[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Rules and Regulations]
[Pages 54250-54259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23517]
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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: Final rule.
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SUMMARY: This document amends the Department of Veterans Affairs (VA)
Schedule for Rating Disabilities (VASRD) by revising the section of the
Rating Schedule that addresses the hematologic and lymphatic systems.
This action will ensure VA uses current medical terminology and
provides detailed and updated criteria for evaluating conditions
pertaining to the hematologic and lymphatic systems.
DATES: This rule is effective on December 9, 2018.
FOR FURTHER INFORMATION CONTACT: Ioulia Vvedenskaya, M.D., M.B.A.,
Medical Officer, Part 4 VASRD Regulations Staff (211C), Compensation
Service, Veterans Benefits Administration, Department of Veterans
Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700.
(This is not a toll-free telephone number.)
[[Page 54251]]
SUPPLEMENTARY INFORMATION: VA published a proposed rule in the Federal
Register at 80 FR 46888 on August 6, 2015, to amend the portion of the
VASRD dealing with the hematologic and lymphatic systems. VA provided a
60-day public comment period and invited interested persons to submit
written comments, suggestions, or objections on or before October 5,
2015. VA received 11 comments.
I. Purpose of the Final Rule
VA revises the section of the VASRD that addresses the hematologic
and lymphatic systems. This final rule updates medical terminology,
adds certain hematologic diseases, and provides detailed and updated
criteria for evaluating conditions pertaining to the hematologic and
lymphatic systems.
II. Technical Corrections
In the proposed rule, VA proposed a new diagnostic code (DC) 7720,
Iron deficiency anemia. In its review of the final rule, VA realized
that the proposed text for 10 percent disability rating contained an
error. Namely, VA required continuous treatment with high-dose oral
supplementation for a 10 percent disability rating, rather than
intravenous iron infusions at least 1 time but less than 4 times per
12-month period, or continuous treatment with oral supplementation.
This document corrects this error by amending the proposed text to read
as follows: ``Requiring intravenous iron infusions at least 1 time but
less than 4 times per 12-month period, or requiring continuous
treatment with oral supplementation.'' The proposed rule specified that
a zero-percent rating would be warranted if the condition is
asymptomatic or treatable by dietary restrictions only. Implicit in the
proposed rule was the premise that, if the condition requires
intravenous treatment less often than required for a 30-percent rating,
then a 10 percent rating would be warranted. This final rule makes that
premise explicit in DC 7720.
In the proposed rule, VA introduced amended criteria for the 100
percent evaluation in DC 7702 based on the requirement for bone marrow
transplant or infections recurring at least once every six weeks per
12-month period. Upon further review, VA inadvertently omitted a
semicolon between these two criteria, which could lead to confusion as
to the application of the 100 percent criteria. To clarify that these
two criteria are separate and distinct and that only one is required to
establish a 100 percent evaluation, VA is inserting a semicolon after
``transplant'';
In the proposed rule, VA introduced criteria for DCs 7714, 7720,
7723, and 7725 which measured the occurrence of infections (7725),
painful episodes (7714), transfusions (7725), infusions (7720), or
medication usage (7723) based on the ``average'' number of episodes per
12-month period. Upon further review, VA determined that including
``average'' in calculating the number of episodes required by the given
criteria will result in unclear guidance and inconsistent application
of the VASRD, in direct conflict with one of the stated goals of the
VASRD revisions. Additionally, references to the average number of
episodes per 12-month period might suggest that evaluations should in
all instances be based on the average frequency of the episodes over an
unspecified number of years. Although VA must evaluate conditions ``in
relation to [their] history,'' 38 CFR 4.1, there may be instances where
there has been a discernible change in the severity of a condition and
it is more appropriate to evaluate the disability primarily on current
manifestations than on an average of the manifestations over a number
of prior years. Accordingly, to increase consistency in the application
of the criteria, promote clarity in the requirements for each
evaluation level, and to ensure that evaluations may reflect changes in
a condition's severity and the frequency of episodes, VA will remove
the reference to ``average'' from the criteria in DCs 7714, 7720, 7723,
and 7725 and replace it with a quantifiable range at each criteria
level. This change to the language does not result to any substantive
changes to the criteria in the identified DCs.
