Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems, 46888-46900 [2015-19197]

Download as PDF 46888 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules becomes the southern boundary of Cheboygan County, and continuing along the Cheboygan county line to the intersection of the Cheboygan county line with the eastern boundary of Charlevoix County; then (6) Proceed south then east along the Charlevoix county line to the intersection of the Charlevoix county line with the eastern boundary of Antrim County; then (7) Proceed south along the Antrim county line to the point where the county line turns due east; then (8) Proceed west in a straight line to the eastern shoreline of Grand Traverse Bay; then (9) Proceed north-northeasterly along the shorelines of Grand Traverse Bay, Lake Michigan, Little Traverse Bay, Sturgeon Bay, Trails End Bay, and the Straits of Mackinac, returning to the beginning point. Signed: July 28, 2015. John J. Manfreda, Administrator. [FR Doc. 2015–19277 Filed 8–5–15; 8:45 am] BILLING CODE 4810–31–P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 4 RIN 2900–AO19 Schedule for Rating Disabilities: The Hematologic and Lymphatic Systems Department of Veterans Affairs. Proposed rule. AGENCY: ACTION: The Department of Veterans Affairs (VA) proposes to amend the portion of the VA Schedule for Rating Disabilities (Rating Schedule) that addresses the hematologic and lymphatic systems. The intended effect of this change is to incorporate medical advances that have occurred since the last review, update medical terminology, add medical conditions not currently in the Rating Schedule, and refine criteria for further clarity and ease of rater application. DATES: Comments must be received by VA on or before October 5, 2015. ADDRESSES: Written comments may be submitted through www.Regulations.gov; by mail or handdelivery to the Director, Regulation Policy and Management (02REG), Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1068, Washington, DC 20420; or by fax to (202) 273–9026. Comments should indicate that they are submitted in response to RIN 2900–AO19—Schedule mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 for Rating Disabilities: The Hematologic and Lymphatic Systems. Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1068, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461–4902 for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at www.Regulations.gov. FOR FURTHER INFORMATION CONTACT: Nick Olmos-Lau, M.D., Medical Officer (211C), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461– 9695. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: As part of our ongoing revision of the VA Schedule for Rating Disabilities (Rating Schedule), we are proposing changes to 38 CFR 4.117, Schedule of ratings— hemic and lymphatic systems, and appendices A, B, and C of part 4 pertaining to this section. This section was last updated in 1995. By these revisions, we aim to update medical terminology; add medical conditions not currently in the Rating Schedule; and revise the rating criteria to reflect medical advances and to clarify them for ease of application. Proposed Title Change: The Hematologic and Lymphatic Systems ‘‘Hemic’’ is an adjective previously used to describe diseases of or related to the blood. The current medical term for diseases of the blood or blood-forming organs is ‘‘hematologic.’’ In addition, the 2013 National Library of MedicineMedical Subject Headings (MESH) descriptor advisory discourages the use of the term ‘‘hemic’’ as too general, and recommends instead the use of the term ‘‘hematologic’’ as more specific (https:// www.nlm.nih.gov/cgi/mesh/2013/MB _cgi?mode=&index=6154&field=all &HM=&II=&PA=&form=&input=). VA therefore proposes to edit the header of § 4.117 to ‘‘The Hematologic and Lymphatic Systems’’ and the title of § 4.117 to ‘‘Schedule of ratings— hematologic and lymphatic systems.’’ Modification and Reorganization of Current Diagnostic Code (DC) 7700 (Anemia, Hypochromic-Microcytic and Megaloblastic, Such as Iron-Deficiency and Pernicious Anemia) Anemia is predominantly hereditary or secondary, a symptom of another condition. Secondary anemia is corrected by treatment of the underlying PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 condition. Examples of conditions that cause secondary anemia include osteomyelitis (DC 5000) and hypothyroidism (DC 7903). Anemia is most appropriately evaluated as part of the underlying service-connected disability causing the anemia. VA proposes to address in proposed DCs 7720, 7721, 7722, and 7723 anemias that are neither hereditary nor addressed under DCs for the causative conditions. The title of current DC 7700 is ‘‘Anemia, hypochromic-microcytic and megaloblastic, such as iron-deficiency and pernicious anemia.’’ This title groups anemias based on red blood cell (RBC) morphology. VA proposes separate DCs and criteria for the major types of anemia. Separation would assist raters in distinguishing amongst and clarifying severity of anemias. Accordingly, VA proposes the removal of DC 7700 from the Rating Schedule, and adding DC 7720 Iron deficiency anemia, 7721 Folic acid deficiency, 7722 Pernicious anemia and Vitamin B12 deficiency anemia, and 7723 Acquired hemolytic anemia. Anemia is currently rated at levels of 100, 70, 30, 10, and 0-percent, depending on the hemoglobin level and the associated signs and symptoms. It is evaluated at 100-percent for hemoglobin of 5gm/100ml or less, with findings such as high-output congestive heart failure or dyspnea at rest. It is evaluated at 70-percent for hemoglobin of 7gm/ 100ml or less, with findings such as dyspnea on mild exertion, cardiomegaly, tachycardia (100 to 120 beats per minute) or syncope (three episodes in the last six months). It is evaluated at 30-percent for hemoglobin of 8gm/100ml or less, with findings such as weakness, easy fatigability, headaches, lightheadedness, or shortness of breath. It is evaluated at 10percent for hemoglobin of 10gm/100ml or less, with findings such as weakness, easy fatigability, or headaches. It is evaluated at 0-percent for hemoglobin of 10gm/100ml or less and asymptomatic. While there is a high correlation between hemoglobin levels and signs or symptoms of anemia in acute anemia, the correlation is less accurate in chronic anemia. As the duration of the anemia lengthens, the individual becomes more tolerant of lower hemoglobin levels and symptom manifestation decreases. The functional impact of chronic anemia is more accurately measured by mode and frequency of treatment. VA proposes rating criteria based on the specific mode(s) and frequency of treatment. VA notes that the existing 100 and 70 percent categories for rating anemia are more descriptive of acute rather than E:\FR\FM\06AUP1.SGM 06AUP1 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS chronic anemia. Acute anemia is usually related to gastrointestinal or uterine bleeding or traumatic injuries with acute hemorrhage. The descriptors in the 100 and 70 percent categories reflect a clinical picture of rapid and extensive blood loss, and their symptoms include high output cardiac failure with hypoxemia due to inability to sustain proper tissue oxygenation, caused by low hemoglobin levels which can lead to shock or collapse. The laboratory values and symptoms described in the 100 and 70 percent categories of the current anemia DC reflect intolerable and life threatening symptoms that require emergency hospitalization and transfusion. See