[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Proposed Rules]
[Pages 10730-10740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04124]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2007-0082]
RIN 0960-AG71


Revised Medical Criteria for Evaluating Human Immunodeficiency 
Virus (HIV) Infection and for Evaluating Functional Limitations in 
Immune System 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 claims involving human 
immunodeficiency virus (HIV) infection in adults and children under 
titles II and XVI of the Social Security Act (Act). We also propose to 
revise the introductory text of the listings that we use to evaluate 
functional limitations resulting from immune system disorders. The 
proposed revisions reflect our program experience, advances in medical 
knowledge, recommendations from a commissioned report and comments from 
medical experts and the public.

DATES: To ensure that your comments are considered, we must receive 
them by 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-2007-0082 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-2007-0082. 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 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:

Why are we proposing to revise the listings for evaluating HIV 
infection?

    We have not comprehensively revised the HIV infection listings, 
14.08 for adults and 114.08 for children, since we first published 
final rules for them on July 2, 1993.\1\ Although we published final 
rules for immune system disorders on March 18, 2008 that included 
changes to listings 14.08 and 114.08, the criteria in the current HIV 
infection listings are not substantively different from the criteria in 
the final rules we published in 1993.\2\
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    \1\ 58 FR 36008.
    \2\ 73 FR 14570.
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What revisions are we proposing?

    We propose to:
     Revise and expand the introductory text for evaluating HIV 
infection for both adults (section 14.00) and children (section 
114.00);
     Revise the introductory text for evaluating functional 
limitations resulting from immune system disorders for adults (section 
14.00);
     Remove current HIV infection listings 14.08A-J for adults;
     Add HIV infection listings 14.11A-H for adults;
     Redesignate and revise current HIV infection listing 
14.08K for adults as proposed listing 14.11I;
     Remove current HIV infection listings 114.08A-K for 
children; and
     Add HIV infection listings 114.11A-H for children.

How did we develop these proposed rules?

    In addition to our adjudicative experience and our review of the 
advances in medical knowledge, treatment, and methods of evaluating HIV 
infection, we asked experts and the public to provide us with 
information that helped us develop the proposals.
    We published an Advanced Notice of Proposed Rulemaking (ANPRM) in 
the Federal Register on March 18, 2008.\3\ We informed the public that 
we were considering whether and how to update and revise the rules we 
use to evaluate HIV infection. We also invited interested persons and 
organizations to send us comments and suggestions about whether we 
should add, change, or remove any of the criteria in listings 14.08 and 
114.08, and if so, what revisions did the commenters think we should 
make. We received comments from medical experts, advocates, and our 
adjudicators.\4\
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    \3\ 73 FR 14409.
    \4\ We received seven comment letters. You may read the comment 
letters at http://www.regulations.gov under the same docket number 
as this notice.
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    In addition, we hosted a policy conference called ``HIV Infection 
in the Disability Programs'' in New York, N.Y., on September 10, 
2008.\5\ At this conference, we received comments and suggestions about 
how to update and revise our rules from professionals who work with 
patients with HIV infection, including physicians, medical experts, and 
advocates, as well as a person with HIV infection, and a mother of a 
child with HIV infection.
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    \5\ You can read a transcript of the policy conference at http://www.ssa.gov/disability/SSA_HIV_Policy_Conf_Transcript.pdf.
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    In 2009, we commissioned a report from the Institute of Medicine 
(IOM) of The National Academies on the criteria that we use to evaluate 
disability in persons with HIV infection. The IOM published the report, 
HIV and Disability: Updating the Social Security

[[Page 10731]]

Listings, in 2010.\6\ The report recommended ways to improve the 
utility of the HIV infection listings by improving the sensitivity and 
specificity of listing criteria to identify people with HIV infection 
who meet our definition of disability. The IOM committee reviewed the 
most current medical literature to determine the:
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    \6\ You can read the report at http://www.nap.edu/catalog.php?record_id=12941# toc. You can also access the report at 
http://www.ssa.gov/disabilityresearch/research.htm# HIV.
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     Latest standards of care for HIV infection;
     Latest technology for the understanding of disease 
processes; and
     Latest science demonstrating the impact of HIV infection 
on patients' health and functional capacity.
    Although we are not summarizing or formally responding to the 
comments that we received on the ANPRM or at our September 2008 policy 
conference, some of the changes we propose here reflect those comments.

Would our proposal to revise the listing for evaluating HIV infection 
affect people who are already receiving benefits based on HIV 
infection?

    If these rules become final, we will not terminate any person's 
disability benefits solely because we have revised the listing for 
evaluating HIV infection, nor will we review prior allowances based on 
the HIV infection listing under the new rules. Unless we are otherwise 
required to do so (for example, by statute), we do not readjudicate 
previously decided cases when we revise our listings. We must 
periodically conduct continuing disability reviews to determine whether 
beneficiaries are still disabled.\7\ When we do, we will not find that 
a person's disability has ended based on a change in a listing. In most 
cases, we must show that the person's impairment(s) has medically 
improved and that any medical improvement is ``related to the ability 
to work.'' \8\ Even where the impairment(s) has medically improved, our 
regulations provide that the improvement is not ``related to the 
ability to work'' if it continues to meet or medically equal the ``same 
listing section used to make our most recent favorable decision.'' This 
is true even if we have deleted the listing section we used to make the 
most recent favorable decision.\9\ When we find that medical 
improvement is not related to the ability to work (or, in the case of a 
person under age 18, the impairment still meets or medically equals the 
prior listing), we will find that disability continues, unless an 
exception to medical improvement applies.
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    \7\ Sec. Sec.  404.1589 and 416.989.
    \8\ Sec. Sec.  404.1594 and 416.994.
    \9\ Sec. Sec.  404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). Our 
regulations contain a similar provision for continuing disability 
reviews for children eligible for SSI based on disability. See, 
Sec.  416.994a(b)(2).
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What changes are we proposing to the introductory text of the immune 
system disorders listings for adults?

    We have made one editorial change to shorten the heading in 
proposed 14.00F by using the commonly known abbreviation for human 
immunodeficiency virus, HIV.
    The following is a detailed explanation of the proposed changes to 
the introductory text.

Proposed Section 14.00A--What disorders do we evaluate under the immune 
system disorders listings?

    We propose to revise current section 14.00A4 to explain that people 
with HIV infection have an increased susceptibility to ``common 
infections'' as well as to the conditions that we describe in our HIV 
infection listings. We also propose to revise this section to reflect 
our proposal to redesignate current listing 14.08 as proposed listing 
14.11.

Proposed Section 14.00F--How do we document and evaluate HIV infection?

    We propose to update and expand the information on HIV infection 
that is in current section 14.00F. We also propose to remove 
information that is obsolete or no longer useful to our adjudicators.
    We propose to revise the sentence in the introductory language of 
current section 14.00F to reflect the redesignation of current listing 
14.08 as proposed listing 14.11.
    We propose to revise current section 14.00F1 by requiring positive 
findings on one or more definitive laboratory tests to document HIV 
infection in proposed section 14.00F1a. We would no longer accept 
nondefinitive tests as documentation of HIV infection as the guidance 
in current section 14.00F1b provides. We base the guidance in the 
current section on the prevailing state of medical knowledge and 
clinical practice at the time that we published final rules in 1993. 
The change that we are proposing in section 14.00F1a is consistent with 
the current prevailing state of medical knowledge and clinical practice 
that requires positive findings on a definitive laboratory test(s) to 
diagnose HIV infection.\10\
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    \10\ Centers for Disease Control and Prevention. Revised 
surveillance case definitions for HIV infection among adults, 
adolescents, and children aged <18 months and for HIV infection and 
AIDS among children aged 18 months to <13 years -- United States, 
2008. Morbidity and Mortality Weekly Report 2008; 57(RR-10):1-8. 
(available at http://www.cdc.gov/mmwr/PDF/rr/rr5710.pdf).
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    We propose to update the information on definitive laboratory tests 
in current section 14.00F1a that we use to document HIV infection as 
follows:
     Replace the ELISA screening test in current section 
14.00F1a(i) with the more inclusive and commonly used term of enzyme 
immunoassay (EIA) in proposed section 14.00F1a(i);
     Combine positive ``viral load'' tests in current section 
14.00F1a(ii) and HIV DNA detection by polymerase chain reaction (PCR) 
in current section 14.00F1a(iii) under the more commonly used term of 
HIV nucleic acid (DNA or RNA) detection test in proposed section 
14.00F1a(ii);
     Replace the descriptive language of an HIV antigen test in 
current section 14.00F1a(iv) with the specific term of HIV p24 antigen 
test in proposed section 14.00F1a(iii);
     Replace the terminology in current section 14.00F1a(v) 
with simpler terminology in proposed section 14.00F1a(iv) regarding HIV 
in viral culture; and
     Redesignate current section 14.00F1a(vi) for ``[o]ther 
tests that are highly specific for detection of HIV and that are 
consistent with the prevailing state of medical knowledge'' as proposed 
section 14.00F1a(v).
    We propose to remove the guidance on other acceptable documentation 
of HIV infection in current section 14.00F1b since we would no longer 
accept nondefinitive laboratory tests or methods to document HIV 
infection. We propose to move the guidance in current section 14.00F1--
that we will make every reasonable effort to obtain the results of 
laboratory testing--to proposed section 14.00F1b. We also explain in 
this section that we would not purchase laboratory testing to establish 
whether you have HIV infection.
    We propose to add guidance in section 14.00F1c to explain what 
documentation we require to document a diagnosis of HIV infection when 
we do not have a copy of a definitive laboratory test(s).
    We propose to remove the information on CD4 tests in current 
section 14.00F2 because it contains general information that our 
adjudicators do not need, is inconsistent with our proposed requirement 
to document HIV infection by definitive laboratory test(s), and does 
not reflect the CD4 count or CD4 percentage criteria in proposed 
listings 14.11F and 14.11G. We explain how we would use CD4 
measurements in the proposed

