[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Rules and Regulations]
[Pages 54081-54089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19997]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AQ71


Schedule for Rating Disabilities; The Genitourinary Diseases and 
Conditions

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA) 
Schedule for Rating Disabilities (VASRD) by revising the portion of the 
schedule that addresses the genitourinary system. This action ensures 
that the rating schedule uses current medical terminology and provides 
detailed and updated criteria for evaluation of genitourinary 
conditions for disability rating purposes.

DATES: This final rule is effective November 14, 2021.

FOR FURTHER INFORMATION CONTACT: Ioulia Vvedenskaya, M.D., M.B.A., 
Medical Officer, VASRD Program Office (210), Compensation Service 
(21C), Veterans Benefits Administration, Department of Veterans 
Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9752. 
(This is not a toll-free telephone number.)

SUPPLEMENTARY INFORMATION: On October 15, 2019, VA published the 
proposed rule for Schedule of Rating Disabilities; The Genitourinary 
Diseases and Conditions in the Federal Register. See 84 FR 55086. VA 
received 12 comments during the 60-day comment period. VA appreciates 
the comments submitted in response to the proposed rule. Based on the 
rationale stated in the proposed rule and in this document, the 
proposed rule is adopted as a final rule with minor changes noted 
below.

[[Page 54082]]

I. Comments of General Support

    One commenter welcomed the proposed changes to 38 CFR 4.115a, 
including the replacement of a vague term (``intermittent intensive 
management'') with a more specific reference (``suppressive drug 
therapy'') in the urinary tract infection (UTI) criteria. The commenter 
supported VA's proposal to eliminate subjective terms such as 
``markedly,'' ``some,'' and ``slight'' in the renal dysfunction 
criteria and to replace them with specific, objective laboratory 
findings, such as the glomerular filtration rate (GFR) and albumin/
creatinine ratio (ACR). The commenter noted that these revisions will 
likely result in a more efficient application of the rating schedule of 
disabilities and will benefit many veterans with kidney diseases. VA 
appreciates the commenter's support and makes no changes based on this 
comment.
    Another commenter supported VA's proposal to update medical 
terminology and 38 CFR 4.115a. The commenter noted that the proposed 
changes include more specific, objective laboratory findings such as 
GFR. The commenter also noted that the National Kidney Foundation 
indicated that an estimated glomerular filtration (eGFR) is the best 
test to measure the level of kidney function and to determine the stage 
of the kidney disease. VA appreciates the commenter's support and makes 
no changes based on this comment.

