Schedule for Rating Disabilities; The Genitourinary Diseases and Conditions, 55086-55094 [2019-22165]
Download as PDF
<![CDATA[
55086
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
the beginning point, proceed east in a
straight line for 3.71 miles to the
intersection of two unnamed,
unimproved roads north of Rancho San
Juan; then
(2) Proceed east-southeast in a straight
line for approximately 1.2 miles to an
unnamed hilltop with a marked
elevation of 1,424 feet in the La Laguna
Grant; then
(3) Proceed southwest in a straight
line for approximately 1.7 miles,
crossing onto the Zaca Creek map, to a
point designated ‘‘Oil,’’ adjacent to the
north fork of San Antonio Creek and the
intersection of three unnamed light-duty
roads in the Can˜ada del Comasa, La
Laguna Grant; then
(4) Proceed west-southwest in a
straight line for approximately 1.56
miles to the intersection of the north
fork of San Antonio Creek and the 800foot elevation contour in the Can˜ada del
Comasa, La Laguna Grant; then
(5) Proceed west in a straight line 1.95
miles to an unnamed rectangular
structure northeast of the terminus of an
unnamed, unimproved road north of
U.S. Highway 101 and BM 684 in the La
Laguna Grant; then
(6) Proceed northwesterly in a straight
line 0.32 mile to the intersection of
Alisos Canyon Road and an unnamed,
unimproved road east of the Can˜ada de
los Coches in the La Laguna Grant; then
(7) Proceed north-northwest in a
straight line for 1.68 miles, crossing
onto the Foxen Canyon map, to an
unnamed hilltop with a marked
elevation of 997 feet in the La Laguna
Grant; then
(8) Proceed northeast in a straight line
for 0.5 mile to return to the beginning
point.
Signed: August 6, 2019.
Mary G. Ryan
Acting Administrator.
Approved: September 23, 2019.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and
Tariff Policy).
[FR Doc. 2019–22264 Filed 10–11–19; 8:45 am]
BILLING CODE 4810–31–P
khammond on DSKJM1Z7X2PROD with PROPOSALS
DEPARTMENT OF VETERANS
AFFAIRS
RIN 2900–AQ71
Schedule for Rating Disabilities; The
Genitourinary Diseases and
Conditions
ACTION:
Department of Veterans Affairs.
Proposed rule.
VerDate Sep<11>2014
16:07 Oct 11, 2019
Jkt 250001
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.)
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,
SUPPLEMENTARY INFORMATION:
38 CFR Part 4
AGENCY:
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 handdelivery 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.
SUMMARY:
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
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 21_EXECASST.VBACO@va.gov
for a copy of the public forum
transrcript.
I. Proposed Changes to § 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 § 4.115, is
unnecessary and VA proposes to remove
this language.
However, VA proposes to retain the
remainder of the language in § 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 ‘‘Coexistence of renal and cardiovascular
conditions’’ to better address the
amended content.
II. Proposed Changes to § 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
§ 4.115a address impairment of the
genitourinary system, including renal
dysfunction, voiding dysfunction, and
infections.
The introductory paragraph in
§ 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 § 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.
E:\FR\FM\15OCP1.SGM
15OCP1
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
khammond on DSKJM1Z7X2PROD with PROPOSALS
Distinct disabilities resulting in nonoverlapping symptoms may be assigned
separate evaluations, however.
VA also proposes to make changes to
the rating criteria found in § 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 noncompensable 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
VerDate Sep<11>2014
16:07 Oct 11, 2019
Jkt 250001
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 m2 are considered to have
chronic kidney disease. Id. A GFR less
than 15 mL/min/1.73 m2 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 m2 for at least three consecutive
months; an 80 percent evaluation for a
GFR between 15 and 29 mL/min/1.73
m2 for at least three consecutive
months; a 60 percent evaluation for a
GFR between 30 and 44 mL/min/1.73
m2 for at least three consecutive
months; and a 30 percent evaluation for
a GFR between 45 and 59 mL/min/1.73
m2 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 m2 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
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
55087
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), https://
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
E:\FR\FM\15OCP1.SGM
15OCP1
55088
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
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.
khammond on DSKJM1Z7X2PROD with PROPOSALS
III. Proposed Changes to § 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 noninvasive 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
VerDate Sep<11>2014
16:07 Oct 11, 2019
Jkt 250001
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
§ 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 § 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
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
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
E:\FR\FM\15OCP1.SGM
15OCP1
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
khammond on DSKJM1Z7X2PROD with PROPOSALS
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.