G. Limbruno, ‘‘Recommendations for transfusion of red blood cells,’’ 7 Blood Transfusion 49 (2009). Chronic anemia on the other hand, develops at a more gradual pace, and is usually related to serious medical conditions such as malignancies (cancer) on chemotherapy, infection (osteomyelitis), thyroid disease, hemoglobin disorders (such as sicklecell disease or thalassemia), renal failure or chronic lower gastrointestinal bleeding. In such cases a slower decline in hemoglobin values allows gradual adjustment. However, even when an individual reaches such low levels as contemplated in the 100 and 70 percent evaluation, such a case reflects acute critical health emergencies that are unsustainable rather than having an ongoing chronic long term disability impairment as with chronic anemia. In those cases where chronic anemia results in urgent hospitalization, VA finds that compensation is more appropriately determined by evaluating the underlying primary medical problem that gave rise to the serviceconnected chronic anemia. As these more severe cases represent less than 2 percent of the total number of disability awards for anemia in the past years, VA does not anticipate a significant impact on future evaluations based on anemia. Proposed DC 7720 (Iron Deficiency Anemia) Iron deficiency anemia is defined as a decrease in total body iron content. Total body iron content is regulated through the balance of iron absorption and loss. Iron deficiency anemia is most commonly due to blood loss, posthemorrhagic anemia. Iron deficiency anemia due to blood loss would be evaluated under criteria for the causative condition, e.g., duodenal ulcer (DC 7305) or hemorrhoids (DC 7336), rather than under DC 7720. VA proposes to clarify the rating of anemia due to blood loss by adding the following note: VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 ‘‘Do not evaluate iron deficiency anemia due to blood loss under this diagnostic code. Evaluate iron deficiency anemia due to blood loss under the criteria for the condition causing the blood loss.’’ Iron deficiency anemia can be readily treated by diet or dietary supplements. It is ordinarily short term with mild symptoms and responds to treatment. However, fatigue due to chronic, severe iron deficiency anemia can decrease the ability to perform physical labor. VA proposes rating levels of 30, 10, and 0percent for iron deficiency anemia not due to blood loss. VA proposes a 30percent evaluation for iron deficiency anemia requiring intravenous (IV) iron infusions on average 4 or more times per 12-month period; a 10-percent evaluation if requiring continuous treatment with high-dose oral supplementation; and a 0-percent evaluation if asymptomatic or requiring treatment only by dietary modification. Proposed DC 7721 (Folic Acid Deficiency) The prevalence of folic acid deficiency has decreased in the United States due to dietary fortification. This form of anemia is amenable to dietary modification and oral supplementation. VA proposes a 10-percent evaluation for folic acid deficiency requiring continuous treatment with high-dose oral supplementation. VA proposes a 0percent evaluation when asymptomatic or requiring treatment only by dietary modification. Proposed DC 7722 (Pernicious Anemia and Vitamin B12 Deficiency Anemia) Pernicious anemia is the most common form of severe Vitamin B12 deficiency. S. Stabler, ‘‘Vitamin B12 deficiency,’’ 368(2) New Eng. J. Med. 149 (2013). Other causes of Vitamin B12 deficiency that could lead to anemia include: Dietary avoidance (vegetarianism), malabsorption, gastrectomy or gastric bypass, inflammatory bowel disease (IBD), pancreatic insufficiency, use of histamine 2-blockers and proton pump inhibitors. Pernicious anemia is associated with gastric atrophy, due to autoimmune destruction, and a lack of intrinsic factor, a glycoprotein necessary for the absorption of Vitamin B12, in the gastric mucosa. Pernicious anemia requires lifelong treatment with Vitamin B12 injections, sublingual or high-dose oral Vitamin B12 tablets, or Vitamin B12 nasal spray or gel. Since disabilities from nutritional B12 deficiency are consistent with pernicious anemia, nutritional B12 deficiency would be rated under the same diagnostic code as pernicious anemia. PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 46889 In accordance with the above discussion, VA proposes to evaluate pernicious anemia and other forms of severe B12 deficiency at 100 percent for initial diagnosis requiring transfusion due to severe anemia, or if there are signs or symptoms related to central nervous system impairment, such as encephalopathy, myelopathy, or severe peripheral neuropathy, requiring parenteral B12 therapy. Since certitude of neurologic reversibility cannot be initially determined, and B12 absorption issues may require lifelong supplementation with B12 injections every 1–3 months, VA proposes to reevaluate at 6 months and rate according to presence of neurologic or gastrointestinal residuals. If absorption is adequate, lifelong oral or intranasal B12 treatment may be used. VA proposes to evaluate pernicious anemia and other forms of severe Vitamin B12 deficiency at 10 percent if it requires continuous treatment with Vitamin B12 injections, Vitamin B12 sublingual or high-dose oral tablets, or Vitamin B12 nasal spray or gel. VA proposes to add a note regarding evaluation which states that the 100percent evaluation for pernicious anemia and Vitamin B12 deficiency shall be assigned as of the date of initial diagnosis requiring transfusion due to severe anemia or parenteral B12 therapy and shall continue with a mandatory VA examination six months following hospital discharge or cessation of continuous parenteral B12 therapy. The note would also state that any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of 38 CFR 3.105(e) and that, thereafter, evaluation would be at 10-percent and any residual effects of pernicious anemia, such as neurologic involvement causing peripheral neuropathy, myelopathy, dementia, or related gastrointestinal residuals, would be separately evaluated under the most appropriate diagnostic code. Proposed 7723 (Acquired Hemolytic Anemia) There are over 200 causes of hemolytic anemia, including both acquired and hereditary types. The causes of acquired hemolytic anemia include immune disorders, toxic chemicals, medications, physical damage (such as may occur with prosthetic heart valves), and infections. Treatment may include intermittent corticosteroids; other immunosuppressive drugs; immune globulin; monoclonal antibody therapy, such as rituximab; splenectomy; erythropoiesis stimulating agent (ESA) to boost production of RBC; E:\FR\FM\06AUP1.SGM 06AUP1 46890 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS plasmapheresis (a process similar to dialysis that can remove certain components, such as harmful antibodies, from the blood); blood transfusions; and peripheral blood or bone marrow stem cell transplantation (www.nhlbi.nih.gov/health). VA proposes to list the evaluation criteria for acquired hemolytic anemia under DC 7723. VA proposes to rate acquired hemolytic anemia at 100 percent, if requiring a bone marrow transplant or continuous intravenous or immunosuppressive therapy (e.g., prednisone, Cytoxan (cyclophosphamide), azathioprine, or rituximab). VA proposes to rate acquired hemolytic anemia at 60 percent, if requiring immunosuppressive medication an average of 4 or more times per 12-month period. VA proposes to rate acquired