Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems, 46888-46900 [2015-19197]
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becomes the southern boundary of
Cheboygan County, and continuing
along the Cheboygan county line to the
intersection of the Cheboygan county
line with the eastern boundary of
Charlevoix County; then
(6) Proceed south then east along the
Charlevoix county line to the
intersection of the Charlevoix county
line with the eastern boundary of
Antrim County; then
(7) Proceed south along the Antrim
county line to the point where the
county line turns due east; then
(8) Proceed west in a straight line to
the eastern shoreline of Grand Traverse
Bay; then
(9) Proceed north-northeasterly along
the shorelines of Grand Traverse Bay,
Lake Michigan, Little Traverse Bay,
Sturgeon Bay, Trails End Bay, and the
Straits of Mackinac, returning to the
beginning point.
Signed: July 28, 2015.
John J. Manfreda,
Administrator.
[FR Doc. 2015–19277 Filed 8–5–15; 8:45 am]
BILLING CODE 4810–31–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 4
RIN 2900–AO19
Schedule for Rating Disabilities: The
Hematologic and Lymphatic Systems
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) proposes to amend the
portion of the VA Schedule for Rating
Disabilities (Rating Schedule) that
addresses the hematologic and
lymphatic systems. The intended effect
of this change is to incorporate medical
advances that have occurred since the
last review, update medical
terminology, add medical conditions
not currently in the Rating Schedule,
and refine criteria for further clarity and
ease of rater application.
DATES: Comments must be received by
VA on or before October 5, 2015.
ADDRESSES: Written comments may be
submitted through
www.Regulations.gov; by mail or handdelivery to the Director, Regulation
Policy and Management (02REG),
Department of Veterans Affairs, 810
Vermont Ave. 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–AO19—Schedule
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SUMMARY:
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for Rating Disabilities: The Hematologic
and Lymphatic Systems. 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: Nick
Olmos-Lau, M.D., Medical Officer
(211C), Compensation Service, Veterans
Benefits Administration, Department of
Veterans Affairs, 810 Vermont Avenue
NW., Washington, DC 20420, (202) 461–
9695. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: As part of
our ongoing revision of the VA
Schedule for Rating Disabilities (Rating
Schedule), we are proposing changes to
38 CFR 4.117, Schedule of ratings—
hemic and lymphatic systems, and
appendices A, B, and C of part 4
pertaining to this section. This section
was last updated in 1995. By these
revisions, we aim to update medical
terminology; add medical conditions
not currently in the Rating Schedule;
and revise the rating criteria to reflect
medical advances and to clarify them
for ease of application.
Proposed Title Change: The
Hematologic and Lymphatic Systems
‘‘Hemic’’ is an adjective previously
used to describe diseases of or related to
the blood. The current medical term for
diseases of the blood or blood-forming
organs is ‘‘hematologic.’’ In addition,
the 2013 National Library of MedicineMedical Subject Headings (MESH)
descriptor advisory discourages the use
of the term ‘‘hemic’’ as too general, and
recommends instead the use of the term
‘‘hematologic’’ as more specific (https://
www.nlm.nih.gov/cgi/mesh/2013/MB
_cgi?mode=&index=6154&field=all
&HM=&II=&PA=&form=&input=).
VA therefore proposes to edit the
header of § 4.117 to ‘‘The Hematologic
and Lymphatic Systems’’ and the title of
§ 4.117 to ‘‘Schedule of ratings—
hematologic and lymphatic systems.’’
Modification and Reorganization of
Current Diagnostic Code (DC) 7700
(Anemia, Hypochromic-Microcytic and
Megaloblastic, Such as Iron-Deficiency
and Pernicious Anemia)
Anemia is predominantly hereditary
or secondary, a symptom of another
condition. Secondary anemia is
corrected by treatment of the underlying
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condition. Examples of conditions that
cause secondary anemia include
osteomyelitis (DC 5000) and
hypothyroidism (DC 7903). Anemia is
most appropriately evaluated as part of
the underlying service-connected
disability causing the anemia. VA
proposes to address in proposed DCs
7720, 7721, 7722, and 7723 anemias that
are neither hereditary nor addressed
under DCs for the causative conditions.
The title of current DC 7700 is
‘‘Anemia, hypochromic-microcytic and
megaloblastic, such as iron-deficiency
and pernicious anemia.’’ This title
groups anemias based on red blood cell
(RBC) morphology. VA proposes
separate DCs and criteria for the major
types of anemia. Separation would
assist raters in distinguishing amongst
and clarifying severity of anemias.
Accordingly, VA proposes the removal
of DC 7700 from the Rating Schedule,
and adding DC 7720 Iron deficiency
anemia, 7721 Folic acid deficiency,
7722 Pernicious anemia and Vitamin
B12 deficiency anemia, and 7723
Acquired hemolytic anemia.
Anemia is currently rated at levels of
100, 70, 30, 10, and 0-percent,
depending on the hemoglobin level and
the associated signs and symptoms. It is
evaluated at 100-percent for hemoglobin
of 5gm/100ml or less, with findings
such as high-output congestive heart
failure or dyspnea at rest. It is evaluated
at 70-percent for hemoglobin of 7gm/
100ml or less, with findings such as
dyspnea on mild exertion,
cardiomegaly, tachycardia (100 to 120
beats per minute) or syncope (three
episodes in the last six months). It is
evaluated at 30-percent for hemoglobin
of 8gm/100ml or less, with findings
such as weakness, easy fatigability,
headaches, lightheadedness, or
shortness of breath. It is evaluated at 10percent for hemoglobin of 10gm/100ml
or less, with findings such as weakness,
easy fatigability, or headaches. It is
evaluated at 0-percent for hemoglobin of
10gm/100ml or less and asymptomatic.
While there is a high correlation
between hemoglobin levels and signs or
symptoms of anemia in acute anemia,
the correlation is less accurate in
chronic anemia. As the duration of the
anemia lengthens, the individual
becomes more tolerant of lower
hemoglobin levels and symptom
manifestation decreases. The functional
impact of chronic anemia is more
accurately measured by mode and
frequency of treatment. VA proposes
rating criteria based on the specific
mode(s) and frequency of treatment.
VA notes that the existing 100 and 70
percent categories for rating anemia are
more descriptive of acute rather than
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chronic anemia. Acute anemia is
usually related to gastrointestinal or
uterine bleeding or traumatic injuries
with acute hemorrhage. The descriptors
in the 100 and 70 percent categories
reflect a clinical picture of rapid and
extensive blood loss, and their
symptoms include high output cardiac
failure with hypoxemia due to inability
to sustain proper tissue oxygenation,
caused by low hemoglobin levels which
can lead to shock or collapse. The
laboratory values and symptoms
described in the 100 and 70 percent
categories of the current anemia DC
reflect intolerable and life threatening
symptoms that require emergency
hospitalization and transfusion. See G.
Limbruno, ‘‘Recommendations for
transfusion of red blood cells,’’ 7 Blood
Transfusion 49 (2009).
Chronic anemia on the other hand,
develops at a more gradual pace, and is
usually related to serious medical
conditions such as malignancies
(cancer) on chemotherapy, infection
(osteomyelitis), thyroid disease,
hemoglobin disorders (such as sicklecell disease or thalassemia), renal failure
or chronic lower gastrointestinal
bleeding. In such cases a slower decline
in hemoglobin values allows gradual
adjustment. However, even when an
individual reaches such low levels as
contemplated in the 100 and 70 percent
evaluation, such a case reflects acute
critical health emergencies that are
unsustainable rather than having an
ongoing chronic long term disability
impairment as with chronic anemia. In
those cases where chronic anemia
results in urgent hospitalization, VA
finds that compensation is more
appropriately determined by evaluating
the underlying primary medical
problem that gave rise to the serviceconnected chronic anemia. As these
more severe cases represent less than 2
percent of the total number of disability
awards for anemia in the past years, VA
does not anticipate a significant impact
on future evaluations based on anemia.
Proposed DC 7720 (Iron Deficiency
Anemia)
Iron deficiency anemia is defined as
a decrease in total body iron content.
Total body iron content is regulated
through the balance of iron absorption
and loss. Iron deficiency anemia is most
commonly due to blood loss, posthemorrhagic anemia. Iron deficiency
anemia due to blood loss would be
evaluated under criteria for the
causative condition, e.g., duodenal ulcer
(DC 7305) or hemorrhoids (DC 7336),
rather than under DC 7720. VA proposes
to clarify the rating of anemia due to
blood loss by adding the following note:
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‘‘Do not evaluate iron deficiency anemia
due to blood loss under this diagnostic
code. Evaluate iron deficiency anemia
due to blood loss under the criteria for
the condition causing the blood loss.’’
Iron deficiency anemia can be readily
treated by diet or dietary supplements.
It is ordinarily short term with mild
symptoms and responds to treatment.
However, fatigue due to chronic, severe
iron deficiency anemia can decrease the
ability to perform physical labor. VA
proposes rating levels of 30, 10, and 0percent for iron deficiency anemia not
due to blood loss. VA proposes a 30percent evaluation for iron deficiency
anemia requiring intravenous (IV) iron
infusions on average 4 or more times per
12-month period; a 10-percent
evaluation if requiring continuous
treatment with high-dose oral
supplementation; and a 0-percent
evaluation if asymptomatic or requiring
treatment only by dietary modification.
Proposed DC 7721 (Folic Acid
Deficiency)
The prevalence of folic acid
deficiency has decreased in the United
States due to dietary fortification. This
form of anemia is amenable to dietary
modification and oral supplementation.
VA proposes a 10-percent evaluation for
folic acid deficiency requiring
continuous treatment with high-dose
oral supplementation. VA proposes a 0percent evaluation when asymptomatic
or requiring treatment only by dietary
modification.
Proposed DC 7722 (Pernicious Anemia
and Vitamin B12 Deficiency Anemia)
Pernicious anemia is the most
common form of severe Vitamin B12
deficiency. S. Stabler, ‘‘Vitamin B12
deficiency,’’ 368(2) New Eng. J. Med.
149 (2013). Other causes of Vitamin B12
deficiency that could lead to anemia
include: Dietary avoidance
(vegetarianism), malabsorption,
gastrectomy or gastric bypass,
inflammatory bowel disease (IBD),
pancreatic insufficiency, use of
histamine 2-blockers and proton pump
inhibitors. Pernicious anemia is
associated with gastric atrophy, due to
autoimmune destruction, and a lack of
intrinsic factor, a glycoprotein necessary
for the absorption of Vitamin B12, in the
gastric mucosa. Pernicious anemia
requires lifelong treatment with Vitamin
B12 injections, sublingual or high-dose
oral Vitamin B12 tablets, or Vitamin B12
nasal spray or gel. Since disabilities
from nutritional B12 deficiency are
consistent with pernicious anemia,
nutritional B12 deficiency would be
rated under the same diagnostic code as
pernicious anemia.
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In accordance with the above
discussion, VA proposes to evaluate
pernicious anemia and other forms of
severe B12 deficiency at 100 percent for
initial diagnosis requiring transfusion
due to severe anemia, or if there are
signs or symptoms related to central
nervous system impairment, such as
encephalopathy, myelopathy, or severe
peripheral neuropathy, requiring
parenteral B12 therapy. Since certitude
of neurologic reversibility cannot be
initially determined, and B12 absorption
issues may require lifelong
supplementation with B12 injections
every 1–3 months, VA proposes to reevaluate at 6 months and rate according
to presence of neurologic or
gastrointestinal residuals.
If absorption is adequate, lifelong oral
or intranasal B12 treatment may be used.
VA proposes to evaluate pernicious
anemia and other forms of severe
Vitamin B12 deficiency at 10 percent if
it requires continuous treatment with
Vitamin B12 injections, Vitamin B12
sublingual or high-dose oral tablets, or
Vitamin B12 nasal spray or gel.
VA proposes to add a note regarding
evaluation which states that the 100percent evaluation for pernicious
anemia and Vitamin B12 deficiency shall
be assigned as of the date of initial
diagnosis requiring transfusion due to
severe anemia or parenteral B12 therapy
and shall continue with a mandatory
VA examination six months following
hospital discharge or cessation of
continuous parenteral B12 therapy. The
note would also state that any reduction
in evaluation based upon that or any
subsequent examination shall be subject
to the provisions of 38 CFR 3.105(e) and
that, thereafter, evaluation would be at
10-percent and any residual effects of
pernicious anemia, such as neurologic
involvement causing peripheral
neuropathy, myelopathy, dementia, or
related gastrointestinal residuals, would
be separately evaluated under the most
appropriate diagnostic code.
Proposed 7723 (Acquired Hemolytic
Anemia)
There are over 200 causes of
hemolytic anemia, including both
acquired and hereditary types. The
causes of acquired hemolytic anemia
include immune disorders, toxic
chemicals, medications, physical
damage (such as may occur with
prosthetic heart valves), and infections.
Treatment may include intermittent
corticosteroids; other
immunosuppressive drugs; immune
globulin; monoclonal antibody therapy,
such as rituximab; splenectomy;
erythropoiesis stimulating agent (ESA)
to boost production of RBC;
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plasmapheresis (a process similar to
dialysis that can remove certain
components, such as harmful
antibodies, from the blood); blood
transfusions; and peripheral blood or
bone marrow stem cell transplantation
(www.nhlbi.nih.gov/health).
VA proposes to list the evaluation
criteria for acquired hemolytic anemia
under DC 7723.
VA proposes to rate acquired
hemolytic anemia at 100 percent, if
requiring a bone marrow transplant or
continuous intravenous or
immunosuppressive therapy (e.g.,
prednisone, Cytoxan
(cyclophosphamide), azathioprine, or
rituximab). VA proposes to rate
acquired hemolytic anemia at 60
percent, if requiring
immunosuppressive medication an
average of 4 or more times per 12-month
period. VA proposes to rate acquired
hemolytic anemia at 30 percent, if
requiring an average of 2–3 courses of
immunosuppressive therapy per 12month period. VA proposes to rate
acquired hemolytic anemia at 10
percent, if requiring an average of 1
course of immunosuppressive therapy
per 12-month period. VA proposes to
evaluate acquired hemolytic anemia at 0
percent if asymptomatic.
VA also proposes to add a Note (1) in
relation to this DC, stating that a 100percent evaluation for bone marrow
transplant shall be assigned as of the
date of hospital admission and shall
continue for six months after hospital
discharge with a mandatory VA
examination six months following
hospital discharge. The note would also
state that any reduction in evaluation
based upon that or any subsequent
examination shall be subject to the
provisions of 38 CFR 3.105(e).
To remind rating specialists that there
is a separate DC for splenectomy, VA
proposes to add a Note (2), which would
state that VA will separately evaluate
splenectomy under DC 7706 and
combine with an evaluation under DC
7723.
DC 7702 (Agranulocytosis, Acute);
Proposed DC 7702 (Agranulocytosis,
Acquired)
Agranulocytosis, by definition, is an
acute condition. Therefore, this disease
is better categorized as agranulocytosis,
acquired, than as agranulocytosis, acute.
VA proposes to list updated evaluation
criteria for this condition under DC
7702 with the title ‘‘Agranulocytosis,
acquired’’ to reflect current medical
terminology.
Acute agranulocytosis is currently
evaluated at levels of 100, 60, 30, and
10 percent based on type of treatment or
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frequency of episodes of recurring
infections. A 100-percent evaluation is
currently assigned if requiring bone
marrow transplant or transfusion of
platelets or red cells at least once every
six weeks or if infections recur at least
once every six weeks. A 60-percent
evaluation is assigned if requiring
transfusion of platelets or red cells at
least once every three months or if
infections recur at least once every three
months. A 30-percent evaluation is
assigned if requiring transfusion of
platelets or red cells at least once per
year but less than once every three
months or if infections recur at least
once per year but less than once every
three months. A 10-percent evaluation
is assigned if requiring continuous
medication for control.
Due to advances in the
pharmacological treatment of
agranulocytosis and a shift in standard
of care, VA proposes the deletion of the
number of transfusions as a criterion for
rating agranulocytosis. ‘‘Granulocyte
transfusions have undergone a cycle of
popularity followed by disfavor,’’
although they may be useful in patients
with life-threatening infections whose
conditions are not responding to
antibiotics. A. Distenfeld, M.D., N.Y.
Univ. Sch. of Med., ‘‘Agranulocytosis,’’
eMedicine (Updated Jan 9, 2015, by C.
Braden). These transfusions are
accompanied by many complications,
including severe febrile reactions. The
use of granulocyte transfusions remains
controversial. VA proposes to evaluate
agranulocytosis based on type and
frequency of treatment or the average
number of infections per 12-month
period. VA proposes to evaluate
agranulocytosis at 100 percent if
requiring bone marrow transplant or if
infections recur, on average, at least
once every six weeks per 12-month
period. VA proposes to evaluate
agranulocytosis at 60 percent if
requiring intermittent myeloid growth
factors (granulocyte colony-stimulating
factor (G–CSF) or granulocytemacrophage colony-stimulating factor
(GM–CSF)) or continuous
immunosuppressive therapy such as
cyclosporine to maintain absolute
neutrophil count (ANC) greater than
500/ml but less than 1000/ml, or if
infections recur, on average, at least
once every three months per 12-month
period. VA proposes to evaluate
agranulocytosis at 30 percent if
requiring intermittent myeloid growth
factors to maintain ANC greater than
1000/ml or if infections recur, on
average, at least once per 12-month
period but less than once every three
months per 12-month period. VA
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proposes to evaluate agranulocytosis at
10 percent if requiring continuous
medication (e.g., antibiotics) for control
or if requiring intermittent use of a
myeloid growth factor to maintain ANC
greater than or equal to 1500/ml.
