Revised Medical Criteria for Evaluating Immune System Disorders, 44432-44464 [06-6655]

Agencies

• Social Security Administration

[Federal Register Volume 71, Number 150 (Friday, August 4, 2006)]
[Proposed Rules]
[Pages 44432-44464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6655]



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Part IV





Social Security Administration





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20 CFR Part 404



Revised Medical Criteria for Evaluating Immune System Disorders; 
Proposed Rule

Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / 
Proposed Rules

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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

RIN 0960-AF33


Revised Medical Criteria for Evaluating Immune System Disorders

AGENCY: Social Security Administration.

ACTION: Proposed rule.

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SUMMARY: We propose to revise the criteria in the Listing of 
Impairments (the listings) that we use to evaluate claims involving 
immune system disorders. We apply these criteria when you claim 
benefits based on disability under title II and title XVI of the Social 
Security Act (the Act). The proposed revisions reflect our adjudicative 
experience, as well as advances in medical knowledge, treatment, and 
methods of evaluating immune system disorders.

DATES: To be sure your comments are considered, we must receive them by 
October 3, 2006.

ADDRESSES: You may give us your comments by: using our Internet 
facility (i.e., Social Security Online) at https://policy.ssa.gov/erm/
rules.nsf/Rules+Open+To+Comment or the Federal eRulemaking Portal at 
https://www.regulations.gov; e-mail to regulations@ssa.gov; telefax to 
(410) 966-2830; or, letter to the Commissioner of Social Security, P.O. 
Box 17703, Baltimore, MD 21235-7703. You may also deliver them to the 
Office of Regulations, Social Security Administration, 107 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, between 8 
a.m. and 4:30 p.m. on regular business days. Comments are posted on our 
Internet site, or you may inspect them physically on regular business 
days by making arrangements with the contact person shown in this 
preamble.

FOR FURTHER INFORMATION CONTACT: Greg Zwitch, SSA Regulations Officer, 
Office of Regulations, Social Security Administration, 107 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, 
(410) 965-1887 or TTY (410) 966-5609. For information on eligibility or 
filing for benefits, call our national toll-free number, 1-800-772-1213 
or TTY 1-800-325-0778, or visit our Internet Web site, Social Security 
Online, at https://www.socialsecurity.gov/.

SUPPLEMENTARY INFORMATION: Electronic Access: The electronic file of 
this document is available on the date of publication in the Federal 
Register at https://www.gpoaccess.gov/fr/. It is also 
available on the Internet site for SSA (i.e., Social Security Online) 
at https://policy.ssa.gov/pnpublic.nsf/LawsRegs.

What programs would these proposed regulations affect?

    These proposed regulations would affect disability determinations 
and decisions that we make for you under title II and title XVI of the 
Act. In addition, to the extent that Medicare entitlement and Medicaid 
eligibility are based on whether you qualify for disability benefits 
under title II and title XVI, these proposed regulations would also 
affect the Medicare and Medicaid programs.

Who can get disability benefits?

    Under title II of the Act, we provide for the payment of disability 
benefits if you are disabled and belong to one of the following three 
groups:
     Workers insured under the Act,
     Children of insured workers, and
     Widows, widowers, and surviving divorced spouses (see 
Sec.  404.336) of insured workers.
    Under title XVI of the Act, we provide for Supplemental Security 
Income (SSI) payments on the basis of disability if you are disabled 
and have limited income and resources.

How do we define disability?

    Under both the title II and title XVI programs, disability must be 
the result of any medically determinable physical or mental impairment 
or combination of impairments that is expected to result in death or 
which has lasted or is expected to last for a continuous period of at 
least 12 months. Our definitions of disability are shown in the 
following table:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Disability means you have a medically determinable impairment(s) as described above that
   If you file a claim under * * *       And you are * * *                                          results in * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Title II............................  an adult or a child....  the inability to do any substantial gainful activity (SGA).
Title XVI...........................  a person age 18 or       the inability to do any SGA.
                                       older.
Title XVI...........................  a person under age 18..  marked and severe functional limitations.
--------------------------------------------------------------------------------------------------------------------------------------------------------

What are the listings?

    The listings are examples of impairments that we consider severe 
enough to prevent you as an adult from doing any gainful activity. If 
you are a child seeking SSI payments based on disability, the listings 
describe impairments that we consider severe enough to result in 
``marked and severe functional limitations.'' Although we publish the 
listings only in appendix 1 to subpart P of part 404 of our rules, we 
incorporate them by reference in the SSI program in Sec.  416.925 of 
our regulations, and apply them to claims under both title II and title 
XVI of the Act.

How do we use the listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are a person age 18 or over, we 
apply the listings in part A when we assess your claim, and we never 
use the listings in part B.
    If you are a person under age 18, we first use the criteria in part 
B of the listings. If the listings in part B do not apply, and if the 
specific disease process(es) has a similar effect on adults and 
children, we then use the criteria in part A. (See Sec. Sec.  404.1525 
and 416.925.)
    If your impairment(s) does not meet any listing, we will also 
consider whether it medically equals any listing; that is, whether it 
is as medically severe. (See Sec. Sec.  404.1526 and 416.926.)
    We use the listings only to decide that you are disabled or that 
you are still disabled. We will never deny your claim or decide that 
you no longer qualify for benefits because your impairment(s) does not 
meet or medically equal a listing. If you have a severe impairment(s) 
that does not meet or medically equal any listing, we may still find 
you disabled based on other rules in the ``sequential evaluation 
process'' that we use to evaluate all disability claims. (See 
Sec. Sec.  404.1520, 416.920, and 416.924.)
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended based only 
on any changes in the listings. Our regulations explain that, when we 
change our listings, we continue to use our prior listings when we 
review your case, if you qualified for disability benefits or SSI 
payments based on our determination or decision that your impairment(s) 
met or medically equaled the listings. In these cases, we determine 
whether you have experienced medical improvement and,

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if so, whether the medical improvement is related to the ability to 
work. If your condition(s) has medically improved so that you no longer 
meet or medically equal the prior listing, we evaluate your case 
further to determine whether you are currently disabled. We may find 
that you are currently disabled, depending on the full circumstances of 
your case. See Sec. Sec.  404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). 
If you are a child who is eligible for SSI payments, we follow a 
similar rule after we decide that you have experienced medical 
improvement in your condition(s). See Sec.  416.994a(b)(2).

Why are we proposing to revise the listings for immune system 
disorders?

    We are proposing these revisions to update the listings and to 
provide more information about how we evaluate immune system disorders. 
We have not updated these rules since we first published them in 1993 
(58 FR 36008). At that time, we established body system listings for 
immune system disorders in part A and part B. We made those rules 
effective for 5 years from the date of publication, unless we extended 
them, or revised and issued them again (58 FR at 36051). Since that 
time, we have extended the expiration date of the immune body system 
listings but we have not comprehensively revised them.
    We have, however, made several changes to these listings over the 
years. On November 19, 2001, we also published final rules in the 
Federal Register adding listings 14.09 and 114.09, for inflammatory 
arthritis, to these body system listings, including introductory text 
to those listings in sections 14.00B6 and 114.00E (66 FR 58009). We 
published minor technical changes to these body system listings on 
February 24, 2002 (67 FR 20018).

