80 FR 10637 - Schedule for Rating Disabilities; Gynecological Conditions and Disorders of the Breast

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 80, Issue 39 (February 27, 2015)

Page Range		10637-10644
FR Document		2015-03851

The Department of Veterans Affairs (VA) proposes to amend the portion of the VA Schedule for Rating Disabilities (VASRD or rating schedule) that addresses gynecological conditions and disorders of the breast. The purpose of these changes is to incorporate medical advances that have occurred since the last review, update current medical terminology, and provide clear evaluation criteria. The proposed rule reflects advances in medical knowledge, recommendations from the Gynecological Conditions and Disorders of the Breast Work Group (Work Group), which is comprised of subject matter experts from both the Veterans Benefits Administration (VBA) and the Veterans Health Administration (VHA), and comments from experts and the public gathered as part of a public forum. The public forum, focusing on revisions to the gynecological conditions and disorders of the breast section of the VASRD, was held on January 24, 2012.

Federal Register, Volume 80 Issue 39 (Friday, February 27, 2015)

[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Proposed Rules]
[Pages 10637-10644]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-03851]

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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AP13

Schedule for Rating Disabilities; Gynecological Conditions and
Disorders of the Breast

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend the
portion of the VA Schedule for Rating Disabilities (VASRD or rating
schedule) that addresses gynecological conditions and disorders of the
breast. The purpose of these changes is to incorporate medical advances
that have occurred since the last review, update current medical
terminology, and provide clear evaluation criteria. The proposed rule
reflects advances in medical knowledge, recommendations from the
Gynecological Conditions and Disorders of the Breast Work Group (Work
Group), which is comprised of subject matter experts from both the
Veterans Benefits Administration (VBA) and the Veterans Health
Administration (VHA), and comments from experts and the public gathered
as part of a public forum. The public forum, focusing on revisions to
the gynecological conditions and disorders of the breast section of the
VASRD, was held on January 24, 2012.

[[Page 10638]]

DATES: Comments must be received on or before April 28, 2015.

ADDRESSES: Written comments may be submitted through
www.Regulations.gov; by mail or hand-delivery to Director, Regulation
Policy and Management (02REG), Department of Veterans Affairs, 810
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202)
273-9026. Comments should indicate that they are submitted in response
to ``RIN 2900-AP13--Schedule for Rating Disabilities; Gynecological
Conditions and Disorders of the Breast.'' Copies of comments received
will be available for public inspection in the Office of Regulation
Policy and Management, Room 1068, 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 (FDMS) at
www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ioulia Vvedenskaya, Medical Officer,
Part 4 VASRD Regulations Staff (211C), Compensation Service, Veterans
Benefits Administration, Department of Veterans Affairs, 810 Vermont
Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll-
free telephone number.)

SUPPLEMENTARY INFORMATION: As part of VA's ongoing revision of the VA
Schedule for Rating Disabilities (VASRD or rating schedule), VA
proposes changes to 38 CFR 4.116, which pertains to gynecological
conditions and disorders of the breast. The proposed changes will: (1)
Update the medical terminology of certain gynecological conditions and
disorders of the breast, (2) add medical conditions not currently in
the rating schedule, and (3) refine evaluation criteria based on
medical advances that have occurred since the last revision and current
understanding of functional changes associated with or resulting from
disease or injury (pathophysiology).

Schedule of Ratings--Gynecological Conditions and Disorders of the
Breast

Section 4.116 currently lists 19 diagnostic codes encompassing
conditions involving injury or disease of female reproductive organs
and of the breast. VA proposes to revise these codes, through addition,
removal, or other revisions, to reflect current medical science and
terminology, and functional impairment.

Diagnostic Code 7610 ``Vulva, disease or injury of (including
vulvovaginitis)''

Current diagnostic code 7610 addresses impairments associated with
disease or injury of the vulva. The vulva refers to the exterior
anatomical portion of the female genitalia and includes the clitoris.
``Vulva,'' Mayo Clinic, http://www.mayoclinic.org/vulva/img-20005974
(last visited June 20, 2014). To provide clarity as to the
applicability of this diagnostic code and to promote consistent and
adequate evaluations, VA proposes to update the title of this
diagnostic code to specifically include injury or disease of the
clitoris, in addition to the vulva.

Diagnostic Code 7615 ``Ovary, disease, injury, or adhesions of''

Current diagnostic code 7615 addresses impairments associated with
disease, injury or adhesions of the ovaries. VA proposes to place a
note under diagnostic code 7615 to identify two common diseases
associated with ovarian dysfunction resulting in abnormal menstrual
cycles: Dysmenorrhea and secondary amenorrhea. Dysmenorrhea is pain
associated with menstruation and is the most commonly reported
menstrual disorder. ``Dysmenorrhea,'' American College of Obstetricians
and Gynecologists (July 2012), http://www.acog.org/~/media/
For%20Patients/faq046.pdf?dmc=1&ts=20130904T1049007771 (last visited
Jan. 21, 2014). Secondary amenorrhea occurs when a woman who has been
having normal menstrual cycles stops menstruating for 6 or more months.
Tarannum Master-Hunter & Diana L. Heiman, ``Amenorrhea: Evaluation and
Treatment,'' 73 American Family Physician 1374, 1374-82 (2006). The
proposed note will state that for the purpose of disability evaluation,
a disease, injury, or adhesions of the ovaries resulting in ovarian
dysfunction affecting the menstrual cycle, such as dysmenorrhea and
secondary amenorrhea, shall be rated under diagnostic code 7615.

