[Federal Register Volume 79, Number 197 (Friday, October 10, 2014)]
[Rules and Regulations]
[Pages 61221-61226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24114]


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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: Final rules.

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SUMMARY: These final rules revise the criteria in the Listing of 
Impairments (listings) that we use to evaluate cases

[[Page 61222]]

involving genitourinary disorders in adults and children under titles 
II and XVI of the Social Security Act (Act). The revisions reflect our 
program experience and address adjudicator questions we have received 
since we last comprehensively revised this body system in 2005.

DATES: These rules are effective December 9, 2014.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Medical 
Policy, 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 http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Background

    We are making final the rules for evaluating genitourinary 
disorders that we proposed in a notice of proposed rulemaking (NPRM) we 
published in the Federal Register on February 4, 2013 at 78 FR 7695. 
The preamble to the NPRM provides the background for these revisions. 
You can view the preamble to the NPRM by visiting http://www.regulations.gov and searching for document ``SSA-2009-0038-0005.'' 
We are making a number of changes in response to public comments to the 
NPRM, which we explain below.

Why are we revising the listings for evaluating genitourinary 
disorders?

    We are revising the listings for evaluating genitourinary disorders 
to update the medical criteria, clarify how we evaluate genitourinary 
disorders, and address adjudicator questions.

Public Comments

    In the NPRM, we provided the public with a 60-day comment period, 
which ended on April 5, 2013. We received six comments. The comments 
came from members of the public, disability adjudicators, and a 
national association representing disability examiners in the State 
agencies that make disability determinations for us.
    We carefully considered all of the comments. We have tried to 
summarize the commenters' views accurately and respond to all of the 
significant issues raised by the commenters that were within the scope 
of these rules. Some commenters noted provisions with which they agreed 
and did not make suggestions for changes in those provisions. We did 
not summarize or respond to those comments.
    Comment: One commenter asked if we would require the estimated 
glomerular filtration rate (eGFR) to be adjusted for race and sex. The 
commenter also suggested that we establish an eGFR calculator to 
calculate the eGFR for the criterion in proposed 6.05A.
    Response: We did not adopt this comment. The eGFR is a calculated 
value based on the measured serum creatinine. The formulas used by 
laboratories to calculate eGFR all include adjustments for age, race, 
and sex. We will use the eGFR value as calculated by the laboratory and 
will not independently calculate eGFR. Thus, we will not develop a 
calculator for eGFR.
    Comment: Another commenter noted that the weight loss criterion in 
proposed listing 6.05B4 (body mass index (BMI) of 18.0 or less) is not 
consistent with the weight loss criterion in listing 5.08 (BMI of less 
than 17.5) and suggested that we change the criterion for consistency.
    Response: We did not adopt this comment. We believe it is 
appropriate to use a different BMI criterion for listing 6.05B4 than we 
use in listing 5.08. The criterion in listing 6.05B4 considers the 
severity of a person's underlying chronic kidney disease (CKD) and its 
effect on his or her nutrition and metabolic status. People with CKD 
are unable to maintain adequate weight due to decreased dietary protein 
intake and decreased dietary energy intake, which are hallmarks of 
kidney failure. People with CKD may have an increased prevalence of 
protein energy malnutrition. Furthermore, listing 5.08 requires a lower 
BMI because the listing considers only weight loss due to any digestive 
disorder. Listing 5.08 does not consider the severity of the 
individual's underlying digestive disorder.
    In listing 5.08, we require BMI of less than 17.5 calculated on at 
least two evaluations, at least 60 days apart, within a consecutive 6-
month period. In final listing 6.05B4, we require the same number of 
BMI evaluations within a consecutive 12-month period. We are using the 
consecutive 12-month period to be consistent with the 12-month duration 
requirement.\1\ The 12-month period is also consistent with the period 
we use when we evaluate hospitalizations due complications of a 
genitourinary disorder in 6.09 and 106.09.
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    \1\ 20 CFR 404.1509 and 416.909.
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    Comment: One commenter expressed concern about proposed listing 
6.09, regarding how to explain ``CKD complications requiring 
hospitalizations versus hospitalizations due to a group of co-morbid 
conditions, including CKD.'' The same commenter also suggested that we 
add guidance in the introductory text to address acute worsening of CKD 
during hospitalizations for co-occurring conditions.
    Response: We agree with the comment and provided clarification 
regarding CKD complications in final listings 6.00C8 and 106.00C5.
    Comment: A commenter suggested revisions to proposed listing 106.07 
requesting a 24-month period with 3 surgeries for childhood 
genitourinary disorders instead of 3 surgeries within 12-month period.
    Response: We are not adopting this comment because using a 12-month 
period for evaluating an impairment is an intrinsic part of our basic 
definition of disability.\2\ We consider the combinations of 
impairments and limitations in functioning at step 3 of the sequential 
evaluation process, using our medical equivalence and functional 
equivalence rules.\3\ We recognize that some children who have multiple 
surgeries for genitourinary impairments may have limitations in 
functioning that last longer. In such cases, we evaluate those 
limitations under our medical equivalence and functional equivalence 
rules.
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    \2\ See 42 U.S.C. 423(d)(1)(a) and (d)(2)(a), and 1382c(a)(3)(A) 
and 20 CFR 404.1505, 404.1509, 416.905, 416.906, and 416.909.
    \3\ See 20 CFR 416.926 and 416.926a(a).
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    Comment: One commenter stated that there are undefined and poorly 
defined terms in the genitourinary listings. The commenter said these 
terms included ``frequent,'' ``intractable,'' ``interferes,'' 
``anasarca,'' ``anorexia,'' and ``severe bone pain.''
    Response: We partially adopted this comment. We provide brief 
definitions for several medical terms when we first use the terms in 
the introductory text of these final listings. We define anasarca in 
6.00C6 and 106.00C3; anorexia in 6.00C7; and ``severe bone pain'' and 
``intractable'' in 6.00C3. We have not provided definitions for the 
terms ``frequent'' and ``interferes.'' We use these two terms in our 
definition of ``severe bone pain'' and use them in their common English 
usage.
    Comment: A commenter stated that there are no listings for 
combinations of impairments. The commenter stated that the NPRM 
includes only single genitourinary disorders and leaves out many 
important combinations of disorders. Examples that the commenter 
provided included severe CKD not requiring dialysis and coronary artery 
disease; peripheral neuropathy and