Additionally, in DC 7705, VA inadvertently omitted semicolons
between these distinct criteria in the 100, 70, and 0 percent
evaluations, which could lead to confusion as to the application of
these evaluation levels. To reiterate and clarify that the criteria in
these evaluation levels are separate and distinct, and that only one is
required to establish a given evaluation, VA is inserting a semicolon
between the criteria for clarification purposes. No substantive change
to the evaluation criteria results from this change.
In the proposed rule, VA introduced several changes to DC 7704,
Polycythemia vera, including a revision for a 30 percent disability
rating. Namely, for a 30 percent disability rating, VA required
phlebotomy 4-5 times per 12-month period or continuous biologic therapy
or myelosuppressive agents to maintain platelets <200,000 or white
blood cells (WBC) <12,000. VA would like to clarify that
myelosuppressive agents, which are used to maintain platelets <200,000
or white blood cells (WBC) <12,000, include interferon. This document
includes this clarification by amending the proposed text to read as
follows: ``Requiring phlebotomy 4-5 times per 12-month period, or if
requiring continuous biologic therapy or myelosuppressive agents, to
include interferon, to maintain platelets <200,000 or white blood cells
(WBC) <12,000.'' VA also makes a clarifying change in the proposed text
for 60 percent disability amending the reference to ``targeted agents
such as imatinib or ruxolitinib'' to ``molecularly targeted therapy,''
which includes imatinib, ruxolitinib, and other agents. Upon further
review, VA has determined that including the ``chemotherapy'' reference
in the evaluation criteria at both the 60 percent and 100 percent
levels in the proposed rule would create a conflict such that the
criteria could not be applied consistently and accurately, potentially
resulting in over- and under-evaluation. Accordingly, to increase
consistency in the application of the criteria, promote clarity in the
requirements for each evaluation level, and to ensure the VASRD
criteria do not conflict with the guidance set forth in Note 3, VA will
remove the reference to ``chemotherapy'' from the criteria in proposed
DC 7704 for the 60 percent rating criteria. Because the requirement for
chemotherapy supports a 100 percent rating, this change to the criteria
for the lower 60 percent rating will not affect any claims but will
eliminate potential confusion. Additionally, VA made an editorial
change to the proposed language. Namely, VA clarified the 60 percent
disability rating criteria to read as follows: ``Requiring phlebotomy 6
or more times per 12-month period or molecularly targeted therapy for
the purpose of controlling RBC count.'' This change to the language
does not result in any substantive changes to the criteria in the
identified DC.
VA also corrects the spelling of ``myelosuppressive,'' which was
misspelled in the proposed regulatory text.
Additionally, VA realized that the proposed text for 10 percent
disability rating under DC 7704 contained a grammatical error that
would have made the rule more confusing and difficult to apply than VA
intended. Namely, VA identified a 10 percent disability rating in the
proposed rule as: ``Requiring phlebotomy, biologic therapy, or
interferon on an intermittent basis, as needed, 3 or fewer times per
12-month
[[Page 54252]]
period.'' VA did not intend to apply two different frequency
standards--i.e., ``on an intermittent basis'' and ``3 or fewer times
per 12-month period''--to the same events, but the proposed text could
suggest that both standards apply to each of the listed events. Rather,
consistent with the requirements for the 60 percent and 30 percent
ratings, VA intended that the ``3 or fewer times per 12-month period''
requirement would apply only to phlebotomy, and that the ``on an
intermittent basis'' requirement would apply to the other listed
treatments. In order to increase consistency in the application of the
criteria and promote clarity in the requirements for each evaluation
level, VA has included additional reference to the outcome of the
treatment for polycythemia vera for 10 percent and 100 percent
evaluation levels. This document corrects the above-referenced
grammatical error and includes additional guidance by amending the
proposed text for 10 percent evaluation to read as follows: ``Requiring
phlebotomy 3 or fewer times per 12-month period or if requiring
biologic therapy or interferon on an intermittent basis as needed to
maintain all blood levels at reference range levels.'' Additionally, VA
amends the proposed text for 100 percent evaluation to read as follows:
``Requiring peripheral blood or bone marrow stem-cell transplant or
chemotherapy (including myelosuppressants) for the purpose of
ameliorating the symptom burden.''