[[Page 10732]]

listings in proposed sections 14.00F4 and 14.00F5.
    We propose to redesignate and revise current section 14.00F3 as 
proposed section 14.00F2. For the same reason articulated in proposed 
section 14.00F1a for the documentation of HIV infection, we would 
require positive findings on definitive laboratory tests to document a 
manifestation of HIV infection in proposed section 14.00F2a. This 
change is consistent with the current prevailing state of medical 
knowledge and clinical practice that requires positive findings on a 
definitive laboratory test(s) to diagnose a manifestation of HIV 
infection.\11\
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    \11\ Id.
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    We propose to move the guidance in current section 14.00F3a, that 
we will make every reasonable effort to obtain the results of 
laboratory testing, to proposed section 14.00F2b. We also explain in 
this section that we would not purchase laboratory testing to establish 
whether you have a manifestation of HIV infection.
    We propose to move and revise the guidance in current section 
14.00F3a on how to document a manifestation of HIV infection when we do 
not have a copy of a definitive laboratory test(s) to proposed section 
14.00F2c.
    We also propose to remove the guidance on other acceptable 
documentation of manifestations of HIV infection in current section 
14.00F3b since we would no longer accept nondefinitive laboratory tests 
to document manifestations of HIV infection. We also propose to remove 
for the same reason the guidance for other acceptable documentation in 
current section 14.00F3b(i) for Pneumocystis pneumonia, current section 
14.00F3b(ii) for Cytomegalovirus, current section 14.00F3b(iii) for 
toxoplasmosis of the brain, and current section 14.00F3b(iv) for 
candidiasis of the esophagus.
    We propose to add information in proposed section 14.00F3 about 
disorders connected with HIV infection that reflects proposed new 
listings 14.11A for multicentric Castleman disease, 14.11B for primary 
central nervous system lymphoma, 14.11C for primary effusion lymphoma, 
14.11D for progressive multifocal leukoencephalopathy, and 14.11E for 
pulmonary Kaposi sarcoma.
    We provide information on multicentric Castleman disease (MCD) in 
proposed section 14.00F3a. We explain what distinguishes MCD from 
localized (or unicentric) Castleman disease. We also explain what we 
would require to establish the diagnosis of MCD.
    We provide information on primary central nervous system lymphoma 
(PCNSL) in proposed section 14.00F3b. We explain where it originates 
and what we would require to establish the diagnosis of PCNSL.
    We provide information on primary effusion lymphoma (PEL) in 
proposed section 14.00F3c. We explain what we would require to 
establish the diagnosis of PEL.
    We provide information on progressive multifocal 
leukoencephalopathy (PML) in proposed section 14.00F3d. We identify 
clinical findings associated with PML. We also explain what we would 
require to establish the diagnosis of PML.
    We provide information on pulmonary Kaposi sarcoma (PKS) in 
proposed section 14.00F3e. We explain how this form of Kaposi sarcoma 
differs from other forms of the condition and what we would require to 
establish the diagnosis of PKS.
    We propose to remove the guidance on HIV infection manifestations 
specific to women in current section 14.00F4 for two reasons. First, 
the proposed HIV infection listings do not contain criteria that are 
gender-specific. We would evaluate the manifestations of HIV infection 
using the same criteria regardless of a person's gender. Second, while 
we recognize that manifestations of HIV infection may still affect a 
person's ability to function, we believe that the guidance in the 
following sections instruct our adjudicators to consider signs, 
symptoms, and effects of treatment when evaluating the severity of a 
person's HIV infection and resulting functional limitations.
     Current section 14.00G5, How we evaluate the effects of 
treatment for HIV infection on your ability to function.
     Current section 14.00H, How do we consider your symptoms, 
including your pain, severe fatigue, and malaise?
    We would add information in proposed section 14.00F4 that reflects 
proposed new listing 14.11F. We explain that we would need one 
measurement of the absolute CD4 count to evaluate HIV infection under 
the proposed listing. We explain that we would require the absolute CD4 
count to occur within the period we are considering in connection with 
an application or continuing disability review. We also explain that if 
there were more than one measurement of the absolute CD4 count within 
this period, we would use the lowest one to evaluate HIV infection 
under the proposed listing.
    We propose to remove the guidance in current section 14.00F5 that 
explains how we evaluate involuntary weight loss for the purposes of 
current listing 14.08H for HIV wasting syndrome. We propose to remove 
this listing based on recommendations from the IOM report; therefore, 
we would no longer need the guidance in current section 14.00F5. Our 
adjudicators, however, would continue to consider involuntary weight 
loss resulting from HIV infection under our listing for repeated 
manifestations of HIV infection (proposed listing 14.11I, which is 
redesignated from current listing 14.08K). We also propose to remove 
the guidance in this section, which explains that we can evaluate HIV 
infection affecting the digestive system under current listing 5.08. It 
is redundant since we have similar guidance in current section 
14.00J2e.
    We would add information in proposed section 14.00F5 that reflects 
proposed new listing 14.11G. We explain how we would use a CD4 
measurement (absolute count or percentage) and either a measurement of 
body mass index (BMI) or hemoglobin to evaluate HIV infection under the 
proposed listing. We also explain that we would require the 
measurements of CD4 (absolute count or percentage) and BMI or 
hemoglobin to occur within the period we are considering in connection 
with an application or continuing disability review. We also explain 
that if there is more than one measurement of CD4 (absolute count or 
percentage), BMI, or hemoglobin within this period, we would use the 
lowest one to evaluate HIV infection under the proposed listing.
    We propose to add information in new section 14.00F6 on how to 
evaluate complications of HIV infection requiring hospitalization under 
proposed listing 14.11H. We provide examples of complications that may 
result in hospitalization in proposed section 14.00F6a. We explain in 
proposed section 14.00F6b our requirements for evaluating 
hospitalizations under the proposed listing.
    We propose to add information in new section 14.00F7 describing 
HIV-associated dementia (HAD). We explain that we evaluate HAD under 
current listing 12.02.

Section 14.00I--How do we use the functional criteria in these 
listings?

    We propose to revise current section 14.00I by making a minor 
change to reflect the redesignation of current listing 14.08K as 
proposed listing 14.11I and clarifying what we mean by ``marked'' in 
proposed section 14.00I5.
    We would remove the description of ``marked'' as ``more than 
moderate but less than extreme'' and replace it with an explanation 
based on the language

[[Page 10733]]

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, it would be unnecessary 
to state that ``marked'' falls between ``moderate'' and ``extreme.''