[[Page 61223]]

generalized edema; and fluid overload and coronary artery disease. The 
commenter also noted ``a complete lack of listings that consider 
obesity.''
    Response: We did not adopt this comment. We recognize that 
genitourinary disorders may co-occur with impairments in other body 
systems. In some cases, the impairment in another body system results 
from a genitourinary disorder; for example, peripheral neuropathy 
resulting from CKD. In other cases, the impairment in another body 
system is not related to the genitourinary disorder; for example, 
peripheral neuropathy resulting from diabetes mellitus.
    We intend the listings to address genitourinary disorders and the 
complications of those disorders. When the co-occurring condition or 
complication is due to a genitourinary disorder, we evaluate it under 
final listing 6.09. However, when the co-occurring impairments are 
unrelated, we believe it is more appropriate to evaluate the 
combination under our medical equivalence rule at step 3 of the 
sequential evaluation process, or at steps 4 and 5 of the sequential 
evaluation process.\4\ At these steps, adjudicators can account for 
specific combinations of impairments, complications of those 
impairments, and limitations of functioning on an individual case 
basis. We address this in the introductory text of final listing 
6.00C8.
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    \4\ See 20 CFR 404.1526 and 416.926.
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    Comment: A commenter noted that we provide no quantitative data to 
show the validity of any of our genitourinary proposed listings and 
noted that many people engage in substantial gainful activity (SGA) 
even though they meet the requirements of a listing. The commenter 
believes that this challenges the validity of using the listings to 
determine whether a person is disabled.
    Response: We disagree with this comment. Our NPRM included an 
extensive list of medical and other references that we relied on in 
proposing these rules. We also invited the public to comment on these 
references and the data contained within them.
    The listings help to ensure that determinations or decisions of 
disability have a sound medical basis, that claimants receive equal 
treatment throughout the country, and that we can readily identify the 
majority of persons who are disabled. The level of severity described 
in the listings is such that an individual, whom is not engaging in SGA 
and has an impairment that meets or medically equals all of the 
criteria of the listing, is generally considered unable to work because 
of the medical impairment alone at step three of the sequential 
evaluation process. Thus, when such a person's impairment or 
combination of impairments meets or medically equals the level of 
severity described in the listing for the required duration, disability 
will be found on the basis of the medical facts alone in the absence of 
evidence to the contrary, for example, the actual performance of SGA.
    Comment: A commenter stated that the proposed criteria discriminate 
against the poor because they include medical tests that people cannot 
afford and that we will not purchase, such as kidney or bone biopsies, 
imaging studies, and 24-hour urine protein tests. The same commenter 
also stated that requirements, such as 90 consecutive days of 
prescribed therapy, urologic surgical procedures, and hospitalization, 
discriminate against people who cannot afford treatment, and suggested 
that we delete the requirements ``[u]nless the Administration is 
willing to make a commitment to purchase these.''
    Response: We did not adopt the commenter's suggestion. People with 
the very serious genitourinary impairments described in these listings 
generally receive the kinds of diagnostic tests and treatments 
described in these final rules because of urgent medical need. However, 
we do not penalize people who do not have the kinds of medical evidence 
that we describe in these listings. Under our rules, we may purchase 
medical examinations or tests to obtain the evidence that we need, but 
we will not purchase diagnostic tests that involve significant risk to 
the person, such as kidney or bone biopsies.\5\ Furthermore, we provide 
several alternatives for people with genitourinary impairments to 
establish that their impairment is of listing-level severity at step 
three of the sequential evaluation process. If the impairment is not of 
listing-level severity, we may find the person disabled at subsequent 
steps of the sequential evaluation process when considering the 
person's residual functional capacity, age, education, and work 
experience.
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    \5\ See 20 CFR 404.1519m and 416.919m.
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    Comment: Two commenters pointed out stylistic and technical 
editorial issues in the preamble and the proposed rules.
    Response: We have made appropriate corrections in these final 
rules.

