[Federal Register Volume 69, Number 162 (Monday, August 23, 2004)]
[Proposed Rules]
[Pages 51777-51784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19188]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 69, No. 162 / Monday, August 23, 2004 / 
Proposed Rules  

[[Page 51777]]



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: Proposed rules.

-----------------------------------------------------------------------

SUMMARY: We propose to revise 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 proposed revisions reflect advances in 
medical knowledge, treatment, and methods of evaluating genitourinary 
impairments.

DATES: To be sure your comments are considered, we must receive them by 
October 22, 2004.

ADDRESSES: You may give us your comments by: using our Internet site 
facility (i.e., Social Security Online) at: http://policy.ssa.gov/pnpublic.nsf/LawsRegs or the Federal eRulemaking Portal at http://www.regulations.gov; e-mail to [email protected]; by telefax to (410) 
966-2830, or by letter to the Commissioner of Social Security, P.O. Box 
17703, Baltimore, Maryland 21235-7703. You may also deliver them to the 
Office of Regulations, Social Security Administration, 100 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, 
between 8 a.m. and 4:30 p.m. on regular business days. Comments are 
posted on our Internet site, at http://policy.ssa.gov/pnpublic.nsf/LawsRegs or you may inspect them on regular business days by making 
arrangements with the contact person shown in this preamble.
    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: Martin Sussman, SSA Regulations 
Officer, Social Security Administration, 100 Altmeyer Building, 6401 
Security Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1767 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 http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

What Programs Would These Proposed Regulations Affect?

    These proposed regulations would 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 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 20 
CFR 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
 If you file                        medically determinable impairment(s)
   a claim      And you are . . .    as described above and that results
 under . . .                                      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    Marked and severe functional
               18                    limitations.
------------------------------------------------------------------------

What Are the Listings?

    The listings are examples of impairments that we consider severe 
enough to prevent a person from doing any gainful activity or that 
result in ``marked and severe functional limitations'' in children 
seeking SSI payments under title XVI of the Act. 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 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 people are disabled or that 
they are still disabled. We will never deny your claim or decide that 
you no longer qualify for benefits because your impairment(s)

[[Page 51778]]

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 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 the Genitourinary 
System?

    We last published final rules revising the listings for the 
genitourinary system in the Federal Register on December 6, 1985 (50 FR 
50068). In that notice, we said that those rules would be effective for 
8 years unless we extended them, or revised and issued them again. The 
current listings for the genitourinary system will no longer be 
effective on July 1, 2005, unless we extend them, or revise and issue 
them again.
    We are proposing these revisions because we decided to update the 
medical criteria in the listings and to provide more information about 
how we evaluate genitourinary impairments.

When Will We Start To Use These Rules?

    We will not use these 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 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 Rules Be Effective?

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

What Revisions Are We Proposing To Make?

    We are proposing to present the listings criteria in a more logical 
order, and to make the listings easier to use. To do this, we propose 
to:
     Expand the language in the introductory text (preface) in 
proposed 6.00 and 106.00 to bring it up to date and to reflect the new 
listings. We are designating the paragraphs numerically to make it 
easier to use the proposed listings.
     Add a new section in proposed 6.00 and 106.00 defining 
important terms in the listings.
     Remove listings that are obsolete due to the fact that 
dialysis is now initiated earlier in the treatment of chronic renal 
failure, before some of the associated complications specified in the 
current listings appear or reach listing-level severity. (We define the 
medical term ``renal'' in section 6.00A, as pertaining to the kidney. 
We use ``renal'' in most of these listings because it is the term that 
physicians use.) For example, while intractable pruritis still may 
occur (current listing 6.02C4), you usually will be receiving dialysis 
for the underlying chronic renal disease, and as such, your impairment 
will meet listing 6.02A. In addition, treatment modalities for many of 
the side effects and complications of chronic renal disease have 
improved.
     Revise 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 would change ``Renal 
transplant'' (current listing 106.02D) to ``Kidney transplantation.''
     Remove reference listings and replace them with guidance 
in the preface. Reference listings are listings that are met by 
satisfying the criteria of another listing. For example, current 
listing 6.02C6 for chronic renal disease with persistent anorexia is a 
reference listing that requires evaluation under current listing 5.08 
for weight loss. Therefore, it is redundant. Instead of using a 
reference listing, we propose to provide general guidance in the 
preface to the listings (proposed 6.00H), stating that resulting 
impairments should be evaluated under the criteria for the affected 
body system.
     Redesignate the listings in part B to correspond with 
listings addressing the same impairments in part A. Except for minor 
changes to refer to children, we have repeated much of the language of 
proposed 6.00 in proposed 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.
     Add a listing in part B, proposed listing 106.07, to 
address congenital genitourinary impairments that are not addressed in 
listings 106.02 or 106.06.
    We also propose to make nonsubstantive editorial changes to update 
the medical terminology in the listings and to make the language 
clearer.