In the proposed rule, VA proposed several changes to DC 7705,
including criteria based on platelet counts. VA specifically proposed
to assign a 100 percent evaluation for platelet count below 30,000.
However, for the 70 percent criteria, which apply in circumstances
involving a platelet count higher than 30,000, VA omitted criteria for
when platelet count is at 30,000. Accordingly, VA has changed the 100
percent criteria to read ``platelet count 30,000 or below'' to avoid a
gap in the platelet count range considered in the evaluation criteria.
In the proposed rule, VA introduced several changes to DC 7716,
Aplastic anemia, including a revision for a 60 percent disability
rating. Namely, for a 60 percent rating, VA required the use of
continuous immunosuppressive therapy. In order to capture the full
range of therapeutic agents that are used to treat this condition, VA
makes a clarifying change that amends the proposed text to reference
the use of ``newer platelet stimulating factors'' in the evaluation
criteria. Additionally, VA has added an explanatory note (2) regarding
the definition of ``newer platelet stimulating factors'' for
clarification purposes and redesignated the existing note as note (1).
In the proposed rule, VA introduced several changes to DC 7718,
Essential thrombocythemia and primary myelofibrosis, including
revisions for 70 and 30 percent disability ratings. Namely, for 70 and
30 percent ratings, VA required the use of continuous or intermittent
myelosuppressive therapy. In order to capture the full range of
therapeutic agents that are used to treat these conditions, VA makes a
clarifying change that amends the proposed text for 70 percent
disability rating to read as follows: ``Requiring continuous or
intermittent myelosuppressive therapy, or chemotherapy, or interferon
treatment to maintain platelet count < 500 x 10\9\/L.'' VA makes a
clarifying change that amends the proposed text for 30 percent
disability rating to read as follows: ``Requiring continuous or
intermittent myelosuppressive therapy, or chemotherapy, or interferon
treatment to maintain platelet count of 200,000-400,000, or white blood
cell (WBC) count of 4,000-10,000.''
In the proposed rule, VA introduced several changes to DC 7719,
Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic
granulocytic leukemia), including revisions for 60 and 30 percent
disability ratings. Namely, for 60 and 30 percent ratings, VA required
the use of targeted therapy with tyrosine kinase inhibitors. In order
to capture the full range of targeted therapy agents that are used to
treat these conditions, VA makes a clarifying change that amends the
proposed text for 60 percent disability rating to read as follows:
``Requiring intermittent myelosuppressive therapy, or molecularly
targeted therapy with tyrosine kinase inhibitors, or interferon
treatment when not in apparent remission.'' VA makes a clarifying
change that amends the proposed text for 30 percent disability rating
to read as follows: ``In apparent remission on continuous molecularly
targeted therapy with tyrosine kinase inhibitors.''
III. Public Comments
One commenter asked why the hematological system did not include
Lyme disease. Lyme disease is an infectious disease evaluated under 38
CFR 4.88b. DC 6319 specifically addresses Lyme disease and its
residuals. Therefore, VA makes no changes based on this comment.
One commenter urged VA to include in the rating schedule the
debilitating side effects of daily tyrosine kinase inhibitors (TKIs)
therapy for chronic myelogenous leukemia (CML). In the proposed rule,
DC 7719 assigns a 60 percent evaluation for intermittent
myelosuppressive therapy, or targeted therapy with TKIs, such as
ruxolitinib, and a 100 percent evaluation for continuous
myelosuppressive or immunosuppressive therapy. However, in cases of
debilitating side effects of therapy for a service-connected disease,
such as CML, VA may grant service connection on a secondary basis for
disabilities that are proximately due to, or aggravated by, service-
connected disease or injury pursuant to 38 CFR 3.310. Therefore, VA
makes no changes based on this comment.
