, seriously limit 
social interaction on a sustained basis.
    d. Completing tasks in a timely manner involves the ability to 
sustain concentration, persistence, or pace to permit timely completion 
of tasks. We will find that you have ``marked'' limitation in this area 
if your symptoms, such as pain, physical or mental fatigue, or 
difficulty concentrating, caused by your neurological disorder or its 
treatment seriously limit your ability to sustain concentration or pace 
adequate to complete tasks.
    4. Symptoms and signs of your disorder and the effects of 
treatment.
    a. We will consider your symptoms and signs and how they affect 
your ability to function in work-related activities. When we evaluate 
your functioning, we will consider whether

[[Page 10646]]

your symptoms and signs 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 
symptoms, signs, 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, 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. 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 commonly 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 the 
course of the seizure, a dyscognitive seizure may progress into a 
generalized tonic-clonic seizure (see 11.00H1a).
    2. 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 lack of facility with the 
English language). We will consider you to have good reason for not 
following prescribed treatment if the treatment is very risky for you 
due to its magnitude 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 not follow guidelines 
in our policy that are not relevant to the number of seizures that you 
experience. For example, we will not consider amputation of an 
extremity or cataract surgery in one eye when there is a severe visual 
impairment not expected to improve with treatment in the other eye to 
be good reasons to not follow prescribed treatment for your seizures. 
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.
    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.
    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, 
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.
    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 the functional criteria 
under listing 11.04C, or under mental listing 12.02.
    3. We generally need evidence from at least 3 months after the 
vascular insult to evaluate your physical limitations under 11.04B or 
the impact that your disorder has on your functioning under 11.04C. In 
some cases, evidence of your vascular insult is sufficient to determine 
disability within 3 months post-vascular insult. If we are unable to 
determine disability 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 motor functioning, oral communication, or on several 
areas of functioning (see 11.00G3). We evaluate malignant brain tumors 
under the malignant neoplastic diseases body system in 13.00.
    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

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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. 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 insults, and how do we evaluate them under 
11.08?
    1. Spinal cord insults are lesions that transect or contuse the 
spinal cord. Motor signs and symptoms of spinal cord insults include 
paralysis, flaccidity, spasticity, and weakness.
    2. Spinal cord insults with complete loss of function (11.08A) 
addresses spinal cord insults that result in complete lack of motor, 
sensory, and autonomic function of the affected part(s) of the body.
    3. Spinal cord insults with disorganization of motor function 
(11.08B) addresses spinal cord insults 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 insult, we generally need 
evidence from at least 3 months after the spinal cord insult to 
evaluate your disorganization of motor function. In some cases, 
evidence of your spinal cord insult may be sufficient to determine 
disability within 3 months after the spinal cord insult.
    N. What is multiple sclerosis, and how do we evaluate it under 
11.09?
    1. Multiple sclerosis (MS) is a chronic, inflammatory, degenerative 
disorder of the brain and spinal cord 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 
person to person.
    2. We evaluate your signs and symptoms, such as flaccidity, 
spasticity, spasms, in-coordination, 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 using your arms, hands, and fingers. We will 
consider your other impairments or signs and symptoms that develop 
secondary to the disorder, such as mental fatigue; visual loss; trouble 
sleeping; impaired attention, concentration, memory, or judgment; mood 
swings; and depression in determining a combination of functional 
limitations.
    O. What is amyotrophic lateral sclerosis, and how do we evaluate it 
under 11.10? Amyotrophic lateral sclerosis (ALS) is one type of motor 
neuron disorder. We establish ALS under 11.10 when you have a 
documented diagnosis of ALS. Documentation must be 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 disease, Friedreich 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 or 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 
disease (HD), Friedreich ataxia, spinocerebellar degeneration, 
Creutzfeldt-Jakob disease (CJD), progressive supranuclear palsy (PSP), 
early onset Alzheimer disease, and frontotemporal dementia (Pick 
disease). When these disorders result in solely cognitive and other 
mental function effects, we will evaluate the disorder under 12.02.
    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 either your physical limitations under 11.18A or the impact 
that your disorder has on your functioning under 11.18C. In some cases, 
evidence of your TBI is sufficient to determine disability within 3 
months post-TBI. If we are unable to determine disability 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.
    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