II. Comments Regarding 38 CFR 4.115a

    One commenter expressed an opinion that the GFR values in a 
previously proposed rule, which was published on July 28, 2017, are 
more in line with National Kidney Foundation standards. See 82 FR 
35140. However, that July 2017 proposal was formally withdrawn through 
notice published in the Federal Register on March 5, 2019. See 84 FR 
7844. Although the commenter asserted that the July 2017 proposal's GFR 
values more accurately reflected disease progression, VA found during 
its internal review that the renal dysfunction rating criteria proposed 
in July 2017 contained erroneous values and units of measure for ACR 
and GFR. These erroneous proposed values were not in line with the 
National Kidney Foundation guidelines and would have resulted in 
erroneous disability evaluations for multiple renal disabilities. In 
contrast, the October 2019 proposed rule cited corrected GFR values 
aligned with the National Kidney Foundation's definition and 
classification of chronic kidney disease. Nat'l Kidney Found., ``KDIGO 
2012 Clinical Practice Guideline for the Evaluation and Management of 
Chronic Kidney Disease,'' 3(1) Kidney Int'l Suppl. 5 (Jan. 2013), 
available at https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf (last viewed May 15, 2020) [hereinafter 
``KDIGO'']. Therefore, VA makes no changes based on this comment.
    Another commenter stated that a recent study showed that an 
overestimation of renal function was correlated with patients' post-
amputation status. The commenter stated that this study suggested that 
a cystatin C test would be a more accurate measure of kidney function 
in patients who have had amputations. According to the National Kidney 
Foundation, a blood test for cystatin C can be helpful in some 
instances, but it is not the usual or regular way to estimate a GFR. 
National Kidney Foundation, ``Cystatin C,'' https://www.kidney.org/atoz/content/cystatinC (last viewed May 15, 2020). A recently published 
study examined the accuracy of kidney function estimates when 
prescribing renally-eliminated medications in non-traumatic amputees. 
Aakjaer et al., ``Differences in Kidney Function Estimates Based on 
Creatinine and/or Cystatin C in Non-Traumatic Amputation Patients and 
Their Impact on Drug Prescribing,'' 8(1) J Clin Med. 89 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351924/ (last viewed May 15, 
2020). The conclusions of this study highlighted the fact that a non-
traumatic amputation of a lower extremity has a significant effect on 
both eGFR and cystatin C. Furthermore, there are significant 
differences between eGFR and cystatin C (both before and after 
amputation) and these differences impact how renally-eliminated 
medications should be prescribed. VA appreciates this comment. However, 
the VA rating schedule for disabilities is not used for diagnosis and 
treatment of medical conditions; it is used to evaluate disabilities in 
accord with average earnings loss. VA has determined that, for VA 
disability evaluation purposes, GFR, eGFR, and ACR values present 
adequate measurements of functional impairment due to kidney disease. 
VA makes no changes based on this comment.
    Another commenter disagreed with the changes made in 38 CFR 4.115a 
by stating that decreasing the required GFR for the 80, 60 and 30 
percent rating criteria would disqualify many veterans with chronic 
kidney disease from future increases in their disability rating if 
their conditions worsen. However, VA did not propose a decrease in GFR 
values; rather, VA replaced subjective terms such as ``markedly,'' 
``some,'' and ``slight'' in the current evaluation criteria with 
specific, objective laboratory findings, such as GFR and ACR. To the 
extent that the comment was intended to suggest that VA should use the 
GFR values in the proposed rule published in July 2017 and later 
withdrawn, VA has determined, as stated above, that the GFR values 
proposed in October 2019 are more accurate and better aligned with the 
National Kidney Foundation's definition and classification of chronic 
kidney disease. VA makes no changes based on this comment.
    The same commenter was concerned that, under the proposed GFR 
values, a veteran would have to be at the point of getting a kidney 
transplant in order to reach an 80 percent disability evaluation. VA 
proposed an 80 percent evaluation for individuals with a GFR between 15 
and 29 mL/min/1.73 m\2\ for at least three consecutive months. This 
aligned VA's functional impairment evaluation with the most current 
clinical guidelines. Nat'l Kidney Found., ``Managing Your Adult 
Patients Who Have a Kidney Transplant,'' at 2 (2011), available at 
https://www.kidney.org/sites/default/files/02-50-4079_ABB_ManagingTransRecipBk_PC.pdf (last viewed May 15, 2020) 
[hereinafter ``Managing'']. According to the National Kidney Foundation 
guidelines, only patients with kidney failure (GFR value <15 or 
dialysis) are considered for kidney replacement therapy (kidney 
transplant). Id. For patients with severely decreased kidney function 
(GFR between 15 and 29 mL/min/1.73 m\2\), a referral to a nephrologist 
for evaluation of chronic kidney disease progression is recommended. 
Id. Such evaluation would include a range of activities in preparation 
for kidney replacement therapy such as patient and family education, 
dialysis access, and preemptive transplant. Id. VA makes no changes 
based on this comment.
    Another commenter referenced a study that showed a link between 
kidney disease and/or kidney failure and prolonged use of proton pump 
inhibitors such as Prilosec and Nexium. The commenter suggested that 
the overuse and/or prolonged use of proton pump inhibitors during 
military service and the medications' side effects should be included 
in the schedule for rating disabilities. VA appreciates this comment. 
The comment appears directed more toward establishment of service 
connection for a condition resulting in disability than to rating the 
level of disability attributable to the

[[Page 54083]]

condition. Nonetheless, to ensure that the full range of relevant 
factors is adequately addressed, VA intends to establish a work group 
that will consider this issue at a future time. Upon consideration and 
assessment of the work group's findings, VA will determine whether any 
additional amendments to the criteria are necessary; if so, they would 
be addressed in a future proposal. At this time, however, VA makes no 
changes based on this comment.
    Another commenter expressed concern that the proposed rule did not 
make clear how the stages of chronic kidney disease (CKD) translate 
into the proposed rating criteria for renal disfunction. To be clear, 
VA proposed 100, 80, 60, 30, and 0 percent evaluations based on the 
stages of CKD according to most current clinical guidelines, 
specifically, those of the National Kidney Foundation. See KDIGO at 8. 
The National Kidney Foundation guidelines distinguish between patients 
with kidney failure (that is, GFR value <15 or dialysis), severely 
decreased kidney function (GFR value 15 to 29), moderately to severely 
decreased kidney function (GFR value 30 to 44), mildly to moderately 
decreased kidney function (GFR value 45 to 59), and mildly decreased 
kidney function (GFR value 60 to 89). Id. VA's proposed (and now final) 
rating criteria for renal dysfunction provide the same staging. VA 
makes no changes based on this comment.
    Another commenter welcomed VA's decision to base its disability 
evaluations for renal dysfunction on GFR and ACR laboratory findings, 
but was concerned that VA would use only these laboratory findings 
without taking into consideration other available evidence in the 
claims file. By law, VA must consider all available evidence when 
determining whether the criteria for a particular a disability 
evaluation are met. 38 U.S.C. 5107(b). As noted above, the GFR and ACR 
laboratory findings are an objective, accurate, and standard method for 
measuring renal dysfunction. Other relevant evidence in the claims file 
may implicate broader issues such as separate ratings or secondary 
service connection in a given case but, for the renal dysfunction 
rating specifically, the GFR and ACR laboratory findings will govern. 
VA makes no changes based on this comment.
    The same commenter referenced a National Institutes of Health (NIH) 
study and alleged that renal dysfunction due to cold injury-related 
venous congestion cannot be rated based on GFR values. VA disagrees. 
The NIH report does not appear to make such an allegation; indeed, it 
used GFR values to measure renal impairment. Mullens et al., 
``Importance of Venous Congestion for Worsening of Renal Function in 
Advanced Decompensated Heart Failure,'' 53(7) J Am Coll Cardiol. 589-
596 (2009), available at https://pubmed.ncbi.nlm.nih.gov/19215833/ 
(last visited May 19, 2020). According to the National Kidney 
Foundation, GFR is widely accepted as the best overall index of kidney 
function, KDIGO at 19, and the commenter does not appear to present an 
alternative measure. VA makes no changes based on this comment.
    The same commenter stated that basing the renal dysfunction rating 
on GFR values would exclude combat veterans with warm water immersion 
foot and paddy foot injuries from receiving VA disability compensation. 
VA disagrees. To the extent that these injuries cause renal 
dysfunction, that dysfunction can be measured through GFR, and 
compensation can be provided based on the GFR value. VA makes no 
changes based on this comment.
    The same commenter proposed the addition of new diagnostic codes 
for kidney dysfunction due to the warm water immersion foot and paddy 
foot injuries. VA appreciates this comment. To ensure that the full 
range of relevant factors is adequately addressed, VA intends to 
establish a work group that will consider this issue at a future time. 
Upon consideration and assessment of the work group's findings, VA will 
determine whether any additional amendments to the criteria are 
necessary; if so, they would be addressed in a future proposal. At this 
time, however, VA makes no changes based on this comment.
    Based on its internal review, however, VA makes one change to the 
general rating formula for renal dysfunction: Adding the word 
``eligible'' to the 100 percent evaluation that describes a kidney 
transplant recipient. This addition is made to ensure that all veterans 
with service-connected renal disease who are eligible to receive a 
kidney transplant will be entitled to a 100 percent evaluation as soon 
as they are deemed eligible for a kidney transplant, whether or not the 
transplant has been scheduled.