How Are We Proposing To Change the Introductory Text to the Listings 
for Evaluating Genitourinary Impairments in Adults?

6.00 Genitourinary Impairments

    We propose to change the name of this body system from Genito-
Urinary System to Genitourinary Impairments to more accurately reflect 
that we use these listings to evaluate genitourinary impairments in 
accordance with the requirements of the disability program. 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 propose to expand and reorganize the introductory text to these 
listings to provide additional guidance and to reflect the new 
listings. The proposed changes to the preface should also improve 
clarity and readability. The following is a detailed explanation of the 
proposed rules.

Proposed 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. Proposed 6.00A2 replaces the parenthetical statement in 
current listing 6.02, giving examples of chronic renal disease that can 
lead to renal dysfunction. Proposed 6.00A3 explains that we use the 
criteria in listing 6.06 to evaluate nephrotic syndrome due to 
glomerular disease.

[[Page 51779]]

Proposed 6.00B--What Do We Mean by the Following Terms?

    In proposed 6.00B, we define what we mean by important terms in 
these listings.

Proposed 6.00C--What Evidence Do We Need?

    In proposed 6.00C1, we expand and clarify the documentation 
requirements discussed in current 6.00A.
    In proposed 6.00C2, we explain that we need a longitudinal clinical 
record covering a period of at least 3 months of observations and 
treatments, 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.
    Proposed 6.00C3 corresponds to current 6.00C. We explain that 
laboratory findings should include pre-dialysis renal function.
    Proposed 6.00C4 and 6.00C5 correspond to current 6.00B, which 
discusses nephrotic syndrome. We clarify the language and specify 
appropriate laboratory evidence. In the last sentence of proposed 
6.00C5, we clarify the documentation requirements in the absence of a 
pathology report. We did not retain the last sentence of current 6.00B, 
which explains how we consider complications of nephrotic syndrome such 
as severe orthostatic hypotension, recurrent infections or venous 
thromboses; however, proposed 6.00D2 addresses these complications of 
nephrotic syndrome.

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

    In this new section, we set forth our policy concerning treatment, 
including your response to treatment, its efficacy, and any adverse 
consequences.

Proposed 6.00E--What Other Things Do We Consider When We Evaluate 
Chronic Renal Disease Under These Listings?

    In this new section, proposed 6.00E1 explains that if you have a 
kidney transplant, we will consider you disabled for 12 months 
following the surgery. We explain further that we will determine 
whether your disability is ongoing based upon any residual 
impairment(s), as shown by signs, symptoms, and laboratory findings, 
following the first year after the date of transplantation.
    In proposed 6.00E2, we explain what the longitudinal clinical 
record should include in order for us to evaluate nephrotic syndrome.

Proposed 6.00F--What Does the Term Persistent Mean in These Listings?

    In proposed 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.

Proposed 6.00G--How Do We Evaluate Specific Genitourinary Listings?

    In this new section, we provide additional information on the 
documentation requirements for three specific listings: 6.02A, Chronic 
hemodialysis or peritoneal dialysis; 6.02C1, Renal osteodystrophy; and 
6.02C2, Persistent motor or sensory neuropathy.

Proposed 6.00H--How Do We Evaluate Impairments That Do Not Meet One of 
the Genitourinary Listings?

    In this new section, we state our basic adjudicative principle that 
if your 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 Proposing To Change the Criteria in the Listings for 
Evaluating Genitourinary Impairments in Adults?

