[Federal Register Volume 70, Number 127 (Tuesday, July 5, 2005)]
[Rules and Regulations]
[Pages 38582-38593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13097]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulation No. 4]
RIN 0960-AF30


Revised Medical Criteria for Evaluating Genitourinary Impairments

AGENCY: Social Security Administration.

ACTION: Final rules.

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SUMMARY: We are revising the criteria in the Listing of Impairments 
(the listings) that we use to evaluate claims involving genitourinary 
impairments. 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 revisions reflect advances in medical knowledge, treatment, 
and methods of evaluating genitourinary impairments.

DATES: These rules are effective September 6, 2005.

Electronic Version

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

FOR FURTHER INFORMATION CONTACT: Richard Bresnick, Social Insurance 
Specialist, Office of Regulations, Social Security Administration, 100 
Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, 
(410) 965-1758 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 site, Social Security 
Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION: We are revising and making final the rules 
we proposed for evaluating genitourinary impairments in the Notice of 
Proposed Rulemaking (NPRM) we published in the Federal Register on 
August 23, 2004 (69 FR 51777).

What Programs Do These Final Regulations Affect?

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

Who Can Get Disability Benefits?

    Under title II of the Act, we provide for the payment of disability 
benefits if you are disabled and belong to one of the following three 
groups:
     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
        If you claim under . . .               And you are . . .        determinable impairment(s) as described
                                                                            above and that 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 order...  the inability to do any SGA.
title XVI...............................  a person under age 18......  marked and severe functional limitations.
----------------------------------------------------------------------------------------------------------------


[[Page 38583]]

How Do We Decide Whether You Are Disabled?

    If you are seeking benefits under title II of the Act, or if you 
are an adult seeking benefits under title XVI of the Act, we use a 
five-step ``sequential evaluation process'' to decide whether you are 
disabled. We describe this five-step process in our regulations at 
Sec. Sec.  404.1520 and 416.920. We follow the five steps in order and 
stop as soon as we can make a determination or decision. The steps are:
    1. Are you working and is the work you are doing substantial 
gainful activity (SGA)? If you are working and the work you are doing 
is SGA, we will find that you are not disabled, regardless of your 
medical condition or your age, education, and work experience. If you 
are not performing SGA, we will go on to step 2.
    2. Do you have a ``severe'' impairment? If you do not have an 
impairment or combination of impairments that significantly limits your 
physical or mental ability to do basic work activities, we will find 
that you are not disabled. If you do have a severe impairment(s), we 
will go on to step 3.
    3. Do you have an impairment(s) that meets or medically equals the 
severity of an impairment in the listings? If you do, and the 
impairment(s) meets the duration requirement, we will find that you are 
disabled. If you do not, we will go on to step 4.
    4. Do you have the residual functional capacity to do your past 
relevant work? If you do, we will find that you are not disabled. If 
you do not, we will go on to step 5.
    5. Does your impairment(s) prevent you from doing any other work 
that exists in significant numbers in the national economy, considering 
your residual functional capacity, age, education, and work experience? 
If it does, and it meets the duration requirement, we will find that 
you are disabled. If it does not, we will find that you are not 
disabled.
    We use a different sequential evaluation process for children who 
apply for payments based on disability under title XVI of the Act. We 
describe that sequential evaluation process in Sec.  416.924 of our 
regulations. If you are already receiving benefits, we also use a 
different sequential evaluation process when we decide whether your 
disability continues. (See Sec. Sec.  404.1594, 416.924, 416.994, and 
416.994a of our regulations.) However, all of these processes include 
steps at which we consider whether your impairment meets or medically 
equals one of our listings.

What Are the Listings?

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

How Do We Use the Listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we never 
use the listings in part B.
    If you are an individual under age 18, we first use the criteria in 
part B of the listings. If the listings in part B do not apply, and the 
specific disease process(es) has a similar effect on adults and 
children, we then use the criteria in part A. (See Sec. Sec.  404.1525 
and 416.925 of our regulations.)
    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 of our 
regulations.)

What If You Do Not Have an Impairment(s) That Meets or Medically Equals 
a Listing?

    We use the listings only to decide that individuals are disabled or 
that they are still disabled. We will not 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 are not working and you 
have a severe impairment(s) that does not meet or medically equal any 
listing, we may still find you disabled based on other rules in the 
``sequential evaluation process.'' Likewise, we will not decide that 
your disability has ended only because your impairment(s) does not meet 
or medically equal a listing.
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended because we 
have changed a listing. Our regulations explain that, when we change 
our listings, we continue to use our prior listings when we review your 
case, if you qualified for disability benefits or SSI payments based on 
our determination or decision that your impairment(s) met or medically 
equaled a listing. In these cases, we determine whether you have 
experienced medical improvement, and if so, whether the medical 
improvement is related to the ability to work. If your condition(s) has 
medically improved so that you no longer meet or medically 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) of our regulations.) If you 
are a child who is eligible for SSI payments, we follow a similar rule 
when we decide that you have experienced medical improvement in your 
condition(s). (See Sec.  416.994a(b)(2) of our regulations.)

Why Are We Revising the Listings for the Genitourinary System?

    We are revising these listings to update our medical criteria for 
evaluating genitourinary impairments and to provide more information 
about how we evaluate such impairments. We last published final rules 
comprehensively revising the listings for the genitourinary system in 
the Federal Register on December 6, 1985 (50 FR 50068). Because we have 
not comprehensively revised the listings for this body system since 
1985, we believe that we need to revise and update these rules.

What Do We Mean by ``Final Rules'' and ``Prior Rules''?

    Even though these rules will not go into effect until 30 days after 
publication of this notice, for clarity, we refer to the changes we are 
making here as the ``final rules'' and to the rules that will be 
changed by these final rules as the ``prior rules.''

When Will We Start To Use These Final Rules?

    We will start to use these final rules on their effective date. We 
will continue to use our prior rules until the effective date of these 
final rules. When the final rules become effective, we will apply them 
to new applications filed on or after the effective date of these rules 
and to claims pending before us, as we describe below.
    As is our usual practice when we make changes to our regulations, 
we will apply these final rules on or after their effective date 
whenever we make a determination or decision, including

[[Page 38584]]

in those claims in which we make a determination or decision after 
remand to us from a Federal court. With respect to claims in which we 
have made a final decision and that are pending judicial review in 
Federal court, we expect that the court's review of the Commissioner's 
final decision would be made in accordance with the rules in effect at 
the time of the administrative law judge's (ALJ's) decision when the 
ALJ's decision is the final decision of the Commissioner. If the court 
determines that the Commissioner's final decision is not supported by 
substantial evidence or contains an error of law, we would expect that 
the court would reverse the Commissioner's decision and remand the case 
for further administrative proceedings pursuant to the fourth sentence 
of section 205(g) of the Act, except in those few instances in which 
the court determines that it is appropriate to reverse the final 
decision and award benefits without remanding the case for further 
administrative proceedings. If a court reverses the Commissioner's 
final decision and remands the case for further administrative 
proceedings after the effective date of these final rules, we will 
apply the provisions of these final rules to the entire period at issue 
in the claim in our new decision issued pursuant to the court's remand.

How Long Will These Final Rules Be Effective?

    These final rules will no longer be effective 8 years after the 
date on which they become effective, unless we extend them or revise 
and issue them again. This is a technical change from the 5-year 
effective date as we proposed in the NPRM. We made this revision from 5 
to 8 years because we believe this is medically appropriate for the 
impairments contained in this body system. This change is also 
consistent with other recent final rules where we also determined that 
it was medically appropriate to set an expiration date 8 years from the 
effective date of the rules. For example, we recently set an 8-year 
effective date for our final rules for evaluating skin disorders (69 FR 
32260, 32269 (June 9, 2004)) and for our final rules for evaluating 
musculoskeletal impairments (66 FR 58010, 58037 (November 19, 2001)).

What Revisions Are We Making With These Final Rules?

