Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems, 54250-54259 [2018-23517]

Download as PDF 54250 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator. Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency’s responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1– 888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. amozie on DSK3GDR082PROD with RULES C. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). D. Federalism and Indian Tribal Government A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 responsibilities between the Federal Government and Indian tribes. E. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. F. Environment We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2–1, paragraph (32)(e), of the Instruction. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this rule. G. Protest Activities The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. List of Subjects in 33 CFR Part 117 Bridges. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows: PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: ■ Authority: 33 U.S.C. 499; 33 CFR 1.05–1; Department of Homeland Security Delegation No. 0170.1. 2. From 12:01 a.m. on date of publication, through 12:01 a.m. on ■ PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 December 31, 2018, in § 117.723, suspend paragraph (b) and temporarily add paragraph (k) to read as follows: § 117.723 Hackensack River. * * * * * (k) The draw of the PATH Bridge, mile 3.0, at Jersey City, shall open on signal provided at least a two-hour advance notice is provided by calling the number posted at the bridge. The draw need not open for the passage of vessel traffic Monday through Friday, except Federal holidays, from 6 a.m. to 10 a.m. and from 4 p.m. to 8 p.m.; and from 12:01 a.m. Saturday to 12:01 a.m. Monday. Weekdays additional bridge openings shall be provided for commercial vessels from 6 a.m. to 7:20 a.m.; 9:20 a.m. to 10 a.m.; 4 p.m. to 4:30 p.m. and from 6:50 p.m. to 8 p.m. provided at least a two-hour advance notice is given by calling the number posted at the bridge. Dated: October 12, 2018. A.J. Tiongson, Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District. [FR Doc. 2018–23596 Filed 10–26–18; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 4 RIN 2900–AO19 Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems Department of Veterans Affairs. Final rule. AGENCY: ACTION: 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.) SUMMARY: E:\FR\FM\29OCR1.SGM 29OCR1 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations 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. SUPPLEMENTARY INFORMATION: 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. amozie on DSK3GDR082PROD with RULES 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 12month period, or requiring continuous treatment with oral supplementation.’’ The proposed rule specified that a zeropercent 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’’; VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 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 12month 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 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 54251 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 12month 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 E:\FR\FM\29OCR1.SGM 29OCR1 amozie on DSK3GDR082PROD with RULES 54252 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations 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 12month 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 VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 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 × 109/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 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 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. E:\FR\FM\29OCR1.SGM 29OCR1 amozie on DSK3GDR082PROD with RULES Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations 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 VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 54253 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 E:\FR\FM\29OCR1.SGM 29OCR1 54254 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations 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. amozie on DSK3GDR082PROD with RULES 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 VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 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. 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. 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. 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. 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 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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. 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 1. The authority citation for part 4 continues to read as follows: ■ Authority: 38 U.S.C. 1155, unless otherwise noted. 2. Revise the undesignated center heading preceding § 4.117 to read as follows: ■ The Hematologic and Lymphatic Systems 3. Amend § 4.117 by: a. Removing the entry for diagnostic code 7700; ■ b. Revising the entries for diagnostic codes 7702 through 7706, 7709, 7710 and 7714 through 7716; ■ c. Adding, in numerical order, an entry for diagnostic code 7712 and 7718 through 7725. ■ ■ E:\FR\FM\29OCR1.SGM 29OCR1 54255 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations The revisions, and additions to read as follows: § 4.117 Schedule of ratings—hematologic and lymphatic systems Rating amozie on DSK3GDR082PROD with RULES 7702 Agranulocytosis, acquired: Requiring bone marrow transplant; or infections recurring, on average, at least once every six weeks per 12-month period .. Requiring intermittent myeloid growth factors (granulocyte colony-stimulating factor (G–CSF) or granulocyte-macrophage 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 ........................................................................................................................ 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 .............................................. 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 ....................................................................................................................... Note: A 100 percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue with a mandatory VA examination six months following hospital discharge. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7703 Leukemia (except for chronic myelogenous leukemia): When there is active disease or during a treatment phase ......................................................................................................... Otherwise rate residuals under the appropriate diagnostic code(s). Chronic lymphocytic leukemia or monoclonal B-cell lymphocytosis (MBL), asymptomatic, Rai Stage ...................................... Note (1): A 100 percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals. Note (2): Evaluate symptomatic chronic lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as any other leukemia evaluated under this diagnostic code. Note (3): Evaluate residuals of leukemia or leukemia therapy under the appropriate diagnostic code(s). Myeloproliferative Disorders: (Diagnostic Codes 7704, 7718, 7719). 7704 Polycythemia vera: Requiring peripheral blood or bone marrow stem-cell transplant or chemotherapy (including myelosuppressants) for the purpose of ameliorating the symptom burden ............................................................................................................................... Requiring phlebotomy 6 or more times per 12-month period or molecularly targeted therapy for the purpose of controlling RBC count ................................................................................................................................................................................. 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 ........................................ 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 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 § 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 ...... Requiring immunosuppressive therapy; or for a platelet count higher than 30,000 but not higher than 50,000, with history of hospitalization because of severe bleeding requiring intravenous immune globulin, high-dose parenteral corticosteroids, and platelet transfusions ........................................................................................................................................................... Platelet count higher than 30,000 but not higher than 50,000, with either immune thrombocytopenia or mild mucous membrane bleeding which requires oral corticosteroid therapy or intravenous immune globulin ................................................... Platelet count higher than 30,000 but not higher than 50,000, not requiring treatment .............................................................. Platelet count above 50,000 and asymptomatic; or for immune thrombocytopenia in remission ............................................... Note (1): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under this diagnostic code. Note (2): A 100 percent evaluation shall continue beyond the cessation of chemotherapy. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7706 Splenectomy ............................................................................................................................................................................. Note: Separately rate complications such as systemic infections with encapsulated bacteria. * * * * * * 7709 Hodgkin’s lymphoma: With active disease or during a treatment phase ........................................................................................................................ Note: A 100 percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no local recurrence or metastasis, rate on residuals under the appropriate diagnostic code(s). 7710 Adenitis, tuberculous, active or inactive: Rate under § 4.88c or 4.89 of this part, whichever is appropriate. 7712 Multiple myeloma: Symptomatic multiple myeloma .................................................................................................................................................... VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\29OCR1.SGM 29OCR1 100 60 30 10 100 0 100 60 30 10 100 70 30 10 0 20 * 100 100 54256 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations Rating amozie on DSK3GDR082PROD with RULES Asymptomatic, smoldering, or monoclonal gammopathy 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 § 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 ............................................................................................................................................................ With 3 painful episodes per 12-month period or with symptoms precluding other than light manual labor ............................... With 1 or 2 painful episodes per 12-month period ....................................................................................................................... Asymptomatic, established case in remission, but with identifiable organ impairment ............................................................... Note: Sickle cell trait alone, without a history of directly attributable pathological findings, is not a ratable disability. Cases of symptomatic sickle cell trait will be forwarded to the Director, Compensation Service, for consideration under § 3.321(b)(1) of this chapter. 7715 Non-Hodgkin’s lymphoma: When there is active disease, during treatment phase, or with indolent and non-contiguous phase of low grade NHL ........... Note: A 100 percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Two years after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals under the appropriate diagnostic code(s). 7716 Aplastic anemia: Requiring peripheral blood or bone marrow stem cell transplant; or requiring transfusion of platelets or red cells, on average, at least once every six weeks per 12-month period; or infections recurring, on average, at least once every six weeks per 12-month period ...................................................................................................................................................... Requiring transfusion of platelets or red cells, on average, at least once every three months per 12-month period; or infections recurring, on average, at least once every three months per 12-month period; or using continuous therapy with immunosuppressive agent or newer platelet stimulating factors ................................................................................................. Requiring transfusion of platelets or red cells, on 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 § 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 ......................................................................... Requiring continuous or intermittent myelosuppressive therapy, or chemotherapy, or interferon treatment to maintain platelet count <500 × 10 9/L .............................................................................................................................................................. 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 .................................................................. Asymptomatic ............................................................................................................................................................................... Note (1): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703. Note (2): A 100 percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant; or during the period of treatment with 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 § 3.105(e) of this chapter. 7719 Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia): Requiring peripheral blood or bone marrow stem cell transplant, or continuous myelosuppressive or immunosuppressive therapy treatment ...................................................................................................................................................................... Requiring intermittent myelosuppressive therapy, or molecularly targeted therapy with tyrosine kinase inhibitors, or interferon treatment when not in apparent remission ............................................................................................................... In apparent remission on continuous molecularly 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 § 3.105 of this chapter. 7720 Iron deficiency anemia: Requiring intravenous iron infusions 4 or more times per 12-month period ............................................................................... Requiring intravenous iron infusions at least 1 time but less than 4 times per 12-month period, or requiring continuous treatment with oral supplementation ................................................................................................................................................ Asymptomatic or requiring treatment only by dietary modification .............................................................................................. VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\29OCR1.SGM 29OCR1 0 100 60 30 10 100 100 60 30 * 100 70 30 0 100 60 30 30 10 0 54257 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations 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 ........................................................................................ Asymptomatic or requiring treatment only by dietary modification .............................................................................................. 7722 Pernicious anemia and Vitamin B12 deficiency anemia: For initial diagnosis requiring transfusion due to severe anemia, or if there are signs or symptoms related to central nervous system impairment, such as encephalopathy, myelopathy, or severe peripheral neuropathy, requiring parenteral B12 therapy ............................................................................................................................................................................................ Requiring continuous treatment with Vitamin B12 injections, Vitamin B12 sublingual or high-dose oral tablets, or Vitamin B12 nasal spray or gel ..................................................................................................................................................................... Note: A 100 percent evaluation for pernicious anemia and Vitamin B12 deficiency shall be assigned as of the date of the initial diagnosis requiring transfusion due to severe anemia or parenteral B12 therapy and shall continue with a mandatory VA examination six months following hospital discharge or cessation of parenteral B12 therapy. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Thereafter, evaluate at 10 percent and separately evaluate any residual effects of pernicious anemia, such as neurologic involvement causing peripheral neuropathy, myelopathy, dementia, or related gastrointestinal residuals, under the most appropriate diagnostic code. 7723 Acquired hemolytic anemia: Requiring a bone marrow transplant or continuous intravenous or immunosuppressive therapy (e.g., prednisone, Cytoxan, azathioprine, or rituximab) ........................................................................................................................................................ Requiring immunosuppressive medication 4 or more times per 12-month period ...................................................................... Requiring at least 2 but less than 4 courses of immunosuppressive therapy per 12-month period ........................................... Requiring one course of immunosuppressive therapy per 12-month period ............................................................................... Asymptomatic ............................................................................................................................................................................... Note (1): A 100 percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue for six months after hospital discharge with a mandatory VA examination six months following hospital discharge. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Note (2): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under diagnostic code 7723. 7724 Solitary plasmacytoma: Solitary plasmacytoma, when there is active disease or during a treatment phase ................................................................... Note (1): A 100 percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures (including autologous stem cell transplantation). Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate residuals under the appropriate diagnostic codes. Note (2): Rate a solitary plasmacytoma that has developed into multiple myeloma as symptomatic multiple myeloma. Note (3): Rate residuals of plasma cell dysplasia (e.g., thrombosis) and adverse effects of medical treatment (e.g., neuropathy) under the appropriate diagnostic codes. 7725 Myelodysplastic syndromes: Requiring peripheral blood or bone marrow stem cell transplant; or requiring chemotherapy ................................................... Requiring 4 or more blood or platelet transfusions 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 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 § 3.105(e) of this chapter. If there has been no recurrence, residuals will be rated under the appropriate diagnostic codes. 3. Amend Appendix A to Part 4 by: a. Revising the entries for diagnostic codes 7700, 7702 through 7706, 7709 through 7710, and 7714 through 7716; ■ ■ 100 10 100 60 30 10 0 100 100 60 30 Appendix A to Part 4—Table of Amendments and Effective Dates Since 1946 Diagnostic code No. Sec. amozie on DSK3GDR082PROD with RULES b. Adding, in numerical order, an entry for diagnostic code 7712 and 7718 through 7725. The revisions and additions read as follows: ■ 10 0 * 4.117 ............ * VerDate Sep<11>2014 * 7700 * Removed December 9, 2018. * 7702 * * * * Evaluation October 23, 1995; title December 9, 2018; evaluation December 9, 2018. 16:53 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00029 * Fmt 4700 * Sfmt 4700 E:\FR\FM\29OCR1.SGM * 29OCR1 * * 54258 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations Diagnostic code No. Sec. 7703 7706 Evaluation 2018. Evaluation Evaluation 2018. Evaluation * * 7709 7710 7712 7714 7715 7716 * * * * * Evaluation March 10, 1976; criterion October 23, 1995; title December 9, 2018; criterion December 9, 2018. Criterion October 23, 1995; criterion December 9, 2018. Added December 9, 2018. Added September 9, 1975; criterion October 23, 1995; criterion December 9, 2018. Added October 26, 1990; criterion December 9, 2018. Added October 23, 1995; evaluation December 9, 2018; criterion December 9, 2018. * * 7718 7719 7720 7721 7722 7723 7724 7725 Added Added Added Added Added Added Added Added 7704 7705 * August 23, 1948; criterion October 23, 1995; evaluation December 9, 2018; criterion December 9, October 23, 1995; evaluation December 9, 2018. October 23, 1995; title December 9, 2018; evaluation December 9, 2018; criterion December 9, October 23, 1995; note December 9, 2018; criterion October 23, 1995. * December 9, December 9, December 9, December 9, December 9, December 9, December 9, December 9, * * 4. Amend Appendix B to Part 4 by: a. Revising the undesignated center heading immediately preceding diagnostic code 7700. * * * * * * * * 2018. 2018. 2018. 2018. 2018. 2018. 2018. 2018. b. Revising the entries for diagnostic codes 7700, 7702, 7705, and 7709. ■ 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. amozie on DSK3GDR082PROD with RULES * * * * * The Hematologic and Lymphatic Systems * * 7700 ............. [Removed] * 7702 ............. * Agranulocytosis, acquired. * * * * * * 7705 ............. * Immune thrombocytopenia. * * * * * * 7709 ............. * Hodgkin’s lymphoma. * * * * * * 7712 ............. * Multiple myeloma. * * * * * 7718 7719 7720 7721 7722 7723 7724 7725 * ............. ............. ............. ............. ............. ............. ............. ............. * VerDate Sep<11>2014 * * * * * Essential thrombocythemia and primary myelofibrosis. Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia). Iron deficiency anemia. Folic acid deficiency. Pernicious anemia and Vitamin B12 deficiency anemia. Acquired hemolytic anemia. Solitary plasmacytoma. Myelodysplastic syndromes. * 16:53 Oct 26, 2018 * Jkt 247001 PO 00000 * Frm 00030 Fmt 4700 * Sfmt 4700 E:\FR\FM\29OCR1.SGM * 29OCR1 * * 54259 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Rules and Regulations 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 .................................................................................................................................................................... * * * * * * * Anemia: Acquired hemolytic anemia .......................................................................................................................................................... Folic acid deficiency ..................................................................................................................................................................... Iron deficiency anemia ................................................................................................................................................................. Pernicious anemia and Vitamin B12 deficiency anemia ............................................................................................................... * * * * * * * Hematologic: Essential thrombocythemia and primary myelofibrosis ................................................................................................................ Immune thrombocytopenia ........................................................................................................................................................... Multiple myeloma .......................................................................................................................................................................... Myelodysplastic syndromes .......................................................................................................................................................... Solitary plasmacytoma ................................................................................................................................................................. * * * * * * * Hodgkin’s lymphoma ........................................................................................................................................................................... * * * * * * * Leukemia: Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia) ....................................... Leukemia ...................................................................................................................................................................................... * * * * * * [FR Doc. 2018–23517 Filed 10–26–18; 8:45 am] 178 (see also Unit I.C. of the BILLING CODE 8320–01–P SUPPLEMENTARY INFORMATION). 40 CFR Part 180 [EPA–HQ–OPP–2017–0334; FRLc–9983–29] Pyroxasulfone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of pyroxasulfone in or on multiple commodities which are identified and discussed later in this document. In addition, the established pyroxasulfone tolerance on cotton, undelinted seed is removed. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 29, 2018. Objections and requests for hearings must be received on or before December 28, 2018, and must be filed in accordance with the instructions provided in 40 CFR part amozie on DSK3GDR082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:53 Oct 26, 2018 Jkt 247001 FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 7718 7705 7712 7725 7724 7709 7719 7703 * A. Does this action apply to me? The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0334, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. SUPPLEMENTARY INFORMATION: 7723 7721 7720 7722 I. General Information ADDRESSES: ENVIRONMENTAL PROTECTION AGENCY * 7702 You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. E:\FR\FM\29OCR1.SGM 29OCR1