How did we develop these proposed rules?

    These proposed rules reflect our adjudicative experience and 
advances in medical knowledge, treatment, and methods of evaluating 
immune system disorders. They also reflect comments we asked you to 
provide to help us develop the proposals.
    We published an Advance Notice of Proposed Rulemaking (ANPRM) in 
the Federal Register on May 9, 2003 (68 FR 24896). The purpose of the 
ANPRM was to inform the public that we were planning to update and 
revise the rules we use to evaluate immune system disorders and to 
invite interested individuals and organizations to send us comments and 
suggestions for updating and revising the immune system listings. In 
the ANPRM, we provided a 60-day period for comments and suggestions; 
that period ended on July 8, 2003. We received over 200 letters and e-
mails in response to the notice, many from individuals who have immune 
system disorders or who have family members with such disorders. We 
also received comments from medical experts, advocates, and people who 
adjudicate claims for us. Although we are not summarizing or responding 
to the comments in this notice, we read and considered them carefully 
and are proposing changes in our rules based on some of the suggestions 
we received.
    We also hosted policy conferences on ``Immune System Disorders in 
the Disability Programs'' in Philadelphia, PA, on December 15, 2003, 
and in San Francisco, CA, on February 18 and 19, 2004. At these 
conferences, we heard comments and suggestions for updating and 
revising these rules from individuals who have immune system disorders 
and their family members, physicians who treat individuals with immune 
system disorders, other professionals who work with people who have 
immune system disorders, advocates who represent individuals with 
immune system disorders, and individuals who make disability 
determinations and decisions for us in the State agencies and the 
Office of Hearings and Appeals. Several of the changes we propose in 
these rules are based on information we obtained at these conferences.

When will we start to use these rules?

    We will not use these proposed rules until we evaluate the public 
comments we receive on them, determine whether they should be issued as 
final rules, and issue final rules in the Federal Register. If we 
publish final rules, we will explain in the preamble how we will apply 
them, and we will summarize and respond to the public comments. Until 
the effective date of any final rules, we will continue to use our 
current rules.

How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 8 years after the date they become effective, unless we 
extend them, or revise and issue them again.

What revisions are we proposing to make?

    We are proposing to:
     Expand and reorganize the introductory text in proposed 
14.00 and 114.00 to provide more guidance for our adjudicators, to 
update it, and to reflect the revised listings.
     Add paragraph headings to the introductory text in 
proposed 14.00 and 114.00 for easier reference.
     Add proposed 14.00C and 114.00C to explain the meaning of 
key terms.
     Remove all reference listings. Reference listings are 
listings that are met by satisfying the criteria of another listing. 
For example, current listing 14.08G1 for human immunodeficiency virus 
(HIV) infection with anemia is a reference listing that requires 
evaluation under current listing 7.02 for chronic anemia. Therefore, it 
is redundant. Instead of using a reference listing, we propose to 
provide general guidance in the introductory text to the immune system 
listings (proposed 14.00J2g) stating that hematologic abnormalities, 
such as anemia, may be evaluated under 7.00ff. In some cases, we are 
also replacing reference listings with new specific listing criteria 
for the impairments. For example, current listing 14.06, for 
undifferentiated connective tissue disorders, is entirely a reference 
listing. In the proposed rules, we are replacing the reference listing 
criterion with criteria that are specific to these disorders.
     Add proposed listings 14.10 and 114.10 for evaluating 
Sjo[ouml]gren's syndrome.
     Add criteria to the listings, similar to those in current 
HIV infection listings 14.08N and 114.08O, for each of the other listed 
immune system disorders (for example, systemic lupus erythematosus and 
systemic vasculitis).
     Make nonsubstantive editorial changes to update the 
medical terminology in the introductory text and the listings and to 
make their language simpler and clearer.

How are we proposing to change the introductory text to the adult 
immune system listings?

    We propose to expand and reorganize the introductory text to these 
listings. There are four major sections in current 14.00, and the 
longest of those sections, 14.00D, addresses only the evaluation of HIV 
infection. In these proposed rules, we add more sections and expand the 
guidance we provide about evaluating other kinds of immune system 
disorders.
    Some of the guidance in current 14.00D is useful for evaluating 
other kinds of immune system disorders in addition to HIV infection. We 
are proposing to move that guidance from current 14.00D to new sections 
that would have more general applicability to immune system disorders. 
We are not proposing to remove any substantive guidance about how we 
evaluate HIV infection, only to reorganize some of the

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information now in 14.00D of the current rules and to give it broader 
applicability where appropriate. We are also proposing to update and 
expand some of the guidance we provide for evaluating HIV infection and 
its effects, as we describe in more detail below.
    The four sections in the current rules are:
     Current 14.00A, a short paragraph that describes generally 
the kinds of disorders we include in this body system.
     Current 14.00B, a lengthy section that discusses the 
evaluation of connective tissue disorders; that is, autoimmune 
disorders. It includes six undesignated paragraphs that primarily 
explain the kinds of evidence we need to document the existence and 
severity of these disorders, including how we evaluate loss of 
function. These paragraphs are followed by six numbered sections that 
provide guidance about specific impairments in the listings.
     Current 14.00C, a single sentence that explains that we 
evaluate allergic disorders under the appropriate listing of the 
affected body system.
     Current 14.00D, a lengthy section that explains how we 
document the existence and severity of HIV infection, including how we 
evaluate loss of function under listing 14.08N. It includes eight 
numbered subsections and many paragraphs that are not designated with 
letters or numbers within those subsections.
    In the proposed rules, there are 10 sections in the introductory 
text. The first three sections (proposed 14.00A, B, and C) provide 
general information about this body system, including definitions of 
terms. Each of the next three sections describes a particular category 
or type of immune system disorder: Autoimmune disorders (proposed 
14.00D); immune deficiency disorders, excluding HIV infection (proposed 
14.00E); and HIV infection (proposed 14.00F). The next three sections 
explain how we consider the effects of your treatment (proposed 
14.00G), your symptoms (proposed 14.00H), and the functional 
limitations from your immune system disorder under these listings 
(proposed 14.00I). The last section, proposed section 14.00J, explains 
how we consider the effects of your immune system disorder when it does 
not meet the requirements of one of the proposed immune system 
listings. We are designating all paragraphs in the proposed rules with 
letters or numbers to make it easier to refer to them. We are also 
providing headings for all of the major sections and many of the 
subsections.
    The following are the names of the major sections in proposed 
14.00. We describe each section in detail later in this preamble.
     Proposed 14.00A: What disorders do we evaluate under the 
immune system listings? 
     Proposed 14.00B: What information do we need to show that 
you have an immune system disorder? 
     Proposed 14.00C: Definitions 
     Proposed 14.00D: What are the listed autoimmune disorders 
in these listings? 
     Proposed 14.00E: How do we evaluate immune deficiency 
disorders, excluding HIV infection (14.07)? 
     Proposed 14.00F: How do we evaluate human immunodeficiency 
virus (HIV) infection? 
     Proposed 14.00G: How will we consider the effect of 
treatment in evaluating your autoimmune disorder, immune deficiency 
disorder, or HIV infection? 
     Proposed 14.00H: How do we consider your symptoms, 
including your constitutional symptoms or pain? 
     Proposed 14.00I: How do we use the functional criteria in 
these listings? 
     Proposed 14.00J: How do we evaluate your immune system 
disorder when it does not meet one of these listings? 
    The following is a detailed description of the proposed changes in 
the introductory text of these proposed rules.