    We are revising the listings criteria to present them in a more 
logical order and to make them easier to use. To do this, we are:
     Expanding the language in the introductory text (preface) 
in sections 6.00 and 106.00 to provide more guidance for our 
adjudicators, to bring it up to date, and to reflect the revised 
listings. We are designating all of the paragraphs in the preface with 
letters or numbers to make it easier to refer to them.
     Adding final sections 6.00B and 106.00B defining important 
terms in the listings.
     Removing listings that are obsolete to reflect the current 
medical practice of initiating dialysis earlier in the treatment of 
chronic renal failure. (We define the medical term ``renal'' in final 
sections 6.00B and 106.00B as ``pertaining to the kidney.'' We use the 
term ``renal'' in most of these listings because it is the term that 
physicians use.) Because of current medical practice, some of the 
associated complications specified in the prior listings no longer 
occur or reach listing-level severity. For example, we are removing 
prior listing 6.02C4, chronic renal disease with intractable pruritus. 
Although you may still have intractable pruritus, you usually will be 
receiving dialysis for the underlying chronic renal disease; in that 
case, your impairment will meet final listing 6.02A. In addition, the 
treatments for many of the side effects and complications of chronic 
renal disease have improved.
     Revising listings to reflect current medical practice and 
to be consistent with the terminology used in other body system 
listings. For example, in the childhood listings, we are changing 
``Renal transplant'' (prior listing 106.02D) to ``Kidney 
transplantation'' (final listing 106.02B).
     Redesignating the listings in part B to correspond to 
listings addressing the same impairments in part A. Except for minor 
changes to refer to children, we are also repeating much of the 
language of final section 6.00 in final section 106.00. This is because 
the same basic rules for establishing and evaluating the existence and 
severity of genitourinary impairments in adults also apply to children. 
In the discussion of the part B listings below, we only discuss changes 
to the childhood listings that we have not already discussed under the 
changes to the adult listings in part A.
     Adding final listing 106.07 in part B to address 
congenital genitourinary impairments that are not addressed in final 
listings 106.02 or 106.06.
    We are also making nonsubstantive editorial changes to update the 
medical terminology in the introductory text and the listings and to 
make the language clearer.

How Are We Changing the Introductory Text to the Listings for 
Evaluating Genitourinary Impairments in Adults?

Final Section 6.00 Genitourinary Impairments

    We are changing the name of this body system from ``Genito-Urinary 
System'' to ``Genitourinary Impairments'' to more accurately show that 
we use these listings to evaluate whether individuals are disabled in 
our disability programs. We are using the same heading for section 6.00 
of these final rules as for final section 106.00, even though we 
recognize that we list only kidney impairments in part A of the 
listings. We believe it is preferable to use the same heading in part A 
and part B of the listings, and since kidney impairments are types of 
genitourinary impairments, we believe this heading is appropriate.
    We are expanding and reorganizing the introductory text to these 
listings to:
     Provide additional guidance,
     Reflect the final listings, and
     Improve clarity and readability.
    Throughout the final rules, we have also made a number of minor 
editorial changes from the language we proposed in the NPRM; for 
example, to use consistent terminology throughout the final rules, to 
simplify language, and to correct punctuation. Because these changes 
were only for clarity and did not change the substance of the rules we 
proposed in the NPRM, we do not summarize them below.
    The following is an explanation of the major features of the final 
rules.

Final Section 6.00A--What Impairments Do These Listings Cover?

    In this new section, we explain that we use these listings to 
evaluate genitourinary impairments resulting from chronic renal 
disease. In final section 6.00A2, we provide a list of examples of 
chronic renal disease that can lead to renal dysfunction. This 
provision replaces the parenthetical statement we included in prior 
listing 6.02. In final section 6.00A3, we explain that we use the 
criteria in listing 6.06 to evaluate nephrotic syndrome due to 
glomerular disease.
    In a technical change from the NPRM, we revised the list of 
examples of chronic renal disease in final section 6.00A2. The revision 
corrects medically inaccurate statements from the NPRM but does not 
change the provision substantively.

[[Page 38585]]

Final Section 6.00B--What Do We Mean by the Following Terms in These 
Listings?

    In final section 6.00B, we define what we mean by important terms 
in these listings. In final section 6.00B5, we revised the list of 
examples of symptoms and signs of persistent fluid overload syndrome in 
response to a commenter who pointed out inconsistencies between the 
examples in the preamble to the NPRM and the proposed rules. In several 
other definitions, we made minor changes for medical accuracy and 
consistency of terms within the final listing:
     In final section 6.00B9, we reorganized the text, changed 
the description from ``massive'' proteinuria to ``heavy'' proteinuria, 
and removed the reference to lipiduria because it is not a defining 
characteristic of nephrotic syndrome.
     In final section 6.00B10, we removed the reference to 
``swelling'' from the list of effects of neuropathy because it is not 
generally a feature of neuropathy.
     In final section 6.00B14, we removed the example of 
osteomyelitis, which we do not mention in these listings, and replaced 
it with the example of osteoporosis, which we do. We also removed the 
reference to ``other diseases'' because we are providing only examples 
in this section.
    We are revising the heading of proposed section 6.00B--``What do we 
mean by the following terms?''--by adding ``in these listings'' in the 
heading of final section 6.00B. We are doing this to clarify why the 
list of terms in final section 6.00B is different from the list of 
terms in final section 106.00B in the childhood listings. We do not use 
all of the same terms in part B as we do in part A, so the list is 
different. We are also revising the heading of final section 106.00B so 
that it is the same as the heading of final section 6.00B.

Final Section 6.00C--What Evidence Do We Need?

    In final sections 6.00C1 and C2, we expand and clarify the 
documentation requirements discussed in prior section 6.00A. In final 
section 6.00C1, we briefly explain the kinds of evidence we need to 
evaluate claims of renal impairment.
    In final section 6.00C2, we explain that we generally need a 
longitudinal clinical record covering a period of at least 3 months of 
observations and treatment, unless we can make a fully favorable 
determination or decision without it. We also explain that the record 
should include laboratory findings, such as serum creatinine or serum 
albumin values, obtained on more than one examination over at least a 
3-month period.
    Final section 6.00C3 corresponds to prior section 6.00C. We explain 
that we should have laboratory findings that show your renal function 
before you started dialysis.
    Final sections 6.00C4 and 6.00C5 correspond to prior section 6.00B, 
which discussed nephrotic syndrome. We are clarifying the language and 
specifying appropriate laboratory evidence. In the last sentence of 
final section 6.00C5, we explain the evidence we can use when we do not 
have a pathology report.

Final Section 6.00D--How Do We Consider the Effects of Treatment?

    In this new section, we explain how we consider your treatment, 
including your response to treatment, its efficacy, and any adverse 
consequences.

Final Section 6.00E--What Other Things Do We Consider When We Evaluate 
Your Chronic Renal Disease Under Specific Listings?