Agencies

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Rules and Regulations]
[Pages 54250-54259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23517]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AO19


Schedule for Rating Disabilities: The Hematologic and Lymphatic 
Systems

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA) 
Schedule for Rating Disabilities (VASRD) by revising the section of the 
Rating Schedule that addresses the hematologic and lymphatic systems. 
This action will ensure VA uses current medical terminology and 
provides detailed and updated criteria for evaluating conditions 
pertaining to the hematologic and lymphatic systems.

DATES: This rule is effective on December 9, 2018.

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

[[Page 54251]]


SUPPLEMENTARY INFORMATION: VA published a proposed rule in the Federal 
Register at 80 FR 46888 on August 6, 2015, to amend the portion of the 
VASRD dealing with the hematologic and lymphatic systems. VA provided a 
60-day public comment period and invited interested persons to submit 
written comments, suggestions, or objections on or before October 5, 
2015. VA received 11 comments.

I. Purpose of the Final Rule

    VA revises the section of the VASRD that addresses the hematologic 
and lymphatic systems. This final rule updates medical terminology, 
adds certain hematologic diseases, and provides detailed and updated 
criteria for evaluating conditions pertaining to the hematologic and 
lymphatic systems.

II. Technical Corrections

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

[[Page 54252]]

period.'' VA did not intend to apply two different frequency 
standards--i.e., ``on an intermittent basis'' and ``3 or fewer times 
per 12-month period''--to the same events, but the proposed text could 
suggest that both standards apply to each of the listed events. Rather, 
consistent with the requirements for the 60 percent and 30 percent 
ratings, VA intended that the ``3 or fewer times per 12-month period'' 
requirement would apply only to phlebotomy, and that the ``on an 
intermittent basis'' requirement would apply to the other listed 
treatments. In order to increase consistency in the application of the 
criteria and promote clarity in the requirements for each evaluation 
level, VA has included additional reference to the outcome of the 
treatment for polycythemia vera for 10 percent and 100 percent 
evaluation levels. This document corrects the above-referenced 
grammatical error and includes additional guidance by amending the 
proposed text for 10 percent evaluation to read as follows: ``Requiring 
phlebotomy 3 or fewer times per 12-month period or if requiring 
biologic therapy or interferon on an intermittent basis as needed to 
maintain all blood levels at reference range levels.'' Additionally, VA 
amends the proposed text for 100 percent evaluation to read as follows: 
``Requiring peripheral blood or bone marrow stem-cell transplant or 
chemotherapy (including myelosuppressants) for the purpose of 
ameliorating the symptom burden.''
    In the proposed rule, VA proposed several changes to DC 7705, 
including criteria based on platelet counts. VA specifically proposed 
to assign a 100 percent evaluation for platelet count below 30,000. 
However, for the 70 percent criteria, which apply in circumstances 
involving a platelet count higher than 30,000, VA omitted criteria for 
when platelet count is at 30,000. Accordingly, VA has changed the 100 
percent criteria to read ``platelet count 30,000 or below'' to avoid a 
gap in the platelet count range considered in the evaluation criteria.
    In the proposed rule, VA introduced several changes to DC 7716, 
Aplastic anemia, including a revision for a 60 percent disability 
rating. Namely, for a 60 percent rating, VA required the use of 
continuous immunosuppressive therapy. In order to capture the full 
range of therapeutic agents that are used to treat this condition, VA 
makes a clarifying change that amends the proposed text to reference 
the use of ``newer platelet stimulating factors'' in the evaluation 
criteria. Additionally, VA has added an explanatory note (2) regarding 
the definition of ``newer platelet stimulating factors'' for 
clarification purposes and redesignated the existing note as note (1).
    In the proposed rule, VA introduced several changes to DC 7718, 
Essential thrombocythemia and primary myelofibrosis, including 
revisions for 70 and 30 percent disability ratings. Namely, for 70 and 
30 percent ratings, VA required the use of continuous or intermittent 
myelosuppressive therapy. In order to capture the full range of 
therapeutic agents that are used to treat these conditions, VA makes a 
clarifying change that amends the proposed text for 70 percent 
disability rating to read as follows: ``Requiring continuous or 
intermittent myelosuppressive therapy, or chemotherapy, or interferon 
treatment to maintain platelet count < 500 x 10\9\/L.'' VA makes a 
clarifying change that amends the proposed text for 30 percent 
disability rating to read as follows: ``Requiring continuous or 
intermittent myelosuppressive therapy, or chemotherapy, or interferon 
treatment to maintain platelet count of 200,000-400,000, or white blood 
cell (WBC) count of 4,000-10,000.''
    In the proposed rule, VA introduced several changes to DC 7719, 
Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic 
granulocytic leukemia), including revisions for 60 and 30 percent 
disability ratings. Namely, for 60 and 30 percent ratings, VA required 
the use of targeted therapy with tyrosine kinase inhibitors. In order 
to capture the full range of targeted therapy agents that are used to 
treat these conditions, VA makes a clarifying change that amends the 
proposed text for 60 percent disability rating to read as follows: 
``Requiring intermittent myelosuppressive therapy, or molecularly 
targeted therapy with tyrosine kinase inhibitors, or interferon 
treatment when not in apparent remission.'' VA makes a clarifying 
change that amends the proposed text for 30 percent disability rating 
to read as follows: ``In apparent remission on continuous molecularly 
targeted therapy with tyrosine kinase inhibitors.''

III. Public Comments

    One commenter asked why the hematological system did not include 
Lyme disease. Lyme disease is an infectious disease evaluated under 38 
CFR 4.88b. DC 6319 specifically addresses Lyme disease and its 
residuals. Therefore, VA makes no changes based on this comment.
    One commenter urged VA to include in the rating schedule the 
debilitating side effects of daily tyrosine kinase inhibitors (TKIs) 
therapy for chronic myelogenous leukemia (CML). In the proposed rule, 
DC 7719 assigns a 60 percent evaluation for intermittent 
myelosuppressive therapy, or targeted therapy with TKIs, such as 
ruxolitinib, and a 100 percent evaluation for continuous 
myelosuppressive or immunosuppressive therapy. However, in cases of 
debilitating side effects of therapy for a service-connected disease, 
such as CML, VA may grant service connection on a secondary basis for 
disabilities that are proximately due to, or aggravated by, service-
connected disease or injury pursuant to 38 CFR 3.310. Therefore, VA 
makes no changes based on this comment.
    Another commenter suggested separating evaluations for pernicious 
anemia from evaluations for Vitamin B12 deficiency anemia. 
Pernicious anemia is caused by too little Vitamin B12; it is 
one form of Vitamin B12 deficiency anemia. VA recognizes the 
importance of separating pernicious anemia from Vitamin B12 
deficiency anemia for diagnosis and treatment. However, for disability 
compensation, VA evaluates common signs and symptoms and functional 
impairment of Vitamin B12 deficiency, also seen in 
pernicious anemia, under one diagnostic code. Therefore, VA makes no 
changes based on this comment.
    The same commenter noted that anemia secondary to autoimmune 
pernicious anemia is not corrected but maintained by Vitamin 
B12 injections. VA agrees. In the proposed rule, DC 7722 
provides a 10 percent evaluation for pernicious anemia and other forms 
of severe Vitamin B12 deficiency if it requires continuous 
treatment with Vitamin B12 injections, Vitamin 
B12 sublingual or high-dose oral tablets, or Vitamin 
B12 nasal spray or gel. Therefore, VA makes no changes based 
on this comment.
    The same commenter suggested including all body systems sequelae of 
pernicious anemia into hematologic system evaluations. In cases when 
debilitating effects of pernicious anemia affect other body systems, VA 
may grant service connection on a secondary basis for disabilities that 
are proximately due to, or aggravated by, service-connected disease or 
injury, pursuant to 38 CFR 3.310. Therefore, VA makes no changes based 
on this comment.
    The same commenter suggested VA conduct a study to determine 
whether the degree of neurologic or gastrointestinal residuals 
correlates with treatment variations. While VA appreciates this 
comment, it is beyond the scope of this rulemaking. Therefore, VA makes 
no changes based on it.

[[Page 54253]]

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

[[Page 54254]]

conditions called monoclonal gammopathy of undetermined significance 
(MGUS) and smoldering myeloma, which are not acute myeloma but may 
indicate a future need for treatment. The commenter suggested removing 
an outdated reference to indolent myeloma from DC 7712 and replacing it 
with MGUS. VA agrees and removes the reference to indolent myeloma from 
DC 7712 and replaces the reference with MGUS.
    VA appreciates the comments submitted in response to the proposed 
rule. Based on the rationale stated in the proposed rule and in this 
document, the final rule is adopted with the changes noted.
    We are additionally adding updates to 38 CFR part 4, Appendices A, 
B, and C, to reflect changes to the hematologic and lymphatic systems 
rating criteria made by this rulemaking. VA designs the appendices for 
users of the VASRD. They do not contain substantive content regarding 
disability evaluations.

