[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Proposed Rules]
[Pages 55086-55094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22165]


=======================================================================
-----------------------------------------------------------------------

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: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Veterans Affairs (VA) proposes to amend the 
portion of the Schedule for Rating Disabilities that addresses the 
genitourinary system. The purpose of this change is to update current 
medical terminology, incorporate medical advances that have occurred 
since the last review, and provide well-defined criteria in accordance 
with actual, standard medical clinical practice. In fashioning this 
proposed rule, VA considered the most up-to-date medical knowledge and 
clinical practice of nephrology and urology specialties. Contact 
information for that office is noted in the ADDRESSES section of this 
proposed rule.

DATES: Comments must be received on or before December 16, 2019.

ADDRESSES: Written comments may be submitted through 
www.Regulations.gov; by mail or hand-delivery to Director, Office of 
Regulation Policy and Management (00REG), Department of Veterans 
Affairs, 810 Vermont Avenue NW, Room 1064, Washington, DC 20420; or by 
fax to (202) 273-9026. Comments should indicate that they are submitted 
in response to ``RIN 2900-AQ71--Schedule for Rating Disabilities; The 
Genitourinary Diseases and Conditions.'' Copies of comments received 
will be available for public inspection in the Office of Regulation 
Policy and Management, Room 1064, between the hours of 8:00 a.m. and 
4:30 p.m., Monday through Friday (except holidays). Please call (202) 
461-4902 for an appointment. (This is not a toll-free number.) In 
addition, during the comment period, comments may be viewed online 
through the Federal Docket Management System at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ioulia Vvedenskaya, M.D., M.B.A., 
Medical Officer, Part 4 VASRD Regulations Staff (211D), Compensation 
Service, 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: As part of VA's ongoing revision of the 
Schedule for Rating Disabilities (VASRD), VA proposes changes to the 
portion of the VASRD that addresses the genitourinary system, which was 
last revised in 1994. See 59 FR 2523 (Jan. 18, 1994); see also 59 FR 
46338 (Sep. 8, 1994). Through this revision, VA aims to eliminate 
ambiguities, include medical conditions not currently in the rating 
schedule, implement current, well-refined medical criteria, and update 
terminology to reflect the most recent medical advances. For this 
proposed rule, VA considered the most up-to-date medical knowledge and 
clinical practice of nephrology and urology specialties, as well as 
feedback from a public forum held on January 27-28, 2011. Please email 
at [email protected] for a copy of the public forum transrcript.

I. Proposed Changes to Sec.  4.115

    Currently, 38 CFR 4.115 (``Nephritis'') does not adequately reflect 
current concepts of renal and urinary tract diseases and conditions. 
Regardless of specific disease pathology, kidney conditions generally 
produce the same symptomatology and lead to the same functional 
impairment. Therefore, for rating purposes, analysis of pathology, such 
as is currently presented in the first three sentences of Sec.  4.115, 
is unnecessary and VA proposes to remove this language.
    However, VA proposes to retain the remainder of the language in 
Sec.  4.115, which addresses the assignment of ratings when both renal 
and cardiovascular conditions are present, but to replace the reference 
to ``nephritis'' in the first sentence of the proposed revised section 
with ``renal disease'' to more accurately reflect the applicability of 
the provision. VA proposes to retitle this provision as ``Co-existence 
of renal and cardiovascular conditions'' to better address the amended 
content.

II. Proposed Changes to Sec.  4.115a

    Under the current VASRD, diseases of the genitourinary system are 
listed at 38 CFR 4.115b with instructions directing rating personnel to 
various rating criteria found at 38 CFR 4.115a, when appropriate. The 
rating criteria in Sec.  4.115a address impairment of the genitourinary 
system, including renal dysfunction, voiding dysfunction, and 
infections.
    The introductory paragraph in Sec.  4.115a states that when the 
VASRD refers a decision-maker to these areas of dysfunction, only the 
predominant area of dysfunction will be considered for rating purposes. 
VA proposes clarifying this statement by noting that distinct 
disabilities may be assigned separate evaluations under this section, 
consistent with the anti-pyramiding provisions in Sec.  4.14. This 
statement is intended to reflect that when a particular diagnostic code 
refers to multiple dysfunctions, only the predominant dysfunction will 
be evaluated for that diagnostic code.