    This section includes guidance about how we consider issues under 
specific listings. In the final rules, we are moving the text from 
proposed section 6.00G--``How do we evaluate specific genitourinary 
listings?''--into this section. The subparagraphs of final section 
6.00E now follow the order of the listings. We believe that this is a 
more logical organization than the one we originally proposed. Except 
as noted below, there is no significant change in the text of these 
rules from the NPRM.
    Final section 6.00E1, ``Chronic hemodialysis or peritoneal 
dialysis,'' corresponds to proposed section 6.00G1. It provides 
information for using final listing 6.02A.
    Final section 6.00E2, ``Kidney transplantation,'' corresponds to 
proposed section 6.00E1. It provides information for using final 
listing 6.02B. In it, we explain that if you have had a kidney 
transplant, we will consider you disabled for 12 months following the 
surgery because there is a greater likelihood of organ rejection and 
infection during the first year. We explain further that after that 
year we will determine whether you are still disabled based on any 
residual impairment(s) you have.
    In a technical change from the NPRM, we deleted the proposed 
provision in the second sentence of the paragraph that said that we 
would base our continuing disability evaluation on ``the residual 
impairment as shown by symptoms, signs, and laboratory findings.'' We 
determined that the proposed provision was unnecessary and that it 
could have been misinterpreted. When we determine whether you are still 
disabled, we consider whether there has been medical improvement in 
your impairment(s) based on symptoms, signs, and laboratory findings; 
however, at other steps of the process we use to determine whether your 
disability continues, we consider all other relevant evidence as well. 
(See Sec. Sec.  404.1579, 404.1594, and 416.994 of our regulations.) We 
also simplified the fourth sentence of the paragraph. Neither of these 
changes is a substantive change in the meaning of the rules we 
proposed.
    We also revised the list of complications at the end of the fourth 
sentence of the paragraph for technical medical reasons and to clarify 
our intent. Proposed section 6.00E1b indicated that we would consider 
the ``use of'' immunosuppressants; however, all people who have kidney 
transplants must use immunosuppressants. We are clarifying in final 
section 6.00E2b what we meant: that when we consider whether your 
disability continues 1 year after your transplant we will consider any 
side effects from your immunosuppressant treatment. We also combined 
proposed sections 6.00E1b and 6.00E1d, because corticosteroids are used 
for immunosuppression in individuals with kidney transplants. 
Therefore, in final section 6.00E2b, we now indicate that we consider 
the side effects of your immunosuppressants, including corticosteroids. 
These revisions in the final rules do not change the substance of the 
rules as we proposed them.
    Final section 6.00E3, ``Renal osteodystrophy,'' corresponds to 
proposed section 6.00G2. It provides information for using final 
listing 6.02C1. In the final rule, we removed the list of examples from 
final section 6.00E3 that we proposed in section 6.00G2 of the NPRM 
because final listing 6.02C1 also includes examples and the lists were 
inconsistent. In final section 6.00E3, we now refer to the list of 
examples in final listing 6.02C1.
    Final section 6.00E4, ``Persistent motor or sensory neuropathy,'' 
corresponds to proposed section 6.00G3. It provides information for 
using final listing 6.02C2. In it, we explain what the longitudinal 
clinical record of persistent neuropathy must show.
    Final section 6.00E5, ``Nephrotic syndrome,'' corresponds to 
proposed section 6.00E2. It explains what the evidence must show for 
your impairment to meet the requirements of

[[Page 38586]]

final listing 6.06A or B. In a technical change from the NPRM, we are 
restoring the examples of complications of nephrotic syndrome that we 
evaluate under other listings. In the NPRM, we proposed to remove the 
last sentence of prior section 6.00B, which indicated that we consider 
complications of nephrotic syndrome, such as severe orthostatic 
hypotension, recurrent infections or venous thromboses, under 
appropriate listings. In reviewing this proposal, we determined that 
this guidance could still be helpful, so we decided to include it in 
our section devoted to nephrotic syndrome, final section 6.00E5. In 
these final rules, we made minor editorial changes in the sentence for 
context and clarity. We also deleted the word ``severe'' from the 
phrase ``severe hypotension'' because we believe it is unnecessary in 
the sentence, which only describes some of the complications that may 
be associated with nephrotic syndrome, not necessarily how severe your 
complications must be to show disability.
    The changes we made to combine proposed sections 6.00E and 6.00G in 
the final rules necessitated redesignation of proposed section 6.00H as 
final section 6.00G and changes to cross-references throughout the 
final rules in the preamble and listings. None of these was a 
substantive change to the provisions of the affected rules.

Final Section 6.00F--What Does the Term ``Persistent'' Mean in These 
Listings?

    In final section 6.00F, we explain that the term ``persistent'' in 
these listings means that the longitudinal clinical record shows that, 
with few exceptions, the required finding(s) has been at, or is 
expected to be at, the level specified in the listing for a continuous 
period of at least 12 months. We use this term in final listings 6.02C.

Final Section 6.00G--How Do We Evaluate Impairments That Do Not Meet 
One of the Genitourinary Listings?

    Final section 6.00G (proposed section 6.00H) is new to this body 
system. In it, we state our basic adjudicative principle that, if your 
severe impairment(s) does not meet or medically equal the requirements 
of a listing, we will continue the sequential evaluation process to 
determine whether or not you are disabled.

How Are We Changing the Criteria in the Listings for Evaluating 
Genitourinary Impairments in Adults?

6.01 Category of Impairments, Genitourinary Impairments

Final Listing 6.02--Impairment of Renal Function
    We are removing the parenthetical examples that were in the first 
sentence of prior listing 6.02 because we address them in final section 
6.00A2, making their inclusion in the listing redundant. In a technical 
change from the NPRM, we are also revising the first sentence in final 
listing 6.02 regarding the duration of your chronic renal disease from 
``expected to last 12 months'' to ``that has lasted or can be expected 
to last for a continuous period of at least 12 months'' to be 
consistent with our definition of duration in Sec. Sec.  404.1509 and 
416.909.
    Final listing 6.02A, ``Chronic hemodialysis or peritoneal 
dialysis,'' corresponds to prior listing 6.02A, except that we are 
removing the statement ``necessitated by irreversible renal failure'' 
because it is redundant.
    Final listing 6.02B, ``Kidney transplantation,'' corresponds to 
prior listing 6.02B, ``Kidney transplant.'' We are changing the heading 
to use terminology that is consistent with other body system listings, 
such as in listing 4.09, ``Cardiac transplantation.''
    Final listing 6.02C, for persistent elevation of serum creatinine 
or reduction of creatinine clearance, corresponds to prior listing 
6.02C. In final listing 6.02C1, for renal osteodystrophy, we are 
replacing the word ``marked'' with the word ``significant'' in the 
phrase describing osteoporosis. We use the term ``marked'' in various 
other listings (for example, the mental disorders listings in section 
12.00) and other regulations (for example, the functional equivalence 
regulation for evaluating disability in children, Sec.  416.926a) to 
describe a particular measure of functional limitations, and it does 
not describe what we intend in this final listing. The change we are 
making in this final rule will remove any potential confusion about our 
intent. However, we are not changing the degree of osteoporosis 
required to meet this listing.
    In the NPRM, we also proposed to remove the word ``severe'' from 
the phrase that described bone pain in the prior listing. In final 
listing 6.02C1, we are restoring the word in response to a comment, as 
discussed below. See the public comments section of this preamble for 
an explanation of why we decided to keep the word in this listing.
    We are removing prior listings 6.02C2, for a clinical episode of 
pericarditis, and 6.02C4, for intractable pruritus, because current 
treatment for most individuals with chronic renal disease includes the 
initiation of dialysis earlier in the course of treatment. Previously, 
dialysis would be delayed, and individuals would be maintained on a low 
protein diet. Prior listings 6.02C2 and 6.02C4 were useful for 
establishing disability in these individuals. However, now it is known 
that the long-term prognosis improves for individuals when dialysis is 
initiated earlier in the course of treatment, so most patients begin 
dialysis earlier. Therefore, if you have pericarditis or intractable 
pruritus, you usually will be receiving dialysis; in that case, your 
impairment will meet final listing 6.02A.
    Because we are removing prior listing 6.02C2, we are redesignating 
prior listing 6.02C3, for persistent motor or sensory neuropathy, as 
final listing 6.02C2.
    We are reorganizing prior listing 6.02C5, for persistent fluid 
overload syndrome, and redesignating it as final listing 6.02C3. In 
addition, we provide that there must be persistent signs of vascular 
congestion despite prescribed therapy. In a technical change from the 
proposed rules, we are removing the requirement we proposed that you 
must demonstrate that you have symptoms in addition to the signs we 
required to meet this listing. If you have the signs we require in this 
listing, you will be unable to do any gainful activity and it is 
unnecessary for you to show that you also have symptoms. We are also 
adding a cross-reference to final section 6.00B5, where we list some 
examples of symptoms and signs of fluid overload syndrome.
    In the NPRM, we proposed to remove prior listing 6.02C6, for 
persistent elevation of serum creatinine or reduction of creatinine 
clearance with anorexia that meets the values in table III or IV of 
listing 5.08. In response to public comments described below, we 
decided to retain the listing in the final rules. The listing is 
redesignated as final listing 6.02C4.
    We are removing prior listing 6.02C7, for persistent hematocrits of 
30 percent or less, because hematocrits at this level do not 
necessarily correlate with an inability to do any gainful activity.
    We may still find you disabled if you have chronic renal disease 
and persistently low hematocrit levels. As we discuss in final section 
6.00G, we must consider whether your impairment(s) satisfies the 
criteria of any appropriate listing. If your impairment(s) does not 
meet a listing,