Executive Orders 12866, 13563 and 13771

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
Create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) Materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) Raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined not to be a significant regulatory action under 
Executive Order 12866. VA's impact analysis can be found as a 
supporting document at http://www.regulations.gov, usually within 48 
hours after the rulemaking document is published. Additionally, a copy 
of this rulemaking and its impact analysis are available on VA's 
website at http://www.va.gov/orpm/, by following the link for ``VA 
Regulations Published From FY 2004 Through Fiscal Year to Date.''
    This rule is not an Executive Order 13771 regulatory action because 
this rule is not significant under Executive Order 12866.

Regulatory Flexibility Act

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

Unfunded Mandates

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

Paperwork Reduction Act

    This final rule contains provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). Specifically, this final rule is associated with information 
collections related to the filing of disability claims (VA Form 21-
526EZ) as well as Disability Benefits Questionnaires (DBQs) which 
enable a claimant to gather the necessary information from his or her 
treating physician as to the current symptoms and severity of a 
disability. Both information collections are currently approved by the 
Office of Management and Budget (OMB) and have been assigned OMB 
control Numbers 2900-0749 and 2900-0779, respectively. There are no 
changes to any of these information collections and, thus, no 
incremental costs associated with this rulemaking.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance program numbers and 
titles for this rule are 64.104, Pension for Non-Service-Connected 
Disability for Veterans; 64.109, Veterans Compensation for Service-
Connected Disability; and 64.110, Veterans Dependency and Indemnity 
Compensation for Service-Connected Death.

List of Subjects in 38 CFR Part 4

    Disability benefits, Pensions, Veterans.

Signing Authority

    The Secretary of Veterans Affairs approved this document and 
authorized the undersigned to sign and submit the document to the 
Office of the Federal Register for publication electronically as an 
official document of the Department of Veterans Affairs. Robert L. 
Wilkie, Secretary, Department of Veterans Affairs, approved this 
document on October 23, 2018, for publication.

    Dated: October 23, 2018.
Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of 
the Secretary, Department of Veterans Affairs.
    For the reasons set out in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 4, subpart B as follows:

PART 4--SCHEDULE FOR RATING DISABILITIES

Subpart B--Disability Ratings

0
1. The authority citation for part 4 continues to read as follows:

    Authority:  38 U.S.C. 1155, unless otherwise noted.

0
2. Revise the undesignated center heading preceding Sec.  4.117 to read 
as follows:

The Hematologic and Lymphatic Systems

0
3. Amend Sec.  4.117 by:
0
a. Removing the entry for diagnostic code 7700;
0
b. Revising the entries for diagnostic codes 7702 through 7706, 7709, 
7710 and 7714 through 7716;
0
c. Adding, in numerical order, an entry for diagnostic code 7712 and 
7718 through 7725.

[[Page 54255]]

    The revisions, and additions to read as follows:


Sec.  4.117  Schedule of ratings--hematologic and lymphatic systems

------------------------------------------------------------------------
                                                              Rating
------------------------------------------------------------------------
7702 Agranulocytosis, acquired:
    Requiring bone marrow transplant; or infections                  100
     recurring, on average, at least once every six
     weeks per 12-month period..........................
    Requiring intermittent myeloid growth factors                     60
     (granulocyte colony-stimulating factor (G-CSF) or
     granulocyte-macrophage colony-stimulating factor
     (GM-CSF) or continuous immunosuppressive therapy
     such as cyclosporine to maintain absolute
     neutrophil count (ANC) greater than 500/microliter
     ([micro]l) but less than 1000/[micro]l; or
     infections recurring, on average, at least once
     every three months per 12-month period.............
    Requiring intermittent myeloid growth factors to                  30
     maintain ANC greater than 1000/[micro]l; or
     infections recurring, on average, at least once per
     12-month period but less than once every three
     months per 12-month period.........................
    Requiring continuous medication (e.g., antibiotics)               10
     for control; or requiring intermittent use of a
     myeloid growth factor to maintain ANC greater than
     or equal to 1500/[micro]l..........................
    Note: A 100 percent evaluation for bone marrow
     transplant shall be assigned as of the date of
     hospital admission and shall continue with a
     mandatory VA examination six months following
     hospital discharge. Any change in evaluation based
     upon that or any subsequent examination shall be
     subject to the provisions of Sec.   3.105(e) of
     this chapter.......................................
7703 Leukemia (except for chronic myelogenous leukemia):
    When there is active disease or during a treatment               100
     phase..............................................
    Otherwise rate residuals under the appropriate
     diagnostic code(s).................................
    Chronic lymphocytic leukemia or monoclonal B-cell                  0
     lymphocytosis (MBL), asymptomatic, Rai Stage.......
    Note (1): A 100 percent evaluation shall continue
     beyond the cessation of any surgical therapy,
     radiation therapy, antineoplastic chemotherapy, or
     other therapeutic procedures. Six months after
     discontinuance of such treatment, the appropriate
     disability rating shall be determined by mandatory
     VA examination. Any change in evaluation based upon
     that or any subsequent examination shall be subject
     to the provisions of Sec.   3.105(e) of this
     chapter. If there has been no recurrence, rate on
     residuals..........................................
    Note (2): Evaluate symptomatic chronic lymphocytic
     leukemia that is at Rai Stage I, II, III, or IV the
     same as any other leukemia evaluated under this
     diagnostic code....................................
    Note (3): Evaluate residuals of leukemia or leukemia
     therapy under the appropriate diagnostic code(s).
     Myeloproliferative Disorders: (Diagnostic Codes
     7704, 7718, 7719)..................................
7704 Polycythemia vera:
    Requiring peripheral blood or bone marrow stem-cell              100
     transplant or chemotherapy (including
     myelosuppressants) for the purpose of ameliorating
     the symptom burden.................................
    Requiring phlebotomy 6 or more times per 12-month                 60
     period or molecularly targeted therapy for the
     purpose of controlling RBC count...................
    Requiring phlebotomy 4-5 times per 12-month period,               30
     or if requiring continuous biologic therapy or
     myelosuppressive agents, to include interferon, to
     maintain platelets <200,000 or white blood cells
     (WBC) <12,000......................................
    Requiring phlebotomy 3 or fewer times per 12-month                10
     period or if requiring biologic therapy or
     interferon on an intermittent basis as needed to
     maintain all blood values at reference range levels
    Note (1): Rate complications such as hypertension,
     gout, stroke, or thrombotic disease separately.....
    Note (2): If the condition undergoes leukemic
     transformation, evaluate as leukemia under
     diagnostic code 7703...............................
    Note (3): A 100 percent evaluation shall be assigned
     as of the date of hospital admission for peripheral
     blood or bone marrow stem cell transplant; or
     during the period of treatment with chemotherapy
     (including myelosuppressants). Six months following
     hospital discharge or, in the case of chemotherapy
     treatment, six months after completion of
     treatment, the appropriate disability rating shall
     be determined by mandatory VA examination. Any
     reduction in evaluation based upon that or any
     subsequent examination shall be subject to the
     provisions of Sec.   3.105(e) of this chapter......
7705 Immune thrombocytopenia:
    Requiring chemotherapy for chronic refractory                    100
     thrombocytopenia; or a platelet count 30,000 or
     below despite treatment............................
    Requiring immunosuppressive therapy; or for a                     70
     platelet count higher than 30,000 but not higher
     than 50,000, with history of hospitalization
     because of severe bleeding requiring intravenous
     immune globulin, high-dose parenteral
     corticosteroids, and platelet transfusions.........
    Platelet count higher than 30,000 but not higher                  30
     than 50,000, with either immune thrombocytopenia or
     mild mucous membrane bleeding which requires oral
     corticosteroid therapy or intravenous immune
     globulin...........................................
    Platelet count higher than 30,000 but not higher                  10
     than 50,000, not requiring treatment...............
    Platelet count above 50,000 and asymptomatic; or for               0
     immune thrombocytopenia in remission...............
    Note (1): Separately evaluate splenectomy under
     diagnostic code 7706 and combine with an evaluation
     under this diagnostic code.........................
    Note (2): A 100 percent evaluation shall continue
     beyond the cessation of chemotherapy. Six months
     after discontinuance of such treatment, the
     appropriate disability rating shall be determined
     by mandatory VA examination. Any reduction in
     evaluation based upon that or any subsequent
     examination shall be subject to the provisions of
     Sec.   3.105(e) of this chapter....................
7706 Splenectomy........................................              20
    Note: Separately rate complications such as systemic
     infections with encapsulated bacteria..............
 