14.00 Immune System Disorders

    We propose to change the name of this body system from ``Immune 
System'' to ``Immune System Disorders'' to more accurately reflect that 
we use these listings to evaluate immune system disorders in accordance 
with the requirements of the disability program.
Proposed 14.00A--What disorders do we evaluate under the immune system 
listings?
    In proposed 14.00A, we provide a brief overview of this body 
system. We explain the kinds of disorders we evaluate under the immune 
system listings and that we organize these impairments under the 
categories of ``autoimmune disorders,'' ``immune deficiency disorders, 
excluding HIV infection,'' and ``HIV infection.'' Proposed 14.00A has 
four subsections.
    We incorporate current 14.00A in the opening sentence of proposed 
14.00A1. We propose to revise the sentence, which explains the kinds of 
immune system dysfunction that immune system disorders may cause, to 
update and simplify it. In proposed 14.00A1a and 14.00A1b, we 
incorporate the first sentence in the sixth paragraph of current 14.00B 
to explain that immune system disorders can cause dysfunction in one or 
more components of the immune system, and describe ways in which immune 
system disorders may result in loss of function. In the second sentence 
of 14.001b, we propose to add ``involuntary'' as a descriptor of weight 
loss to clarify that we mean weight loss due to an immune system 
disorder(s) or its treatment. We are adding ``involuntary'' as a 
descriptor of weight loss throughout the introductory text in part A 
and part B for this same reason. Proposed 14.00A1c is a new paragraph 
that explains how we have organized immune system disorders in the 
preface (introductory text) of these listings.
    In proposed 14.00A2, Autoimmune disorders, we incorporate the first 
paragraph in current 14.00B to provide a brief description of 
autoimmune disorders. We propose to add an explanation that these 
disorders are sometimes referred to as ``rheumatic diseases,'' 
``connective tissue disorders,'' or ``collagen vascular disorders'' and 
that some of the features of these disorders in adults differ from the 
features of the same disorders in children. We provide a cross-
reference to proposed 14.00D, the section of the introductory text that 
addresses autoimmune disorders in detail. We also propose to remove the 
last sentence of the first paragraph of current 14.00B, which explains 
that connective tissue disorders generally evolve and persist over 
time, may result in functional loss, and may require long-term, 
repeated evaluation and management, because it does not provide useful 
adjudicative guidance. However, we do explain in proposed 14.00A1b that 
immune system disorders can cause limitation(s) that result in an 
``extreme'' loss of function.
    Proposed 14.00A3, Immune deficiency disorders, excluding HIV 
infection, is new. We explain that these disorders can be classified as 
``primary'' or ``acquired,'' are characterized by recurrent or unusual 
infections, and are associated with an increased risk of malignancies 
and of other autoimmune disorders. We also provide a cross-reference to 
proposed 14.00E, the introductory section that addresses immune 
deficiency disorders in detail.
    In proposed 14.00A4, Human immunodeficiency virus (HIV) infection, 
we provide a brief description of HIV infection. We propose to move the 
first sentence in current 14.00D1 to this section. The sentence 
explains that HIV infection is caused by a specific retrovirus and may 
be characterized by increased susceptibility to opportunistic 
infections, cancers, or other conditions.