6.01 Category of Impairments, Genitourinary Impairments.

Proposed Listing 6.02--Impairment of Renal Function

    We propose to remove the examples listed in the parenthetical 
statement under the heading for this listing because we address them in 
proposed 6.00A, making their inclusion in the listing redundant.
    Proposed listing 6.02A, Chronic hemodialysis or peritoneal 
dialysis, corresponds to current listing 6.02A, except that we propose 
to remove the statement ``necessitated by irreversible renal failure'' 
because it is redundant.
    Proposed listing 6.02B corresponds to current listing 6.02B, except 
that we propose to change the name to ``kidney transplantation'' to be 
consistent with the terminology used in other body system listings.
    Proposed listing 6.02C corresponds to current listing 6.02C, except 
that we propose to remove the word ``severe'' from the phrase 
describing bone pain, and to replace the word ``marked'' with the word 
``significant'' in the phrase describing osteoporosis in proposed 
listing 6.02C1, Renal osteodystrophy. We use the term ``severe'' in our 
regulations to describe a measure of functional limitations. An 
impairment is ``severe'' if it significantly limits an individual's 
physical or mental ability to do basic work activities. Renal 
osteodystrophy with bone pain is always a ``severe'' impairment. We 
also use the term ``marked'' in our regulations to describe a measure 
of functional limitations, and to avoid confusion with our use of 
``marked'' in these regulations, we are replacing it with 
``significant.'' However, we are not changing the degree of 
osteoporosis required to meet this listing.
    We propose to remove current listings 6.02C2, A clinical episode of 
pericarditis, and 6.02C4, 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 the individual would be maintained on a 
low protein diet. However, now it is known that the long*term prognosis 
improves for individuals when dialysis is initiated earlier in the 
course of treatment. Therefore, if you have pericarditis or intractable 
pruritus, you usually will be receiving dialysis and your impairment 
will satisfy the criteria in proposed listing 6.02A.
    Because of the proposal to remove current listing 6.02C2, we would 
redesignate current listing 6.02C3, Persistent motor or sensory 
neuropathy, as proposed listing 6.02C2.
    We propose to reorganize current listing 6.02C5, Persistent fluid 
overload syndrome, and to redesignate it as listing 6.02C3. In 
addition, we propose that there must be persistent symptoms and signs 
of congestion despite therapy when considering vascular congestion. 
Symptoms and signs may include shortness of breath, edema, ascites, and 
pleural effusion demonstrated on imaging studies.
    We propose to remove current listing 6.02C6, Persistent anorexia, 
since it is a reference listing and we are removing such listings. We 
have proposed guidance in the preface on evaluating an impairment(s) 
when it is more appropriately addressed under the affected body system.
    We also propose to remove current listing 6.02C7, Persistent 
hematocrits of 30 percent or less, because hematocrits at this level do 
not necessarily correlate with an inability to do any gainful activity. 
An individual with chronic renal disease generally will tolerate 
hematocrit levels persistently at 30 percent or less.
    This does not preclude us from finding you disabled if you have 
chronic renal disease and persistently low

[[Page 51780]]

hematocrit levels. As we discuss in proposed 6.00H, we must consider 
whether your impairment(s) satisfies the criteria of any appropriate 
listing. If your impairment(s) does not meet a listing, we will 
determine whether it medically equals a listing. If your impairment(s) 
does not meet or medically equal a listing, we 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.

Proposed Listing 6.06--Nephrotic Syndrome

    We propose to remove the word ``significant'' from the description 
of anasarca. Anasarca is, by definition, significant.

How Are We Proposing To Change the Preface to the Listings for 
Evaluating Genitourinary Impairments in Children?

106.00 Genitourinary Impairments

    As in proposed 6.00 in the adult rules, we propose to change the 
name of this body system to ``Genitourinary Impairments.''
    We propose to add a new section 106.00H to explain how we evaluate 
episodic genitourinary impairments in children. We also propose to add 
a new section 106.00I to explain what we mean by ``systemic 
infection,'' a criterion we use in proposed listing 106.07B.
    We also propose to repeat much of the preface of proposed 6.00 in 
the preface to proposed 106.00, except for minor changes that are 
specific to the childhood listings. This is because the same basic 
rules for establishing and evaluating the existence and severity of 
genitourinary impairments in adults also apply to children. Because we 
already have described these provisions under the explanation of 
proposed 6.00ff, the following discussions describe only those 
provisions that are unique to the childhood rules or that require 
further explanation specific to the evaluation of children's claims.

Proposed 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. We propose changes to this section to give 
additional information about types of renal and urinary tract 
impairments that are specific to children. For example, we explain that 
we use the criteria in proposed listing 106.07 to evaluate congenital 
genitourinary impairments and give examples of such impairments.

Proposed 106.00G--How Do We Evaluate Specific Genitourinary Listings?

    We propose to add guidance for proposed listing 106.07, Congenital 
genitourinary impairments, to explain some factors that we need to 
consider when evaluating congenital genitourinary impairments under 
this proposed listing. We also define hospital admissions as inpatient 
admissions of at least 24 hours duration.