                              * * * * * * *
7709 Hodgkin's lymphoma:
    With active disease or during a treatment phase.....             100
    Note: A 100 percent evaluation shall continue beyond
     the cessation of any surgical therapy, radiation
     therapy, antineoplastic chemotherapy, or other
     therapeutic procedures. Six months after
     discontinuance of such treatment, the appropriate
     disability rating shall be determined by mandatory
     VA examination. Any reduction in evaluation based
     upon that or any subsequent examination shall be
     subject to the provisions of Sec.   3.105(e) of
     this chapter. If there has been no local recurrence
     or metastasis, rate on residuals under the
     appropriate diagnostic code(s).....................
7710 Adenitis, tuberculous, active or inactive:
    Rate under Sec.   4.88c or 4.89 of this part,
     whichever is appropriate...........................
7712 Multiple myeloma:
    Symptomatic multiple myeloma........................             100

[[Page 54256]]

 
    Asymptomatic, smoldering, or monoclonal gammopathy                 0
     of undetermined significance (MGUS)................
    Note (1): Current validated biomarkers of
     symptomatic multiple myeloma and asymptomatic
     multiple myeloma, smoldering, or monoclonal
     gammopathy of undetermined significance (MGUS) are
     acceptable for the diagnosis of multiple myeloma as
     defined by the American Society of Hematology (ASH)
     and International Myeloma Working Group (IMWG).....
    Note (2): The 100 percent evaluation shall continue
     for five years after the diagnosis of symptomatic
     multiple myeloma, at which time the appropriate
     disability evaluation shall be determined by
     mandatory VA examination. Any reduction in
     evaluation based upon that or any subsequent
     examination shall be subject to the provisions of
     Sec.   3.105(e) and Sec.   3.344 (a) and (b) of
     this chapter.......................................
7714 Sickle cell anemia:
    With at least 4 or more painful episodes per 12-                 100
     month period, occurring in skin, joints, bones, or
     any major organs, caused by hemolysis and sickling
     of red blood cells, with anemia, thrombosis, and
     infarction, with residual symptoms precluding even
     light manual labor.................................
    With 3 painful episodes per 12-month period or with               60
     symptoms precluding other than light manual labor..
    With 1 or 2 painful episodes per 12-month period....              30
    Asymptomatic, established case in remission, but                  10
     with identifiable organ impairment.................
    Note: Sickle cell trait alone, without a history of
     directly attributable pathological findings, is not
     a ratable disability. Cases of symptomatic sickle
     cell trait will be forwarded to the Director,
     Compensation Service, for consideration under Sec.
      3.321(b)(1) of this chapter.......................
7715 Non-Hodgkin's lymphoma:
    When there is active disease, during treatment                   100
     phase, or with indolent and non-contiguous phase of
     low grade NHL......................................
    Note: A 100 percent evaluation shall continue beyond
     the cessation of any surgical therapy, radiation
     therapy, antineoplastic chemotherapy, or other
     therapeutic procedures. Two years after
     discontinuance of such treatment, the appropriate
     disability rating shall be determined by mandatory
     VA examination. Any reduction in evaluation based
     upon that or any subsequent examination shall be
     subject to the provisions of Sec.   3.105(e) of
     this chapter. If there has been no recurrence, rate
     on residuals under the appropriate diagnostic
     code(s)............................................
7716 Aplastic anemia:
    Requiring peripheral blood or bone marrow stem cell              100
     transplant; or requiring transfusion of platelets
     or red cells, on average, at least once every six
     weeks per 12-month period; or infections recurring,
     on average, at least once every six weeks per 12-
     month period.......................................
    Requiring transfusion of platelets or red cells, on               60
     average, at least once every three months per 12-
     month period; or infections recurring, on average,
     at least once every three months per 12-month
     period; or using continuous therapy with
     immunosuppressive agent or newer platelet
     stimulating factors................................
    Requiring transfusion of platelets or red cells, on               30
     average, at least once per 12-month period; or
     infections recurring, on average, at least once per
     12-month period....................................
    Note (1): A 100 percent evaluation for peripheral
     blood or bone marrow stem cell transplant shall be
     assigned as of the date of hospital admission and
     shall continue with a mandatory VA examination six
     months following hospital discharge. Any change in
     evaluation based upon that or any subsequent
     examination shall be subject to the provisions of
     Sec.   3.105(e) of this chapter....................
    Note (2): The term ``newer platelet stimulating
     factors'' includes medication, factors, or other
     agents approved by the United States Food and Drug
     Administration.....................................
 