VerDate Sep<11>2014
16:07 Oct 11, 2019
Jkt 250001
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/maleinfertility/treatment/varicocelerepair.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.
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
55089
VA proposes to evaluate this DC as
renal dysfunction under § 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, ‘‘HIVAssociated Nephropathy,’’ Medscape,
https://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/urologicconditions/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).
E:\FR\FM\15OCP1.SGM
15OCP1
55090
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
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.
Authority: 38 U.S.C. 1155, unless
otherwise noted.
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
1. The authority citation for part 4
continues to read as follows:
■
Subpart B—Disability Ratings
2. Revise § 4.115 to read as follows:
§ 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.
■ 3. Amend § 4.115a by revising the
introductory text and the table entries
for ‘‘Renal dysfuntion’’ and ‘‘Urinary
tract infection’’ to read as follows:
§ 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 § 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.
khammond on DSKJM1Z7X2PROD with PROPOSALS
Rating
Renal dysfunction:
Chronic kidney disease with glomerular filtration rate (GFR) less than 15 mL/min/1.73 m2 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/1.73 m2 for at least 3 consecutive months .......................................
Chronic kidney disease with GFR from 30 to 44 mL/min/1.73 m2 for at least 3 consecutive months .......................................
Chronic kidney disease with GFR from 45 to 59 mL/min/1.73 m2 for at least 3 consecutive months .......................................
GFR from 60 to 89 mL/min/1.73 m2 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 m2 and structural kidney abnormalities (cystic, obstructive, or glomerular) for at least 3
consecutive months or.
GFR from 60 to 89 mL/min/1.73 m2 and albumin/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:
VerDate Sep<11>2014
*
16:07 Oct 11, 2019
*
Jkt 250001
PO 00000
*
Frm 00018
Fmt 4702
*
Sfmt 4702
E:\FR\FM\15OCP1.SGM
*
15OCP1
100
80
60
30
0
*
55091
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
Rating
Poor renal function: Rate as renal dysfunction.
Recurrent symptomatic infection requiring drainage by stent or nephrostomy tube; or requiring greater than 2 hospitalizations per year; or requiring continuous intensive management ...............................................................................................
Recurrent symptomatic infection requiring 1–2 hospitalizations per year or suppressive drug therapy lasting six months or
longer ........................................................................................................................................................................................
Recurrent symptomatic infection not requiring hospitalization, but requiring suppressive drug therapy for less than 6 months
4. Amend § 4.115b by:
a. Removing diagnostic code 7510.
b. Revising diagnostic codes 7508,
7520, 7521, 7522, 7524, 7525, 7527,
7533, 7534, 7537, 7539, 7541, and 7542.
■
■
■
30
10
0
§ 4.115b Ratings of the genitourinary
system—diagnoses.
c. Adding diagnostic codes 7543,
7544, and 7545.
The revisions and additions read as
follows:
■
khammond on DSKJM1Z7X2PROD with PROPOSALS
Rating
*
*
*
*
*
*
7508 Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis:
Rate as hydronephrosis, except for recurrent stone formation requiring invasive or non-invasive procedures more than two
times/year ..................................................................................................................................................................................
*
*
*
*
*
*
*
7520 Penis, removal of half or more ................................................................................................................................................
7521 Penis, removal of glans ...........................................................................................................................................................
7522 Erectile dysfunction, with or without penile deformity ..............................................................................................................
*
*
*
*
*
*
*
7524 Testis, removal:
Both ..............................................................................................................................................................................................
One ...............................................................................................................................................................................................
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 §§ 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.
*
*
*
30
1 30
1 20
10
1 30
10
*
*
*
*
*
*
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 ...............................................................................................................................................................
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:
*
VerDate Sep<11>2014
17:47 Oct 11, 2019
Jkt 250001
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
E:\FR\FM\15OCP1.SGM
15OCP1
10
55092
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
Rating
Rate as voiding dysfunction or urinary tract infection, whichever is predominant.
1 Review
■
■
■
■
for entitlement to special monthly compensation under § 3.350 of this chapter.
5. Amend Appendix A to Part 4 by:
a. Adding § 4.115.
b. Revising § 4.115a.
c. In § 4.115b,
i. Revising the entries for diagnostic
codes 7508, 7510, 7520 through 7522,
7524, 7525, 7527, 7533, 7534, 7537,
7539, 7541, and 7542.
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
Sec.
Diagnostic
Code No.
*
4.115 ..............
4.115a ............
*
........................
........................