[[Page 10648]]

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 a combination of functional 
limitations.
    T. How do we consider your symptom of fatigue in these listings? 
Fatigue is one of the most common and debilitating 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 
combination of functional limitations described in 11.00G.
    U. How do we evaluate your neurological disorder when it does not 
meet one of these listings? 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. 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 engage in substantial gainful activity, 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. 
See also Sec. Sec.  404.1545, 404.1560, 416.945, and 416.960 of this 
chapter. 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 
marked limitation in one of the following:
    1. Physical functioning (see 11.00G3a); or
    2. Activities of daily living (see 11.00G3b); or
    3. Maintaining social functioning (see 11.00G3c); or
    4. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00 G3d).

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 marked limitation 
in one of the following:
    1. Physical functioning (see 11.00G3a); or
    2. Activities of daily living (see 11.00G3b); or
    3. Maintaining social functioning (see 11.00G3c); or
    4. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    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 (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements, 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, both persisting for at 
least 3 consecutive months after the insult:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.05 Benign brain tumors, characterized by A or B:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    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 (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.07 Cerebral palsy, characterized by A, B, or C:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).


[[Page 10649]]


OR

    C. Significant interference in communication due to speech, 
hearing, or visual defect (see 11.00E2).
    11.08 Spinal cord insults, characterized by A, B, or C:
    A. Complete loss of function, as described in 11.00M2, persisting 
for 3 consecutive months after the insult (see 11.00M4).

OR

    B. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements persisting for 3 
consecutive months after the insult (see 11.00M4).

OR

    C. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a) and in one of the following areas, both persisting for 3 
consecutive months after the insult (see 11.00M4):
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.09 Multiple sclerosis, characterized by A or B:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.10 Amyotrophic lateral sclerosis established by clinical and 
laboratory findings.
    11.11 Post-polio syndrome, characterized by A, B, C, or D:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Unintelligible speech.

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. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    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 (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

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. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.13 Muscular dystrophy, characterized by A or B:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.14 Peripheral neuropathy, characterized by A or B:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.15 [Reserved]
    11.16 [Reserved]
    11.17 Neurodegenerative disorders of the central nervous system, 
such as Huntington disease, Friedreich ataxia, and spinocerebellar 
degeneration, characterized by A or B:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

OR

    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.18 Traumatic brain injury, characterized by A or B:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements, 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, persisting for at least 3 
consecutive months after the injury:
    1. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
    11.19 [Reserved]
    11.20 Coma or persistent vegetative state, persisting for at least 
1 month.

[[Page 10650]]

    11.21 [Reserved]
    11.22 Motor neuron disorders other than ALS, characterized by A, B, 
or C:
    A. Disorganization of motor function (see 11.00D1), resulting in 
extreme limitation (see 11.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

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. Activities of daily living (see 11.00G3b); or
    2. Social functioning (see 11.00G3c); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 11.00G3d).
* * * * *
12.00 MENTAL DISORDERS
* * * * *
    D. Documentation. * * *
    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 Substance Addiction Disorders: * * *
    I. Seizures. Evaluate under 11.02.
* * * * *
Part B
* * * * *
    111.00 Neurological Disorders.
* * * * *
101.00 MUSCULOSKELETAL SYSTEM
* * * * *
    B. Loss of function.
    1. General. * * * Impairments with neurological causes are to be 
evaluated under 111.00ff, 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, and 
neurological disorders that cause disorganization of motor function, or 
bulbar and neuromuscular dysfunction.

B. What evidence do we need to document your neurological disorder?

    1. We need medical evidence 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 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. We will not purchase imaging or 
laboratory tests that are complex, costly, or invasive.

