Revised Medical Criteria for Evaluating Genitourinary Disorders, 7695-7702 [2013-02166]
Download as PDF
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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
Where:
LL,A = value as defined in section 11.2.7 of
ASHRAE 103–1993
LG = value as defined in section 11.3.11.1 of
ASHRAE 103–1993 at reduced input
rate,
LC = value as defined in section 11.3.11.2 of
ASHRAE 103–1993 at reduced input
rate,
LJ = value as defined in section 11.4.8.1.1 of
ASHRAE 103–1993 at maximum input
rate,
tON = value as defined in section 11.4.9.11 of
ASHRAE 103–1993,
QP = pilot flame fuel input rate determined
in accordance with section 9.2 of
ASHRAE 103–1993 in Btu/h
QIN = value as defined in section 11.4.8.1.1
of ASHRAE 103–1993,
tOFF = value as defined in section 11.4.9.12
of ASHRAE 103–1993 at reduced input
rate,
LS,ON = value as defined in section 11.4.10.5
of ASHRAE 103–1993 at reduced input
rate,
LS,OFF = value as defined in section 11.4.10.6
of ASHRAE 103–1993 at reduced input
rate,
LI,ON = value as defined in section 11.4.10.7
of ASHRAE 103–1993 at reduced input
rate,
LI,OFF = value as defined in section 11.4.10.8
of ASHRAE 103–1993 at reduced input
rate,
CJ = jacket loss factor and equal to:
= 0.0 for furnaces or boilers intended to be
installed indoors
= 1.7 for furnaces intended to be installed
as isolated combustion systems
= 2.4 for boilers (other than finned-tube
boilers) intended to be installed as
isolated combustion systems
= 3.3 for furnaces intended to be installed
outdoors
7695
= 4.7 for boilers (other than finned-tube
boilers) intended to be installed outdoors
= 1.0 for finned-tube boilers intended to be
installed outdoors
= 0.5 for finned-tube boilers intended to be
installed in ICS applications
LS,SS = value as defined in section 11.5.6 of
ASHRAE 103–1993 at reduced input
rate,
CS = value as defined in section 11.5.10.1 of
ASHRAE 103–1993 at reduced input
rate.
10. 3 Part-Load Efficiency at Maximum
Fuel Input Rate. Calculate the part-load
efficiency at maximum fuel input rate,
EffyU,H, for condensing furnace and boilers
equipped with two-stage controls, expressed
as a percent and defined as:
VerDate Mar<15>2010
18:16 Feb 01, 2013
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LI,OFF = value as defined in section 11.4.10.8
of ASHRAE 103–1993 at maximum input
rate,
CJ = value as defined in section 10.2 of this
appendix,
LS,SS = value as defined in section 11.5.6 of
ASHRAE 103–1993 at maximum input
rate,
CS = value as defined in section 11.5.10.1 of
ASHRAE 103–1993 at maximum input
rate.
*
*
*
*
*
[FR Doc. 2013–02168 Filed 2–1–13; 8:45 am]
BILLING CODE 6450–01–P
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
[Docket No. SSA–2009–0038]
RIN 0960–AH03
Revised Medical Criteria for Evaluating
Genitourinary Disorders
Social Security Administration.
Notice of proposed rulemaking.
AGENCY:
ACTION:
We propose to revise the
criteria in the Listing of Impairments
(listings) that we use to evaluate claims
SUMMARY:
PO 00000
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involving genitourinary disorders in
adults and children under titles II and
XVI of the Social Security Act (Act). The
proposed revisions reflect our program
experience, advances in methods of
evaluating genitourinary disorders, and
comments we received in response to an
advance notice of proposed rulemaking
(ANPRM).
DATES: To ensure that your comments
are considered, we must receive them
by no later than April 5, 2013.
ADDRESSES: You may submit comments
by any one of three methods—Internet,
fax, or mail. Do not submit the same
comments multiple times or by more
than one method. Regardless of which
method you choose, please state that
your comments refer to Docket No.
SSA–2009–0038 so that we may
associate your comments with the
correct regulation.
Caution: You should be careful to
include in your comments only
information that you wish to make
publicly available. We strongly urge you
not to include in your comments any
personal information, such as Social
Security numbers or medical
information.
E:\FR\FM\04FEP1.SGM
04FEP1
EP04FE13.050</GPH>
Where:
LL,A = value as defined in section 11.2.7 of
ASHRAE 103–1993,
LG = value as defined in section 11.3.11.1 of
ASHRAE 103–1993 at maximum input
rate,
LC = value as defined in section 11.3.11.2 of
ASHRAE 103–1993 at maximum input
rate,
LJ = value as defined in section 11.4.8.1.1 of
ASHRAE 103–1993 at maximum input
rate,
tON = value as defined in section 11.4.9.11 of
ASHRAE 103–1993 of ASHRAE 103–
1993,
QP = pilot flame fuel input rate determined
in accordance with section 9.2 of
ASHRAE 103–1993 in Btu/h,
QIN = value as defined in section 11.4.8.1.1
of ASHRAE 103–1993,
tOFF = value as defined in section 11.4.9.12
of ASHRAE 103–1993 at maximum input
rate,
LS,ON = value as defined in section 11.4.10.5
of ASHRAE 103–1993 at maximum input
rate,
LS,OFF = value as defined in section 11.4.10.6
of ASHRAE 103–1993 at maximum input
rate,
LI,ON = value as defined in section 11.4.10.7
of ASHRAE 103–1993 at maximum input
rate,
EP04FE13.049</GPH>
sroberts on DSK5SPTVN1PROD with PROPOSALS
If the option in section 9.10 of ASHRAE
103–1993 (incorporated by reference, see
§ 430.3) is employed:
7696
Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
1. Internet: We strongly recommend
that you submit your comments via the
Internet. Please visit the Federal
eRulemaking portal at https://
www.regulations.gov. Use the Search
function to find docket number SSA–
2009–0038. The system will issue you a
tracking number to confirm your
submission. You will not be able to
view your comment immediately
because we must post each comment
manually. It may take up to a week for
your comment to be viewable.
2. Fax: Fax comments to (410) 966–
2830.
3. Mail: Address your comments to
the Office of Regulations and Reports
Clearance, Social Security
Administration, 107 Altmeyer Building,
6401 Security Boulevard, Baltimore,
Maryland 21235–6401.
Comments are available for public
viewing on the Federal eRulemaking
portal at https://www.regulations.gov or
in person, during regular business
hours, by arranging with the contact
person identified below.
FOR FURTHER INFORMATION CONTACT:
Cheryl A. Williams, Office of Medical
Listings Improvement, Social Security
Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235–
6401, (410) 965–1020. For information
on eligibility or filing for benefits, call
our national toll-free number, 1–800–
772–1213, or TTY 1–800–325–0778, or
visit our Internet site, Social Security
Online, at https://
www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
Why are we proposing to revise this
body system?
We last published final rules making
comprehensive revisions to
genitourinary body system listings on
July 5, 2005.1 These listings are
scheduled to expire on September 6,
2013.2 We published an ANPRM on
November 10, 2009, in which we
invited interested people and
organizations to send us written
comments and suggestions about
whether and how we should revise
these listings.3 We are now proposing to
update the medical criteria in the
listings to reflect our program
experience and to address adjudicator
questions and public comments that we
have received since 2005.
What revisions are we proposing?
We propose to:
• Revise the name of the body system
from ‘‘Genitourinary Impairments’’ to
‘‘Genitourinary Disorders’’;
• Reorganize and revise the
introductory text for the adult listings
(section 6.00) and the childhood listings
(section 106.00);
• Reorganize, revise, and rename
adult listing 6.02 and childhood listing
106.02 for impairment of renal function;
• Add a listing criterion for
evaluating chronic kidney disease
(CKD), with impairment of kidney
function, in adults (6.05) and in
children (106.05);
• Reorganize and revise adult listing
6.06 and childhood listing 106.06 for
nephrotic syndrome;
• Add an adult listing (6.09) for
evaluating complications of CKD
requiring hospitalizations; and
• Reorganize and revise childhood
listing 106.07 for congenital
genitourinary disorders.
Why are we proposing to change the
name of this body system?
We propose to change the name of
this body system from ‘‘Genitourinary
Impairments’’ to ‘‘Genitourinary
Disorders’’ to make it consistent with
our names for other body systems. We
have re-named other body systems to
include the word ‘‘disorders’’ as we
revise them, and the name change we
are proposing in this NPRM is
consistent with that approach.
What changes are we proposing to the
introductory text of the genitourinary
adult listings?
The following chart provides a
comparison of the current introductory
text for adults and the proposed
introductory text:
Proposed introductory text
6.00A What impairments do these listings cover?
6.00B What do we mean by the following terms in these listings?
6.00C What evidence do we need?
6.00D How do we consider the effects of treatment?
6.00E What other things do we consider when we evaluate your
chronic renal disease under specific listings?
6.00F What does the term ‘‘persistent’’ mean in these listings?
6.00G How do we evaluate impairments that do not meet one of the
genitourinary listings?
sroberts on DSK5SPTVN1PROD with PROPOSALS
Current introductory text
6.00A Which disorders do we evaluate under these listings?
Removed.
6.00B What evidence do we need?
Removed.
6.00C What other factors do we consider when we evaluate your
chronic kidney disease?
Removed.
6.00D How do we evaluate disorders that do not meet one of the
genitourinary listings?
As the chart illustrates, we are
proposing to make minor revisions to
terms in the introductory text (for
example, changing the word
‘‘impairment’’ to ‘‘disorder,’’ where
appropriate) and to reorganize the
information in the text. We propose to
replace the word ‘‘renal’’ with ‘‘kidney’’
throughout the introductory text
because the medical community
commonly uses the word ‘‘kidney.’’ The
only exception to this proposal is that
we would retain the term ‘‘renal
osteodystrophy’’ because it remains a
1 70
FR 38582.
the 2005 final rules, we stated that the rules
would be effective for 8 years unless we extended
them or revised and issued them again.
2 In
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common term in the medical
community.
Proposed section 6.00A corresponds
to current section 6.00A and explains
the disorders we evaluate under the
genitourinary disorders listings.
We propose to remove current 6.00B
that lists definitions because we would
provide a definition, as appropriate,
when we first use a term in the
introductory text.
Proposed section 6.00B corresponds
in part to current 6.00C and explains the
evidence we need to evaluate a person’s
CKD. We propose to revise the text to
remove redundancies and to add a
description of estimated glomerular
filtration rate (eGFR).
Proposed section 6.00C corresponds
to part of current sections 6.00C and
6.00E. We propose to revise the text to
remove redundancies and add guidance
on anorexia with weight loss and on
complications of CKD requiring
hospitalizations.
We propose to remove current 6.00D
because that section’s guidance is not
specific to evaluating genitourinary
3 74 FR 57970. We received three comment
letters. We said in the ANPRM that we would not
respond directly to the comment letters. This notice
of proposed rulemaking (NPRM) does adopt some
of the commenters’ suggestions. You may read the
comment letters at https://www.regulations.gov by
searching under docket number SSA–2009–0038.