Another commenter suggested separating evaluations for pernicious
anemia from evaluations for Vitamin B12 deficiency anemia.
Pernicious anemia is caused by too little Vitamin B12; it is
one form of Vitamin B12 deficiency anemia. VA recognizes the
importance of separating pernicious anemia from Vitamin B12
deficiency anemia for diagnosis and treatment. However, for disability
compensation, VA evaluates common signs and symptoms and functional
impairment of Vitamin B12 deficiency, also seen in
pernicious anemia, under one diagnostic code. Therefore, VA makes no
changes based on this comment.
The same commenter noted that anemia secondary to autoimmune
pernicious anemia is not corrected but maintained by Vitamin
B12 injections. VA agrees. In the proposed rule, DC 7722
provides a 10 percent evaluation for pernicious anemia and other forms
of severe Vitamin B12 deficiency if it requires continuous
treatment with Vitamin B12 injections, Vitamin
B12 sublingual or high-dose oral tablets, or Vitamin
B12 nasal spray or gel. Therefore, VA makes no changes based
on this comment.
The same commenter suggested including all body systems sequelae of
pernicious anemia into hematologic system evaluations. In cases when
debilitating effects of pernicious anemia affect other body systems, VA
may grant service connection on a secondary basis for disabilities that
are proximately due to, or aggravated by, service-connected disease or
injury, pursuant to 38 CFR 3.310. Therefore, VA makes no changes based
on this comment.
The same commenter suggested VA conduct a study to determine
whether the degree of neurologic or gastrointestinal residuals
correlates with treatment variations. While VA appreciates this
comment, it is beyond the scope of this rulemaking. Therefore, VA makes
no changes based on it.
[[Page 54253]]
The same commenter expressed concern regarding the application of
38 CFR 3.105(e), which governs reduction in evaluation, to evaluate the
debilitating residual effects of pernicious anemia. However, VA may
grant service connection on a secondary basis for disabilities that are
proximately due to, or aggravated by, service-connected disease or
injury pursuant to 38 CFR 3.310. Therefore, VA makes no changes based
on this comment.
One commenter discussed his current treatment for chronic myeloid
leukemia and its side effects. The commenter did not offer any specific
suggestions or recommendations for this rulemaking. Therefore, VA makes
no changes based on this comment.
Another commenter urged the Federal Communications Commission (FCC)
to reconsider regulating open-source software. This comment is beyond
the scope of this rulemaking, so VA makes no changes based on it.
Two commenters indicated that security and privacy issues are
important to them. The commenters did not offer any specific
suggestions or recommendations for this rulemaking. Therefore, VA makes
no changes based on these comments.
One commenter discussed his brother's diagnosis of chronic myeloid
leukemia and military service in Vietnam. The commenter did not offer
any specific suggestions or recommendations for this rulemaking.
Therefore, VA makes no changes based on this comment.
Another commenter discussed his diagnosis of chronic myeloid
leukemia, its side effects, and his military service in Vietnam. The
commenter expressed his satisfaction with updates to the hematologic
section of the rating schedule, which includes evaluations for chronic
myeloid leukemia. The commenter did not offer any specific suggestions
or recommendations for this rulemaking. Therefore, VA makes no changes
based on this comment.
One commenter was supportive of many of the changes and additions
made to the hematologic and lymphatic sections of the VASRD, which
include new diagnostic codes for common disorders, clarifying notes on
residuals affecting other body systems, and recognizing common side
effects of various treatments. The commenter offered two minor
suggestions regarding rating criteria for multiple myeloma (DC 7712)
and acquired hemolytic anemia (DC 7723).