Diagnostic Code 7619 ``Ovary, removal of''

Diagnostic code 7619, ``Ovary, removal of,'' addresses impairment
associated with complete and partial removal of the ovaries. Service-
connected complete removal of both ovaries is currently evaluated at
100 percent for the three months following removal and then 30 percent
thereafter. With the continued expansion of women's roles in military
service, better understanding of the health effects on women during and
after service is essential. Women who suffer premature loss of function
in both ovaries are at increased risk for cardiovascular disease,
stroke, lung cancer, cognitive impairment or dementia, Parkinsonism,
osteoporosis, depressive or anxiety symptoms, and sexual dysfunction.
The risks appear to be greater for women who are younger at the time of
premature loss of ovarian function. Studies have shown that even women
who have both ovaries removed ``after the onset of natural menopause
had an increased risk of deleterious outcomes.'' Lynne T. Shuster et
al., ``Prophylactic bilateral oophorectomy jeopardizes long-term
health,'' 18(4), American Society for Reproductive Medicine, Menopausal
Medicine S1, S1-S5 (2010).
Currently, a male Veteran is entitled to a 30 percent evaluation
for service-connected removal of one testicle when the second testicle,
for reasons unrelated to service, is absent or ceases to function. 38
CFR 4.115b, Diagnostic Code 7524, Note. However, the current VASRD does
not provide a similar evaluation for a female Veteran whose second
ovary is absent or ceases to function for reasons unrelated to service.
With consideration of the studies discussed above demonstrating the
significant health risks from removal or loss of function of both
ovaries, VA proposes to add a note to diagnostic code 7619 in order to
equalize VA compensation for female Veterans.

Diagnostic Codes 7621 ``Uterus, prolapse,'' 7622 ``Uterus, displacement
of,'' and 7623 ``Pregnancy, surgical complications of ''

Current diagnostic codes 7621 through 7623 address impairment
associated with various degrees of female pelvic organ prolapse.
Uterine prolapse is evaluated under current diagnostic code 7621, as
either (1) complete uterine prolapse through the vagina and introitus
at 50 percent, or (2) incomplete uterine prolapse at 30 percent.
Uterine displacement is evaluated under current diagnostic code 7622,
as either (1) marked uterine displacement and frequent or continuous
menstrual disturbances at 30 percent, or (2) uterine displacement with
adhesions and irregular menstruation at 10 percent. Finally, surgical
complications of pregnancy are evaluated under current diagnostic code
7623, as either (1) with rectocele or cystocele at 50 percent, or (2)
with relaxation of perineum at 10 percent.
To update VASRD, VA proposes to consolidate these three diagnostic
codes into one diagnostic code. Specifically, VA proposes to amend
diagnostic code

[[Page 10639]]

