83_FR_54459 83 FR 54250 - Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems

83 FR 54250 - Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 83, Issue 209 (October 29, 2018)

Page Range54250-54259
FR Document2018-23517

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.

Federal Register, Volume 83 Issue 209 (Monday, October 29, 2018)
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Rules and Regulations]
[Pages 54250-54259]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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



                                           54250            Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations

                                           significant economic impact on a                        responsibilities between the Federal                  December 31, 2018, in § 117.723,
                                           substantial number of small entities.                   Government and Indian tribes.                         suspend paragraph (b) and temporarily
                                              While some owners or operators of                                                                          add paragraph (k) to read as follows:
                                           vessels intending to transit the bridge                 E. Unfunded Mandates Reform Act
                                           may be small entities, for the reasons                    The Unfunded Mandates Reform Act                    § 117.723   Hackensack River.
                                           stated in section V.A above, this rule                  of 1995 (2 U.S.C. 1531–1538) requires                 *      *    *     *     *
                                           will not have a significant economic                    Federal agencies to assess the effects of                (k) The draw of the PATH Bridge,
                                           impact on any vessel owner or operator.                 their discretionary regulatory actions. In            mile 3.0, at Jersey City, shall open on
                                              Under section 213(a) of the Small                    particular, the Act addresses actions                 signal provided at least a two-hour
                                           Business Regulatory Enforcement                         that may result in the expenditure by a               advance notice is provided by calling
                                           Fairness Act of 1996 (Pub. L. 104–121),                 State, local, or tribal government, in the            the number posted at the bridge. The
                                           we want to assist small entities in                     aggregate, or by the private sector of                draw need not open for the passage of
                                           understanding this rule. If the rule                    $100,000,000 (adjusted for inflation) or              vessel traffic Monday through Friday,
                                           would affect your small business,                       more in any one year. Though this rule                except Federal holidays, from 6 a.m. to
                                           organization, or governmental                           will not result in such an expenditure,               10 a.m. and from 4 p.m. to 8 p.m.; and
                                           jurisdiction and you have questions                     we do discuss the effects of this rule                from 12:01 a.m. Saturday to 12:01 a.m.
                                           concerning its provisions or options for                elsewhere in this preamble.                           Monday. Weekdays additional bridge
                                           compliance, please contact the person                                                                         openings shall be provided for
                                                                                                   F. Environment
                                           listed in the FOR FURTHER INFORMATION                                                                         commercial vessels from 6 a.m. to 7:20
                                           CONTACT, above.                                            We have analyzed this rule under                   a.m.; 9:20 a.m. to 10 a.m.; 4 p.m. to 4:30
                                              Small businesses may send comments                   Department of Homeland Security                       p.m. and from 6:50 p.m. to 8 p.m.
                                           on the actions of Federal employees                     Management Directive 023–01 and                       provided at least a two-hour advance
                                           who enforce, or otherwise determine                     Commandant Instruction M16475.lD,                     notice is given by calling the number
                                           compliance with, Federal regulations to                 which guides the Coast Guard in                       posted at the bridge.
                                           the Small Business and Agriculture                      complying with the National
                                                                                                                                                           Dated: October 12, 2018.
                                           Regulatory Enforcement Ombudsman                        Environmental Policy Act of 1969
                                                                                                   (NEPA) (42 U.S.C. 4321–4370f), and                    A.J. Tiongson,
                                           and the Regional Small Business
                                           Regulatory Fairness Boards. The                         have made a determination that this                   Rear Admiral, U.S. Coast Guard, Commander,
                                                                                                   action is one of a category of actions                First Coast Guard District.
                                           Ombudsman evaluates these actions
                                                                                                   which do not individually or                          [FR Doc. 2018–23596 Filed 10–26–18; 8:45 am]
                                           annually and rates each agency’s
                                           responsiveness to small business. If you                cumulatively have a significant effect on             BILLING CODE 9110–04–P

                                           wish to comment on actions by                           the human environment. This rule
                                           employees of the Coast Guard, call 1–                   simply promulgates the operating
                                           888–REG–FAIR (1–888–734–3247). The                      regulations or procedures for                         DEPARTMENT OF VETERANS
                                           Coast Guard will not retaliate against                  drawbridges. This action is categorically             AFFAIRS
                                           small entities that question or complain                excluded from further review, under
                                           about this rule or any policy or action                 figure 2–1, paragraph (32)(e), of the                 38 CFR Part 4
                                           of the Coast Guard.                                     Instruction. A preliminary Record of
                                                                                                   Environmental Consideration and a                     RIN 2900–AO19
                                           C. Collection of Information                            Memorandum for the Record are not
                                             This rule calls for no new collection                 required for this rule.                               Schedule for Rating Disabilities: The
                                           of information under the Paperwork                                                                            Hematologic and Lymphatic Systems
                                           Reduction Act of 1995 (44 U.S.C. 3501–                  G. Protest Activities
                                                                                                                                                         AGENCY:    Department of Veterans Affairs.
                                           3520).                                                    The Coast Guard respects the First
                                                                                                   Amendment rights of protesters.                       ACTION:   Final rule.
                                           D. Federalism and Indian Tribal                         Protesters are asked to contact the
                                           Government                                                                                                    SUMMARY:   This document amends the
                                                                                                   person listed in the FOR FURTHER                      Department of Veterans Affairs (VA)
                                              A rule has implications for federalism               INFORMATION CONTACT section to
                                                                                                                                                         Schedule for Rating Disabilities
                                           under Executive Order 13132,                            coordinate protest activities so that your            (VASRD) by revising the section of the
                                           Federalism, if it has a substantial direct              message can be received without                       Rating Schedule that addresses the
                                           effect on the States, on the relationship               jeopardizing the safety or security of                hematologic and lymphatic systems.
                                           between the national government and                     people, places or vessels.                            This action will ensure VA uses current
                                           the States, or on the distribution of
                                                                                                   List of Subjects in 33 CFR Part 117                   medical terminology and provides
                                           power and responsibilities among the
                                                                                                     Bridges.                                            detailed and updated criteria for
                                           various levels of government. We have
                                                                                                                                                         evaluating conditions pertaining to the
                                           analyzed this rule under that Order and                   For the reasons discussed in the
                                                                                                                                                         hematologic and lymphatic systems.
                                           have determined that it is consistent                   preamble, the Coast Guard amends 33
                                           with the fundamental federalism                         CFR part 117 as follows:                              DATES: This rule is effective on
                                           principles and preemption requirements                                                                        December 9, 2018.
                                           described in Executive Order 13132.                     PART 117—DRAWBRIDGE                                   FOR FURTHER INFORMATION CONTACT:
                                              Also, this rule does not have tribal                 OPERATION REGULATIONS                                 Ioulia Vvedenskaya, M.D., M.B.A.,
                                           implications under Executive Order                                                                            Medical Officer, Part 4 VASRD
                                           13175, Consultation and Coordination                    ■ 1. The authority citation for part 117              Regulations Staff (211C), Compensation
amozie on DSK3GDR082PROD with RULES