[[Page 55087]]

Distinct disabilities resulting in non-overlapping symptoms may be 
assigned separate evaluations, however.
    VA also proposes to make changes to the rating criteria found in 
Sec.  4.115a; these proposed changes are discussed below.

A. Renal Dysfunction

    Currently, VA evaluates renal dysfunction as follows:
    A 100 percent evaluation is assigned for any of the following: 
Requiring regular dialysis, or precluding more than sedentary activity 
from one of the following: Persistent edema and albuminuria; or, BUN 
more than 80 mg%; or, creatinine more than 8 mg%; or, markedly 
decreased function of kidney or other organ systems, especially 
cardiovascular.
    An 80 percent evaluation is assigned for any of the following: 
Persistent edema and albuminuria with BUN 40 to 80 mg%; or, creatinine 
4 to 8 mg%; or, generalized poor health characterized by lethargy, 
weakness, anorexia, weight loss, or limitation of exertion.
    A 60 percent evaluation is assigned for any of the following: 
Constant albuminuria with some edema; or, definite decrease in kidney 
function; or, hypertension at least 40 percent disabling under 
diagnostic code 7101.
    A 30 percent evaluation is assigned for any of the following: 
Albumin constant or recurring with hyaline and granular casts or red 
blood cells; or, transient or slight edema or hypertension at least 10 
percent disabling under diagnostic code 7101.
    A 0 percent evaluation is assigned for either albumin and casts 
with a history of acute nephritis; or, hypertension non-compensable 
under diagnostic code 7101.
    Subjective terms such as ``markedly,'' ``some,'' and ``slight'' in 
the current evaluation criteria contribute to inconsistent evaluation 
of genitourinary disabilities rated under these criteria. Therefore, VA 
proposes to replace these subjective criteria with specific, objective 
laboratory findings, such as the glomerular filtration rate (GFR) and 
albumin/creatinine ratio (ACR). Modern medicine states that the ``[GFR] 
is widely accepted as the best overall measure of kidney function in 
health and 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. 19 (Jan. 2013), available at 
https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf 
(last viewed Jan. 4, 2019). In clinical practice, subject matter 
experts have noted an inverse correlation between GFR and functional 
impairment (i.e., lower GFRs correspond to greater impairment), and 
individuals with GFRs less than 60 mL/min/1.73 m\2\ are considered to 
have chronic kidney disease. Id. A GFR less than 15 mL/min/1.73 m\2\ is 
also a sign of renal failure. Id. In addition to using the GFR for 
evaluation purposes, VA also proposes adding a note to the evaluation 
criteria specifying that GFR, estimated GFR (eGFR), and creatinine 
based approximations are acceptable for evaluation purposes, as each 
has been shown to be an adequate indicator of the stage of chronic 
kidney disease. The GFR used must be medically appropriate and 
calculated by a medical professional.
    Based on the level of kidney function generally associated with a 
specific GFR, VA proposes assigning a 100 percent evaluation for 
chronic kidney disease with GFR less than 15 mL/min/1.73 m\2\ for at 
least three consecutive months; an 80 percent evaluation for a GFR 
between 15 and 29 mL/min/1.73 m\2\ for at least three consecutive 
months; a 60 percent evaluation for a GFR between 30 and 44 mL/min/1.73 
m\2\ for at least three consecutive months; and a 30 percent evaluation 
for a GFR between 45 and 59 mL/min/1.73 m\2\ for at least three 
consecutive months. Additionally, a 100 percent evaluation would still 
be assigned for chronic kidney disease requiring regular routine 
dialysis. VA intends to also extend this evaluation to individuals who 
are the recipients of a kidney transplant.
    VA proposes assigning a 0 percent evaluation for certain markers of 
kidney damage for at least three consecutive months: A GFR between 60 
and 89 mL/min/1.73 m\2\ and the presence of recurrent red blood cell 
(RBC) casts, white blood cell (WBC) casts, granular casts, structural 
kidney abnormalities (cystic, obstructive, or glomerular), or increased 
secretion of protein in the urine (proteinuria). Proteinuria, as 
measured by increased urinary excretion of albumin, is an early and 
sensitive marker of kidney damage and is reflected by an albumin/
creatinine ratio (ACR) of 30 mg/g or greater.
    These levels of evaluation correlate to a modified staging 
classification of chronic kidney disease by the National Kidney 
Foundation. At the 100 percent evaluation, the designated GFR is 
associated with kidney failure and, at the 0 percent evaluation, the 
designated GFR and proteinuria are associated with an increased risk of 
kidney damage even without a diagnosis of chronic kidney disease. 
Intermediate levels of evaluation at the 30, 60, and 80 percent levels 
correspond to the remaining stages of chronic kidney disease as they 
increase in severity as manifest by declining GFR.