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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
disorders. Only one listing, proposed
6.06, would require the presence of a
particular medical finding despite
treatment. We do not propose to
evaluate a person’s response to
treatment under any other listings in
this section.
We propose to remove current 6.00F
because we would no longer use the
term ‘‘persistent’’ in these listings.
Instead, we would provide specific
parameters for determining whether an
impairment meets the duration
requirement.
Proposed section 6.00D corresponds
to current section 6.00G. We propose to
make minor editorial changes to the way
that we cite regulations in the current
Current listing
6.02
section by removing the paragraph
levels of the citations to shorten them.
What changes are we proposing to the
genitourinary listings for adults?
The following chart provides a
comparison of the current listings for
adults and the proposed listings:
Proposed listing
Impairment of renal function
6.06
7697
6.02 Removed.
6.03 Chronic kidney disease, with chronic hemodialysis or peritoneal
dialysis.
6.04 Chronic kidney disease, with kidney transplant.
6.05 Chronic kidney disease, with impairment of kidney function.
6.06 Nephrotic syndrome.
6.09 Complications of chronic kidney disease.
Nephrotic syndrome
We propose to revise current listing
6.02 by making each of the three criteria
a separate listing. We believe that this
revision would improve our ability to
monitor claims involving CKD. It would
also improve our ability to schedule
continuing disability reviews because
the timing of these reviews is different
for each of the three criteria. We also
propose to replace the term
‘‘impairment of renal function’’ in the
listing title with ‘‘chronic kidney
disease.’’
Proposed listing 6.03 and 6.04
correspond to current listings 6.02A and
6.02B, respectively. We are not
proposing any changes to the current
criteria.
Proposed listing 6.05 corresponds to
current listing 6.02C. We propose to
restructure the listing to clarify the
requirements in the current listing.
We propose to add a criterion to
proposed listing 6.05A3 for estimated
glomerular filtration rate (eGFR). The
glomerular filtration rate (GFR) is the
best overall measure of kidney function;
however, it is difficult to measure
directly. Most clinicians who treat CKD
use the eGFR instead of the GFR to
determine the severity of a person’s
CKD and to make decisions about the
course of treatment. The eGFR values
will likely be readily available in the
medical records for people with CKD.
We would replace the criterion for
‘‘[p]ersistent motor or sensory
neuropathy’’ in current 6.02C2 with
‘‘[p]eripheral neuropathy’’ in proposed
6.05B2. People with CKD develop
neuropathy at a later stage of the disease
than they once did because of advances
in CKD treatment. We do not need to
replace ‘‘persistent’’ with a criterion
based on a defined period of time
because when neuropathy develops at a
later stage of CKD, it is invariably
persistent.
We would replace the criterion for
‘‘[p]ersistent’’ in current 6.02C3 with a
criterion based on a defined period of
time to evaluate hypertension (proposed
6.05B3a), vascular congestion (proposed
6.05B3b), and anorexia (proposed
6.05B4).
Proposed listing 6.06 for nephrotic
syndrome corresponds to current listing
6.06. We propose to restructure the
listing to clarify the requirements in the
current listing. We would add a
criterion for the urine total-protein-tocreatinine ratio (a laboratory calculation
based on total protein and creatinine in
a urine sample). This ratio is an
alternative to the 24-hour measurement
in 6.06A2a and is widely used in the
clinical community to monitor
proteinuria.
We propose to add listing 6.09 to
evaluate complications of CKD that
require periodic hospitalization. We
would require a person to have at least
three hospitalizations occurring at least
30 days apart to ensure that we are
evaluating separate complication events.
Each hospitalization must last at least
48 hours, including hours in a hospital
emergency department immediately
before the hospitalization. We would
require that each hospitalization last at
least 48 hours because we believe this
period is indicative of a severe
complication of CKD. We would include
the hours the person spends in the
emergency department immediately
before hospital admission because the
person is likely to be receiving the same
intensity of care as he or she will
receive in the hospital. We would also
require that these three hospitalizations
occur within a consecutive 12-month
period, consistent with our rules in
other body systems.
What changes are we proposing to the
introductory text of the genitourinary
listings for children?
The following chart provides a
comparison of the current introductory
text for children and the proposed
introductory text:
sroberts on DSK5SPTVN1PROD with PROPOSALS
Current introductory text
Proposed introductory text
106.00A What impairments do these listings cover?
106.00B What do we mean by the following terms in these listings?
106.00C What evidence do we need?
106.00D How do we consider the effects of treatment?
106.00E What other things do we consider when we evaluate your
genitourinary impairment under specific listings?
106.00F What does the term ‘‘persistent’’ mean in these listings?
106.00G How do we evaluate impairments that do not meet one of
the genitourinary listings?
106.00A Which disorders do we evaluate under these listings?
Removed.
106.00B What evidence do we need?
Removed.
106.00C What other factors do we consider when we evaluate your
genitourinary disorder?
Removed.
106.00D How do we evaluate disorders that do not meet one of the
genitourinary listings?
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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
The same basic rules for evaluating
genitourinary disorders in adults apply
to children. Except for minor editorial
changes to make the text specific to
children, we propose to repeat much of
the introductory text of proposed 6.00 in
the introductory text of proposed
106.00.
Current listing
106.02
106.03
toneal
106.04
106.05
106.06
106.07
106.09
sroberts on DSK5SPTVN1PROD with PROPOSALS
106.06 Nephrotic syndrome
106.07 Congenital genitourinary impairments
The proposed childhood
genitourinary listings are designated
106.03 through 106.07 and 106.09. They
have the same headings as their
counterparts in the proposed adult
listings, except for proposed 106.07,
which does not have an adult
counterpart.
The criteria we propose for children
are the same as, or based on, the current
childhood genitourinary criteria. Many
of the proposed changes to the
childhood listings correspond to the
changes we propose to make in the
adult listing. Since we have already
described these proposed changes
above, we describe here only those
changes that are unique to children or
that require further explanation.
Proposed listing 106.05 for CKD with
impairment of kidney function
incorporates the criteria in current
106.02C and 106.02D. We would revise
the current requirement that a finding is
present ‘‘over at least 3 months.’’ We
would require, instead, that the finding
is present ‘‘on at least two occasions at
least 90 days apart during a consecutive
12-month period.’’ This proposed
revision corresponds to our proposal to
replace the word ‘‘persistent’’ in the
adult listings. The proposed revision is
also consistent with our rules in other
body systems.
In proposed 106.06 for nephrotic
syndrome, we would change the
required serum albumin level from ‘‘2.0
g/dL (100 ml) or less’’ to 3.0 g/dL or
less. We are proposing this change so
that the childhood criterion is
consistent with the corresponding adult
criterion.
We propose to revise current 106.07
by creating two listings: proposed
106.07 and proposed 106.09.
Proposed 106.07 for congenital
genitourinary disorder corresponds to
current 106.07A. We would incorporate
the guidance in current 106.00E4 by
adding a requirement that a child must
have at least three urological surgical
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The following chart provides a
comparison of the current listings for
children and the proposed listings:
Proposed listing
106.02 Impairment of renal function
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What changes are we proposing to the
genitourinary listings for children?
Removed.
Chronic kidney disease, with chronic hemodialysis or peridialysis.
Chronic kidney disease, with kidney transplant.
Chronic kidney disease, with impairment of kidney function
Nephrotic syndrome.
Congenital genitourinary disorder.
Complications of chronic kidney disease.
procedures occurring in a consecutive
12-month period, with at least 30 days
between procedures. We would also add
a criterion that would consider a child
disabled for 1 year from the date of the
last urological surgery. Our program
experience has shown that children who
have had these surgeries need a period
of 1 year before we can evaluate any
remaining limitations resulting from the
impairment.
Proposed 106.09 for complications of
CKD corresponds to current 106.07B
and 106.07C. We would expand our
consideration of complications to
include other types of CKD
complications that require
hospitalization. Current 106.07B does
not require hospitalization. We propose
to add a hospitalization requirement in
proposed 106.09 for consistency with
the adult criteria. We believe this
change would have minimal impact on
children with CKD complications
because most children who require
parenteral antibiotics are hospitalized
for this treatment. We believe that three
hospitalizations in a 12-month period
establish CKD complications of listinglevel severity because CKD
complications that require
hospitalization are generally more
serious and involve longer recovery
periods than those treated solely in
outpatient settings.
What time period should we use for
finding disability following a kidney
transplant?
We propose to retain our current
policy for a finding of disability for a
period of one year following a kidney
transplant. Thereafter, we consider the
residual impairment, including posttransplant kidney function, any
rejection episodes, adverse effects of ongoing treatment, and complications in
other body systems. We are specifically
interested in any comments of
suggestions you have about this policy,
such as whether the time period we use
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is appropriate, whether we should use
a longer time period, and, if so, what
time period we should use.
What is our authority to make rules
and set procedures for determining
whether a person is disabled under the
statutory definition?
The Act authorizes us to make rules
and regulations and to establish
necessary and appropriate procedures to
implement them. Sections 205(a),
702(a)(5), and 1631(d)(1).
How long would these proposed rules
be effective?
If we publish these proposed rules as
final rules, they will remain in effect for
5 years after the date they become
effective, unless we extend them, or
revise and issue them again.
Clarity of These Proposed Rules
Executive Order 12866, as
supplemented by Executive Order
13563, requires each agency to write all
rules in plain language. In addition to
your substantive comments on these
proposed rules, we invite your
comments on how to make them easier
to understand.
For example:
• Would more, but shorter, sections
be better?
• Are the requirements in the rules
clearly stated?
• Have we organized the material to
suit your needs?
• Could we improve clarity by adding
tables, lists, or diagrams?
• What else could we do to make the
rules easier to understand?
• Do the rules contain technical
language or jargon that is not clear?
• Would a different format make the
rules easier to understand, e.g., grouping
and order of sections, use of headings,
paragraphing?
When will we start to use these rules?
We will not use these rules until we
evaluate public comments and publish
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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
final rules in the Federal Register. All
final rules we issue include an effective
date. We will continue to use our
current rules until that date. If we
publish final rules, we will include a
summary of those relevant comments
we received along with responses and
an explanation of how we will apply the
new rules.
Regulatory Procedures
Executive Order 12866, as
Supplemented by Executive Order
13563
We consulted with the Office of
Management and Budget (OMB) and
determined that this NPRM meets the
criteria for a significant regulatory
action under Executive Order 12866, as
supplemented by Executive Order
13563. Therefore, OMB reviewed it.
Regulatory Flexibility Act
We certify that this NPRM will not
have a significant economic impact on
a substantial number of small entities
because it affects individuals only.
Therefore, the Regulatory Flexibility
Act, as amended, does not require us to
prepare a regulatory flexibility analysis.