III. Comments Regarding Diagnostic Codes 7520 Through 7522

    VA received several comments regarding the proposed changes to DCs 
7520 through 7522, which address removal and deformity of the penis.
    One commenter asked VA to provide a rationale for its decision to 
remove the ability to rate the removal of the penis or glans as voiding 
dysfunction. Under most circumstances, the removal of the penis or 
glans does not result in voiding dysfunction. Most commonly, the loss 
of penis or glans will affect the ability to void while standing, which 
is not considered a compensable functional impairment under the 
criteria for voiding dysfunction in 38 CFR 4.115a. Santucci et al., 
``Penile Fracture and Trauma,'' Medscape (updated 2019), https://emedicine.medscape.com/article/456305-overview (last visited May 15, 
2020). Furthermore, if, in the course of penis or glans surgical 
removal, there is associated urethral trauma resulting in voiding 
dysfunction, it should be separately rated under DC 7518, which 
addresses the stricture of the urethra. For these reasons, VA does not 
find it appropriate to direct rating personnel to reference the voiding 
dysfunction criteria of 38 CFR 4.115a when evaluating DCs 7520 and 
7521. VA therefore makes no changes based on this comment.
    The same commenter recognized that erectile dysfunction alone may 
not equate to a reduction in earning capacity, but nevertheless 
asserted that VA should acknowledge that erectile dysfunction could 
lead to mental distress, such as depression and anxiety, and could 
impact a veteran's ability to work. The commenter recommended that VA 
grant compensation for any secondary condition that is related to 
erectile dysfunction that causes a reduction in earning capacity. VA 
agrees with the commenter's assessment that a mental disorder related 
to service-connected erectile dysfunction could warrant secondary 
service connection. That mental disorder would require its own 
diagnosis, service connection, and a disability evaluation under 38 CFR 
4.130, which governs ratings for mental disorders. VA already 
recognizes this concept in 38 CFR 3.310(a), which directs that any 
disability which is proximately due to or the result of a service-
connected disability shall be service connected. VA makes no changes 
based on this comment.
    Another commenter disagreed with the proposed changes to DC 7522, 
which addresses erectile dysfunction and penile deformity. The 
commenter expressed concern that, by removing a compensable evaluation 
for penis deformity, VA will unreasonably deprive certain veterans of 
benefits, specifically, veterans with Peyronie's disease. The commenter 
listed several signs and symptoms of Peyronie's disease to include scar 
tissue, a

[[Page 54084]]