B. Urinary Tract Infection

    VA proposes to preserve the existing rating criteria for urinary 
tract infection with little change. VA does, however, propose to 
clarify the criteria for a 30 percent evaluation by specifying that 
drainage would be by stent or nephrostomy tube. This differentiates 
drainage via catheterization. Stent or nephrostomy tube insertion are 
surgical procedures and require more intensive medical management than 
drainage via catheterization. Catheterization is not medically 
consistent with the remainder of the criteria required for a 30 percent 
evaluation because the need for catheterization is not generally 
accompanied by frequent hospitalization (greater than two times/year) 
or continuous intensive management.
    For the 10 percent evaluation, VA proposes to replace the ambiguous 
phrase ``intermittent intensive management'' with ``suppressive drug 
therapy lasting six months or longer.'' Antibiotic and suppressive 
medications are typically the treatment used to treat urinary tract 
infections. Charles Kodner et al., ``Recurrent Urinary Tract Infections 
in Women: Diagnosis and Management,'' 82(6) Am. Family Physician 638-43 
(2010); B. Lee et al., ``Methenamine hippurate for preventing urinary 
tract infections,'' The Cochrane Library (Oct. 17, 2012), http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003265.pub3/abstract 
(last visited April 10, 2019). However, the term ``intensive 
management'' suggests something beyond short-term courses of antibiotic 
treatment for urinary tract infections; this is not clear from the 
current definition. As such, VA intends to replace ``intermittent 
intensive management'' with the objective criterion of ``suppressive 
drug therapy lasting six months or longer.'' As for the length of time 
selected, suppressive therapy is more appropriate for a chronic 
infection. B. Lee, supra. Recurrent, or chronic, infections are 
generally defined as two or more infections in six months, and the 
recommended treatment is six to twelve months of suppressive drug 
therapy. Kodner, supra. Therefore, VA proposes a 10 percent evaluation 
when there are one to two hospitalizations per year for urinary tract 
infections, or suppressive drug therapy lasting six months or longer is 
required.
    The addition of a 0 percent evaluation is also proposed and would 
be

[[Page 55088]]

applicable if a Veteran has recurrent urinary tract infections that 
require suppressive drug therapy for less than six months. Under this 
evaluation, drug suppressive therapy lasting six months or longer is 
not required. This proposed evaluation would cover cases that are 
responsive to treatment and/or are not severe enough to require 
suppressive drug therapy for six months or more. It would also ease 
field application by specifying non-compensable criteria that can be 
compared to the criteria warranting a compensable evaluation.