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We also provide a cross-reference to proposed 14.00F, the section of 
the introductory text that addresses HIV infection in detail.
Proposed 14.00B--What information do we need to show that you have an 
immune system disorder?
    In proposed 14.00B, we incorporate the first sentence of the second 
paragraph of current 14.00B to explain what information we need to show 
that you have an immune system disorder. We moved the second and third 
sentences of the second paragraph of current 14.00B, which define our 
term ``appropriate medically acceptable imaging,'' to proposed 14.00C, 
a new section that provides definitions of terms in these listings. We 
propose to remove the last two sentences of the current paragraph. They 
explain that we will not purchase tests that may involve significant 
risk; however, we already include this general policy in Sec. Sec.  
404.1519m and 416.919m of our regulations so it is not necessary to 
repeat them in this section.
    In the second sentence of proposed 14.00B, we provide that ``we 
will make every reasonable effort'' to obtain your medical history, 
medical findings, and the results of laboratory tests in documenting 
whether you have an immune system disorder. We include this requirement 
in current 14.00D, for HIV infection, but we do not include similar 
guidance in current 14.00B, for connective tissue disorders. We propose 
to add this guidance under proposed 14.00B because it is appropriate 
for all immune system disorders.
    We also propose to remove the third and fourth paragraphs of 
current 14.00B. The third paragraph of current 14.00B provides that we 
need a longitudinal clinical record of at least 3 months demonstrating 
active disease to assess the severity and duration of your impairment. 
However, this is not always the case, even under the current rules. For 
example, individuals with HIV infection and cryptococcal meningitis 
(current listing 14.08B4) or Kaposi's sarcoma (current listing 
14.08B8), and individuals with ankylosing spondylitis with fixation 
(ankylosis) of the dorsolumbar spine at 45[deg] (current listing 
14.09B2) are disabled based on those findings alone. In that case, we 
do not need 3 months of evidence or evidence showing active disease. 
Other cases may be decided with less than 3 months of evidence, while 
others may require more than 3 months of evidence. Therefore, we are 
removing this guidance because each case should be decided on an 
individual basis.
Proposed 14.00C--Definitions
    In proposed 14.00C, we define what we mean by important terms in 
these listings. As already noted, we include the definition of 
``appropriate medically acceptable imaging'' from the second paragraph 
of current 14.00B. However, we propose to replace the word ``proper'' 
in the second sentence of this definition with the phrase ``generally 
accepted and consistent with the prevailing state of medical knowledge 
and clinical practice'' to more clearly explain what we mean. We also 
propose to include in this new section the definitions of the terms 
``severe'' from the sixth paragraph of current 14.00B, ``inability to 
ambulate effectively'' and ``inability to perform fine and gross 
movements effectively'' from current 14.00B6b, and ``resistant to 
treatment,'' ``recurrent,'' and ``disseminated'' from the second, 
third, and fourth paragraphs of current 14.00D2. All of these terms 
will apply to several, and sometimes all, of the proposed listings in 
this body system.
    In proposed 14.00C, we do not include the phrase ``must have 
lasted, or be expected to last, for at least 12 months'' from the 
definitions of ``inability to ambulate effectively'' and ``inability to 
perform fine and gross movements effectively'' in current 14.00B6b 
because we believe it is unnecessary. Unless an impairment is expected 
to result in death, it must have lasted or must be expected to last for 
a continuous period of at least 12 months to meet the definition of 
disability. This proposed change would also make the definitions of the 
terms consistent with the definitions of the same terms in 1.00B2b and 
1.00B2c in the musculoskeletal body system.
    We also propose to move and simplify the definitions of the terms 
``resistant to treatment,'' ``recurrent,'' and ``disseminated'' in 
current 14.00D2, primarily to remove language that we believe is 
unnecessary. For example, we removed the explanation that the terms 
``have the same general meaning as used by the medical community.'' 
These changes are only editorial. We do not intend the proposed 
definitions to be substantively different from the current rules.
    In proposed 14.00C8, we reference current 1.00F for the definition 
of ``major peripheral joints'' instead of restating the definition as 
we do in current 14.00B6a. We also propose to add the definitions of 
several other important terms in these listings, including in proposed 
14.00C2, the term ``constitutional symptoms or signs.'' In proposed 
14.00C2, we also provide brief definitions for the constitutional 
symptoms ``severe fatigue'' and ``malaise.'' We propose to add these 
definitions in response to the many comments we received that indicated 
that the fatigue and malaise that people who have immune system 
disorders experience can be very limiting.
Proposed 14.00D--What are the listed autoimmune disorders in these 
listings?
    In proposed 14.00D, we incorporate and expand upon the information 
in current 14.00B1 through 14.00B6, which describe features commonly 
associated with each of the listed autoimmune system disorders. 
Throughout these sections, we refer to ``autoimmune disorders'' instead 
of ``connective tissue disorders'' because the phrase ``autoimmune 
disorders'' is more medically accurate and more frequently used. We 
also propose to add a new section 14.00D7 for Sj[ouml]gren's syndrome 
because we are proposing to add new listing 14.10 for that autoimmune 
disorder.
    In proposed 14.00D1, Systemic lupus erythematosus (14.02), we 
expand and clarify the information in current 14.00B1. In proposed 
14.00D1a, General, we explain that systemic lupus erythematosus (SLE) 
may involve any organ or body system and describe by body system some 
potential manifestations that may be involved. We expand our 
explanation of how SLE is frequently characterized clinically and 
propose to change ``fatigability'' used in current 14.00B1 to 
``fatigue'' to be consistent with how we describe this symptom 
throughout the immune system listings. We also add ``involuntary'' as a 
descriptor of weight loss to clarify that we mean weight loss due to 
SLE or its treatment. In proposed 14.00D1b, Documentation of SLE, we 
propose to update our rules to explain that your medical evidence will 
generally, but not always, show that your SLE satisfies the criteria in 
the ``Criteria for the Classification of Systemic Lupus Erythematosus'' 
by the American College of Rheumatology, found in the most recent 
edition of the Primer on the Rheumatic Diseases published by the 
Arthritis Foundation. This is a more up-to-date reference than the 1982 
reference in the current rules.
    In proposed 14.00D2, Systemic vasculitis (14.03), we clarify the 
information in the current rule. Proposed 14.00D2a, General, 
corresponds to the first three sentences of current 14.00B2. In it, we 
explain that vasculitis is an inflammation of blood vessels that may 
occur acutely in association with adverse drug reactions, certain 
chronic infections, and