7621 to be titled, ``Pelvic organ prolapse due to injury, disease, or
surgical complications of pregnancy.'' VA proposes this consolidation
because all of these diagnostic codes represent different types of
pelvic organ prolapse (displacement) and describe various degrees of
their displacement to or beyond the vaginal walls. Furthermore, as
discussed in more detail below, current medicine has a reliable
classification system that provides for uniform evaluation of
functional impairment due to pelvic organ prolapse (displacement),
regardless of which pelvic organ is involved. Therefore, combining the
evaluations currently found in diagnostic codes 7621 through 7623 would
better reflect the current understanding of anatomy, physiology, and
functional impairment due to disease or injury of pelvic organs. VA
also proposes to place a note under diagnostic code 7621 that will
describe pelvic organ prolapse and identify common types of prolapse,
including uterine or vaginal vault prolapse, cystocele, urethrocele,
rectocele, enterocele, or any combination. This note would assist field
personnel in selecting the appropriate diagnostic code for these
diagnosed conditions.
Currently, diagnostic codes 7621 and 7622 address uterine prolapse
and uterine displacement, respectively; however, uterine displacement
is just an outdated reference to uterine prolapse. Therefore, separate
diagnostic codes are redundant and unnecessary. As for diagnostic code
7623, it provides for evaluation of pelvic organ displacement such as
rectocele, cystocele, and relaxation of perineum when due to surgical
complications of pregnancy. However, all of these pelvic organ
displacements can occur independently from surgical complications of
pregnancy. Therefore, an update to VASRD is needed to account for these
situations.
This proposed revision is also necessary to eliminate disparate
treatment of pelvic organ displacement found in the current VASRD. In
this regard, rectocele or cystocele are rated under current diagnostic
code 7623 without regard to the severity of the displacement (and, in
turn, the symptoms associated with the displacement), whereas uterine
prolapse and displacement (rated under diagnostic codes 7621 and 7622)
are evaluated based on the degree of displacement.
Pelvic organs, such as the uterus, bladder or bowel, may protrude
into the vagina due to weakness in the tissues that normally support
them. In the most severe cases, part or all of the uterus or vagina can
protrude beyond the vaginal opening (introitus). Pelvic organ prolapse
includes anterior vaginal wall prolapse (cystocele, urethrocele),
posterior vaginal wall prolapse (enterocele, rectocele, perineal
deficiency) and uterine or vaginal vault prolapse. A woman can present
with prolapse of one or more of these sites. Christopher Maher et al.,
``Surgical management of pelvic organ prolapse in women,'' Cochrane
Database of Systematic Reviews (2010), http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004014.pub4/abstract (last accessed Jan. 21,
2014). A woman's symptoms are largely based on the severity of her
prolapse. Women with mild cases of uterine prolapse may have no obvious
symptoms or require no active intervention. However, as the uterus
slips further out of normal position, it can place pressure on other
pelvic organs (such as the bladder or bowel) causing a variety of
symptoms such as a feeling of heaviness or pressure in the pelvis,
pelvic pain, abdomen or lower back pain, pain during intercourse, a
protrusion of tissue from the opening of the vagina, recurrent bladder
infections, constipation, difficulty with urination or urinary
frequency or urgency. G. Willy Davila et al., ``Vaginal Vault
Suspension'' (updated Sept. 6, 2013), Medscape, http://emedicine.medscape.com/article/1848619-overview#aw2aab6b9 (last
accessed Jan. 21, 2014). Therefore, it is essential to identify the
severity of any pelvic organ prolapse in order to determine the level
of functional impairment.
To ensure consistent evaluation of pelvic organ prolapse, VA
proposes to base its rating criteria on the pelvic organ prolapse (POP)
classification system. POP presents the herniation of the pelvic organs
to or beyond the vaginal opening (at the level of the hymen) and is
described using the findings during pelvic examination. ``Pelvic Organ
Prolapse,'' American College of Obstetricians and Gynecologists
Practice Bulletin, Vol. 110, No. 3 (Sept. 2007). The severity of
prolapse is graded using the standard Pelvic Organ Prolapse
Quantification (POP-Q) classification system. The POP-Q examination is
an objective, site-specific system that is used to quantify, describe,
and stage pelvic support. The POP-Q system has proven interobserver and
intraobserver reliability. A.F. Hall et al., ``Interobserver and
intraobserver reliability of the proposed International Continence
Society, Society of Gynecologic Surgeons, and American Urogynecologic
Society pelvic organ prolapse classification system,'' 175 Am J Obstet
Gynecol 1467, 1467-70 (1996).
As for the functional impairment associated with each stage of
severity, VA proposes to assign a 50 percent evaluation in cases of
severe pelvic organ prolapse, where on examination complete or almost
complete eversion of the total length of the vagina is present, and the
length of the protrusion beyond the hymen is within 2 centimeters of
the total vaginal length. VA proposes to assign a 30 percent evaluation
in cases of moderate prolapse, where on examination, the most severe
portion of the prolapse is more than 1 centimeter below the hymen, but
no further than 2 cm less than the total vaginal length. Finally, VA
proposes to assign a 10 percent evaluation in cases of mild prolapse,
where on examination, the most severe portion of the prolapse is
between 1 cm or less above and 1 cm or more below the hymen.
VA also proposes to eliminate references to frequent or continuous
menstrual disturbances, adhesions, and irregular menstruation as a
measure of the degree of uterine displacement, because the symptoms
noted are either outdated or adequately contemplated by the POP-Q
system. For example, uterine displacement, also known as uterine
prolapse, occurs when pelvic floor muscles and ligaments stretch and
weaken and the uterus slips down into or protrudes out of the vagina.
Minimal uterine prolapse generally does not require therapy or cause
any impairment because the patient usually does not have any symptoms.
However, uterine descent of the cervix at or through the vaginal
opening (introitus) can become symptomatic. Symptoms of moderate and
severe uterine prolapse include a sensation of vaginal fullness or
pressure, back pain, vaginal spotting from ulceration of the protruding
cervix or vagina, difficulty with sexual intercourse, lower abdominal
discomfort, and voiding and difficulties with defecation. Typically,
the patient feels a bulge in the lower vagina or the cervix protruding
through the vaginal opening. Cystoceles, rectoceles, or enteroceles may
cause symptoms commonly associated with pelvic organ prolapse and lead
to patient complaints of difficulty with voiding or bowel movements,
recurrent urinary infections, and/or ``splinting'' (manually supporting
the perineum) to defecate. Cespedes RD, Cross CA, McGuire EJ., ``Pelvic
Prolapse: Diagnosing and Treating Uterine and Vaginal Vault Prolapse,''
1(3) MedGenMed (1999). Menstrual abnormalities may occur in women with
or without pelvic organ

[[Page 10640]]

prolapse, but there is usually no causal relationship or association.
Therefore, the references to menstrual disturbances, irregular
menstruation and adhesions as symptoms of uterine prolapse
(displacement) should be removed, because they do not reflect current
medical science and practice.
Finally, and as a consequence of this proposed consolidation, VA
also proposes to delete current diagnostic codes 7622 ``Uterus,
displacement of'' and 7623 ``Pregnancy, surgical complications of'' as
the evaluation criteria are now contained in the proposed diagnostic
code 7621.

