Schedule for Rating Disabilities; The Genitourinary Diseases and Conditions, 35140-35148 [2017-15765]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Proposed Rules]
[Pages 35140-35148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15765]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AP16


Schedule for Rating Disabilities; The Genitourinary Diseases and 
Conditions

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs 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. The proposed rule 
reflects the most up-to-date medical knowledge and clinical practice of 
nephrology and urology specialties, as well as comments from subject 
matter experts and the public garnered during a public forum held 
January 27-28, 2011.

DATES: Comments must be received on or before September 26, 2017.

ADDRESSES: Written comments may be submitted through 
www.Regulations.gov; by mail or hand-delivery to Director, Regulation 
Policy and Management (00REG), Department of Veterans Affairs, 810 
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 
273-9026. Comments should indicate that they are submitted in response 
to ``RIN 2900-AP16--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 1063B, 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 (211C), 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 the Department of Veterans 
Affairs' (VA) 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.

I. Proposed Changes to Sec.  4.115

    Currently, 38 CFR 4.115 (``Nephritis'') does not adequately reflect 
current concepts of renal and urinary tract disease 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 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 disability will be considered for rating purposes. 
VA proposes clarifying this statement by noting that distinct 
disabilities may be assigned separate evaluations under this section, 
pursuant to the pyramiding provisions in Sec.  4.14. This statement is 
intended to reflect that when a particular diagnostic code refers to 
multiple dysfunctions, only the

[[Page 35141]]

predominant dysfunction will be evaluated for that diagnostic code. 
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'' 
contribute to inconsistent evaluation of genitourinary disabilities 
rated under this criteria. Therefore, VA proposes to replace these 
subjective criteria with specific objective laboratory findings, such 
as the glomerular filtration rate (GFR). Modern medicine states the 
``[GFR] is widely accepted as the best overall measure of kidney 
function in health and disease.'' Nat'l Kidney Found., ``K/DOQI 
Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, 
Classification, and Stratification,'' Am. J. Kidney Disease 39:S1-S266, 
S5 (2002), available at https://www.kidney.org/sites/default/files/docs/ckd_evaluation_classification_stratification.pdf (last viewed Oct. 
7, 2016). In clinical practice, subject matter experts have noted an 
inverse correlation between GFR and functional impairment (e.g., lower 
GFRs correspond to greater impairment), and individuals with GFRs less 
than 60 mL/min are considered to have chronic renal disease. Id. at 
S12. A GFR less than 60 mL/min 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. Id. at S81. The GFR used must 
be medically appropriate and calculated by a medical professional.
    Based on the level of kidney function generally associated with a 
particular GFR, VA proposes assigning a 100 percent evaluation for a 
GFR less than 16 mL/min; an 80 percent evaluation for a GFR between 16 
and 29 mL/min; a 60 percent evaluation for a GFR between 30 and 59 mL/
min; a 30 percent evaluation for a GFR greater than or equal to 60 mL/
min with at least one of the following: Albumin/creatinine ratio (ACR) 
greater than or equal to 2.5 g/gm (nephrotic range proteinuria), or 
hypertension at least 10 percent disabling under diagnostic code 7101; 
and a 0 percent evaluation for a GFR greater than or equal to 60 mL/min 
with at least one of the following: ACR greater than or equal to .03 g/
gm but less than or equal to 2.49 g/gm, or hypertension that is non-
compensable under diagnostic code 7101. These levels of evaluation 
correlate to a modified staging classification of chronic kidney 
disease by the National Kidney Foundation. Id. At the 100 percent 
evaluation, the designated GFR is associated with kidney failure and, 
at the 0 percent evaluation, the designated GFR is associated with an 
increased risk of kidney damage where a diagnosis of chronic kidney 
disease has been made. Id. 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 or increasing proteinuria.
    Proteinuria is considered in the evaluation of chronic kidney 
disease at the 30 and 0 percent levels because GFR measures only the 
ability of the kidneys to filter the blood and does not always provide 
a complete picture of renal disease. For example, in the early stages 
of chronic renal disease resulting from kidney damage, GFR may be 
within the normal range and impairment may be characterized by other 
diagnostic abnormalities, such as increased secretion of protein in the 
urine (proteinuria). Id. at S71. Proteinuria, as measured by increased 
urinary excretion of albumin, is an early and sensitive marker of 
kidney damage in many types of chronic kidney disease. Id. at S48, 
S101. Therefore, VA proposes that an ACR of 2.5 g/gm or greater (also 
called nephrotic range proteinuria) would warrant a 30 percent 
evaluation and an ACR of at least 0.03 g/gm but no more than 2.49 g/
gm--i.e., urinary albumin that does not reach the level of nephrotic 
range proteinuria--would warrant a 0 percent evaluation. VA would not 
eliminate reference to hypertension in the 0 and 30 percent evaluation 
criteria because sustained elevation of arterial blood pressure may be 
a consequence of chronic kidney disease. Id. at S125-26.
    Finally, 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 requiring a kidney 
transplant who may not yet require regular, routine dialysis. Often, a 
patient with rapidly deteriorating chronic kidney disease will be 
placed on a transplant list before they require regular, routine 
dialysis, although dialysis may actually be required before the 
transplant is performed.