VA proposes to preserve the existing
note under current DC 7702.
DC 7703 (Leukemia)
One type of leukemia, chronic
myelogenous leukemia (CML), is
evaluated as a myeloproliferative
disorder. CML is a heterogeneous
disease with three clinical phases:
Chronic, transitional (accelerated), and
acute (blast). Most individuals with
CML are diagnosed in the chronic phase
and with adequate treatment can remain
in this phase for several years. However,
patients with CML are never ‘‘cured’’
with current therapy, but often have no
evidence of the disease at a molecular
level. The term used for this state is
‘‘complete molecular remission’’ (CMR).
These patients require continuous
treatment because otherwise they would
relapse. Patients with CML need to be
considered as having active disease
even when they would otherwise appear
to be in remission. Therefore, VA
proposes to evaluate CML under
separate DC 7719.
Leukemia is currently evaluated at
100 percent for active disease or during
a treatment phase. There is also a
directive to otherwise rate as anemia
(current DC 7700) or aplastic anemia
(DC 7716), whichever would result in
the greater benefit.
VA proposes to evaluate all forms of
active leukemia other than chronic
myelogenous leukemia under DC 7703.
VA proposes to retain the 100-percent
evaluation ‘‘[w]hen there is active
disease or during a treatment phase.’’
For rating purposes, VA considers any
diagnosed cancer as ‘‘active disease’’ if
medical evidence does not demonstrate
the eradication of cancerous cells, if the
cancer is not in remission, or when the
condition requires continuous treatment
since otherwise there would invariably
be a relapse.
Since there are numerous residual
effects of leukemia and its treatment,
which may involve any body system,
VA proposes to remove the current
directive, which addresses only certain
hematologic residuals: ‘‘Otherwise rate
as anemia (code 7700) or aplastic
anemia (code 7716), whichever would
result in the greater benefit.’’ VA
proposes another directive, which
would read: ‘‘Otherwise rate residuals
under the appropriate diagnostic
code(s).’’
One of the four main types of
leukemia, chronic lymphocytic
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leukemia (CLL), is now often diagnosed
at a very early stage when the blood
lymphocyte count is high, but the
patient does not have enlargement of the
lymph nodes, spleen, or liver, and the
red blood cells and platelets are normal
or nearly so. The average age of patients
with this type of leukemia is 70. In the
staging system commonly used to assess
the severity of CLL, this early stage is
known as Rai Stage 0. Occasionally
patients are diagnosed instead as having
monoclonal B-cell lymphocytosis
(MBL). The diagnosis is in a similar
category as Rai Stage 0 CLL. Unlike the
course of the other major types of
leukemia, this early stage of CLL may
not progress for many years. The
median survival time for this stage of
disease is over 12 years. No treatment is
required, and it is considered a low risk
stage. For individuals with CLL at Rai
Stage 0, assigning a 100-percent
evaluation would be inappropriate,
since antineoplastic treatment is not
warranted, and at this early stage, there
is little or no effect on a patient’s wellbeing, according to the Leukemia and
Lymphoma Society (www.leukemialymphoma.org/). Therefore, VA
proposes to add a 0-percent evaluation
level for asymptomatic low risk level
patients with CLL at Rai Stage 0.
Patients with lymphocytosis, enlarged
lymph nodes and splenomegaly or
hepatomegaly are defined as having an
intermediate risk for disease progression
(Rai Stages I or II). Patients with
hepatomegaly (enlarged liver), anemia
(Hemoglobin <11 g/dL), or
thrombocytopenia (platelet counts lower
than 100,000) are considered to be in
the higher risk categories for disease
progression (Rai Stages III and IV).
Oncologists have developed criteria to
determine when to initiate treatment
based on the presence of genetic
mutation, micro-globulins, lymphocyte
doubling times and other markers to
help boost the accuracy criteria of the
CLL tumor burden along with staging
provided by the Rai scale. Patients with
newly diagnosed asymptomatic earlystage disease are generally monitored
without therapy unless they show signs
of disease progression or symptoms.
Patients with intermediate risk (Rai
Stages I and II) and those with high risk
(Rai Stages III or IV) are usually started
on treatment.
VA proposes editorial changes to the
currently existing note, which would be
numbered as Note (1).
Rai Stages I–IV (intermediate and high
risk) usually require progressively
aggressive therapy, consistent with
leukemias and other malignancies. VA
proposes addition of notes to clarify
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evaluation of CLL that progresses
beyond Rai Stage 0.
The proposed Note (2) would read:
‘‘Evaluate symptomatic chronic
lymphocytic leukemia that is at Rai
Stage I, II, III, or IV the same as any
other leukemia evaluated under this
diagnostic code.’’
The proposed Note (3) would read:
‘‘Evaluate residuals of leukemia or
leukemia therapy under the appropriate
diagnostic code(s). Myeloproliferative
Disorders: (Diagnostic Codes 7704,
7718, 7719).’’
Myeloproliferative Disorders
This section includes: DC 7704
(Polycythemia vera); Proposed DC 7718
(Essential thrombocythemia and
primary myelofibrosis); Proposed DC
7719 (Chronic myelogenous leukemia
(CML) (chronic myeloid leukemia or
chronic granulocytic leukemia)).
Myeloproliferative disorders are a
group of slow-growing blood neoplasms
in which the bone marrow produces
excess numbers of red blood cells, white
blood cells, or platelets. Polycythemia
vera is one type of myeloproliferative
disorder. Other conditions included in
this category are essential
thrombocythemia, primary idiopathic
myelofibrosis, and chronic myelogenous
leukemia (CML) (also called chronic
myeloid leukemia or chronic
granulocytic leukemia)
(www.cancer.gov/cancertopics/types/
myeloproliferative and www.leukemialymphoma.org). These conditions may
evolve into acute leukemia.
According to the National Cancer
Institute of the U.S. National Institutes
of Health, a variety of treatments are
used for myeloproliferative disorders.
For example, polycythemia vera is
commonly treated by phlebotomy
(removal of blood, as needed, to
decrease the number of red blood cells
and platelets). However, other
treatments used to achieve appropriate
levels of cells and to reduce
complications, such as thrombosis,
include radioactive phosphorous (which
suppresses the overproduction of blood
cells), interferon alpha (which boosts
the immune system), chemotherapeutic
agents (including myelosuppressants,
which decrease bone marrow
production), and low dose aspirin.
Some of these treatments are also used
for other myeloproliferative disorders.
Other treatments used for
myeloproliferative disorders include:
stem cell transplant; platelet apheresis
(removal of platelets from the blood in
a process similar to dialysis); blood or
platelet transfusions (when the bone
marrow production is insufficient);
periods of hospitalizations to treat
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infections (since patients with these
conditions are at high risk for serious
infections); erythropoiesis-stimulating
agents (ESA) to boost production of red
blood cells; tyrosine kinase inhibitors
such as imatinib (Gleevec) (commonly
used to treat chronic myelogenous
leukemia) or ruxolitinib (new kinase
inhibitor); and androgen-like drugs
(which also may stimulate the bone
marrow).
Polycythemia vera is the only
myeloproliferative disorder, of the
above-mentioned disorders, currently
evaluated in the Rating Schedule.
Therefore, VA proposes the addition of
DCs to provide rating criteria for other
diseases under the category of
myeloproliferative disorders: 7718
Essential thrombocythemia/primary
myelofibrosis, and 7719 Chronic
myelogenous leukemia (CML) (chronic
myeloid leukemia or chronic
granulocytic leukemia).
VA proposes to add a note applicable
to all myeloproliferative disorders,
which would state that if the condition
undergoes leukemic transformation, it
should be evaluated as leukemia under
DC 7703. This note is intended to
remind rating specialists that a
myeloproliferative disorder may
undergo leukemic transformation and
warrant evaluation under DC 7703.
VA also proposes to add another note
applicable to all myeloproliferative
disorders, which would state that a 100percent evaluation shall be assigned as
of the date of hospital admission for
peripheral blood or bone marrow stem
cell transplant, or during the period of
treatment with radioactive phosphorus
or chemotherapy (including
myelosuppressants), and that six
months following hospital discharge or,
in the case of radioactive phosphorus or
chemotherapy treatment, six months
after completion of treatment, the
appropriate disability rating shall be
determined by mandatory VA
examination. The note would also state
that any reduction in evaluation based
upon that or any subsequent
examination shall be subject to the
provisions of 38 CFR 3.105(e).
DC 7704 (Polycythemia Vera)
VA proposes a 100-percent evaluation
if requiring peripheral blood or bone
marrow stem-cell transplant or
treatment with radioactive phosphorus
or chemotherapy (including
myelosuppressants).
VA proposes a 60-percent evaluation
if requiring phlebotomy 6 or more times
per 12-month period to control RBC
count or if requiring radioactive
phosphorous treatment, chemotherapy,
or targeted agents like ruxolitinib or
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imatinib. VA proposes a 30-percent
evaluation if requiring phlebotomy 4–5
times per 12-month period or if
requiring continuous biologic therapy or
myelosuppressive agents to maintain
platelet count in the less than 200,000
range or white blood cells (WBC) in the
less than 12,000 range. VA proposes a
10-percent evaluation if requiring, on an
intermittent basis, phlebotomy, biologic
therapy, or interferon, as needed, but
less than 4 times per 12-month period.
VA proposes to number the current
note for DC 7704 as Note (1). VA
proposes the addition of the two notes
described above for all
myeloproliferative disorders to be added
as Notes (2) and (3) after the current
note for DC 7704.
Proposed DC 7718 (Essential
Thrombocythemia and Primary
Myelofibrosis)
VA proposes a 100-percent evaluation
if requiring either continuous
myelosuppressive therapy or, for six
months following hospital admission,
any of the following treatments:
Peripheral blood or bone marrow stem
cell transplant, or treatment with
radioactive phosphorus or
chemotherapy (including
myelosuppressants); a 70 percent
evaluation if requiring either continuous
or intermittent myelosuppressive
therapy to maintain platelet count less
than 500 × 10 9/L; a 30-percent
evaluation if requiring continuous or
intermittent myelosuppressive therapy
to maintain platelet count of 200,000–
400,000 or white blood cell (WBC)
count of 4,000–10,000; and a 0-percent
evaluation if asymptomatic.
VA proposes the addition of the two
notes described above for all
myeloproliferative disorders.
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Proposed DC 7719 (Chronic
Myelogenous Leukemia (CML) (Chronic
Myeloid Leukemia or Chronic
Granulocytic Leukemia))
VA proposes a 100-percent evaluation
if requiring peripheral blood or bone
marrow stem cell transplant or requiring
continuous myelosuppressive or
immunosuppressive therapy. VA
proposes a 60-percent evaluation if
requiring intermittent myelosuppressive
therapy, or targeted therapy with
tyrosine kinase inhibitors, or interferon
treatment. VA proposes a 30-percent
evaluation if in apparent remission on
continuous targeted therapy with
tyrosine kinase inhibitors.
VA proposes the addition of the two
notes described above for all
myeloproliferative disorders.
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Current DC 7705 (Thrombocytopenia,
Primary, Idiopathic or Immune);
Proposed DC 7705 (Immune
Thrombocytopenia)
Thrombocytopenia is currently
evaluated at levels of 100, 70, 30, and
0 percent based on the platelet count,
the presence or absence of bleeding
episodes, and whether treatment is
required. VA proposes to change the
title from ‘‘Thrombocytopenia, primary,
idiopathic or immune’’ to ‘‘Immune
thrombocytopenia.’’
VA proposes to use the same bases for
evaluation of disability, while updating
criteria to reflect advances in medical
knowledge. A 100-percent evaluation is
currently assigned if the platelet count
is less than 20,000, with active bleeding,
requiring treatment with medication
and transfusions. A 70-percent
evaluation is currently assigned for a
platelet count between 20,000 and
70,000, not requiring treatment, without
bleeding. A 30-percent evaluation is
currently assigned for a stable platelet
count between 70,000 and 100,000,
without bleeding. A 0-percent
evaluation is currently assigned for a
stable platelet count of 100,000 or more,
without bleeding. VA proposes to
provide evaluation levels of 100, 70, 30,
10 and 0 percent, with criteria based in
part on the recommendations of the
American Society of Hematology for
diagnosis and treatment of idiopathic
thrombocytopenic purpura, updated in
2010.
VA proposes to assign a 100-percent
evaluation for immune
thrombocytopenia requiring
chemotherapy for chronic refractory
thrombocytopenia or a platelet count
from 20,000 to 30,000 despite treatment.
VA proposes to assign a 70-percent
evaluation if requiring
immunosuppressive therapy or for a
platelet count higher than 30,000 but
not higher than 50,000, with history of
hospitalization because of severe
bleeding requiring intravenous immune
globulin, high-dose parenteral
corticosteroids, and platelet
transfusions. VA proposes to assign a
30-percent evaluation for a platelet
count higher than 30,000 but not higher
than 50,000, with either immune
thrombocytopenia or mild mucous
membrane bleeding which requires oral
corticosteroid therapy or intravenous
immune globulin. VA proposes to assign
a 10-percent evaluation for a platelet
count higher than 30,000 but not higher
than 50,000, not requiring treatment. VA
proposes to assign a 0-percent
evaluation for platelet count above
50,000 and asymptomatic, or for
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Sfmt 4702
immune thrombocytopenia in
remission.
VA also proposes to add a note
instructing raters to separately evaluate
splenectomy under DC 7706 and
combine with an evaluation under this
DC. VA proposes to add a second note
clarifying re-evaluation following
chemotherapy as follows: ‘‘A 100percent evaluation shall continue
beyond the cessation of chemotherapy.
Six months after discontinuance of such
treatment, the appropriate disability
rating shall be determined by mandatory
VA examination. Any reduction in
evaluation based upon that or any
subsequent examination shall be subject
to the provisions of [38 CFR 3.105(e)].’’
DC 7706 (Splenectomy); DC 7707
(Spleen, Injury of, Healed)
VA proposes no change to these DCs
except to move the word ‘‘separately’’ in
the note following DC 7706 to clarify the
meaning.
Current DC 7709 (Hodgkin’s Disease);
Proposed DC 7709 (Hodgkin’s
Lymphoma)
VA proposes to change the title
associated with current DC 7709 from
‘‘Hodgkin’s disease’’ to ‘‘Hodgkin’s
lymphoma’’ to be consistent with
current medical terminology and
knowledge. VA proposes minor editorial
changes to the existing note. The
following sentence was modified to read
as follows at the end of the existing
note: ‘‘If there has been no local
recurrence or metastasis, rate on
residuals under the appropriate
diagnostic code(s).’’
DC 7710 (Adenitis, Tuberculous, Active
or Inactive)
VA proposes no changes for this
diagnostic code except for the deletion
of a section symbol (§ ).
Proposed DC 7712 (Multiple Myeloma)
VA proposes to add a new DC 7712
for multiple myeloma (MM). MM is a
type of systemic, incurable malignancy
resulting from the proliferation of
abnormal plasma cells in the bone
marrow. The overgrowth of these
plasma cells results in tumors that are
deposited primarily in the bones, but
also in the kidneys and other organs.
The median age at diagnosis is 65 years,
and the average 5-year survival rate is
about 30 percent. Survival time depends
on many factors, such as age, gender,
race, stage of disease at time of
diagnosis, and treatment. Recent
therapeutic advances have improved the
quality of life and length of survival
time, but MM remains incurable. Some
patients go into remission for various
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periods but require maintenance
therapy even while in remission.
MM has a wide variety of clinical
presentations that can vary between
asymptomatic to severely symptomatic.
Asymptomatic (smoldering or
indolent) myeloma is a slow-growing,
asymptomatic precursor or premalignant phase of MM. It is usually not
treated until evidence of end organ
damage develops. It has a high risk of
developing into MM. However, since it
is not malignant, is asymptomatic, and
does not require treatment, it would not
warrant a compensable evaluation
under this diagnostic code, and VA
proposes to rate it at 0 percent.
Even if smoldering MM is currently
regarded as a pre-malignant state, there
are subsets of patients with different
rates of progression towards MM. No
single pathological or molecular feature
can be used to distinguish between
smoldering and pre-malignant MM with
clonal plasma cells from those with
clonal malignant plasma cells. A
biomarker-based definition that can
predict this transformation is needed
but is not yet currently available.
Symptomatic multiple myeloma, as
further defined in the below proposed
notes to new DC 7712, would therefore
be rated at 100 percent. VA proposes the
following notes to new DC 7712 based
on the most recently updated diagnostic
criteria staging system of the
International Diagnostic Working Group
of 2014. See S. Rajkumar, M.D.,
‘‘International Myeloma Working Group
updated criteria for the diagnosis of
multiple myeloma,’’ 15(12) Lancet
Oncol. e538 (2014).
The first note would state the
following: ‘‘Symptomatic myeloma
requires an elevated serum or urine M
(monoclonal) protein value (however no
specific concentration is required for
diagnosis) or presence of increased bone
marrow clonal plasma cells ≥10%.
There must be also evidence of related
organ tissue impairment (ROTI) due to
the plasma cell proliferation. This
process is manifested by elevated serum
calcium, renal failure, anemia, and bone
lesions (CRAB). The corresponding
laboratory values are: Serum calcium
≥11.5 mg/100 mL, renal insufficiency
with creatinine clearance <40 cc/min or
serum creatinine >1.73 mmol/L,
normochromic, normocytic anemia with
a hemoglobin value >2 g/100 mL below
the lower limit of normal, or a
hemoglobin value <10 g/100 mL, lytic
lesions (one or more osteolytic lesions
by radiographic or other imaging
system), severe osteopenia, or
pathologic bone fractures. A small
percentage of patients with symptomatic
myeloma have no detectable M-protein
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in serum or urine but do have myelomarelated organ impairment ROTI and
increased bone marrow plasma cells.