Diagnostic Codes 7627 ``Malignant neoplasms of gynecological system or
breast'' and 7628 ``Benign neoplasms of the gynecological system or
breast''

Current diagnostic codes 7627 and 7628 address impairment
associated with malignant and benign neoplasms of the gynecological
system and the breast. VA proposes to restructure the current rating
criteria by separating the evaluations for impairments due to
gynecological neoplasms from the evaluations for impairments due to
breast neoplasms. This proposed separation keeps disability
compensation data related to male breast cancer and non-cancerous
tumors separate from disability compensation data related to
gynecological neoplasms and also provides ease of use for disability
rating specialists. Men possess a small amount of nonfunctioning breast
tissue (breast tissue that cannot produce milk) that is concentrated in
the area directly behind the nipple on the chest wall. Like breast
cancer in women, cancer of the male breast is the uncontrolled growth
of the abnormal cells of this breast tissue. Male breast cancer
constitutes about 1 percent of all cases of breast cancers. ``Male
Breast Cancer,'' National Cancer Institute--National Institutes of
Health (Updated Sept. 19, 2013), http://www.cancer.gov/cancertopics/pdq/treatment/malebreast/Patient/page1 (last accessed Jan. 21, 2014).
Therefore, VA proposes to retitle diagnostic code 7627 as,
``Malignant neoplasms of gynecological system'' and diagnostic code
7628 as, ``Benign neoplasms of gynecological system.'' Additionally,
under diagnostic codes 7627 and 7628, VA proposes to clarify the
existing note which instructs rating specialists to rate chronic
residuals (following surgery or other treatments). Specifically, VA
proposes to identify those chronic residuals commonly associated with
treatment for neoplasms of the gynecological system, to include
impairment of function due to scars, lymphedema, or disfigurement, as
well as to direct rating specialists to evaluate any other residual
impairment of function, including gynecological, under appropriate
diagnostic code(s) within the appropriate body system. The surgical
management of gynecologic malignancies and benign diseases has evolved
over the last decades. However, these sometimes complex procedures
encompass radical pelvic and upper abdominal surgery, including
associated urologic and intestinal procedures that may be required to
remove the neoplasm. Oliver Zivanovic & Dennis Chi, ``Surgical
Resection and Reconstruction for Advanced and Recurrent Gynecologic
Malignancies,'' 3 Expert Rev. of Obstetrics & Gynecology 677, 677-690
(2008). Additionally, VA proposes a minor editorial revision of
replacing the word ``X-ray'' with the word ``radiation'' as it pertains
to therapeutic procedure to reflect a change in medical terminology.
Within this reorganization, VA also proposes to add two new
diagnostic codes, 7630 ``Malignant neoplasms of the breast'' and 7631
``Benign neoplasms of the breast and other injuries of the breast'' in
order to account for impairment due to benign and malignant breast
tumors (neoplasms) as well as other injuries to the breast not included
elsewhere in the VASRD. This addition would allow VA to adequately
evaluate and track disabilities due to benign breast neoplasms as well
as other injuries, such as blast trauma. VA proposes to place two notes
under diagnostic codes 7630 and 7631 to identify common chronic
residuals associated with injuries of the breast and benign and
malignant breast tumors and to instruct rating specialists to rate
accordingly. Breast surgery is the most common choice of treatment for
benign and malignant tumors of the breast and is an established risk
factor for development of scars, lymphedema, or disfigurement. These
chronic post-treatment residuals result in functional impairment such
as limitation of arm, shoulder, and wrist motion, or loss of grip
strength, or loss of sensation, or residuals from harvesting of muscles
for reconstructive purposes. Angelique F. Vitug & Lisa A. Newman,
``Complications in Breast Surgery,'' 87 Surgical Clinics of North
America 431, 431-451 (2007).
The proposed notes will therefore instruct rating specialists to
rate chronic residuals according to impairment of function due to
scars, lymphedema, or disfigurement (e.g., limitation of arm, shoulder,
and wrist motion, or loss of grip strength, or loss of sensation, or
residuals from harvesting of muscles for reconstructive purposes), and/
or under diagnostic code 7626, if appropriate. Again, no change to the
existing evaluation criteria (found in current diagnostic codes 7627
and 7628) is proposed.

New Diagnostic Code 7632 ``Female sexual arousal disorder (FSAD)''

VA proposes to add a new diagnostic code 7632, titled ``Female
sexual arousal disorder (FSAD),'' in order to account for impairment
due to this condition in the female Veteran population. FSAD refers to
the continual or recurrent inability of a woman to accomplish or
maintain an ample lubrication-swelling reaction during sexual
intercourse. This lack of physical response may be either lifelong or
acquired, and either generalized or situation-specific. FSAD is the
second most common sexual health concern for women, affecting 26
percent of adult women. Emma Hitt, ``Alprostadil Shows Efficacy in
Female Sexual Arousal Disorder'' (May 25, 2012), Medscape, http://www.medscape.com/viewarticle/764590 (last accessed Jan. 21, 2014).
Current statistics show that FSAD affects an estimated 30 to 45 million
women in the United States alone. Medscape Medical News, ``Potential
Drug Therapy for Female Sexual Dysfunction Presented'' (June 28, 2000),
Medscape, http://www.medscape.com/viewarticle/411930 (last accessed
Jan. 21, 2014). Clinical research shows that some aspects of FSAD are
likely caused in part by decreased blood flow to the genital area.
Therefore, poor genital blood flow is believed to contribute to FSAD
similar to the role of vascular disease in male erectile dysfunction.
Medscape Medical News, ``New Approaches to Female Sexual Arousal
Disorder'' (May 31, 2001), Medscape, http://www.medscape.com/viewarticle/434478 (last accessed Jan. 21, 2014). Although treatment of
sexual dysfunction in men has been improved by currently marketed
pharmaceuticals there are no US Food and Drug Administration (FDA)
approved treatments for FSAD. FDA recently issued draft guidance for
industry regarding clinical development of drug products for FSAD.
Currently, male Veterans with service connected penile deformity
and loss of erectile power receive a 20 percent disability evaluation
under diagnostic code 7522 and are eligible for special monthly
compensation. In cases where there is no penile deformity present, but
there is service connected loss of erectile power, VA's policy is to
evaluate male Veterans analogous to diagnostic code 7522, assigning a 0
percent rating; Eligibility for special