[[Page 38587]]

we will determine whether it medically equals a listing. If your 
impairment(s) does not meet or medically equal a listing, we will 
proceed to the fourth and, if necessary, the fifth steps of the 
sequential evaluation process as described in Sec. Sec.  404.1520 and 
416.920. We will consider the facts of your individual case, including 
your symptoms, such as fatigue and weakness, which may limit your 
functioning.
Final Listing 6.06--Nephrotic Syndrome
    We are removing the word ``significant'' from the description of 
anasarca in prior listing 6.06. Anasarca is, by definition, 
significant.

How Are We Changing the Preface to the Listings for Evaluating 
Genitourinary Impairments in Children?

Final Section 106.00 Genitourinary Impairments
    As in final section 6.00 in the adult rules, we are changing the 
name of this body system to ``Genitourinary Impairments.''
    We are adding a new section 106.00E4a (proposed section 106.00H) to 
explain how we evaluate episodic genitourinary impairments in children 
under final listings 106.07A, B, and C. We are also adding a new 
section 106.00E4c (proposed section 106.00I) to explain what we mean by 
``systemic infection,'' a criterion we use in final listing 106.07B.
    We are also repeating much of the preface of final section 6.00 in 
the preface to final section 106.00, except for minor changes that are 
specific to the childhood listings. We are doing this because the same 
basic rules for establishing and evaluating the existence and severity 
of genitourinary impairments in adults also apply to children.
    Because we have already described these provisions under the 
explanation of final section 6.00, the following discussion describes 
only those provisions that are unique to the childhood rules or that 
require further explanation specific to the evaluation of children's 
claims. When the provisions in section 106.00 are the same as the 
provisions in section 6.00 and we are revising provisions in section 
6.00 from the provisions we proposed in the NPRM, we are making the 
same changes in final section 106.00 as we are making in final section 
6.00.

Final Section 106.00A--What Impairments Do These Listings Cover?

    In this section, we provide general guidance on evaluating chronic 
renal disease or renal dysfunction and congenital genitourinary 
impairments in children. In final section 106.00A4, we explain that we 
use the criteria in final listing 106.07 to evaluate congenital 
genitourinary impairments and give examples of such impairments. In the 
final rule, we are adding another example of a congenital genitourinary 
impairment, extrophic urinary bladder.

Final Section 106.00E--What Other Things Do We Consider When We 
Evaluate Your Genitourinary Impairment Under Specific Listings?

    In this section, we are significantly reorganizing the rules we 
proposed in sections 106.00E, G, H, and I of the NPRM. We are combining 
proposed sections 106.00E and 106.00G for the same reasons we combined 
proposed sections 6.00E and 6.00G in part A. However, we are using a 
different heading for this section because in final section 106.00E4, 
it includes information about how we evaluate congenital genitourinary 
impairments under listing 106.07. Therefore, unlike the corresponding 
section in the adult rules, it is not only about chronic renal disease.
    We are also moving the provisions of proposed sections 106.00H and 
I to final section 106.00E4 together with relevant provisions from 
proposed section 106.00G. In the NPRM, we proposed three separate 
sections that included guidance about how we use listing 106.07:
     In proposed section 106.00G2, we provided four 
subparagraphs that described features of listing 106.07. Proposed 
section 106.00G2a simply described what proposed listing 106.07 
contained. Proposed section 106.00G2b, explained that diagnostic 
cystoscopy did not satisfy the requirement for repeated surgical 
procedures, a requirement in listing 106.07A. Proposed sections 
106.00G2c and G2d provided guidance about the criteria for electrolyte 
disturbance and hospitalizations in listing 106.07C.
     Proposed section 106.00H--``How do we evaluate episodic 
genitourinary impairments?''--provided guidance that was relevant only 
to the provisions of listing 106.07. Only listings 106.07A, B, and C 
include criteria for episodic events.
     Likewise, proposed section 106.00I--``What do we mean by 
systemic infection?''--provided guidance that was relevant only to 
listing 106.07B.
    We are combining all of these rules in final section 106.00E4 
because they all address the same listing section and we believe that 
it will be clearer to keep this guidance together. However, we are 
removing proposed section 106.00G2a in these final rules because it 
merely repeated what listing 106.07 requires and was unnecessary. We 
are also organizing the sections of 106.00E4 so they address listings 
106.07A, B, and C in order, starting with general information about the 
overall listing section.
    We did not make any substantive changes in the provisions in final 
section 106.00E4, but only removed headings, reorganized the sections 
into a clearer and more logical presentation, and made editorial 
changes as described below. The final rule is as follows.
    Final section 106.00E4a corresponds to proposed section 106.00H. In 
it, we explain that each of the listings in 106.07 (that is, listings 
106.07A, B, and C) includes a criterion for at least three events 
within a consecutive 12-month period with intervening periods of 
improvement. These events include urologic surgical procedures, 
hospitalizations, and treatment with parenteral antibiotics. The 
occurrence of these events within the specified time period supports 
the severity and chronicity of the underlying impairment(s). We also 
indicate that there must be at least 1 month between the events to 
ensure that we are evaluating separate episodes. As an editorial 
clarification from the NPRM, we are adding ``(that is, 30 days)'' after 
``at least 1 month'' to indicate we do not necessarily mean a calendar 
month.
    In final section 106.00E4a, we are making minor editorial changes 
from the language in proposed section 106.00H. For example, in section 
106.00H of the proposed rules we indicated that ``some listings'' are 
met when the longitudinal clinical record shows that at least three 
events have occurred within a period of 12 consecutive months. However, 
as we have already noted, the only listings in which we included such 
criteria were listings 106.07A, B, and C. Therefore, we clarified the 
final rule to refer specifically to final listing 106.07. We believe 
that these editorial changes will make final section 106.00E4a easier 
to understand and use.
    Final section 106.00E4b corresponds to proposed section 106.00G2b. 
It explains that diagnostic cystoscopy does not satisfy the requirement 
for repeated urologic surgical procedures in listing 106.07A. In the 
final rule, we added a reference to final listing 106.07A and the word 
``urologic'' before the word ``surgical'' to match the language of the 
listing.
    Final section 106.00E4c corresponds to proposed section 106.00I, 
``What do

[[Page 38588]]

we mean by systemic infection?''. In this section, we explain that the 
criterion for systemic infection in listing 106.07B means an infection 
requiring an initial course of parenterally administered antibiotics 
occurring at least once every 4 months or at least 3 times a year. This 
chronicity supports the severity required for this listing. In the 
final rule, we removed a sentence that included a cross-reference 
because we no longer need it. All of the provisions that explain 
listing 106.07 are now together in final section 106.00E4. We also made 
a minor editorial change for context.
    Final section 106.00E4d corresponds to proposed sections 106.00G2c 
and G2d. As we have already noted, these were the proposed provisions 
that explained terms in listing 106.07C. In an editorial change from 
the NPRM, we changed our reference to ``hospital admissions'' to 
``hospitalizations'' to use language that is closer to the provision in 
final listing 106.07C.
    The changes we made to combine proposed sections 106.00E, 106.00G, 
106.00H, and 106.00I in the final rules necessitated redesignation of 
proposed section 106.00J as final section 106.00G and changes to cross-
references throughout the final rules in the preamble and listings. 
None of these was a substantive change to the provisions of the 
affected rules.