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

    We propose to make the following changes to the HIV infection 
listing for adults:
     Remove current listings 14.08A-J;
     Add proposed listings 14.11A-H; and
     Redesignate and revise current listing 14.08K as proposed 
listing 14.11I.
    We are proposing to remove current listings 14.08A-J based on our 
program experience, advances in medical knowledge, and recommendations 
from the IOM report. They are substantially the same listings that we 
published in 1993 and, as a result of advances in the treatment of HIV 
infection, some of the current listings no longer describe impairments 
that are of listing-level severity. This includes current HIV infection 
listings 14.08A, 14.08B, 14.08C, 14.08D, 14.08F, and 14.08J that the 
IOM report recommended we remove from the listings.
    The IOM report recommended that we evaluate malignant neoplastic 
diseases associated with HIV infection, other than primary central 
nervous system lymphoma, primary effusion lymphoma, and pulmonary 
Kaposi sarcoma, under the malignant neoplastic diseases listings in 
13.00. We, therefore, propose to remove current listing 14.008E for 
evaluating malignant neoplasms associated with HIV infection and to add 
proposed listings 14.11B for primary central nervous system lymphoma, 
14.11C for primary effusion lymphoma, and 14.11E for pulmonary Kaposi 
sarcoma. We also propose to revise our guidance in current section 
13.00A to indicate how we evaluate malignant neoplastic diseases 
associated with HIV infection in proposed section 13.00A.
    We propose to remove current listing 14.08G for evaluating HIV 
encephalopathy, also known as HAD, which we would evaluate under 
current listing 12.02. We also propose to add the revision 
``neurocognitive limitation (including dementia not meeting the 
criteria in 12.02)'' in proposed listing 14.11I. We would add this 
revision to indicate that we may consider neurocognitive limitations 
associated with HIV infection that do not satisfy the criteria in 
current listing 12.02 under proposed listing 14.11I.
    We propose to remove current listings 14.08H for HIV wasting 
syndrome and 14.08I for diarrhea for the same reason. As noted in the 
IOM report, it is uncommon that these manifestations alone are 
predictive of disability, but they may be persistent and result in a 
marked level of limitation(s) in activities of daily living, 
maintaining social functioning, or completing tasks in a timely manner 
due to deficiencies in concentration, persistence, or pace. We consider 
these areas of functioning under current listing 14.08K that we propose 
to redesignate as listing 14.11I. We therefore propose to remove 
current listings 14.08H and 14.08I and evaluate these manifestations 
under proposed listing 14.11I.
    We describe proposed HIV infection listings 14.11A-I for adults 
below.

Listings 14.11A-E

    We propose to add listings for the following HIV-associated 
disorders:
     Multicentric Castleman disease (14.11A);
     Primary central nervous system lymphoma (14.11B);
     Primary effusion lymphoma (14.11C);
     Progressive multifocal leukoencephalopathy (14.11D); and
     Pulmonary Kaposi sarcoma (14.11E).
    Even with the advances in HIV treatment, there are people with HIV 
infection who continue to develop very aggressive and generally 
untreatable conditions. We propose, therefore, to add listings 14.11A-E 
for these conditions due to their aggressive nature and lack of 
response to treatment that result in loss of function consistent with a 
listing-level impairment when associated with HIV infection.
    In addition to the proposed listings, we added these disorders to 
our list of Compassionate Allowances (CAL) conditions. CAL are a way of 
quickly identifying diseases and other medical conditions that 
invariably qualify under the Listings of Impairments based on minimal 
objective medical information. For more information about CAL, please 
visit our Web site at http://www.ssa.gov/compassionateallowances/.

Listing 14.11F, Absolute CD4 Count of 50 Cells/mm\3\ or Less

    We propose to add listing 14.11F for absolute CD4 count of 50 
cells/mm\3\ or less because it is predictive of disease progression, 
morbidity, and mortality that is consistent with a listing-level 
impairment when associated with HIV infection. We would require one 
absolute CD4 count of 50 cells/mm\3\ or less to satisfy this listing.

Listing 14.11G, Absolute CD4 Count of Less Than 200 Cells/mm\3\, or CD4 
Percentage of Less Than 14 Percent

    We propose to add listing 14.11G with criteria for specific 
combinations of values (either absolute CD4 count or CD4 percentage, 
and either BMI or hemoglobin measurement) because either of these 
combinations of values is indicative of a loss of function that is 
consistent with a listing-level impairment when associated with HIV 
infection. We would require only one set of values at the specified 
listing-level to satisfy this listing.

Listing 14.11H, Complication(s) of HIV Infection Requiring at Least 
Three Hospitalizations

    We propose to add listing 14.11H to provide criteria that recognize 
the medical severity of complications of HIV infection that lead to at 
least three hospitalizations in a 12-month period. Each hospitalization 
would need to last at least 48 hours, including hours in a hospital 
emergency department immediately before the hospitalization, with at 
least 30 days between hospitalizations. We would require that each 
hospitalization last at least 48 hours because we believe this period 
is indicative of a severe complication of HIV infection. We would 
include the hours the person spends in the emergency department 
immediately before hospital admission because the person is likely to 
be receiving the same intensity of care as he or she will receive in 
the hospital.

Listing 14.11I, Repeated Manifestations of HIV Infection

    We propose to redesignate and revise current listing 14.08K as 
proposed listing 14.11I. We would revise the listing to reflect the 
changes that we have made in proposed listings 14.11A-H. We would also 
expand our guidance on manifestations we evaluate under the listing by 
adding ``distal sensory polyneuropathy,'' ``infections (bacterial, 
fungal, parasitic, or viral),'' ``lipodystrophy (lipoatrophy or 
lipohypertrophy),'' and ``osteoporosis'' as new examples based on 
recommendations from the IOM report

[[Page 10734]]

and our program experience. In addition, we would revise ``cognitive or 
other mental limitation'' used in current listing 14.08K to 
``neurocognitive limitation (including dementia not meeting the 
criteria in 12.02).'' We would do this because it is a better 
description of the limitation associated with HIV infection and to 
indicate that we may consider neurocognitive limitations associated 
with HIV infection that do not satisfy the criteria in current listing 
12.02 under proposed listing 14.11I.

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

    The same basic rules for evaluating immune system disorders in 
adults also apply to children. Except for minor editorial changes to 
make the text specific to children, we have repeated much of the 
introductory text of proposed section 14.00 in the introductory text of 
proposed section 114.00. Since we have already described these proposed 
rules under the explanation of proposed section 14.00, we describe here 
only the significant sections of the proposed rules that are unique to 
children or that require further explanation.
    In proposed section 114.00F1a(iii), we clarify that the HIV p24 
antigen test is a definitive laboratory test for documentation of HIV 
infection for any child age 1 month or older.
    We propose to remove current section 114.00F1a(vi) because the 
immunoglobulin serological assay that we list in this section is no 
longer used to document HIV infection.
    We propose to remove current section 114.00F1b because the 
laboratory tests and findings described in this section no longer 
represent the current standard of medical practice for documenting HIV 
infection and have been supplanted by the laboratory tests listed in 
proposed section 114.00F1a.
    In proposed section 114.00F4, we explain that we will require one 
measurement of an absolute CD4 count for children from age 5 to 
attainment of age 18, or CD4 percentage for children from birth to 
attainment of age 5, to evaluate HIV infection under proposed listing 
114.11F.
    We propose to add section 114.00F5. We explain we would evaluate 
linear growth failure under the growth impairment listing in 100.00. We 
also explain that if a child's growth failure does not meet or 
medically equal a listing in 100.00, we will consider whether the 
child's HIV infection meets or medically equals the criteria of a 
listing in another body system. We provide an example of when we would 
evaluate a child's HIV infection under the digestive system listing in 
105.00.
    We propose to move and revise the guidance in current section 
114.00F4 to proposed section 114.00F7. We would remove the examples of 
onset and HIV manifestations at different ages in current section 
114.00F4a. This information was useful when we first published the HIV 
infection listings in 1993. Our adjudicators, however, no longer need 
this information based on our extensive program experience evaluating 
HIV infection under our listings. We would revise the information about 
neurological and growth abnormalities under proposed sections 114.00F5 
and 114.00F7.
    We propose to redesignate and revise current section 114.00F4b as 
proposed section 114.00F7. We would primarily retain the information in 
the current section with editorial changes for clarity. We would 
explain, however, that the loss of acquired developmental milestones in 
infants and young children is also known as developmental regression. 
We would also explain that we evaluate developmental delays without 
regression under 111.00.
    We would remove current section 114.00F4c because it provides 
information on evaluating bacterial infections under current listing 
114.08A4 and pelvic inflammatory disease under current listing 
114.08A5. We would no longer need this information because we are 
proposing to remove both of the listings.