Paperwork Reduction Act
This NPRM does not create any new
or affect any existing collections and,
therefore, does not require Office of
Management and Budget approval
under the Paperwork Reduction Act.
sroberts on DSK5SPTVN1PROD with PROPOSALS
References
We consulted the following references
when we developed these proposed
rules:
Copelovitch, L., Warady, B., & Furth, S.
(2011). Insights from the Chronic Kidney
Disease in Children. Clinical Journal of
the American Society of Nephrology,
6(8), 2047–2053. doi:10.2215/
CJN.10751210.
Furth, S., Abraham, A. G., Jerry-Fluker, J.,
Schwartz, G. J. Benfield, M., Kaskel, F.,
et al. (2011). Metabolic Abnormalities,
Cardiovascular Disease Risk Factors, and
GFR Decline in Children with Chronic
Kidney Disease. Clinical Journal of the
American Society of Nephrology, 6(9),
2132–2140. doi:10.2215/CJN.07100810.
Furth, S. L., Cole, S. R., Moxey-Mims, M.,
Kaskel, F., Mak, R., Schwartz, G., et al.
(2006). Design and Methods of the
Chronic Kidney in Children (CKiD)
Prospective Cohort Study. Clinical
Journal of the American Society of
Nephrology, 1(5), 1006–1015.
doi:10.2215/CJN.01941205.
Gipson, D. S., Massengill, S. F., Trachtman,
H., Greenbaum, L. A., Yao, L., Nagaraj,
S., et al. (2009). Management of
Childhood Onset Nephrotic Syndrome.
Pediatrics, 124(2), 747–757. doi:10.1542/
peds.2008–1559.
Gordillo, R., & Sptizer, A. (2009). The
Nephrotic Syndrome. Pediatrics in
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Review, 30(3), 94–105. doi:10.1542/
pir.30–3–94.
Gulati, S. (2011, June 21). Chronic Kidney
Disease in Children. Medscape
Reference. Retrieved from https://
emedicine.medscape.com/article/
984358-overview.
Hogg, R., Furth, S., Eknoyan, G., Levey, A. S.,
Lemley, K. V., Portman, R., et al. (2003).
National Kidney Foundation’s Kidney
Disease Outcome Quality Initiative
Clinical Practice Guidelines for Chronic
Kidney Disease in Children and
Adolescents: Evaluation, Classification,
and Stratification. Pediatrics, 111(6),
1416–1421. doi:10.1542/
peds.111.6.1416.
Kliegman, R. M., Stanton, B. F., Schor, N. F.,
St. Geme III, J. W., & Behrman, R. E.
(2011). Nelson Textbook of Pediatrics
(19th ed.). Philadelphia, PA: Elsevier
Saunders.
Lurbe, E., Alvarez, V., & Redon. J. (2004).
Predictors of Progression in
Hypertensive Renal Disease in Children.
Journal of Clinical Hypertension, 64(4),
186–191. doi:10.1111/j.1524–
6175.2004.02617.x.
Miller, W.G. (2009). Estimating Equations for
Glomerular Filtration Rate in Children:
Laboratory Considerations. Clinical
Chemistry, 55(3), 402–403. doi:10.1373/
clinchem.2008.122218.
National Kidney Foundation (2010).
Frequently Asked Questions About GFR
Estimates. Retrieved from: https://www.
kidney.org/professionals/kls/pdf/12-104004_KBB_FAQs_AboutGFR–1.pdf.
National Kidney Foundation (2006). KDOQI
Clinical Practice Guidelines and Clinical
Practice Recommendations for Anemia
in Chronic Kidney Disease. The
Guidelines are available at: https://www.
kidney.org/professionals/kdoqi/
guidelines_anemia/pdf/
AnemiaInCKD.pdf.
National Kidney Foundation (2007). KDOQI
Clinical Practice Guidelines and Clinical
Practice Recommendations for Diabetes
and Chronic Kidney Disease. These
Guidelines are available at: https://www.
kidney.org/professionals/kdoqi/pdf/
Diabetes_AJKD_FebSuppl_07.pdf]
National Kidney Foundation (2005). KDOQI
Clinical Practice Guidelines for Bone
Metabolism and Disease in Children
with Chronic Kidney Disease. The
Guidelines are available at: https://www.
kidney.org/professionals/kdoqi/
guidelines_pedbone/index.htm.
National Kidney Foundation (2003). KDOQI
Clinical Practice Guidelines for Bone
Metabolism and Disease in Chronic
Kidney Disease. The Guidelines are
available at: https://www.kidney.org/
professionals/KDOQI/guidelines_bone/
index.htm.
National Kidney Foundation (2002). KDOQI
Clinical Practice Guidelines for Chronic
Kidney Disease: Evaluation,
Classification and Stratification. These
Guidelines are available at: https://www.
kidney.org/professionals/kdoqi/pdf/ckd_
evaluation_classification_
stratification.pdf.
National Kidney Foundation (2009). KDOQI
Clinical Practice Guidelines for Nutrition
PO 00000
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Sfmt 4702
in Children with CKD: 2008 Update.
American Journal of Kidney Diseases,
53(Supp.2), S1–S124. doi:10.1053/
S0272–6386(09)00054–7. These
Guidelines are available at: https://www.
kidney.org/professionals/kdoqi/
guidelines_updates/pdf/
CPGPedNutr2008.pdf.
Renal Physicians Association (2010). Shared
Decision-Making in the Appropriate
Initiation of and Withdrawal from
Dialysis. RPA Clinical Practice Guideline
(Second ed., pp. 121–155). Rockville,
MD: Renal Physicians Association.
Vassalotti, J., Stevens, L., & Levey, A. (2007)
Testing for Chronic Kidney Disease: A
Position Statement from the National
Kidney Foundation. American Journal of
Kidney Diseases, 50(2), 169–180.
doi:10.1053/j/ajkd.2007.06.013.
We included these references in the
rulemaking record for these proposed
rules and will make them available for
inspection by interested individuals
who make arrangements with the
contact person identified above.
(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social Security—
Disability Insurance; 96.002, Social
Security—Retirement Insurance; 96.004,
Social Security—Survivors Insurance; and
96.006, Supplemental Security Income).
List of Subjects in 20 CFR Part 404
Administrative practice and
procedure; Blind, Disability benefits;
Old-Age, survivors, and disability
insurance; Reporting and recordkeeping
requirements; Social Security.
Dated: January 25, 2013.
Michael J. Astrue,
Commissioner of Social Security.
For the reasons set out in the
preamble, we propose to amend 20 CFR
part 404, subpart P as set forth below:
PART 404—FEDERAL OLD–AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950–
)
Subpart P—[Amended]
1. The authority citation for subpart P
of part 404 continues to read as follows:
■
Authority: Secs. 202, 205(a)–(b) and (d)–
(h), 216(i), 221(a), (i), and (j), 222(c), 223,
225, and 702(a)(5) of the Social Security Act
(42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i),
421(a), (i), and (j), 422(c), 423, 425, and
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108–203,
118 Stat. 509 (42 U.S.C. 902 note).
2. Amend appendix 1 to subpart P of
part 404 by revising item 7 of the
introductory text before part A of
appendix 1 to read as follows:
■
Appendix 1 to Subpart P of Part 404—
Listing of Impairments
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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
7. Genitourinary Disorders (6.00 and
106.00): [DATE 5 YEARS FROM THE
EFFECTIVE DATE OF THE FINAL RULES].
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■ 3. Amend part A of appendix 1 to
subpart P of part 404 by revising the
body system name for section 6.00 in
the table of contents to read as follows:
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Part A
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6.00
Genitourinary Disorders
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4. Revise section 6.00 in part A of
appendix 1 to subpart P of part 404 to
read as follows:
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Part A
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6.00
Genitourinary Disorders
sroberts on DSK5SPTVN1PROD with PROPOSALS
A. Which disorders do we evaluate under
these listings?
We evaluate genitourinary disorders
resulting in chronic kidney disease.
Examples of such disorders include chronic
glomerulonephritis, hypertensive
nephropathy, diabetic nephropathy, chronic
obstructive uropathy, and hereditary
nephropathies. We also evaluate nephrotic
syndrome due to glomerular dysfunction
under these listings.
B. What evidence do we need?
1. We need evidence that documents the
signs, symptoms, and laboratory findings of
your chronic kidney disease. This evidence
should include reports of clinical
examinations, treatment records, and
documentation of your response to treatment.
Laboratory findings, such as serum creatinine
or serum albumin levels, may document your
kidney function. We generally need evidence
covering a period of at least 90 days unless
we can make a fully favorable determination
or decision without it.
2. Estimated glomerular filtration rate
(eGFR). The eGFR is an estimate of the
filtering capacity of the kidneys that takes
into account serum creatinine concentration
and other variables such as your age, gender,
and body size. If your medical evidence
includes eGFR findings, we will consider
them when we evaluate your chronic kidney
disease under 6.05.
3. Kidney or bone biopsy. If you have had
a kidney or bone biopsy, we need a copy of
the pathology report. When we cannot get a
copy of the pathology report, we will accept
a statement from an acceptable medical
source verifying that a biopsy was performed
and describing the results.
C. What other factors do we consider when
we evaluate your chronic kidney disease?
1. Chronic hemodialysis or peritoneal
dialysis.
a. Dialysis is a treatment for chronic kidney
disease that uses artificial means to remove
toxic metabolic byproducts from the blood.
Hemodialysis uses an artificial kidney
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machine to clean waste products from the
blood; peritoneal dialysis uses a dialyzing
solution that is introduced into and removed
from the abdomen (peritoneal cavity) either
continuously or intermittently. Under 6.03,
your ongoing dialysis must have lasted or be
expected to last for a continuous period of at
least 12 months. We will accept a report from
an acceptable medical source that describes
your chronic kidney disease and the need for
ongoing dialysis to satisfy the requirements
in 6.03.
b. If you are undergoing chronic
hemodialysis or peritoneal dialysis, your
chronic kidney disease may meet our
definition of disability before you started
dialysis. We will determine the onset of your
disability based on the facts in your case
record.
2. Kidney transplant.
a. If you receive a kidney transplant, we
will consider you to be disabled under 6.04
for 1 year from the date of transplant. After
that, we will evaluate your residual
impairment(s) by considering your posttransplant function, any rejection episodes
you have had, complications in other body
systems, and any adverse effects related to
ongoing treatment.
b. If you received a kidney transplant, your
chronic kidney disease may meet our
definition of disability before you received
the transplant. We will determine the onset
of your disability based on the facts in your
case record.
3. Renal osteodystrophy. This condition is
the bone degeneration resulting from chronic
kidney disease-mineral and bone disorder
(CKD–MBD). CKD–MBD occurs when the
kidneys are unable to maintain the necessary
levels of minerals, hormones, and vitamins
required for bone structure and function.
Under 6.05B1, ‘‘severe bone pain’’ means
frequent or intractable bone pain that
interferes with physical activity or mental
functioning.