hemolytic anemia at 30 percent, if requiring an average of 2–3 courses of immunosuppressive therapy per 12month period. VA proposes to rate acquired hemolytic anemia at 10 percent, if requiring an average of 1 course of immunosuppressive therapy per 12-month period. VA proposes to evaluate acquired hemolytic anemia at 0 percent if asymptomatic. VA also proposes to add a Note (1) in relation to this DC, stating that a 100percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue for six months after hospital discharge with a mandatory VA examination six months following hospital discharge. The note would also state that any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of 38 CFR 3.105(e). To remind rating specialists that there is a separate DC for splenectomy, VA proposes to add a Note (2), which would state that VA will separately evaluate splenectomy under DC 7706 and combine with an evaluation under DC 7723. DC 7702 (Agranulocytosis, Acute); Proposed DC 7702 (Agranulocytosis, Acquired) Agranulocytosis, by definition, is an acute condition. Therefore, this disease is better categorized as agranulocytosis, acquired, than as agranulocytosis, acute. VA proposes to list updated evaluation criteria for this condition under DC 7702 with the title ‘‘Agranulocytosis, acquired’’ to reflect current medical terminology. Acute agranulocytosis is currently evaluated at levels of 100, 60, 30, and 10 percent based on type of treatment or VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 frequency of episodes of recurring infections. A 100-percent evaluation is currently assigned if requiring bone marrow transplant or transfusion of platelets or red cells at least once every six weeks or if infections recur at least once every six weeks. A 60-percent evaluation is assigned if requiring transfusion of platelets or red cells at least once every three months or if infections recur at least once every three months. A 30-percent evaluation is assigned if requiring transfusion of platelets or red cells at least once per year but less than once every three months or if infections recur at least once per year but less than once every three months. A 10-percent evaluation is assigned if requiring continuous medication for control. Due to advances in the pharmacological treatment of agranulocytosis and a shift in standard of care, VA proposes the deletion of the number of transfusions as a criterion for rating agranulocytosis. ‘‘Granulocyte transfusions have undergone a cycle of popularity followed by disfavor,’’ although they may be useful in patients with life-threatening infections whose conditions are not responding to antibiotics. A. Distenfeld, M.D., N.Y. Univ. Sch. of Med., ‘‘Agranulocytosis,’’ eMedicine (Updated Jan 9, 2015, by C. Braden). These transfusions are accompanied by many complications, including severe febrile reactions. The use of granulocyte transfusions remains controversial. VA proposes to evaluate agranulocytosis based on type and frequency of treatment or the average number of infections per 12-month period. VA proposes to evaluate agranulocytosis at 100 percent if requiring bone marrow transplant or if infections recur, on average, at least once every six weeks per 12-month period. VA proposes to evaluate agranulocytosis at 60 percent if requiring intermittent myeloid growth factors (granulocyte colony-stimulating factor (G–CSF) or granulocytemacrophage colony-stimulating factor (GM–CSF)) or continuous immunosuppressive therapy such as cyclosporine to maintain absolute neutrophil count (ANC) greater than 500/ml but less than 1000/ml, or if infections recur, on average, at least once every three months per 12-month period. VA proposes to evaluate agranulocytosis at 30 percent if requiring intermittent myeloid growth factors to maintain ANC greater than 1000/ml or if infections recur, on average, at least once per 12-month period but less than once every three months per 12-month period. VA PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 proposes to evaluate agranulocytosis at 10 percent if requiring continuous medication (e.g., antibiotics) for control or if requiring intermittent use of a myeloid growth factor to maintain ANC greater than or equal to 1500/ml. VA proposes to preserve the existing note under current DC 7702. DC 7703 (Leukemia) One type of leukemia, chronic myelogenous leukemia (CML), is evaluated as a myeloproliferative disorder. CML is a heterogeneous disease with three clinical phases: Chronic, transitional (accelerated), and acute (blast). Most individuals with CML are diagnosed in the chronic phase and with adequate treatment can remain in this phase for several years. However, patients with CML are never ‘‘cured’’ with current therapy, but often have no evidence of the disease at a molecular level. The term used for this state is ‘‘complete molecular remission’’ (CMR). These patients require continuous treatment because otherwise they would relapse. Patients with CML need to be considered as having active disease even when they would otherwise appear to be in remission. Therefore, VA proposes to evaluate CML under separate DC 7719. Leukemia is currently evaluated at 100 percent for active disease or during a treatment phase. There is also a directive to otherwise rate as anemia (current DC 7700) or aplastic anemia (DC 7716), whichever would result in the greater benefit. VA proposes to evaluate all forms of active leukemia other than chronic myelogenous leukemia under DC 7703. VA proposes to retain the 100-percent evaluation ‘‘[w]hen there is active disease or during a treatment phase.’’ For rating purposes, VA considers any diagnosed cancer as ‘‘active disease’’ if medical evidence does not demonstrate the eradication of cancerous cells, if the cancer is not in remission, or when the condition requires continuous treatment since otherwise there would invariably be a relapse. Since there are numerous residual effects of leukemia and its treatment, which may involve any body system, VA proposes to remove the current directive, which addresses only certain hematologic residuals: ‘‘Otherwise rate as anemia (code 7700) or aplastic anemia (code 7716), whichever would result in the greater benefit.’’ VA proposes another directive, which would read: ‘‘Otherwise rate residuals under the appropriate diagnostic code(s).’’ One of the four main types of leukemia, chronic lymphocytic E:\FR\FM\06AUP1.SGM 06AUP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules leukemia (CLL), is now often diagnosed at a very early stage when the blood lymphocyte count is high, but the patient does not have enlargement of the lymph nodes, spleen, or liver, and the red blood cells and platelets are normal or nearly so. The average age of patients with this type of leukemia is 70. In the staging system commonly used to assess the severity of CLL, this early stage is known as Rai Stage 0. Occasionally patients are diagnosed instead as having monoclonal B-cell lymphocytosis (MBL). The diagnosis is in a similar category as Rai Stage 0 CLL. Unlike the course of the other major types of leukemia, this early stage of CLL may not progress for many years. The median survival time for this stage of disease is over 12 years. No treatment is required, and it is considered a low risk stage. For individuals with CLL at Rai Stage 0, assigning a 100-percent evaluation would be inappropriate, since antineoplastic treatment is not warranted, and at this early stage, there is little or no effect