Any of the following validated
biomarkers of malignancy are acceptable
for the diagnosis of MM, including
clonal bone marrow plasma cells ≥60%,
serum free light chain ratio ≥100, or free
light chain ≥100 mg/L, or more than one
focal bone or bone marrow lesion on
MRI >5 mm in size.’’
The second note would state the
following: ‘‘A nonsecretory myeloma (a
variant form of symptomatic myeloma)
shows absent M-protein in the serum
and urine, bone marrow plasmacytosis,
and ROTI. While this group of patients
represents a minority of cases (1–2%),
this uncommon presentation may lead
to delay in diagnosis because of the
scarcity of laboratory findings
commonly in the face of an isolated
bone process such as low back pain.’’
The third note would state the
following: ‘‘The diagnostic criteria for
asymptomatic (smoldering or indolent)
myeloma requires the following two
criteria: (1) An elevated serum
monoclonal protein (IgG or IgA) >30
g/L, urine monoclonal protein >500 mg/
24 hrs. or clonal bone marrow plasmal
cells 10%–60%, and (2) absence of
myeloma defining events or amyloidosis
without any related organ or tissue
impairment (ROTI) or end-organ
damage. There is usually normal serum
calcium, hemoglobin, and serum
creatinine, and no bone lesions on full
skeletal survey and no evidence of
amyloidosis or light chain deposition
disease.’’
Multiple myeloma is incurable, and
carries a poor prognosis. Therefore, VA
proposes Note (4), which would state
that the 100-percent evaluation shall
continue for five years after the
diagnosis of symptomatic multiple
myeloma, at which time the appropriate
disability evaluation shall be
determined by mandatory VA
examination. It would also state that any
reduction in evaluation based upon that
or any subsequent examination shall be
subject to the provisions of 38 CFR
3.105(e) and 3.344 (a) and (b).
DC 7714 (Sickle Cell Anemia)
Sickle cell anemia is currently
evaluated at levels of 100, 60, 30, and
10 percent. The current 100-percent
evaluation criteria are: ‘‘With repeated
painful crises, occurring in skin, joints,
bones or any major organs caused by
hemolysis and sickling of red blood
cells, with anemia, thrombosis and
infarction, with symptoms precluding
even light manual labor.’’ VA proposes
at the 100-percent level to change the
term ‘‘painful crises’’ to ‘‘painful
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46893
episodes’’ in keeping with current
medical terminology, to insert the word
‘‘residual’’ before the word
‘‘symptoms,’’ and to change punctuation
to clarify meaning. The 100 percent
category would also require at least 4 or
more painful episodes in the past 12
months for clarification purposes.
The current 60-percent evaluation
criteria are: ‘‘With painful crises several
times a year or with symptoms
precluding other than light manual
labor.’’ As in the 100-percent evaluation
criteria, VA proposes to change the term
‘‘painful crises’’ to ‘‘painful episodes.’’
To remove ambiguity, we also propose
replacement of the phrase ‘‘With painful
crises several times a year’’ with
‘‘Averaging 3 or more painful episodes
per 12-month period.’’
The current 30-percent evaluation
criterion is: ‘‘Following repeated
hemolytic sickling crises with
continuing impairment of health.’’ VA
proposes to replace ‘‘Following repeated
hemolytic sickling crises with
continuing impairment of health’’ with
‘‘Averaging 1 or 2 painful episodes per
12-month period’’ in order to make the
criterion less ambiguous and promote
consistent evaluations. VA proposes no
change in the current 10-percent
evaluation criteria of ‘‘Asymptomatic,
established case in remission, but with
identifiable organ impairment,’’ and
only an editorial change in the note
under this DC to reflect the fact that the
former Compensation and Pension
Service has been reorganized as the
Compensation Service and the Pension
and Fiduciary Service.
DC 7715 (Non-Hodgkin’s Lymphoma)
Currently, non-Hodgkin’s lymphoma
(NHL), DC 7715, is evaluated at 100
percent for active disease or during a
treatment phase. VA proposes to modify
the current note under DC 7715 with
some non-substantive changes and by
extending the allowable time required
for mandatory examination from six
months to 2 years, as provided in the
proposed note to DC 7715. This is based
upon current medical information
suggesting that recurrences in nonHodgkin’s lymphoma are very high,
with common tumor recurrences within
or after the period that mandates
lowering of disability rating for
treatment completion or apparent
remission of 6 months. Data on relapsed
aggressive NHL: https://
www.texasoncology.com/types-ofcancer/non-hodgkins-lymphoma/
intermediate-grade-aggressive-gradenhl/relapsed-aggressive-nhl/). VA also
proposes to modify the criteria as,
‘‘When there is active disease, during
treatment phase or with indolent and
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Proposed DC 7724 (Solitary
Plasmacytoma)
non-contiguous phase of low grade
NHL.’’ See National Cancer Institute
Adult NHL PDQ treatment Update
(https://www.cancer.gov/cancertopics/
pdq/treatment/adult-non-hodgkins/
HealthProfessional/page9#_195_toc
(Dec. 2014).
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DC 7716 (Aplastic Anemia)
Aplastic anemia, DC 7716, is
currently evaluated at levels of 100, 60,
30, and 10 percent. The current 100percent evaluation criteria are:
‘‘Requiring bone marrow transplant, or;
requiring transfusion of platelets or red
cells at least once every six weeks, or;
infections recurring at least once every
six weeks.’’ VA proposes to expand
‘‘bone marrow transplant’’ to
‘‘peripheral blood or bone marrow stem
cell transplant,’’ as either may be used
for treatment. In addition, VA proposes
to add the phrase ‘‘on average’’ to the
specific numbers of platelet or red cell
transfusions required and to the
frequency of recurring infections, and to
add ‘‘per 12-month period’’ to promote
consistent evaluations at the 100-, 60-,
and 30-percent levels.
The current 60-percent criteria are:
‘‘Requiring transfusion of platelets or
red cells at least once every three
months, or; infections recurring at least
once every three months.’’ Continuous
immunosuppressive therapy is currently
a standard treatment option for aplastic
anemia. A. Bacigalupo, ‘‘Diagnosis and
treatment of acquired aplastic anemia,’’
23(2) Hematol Oncol. Clinical N. Am.
159 (2009). We therefore propose to add,
‘‘using continuous immunosuppressive
therapy’’ as an alternative criterion for
the 60-percent level. VA also proposes
the changes described above for the 100percent criteria concerning adding ‘‘on
average’’ and ‘‘per 12-month period.’’
The current 30-percent evaluation
criteria are: ‘‘Requiring transfusion of
platelets or red cells at least once per
year but less than once every three
months, or; infections recurring at least
once per year but less than once every
three months.’’ VA proposes only the
changes described above for the 100percent criteria concerning adding ‘‘on
average’’ and ‘‘per 12-month period.’’
The current 10-percent criterion is
‘‘Requiring continuous medication for
control.’’ VA proposes to delete this
evaluation level as the medications used
to treat aplastic anemia warrant higher
levels of evaluation.
VA proposes a change in the note
following this DC stating that a 100percent evaluation will be provided for
either peripheral blood or bone marrow
stem cell transplant. The reminder of
the note is otherwise unchanged.
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Solitary bone or extramedullary
(occurring in soft tissue outside of the
bone marrow) plasmacytomas are
malignant plasma cell neoplasms that
are closely related to multiple myeloma.
A solitary bone plasmacytoma develops
into multiple myeloma in 50 to 60
percent of cases, and into an
extramedullary plasmacytoma in 10 to
30 percent of cases. A solitary
plasmacytoma that remains solitary has
a better prognosis than multiple
myeloma and may be curable. VA
proposes to rate solitary plasmacytomas
similarly to other malignant neoplasms
that are potentially curable. VA
proposes to rate solitary plasmacytoma
at 100 percent when there is active
disease or during a treatment phase and
to add Note (1) to state that a 100percent evaluation shall continue
beyond the cessation of any surgical
therapy, radiation therapy,
antineoplastic chemotherapy, or other
therapeutic procedures (including
autologous stem cell transplantation),
and that six months after
discontinuance of such treatment, the
appropriate disability rating shall be
determined by mandatory VA
examination. The note would also state
that any change in evaluation based
upon that or any subsequent
examination shall be subject to the
provisions of 38 CFR 3.105(e) and that,
if there has been no recurrence, to rate
residuals under the appropriate
diagnostic codes.
VA proposes to add Note (2) to
remind rating specialists of the potential
for the transformation of solitary
plasmacytomas into multiple myeloma.
VA also proposes to add Note (3) to
remind rating specialists of the residual
effects of a solitary plasmacytoma and
the adverse effects of medical treatment.
Proposed DC 7725 (Myelodysplastic
Syndromes)
VA proposes to add a new DC 7725
for myelodysplastic syndromes because
these conditions are relatively common
in veterans and do not have a diagnostic
code under which they can be
appropriately evaluated. These
syndromes, sometimes called ‘‘preleukemia’’ in the past, are a group of
disorders associated with bone marrow
dysfunction, in which healthy and
mature red blood cells, white blood
cells, and platelets are not produced.
Therefore, there may be a deficiency of
any type of blood cell. About one-third
of those with myelodysplastic
syndromes progress to acute
myelogenous leukemia in months or
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years. Some types of myelodysplastic
syndromes are primary, in which there
is no known cause for the syndromes,
and others are secondary types, which
develop after treatment with
chemotherapy or radiation therapy for
other diseases. The classification of
these disorders is complex and differs
among different medical organizations.
Treatment depends in part on the
specific disorder but also on many other
factors. The mean overall survival time
for these conditions is 6 months to 6
years.
VA proposes to evaluate
myelodysplastic syndromes based on
type and frequency of treatment and
number of infections per 12-month
period. VA also proposes to include in
the evaluation criteria treatment with
biologic therapy, either interferon alpha
on an ongoing basis or erythropoiesisstimulating agent (ESA) to boost red
blood cell production. These treatments
are used in some types of
myelodysplastic disorders. VA proposes
to provide evaluation levels of 100, 60,
and 30 percent. VA proposes to assign
100 percent for either of the following:
Requiring peripheral blood or bone
marrow stem cell transplant, or
requiring chemotherapy (including
hypomethylating agents and
immunmodulators, e.g., lenalidomide).
VA proposes to assign 60 percent for
either of the following: Requiring, on
average, 4 or more blood or platelet
transfusions per 12-month period, or
infections requiring hospitalization, on
average, 3 or more times per 12-month
period. VA proposes to assign 30
percent for any of the following:
Requiring, on average, 1 to 3 blood or
platelet transfusions per 12-month
period, infections requiring
hospitalization, on average, 1 to 2 times
per 12-month period; or requiring
biologic therapy, either interferon alpha
on an ongoing basis or erythropoiesis
stimulating agent (ESA) for up to 12
weeks per 12-month period.
VA also proposes to add Note (1)
stating that if this condition progresses
to leukemia, to evaluate it as leukemia
under DC 7703 and Note (2) stating that
a 100-percent evaluation shall be
assigned as of the date of hospital
admission for peripheral blood or bone
marrow stem cell transplant, or during
the period of treatment with
chemotherapy and shall continue with a
mandatory VA examination six months
following hospital discharge or, in the
case of radioactive phosphorus or
chemotherapy treatment, six months
after completion of treatment. Note (2)
would also state that any reduction in
evaluation based upon that or any
subsequent examination shall be subject
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to the provisions of 38 CFR 3.105(e) and
that, if there has been no recurrence,
residuals will be rated under the
appropriate diagnostic codes.
Proposed Changes to Appendices A, B,
and C to Part 4
VA proposes to amend appendices A,
B, and C to reflect the above-noted
proposed changes. In appendix A to part
4, § 4.117, remove diagnostic code 7700,
revise diagnostic codes 7702–7705,
7709, and 7714–7716, and add
diagnostic codes 7718–7725.
In appendix B to part 4, revise the
title from ‘‘The Hemic and Lymphatic
Systems’’ to ‘‘The Hematologic and
Lymphatic Systems’’, remove diagnostic
code 7700 and its disability entry, revise
the section heading and the disability
entry for diagnostic codes 7702, 7705
and 7709, and add disability codes and
disability entries for 7712 and 7718–
7725.
In appendix C to part 4, convert the
existing entry for ‘‘Anemia’’ into a new
section titled ‘‘Anemia’’, remove
diagnostic code 7700 and its disability
entry and insert diagnostic codes 7720–
7723 and their disability entries in that
section; revise the disability entry for
diagnostic codes 7702, 7705 and 7709;
create a new section titled
‘‘Hematologic’’ and insert diagnostic
codes 7705, 7712, 7718, 7724 and 7725
and their disability entries in that
section; and convert the existing entry
for leukemia into a new section titled
‘‘Leukemia’’ and insert diagnostic codes
7703 and 7719 into that section.
Paperwork Reduction Act
This document contains no provisions
constituting a collection of information
under the Paperwork Reduction Act (44
U.S.C. 3501–3521).
mstockstill on DSK4VPTVN1PROD with PROPOSALS
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. 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.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess the costs and
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benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, and other advantages;
distributive impacts; and equity).
Executive Order 13563 (Improving
Regulation and Regulatory Review)
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility. Executive Order
12866 (Regulatory Planning and
Review) defines a ‘‘significant
regulatory action,’’ which requires
review by the Office of Management and
Budget, as ‘‘any regulatory action that is
likely to result in a rule that may: (1)
Have an annual effect on the economy
of $100 million or more or adversely
affect in a material way the economy, a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency; (3)
Materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) Raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in this Executive
Order.’’
The economic, interagency,
budgetary, legal, and policy
implications of this regulatory action
has 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
https://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 https://www1.va.gov/orpm/, by
following the link for ‘‘VA Regulations
Published.’’
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
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private sector, of $100 million or more
(adjusted annually for inflation) in any
year. This proposed rule would have no
such effect on State, local, and tribal
governments, or on the private sector.
Catalog of Federal Domestic Assistance
Numbers and Titles
The Catalog of Federal Domestic
Assistance program numbers and titles
for this proposal are 64.104, Pension for
Non-Service-Connected Disability for
Veterans, and 64.109, Veterans
Compensation for Service-Connected
Disability.
Signing Authority
The Secretary of Veterans Affairs, or
designee, approved this document and
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs.
Robert L. Nabors II, Chief of Staff,
Department of Veterans Affairs,
approved this document on July 30,
2015, for publication.
List of Subjects in 38 CFR Part 4
Disability benefits, Pensions,
Veterans.
Dated: July 31, 2015.
Jeffrey M. Martin,
Office Program Manager, Office of Regulation
Policy & Management, Office of the General
Counsel, Department of Veterans Affairs.
For the reasons set out in the
preamble, VA proposes to amend 38
CFR part 4, subpart B, to read as
follows:
PART 4—SCHEDULE FOR RATING
DISABILITIES
Subpart B—Disability Ratings
1. The authority citation for part 4
continues to read as follows:
■
Authority: 38 U.S.C. 1155, unless
otherwise noted.
2. Revise the undesignated center
heading preceding § 4.117 to read as
follows:
■
The Hematologic and Lymphatic
Systems
■
3. Revise § 4.117 to read as follows:
§ 4.117 Schedule of ratings—hematologic
and lymphatic systems.
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7702 Agranulocytosis, acquired:
Requiring bone marrow transplant or infections recurring, on average, at least once every six weeks per 12-month period ............
Requiring intermittent myeloid growth factors (granulocyte colony-stimulating factor (G–CSF) or granulocyte-macrophage colonystimulating factor (GM–CSF)) or continuous immunosuppressive therapy such as cyclosporine to maintain absolute neutrophil
count (ANC) greater than 500/μl but less than 1,000/μl; or infections recurring, on average, at least once every three months
per 12-month period ...........................................................................................................................................................................
Requiring intermittent myeloid growth factors to maintain ANC greater than 1,000/μl; or infections recurring, on average, at least
once per 12-month period but less than once every three months per 12-month period .................................................................
Requiring continuous medication (e.g., antibiotics) for control; or requiring intermittent use of a myeloid growth factor to maintain
ANC greater than or equal to 1,500/μl ...............................................................................................................................................
Note: A 100-percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue
with a mandatory VA examination six months following hospital discharge. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter.
7703 Leukemia (except for chronic myelogenous leukemia):
When there is active disease or during a treatment phase ...................................................................................................................
Otherwise rate residuals under the appropriate diagnostic code(s).
Chronic lymphocytic leukemia or monoclonal B-cell lymphocytosis (MBL), asymptomatic, Rai Stage 0 .............................................
Note (1): A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, 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 § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals.
Note (2): Evaluate symptomatic chronic lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as any other leukemia evaluated under this diagnostic code.
Note (3): Evaluate residuals of leukemia or leukemia therapy under the appropriate diagnostic code(s). Myeloproliferative Disorders:
(Diagnostic Codes 7704, 7718, 7719).
7704 Polycythemia vera:
Requiring peripheral blood or bone marrow stem-cell transplant or treatment with radioactive phosphorus or chemotherapy (including myelosuppressants) ...............................................................................................................................................................
Requiring phlebotomy 6 or more times per 12-month period to control RBC count or if requiring radioactive phosphorous treatment, chemotherapy, or targeted agents such as imatinib or ruxolitinib ...........................................................................................