III. Proposed Changes to Sec.  4.115b

A. Diagnostic Codes (DCs) 7508 and 7510

    VA proposes to amend these DCs based on a better understanding of 
the disease process and the impact of treatment. When imbalances occur 
in the body, substances in urine can form solid pieces within the 
urinary tract. These pieces are commonly referred to as stones. 
Nephrolithiasis, to which diagnostic code 7508 currently applies, is 
another name for kidney stones. Ureterolithiasis (current DC 7510) 
refers to stones in the ureter, which is the tube that carries urine 
from the kidney to the bladder.
    Regardless of whether the stone is in the kidney or the ureter, 
symptoms may include abdominal and/or back pain and blood in the urine. 
This shared symptomology leads to similar functional impairment. 
Therefore, VA proposes to delete existing DC 7510 and to evaluate 
stones in either the kidney or the ureter under diagnostic code 7508.
    Nephrocalcinosis, a disorder in which excess calcium accumulates in 
the kidneys, does not result in symptoms. Rather, if the accumulation 
of calcium leads to the creation of stones, the stones themselves may 
cause symptoms. This condition is commonly evaluated under DC 7508 as 
analogous to nephrolithiasis, and VA proposes that it continue to be 
evaluated under this code, but that it be expressly added to the 
diagnostic code for ease of field application. Therefore, to better 
express the conditions to be evaluated under DC 7508, VA proposes to 
rename it as ``Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis.''
    Proposed DC 7508 would provide a 30-percent rating for recurrent 
stone formation requiring invasive or non-invasive procedures more than 
two times per year, as current DC 7508 does, but would no longer 
require diet or drug therapy, because such therapies have no specific 
relationship to these disabilities and are widely recommended for the 
majority of medical diseases and conditions.

B. DCs 7520 Through 7522

    Current DCs 7520 and 7521 provide compensation for actual physical 
removal of the penis or glans. An evaluation of 30 percent is provided 
when there is removal of half or more of the penis under DC 7520. In 
addition, a 20 percent evaluation is assigned when there is removal of 
the glans under DC 7521. Current DCs 7520 and 7521 also permit rating 
these conditions alternatively as voiding dysfunction in Sec.  4.115a. 
VA proposes to no longer rate these conditions as voiding dysfunction, 
which pertains to issues of leakage and frequency and the use of an 
appliance or absorbent materials. VA also proposes to revise DCs 7520 
and 7521 to include a footnote reference to consider entitlement to 
Special Monthly Compensation (SMC) for loss of a creative organ under 
Sec.  3.350. This is meant to correct the omission of this note from 
previous versions of the VASRD. Removal of half or more of the penis, 
or removal of the glans, may result in loss of a creative organ. 
Therefore, although consideration of SMC is considered with application 
of these diagnostic codes under current policy, this change would 
ensure consistent consideration of SMC for loss of a creative organ.
    VA proposes to revise DC 7522 to encompass erectile dysfunction 
(ED), regardless of etiology. In making this change, VA intends to 
retitle this diagnostic code, ``Erectile dysfunction, with or without 
penile deformity.'' ED can occur with or without deformity of the 
penis, and is a symptom of many systemic, psychological, and metabolic 
diseases. W. Ludwig, ``Organic causes of erectile dysfunction in men 
under 40,'' 92(1) Urologia Internationalis 1-6 (2014).
    VA proposes to no longer provide a 20-percent rating for this 
condition, whether with or without penile deformity. VA provides 
disability compensation for conditions that result in reduced earning 
capacity. 38 U.S.C. 1155. Erectile dysfunction, with or without penile 
deformity, is not associated with reductions in earning capacity. 
Therefore, VA proposes to provide a 0 percent evaluation for this 
condition. Section 4.115b's footnote regarding consideration of SMC for 
loss of use a creative organ where warranted would continue to apply to 
DC 7522. Similarly, 38 CFR 4.116, DC 7632, provides a 0 percent 
evaluation for female Veterans with service-connected female sexual 
arousal disorder (FSAD) without physical damage to female genitalia, 
with a note directing rating personnel to consider eligibility for SMC.

C. DC 7524

    VA does not propose any substantive changes to current DC 7524. 
However, it does intend to correct a typographical error in the last 
sentence of the existing note, which refers to ``underscended'' rather 
than ``undescended'' testis.