significant bend to the penis, erection problems, shortening of the 
penis, pain with or without erection, and mental health disorders due 
to stress and anxiety. The commenter indicated that the severity of the 
overall impact of Peyronie's disease on male veterans is evidenced by 
the prevalence of mental health disorders associated with it. The 
commenter expressed an opinion that the functional impairment due to 
Peyronie's disease affects veterans' ability to function under the 
ordinary conditions of life and work. Additionally, the commenter 
stated that, though disabilities relating to creative organs may not 
affect earning capacity directly, they impact non-economic factors such 
as personal inconvenience, social inadaptability, or psychological 
factors. The commenter proposed the addition of a diagnostic code and 
specific rating criteria for Peyronie's disease, including penile 
deformity and pain.
    Moreover, two commenters asked VA to provide a rationale for its 
decision to exclude Peyronie's disease from ratable conditions. The 
commenters expressed concern that Peyronie's disease may be caused by 
trauma as a result of an in-service injury and, in some cases, prevent 
a veteran from having sexual intercourse or make it difficult to get or 
maintain an erection.
    Peyronie's disease is typically associated with painful erections 
or intercourse or a curve in the penis that prevents sexual 
intercourse. According to the NIH, and based on studies of men who 
reported having symptoms of Peyronie's disease, researchers estimate 
that Peyronie's disease affects more than one in 10 men. ``Penile 
Curvature (Peyronie's Disease),'' National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK), NIH, https://www.niddk.nih.gov/health-information/urologic-diseases/penile-curvature-peyronies-disease 
(last viewed May 15, 2020). The etiology of Peyronie's disease remains 
partially understood. More recently, Peyronie's disease has been 
thought to result from vascular trauma or injury to the penis that 
causes scarring and deformity of the penis. Lizza et al., ``Peyronie's 
Disease,'' Medscape (2018), https://emedicine.medscape.com/article/456574-overview#a7 (last visited May 15, 2020).
    VA agrees with the commenters that penile trauma as a result of an 
in-service injury should be recognized under DC 7522. Accordingly, VA 
in this final rule is adding a note under DC 7522 to clarify how rating 
personnel should evaluate disabling effects of penile trauma or 
disease, to include Peyronie's disease. The note states that, for the 
purpose of VA disability evaluation, a disease or traumatic injury of 
the penis resulting in scarring or deformity shall be rated under DC 
7522. With this clarification, VA ensures that a traumatic injury or 
disease of the penis will be recognized by the VASRD. VA would review 
any mental health disorders associated with erectile dysfunction or 
Peyronie's disease under 38 CFR 4.125, 4.126, and 4.130. Furthermore, 
DC 7522's footnote regarding consideration of special monthly 
compensation for loss of use of a creative organ, where warranted, will 
apply for both erectile dysfunction or Peyronie's disease.
    Nevertheless, as noted in the preamble to the proposed rule, VA 
provides disability compensation for conditions based on the average 
impairment of earning capacity pursuant to 38 U.S.C. 1155. Erectile 
dysfunction, with or without penile deformity, is not associated 
directly with reductions in earning capacity, which is why VA proposed 
to provide a noncompensable evaluation for erectile dysfunction under 
DC 7522. Similarly, the potentially painful erections and intercourse 
associated with Peyronie's disease do not, on average, impair earning 
capacity at a compensable level. To the extent these conditions impact 
social or psychological factors, VA has a variety of mental health and 
counseling services available for service-connected veterans. But the 
law specifically links disability compensation to impairment of earning 
capacity. 38 U.S.C. 1155. VA thanks the commenters for their input.

IV. Comments Regarding Diagnostic Code 7542

    One commenter expressed concern with VA's proposal to rate 
neurogenic bladder as voiding dysfunction or urinary tract infection, 
whichever is predominant. The commenter asserted that VA would fail to 
adequately compensate a veteran who suffers from both effects. 
Historically, 38 CFR 4.115a has recognized that ``[d]iseases of the 
genitourinary system generally result in disabilities related to renal 
or voiding dysfunctions, infections, or a combination of these.'' 
Further, Sec.  4.115a directs rating personnel to evaluate such 
disabilities on the ``predominant area of dysfunction.'' VA's proposal 
for DC 7542 to evaluate neurogenic bladder conditions based on voiding 
dysfunction or urinary tract infection mirrors the instructions in 
Sec.  4.115a, which instruct that only the predominant area of 
dysfunction shall be considered when evaluating genitourinary 
conditions. Moreover, Sec.  4.14 directs that the evaluation of the 
same disability under various diagnoses is to be avoided. Both urinary 
tract infections and voiding dysfunctions affect urinary tract 
functioning, specifically, urination. Consequently, these dysfunctions 
do not lend themselves to distinct and separate disability evaluations 
without violating the fundamental principle relating to pyramiding as 
outlined in Sec.  4.14. VA declines to make any changes based on this 
comment.

V. Comments Regarding Diagnostic Code 7543

    One commenter expressed concern that the noncompensable disability 
rating for varicocele and hydrocele under proposed DC 7543 does not 
provide proper compensation for individuals with severe cases of 
varicocele or hydrocele that result in acute pain during walking or 
driving. The commenter suggested a 10 percent disability rating for 
such severe cases of varicocele or hydrocele. However, the evidence 
indicates that varicoceles are often asymptomatic and hydroceles are 
usually painless and disappear without treatment. See Junnile, J. and 
Lassen, P., ``Testicular Masses,'' 57(4) Am Fam Physician 685-692 
(1998), available at https://www.aafp.org/afp/1998/0215/p685.html (last 
viewed May 15, 2020). While these conditions may cause a decrease in 
fertility, or the existence of infertility, neither cause a reduction 
in earning capacity that would warrant a compensable rating. However, 
where varicocele or hydrocele causes pain that necessitates surgery, a 
rating under an appropriate diagnostic code may be available for post-
surgery residuals. Also, in any instance in which a veteran has loss of 
use of a creative organ due to a service-connected condition, VA 
provides special monthly compensation for this functional loss. See 38 
CFR 3.350(a). VA makes no changes based on these comments.