4. Peripheral neuropathy. This disorder
results when the kidneys do not adequately
filter toxic substances from the blood. These
toxins can adversely affect nerve tissue. The
resulting neuropathy may affect peripheral
motor or sensory nerves, or both, causing
pain, numbness, tingling, and muscle
weakness in various parts of the body. Under
6.05B2, the peripheral neuropathy must be a
severe impairment. (See §§ 404.1520(c),
404.1521, 416.920(c), and 416.921 of this
chapter.) It must also have lasted or be
expected to last for a continuous period of at
least 12 months.
5. Fluid overload syndrome. This condition
occurs when excess sodium and water
retention in the body due to chronic kidney
disease results in vascular congestion. Under
6.05B3, we need a description of a physical
examination that documents signs and
symptoms of vascular congestion, such as
congestive heart failure, pleural effusion
(excess fluid in the chest), ascites (excess
fluid in the abdomen), hypertension, fatigue,
shortness of breath, or peripheral edema.
6. Anasarca (generalized massive edema or
swelling). Under 6.05B3 and 6.06B, we need
a description of the extent of edema,
including pretibial (in front of the tibia),
periorbital (around the eyes), or presacral (in
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front of the sacrum) edema. We also need a
description of any ascites, pleural effusion, or
pericardial effusion.
7. Anorexia with weight loss. Anorexia is
a frequent sign of chronic kidney disease and
can result in weight loss. We will use body
mass index (BMI) to determine the severity
of your weight loss under 6.05B4. (BMI is the
ratio of your measured weight to the square
of your measured height.) The formula for
calculating BMI is in section 5.00G.
8. Complications of chronic kidney disease.
The hospitalizations in 6.09 may be for
different complications of chronic kidney
disease. Examples of complications that may
result in hospitalization include stroke,
congestive heart failure, hypertensive crisis,
or acute kidney failure requiring a short
course of hemodialysis.
D. How do we evaluate disorders that do not
meet one of the genitourinary listings?
1. The listed disorders are only examples
of common genitourinary disorders 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.
2. If you have a severe medically
determinable impairment(s) that does not
meet a listing, we will determine whether
your impairment(s) medically equals a
listing. (See §§ 404.1526 and 416.926 of this
chapter.) Genitourinary disorders may be
associated with disorders in other body
systems, and we consider the combined
effects of multiple impairments when we
determine whether they medically equal a
listing. If your impairment(s) does not meet
or medically equal the criteria of a listing,
you may or may not have the residual
functional capacity to engage in substantial
gainful activity. We proceed to the fourth
and, if necessary, the fifth steps of the
sequential evaluation process in §§ 404.1520
and 416.920 of this chapter. We use the rules
in §§ 404.1594 and 416.994 of this chapter,
as appropriate, when we decide whether you
continue to be disabled.
6.01 Category of Impairments,
Genitourinary Disorders
6.03 Chronic kidney disease, with
chronic hemodialysis or peritoneal dialysis
(see 6.00C1).
6.04 Chronic kidney disease, with kidney
transplant. Consider under a disability for 1
year following the transplant; thereafter,
evaluate the residual impairment (see
6.00C2).
6.05 Chronic kidney disease, with
impairment of kidney function, with A and
B:
A. Reduced glomerular filtration evidenced
by one of the following laboratory findings
documented on at least two occasions at least
90 days apart during a consecutive 12-month
period:
1. Serum creatinine of 4 mg/dL or greater;
or
2. Creatinine clearance of 20 ml/min. or
less; or
3. Estimated glomerular filtration rate
(eGFR) of 20 ml/min/1.73m2 or less; and
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B. One of the following:
1. Renal osteodystrophy (see 6.00C3) with
severe bone pain and imaging studies
documenting bone abnormalities, such as
osteitis fibrosa, osteomalacia, or pathologic
fractures; or
2. Peripheral neuropathy (see 6.00C4); or
3. Fluid overload syndrome (see 6.00C5)
documented by one of the following:
a. Diastolic hypertension greater than or
equal to diastolic blood pressure of 110 mm
Hg despite at least 90 consecutive days of
prescribed therapy, documented by at least
two measurements of diastolic blood
pressure at least 90 days apart during a
consecutive 12-month period; or
b. Signs of vascular congestion or anasarca
(see 6.00C6) despite at least 90 consecutive
days of prescribed therapy, documented on at
least two occasions at least 90 days apart
during a consecutive 12-month period; or
4. Anorexia with weight loss (see 6.00C7)
determined by body mass index (BMI) of 18.0
or less, calculated on at least two occasions
at least 90 days apart during a consecutive
12-month period.
6.06 Nephrotic syndrome, with A and B:
A. Laboratory findings as described in 1 or
2, documented on at least two occasions at
least 90 days apart during a consecutive 12month period:
1. Proteinuria of 10.0 g or greater per 24
hours; or
2. Serum albumin of 3.0 g/dL) or less, and
a. Proteinuria of 3.5 g or greater per 24
hours; or
b. Urine total-protein-to-creatinine ratio of
3.5 or greater; and
B. Anasarca (see 6.00C6) persisting for at
least 90 days despite prescribed treatment.
6.09 Complications of chronic kidney
disease (see 6.00C8) requiring at least three
hospitalizations within a consecutive 12month period and occurring at least 30 days
apart. Each hospitalization must last at least
48 hours, including hours in a hospital
emergency department immediately before
the hospitalization.
*
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*
5. Amend part B of appendix 1 to
subpart P of part 404 by revising the
body system name for section 106.00 in
the table of contents to read as follows:
*
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Part B
*
*
106.00
*
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*
Genitourinary Disorders
*
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*
6. Revise section 106.00 in part B of
appendix 1 to subpart P of part 404 to
read as follows:
*
*
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*
*
■
sroberts on DSK5SPTVN1PROD with PROPOSALS
Part B
*
*
106.00
*
*
*
Genitourinary Disorders
A. Which disorders do we evaluate under
these listings?
We evaluate genitourinary disorders
resulting in chronic kidney disease.
Examples of such disorders include chronic
glomerulonephritis, hypertensive
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nephropathy, diabetic nephropathy, chronic
obstructive uropathy, and hereditary
nephropathies. We also evaluate nephrotic
syndrome due to glomerular dysfunction,
and congenital genitourinary disorders, such
as ectopic ureter, exotrophic urinary bladder,
urethral valves, and Eagle-Barrett syndrome
(prune belly syndrome), under these listings.
B. What evidence do we need?
1. We need evidence that documents the
signs, symptoms, and laboratory findings of
your chronic kidney disease. This evidence
should include reports of clinical
examinations, treatment records, and
documentation of your response to treatment.
Laboratory findings, such as serum creatinine
or serum albumin levels, may document your
kidney function. We generally need evidence
covering a period of at least 90 days unless
we can make a fully favorable determination
or decision without it.
2. Estimated glomerular filtration rate
(eGFR). The eGFR is an estimate of the
filtering capacity of the kidneys that takes
into account serum creatinine concentration
and other variables such as your age, gender,
and body size. If your medical evidence
includes eGFR findings, we will consider
them when we evaluate your chronic kidney
disease under 106.05.
3. Kidney or bone biopsy. If you have had
a kidney or bone biopsy, we need a copy of
the pathology report. When we cannot get a
copy of the pathology report, we will accept
a statement from an acceptable medical
source verifying that a biopsy was performed
and describing the results.
C. What other factors do we consider when
we evaluate your genitourinary disorder?
1. Chronic hemodialysis or peritoneal
dialysis.
a. Dialysis is a treatment for chronic kidney
disease that uses artificial means to remove
toxic metabolic byproducts from the blood.
Hemodialysis uses an artificial kidney
machine to clean waste products from the
blood; peritoneal dialysis uses a dialyzing
solution that is introduced into and removed
from the abdomen (peritoneal cavity) either
continuously or intermittently. Under 106.03,
your ongoing dialysis must have lasted or be
expected to last for a continuous period of at
least 12 months. We will accept a report from
an acceptable medical source that describes
your chronic kidney disease and the need for
ongoing dialysis to satisfy the requirements
in 106.03.
b. If you are undergoing chronic
hemodialysis or peritoneal dialysis, your
chronic kidney disease may meet our
definition of disability before you started
dialysis. We will determine the onset of your
disability based on the facts in your case
record.
2. Kidney transplant.
a. If you receive a kidney transplant, we
will consider you to be disabled under
106.04 for 1 year from the date of transplant.
After that, we will evaluate your residual
impairment(s) by considering your posttransplant function, any rejection episodes
you have had, complications in other body
systems, and any adverse effects related to
ongoing treatment.
PO 00000
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Fmt 4702
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7701
b. If you received a kidney transplant, your
chronic kidney disease may meet our
definition of disability before you received
the transplant. We will determine the onset
of your disability based on the facts in your
case record.
3. Anasarca (generalized massive edema or
swelling). Under 106.06B, we need a
description of the extent of edema, including
pretibial (in front of the tibia), periorbital
(around the eyes), or presacral (in front of the
sacrum) edema. We also need a description
of any ascites, pleural effusion, or pericardial
effusion.
4. Congenital genitourinary disorder.
Procedures such as diagnostic cystoscopy or
circumcision do not satisfy the requirement
for urologic surgical procedures in 106.07.
5. Complications of chronic kidney disease.
The hospitalizations in 106.09 may be for
different complications of chronic kidney
disease. Examples of complications that may
result in hospitalization include stroke,
congestive heart failure, hypertensive crisis,
or acute kidney failure requiring a short
course of hemodialysis.
D. How do we evaluate disorders that do not
meet one of the genitourinary listings?
1. The listed disorders are only examples
of common genitourinary disorders that we
consider severe enough to result in marked
and severe 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 severe medically
determinable impairment(s) that does not
meet a listing, we will determine whether
your impairment(s) medically equals a
listing. (See § 416.926 of this chapter.)
Genitourinary disorders may be associated
with disorders in other body systems, and we
consider the combined effects of multiple
impairments when we determine whether
they medically equal a listing. If your
impairment(s) does not medically equal a
listing, we will also consider whether it
functionally equals the listings. (See
§ 416.926a of this chapter.) We use the rules
in § 416.994a of this chapter when we decide
whether you continue to be disabled.
106.01 Category of Impairments,
Genitourinary Disorders
106.03 Chronic kidney disease, with
chronic hemodialysis or peritoneal dialysis
(see 106.00C1).
106.04 Chronic kidney disease, with
kidney transplant. Consider under a
disability for 1 year following the transplant;
thereafter, evaluate the residual impairment
(see 106.00C2).
106.05 Chronic kidney disease, with
impairment of kidney function, with one of
the following documented on at least two
occasions at least 90 days apart during a
consecutive 12-month period:
A. Serum creatinine of 3 mg/dL or greater;
or
B. Creatinine clearance of 30 ml/min/
1.73m2 or less; or
C. Estimated glomerular filtration rate
(eGFR) of 30 ml/min/1.73m2 or less.