Proposed 106.00H--How Do We Evaluate Episodic Genitourinary 
Impairments?

    In this new section, we explain that some episodic genitourinary 
impairments will meet a listing when the longitudinal clinical record 
shows that at least three events have occurred within a consecutive 12-
month period, with intervening periods of improvement. These events 
include surgical procedures, hospitalizations, and treatment with 
parenteral antibiotics. The occurrence of these events within the 
specified time period serves to support the severity and chronicity of 
the underlying impairment(s).
    We also indicate that in every listing in which we require more 
than one event, there must be at least 1 month between the events. We 
propose this requirement to ensure that we are evaluating separate 
episodes.

Proposed 106.00I--What Do 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.

Proposed 106.00J--How Do We Evaluate Impairments That Do Not Meet One 
of the Genitourinary Listings?

    In this section, we repeat the guidelines used in 6.00H, but we 
include the definition of disability for children who claim SSI 
payments.

How Are We Proposing To Change the Criteria in the Listings for 
Evaluating Genitourinary Impairments in Children?

106.01 Category of Impairments, Genitourinary Impairments

    We propose to add a new listing 106.07, Congenital genitourinary 
impairments, specifically for children. There is no parallel in the 
adult genitourinary listings because we expect with treatment that 
these impairments will have been resolved before a child reaches 
adulthood. We also propose to redesignate the childhood listings to be 
consistent with the adult listings. Because of this, the numbers of the 
proposed childhood listings are not consecutive.

Proposed Listing 106.02--Impairment of Renal Function

    In proposed listing 106.02, we propose to change the heading to 
make it consistent with the proposed adult criteria.
    We also propose to reorder the sequence of disorders included under 
listing 106.02 to more closely follow the order as those in proposed 
listing 6.02. Thus:
     Proposed listing 106.02A, Chronic hemodialysis or 
peritoneal dialysis, would replace current listing 106.02C.
     Proposed listing 106.02B, Kidney transplantation, would 
replace current listing 106.02D.
     Proposed listing 106.02C, Persistent elevation of serum 
creatinine, would replace current listing 106.02A.
     Proposed listing 106.02D, Reduction of creatinine 
clearance, would replace current listing 106.02B.

Proposed Listing 106.06--Nephrotic Syndrome

    In proposed listing 106.06, Nephrotic syndrome, we specify that 
anasarca must persist despite at least 3 months of prescribed therapy. 
Anasarca, rather than edema, is a more accurate term to define this 
criterion.
    In proposed listing 106.06B, we are revising the terminology in 
current listing 106.06B for measuring proteinuria to reflect current 
medical practice. This revision does not make the criteria more 
stringent. Rather, it is a more appropriate method of measuring 
proteinuria in children and is equivalent to the measurements used in 
current listing 106.06B.

Proposed Listing 106.07--Congenital Genitourinary Impairments

    In this proposed new listing, we provide criteria that include 
consideration of repeated surgical

[[Page 51781]]

procedures, episodic systemic infections requiring parenteral 
antibiotics, and episodes of electrolyte disturbance requiring repeated 
hospitalizations.
Clarity of These Proposed Rules
    Executive Order (E.O.) 12866, as amended by E.O. 13258, requires 
each agency to write all rules in plain language. In addition to your 
substantive comments on these proposed rules, we invite your comments 
on how to make these proposed rules easier to understand. For example:
     Have we organized the material to suit your needs?
     Are the requirements in the rules clearly stated?
     Do the rules contain technical language or jargon that 
isn't clear?
     Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rules easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?

Regulatory Procedures

Executive Order 12866

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

Regulatory Flexibility Act

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

Paperwork Reduction Act

    These proposed rules contain reporting requirements at 6.00C, 
6.00E, 6.00G, 106.00C, 106.00E and106.00G. The public reporting burden 
is accounted for in the Information Collection Requests for the various 
forms that the public uses to submit the information to SSA. 
Consequently, a 1-hour placeholder burden is being assigned to the 
specific reporting requirement(s) contained in these rules. We are 
seeking clearance of the burdens referenced in these rules because they 
were not considered during the clearance of the forms. An Information 
Collection Request has been submitted to OMB. We are soliciting 
comments on the burden estimate; the need for the information; its 
practical utility; ways to enhance its quality, utility and clarity; 
and on ways to minimize the burden on respondents, including the use of 
automated collection techniques or other forms of information 
technology. Comments should be submitted and/or faxed to the Office of 
Management and Budget and to the Social Security Administration at the 
following addresses/numbers: Office of Management and Budget, Attn: 
Desk Officer for SSA, Fax Number: 202-395-6974; Social Security 
Administration, Attn: SSA Reports Clearance Officer, Rm: 1338 Annex 
Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, 410-965-
6400.
    Comments can be received for up to 60 days after publication of 
this notice and will be most useful if received within 30 days of 
publication. To receive a copy of the OMB clearance package, you may 
call the SSA Reports Clearance Officer on 410-965-0454.