Other Changes

    In addition to the changes we made in response to public comments, 
we revised 6.00C1 and 106.00C1 to clarify the documentation requirement 
for hemodialysis or peritoneal dialysis.

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.\6\
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    \6\ 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1).
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How long will these final rules be effective?

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

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that these final rules meet the criteria for a significant 
regulatory action under Executive Order 12866, as supplemented by 
Executive Order 13563 and was reviewed by OMB.

Regulatory Flexibility Act

    We certify that these final rules will not have a significant 
economic impact on a substantial number of small entities because they 
affect individuals only. Therefore, the Regulatory Flexibility Act, as 
amended, does not require us to prepare a regulatory flexibility 
analysis.

Paperwork Reduction Act

    These final rules do not create any new or affect any existing 
collections and, therefore, do not require OMB approval under the 
Paperwork Reduction Act.

(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

[[Page 61224]]

insurance, Reporting and recordkeeping requirements, Social Security.

Carolyn W. Colvin,
Acting Commissioner of Social Security.
    For the reasons set out in the preamble, we are amending 20 CFR 
part 404, subpart P as set forth below:

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

Subpart P--Determining Disability and Blindness

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:
0
a. Revising item 7 of the introductory text before part A;
0
b. In part A:
0
i. Revising the body system name for section 6.00 in the table of 
contents; and
0
ii. Revising section 6.00;
0
c. In part B:
0
i. Revising the body system name for section 106.00 in the table of 
contents; and
0
ii. Revising section 106.00.
    The revisions read as follows:

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

* * * * *
    7. Genitourinary Disorders (6.00 and 106.00): December 9, 2019.
* * * * *

Part A

* * * * *
    6.00 Genitourinary Disorders.
* * * * *

6.00 GENITOURINARY DISORDERS

A. Which disorders do we evaluate under these listings?

    We evaluate genitourinary disorders resulting in chronic kidney 
disease (CKD). 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 CKD. 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 CKD 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 
genitourinary disorder?

    1. Chronic hemodialysis or peritoneal dialysis.
    a. Dialysis is a treatment for CKD 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. To satisfy the requirements in 6.03, we will 
accept a report from an acceptable medical source that describes 
your CKD and your current dialysis, and indicates that your dialysis 
will be ongoing.
    b. If you are undergoing chronic hemodialysis or peritoneal 
dialysis, your CKD 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 CKD 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 (resistant to treatment) 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 CKD 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 (diminished appetite) with weight loss. Anorexia is 
a frequent sign of CKD 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 CKD. The hospitalizations in 6.09 may be for 
different complications of CKD. Examples of complications from CKD 
that may result in hospitalization include stroke, congestive heart 
failure, hypertensive crisis, or acute kidney failure requiring a 
short course of hemodialysis. If the CKD complication occurs during 
a hospitalization that was initially for a co-occurring condition, 
we will evaluate it under our rules for determining medical 
equivalence. (See Sec. Sec.  404.1526 and 416.926 of this chapter.) 
We will evaluate co-occurring conditions, including those that 
result in hospitalizations, under the listings for the affected body 
system or under our rules for medical equivalence.

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

[[Page 61225]]

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

    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.
* * * * *

Part B

* * * * *
    106.00 Genitourinary Disorders.
* * * * *

106.00 GENITOURINARY DISORDERS

A. Which disorders do we evaluate under these listings?

    We evaluate genitourinary disorders resulting in chronic kidney 
disease (CKD). 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 CKD. 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 CKD 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 CKD 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. To satisfy the requirement in 106.03, we will 
accept a report from an acceptable medical source that describes 
your CKD and your current dialysis, and indicates that your dialysis 
will be ongoing.
    b. If you are undergoing chronic hemodialysis or peritoneal 
dialysis, your CKD 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 CKD 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 CKD. The hospitalizations in 106.09 may be 
for different complications of CKD. Examples of complications from 
CKD that may result in hospitalization include stroke, congestive 
heart failure, hypertensive crisis, or acute kidney failure 
requiring a short course of hemodialysis. If the CKD complication 
occurs during a hospitalization that was initially for a co-
occurring condition, we will evaluate it under our rules for 
determining medical equivalence. (See Sec.  416.926 of this 
chapter.) We will evaluate co-occurring conditions, including those 
that result in hospitalizations, under the listings for the affected 
body system or under our rules for medical equivalence.

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 functional limitations. If your impairment(s) does 
not meet the criteria of any of these listings, we must also 
consider whether you have an impairment(s) that satisfies the 
criteria of a listing in another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not

[[Page 61226]]

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:
    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. 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 
date 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. 2014-24114 Filed 10-9-14; 8:45 am]
BILLING CODE 4191-02-P