106.06 Nephrotic syndrome, with A and
B:
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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Proposed Rules
[FR Doc. 2013–02166 Filed 2–1–13; 8:45 am]
• Federal Rulemaking portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Email: r9azreghaze@epa.gov.
• Fax: 415–947–3579 (Attention:
Gregory Nudd)
• Mail, Hand Delivery or Courier:
Gregory Nudd, EPA Region 9, Air
Division (AIR–2), 75 Hawthorne Street,
San Francisco, California 94105. Hand
and courier deliveries are only accepted
Monday through Friday, 8:30 a.m. to
4:30 p.m., excluding Federal holidays.
Special arrangements should be made
for deliveries of boxed information.
FOR FURTHER INFORMATION CONTACT:
Gregory Nudd, U.S. EPA, Region 9,
Planning Office, Air Division, Air-2, 75
Hawthorne Street, San Francisco, CA
94105. Gregory Nudd can be reached at
telephone number (415) 947–4107 and
via electronic mail at
r9azreghaze@epa.gov.
documents, information and data that
are listed in the index on https://
www.regulations.gov under docket
number EPA–R09–OAR–2012–0904.
Although listed in the index, some
information is not publicly available
(e.g., Confidential Business Information
(CBI)). Certain other material, such as
copyrighted material, is publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically at https://
www.regulations.gov or in hard copy at
the Planning Office of the Air Division,
AIR–2, EPA Region 9, 75 Hawthorne
Street, San Francisco, CA 94105. EPA
requests that you contact the individual
listed in the FOR FURTHER INFORMATION
CONTACT section to view the hard copy
of the docket. You may view the hard
copy of the docket Monday through
Friday, 9–5:00 PST, excluding Federal
holidays.
BILLING CODE 4191–02–P
SUPPLEMENTARY INFORMATION:
C. Submitting Confidential Business
Information
Do not submit CBI to EPA through
https://www.regulations.gov or email.
Clearly mark the part or all of the
information that you claim as CBI. For
CBI information in a disk or CD ROM
that you mail to EPA, mark the outside
of the disk or CD–ROM as CBI and
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI,
you must submit a copy of the comment
that does not contain the information
claimed as CBI for inclusion in the
public docket. We will not disclose
information so marked except in
accordance with procedures set forth in
40 CFR part 2.
A. One of the following laboratory findings
documented on at least two occasions at least
90 days apart during a consecutive 12-month
period:
1. Serum albumin of 3.0 g/dL or less, or
2. Proteinuria of 40 mg/m2/hr or greater;
and
B. Anasarca (see 106.00C3) persisting for at
least 90 days despite prescribed treatment.
106.07 Congenital genitourinary disorder
(see 106.00C4) requiring urologic surgical
procedures at least three times in a
consecutive 12-month period, with at least 30
days between procedures. Consider under a
disability for 1 year following the day of the
last surgery; thereafter, evaluate the residual
impairment.
106.09 Complications of chronic kidney
disease (see 106.00C5) requiring at least three
hospitalizations within a consecutive 12month period and occurring at least 30 days
apart. Each hospitalization must last at least
48 hours, including hours in a hospital
emergency department immediately before
the hospitalization.
A. Instructions for Submitting
Comments
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 51
[EPA–R09–OAR–2012–0904, FRL–9775–9]
Partial Approval and Disapproval of Air
Quality Implementation Plans; Arizona;
Regional Haze and Visibility Transport;
Extension of Comment Period
Environmental Protection
Agency (EPA).
ACTION: Notice; extension of comment
period.
AGENCY:
EPA is extending the public
comment period for a proposed rule
published in the Federal Register on
December 21, 2012, with a former
deadline for comments of February 4,
2013. The new deadline of March 6,
2013, will provide an additional 30 days
for a total of 75 days to comment on our
proposal. The proposal is to approve in
part and disapprove in part a revision to
Arizona’s State Implementation Plan
(SIP) to implement the regional haze
program for the first planning period
through 2018. The proposal includes all
portions of the State’s regional haze SIP
except for three electric generating
stations that were addressed in a final
rule published on December 5, 2012.
DATES: Comments on the proposed rule
published on December 21, 2012 (77 FR
75704) must be received on or before
March 6, 2013.
ADDRESSES: You may submit comments,
identified by Docket ID No. EPA–R09–
OAR–2012–0904, by one of the
following methods:
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SUMMARY:
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EPA’s policy is to include all
comments received in the public docket
without change. We may make
comments available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be CBI or other information
for which disclosure is restricted by
statute. Do not submit information that
you consider to be CBI or that is
otherwise protected through https://
www.regulations.gov or email. The
https://www.regulations.gov web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA, without going through https://
www.regulations.gov, we will include
your email address as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should not
include special characters or any form
of encryption, and be free of any defects
or viruses.
B. Docket
The proposed rule published on
December 21, 2012, relies on
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
D. Tips for Preparing Comments
When submitting comments,
remember to:
• Identify the rulemaking by docket
number and other identifying
information (e.g., subject heading,
Federal Register date and page number).
• Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
• Describe any assumptions and
provide any technical information and/
or data that you used.
• If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
• Provide specific examples to
illustrate your concerns, and suggest
alternatives.
• Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
E:\FR\FM\04FEP1.SGM
04FEP1
]]>Agencies
[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Proposed Rules]
[Pages 7695-7702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02166]
=======================================================================
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
[Docket No. SSA-2009-0038]
RIN 0960-AH03
Revised Medical Criteria for Evaluating Genitourinary Disorders
AGENCY: Social Security Administration.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: We propose to revise the criteria in the Listing of
Impairments (listings) that we use to evaluate claims involving
genitourinary disorders in adults and children under titles II and XVI
of the Social Security Act (Act). The proposed revisions reflect our
program experience, advances in methods of evaluating genitourinary
disorders, and comments we received in response to an advance notice of
proposed rulemaking (ANPRM).
DATES: To ensure that your comments are considered, we must receive
them by no later than April 5, 2013.
ADDRESSES: You may submit comments by any one of three methods--
Internet, fax, or mail. Do not submit the same comments multiple times
or by more than one method. Regardless of which method you choose,
please state that your comments refer to Docket No. SSA-2009-0038 so
that we may associate your comments with the correct regulation.
Caution: You should be careful to include in your comments only
information that you wish to make publicly available. We strongly urge
you not to include in your comments any personal information, such as
Social Security numbers or medical information.
[[Page 7696]]
1. Internet: We strongly recommend that you submit your comments
via the Internet. Please visit the Federal eRulemaking portal at https://www.regulations.gov. Use the Search function to find docket number
SSA-2009-0038. The system will issue you a tracking number to confirm
your submission. You will not be able to view your comment immediately
because we must post each comment manually. It may take up to a week
for your comment to be viewable.
2. Fax: Fax comments to (410) 966-2830.
3. Mail: Address your comments to the Office of Regulations and
Reports Clearance, Social Security Administration, 107 Altmeyer
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
Comments are available for public viewing on the Federal
eRulemaking portal at https://www.regulations.gov or in person, during
regular business hours, by arranging with the contact person identified
below.
FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Medical
Listings Improvement, Social Security Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020. For
information on eligibility or filing for benefits, call our national
toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our
Internet site, Social Security Online, at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
Why are we proposing to revise this body system?
We last published final rules making comprehensive revisions to
genitourinary body system listings on July 5, 2005.\1\ These listings
are scheduled to expire on September 6, 2013.\2\ We published an ANPRM
on November 10, 2009, in which we invited interested people and
organizations to send us written comments and suggestions about whether
and how we should revise these listings.\3\ We are now proposing to
update the medical criteria in the listings to reflect our program
experience and to address adjudicator questions and public comments
that we have received since 2005.
---------------------------------------------------------------------------
\1\ 70 FR 38582.
\2\ In the 2005 final rules, we stated that the rules would be
effective for 8 years unless we extended them or revised and issued
them again.
\3\ 74 FR 57970. We received three comment letters. We said in
the ANPRM that we would not respond directly to the comment letters.
This notice of proposed rulemaking (NPRM) does adopt some of the
commenters' suggestions. You may read the comment letters at https://www.regulations.gov by searching under docket number SSA-2009-0038.
---------------------------------------------------------------------------
What revisions are we proposing?
We propose to:
Revise the name of the body system from ``Genitourinary
Impairments'' to ``Genitourinary Disorders'';
Reorganize and revise the introductory text for the adult
listings (section 6.00) and the childhood listings (section 106.00);
Reorganize, revise, and rename adult listing 6.02 and
childhood listing 106.02 for impairment of renal function;
Add a listing criterion for evaluating chronic kidney
disease (CKD), with impairment of kidney function, in adults (6.05) and
in children (106.05);
Reorganize and revise adult listing 6.06 and childhood
listing 106.06 for nephrotic syndrome;
Add an adult listing (6.09) for evaluating complications
of CKD requiring hospitalizations; and
Reorganize and revise childhood listing 106.07 for
congenital genitourinary disorders.
Why are we proposing to change the name of this body system?
We propose to change the name of this body system from
``Genitourinary Impairments'' to ``Genitourinary Disorders'' to make it
consistent with our names for other body systems. We have re-named
other body systems to include the word ``disorders'' as we revise them,
and the name change we are proposing in this NPRM is consistent with
that approach.
What changes are we proposing to the introductory text of the
genitourinary adult listings?
The following chart provides a comparison of the current
introductory text for adults and the proposed introductory text:
------------------------------------------------------------------------
Current introductory text Proposed introductory text
------------------------------------------------------------------------
6.00A What impairments do these listings 6.00A Which disorders do we
cover? evaluate under these
listings?
6.00B What do we mean by the following Removed.
terms in these listings?
6.00C What evidence do we need? 6.00B What evidence do we
need?
6.00D How do we consider the effects of Removed.
treatment?
6.00E What other things do we consider 6.00C What other factors do
when we evaluate your chronic renal we consider when we
disease under specific listings? evaluate your chronic
kidney disease?
6.00F What does the term ``persistent'' Removed.
mean in these listings?
6.00G How do we evaluate impairments that 6.00D How do we evaluate
do not meet one of the genitourinary disorders that do not meet
listings? one of the genitourinary
listings?
------------------------------------------------------------------------
As the chart illustrates, we are proposing to make minor revisions
to terms in the introductory text (for example, changing the word
``impairment'' to ``disorder,'' where appropriate) and to reorganize
the information in the text. We propose to replace the word ``renal''
with ``kidney'' throughout the introductory text because the medical
community commonly uses the word ``kidney.'' The only exception to this
proposal is that we would retain the term ``renal osteodystrophy''
because it remains a common term in the medical community.
Proposed section 6.00A corresponds to current section 6.00A and
explains the disorders we evaluate under the genitourinary disorders
listings.
We propose to remove current 6.00B that lists definitions because
we would provide a definition, as appropriate, when we first use a term
in the introductory text.
Proposed section 6.00B corresponds in part to current 6.00C and
explains the evidence we need to evaluate a person's CKD. We propose to
revise the text to remove redundancies and to add a description of
estimated glomerular filtration rate (eGFR).