D. DCs 7525, 7527, 7533, 7534, and 7537

    Currently, each of these diagnostic codes identifies one or more 
conditions that have similar symptomatology and functional impairment. 
The conditions identified are not an exclusive list; therefore, other 
conditions are often rated as analogous to one of these diagnostic 
codes. To assist the field in ensuring that the appropriate diagnostic 
criteria is used to evaluate other conditions not currently listed, VA 
proposes to rename each of these diagnostic codes and/or include a note 
identifying those conditions not currently listed.
    First, VA proposes to rename DC 7525 as ``Prostatitis, urethritis, 
epididymitis, orchitis (unilateral or bilateral), chronic only,'' as 
these diagnoses all refer to urinary tract infections that do not 
involve the kidneys and have similar symptoms. Prostatitis would not be 
included in proposed revised DC 7527, ``Prostate gland injuries, 
infections, hypertrophy, postoperative residuals, bladder outlet 
obstruction,'' because it is rarely caused by a bacterial infection and 
generally results in repeated bladder infections. J. Stevermer et al., 
``Treatment of Prostatitis,'' 61(10) Am. Family Physician 3015-22 
(2000). The diagnoses contained in DC 7527 are not consistent with non-
bacterial prostatitis. In addition, the symptoms caused by 
prostatitis--recurrent bladder infections--are more similar to the 
diagnoses contained in DC 7525. There is no change to the evaluation 
criteria for this DC.
    VA also proposes to rename DC 7527 to include bladder outlet 
obstruction, which has the same functional impairment and 
symptomatology as the other conditions currently encompassed in this 
code. Bladder outlet obstruction is not included in current DC 7517, 
``Bladder, injury of,'' because this condition is not caused by an 
injury to the bladder, but is generally caused by another condition, 
such as benign prostatic hypertrophy (BPH), which is addressed in DC 
7527. R. Dmochowski, ``Bladder Outlet Obstruction: Etiology and 
Evaluation,'' 7(Supp. 6) Reviews in Urology S3-S13 (2005). In addition, 
the

[[Page 55089]]

symptomatology for this condition may include urinary tract infections, 
rather than only voiding dysfunction, as contemplated by DC 7517. There 
is no change to the evaluation criteria for this DC.
    VA proposes to add a note to DC 7533 to identify some of the most 
common cystic kidney diseases seen in the Veteran population, to 
include polycystic disease, uremic medullary cystic disease, medullary 
sponge kidney, and similar conditions such as Alport's syndrome, 
cystinosis, primary oxalosis, and Fabry's disease. M. Bisceglia et al., 
``Renal cystic diseases: a review,'' 13(1) Advances in Anatomic 
Pathology 26-56 (2006). These diseases are being added as a medical 
update and would ensure proper field application of this DC. There is 
no change to the evaluation criteria for this DC.
    Regarding DC 7534, which deals with atherosclerotic renal disease, 
VA proposes to specifically identify another atherosclerotic renal 
disease--large vessel disease, unspecified. Renal Failure: Diagnosis 
and Treatment 65 (J. Gary Abuelo ed. 1995). This disease is being added 
as a medical update and would ensure proper field application of this 
DC. There is no change to the evaluation criteria.
    Finally, VA proposes to retitle DC 7537 to identify the most common 
forms of interstitial nephritis resulting from the high prevalence of 
the disease, including gouty nephropathy and disorders of calcium 
metabolism. There is no change to the evaluation criteria.

E. DCs 7539 and 7541

    VA proposes to move all conditions contained in DC 7541 over to DC 
7539, with the exception of renal involvement in diabetes mellitus, to 
encompass all systemic conditions that impact the kidneys. All of these 
conditions are, as amyloid diseases, systemic diseases with renal 
involvement and therefore are more appropriately evaluated under a 
single DC. For clarity and ease of field application, VA proposes to 
add a note to DC 7539 to identify all forms of glomerulonephritis, 
nephritis, and renal vasculitis encountered with systemic diseases. 
There is no change to the evaluation criteria.
    As for renal involvement in diabetes mellitus (e.g., diabetic 
nephropathy), VA proposes to continue rating this condition separately 
under DC 7541. Although this condition would also be rated as renal 
dysfunction, VA finds there is a need to track this particular 
condition given its incidence and prevalence in the Veteran population, 
especially with regard to claims related to Agent Orange exposure.

F. DC 7542

    Based on modern clinical findings, neurogenic bladder should 
continue to be rated as a voiding dysfunction. However, due to high 
rate of urinary tract infections, VA proposes that this condition may 
be rated as voiding dysfunction or urinary tract infection, whichever 
is predominant. D. Sauerwein, ``Urinary tract infection in patients 
with neurogenic bladder dysfunction,'' 19(6) Int'l J. of Antimicrobial 
Agents 592-97 (2002).