                                           with Indian Tribal Governments,                         continues to read as follows:                         Service, Veterans Benefits
                                           because it does not have a substantial                    Authority: 33 U.S.C. 499; 33 CFR 1.05–1;            Administration, Department of Veterans
                                           direct effect on one or more Indian                     Department of Homeland Security Delegation            Affairs, 810 Vermont Avenue NW,
                                           tribes, on the relationship between the                 No. 0170.1.                                           Washington, DC 20420, (202) 461–9700.
                                           Federal Government and Indian tribes,                   ■ 2. From 12:01 a.m. on date of                       (This is not a toll-free telephone
                                           or on the distribution of power and                     publication, through 12:01 a.m. on                    number.)


                                      VerDate Sep<11>2014   16:53 Oct 26, 2018   Jkt 247001   PO 00000   Frm 00022   Fmt 4700   Sfmt 4700   E:\FR\FM\29OCR1.SGM   29OCR1


                                                            Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations                                          54251

                                           SUPPLEMENTARY INFORMATION:    VA                          In the proposed rule, VA introduced                 that myelosuppressive agents, which are
                                           published a proposed rule in the                        criteria for DCs 7714, 7720, 7723, and                used to maintain platelets <200,000 or
                                           Federal Register at 80 FR 46888 on                      7725 which measured the occurrence of                 white blood cells (WBC) <12,000,
                                           August 6, 2015, to amend the portion of                 infections (7725), painful episodes                   include interferon. This document
                                           the VASRD dealing with the                              (7714), transfusions (7725), infusions                includes this clarification by amending
                                           hematologic and lymphatic systems. VA                   (7720), or medication usage (7723)                    the proposed text to read as follows:
                                           provided a 60-day public comment                        based on the ‘‘average’’ number of                    ‘‘Requiring phlebotomy 4–5 times per
                                           period and invited interested persons to                episodes per 12-month period. Upon                    12-month period, or if requiring
                                           submit written comments, suggestions,                   further review, VA determined that                    continuous biologic therapy or
                                           or objections on or before October 5,                   including ‘‘average’’ in calculating the              myelosuppressive agents, to include
                                           2015. VA received 11 comments.                          number of episodes required by the                    interferon, to maintain platelets
                                                                                                   given criteria will result in unclear                 <200,000 or white blood cells (WBC)
                                           I. Purpose of the Final Rule                            guidance and inconsistent application                 <12,000.’’ VA also makes a clarifying
                                             VA revises the section of the VASRD                   of the VASRD, in direct conflict with                 change in the proposed text for 60
                                           that addresses the hematologic and                      one of the stated goals of the VASRD                  percent disability amending the
                                           lymphatic systems. This final rule                      revisions. Additionally, references to                reference to ‘‘targeted agents such as
                                           updates medical terminology, adds                       the average number of episodes per 12-                imatinib or ruxolitinib’’ to ‘‘molecularly
                                           certain hematologic diseases, and                       month period might suggest that                       targeted therapy,’’ which includes
                                           provides detailed and updated criteria                  evaluations should in all instances be                imatinib, ruxolitinib, and other agents.
                                           for evaluating conditions pertaining to                 based on the average frequency of the                 Upon further review, VA has
                                           the hematologic and lymphatic systems.                  episodes over an unspecified number of                determined that including the
                                                                                                   years. Although VA must evaluate                      ‘‘chemotherapy’’ reference in the
                                           II. Technical Corrections                               conditions ‘‘in relation to [their]                   evaluation criteria at both the 60 percent
                                              In the proposed rule, VA proposed a                  history,’’ 38 CFR 4.1, there may be                   and 100 percent levels in the proposed
                                           new diagnostic code (DC) 7720, Iron                     instances where there has been a                      rule would create a conflict such that
                                           deficiency anemia. In its review of the                 discernible change in the severity of a               the criteria could not be applied
                                           final rule, VA realized that the proposed               condition and it is more appropriate to               consistently and accurately, potentially
                                           text for 10 percent disability rating                   evaluate the disability primarily on                  resulting in over- and under-evaluation.
                                           contained an error. Namely, VA                          current manifestations than on an                     Accordingly, to increase consistency in
                                           required continuous treatment with                      average of the manifestations over a                  the application of the criteria, promote
                                           high-dose oral supplementation for a 10                 number of prior years. Accordingly, to                clarity in the requirements for each
                                           percent disability rating, rather than                  increase consistency in the application               evaluation level, and to ensure the