7501
7502
*
*
*
*
*
Retitled and revised [Effective date of final rule].
Re-designated and revised as § 4.115b; new § 4.115a ‘‘Ratings of the genitourinary system-dysfunctions’’
added February 17, 1994; revised [Effective date of final rule].
Note July 6, 1950; evaluation February 17, 1994, criterion September 8, 1994; criterion [Effective date of final
rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
*
*
7504
*
*
*
Evaluation February 17, 1994; criterion [Effective date of final rule].
*
*
7507
7508
7509
7510
Evaluation
Evaluation
Evaluation
Evaluation
*
*
7516
*
*
khammond on DSKJM1Z7X2PROD with PROPOSALS
4.115b
7500
*
*
*
*
*
*
*
Evaluation February 17, 1994; criterion [Effective date of final rule].
*
*
*
7520
7521
7522
*
*
*
Criterion February 17, 1994; criterion, footnote [Effective date of final rule].
Criterion February 17, 1994; criterion, footnote [Effective date of final rule].
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].
Criterion March 11, 1969; evaluation February 17, 1994; title and criterion [Effective date of final rule].
Criterion February 17, 1994; title and criterion [Effective date of final rule].
Criterion March 10, 1976; criterion February 17, 1994; criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Added September 9, 1975; evaluation February 17, 1994; criterion [Effective date of final rule].
Added September 9, 1975; criterion February 17, 1994; criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Added February 17, 1994; title, criterion, and note [Effective date of final rule].
Added February 17, 1994; title and criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Added February 17, 1994; title and criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Added February 17, 1994; note and criterion [Effective date of final rule].
Evaluation February 17, 1994; criterion [Effective date of final rule].
Added February 17, 1994; title and criterion [Effective date of final rule].
Added February 17, 1994; criterion [Effective date of final rule].
Added [Effective date of final rule].
Added [Effective date of final rule].
Added [Effective date of final rule].
7525
7527
7528
7529
7530
7531
7532
7533
7534
7535
7536
7537
7538
7539
7540
7541
7542
7543
7544
7545
*
■
*
16:07 Oct 11, 2019
17,
17,
17,
17,
1994;
1994;
1994;
1994;
*
*
criterion [Effective date of final rule].
title, criterion [Effective date of final rule].
criterion [Effective date of final rule].
removed [Effective date of final rule].
*
6. Amend Appendix B to Part 4 by:
VerDate Sep<11>2014
*
February
February
February
February
Jkt 250001
*
*
a. Revising diagnostic codes 7508,
7522, 7525, 7527, 7533, 7534, 7537, and
7541.
■
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
*
*
b. Removing diagnostic code 7510;
c. Adding diagnostic codes 7543
through 7545.
■
■
E:\FR\FM\15OCP1.SGM
15OCP1
55093
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
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 ................
7527 ................
*
*
*
*
*
Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only.
Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction.
*
7533 ................
7534 ................
*
*
*
*
*
*
Cystic diseases of the kidneys.
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 ................
7544 ................
7545 ................
*
*
*
*
*
*
Varicocele/Hydrocele.
Renal disease caused by viral infection such as human immunodeficiency viruses (HIV), Hepatitis B, and Hepatitis C.
Bladder, diverticulum of.
*
*
*
7. Amend Appendix C to Part 4 by:
a. Revising the entries for diagnostic
codes 7508, 7522, 7525, 7527, 7533,
7537, and 7541.
■
■
*
*
*
*
b. Removing the reference to
diagnostic code 7510;
■ 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 ..............................................................................................................................................................................
*
*
*
*
*
*
*
Erectile dysfunction, with or without penile deformity .........................................................................................................................
*
*
*
*
*
*
*
Interstitial nephritis, including gouty nephropathy, disorders of calcium metabolism .........................................................................
*
*
*
*
*
*
*
7545
7522
7537
*
khammond on DSKJM1Z7X2PROD with PROPOSALS
Kidney:
*
*
*
*
*
*
Cystic diseases of the ..................................................................................................................................................................
*
*
*
*
*
*
*
Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis ................................................................................................................................
*
*
*
*
*
*
*
Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction ................................................
Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only .................................................................................
*
VerDate Sep<11>2014
16:07 Oct 11, 2019
Jkt 250001
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
E:\FR\FM\15OCP1.SGM
15OCP1
7533
7508
7527
7525
55094
Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Proposed Rules
APPENDIX C TO PART 4—ALPHABETICAL INDEX OF DISABILITIES—Continued
Diagnostic
code No.