G. New Proposed DC 7543

    VA proposes the introduction of new DC 7543, ``Varicocele/
Hydrocele,'' to reflect related conditions of the urinary tract that 
have not previously been recognized for disability evaluation purposes. 
Varicocele is a dilatation of the veins along the cord that receives 
blood from the testicles. Hydrocele is a collection of fluid in the 
scrotum.
    The medical community now recognizes that these conditions may be 
associated with a decrease in fertility and, in rare instances, may be 
associated with infertility. Center for Male Reproductive Medicine and 
Vasectomy Reversal, ``Varicocele Repair,'' http://www.malereproduction.com/male-infertility/treatment/varicocele-repair.php (last accessed April 9, 2019). As a decrease in fertility, 
or the existence of infertility, does not cause a reduction in earning 
capacity, VA proposes to assign a 0 percent evaluation to these 
conditions. In instances where there is a clinical finding of 
infertility, these conditions may support eligibility for SMC due to 
loss of use of a creative organ. Therefore, to best administer this 
benefit, VA proposes a diagnostic code for these conditions that 
provides a 0 percent evaluation. Section 4.115b's footnote directing 
consideration of SMC would apply to DC 7543, consistent with the other 
DCs in the VASRD addressing a creative organ.

H. New Proposed DC 7544

    VA proposes the introduction of new DC 7544, ``Renal disease caused 
by viral infection such as human immunodeficiency virus (HIV), 
Hepatitis B, and Hepatitis C,'' to reflect renal dysfunctions 
associated with HIV and hepatitis because of increasing prevalence and 
incidence of diseases caused by these viruses. Perico Norberto et al., 
``Hepatitis C Infection and Chronic Renal Diseases,'' 4(1) Clinical J. 
Am. Soc'y of Nephrology 207-20 (2009). Hepatitis A, an acute liver 
disease, does not cause chronic renal disease and is therefore not 
included in this DC.
    VA proposes to evaluate this DC as renal dysfunction under Sec.  
4.115a because, when the liver is damaged due to Hepatitis B or C 
infection, the accumulation of toxins in the blood can damage the 
kidneys, causing renal dysfunction. HIV-associated renal dysfunctions 
have several different etiologies, but can include direct HIV infection 
of the kidney, kidney damage caused by drugs used to treat HIV, and 
fluid loss caused by various processes associated with the advanced 
disease process. Moro O. Salifu, ``HIV-Associated Nephropathy,'' 
Medscape, http://emedicine.medscape.com/article/246031-overview (Vecihi 
Batuman ed., 2013) (last accessed April 10, 2019).

I. New Proposed DC 7545

    VA proposes the introduction of new DC 7545, ``Bladder, 
diverticulum of.'' Currently, there is no DC for diverticulum of the 
bladder and, as such, it is generally evaluated in the field as 
analogous to fistula of the bladder. A bladder fistula is an abnormal 
connection between the bladder and another organ of the body (e.g., the 
bowel). A bladder diverticulum is an abnormal pouch or sac due to 
weakness in the bladder's muscular wall that allows a portion of the 
bladder to protrude. Urology Care Foundation, ``What is Bladder 
Diverticulum?'' https://www.urologyhealth.org/urologic-conditions/bladder-diverticulum (last accessed April 9, 2019). The two conditions 
have dissimilar symptomatology and result in dissimilar functional 
impairment. A bladder fistula allows urine to escape the confines of 
the bladder into another space such as the rectum, or externally, 
causing urinary leakage. A bladder diverticulum allows urine to remain 
in the bladder longer, often resulting in infection as well as voiding 
dysfunction.
    The proposed addition of this new DC would ensure that the 
condition is more appropriately rated. VA proposes to rate DC 7545 as 
voiding dysfunction or urinary tract infection, whichever is 
predominant, because these criteria best capture the functional 
impairment associated with this condition.

Executive Orders 12866, 13563, and 13771

    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).