Requiring phlebotomy 4–5 times per 12-month period or if requiring continuous biologic therapy or myelosuppresive agents to
maintain platelets <200,000 or white blood cells (WBC) <12,000 .....................................................................................................
Requiring phlebotomy, biologic therapy, or interferon on an intermittent basis, as needed, 3 or fewer times per 12-month period ...
Note (1): Rate complications such as hypertension, gout, stroke, or thrombotic disease separately.
Note (2): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703.
Note (3): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem
cell transplant; or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). Six
months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation
based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter.
7705 Immune thrombocytopenia:
Requiring chemotherapy for chronic refractory thrombocytopenia or a platelet count from 20,000 to 30,000 despite treatment .......
Requiring immunosuppressive therapy or for a platelet count higher than 30,000 but not higher than 50,000, with history of hospitalization because of severe bleeding requiring intravenous immune globulin, high-dose parenteral corticosteroids, and platelet transfusions ....................................................................................................................................................................................
Platelet count higher than 30,000 but not higher than 50,000, with either immune thrombocytopenia or mild mucous membrane
bleeding which requires oral corticosteroid therapy or intravenous immune globulin .......................................................................
Platelet count higher than 30,000 but not higher than 50,000, not requiring treatment .......................................................................
Platelet count above 50,000 and asymptomatic, or for immune thrombocytopenia in remission. ........................................................
Note (1): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under this diagnostic code.
Note (2): A 100-percent evaluation shall continue beyond the cessation of chemotherapy. Six months after discontinuance of such
treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based
upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter.
7706 Splenectomy .......................................................................................................................................................................................
Note: Separately rate complications such as systemic infections with encapsulated bacteria.
7707 Spleen, injury of, healed.
Rate for any residuals.
7709 Hodgkin’s lymphoma:
With active disease or during a treatment phase ..................................................................................................................................
Note: A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, 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 reduction in evaluation based upon that or any subsequent examination shall be
subject to the provisions of § 3.105(e) of this chapter. If there has been no local recurrence or metastasis, rate on residuals under
the appropriate diagnostic code(s).
7710 Adenitis, tuberculous, active or inactive.
Rate under § 4.88c or 4.89 of this part, whichever is appropriate.
7712 Multiple myeloma:
Symptomatic multiple myeloma ..............................................................................................................................................................
Asymptomatic (smoldering or indolent) ..................................................................................................................................................
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Note (1): Symptomatic myeloma requires, (i) an elevated serum or urine M (monoclonal) protein value (however no specific concentration is required for diagnosis), or (ii) presence of increased bone marrow clonal plasma cells ≥10%. There must be also evidence of related organ tissue impairment (ROTI) due to the plasma cell proliferation. This process is manifested by elevated serum
calcium, renal failure, anemia, and bone lesions (CRAB). The corresponding laboratory values are: Serum calcium ≥11.5 mg/100
mL, renal insufficiency with creatinine clearance <40 cc/min or serum creatinine >1.73 mmol/L, normochromic, normocytic anemia
with a hemoglobin value >2 g/100 mL below the lower limit of normal, or a hemoglobin value <10 g/100 mL, lytic lesions (one or
more osteolytic lesions by radiographic or other imaging system) severe osteopenia, or pathologic bone fractures. A small percentage of patients with symptomatic myeloma have no detectable M-protein in serum or urine but do have myeloma-related organ impairment ROTI and increased bone marrow plasma cells. Any of the following validated biomarkers of malignancy are acceptable
for the diagnosis of MM, including clonal bone marrow plasma cells ≥60%, serum free light chain ratio of ≥100, or free light chain of
≥100 mg/L, or more than one focal bone or bone marrow lesion on MRI >5 mm in size.
Note (2): A nonsecretory myeloma (a variant form of symptomatic myeloma) shows absent M-protein in the serum and urine, bone
marrow plasmacytosis, and ROTI. While this group of patients represents a minority of cases (1–2%), this uncommon presentation
may lead to delay in diagnosis because of the scarcity of laboratory findings commonly in the face of an isolated bone process
such as low back pain.
Note (3): The diagnostic criteria for asymptomatic (smoldering or indolent) myeloma requires the following two criteria: (1) An elevated
serum monoclonal protein (IgG or IgA) >30 g/L, urine monoclonal protein >500 mg/24 hrs., or clonal bone marrow plasma cells
10%–60%, and (2) absence of myeloma defining events of amyloidosis without any related organ or tissue impairment (ROTI) or
end-organ damage. There is usually normal serum calcium, hemoglobin, and serum creatinine, and no bone lesions on full skeletal
survey and no evidence of amyloidosis or light chain deposition disease.
Note (4): The 100-percent evaluation shall continue for five years after the diagnosis of symptomatic multiple myeloma, at which time
the appropriate disability evaluation shall be determined by mandatory VA examination. Any reduction in evaluation based upon that
or any subsequent examination shall be subject to the provisions of § 3.105(e) and § 3.344 (a) and (b) of this chapter.
7714 Sickle cell anemia:
With at least 4 or more painful episodes per 12-month period, occurring in skin, joints, bones, or any major organs, caused by
hemolysis and sickling of red blood cells, with anemia, thrombosis, and infarction, with residual symptoms precluding even light
manual labor .......................................................................................................................................................................................
Averaging 3 or more painful episodes per 12-month period or with symptoms precluding other than light manual labor ..................
Averaging 1 or 2 painful episodes per 12-month period .......................................................................................................................
Asymptomatic, established case in remission, but with identifiable organ impairment .........................................................................
Note: Sickle cell trait alone, without a history of directly attributable pathological findings, is not a ratable disability. Cases of symptomatic sickle cell trait will be forwarded to the Director, Compensation Service, for consideration under § 3.321(b)(1) of this chapter.
7715 Non-Hodgkin’s lymphoma:
When there is active disease, during treatment phase or with indolent and non-contiguous phase of low grade NHL ......................
Note: A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Two years after discontinuance of such treatment, the appropriate disability rating shall be
determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be
subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals under the appropriate diagnostic code(s).
7716 Aplastic anemia:
Requiring peripheral blood or bone marrow stem cell transplant; or requiring transfusion of platelets or red cells, on average, at
least once every six weeks per 12-month period; or infections recurring, on average, at least once every six weeks per 12month period .......................................................................................................................................................................................
Requiring transfusion of platelets or red cells, on average, at least once every three months per 12-month period; or infections recurring, on average, at least once every three months per 12-month period; or using continuous immunosuppressive therapy ...
Requiring transfusion of platelets or red cells, on average, at least once per 12-month period, but less than once every three
months per 12-month period; or infections recurring, on average, at least once per 12-month period, but less than once every
three months per 12-month period .....................................................................................................................................................
Note: A 100-percent evaluation for peripheral blood or bone marrow stem cell transplant shall be assigned as of the date of hospital
admission and shall continue with a mandatory VA examination six months following hospital discharge. Any change in evaluation
based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter.
7718 Essential thrombocythemia and primary myelofibrosis
Requiring either continuous myelosuppressive therapy or, for six months following hospital admission, peripheral blood or bone
marrow stem cell transplant, or treatment with radioactive phosphorus or chemotherapy (including myelosuppressants) .............
Requiring continuous or intermittent myelosuppressive therapy to maintain platelet count <500 × 109/L ...........................................
Requiring continuous or intermittent myelosuppressive therapy to maintain platelet count of 200,000–400,000, or white blood cell
(WBC) count of 4,000–10,000 ............................................................................................................................................................
Asymptomatic .........................................................................................................................................................................................
Note (1): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703.
Note (2): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem
cell transplant; or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). Six
months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation
based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter.
7719 Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia):
Requiring peripheral blood or bone marrow stem cell transplant, or continuous myelosuppressive or immunosuppressive therapy
treatment .............................................................................................................................................................................................
Requiring intermittent myelosuppressive therapy, or targeted therapy with tyrosine kinase inhibitors, or interferon treatment ..........
In apparent remission on continuous targeted therapy with tyrosine kinase inhibitors .........................................................................
Note (1): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703.
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Note (2): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem
cell transplant; or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). Six
months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation
based upon that or any subsequent examination shall be subject to the provisions of § 3.105 of this chapter.
7720 Iron deficiency anemia:
Requiring intravenous iron infusions on average 4 or more times per 12-month period ......................................................................
Requiring continuous treatment with high-dose oral supplementation ..................................................................................................
Asymptomatic or requiring treatment only by dietary modification ........................................................................................................
Note: Do not evaluate iron deficiency anemia due to blood loss under this diagnostic code. Evaluate iron deficiency anemia due to
blood loss under the criteria for the condition causing the blood loss.
7721 Folic acid deficiency:
Requiring continuous treatment with high-dose oral supplementation ..................................................................................................
Asymptomatic or requiring treatment only by dietary modification ........................................................................................................
7722 Pernicious anemia and Vitamin B12 deficiency anemia:
For initial diagnosis requiring transfusion due to severe anemia, or if there are signs or symptoms related to central nervous system impairment, such as encephalopathy, myelopathy, or severe peripheral neuropathy, requiring parenteral B12 therapy ..........
Requiring continuous treatment with Vitamin B12 injections, Vitamin B12 sublingual or high-dose oral tablets, or Vitamin B12 nasal
spray or gel .........................................................................................................................................................................................
Note: A 100-percent evaluation for pernicious anemia and Vitamin B12 deficiency shall be assigned as of the date of the initial diagnosis requiring transfusion due to severe anemia or parenteral B12 therapy and shall continue with a mandatory VA examination six
months following hospital discharge or cessation of parenteral B12 therapy. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Thereafter, evaluate at 10-percent and separately evaluate any residual effects of pernicious anemia, such as neurologic involvement causing peripheral neuropathy, myelopathy, dementia, or related gastrointestinal residuals, under the most appropriate diagnostic code.
7723 Acquired hemolytic anemia:
Requiring a bone marrow transplant or continuous intravenous or immunosuppressive therapy (e.g., prednisone, Cytoxan,
azathioprine, or rituximab) ..................................................................................................................................................................
Requiring immunosuppressive medication an average of 4 or more times per 12-month period ........................................................
Requiring an average of 2–3 courses of immunosuppressive therapy per 12-month period ...............................................................
Requiring an average of one course of immunosuppressive therapy per 12-month period .................................................................
Asymptomatic .........................................................................................................................................................................................
Note (1): A 100-percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue for six months after hospital discharge with a mandatory VA examination six months following hospital discharge. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter.
Note (2): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under diagnostic code 7723.
7724 Solitary plasmacytoma:
Solitary plasmacytoma, when there is active disease or during a treatment phase .............................................................................
Note (1): A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic
chemotherapy, or other therapeutic procedures (including autologous stem cell transplantation). 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 § 3.105(e) of this chapter. If there has been no recurrence, rate residuals under the appropriate diagnostic codes.
Note (2): Rate a solitary plasmacytoma that has developed into multiple myeloma as symptomatic multiple myeloma.
Note (3): Rate residuals of plasma cell dysplasia (e.g., thrombosis) and adverse effects of medical treatment (e.g., neuropathy) under
the appropriate diagnostic codes.
7725 Myelodysplastic syndromes:
Requiring peripheral blood or bone marrow stem cell transplant; or requiring chemotherapy .............................................................
Requiring, on average, 4 or more blood or platelet transfusions per 12-month period; or infections requiring hospitalization, on average, 3 or more times per 12-month period .....................................................................................................................................
Requiring, on average, 1 to 3 blood or platelet transfusions per 12-month period; infections requiring hospitalization, on average,
1 to 2 times per 12-month period; or requiring biologic therapy, either interferon alpha on an ongoing basis or erythropoiesis
stimulating agent (ESA) for 12 weeks or less per 12-month period ..................................................................................................
Note (1): If the condition progresses to leukemia, evaluate as leukemia under diagnostic code 7703.
Note (2): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem
cell transplant, or during the period of treatment with chemotherapy and shall continue with a mandatory VA examination six
months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of
§ 3.105(e) of this chapter. If there has been no recurrence, residuals will be rated under the appropriate diagnostic codes.
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a. Revising the entries for diagnostic
codes 7700, 7702 through 7705, 7709,
7712, and 7714 through 7716; and
■ b. Adding entries for diagnostic codes
7718 through 7725.
■
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The revisions and additions read as
follows:
APPENDIX A TO PART 4—TABLE OF AMENDMENTS AND EFFECTIVE DATES SINCE 1946
Diagnostic
Code No.
Sec.
*
4.117 ...
7700
*
7702
7703
7704
7705
*
*
*
Removed [effective date of final rule].
*
*
*
*
*
*
*
*
*
*
Evaluation October 23, 1995; title [effective date of final rule]; evaluation [effective date of final rule].
Evaluation August 23, 1948; criterion October 23, 1995; evaluation [effective date of final rule]; criterion [effective
date of final rule].
Evaluation October 23, 1995; evaluation [effective date of final rule].
Evaluation October 23, 1995; title [insert effective date of final rule]; evaluation [effective date of final rule]; criterion
[effective date of final rule].
7709
*
*
*
*
*
*
Evaluation March 10, 1976; criterion October 23, 1995; title [effective date of final rule]; criterion [effective date of
final rule].
7712
*
*
Added [effective date of final rule].
*
*
*
*
*
Added September 9, 1975; criterion October 23, 1995; criterion [effective date of final rule]
Added October 26, 1990; criterion [effective date of final rule].
Added October 23, 1995; evaluation [effective date of final rule]; criterion [effective date of final rule].
*
7714
7715
7716
7718
7719
7720
7721
7722
7723
7724
7725
*
Added
Added
Added
Added
Added
Added
Added
Added
*
*
*
*
[effective
[effective
[effective
[effective
[effective
[effective
[effective
[effective
date
date
date
date
date
date
date
date
*
of final
of final
of final
of final
of final
of final
of final
of final
*
*
4. Amend appendix B to part 4 by:
a. Revising the undesignated center
heading immediately preceding
diagnostic code 7700;
*
*
*
*
*
*
*
*
*
*
rule].
rule].
rule].
rule].
rule].
rule].
rule].
rule].
*
■
■
*
b. Removing the entry for diagnostic
code 7700;
■ c. Revising the entries for diagnostic
codes 7702, 7705 and 7709; and
d. Adding entries for diagnostic codes
7712 and 7718 through 7725.
The revisions and additions read as
follows:
■
■
APPENDIX B TO PART 4—NUMERICAL INDEX OF DISABILITIES
Diagnostic Code No.
*
*
*
*
*
*
*
THE HEMATOLOGIC AND LYMPHATIC SYSTEMS
Agranulocytosis, acquired.
*
*
7705 .........................................................
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7702 .........................................................
*
*
Immune thrombocytopenia.
*
*
*
*
*
7709 .........................................................
*
Hodgkin’s lymphoma.
*
*
*
*
*
*
7712 .........................................................
*
Multiple myeloma.
*
*
*
*
*
*
7718 .........................................................
*
*
*
Essential thrombocythemia and primary myelofibrosis.
*
*
*
*
7719 .........................................................
*
*
*
*
*
Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia).
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APPENDIX B TO PART 4—NUMERICAL INDEX OF DISABILITIES—Continued
Diagnostic Code No.
7720
7721
7722
7723
7724
7725
.........................................................
.........................................................
.........................................................
.........................................................
.........................................................
.........................................................
*
Iron deficiency anemia.
Folic acid deficiency.
Pernicious anemia and Vitamin B12 deficiency anemia.
Acquired hemolytic anemia.
Solitary plasmacytoma.
Myelodysplastic syndromes.
*
*
5. Amend appendix C to part 4 by:
a. Revising the entries for
Agranulocytosis and Anemia;
■ c. Adding an entry for Hematologic in
alphabetical order;
■
■
*
*
d. Removing the entry for Hodgkin’s
disease and adding in its place an entry
for Hodgkin’s lymphoma;
■ e. Revising the entry for Leukemia;
■
*
*
The revisions and additions read as
follows:
APPENDIX C TO PART 4—ALPHABETICAL INDEX OF DISABILITIES
Diagnostic Code
No.
*
*
*
*
*
*
Agranulocytosis, acquired ..............................................................................................................................................................
*
*
*
*
*
*
*
Anemia:
Acquired hemolytic anemia ....................................................................................................................................................
Folic acid deficiency ...............................................................................................................................................................
Iron deficiency anemia ...........................................................................................................................................................
Pernicious anemia and Vitamin B12 deficiency anemia .........................................................................................................
*
*
*
*
*
*
*
Hematologic:
Essential thrombocythemia and primary myelofibrosis ..........................................................................................................
Immune thrombocytopenia .....................................................................................................................................................
Multiple myeloma ....................................................................................................................................................................
Myelodysplastic syndromes ....................................................................................................................................................
Solitary plasmacytoma ...........................................................................................................................................................
*
*
*
*
*
*
*
Hodgkin’s lymphoma .....................................................................................................................................................................
*
*
*
*
*
*
*
Leukemia:
Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia) .................................
Leukemia ................................................................................................................................................................................
*
*
*
*
*
ACTION:
[FR Doc. 2015–19197 Filed 8–5–15; 8:45 am]
*
Proposed rule.
This document proposes
updates to the rules that govern the
evaluation and approval of RF devices.
The Commission last comprehensively
reviewed its equipment authorization
procedures more than fifteen years ago.
The RF equipment ecosystem has
significantly expanded in that time, and
the manner in which today’s RF
equipment is now designed,
manufactured, and marketed—as well as
the sheer number of devices subject to
authorization—warrant the proposed
rule modifications.