[[Page 10641]]

monthly compensation due to loss of use of a creative organ (SMC-K) is
also considered. See 38 CFR 4.20 and 4.115b, Diagnostic Code 7522.
In order to ensure gender parity, VA proposes the creation of a new
diagnostic code 7632 ``Female sexual arousal disorder (FSAD).'' There
is no diagnostic code in current Sec. 4.116 which allows for analogous
rating of female sexual arousal disorder, to include consideration of
special monthly compensation. Under proposed diagnostic code 7632,
female Veterans with service connected FSAD but without physical damage
to female genitalia would be evaluated at 0 percent with a note
directing rating personnel to consider eligibility for special monthly
compensation (SMC-K).

Technical Amendments

VA also proposes several technical amendments. We would add a
citation reference to 38 U.S.C. 1155 at the end of Sec. 4.116, and we
would update Appendix A, B, and C of part 4 to reflect the above noted
proposed amendments.

Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' requiring review by the Office of
Management and Budget (OMB), unless OMB waives such review, as ``any
regulatory action that is likely to result in a rule that may: (1) Have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
Create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) Materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) Raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.''
The economic, interagency, budgetary, legal, and policy
implications of this proposed rule have been examined, and it has been
determined not to be a significant regulatory action under Executive
Order 12866. VA's impact analysis can be found as a supporting document
at http://www.regulations.gov, usually within 48 hours after the
rulemaking document is published. Additionally, a copy of this
rulemaking and its impact analysis are available on VA's Web site at
http://www.va.gov/orpm/, by following the link for ``VA Regulations
Published From FY 2004 Through Fiscal Year to Date.''

Regulatory Flexibility Act

The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. This proposed rule would not affect any small entities.
Only certain VA beneficiaries could be directly affected. Therefore,
pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial
and final regulatory flexibility analysis requirements of sections 603
and 604.

Unfunded Mandates

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

Paperwork Reduction Act

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

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance program numbers and
titles for this rule 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; and
64.110, Veterans Dependency and Indemnity Compensation for Service
Connected Death.

Signing Authority

The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Jose D.
Riojas, Chief of Staff, Department of Veterans Affairs, approved this
document on December 1, 2014, for publication.

List of Subjects in 38 CFR Part 4

Disability benefits, Pensions, Veterans.

Dated: February 20, 2015.
William F. Russo,
Acting Director, Office of Regulation Policy & Management, Office of
the General Counsel, U.S. Department of Veterans Affairs.

For the reasons set out in the preamble, VA 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. Amend Sec. 4.116 as follows:
0
a. Revise the entry for diagnostic code 7610;
0
b. Add a note at the end of the entries for diagnostic codes 7615 and
7619;
0
c. Revise the entry for diagnostic code 7621;
0
d. Remove the entries for diagnostic codes 7622 and 7623;
0
e. Revise the entries for diagnostic codes 7627 and 7628;
0
f. Add entries for diagnostic codes 7630 through 7632 in numerical
order; and
0
g. Add an authority citation at the end of the section.
The revisions and additions to read as follows:

Sec. 4.116 Schedule of ratings--gynecological conditions and
disorders of the breast.

[[Page 10642]]

------------------------------------------------------------------------
Rating
------------------------------------------------------------------------

* * * * * * *
7610 Vulva or clitoris, disease or injury of (including
vulvovaginitis).

* * * * * * *
7615 * * *
Note: For the purpose of VA disability evaluation, a
disease, injury, or adhesions of the ovaries
resulting in ovarian dysfunction affecting the
menstrual cycle, such as dysmenorrhea and secondary
amenorrhea, shall be rated under diagnostic code
7615.

* * * * * * *
7619 * * *
Note: In cases of the removal of one ovary as the
result of a service-connected injury or disease,
with the absence or nonfunctioning of a second
ovary unrelated to service, an evaluation of 30
percent will be assigned for the service-connected
ovarian loss.