The commenter suggests deleting Note 2, Note 3, and part of Note 1
under DC 7712 in order to simplify the rating process. VA agrees and
removes the references to specific laboratory values by deleting Note
(2) and Note (3). VA edits Note (1) by removing the references to
specific laboratory values and replaces them with more general
references to what are acceptable for the diagnosis of multiple myeloma
as defined by the American Society of Hematology (ASH) and
International Myeloma Working Group. Lastly, VA renumbers the proposed
Note (4) to become Note (2).
The same commenter suggested including two additional treatment
modalities for acquired hemolytic anemia under DC 7723. The commenter
noted that, according to guidelines of the National Institutes of
Health, the National Heart, Lung, and Blood Institute, and ASH,
treatments for symptomatic acquired hemolytic anemia may include blood
transfusion or plasmapheresis. VA identifies four levels of disability
for symptomatic acquired hemolytic anemia, each of which includes blood
transfusion or plasmapheresis. The defining feature for each level of
disability is the frequency of immunosuppressive therapy or the need
for a bone marrow transplant. Therefore, VA makes no changes based on
this comment.
Another commenter noted that further revisions are needed for
hematologic and lymphatic section of the VASRD to ensure its congruency
with current understanding of hematologic diseases. The commenter
offered multiple recommendations on selected diagnostic codes.
The commenter recommended deleting the references to obsolete or
never used treatments. VA agrees and removes all references to
treatment with radioactive phosphorus (DCs 7704, 7718, 7719, and 7725),
imantib (DC 7704), interferon alpha (DC 7725), and multiple references
to outdated laboratory values under DCs 7705 and 7712, Note (1).
Proposed DC 7705 referred to a platelet count range from 20,000 to
30,000 despite treatment under a 100-percent rating level. The final
rule revises this value to include all platelet counts of 30,000 or
below.
The commenter noted that various anemia sections (DCs 7714, 7716,
7720, 7722, and 7723) did not link to comorbidities, such as cardiac
disease and chronic obstructive pulmonary disease. The commenter
advised VA to revise anemia DCs to include comorbidities because
different hemoglobin levels might have vastly different implications in
patients with cardiac disease, chronic obstructive pulmonary disease,
or other significant comorbid conditions. As the hematopoietic system
supports other cells or organs of the body, VA assigns disability
ratings resulting from identifiable defects in these organs due to
hematologic disease. The hematologic rating does not generally include
the physiologic effects on the function of other end-organs. For
example, very severe anemia can reduce oxygen delivery to the point
where the individual suffers a myocardial infarction. The disability
ratings for both the anemia and the myocardial infarction would be
rated separately and then combined. VA may grant service connection on
a secondary basis for disabilities that are proximately due to, or
aggravated by, service connected disease or injury pursuant to 38 CFR
3.310. Therefore, VA makes no changes based on this comment.
The commenter noted that current practice infrequently transplants
bone marrow to treat agranulocytosis (DC 7702). Additionally, current
medical protocol never uses platelet and red cell transfusions. Even
though use of bone marrow transplants may be infrequent, the fact that
it is still used for cases that do not respond to other types of
treatment justifies including it as part of the 100 percent rating
criteria. Additionally, the proposed rule does not refer to platelet
and red cell transfusions for the treatment of agranulocytosis.
Therefore, VA makes no changes based on this comment.
The commenter indicated that current practice does not use
radioactive phosphorus or interferon alpha to treat myelodysplastic
syndromes (DC 7725). VA agrees and removes all references to such
treatment from this DC.
The commenter suggested editing platelet count reference for a 100
percent evaluation under DC 7705, Immune thrombocytopenia. ASH
guidelines for immune thrombocytopenia recommend treatment for patients
with platelet counts below 30,000. VA agrees and replaces the reference
to ``a platelet count from 20,000 to 30,000'' under DC 7705 with ``a
platelet count 30,000 or below despite treatment''.
The commenter noted that the 100 percent evaluation under DC 7705
included chemotherapy but the relevance of immunosuppressive therapy to
this evaluation was unclear. However, VA did not intend to include
immunosuppressive therapy as part of a 100 percent evaluation. VA
includes immunosuppressive therapy as part of a 70 percent evaluation.