FEDERAL COMMUNICATIONS
COMMISSION
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47 CFR Parts 0, 2, 15, and 18
[ET Docket No. 15–170; RM–11673; FCC 15–
92]
Equipment Authorization and
Electronic Labeling for Wireless
Devices
Federal Communications
Commission.
AGENCY:
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7723
7721
7720
7722
7718
7705
7712
7725
7724
7709
7719
7703
*
Comments must be filed on or
before September 8, 2015, and reply
comments must be filed on or before
September 21, 2015.
FOR FURTHER INFORMATION CONTACT:
Brian Butler, Office of Engineering and
Technology, (202) 418–2702, email:
Brian.Butler@fcc.gov., TTY (202) 418–
2989.
ADDRESSES: You may submit comments,
identified by ET Docket No. 15–170;
RM–11673, by any of the following
methods:
• Federal Communications
Commission’s Web site: https://
apps.fcc.gov/ecfs//. Follow the
instructions for submitting comments.
DATES:
BILLING CODE 8320–01–P
SUMMARY:
*
7702
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Agencies
[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Proposed Rules]
[Pages 46888-46900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19197]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 4
RIN 2900-AO19
Schedule for Rating Disabilities: The Hematologic and Lymphatic
Systems
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) proposes to amend the
portion of the VA Schedule for Rating Disabilities (Rating Schedule)
that addresses the hematologic and lymphatic systems. The intended
effect of this change is to incorporate medical advances that have
occurred since the last review, update medical terminology, add medical
conditions not currently in the Rating Schedule, and refine criteria
for further clarity and ease of rater application.
DATES: Comments must be received by VA on or before October 5, 2015.
ADDRESSES: Written comments may be submitted through
www.Regulations.gov; by mail or hand-delivery to the Director,
Regulation Policy and Management (02REG), Department of Veterans
Affairs, 810 Vermont Ave. 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-AO19--Schedule for Rating Disabilities: The
Hematologic and Lymphatic Systems. 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: Nick Olmos-Lau, M.D., Medical Officer
(211C), Compensation Service, Veterans Benefits Administration,
Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC
20420, (202) 461-9695. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: As part of our ongoing revision of the VA
Schedule for Rating Disabilities (Rating Schedule), we are proposing
changes to 38 CFR 4.117, Schedule of ratings--hemic and lymphatic
systems, and appendices A, B, and C of part 4 pertaining to this
section. This section was last updated in 1995. By these revisions, we
aim to update medical terminology; add medical conditions not currently
in the Rating Schedule; and revise the rating criteria to reflect
medical advances and to clarify them for ease of application.
Proposed Title Change: The Hematologic and Lymphatic Systems
``Hemic'' is an adjective previously used to describe diseases of
or related to the blood. The current medical term for diseases of the
blood or blood-forming organs is ``hematologic.'' In addition, the 2013
National Library of Medicine-Medical Subject Headings (MESH) descriptor
advisory discourages the use of the term ``hemic'' as too general, and
recommends instead the use of the term ``hematologic'' as more specific
(https://www.nlm.nih.gov/cgi/mesh/2013/MB_cgi?mode=&index=6154&field=all&HM=&II=&PA=&form=&input=).
VA therefore proposes to edit the header of Sec. 4.117 to ``The
Hematologic and Lymphatic Systems'' and the title of Sec. 4.117 to
``Schedule of ratings--hematologic and lymphatic systems.''
Modification and Reorganization of Current Diagnostic Code (DC) 7700
(Anemia, Hypochromic-Microcytic and Megaloblastic, Such as Iron-
Deficiency and Pernicious Anemia)
Anemia is predominantly hereditary or secondary, a symptom of
another condition. Secondary anemia is corrected by treatment of the
underlying condition. Examples of conditions that cause secondary
anemia include osteomyelitis (DC 5000) and hypothyroidism (DC 7903).
Anemia is most appropriately evaluated as part of the underlying
service-connected disability causing the anemia. VA proposes to address
in proposed DCs 7720, 7721, 7722, and 7723 anemias that are neither
hereditary nor addressed under DCs for the causative conditions.
The title of current DC 7700 is ``Anemia, hypochromic-microcytic
and megaloblastic, such as iron-deficiency and pernicious anemia.''
This title groups anemias based on red blood cell (RBC) morphology. VA
proposes separate DCs and criteria for the major types of anemia.
Separation would assist raters in distinguishing amongst and clarifying
severity of anemias. Accordingly, VA proposes the removal of DC 7700
from the Rating Schedule, and adding DC 7720 Iron deficiency anemia,
7721 Folic acid deficiency, 7722 Pernicious anemia and Vitamin
B12 deficiency anemia, and 7723 Acquired hemolytic anemia.
Anemia is currently rated at levels of 100, 70, 30, 10, and 0-
percent, depending on the hemoglobin level and the associated signs and
symptoms. It is evaluated at 100-percent for hemoglobin of 5gm/100ml or
less, with findings such as high-output congestive heart failure or
dyspnea at rest. It is evaluated at 70-percent for hemoglobin of 7gm/
100ml or less, with findings such as dyspnea on mild exertion,
cardiomegaly, tachycardia (100 to 120 beats per minute) or syncope
(three episodes in the last six months). It is evaluated at 30-percent
for hemoglobin of 8gm/100ml or less, with findings such as weakness,
easy fatigability, headaches, lightheadedness, or shortness of breath.
It is evaluated at 10-percent for hemoglobin of 10gm/100ml or less,
with findings such as weakness, easy fatigability, or headaches. It is
evaluated at 0-percent for hemoglobin of 10gm/100ml or less and
asymptomatic.
While there is a high correlation between hemoglobin levels and
signs or symptoms of anemia in acute anemia, the correlation is less
accurate in chronic anemia. As the duration of the anemia lengthens,
the individual becomes more tolerant of lower hemoglobin levels and
symptom manifestation decreases. The functional impact of chronic
anemia is more accurately measured by mode and frequency of treatment.
VA proposes rating criteria based on the specific mode(s) and frequency
of treatment.
VA notes that the existing 100 and 70 percent categories for rating
anemia are more descriptive of acute rather than
[[Page 46889]]
chronic anemia. Acute anemia is usually related to gastrointestinal or
uterine bleeding or traumatic injuries with acute hemorrhage. The
descriptors in the 100 and 70 percent categories reflect a clinical
picture of rapid and extensive blood loss, and their symptoms include
high output cardiac failure with hypoxemia due to inability to sustain
proper tissue oxygenation, caused by low hemoglobin levels which can
lead to shock or collapse. The laboratory values and symptoms described
in the 100 and 70 percent categories of the current anemia DC reflect
intolerable and life threatening symptoms that require emergency
hospitalization and transfusion. See G. Limbruno, ``Recommendations for
transfusion of red blood cells,'' 7 Blood Transfusion 49 (2009).
Chronic anemia on the other hand, develops at a more gradual pace,
and is usually related to serious medical conditions such as
malignancies (cancer) on chemotherapy, infection (osteomyelitis),
thyroid disease, hemoglobin disorders (such as sickle-cell disease or
thalassemia), renal failure or chronic lower gastrointestinal bleeding.
In such cases a slower decline in hemoglobin values allows gradual
adjustment. However, even when an individual reaches such low levels as
contemplated in the 100 and 70 percent evaluation, such a case reflects
acute critical health emergencies that are unsustainable rather than
having an ongoing chronic long term disability impairment as with
chronic anemia. In those cases where chronic anemia results in urgent
hospitalization, VA finds that compensation is more appropriately
determined by evaluating the underlying primary medical problem that
gave rise to the service-connected chronic anemia. As these more severe
cases represent less than 2 percent of the total number of disability
awards for anemia in the past years, VA does not anticipate a
significant impact on future evaluations based on anemia.
Proposed DC 7720 (Iron Deficiency Anemia)
Iron deficiency anemia is defined as a decrease in total body iron
content. Total body iron content is regulated through the balance of
iron absorption and loss. Iron deficiency anemia is most commonly due
to blood loss, post- hemorrhagic anemia. Iron deficiency anemia due to
blood loss would be evaluated under criteria for the causative
condition, e.g., duodenal ulcer (DC 7305) or hemorrhoids (DC 7336),
rather than under DC 7720. VA proposes to clarify the rating of anemia
due to blood loss by adding the following note: ``Do not evaluate iron
deficiency anemia due to blood loss under this diagnostic code.
Evaluate iron deficiency anemia due to blood loss under the criteria
for the condition causing the blood loss.''
Iron deficiency anemia can be readily treated by diet or dietary
supplements. It is ordinarily short term with mild symptoms and
responds to treatment. However, fatigue due to chronic, severe iron
deficiency anemia can decrease the ability to perform physical labor.
VA proposes rating levels of 30, 10, and 0-percent for iron deficiency
anemia not due to blood loss. VA proposes a 30-percent evaluation for
iron deficiency anemia requiring intravenous (IV) iron infusions on
average 4 or more times per 12-month period; a 10-percent evaluation if
requiring continuous treatment with high-dose oral supplementation; and
a 0-percent evaluation if asymptomatic or requiring treatment only by
dietary modification.
Proposed DC 7721 (Folic Acid Deficiency)
The prevalence of folic acid deficiency has decreased in the United
States due to dietary fortification. This form of anemia is amenable to
dietary modification and oral supplementation. VA proposes a 10-percent
evaluation for folic acid deficiency requiring continuous treatment
with high-dose oral supplementation. VA proposes a 0-percent evaluation
when asymptomatic or requiring treatment only by dietary modification.
Proposed DC 7722 (Pernicious Anemia and Vitamin B12 Deficiency Anemia)
Pernicious anemia is the most common form of severe Vitamin
B12 deficiency. S. Stabler, ``Vitamin B12 deficiency,''
368(2) New Eng. J. Med. 149 (2013). Other causes of Vitamin
B12 deficiency that could lead to anemia include: Dietary
avoidance (vegetarianism), malabsorption, gastrectomy or gastric
bypass, inflammatory bowel disease (IBD), pancreatic insufficiency, use
of histamine 2-blockers and proton pump inhibitors. Pernicious anemia
is associated with gastric atrophy, due to autoimmune destruction, and
a lack of intrinsic factor, a glycoprotein necessary for the absorption
of Vitamin B12, in the gastric mucosa. Pernicious anemia
requires lifelong treatment with Vitamin B12 injections,
sublingual or high-dose oral Vitamin B12 tablets, or Vitamin
B12 nasal spray or gel. Since disabilities from nutritional
B12 deficiency are consistent with pernicious anemia,
nutritional B12 deficiency would be rated under the same
diagnostic code as pernicious anemia.
In accordance with the above discussion, VA proposes to evaluate
pernicious anemia and other forms of severe B12 deficiency
at 100 percent for initial diagnosis requiring transfusion due to
severe anemia, or if there are signs or symptoms related to central
nervous system impairment, such as encephalopathy, myelopathy, or
severe peripheral neuropathy, requiring parenteral B12
therapy. Since certitude of neurologic reversibility cannot be
initially determined, and B12 absorption issues may require
lifelong supplementation with B12 injections every 1-3
months, VA proposes to re-evaluate at 6 months and rate according to
presence of neurologic or gastrointestinal residuals.
If absorption is adequate, lifelong oral or intranasal
B12 treatment may be used. VA proposes to evaluate
pernicious anemia and other forms of severe Vitamin B12
deficiency at 10 percent if it requires continuous treatment with
Vitamin B12 injections, Vitamin B12 sublingual or
high-dose oral tablets, or Vitamin B12 nasal spray or gel.
VA proposes to add a note regarding evaluation which states that
the 100-percent evaluation for pernicious anemia and Vitamin
B12 deficiency shall be assigned as of the date of initial
diagnosis requiring transfusion due to severe anemia or parenteral
B12 therapy and shall continue with a mandatory VA
examination six months following hospital discharge or cessation of
continuous parenteral B12 therapy. The note would also state
that any reduction in evaluation based upon that or any subsequent
examination shall be subject to the provisions of 38 CFR 3.105(e) and
that, thereafter, evaluation would be at 10-percent and any residual
effects of pernicious anemia, such as neurologic involvement causing
peripheral neuropathy, myelopathy, dementia, or related
gastrointestinal residuals, would be separately evaluated under the
most appropriate diagnostic code.
Proposed 7723 (Acquired Hemolytic Anemia)
There are over 200 causes of hemolytic anemia, including both
acquired and hereditary types. The causes of acquired hemolytic anemia
include immune disorders, toxic chemicals, medications, physical damage
(such as may occur with prosthetic heart valves), and infections.
Treatment may include intermittent corticosteroids; other
immunosuppressive drugs; immune globulin; monoclonal antibody therapy,
such as rituximab; splenectomy; erythropoiesis stimulating agent (ESA)
to boost production of RBC;
[[Page 46890]]
plasmapheresis (a process similar to dialysis that can remove certain
components, such as harmful antibodies, from the blood); blood
transfusions; and peripheral blood or bone marrow stem cell
transplantation (www.nhlbi.nih.gov/health).
VA proposes to list the evaluation criteria for acquired hemolytic
anemia under DC 7723.
VA proposes to rate acquired hemolytic anemia at 100 percent, if
requiring a bone marrow transplant or continuous intravenous or
immunosuppressive therapy (e.g., prednisone, Cytoxan
(cyclophosphamide), azathioprine, or rituximab). VA proposes to rate
acquired hemolytic anemia at 60 percent, if requiring immunosuppressive
medication an average of 4 or more times per 12-month period. VA
proposes to rate acquired hemolytic anemia at 30 percent, if requiring
an average of 2-3 courses of immunosuppressive therapy per 12-month
period. VA proposes to rate acquired hemolytic anemia at 10 percent, if
requiring an average of 1 course of immunosuppressive therapy per 12-
month period. VA proposes to evaluate acquired hemolytic anemia at 0
percent if asymptomatic.
VA also proposes to add a Note (1) in relation to this DC, stating
that a 100-percent evaluation for bone marrow transplant shall be
assigned as of the date of hospital admission and shall continue for
six months after hospital discharge with a mandatory VA examination six
months following hospital discharge. The note would also state that any
reduction in evaluation based upon that or any subsequent examination
shall be subject to the provisions of 38 CFR 3.105(e).
To remind rating specialists that there is a separate DC for
splenectomy, VA proposes to add a Note (2), which would state that VA
will separately evaluate splenectomy under DC 7706 and combine with an
evaluation under DC 7723.
DC 7702 (Agranulocytosis, Acute); Proposed DC 7702 (Agranulocytosis,
Acquired)
Agranulocytosis, by definition, is an acute condition. Therefore,
this disease is better categorized as agranulocytosis, acquired, than
as agranulocytosis, acute. VA proposes to list updated evaluation
criteria for this condition under DC 7702 with the title
``Agranulocytosis, acquired'' to reflect current medical terminology.
Acute agranulocytosis is currently evaluated at levels of 100, 60,
30, and 10 percent based on type of treatment or frequency of episodes
of recurring infections. A 100-percent evaluation is currently assigned
if requiring bone marrow transplant or transfusion of platelets or red
cells at least once every six weeks or if infections recur at least
once every six weeks. A 60-percent evaluation is assigned if requiring
transfusion of platelets or red cells at least once every three months
or if infections recur at least once every three months. A 30-percent
evaluation is assigned if requiring transfusion of platelets or red
cells at least once per year but less than once every three months or
if infections recur at least once per year but less than once every
three months. A 10-percent evaluation is assigned if requiring
continuous medication for control.
Due to advances in the pharmacological treatment of agranulocytosis
and a shift in standard of care, VA proposes the deletion of the number
of transfusions as a criterion for rating agranulocytosis.
``Granulocyte transfusions have undergone a cycle of popularity
followed by disfavor,'' although they may be useful in patients with
life-threatening infections whose conditions are not responding to
antibiotics. A. Distenfeld, M.D., N.Y. Univ. Sch. of Med.,
``Agranulocytosis,'' eMedicine (Updated Jan 9, 2015, by C. Braden).
These transfusions are accompanied by many complications, including
severe febrile reactions. The use of granulocyte transfusions remains
controversial. VA proposes to evaluate agranulocytosis based on type
and frequency of treatment or the average number of infections per 12-
month period. VA proposes to evaluate agranulocytosis at 100 percent if
requiring bone marrow transplant or if infections recur, on average, at
least once every six weeks per 12-month period. VA proposes to evaluate
agranulocytosis at 60 percent if requiring intermittent myeloid growth
factors (granulocyte colony-stimulating factor (G-CSF) or granulocyte-
macrophage colony-stimulating factor (GM-CSF)) or continuous
immunosuppressive therapy such as cyclosporine to maintain absolute
neutrophil count (ANC) greater than 500/[mu]l but less than 1000/[mu]l,
or if infections recur, on average, at least once every three months
per 12-month period. VA proposes to evaluate agranulocytosis at 30
percent if requiring intermittent myeloid growth factors to maintain
ANC greater than 1000/[mu]l or if infections recur, on average, at
least once per 12-month period but less than once every three months
per 12-month period. VA proposes to evaluate agranulocytosis at 10
percent if requiring continuous medication (e.g., antibiotics) for
control or if requiring intermittent use of a myeloid growth factor to
maintain ANC greater than or equal to 1500/[mu]l.
VA proposes to preserve the existing note under current DC 7702.
DC 7703 (Leukemia)
One type of leukemia, chronic myelogenous leukemia (CML), is
evaluated as a myeloproliferative disorder. CML is a heterogeneous
disease with three clinical phases: Chronic, transitional
(accelerated), and acute (blast). Most individuals with CML are
diagnosed in the chronic phase and with adequate treatment can remain
in this phase for several years. However, patients with CML are never
``cured'' with current therapy, but often have no evidence of the
disease at a molecular level. The term used for this state is
``complete molecular remission'' (CMR). These patients require
continuous treatment because otherwise they would relapse. Patients
with CML need to be considered as having active disease even when they
would otherwise appear to be in remission. Therefore, VA proposes to
evaluate CML under separate DC 7719.