on a patient’s wellbeing, according to the Leukemia and Lymphoma Society (www.leukemialymphoma.org/). Therefore, VA proposes to add a 0-percent evaluation level for asymptomatic low risk level patients with CLL at Rai Stage 0. Patients with lymphocytosis, enlarged lymph nodes and splenomegaly or hepatomegaly are defined as having an intermediate risk for disease progression (Rai Stages I or II). Patients with hepatomegaly (enlarged liver), anemia (Hemoglobin <11 g/dL), or thrombocytopenia (platelet counts lower than 100,000) are considered to be in the higher risk categories for disease progression (Rai Stages III and IV). Oncologists have developed criteria to determine when to initiate treatment based on the presence of genetic mutation, micro-globulins, lymphocyte doubling times and other markers to help boost the accuracy criteria of the CLL tumor burden along with staging provided by the Rai scale. Patients with newly diagnosed asymptomatic earlystage disease are generally monitored without therapy unless they show signs of disease progression or symptoms. Patients with intermediate risk (Rai Stages I and II) and those with high risk (Rai Stages III or IV) are usually started on treatment. VA proposes editorial changes to the currently existing note, which would be numbered as Note (1). Rai Stages I–IV (intermediate and high risk) usually require progressively aggressive therapy, consistent with leukemias and other malignancies. VA proposes addition of notes to clarify VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 evaluation of CLL that progresses beyond Rai Stage 0. The proposed Note (2) would read: ‘‘Evaluate symptomatic chronic lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as any other leukemia evaluated under this diagnostic code.’’ The proposed Note (3) would read: ‘‘Evaluate residuals of leukemia or leukemia therapy under the appropriate diagnostic code(s). Myeloproliferative Disorders: (Diagnostic Codes 7704, 7718, 7719).’’ Myeloproliferative Disorders This section includes: DC 7704 (Polycythemia vera); Proposed DC 7718 (Essential thrombocythemia and primary myelofibrosis); Proposed DC 7719 (Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia)). Myeloproliferative disorders are a group of slow-growing blood neoplasms in which the bone marrow produces excess numbers of red blood cells, white blood cells, or platelets. Polycythemia vera is one type of myeloproliferative disorder. Other conditions included in this category are essential thrombocythemia, primary idiopathic myelofibrosis, and chronic myelogenous leukemia (CML) (also called chronic myeloid leukemia or chronic granulocytic leukemia) (www.cancer.gov/cancertopics/types/ myeloproliferative and www.leukemialymphoma.org). These conditions may evolve into acute leukemia. According to the National Cancer Institute of the U.S. National Institutes of Health, a variety of treatments are used for myeloproliferative disorders. For example, polycythemia vera is commonly treated by phlebotomy (removal of blood, as needed, to decrease the number of red blood cells and platelets). However, other treatments used to achieve appropriate levels of cells and to reduce complications, such as thrombosis, include radioactive phosphorous (which suppresses the overproduction of blood cells), interferon alpha (which boosts the immune system), chemotherapeutic agents (including myelosuppressants, which decrease bone marrow production), and low dose aspirin. Some of these treatments are also used for other myeloproliferative disorders. Other treatments used for myeloproliferative disorders include: stem cell transplant; platelet apheresis (removal of platelets from the blood in a process similar to dialysis); blood or platelet transfusions (when the bone marrow production is insufficient); periods of hospitalizations to treat PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 46891 infections (since patients with these conditions are at high risk for serious infections); erythropoiesis-stimulating agents (ESA) to boost production of red blood cells; tyrosine kinase inhibitors such as imatinib (Gleevec) (commonly used to treat chronic myelogenous leukemia) or ruxolitinib (new kinase inhibitor); and androgen-like drugs (which also may stimulate the bone marrow). Polycythemia vera is the only myeloproliferative disorder, of the above-mentioned disorders, currently evaluated in the Rating Schedule. Therefore, VA proposes the addition of DCs to provide rating criteria for other diseases under the category of myeloproliferative disorders: 7718 Essential thrombocythemia/primary myelofibrosis, and 7719 Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia). VA proposes to add a note applicable to all myeloproliferative disorders, which would state that if the condition undergoes leukemic transformation, it should be evaluated as leukemia under DC 7703. This note is intended to remind rating specialists that a myeloproliferative disorder may undergo leukemic transformation and warrant evaluation under DC 7703. VA also proposes to add another note applicable to all myeloproliferative disorders, which would state that a 100percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant, or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants), and that six months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. The note would also state that any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of 38 CFR 3.105(e). DC 7704 (Polycythemia Vera) VA proposes a 100-percent evaluation if requiring peripheral blood or bone marrow stem-cell transplant or treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). VA proposes a 60-percent evaluation if requiring phlebotomy 6 or more times per 12-month period to control RBC count or if requiring radioactive phosphorous treatment, chemotherapy, or targeted agents like ruxolitinib or E:\FR\FM\06AUP1.SGM 06AUP1 46892 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules imatinib. VA proposes a 30-percent evaluation if requiring phlebotomy 4–5 times per 12-month period or if requiring continuous biologic therapy or myelosuppressive agents to maintain platelet count in the less than 200,000 range or white blood cells (WBC) in the less than 12,000 range. VA proposes a 10-percent evaluation if requiring, on an intermittent basis, phlebotomy, biologic therapy, or interferon, as needed, but less than 4 times per 12-month period. VA proposes to number the current note for DC 7704 as Note (1). VA proposes the addition of the two notes described above for all myeloproliferative disorders to be added as Notes (2) and (3) after the current note for DC 7704. Proposed DC 7718 (Essential Thrombocythemia and Primary Myelofibrosis) VA proposes a 100-percent evaluation if requiring either continuous myelosuppressive therapy or, for six months following hospital admission, any of the following treatments: Peripheral blood or bone marrow stem cell transplant, or treatment with radioactive phosphorus or chemotherapy (including myelosuppressants); a 70 percent evaluation if requiring either continuous or intermittent myelosuppressive therapy to maintain platelet count less than 500 × 10 9/L; a 30-percent evaluation if requiring continuous or intermittent myelosuppressive therapy to maintain platelet count of 200,000– 400,000 or white blood cell (WBC) count of 4,000–10,000; and a 0-percent evaluation if asymptomatic. VA proposes the addition of the two notes described above for all myeloproliferative