                                           intravenous iron infusions at least 1                   of the criteria, promote clarity in the               VASRD criteria do not conflict with the
                                           time but less than 4 times per 12-month                 requirements for each evaluation level,               guidance set forth in Note 3, VA will
                                           period, or continuous treatment with                    and to ensure that evaluations may                    remove the reference to
                                           oral supplementation. This document                     reflect changes in a condition’s severity             ‘‘chemotherapy’’ from the criteria in
                                           corrects this error by amending the                     and the frequency of episodes, VA will                proposed DC 7704 for the 60 percent
                                           proposed text to read as follows:                       remove the reference to ‘‘average’’ from              rating criteria. Because the requirement
                                                                                                   the criteria in DCs 7714, 7720, 7723, and             for chemotherapy supports a 100
                                           ‘‘Requiring intravenous iron infusions at
                                                                                                   7725 and replace it with a quantifiable               percent rating, this change to the criteria
                                           least 1 time but less than 4 times per 12-
                                                                                                   range at each criteria level. This change             for the lower 60 percent rating will not
                                           month period, or requiring continuous
                                                                                                   to the language does not result to any                affect any claims but will eliminate
                                           treatment with oral supplementation.’’
                                                                                                   substantive changes to the criteria in the            potential confusion. Additionally, VA
                                           The proposed rule specified that a zero-
                                                                                                   identified DCs.                                       made an editorial change to the
                                           percent rating would be warranted if the                  Additionally, in DC 7705, VA                        proposed language. Namely, VA
                                           condition is asymptomatic or treatable                  inadvertently omitted semicolons                      clarified the 60 percent disability rating
                                           by dietary restrictions only. Implicit in               between these distinct criteria in the                criteria to read as follows: ‘‘Requiring
                                           the proposed rule was the premise that,                 100, 70, and 0 percent evaluations,                   phlebotomy 6 or more times per 12-
                                           if the condition requires intravenous                   which could lead to confusion as to the               month period or molecularly targeted
                                           treatment less often than required for a                application of these evaluation levels.               therapy for the purpose of controlling
                                           30-percent rating, then a 10 percent                    To reiterate and clarify that the criteria            RBC count.’’ This change to the
                                           rating would be warranted. This final                   in these evaluation levels are separate               language does not result in any
                                           rule makes that premise explicit in DC                  and distinct, and that only one is                    substantive changes to the criteria in the
                                           7720.                                                   required to establish a given evaluation,             identified DC.
                                              In the proposed rule, VA introduced                  VA is inserting a semicolon between the                  VA also corrects the spelling of
                                           amended criteria for the 100 percent                    criteria for clarification purposes. No               ‘‘myelosuppressive,’’ which was
                                           evaluation in DC 7702 based on the                      substantive change to the evaluation                  misspelled in the proposed regulatory
                                           requirement for bone marrow transplant                  criteria results from this change.                    text.
                                           or infections recurring at least once                     In the proposed rule, VA introduced                    Additionally, VA realized that the
                                           every six weeks per 12-month period.                    several changes to DC 7704,                           proposed text for 10 percent disability
                                           Upon further review, VA inadvertently                   Polycythemia vera, including a revision               rating under DC 7704 contained a
                                           omitted a semicolon between these two                   for a 30 percent disability rating.                   grammatical error that would have made
                                           criteria, which could lead to confusion                 Namely, for a 30 percent disability                   the rule more confusing and difficult to
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                                           as to the application of the 100 percent                rating, VA required phlebotomy 4–5                    apply than VA intended. Namely, VA
                                           criteria. To clarify that these two criteria            times per 12-month period or                          identified a 10 percent disability rating
                                           are separate and distinct and that only                 continuous biologic therapy or                        in the proposed rule as: ‘‘Requiring
                                           one is required to establish a 100                      myelosuppressive agents to maintain                   phlebotomy, biologic therapy, or
                                           percent evaluation, VA is inserting a                   platelets <200,000 or white blood cells               interferon on an intermittent basis, as
                                           semicolon after ‘‘transplant’’;                         (WBC) <12,000. VA would like to clarify               needed, 3 or fewer times per 12-month