VI. Comments Beyond the Scope of This Rulemaking

    One commenter stated that many combat veterans are unknowingly and 
silently enduring cold injury kidney dysfunction, and VA neglected to 
notify 1.7 million combat veterans of the long-term sequelae of warm 
water immersion foot injuries. These aspects of the comment relate to 
notice and education for veterans, not the rating criteria used in the 
evaluation of service-connected genitourinary conditions. Therefore, 
these issues are not within the scope of this rulemaking. VA makes no 
changes based on these comments.

[[Page 54085]]

    The same commenter stated that physicians at VA medical centers do 
not know and have no reasonable means to ascertain information related 
to the disability rating criteria associated with immersion foot 
injuries and related kidney dysfunction, in order to properly treat 
disabled veterans. Furthermore, the commenter discussed in detail his 
medical conditions and claims' adjudication process. VA appreciates 
these comments; however, the comments relate to diagnosis and treatment 
of cardiovascular and renal conditions rather than disability 
evaluations in the rating schedule. Therefore, these issues are not 
within the scope of this rulemaking. VA makes no changes based on these 
comments.

VII. Proposed Changes to Sec.  4.115

    In its proposed rule, VA deemed the first three sentences of Sec.  
4.115 unnecessary and proposed to remove them. However, during its 
internal review and additional considerations of such removal, VA 
realized that further study of this action is warranted to account for 
complex relationships between cardiovascular and genitourinary 
disabilities.
    Currently, VA does not assign separate evaluations for heart 
disease and any form of nephritis due to its close interrelationship 
with cardiovascular disabilities. However, VA can separately evaluate 
non-nephritis renal disease and cardiovascular disease (e.g., diabetic 
nephropathy and coronary artery disease) when complications do not 
overlap.
    VA proposed new terminology for Sec.  4.115, but did not clearly 
define renal disease and its relationship with cardiovascular 
conditions. Thus, if the proposed changes were to be made effective, 
they might be interpreted as precluding separate evaluations for non-
nephritis renal disease and cardiovascular disabilities. This was not 
an intended consequence of this rulemaking, and would be 
disadvantageous to veterans who suffer from service-connected renal and 
cardiovascular conditions.
    Therefore, VA withdraws its proposal to revise Sec.  4.115. VA will 
review and update Sec.  4.115 during its next revision of the VA Rating 
Schedule for Disabilities.

VII. Technical Correction

    In the proposed rule, VA updated its general rating formula for 
renal dysfunction by replacing subjective criteria with specific, 
objective laboratory findings, such as the GFR and ACR. Upon further 
review, VA realized that it inadvertently omitted a reference to the 
period of evaluation for the GFR and ACR values. VA makes a clarifying 
change in the text for the 100, 80, 60, 30, and 0 percent disability 
evaluations by adding the reference ``during the past 12 months'' to 
``Chronic kidney disease with GFR . . . for at least 3 consecutive 
months.'' This change to the language does not result to any 
substantive changes to the criteria in the general rating formula for 
renal dysfunction.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health, and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
The Office of Information and Regulatory Affairs has determined that 
this rule is a significant regulatory action under Executive Order 
12866. The Regulatory Impact Analysis associated with this rulemaking 
can be found as a supporting document at www.regulations.gov.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-
612). The certification is based on the fact that small entities or 
businesses are not affected by revisions to the VASRD. Therefore, 
pursuant to 5 U.S.C. 605(b), the initial and final regulatory 
flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance program numbers and 
titles affected by this document are 64.009, Veterans Medical Care 
Benefits; 64.104, Pension for Non-Service-Connected Disability for 
Veterans; 64.109, Veterans Compensation for Service-Connected 
Disability.

List of Subjects in 38 CFR Part 4

    Disability benefits, Pensions, Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on June 22, 2021, and authorized the undersigned to sign and 
submit the document to the Office of the Federal Register for 
publication electronically as an official document of the Department of 
Veterans Affairs.

Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of 
the Secretary, Department of Veterans Affairs.

    For the reasons set out in the preamble of this rule and the 
proposed rule, the Department of Veterans Affairs amends 38 CFR part 4 
as follows:

PART 4--SCHEDULE FOR RATING DISABILITIES

0
1. The authority citation for part 4 continues to read as follows:

    Authority:  38 U.S.C. 1155, unless otherwise noted.

Subpart B--Disability Ratings

0
2. Amend Sec.  4.115a by revising the introductory text and the table 
entries for ``Renal dysfunction'' and ``Urinary tract infection'' to 
read as follows:


Sec.  4.115a   Ratings of the genitourinary system--dysfunctions.

    Diseases of the genitourinary system generally result in 
disabilities related to renal or voiding dysfunctions, infections, or a 
combination of these. The following section provides descriptions of 
various levels of disability in each of these symptom

[[Page 54086]]

areas. Where diagnostic codes refer the decision maker to these 
specific areas of dysfunction, only the predominant area of dysfunction 
shall be considered for rating purposes. Distinct disabilities may be 
evaluated separately under this section, pursuant to Sec.  4.14, if the 
symptoms do not overlap. Since the areas of dysfunction described below 
do not cover all symptoms resulting from genitourinary diseases, 
specific diagnoses may include a description of symptoms assigned to 
that diagnosis.