Final Section 106.00G--How Do We Evaluate Impairments That Do Not Meet 
One of the Genitourinary Listings?

    In final section 106.00G (proposed section 106.00J), we repeat the 
provisions of final section 6.00G, but also include the definition of 
disability for children who claim SSI payments in final section 
106.00G2.

How Are We Changing the Criteria in the Listings for Evaluating 
Genitourinary Impairments in Children?

106.01 Category of Impairments, Genitourinary Impairments

    We are adding a new listing 106.07, ``Congenital genitourinary 
impairments,'' specifically for children. There is no parallel listing 
in the adult genitourinary listings because we expect that these 
impairments will have been treated or resolved before adulthood. We are 
also redesignating the childhood listings to be consistent with the 
adult listings.
Final Listing 106.02--Impairment of Renal Function
    In final listing 106.02, we are changing the heading of the prior 
listing to make it consistent with the final adult listing.
    We are also reordering the sequence of impairments included under 
listing 106.02 to more closely follow the order in final listing 6.02:
     Final listing 106.02A, ``Chronic hemodialysis or 
peritoneal dialysis,'' replaces prior listing 106.02C.
     Final listing 106.02B, ``Kidney transplantation,'' 
replaces prior listing 106.02D.
     Final listing 106.02C, ``Persistent elevation of serum 
creatinine,'' replaces prior listing 106.02A.
     Final listing 106.02D, ``Reduction of creatinine 
clearance,'' replaces prior listing 106.02B.
Final Listing 106.06--Nephrotic Syndrome
    In final listing 106.06, ``Nephrotic syndrome,'' we specify that 
anasarca must persist despite at least 3 months of prescribed therapy. 
``Anasarca'' is a more accurate term than ``edema'' for this listing.
    In final listing 106.06B, we are revising the terminology in prior 
listing 106.06B for measuring proteinuria to reflect current medical 
practice. This revision does not make the criterion more stringent. 
Rather, it is a more appropriate method of measuring proteinuria in 
children and is equivalent to the measurements used in prior listing 
106.06B.
Final Listing 106.07--Congenital Genitourinary Impairments
    In this new listing, we provide criteria that include consideration 
of repeated urologic surgical procedures, episodic systemic infections 
requiring parenteral antibiotics, and episodes of electrolyte 
disturbance requiring repeated hospitalizations. In final listing 
106.07C, we made an editorial change to replace the parenthetical 
reference to hospitalizations ``for 24 hours or more'' with a cross-
reference to final section 106.00E4d, which already explains that 
hospitalizations in listing 106.07C must be inpatient hospitalizations 
for 24 hours or more. The change eliminates an unnecessary redundancy.

Public Comments

    In the NPRM we published on August 23, 2004 (69 FR 51777), we 
provided the public with a 60-day period in which to comment. The 
period ended on October 22, 2004.
    We received comments from four public commenters. We carefully 
considered all of the comments. Because some of the comments were long, 
we have condensed, summarized, and paraphrased them. We have tried, 
however, to summarize the commenters' views accurately and to respond 
to all of the significant issues raised by the commenters that were 
within the scope of these rules.
    One commenter submitted a markup of the notice pointing out 
stylistic and technical editorial issues in the preamble and the 
proposed rules. Although we do not summarize and respond to those 
comments below, we have made appropriate corrections in these final 
rules.
    Other commenters noted provisions with which they agreed and did 
not make suggestions for changes in those provisions. We did not 
summarize or respond to those comments either.
    The following are the significant public comments that do require a 
response.

Proposed Listing 6.02A, Chronic Hemodialysis or Peritoneal Dialysis

    Comment: One commenter disagreed with our proposal to delete the 
parenthetical statement ``necessitated by irreversible renal failure'' 
from prior listing 6.02A. The commenter did not agree that all 
individuals who require chronic hemodialysis for at least 12 months 
would necessarily have irreversible renal failure. For example, a 
particular claimant could have several acute renal failures for a 
variety of different reasons in the course of a year. The commenter 
said that an individual with such episodic crises for 12 months would 
have an impairment that medically equals the listing but recommended 
that we specify that only individuals who have dialysis ``necessitated 
by [an] end-stage renal disease process'' would have an impairment that 
meets listing 6.02.
    Response: We did not adopt the comment. Listing 6.02A requires that 
the individual have ``chronic'' renal disease with ``chronic'' 
hemodialysis or peritoneal dialysis. Therefore, we believe that the 
reference to irreversible failure was redundant and that the listing 
clearly does not include individuals who have a series of acute events 
that require dialysis.

Proposed Listing 6.02B, Kidney Transplantation

    Comment: One commenter recommended that we add a cross-reference to 
proposed section 6.00E1 (final section 6.00E2) at the end of listing 
6.02B. The commenter said that this would emphasize to our adjudicators 
the critical need to carefully look at the residuals of the treatment 
required by the transplant.
    Response: We adopted the comment. In the proposed rules, we already 
included a cross-reference to proposed section 6.00E1 (final section 
6.00E2) at

[[Page 38589]]

the beginning of proposed listing 6.02. In these final rules, we have 
moved the cross-reference to the end of the listing. For consistency, 
we made the same change in final listing 106.02B.

Listing 6.02C, Persistent Elevation of Serum Creatinine or Reduction of 
Creatinine Clearance

    Comment: One commenter disagreed with our proposal to eliminate the 
requirement for ``severe'' bone pain for individuals with renal 
osteodystrophy under listing 6.02C1 and to require only that there be 
pain of an unspecified degree. The commenter believed that the change 
would require adjudicators to have to choose more frequently between 
whether an impairment meets or medically equals a listing and to weigh 
the issue of the credibility of an individual's symptoms more than the 
medical documentation itself. The commenter said that there was no 
specific demand for this modification because unspecified pain is never 
a basis for an allowance under our rules, but that severe pain that is 
``fully documented by medical and lay evidence can be.''
    Response: Although we did not agree with the commenter's rationale, 
we did adopt the comment. Many people with osteodystrophy do not have 
severe bone pain, and in reconsidering our proposed rule we realized 
that by deleting the word ``severe'' we might include some individuals 
under the listing who should not be presumed to be disabled. In final 
listing 6.02C1, we use the word ``severe'' to describe medical 
severity; it does not have the same meaning as it does when we use it 
in connection with a finding at the second step of the sequential 
evaluation process.
    We do not agree with the commenter that the proposed listing would 
have required adjudicators to choose more frequently between whether an 
impairment meets or medically equals this listing or to make more 
difficult findings about an individual's credibility. To the contrary, 
we believe that these issues would have arisen less often under the 
proposed listing because it required only the finding of pain and not 
``severe'' pain as in the prior listing. However, like the prior 
listing, we are restoring the word ``severe'' in the final listing for 
the reason stated in the previous paragraph.
    Finally, although it is true that under the Act and our regulations 
an individual cannot be found disabled solely on the basis of a 
symptom, such as pain, the commenter may have misunderstood other 
aspects of our policies on the evaluation of symptoms. For example, in 
Sec. Sec.  404.1525(f) and 416.925(f) of our regulations we explain 
that some listed impairments include symptoms usually associated with 
those impairments among their criteria. We then explain that:

    [g]enerally, when a symptom is one of the criteria in a 
[listing], it is only necessary that the symptom be present in 
combination with the other criteria. It is not necessary, unless the 
listing specifically states otherwise, to provide information about 
the intensity, persistence or limiting effects of the symptom as 
long as all other findings required by the specific listing are 
present.