[[Page 55090]]

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. 
VA's impact analysis can be found as a supporting document at 
www.regulations.gov, usually within 48 hours after the rulemaking 
document is published. Additionally, a copy of this rulemaking and its 
impact analysis are available on VA's website at www.va.gov/orpm/, by 
following the link for VA Regulations Published from FY 2004 Through 
Fiscal Year to Date. This rule is not expected to be subject to the 
requirements of Executive Order 13771 because this rulemaking is 
expected to result in no more than de minimis costs.

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed 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 VA is the only entity involved with the provisions 
of this rulemaking. There are no outside or small entities involved, 
impacted and/or affiliated with VA's authorization to evaluate and and 
revise disability compensation criteria. Therefore, VA is exempt from 
the intial and final requlatory flexibility analysis requirements of 5 
U.S.C. 603 and 604.

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 proposed rule would have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Paperwork Reduction Act

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

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

    The Secretary of Veterans Affairs approved this document 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. Robert L. 
Wilkie, Secretary, Department of Veterans Affairs, approved this 
document on June 4, 2019, for publication.

    Dated: October 4, 2019.
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, the Department of Veterans 
Affairs proposes to amend 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. Revise Sec.  4.115 to read as follows:


Sec.  4.115  Co-Existence of renal and cardiovascular conditions.

    Separate ratings are not to be assigned for disability from disease 
of the heart and any form of renal disease, on account of the close 
interrelationships of cardiovascular diseases. If, however, absence of 
a kidney is the sole renal disability, even if removal was required 
because of nephritis, the absent kidney and any hypertension or heart 
disease will be separately rated. Also, in the event that chronic renal 
disease has progressed to the point where regular dialysis is required, 
any coexisting hypertension or heart disease will be separately rated.
0
3. Amend Sec.  4.115a by revising the introductory text and the table 
entries for ``Renal dysfuntion'' 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 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; or requiring regular
     routine dialysis; or 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........
    Chronic kidney disease with GFR from 30 to 44 mL/min/             60
     1.73 m\2\ for at least 3 consecutive months........
    Chronic kidney disease with GFR from 45 to 59 mL/min/             30
     1.73 m\2\ for at least 3 consecutive 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 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 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.................................
    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:

[[Page 55091]]

 
    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
4. Amend Sec.  4.115b by:
0
 a. Removing diagnostic code 7510.
0
 b. Revising diagnostic codes 7508, 7520, 7521, 7522, 7524, 7525, 7527, 
7533, 7534, 7537, 7539, 7541, and 7542.
0
 c. Adding 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..............................................
 
                              * * * * * * *
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................
 
                              * * * * * * *
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:

[[Page 55092]]

 
    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
5. Amend Appendix A to Part 4 by:
0
a. Adding Sec.  4.115.
0
b. Revising Sec.  4.115a.
0
c. In Sec.  4.115b,
0
i. Revising the entries for diagnostic codes 7508, 7510, 7520 through 
7522, 7524, 7525, 7527, 7533, 7534, 7537, 7539, 7541, and 7542.
0
 ii, Adding diagnostic codes 7543 through 7545.
    The additions and revisions to read as follows:

                    Appendix A to Part 4--Table of Amendments and Effective Dates Since 1946
----------------------------------------------------------------------------------------------------------------
                                        Diagnostic
                Sec.                     Code No.
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
4.115...............................  ..............  Retitled and revised [Effective date of final rule].
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
                                                       [Effective date of final rule].
4.115b                                          7500  Note July 6, 1950; evaluation February 17, 1994, criterion
                                                       September 8, 1994; criterion [Effective date of final
                                                       rule].
                                                7501  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7502  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
 
                                                  * * * * * * *
                                                7504  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
 
                                                  * * * * * * *
                                                7507  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7508  Evaluation February 17, 1994; title, criterion [Effective
                                                       date of final rule].
                                                7509  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7510  Evaluation February 17, 1994; removed [Effective date of
                                                       final rule].
 