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

    The following is a description of the significant proposed changes 
to the immune system disorders listings for children when they are 
different from the changes we propose for adults or require additional 
explanation.
    We propose to remove current listing 114.08H for evaluating growth 
disturbance with an involuntary weight loss (or failure to gain weight 
at an appropriate rate for age) that meets specified criteria. We would 
remove this listing because, as we explain in proposed section 
114.00F5, we would evaluate this impairment under a growth impairment 
listing in 100.00 or a digestive system listing in 105.00.
    We propose to remove current listing 114.08J for evaluating 
lymphoid interstitial pneumonia/pulmonary lymphoid hyperplasia (LIP/PLH 
complex). We propose to remove this listing based on the recommendation 
in the IOM report that LIP/PLH complex no longer describes an 
impairment of listing-level severity.

Listing 114.11F, Absolute CD4 Count or CD4 Percentage

    Proposed listing 114.11F for children is similar to proposed 
listing 14.11F for adults, except for the CD4 percentage requirement 
for children from birth to the attainment of age 5. We would require a 
CD4 percentage in proposed listing 114.11F1 since it fluctuates less 
than absolute CD4 counts for children prior to the attainment of age 5 
and is a more consistent and reliable measurement of immune 
suppression. We would require the same absolute CD4 count of 50 cells/
mm\3\ or less for children age 5 to the attainment of age 18 in 
proposed listing 114.11F2 as for adults in proposed 14.11F because 
children in that age range have CD4 counts comparable to those levels 
found in adults.

Listing 114.11H, A Neurological Manifestation of HIV Infection

    We propose to redesignate and revise current listing 114.08G as 
proposed listing 114.11H. In proposed listing 114.11H1, we would remove 
``marked delay in achieving'' developmental milestones because we 
evaluate infants and young children with serious developmental delays 
without regression under 111.00. We would also add ``documented on two 
examinations at least 60 days apart'' to the loss of previously 
acquired developmental milestones or intellectual ability (including 
the sudden onset of a new learning disability) in proposed listing 
114.11H1. This chronicity supports the severity of a listing-level 
impairment.
    We propose to redesignate and revise current listing 114.08G3 as 
proposed listing 114.11H2. We would add ``documented on two 
examinations at least 60 days apart'' for the same reason as in 
proposed listing 114.11H1.
    We propose to redesignate and revise current listing 114.08G2 as 
proposed listing 114.11H3 for microcephaly and H4 for brain atrophy. In 
proposed listing 114.11H3, we change ``acquired microcephaly'' used in 
current listing 114.08G2 to ``microcephaly'' because ``acquired'' is 
unnecessary. We would evaluate any finding of microcephaly associated 
with HIV infection under this listing for children. We also specify the 
percentile of head circumference that would establish listing-level 
severity and add the same requirement of ``documented on two 
examinations at least 60 days apart'' as in the proposed listings 
114.11H1 and H2 for the same reason.

[[Page 10735]]

    In proposed listing 114.11H4, we clarify that we document brain 
atrophy by appropriate medically acceptable imaging.

Why are we not proposing a listing with functional criteria for 
children with HIV infection?

    On August 19, 2010, we published a Notice of Proposed Rulemaking 
(NPRM) for evaluating mental disorders.\12\ We proposed in the NPRM to 
remove each of the current listings in 114.00 of the immune system 
disorders that cross-refer to the functional criteria in current 
listings 112.02 and 112.12. We proposed to remove these listings 
without replacement, including current listing 114.08L for HIV 
infection.
---------------------------------------------------------------------------

    \12\ 75 FR 51336.
---------------------------------------------------------------------------

    Under current listing 114.08L, we use the functional criteria in 
the childhood mental disorders listings to evaluate both physical and 
mental limitations that result from HIV infection. Due to the changes 
that we are proposing in the mental disorders listing, it would no 
longer be appropriate to cross-refer to the criteria in them. Moreover, 
we may find children disabled under the Supplemental Security Income 
program based on functional equivalence to the listings. Functional 
equivalence considers their functional limitations in domains that we 
designed to cover all childhood physical and mental functioning.
    We are not proposing a similar change to current adult listing 
14.08K because it contains specific criteria for evaluating functioning 
without cross-referring to the mental disorders listings. We are still 
considering the comments that we received in response to the NPRM for 
evaluating mental disorders and we will address them in the final 
rules.

Other Changes

    We also propose conforming changes to current sections 5.00D4a(i), 
5.00D4b(i) and (ii), 105.00D4a(i), and 105.00D4b(i) and (ii) of the 
digestive disorders listings. We would revise these sections to clarify 
how comorbid disorders may affect the clinical course of viral 
hepatitis infection(s) and to provide information on diagnostic tests 
and treatments for chronic hepatitis B infections.
    We also propose to revise current sections 8.00D3 and 108.00D3 of 
the skin disorders listings to indicate that we evaluate HIV infection 
under proposed listings 14.11 and 114.11.
    Finally, we propose to revise current sections 13.00A and 113.00A 
of the malignant neoplastic diseases listings. We would revise these 
sections to indicate that we evaluate primary central nervous system 
lymphoma, primary effusion lymphoma, and pulmonary Kaposi sarcoma 
associated with HIV infection under proposed listings 14.11B, C, or E 
and 114.11B, C, or E. We also propose to evaluate all other malignant 
neoplasms associated with HIV infection under the current listings for 
the malignant neoplastic diseases body system or under proposed 
listings 14.11F-I and 114.11F-H of the immune system disorders body 
system.

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

    The Act authorizes us to make rules and regulations and to 
establish necessary and appropriate procedures to implement them.\13\
---------------------------------------------------------------------------

    \13\ 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1).
---------------------------------------------------------------------------

How long would these rules be effective?

    If we publish these proposed rules as final rules, they will 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, e.g., grouping and order of sections, use of headings, 
paragraphing?

When will we start to use these rules?

    We will not use these rules until we evaluate public comments and 
publish final rules in the Federal Register. All final rules we issue 
include an effective date. We will continue to use our current rules 
until that date. If we publish final rules, we will include a summary 
of those relevant comments we received along with responses and an 
explanation of how we will apply the new rules.

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We have 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, and was subject to OMB review.

Regulatory Flexibility Act

    We certify that these proposed rules will not have a significant 
economic impact on a substantial number of small entities because they 
affect individuals only. Therefore, the Regulatory Flexibility Act, as 
amended, does not require us to prepare a regulatory flexibility 
analysis.

Paperwork Reduction Act

    These proposed rules do not create any new or affect any existing 
collections, and therefore, do not require OMB approval under the 
Paperwork Reduction Act.

References

    We consulted the following references when we developed these 
proposed rules. Some of the references include a DOI name. You can 
access a reference with a DOI name by typing the DOI name in the DOI 
finder at http://dx.doi.org.