Therefore, VA makes no changes based on this comment.
The commenter noted that recent advances in medicine have
identified
[[Page 54254]]
conditions called monoclonal gammopathy of undetermined significance
(MGUS) and smoldering myeloma, which are not acute myeloma but may
indicate a future need for treatment. The commenter suggested removing
an outdated reference to indolent myeloma from DC 7712 and replacing it
with MGUS. VA agrees and removes the reference to indolent myeloma from
DC 7712 and replaces the reference with MGUS.
VA appreciates the comments submitted in response to the proposed
rule. Based on the rationale stated in the proposed rule and in this
document, the final rule is adopted with the changes noted.
We are additionally adding updates to 38 CFR part 4, Appendices A,
B, and C, to reflect changes to the hematologic and lymphatic systems
rating criteria made by this rulemaking. VA designs the appendices for
users of the VASRD. They do not contain substantive content regarding
disability evaluations.
Executive Orders 12866, 13563 and 13771
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action'' requiring review by the Office of
Management and Budget (OMB), unless OMB waives such review, as ``any
regulatory action that is likely to result in a rule that may: (1) Have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
Create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) Materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) Raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.''
The economic, interagency, budgetary, legal, and policy
implications of this regulatory action have been examined, and it has
been determined not to be a significant regulatory action under
Executive Order 12866. VA's impact analysis can be found as a
supporting document at http://www.regulations.gov, usually within 48
hours after the rulemaking document is published. Additionally, a copy
of this rulemaking and its impact analysis are available on VA's
website at http://www.va.gov/orpm/, by following the link for ``VA
Regulations Published From FY 2004 Through Fiscal Year to Date.''
This rule is not an Executive Order 13771 regulatory action because
this rule is not significant under Executive Order 12866.
Regulatory Flexibility Act
The Secretary hereby certifies that this final rule will not have a
significant economic impact on a substantial number of small entities
as defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This
final rule will not affect any small entities. Only certain VA
beneficiaries could be directly affected. Therefore, pursuant to 5
U.S.C. 605(b), this rulemaking is exempt from the initial and final
regulatory flexibility analysis requirements of sections 603 and 604.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This final rule will have no such effect on
State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
This final rule contains provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). Specifically, this final rule is associated with information
collections related to the filing of disability claims (VA Form 21-
526EZ) as well as Disability Benefits Questionnaires (DBQs) which
enable a claimant to gather the necessary information from his or her
treating physician as to the current symptoms and severity of a
disability. Both information collections are currently approved by the
Office of Management and Budget (OMB) and have been assigned OMB
control Numbers 2900-0749 and 2900-0779, respectively. There are no
changes to any of these information collections and, thus, no
incremental costs associated with this rulemaking.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance program numbers and
titles for this rule are 64.104, Pension for Non-Service-Connected
Disability for Veterans; 64.109, Veterans Compensation for Service-
Connected Disability; and 64.110, Veterans Dependency and Indemnity
Compensation for Service-Connected Death.
List of Subjects in 38 CFR Part 4
Disability benefits, Pensions, Veterans.
Signing Authority
The Secretary of Veterans Affairs approved this document and
authorized the undersigned to sign and submit the document to the
Office of the Federal Register for publication electronically as an
official document of the Department of Veterans Affairs. Robert L.
Wilkie, Secretary, Department of Veterans Affairs, approved this
document on October 23, 2018, for publication.
Dated: October 23, 2018.
Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of
the Secretary, Department of Veterans Affairs.
For the reasons set out in the preamble, the Department of Veterans
Affairs amends 38 CFR part 4, subpart B 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. Amend Sec. 4.117 by:
0
a. Removing the entry for diagnostic code 7700;
0
b. Revising the entries for diagnostic codes 7702 through 7706, 7709,
7710 and 7714 through 7716;
0
c. Adding, in numerical order, an entry for diagnostic code 7712 and
7718 through 7725.