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.,

[[Page 35142]]

``Methenamine hippurate for preventing urinary tract infections,'' The 
Cochrane Library (Oct. 17, 2012), https://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003265.pub3/abstract (last visited April 16, 2014). 
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 ``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 applicable if a veteran has urinary tract infections that require 
suppressive drug therapy for less than 6 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 of 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 
provide a 30-percent rating for 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.'' 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.
    VA also proposes to add a note clarifying that Peyronie's disease 
is not a ratable condition. Peyronie's disease should not be rated 
analogously to ED.

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 which 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.

[[Page 35143]]

Family Physician 3015-22 (2000). As a result, the diagnoses contained 
in DC 7527 are not consistent with non-bacterial prostatitis. In 
addition, the symptoms caused by prostatitis--recurrent bladder 
infections--are most 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 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 hereditary nephritis, 
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 amend 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 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,'' https://www.malereproduction.com/male-infertility/treatment/varicocele-repair.php (last accessed April 16, 2014). 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 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, https://emedicine.medscape.com/article/246031-overview (Vecihi 
Batuman ed., 2013) (last accessed April 16, 2014).

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, ``Urology A-Z: Bladder 
Diverticulum,'' https://www.urologyhealth.org/urology/index.cfm?article=111 (last accessed April 16, 2014). The two 
conditions have dissimilar symptomatology and result in dissimilar 
functional impairment. A bladder fistula allows

[[Page 35144]]

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 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. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' which requires review by the Office 
of Management and Budget, as ``any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) Create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) Materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive Order.''
    VA has examined the economic, interagency, budgetary, legal, and 
policy implications of this regulatory action, and it has been 
determined not to be 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 Web site at www.va.gov/orpm/, by 
following the link for VA Regulations Published from FY 2004 Through 
Fiscal Year to Date.

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would 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. This proposed rule would directly affect only 
individuals and would not directly affect any small entities. 
Therefore, pursuant to 5 U.S.C. 605(b), this proposed rule would be 
exempt from the initial and final regulatory flexibility analysis 
requirements of sections 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.

Signing Authority

    The Secretary of Veterans Affairs, or designee, 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. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, 
approved this document on May 26, 2017, for publication.

    Dated: July 21, 2017.
Michael Shores,
Director, Regulation Policy & Management, Office of the Secretary, 
Department of Veterans Affairs.

List of Subjects in 38 CFR Part 4

    Disability benefits, Pensions, Veterans.