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occasionally malignancies, and that it may also be associated with 
other autoimmune disorders. We also give examples of several clinical 
patterns in which it may occur. We propose to remove the fourth 
sentence of current 14.00B2, which describes cutaneous vasculitis, 
because the impairment varies greatly in its manifestation, may not be 
associated with systemic involvement, and would not be expected to 
result in a listing-level impairment.
    Proposed 14.00D2b, Documentation of systemic vasculitis, 
corresponds to the last two sentences of current 14.00B2. In it, we 
describe documentation that we use to confirm the diagnosis of systemic 
vasculitis.
    Proposed 14.00D3, Systemic sclerosis (scleroderma) (14.04), 
corresponds to current 14.00B3. We propose to revise the heading and to 
expand the information in the section. Proposed 14.00D3a, General, 
corresponds to the first three sentences of current 14.00B3. We propose 
to change the term ``Raynaud's phenomena,'' which we use in the second 
and third sentences of current 14.00B3, to ``Raynaud's phenomenon'' 
because the latter is the correct term. We make this same change in 
proposed listing 14.04C. In proposed 14.00D3b, Diffuse cutaneous 
systemic sclerosis, we continue to explain that, in addition to skin or 
blood vessels, major organ or systemic involvement may include the 
gastrointestinal tract, lungs, heart, kidneys, and muscle. This 
guidance corresponds to the fourth sentence in the current rule.
    Proposed 14.00D3c, Localized scleroderma (linear scleroderma or 
morphea), is new. We propose to add this section and appropriate 
listings in proposed 14.04 for these disorders that originate in 
childhood because their disabling effects can persist into adulthood. 
Proposed 14.00D3c is essentially the same as proposed 114.00D3c, which 
we describe in detail later in this preamble.
    Proposed 14.00D3d, Documentation of systemic sclerosis 
(scleroderma), is also new. In it, we explain what documenting systemic 
sclerosis (scleroderma) involves and that there may be an overlap with 
other autoimmune disorders.
    In proposed 14.00D4, Polymyositis and dermatomyositis (14.05), we 
clarify the information in current 14.00B4. Proposed 14.00D4a, General, 
corresponds to the first three sentences of current 14.00B4. It 
describes the characteristics of polymyositis and dermatomyositis. In 
proposed 14.00D4b, Documentation of polymyositis or dermatomyositis, we 
describe the findings that are generally used to document these 
impairments. The first sentence of the proposed rule corresponds to the 
last sentence of current 14.00B4. We propose minor editorial revisions, 
including the removal of the reference to ``myositis'' because there 
are multiple characteristic abnormalities on muscle biopsy that support 
the diagnosis of polymyositis or dermatomyositis. We also propose to 
add a sentence to explain that people with dermatomyositis have a 
characteristic skin rash.
    In proposed 14.00D4c, Additional information about how we evaluate 
polymyositis and dermatomyositis under the listings, we explain how we 
evaluate commonly occurring limitations associated with these 
disorders. Proposed 14.00D4c(i) corresponds to the fourth and fifth 
sentences of current 14.00B4. We propose to delete the example of 
weakness of the anterior neck flexor muscles in the sixth sentence of 
current 14.00B4 because we are proposing to delete the reference to the 
cervical muscles from listing 14.05 for reasons we explain later in 
this preamble. We also propose to add an example of squatting. 
Squatting is a common means for evaluating weakness in the pelvic 
girdle muscles.
    In proposed 14.00D4c(ii), we explain that we will evaluate 
malignancies (which may be associated with these disorders) under the 
malignant neoplastic diseases listings (13.00ff). We do not provide 
this guidance in proposed 114.00D4c in the childhood section for 
polymyositis or dermatomyositis because malignancies are not commonly 
associated with these disorders in children. We also explain that we 
evaluate the involvement of other organs or body systems under the 
affected body system.
    In proposed 14.00D5, Undifferentiated and mixed connective tissue 
disease (14.06), we reorganize and clarify the information in current 
14.00B5. In the proposed rules, we are adding an explicit reference to 
mixed connective tissue disease (MCTD) to clarify what we mean in the 
current rules when we refer to ``overlap'' syndromes. This is not a 
substantive change, but a clarification of our current rules to update 
medical terminology. In proposed 14.00D5a, General, we describe what we 
mean by undifferentiated and mixed connective tissue disease. In 
proposed 14.00D5b, Documentation of undifferentiated and mixed 
connective tissue disease, we explain when clinical features and 
serologic findings may be used to diagnose undifferentiated and mixed 
connective tissue disease. These provisions in proposed 14.00D5a and 
14.00D5b are not substantively different from the provisions in the 
first three sentences of current 14.00B5.
    We propose to delete the last sentence of current 14.00B5. The 
current sentence indicates that the correct designation of an 
``overlap'' disorder is important for the assessment of prognosis. We 
believe that this sentence, while useful in treatment settings, does 
not provide useful adjudicative guidance.
    In proposed 14.00D6, Inflammatory arthritis (14.09), we expand, 
reorganize, and clarify the rules in current 14.00B6. Proposed 
14.00D6a, General, corresponds to the first and fourth sentences of 
current 14.00B6. We continue to explain that inflammatory arthritides 
include a vast array of disorders that differ in cause, course, and 
outcome and may result in difficulties of ambulation or fine and gross 
movements. We edited the fourth sentence of current 14.00B6 to break it 
up into three shorter sentences. However, we do not intend to change 
the meaning of the provision.
    Proposed 14.00D6b, Inflammatory arthritides involving the axial 
spine (spondyloarthropathies), and 14.00D6c, Inflammatory arthritides 
involving the peripheral joints, correspond to the second and third 
sentences of current 14.00B6. In these sections, we list some disorders 
that may be associated with inflammatory spondyloarthropathies 
involving the axial spine (proposed 14.00D6b) and inflammatory 
arthritides affecting the peripheral joints (proposed 14.00D6c). We 
propose to add inflammatory bowel disease (IBD) to the lists of 
examples in both sections because arthritis is the most common extra-
intestinal complication of IBD. In proposed 14.00D6b, we remove the 
examples of ``other reactive arthropathies'' and ``undifferentiated 
spondylitis'' now included in the second sentence of current 14.00D6 
because they are non-specific and the list is not intended to be 
complete, only to provide some examples. Finally, we propose to update 
some of the terminology in this section; for example, we refer to 
``psoriatic arthritis'' instead of ``psoriatic arthropathy.''
    Proposed 14.00D6d, Documentation of inflammatory arthritides, is 
new. In it, we explain that generally, but not always, the diagnosis of 
inflammatory arthritis is made by the clinical features and serologic 
findings described in the most recent edition of the Primer on the 
Rheumatic Diseases.
    Proposed 14.00D6e, How we evaluate the inflammatory arthritides 
under the

[[Page 44437]]