    Likewise, we do not have a requirement that an individual's pain be 
``fully documented'' by the medical and lay evidence in order to 
establish that the individual is disabled. (See Sec. Sec.  404.1529 and 
416.929 of our regulations.)
    Comment: Two commenters disagreed with our proposal to remove 
listing 6.02C6 because it was a reference listing. Both commenters 
pointed out that listing 6.02C6 did not simply describe the same 
impairment described in listing 5.08, because listing 5.08 requires 
weight loss ``due to any persisting gastrointestinal disorder.'' 
Rather, prior listing 6.02C6 described persistent anorexia associated 
with chronic renal disease, and the reference to the current weight 
values in two tables in listing 5.08 was only a severity criterion. 
Both commenters were concerned that some individuals would be 
inappropriately denied if we deleted the listing.
    Response: We adopted the comments. The restored listing is listing 
6.02C4 in these final rules.
    Because of this change from the NPRM, we also deleted the example 
we proposed to include in section 6.00H1 explaining that weight loss 
associated with chronic renal disease should be evaluated under listing 
5.08 in final section 6.00G1. We did not replace it with another 
example because we do not believe an example is necessary in this 
section.

Listing 106.07, Congenital Genitourinary Impairments

    Comment: One commenter recommended that we add a new listing 
106.07D to the proposed listing for children with ``[a]ny anatomical 
congenital malformation of a genito-urinary organ(s) which markedly 
limits adaptive functional capabilities of the child.'' The commenter 
said that this would complete all medical possibilities.
    Response: We did not adopt the comment. The commenter essentially 
described a situation that would be covered by our rules for evaluating 
functional equivalence in Sec.  416.926a of our regulations. That 
standard requires either an ``extreme'' limitation in one of the 
functional domains we list in Sec.  416.926a(b)(1) or ``marked'' 
limitations in two of those domains.

Interstitial Cystitis

    Comment: One commenter noted that in 2002 we issued a Social 
Security Ruling (SSR) explaining how to evaluate cases of individuals 
with interstitial cystitis. (SSR 02-2p, ``Titles II and XVI: Evaluation 
of Interstitial Cystitis,'' 67 FR 67436 (November 5, 2002)). The 
commenter recommended that we address this impairment ``in some 
fashion'' in the listing.
    Response: We did not adopt the comment. As we indicate in SSR 02-
2p, the causes of interstitial cystitis are unknown, and there are no 
definitive tests for the disorder; the diagnosis is made after 
excluding other possibilities for an individual's symptoms. Therefore, 
although we do recognize interstitial cystitis as a medically 
determinable impairment that can be very serious and result in 
disability under our rules, we are unable to include it in our 
genitourinary body system listings at this time. We also believe that 
SSR 02-2p provides more detailed and useful criteria than we would have 
been able to include in the preface to the listings.

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these final rules meet the requirements for a 
significant regulatory action under Executive Order 12866, as amended 
by Executive Order 13258. Thus, they were subject to OMB review.

Regulatory Flexibility Act

    We certify that these final rules do not have a significant 
economic impact on a substantial number of small entities because they 
affect only individuals. Thus, a regulatory flexibility analysis as 
provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    The Paperwork Reduction Act (PRA) of 1995 says that no persons are 
required to respond to a collection of information unless it displays a 
valid Office of Management and Budget (OMB) control number. In 
accordance with the PRA, SSA is providing notice that OMB has approved 
the information collection requirements contained in sections 6.00C, 
6.00E, 106.00C and 106.00E of these final rules. The OMB

[[Page 38590]]

Control Number for these collections is 0960-0642, expiring March 31, 
2008.

(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: March 28, 2005.
Jo Anne B. Barnhart,
Commissioner of Social Security.

0
For the reasons set out in the preamble, subpart P of part 404 of 
chapter III of title 20 of the Code of Federal Regulations is amended 
as set forth below:

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

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

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

Appendix 1 to Subpart P of Part 404--[Amended]

0
2. Appendix 1 to subpart P of part 404 is amended as follows:
0
a. Item 7 of the introductory text before part A of appendix 1 is 
amended by revising the body system name and expiration date.
0
b. The Table of Contents for part A of appendix 1 is amended by 
revising the body system name for section 6.00.
0
c. Section 6.00 of part A of appendix 1 is revised.
0
d. The Table of Contents for part B of appendix 1 is amended by 
revising the body system name for section 106.00.
0
e. Section 106.00 of part B of appendix 1 is revised.
    The revised text is set forth as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    7. Genitourinary Impairments (6.00 and 106.00): September 6, 2013.
* * * * *

Part A

* * * * *

6.00 Genitourinary Impairments

* * * * *

6.00 Genitourinary Impairments

A. What impairments do these listings cover?

    1. We use these listings to evaluate genitourinary impairments 
resulting from chronic renal disease.
    2. We use the criteria in 6.02 to evaluate renal dysfunction due to 
any chronic renal disease, such as chronic glomerulonephritis, 
hypertensive renal vascular disease, diabetic nephropathy, chronic 
obstructive uropathy, and hereditary nephropathies.
    3. We use the criteria in 6.06 to evaluate nephrotic syndrome due 
to glomerular disease.

B. What do we mean by the following terms in these listings?

    1. Anasarca is generalized massive edema (swelling).
    2. Creatinine is a normal product of muscle metabolism.
    3. Creatinine clearance test is a test for renal function based on 
the rate at which creatinine is excreted by the kidney.
    4. Diastolic hypertension is elevated diastolic blood pressure.
    5. Fluid overload syndrome associated with renal disease occurs 
when there is excessive sodium and water retention in the body that 
cannot be adequately removed by the diseased kidneys. Symptoms and 
signs of vascular congestion may include fatigue, shortness of breath, 
hypertension, congestive heart failure, accumulation of fluid in the 
abdomen (ascites) or chest (pleural effusions), and peripheral edema.
    6. Glomerular disease can be classified into two broad categories, 
nephrotic and nephritic. Nephrotic conditions are associated with 
increased urinary protein excretion and nephritic conditions are 
associated with inflammation of the internal structures of the kidneys.
    7. Hemodialysis, or dialysis, is the removal of toxic metabolic 
byproducts from the blood by diffusion in an artificial kidney machine.
    8. Motor neuropathy is neuropathy or polyneuropathy involving only 
the motor nerves.
    9. Nephrotic syndrome is a general name for a group of diseases 
involving defective kidney glomeruli, characterized by heavy 
proteinuria, hypoalbuminemia, hyperlipidemia, and varying degrees of 
edema.
    10. Neuropathy is a problem in peripheral nerve function (that is, 
in any part of the nervous system except the brain and spinal cord) 
that causes pain, numbness, tingling, and muscle weakness in various 
parts of the body.
    11. Osteitis fibrosa is fibrous degeneration with weakening and 
deformity of bones.
    12. Osteomalacia is a softening of the bones.
    13. Osteoporosis is a thinning of the bones with reduction in bone 
mass resulting from the depletion of calcium and bone protein.
    14. Pathologic fractures are fractures resulting from weakening of 
the bone structure by pathologic processes, such as osteomalacia and 
osteoporosis.
    15. Peritoneal dialysis is a method of hemodialysis in which the 
dialyzing solution is introduced into and removed from the peritoneal 
cavity either continuously or intermittently.
    16. Proteinuria is excess protein in the urine.
    17. Renal means pertaining to the kidney.
    18. Renal osteodystrophy refers to a variety of bone disorders 
usually caused by chronic kidney failure.
    19. Sensory neuropathy is neuropathy or polyneuropathy that 
involves only the sensory nerves.
    20. Serum albumin is a major plasma protein that is responsible for 
much of the plasma colloidal osmotic pressure and serves as a transport 
protein.
    21. Serum creatinine is the amount of creatinine in the blood and 
is measured to evaluate kidney function.

C. What evidence do we need?

    1. We need a longitudinal record of your medical history that 
includes records of treatment, response to treatment, hospitalizations, 
and laboratory evidence of renal disease that indicates its progressive 
nature. The laboratory or clinical evidence will indicate deterioration 
of renal function, such as elevation of serum creatinine.
    2. We generally need a longitudinal clinical record covering a 
period of at least 3 months of observations and treatment, unless we 
can make a fully favorable determination or decision without it. The 
record should include laboratory findings, such as serum creatinine or 
serum albumin values, obtained on more than one examination over the 3-
month period.
    3. When you are undergoing dialysis, we should have laboratory 
findings showing your renal function before you started dialysis.
    4. The medical evidence establishing the clinical diagnosis of 
nephrotic syndrome must include a description of the extent of edema, 
including pretibial, periorbital, or presacral edema. The medical 
evidence should describe any ascites, pleural effusion, or pericardial 
effusion. Levels of serum albumin and proteinuria must be included.