Bartlett, John G., Joel E. Gallant, and Paul A. Pham. (2009). 
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Solutions, LLC.
Belperio, P. S., & Rhew, D. C. (2004). Prevalence and outcomes of 
anemia in individuals. The American Journal of Medicine, 116, 27S-
43S. doi:10.1016/j.amjmed.2003.12.010.
Berger, J. (2010). Progressive multifocal encephalopathy. In D. 
Schlossberg (Ed.), Current Therapy of Infectious Disease (pp. 1-6). 
Philadelphia, PA: W.B. Saunders, Harcourt Health Sciences. (Original 
work published 2002).
Boyd, K., Dunn, D., & Castro, H., et al. (2010). Discordance between 
CD4 cell count and CD4 cell percentage: Implications for when to 
start antiretroviral therapy in HIV-1 infected children. AIDS, 
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Branson, B. M., Handsfield, H. H., Lampe, M. A., Janssen, R. S., 
Taylor, A. W., Lyss, S. B., et al. (2006). Revised recommendations 
for HIV testing of adults, adolescents, and pregnant women in 
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Calis, C., et al. (2008). HIV-associated anemia in children: a 
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Callens, F., Shabani, N., Lusiama, J., Lelo, P., Kitetlel, F., 
Colebunders, R., Gizlice, Z., Edmonds, A., Van Rie, A. & Behets, F. 
(2009). Mortality and associated factors after initiation of 
pediatric antiretroviral treatment in the Democratic Republic of the 
Congo. The Pediatric Infectious Disease Journal, 28(1), 35-40.
Campsmith, M. L., Rhodes, P. H., Hall, I., & Green, T. A. (2009). 
Undiagnosed HIV prevalence among adults and adolescents in the 
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Centers for Disease Control. Revision of the CDC surveillance case 
definition for acquired immunodeficiency syndrome. Morbidity and 
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Centers for Disease Control and Prevention. Appendix: Revised 
surveillance case definition for HIV infection. Morbidity and 
Mortality Weekly Report 1999; 48(RR-13): 29-31. Retrieved from: 
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm.
Centers for Disease Control and Prevention. Revised surveillance 
case definitions for HIV infection among adults, adolescents, and 
children aged <18 months and for HIV infection and AIDS among 
children aged 18 months to <13 years--United States, 2008. Morbidity 
and Mortality Weekly Report 2008; 57(RR-10):1-8. Retrieved from 
http://www.cdc.gov/mmwr/PDF/rr/rr5710.pdf.
Centers for Disease Control and Prevention. Guidelines for the 
prevention and treatment of opportunistic infections among HIV-
exposed and HIV-infected children: Recommendations from CDC, the 
National Institutes of Health, the HIV Medicine Association of the 
Infectious Diseases Society of America, the Pediatric Infectious 
Diseases Society, and the American Academy of Pediatrics. Morbidity 
and Mortality Weekly Report 2009; 58(RR-11):1-176. Retrieved from: 
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Chen, Y., Rahemtullah, A., & Hochberg, E. (2007). Primary effusion 
lymphoma. The Oncologist, 12(5), 569-576. doi:10.1634/
theoncologist.12-5-569.
Collins, I., Jourdain, G., Hansudewechakul, R., Kanjanavanit, S., 
Hongsiriwon, S., Ngampiyasakul, C., Duong, T., Le Coeur, S., Jaffar, 
S. & Lallemant, M. (2010). Long-term survival of HIV-infected 
children receiving antiretroviral therapy in Thailand: A 5-year 
observational cohort study. Clinical Infectious Diseases, 51(12), 
1449-1457. doi:10.1086/657401.
Corcoran, C., & Grinspoon, S. (1999). Treatments for wasting in 
patients with the acquired immune deficiency syndrome. The New 
England Journal of Medicine, 340 (22), 1740-1750. doi:10.1056/
NEJM199906033402207.
Denny, T., Yogev, R., Gelman, R. et al. (1992). Lymphocyte subsets 
in healthy children during the first 5 years of life. JAMA, 267(11), 
1484-1488. doi:10.1001/jama.1992.03480110060034.
Dunn, D., Woodburn, P., Duong, T., Peto, J., Phillips, A., Gibb, D., 
& Porter, K. (2008). Current CD4 cell count and the short-term risk 
of AIDS and death before the availability of effective 
antiretroviral therapy in HIV-infected children and adults. The 
Journal of Infectious Diseases, 197(3), 398-404. doi:10.1086/524686.
European Collaborative Study. (2005). Age-related standards for 
total lymphocyte, CD4 and CD8 T-cell counts in children born in 
Europe. The Pediatric Infectious Disease Journal, 24(7), 595-600.
HIV Paediatric Prognostic Markers Collaborative Study Group. (2003). 
Short-term risk of disease progression in HIV-1-infected children 
receiving no antiretroviral therapy or zidovudine monotherapy: A 
meta-analysis. The Lancet, 362(9396), 1605-1611. doi:10.1016/S0140-
6736(03)14793-9.
Human Immunodeficiency Virus (HIV) Infection in Children. (2007). In 
Merck Manual Home Health Handbook. Retrieved from: http://www.merckmanuals.com/home/print/sec23/ch273/ch273e.html.
Institute of Medicine. (2010). HIV and Disability: Updating the 
Social Security Listings. Washington, DC: The National Academies 
Press. Retrieved from: http://www.nap.edu/catalog.php?record_id=12941#toc.
Justice, A., Gange, S., Tate, J., Jacobson, L., Gebo, K., Althoff, 
K., . . . Moore, R. (2010). Report to the Institute of Medicine 
committee evaluating disability criteria for those with HIV 
infection. HIV and Disability: Updating the Social Security 
Listings, Institute of Medicine, Washington, DC: The National 
Academies Press.
Justice, A., McGinnis, K., Braithwaite, R., May, M., Covinsky, K., 
Roberts, M., et al. (2010). Towards a combined prognostic index for 
survival in HIV infection: The role of `non-HIV' biomarkers. HIV 
Medicine, 11(2), 143-151. Retrieved from: http://www.medscape.com/viewarticle/715224.
Kaplan, J. E., Benson, C., & Masur, H., et al. (2009). Guidelines 
for prevention and treatment of opportunistic infections in HIV-
infected adults and adolescents: Recommendations from CDC, the 
National Institutes of Health, and the HIV Medicine Association of 
the Infectious Diseases Society of America. Morbidity and Mortality 
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Kapogiannis, B., Soe, M., & Nesheim, S. et al. (2008). Trends in 
bacteremia in the pre- and post-highly active antiretroviral therapy 
era among HIV-infected children in the U.S. Perinatal AIDS 
Collaborative Transmission Study (1986-2004). Pediatrics, 121(5), 
e1229-e1239. doi:10.1542/peds.2007-0871.
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Kimmel, A. D., Goldie, S. J., Walensky, R. P., Losina, E., 
Weinstein, M. C., Paltiel, A. D., . . . Freedberg, K. (2005). 
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initiation of antiretroviral therapy in HIV-infected patients. 
Antiviral Therapy, 10(1), 41-52. Retrieved from: http://www.intmedpress.com/serveFile.cfm?sUID=1a6a19e0-feb5-47c4-bbc5-aa87ffd4035b.
Lodi, S., Guiguet, M., Costagliola, D., Fisher, M., Luca, A. d., & 
Porter, K. (2010). Kaposi sarcoma incidence and survival among HIV-
infected homosexual men after HIV seroconversion. Journal of the 
National Cancer Institute, 102(11), 784-792. doi:10.1093/jnci/
djq134.
Mandell, Bennett, & Dolin (2007). Clinical findings: acute 
retroviral syndrome. Principles and Practice of Infectious Diseases, 
6th ed., (pp. 1-26). Elsevier Inc. (Original work published 2005).
Mocroft, A., Ledergerber, B., Zilmer, K., Kirk, O., Hirschel, B., 
Viard, J. P., . . . Lundgren, J. D. (2007). Short-term clinical 
disease progression in HIV-1-positive patients taking combination 
antiretroviral therapy: the EuroSIDA risk-score. AIDS, 21(14), 1867-
1875. Retrieved from: http://www.medscape.com/viewarticle/562494.
Mocroft, A., & Lundgren, J. D. (2009). Use of risk equations for 
predicting disease progression in HIV infection. Clinical Infectious 
Diseases, 2009(48), 951-953. doi:10.1086/597355.
Mylona, E., Baraboutis, I., Lekakis, L., Georgiou, O., 
Papastamopoulos, V., & Skoutelis, A. (2008). Multicentric 
Castleman's disease in HIV infection: A systematic review of the 
literature. AIDS Reviews, 10(1), 25-35. Retrieved from: http://www.aidsreviews.com/files/2008_10_1_025-035.pdf.
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predicts new World Health Organization stage 3 and 4 events in HIV-
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Gloghini, A., . . . Tirelli, U. (2003). Clinical features and 
outcome of primary effusion lymphoma in HIV-infected patients: A 
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et al. (2009). Short-term clinical disease progression in HIV-
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B. (2008). Epidemiology, pathophysiology and treatment of Kaposi 
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Lymphomas. Retrieved from: http://emedicine.medscape.com/article/1389907.

    We included these references in the rulemaking record for these 
proposed rules and will make them available for inspection by 
interested individuals who make arrangements with the contact person 
identified above.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002, Social Security--Retirement 
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006, 
Supplemental Security Income).

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure; Blind, Disability benefits; 
Old-Age, Survivors, and Disability Insurance; Reporting and 
recordkeeping requirements; Social Security.

    Dated: February 18, 2014.
Carolyn W. Colvin,
Acting Commissioner of Social Security.