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                                           54252            Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations

                                           period.’’ VA did not intend to apply two                platelet stimulating factors’’ for                    myelogenous leukemia (CML). In the
                                           different frequency standards—i.e., ‘‘on                clarification purposes and redesignated               proposed rule, DC 7719 assigns a 60
                                           an intermittent basis’’ and ‘‘3 or fewer                the existing note as note (1).                        percent evaluation for intermittent
                                           times per 12-month period’’—to the                         In the proposed rule, VA introduced                myelosuppressive therapy, or targeted
                                           same events, but the proposed text                      several changes to DC 7718, Essential                 therapy with TKIs, such as ruxolitinib,
                                           could suggest that both standards apply                 thrombocythemia and primary                           and a 100 percent evaluation for
                                           to each of the listed events. Rather,                   myelofibrosis, including revisions for 70             continuous myelosuppressive or
                                           consistent with the requirements for the                and 30 percent disability ratings.                    immunosuppressive therapy. However,
                                           60 percent and 30 percent ratings, VA                   Namely, for 70 and 30 percent ratings,                in cases of debilitating side effects of
                                           intended that the ‘‘3 or fewer times per                VA required the use of continuous or                  therapy for a service-connected disease,
                                           12-month period’’ requirement would                     intermittent myelosuppressive therapy.                such as CML, VA may grant service
                                           apply only to phlebotomy, and that the                  In order to capture the full range of                 connection on a secondary basis for
                                           ‘‘on an intermittent basis’’ requirement                therapeutic agents that are used to treat             disabilities that are proximately due to,
                                           would apply to the other listed                         these conditions, VA makes a clarifying               or aggravated by, service-connected
                                           treatments. In order to increase                        change that amends the proposed text                  disease or injury pursuant to 38 CFR
                                           consistency in the application of the                   for 70 percent disability rating to read              3.310. Therefore, VA makes no changes
                                           criteria and promote clarity in the                     as follows: ‘‘Requiring continuous or                 based on this comment.
                                           requirements for each evaluation level,                 intermittent myelosuppressive therapy,                   Another commenter suggested
                                           VA has included additional reference to                 or chemotherapy, or interferon                        separating evaluations for pernicious
                                           the outcome of the treatment for                        treatment to maintain platelet count                  anemia from evaluations for Vitamin B12
                                           polycythemia vera for 10 percent and                    < 500 × 109/L.’’ VA makes a clarifying                deficiency anemia. Pernicious anemia is
                                           100 percent evaluation levels. This                     change that amends the proposed text                  caused by too little Vitamin B12; it is one
                                           document corrects the above-referenced                  for 30 percent disability rating to read              form of Vitamin B12 deficiency anemia.
                                           grammatical error and includes                          as follows: ‘‘Requiring continuous or                 VA recognizes the importance of
                                           additional guidance by amending the                     intermittent myelosuppressive therapy,                separating pernicious anemia from
                                           proposed text for 10 percent evaluation                 or chemotherapy, or interferon                        Vitamin B12 deficiency anemia for
                                           to read as follows: ‘‘Requiring                         treatment to maintain platelet count of               diagnosis and treatment. However, for
                                           phlebotomy 3 or fewer times per 12-                     200,000–400,000, or white blood cell                  disability compensation, VA evaluates
                                           month period or if requiring biologic                   (WBC) count of 4,000–10,000.’’                        common signs and symptoms and
                                           therapy or interferon on an intermittent                   In the proposed rule, VA introduced
                                                                                                                                                         functional impairment of Vitamin B12
                                           basis as needed to maintain all blood                   several changes to DC 7719, Chronic
                                                                                                                                                         deficiency, also seen in pernicious
                                           levels at reference range levels.’’                     myelogenous leukemia (CML) (chronic
                                                                                                                                                         anemia, under one diagnostic code.
                                           Additionally, VA amends the proposed                    myeloid leukemia or chronic
                                                                                                                                                         Therefore, VA makes no changes based
                                           text for 100 percent evaluation to read                 granulocytic leukemia), including
                                                                                                                                                         on this comment.
                                           as follows: ‘‘Requiring peripheral blood                revisions for 60 and 30 percent
                                                                                                   disability ratings. Namely, for 60 and 30                The same commenter noted that
                                           or bone marrow stem-cell transplant or                                                                        anemia secondary to autoimmune
                                           chemotherapy (including                                 percent ratings, VA required the use of
                                                                                                   targeted therapy with tyrosine kinase                 pernicious anemia is not corrected but
                                           myelosuppressants) for the purpose of
                                                                                                   inhibitors. In order to capture the full              maintained by Vitamin B12 injections.
                                           ameliorating the symptom burden.’’
                                              In the proposed rule, VA proposed                    range of targeted therapy agents that are             VA agrees. In the proposed rule, DC
                                           several changes to DC 7705, including                   used to treat these conditions, VA                    7722 provides a 10 percent evaluation
                                           criteria based on platelet counts. VA                   makes a clarifying change that amends                 for pernicious anemia and other forms
                                           specifically proposed to assign a 100                   the proposed text for 60 percent                      of severe Vitamin B12 deficiency if it
                                           percent evaluation for platelet count                   disability rating to read as follows:                 requires continuous treatment with
                                           below 30,000. However, for the 70                       ‘‘Requiring intermittent                              Vitamin B12 injections, Vitamin B12
                                           percent criteria, which apply in                        myelosuppressive therapy, or                          sublingual or high-dose oral tablets, or
                                           circumstances involving a platelet count                molecularly targeted therapy with                     Vitamin B12 nasal spray or gel.
                                           higher than 30,000, VA omitted criteria                 tyrosine kinase inhibitors, or interferon             Therefore, VA makes no changes based
                                           for when platelet count is at 30,000.                   treatment when not in apparent                        on this comment.
                                           Accordingly, VA has changed the 100                     remission.’’ VA makes a clarifying                       The same commenter suggested
                                           percent criteria to read ‘‘platelet count               change that amends the proposed text                  including all body systems sequelae of
                                           30,000 or below’’ to avoid a gap in the                 for 30 percent disability rating to read              pernicious anemia into hematologic
                                           platelet count range considered in the                  as follows: ‘‘In apparent remission on                system evaluations. In cases when
                                           evaluation criteria.                                    continuous molecularly targeted therapy               debilitating effects of pernicious anemia
                                              In the proposed rule, VA introduced                  with tyrosine kinase inhibitors.’’                    affect other body systems, VA may grant
                                           several changes to DC 7716, Aplastic                                                                          service connection on a secondary basis
                                           anemia, including a revision for a 60                   III. Public Comments                                  for disabilities that are proximately due
                                           percent disability rating. Namely, for a                   One commenter asked why the                        to, or aggravated by, service-connected
                                           60 percent rating, VA required the use                  hematological system did not include                  disease or injury, pursuant to 38 CFR
                                           of continuous immunosuppressive                         Lyme disease. Lyme disease is an                      3.310. Therefore, VA makes no changes
                                           therapy. In order to capture the full                   infectious disease evaluated under 38                 based on this comment.
                                           range of therapeutic agents that are used               CFR 4.88b. DC 6319 specifically                          The same commenter suggested VA
                                           to treat this condition, VA makes a                     addresses Lyme disease and its                        conduct a study to determine whether
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                                           clarifying change that amends the                       residuals. Therefore, VA makes no                     the degree of neurologic or
                                           proposed text to reference the use of                   changes based on this comment.                        gastrointestinal residuals correlates with
                                           ‘‘newer platelet stimulating factors’’ in                  One commenter urged VA to include                  treatment variations. While VA
                                           the evaluation criteria. Additionally, VA               in the rating schedule the debilitating               appreciates this comment, it is beyond
                                           has added an explanatory note (2)                       side effects of daily tyrosine kinase                 the scope of this rulemaking. Therefore,
                                           regarding the definition of ‘‘newer                     inhibitors (TKIs) therapy for chronic                 VA makes no changes based on it.


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                                                            Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations                                           54253