[[Page 38591]]

    5. If a renal biopsy has been performed, the evidence should 
include a copy of the report of the microscopic examination of the 
specimen. However, if we do not have a copy of the microscopic 
examination in the evidence, we can accept a statement from an 
acceptable medical source that a biopsy was performed, with a 
description of the results.

D. How do we consider the effects of treatment?

    We consider factors such as the:
    1. Type of therapy.
    2. Response to therapy.
    3. Side effects of therapy.
    4. Effects of any post-therapeutic residuals.
    5. Expected duration of treatment.

E. What other things do we consider when we evaluate your chronic renal 
disease under specific listings?

    1. Chronic hemodialysis or peritoneal dialysis (6.02A). A report 
from an acceptable medical source describing the chronic renal disease 
and the need for ongoing dialysis is sufficient to satisfy the 
requirements in 6.02A.
    2. Kidney transplantation (6.02B). If you have undergone kidney 
transplantation, we will consider you to be disabled for 12 months 
following the surgery because, during the first year, there is a 
greater likelihood of rejection of the organ and recurrent infection. 
After the first year posttransplantation, we will base our continuing 
disability evaluation on your residual impairment(s). We will include 
absence of symptoms, signs, and laboratory findings indicative of 
kidney dysfunction in our consideration of whether medical improvement 
(as defined in Sec. Sec.  404.1579(b)(1) and (c)(1), 404.1594(b)(1) and 
(c)(1), 416.994(b)(1)(i) and (b)(2)(i), or 416.994a, as appropriate) 
has occurred. We will consider the:
    a. Occurrence of rejection episodes.
    b. Side effects of immunosuppressants, including corticosteroids.
    c. Frequency of any renal infections.
    d. Presence of systemic complications such as other infections, 
neuropathy, or deterioration of other organ systems.
    3. Renal osteodystrophy (6.02C1). This condition is bone 
deterioration resulting from chronic renal disease. The resultant bone 
disease includes the impairments described in 6.02C1.
    4. Persistent motor or sensory neuropathy (6.02C2). The 
longitudinal clinical record must show that the neuropathy is a 
``severe'' impairment as defined in Sec. Sec.  404.1520(c) and 
416.920(c) that has lasted or can be expected to last for a continuous 
period of at least 12 months.
    5. Nephrotic syndrome (6.06). The longitudinal clinical record 
should include a description of prescribed therapy, response to 
therapy, and any side effects of therapy. In order for your nephrotic 
syndrome to meet 6.06A or B, the medical evidence must document that 
you have the appropriate laboratory findings required by these listings 
and that your anasarca has persisted for at least 3 months despite 
prescribed therapy. However, we will not delay adjudication if we can 
make a fully favorable determination or decision based on the evidence 
in your case record. We may also evaluate complications of your 
nephrotic syndrome, such as orthostatic hypotension, recurrent 
infections, or venous thromboses, under the appropriate listing for the 
resultant impairment.

F. What does the term ``persistent'' mean in these listings?

    Persistent means that the longitudinal clinical record shows that, 
with few exceptions, the required finding(s) has been at, or is 
expected to be at, the level specified in the listing for a continuous 
period of at least 12 months.

G. How do we evaluate impairments that do not meet one of the 
genitourinary listings?

    1. These listings are only examples of common genitourinary 
impairments that we consider severe enough to prevent you from doing 
any gainful activity. If your severe impairment(s) does not meet the 
criteria of any of these listings, we must also consider whether you 
have an impairment(s) that satisfies the criteria of a listing in 
another body system.
    2. If you have a severe medically determinable impairment(s) that 
does not meet a listing, we will determine whether your impairment(s) 
medically equals a listing. (See Sec. Sec.  404.1526 and 416.926.) If 
you have a severe impairment(s) that does not meet or medically equal 
the criteria of a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. 
Therefore, we proceed to the fourth and, if necessary, the fifth steps 
of the sequential evaluation process in Sec. Sec.  404.1520 and 
416.920. When we decide whether you continue to be disabled, we use the 
rules in Sec. Sec.  404.1579(b)(1) and (c)(1), 404.1594(b)(1) and 
(c)(1), 416.994(b)(1)(i) and (b)(2)(i), or 416.994a, as appropriate.
6.01 Category of Impairments, Genitourinary Impairments
    6.02 Impairment of renal function, due to any chronic renal disease 
that has lasted or can be expected to last for a continuous period of 
at least 12 months. With:
    A. Chronic hemodialysis or peritoneal dialysis (see 6.00E1).

or

    B. Kidney transplantation. Consider under a disability for 12 
months following surgery; thereafter, evaluate the residual impairment 
(see 6.00E2).

or

    C. Persistent elevation of serum creatinine to 4 mg per deciliter 
(dL) (100 ml) or greater or reduction of creatinine clearance to 20 ml 
per minute or less, over at least 3 months, with one of the following:
    1. Renal osteodystrophy (see 6.00E3) manifested by severe bone pain 
and appropriate medically acceptable imaging demonstrating 
abnormalities such as osteitis fibrosa, significant osteoporosis, 
osteomalacia, or pathologic fractures; or
    2. Persistent motor or sensory neuropathy (see 6.00E4); or
    3. Persistent fluid overload syndrome with:
    a. Diastolic hypertension greater than or equal to diastolic blood 
pressure of 110 mm Hg; or
    b. Persistent signs of vascular congestion despite prescribed 
therapy (see 6.00B5); or
    4. Persistent anorexia with recent weight loss and current weight 
meeting the values in 5.08, table III or IV.
    6.06 Nephrotic syndrome, with anasarca, persisting for at least 3 
months despite prescribed therapy (see 6.00E5). With:
    A. Serum albumin of 3.0 g per dL (100 ml) or less and proteinuria 
of 3.5 g or greater per 24 hours.

or

    B. Proteinuria of 10.0 g or greater per 24 hours.
* * * * *

Part B

* * * * *

106.00 Genitourinary Impairments

* * * * *

106.00 Genitourinary Impairments

A. What impairments do these listings cover?

    1. We use these listings to evaluate genitourinary impairments 
resulting from chronic renal disease and congenital genitourinary 
disorders.
    2. We use the criteria in 106.02 to evaluate renal dysfunction due 
to any

[[Page 38592]]

chronic renal disease, such as chronic glomerulonephritis, hypertensive 
renal vascular disease, diabetic nephropathy, chronic obstructive 
uropathy, and hereditary nephropathies.
    3. We use the criteria in 106.06 to evaluate nephrotic syndrome due 
to glomerular disease.
    4. We use the criteria in 106.07 to evaluate congenital 
genitourinary impairments such as ectopic ureter, extrophic urinary 
bladder, urethral valves, and neurogenic bladder.

B. What do we mean by the following terms in these listings?

    1. Anasarca is generalized massive edema (swelling).
    2. Creatinine is a normal product of muscle metabolism.
    3. Creatinine clearance test is a test for renal function based on 
the rate at which creatinine is excreted by the kidney.
    4. Glomerular disease can be classified into two broad categories, 
nephrotic and nephritic. Nephrotic conditions are associated with 
increased urinary protein excretion and nephritic conditions are 
associated with inflammation of the internal structures of the kidneys.
    5. Hemodialysis, or dialysis, is the removal of toxic metabolic 
byproducts from the blood by diffusion in an artificial kidney machine.
    6. Nephrotic syndrome is a general name for a group of diseases 
involving defective kidney glomeruli, characterized by heavy 
proteinuria, hypoalbuminemia, hyperlipidemia, and varying degrees of 
edema.
    7. Neuropathy is a problem in peripheral nerve function (that is, 
in any part of the nervous system except the brain and spinal cord) 
that causes pain, numbness, tingling, and muscle weakness in various 
parts of the body.
    8. Parenteral antibiotics refer to the administration of 
antibiotics by intravenous, intramuscular, or subcutaneous injection.
    9. Peritoneal dialysis is a method of hemodialysis in which the 
dialyzing solution is introduced into and removed from the peritoneal 
cavity either continuously or intermittently.
    10. Proteinuria is excess protein in the urine.
    11. Renal means pertaining to the kidney.
    12. Serum albumin is a major plasma protein that is responsible for 
much of the plasma colloidal osmotic pressure and serves as a transport 
protein.
    13. Serum creatinine is the amount of creatinine in the blood and 
is measured to evaluate kidney function.

