[Federal Register: August 23, 2004 (Volume 69, Number 162)]
[Proposed Rules]
[Page 51777-51784]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au04-9]
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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.
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[[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.
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SUMMARY: We propose to revise the criteria in the Listing of
Impairments (the listings) that we use to evaluate claims involving
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 regulations@ssa.gov; 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:
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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 . . .
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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.
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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