                                                  * * * * * * *
                                                7516  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
 
                                                  * * * * * * *
                                                7520  Criterion February 17, 1994; criterion, footnote
                                                       [Effective date of final rule].
                                                7521  Criterion February 17, 1994; criterion, footnote
                                                       [Effective date of final rule].
                                                7522  Criterion September 8, 1994; title, criterion [Effective
                                                       date of final rule].
 
                                                  * * * * * * *
                                                7524  Note July 6, 1950; evaluation February 17, 1994;
                                                       evaluation September 8, 1994; note [Effective date of
                                                       final rule].
                                                7525  Criterion March 11, 1969; evaluation February 17, 1994;
                                                       title and criterion [Effective date of final rule].
                                                7527  Criterion February 17, 1994; title and criterion
                                                       [Effective date of final rule].
                                                7528  Criterion March 10, 1976; criterion February 17, 1994;
                                                       criterion [Effective date of final rule].
                                                7529  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7530  Added September 9, 1975; evaluation February 17, 1994;
                                                       criterion [Effective date of final rule].
                                                7531  Added September 9, 1975; criterion February 17, 1994;
                                                       criterion [Effective date of final rule].
                                                7532  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7533  Added February 17, 1994; title, criterion, and note
                                                       [Effective date of final rule].
                                                7534  Added February 17, 1994; title and criterion [Effective
                                                       date of final rule].
                                                7535  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7536  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7537  Added February 17, 1994; title and criterion [Effective
                                                       date of final rule].
                                                7538  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7539  Added February 17, 1994; note and criterion [Effective
                                                       date of final rule].
                                                7540  Evaluation February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7541  Added February 17, 1994; title and criterion [Effective
                                                       date of final rule].
                                                7542  Added February 17, 1994; criterion [Effective date of
                                                       final rule].
                                                7543  Added [Effective date of final rule].
                                                7544  Added [Effective date of final rule].
                                                7545  Added [Effective date of final rule].
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
6. Amend Appendix B to Part 4 by:
0
a. Revising diagnostic codes 7508, 7522, 7525, 7527, 7533, 7534, 7537, 
and 7541.
0
b. Removing diagnostic code 7510;
0
c. Adding diagnostic codes 7543 through 7545.

[[Page 55093]]

    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 human immunodeficiency viruses (HIV),
                           Hepatitis B, and Hepatitis C.
7545....................  Bladder, diverticulum of.
 
                              * * * * * * *
------------------------------------------------------------------------

0
7. Amend Appendix C to Part 4 by:
0
a. Revising the entries for diagnostic codes 7508, 7522, 7525, 7527, 
7533, 7537, and 7541.
0
b. Removing the reference to diagnostic code 7510;
0
c. Adding diagnostic codes 7543 through 7545.
    The revisions and additions read as follows:

        Appendix C to Part 4--Alphabetical Index of Disabilities
------------------------------------------------------------------------
                                                            Diagnostic
                                                             code No.
------------------------------------------------------------------------
 
                              * * * * * * *
Bladder:
 
                              * * * * * * *
    Diverticulum of.....................................            7545
 
                              * * * * * * *
Erectile dysfunction, with or without penile deformity..            7522
 
                              * * * * * * *
Interstitial nephritis, including gouty nephropathy,                7537
 disorders of calcium metabolism........................
 
                              * * * * * * *
Kidney:
 
                              * * * * * * *
    Cystic diseases of the..............................            7533
 
                              * * * * * * *
Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis.......            7508
 
                              * * * * * * *
Prostate gland injuries, infections, hypertrophy,                   7527
 postoperative residuals, bladder outlet obstruction....
Prostatitis, urethritis, epididymitis, orchitis                     7525
 (unilateral or bilateral), chronic only................
 

[[Page 55094]]

 
                              * * * * * * *
Renal:
 
                              * * * * * * *
    Disease caused by viral infection such as HIV,                  7544
     Hepatitis B, and Hepatitis C.......................
 
                              * * * * * * *
    Involvement in diabetes mellitus type I or II.......            7541
 
                              * * * * * * *
Varicocele/Hydrocele....................................            7543
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2019-22165 Filed 10-11-19; 8:45 am]
BILLING CODE 8320-01-P