C. What evidence do we need?

    1. We need a longitudinal record of your medical history that 
includes records of treatment, response to treatment, hospitalizations, 
and laboratory evidence of renal disease that indicates its progressive 
nature or of congenital genitourinary impairments that documents their 
recurrent or episodic nature. The laboratory or clinical evidence will 
indicate deterioration of renal function, such as elevation of serum 
creatinine, or changes in genitourinary function, such as episodes of 
electrolyte disturbance.
    2. We generally need a longitudinal clinical record covering a 
period of at least 3 months of observations and treatment, unless we 
can make a fully favorable determination or decision without it. The 
record should include laboratory findings, such as serum creatinine or 
serum albumin values, obtained on more than one examination over the 3-
month period.
    3. When you are undergoing dialysis, we should have laboratory 
findings showing your renal function before you started dialysis.
    4. The medical evidence establishing the clinical diagnosis of 
nephrotic syndrome must include a description of the extent of edema, 
including pretibial, periorbital, or presacral edema. The medical 
evidence should describe any ascites, pleural effusion, or pericardial 
effusion. Levels of serum albumin and proteinuria must be included.
    5. If a renal biopsy has been performed, the evidence should 
include a copy of the report of the microscopic examination of the 
specimen. However, if we do not have a copy of the microscopic 
examination in the evidence, we can accept a statement from an 
acceptable medical source that a biopsy was performed, with a 
description of the results.
    6. The medical evidence documenting congenital genitourinary 
impairments should include treating physician records, operative 
reports, and hospital records. It should describe the frequency of your 
episodes, prescribed treatment, laboratory findings, and any surgical 
procedures performed.

D. How do we consider the effects of treatment?

    We consider factors such as the:
    1. Type of therapy.
    2. Response to therapy.
    3. Side effects of therapy.
    4. Effects of any post-therapeutic residuals.
    5. Expected duration of treatment.

E. What other things do we consider when we evaluate your genitourinary 
impairment under specific listings?

    1. Chronic hemodialysis or peritoneal dialysis (106.02A). A report 
from an acceptable medical source describing the chronic renal disease 
and the need for ongoing dialysis is sufficient to satisfy the 
requirements in 106.02A.
    2. Kidney transplantation (106.02B). If you have undergone kidney 
transplantation, we will consider you to be disabled for 12 months 
following the surgery because, during the first year, there is a 
greater likelihood of rejection of the organ and recurrent infection. 
After the first year posttransplantation, we will base our continuing 
disability evaluation on your residual impairment(s). We will include 
absence of symptoms, signs, and laboratory findings indicative of 
kidney dysfunction in our consideration of whether medical improvement 
(as defined in Sec. Sec.  404.1594(b)(1) and (c)(1) and 416.994a, as 
appropriate) has occurred. We will consider the:
    a. Occurrence of rejection episodes.
    b. Side effects of immunosuppressants, including corticosteroids.
    c. Frequency of any renal infections.
    d. Presence of systemic complications such as other infections, 
neuropathy, or deterioration of other organ systems.
    3. Nephrotic syndrome (106.06). The longitudinal clinical record 
should include a description of prescribed therapy, response to 
therapy, and any side effects of therapy. In order for your nephrotic 
syndrome to meet 106.06A or B, the medical evidence must document that 
you have the appropriate laboratory findings required by these listings 
and that your anasarca has persisted for at least 3 months despite 
prescribed therapy. However, we will not delay adjudication if we can 
make a fully favorable determination or decision based on the evidence 
in your case record. We may also evaluate complications of your 
nephrotic syndrome, such as orthostatic hypotension, recurrent 
infections, or venous thromboses, under the appropriate listing for the 
resultant impairment.
    4. Congenital genitourinary impairments (106.07).
    a. Each of the listings in 106.07 requires a longitudinal clinical 
record showing that at least three events have occurred within a 
consecutive 12-month period with intervening periods of improvement. 
Events include urologic surgical procedures, hospitalizations, and 
treatment with parenteral antibiotics. To meet the requirements of

[[Page 38593]]

these listings, there must be at least 1 month (that is, 30 days) 
between the events in order to ensure that we are evaluating separate 
episodes.
    b. Diagnostic cystoscopy does not satisfy the requirement for 
repeated urologic surgical procedures in 106.07A.
    c. In 106.07B, systemic infection means an infection requiring an 
initial course of parenterally administered antibiotics occurring at 
least once every 4 months or at least 3 times a year.
    d. In 106.07C, appropriate laboratory and clinical evidence 
document electrolyte disturbance. Hospitalizations are inpatient 
hospitalizations for 24 hours or more.

F. What does the term ``persistent'' mean in these listings?

    Persistent means that the longitudinal clinical record shows that, 
with few exceptions, the required finding(s) has been at, or is 
expected to be at, the level specified in the listing for a continuous 
period of at least 12 months.

G. How do we evaluate impairments that do not meet one of the 
genitourinary listings?

    1. These listings are only examples of common genitourinary 
impairments that we consider severe enough to prevent you from doing 
any gainful activity or that result in marked and severe functional 
limitations. If your severe impairment(s) does not meet the criteria of 
any of these listings, we must also consider whether you have an 
impairment(s) that satisfies the criteria of a listing in another body 
system.
    2. If you have a severe medically determinable impairment(s) that 
does not meet a listing, we will determine whether your impairment(s) 
medically equals a listing, or, in the case of a claim for SSI 
payments, functionally equals the listings. (See Sec. Sec.  404.1526, 
416.926, and 416.926a.) When we decide whether a child receiving SSI 
payments continues to be disabled, we use the rules in Sec.  416.994a.
106.01 Category of Impairments, Genitourinary Impairments
    106.02 Impairment of renal function, due to any chronic renal 
disease that has lasted or can be expected to last for a continuous 
period of at least 12 months. With:
    A. Chronic hemodialysis or peritoneal dialysis (see 106.00E1).

or

    B. Kidney transplantation. Consider under a disability for 12 
months following surgery; thereafter, evaluate the residual impairment 
(see 106.00E2).

or

    C. Persistent elevation of serum creatinine to 3 mg per deciliter 
(dL) (100 ml) or greater, over at least 3 months.

or

    D. Reduction of creatinine clearance to 30 ml per minute (43 
liters/24 hours) per 1.73 m2 of body surface area over at least 3 
months.
    106.06 Nephrotic syndrome, with anasarca, persisting for at least 3 
months despite prescribed therapy. (See 106.00E3.) With:
    A. Serum albumin of 2.0 g/dL (100 ml) or less.

or

    B. Proteinuria of 40 mg/m2/hr or greater.
    106.07 Congenital genitourinary impairments (see 106.00E4) 
resulting in one of the following:
    A. Repeated urologic surgical procedures, occurring at least 3 
times in a consecutive 12-month period.

or

    B. Documented episodes of systemic infection requiring an initial 
course of parenteral antibiotics, occurring at least 3 times in a 
consecutive 12-month period (see 106.00E4).

or

    C. Hospitalization (see 106.00E4d) for episodes of electrolyte 
disturbance, occurring at least 3 times in a consecutive 12-month 
period.

[FR Doc. 05-13097 Filed 7-1-05; 8:45 am]
BILLING CODE 4191-02-P