listings, corresponds to the information in the last two sentences of 
current 14.00B6, current 14.00B6c, and current 14.00B6d. We are 
reorganizing the text to reflect the proposed reorganization of listing 
14.09, which we explain later in this preamble, and to clarify it.
     Proposed 14.00D6e(i) explains that proposed listings 
14.09A and 14.09C1 (current listings 14.09A and 14.09B) are met by 
showing an impairment that results in an ``extreme limitation.'' This 
is how we describe ``inability to ambulate effectively'' in 1.00B2b in 
our musculoskeletal listings and, therefore, would only be a 
clarification of the current rule. In the proposed rule, we retain the 
provision from current 14.00B6c that the inability to ambulate 
effectively is implicit in proposed listing 14.09C1 (current listing 
14.09B), the listing for ankylosis of the spine with fixation at a 
45[deg] angle, even though individuals who have the degree of ankylosis 
described in the listing ordinarily do not require the use of bilateral 
upper limb assistance.
     Proposed 14.00D6e(ii) explains proposed listings 14.09B 
(current listing 14.09D), 14.09C2 (current listing 14.09E), and 14.09D. 
These listings do not describe a single impairment manifestation that 
results in an ``extreme'' limitation. Rather, they describe 
combinations of impairment manifestations that should result in an 
``extreme'' limitation or in ``marked'' limitations in at least two 
areas of functioning. We also incorporate the provision in the first 
sentence of current 14.00B6d that extra-articular impairments may meet 
listings in other body systems.
     Proposed 14.00D6e(iii) corresponds to the third and fourth 
sentences of current 14.00B6d. It explains that extra-articular 
features of inflammatory arthritis may involve any body system and 
lists examples of commonly occurring extra-articular impairments by 
body system. We propose to reorganize and expand the list of examples 
of such impairments and to clarify the body systems to which they 
belong.
     Proposed 14.00D6e(iv) and 14.00D6e(v) correspond to the 
last sentence of current 14.00B6. In proposed 14.00D6e(iv), we replace 
``persistent'' with ``permanent'' and remove ``without ongoing 
inflammation'' to clarify that we evaluate permanent deformity of a 
major peripheral joint under listing 1.02 when it is the dominant 
feature of your impairment. Proposed 14.00D6e(v) explains that we use 
listing 1.03 to evaluate surgical reconstruction of a major weight-
bearing joint.
     Proposed 14.00D6e(vi) would clarify that we evaluate your 
impairment under any appropriate listing when you have both 
inflammation and chronic deformities.
    We are not including the provisions of current 14.00B6e in proposed 
14.00D6. Current 14.00B6e provides that the fact that an individual is 
dependent on steroids, or any other drug, for the control of 
inflammatory arthritis is insufficient in itself to establish 
disability. We added it to part A of our listings in 2002 for 
consistency with 114.00E6, a provision we added to part B of the 
listings at the same time (66 FR 58010, 58020 (2001)). We are proposing 
to remove that provision for reasons we explain below in our summary of 
the proposed rules in part B. Therefore, we are proposing to remove 
this provision in part A for consistency with that change. However, in 
proposed 14.00G3, we continue to state that we will consider the 
adverse side effects of treatment, including the adverse effects of 
corticosteroids, to ensure that our adjudicators remember to consider 
the side effects an individual might experience from steroids and any 
other treatment.
    Proposed 14.00D7, Sj[ouml]gren's syndrome (14.10), is new. As 
already noted, we are proposing to add a new listing for Sj[ouml]gren's 
syndrome. In connection with that proposed listing, proposed 14.00D7a, 
General, explains the features of the disorder, including its resulting 
symptoms and possible complications. We also list organ systems that 
may be involved and note that Sj[ouml]gren's syndrome may be associated 
with other autoimmune disorders. In proposed 14.00D7b, Documentation of 
Sj[ouml]gren's syndrome, we also explain that if you have 
Sj[ouml]gren's syndrome, your medical evidence will generally, but not 
always, show that your disease satisfies the criteria in the ``Criteria 
for the Classification of Sj[ouml]gren's Syndrome'' found in the most 
recent edition of the Primer on the Rheumatic Diseases.
Proposed 14.00E--How do we evaluate immune deficiency disorders, 
excluding HIV infection (14.07)?
    In proposed 14.00E, we add a new section describing how immune 
deficiency disorders (excluding HIV infection) are classified, 
documented, and evaluated. This section has four subsections.
    In proposed 14.00E1, General, we explain that immune deficiency 
disorders are classified as either ``primary'' or ``acquired.'' Primary 
disorders are mainly seen in children but, due to recent advances in 
treatment, many affected children survive into adulthood.
    In proposed 14.00E2, Documentation of immune deficiency disorders, 
we explain that documentation of these disorders may be made by 
laboratory evidence or by other generally acceptable methods consistent 
with the prevailing state of medical knowledge and clinical practice.
    In proposed 14.00E3, Immune deficiency disorders treated by stem 
cell transplantation, we explain how we evaluate immune deficiency 
disorders that are treated in this way. In proposed 14.00E3a, 
Evaluation in the first 12 months, we explain that if you undergo stem 
cell transplantation we will consider you disabled until at least 12 
months from the date of the transplant. This is the same provision that 
we use for most malignancies treated by bone marrow or stem cell 
transplants in the neoplastic listings. In 13.00L4 of those listings, 
we also included a special provision for autologous bone marrow 
transplants--transplants using your own stem cells (69 FR 67034). We do 
not include such an alternative provision in these proposed rules 
because people with immune deficiency disorders receive allogeneic 
transplants--that is, stem cells taken from other people. Also, we 
propose to use ``stem cell transplantation'' instead of ``bone marrow 
or stem cell transplantation'' in this proposed section and in proposed 
listing 14.07B because ``stem cell transplantation'' is a broader term 
that encompasses different sites for obtaining hematopoetic (blood-
forming) stem cells, including bone marrow, peripheral blood, and 
umbilical cord blood. In proposed 14.00E3b, Evaluation after the 12-
month period has elapsed, we explain that, after that period has 
elapsed, we consider any demonstrable residuals of your immune 
deficiency disorder including any residual impairment(s) resulting from 
your treatment. The provision also is based on 13.00L4 in our malignant 
neoplastic diseases listings.
    Proposed 14.00E4, Medication-induced immune suppression, is new. We 
explain that medication effects can result in immune suppression that 
will usually resolve once the medication is ceased. However, if you 
take prescribed medications for long-term immune suppression, such as 
after an organ transplant, we will look at the frequency and severity 
of any infections you get, residuals from the organ transplant itself, 
and whether there has been any significant deterioration of other organ 
systems.

[[Page 44438]]