Proposed section 6.00C corresponds to part of current sections
6.00C and 6.00E. We propose to revise the text to remove redundancies
and add guidance on anorexia with weight loss and on complications of
CKD requiring hospitalizations.
We propose to remove current 6.00D because that section's guidance
is not specific to evaluating genitourinary
[[Page 7697]]
disorders. Only one listing, proposed 6.06, would require the presence
of a particular medical finding despite treatment. We do not propose to
evaluate a person's response to treatment under any other listings in
this section.
We propose to remove current 6.00F because we would no longer use
the term ``persistent'' in these listings. Instead, we would provide
specific parameters for determining whether an impairment meets the
duration requirement.
Proposed section 6.00D corresponds to current section 6.00G. We
propose to make minor editorial changes to the way that we cite
regulations in the current section by removing the paragraph levels of
the citations to shorten them.
What changes are we proposing to the genitourinary listings for adults?
The following chart provides a comparison of the current listings
for adults and the proposed listings:
------------------------------------------------------------------------
Current listing Proposed listing
------------------------------------------------------------------------
6.02 Impairment of renal function 6.02 Removed.
6.03 Chronic kidney disease,
with chronic hemodialysis
or peritoneal dialysis.
6.04 Chronic kidney disease,
with kidney transplant.
6.05 Chronic kidney disease,
with impairment of kidney
function.
6.06 Nephrotic syndrome 6.06 Nephrotic syndrome.
6.09 Complications of
chronic kidney disease.
------------------------------------------------------------------------
We propose to revise current listing 6.02 by making each of the
three criteria a separate listing. We believe that this revision would
improve our ability to monitor claims involving CKD. It would also
improve our ability to schedule continuing disability reviews because
the timing of these reviews is different for each of the three
criteria. We also propose to replace the term ``impairment of renal
function'' in the listing title with ``chronic kidney disease.''
Proposed listing 6.03 and 6.04 correspond to current listings 6.02A
and 6.02B, respectively. We are not proposing any changes to the
current criteria.
Proposed listing 6.05 corresponds to current listing 6.02C. We
propose to restructure the listing to clarify the requirements in the
current listing.
We propose to add a criterion to proposed listing 6.05A3 for
estimated glomerular filtration rate (eGFR). The glomerular filtration
rate (GFR) is the best overall measure of kidney function; however, it
is difficult to measure directly. Most clinicians who treat CKD use the
eGFR instead of the GFR to determine the severity of a person's CKD and
to make decisions about the course of treatment. The eGFR values will
likely be readily available in the medical records for people with CKD.
We would replace the criterion for ``[p]ersistent motor or sensory
neuropathy'' in current 6.02C2 with ``[p]eripheral neuropathy'' in
proposed 6.05B2. People with CKD develop neuropathy at a later stage of
the disease than they once did because of advances in CKD treatment. We
do not need to replace ``persistent'' with a criterion based on a
defined period of time because when neuropathy develops at a later
stage of CKD, it is invariably persistent.
We would replace the criterion for ``[p]ersistent'' in current
6.02C3 with a criterion based on a defined period of time to evaluate
hypertension (proposed 6.05B3a), vascular congestion (proposed
6.05B3b), and anorexia (proposed 6.05B4).
Proposed listing 6.06 for nephrotic syndrome corresponds to current
listing 6.06. We propose to restructure the listing to clarify the
requirements in the current listing. We would add a criterion for the
urine total-protein-to-creatinine ratio (a laboratory calculation based
on total protein and creatinine in a urine sample). This ratio is an
alternative to the 24-hour measurement in 6.06A2a and is widely used in
the clinical community to monitor proteinuria.
We propose to add listing 6.09 to evaluate complications of CKD
that require periodic hospitalization. We would require a person to
have at least three hospitalizations occurring at least 30 days apart
to ensure that we are evaluating separate complication events. Each
hospitalization must last at least 48 hours, including hours in a
hospital emergency department immediately before the hospitalization.
We would require that each hospitalization last at least 48 hours
because we believe this period is indicative of a severe complication
of CKD. We would include the hours the person spends in the emergency
department immediately before hospital admission because the person is
likely to be receiving the same intensity of care as he or she will
receive in the hospital. We would also require that these three
hospitalizations occur within a consecutive 12-month period, consistent
with our rules in other body systems.
What changes are we proposing to the introductory text of the
genitourinary listings for children?
The following chart provides a comparison of the current
introductory text for children and the proposed introductory text:
------------------------------------------------------------------------
Current introductory text Proposed introductory text
------------------------------------------------------------------------
106.00A What impairments do these listings 106.00A Which disorders do
cover? we evaluate under these
listings?
106.00B What do we mean by the following Removed.
terms in these listings?
106.00C What evidence do we need? 106.00B What evidence do we
need?
106.00D How do we consider the effects of Removed.
treatment?
106.00E What other things do we consider 106.00C What other factors
when we evaluate your genitourinary do we consider when we
impairment under specific listings? evaluate your genitourinary
disorder?
106.00F What does the term ``persistent'' Removed.
mean in these listings?
106.00G How do we evaluate impairments 106.00D How do we evaluate
that do not meet one of the genitourinary disorders that do not meet
listings? one of the genitourinary
listings?
------------------------------------------------------------------------
[[Page 7698]]
The same basic rules for evaluating genitourinary disorders in
adults apply to children. Except for minor editorial changes to make
the text specific to children, we propose to repeat much of the
introductory text of proposed 6.00 in the introductory text of proposed
106.00.
What changes are we proposing to the genitourinary listings for
children?
The following chart provides a comparison of the current listings
for children and the proposed listings:
------------------------------------------------------------------------
Current listing Proposed listing
------------------------------------------------------------------------
106.02 Impairment of renal function 106.02 Removed.
106.03 Chronic kidney
disease, with chronic
hemodialysis or peritoneal
dialysis.
106.04 Chronic kidney
disease, with kidney
transplant.
106.05 Chronic kidney
disease, with impairment of
kidney function
106.06 Nephrotic syndrome 106.06 Nephrotic syndrome.
106.07 Congenital genitourinary 106.07 Congenital
impairments genitourinary disorder.
106.09 Complications of
chronic kidney disease.
------------------------------------------------------------------------
The proposed childhood genitourinary listings are designated 106.03
through 106.07 and 106.09. They have the same headings as their
counterparts in the proposed adult listings, except for proposed
106.07, which does not have an adult counterpart.
The criteria we propose for children are the same as, or based on,
the current childhood genitourinary criteria. Many of the proposed
changes to the childhood listings correspond to the changes we propose
to make in the adult listing. Since we have already described these
proposed changes above, we describe here only those changes that are
unique to children or that require further explanation.
Proposed listing 106.05 for CKD with impairment of kidney function
incorporates the criteria in current 106.02C and 106.02D. We would
revise the current requirement that a finding is present ``over at
least 3 months.'' We would require, instead, that the finding is
present ``on at least two occasions at least 90 days apart during a
consecutive 12-month period.'' This proposed revision corresponds to
our proposal to replace the word ``persistent'' in the adult listings.
The proposed revision is also consistent with our rules in other body
systems.
In proposed 106.06 for nephrotic syndrome, we would change the
required serum albumin level from ``2.0 g/dL (100 ml) or less'' to 3.0
g/dL or less. We are proposing this change so that the childhood
criterion is consistent with the corresponding adult criterion.
We propose to revise current 106.07 by creating two listings:
proposed 106.07 and proposed 106.09.
Proposed 106.07 for congenital genitourinary disorder corresponds
to current 106.07A. We would incorporate the guidance in current
106.00E4 by adding a requirement that a child must have at least three
urological surgical procedures occurring in a consecutive 12-month
period, with at least 30 days between procedures. We would also add a
criterion that would consider a child disabled for 1 year from the date
of the last urological surgery. Our program experience has shown that
children who have had these surgeries need a period of 1 year before we
can evaluate any remaining limitations resulting from the impairment.
Proposed 106.09 for complications of CKD corresponds to current
106.07B and 106.07C. We would expand our consideration of complications
to include other types of CKD complications that require
hospitalization. Current 106.07B does not require hospitalization. We
propose to add a hospitalization requirement in proposed 106.09 for
consistency with the adult criteria. We believe this change would have
minimal impact on children with CKD complications because most children
who require parenteral antibiotics are hospitalized for this treatment.
We believe that three hospitalizations in a 12-month period establish
CKD complications of listing-level severity because CKD complications
that require hospitalization are generally more serious and involve
longer recovery periods than those treated solely in outpatient
settings.
What time period should we use for finding disability following a
kidney transplant?
We propose to retain our current policy for a finding of disability
for a period of one year following a kidney transplant. Thereafter, we
consider the residual impairment, including post-transplant kidney
function, any rejection episodes, adverse effects of on-going
treatment, and complications in other body systems. We are specifically
interested in any comments of suggestions you have about this policy,
such as whether the time period we use is appropriate, whether we
should use a longer time period, and, if so, what time period we should
use.
What is our authority to make rules and set procedures for determining
whether a person is disabled under the statutory definition?
The Act authorizes us to make rules and regulations and to
establish necessary and appropriate procedures to implement them.
Sections 205(a), 702(a)(5), and 1631(d)(1).
How long would these proposed rules be effective?
If we publish these proposed rules as final rules, they will remain
in effect for 5 years after the date they become effective, unless we
extend them, or revise and issue them again.
Clarity of These Proposed Rules
Executive Order 12866, as supplemented by Executive Order 13563,
requires each agency to write all rules in plain language. In addition
to your substantive comments on these proposed rules, we invite your
comments on how to make them easier to understand.
For example:
Would more, but shorter, sections be better?
Are the requirements in the rules clearly stated?
Have we organized the material to suit your needs?
Could we improve clarity by adding tables, lists, or
diagrams?
What else could we do to make the rules easier to
understand?
Do the rules contain technical language or jargon that is
not clear?
Would a different format make the rules easier to
understand, e.g., grouping and order of sections, use of headings,
paragraphing?
When will we start to use these rules?
We will not use these rules until we evaluate public comments and
publish
[[Page 7699]]
final rules in the Federal Register. All final rules we issue include
an effective date. We will continue to use our current rules until that
date. If we publish final rules, we will include a summary of those
relevant comments we received along with responses and an explanation
of how we will apply the new rules.
Regulatory Procedures
Executive Order 12866, as Supplemented by Executive Order 13563
We consulted with the Office of Management and Budget (OMB) and
determined that this NPRM meets the criteria for a significant
regulatory action under Executive Order 12866, as supplemented by
Executive Order 13563. Therefore, OMB reviewed it.
Regulatory Flexibility Act
We certify that this NPRM will not have a significant economic
impact on a substantial number of small entities because it affects
individuals only. Therefore, the Regulatory Flexibility Act, as
amended, does not require us to prepare a regulatory flexibility
analysis.