                                              The same commenter expressed                         process. VA agrees and removes the                    hematopoietic system supports other
                                           concern regarding the application of 38                 references to specific laboratory values              cells or organs of the body, VA assigns
                                           CFR 3.105(e), which governs reduction                   by deleting Note (2) and Note (3). VA                 disability ratings resulting from
                                           in evaluation, to evaluate the                          edits Note (1) by removing the                        identifiable defects in these organs due
                                           debilitating residual effects of                        references to specific laboratory values              to hematologic disease. The hematologic
                                           pernicious anemia. However, VA may                      and replaces them with more general                   rating does not generally include the
                                           grant service connection on a secondary                 references to what are acceptable for the             physiologic effects on the function of
                                           basis for disabilities that are                         diagnosis of multiple myeloma as                      other end-organs. For example, very
                                           proximately due to, or aggravated by,                   defined by the American Society of                    severe anemia can reduce oxygen
                                           service-connected disease or injury                     Hematology (ASH) and International                    delivery to the point where the
                                           pursuant to 38 CFR 3.310. Therefore,                    Myeloma Working Group. Lastly, VA                     individual suffers a myocardial
                                           VA makes no changes based on this                       renumbers the proposed Note (4) to                    infarction. The disability ratings for
                                           comment.                                                become Note (2).                                      both the anemia and the myocardial
                                              One commenter discussed his current                     The same commenter suggested                       infarction would be rated separately and
                                           treatment for chronic myeloid leukemia                  including two additional treatment                    then combined. VA may grant service
                                           and its side effects. The commenter did                 modalities for acquired hemolytic                     connection on a secondary basis for
                                           not offer any specific suggestions or                   anemia under DC 7723. The commenter                   disabilities that are proximately due to,
                                           recommendations for this rulemaking.                    noted that, according to guidelines of                or aggravated by, service connected
                                           Therefore, VA makes no changes based                    the National Institutes of Health, the                disease or injury pursuant to 38 CFR
                                           on this comment.                                        National Heart, Lung, and Blood                       3.310. Therefore, VA makes no changes
                                              Another commenter urged the Federal                  Institute, and ASH, treatments for                    based on this comment.
                                           Communications Commission (FCC) to                      symptomatic acquired hemolytic                           The commenter noted that current
                                           reconsider regulating open-source                       anemia may include blood transfusion                  practice infrequently transplants bone
                                           software. This comment is beyond the                    or plasmapheresis. VA identifies four                 marrow to treat agranulocytosis (DC
                                           scope of this rulemaking, so VA makes                   levels of disability for symptomatic                  7702). Additionally, current medical
                                           no changes based on it.                                 acquired hemolytic anemia, each of                    protocol never uses platelet and red cell
                                              Two commenters indicated that                        which includes blood transfusion or                   transfusions. Even though use of bone
                                           security and privacy issues are                         plasmapheresis. The defining feature for              marrow transplants may be infrequent,
                                           important to them. The commenters did                   each level of disability is the frequency             the fact that it is still used for cases that
                                           not offer any specific suggestions or                   of immunosuppressive therapy or the                   do not respond to other types of
                                           recommendations for this rulemaking.                    need for a bone marrow transplant.                    treatment justifies including it as part of
                                           Therefore, VA makes no changes based                    Therefore, VA makes no changes based                  the 100 percent rating criteria.
                                           on these comments.                                      on this comment.                                      Additionally, the proposed rule does
                                              One commenter discussed his                             Another commenter noted that further               not refer to platelet and red cell
                                           brother’s diagnosis of chronic myeloid                  revisions are needed for hematologic                  transfusions for the treatment of
                                           leukemia and military service in                        and lymphatic section of the VASRD to                 agranulocytosis. Therefore, VA makes
                                           Vietnam. The commenter did not offer                    ensure its congruency with current                    no changes based on this comment.
                                           any specific suggestions or                             understanding of hematologic diseases.                   The commenter indicated that current
                                           recommendations for this rulemaking.                    The commenter offered multiple                        practice does not use radioactive
                                           Therefore, VA makes no changes based                    recommendations on selected diagnostic                phosphorus or interferon alpha to treat
                                           on this comment.                                        codes.                                                myelodysplastic syndromes (DC 7725).
                                              Another commenter discussed his                         The commenter recommended                          VA agrees and removes all references to
                                           diagnosis of chronic myeloid leukemia,                  deleting the references to obsolete or                such treatment from this DC.
                                           its side effects, and his military service              never used treatments. VA agrees and                     The commenter suggested editing
                                           in Vietnam. The commenter expressed                     removes all references to treatment with              platelet count reference for a 100
                                           his satisfaction with updates to the                    radioactive phosphorus (DCs 7704,                     percent evaluation under DC 7705,
                                           hematologic section of the rating                       7718, 7719, and 7725), imantib (DC                    Immune thrombocytopenia. ASH
                                           schedule, which includes evaluations                    7704), interferon alpha (DC 7725), and                guidelines for immune
                                           for chronic myeloid leukemia. The                       multiple references to outdated                       thrombocytopenia recommend
                                           commenter did not offer any specific                    laboratory values under DCs 7705 and                  treatment for patients with platelet
                                           suggestions or recommendations for this                 7712, Note (1). Proposed DC 7705                      counts below 30,000. VA agrees and
                                           rulemaking. Therefore, VA makes no                      referred to a platelet count range from               replaces the reference to ‘‘a platelet
                                           changes based on this comment.                          20,000 to 30,000 despite treatment                    count from 20,000 to 30,000’’ under DC
                                              One commenter was supportive of                      under a 100-percent rating level. The                 7705 with ‘‘a platelet count 30,000 or
                                           many of the changes and additions                       final rule revises this value to include              below despite treatment’’.
                                           made to the hematologic and lymphatic                   all platelet counts of 30,000 or below.                  The commenter noted that the 100
                                           sections of the VASRD, which include                       The commenter noted that various                   percent evaluation under DC 7705
                                           new diagnostic codes for common                         anemia sections (DCs 7714, 7716, 7720,                included chemotherapy but the
                                           disorders, clarifying notes on residuals                7722, and 7723) did not link to                       relevance of immunosuppressive
                                           affecting other body systems, and                       comorbidities, such as cardiac disease                therapy to this evaluation was unclear.
                                           recognizing common side effects of                      and chronic obstructive pulmonary                     However, VA did not intend to include
                                           various treatments. The commenter                       disease. The commenter advised VA to                  immunosuppressive therapy as part of a
                                           offered two minor suggestions regarding                 revise anemia DCs to include                          100 percent evaluation. VA includes
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                                           rating criteria for multiple myeloma (DC                comorbidities because different                       immunosuppressive therapy as part of a
                                           7712) and acquired hemolytic anemia                     hemoglobin levels might have vastly                   70 percent evaluation. Therefore, VA
                                           (DC 7723).                                              different implications in patients with               makes no changes based on this
                                              The commenter suggests deleting                      cardiac disease, chronic obstructive                  comment.
                                           Note 2, Note 3, and part of Note 1 under                pulmonary disease, or other significant                  The commenter noted that recent
                                           DC 7712 in order to simplify the rating                 comorbid conditions. As the                           advances in medicine have identified


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                                           54254            Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations

                                           conditions called monoclonal                            the principles set forth in this Executive            and Budget (OMB) and have been
                                           gammopathy of undetermined                              Order.’’                                              assigned OMB control Numbers 2900–
                                           significance (MGUS) and smoldering                        The economic, interagency,                          0749 and 2900–0779, respectively.
                                           myeloma, which are not acute myeloma                    budgetary, legal, and policy                          There are no changes to any of these
                                           but may indicate a future need for                      implications of this regulatory action                information collections and, thus, no
                                           treatment. The commenter suggested                      have been examined, and it has been                   incremental costs associated with this
                                           removing an outdated reference to                       determined not to be a significant                    rulemaking.
                                           indolent myeloma from DC 7712 and                       regulatory action under Executive Order
                                                                                                   12866. VA’s impact analysis can be                    Catalog of Federal Domestic Assistance
                                           replacing it with MGUS. VA agrees and
                                           removes the reference to indolent                       found as a supporting document at                       The Catalog of Federal Domestic
                                           myeloma from DC 7712 and replaces the                   http://www.regulations.gov, usually                   Assistance program numbers and titles
                                           reference with MGUS.                                    within 48 hours after the rulemaking                  for this rule are 64.104, Pension for
                                              VA appreciates the comments                          document is published. Additionally, a                Non-Service-Connected Disability for
                                           submitted in response to the proposed                   copy of this rulemaking and its impact                Veterans; 64.109, Veterans
                                           rule. Based on the rationale stated in the              analysis are available on VA’s website at             Compensation for Service-Connected
                                           proposed rule and in this document, the                 http://www.va.gov/orpm/, by following                 Disability; and 64.110, Veterans
                                           final rule is adopted with the changes                  the link for ‘‘VA Regulations Published               Dependency and Indemnity
                                           noted.                                                  From FY 2004 Through Fiscal Year to                   Compensation for Service-Connected
                                              We are additionally adding updates to                Date.’’                                               Death.
                                           38 CFR part 4, Appendices A, B, and C,                    This rule is not an Executive Order
                                                                                                                                                         List of Subjects in 38 CFR Part 4
                                           to reflect changes to the hematologic                   13771 regulatory action because this
                                                                                                   rule is not significant under Executive                 Disability benefits, Pensions,
                                           and lymphatic systems rating criteria                                                                         Veterans.
                                           made by this rulemaking. VA designs                     Order 12866.
                                           the appendices for users of the VASRD.                  Regulatory Flexibility Act                            Signing Authority
                                           They do not contain substantive content                   The Secretary hereby certifies that                   The Secretary of Veterans Affairs
                                           regarding disability evaluations.                       this final rule will not have a significant           approved this document and authorized
                                           Executive Orders 12866, 13563 and                       economic impact on a substantial                      the undersigned to sign and submit the
                                           13771                                                   number of small entities as defined in                document to the Office of the Federal
                                                                                                   the Regulatory Flexibility Act, 5 U.S.C.              Register for publication electronically as
                                              Executive Orders 12866 and 13563                     601–612. This final rule will not affect              an official document of the Department
                                           direct agencies to assess the costs and                 any small entities. Only certain VA                   of Veterans Affairs. Robert L. Wilkie,
                                           benefits of available regulatory                        beneficiaries could be directly affected.             Secretary, Department of Veterans
                                           alternatives and, when regulation is                    Therefore, pursuant to 5 U.S.C. 605(b),               Affairs, approved this document on
                                           necessary, to select regulatory                         this rulemaking is exempt from the                    October 23, 2018, for publication.
                                           approaches that maximize net benefits                   initial and final regulatory flexibility                Dated: October 23, 2018.
                                           (including potential economic,                          analysis requirements of sections 603
                                           environmental, public health and safety                                                                       Jeffrey M. Martin,
                                                                                                   and 604.                                              Assistant Director, Office of Regulation Policy
                                           effects, and other advantages;
                                           distributive impacts; and equity).                      Unfunded Mandates                                     & Management, Office of the Secretary,
                                                                                                                                                         Department of Veterans Affairs.
                                           Executive Order 13563 (Improving                           The Unfunded Mandates Reform Act
                                           Regulation and Regulatory Review)                                                                               For the reasons set out in the
                                                                                                   of 1995 requires, at 2 U.S.C. 1532, that              preamble, the Department of Veterans
                                           emphasizes the importance of                            agencies prepare an assessment of
                                           quantifying both costs and benefits,                                                                          Affairs amends 38 CFR part 4, subpart
                                                                                                   anticipated costs and benefits before                 B as follows:
                                           reducing costs, harmonizing rules, and                  issuing any rule that may result in the
                                           promoting flexibility. Executive Order                  expenditure by State, local, and tribal               PART 4—SCHEDULE FOR RATING
                                           12866 (Regulatory Planning and                          governments, in the aggregate, or by the              DISABILITIES
                                           Review) defines a ‘‘significant                         private sector, of $100 million or more
                                           regulatory action’’ requiring review by                 (adjusted annually for inflation) in any              Subpart B—Disability Ratings
                                           the Office of Management and Budget                     one year. This final rule will have no
                                           (OMB), unless OMB waives such                           such effect on State, local, and tribal               ■ 1. The authority citation for part 4
                                           review, as ‘‘any regulatory action that is              governments, or on the private sector.                continues to read as follows:
                                           likely to result in a rule that may: (1)                                                                        Authority: 38 U.S.C. 1155, unless
                                           Have an annual effect on the economy                    Paperwork Reduction Act                               otherwise noted.
                                           of $100 million or more or adversely                      This final rule contains provisions                 ■ 2. Revise the undesignated center
                                           affect in a material way the economy, a                 constituting a collection of information              heading preceding § 4.117 to read as
                                           sector of the economy, productivity,                    under the Paperwork Reduction Act of                  follows:
                                           competition, jobs, the environment,                     1995 (44 U.S.C. 3501–3521).
                                           public health or safety, or State, local,               Specifically, this final rule is associated           The Hematologic and Lymphatic
                                           or tribal governments or communities;                   with information collections related to               Systems
                                           (2) Create a serious inconsistency or                   the filing of disability claims (VA Form              ■ 3. Amend § 4.117 by:
                                           otherwise interfere with an action taken                21–526EZ) as well as Disability Benefits              ■ a. Removing the entry for diagnostic
                                           or planned by another agency; (3)                       Questionnaires (DBQs) which enable a                  code 7700;
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                                           Materially alter the budgetary impact of                claimant to gather the necessary                      ■ b. Revising the entries for diagnostic
                                           entitlements, grants, user fees, or loan                information from his or her treating                  codes 7702 through 7706, 7709, 7710
                                           programs or the rights and obligations of               physician as to the current symptoms                  and 7714 through 7716;
                                           recipients thereof; or (4) Raise novel                  and severity of a disability. Both                    ■ c. Adding, in numerical order, an
                                           legal or policy issues arising out of legal             information collections are currently                 entry for diagnostic code 7712 and 7718
                                           mandates, the President’s priorities, or                approved by the Office of Management                  through 7725.