                              * * * * * * *
7718 Essential thrombocythemia and primary
 myelofibrosis:
    Requiring either continuous myelosuppressive therapy             100
     or, for six months following hospital admission,
     peripheral blood or bone marrow stem cell
     transplant, or chemotherapy, or interferon
     treatment..........................................
    Requiring continuous or intermittent                              70
     myelosuppressive therapy, or chemotherapy, or
     interferon treatment to maintain platelet count
     <500 x 10 \9\/L....................................
    Requiring continuous or intermittent                              30
     myelosuppressive therapy, or chemotherapy, or
     interferon treatment to maintain platelet count of
     200,000-400,000, or white blood cell (WBC) count of
     4,000-10,000.......................................
    Asymptomatic........................................               0
    Note (1): If the condition undergoes leukemic
     transformation, evaluate as leukemia under
     diagnostic code 7703...............................
    Note (2): A 100 percent evaluation shall be assigned
     as of the date of hospital admission for peripheral
     blood or bone marrow stem cell transplant; or
     during the period of treatment with chemotherapy
     (including myelosuppressants). Six months following
     hospital discharge or, in the case of chemotherapy
     treatment, six months after completion of
     treatment, the appropriate disability rating shall
     be determined by mandatory VA examination. Any
     reduction in evaluation based upon that or any
     subsequent examination shall be subject to the
     provisions of Sec.   3.105(e) of this chapter......
7719 Chronic myelogenous leukemia (CML) (chronic myeloid
 leukemia or chronic granulocytic leukemia):
    Requiring peripheral blood or bone marrow stem cell              100
     transplant, or continuous myelosuppressive or
     immunosuppressive therapy treatment................
    Requiring intermittent myelosuppressive therapy, or               60
     molecularly targeted therapy with tyrosine kinase
     inhibitors, or interferon treatment when not in
     apparent remission.................................
    In apparent remission on continuous molecularly                   30
     targeted therapy with tyrosine kinase inhibitors...
    Note (1): If the condition undergoes leukemic
     transformation, evaluate as leukemia under
     diagnostic code 7703...............................
    Note (2): A 100 percent evaluation shall be assigned
     as of the date of hospital admission for peripheral
     blood or bone marrow stem cell transplant; or
     during the period of treatment with chemotherapy
     (including myelosuppressants). Six months following
     hospital discharge or, in the case of chemotherapy
     treatment, six months after completion of
     treatment, the appropriate disability rating shall
     be determined by mandatory VA examination. Any
     reduction in evaluation based upon that or any
     subsequent examination shall be subject to the
     provisions of Sec.   3.105 of this chapter.........
7720 Iron deficiency anemia:
    Requiring intravenous iron infusions 4 or more times              30
     per 12-month period................................
    Requiring intravenous iron infusions at least 1 time              10
     but less than 4 times per 12-month period, or
     requiring continuous treatment with oral
     supplementation....................................
    Asymptomatic or requiring treatment only by dietary                0
     modification.......................................

[[Page 54257]]

 
    Note: Do not evaluate iron deficiency anemia due to
     blood loss under this diagnostic code. Evaluate
     iron deficiency anemia due to blood loss under the
     criteria for the condition causing the blood loss..
7721 Folic acid deficiency:
    Requiring continuous treatment with high-dose oral                10
     supplementation....................................
    Asymptomatic or requiring treatment only by dietary                0
     modification.......................................
7722 Pernicious anemia and Vitamin B12 deficiency
 anemia:
    For initial diagnosis requiring transfusion due to               100
     severe anemia, or if there are signs or symptoms
     related to central nervous system impairment, such
     as encephalopathy, myelopathy, or severe peripheral
     neuropathy, requiring parenteral B12 therapy.......
    Requiring continuous treatment with Vitamin B12                   10
     injections, Vitamin B12 sublingual or high-dose
     oral tablets, or Vitamin B12 nasal spray or gel....
    Note: A 100 percent evaluation for pernicious anemia
     and Vitamin B12 deficiency shall be assigned as of
     the date of the initial diagnosis requiring
     transfusion due to severe anemia or parenteral B12
     therapy and shall continue with a mandatory VA
     examination six months following hospital discharge
     or cessation of parenteral B12 therapy. Any
     reduction in evaluation based upon that or any
     subsequent examination shall be subject to the
     provisions of Sec.   3.105(e) of this chapter.
     Thereafter, evaluate at 10 percent and separately
     evaluate any residual effects of pernicious anemia,
     such as neurologic involvement causing peripheral
     neuropathy, myelopathy, dementia, or related
     gastrointestinal residuals, under the most
     appropriate diagnostic code........................
7723 Acquired hemolytic anemia:
    Requiring a bone marrow transplant or continuous                 100
     intravenous or immunosuppressive therapy (e.g.,
     prednisone, Cytoxan, azathioprine, or rituximab)...
    Requiring immunosuppressive medication 4 or more                  60
     times per 12-month period..........................
    Requiring at least 2 but less than 4 courses of                   30
     immunosuppressive therapy per 12-month period......
    Requiring one course of immunosuppressive therapy                 10
     per 12-month period................................
    Asymptomatic........................................               0
    Note (1): A 100 percent evaluation for bone marrow
     transplant shall be assigned as of the date of
     hospital admission and shall continue for six
     months after hospital discharge with a mandatory VA
     examination six months following hospital
     discharge. Any reduction in evaluation based upon
     that or any subsequent examination shall be subject
     to the provisions of Sec.   3.105(e) of this
     chapter............................................
    Note (2): Separately evaluate splenectomy under
     diagnostic code 7706 and combine with an evaluation
     under diagnostic code 7723.........................
7724 Solitary plasmacytoma:
    Solitary plasmacytoma, when there is active disease              100
     or during a treatment phase........................
    Note (1): A 100 percent evaluation shall continue
     beyond the cessation of any surgical therapy,
     radiation therapy, antineoplastic chemotherapy, or
     other therapeutic procedures (including autologous
     stem cell transplantation). Six months after
     discontinuance of such treatment, the appropriate
     disability rating shall be determined by mandatory
     VA examination. Any change in evaluation based upon
     that or any subsequent examination shall be subject
     to the provisions of Sec.   3.105(e) of this
     chapter. If there has been no recurrence, rate
     residuals under the appropriate diagnostic codes...
    Note (2): Rate a solitary plasmacytoma that has
     developed into multiple myeloma as symptomatic
     multiple myeloma...................................
    Note (3): Rate residuals of plasma cell dysplasia
     (e.g., thrombosis) and adverse effects of medical
     treatment (e.g., neuropathy) under the appropriate
     diagnostic codes...................................
7725 Myelodysplastic syndromes:
    Requiring peripheral blood or bone marrow stem cell              100
     transplant; or requiring chemotherapy..............
    Requiring 4 or more blood or platelet transfusions                60
     per 12-month period; or infections requiring
     hospitalization 3 or more times per 12-month period
    Requiring at least 1 but no more than 3 blood or                  30
     platelet transfusions per 12-month period;
     infections requiring hospitalization at least 1 but
     no more than 2 times per 12-month period; or
     requiring biologic therapy on an ongoing basis or
     erythropoiesis stimulating agent (ESA) for 12 weeks
     or less per 12-month period........................
    Note (1): If the condition progresses to leukemia,
     evaluate as leukemia under diagnostic code 7703....
    Note (2): A 100 percent evaluation shall be assigned
     as of the date of hospital admission for peripheral
     blood or bone marrow stem cell transplant, or
     during the period of treatment with chemotherapy,
     and shall continue with a mandatory VA examination
     six months following hospital discharge or, in the
     case of chemotherapy treatment, six months after
     completion of treatment. Any reduction in
     evaluation based upon that or any subsequent
     examination shall be subject to the provisions of
     Sec.   3.105(e) of this chapter. If there has been
     no recurrence, residuals will be rated under the
     appropriate diagnostic codes.......................
------------------------------------------------------------------------