List of References

    We consulted the following sources when developing these proposed 
rules:
    Richard J. Johnson and John Feehally, Eds., Comprehensive Clinical 
Nephrology, (London: Mosby, 2000).
    Anthony Fauci, et al., Harrison's Principles of Internal Medicine, 
(15th ed., New York: McGraw-Hill, 2001.)
    John P. Gearhart, Richard C. Rink and Pierre D.E. Mouriquand, 
Pediatric Nephrology. (Philadelphia: W.B. Saunders Co., 2001).
    S.G. Massry and R. J. Glassock, Massry & Glassock's Textbook of 
Nephrology, (4th ed. Philadelphia: Lippincott Williams & Wilkins, 
2000).
    Robert W. Schrier, Ed., Diseases of the Kidney and Urinary Tract, 
(7th ed. Philadelphia: Lippincott Williams & Wilkins, 2001).
    These references are included in the rulemaking record for these 
proposed rules and are available for inspection by interested persons 
by making arrangements with the contact person shown in this preamble.

(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: May 19, 2004.
Jo Anne B. Barnhart,
Commissioner of Social Security.
    For the reasons set out in the preamble, we propose to amend 
subpart P of part 404 of chapter III of title 20 of the Code of Federal 
Regulations as set forth below:

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

    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.

PART 404--[AMENDED]

    2. Appendix 1 to subpart P of part 404 is amended as follows:
    a. Item 7 of the introductory text before part A of appendix 1 is 
amended by revising the body system name and expiration date.
    b. The Table of Contents for part A of appendix 1 is amended by 
revising the body system name for section 6.00.
    c. Section 6.00 of part A of appendix 1 is revised.
    d. The Table of Contents for part B of appendix 1 is amended by 
revising the body system name for section 106.00.
    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): (insert date 5 
years from the effective date of the final rules).
* * * * *

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: glomerulonephritis due to 
hypertensive, diabetic, or metabolic renal disease; interstitial 
nephritis; renovascular disease; chronic obstructive uropathy; and 
hereditary nephropathies.
    3. We use the criteria in 6.06 to evaluate nephrotic syndrome 
due to glomerular disease.

[[Page 51782]]

    B. What do we mean by the following terms?
    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. This may 
contribute to hypertension, congestive heart failure, and sometimes 
accumulation of fluid in the abdomen (ascites), or chest (pleural 
effusions).
    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 massive 
proteinuria and lipiduria with varying degrees of edema, 
hypoalbuminemia, and hyperlipidemia.
    10. Neuropathy is a problem in peripheral nerve function (any 
part of the nervous system except the brain and spinal cord) that 
causes pain, numbness, tingling, swelling, 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, 
osteomyelitis, and other diseases.
    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 is 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 
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. If 
present, 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.
    D. 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 chronic 
renal disease under these listings?
    1. Kidney transplantation. 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 
continuing disability evaluation upon the residual impairment as 
shown by symptoms, signs, and laboratory findings. 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 any residual 
impairment arising from:
    a. The occurrence of rejection episodes.
    b. The use of immunosuppressants.
    c. Frequent renal infections.
    d. Side effects of corticosteroids.
    e. The presence of systemic complications such as other 
infections, neuropathy, or deterioration of other organ systems.
    2. Nephrotic syndrome. 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.
    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 specific genitourinary 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. Renal osteodystrophy (6.02C1). This condition is bone 
deterioration resulting from chronic renal disease. The resultant 
bone disease includes osteitis fibrosa cystica, osteomalacia, 
osteoporosis, and osteosclerosis.
    3. 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.
    H. 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 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. For example, weight loss associated with 
chronic renal disease should be evaluated under 5.08.
    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(s). (See Sec. Sec.  
404.1526 and 416.926.) If you have an impairment(s) that does not 
meet or medically equal the criteria of the listings, 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.