------------------------------------------------------------------------
                                                              Rating
------------------------------------------------------------------------
Renal dysfunction:
    Chronic kidney disease with glomerular filtration                100
     rate (GFR) less than 15 mL/min/1.73 m\2\ for at
     least 3 consecutive months during the past 12
     months; or requiring regular routine dialysis; or
     eligible kidney transplant recipient...............
    Chronic kidney disease with GFR from 15 to 29 mL/min/             80
     1.73 m\2\ for at least 3 consecutive months during
     the past 12 months.................................
    Chronic kidney disease with GFR from 30 to 44 mL/min/             60
     1.73 m\2\ for at least 3 consecutive months during
     the past 12 months.................................
    Chronic kidney disease with GFR from 45 to 59 mL/min/             30
     1.73 m\2\ for at least 3 consecutive months during
     the past 12 months.................................
    GFR from 60 to 89 mL/min/1.73 m\2\ and either
     recurrent red blood cell (RBC) casts, white blood
     cell (WBC) casts, or granular casts for at least 3
     consecutive months during the past 12 months; or
    GFR from 60 to 89 mL/min/1.73 m\2\ and structural
     kidney abnormalities (cystic, obstructive, or
     glomerular) for at least 3 consecutive months
     during the past 12 months; or
    GFR from 60 to 89 mL/min/1.73 m\2\ and albumin/                    0
     creatinine ratio (ACR) >=30 mg/g for at least 3
     consecutive months during the past 12 months.......
Note: GFR, estimated GFR (eGFR), and creatinine-based
 approximations of GFR will be accepted for evaluation
 purposes under this section when determined to be
 appropriate and calculated by a medical professional.
 
                              * * * * * * *
Urinary tract infection:
    Poor renal function: Rate as renal dysfunction.
    Recurrent symptomatic infection requiring drainage                30
     by stent or nephrostomy tube; or requiring greater
     than 2 hospitalizations per year; or requiring
     continuous intensive management....................
    Recurrent symptomatic infection requiring 1-2                     10
     hospitalizations per year or suppressive drug
     therapy lasting six months or longer...............
    Recurrent symptomatic infection not requiring                      0
     hospitalization, but requiring suppressive drug
     therapy for less than 6 months.....................
------------------------------------------------------------------------


0
3. Amend Sec.  4.115b by:
0
a. Revising the entry for diagnostic code 7508;
0
b. Removing the entry for diagnostic code 7510;
0
c. Revising the entries for diagnostic codes 7520, 7521, 7522, 7524, 
7525, 7527, 7533, 7534, 7537, 7539, 7541, and 7542; and
0
d. Adding entries in numerical order for diagnostic codes 7543, 7544, 
and 7545.
    The revisions and additions read as follows:


Sec.  4.115b   Ratings of the genitourinary system--diagnoses.

------------------------------------------------------------------------
                                                              Rating
------------------------------------------------------------------------
 
                              * * * * * * *
7508 Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis:
    Rate as hydronephrosis, except for recurrent stone                30
     formation requiring invasive or non-invasive
     procedures more than two times/year................
 
                              * * * * * * *
7520 Penis, removal of half or more.....................          \1\ 30
7521 Penis, removal of glans............................          \1\ 20
7522 Erectile dysfunction, with or without penile                  \1\ 0
 deformity..............................................
Note: For the purpose of VA disability evaluation, a
 disease or traumatic injury of the penis resulting in
 scarring or deformity shall be rated under diagnostic
 code 7522.
 
                              * * * * * * *
7524 Testis, removal:
    Both................................................          \1\ 30
    One.................................................           \1\ 0
Note: In cases of the removal of one testis as the
 result of a service-incurred injury or disease, other
 than an undescended or congenitally undeveloped testis,
 with the absence or nonfunctioning of the other testis
 unrelated to service, an evaluation of 30 percent will
 be assigned for the service-connected testicular loss.
 Testis, undescended, or congenitally undeveloped is not
 a ratable disability.
7525 Prostatitis, urethritis, epididymitis, orchitis
 (unilateral or bilateral), chronic only:
    Rate as urinary tract infection.
    For tubercular infections: Rate in accordance with
     Sec.  Sec.   4.88b or 4.89, whichever is
     appropriate.
7527 Prostate gland injuries, infections, hypertrophy,
 postoperative residuals, bladder outlet obstruction:
    Rate as voiding dysfunction or urinary tract
     infection, whichever is predominant.
 

[[Page 54087]]

 
                              * * * * * * *
7533 Cystic diseases of the kidneys:
    Rate as renal dysfunction.
Note: Cystic diseases of the kidneys include, but are
 not limited to, polycystic disease, uremic medullary
 cystic disease, medullary sponge kidney, and similar
 conditions such as Alport's syndrome, cystinosis,
 primary oxalosis, and Fabry's disease.
7534 Atherosclerotic renal disease (renal artery
 stenosis, atheroembolic renal disease, or large vessel
 disease, unspecified):
    Rate as renal dysfunction.
 