Paperwork Reduction Act
This NPRM does not create any new or affect any existing
collections and, therefore, does not require Office of Management and
Budget approval under the Paperwork Reduction Act.
References
We consulted the following references when we developed these
proposed rules:
Copelovitch, L., Warady, B., & Furth, S. (2011). Insights from the
Chronic Kidney Disease in Children. Clinical Journal of the American
Society of Nephrology, 6(8), 2047-2053. doi:10.2215/CJN.10751210.
Furth, S., Abraham, A. G., Jerry-Fluker, J., Schwartz, G. J.
Benfield, M., Kaskel, F., et al. (2011). Metabolic Abnormalities,
Cardiovascular Disease Risk Factors, and GFR Decline in Children
with Chronic Kidney Disease. Clinical Journal of the American
Society of Nephrology, 6(9), 2132-2140. doi:10.2215/CJN.07100810.
Furth, S. L., Cole, S. R., Moxey-Mims, M., Kaskel, F., Mak, R.,
Schwartz, G., et al. (2006). Design and Methods of the Chronic
Kidney in Children (CKiD) Prospective Cohort Study. Clinical Journal
of the American Society of Nephrology, 1(5), 1006-1015. doi:10.2215/
CJN.01941205.
Gipson, D. S., Massengill, S. F., Trachtman, H., Greenbaum, L. A.,
Yao, L., Nagaraj, S., et al. (2009). Management of Childhood Onset
Nephrotic Syndrome. Pediatrics, 124(2), 747-757. doi:10.1542/
peds.2008-1559.
Gordillo, R., & Sptizer, A. (2009). The Nephrotic Syndrome.
Pediatrics in Review, 30(3), 94-105. doi:10.1542/pir.30-3-94.
Gulati, S. (2011, June 21). Chronic Kidney Disease in Children.
Medscape Reference. Retrieved from https://emedicine.medscape.com/article/984358-overview.
Hogg, R., Furth, S., Eknoyan, G., Levey, A. S., Lemley, K. V.,
Portman, R., et al. (2003). National Kidney Foundation's Kidney
Disease Outcome Quality Initiative Clinical Practice Guidelines for
Chronic Kidney Disease in Children and Adolescents: Evaluation,
Classification, and Stratification. Pediatrics, 111(6), 1416-1421.
doi:10.1542/peds.111.6.1416.
Kliegman, R. M., Stanton, B. F., Schor, N. F., St. Geme III, J. W.,
& Behrman, R. E. (2011). Nelson Textbook of Pediatrics (19th ed.).
Philadelphia, PA: Elsevier Saunders.
Lurbe, E., Alvarez, V., & Redon. J. (2004). Predictors of
Progression in Hypertensive Renal Disease in Children. Journal of
Clinical Hypertension, 64(4), 186-191. doi:10.1111/j.1524-
6175.2004.02617.x.
Miller, W.G. (2009). Estimating Equations for Glomerular Filtration
Rate in Children: Laboratory Considerations. Clinical Chemistry,
55(3), 402-403. doi:10.1373/clinchem.2008.122218.
National Kidney Foundation (2010). Frequently Asked Questions About
GFR Estimates. Retrieved from: https://www.kidney.org/professionals/kls/pdf/12-10-4004_KBB_FAQs_AboutGFR-1.pdf.
National Kidney Foundation (2006). KDOQI Clinical Practice
Guidelines and Clinical Practice Recommendations for Anemia in
Chronic Kidney Disease. The Guidelines are available at: https://www.kidney.org/professionals/kdoqi/guidelines_anemia/pdf/AnemiaInCKD.pdf.
National Kidney Foundation (2007). KDOQI Clinical Practice
Guidelines and Clinical Practice Recommendations for Diabetes and
Chronic Kidney Disease. These Guidelines are available at: https://www.kidney.org/professionals/kdoqi/pdf/Diabetes_AJKD_FebSuppl_07.pdf]
National Kidney Foundation (2005). KDOQI Clinical Practice
Guidelines for Bone Metabolism and Disease in Children with Chronic
Kidney Disease. The Guidelines are available at: https://www.kidney.org/professionals/kdoqi/guidelines_pedbone/index.htm.
National Kidney Foundation (2003). KDOQI Clinical Practice
Guidelines for Bone Metabolism and Disease in Chronic Kidney
Disease. The Guidelines are available at: https://www.kidney.org/professionals/KDOQI/guidelines_bone/index.htm.
National Kidney Foundation (2002). KDOQI Clinical Practice
Guidelines for Chronic Kidney Disease: Evaluation, Classification
and Stratification. These Guidelines are available at: https://www.kidney.org/professionals/kdoqi/pdf/ckd_evaluation_classification_stratification.pdf.
National Kidney Foundation (2009). KDOQI Clinical Practice
Guidelines for Nutrition in Children with CKD: 2008 Update. American
Journal of Kidney Diseases, 53(Supp.2), S1-S124. doi:10.1053/S0272-
6386(09)00054-7. These Guidelines are available at: https://www.kidney.org/professionals/kdoqi/guidelines_updates/pdf/CPGPedNutr2008.pdf.
Renal Physicians Association (2010). Shared Decision-Making in the
Appropriate Initiation of and Withdrawal from Dialysis. RPA Clinical
Practice Guideline (Second ed., pp. 121-155). Rockville, MD: Renal
Physicians Association.
Vassalotti, J., Stevens, L., & Levey, A. (2007) Testing for Chronic
Kidney Disease: A Position Statement from the National Kidney
Foundation. American Journal of Kidney Diseases, 50(2), 169-180.
doi:10.1053/j/ajkd.2007.06.013.
We included these references in the rulemaking record for these
proposed rules and will make them available for inspection by
interested individuals who make arrangements with the contact person
identified above.
(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social
Security-- Disability Insurance; 96.002, Social Security--Retirement
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006,
Supplemental Security Income).
List of Subjects in 20 CFR Part 404
Administrative practice and procedure; Blind, Disability benefits;
Old-Age, survivors, and disability insurance; Reporting and
recordkeeping requirements; Social Security.
Dated: January 25, 2013.
Michael J. Astrue,
Commissioner of Social Security.
For the reasons set out in the preamble, we propose to amend 20 CFR
part 404, subpart P as set forth below:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950- )
Subpart P--[Amended]
0
1. The authority citation for subpart P of part 404 continues to read
as follows:
Authority: Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a),
(i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security
Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a), (i), and
(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193,
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42
U.S.C. 902 note).
0
2. Amend appendix 1 to subpart P of part 404 by revising item 7 of the
introductory text before part A of appendix 1 to read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
[[Page 7700]]
7. Genitourinary Disorders (6.00 and 106.00): [DATE 5 YEARS FROM
THE EFFECTIVE DATE OF THE FINAL RULES].
* * * * *
0
3. Amend part A of appendix 1 to subpart P of part 404 by revising the
body system name for section 6.00 in the table of contents to read as
follows:
* * * * *
Part A
* * * * *
6.00 Genitourinary Disorders
* * * * *
0
4. Revise section 6.00 in part A of appendix 1 to subpart P of part 404
to read as follows:
* * * * *
Part A
* * * * *
6.00 Genitourinary Disorders
A. Which disorders do we evaluate under these listings?
We evaluate genitourinary disorders resulting in chronic kidney
disease. Examples of such disorders include chronic
glomerulonephritis, hypertensive nephropathy, diabetic nephropathy,
chronic obstructive uropathy, and hereditary nephropathies. We also
evaluate nephrotic syndrome due to glomerular dysfunction under
these listings.
B. What evidence do we need?
1. We need evidence that documents the signs, symptoms, and
laboratory findings of your chronic kidney disease. This evidence
should include reports of clinical examinations, treatment records,
and documentation of your response to treatment. Laboratory
findings, such as serum creatinine or serum albumin levels, may
document your kidney function. We generally need evidence covering a
period of at least 90 days unless we can make a fully favorable
determination or decision without it.
2. Estimated glomerular filtration rate (eGFR). The eGFR is an
estimate of the filtering capacity of the kidneys that takes into
account serum creatinine concentration and other variables such as
your age, gender, and body size. If your medical evidence includes
eGFR findings, we will consider them when we evaluate your chronic
kidney disease under 6.05.
3. Kidney or bone biopsy. If you have had a kidney or bone
biopsy, we need a copy of the pathology report. When we cannot get a
copy of the pathology report, we will accept a statement from an
acceptable medical source verifying that a biopsy was performed and
describing the results.
C. What other factors do we consider when we evaluate your chronic
kidney disease?
1. Chronic hemodialysis or peritoneal dialysis.
a. Dialysis is a treatment for chronic kidney disease that uses
artificial means to remove toxic metabolic byproducts from the
blood. Hemodialysis uses an artificial kidney machine to clean waste
products from the blood; peritoneal dialysis uses a dialyzing
solution that is introduced into and removed from the abdomen
(peritoneal cavity) either continuously or intermittently. Under
6.03, your ongoing dialysis must have lasted or be expected to last
for a continuous period of at least 12 months. We will accept a
report from an acceptable medical source that describes your chronic
kidney disease and the need for ongoing dialysis to satisfy the
requirements in 6.03.
b. If you are undergoing chronic hemodialysis or peritoneal
dialysis, your chronic kidney disease may meet our definition of
disability before you started dialysis. We will determine the onset
of your disability based on the facts in your case record.
2. Kidney transplant.
a. If you receive a kidney transplant, we will consider you to
be disabled under 6.04 for 1 year from the date of transplant. After
that, we will evaluate your residual impairment(s) by considering
your post-transplant function, any rejection episodes you have had,
complications in other body systems, and any adverse effects related
to ongoing treatment.
b. If you received a kidney transplant, your chronic kidney
disease may meet our definition of disability before you received
the transplant. We will determine the onset of your disability based
on the facts in your case record.
3. Renal osteodystrophy. This condition is the bone degeneration
resulting from chronic kidney disease-mineral and bone disorder
(CKD-MBD). CKD-MBD occurs when the kidneys are unable to maintain
the necessary levels of minerals, hormones, and vitamins required
for bone structure and function. Under 6.05B1, ``severe bone pain''
means frequent or intractable bone pain that interferes with
physical activity or mental functioning.
4. Peripheral neuropathy. This disorder results when the kidneys
do not adequately filter toxic substances from the blood. These
toxins can adversely affect nerve tissue. The resulting neuropathy
may affect peripheral motor or sensory nerves, or both, causing
pain, numbness, tingling, and muscle weakness in various parts of
the body. Under 6.05B2, the peripheral neuropathy must be a severe
impairment. (See Sec. Sec. 404.1520(c), 404.1521, 416.920(c), and
416.921 of this chapter.) It must also have lasted or be expected to
last for a continuous period of at least 12 months.
5. Fluid overload syndrome. This condition occurs when excess
sodium and water retention in the body due to chronic kidney disease
results in vascular congestion. Under 6.05B3, we need a description
of a physical examination that documents signs and symptoms of
vascular congestion, such as congestive heart failure, pleural
effusion (excess fluid in the chest), ascites (excess fluid in the
abdomen), hypertension, fatigue, shortness of breath, or peripheral
edema.