[[Page 54255]]
The revisions, and additions to read as follows:
Sec. 4.117 Schedule of ratings--hematologic and lymphatic systems
------------------------------------------------------------------------
Rating
------------------------------------------------------------------------
7702 Agranulocytosis, acquired:
Requiring bone marrow transplant; or infections 100
recurring, on average, at least once every six
weeks per 12-month period..........................
Requiring intermittent myeloid growth factors 60
(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/microliter
([micro]l) but less than 1000/[micro]l; or
infections recurring, on average, at least once
every three months per 12-month period.............
Requiring intermittent myeloid growth factors to 30
maintain ANC greater than 1000/[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) 10
for control; or requiring intermittent use of a
myeloid growth factor to maintain ANC greater than
or equal to 1500/[micro]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 100
phase..............................................
Otherwise rate residuals under the appropriate
diagnostic code(s).................................
Chronic lymphocytic leukemia or monoclonal B-cell 0
lymphocytosis (MBL), asymptomatic, Rai Stage.......
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 chemotherapy (including
myelosuppressants) for the purpose of ameliorating
the symptom burden.................................
Requiring phlebotomy 6 or more times per 12-month 60
period or molecularly targeted therapy for the
purpose of controlling RBC count...................
Requiring phlebotomy 4-5 times per 12-month period, 30
or if requiring continuous biologic therapy or
myelosuppressive agents, to include interferon, to
maintain platelets <200,000 or white blood cells
(WBC) <12,000......................................
Requiring phlebotomy 3 or fewer times per 12-month 10
period or if requiring biologic therapy or
interferon on an intermittent basis as needed to
maintain all blood values at reference range levels
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 chemotherapy
(including myelosuppressants). Six months following
hospital discharge or, in the case of 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 30,000 or
below despite treatment............................
Requiring immunosuppressive therapy; or for a 70
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 30
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 10
than 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
infections with encapsulated bacteria..............
* * * * * * *
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
[[Page 54256]]
Asymptomatic, smoldering, or monoclonal gammopathy 0
of undetermined significance (MGUS)................
Note (1): Current validated biomarkers of
symptomatic multiple myeloma and asymptomatic
multiple myeloma, smoldering, or monoclonal
gammopathy of undetermined significance (MGUS) are
acceptable for the diagnosis of multiple myeloma as
defined by the American Society of Hematology (ASH)
and International Myeloma Working Group (IMWG).....
Note (2): 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- 100
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.................................
With 3 painful episodes per 12-month period or with 60
symptoms precluding other than light manual labor..
With 1 or 2 painful episodes per 12-month period.... 30
Asymptomatic, established case in remission, but 10
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 Sec.
3.321(b)(1) of this chapter.......................
7715 Non-Hodgkin's lymphoma:
When there is active disease, during treatment 100
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 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 therapy with
immunosuppressive agent or newer platelet
stimulating factors................................
Requiring transfusion of platelets or red cells, on 30
average, at least once per 12-month period; or
infections recurring, on average, at least once per
12-month period....................................
Note (1): 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....................
Note (2): The term ``newer platelet stimulating
factors'' includes medication, factors, or other
agents approved by the United States Food and Drug
Administration.....................................
* * * * * * *
7718 Essential thrombocythemia and primary
myelofibrosis:
Requiring either continuous myelosuppressive therapy 100
or, for six months following hospital admission,
peripheral blood or bone marrow stem cell
transplant, or chemotherapy, or interferon
treatment..........................................
Requiring continuous or intermittent 70
myelosuppressive therapy, or chemotherapy, or
interferon treatment to maintain platelet count
<500 x 10 \9\/L....................................
Requiring continuous or intermittent 30
myelosuppressive therapy, or chemotherapy, or
interferon treatment 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 chemotherapy
(including myelosuppressants). Six months following
hospital discharge or, in the case of 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
molecularly targeted therapy with tyrosine kinase
inhibitors, or interferon treatment when not in
apparent remission.................................
In apparent remission on continuous molecularly 30
targeted therapy with tyrosine kinase inhibitors...
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 chemotherapy
(including myelosuppressants). Six months following
hospital discharge or, in the case of 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 4 or more times 30
per 12-month period................................