[[Page 51783]]

6.01 Category of Impairments, Genitourinary Impairments

    6.02 Impairment of renal function, due to any chronic renal 
disease expected to last 12 months. With:
    A. Chronic hemodialysis or peritoneal dialysis (see 6.00G1);

or
    B. Kidney transplantation. (See 6.00E1.) Consider under a 
disability for 12 months following surgery; thereafter, evaluate the 
residual impairment;

or
    C. Persistent elevation of serum creatinine to 4 mg per 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 6.00G2) manifested by 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 6.00G3);

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 symptoms and signs of vascular congestion despite 
prescribed therapy.
    6.06 Nephrotic syndrome, with anasarca, persistent for at least 
3 months despite prescribed therapy (see 6.00E2). 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 chronic renal disease, such as: glomerulonephritis due to 
hypertensive, diabetic, or metabolic renal disease; interstitial 
nephritis; renovascular disease; 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, urethral valves, 
and neurogenic bladder.
    B. What do we mean by the following terms?
    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 massive 
proteinuria and lipiduria with varying degrees of edema, 
hypoalbuminemia, and hyperlipidemia.
    7. Neuropathy is a problem in peripheral nerve function(any part 
of the nervous system except the brain and spinal cord) that causes 
pain, numbness, tingling, swelling, 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 
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. If 
present, 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. They should describe the frequency of 
your episodes, prescribed treatment, laboratory findings, and any 
surgical procedures performed.
    D. 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 chronic 
renal disease under these listings?
    1. Kidney transplantation. 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 
continuing disability evaluation upon the residual impairment as 
shown by symptoms, signs, and laboratory findings. 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 any 
residual impairment arising from:

a. The occurrence of rejection episodes.
b. The use of immunosuppressants.
c. Frequent renal infections.
d. Side effects of corticosteroids.
e. The presence of systemic complications such as other infections, 
neuropathy, or deterioration of other organ systems.

    2. Nephrotic syndrome. 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.
    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.

[[Page 51784]]

    G. How do we evaluate specific genitourinary 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. Congenital genitourinary impairments (106.07).
    a. The criteria include the need for repeated surgeries, 
recurrent infection, and electrolyte imbalance.
    b. Diagnostic cystoscopy does not satisfy the requirement for 
repeated surgical procedures.
    c. Appropriate laboratory and clinical evidence document 
electrolyte disturbance.
    d. Hospital admissions are inpatient hospitalizations for 24 
hours or more.
    H. How do we evaluate episodic genitourinary impairments? Some 
listings for genitourinary impairments are met when the longitudinal 
clinical record shows that at least three events have occurred 
within a consecutive 12-month period, with intervening periods of 
improvement. Events include urological surgical procedures, 
hospitalizations, and treatment with parenteral antibiotics. In 
every listing in which we require more than one event, there must be 
at least 1 month between the events, in order to ensure that we are 
evaluating separate episodes.
    I. What do we mean by systemic infection? Systemic infection 
(106.07B) is an infection requiring an initial course of 
parenterally administered antibiotics occurring at least once every 
4 months or at least 3 times a year. See 106.00H for information 
about how we evaluate episodic genitourinary impairments.
    J. 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 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 medically determinable impairment(s) that does 
not meet a listing, we will determine whether your impairment(s) 
medically equals a listing(s), 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 expected to last 12 months. With:
    A. Chronic hemodialysis or peritoneal dialysis (see 106.00G1);

or

    B. Kidney transplantation. (See 106.00E1.) Consider under a 
disability for 12 months following surgery; thereafter, evaluate the 
residual impairment;

or

    C. Persistent elevation of serum creatinine to 3 mg per 
deciliter (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 m\2\ of body surface area over at least 3 
months.
    106.06 Nephrotic syndrome, with anasarca, persistent for at 
least 3 months despite prescribed therapy. (See 106.00E2.)With:
    A. Serum albumin of 2.0 g/dL (100 ml) or less;

or

    B. Proteinuria of 40 mg/m\2\/hr or greater.
    106.07 Congenital genitourinary impairments (see 106.00G3 and 
106.00H) resulting in one of the following:
    A. Repeated urological 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 106.00I);

or

    C. Hospitalization (for 24 hours or more) for episodes of 
electrolyte disturbance, occurring at least 3 times in a consecutive 
12-month period.

[FR Doc. 04-19188 Filed 8-20-04; 8:45 am]
BILLING CODE 4191-02-P