Proposed 14.00F--How do we evaluate human immunodeficiency virus (HIV) 
infection?
    In proposed 14.00F, we incorporate, update, and expand information 
on HIV infection contained in current 14.00D3 through 14.00D7. We also 
make nonsubstantive editorial changes.
    As already noted, we propose to move the first sentence of current 
14.00D1 to proposed 14.00A4. Therefore, we begin proposed 14.00F with 
what is now the second sentence of current 14.00D1. It is a reminder 
that an individual with HIV infection need not meet the Centers for 
Disease Control definition of acquired immune deficiency syndrome 
(AIDS) to meet or medically equal the criteria of listing 14.08. We 
have made minor editorial changes to the sentence, but we do not intend 
to change its meaning.
    We propose to move the provisions of current 14.00D2 to other 
sections in the proposed rules. In the first four paragraphs of current 
14.00D2, we define the terms ``resistant to treatment,'' ``recurrent,'' 
and ``disseminated,'' and we would now define those terms in proposed 
14.00C. In the fifth paragraph of current 14.00D2, we define 
``significant involuntary weight loss'' for purposes of current listing 
14.08I (which has become listing 14.08H in these proposed rules). In 
the proposed rules, we include this definition in 14.00F5.
    Like current 14.00D3, proposed 14.00F1 is in two major sections: A 
section explaining how we document the diagnosis of HIV infection 
definitively (14.00F1a) and a section explaining how we document the 
diagnosis of HIV infection when we do not have definitive evidence 
(14.00F1b). In proposed 14.00F1, Documentation of HIV infection, we 
incorporate and update the information in current 14.00D3 to explain 
the laboratory tests or other evidence we accept as documentation of 
HIV infection. Proposed 14.00F1a, Documentation of HIV infection by 
definitive diagnosis, corresponds to current 14.00D3a. We propose to 
update and expand this section to include newer laboratory diagnostic 
techniques that did not exist or were not widely used when we published 
the current rules in 1993.
     Proposed 14.00F1a(i), for HIV antibody tests, corresponds 
to current 14.00D3a(i). We propose only nonsubstantive editorial 
changes.
     Proposed 14.00F1a(ii) is new. It would add positive 
``viral load'' tests for HIV infection, such as quantitative plasma HIV 
RNA, quantitative plasma HIV branched DNA, and reverse transcriptase-
polymerase chain reaction (RT-PCR), that were not widely available when 
we published the current rules.
     Proposed 14.00F1a(iii) is for HIV DNA detection by 
polymerase chain reaction (PCR). We include it as an example of an 
``other test'' in current 14.00D3a(iii) because it was not widely 
available when we published the current rules.
     Proposed 14.00F1a(iv), for HIV antigen, corresponds to 
current 14.00D3a(ii).
     Proposed 14.00F1a(v) is new. It would add a positive viral 
culture for HIV from peripheral blood mononuclear cells (PBMC) as 
another test that definitively documents HIV infection. Even though it 
is not commonly used, we will accept it as definitive evidence if it is 
in your medical records.
     Proposed 14.00F1a(vi), for other tests that are highly 
specific for detection of HIV, corresponds to the first paragraph in 
current 14.00D3a(iii).
    Proposed 14.00F1b, Other acceptable documentation of HIV infection, 
corresponds to current 14.00D3b. It explains what documentation of HIV 
infection we will accept instead of definitive laboratory testing. The 
proposed rule is essentially the same as the current rule except for 
nonsubstantive editorial changes.
    In proposed 14.00F2, CD4 tests, we combine the provisions in the 
second undesignated paragraph after current 14.00D3a(iii) and the 
second paragraph in current 14.00D4a. We specify that, even though a 
reduced CD4 count or percent alone does not establish a definitive 
diagnosis of HIV infection, a CD4 count below 200/mm\3\ or 14 percent 
along with clinical findings does offer supportive evidence of 
opportunistic infections without a definitive diagnosis. This is 
because a CD4 count below 200 or 14 percent is an indicator of an 
increased susceptibility to developing opportunistic infections. We 
also make nonsubstantive editorial changes.
    In proposed 14.00F3, Documentation of the manifestations of HIV 
infection, we incorporate the information in current 14.00D4 with 
nonsubstantive editorial changes. Like proposed 14.00F1 and current 
14.00D4, proposed 14.00F3 is divided into two main parts. The first 
section explains how we document manifestation of HIV infection 
definitively (14.00F3a), and the second section explains how we 
document manifestations of HIV infection when we do not have definitive 
evidence (14.00F3b).
    Proposed 14.00F3a, Documentation of the manifestations of HIV by 
definitive diagnosis, incorporates the first paragraph in current 
14.00D4a.
    In proposed 14.00F3b, Other acceptable documentation of the 
manifestations of HIV infection, we incorporate information that is in 
the first paragraph of current 14.00D4b. We propose to revise the 
language of this paragraph both editorially and to clarify our original 
intent. In the current rule, we indicate that ``if no definitive 
laboratory evidence is available, manifestations of HIV infection may 
be documented by medical history, clinical and laboratory findings, and 
diagnosis(es) indicated in the medical evidence.'' The sentence may 
imply that we need to have all of the things listed (medical history 
and clinical findings and laboratory findings and diagnosis(es)) to 
determine that you have a manifestation of HIV infection when we do not 
have definitive laboratory findings. That is not our intent, so we are 
clarifying in the proposed rule that we may need only some of this 
information to make a finding that you have a manifestation of HIV 
infection, depending on the prevailing state of medical knowledge and 
clinical practice. We also propose to clarify what we mean by 
``laboratory findings'' in this context; that is, laboratory findings 
that do not in themselves definitively establish the existence of a 
diagnosis of an HIV-related manifestation.
    In 14.00D4 of the current rules we provide specific guidance for 
documenting one particular manifestation of HIV infection without 
definitive evidence: cytomegalovirus (CMV) disease. In proposed 
14.00F3b, we expand the section to include two additional 
manifestations. In proposed 14.00F3b(i), we add guidance to explain 
that Pneumocystis carinii pneumonia (PCP) is frequently diagnosed 
presumptively without definitive evidence and to provide examples of 
evidence that is supportive of a presumptive diagnosis of PCP. We also 
note that Pneumocystis carinii is now known as Pneumocystis jiroveci; 
however, ``PCP'' remains in common usage for the pneumonia caused by 
this organism.
    In proposed 14.00F3b(ii), we incorporate and expand the information 
now in the second paragraph of current 14.00D4b, regarding the 
documentation of CMV disease. We propose to clarify that a positive 
serology test for CMV identifies a ``history'' of infection but does 
not confirm an ``active'' disease process. We do not include 
``documentation of CMV disease requires confirmation by biopsy'' as in 
the last sentence of the second

[[Page 44439]]