    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 regarding ``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

[[Page 35145]]

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 16 mL/min; or requiring
     regular, routine dialysis or kidney transplant.....
    Chronic kidney disease with GFR 16 to 29 mL/min.....              80
    Chronic kidney disease with GFR 30 to 59 mL/min.....              60
    Chronic kidney disease with GFR >=60 mL/min with at
     least one of the following:
        Albumin/creatinine ratio (ACR) >=2.5 g/gm
         (nephrotic range proteinuria); or
        Hypertension at least 10 percent disabling under              30
         diagnostic code 7101...........................
    Chronic kidney disease with GFR >=60 mL/min with at
     least one of the following:
        Albumin/creatinine ratio (ACR) from 0.03 g/gm to
         2.49 g/gm; or
        Hypertension that is non-compensable under                     0
         diagnostic code 7101...........................
    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
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..............................................
    Note: Peyronie's disease is not a ratable condition.
 
                              * * * * * * *
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 hereditary
     nephritis, 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:

[[Page 35146]]

 
    Rate as renal dysfunction.
 
                              * * * * * * *
7539 Renal amyloid disease:
    Rate as renal dysfunction.
    Note: This diagnostic code pertains to renal
     involvement in secondary glomerulonephritis/
     vasculitis and in other systemic diseases, such as
     Lupus erythematosus-Systemic lupus erythematosus
     nephritis, Henoch-Schonlein syndrome, Scleroderma,
     Hemolytic uremic syndrome, Polyarteritis, Wegener's
     granulomatosis, other Vasculitis and its
     derivatives, Goodpasture's syndrome, sickle cell
     disease, and other secondary glomerulonephritis.
 
                              * * * * * * *
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
 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
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, revising the entries for diagnostic codes 7508, 
7510, 7520 through 7522, 7524, 7525, 7527, 7533, 7534, 7537, 7539, 
7541, and 7542.
0
d. In Sec.  4.115b, 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
                    Section                        code No.
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
4.115.........................................  ..............  Retitled and revised [insert 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 [insert effective date of final rule].
4.115b........................................
 
                                                  * * * * * * *
                                                          7508  Evaluation February 17, 1994; title, criterion
                                                                 [insert effective date of final rule].
 
                                                  * * * * * * *
                                                          7510  Evaluation February 17, 1994; removed [insert
                                                                 effective date of final rule].
 
                                                  * * * * * * *
                                                          7520  Criterion February 17, 1994; criterion, footnote
                                                                 [insert effective date of final rule].
                                                          7521  Criterion February 17, 1994; criterion, footnote
                                                                 [insert effective date of final rule].
                                                          7522  Criterion September 8, 1994; title, criterion,
                                                                 note [insert effective date of final rule].
 
                                                  * * * * * * *
                                                          7524  Note July 6, 1950; evaluation February 17, 1994;
                                                                 evaluation September 8, 1994; note [insert
                                                                 effective date of final rule].
                                                          7525  Criterion March 11, 1969; evaluation February
                                                                 17, 1994; title [insert effective date of final
                                                                 rule].
 
                                                  * * * * * * *
                                                          7527  Criterion February 17, 1994; title [insert
                                                                 effective date of final rule].
 
                                                  * * * * * * *
                                                          7533  Added February 17, 1994; title and note [insert
                                                                 effective date of final rule].
                                                          7534  Added February 17, 1994; title [insert effective
                                                                 date of final rule].
 
                                                  * * * * * * *
                                                          7537  Added February 17, 1994; title [insert effective
                                                                 date of final rule].
 
                                                  * * * * * * *
                                                          7539  Added February 17, 1994; note [insert effective
                                                                 date of final rule].
 
                                                  * * * * * * *
                                                          7541  Added February 17, 1994; title [insert effective
                                                                 date of final rule].
                                                          7542  Added February 17, 1994; criterion [insert
                                                                 effective date of final rule].

[[Page 35147]]

 
                                                          7543  Added [insert effective date of final rule].
                                                          7544  Added [insert effective date of final rule].
                                                          7545  Added [insert 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.
    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.
 
                              * * * * * * *
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
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....................................            7522
 
                              * * * * * * *
Interstitial nephritis, including gouty nephropathy,                7537
 disorders of calcium metabolism........................
 
                              * * * * * * *
Kidney:

[[Page 35148]]

 
 
                              * * * * * * *
    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................
 
                              * * * * * * *
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. 2017-15765 Filed 7-27-17; 8:45 am]
 BILLING CODE 8320-01-P