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                                                                  Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations                                                                                           54255

                                             The revisions, and additions to read                                    § 4.117 Schedule of ratings—hematologic
                                           as follows:                                                               and lymphatic systems

                                                                                                                                                                                                                                               Rating

                                           7702 Agranulocytosis, acquired:
                                               Requiring bone marrow transplant; or infections recurring, on average, at least once every six weeks per 12-month period ..                                                                              100
                                               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/microliter (μl) but less than 1000/μl; or infections recurring, on average, at least
                                                 once every three months per 12-month period ........................................................................................................................                                   60
                                               Requiring intermittent myeloid growth factors to maintain ANC greater than 1000/μl; or infections recurring, on average, at
                                                 least once per 12-month period but less than once every three months per 12-month period ..............................................                                                                30
                                               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 1500/μl .......................................................................................................................                                  10
                                               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 .........................................................................................................                                       100
                                               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 ap-
                                                 propriate 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 recur-
                                                 rence, 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 leu-
                                                 kemia 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 chemotherapy (including myelosuppressants) for the pur-
                                                 pose of ameliorating the symptom burden ...............................................................................................................................                                100
                                               Requiring phlebotomy 6 or more times per 12-month period or molecularly targeted therapy for the purpose of controlling
                                                 RBC count .................................................................................................................................................................................             60
                                               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 ........................................                                                               30
                                               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 values at reference range levels                                                                                                                                  10
                                               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 mar-
                                                 row 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 ap-
                                                 propriate 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 30,000 or below despite treatment ......                                                                             100
                                               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 ...........................................................................................................................................................                   70
                                               Platelet count higher than 30,000 but not higher than 50,000, with either immune thrombocytopenia or mild mucous mem-
                                                 brane bleeding which requires oral corticosteroid therapy or intravenous immune globulin ...................................................                                                            30
                                               Platelet count higher than 30,000 but not higher than 50,000, not requiring treatment ..............................................................                                                      10
                                               Platelet count above 50,000 and asymptomatic; or for immune thrombocytopenia in remission ...............................................                                                                  0
                                               Note (1): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under this diag-
                                                 nostic 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 .............................................................................................................................................................................               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 ap-
amozie on DSK3GDR082PROD with RULES




                                                 propriate 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 ....................................................................................................................................................                        100



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                                           54256                  Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations

                                                                                                                                                                                                                                              Rating

                                               Asymptomatic, smoldering, or monoclonal gammopathy of undetermined significance (MGUS) ...............................................                                                                   0
                                               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 eval-
                                                 uation 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 ............................................................................................................................................................                  100
                                               With 3 painful episodes per 12-month period or with symptoms precluding other than light manual labor ...............................                                                                    60
                                               With 1 or 2 painful episodes per 12-month period .......................................................................................................................                                 30
                                               Asymptomatic, established case in remission, but with identifiable organ impairment ...............................................................                                                      10
                                               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 ...........                                                                            100
                                               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 ap-
                                                 propriate 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 recur-
                                                 rence, 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 aver-
                                                 age, 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 ......................................................................................................................................................                      100
                                               Requiring transfusion of platelets or red cells, on average, at least once every three months per 12-month period; or infec-
                                                 tions recurring, on average, at least once every three months per 12-month period; or using continuous therapy with im-
                                                 munosuppressive agent or newer platelet stimulating factors .................................................................................................                                         60
                                               Requiring transfusion of platelets or red cells, on average, at least once per 12-month period; or infections recurring, on av-
                                                 erage, at least once per 12-month period ................................................................................................................................                             30
                                               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 § 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 or, for six months following hospital admission, peripheral blood or
                                                 bone marrow stem cell transplant, or chemotherapy, or interferon treatment .........................................................................                                                  100
                                               Requiring continuous or intermittent myelosuppressive therapy, or chemotherapy, or interferon treatment to maintain plate-
                                                 let count <500 × 10 9/L ..............................................................................................................................................................                70
                                               Requiring continuous or intermittent myelosuppressive therapy, or chemotherapy, or interferon treatment to maintain plate-
                                                 let count of 200,000–400,000, or white blood cell (WBC) count of 4,000–10,000 ..................................................................                                                      30
                                               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 mar-
                                                 row 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 ap-
                                                 propriate 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 ......................................................................................................................................................................              100
                                               Requiring intermittent myelosuppressive therapy, or molecularly targeted therapy with tyrosine kinase inhibitors, or
                                                 interferon treatment when not in apparent remission ...............................................................................................................                                   60
                                               In apparent remission on continuous molecularly targeted therapy with tyrosine kinase inhibitors ............................................                                                           30
                                               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 mar-
                                                 row 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 ap-
amozie on DSK3GDR082PROD with RULES




                                                 propriate 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 4 or more times per 12-month period ...............................................................................                                                30
                                               Requiring intravenous iron infusions at least 1 time but less than 4 times per 12-month period, or requiring continuous treat-
                                                 ment with oral supplementation ................................................................................................................................................                        10
                                               Asymptomatic or requiring treatment only by dietary modification ..............................................................................................                                           0



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                                                                   Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations                                                                                               54257

                                                                                                                                                                                                                                                    Rating

                                               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 ........................................................................................                                                    10
                                               Asymptomatic or requiring treatment only by dietary modification ..............................................................................................                                                 0
                                           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 ther-
                                                 apy ............................................................................................................................................................................................            100
                                               Requiring continuous treatment with Vitamin B12 injections, Vitamin B12 sublingual or high-dose oral tablets, or Vitamin B12
                                                 nasal spray or gel .....................................................................................................................................................................                     10
                                               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 manda-
                                                 tory 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 chap-
                                                 ter. 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) ........................................................................................................................................................                        100
                                               Requiring immunosuppressive medication 4 or more times per 12-month period ......................................................................                                                              60
                                               Requiring at least 2 but less than 4 courses of immunosuppressive therapy per 12-month period ...........................................                                                                      30
                                               Requiring one course of immunosuppressive therapy per 12-month period ...............................................................................                                                          10
                                               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 dis-
                                                 charge. 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 ...................................................................                                                           100
                                               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 ex-
                                                 amination. 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., neurop-
                                                 athy) under the appropriate diagnostic codes.
                                           7725 Myelodysplastic syndromes:
                                               Requiring peripheral blood or bone marrow stem cell transplant; or requiring chemotherapy ...................................................                                                                 100
                                               Requiring 4 or more blood or platelet transfusions per 12-month period; or infections requiring hospitalization 3 or more
                                                 times per 12-month period ........................................................................................................................................................                           60
                                               Requiring at least 1 but no more than 3 blood or platelet transfusions per 12-month period; infections requiring hospitaliza-
                                                 tion 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 .................................................................                                                            30
                                               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 mar-
                                                 row 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 comple-
                                                 tion of treatment. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the pro-
                                                 visions of § 3.105(e) of this chapter. If there has been no recurrence, residuals will be rated under the appropriate diag-
                                                 nostic codes.