*
*
*
*
*
*
*
Renal:
*
*
*
*
*
*
Disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C .............................................................................
*
*
*
*
*
*
*
Involvement in diabetes mellitus type I or II .................................................................................................................................
*
*
*
*
*
*
*
Varicocele/Hydrocele ...........................................................................................................................................................................
*
*
*
*
[FR Doc. 2019–22165 Filed 10–11–19; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R10–OAR–2018–0810, FRL–10001–
04–Region 10]
Air Plan Approval; AK: Infrastructure
Requirements for the 2015 Ozone
Standard
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
Whenever a new or revised
National Ambient Air Quality Standard
is promulgated, the Clean Air Act
requires states to submit plans for the
implementation, maintenance, and
enforcement of such standard,
commonly referred to as infrastructure
requirements. On October 25, 2018, the
State of Alaska submitted such a plan
for the ozone standard revised on
October 1, 2015. In this action, the
Environmental Protection Agency (EPA)
is proposing to approve the Alaska plan
as meeting applicable infrastructure
requirements.
SUMMARY:
Comments must be received on
or before November 14, 2019.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R10–
OAR–2018–0810, at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
The EPA may publish any comment
received to its public docket. Do not
electronically submit any information
you consider to be Confidential
Business Information (CBI) or other
information the disclosure of which is
khammond on DSKJM1Z7X2PROD with PROPOSALS
DATES:
VerDate Sep<11>2014
16:07 Oct 11, 2019
Jkt 250001
*
*
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Kristin Hall, (206) 553–6357,
hall.kristin@epa.gov, or Attn: Kristin
Hall (15–H13), Air and Radiation
Division, EPA Region 10, 1200 6th
Avenue (Suite 155), Seattle, WA 98101.
SUPPLEMENTARY INFORMATION:
Throughout this document wherever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, it refers
to the EPA.
Table of Contents
I. Background
II. Infrastructure Elements
III. EPA Approach To Review of
Infrastructure SIP Submissions
IV. EPA Evaluation
V. Proposed Action
VI. Statutory and Executive Order Review
I. Background
On October 1, 2015, the
Environmental Protection Agency (EPA)
revised the existing ozone National
Ambient Air Quality Standard
(NAAQS), lowering the level of both the
primary and secondary standards from
0.075 parts per million (ppm) to 0.070
ppm, among other changes.1 The
revision triggered the Clean Air Act
1 National Ambient Air Quality Standards for
Ozone, Final rule (October 26, 2015, 80 FR 65292).
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
*
7544
7541
7543
*
(CAA) requirement for states to submit
State Implementation Plans (SIPs)
addressing basic infrastructure elements
required to implement, maintain, and
enforce the 2015 ozone NAAQS. On
October 25, 2018, the Alaska
Department of Environmental
Conservation (ADEC) made such a
submission.2
II. Infrastructure Elements
The CAA provides the procedure and
timing for infrastructure SIP
submissions and lists the required
elements, set forth at sections 110(a)(1)
and (2), respectively. The EPA has
issued guidance to help states address
these requirements, most recently on
September 13, 2013 (2013 Guidance).3
The elements and corresponding CAA
subsections are listed below:
• 110(a)(2)(A): Emission limits and
other control measures.
• 110(a)(2)(B): Ambient air quality
monitoring/data system.
• 110(a)(2)(C): Program for
enforcement of control measures.
• 110(a)(2)(D): Interstate transport.
• 110(a)(2)(E): Adequate resources.
• 110(a)(2)(F): Stationary source
monitoring system.
• 110(a)(2)(G): Emergency episodes.
• 110(a)(2)(H): Future SIP revisions.
• 110(a)(2)(I): Areas designated
nonattainment and applicable
requirements of part D.
2 Alaska’s October 25, 2018 submission not only
addresses infrastructure requirements, but also
requests EPA approval of regulatory updates and
permitting rule revisions. The EPA approved the
regulatory updates and permitting rule revisions in
a separate rulemaking on August 29, 2019 (84 FR
45419).
3 Stephen D. Page, Director, Office of Air Quality
Planning and Standards. ‘‘Guidance on
Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1)
and 110(a)(2).’’ Memorandum to EPA Air Division
Directors, Regions 1–10, September 13, 2013. The
2013 Guidance is available in the docket for this
action and at https://www.epa.gov/air-qualityimplementation-plans/infrastructure-siprequirements-and-guidance.
E:\FR\FM\15OCP1.SGM
15OCP1
]]>Agencies
[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), https://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,'' https://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, https://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