C. How do we consider adherence to prescribed treatment in neurological 
disorders?

    In 111.02 and 111.12, we require that findings occur despite 
adherence to prescribed treatment. ``Despite adherence to prescribed 
treatment'' means that you have taken medication(s) or followed other 
treatment procedures as prescribed by a physician for 3 consecutive 
months. 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 with 
movement of the trunk or lower extremities, or upper extremities 
(including arms, hands, and fingers). All listings in this body system, 
except for 111.02 and 111.20, include a requirement for disorganization 
of motor function that results in extreme limitation in your ability to 
stand up, balance, walk, or use arms, hands, and fingers to perform 
fine and gross motor movements.
    2. Extreme limitation is the inability to stand up from a seated 
position, the inability to maintain balance in a standing position and 
while walking, or the inability to use your upper extremities.
    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 an assistive device, such as a 
walker, a crutch, or a cane.
    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 an 
extreme loss of function of both upper extremities that interferes very 
seriously with your ability to perform fine and gross motor movements. 
Inability to perform fine and gross motor movements could include 
inability to feed oneself, inability to pick up small objects, 
inability to control a pencil or crayon, or inability to throw a ball.
    3. We will find you disabled under these listings if you have 
disorganization of motor function that limits both lower extremities, 
or both upper extremities, or the trunk and one upper or lower 
extremity, or one upper extremity and one lower extremity. Examples of 
extreme limitation that meet this criterion include, but are not 
limited to, very serious limitation in the ability to:
    a. Stand upright without the risk of falling;
    b. Balance in a seated position without the risk of falling;
    c. Walk without the assistance of a device or person without the 
risk of falling; and
    d. Use your fingers, hands, and arms to manipulate, grasp, lift, 
and carry objects.
    4. 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 expectations. For such children, an extreme level of 
limitation means developmental expectations at no more

[[Page 10651]]

than one-half (\1/2\) of the child's chronological age.

E. What do we mean by bulbar and neuromuscular dysfunction?

    Listings 111.12 and 111.22 include criteria for evaluating bulbar 
and neuromuscular dysfunction. Some neuromuscular disorders affect 
functions of the bulbar region of the brain, which controls vital 
functions such as breathing, swallowing, and speaking.

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.
    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 commonly 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 the 
course of the seizure, 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. They are 
never preceded by an aura. Although absence seizures are brief, 
frequent occurrence may limit functioning. This type of seizure usually 
does not occur after adolescence.
    2. 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 lack of facility with the 
English language). We will consider you to have good reason for not 
following prescribed treatment if the treatment is very risky for you 
due to its magnitude 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 not follow guidelines 
in our policy that are not relevant to the number of seizures that you 
experience. For example, we will not consider amputation of an 
extremity or cataract surgery in one eye when there is a severe visual 
impairment not expected to improve with treatment in the other eye to 
be good reasons to not follow prescribed treatment for your seizures. 
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.
    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, 
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.
    2. We generally need evidence from at least 3 months after the 
vascular insult to evaluate your physical limitations under 111.04. In 
some cases, evidence of your vascular insult is sufficient to determine 
disability within 3 months post-vascular insult. If we are unable to 
determine disability 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 motor functioning or oral communication. We evaluate 
malignant brain tumors under the malignant neoplastic diseases body 
system in 113.00.

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 
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,

[[Page 10652]]

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. 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 insults, and how do we evaluate them under 
111.08?

    1. Spinal cord insults are lesions that transect or contuse the 
spinal cord. Motor signs and symptoms of spinal cord insults include 
paralysis, flaccidity, spasticity, and weakness.
    2. Spinal cord insults with complete loss of function (111.08A) 
addresses spinal cord insults that result in complete lack of motor, 
sensory, and autonomic function of the affected part(s) of the body.
    3. Spinal cord insults with disorganization of motor function 
(111.08B) addresses spinal cord insults 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 insult, we generally need 
evidence from at least 3 months after the spinal cord insult to 
evaluate your disorganization of motor function. In some cases, 
evidence of your spinal cord insult may be sufficient to determine 
disability within 3 months after the spinal cord insult.

K. What are communication impairments associated with neurological 
disorders, and how do we evaluate them under 111.09?

    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 a 
description of a 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.
    1. Under 111.09A, we need documentation from a qualified 
professional that your neurological disorder has resulted in a speech 
deficit which significantly affects your ability to communicate. 
Significantly affects means that you demonstrate serious limitation in 
communicating, and you are not easily understood or interpreted by 
individuals who are unfamiliar to you.
    2. 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 age. 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.
    3. 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 102.111.
    4. 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 Huntington disease and Friedreich 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. Under 
111.17, we consider neurodegenerative disorders of the central nervous 
system that we do not evaluate elsewhere in section 111.00, such as 
juvenile onset Huntington disease (HD) and Friedreich ataxia. When 
these disorders result in solely cognitive and other mental function 
effects, we will evaluate the disorder under 112.02.