6. Anasarca (generalized massive edema or swelling). Under
6.05B3 and 6.06B, we need a description of the extent of edema,
including pretibial (in front of the tibia), periorbital (around the
eyes), or presacral (in front of the sacrum) edema. We also need a
description of any ascites, pleural effusion, or pericardial
effusion.
7. Anorexia with weight loss. Anorexia is a frequent sign of
chronic kidney disease and can result in weight loss. We will use
body mass index (BMI) to determine the severity of your weight loss
under 6.05B4. (BMI is the ratio of your measured weight to the
square of your measured height.) The formula for calculating BMI is
in section 5.00G.
8. Complications of chronic kidney disease. The hospitalizations
in 6.09 may be for different complications of chronic kidney
disease. Examples of complications that may result in
hospitalization include stroke, congestive heart failure,
hypertensive crisis, or acute kidney failure requiring a short
course of hemodialysis.
D. How do we evaluate disorders that do not meet one of the
genitourinary listings?
1. The listed disorders are only examples of common
genitourinary disorders 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.
2. If you have a severe medically determinable impairment(s)
that does not meet a listing, we will determine whether your
impairment(s) medically equals a listing. (See Sec. Sec. 404.1526
and 416.926 of this chapter.) Genitourinary disorders may be
associated with disorders in other body systems, and we consider the
combined effects of multiple impairments when we determine whether
they medically equal a listing. If your impairment(s) does not meet
or medically equal the criteria of a listing, you may or may not
have the residual functional capacity to engage in substantial
gainful activity. We proceed to the fourth and, if necessary, the
fifth steps of the sequential evaluation process in Sec. Sec.
404.1520 and 416.920 of this chapter. We use the rules in Sec. Sec.
404.1594 and 416.994 of this chapter, as appropriate, when we decide
whether you continue to be disabled.
6.01 Category of Impairments, Genitourinary Disorders
6.03 Chronic kidney disease, with chronic hemodialysis or
peritoneal dialysis (see 6.00C1).
6.04 Chronic kidney disease, with kidney transplant. Consider
under a disability for 1 year following the transplant; thereafter,
evaluate the residual impairment (see 6.00C2).
6.05 Chronic kidney disease, with impairment of kidney function,
with A and B:
A. Reduced glomerular filtration evidenced by one of the
following laboratory findings documented on at least two occasions
at least 90 days apart during a consecutive 12-month period:
1. Serum creatinine of 4 mg/dL or greater; or
2. Creatinine clearance of 20 ml/min. or less; or
3. Estimated glomerular filtration rate (eGFR) of 20 ml/min/
1.73m\2\ or less; and
[[Page 7701]]
B. One of the following:
1. Renal osteodystrophy (see 6.00C3) with severe bone pain and
imaging studies documenting bone abnormalities, such as osteitis
fibrosa, osteomalacia, or pathologic fractures; or
2. Peripheral neuropathy (see 6.00C4); or
3. Fluid overload syndrome (see 6.00C5) documented by one of the
following:
a. Diastolic hypertension greater than or equal to diastolic
blood pressure of 110 mm Hg despite at least 90 consecutive days of
prescribed therapy, documented by at least two measurements of
diastolic blood pressure at least 90 days apart during a consecutive
12-month period; or
b. Signs of vascular congestion or anasarca (see 6.00C6) despite
at least 90 consecutive days of prescribed therapy, documented on at
least two occasions at least 90 days apart during a consecutive 12-
month period; or
4. Anorexia with weight loss (see 6.00C7) determined by body
mass index (BMI) of 18.0 or less, calculated on at least two
occasions at least 90 days apart during a consecutive 12-month
period.
6.06 Nephrotic syndrome, with A and B:
A. Laboratory findings as described in 1 or 2, documented on at
least two occasions at least 90 days apart during a consecutive 12-
month period:
1. Proteinuria of 10.0 g or greater per 24 hours; or
2. Serum albumin of 3.0 g/dL) or less, and
a. Proteinuria of 3.5 g or greater per 24 hours; or
b. Urine total-protein-to-creatinine ratio of 3.5 or greater;
and
B. Anasarca (see 6.00C6) persisting for at least 90 days despite
prescribed treatment.
6.09 Complications of chronic kidney disease (see 6.00C8)
requiring at least three hospitalizations within a consecutive 12-
month period and occurring at least 30 days apart. Each
hospitalization must last at least 48 hours, including hours in a
hospital emergency department immediately before the
hospitalization.
* * * * *
0
5. Amend part B of appendix 1 to subpart P of part 404 by revising the
body system name for section 106.00 in the table of contents to read as
follows:
* * * * *
Part B
* * * * *
106.00 Genitourinary Disorders
* * * * *
0
6. Revise section 106.00 in part B of appendix 1 to subpart P of part
404 to read as follows:
* * * * *
Part B
* * * * *
106.00 Genitourinary Disorders
A. Which disorders do we evaluate under these listings?
We evaluate genitourinary disorders resulting in chronic kidney
disease. Examples of such disorders include chronic
glomerulonephritis, hypertensive nephropathy, diabetic nephropathy,
chronic obstructive uropathy, and hereditary nephropathies. We also
evaluate nephrotic syndrome due to glomerular dysfunction, and
congenital genitourinary disorders, such as ectopic ureter,
exotrophic urinary bladder, urethral valves, and Eagle-Barrett
syndrome (prune belly syndrome), under these listings.
B. What evidence do we need?
1. We need evidence that documents the signs, symptoms, and
laboratory findings of your chronic kidney disease. This evidence
should include reports of clinical examinations, treatment records,
and documentation of your response to treatment. Laboratory
findings, such as serum creatinine or serum albumin levels, may
document your kidney function. We generally need evidence covering a
period of at least 90 days unless we can make a fully favorable
determination or decision without it.
2. Estimated glomerular filtration rate (eGFR). The eGFR is an
estimate of the filtering capacity of the kidneys that takes into
account serum creatinine concentration and other variables such as
your age, gender, and body size. If your medical evidence includes
eGFR findings, we will consider them when we evaluate your chronic
kidney disease under 106.05.
3. Kidney or bone biopsy. If you have had a kidney or bone
biopsy, we need a copy of the pathology report. When we cannot get a
copy of the pathology report, we will accept a statement from an
acceptable medical source verifying that a biopsy was performed and
describing the results.
C. What other factors do we consider when we evaluate your
genitourinary disorder?
1. Chronic hemodialysis or peritoneal dialysis.
a. Dialysis is a treatment for chronic kidney disease that uses
artificial means to remove toxic metabolic byproducts from the
blood. Hemodialysis uses an artificial kidney machine to clean waste
products from the blood; peritoneal dialysis uses a dialyzing
solution that is introduced into and removed from the abdomen
(peritoneal cavity) either continuously or intermittently. Under
106.03, your ongoing dialysis must have lasted or be expected to
last for a continuous period of at least 12 months. We will accept a
report from an acceptable medical source that describes your chronic
kidney disease and the need for ongoing dialysis to satisfy the
requirements in 106.03.
b. If you are undergoing chronic hemodialysis or peritoneal
dialysis, your chronic kidney disease may meet our definition of
disability before you started dialysis. We will determine the onset
of your disability based on the facts in your case record.
2. Kidney transplant.
a. If you receive a kidney transplant, we will consider you to
be disabled under 106.04 for 1 year from the date of transplant.
After that, we will evaluate your residual impairment(s) by
considering your post-transplant function, any rejection episodes
you have had, complications in other body systems, and any adverse
effects related to ongoing treatment.
b. If you received a kidney transplant, your chronic kidney
disease may meet our definition of disability before you received
the transplant. We will determine the onset of your disability based
on the facts in your case record.
3. Anasarca (generalized massive edema or swelling). Under
106.06B, we need a description of the extent of edema, including
pretibial (in front of the tibia), periorbital (around the eyes), or
presacral (in front of the sacrum) edema. We also need a description
of any ascites, pleural effusion, or pericardial effusion.
4. Congenital genitourinary disorder. Procedures such as
diagnostic cystoscopy or circumcision do not satisfy the requirement
for urologic surgical procedures in 106.07.
5. Complications of chronic kidney disease. The hospitalizations
in 106.09 may be for different complications of chronic kidney
disease. Examples of complications that may result in
hospitalization include stroke, congestive heart failure,
hypertensive crisis, or acute kidney failure requiring a short
course of hemodialysis.
D. How do we evaluate disorders that do not meet one of the
genitourinary listings?
1. The listed disorders are only examples of common
genitourinary disorders that we consider severe enough to result in
marked and severe 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 severe medically determinable impairment(s)
that does not meet a listing, we will determine whether your
impairment(s) medically equals a listing. (See Sec. 416.926 of this
chapter.) Genitourinary disorders may be associated with disorders
in other body systems, and we consider the combined effects of
multiple impairments when we determine whether they medically equal
a listing. If your impairment(s) does not medically equal a listing,
we will also consider whether it functionally equals the listings.
(See Sec. 416.926a of this chapter.) We use the rules in Sec.
416.994a of this chapter when we decide whether you continue to be
disabled.
106.01 Category of Impairments, Genitourinary Disorders
106.03 Chronic kidney disease, with chronic hemodialysis or
peritoneal dialysis (see 106.00C1).
106.04 Chronic kidney disease, with kidney transplant. Consider
under a disability for 1 year following the transplant; thereafter,
evaluate the residual impairment (see 106.00C2).
106.05 Chronic kidney disease, with impairment of kidney
function, with one of the following documented on at least two
occasions at least 90 days apart during a consecutive 12-month
period:
A. Serum creatinine of 3 mg/dL or greater; or
B. Creatinine clearance of 30 ml/min/1.73m\2\ or less; or
C. Estimated glomerular filtration rate (eGFR) of 30 ml/min/
1.73m\2\ or less.
106.06 Nephrotic syndrome, with A and B:
[[Page 7702]]
A. One of the following laboratory findings documented on at
least two occasions at least 90 days apart during a consecutive 12-
month period:
1. Serum albumin of 3.0 g/dL or less, or
2. Proteinuria of 40 mg/m\2\/hr or greater; and
B. Anasarca (see 106.00C3) persisting for at least 90 days
despite prescribed treatment.
106.07 Congenital genitourinary disorder (see 106.00C4)
requiring urologic surgical procedures at least three times in a
consecutive 12-month period, with at least 30 days between
procedures. Consider under a disability for 1 year following the day
of the last surgery; thereafter, evaluate the residual impairment.
106.09 Complications of chronic kidney disease (see 106.00C5)
requiring at least three hospitalizations within a consecutive 12-
month period and occurring at least 30 days apart. Each
hospitalization must last at least 48 hours, including hours in a
hospital emergency department immediately before the
hospitalization.
[FR Doc. 2013-02166 Filed 2-1-13; 8:45 am]
BILLING CODE 4191-02-P