0
3. Amend Appendix A to Part 4 by:
0
a. Revising the entries for diagnostic codes 7700, 7702 through 7706, 
7709 through 7710, and 7714 through 7716;
0
b. Adding, in numerical order, an entry for diagnostic code 7712 and 
7718 through 7725.
    The revisions and additions read as follows:

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

------------------------------------------------------------------------
                             Diagnostic
           Sec.               code No.
------------------------------------------------------------------------
 
                              * * * * * * *
4.117....................            7700  Removed December 9, 2018.
 
                              * * * * * * *
                                     7702  Evaluation October 23, 1995;
                                            title December 9, 2018;
                                            evaluation December 9, 2018.

[[Page 54258]]

 
                                     7703  Evaluation August 23, 1948;
                                            criterion October 23, 1995;
                                            evaluation December 9, 2018;
                                            criterion December 9, 2018.
                                     7704  Evaluation October 23, 1995;
                                            evaluation December 9, 2018.
                                     7705  Evaluation October 23, 1995;
                                            title December 9, 2018;
                                            evaluation December 9, 2018;
                                            criterion December 9, 2018.
                                     7706  Evaluation October 23, 1995;
                                            note December 9, 2018;
                                            criterion October 23, 1995.
 
                              * * * * * * *
                                     7709  Evaluation March 10, 1976;
                                            criterion October 23, 1995;
                                            title December 9, 2018;
                                            criterion December 9, 2018.
                                     7710  Criterion October 23, 1995;
                                            criterion December 9, 2018.
                                     7712  Added December 9, 2018.
                                     7714  Added September 9, 1975;
                                            criterion October 23, 1995;
                                            criterion December 9, 2018.
                                     7715  Added October 26, 1990;
                                            criterion December 9, 2018.
                                     7716  Added October 23, 1995;
                                            evaluation December 9, 2018;
                                            criterion December 9, 2018.
 
                              * * * * * * *
                                     7718  Added December 9, 2018.
                                     7719  Added December 9, 2018.
                                     7720  Added December 9, 2018.
                                     7721  Added December 9, 2018.
                                     7722  Added December 9, 2018.
                                     7723  Added December 9, 2018.
                                     7724  Added December 9, 2018.
                                     7725  Added December 9, 2018.
 
                              * * * * * * *
------------------------------------------------------------------------


0
4. Amend Appendix B to Part 4 by:
0
a. Revising the undesignated center heading immediately preceding 
diagnostic code 7700.
0
b. Revising the entries for diagnostic codes 7700, 7702, 7705, and 
7709.
0
c. Adding, in numerical order, entries for diagnostic codes 7712 and 
7718 through 7725.
    The revisions and additions read as follows:

Appendix B to Part 4--Numerical Index of Disabilities

------------------------------------------------------------------------
     Diagnostic code No.
------------------------------------------------------------------------
 
                              * * * * * * *
                  The Hematologic and Lymphatic Systems
------------------------------------------------------------------------
7700........................  [Removed]
 
                              * * * * * * *
7702........................  Agranulocytosis, acquired.
 
                              * * * * * * *
7705........................  Immune thrombocytopenia.
 
                              * * * * * * *
7709........................  Hodgkin's lymphoma.
 
                              * * * * * * *
7712........................  Multiple myeloma.
 
                              * * * * * * *
7718........................  Essential thrombocythemia and primary
                               myelofibrosis.
7719........................  Chronic myelogenous leukemia (CML)
                               (chronic myeloid leukemia or chronic
                               granulocytic leukemia).
7720........................  Iron deficiency anemia.
7721........................  Folic acid deficiency.
7722........................  Pernicious anemia and Vitamin B12
                               deficiency anemia.
7723........................  Acquired hemolytic anemia.
7724........................  Solitary plasmacytoma.
7725........................  Myelodysplastic syndromes.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 54259]]


0
5. Amend Appendix C to Part 4 by revising the entries for 
Agranulocytosis, Anemia, Hodgkin's lymphoma, and Leukemia and adding in 
alphabetical order, a new entry for Hematologic to read as follows:.

Appendix C to Part 4--Alphabetical Index of Disabilities

------------------------------------------------------------------------
                                                            Diagnostic
                                                             code No.
------------------------------------------------------------------------
 
                              * * * * * * *
Agranulocytosis, acquired...............................            7702
 
                              * * * * * * *
Anemia:
    Acquired hemolytic anemia...........................            7723
    Folic acid deficiency...............................            7721
    Iron deficiency anemia..............................            7720
    Pernicious anemia and Vitamin B12 deficiency anemia.            7722
 
                              * * * * * * *
Hematologic:
    Essential thrombocythemia and primary myelofibrosis.            7718
    Immune thrombocytopenia.............................            7705
    Multiple myeloma....................................            7712
    Myelodysplastic syndromes...........................            7725
    Solitary plasmacytoma...............................            7724
 
                              * * * * * * *
Hodgkin's lymphoma......................................            7709
 
                              * * * * * * *
Leukemia:
    Chronic myelogenous leukemia (CML) (chronic myeloid             7719
     leukemia or chronic granulocytic leukemia).........
    Leukemia............................................            7703
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-23517 Filed 10-26-18; 8:45 am]
 BILLING CODE 8320-01-P