* * * * * * *
7621 Pelvic organ prolapse due to injury, disease, or
surgical complications of pregnancy.
Severe prolapse: Complete or almost complete 50
eversion of the total length of the vagina shown on
examination, with the length of the protrusion (or
prolapse) extending beyond the hymen within 2 cm of
total vaginal length...............................
Moderate prolapse: On examination the most severe 30
portion of the prolapse is more than 1 cm below the
hymen, but protrudes no further than 2 cm less than
the total vaginal length...........................
Mild prolapse: On examination the most severe 10
portion of the prolapse is between 1 cm or less
above the hymen and 1 cm or more below the hymen...
Note: Pelvic organ prolapse occurs when a pelvic
organ such as bladder, urethra, uterus, vagina,
small bowel, or rectum drops (prolapse) from its
normal place in the abdomen. Conditions associated
with pelvic organ prolapse include: Uterine or
vaginal vault prolapse, cystocele, urethrocele,
rectocele, enterocele, or any combination thereof.

* * * * * * *
7627 Malignant neoplasms of gynecological system........ 100
Note: A rating of 100 percent shall continue beyond
the cessation of any surgical, radiation,
antineoplastic chemotherapy or other therapeutic
procedures. Six months after discontinuance of such
treatment, the appropriate disability rating shall
be determined by mandatory VA examination. Any
change in evaluation based upon that or any
subsequent examination shall be subject to the
provisions of Sec. 3.105(e) of this chapter. Rate
chronic residuals to include scars, lymphedema,
disfigurement, and/or other impairment of function
under the appropriate diagnostic code(s) within the
appropriate body system.
7628 Benign neoplasms of gynecological system. Rate
chronic residuals to include scars, lymphedema,
disfigurement, and/or other impairment of function
under the appropriate diagnostic code(s) within the
appropriate body system.

* * * * * * *
7630 Malignant neoplasms of the breast.................. 100
Note: A rating of 100 percent shall continue beyond
the cessation of any surgical, radiation,
antineoplastic chemotherapy or other therapeutic
procedure. Six months after discontinuance of such
treatment, the appropriate disability rating shall
be determined by mandatory VA examination. Any
change in evaluation based upon that or any
subsequent examination shall be subject to the
provisions of Sec. 3.105(e) of this chapter. Rate
chronic residuals according to impairment of
function due to scars, lymphedema, or disfigurement
(e.g., limitation of arm, shoulder, and wrist
motion, or loss of grip strength, or loss of
sensation, or residuals from harvesting of muscles
for reconstructive purposes), and/or under
diagnostic code 7626.
7631 Benign neoplasms of the breast and other injuries
of the breast. Rate chronic residuals according to
impairment of function due to scars, lymphedema, or
disfigurement (e.g., limitation of arm, shoulder, and
wrist motion, or loss of grip strength, or loss of
sensation, or residuals from harvesting of muscles for
reconstructive purposes), and/or under diagnostic code
7626.
7632 Female sexual arousal disorder (FSAD).............. \1\ 0
------------------------------------------------------------------------
\1\ Review for entitlement to special monthly compensation under Sec.
3.350 of this chapter.

(Authority: 38 U.S.C. 1155)

0
3. Amend Appendix A to Part 4 as follows:
0
a. At Sec. 4.116, revise the entries for diagnostic codes 7610, 7615,
7619, 7621, 7622, 7623, 7627, and 7628; and
0
b. At Sec. 4.116, add entries for diagnostic codes 7630 through 7632 in
numerical order.
The revisions and additions to read as follows:

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

----------------------------------------------------------------------------------------------------------------
Diagnostic
Sec. code No.
----------------------------------------------------------------------------------------------------------------

* * * * * * *
4.116.

* * * * * * *
7610 Criterion May 22, 1995; title [effective date of final
rule].

[[Page 10643]]

* * * * * * *
7615 Criterion May 22, 1995; note [effective date of final
rule].

* * * * * * *
7619 Criterion May 22, 1995; note [effective date of final
rule].

* * * * * * *
7621 Criterion May 22, 1995; evaluation [effective date of final
rule].
7622 Removed [effective date of final rule].
7623 Removed [effective date of final rule].

* * * * * * *
7627 Criterion March 10, 1976; criterion May 22, 1995; title,
note [effective date of final rule].
7628 Added May 22, 1995; title, criterion [effective date of
final rule].

* * * * * * *
7630 Added [effective date of final rule].
7631 Added [effective date of final rule].
7632 Added [effective date of final rule].

* * * * * * *
----------------------------------------------------------------------------------------------------------------

0
4. Amend Appendix B to Part 4 as follows:
0
a. Revise the entries for diagnostic codes 7610, 7621, 7627, and 7628;
and
0
b. Add entries for diagnostic codes 7630 through 7632 in numerical
order.
The revisions and additions to read as follows:

Appendix B to Part 4--Numerical Index of Disabilities

------------------------------------------------------------------------
Diagnostic code No.
------------------------------------------------------------------------

* * * * * * *
------------------------------------------------------------------------
Gynecological Conditions and Disorders of the Breast
------------------------------------------------------------------------
7610................... Vulva or clitoris, disease or injury of
(including vulvovaginitis).

* * * * * * *
7621................... Pelvic organ prolapse due to injury or disease
or surgical complications of pregnancy.

* * * * * * *
7627................... Malignant neoplasms of gynecological system.
7628................... Benign neoplasms of gynecological system.

* * * * * * *
7630................... Malignant neoplasms of the breast.
7631................... Benign neoplasms of the breast and other
injuries of the breast.
7632................... Female sexual arousal disorder (FSAD).