                                           ■ 3. Amend Appendix A to Part 4 by:                                         ■ b. Adding, in numerical order, an                                         Appendix A to Part 4—Table of
                                           ■ a. Revising the entries for diagnostic                                    entry for diagnostic code 7712 and 7718                                     Amendments and Effective Dates Since
                                           codes 7700, 7702 through 7706, 7709                                         through 7725.                                                               1946
                                                                                                                         The revisions and additions read as
                                           through 7710, and 7714 through 7716;
                                                                                                                       follows:

                                                                        Diagnostic
                                                  Sec.                  code No.
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                                                     *                                 *                    *                                             *                               *                                *                        *
                                           4.117 ............                       7700       Removed December 9, 2018.

                                                         *                             *                       *                     *                   *                  *                                                                       *
                                                                                    7702       Evaluation October 23, 1995; title December 9, 2018; evaluation December 9, 2018.



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                                           54258                   Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations

                                                                       Diagnostic
                                                 Sec.                  code No.

                                                                                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.

                                                        *                           *                         *                          *                       *                      *            *



                                           ■ 4. Amend Appendix B to Part 4 by:                            ■ b. Revising the entries for diagnostic                      The revisions and additions read as
                                           ■ a. Revising the undesignated center                          codes 7700, 7702, 7705, and 7709.                           follows:
                                                                                                          ■ c. Adding, in numerical order, entries
                                           heading immediately preceding                                                                                              Appendix B to Part 4—Numerical Index
                                           diagnostic code 7700.                                          for diagnostic codes 7712 and 7718
                                                                                                          through 7725.                                               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.
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                                           7724    .............    Solitary plasmacytoma.
                                           7725    .............    Myelodysplastic syndromes.

                                                        *                           *                         *                          *                       *                      *            *




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                                                                   Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations                                                                                              54259

                                           ■ 5. Amend Appendix C to Part 4 by                                        Leukemia and adding in alphabetical                                         Appendix C to Part 4—Alphabetical
                                           revising the entries for Agranulocytosis,                                 order, a new entry for Hematologic to                                       Index of Disabilities
                                           Anemia, Hodgkin’s lymphoma, and                                           read as follows:.

                                                                                                                                                                                                                                                 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 leukemia or chronic granulocytic leukemia) .......................................                                                                    7719
                                               Leukemia ......................................................................................................................................................................................           7703

                                                         *                               *                               *                              *                               *                               *                          *



                                           [FR Doc. 2018–23517 Filed 10–26–18; 8:45 am]                              178 (see also Unit I.C. of the                                             I. General Information
                                           BILLING CODE 8320–01–P                                                    SUPPLEMENTARY INFORMATION).
                                                                                                                                                                                                A. Does this action apply to me?
                                                                                                                     ADDRESSES:    The docket for this action,
                                                                                                                     identified by docket identification (ID)                                      You may be potentially affected by
                                                                                                                     number EPA–HQ–OPP–2017–0334, is                                            this action if you are an agricultural
                                           ENVIRONMENTAL PROTECTION
                                           AGENCY                                                                    available at http://www.regulations.gov                                    producer, food manufacturer, or
                                                                                                                     or at the Office of Pesticide Programs                                     pesticide manufacturer. The following
                                           40 CFR Part 180                                                           Regulatory Public Docket (OPP Docket)                                      list of North American Industrial
                                                                                                                     in the Environmental Protection Agency                                     Classification System (NAICS) codes is
                                           [EPA–HQ–OPP–2017–0334; FRLc–9983–29]                                      Docket Center (EPA/DC), West William                                       not intended to be exhaustive, but rather
                                                                                                                     Jefferson Clinton Bldg., Rm. 3334, 1301                                    provides a guide to help readers
                                           Pyroxasulfone; Pesticide Tolerances                                                                                                                  determine whether this document
                                                                                                                     Constitution Ave. NW, Washington, DC
                                           AGENCY:  Environmental Protection                                         20460–0001. The Public Reading Room                                        applies to them. Potentially affected
                                           Agency (EPA).                                                             is open from 8:30 a.m. to 4:30 p.m.,                                       entities may include:
                                           ACTION: Final rule.                                                       Monday through Friday, excluding legal                                        • Crop production (NAICS code 111).
                                                                                                                     holidays. The telephone number for the                                        • Animal production (NAICS code
                                           SUMMARY:   This regulation establishes                                    Public Reading Room is (202) 566–1744,                                     112).
                                           tolerances for residues of pyroxasulfone                                  and the telephone number for the OPP
                                           in or on multiple commodities which                                                                                                                     • Food manufacturing (NAICS code
                                                                                                                     Docket is (703) 305–5805. Please review
                                           are identified and discussed later in this                                                                                                           311).
                                                                                                                     the visitor instructions and additional
                                           document. In addition, the established                                    information about the docket available                                        • Pesticide manufacturing (NAICS
                                           pyroxasulfone tolerance on cotton,                                        at http://www.epa.gov/dockets.                                             code 32532).
                                           undelinted seed is removed.
                                           Interregional Research Project Number 4                                   FOR FURTHER INFORMATION CONTACT:                                           B. How can I get electronic access to
                                           (IR–4) requested these tolerances under                                   Michael L. Goodis, Registration Division                                   other related information?
                                           the Federal Food, Drug, and Cosmetic                                      (7505P), Office of Pesticide Programs,
                                                                                                                                                                                                   You may access a frequently updated
                                           Act (FFDCA).                                                              Environmental Protection Agency, 1200
amozie on DSK3GDR082PROD with RULES




                                                                                                                                                                                                electronic version of EPA’s tolerance
                                           DATES: This regulation is effective                                       Pennsylvania Ave. NW, Washington, DC
                                                                                                                                                                                                regulations at 40 CFR part 180 through
                                           October 29, 2018. Objections and                                          20460–0001; main telephone number:
                                                                                                                                                                                                the Government Printing Office’s e-CFR
                                           requests for hearings must be received                                    (703) 305–7090; email address:
                                                                                                                                                                                                site at http://www.ecfr.gov/cgi-bin/text-
                                           on or before December 28, 2018, and                                       RDFRNotices@epa.gov.
                                                                                                                                                                                                idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                           must be filed in accordance with the
                                                                                                                     SUPPLEMENTARY INFORMATION:                                                 40tab_02.tpl.
                                           instructions provided in 40 CFR part


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Document Created: 2018-10-27 01:10:44
Document Modified: 2018-10-27 01:10:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective on December 9, 2018.
ContactIoulia 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.)
FR Citation83 FR 54250 
RIN Number2900-AO19
CFR AssociatedDisability Benefits; Pensions and Veterans

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