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 TBI that results in 
coma or persistent vegetative state under 111.20.
    2. We generally need evidence from at least 3 months after the TBI 
to evaluate your physical limitations under 111.18A. In some cases, 
evidence of your TBI is sufficient to determine disability within 3 
months post-TBI. If we are unable to determine disability 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 TBI, a nontraumatic 
insult to the brain (such as a vascular insult, infection, or brain 
tumor), or a neurodegenerative or metabolic disorder.

O. What is multiple sclerosis, and how do we evaluate it under 111.21?

    1. Multiple sclerosis (MS) is a chronic, inflammatory, degenerative 
disorder of the brain and spinal cord 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, in-coordination, 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

[[Page 10653]]

movements, such as using your arms, hands, and fingers.

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, bulbar and neuromuscular functioning, 
or a combination of functional limitations.

Q. How do we consider your symptom of fatigue in these listings?

    Fatigue is one of the most common and debilitating 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?

    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. 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. Sec.  416.924(a) and 416.926(a) of this 
chapter. We use the rules in Sec.  416.994(a) 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 (see 111.00D1), resulting in extreme 
limitation (see 111.00D2) in the ability to stand up, balance, walk, or 
perform fine and gross motor movements, persisting for at least 3 
consecutive months after the insult.
    111.05 Benign brain tumors, characterized by disorganization of 
motor function (see 111.00D1), resulting in extreme limitation (see 
111.00D2) in the ability to stand up, balance, walk, or perform fine 
and gross motor movements.
    111.06 [Reserved]
    111.07 Cerebral palsy, characterized by disorganization of motor 
function (see 111.00D1), resulting in extreme limitation (see 111.00D2) 
in the ability to stand up, balance, walk, or perform fine and gross 
motor movements.
    111.08 Spinal cord insults, characterized by A or B:
    A. Complete loss of function, as described in 111.00J2, persisting 
for 3 consecutive months after insult (see 111.00J4).

OR

    B. Disorganization of motor function (see 111.00D1), resulting in 
extreme limitation (see 111.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements persisting for 3 
consecutive months after the insult (see 111.00J4).
    111.09 Communication impairment, associated with documented 
neurological disorder. And one of the following:
    A. Documented speech deficit which 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

    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 (see 111.00D1), resulting in 
extreme limitation (see 111.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

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 (see 111.00D1), resulting in extreme limitation (see 
111.00D2) in the ability to stand up, balance, walk, or perform fine 
and gross motor movements.
    111.14 Peripheral neuropathy, characterized by disorganization of 
motor function (see 111.00D1), resulting in extreme limitation (see 
11.00D2) in the ability to stand up, balance, walk, or perform fine and 
gross motor movements.
    111.15 [Reserved]
    111.16 [Reserved]
    111.17 Neurodegenerative disorders of the central nervous system, 
such as Juvenile Huntington disease and Friedreich ataxia, 
characterized by disorganization of motor function (see 111.00D1), 
resulting in extreme limitation (see 111.00D2) in the ability to stand 
up, balance, walk, or perform fine and gross motor movements.
    111.18 Traumatic brain injury, characterized by disorganization of 
motor function (see 111.00D1), resulting in extreme limitation (see 
111.00D2) in the ability to stand up, balance, walk, or perform fine 
and gross motor movements, 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 (see 111.00D1), resulting in extreme limitation (see 
111.00D2) in the ability to stand up, balance, walk, or perform fine 
and gross motor movements.

[[Page 10654]]

    111.22 Motor neuron disorders, characterized by A or B:
    A. Disorganization of motor function (see 111.00D1), resulting in 
extreme limitation (see 111.00D2) in the ability to stand up, balance, 
walk, or perform fine and gross motor movements.

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. 2014-02659 Filed 2-24-14; 8:45 am]
BILLING CODE 4191-02-P