Leukemia is currently evaluated at 100 percent for active disease
or during a treatment phase. There is also a directive to otherwise
rate as anemia (current DC 7700) or aplastic anemia (DC 7716),
whichever would result in the greater benefit.
VA proposes to evaluate all forms of active leukemia other than
chronic myelogenous leukemia under DC 7703.
VA proposes to retain the 100-percent evaluation ``[w]hen there is
active disease or during a treatment phase.'' For rating purposes, VA
considers any diagnosed cancer as ``active disease'' if medical
evidence does not demonstrate the eradication of cancerous cells, if
the cancer is not in remission, or when the condition requires
continuous treatment since otherwise there would invariably be a
relapse.
Since there are numerous residual effects of leukemia and its
treatment, which may involve any body system, VA proposes to remove the
current directive, which addresses only certain hematologic residuals:
``Otherwise rate as anemia (code 7700) or aplastic anemia (code 7716),
whichever would result in the greater benefit.'' VA proposes another
directive, which would read: ``Otherwise rate residuals under the
appropriate diagnostic code(s).''
One of the four main types of leukemia, chronic lymphocytic
[[Page 46891]]
leukemia (CLL), is now often diagnosed at a very early stage when the
blood lymphocyte count is high, but the patient does not have
enlargement of the lymph nodes, spleen, or liver, and the red blood
cells and platelets are normal or nearly so. The average age of
patients with this type of leukemia is 70. In the staging system
commonly used to assess the severity of CLL, this early stage is known
as Rai Stage 0. Occasionally patients are diagnosed instead as having
monoclonal B-cell lymphocytosis (MBL). The diagnosis is in a similar
category as Rai Stage 0 CLL. Unlike the course of the other major types
of leukemia, this early stage of CLL may not progress for many years.
The median survival time for this stage of disease is over 12 years. No
treatment is required, and it is considered a low risk stage. For
individuals with CLL at Rai Stage 0, assigning a 100-percent evaluation
would be inappropriate, since antineoplastic treatment is not
warranted, and at this early stage, there is little or no effect on a
patient's well-being, according to the Leukemia and Lymphoma Society
(www.leukemia-lymphoma.org/). Therefore, VA proposes to add a 0-percent
evaluation level for asymptomatic low risk level patients with CLL at
Rai Stage 0.
Patients with lymphocytosis, enlarged lymph nodes and splenomegaly
or hepatomegaly are defined as having an intermediate risk for disease
progression (Rai Stages I or II). Patients with hepatomegaly (enlarged
liver), anemia (Hemoglobin <11 g/dL), or thrombocytopenia (platelet
counts lower than 100,000) are considered to be in the higher risk
categories for disease progression (Rai Stages III and IV). Oncologists
have developed criteria to determine when to initiate treatment based
on the presence of genetic mutation, micro-globulins, lymphocyte
doubling times and other markers to help boost the accuracy criteria of
the CLL tumor burden along with staging provided by the Rai scale.
Patients with newly diagnosed asymptomatic early-stage disease are
generally monitored without therapy unless they show signs of disease
progression or symptoms. Patients with intermediate risk (Rai Stages I
and II) and those with high risk (Rai Stages III or IV) are usually
started on treatment.
VA proposes editorial changes to the currently existing note, which
would be numbered as Note (1).
Rai Stages I-IV (intermediate and high risk) usually require
progressively aggressive therapy, consistent with leukemias and other
malignancies. VA proposes addition of notes to clarify evaluation of
CLL that progresses beyond Rai Stage 0.
The proposed Note (2) would read: ``Evaluate symptomatic chronic
lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as
any other leukemia evaluated under this diagnostic code.''
The proposed Note (3) would read: ``Evaluate residuals of leukemia
or leukemia therapy under the appropriate diagnostic code(s).
Myeloproliferative Disorders: (Diagnostic Codes 7704, 7718, 7719).''
Myeloproliferative Disorders
This section includes: DC 7704 (Polycythemia vera); Proposed DC
7718 (Essential thrombocythemia and primary myelofibrosis); Proposed DC
7719 (Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or
chronic granulocytic leukemia)).
Myeloproliferative disorders are a group of slow-growing blood
neoplasms in which the bone marrow produces excess numbers of red blood
cells, white blood cells, or platelets. Polycythemia vera is one type
of myeloproliferative disorder. Other conditions included in this
category are essential thrombocythemia, primary idiopathic
myelofibrosis, and chronic myelogenous leukemia (CML) (also called
chronic myeloid leukemia or chronic granulocytic leukemia)
(www.cancer.gov/cancertopics/types/myeloproliferative and www.leukemia-lymphoma.org). These conditions may evolve into acute leukemia.
According to the National Cancer Institute of the U.S. National
Institutes of Health, a variety of treatments are used for
myeloproliferative disorders. For example, polycythemia vera is
commonly treated by phlebotomy (removal of blood, as needed, to
decrease the number of red blood cells and platelets). However, other
treatments used to achieve appropriate levels of cells and to reduce
complications, such as thrombosis, include radioactive phosphorous
(which suppresses the overproduction of blood cells), interferon alpha
(which boosts the immune system), chemotherapeutic agents (including
myelosuppressants, which decrease bone marrow production), and low dose
aspirin. Some of these treatments are also used for other
myeloproliferative disorders.
Other treatments used for myeloproliferative disorders include:
stem cell transplant; platelet apheresis (removal of platelets from the
blood in a process similar to dialysis); blood or platelet transfusions
(when the bone marrow production is insufficient); periods of
hospitalizations to treat infections (since patients with these
conditions are at high risk for serious infections); erythropoiesis-
stimulating agents (ESA) to boost production of red blood cells;
tyrosine kinase inhibitors such as imatinib (Gleevec) (commonly used to
treat chronic myelogenous leukemia) or ruxolitinib (new kinase
inhibitor); and androgen-like drugs (which also may stimulate the bone
marrow).
Polycythemia vera is the only myeloproliferative disorder, of the
above-mentioned disorders, currently evaluated in the Rating Schedule.
Therefore, VA proposes the addition of DCs to provide rating criteria
for other diseases under the category of myeloproliferative disorders:
7718 Essential thrombocythemia/primary myelofibrosis, and 7719 Chronic
myelogenous leukemia (CML) (chronic myeloid leukemia or chronic
granulocytic leukemia).
VA proposes to add a note applicable to all myeloproliferative
disorders, which would state that if the condition undergoes leukemic
transformation, it should be evaluated as leukemia under DC 7703. This
note is intended to remind rating specialists that a myeloproliferative
disorder may undergo leukemic transformation and warrant evaluation
under DC 7703.
VA also proposes to add another note applicable to all
myeloproliferative disorders, which would state that a 100-percent
evaluation shall be assigned as of the date of hospital admission for
peripheral blood or bone marrow stem cell transplant, or during the
period of treatment with radioactive phosphorus or chemotherapy
(including myelosuppressants), and that six months following hospital
discharge or, in the case of radioactive phosphorus or chemotherapy
treatment, six months after completion of treatment, the appropriate
disability rating shall be determined by mandatory VA examination. The
note would also state that any reduction in evaluation based upon that
or any subsequent examination shall be subject to the provisions of 38
CFR 3.105(e).
DC 7704 (Polycythemia Vera)
VA proposes a 100-percent evaluation if requiring peripheral blood
or bone marrow stem-cell transplant or treatment with radioactive
phosphorus or chemotherapy (including myelosuppressants).
VA proposes a 60-percent evaluation if requiring phlebotomy 6 or
more times per 12-month period to control RBC count or if requiring
radioactive phosphorous treatment, chemotherapy, or targeted agents
like ruxolitinib or
[[Page 46892]]
imatinib. VA proposes a 30-percent evaluation if requiring phlebotomy
4-5 times per 12-month period or if requiring continuous biologic
therapy or myelosuppressive agents to maintain platelet count in the
less than 200,000 range or white blood cells (WBC) in the less than
12,000 range. VA proposes a 10-percent evaluation if requiring, on an
intermittent basis, phlebotomy, biologic therapy, or interferon, as
needed, but less than 4 times per 12-month period.
VA proposes to number the current note for DC 7704 as Note (1). VA
proposes the addition of the two notes described above for all
myeloproliferative disorders to be added as Notes (2) and (3) after the
current note for DC 7704.
Proposed DC 7718 (Essential Thrombocythemia and Primary Myelofibrosis)
VA proposes a 100-percent evaluation if requiring either continuous
myelosuppressive therapy or, for six months following hospital
admission, any of the following treatments: Peripheral blood or bone
marrow stem cell transplant, or treatment with radioactive phosphorus
or chemotherapy (including myelosuppressants); a 70 percent evaluation
if requiring either continuous or intermittent myelosuppressive therapy
to maintain platelet count less than 500 x 10 \9\/L; a 30-percent
evaluation if requiring continuous or intermittent myelosuppressive
therapy to maintain platelet count of 200,000-400,000 or white blood
cell (WBC) count of 4,000-10,000; and a 0-percent evaluation if
asymptomatic.
VA proposes the addition of the two notes described above for all
myeloproliferative disorders.
Proposed DC 7719 (Chronic Myelogenous Leukemia (CML) (Chronic Myeloid
Leukemia or Chronic Granulocytic Leukemia))
VA proposes a 100-percent evaluation if requiring peripheral blood
or bone marrow stem cell transplant or requiring continuous
myelosuppressive or immunosuppressive therapy. VA proposes a 60-percent
evaluation if requiring intermittent myelosuppressive therapy, or
targeted therapy with tyrosine kinase inhibitors, or interferon
treatment. VA proposes a 30-percent evaluation if in apparent remission
on continuous targeted therapy with tyrosine kinase inhibitors.
VA proposes the addition of the two notes described above for all
myeloproliferative disorders.
Current DC 7705 (Thrombocytopenia, Primary, Idiopathic or Immune);
Proposed DC 7705 (Immune Thrombocytopenia)
Thrombocytopenia is currently evaluated at levels of 100, 70, 30,
and 0 percent based on the platelet count, the presence or absence of
bleeding episodes, and whether treatment is required. VA proposes to
change the title from ``Thrombocytopenia, primary, idiopathic or
immune'' to ``Immune thrombocytopenia.''
VA proposes to use the same bases for evaluation of disability,
while updating criteria to reflect advances in medical knowledge. A
100-percent evaluation is currently assigned if the platelet count is
less than 20,000, with active bleeding, requiring treatment with
medication and transfusions. A 70-percent evaluation is currently
assigned for a platelet count between 20,000 and 70,000, not requiring
treatment, without bleeding. A 30-percent evaluation is currently
assigned for a stable platelet count between 70,000 and 100,000,
without bleeding. A 0-percent evaluation is currently assigned for a
stable platelet count of 100,000 or more, without bleeding. VA proposes
to provide evaluation levels of 100, 70, 30, 10 and 0 percent, with
criteria based in part on the recommendations of the American Society
of Hematology for diagnosis and treatment of idiopathic
thrombocytopenic purpura, updated in 2010.
VA proposes to assign a 100-percent evaluation for immune
thrombocytopenia requiring chemotherapy for chronic refractory
thrombocytopenia or a platelet count from 20,000 to 30,000 despite
treatment. VA proposes to assign a 70-percent evaluation if requiring
immunosuppressive therapy or for a platelet count higher than 30,000
but not higher than 50,000, with history of hospitalization because of
severe bleeding requiring intravenous immune globulin, high-dose
parenteral corticosteroids, and platelet transfusions. VA proposes to
assign a 30-percent evaluation for a platelet count higher than 30,000
but not higher than 50,000, with either immune thrombocytopenia or mild
mucous membrane bleeding which requires oral corticosteroid therapy or
intravenous immune globulin. VA proposes to assign a 10-percent
evaluation for a platelet count higher than 30,000 but not higher than
50,000, not requiring treatment. VA proposes to assign a 0-percent
evaluation for platelet count above 50,000 and asymptomatic, or for
immune thrombocytopenia in remission.
VA also proposes to add a note instructing raters to separately
evaluate splenectomy under DC 7706 and combine with an evaluation under
this DC. VA proposes to add a second note clarifying re-evaluation
following chemotherapy as follows: ``A 100-percent evaluation shall
continue beyond the cessation of chemotherapy. Six months after
discontinuance of such treatment, the appropriate disability rating
shall be determined by mandatory VA examination. Any reduction in
evaluation based upon that or any subsequent examination shall be
subject to the provisions of [38 CFR 3.105(e)].''
DC 7706 (Splenectomy); DC 7707 (Spleen, Injury of, Healed)
VA proposes no change to these DCs except to move the word
``separately'' in the note following DC 7706 to clarify the meaning.
Current DC 7709 (Hodgkin's Disease); Proposed DC 7709 (Hodgkin's
Lymphoma)
VA proposes to change the title associated with current DC 7709
from ``Hodgkin's disease'' to ``Hodgkin's lymphoma'' to be consistent
with current medical terminology and knowledge. VA proposes minor
editorial changes to the existing note. The following sentence was
modified to read as follows at the end of the existing note: ``If there
has been no local recurrence or metastasis, rate on residuals under the
appropriate diagnostic code(s).''
DC 7710 (Adenitis, Tuberculous, Active or Inactive)
VA proposes no changes for this diagnostic code except for the
deletion of a section symbol (Sec. ).
Proposed DC 7712 (Multiple Myeloma)
VA proposes to add a new DC 7712 for multiple myeloma (MM). MM is a
type of systemic, incurable malignancy resulting from the proliferation
of abnormal plasma cells in the bone marrow. The overgrowth of these
plasma cells results in tumors that are deposited primarily in the
bones, but also in the kidneys and other organs. The median age at
diagnosis is 65 years, and the average 5-year survival rate is about 30
percent. Survival time depends on many factors, such as age, gender,
race, stage of disease at time of diagnosis, and treatment. Recent
therapeutic advances have improved the quality of life and length of
survival time, but MM remains incurable. Some patients go into
remission for various
[[Page 46893]]
periods but require maintenance therapy even while in remission.
MM has a wide variety of clinical presentations that can vary
between asymptomatic to severely symptomatic.
Asymptomatic (smoldering or indolent) myeloma is a slow-growing,
asymptomatic precursor or pre-malignant phase of MM. It is usually not
treated until evidence of end organ damage develops. It has a high risk
of developing into MM. However, since it is not malignant, is
asymptomatic, and does not require treatment, it would not warrant a
compensable evaluation under this diagnostic code, and VA proposes to
rate it at 0 percent.
Even if smoldering MM is currently regarded as a pre-malignant
state, there are subsets of patients with different rates of
progression towards MM. No single pathological or molecular feature can
be used to distinguish between smoldering and pre-malignant MM with
clonal plasma cells from those with clonal malignant plasma cells. A
biomarker-based definition that can predict this transformation is
needed but is not yet currently available.
Symptomatic multiple myeloma, as further defined in the below
proposed notes to new DC 7712, would therefore be rated at 100 percent.
VA proposes the following notes to new DC 7712 based on the most
recently updated diagnostic criteria staging system of the
International Diagnostic Working Group of 2014. See S. Rajkumar, M.D.,
``International Myeloma Working Group updated criteria for the
diagnosis of multiple myeloma,'' 15(12) Lancet Oncol. e538 (2014).
The first note would state the following: ``Symptomatic myeloma
requires an elevated serum or urine M (monoclonal) protein value
(however no specific concentration is required for diagnosis) or
presence of increased bone marrow clonal plasma cells >=10%. There must
be also evidence of related organ tissue impairment (ROTI) due to the
plasma cell proliferation. This process is manifested by elevated serum
calcium, renal failure, anemia, and bone lesions (CRAB). The
corresponding laboratory values are: Serum calcium >=11.5 mg/100 mL,
renal insufficiency with creatinine clearance <40 cc/min or serum
creatinine >1.73 mmol/L, normochromic, normocytic anemia with a
hemoglobin value >2 g/100 mL below the lower limit of normal, or a
hemoglobin value <10 g/100 mL, lytic lesions (one or more osteolytic
lesions by radiographic or other imaging system), severe osteopenia, or
pathologic bone fractures. A small percentage of patients with
symptomatic myeloma have no detectable M-protein in serum or urine but
do have myeloma-related organ impairment ROTI and increased bone marrow
plasma cells. Any of the following validated biomarkers of malignancy
are acceptable for the diagnosis of MM, including clonal bone marrow
plasma cells >=60%, serum free light chain ratio >=100, or free light
chain >=100 mg/L, or more than one focal bone or bone marrow lesion on
MRI >5 mm in size.''
The second note would state the following: ``A nonsecretory myeloma
(a variant form of symptomatic myeloma) shows absent M-protein in the
serum and urine, bone marrow plasmacytosis, and ROTI. While this group
of patients represents a minority of cases (1-2%), this uncommon
presentation may lead to delay in diagnosis because of the scarcity of
laboratory findings commonly in the face of an isolated bone process
such as low back pain.''
The third note would state the following: ``The diagnostic criteria
for asymptomatic (smoldering or indolent) myeloma requires the
following two criteria: (1) An elevated serum monoclonal protein (IgG
or IgA) >30 g/L, urine monoclonal protein >500 mg/24 hrs. or clonal
bone marrow plasmal cells 10%-60%, and (2) absence of myeloma defining
events or amyloidosis without any related organ or tissue impairment
(ROTI) or end-organ damage. There is usually normal serum calcium,
hemoglobin, and serum creatinine, and no bone lesions on full skeletal
survey and no evidence of amyloidosis or light chain deposition
disease.''