paragraph of current 14.00D4 because we are providing information on 
documentation other than definitive laboratory findings. Also, instead 
of stating that we can use generally acceptable methods to confirm the 
diagnosis of CMV, we provide examples of evidence, such as fever and 
positive CMV serology test, that are supportive evidence of a 
presumptive diagnosis of CMV disease.
    In proposed 14.00F3b(iii), we add guidance on how toxoplasmosis of 
the brain is presumptively diagnosed since the definitive method of 
diagnosing toxoplasmosis of the brain by biopsy is not commonly 
performed.
    In proposed 14.00F4, Manifestations specific to women, we 
incorporate the information in current 14.00D5. In proposed 14.00F4a, 
General, we incorporate the first paragraph of current 14.00D5 and in 
proposed 14.00F4b, Additional considerations for evaluating HIV 
infection in women, we incorporate the second paragraph of current 
14.00D5. Except for adding paragraph designations and headings and 
minor editorial changes (including changes to reflect proposed changes 
in the paragraph designations of the listings explained below), the 
proposed provisions are the same as in the current rules.
    In proposed 14.00F5, involuntary weight loss, we incorporate the 
last paragraph of current 14.00D2 with nonsubstantive editorial 
changes, including a change that reflects our proposal to redesignate 
listing 14.08I to listing 14.08H.
Proposed 14.00G--How will we consider the effect of treatment in 
evaluating your autoimmune disorder, immune deficiency disorder, or HIV 
infection?
    In the current rules, we refer to treatment and its effects in four 
places.
     In the third paragraph of 14.00B, we provide that, for 
connective tissue diseases, we need a longitudinal clinical record of 
at least 3 months demonstrating active disease despite prescribed 
treatment, with the expectation that the disease will remain active for 
12 months.
     In the fifth paragraph of 14.00B, we explain that ``the 
chronic adverse effects of treatment (e.g., corticosteroid-related 
ischemic necrosis of bone) may result in functional loss'' in 
individuals with connective tissue disease.
     In 14.00B6e, we explain that the fact that an individual 
with inflammatory arthritis is dependent on steroids or any other drug 
for the control of the arthritis is not in itself sufficient to 
establish that the individual is disabled. We also explain that we must 
evaluate each case on its own merits, taking into consideration any 
adverse effects of treatment.
     In 14.00D7, Effect of treatment, we provide three 
paragraphs discussing how we consider treatment in people with HIV 
infection. This section explains that we must consider both the 
positive effects and negative side effects of treatment for HIV 
infection and its manifestations, special considerations in evaluating 
treatment in individuals with HIV infection and, briefly, the kinds of 
evidence we need.
    We are proposing to remove the provisions in the third paragraph of 
14.00B and paragraph 14.00B6e. Neither of those sections nor the other 
current rules we will continue to use contain provisions that explain 
in detail how we evaluate the positive effects and negative side 
effects of treatment in individuals who have autoimmune disorders and 
immune deficiency disorders apart from HIV infection. Also, most 
current treatments for HIV infection came into use, or came into wide 
use, after we first published listing 14.08 in 1993. As a consequence, 
we believe that current 14.00D7 needs to be updated to reflect the 
newer and more widely used treatments and treatment protocols for HIV 
infection and to reflect the considerable medical experience that has 
been gained since 1993 about the long-term effects, usefulness, and 
limitations of such treatments.
    Therefore, we propose to add a new separate section 14.00G--How 
will we consider the effect of treatment in evaluating your autoimmune 
disorder, immune deficiency disorder, or HIV infection? The new section 
would address in one place issues of treatment that are common to all 
three types of immune system disorders as well as issues of treatment 
that are unique to each type of disorder, including treatment that is 
specifically for HIV infection. We do not propose to remove any 
guidance about treatment for HIV infection that is still relevant, only 
to move it to this new section. In fact, we propose to expand and 
update our rules to reflect what has been learned in applying different 
treatments for HIV infection since we published the current rules more 
than a decade ago. The provisions for addressing both the positive 
effects and negative side effects of treatment in individuals who have 
autoimmune disorders and immune deficiency disorders other than HIV 
infection would be new in these listings and, we believe, would provide 
useful adjudicative guidance that is lacking in our current rules.
    Section 14.00G has six subsections. The first two (proposed 14.00G1 
and 14.00G2) and the last one (proposed 14.00G6) are applicable to all 
immune system disorders. Proposed 14.00G3-14.00G5 provide guidance 
specific to each of the three main types of immune system disorders: 
Autoimmune disorders (proposed 14.00G3), immune deficiency disorders, 
excluding HIV infection (proposed 14.00G4), and HIV infection (proposed 
14.00G5).
    In proposed 14.00G1, General, we incorporate the first and fifth 
sentences of current 14.00D7. We believe that this guidance has general 
applicability to all immune system disorders, not just HIV infection. 
We first explain that we consider both the effectiveness of your 
treatment on your signs, symptoms, and laboratory findings, and the 
negative side effects of your treatment on your functioning. We also 
explain that we will make every reasonable effort to obtain a specific 
description of the treatment you receive. Then, we list eight factors 
we consider when we evaluate your treatment. They are mostly based on 
factors we mention in the current rule, but we propose to expand the 
list and in some cases to clarify the existing factors in our current 
rules. For example, instead of referring only to the ``dosage [and] 
frequency of administration'' of your treatment, we refer to ``the 
intrusiveness and complexity of your treatment (the dosing schedule, 
need for injections, etc).'' In proposed 14.00G1e, we also introduce 
the term ``variability of your response to treatment,'' a concept we 
address for HIV infection in current 14.00D7 but that we believe is of 
particular importance in considering the effects of treatment in all 
individuals with immune system disorders. We explain this concept in 
more detail in proposed 14.00G2.
    Proposed 14.00G1f is new. It describes the interactive and 
cumulative effects of treatments for immune system disorders and other 
disorders that people with immune system disorders may also have. We 
explain that the effects of these treatments taken together may be 
greater than they would be if we considered them separately, and we 
provide an example of treatment for HIV infection together with 
treatment for hepatitis C. Proposed 14.00G1g is also new. It explains 
that we will also consider the duration of your treatment. Proposed 
14.00G1h is a catchall for other relevant factors we have not listed in 
14.00G1a-14.00G1g.
    In proposed 14.00G2, Variability of your response to treatment, we 
explain what we mean by this factor in terms of both HIV infection and 
other immune

[[Page 44440]]

system disorders. This proposed rule is based on the language of the 
second paragraph in current 14.00D7 and the second sentence of the 
third paragraph of that section. However, we propose to expand that 
guidance and to apply it to all other immune system disorders in 
addition to HIV infection. For example, we explain in a general way 
applicable to all immune system disorders that some individuals may 
show an initial positive response to drug treatment (or a combination 
of drugs), but the initial positive response may be followed by a 
decrease in the effectiveness of the medication.
    We provide more specific information about treatment of autoimmune 
disorders in proposed 14.00G3, How we evaluate the effects of treatment 
for autoimmune disorders on your ability to function. This proposed 
rule repeats the rule in the fifth paragraph of current 14.00B that, 
when we evaluate the effects of your treatment for your autoimmune 
disorder(s), we will consider the adverse effects that may result in 
loss of function. We propose to expand this guidance to include more 
examples of potential chronic adverse effects of steroid treatment and 
to explain that the side effects of some medications may be acute or 
long-term. We also propose to add a provision that recognizes that the 
medications used in the treatment of autoimmune disorders may have 
effects on mental function, including cognition (memory), 
concentration, and mood.
    Proposed 14.00G4, How we evaluate the effects of treatment for 
immune deficiency disorders, excluding HIV infection, on your ability 
to function, is new. As in proposed 14.00G3, we repeat the principle 
that we will consider the side effects of your treatment when we 
evaluate your ability to function. We cite intravenous immunoglobulin 
and gamma interferon therapy as examples of treatment you may be 
receiving. We also provide examples of side effects of treatment for 
immune deficiency disorders, including physical symptoms (such as 
fatigue and headaches), clinical signs (such as high blood pressure and 
joint swelling), and limitations in mental function, including 
cognition, concentration, and mood.
    Proposed 14.00G5, How we evaluate the effects of treatment for HIV 
infection on your ability to function, is in two parts. In proposed 
14.00G5a, General, as in proposed 14.00G3 and 14.00G4, we repeat the 
principle from 14.00D7 that we consider the side effects of 
antiretroviral treatment and treatment for the manifestation of HIV 
infection on your ability to function. We propose to expand our 
guidance to provide examples of the physical and mental side effects of 
antiretroviral drugs. We also note that the symptoms of HIV infection 
and the side effects of medications may be indistinguishable, but that 
we will consider your functional limitations whether they are a result 
of your symptoms from HIV infection or the side effects of your 
treatment.
    In proposed 14.00G5b, Structured treatment interruptions, we 
provide new guidance specifically about structured treatment 
interruptions (STIs, also called drug holidays) in individuals with HIV 
infection. The proposed guidance clarifies that STIs are part of a 
prescribed treatment plan and do not show that an individual is failing 
to follow treatment, or in themselves establish that an individual's 
impairment is not as severe as alleged.
    In proposed 14.00G6, When there is no record of ongoing treatment, 
we explain how we will evaluate the medical severity and duration of 
your immune system disorder when you have not received ongoing 
treatment or have not had an ongoing relationship with any treatment 
source despite the existence of a severe impairment(s). The provision 
is based on a standard provision we include in most other body systems 
listings, for example, 1.00H3 in the musculoskeletal system, the third 
paragraph of 3.00A in the respiratory system, and the third paragraph 
of 4.00B3 in the cardiovascular system. We also explain that if you 
have just begun treatment and we cannot decide whether you are disabled 
based on the evidence we have, we may need to wait to determine the 
effect of your treatment. We explain that there is no set period 
because how long we may need to wait will depend on the facts of your 
individual case. This is consistent with the guidance we provide in the 
last sentence of the third paragraph in cur