    For the reasons set out in the preamble, we propose to amend 20 CFR 
chapter III, part 404 subpart P as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

Subpart P--Determining Disability and Blindness

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority: Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a), 
(i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security 
Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a), (i), and 
(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).

0
2. Amend appendix 1 to subpart P of part 404 by:
0
a. Revising item 15 of the introductory text before part A;
0
b. Adding a sentence to paragraph 5.00D4a(i) of part A;
0
c. Revising paragraph 5.00D4b of part A;
0
d. Revising the last sentence of paragraph 8.00D3 of part A;
0
e. Revising paragraph 13.00A of part A;
0
f. Revising paragraphs 14.00A4, 14.00F, 14.00I1, and 14.00I5 of part A;
0
g. Removing and reserving paragraph 14.08 of part A;
0
h. Adding paragraph 14.11 to part A;
0
i. Adding a sentence to paragraph 105.00D4a(i) of part B;
0
j. Revising paragraph 105.00D4b of part B;
0
k. Revising the last sentence of paragraph 108.00D3 of part B;
0
l. Revising paragraph 113.00A of part B;
0
m. Revising paragraphs 114.00A4 and 114.00F of part B, and
0
n. Removing and reserving paragraph 114.08 of part B; and
0
o. Adding paragraph 114.11 to part B.
    The revisions and additions read as follows:

APPENDIX 1 TO SUBPART P OF PART 404--LISTING OF IMPAIRMENTS

* * * * *
    15. Immune System Disorders (14.00 and 114.00): [date 5 years 
from the effective date of the final rule].
* * * * *

Part A

* * * * *

5.00 DIGESTIVE SYSTEM

* * * * *
    D. How do we evaluate chronic liver disease?
* * * * *
    4. Chronic viral hepatitis infections.
    a. General.
    (i) * * * Comorbid disorders, such as HIV infection, may 
accelerate the clinical course of viral hepatitis infection(s) or 
may result in a poorer response to medical treatment.
* * * * *
    b. Chronic hepatitis B virus (HBV) infection.
    (i) Chronic HBV infection can be diagnosed by the detection of 
hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV 
DNA) in the blood for at least 6 months. In addition, detection of 
the hepatitis B e antigen (HBeAg) suggests an increased likelihood 
of progression to cirrhosis, ESLD, and hepatocellular carcinoma. 
(HBeAg may also be referred to as ``hepatitis B early antigen'' or 
``hepatitis B envelope antigen.'')
    (ii) The therapeutic goal of treatment is to suppress HBV 
replication and thereby prevent progression to cirrhosis, ESLD, and 
hepatocellular carcinoma. Treatment usually includes interferon 
injections, oral antiviral agents, or a combination of both. Common 
adverse effects of treatment are the same as noted in 5.00D4c(ii) 
for HCV, and generally end within a few days after treatment is 
discontinued.
* * * * *

8.00 SKIN DISORDERS

* * * * *
    D. How do we assess impairments that may affect the skin and 
other body systems?
* * * * *
    3. * * * We evaluate SLE under 14.02, scleroderma under 14.04, 
Sj[ouml]gren's syndrome under 14.10, and HIV infection under 14.11.
* * * * *

13.00 MALIGNANT NEOPLASTIC DISEASES

    A. What impairments do these listings cover? We use these 
listings to evaluate all malignant neoplasms except certain 
neoplasms associated with human immunodeficiency virus (HIV) 
infection. We use the criteria in 14.11B to evaluate primary central 
nervous system lymphoma, 14.11C to evaluate primary effusion 
lymphoma, and 14.11E to evaluate pulmonary Kaposi

[[Page 10738]]

sarcoma if you also have HIV infection. We evaluate all other 
malignant neoplasms associated with HIV infection, for example, 
Hodgkin's lymphoma or non-pulmonary Kaposi sarcoma, under this body 
system or under 14.11F-I in the immune system disorders body system.
* * * * *

14.00 IMMUNE SYSTEM DISORDERS

    A. What disorders do we evaluate under the immune system 
disorders listings?
* * * * *
    4. Human immunodeficiency virus (HIV) infection (14.00F). HIV 
infection may be characterized by increased susceptibility to common 
infections as well as opportunistic infections, cancers, or other 
conditions listed in 14.11.
* * * * *
    F. How do we document and evaluate HIV infection? Any individual 
with HIV infection, including one with a diagnosis of acquired 
immune deficiency syndrome (AIDS), may be found disabled under 14.11 
if his or her impairment meets the criteria in that listing or is 
medically equivalent to the criteria in that listing.
    1. Documentation of HIV infection.
    a. We require positive findings on one or more of the following 
definitive laboratory tests:
    (i) HIV antibody screening test (for example, enzyme 
immunoassay, or EIA), confirmed by a supplemental HIV antibody test 
such as the Western blot, an immunofluorescence assay, or an HIV-1/
HIV-2 antibody differentiation immunoassay.
    (ii) HIV nucleic acid (DNA or RNA) detection test (for example, 
polymerase chain reaction, or PCR).
    (iii) HIV p24 antigen test.
    (iv) Isolation of HIV in viral culture.
    (v) Other tests that are highly specific for detection of HIV 
and that are consistent with the prevailing state of medical 
knowledge.
    b. We will make every reasonable effort to obtain the results of 
your laboratory testing. However, we will not purchase laboratory 
testing to establish whether you have HIV infection.
    c. When we do not have the results of a definitive laboratory 
test(s), we need a persuasive report from a physician that a 
positive diagnosis of your HIV infection was confirmed by an 
appropriate laboratory test(s). To be persuasive, this report must 
state that you had the appropriate definitive laboratory test(s) for 
diagnosing your HIV infection and provide the results.
    2. Documentation of the manifestations of HIV infection.
    a. We require positive findings of manifestations of HIV 
infection on culture, microscopic examination of biopsied tissue or 
other material (for example, bronchial washings), serologic tests, 
or on other generally acceptable definitive tests consistent with 
the prevailing state of medical knowledge and clinical practice.
    b. We will make every reasonable effort to obtain the results of 
your laboratory testing. However, we will not purchase laboratory 
testing to establish whether you have a manifestation of HIV 
infection.
    c. When we do not have the results of a definitive laboratory 
test(s), we need a persuasive report from a physician that a 
positive diagnosis of your manifestation of HIV infection was 
confirmed by an appropriate laboratory test(s). To be persuasive, 
this report must state that you had the appropriate definitive 
laboratory test(s) for diagnosing your manifestation of HIV 
infection and provide the results.
    3. Disorders associated with HIV infection (14.11A-E).
    a. Multicentric Castleman disease (MCD, 14.11A) affects multiple 
groups of lymph nodes and organs containing lymphoid tissue. This 
widespread involvement distinguishes MCD from localized (or 
unicentric) Castleman disease, which affects only a single set of 
lymph nodes. We require characteristic findings on microscopic 
examination of the biopsied lymph nodes to establish the diagnosis.
    b. Primary central nervous system lymphoma (PCNSL, 14.11B) 
originates in the brain, spinal cord, meninges, or eye. Imaging 
tests (for example, MRI) of the brain, while not diagnostic, may 
show a single lesion or multiple lesions in the white matter of the 
brain. We require characteristic findings on microscopic examination 
of the cerebral spinal fluid or of the biopsied brain tissue to 
establish the diagnosis.
    c. Primary effusion lymphoma (PEL, 14.11C) is also known as body 
cavity lymphoma. We require characteristic findings on microscopic 
examination of the effusion fluid or of the biopsied tissue from the 
affected internal organ to establish the diagnosis.
    d. Progressive multifocal leukoencephalopathy (PML, 14.11D) is a 
progressive neurological degenerative syndrome caused by the JC 
virus in immunosuppressed people. Clinical findings of PML include 
clumsiness, progressive weakness, and visual and speech changes. 
Personality and cognitive changes may also occur. We require 
appropriate clinical findings, characteristic white matter lesions 
on MRI, and a positive PCR test for the JC virus in the cerebral 
spinal fluid to establish the diagnosis. We also accept a positive 
brain biopsy for JC virus to establish the diagnosis.
    e. Pulmonary Kaposi sarcoma (Kaposi sarcoma in the lung, 14.11E) 
is the most serious form of Kaposi sarcoma (KS). Other internal KS 
tumors (for example, the gastrointestinal tract) have a more 
variable prognosis. We require characteristic findings on 
microscopic examination of the induced sputum or bronchoalveolar 
lavage washings, or of the biopsied transbronchial tissue, to 
establish the diagnosis.
    4. CD4 measurement (14.11F). To evaluate your HIV infection 
under 14.11F, we require one measurement of your absolute CD4 count 
(also known as CD4 count or CD4+ T-helper lymphocyte count). This 
measurement must occur within the period we are considering in 
connection with your application or continuing disability review. If 
you have more than one measurement of your absolute CD4 count within 
this period, we will use your lowest absolute CD4 count.
    5. Measurement of CD4 and either body mass index or hemoglobin 
(14.11G). To evaluate your HIV infection under 14.11G, we require 
one measurement of your absolute CD4 count or CD4 percentage and 
either a measurement of your body mass index (BMI) or hemoglobin. 
These measurements must occur within the period we are considering 
in connection with your application or continuing disability review. 
If you have more than one measurement of your CD4 (absolute count or 
percentage), BMI, or hemoglobin within this period, we will use the 
lowest of your CD4 (absolute count or percentage), BMI, or 
hemoglobin. We calculate your BMI using the formulas in 5.00G2.
    6. Complications of HIV infection requiring hospitalization 
(14.11H).
    a. Complications of HIV infection may include infections (common 
or opportunistic), cancers, and other conditions. Examples of 
complications that may result in hospitalization include: 
Depression; diarrhea; immune reconstitution inflammatory syndrome; 
malnutrition; and Pneumocystis pneumonia and other severe 
infections.
    b. Under 14.11H, we require three hospitalizations within a 12-
month period resulting from a complication(s) of HIV infection. The 
hospitalizations may be for the same complication or different 
complications of HIV infection. All three hospitalizations must 
occur within the period we are considering in connection with your 
application or continuing disability review.
    7. HIV-associated dementia (HAD). HAD (also known as AIDS 
dementia complex, HIV dementia, or HIV encephalopathy) is an 
advanced neurocognitive disorder, characterized by a significant 
decline in cognitive functioning. We evaluate HAD under 12.02.
* * * * *
    I. How do we use the functional criteria in these listings?
    1. The following listings in this body system include standards 
for evaluating the functional limitations resulting from immune 
system disorders: 14.02B, for systemic lupus erythematosus; 14.03B, 
for systemic vasculitis; 14.04D, for systemic sclerosis 
(scleroderma); 14.05E, for polymyositis and dermatomyositis; 14.06B, 
for undifferentiated and mixed connective tissue disease; 14.07C, 
for immune deficiency disorders, excluding HIV infection; 14.09D, 
for inflammatory arthritis; 14.10B, for Sj[ouml]gren's syndrome; and 
14.11I, for HIV infection.
* * * * *
    5. Marked limitation means that the symptoms and signs of your 
immune system disorder interfere seriously with your ability to 
function. Although we do not require the use of such a scale, 
``marked'' would be the fourth point on a five-point scale 
consisting of no limitation, mild limitation, moderate limitation, 
marked limitation, and extreme limitation. * * *
* * * * *
    14.01 Category of Impairments, Immune System Disorders.
* * * * *
    14.11 Human immunodeficiency virus (HIV) infection. With 
documentation as described in 14.00F1 and one of the following:

[[Page 10739]]

    A. Multicentric Castleman disease (see 14.00F3a). OR
    B. Primary central nervous system lymphoma (see 14.00F3b). OR
    C. Primary effusion lymphoma (see 14.00F3c). OR
    D. Progressive multifocal leukoencephalopathy (see 14.00F3d). OR
    E. Pulmonary Kaposi sarcoma (see 14.00F3e). OR
    F. Absolute CD4 count of 50 cells/mm\3\ or less (see 14.00F4). 
OR
    G. Absolute CD4 count of less than 200 cells/mm\3\ or CD4 
percentage of less than 14 percent (see 14.00F5), and one of the 
following:
    1. BMI measurement of less than 18.5; or
    2. Hemoglobin measurement of less than 8.0 grams per deciliter 
(g/dL). OR
    H. Complication(s) of HIV infection requiring at least three 
hospitalizations within a 12-month period and at least 30 days apart 
(see 14.00F6). Each hospitalization must last at least 48 hours, 
including hours in a hospital emergency department immediately 
before the hospitalization. OR
    I. Repeated (as defined in 14.00I3) manifestations of HIV 
infection, including those listed in 14.11A-H, but without the 
requisite findings for those listings (for example, Kaposi sarcoma 
not meeting the criteria in 14.11E), or other manifestations (for 
example, diarrhea, distal sensory polyneuropathy, glucose 
intolerance, hepatitis, infections (bacterial, fungal, parasitic, or 
viral), lipodystrophy (lipoatrophy or lipohypertrophy), muscle 
weakness, myositis, neurocognitive limitation (including dementia 
not meeting the criteria in 12.02), oral hairy leukoplakia, 
osteoporosis, pancreatitis, peripheral neuropathy) resulting in 
significant, documented symptoms or signs (for example, fever, 
headaches, insomnia, involuntary weight loss, malaise, nausea, night 
sweats, pain, severe fatigue, or vomiting) and one of the following 
at the marked level:
    1. Limitation of activities of daily living.
    2. Limitation in maintaining social functioning.
    3. Limitation in completing tasks in a timely manner due to 
deficiencies in concentration, persistence, or pace.
* * * * *

Part B

* * * * *

105.00 DIGESTIVE SYSTEM

* * * * *
    D. How do we evaluate chronic liver disease?
* * * * *
    4. Chronic viral hepatitis infections.
    a. General.
    (i) * * * Comorbid disorders, such as HIV infection, may 
accelerate the clinical course of viral hepatitis infection(s) or 
may result in a poorer response to medical treatment.
* * * * *
    b. Chronic hepatitis B virus (HBV) infection.
    (i) Chronic HBV infection can be diagnosed by the detection of 
hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV 
DNA) in the blood for at least 6 months. In addition, detection of 
the hepatitis B e antigen (HBeAg) suggests an increased likelihood 
of progression to cirrhosis, ESLD, and hepatocellular carcinoma. 
(HBeAg may also be referred to as ``hepatitis B early antigen'' or 
``hepatitis B envelope antigen.'')
    (ii) The therapeutic goal of treatment is to suppress HBV 
replication and thereby prevent progression to cirrhosis, ESLD, and 
hepatocellular carcinoma. Treatment usually includes interferon 
injections, oral antiviral agents, or a combination of both. Common 
adverse effects of treatment are the same as noted in 105.00D4c(ii) 
for HCV, and generally end within a few days after treatment is 
discontinued.
* * * * *

108.00 SKIN DISORDERS

* * * * *
    D. How do we assess impairments that may affect the skin and 
other body systems? * * *
* * * * *
    3. * * * We evaluate SLE under 114.02, scleroderma under 114.04, 
Sj[ouml]gren's syndrome under 114.10, and HIV infection under 
114.11.
* * * * *

113.00 MALIGNANT NEOPLASTIC DISEASES

    A. What impairments do these listings cover? We use these 
listings to evaluate all malignant neoplasms except certain 
neoplasms associated with human immunodeficiency virus (HIV) 
infection. If you have HIV infection, we use the criteria in 114.08E 
to evaluate carcinoma of the cervix, Kaposi sarcoma, lymphoma, and 
squamous cell carcinoma of the anal canal and anal margin. We use 
the criteria in 114.11B to evaluate primary central nervous system 
lymphoma, 114.11C to evaluate primary effusion lymphoma, and 114.11E 
to evaluate pulmonary Kaposi sarcoma if you also have HIV infection. 
We evaluate all other malignant neoplasms associated with HIV 
infection, for example, Hodgkin's lymphoma or non-pulmonary Kaposi 
sarcoma, under this body system or under 114.11F-I in the immune 
system disorders body system.
* * * * *