* * * * * * *
------------------------------------------------------------------------

0
5. Amend Appendix C to Part 4 as follows:
0
a. Add in alphabetical order the heading ``Female sexual arousal
disorder (FSAD)'' and its diagnostic code ``7632''.
0
b. Under the heading ``Injury'' add in alphabetical order new entry
``Breast'' and its diagnostic code ``7631''.
0
c. Under the heading ``Neoplasms: Benign:'' add in alphabetical order
an entry ``Breast'' and its diagnostic code ``7631''.
0
d. Under the heading ``Neoplasms: Benign:'' remove ``Gynecological or
breast'' and in its place add the entry ``Gynecological''.
0
e. Under the heading ``Neoplasms: Malignant:'' add in alphabetical
order new entry ``Breast'' and its diagnostic code ``7630''.
0
f. Under the heading ``Neoplasms: Malignant:'' remove ``Gynecological
or breast'' and in its place add the entry ``Gynecological''.
0
g. Add in alphabetical order the heading ``Pelvic organ prolapse due to
injury or disease or surgical complications of pregnancy, including
uterine or vaginal vault prolapse, cystocele, urethrocele, rectocele,
enterocele, or combination'' and its diagnostic code ``7621''.
0
h. Remove the heading ``Pregnancy, surgical complications'' and its
diagnostic code ``7623''.

[[Page 10644]]

0
i. Under the heading ``Uterus'' remove the entry ``Displacement'' and
its diagnostic code ``7622''.
0
j. Remove the heading ``Vulva disease or injury of'' and add in its
place ``Vulva or clitoris, disease or injury of''.
The additions and revisions to read as follows:

Appendix C to Part 4--Alphabetical Index of Disabilities

------------------------------------------------------------------------
Diagnostic
code No.
------------------------------------------------------------------------

* * * * * * *
Female sexual arousal disorder (FSAD)................... 7632

* * * * * * *
Injury:

* * * * * * *
Breast.............................................. 7631

* * * * * * *
Neoplasms:
Benign:
Breast.......................................... 7631

* * * * * * *
Gynecological................................... 7628

* * * * * * *
Malignant:
Breast.......................................... 7630

* * * * * * *
Gynecological................................... 7627

* * * * * * *
Pelvic organ prolapse due to injury or disease or 7621
surgical complications of pregnancy, including uterine
or vaginal vault prolapse, cystocele, urethrocele,
rectocele, enterocele, or combination..................

* * * * * * *
Vulva or clitoris, disease or injury of................. 7610

* * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-03851 Filed 2-26-15; 8:45 am]
BILLING CODE 8320-01-P

$Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10643 Diagnostic Sec. code No. * * * * * * * 7615 Criterion May 22, 1995; note [effective date of final rule]. * * * * * * * 7619 Criterion May 22, 1995; note [effective date of final rule]. * * * * * * * 7621 Criterion May 22, 1995; evaluation [effective date of final rule]. 7622 Removed [effective date of final rule]. 7623 Removed [effective date of final rule]. * * * * * * * 7627 Criterion March 10, 1976; criterion May 22, 1995; title, note [effective date of final rule]. 7628 Added May 22, 1995; title, criterion [effective date of final rule]. * * * * * * * 7630 Added [effective date of final rule]. 7631 Added [effective date of final rule]. 7632 Added [effective date of final rule]. * * * * * * * ■ 4. Amend Appendix B to Part 4 as ■ b. Add entries for diagnostic codes Appendix B to Part 4—Numerical Index follows: 7630 through 7632 in numerical order. of Disabilities ■ a. Revise the entries for diagnostic The revisions and additions to read as codes 7610, 7621, 7627, and 7628; and follows: Diagnostic code No. * * * * * * * Gynecological Conditions and Disorders of the Breast 7610 .............. Vulva or clitoris, disease or injury of (including vulvovaginitis). * * * * * * * 7621 .............. Pelvic organ prolapse due to injury or disease or surgical complications of pregnancy. * * * * * * * 7627 .............. Malignant neoplasms of gynecological system. 7628 .............. Benign neoplasms of gynecological system. * * * * * * * 7630 .............. Malignant neoplasms of the breast. 7631 .............. Benign neoplasms of the breast and other injuries of the breast. 7632 .............. Female sexual arousal disorder (FSAD). * * * * * * * ■ 5. Amend Appendix C to Part 4 as ■ d. Under the heading ‘‘Neoplasms: ■ g. Add in alphabetical order the follows: Benign:’’ remove ‘‘Gynecological or heading ‘‘Pelvic organ prolapse due to ■ a. Add in alphabetical order the breast’’ and in its place add the entry injury or disease or surgical heading ‘‘Female sexual arousal ‘‘Gynecological’’. complications of pregnancy, including disorder (FSAD)’’ and its diagnostic ■ e. Under the heading ‘‘Neoplasms: uterine or vaginal vault prolapse, code ‘‘7632’’. Malignant:’’ add in alphabetical order cystocele, urethrocele, rectocele, ■ b. Under the heading ‘‘Injury’’ add in new entry ‘‘Breast’’ and its diagnostic enterocele, or combination’’ and its alphabetical order new entry ‘‘Breast’’ code ‘‘7630’’. diagnostic code ‘‘7621’’. tkelley on DSK3SPTVN1PROD with PROPOSALS and its diagnostic code ‘‘7631’’. ■ h. Remove the heading ‘‘Pregnancy, ■ f. Under the heading ‘‘Neoplasms: ■ c. Under the heading ‘‘Neoplasms: Malignant:’’ remove ‘‘Gynecological or surgical complications’’ and its Benign:’’ add in alphabetical order an breast’’ and in its place add the entry diagnostic code ‘‘7623’’. entry ‘‘Breast’’ and its diagnostic code ‘‘Gynecological’’. ‘‘7631’’. VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1$