                              * * * * * * *
7537 Interstitial nephritis, including gouty
 nephropathy, disorders of calcium metabolism:
    Rate as renal dysfunction.
 
                              * * * * * * *
7539 Renal amyloid disease:
    Rate as renal dysfunction.
Note: This diagnostic code pertains to renal involvement
 secondary to all glomerulonephritis conditions, all
 vasculitis conditions and their derivatives, and other
 renal conditions caused by systemic diseases, such as
 Lupus erythematosus, systemic lupus erythematosus
 nephritis, Henoch-Schonlein syndrome, scleroderma,
 hemolytic uremic syndrome, polyarthritis, Wegener's
 granulomatosis, Goodpasture's syndrome, and sickle cell
 disease.
 
                              * * * * * * *
7541 Renal involvement in diabetes mellitus type I or
 II:
    Rate as renal dysfunction.
7542 Neurogenic bladder:
    Rate as voiding dysfunction or urinary tract
     infection, whichever is predominant.
7543 Varicocele/Hydrocele...............................           \1\ 0
7544 Renal disease caused by viral infection such as
 human immunodeficiency virus (HIV), Hepatitis B, and
 Hepatitis C:
    Rate as renal dysfunction.
7545 Bladder, diverticulum of:
    Rate as voiding dysfunction or urinary tract
     infection, whichever is predominant.
------------------------------------------------------------------------
\1\ Review for entitlement to special monthly compensation under Sec.
  3.350 of this chapter.


0
4. Amend appendix A to part 4 by:
0
a. Revising the entry for Sec.  4.115a;
0
b. Under the entry for Sec.  4.115b, revising the entries for 
diagnostic codes 7500, 7501, 7502, 7504, 7507, 7508, 7509, 7510, 7511, 
7516, 7520, 7521, 7522, 7524, 7525, 7527, 7528, 7529, 7530, 7531, 7532, 
7533, 7534, 7535, 7536, 7537, 7538, 7539, 7540, 7541, and 7542; and
0
c. Under the entry for Sec.  4.115b, adding in numerical order entries 
for diagnostic codes 7543 through 7545.
    The revisions and additions read as follows:

Appendix A to Part 4--Table of Amendments and Effective Dates Since 
1946

------------------------------------------------------------------------
                         Diagnostic
         Sec.             code No.
------------------------------------------------------------------------
 
                              * * * * * * *
4.115a...............  ..............  Re-designated and revised as Sec.
                                          4.115b; new Sec.   4.115a
                                        ``Ratings of the genitourinary
                                        system-dysfunctions'' added
                                        February 17, 1994; revised
                                        November 14, 2021.
4.115b...............            7500  Note July 6, 1950; evaluation
                                        February 17, 1994, criterion
                                        September 8, 1994; criterion
                                        November 14, 2021.
                                 7501  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7502  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
 
                              * * * * * * *
                                 7504  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
 
                              * * * * * * *
                                 7507  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7508  Evaluation February 17, 1994;
                                        title, criterion November 14,
                                        2021.
                                 7509  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7510  Evaluation February 17, 1994;
                                        removed November 14, 2021.
                                 7511  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
 
                              * * * * * * *
                                 7516  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
 
                              * * * * * * *
                                 7520  Criterion February 17, 1994;
                                        criterion, footnote November 14,
                                        2021.
                                 7521  Criterion February 17, 1994;
                                        criterion, footnote November 14,
                                        2021.
                                 7522  Criterion September 8, 1994;
                                        title, criterion, note November
                                        14, 2021.
 
                              * * * * * * *
                                 7524  Note July 6, 1950; evaluation
                                        February 17, 1994; evaluation
                                        September 8, 1994; note November
                                        14, 2021.
                                 7525  Criterion March 11, 1969;
                                        evaluation February 17, 1994;
                                        title and criterion November 14,
                                        2021.

[[Page 54088]]

 
 
                              * * * * * * *
                                 7527  Criterion February 17, 1994;
                                        title and criterion November 14,
                                        2021.
                                 7528  Criterion March 10, 1976;
                                        criterion February 17, 1994;
                                        criterion November 14, 2021.
                                 7529  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7530  Added September 9, 1975;
                                        evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7531  Added September 9, 1975;
                                        criterion February 17, 1994;
                                        criterion November 14, 2021.
                                 7532  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7533  Added February 17, 1994; title,
                                        criterion, and note November 14,
                                        2021.
                                 7534  Added February 17, 1994; title
                                        and criterion November 14, 2021.
                                 7535  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7536  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7537  Added February 17, 1994; title
                                        and criterion November 14, 2021.
                                 7538  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7539  Added February 17, 1994; note and
                                        criterion November 14, 2021.
                                 7540  Evaluation February 17, 1994;
                                        criterion November 14, 2021.
                                 7541  Added February 17, 1994; title
                                        and criterion November 14, 2021.
                                 7542  Added February 17, 1994;
                                        criterion November 14, 2021.
                                 7543  Added November 14, 2021.
                                 7544  Added November 14, 2021.
                                 7545  Added November 14, 2021.
 