114.00 IMMUNE SYSTEM DISORDERS

    A. What disorders do we evaluate under the immune system 
disorders listings?
* * * * *
    4. Human immunodeficiency virus (HIV) infection (114.00F). HIV 
infection may be characterized by increased susceptibility to common 
infections as well as opportunistic infections, cancers, or other 
conditions listed in 114.11.
* * * * *
    F. How do we document and evaluate HIV infection? Any child with 
HIV infection, including one with a diagnosis of acquired immune 
deficiency syndrome (AIDS), may be found disabled under 114.11 if 
his or her impairment meets the criteria in that listing or is 
medically equivalent to the criteria in that listing.
    1. Documentation of HIV infection.
    a. We require positive findings on one or more of the following 
definitive laboratory tests:
    (i) HIV antibody screening test (for example, enzyme 
immunoassay, or EIA), confirmed by a supplemental HIV antibody test 
such as the Western blot or immunofluorescence assay, for any child 
age 18 months or older.
    (ii) HIV nucleic acid (DNA or RNA) detection test (for example, 
polymerase chain reaction, or PCR).
    (iii) HIV p24 antigen test, for any child age 1 month or older.
    (iv) Isolation of HIV in viral culture.
    (v) Other tests that are highly specific for detection of HIV 
and that are consistent with the prevailing state of medical 
knowledge.
    b. We will make every reasonable effort to obtain the results of 
your laboratory testing. However, we will not purchase laboratory 
testing to establish whether you have HIV infection.
    c. When we do not have the results of a definitive laboratory 
test(s), we need a persuasive report from a physician that a 
positive diagnosis of your HIV infection was confirmed by an 
appropriate laboratory test(s). To be persuasive, this report must 
state that you had the appropriate definitive laboratory test(s) for 
diagnosing your HIV infection and provide the results.
    2. Documentation of the manifestations of HIV infection.
    a. We require positive findings of manifestations of HIV 
infection on culture, microscopic examination of biopsied tissue or 
other material (for example, bronchial washings), serologic tests, 
or on other generally acceptable definitive tests consistent with 
the prevailing state of medical knowledge and clinical practice.
    b. We will make every reasonable effort to obtain the results of 
your laboratory testing. However, we will not purchase laboratory 
testing to establish whether you have a manifestation of HIV 
infection.
    c. When we do not have the results of a definitive laboratory 
test(s), we need a persuasive report from a physician that a 
positive diagnosis of your manifestation of HIV infection was 
confirmed by an appropriate laboratory test(s). To be persuasive, 
this report must state that you had the appropriate definitive 
laboratory test(s) for diagnosing your manifestation of HIV 
infection and provide the results.
    3. Disorders associated with HIV infection (114.11A-E).
    a. Multicentric Castleman disease (MCD, 114.11A) affects 
multiple groups of lymph nodes and organs containing lymphoid 
tissue. This widespread involvement distinguishes MCD from localized 
(or unicentric) Castleman disease, which affects only a single set 
of lymph nodes. We require characteristic findings on microscopic 
examination of the biopsied lymph nodes to establish the diagnosis.
    b. Primary central nervous system lymphoma (PCNSL, 114.11B) 
originates in the brain, spinal cord, meninges, or eye. Imaging 
tests (for example, MRI) of the brain, while not diagnostic, may 
show a single lesion or multiple lesions in the white matter

[[Page 10740]]

of the brain. We require characteristic findings on microscopic 
examination of the cerebral spinal fluid or of the biopsied brain 
tissue to establish the diagnosis.
    c. Primary effusion lymphoma (PEL, 114.11C) is also known as 
body cavity lymphoma. We require characteristic findings on 
microscopic examination of the effusion fluid or of the biopsied 
tissue from the affected internal organ to establish the diagnosis.
    d. Progressive multifocal leukoencephalopathy (PML, 114.11D) is 
a progressive neurological degenerative syndrome caused by the JC 
virus in immunosuppressed children. Clinical findings of PML include 
clumsiness, progressive weakness, and visual and speech changes. 
Personality and cognitive changes may also occur. We require 
appropriate clinical findings, characteristic white matter lesions 
on MRI, and a positive PCR test for the JC virus in the cerebral 
spinal fluid to establish the diagnosis. We also accept a positive 
brain biopsy for JC virus to establish the diagnosis.
    e. Pulmonary Kaposi sarcoma (Kaposi sarcoma in the lung, 
114.11E) is the most serious form of Kaposi sarcoma (KS). Other 
internal KS tumors (for example, the gastrointestinal tract) have a 
more variable prognosis. We require characteristic findings on 
microscopic examination of the induced sputum or bronchoalveolar 
lavage washings, or of the biopsied transbronchial tissue, to 
establish the diagnosis.
    4. CD4 measurement (114.11F). To evaluate your HIV infection 
under 114.11F, we require one measurement of your absolute CD4 count 
(also known as CD4 count or CD4+ T-helper lymphocyte count), for 
children from age 5 to attainment of age 18, or your CD4 percentage, 
for children from birth to attainment of age 5. This measurement 
(absolute CD4 count or CD4 percentage) must occur within the period 
we are considering in connection with your application or continuing 
disability review. If you have more than one CD4 measurement within 
this period, we will use your lowest absolute CD4 count or CD4 
percentage.
    5. Growth failure due to HIV immune suppression. We evaluate 
linear growth failure under a growth impairment listing in 100.00. 
If your growth failure does not meet or medically equal the criteria 
of a listing in 100.00, we will consider whether your HIV infection 
meets or medically equals the criteria of a listing in another body 
system. For example, if your HIV infection has resulted in weight 
loss or a combination of weight loss and linear growth failure, we 
will evaluate your impairment under a digestive system listing in 
105.00.
    6. Complications of HIV infection requiring hospitalization 
(114.11G).
    a. Complications of HIV infection may include infections (common 
or opportunistic), cancers, and other conditions. Examples of 
complications that may result in hospitalization include: 
Depression; diarrhea; immune reconstitution inflammatory syndrome; 
malnutrition; and Pneumocystis pneumonia and other severe 
infections.
    b. Under 114.11G, we require three hospitalizations within a 12-
month period resulting from a complication(s) of HIV infection. The 
hospitalizations may be for the same complication or different 
complications of HIV infection. All three hospitalizations must 
occur within the period we are considering in connection with your 
application or continuing disability review.
    7. Neurological manifestations specific to children (114.11H). 
The methods of identifying and evaluating neurological 
manifestations may vary depending on a child's age. For example, in 
an infant, impaired brain growth can be documented by a decrease in 
the growth rate of the head. In an older child, impaired brain 
growth may be documented by brain atrophy on a CT scan or MRI. 
Neurological manifestations in infants and young children may 
present in the loss of acquired developmental milestones 
(developmental regression) or, in school-age children and 
adolescents, the loss of acquired intellectual abilities. A child 
may demonstrate loss of intellectual abilities by a decrease in IQ 
scores, by forgetting information previously learned, by inability 
to learn new information, or by a sudden onset of a new learning 
disability. When infants and young children present with serious 
developmental delays (without regression), we evaluate the child's 
impairment(s) under 111.00.
* * * * *
    114.11 Human immunodeficiency virus (HIV) infection. With 
documentation as described in 114.00F1 and one of the following:
    A. Multicentric Castleman disease (see 114.00F3a). OR
    B. Primary central nervous system lymphoma (see 114.00F3b). OR
    C. Primary effusion lymphoma (see 114.00F3c). OR
    D. Progressive multifocal leukoencephalopathy (see 114.00F3d). 
OR
    E. Pulmonary Kaposi sarcoma (see 114.00F3e). OR
    F. Absolute CD4 count or CD4 percentage (see 114.00F4):
    1. For children from birth to attainment of age 5, CD4 
percentage of less than 15 percent; or
    2. For children age 5 to attainment of age 18, absolute CD4 
count of 50 cells/mm\3\ or less. OR
    G. Complications(s) of HIV infection requiring at least three 
hospitalizations within a 12-month period and at least 30 days apart 
(see 114.00F6). Each hospitalization must last at least 48 hours, 
including hours in a hospital emergency department immediately 
before the hospitalization. OR
    H. A neurological manifestation of HIV infection (for example, 
HIV encephalopathy or peripheral neuropathy) (see 114.00F7) 
resulting in one of the following:
    1. Loss of previously acquired developmental milestones or 
intellectual ability (including the sudden onset of a new learning 
disability), documented on two examinations at least 60 days apart; 
or
    2. Progressive motor dysfunction affecting gait and station or 
fine and gross motor skills, documented on two examinations at least 
60 days apart; or
    3. Microcephaly with head circumference that is less than the 
third percentile for age, documented on two examinations at least 60 
days apart; or
    4. Brain atrophy, documented by appropriate medically acceptable 
imaging.

[FR Doc. 2014-04124 Filed 2-25-14; 8:45 am]
BILLING CODE 4191-02-P