10644 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules

■ i. Under the heading ‘‘Uterus’’ remove ■ j. Remove the heading ‘‘Vulva disease The additions and revisions to read as
the entry ‘‘Displacement’’ and its or injury of’’ and add in its place ‘‘Vulva follows:
diagnostic code ‘‘7622’’. or clitoris, disease or injury of’’. Appendix C to Part 4—Alphabetical
Index of Disabilities

Diagnostic
code No.

* * * * * * *
Female sexual arousal disorder (FSAD) ............................................................................................................................................. 7632

* * * * * * *
Injury:

* * * * * * *
Breast ........................................................................................................................................................................................... 7631

* * * * * * *
Neoplasms:
Benign:
Breast .................................................................................................................................................................................... 7631

* * * * * * *
Gynecological ........................................................................................................................................................................ 7628

* * * * * * *
Malignant:
Breast .................................................................................................................................................................................... 7630

* * * * * * *
Gynecological ........................................................................................................................................................................ 7627

* * * * * * *
Pelvic organ prolapse due to injury or disease or surgical complications of pregnancy, including uterine or vaginal vault
prolapse, cystocele, urethrocele, rectocele, enterocele, or combination ......................................................................................... 7621

* * * * * * *
Vulva or clitoris, disease or injury of ................................................................................................................................................... 7610

* * * * * * *

[FR Doc. 2015–03851 Filed 2–26–15; 8:45 am] (NAAQS). The infrastructure Maintenance Section, Air Programs
BILLING CODE 8320–01–P requirements are designed to ensure that Branch (AR–18J), U.S. Environmental
the structural components of each Protection Agency, 77 West Jackson
state’s air quality management program Boulevard, Chicago, Illinois 60604.
ENVIRONMENTAL PROTECTION are adequate to meet the state’s Such deliveries are only accepted
AGENCY responsibilities under the CAA. during the Regional Office normal hours
DATES: Comments must be received on of operation, and special arrangements
40 CFR Part 52 or before March 30, 2015. should be made for deliveries of boxed
[EPA–R05–OAR–2012–0991; EPA–R05– ADDRESSES: Submit your comments, information. The Regional Office official
OAR–2013–0435; FRL–9923–43–Region 5] identified by Docket ID No. EPA–R05– hours of business are Monday through
OAR–2012–0991 (2010 NO2 Friday, 8:30 a.m. to 4:30 p.m., excluding
Approval and Promulgation of Air infrastructure SIP elements) and Docket Federal holidays.
Quality Implementation Plans; Indiana; ID No. EPA–R05–OAR–2013–0435 Instructions: Direct your comments to
Infrastructure SIP Requirements for (2010 SO2 infrastructure SIP elements) Docket ID. EPA–R05–OAR–2012–0991
the 2010 NO2 and SO2 NAAQS by one of the following methods: and EPA–R05–OAR–2013–0435. EPA’s
AGENCY: Environmental Protection 1. www.regulations.gov: Follow the policy is that all comments received
Agency. on-line instructions for submitting will be included in the public docket
ACTION: Proposed rule. comments. without change and may be made
2. Email: aburano.douglas@epa.gov. available online at www.regulations.gov,
SUMMARY: The Environmental Protection 3. Fax: (312) 408–2279. including any personal information
tkelley on DSK3SPTVN1PROD with PROPOSALS

Agency (EPA) is proposing to approve 4. Mail: Douglas Aburano, Chief, provided, unless the comment includes
elements of state implementation plan Attainment Planning and Maintenance information claimed to be Confidential
(SIP) submissions from Indiana Section, Air Programs Branch (AR–18J), Business Information (CBI) or other
regarding the infrastructure U.S. Environmental Protection Agency, information whose disclosure is
requirements of section 110 of the Clean 77 West Jackson Boulevard, Chicago, restricted by statute. Do not submit
Air Act (CAA) for the 2010 nitrogen Illinois 60604. information that you consider to be CBI
dioxide (NO2) and sulfur dioxide (SO2) 5. Hand Delivery: Douglas Aburano, or otherwise protected through
National Ambient Air Quality Standards Chief, Attainment Planning and www.regulations.gov or email. The

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1

Document Created: 2015-12-18 13:14:39
Document Modified: 2015-12-18 13:14:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule.
Dates		Comments must be received on or before April 28, 2015.
Contact		Ioulia Vvedenskaya, Medical Officer, Part 4 VASRD Regulations Staff (211C), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll- free telephone number.)
FR Citation		80 FR 10637
RIN Number		2900-AP13
CFR Associated		Disability Benefits; Pensions and Veterans