Requiring intravenous iron infusions at least 1 time 10
but less than 4 times per 12-month period, or
requiring continuous treatment with oral
supplementation....................................
Asymptomatic or requiring treatment only by dietary 0
modification.......................................
[[Page 54257]]
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 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 100
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 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 4 or more 60
times per 12-month period..........................
Requiring at least 2 but less than 4 courses of 30
immunosuppressive therapy per 12-month period......
Requiring one course of immunosuppressive therapy 10
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 100
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 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 4 or more blood or platelet transfusions 60
per 12-month period; or infections requiring
hospitalization 3 or more times per 12-month period
Requiring at least 1 but no more than 3 blood or 30
platelet transfusions per 12-month period;
infections requiring hospitalization at least 1 but
no more than 2 times per 12-month period; or
requiring biologic therapy 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 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.......................
------------------------------------------------------------------------
0
3. Amend Appendix A to Part 4 by:
0
a. Revising the entries for diagnostic codes 7700, 7702 through 7706,
7709 through 7710, and 7714 through 7716;
0
b. Adding, in numerical order, an entry for diagnostic code 7712 and
7718 through 7725.
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 December 9, 2018.
* * * * * * *
7702 Evaluation October 23, 1995;
title December 9, 2018;
evaluation December 9, 2018.
[[Page 54258]]
7703 Evaluation August 23, 1948;
criterion October 23, 1995;
evaluation December 9, 2018;
criterion December 9, 2018.
7704 Evaluation October 23, 1995;
evaluation December 9, 2018.
7705 Evaluation October 23, 1995;
title December 9, 2018;
evaluation December 9, 2018;
criterion December 9, 2018.
7706 Evaluation October 23, 1995;
note December 9, 2018;
criterion October 23, 1995.
* * * * * * *
7709 Evaluation March 10, 1976;
criterion October 23, 1995;
title December 9, 2018;
criterion December 9, 2018.
7710 Criterion October 23, 1995;
criterion December 9, 2018.
7712 Added December 9, 2018.
7714 Added September 9, 1975;
criterion October 23, 1995;
criterion December 9, 2018.
7715 Added October 26, 1990;
criterion December 9, 2018.
7716 Added October 23, 1995;
evaluation December 9, 2018;
criterion December 9, 2018.
* * * * * * *
7718 Added December 9, 2018.
7719 Added December 9, 2018.
7720 Added December 9, 2018.
7721 Added December 9, 2018.
7722 Added December 9, 2018.
7723 Added December 9, 2018.
7724 Added December 9, 2018.
7725 Added December 9, 2018.
* * * * * * *
------------------------------------------------------------------------
0
4. Amend Appendix B to Part 4 by:
0
a. Revising the undesignated center heading immediately preceding
diagnostic code 7700.
0
b. Revising the entries for diagnostic codes 7700, 7702, 7705, and
7709.
0
c. Adding, in numerical order, 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
------------------------------------------------------------------------
7700........................ [Removed]
* * * * * * *
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).
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.
* * * * * * *
------------------------------------------------------------------------
[[Page 54259]]
0
5. Amend Appendix C to Part 4 by revising the entries for
Agranulocytosis, Anemia, Hodgkin's lymphoma, and Leukemia and adding in
alphabetical order, a new entry for Hematologic to 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 anemia. 7722
* * * * * * *
Hematologic:
Essential thrombocythemia and primary myelofibrosis. 7718
Immune thrombocytopenia............................. 7705
Multiple myeloma.................................... 7712
Myelodysplastic syndromes........................... 7725
Solitary plasmacytoma............................... 7724
* * * * * * *
Hodgkin's lymphoma...................................... 7709
* * * * * * *
Leukemia:
Chronic myelogenous leukemia (CML) (chronic myeloid 7719
leukemia or chronic granulocytic leukemia).........
Leukemia............................................ 7703
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2018-23517 Filed 10-26-18; 8:45 am]
BILLING CODE 8320-01-P