Multiple myeloma is incurable, and carries a poor prognosis.
Therefore, VA proposes Note (4), which would state that the 100-percent
evaluation shall continue for five years after the diagnosis of
symptomatic multiple myeloma, at which time the appropriate disability
evaluation shall be determined by mandatory VA examination. It would
also state that any reduction in evaluation based upon that or any
subsequent examination shall be subject to the provisions of 38 CFR
3.105(e) and 3.344 (a) and (b).
DC 7714 (Sickle Cell Anemia)
Sickle cell anemia is currently evaluated at levels of 100, 60, 30,
and 10 percent. The current 100-percent evaluation criteria are: ``With
repeated painful crises, occurring in skin, joints, bones or any major
organs caused by hemolysis and sickling of red blood cells, with
anemia, thrombosis and infarction, with symptoms precluding even light
manual labor.'' VA proposes at the 100-percent level to change the term
``painful crises'' to ``painful episodes'' in keeping with current
medical terminology, to insert the word ``residual'' before the word
``symptoms,'' and to change punctuation to clarify meaning. The 100
percent category would also require at least 4 or more painful episodes
in the past 12 months for clarification purposes.
The current 60-percent evaluation criteria are: ``With painful
crises several times a year or with symptoms precluding other than
light manual labor.'' As in the 100-percent evaluation criteria, VA
proposes to change the term ``painful crises'' to ``painful episodes.''
To remove ambiguity, we also propose replacement of the phrase ``With
painful crises several times a year'' with ``Averaging 3 or more
painful episodes per 12-month period.''
The current 30-percent evaluation criterion is: ``Following
repeated hemolytic sickling crises with continuing impairment of
health.'' VA proposes to replace ``Following repeated hemolytic
sickling crises with continuing impairment of health'' with ``Averaging
1 or 2 painful episodes per 12-month period'' in order to make the
criterion less ambiguous and promote consistent evaluations. VA
proposes no change in the current 10-percent evaluation criteria of
``Asymptomatic, established case in remission, but with identifiable
organ impairment,'' and only an editorial change in the note under this
DC to reflect the fact that the former Compensation and Pension Service
has been reorganized as the Compensation Service and the Pension and
Fiduciary Service.
DC 7715 (Non-Hodgkin's Lymphoma)
Currently, non-Hodgkin's lymphoma (NHL), DC 7715, is evaluated at
100 percent for active disease or during a treatment phase. VA proposes
to modify the current note under DC 7715 with some non-substantive
changes and by extending the allowable time required for mandatory
examination from six months to 2 years, as provided in the proposed
note to DC 7715. This is based upon current medical information
suggesting that recurrences in non-Hodgkin's lymphoma are very high,
with common tumor recurrences within or after the period that mandates
lowering of disability rating for treatment completion or apparent
remission of 6 months. Data on relapsed aggressive NHL: https://www.texasoncology.com/types-of-cancer/non-hodgkins-lymphoma/intermediate-grade-aggressive-grade-nhl/relapsed-aggressive-nhl/). VA
also proposes to modify the criteria as, ``When there is active
disease, during treatment phase or with indolent and
[[Page 46894]]
non-contiguous phase of low grade NHL.'' See National Cancer Institute
Adult NHL PDQ treatment Update (https://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins/HealthProfessional/page9#_195_toc (Dec.
2014).
DC 7716 (Aplastic Anemia)
Aplastic anemia, DC 7716, is currently evaluated at levels of 100,
60, 30, and 10 percent. The current 100-percent evaluation criteria
are: ``Requiring bone marrow transplant, or; requiring transfusion of
platelets or red cells at least once every six weeks, or; infections
recurring at least once every six weeks.'' VA proposes to expand ``bone
marrow transplant'' to ``peripheral blood or bone marrow stem cell
transplant,'' as either may be used for treatment. In addition, VA
proposes to add the phrase ``on average'' to the specific numbers of
platelet or red cell transfusions required and to the frequency of
recurring infections, and to add ``per 12-month period'' to promote
consistent evaluations at the 100-, 60-, and 30-percent levels.
The current 60-percent criteria are: ``Requiring transfusion of
platelets or red cells at least once every three months, or; infections
recurring at least once every three months.'' Continuous
immunosuppressive therapy is currently a standard treatment option for
aplastic anemia. A. Bacigalupo, ``Diagnosis and treatment of acquired
aplastic anemia,'' 23(2) Hematol Oncol. Clinical N. Am. 159 (2009). We
therefore propose to add, ``using continuous immunosuppressive
therapy'' as an alternative criterion for the 60-percent level. VA also
proposes the changes described above for the 100-percent criteria
concerning adding ``on average'' and ``per 12-month period.'' The
current 30-percent evaluation criteria are: ``Requiring transfusion of
platelets or red cells at least once per year but less than once every
three months, or; infections recurring at least once per year but less
than once every three months.'' VA proposes only the changes described
above for the 100-percent criteria concerning adding ``on average'' and
``per 12-month period.'' The current 10-percent criterion is
``Requiring continuous medication for control.'' VA proposes to delete
this evaluation level as the medications used to treat aplastic anemia
warrant higher levels of evaluation.
VA proposes a change in the note following this DC stating that a
100-percent evaluation will be provided for either peripheral blood or
bone marrow stem cell transplant. The reminder of the note is otherwise
unchanged.
Proposed DC 7724 (Solitary Plasmacytoma)
Solitary bone or extramedullary (occurring in soft tissue outside
of the bone marrow) plasmacytomas are malignant plasma cell neoplasms
that are closely related to multiple myeloma. A solitary bone
plasmacytoma develops into multiple myeloma in 50 to 60 percent of
cases, and into an extramedullary plasmacytoma in 10 to 30 percent of
cases. A solitary plasmacytoma that remains solitary has a better
prognosis than multiple myeloma and may be curable. VA proposes to rate
solitary plasmacytomas similarly to other malignant neoplasms that are
potentially curable. VA proposes to rate solitary plasmacytoma at 100
percent when there is active disease or during a treatment phase and to
add Note (1) to state that a 100-percent evaluation shall continue
beyond the cessation of any surgical therapy, radiation therapy,
antineoplastic chemotherapy, or other therapeutic procedures (including
autologous stem cell transplantation), and that six months after
discontinuance of such treatment, the appropriate disability rating
shall be determined by mandatory VA examination. The note would also
state that any change in evaluation based upon that or any subsequent
examination shall be subject to the provisions of 38 CFR 3.105(e) and
that, if there has been no recurrence, to rate residuals under the
appropriate diagnostic codes.
VA proposes to add Note (2) to remind rating specialists of the
potential for the transformation of solitary plasmacytomas into
multiple myeloma. VA also proposes to add Note (3) to remind rating
specialists of the residual effects of a solitary plasmacytoma and the
adverse effects of medical treatment.
Proposed DC 7725 (Myelodysplastic Syndromes)
VA proposes to add a new DC 7725 for myelodysplastic syndromes
because these conditions are relatively common in veterans and do not
have a diagnostic code under which they can be appropriately evaluated.
These syndromes, sometimes called ``pre-leukemia'' in the past, are a
group of disorders associated with bone marrow dysfunction, in which
healthy and mature red blood cells, white blood cells, and platelets
are not produced. Therefore, there may be a deficiency of any type of
blood cell. About one-third of those with myelodysplastic syndromes
progress to acute myelogenous leukemia in months or years. Some types
of myelodysplastic syndromes are primary, in which there is no known
cause for the syndromes, and others are secondary types, which develop
after treatment with chemotherapy or radiation therapy for other
diseases. The classification of these disorders is complex and differs
among different medical organizations. Treatment depends in part on the
specific disorder but also on many other factors. The mean overall
survival time for these conditions is 6 months to 6 years.
VA proposes to evaluate myelodysplastic syndromes based on type and
frequency of treatment and number of infections per 12-month period. VA
also proposes to include in the evaluation criteria treatment with
biologic therapy, either interferon alpha on an ongoing basis or
erythropoiesis-stimulating agent (ESA) to boost red blood cell
production. These treatments are used in some types of myelodysplastic
disorders. VA proposes to provide evaluation levels of 100, 60, and 30
percent. VA proposes to assign 100 percent for either of the following:
Requiring peripheral blood or bone marrow stem cell transplant, or
requiring chemotherapy (including hypomethylating agents and
immunmodulators, e.g., lenalidomide). VA proposes to assign 60 percent
for either of the following: Requiring, on average, 4 or more blood or
platelet transfusions per 12-month period, or infections requiring
hospitalization, on average, 3 or more times per 12-month period. VA
proposes to assign 30 percent for any of the following: Requiring, on
average, 1 to 3 blood or platelet transfusions per 12-month period,
infections requiring hospitalization, on average, 1 to 2 times per 12-
month period; or requiring biologic therapy, either interferon alpha on
an ongoing basis or erythropoiesis stimulating agent (ESA) for up to 12
weeks per 12-month period.
VA also proposes to add Note (1) stating that if this condition
progresses to leukemia, to evaluate it as leukemia under DC 7703 and
Note (2) stating that a 100-percent evaluation shall be assigned as of
the date of hospital admission for peripheral blood or bone marrow stem
cell transplant, or during the period of treatment with chemotherapy
and shall continue with a mandatory VA examination six months following
hospital discharge or, in the case of radioactive phosphorus or
chemotherapy treatment, six months after completion of treatment. Note
(2) would also state that any reduction in evaluation based upon that
or any subsequent examination shall be subject
[[Page 46895]]
to the provisions of 38 CFR 3.105(e) and that, if there has been no
recurrence, residuals will be rated under the appropriate diagnostic
codes.
Proposed Changes to Appendices A, B, and C to Part 4
VA proposes to amend appendices A, B, and C to reflect the above-
noted proposed changes. In appendix A to part 4, Sec. 4.117, remove
diagnostic code 7700, revise diagnostic codes 7702-7705, 7709, and
7714-7716, and add diagnostic codes 7718-7725.
In appendix B to part 4, revise the title from ``The Hemic and
Lymphatic Systems'' to ``The Hematologic and Lymphatic Systems'',
remove diagnostic code 7700 and its disability entry, revise the
section heading and the disability entry for diagnostic codes 7702,
7705 and 7709, and add disability codes and disability entries for 7712
and 7718-7725.
In appendix C to part 4, convert the existing entry for ``Anemia''
into a new section titled ``Anemia'', remove diagnostic code 7700 and
its disability entry and insert diagnostic codes 7720-7723 and their
disability entries in that section; revise the disability entry for
diagnostic codes 7702, 7705 and 7709; create a new section titled
``Hematologic'' and insert diagnostic codes 7705, 7712, 7718, 7724 and
7725 and their disability entries in that section; and convert the
existing entry for leukemia into a new section titled ``Leukemia'' and
insert diagnostic codes 7703 and 7719 into that section.
Paperwork Reduction Act
This document contains no provisions constituting a collection of
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
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.
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.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' which requires review by the Office
of Management and Budget, as ``any regulatory action that is likely to
result in a rule that may: (1) Have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy,
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) Create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.''
The economic, interagency, budgetary, legal, and policy
implications of this regulatory action has 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 https://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 https://www1.va.gov/orpm/, by following the link for ``VA
Regulations Published.''
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 year. This proposed rule would have no such effect on
State, local, and tribal governments, or on the private sector.
Catalog of Federal Domestic Assistance Numbers and Titles
The Catalog of Federal Domestic Assistance program numbers and
titles for this proposal are 64.104, Pension for Non-Service-Connected
Disability for Veterans, and 64.109, Veterans Compensation for Service-
Connected Disability.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Robert L.
Nabors II, Chief of Staff, Department of Veterans Affairs, approved
this document on July 30, 2015, for publication.
List of Subjects in 38 CFR Part 4
Disability benefits, Pensions, Veterans.
Dated: July 31, 2015.
Jeffrey M. Martin,
Office Program Manager, Office of Regulation Policy & Management,
Office of the General Counsel, Department of Veterans Affairs.
For the reasons set out in the preamble, VA proposes to amend 38
CFR part 4, subpart B, to read as follows:
PART 4--SCHEDULE FOR RATING DISABILITIES
Subpart B--Disability Ratings
0
1. The authority citation for part 4 continues to read as follows:
Authority: 38 U.S.C. 1155, unless otherwise noted.
0
2. Revise the undesignated center heading preceding Sec. 4.117 to read
as follows:
The Hematologic and Lymphatic Systems
0
3. Revise Sec. 4.117 to read as follows:
Sec. 4.117 Schedule of ratings--hematologic and lymphatic systems.
[[Page 46896]]
------------------------------------------------------------------------
Rating
------------------------------------------------------------------------
7702 Agranulocytosis, acquired:
Requiring bone marrow transplant or infections recurring, 100
on average, at least once every six weeks per 12-month
period...................................................
Requiring intermittent myeloid growth factors (granulocyte 60
colony-stimulating factor (G-CSF) or granulocyte-
macrophage colony-stimulating factor (GM-CSF)) or
continuous immunosuppressive therapy such as cyclosporine
to maintain absolute neutrophil count (ANC) greater than
500/[mu]l but less than 1,000/[mu]l; or infections
recurring, on average, at least once every three months
per 12-month period......................................
Requiring intermittent myeloid growth factors to maintain 30
ANC greater than 1,000/[micro]l; or infections recurring,
on average, at least once per 12-month period but less
than once every three months per 12-month period.........
Requiring continuous medication (e.g., antibiotics) for 10
control; or requiring intermittent use of a myeloid
growth factor to maintain ANC greater than or equal to
1,500/[mu]l..............................................
Note: A 100-percent evaluation for bone marrow transplant
shall be assigned as of the date of hospital admission and
shall continue with a mandatory VA examination six months
following hospital discharge. 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.
7703 Leukemia (except for chronic myelogenous leukemia):
When there is active disease or during a treatment phase.. 100
Otherwise rate residuals under the appropriate diagnostic
code(s).
Chronic lymphocytic leukemia or monoclonal B-cell 0
lymphocytosis (MBL), asymptomatic, Rai Stage 0...........
Note (1): A 100-percent evaluation shall continue beyond the
cessation of any surgical therapy, radiation therapy,
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. If there has
been no recurrence, rate on residuals.
Note (2): Evaluate symptomatic chronic lymphocytic leukemia
that is at Rai Stage I, II, III, or IV the same as any other
leukemia evaluated under this diagnostic code.
Note (3): Evaluate residuals of leukemia or leukemia therapy
under the appropriate diagnostic code(s). Myeloproliferative
Disorders: (Diagnostic Codes 7704, 7718, 7719).
7704 Polycythemia vera:
Requiring peripheral blood or bone marrow stem-cell 100
transplant or treatment with radioactive phosphorus or
chemotherapy (including myelosuppressants)...............
Requiring phlebotomy 6 or more times per 12-month period 60
to control RBC count or if requiring radioactive
phosphorous treatment, chemotherapy, or targeted agents
such as imatinib or ruxolitinib..........................
Requiring phlebotomy 4-5 times per 12-month period or if 30
requiring continuous biologic therapy or myelosuppresive
agents to maintain platelets <200,000 or white blood
cells (WBC) <12,000......................................
Requiring phlebotomy, biologic therapy, or interferon on 10
an intermittent basis, as needed, 3 or fewer times per 12-
month period.............................................
Note (1): Rate complications such as hypertension, gout, ........
stroke, or thrombotic disease separately.
Note (2): If the condition undergoes leukemic transformation,
evaluate as leukemia under diagnostic code 7703.
Note (3): A 100-percent evaluation shall be assigned as of the
date of hospital admission for peripheral blood or bone
marrow stem cell transplant; or during the period of
treatment with radioactive phosphorus or chemotherapy
(including myelosuppressants). Six months following hospital
discharge or, in the case of radioactive phosphorus or
chemotherapy treatment, six months after completion of
treatment, the appropriate disability rating shall be
determined by mandatory VA examination. Any reduction in
evaluation based upon that or any subsequent examination
shall be subject to the provisions of Sec. 3.105(e) of this
chapter.
7705 Immune thrombocytopenia:
Requiring chemotherapy for chronic refractory 100
thrombocytopenia or a platelet count from 20,000 to
30,000 despite treatment.................................
Requiring immunosuppressive therapy or for a platelet 70
count higher than 30,000 but not higher than 50,000, with
history of hospitalization because of severe bleeding
requiring intravenous immune globulin, high-dose
parenteral corticosteroids, and platelet transfusions....
Platelet count higher than 30,000 but not higher than 30
50,000, with either immune thrombocytopenia or mild
mucous membrane bleeding which requires oral
corticosteroid therapy or intravenous immune globulin....
Platelet count higher than 30,000 but not higher than 10
50,000, not requiring treatment..........................
Platelet count above 50,000 and asymptomatic, or for 0
immune thrombocytopenia in remission.....................
Note (1): Separately evaluate splenectomy under diagnostic
code 7706 and combine with an evaluation under this
diagnostic code.
Note (2): A 100-percent evaluation shall continue beyond the
cessation of chemotherapy. Six months after discontinuance of
such treatment, the appropriate disability rating shall be
determined by mandatory VA examination. Any reduction in
evaluation based upon that or any subsequent examination
shall be subject to the provisions of Sec. 3.105(e) of this
chapter.
7706 Splenectomy.............................................. 20
Note: Separately rate complications such as systemic 20
infections with encapsulated bacteria.
7707 Spleen, injury of, healed.
Rate for any residuals.