                              * * * * * * *
------------------------------------------------------------------------


0
5. Amend appendix B to part 4 by:
0
a. Revising the entries for diagnostic codes 7508, 7522, 7525, 7527, 
7533, 7534, 7537, and 7541;
0
b. Removing the entry for diagnostic code 7510; and
0
c. Adding in numerical order entries for diagnostic codes 7543 through 
7545.
    The revisions and additions read as follows:

Appendix B to Part 4--Numerical Index of Disabilities

------------------------------------------------------------------------
     Diagnostic code No.
------------------------------------------------------------------------
                        The Genitourinary System
------------------------------------------------------------------------
 
                              * * * * * * *
7508.........................  Nephrolithiasis/Ureterolithiasis/
                                Nephrocalcinosis.
 
                              * * * * * * *
7522.........................  Erectile dysfunction, with or without
                                penile deformity.
 
                              * * * * * * *
7525.........................  Prostatitis, urethritis, epididymitis,
                                orchitis (unilateral or bilateral),
                                chronic only.
7527.........................  Prostate gland injuries, infections,
                                hypertrophy, postoperative residuals,
                                bladder outlet obstruction.
 
                              * * * * * * *
7533.........................  Cystic diseases of the kidneys.
7534.........................  Atherosclerotic renal disease (renal
                                artery stenosis, atheroembolic renal
                                disease, or large vessel disease,
                                unspecified).
 
                              * * * * * * *
7537.........................  Interstitial nephritis, including gouty
                                nephropathy, disorders of calcium
                                metabolism.
 
                              * * * * * * *
7541.........................  Renal involvement in diabetes mellitus
                                type I or II.
 
                              * * * * * * *
7543.........................  Varicocele/Hydrocele.
7544.........................  Renal disease caused by viral infection
                                such as HIV, Hepatitis B, and Hepatitis
                                C.
7545.........................  Bladder, diverticulum of.
 
                              * * * * * * *
------------------------------------------------------------------------


0
6. Amend appendix C to part 4 by:
0
a. Under the heading ``Bladder,'' adding in alphabetical order an entry 
for ``Diverticulum of'' (diagnostic code 7545);
0
b. Revising the entry for ``Interstitial nephritis'' (diagnostic code 
7537);
0
c. Revising the entry for ``Nephrolithiasis'' (diagnostic code 7508);
0
d. Under the heading ``Penis,'' removing the entry for ``Deformity, 
with loss of erectile power'' (diagnostic code 7522), and adding an 
entry for ``Erectile dysfunction'' in its place;

[[Page 54089]]

0
e. Revising the entry for ``Prostate gland'' (diagnostic code 7527);
0
f. Under the heading ``Renal,'' adding in alphabetical order an entry 
for ``Disease caused by viral infection such as HIV, Hepatitis B, and 
Hepatitis C'' (diagnostic code 7544);
0
g. Under the heading ``Renal,'' removing the entry for ``Involvement in 
systemic diseases'' (diagnostic code 7541), and adding an entry for 
``Involvement in diabetes mellitus type I or II'' in its place;
0
h. Removing the entry for ``Ureterolithiasis'' (diagnostic code 7510);
0
i. Removing the entry for ``Epididymo-orchitis'' (diagnostic code 
7525);
0
j. Adding in alphabetical order an entry for ``Prostatitis, urethritis, 
epididymitis, orchitis (unilateral or bilateral), chronic only'' 
(diagnostic code 7525); and
0
k. Adding in alphabetical order an entry for ``Varicocele/Hydrocele'' 
(diagnostic code 7543).
    The additions and revisions read as follows:

Appendix C to Part 4--Alphabetical Index of Disabilities

------------------------------------------------------------------------
                                                            Diagnostic
                                                             code No.
------------------------------------------------------------------------
 
                              * * * * * * *
Bladder:
    Calculus in.........................................            7515
    Diverticulum of.....................................            7545
    Fistula in..........................................            7516
    Injury of...........................................            7517
    Neurogenic..........................................            7542
 
                              * * * * * * *
Interstitial nephritis, including gouty nephropathy,                7537
 disorders of calcium metabolism........................
 
                              * * * * * * *
Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis.......            7508
 
                              * * * * * * *
Penis:
    Erectile dysfunction................................            7522
    Removal of glans....................................            7521
    Removal of half or more.............................            7520
 
                              * * * * * * *
Prostate gland injuries, infections, hypertrophy,                   7527
 postoperative residuals, bladder outlet obstruction....
Prostatitis, urethritis, epididymitis, orchitis                     7525
 (unilateral or bilateral), chronic only................
 
                              * * * * * * *
Renal:
    Amyloid disease.....................................            7539
    Disease, chronic....................................            7530
    Disease caused by viral infection such as HIV,                  7544
     Hepatitis B, and Hepatitis C.......................
    Involvement in diabetes mellitus type I or II.......            7541
    Tubular disorders...................................            7532
 
                              * * * * * * *
Varicocele/Hydrocele....................................            7543
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2021-19997 Filed 9-29-21; 8:45 am]
BILLING CODE 8320-01-P