[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Proposed Rules]
[Pages 7695-7702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02166]


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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: Notice of proposed rulemaking.

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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 http://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 http://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 http://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.
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    \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 http://www.regulations.gov by searching under docket number SSA-2009-0038.
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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 http://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: http://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: http://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: http://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: http://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: http://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: http://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: http://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