7709 Hodgkin's lymphoma:
With active disease or during a treatment phase........... 100
Note: A 100-percent evaluation shall continue beyond the
cessation of any surgical therapy, radiation therapy,
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 reduction in evaluation based
upon that or any subsequent examination shall be subject to
the provisions of Sec. 3.105(e) of this chapter. If there
has been no local recurrence or metastasis, rate on residuals
under the appropriate diagnostic code(s).
7710 Adenitis, tuberculous, active or inactive.
Rate under Sec. 4.88c or 4.89 of this part, whichever is
appropriate.
7712 Multiple myeloma:
Symptomatic multiple myeloma.............................. 100
Asymptomatic (smoldering or indolent)..................... 0
[[Page 46897]]
Note (1): Symptomatic myeloma requires, (i) an elevated serum
or urine M (monoclonal) protein value (however no specific
concentration is required for diagnosis), or (ii) presence of
increased bone marrow clonal plasma cells >=10%. There must
be also evidence of related organ tissue impairment (ROTI)
due to the plasma cell proliferation. This process is
manifested by elevated serum calcium, renal failure, anemia,
and bone lesions (CRAB). The corresponding laboratory values
are: Serum calcium >=11.5 mg/100 mL, renal insufficiency with
creatinine clearance <40 cc/min or serum creatinine >1.73
mmol/L, normochromic, normocytic anemia with a hemoglobin
value >2 g/100 mL below the lower limit of normal, or a
hemoglobin value <10 g/100 mL, lytic lesions (one or more
osteolytic lesions by radiographic or other imaging system)
severe osteopenia, or pathologic bone fractures. A small
percentage of patients with symptomatic myeloma have no
detectable M-protein in serum or urine but do have myeloma-
related organ impairment ROTI and increased bone marrow
plasma cells. Any of the following validated biomarkers of
malignancy are acceptable for the diagnosis of MM, including
clonal bone marrow plasma cells >=60%, serum free light chain
ratio of >=100, or free light chain of >=100 mg/L, or more
than one focal bone or bone marrow lesion on MRI >5 mm in
size.
Note (2): A nonsecretory myeloma (a variant form of
symptomatic myeloma) shows absent M-protein in the serum and
urine, bone marrow plasmacytosis, and ROTI. While this group
of patients represents a minority of cases (1-2%), this
uncommon presentation may lead to delay in diagnosis because
of the scarcity of laboratory findings commonly in the face
of an isolated bone process such as low back pain.
Note (3): The diagnostic criteria for asymptomatic (smoldering
or indolent) myeloma requires the following two criteria: (1)
An elevated serum monoclonal protein (IgG or IgA) >30 g/L,
urine monoclonal protein >500 mg/24 hrs., or clonal bone
marrow plasma cells 10%-60%, and (2) absence of myeloma
defining events of amyloidosis without any related organ or
tissue impairment (ROTI) or end-organ damage. There is
usually normal serum calcium, hemoglobin, and serum
creatinine, and no bone lesions on full skeletal survey and
no evidence of amyloidosis or light chain deposition disease.
Note (4): The 100-percent evaluation shall continue for five
years after the diagnosis of symptomatic multiple myeloma, at
which time the appropriate disability evaluation shall be
determined by mandatory VA examination. Any reduction in
evaluation based upon that or any subsequent examination
shall be subject to the provisions of Sec. 3.105(e) and
Sec. 3.344 (a) and (b) of this chapter.
7714 Sickle cell anemia:
With at least 4 or more painful episodes per 12-month 100
period, occurring in skin, joints, bones, or any major
organs, caused by hemolysis and sickling of red blood
cells, with anemia, thrombosis, and infarction, with
residual symptoms precluding even light manual labor.....
Averaging 3 or more painful episodes per 12-month period 60
or with symptoms precluding other than light manual labor
Averaging 1 or 2 painful episodes per 12-month period..... 30
Asymptomatic, established case in remission, but with 10
identifiable organ impairment............................
Note: Sickle cell trait alone, without a history of directly
attributable pathological findings, is not a ratable
disability. Cases of symptomatic sickle cell trait will be
forwarded to the Director, Compensation Service, for
consideration under Sec. 3.321(b)(1) of this chapter.
7715 Non-Hodgkin's lymphoma:
When there is active disease, during treatment phase or 100
with indolent and non-contiguous phase of low grade NHL..
Note: A 100-percent evaluation shall continue beyond the
cessation of any surgical therapy, radiation therapy,
antineoplastic chemotherapy, or other therapeutic procedures.
Two years after discontinuance of such treatment, the
appropriate disability rating shall be determined by
mandatory VA examination. Any reduction in evaluation based
upon that or any subsequent examination shall be subject to
the provisions of Sec. 3.105(e) of this chapter. If there
has been no recurrence, rate on residuals under the
appropriate diagnostic code(s).
7716 Aplastic anemia:
Requiring peripheral blood or bone marrow stem cell 100
transplant; or requiring transfusion of platelets or red
cells, on average, at least once every six weeks per 12-
month period; or infections recurring, on average, at
least once every six weeks per 12-month period...........
Requiring transfusion of platelets or red cells, on 60
average, at least once every three months per 12-month
period; or infections recurring, on average, at least
once every three months per 12-month period; or using
continuous immunosuppressive therapy.....................
Requiring transfusion of platelets or red cells, on 30
average, at least once per 12-month period, but less than
once every three months per 12-month period; or
infections recurring, on average, at least once per 12-
month period, but less than once every three months per
12-month period..........................................
Note: A 100-percent evaluation for peripheral blood or bone
marrow stem cell transplant shall be assigned as of the date
of hospital admission and shall continue with a mandatory VA
examination six months following hospital discharge. 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.
7718 Essential thrombocythemia and primary myelofibrosis
Requiring either continuous myelosuppressive therapy or, 100
for six months following hospital admission, peripheral
blood or bone marrow stem cell transplant, or treatment
with radioactive phosphorus or chemotherapy (including
myelosuppressants).......................................
Requiring continuous or intermittent myelosuppressive 70
therapy to maintain platelet count <500 x 10\9\/L........
Requiring continuous or intermittent myelosuppressive 30
therapy to maintain platelet count of 200,000-400,000, or
white blood cell (WBC) count of 4,000-10,000.............
Asymptomatic.............................................. 0
Note (1): If the condition undergoes leukemic transformation,
evaluate as leukemia under diagnostic code 7703.
Note (2): A 100-percent evaluation shall be assigned as of the
date of hospital admission for peripheral blood or bone
marrow stem cell transplant; or during the period of
treatment with radioactive phosphorus or chemotherapy
(including myelosuppressants). Six months following hospital
discharge or, in the case of radioactive phosphorus or
chemotherapy treatment, six months after completion of
treatment, the appropriate disability rating shall be
determined by mandatory VA examination. Any reduction in
evaluation based upon that or any subsequent examination
shall be subject to the provisions of Sec. 3.105(e) of this
chapter.
7719 Chronic myelogenous leukemia (CML) (chronic myeloid
leukemia or chronic granulocytic leukemia):
Requiring peripheral blood or bone marrow stem cell 100
transplant, or continuous myelosuppressive or
immunosuppressive therapy treatment......................
Requiring intermittent myelosuppressive therapy, or 60
targeted therapy with tyrosine kinase inhibitors, or
interferon treatment.....................................
In apparent remission on continuous targeted therapy with 30
tyrosine kinase inhibitors...............................
Note (1): If the condition undergoes leukemic transformation,
evaluate as leukemia under diagnostic code 7703.
[[Page 46898]]
Note (2): A 100-percent evaluation shall be assigned as of the
date of hospital admission for peripheral blood or bone
marrow stem cell transplant; or during the period of
treatment with radioactive phosphorus or chemotherapy
(including myelosuppressants). Six months following hospital
discharge or, in the case of radioactive phosphorus or
chemotherapy treatment, six months after completion of
treatment, the appropriate disability rating shall be
determined by mandatory VA examination. Any reduction in
evaluation based upon that or any subsequent examination
shall be subject to the provisions of Sec. 3.105 of this
chapter.
7720 Iron deficiency anemia:
Requiring intravenous iron infusions on average 4 or more 30
times per 12-month period................................
Requiring continuous treatment with high-dose oral 10
supplementation..........................................
Asymptomatic or requiring treatment only by dietary 0
modification.............................................
Note: Do not evaluate iron deficiency anemia due to blood loss 0
under this diagnostic code. Evaluate iron deficiency anemia
due to blood loss under the criteria for the condition
causing the blood loss.
7721 Folic acid deficiency:
Requiring continuous treatment with high-dose oral 10
supplementation..........................................
Asymptomatic or requiring treatment only by dietary 0
modification.............................................
7722 Pernicious anemia and Vitamin B12 deficiency anemia:
For initial diagnosis requiring transfusion due to severe 100
anemia, or if there are signs or symptoms related to
central nervous system impairment, such as
encephalopathy, myelopathy, or severe peripheral
neuropathy, requiring parenteral B12 therapy.............
Requiring continuous treatment with Vitamin B12 10
injections, Vitamin B12 sublingual or high-dose oral
tablets, or Vitamin B12 nasal spray or gel...............
Note: A 100-percent evaluation for pernicious anemia and
Vitamin B12 deficiency shall be assigned as of the date of
the initial diagnosis requiring transfusion due to severe
anemia or parenteral B12 therapy and shall continue with a
mandatory VA examination six months following hospital
discharge or cessation of parenteral B12 therapy. Any
reduction in evaluation based upon that or any subsequent
examination shall be subject to the provisions of Sec.
3.105(e) of this chapter. Thereafter, evaluate at 10-percent
and separately evaluate any residual effects of pernicious
anemia, such as neurologic involvement causing peripheral
neuropathy, myelopathy, dementia, or related gastrointestinal
residuals, under the most appropriate diagnostic code.
7723 Acquired hemolytic anemia:
Requiring a bone marrow transplant or continuous 100
intravenous or immunosuppressive therapy (e.g.,
prednisone, Cytoxan, azathioprine, or rituximab).........
Requiring immunosuppressive medication an average of 4 or 60
more times per 12-month period...........................
Requiring an average of 2-3 courses of immunosuppressive 30
therapy per 12-month period..............................
Requiring an average of one course of immunosuppressive 10
therapy per 12-month period..............................
Asymptomatic.............................................. 0
Note (1): A 100-percent evaluation for bone marrow transplant
shall be assigned as of the date of hospital admission and
shall continue for six months after hospital discharge with a
mandatory VA examination six months following hospital
discharge. Any reduction in evaluation based upon that or any
subsequent examination shall be subject to the provisions of
Sec. 3.105(e) of this chapter.
Note (2): Separately evaluate splenectomy under diagnostic
code 7706 and combine with an evaluation under diagnostic
code 7723.
7724 Solitary plasmacytoma:
Solitary plasmacytoma, when there is active disease or 100
during a treatment phase.................................
Note (1): A 100-percent evaluation shall continue beyond the
cessation of any surgical therapy, radiation therapy,
antineoplastic chemotherapy, or other therapeutic procedures
(including autologous stem cell transplantation). 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. If there has been no
recurrence, rate residuals under the appropriate diagnostic
codes.
Note (2): Rate a solitary plasmacytoma that has developed into
multiple myeloma as symptomatic multiple myeloma.
Note (3): Rate residuals of plasma cell dysplasia (e.g.,
thrombosis) and adverse effects of medical treatment (e.g.,
neuropathy) under the appropriate diagnostic codes.
7725 Myelodysplastic syndromes:
Requiring peripheral blood or bone marrow stem cell 100
transplant; or requiring chemotherapy....................
Requiring, on average, 4 or more blood or platelet 60
transfusions per 12-month period; or infections requiring
hospitalization, on average, 3 or more times per 12-month
period...................................................
Requiring, on average, 1 to 3 blood or platelet 30
transfusions per 12-month period; infections requiring
hospitalization, on average, 1 to 2 times per 12-month
period; or requiring biologic therapy, either interferon
alpha on an ongoing basis or erythropoiesis stimulating
agent (ESA) for 12 weeks or less per 12-month period.....
Note (1): If the condition progresses to leukemia, evaluate as
leukemia under diagnostic code 7703.
Note (2): A 100-percent evaluation shall be assigned as of the
date of hospital admission for peripheral blood or bone
marrow stem cell transplant, or during the period of
treatment with chemotherapy and shall continue with a
mandatory VA examination six months following hospital
discharge or, in the case of radioactive phosphorus or
chemotherapy treatment, six months after completion of
treatment. Any reduction in evaluation based upon that or any
subsequent examination shall be subject to the provisions of
Sec. 3.105(e) of this chapter. If there has been no
recurrence, residuals will be rated under the appropriate
diagnostic codes.
------------------------------------------------------------------------
(Authority: 38 U.S.C. 1155.)
0
3. Amend appendix A to part 4 by:
0
a. Revising the entries for diagnostic codes 7700, 7702 through 7705,
7709, 7712, and 7714 through 7716; and
0
b. Adding entries for diagnostic codes 7718 through 7725.
[[Page 46899]]
The revisions and additions read as follows:
Appendix A to Part 4--Table of Amendments and Effective Dates Since 1946
------------------------------------------------------------------------
Diagnostic
Sec. Code No.
------------------------------------------------------------------------
* * * * * * *
4.117................. 7700 Removed [effective date of final
rule].
* * * * * * *
7702 Evaluation October 23, 1995;
title [effective date of final
rule]; evaluation [effective
date of final rule].
7703 Evaluation August 23, 1948;
criterion October 23, 1995;
evaluation [effective date of
final rule]; criterion
[effective date of final rule].
7704 Evaluation October 23, 1995;
evaluation [effective date of
final rule].
7705 Evaluation October 23, 1995;
title [insert effective date of
final rule]; evaluation
[effective date of final rule];
criterion [effective date of
final rule].
* * * * * * *
7709 Evaluation March 10, 1976;
criterion October 23, 1995;
title [effective date of final
rule]; criterion [effective
date of final rule].
* * * * * * *
7712 Added [effective date of final
rule].
* * * * * * *
7714 Added September 9, 1975;
criterion October 23, 1995;
criterion [effective date of
final rule]
7715 Added October 26, 1990;
criterion [effective date of
final rule].
7716 Added October 23, 1995;
evaluation [effective date of
final rule]; criterion
[effective date of final rule].
* * * * * * *
7718 Added [effective date of final
rule].
7719 Added [effective date of final
rule].
7720 Added [effective date of final
rule].
7721 Added [effective date of final
rule].
7722 Added [effective date of final
rule].
7723 Added [effective date of final
rule].
7724 Added [effective date of final
rule].
7725 Added [effective date of final
rule].
* * * * * * *
------------------------------------------------------------------------
0
4. Amend appendix B to part 4 by:
0
a. Revising the undesignated center heading immediately preceding
diagnostic code 7700;
0
b. Removing the entry for diagnostic code 7700;
0
c. Revising the entries for diagnostic codes 7702, 7705 and 7709; and
0
d. Adding entries for diagnostic codes 7712 and 7718 through 7725.
The revisions and additions read as follows:
Appendix B to Part 4--Numerical Index of Disabilities
------------------------------------------------------------------------
Diagnostic Code No.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
THE HEMATOLOGIC AND LYMPHATIC SYSTEMS
------------------------------------------------------------------------
7702................................. Agranulocytosis, acquired.
* * * * * * *
7705................................. Immune thrombocytopenia.
* * * * * * *
7709................................. Hodgkin's lymphoma.
* * * * * * *
7712................................. Multiple myeloma.
* * * * * * *
7718................................. Essential thrombocythemia and
primary myelofibrosis.
* * * * * * *
7719................................. Chronic myelogenous leukemia
(CML) (chronic myeloid leukemia
or chronic granulocytic
leukemia).
[[Page 46900]]
7720................................. Iron deficiency anemia.
7721................................. Folic acid deficiency.
7722................................. Pernicious anemia and Vitamin B12
deficiency anemia.
7723................................. Acquired hemolytic anemia.
7724................................. Solitary plasmacytoma.
7725................................. Myelodysplastic syndromes.
* * * * * * *
------------------------------------------------------------------------
0
5. Amend appendix C to part 4 by:
0
a. Revising the entries for Agranulocytosis and Anemia;
0
c. Adding an entry for Hematologic in alphabetical order;
0
d. Removing the entry for Hodgkin's disease and adding in its place an
entry for Hodgkin's lymphoma;
0
e. Revising the entry for Leukemia;
The revisions and additions read as follows:
Appendix C to Part 4--Alphabetical Index of Disabilities
------------------------------------------------------------------------
Diagnostic Code
No.
------------------------------------------------------------------------
* * * * * * *
Agranulocytosis, acquired............................ 7702
* * * * * * *
Anemia:
Acquired hemolytic anemia........................ 7723
Folic acid deficiency............................ 7721
Iron deficiency anemia........................... 7720
Pernicious anemia and Vitamin B12 deficiency 7722
anemia..........................................
* * * * * * *
Hematologic:
Essential thrombocythemia and primary 7718
myelofibrosis...................................
Immune thrombocytopenia.......................... 7705
Multiple myeloma................................. 7712
Myelodysplastic syndromes........................ 7725
Solitary plasmacytoma............................ 7724
* * * * * * *
Hodgkin's lymphoma................................... 7709
* * * * * * *
Leukemia:
Chronic myelogenous leukemia (CML) (chronic 7719
myeloid leukemia or chronic granulocytic
leukemia).......................................
Leukemia......................................... 7703
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2015-19197 Filed 8-5-15; 8:45 am]
BILLING CODE 8320-01-P