disorders. mstockstill on DSK4VPTVN1PROD with PROPOSALS Proposed DC 7719 (Chronic Myelogenous Leukemia (CML) (Chronic Myeloid Leukemia or Chronic Granulocytic Leukemia)) VA proposes a 100-percent evaluation if requiring peripheral blood or bone marrow stem cell transplant or requiring continuous myelosuppressive or immunosuppressive therapy. VA proposes a 60-percent evaluation if requiring intermittent myelosuppressive therapy, or targeted therapy with tyrosine kinase inhibitors, or interferon treatment. VA proposes a 30-percent evaluation if in apparent remission on continuous targeted therapy with tyrosine kinase inhibitors. VA proposes the addition of the two notes described above for all myeloproliferative disorders. VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 Current DC 7705 (Thrombocytopenia, Primary, Idiopathic or Immune); Proposed DC 7705 (Immune Thrombocytopenia) Thrombocytopenia is currently evaluated at levels of 100, 70, 30, and 0 percent based on the platelet count, the presence or absence of bleeding episodes, and whether treatment is required. VA proposes to change the title from ‘‘Thrombocytopenia, primary, idiopathic or immune’’ to ‘‘Immune thrombocytopenia.’’ VA proposes to use the same bases for evaluation of disability, while updating criteria to reflect advances in medical knowledge. A 100-percent evaluation is currently assigned if the platelet count is less than 20,000, with active bleeding, requiring treatment with medication and transfusions. A 70-percent evaluation is currently assigned for a platelet count between 20,000 and 70,000, not requiring treatment, without bleeding. A 30-percent evaluation is currently assigned for a stable platelet count between 70,000 and 100,000, without bleeding. A 0-percent evaluation is currently assigned for a stable platelet count of 100,000 or more, without bleeding. VA proposes to provide evaluation levels of 100, 70, 30, 10 and 0 percent, with criteria based in part on the recommendations of the American Society of Hematology for diagnosis and treatment of idiopathic thrombocytopenic purpura, updated in 2010. VA proposes to assign a 100-percent evaluation for immune thrombocytopenia requiring chemotherapy for chronic refractory thrombocytopenia or a platelet count from 20,000 to 30,000 despite treatment. VA proposes to assign a 70-percent evaluation if requiring immunosuppressive therapy or for a platelet count higher than 30,000 but not higher than 50,000, with history of hospitalization because of severe bleeding requiring intravenous immune globulin, high-dose parenteral corticosteroids, and platelet transfusions. VA proposes to assign a 30-percent evaluation for a platelet count higher than 30,000 but not higher than 50,000, with either immune thrombocytopenia or mild mucous membrane bleeding which requires oral corticosteroid therapy or intravenous immune globulin. VA proposes to assign a 10-percent evaluation for a platelet count higher than 30,000 but not higher than 50,000, not requiring treatment. VA proposes to assign a 0-percent evaluation for platelet count above 50,000 and asymptomatic, or for PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 immune thrombocytopenia in remission. VA also proposes to add a note instructing raters to separately evaluate splenectomy under DC 7706 and combine with an evaluation under this DC. VA proposes to add a second note clarifying re-evaluation following chemotherapy as follows: ‘‘A 100percent evaluation shall continue beyond the cessation of chemotherapy. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of [38 CFR 3.105(e)].’’ DC 7706 (Splenectomy); DC 7707 (Spleen, Injury of, Healed) VA proposes no change to these DCs except to move the word ‘‘separately’’ in the note following DC 7706 to clarify the meaning. Current DC 7709 (Hodgkin’s Disease); Proposed DC 7709 (Hodgkin’s Lymphoma) VA proposes to change the title associated with current DC 7709 from ‘‘Hodgkin’s disease’’ to ‘‘Hodgkin’s lymphoma’’ to be consistent with current medical terminology and knowledge. VA proposes minor editorial changes to the existing note. The following sentence was modified to read as follows at the end of the existing note: ‘‘If there has been no local recurrence or metastasis, rate on residuals under the appropriate diagnostic code(s).’’ DC 7710 (Adenitis, Tuberculous, Active or Inactive) VA proposes no changes for this diagnostic code except for the deletion of a section symbol (§ ). Proposed DC 7712 (Multiple Myeloma) VA proposes to add a new DC 7712 for multiple myeloma (MM). MM is a type of systemic, incurable malignancy resulting from the proliferation of abnormal plasma cells in the bone marrow. The overgrowth of these plasma cells results in tumors that are deposited primarily in the bones, but also in the kidneys and other organs. The median age at diagnosis is 65 years, and the average 5-year survival rate is about 30 percent. Survival time depends on many factors, such as age, gender, race, stage of disease at time of diagnosis, and treatment. Recent therapeutic advances have improved the quality of life and length of survival time, but MM remains incurable. Some patients go into remission for various E:\FR\FM\06AUP1.SGM 06AUP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules periods but require maintenance therapy even while in remission. MM has a wide variety of clinical presentations that can vary between asymptomatic to severely symptomatic. Asymptomatic (smoldering or indolent) myeloma is a slow-growing, asymptomatic precursor or premalignant phase of MM. It is usually not treated until evidence of end organ damage develops. It has a high risk of developing into MM. However, since it is not malignant, is asymptomatic, and does not require treatment, it would not warrant a compensable evaluation under this diagnostic code, and VA proposes to rate it at 0 percent. Even if smoldering MM is currently regarded as a pre-malignant state, there are subsets of patients with different rates of progression towards MM. No single pathological or molecular feature can be used to distinguish between smoldering and pre-malignant MM with clonal plasma cells from those with clonal malignant plasma cells. A biomarker-based definition that can predict this transformation is needed but is not yet currently available. Symptomatic multiple myeloma, as further defined in the below proposed notes to new DC 7712, would therefore be rated at 100 percent. VA proposes the following notes to new DC 7712 based on the most recently updated diagnostic criteria staging system of the International Diagnostic Working Group of 2014. See S. Rajkumar, M.D., ‘‘International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma,’’ 15(12) Lancet Oncol. e538 (2014). The first note would state the following: ‘‘Symptomatic myeloma requires an elevated serum or urine M (monoclonal) protein value (however no specific concentration is required for diagnosis) or presence of increased bone marrow clonal plasma cells ≥10%. There must be also evidence of related organ tissue impairment (ROTI) due to the plasma cell proliferation. This process is manifested by elevated serum calcium, renal failure, anemia, and bone lesions (CRAB). The corresponding laboratory values are: Serum calcium ≥11.5 mg/100 mL, renal insufficiency with creatinine clearance <40 cc/min or serum creatinine >1.73 mmol/L, normochromic, normocytic anemia with a hemoglobin value >2 g/100 mL below the lower limit of normal, or a hemoglobin value <10 g/100 mL, lytic lesions (one or more osteolytic lesions by radiographic or other imaging system), severe osteopenia, or pathologic bone fractures. A small percentage of patients with symptomatic myeloma have no detectable M-protein VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 in serum or urine but do have myelomarelated organ impairment ROTI and increased bone marrow plasma cells. Any of the following validated biomarkers of malignancy are acceptable for the diagnosis of MM, including clonal bone marrow plasma cells ≥60%, serum free light chain ratio ≥100, or free light chain ≥100 mg/L, or more than one focal bone or bone marrow lesion on MRI >5 mm in size.’’ The second note would state the following: ‘‘A nonsecretory myeloma (a variant form of symptomatic myeloma) shows absent M-protein in the serum and urine, bone marrow plasmacytosis, and ROTI. While this group of patients represents a minority of cases (1–2%), this uncommon presentation may lead to delay in diagnosis because of the scarcity of laboratory findings commonly in the face of an isolated bone process such as low back pain.’’ The third note would state the following: ‘‘The diagnostic criteria for asymptomatic (smoldering or indolent) myeloma requires the following two criteria: (1) An elevated serum monoclonal protein (IgG or IgA) >30 g/L, urine monoclonal protein >500 mg/ 24 hrs. or clonal bone marrow plasmal cells 10%–60%, and (2) absence of myeloma defining events or amyloidosis without any related organ or tissue impairment (ROTI) or end-organ damage. There is usually normal serum calcium, hemoglobin, and serum creatinine, and no bone lesions on full skeletal survey and no evidence of amyloidosis or light chain deposition disease.’’ Multiple myeloma is incurable, and carries a poor prognosis. Therefore, VA proposes Note (4), which would state that the 100-percent evaluation shall continue for five years after the diagnosis of symptomatic multiple myeloma, at which time the appropriate disability evaluation shall be determined by mandatory VA examination. It would also state that any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of 38 CFR 3.105(e) and 3.344 (a) and (b). DC 7714 (Sickle Cell Anemia) Sickle cell anemia is currently evaluated at levels of 100, 60, 30, and 10 percent. The current 100-percent evaluation criteria are: ‘‘With repeated painful crises, occurring in skin, joints, bones or any major organs caused by hemolysis and sickling of red blood cells, with anemia, thrombosis and infarction, with symptoms precluding even light manual labor.’’ VA proposes at the 100-percent level to change the term ‘‘painful crises’’ to ‘‘painful PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 46893 episodes’’ in keeping with current medical terminology, to insert the word ‘‘residual’’ before the word ‘‘symptoms,’’ and to change punctuation to clarify meaning. The 100 percent category would also require at least 4 or more painful episodes in the past 12 months for clarification purposes. The current 60-percent evaluation criteria are: ‘‘With painful crises several times a year or with symptoms precluding other than light manual labor.’’ As in the 100-percent evaluation criteria, VA proposes to change the term ‘‘painful crises’’ to ‘‘painful episodes.’’ To remove ambiguity, we also propose replacement of the phrase ‘‘With painful crises several times a year’’ with ‘‘Averaging 3 or more painful episodes per 12-month period.’’ The current 30-percent evaluation criterion is: ‘‘Following repeated hemolytic sickling crises with continuing impairment of health.’’ VA proposes to replace ‘‘Following repeated hemolytic sickling crises with continuing impairment of health’’ with ‘‘Averaging 1 or 2 painful episodes per 12-month period’’ in order to make the criterion less ambiguous and promote consistent evaluations. VA proposes no change in the current 10-percent evaluation criteria of ‘‘Asymptomatic, established case in remission, but with identifiable organ impairment,’’ and only an editorial change in the note under this DC to reflect the fact that the former Compensation and Pension Service has been reorganized as the Compensation Service and the Pension and Fiduciary Service. DC 7715 (Non-Hodgkin’s Lymphoma) Currently, non-Hodgkin’s lymphoma (NHL), DC 7715, is evaluated at 100 percent for active disease or during a treatment phase. VA proposes to modify the current note under DC 7715 with some non-substantive changes and by extending the allowable time required for mandatory examination from six months to 2 years, as provided in the proposed note to DC 7715. This is based upon current medical information suggesting that recurrences in nonHodgkin’s lymphoma are very high, with common tumor recurrences within or after the period that mandates lowering of disability rating for treatment completion or apparent remission of 6 months. Data on relapsed aggressive NHL: https:// www.texasoncology.com/types-ofcancer/non-hodgkins-lymphoma/ intermediate-grade-aggressive-gradenhl/relapsed-aggressive-nhl/). VA also proposes to modify the criteria as, ‘‘When there is active disease, during treatment phase or with indolent and E:\FR\FM\06AUP1.SGM 06AUP1 46894 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules Proposed DC 7724 (Solitary Plasmacytoma) non-contiguous phase of low grade NHL.’’ See National Cancer Institute Adult NHL PDQ treatment Update (https://www.cancer.gov/cancertopics/ pdq/treatment/adult-non-hodgkins/ HealthProfessional/page9#_195_toc (Dec. 2014). mstockstill on DSK4VPTVN1PROD with PROPOSALS DC 7716 (Aplastic Anemia) Aplastic anemia, DC 7716, is currently evaluated at levels of 100, 60, 30, and 10 percent. The current 100percent evaluation criteria are: ‘‘Requiring bone marrow transplant, or; requiring transfusion of platelets or red cells at least once every six weeks, or; infections recurring at least once every six weeks.’’ VA proposes to expand ‘‘bone marrow transplant’’ to ‘‘peripheral blood or bone marrow stem cell transplant,’’ as either may be used for treatment. In addition, VA proposes to add the phrase ‘‘on average’’ to the specific numbers of platelet or red cell transfusions required and to the frequency of recurring infections, and to add ‘‘per 12-month period’’ to promote consistent evaluations at the 100-, 60-, and 30-percent levels. The current 60-percent criteria are: ‘‘Requiring transfusion of platelets or red cells at least once every three months, or; infections recurring at least once every three months.’’ Continuous immunosuppressive therapy is currently a standard treatment option for aplastic anemia. A. Bacigalupo, ‘‘Diagnosis and treatment of acquired aplastic anemia,’’ 23(2) Hematol Oncol. Clinical N. Am. 159 (2009). We therefore propose to add, ‘‘using continuous immunosuppressive therapy’’ as an alternative criterion for the 60-percent level. VA also proposes the changes described above for the 100percent criteria concerning adding ‘‘on average’’ and ‘‘per 12-month period.’’ The current 30-percent evaluation criteria are: ‘‘Requiring transfusion of platelets or red cells at least once per year but less than once every three months, or; infections recurring at least once per year but less than once every three months.’’ VA proposes only the changes described above for the 100percent criteria concerning adding ‘‘on average’’ and ‘‘per 12-month period.’’ The current 10-percent criterion is ‘‘Requiring continuous medication for control.’’ VA proposes to delete this evaluation level as the medications used to treat aplastic anemia warrant higher levels of evaluation. VA proposes a change in the note following this DC stating that a 100percent evaluation will be provided for either peripheral blood or bone marrow stem cell transplant. The reminder of the note is otherwise unchanged. VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 Solitary bone or extramedullary (occurring in soft tissue outside of the bone marrow) plasmacytomas are malignant plasma cell neoplasms that are closely related to multiple myeloma. A solitary bone plasmacytoma develops into multiple myeloma in 50 to 60 percent of cases, and into an extramedullary plasmacytoma in 10 to 30 percent of cases. A solitary plasmacytoma that remains solitary has a better prognosis than multiple myeloma and may be curable. VA proposes to rate solitary plasmacytomas similarly to other malignant neoplasms that are potentially curable. VA proposes to rate solitary plasmacytoma at 100 percent when there is active disease or during a treatment phase and to add Note (1) to state that a 100percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures (including autologous stem cell transplantation), and that six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. The note would also state that any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of 38 CFR 3.105(e) and that, if there has been no recurrence, to rate residuals under the appropriate diagnostic codes. VA proposes to add Note (2) to remind rating specialists of the potential for the transformation of solitary plasmacytomas into multiple myeloma. VA also proposes to add Note (3) to remind rating specialists of the residual effects of a solitary plasmacytoma and the adverse effects of medical treatment. Proposed DC 7725 (Myelodysplastic Syndromes) VA proposes to add a new DC 7725 for myelodysplastic syndromes because these conditions are relatively common in veterans and do not have a diagnostic code under which they can be appropriately evaluated. These syndromes, sometimes called ‘‘preleukemia’’ in the past, are a group of disorders associated with bone marrow dysfunction, in which healthy and mature red blood cells, white blood cells, and platelets are not produced. Therefore, there may be a deficiency of any type of blood cell. About one-third of those with myelodysplastic syndromes progress to acute myelogenous leukemia in months or PO 00000 Frm 00042 Fmt 4702 Sfmt 4702 years. Some types of myelodysplastic syndromes are primary, in which there is no known cause for the syndromes, and others are secondary types, which develop after treatment with chemotherapy or radiation therapy for other diseases. The classification of these disorders is complex and differs among different medical organizations. Treatment depends in part on the specific disorder but also on many other factors. The mean overall survival time for these conditions is 6 months to 6 years. VA proposes to evaluate myelodysplastic syndromes based on type and frequency of treatment and number of infections per 12-month period. VA also proposes to include in the evaluation criteria treatment with biologic therapy, either interferon alpha on an ongoing basis or erythropoiesisstimulating agent (ESA) to boost red blood cell production. These treatments are used in some types of myelodysplastic disorders. VA proposes to provide evaluation levels of 100, 60, and 30 percent. VA proposes to assign 100 percent for either of the following: Requiring peripheral blood or bone marrow stem cell transplant, or requiring chemotherapy (including hypomethylating agents and immunmodulators, e.g., lenalidomide). VA proposes to assign 60 percent for either of the following: Requiring, on average, 4 or more blood or platelet transfusions per 12-month period, or infections requiring hospitalization, on average, 3 or more times per 12-month period. VA proposes to assign 30 percent for any of the following: Requiring, on average, 1 to 3 blood or platelet transfusions per 12-month period, infections requiring hospitalization, on average, 1 to 2 times per 12-month period; or requiring biologic therapy, either interferon alpha on an ongoing basis or erythropoiesis stimulating agent (ESA) for up to 12 weeks per 12-month period. VA also proposes to add Note (1) stating that if this condition progresses to leukemia, to evaluate it as leukemia under DC 7703 and Note (2) stating that a 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant, or during the period of treatment with chemotherapy and shall continue with a mandatory VA examination six months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment. Note (2) would also state that any reduction in evaluation based upon that or any subsequent examination shall be subject E:\FR\FM\06AUP1.SGM 06AUP1 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules to the provisions of 38 CFR 3.105(e) and that, if there has been no recurrence, residuals will be rated under the appropriate diagnostic codes. Proposed Changes to Appendices A, B, and C to Part 4 VA proposes to amend appendices A, B, and C to reflect the above-noted proposed changes. In appendix A to part 4, § 4.117, remove diagnostic code 7700, revise diagnostic codes 7702–7705, 7709, and 7714–7716, and add diagnostic codes 7718–7725. In appendix B to part 4, revise the title from ‘‘The Hemic and Lymphatic Systems’’ to ‘‘The Hematologic and Lymphatic Systems’’, remove diagnostic code 7700 and its disability entry, revise the section heading and the disability entry for diagnostic codes 7702, 7705 and 7709, and add disability codes and disability entries for 7712 and 7718– 7725. In appendix C to part 4, convert the existing entry for ‘‘Anemia’’ into a new section titled ‘‘Anemia’’, remove diagnostic code 7700 and its disability entry and insert diagnostic codes 7720– 7723 and their disability entries in that section; revise the disability entry for diagnostic codes 7702, 7705 and 7709; create a new section titled ‘‘Hematologic’’ and insert diagnostic codes 7705, 7712, 7718, 7724 and 7725 and their disability entries in that section; and convert the existing entry for leukemia into a new section titled ‘‘Leukemia’’ and insert diagnostic codes 7703 and 7719 into that section. Paperwork Reduction Act This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501–3521). mstockstill on DSK4VPTVN1PROD with PROPOSALS Regulatory Flexibility Act The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601–612. This proposed rule would not affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Executive Orders 12866 and 13563 Executive Orders 12866 and 13563 direct agencies to assess the costs and VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a ‘‘significant regulatory action,’’ which requires review by the Office of Management and Budget, as ‘‘any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive Order.’’ The economic, interagency, budgetary, legal, and policy implications of this regulatory action has been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA’s impact analysis can be found as a supporting document at https://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of this rulemaking and its impact analysis are available on VA’s Web site at https://www1.va.gov/orpm/, by following the link for ‘‘VA Regulations Published.’’ Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 46895 private sector, of $100 million or more (adjusted annually for inflation) in any year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance Numbers and Titles The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.104, Pension for Non-Service-Connected Disability for Veterans, and 64.109, Veterans Compensation for Service-Connected Disability. Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on July 30, 2015, for publication. List of Subjects in 38 CFR Part 4 Disability benefits, Pensions, Veterans. Dated: July 31, 2015. Jeffrey M. Martin, Office Program Manager, Office of Regulation Policy & Management, Office of the General Counsel, Department of Veterans Affairs. For the reasons set out in the preamble, VA proposes to amend 38 CFR part 4, subpart B, to read as follows: PART 4—SCHEDULE FOR RATING DISABILITIES Subpart B—Disability Ratings 1. The authority citation for part 4 continues to read as follows: ■ Authority: 38 U.S.C. 1155, unless otherwise noted. 2. Revise the undesignated center heading preceding § 4.117 to read as follows: ■ The Hematologic and Lymphatic Systems ■ 3. Revise § 4.117 to read as follows: § 4.117 Schedule of ratings—hematologic and lymphatic systems. E:\FR\FM\06AUP1.SGM 06AUP1 46896 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS Rating 7702 Agranulocytosis, acquired: Requiring bone marrow transplant or infections recurring, on average, at least once every six weeks per 12-month period ............ Requiring intermittent myeloid growth factors (granulocyte colony-stimulating factor (G–CSF) or granulocyte-macrophage colonystimulating factor (GM–CSF)) or continuous immunosuppressive therapy such as cyclosporine to maintain absolute neutrophil count (ANC) greater than 500/μl but less than 1,000/μl; or infections recurring, on average, at least once every three months per 12-month period ........................................................................................................................................................................... Requiring intermittent myeloid growth factors to maintain ANC greater than 1,000/μl; or infections recurring, on average, at least once per 12-month period but less than once every three months per 12-month period ................................................................. Requiring continuous medication (e.g., antibiotics) for control; or requiring intermittent use of a myeloid growth factor to maintain ANC greater than or equal to 1,500/μl ............................................................................................................................................... Note: A 100-percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue with a mandatory VA examination six months following hospital discharge. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7703 Leukemia (except for chronic myelogenous leukemia): When there is active disease or during a treatment phase ................................................................................................................... Otherwise rate residuals under the appropriate diagnostic code(s). Chronic lymphocytic leukemia or monoclonal B-cell lymphocytosis (MBL), asymptomatic, Rai Stage 0 ............................................. Note (1): A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals. Note (2): Evaluate symptomatic chronic lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as any other leukemia evaluated under this diagnostic code. Note (3): Evaluate residuals of leukemia or leukemia therapy under the appropriate diagnostic code(s). Myeloproliferative Disorders: (Diagnostic Codes 7704, 7718, 7719). 7704 Polycythemia vera: Requiring peripheral blood or bone marrow stem-cell transplant or treatment with radioactive phosphorus or chemotherapy (including myelosuppressants) ............................................................................................................................................................... Requiring phlebotomy 6 or more times per 12-month period to control RBC count or if requiring radioactive phosphorous treatment, chemotherapy, or targeted agents such as imatinib or ruxolitinib ........................................................................................... Requiring phlebotomy 4–5 times per 12-month period or if requiring continuous biologic therapy or myelosuppresive agents to maintain platelets <200,000 or white blood cells (WBC) <12,000 ..................................................................................................... Requiring phlebotomy, biologic therapy, or interferon on an intermittent basis, as needed, 3 or fewer times per 12-month period ... Note (1): Rate complications such as hypertension, gout, stroke, or thrombotic disease separately. Note (2): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703. Note (3): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant; or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). Six months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7705 Immune thrombocytopenia: Requiring chemotherapy for chronic refractory thrombocytopenia or a platelet count from 20,000 to 30,000 despite treatment ....... Requiring immunosuppressive therapy or for a platelet count higher than 30,000 but not higher than 50,000, with history of hospitalization because of severe bleeding requiring intravenous immune globulin, high-dose parenteral corticosteroids, and platelet transfusions .................................................................................................................................................................................... Platelet count higher than 30,000 but not higher than 50,000, with either immune thrombocytopenia or mild mucous membrane bleeding which requires oral corticosteroid therapy or intravenous immune globulin ....................................................................... Platelet count higher than 30,000 but not higher than 50,000, not requiring treatment ....................................................................... Platelet count above 50,000 and asymptomatic, or for immune thrombocytopenia in remission. ........................................................ Note (1): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under this diagnostic code. Note (2): A 100-percent evaluation shall continue beyond the cessation of chemotherapy. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7706 Splenectomy ....................................................................................................................................................................................... Note: Separately rate complications such as systemic infections with encapsulated bacteria. 7707 Spleen, injury of, healed. Rate for any residuals. 7709 Hodgkin’s lymphoma: With active disease or during a treatment phase .................................................................................................................................. Note: A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no local recurrence or metastasis, rate on residuals under the appropriate diagnostic code(s). 7710 Adenitis, tuberculous, active or inactive. Rate under § 4.88c or 4.89 of this part, whichever is appropriate. 7712 Multiple myeloma: Symptomatic multiple myeloma .............................................................................................................................................................. Asymptomatic (smoldering or indolent) .................................................................................................................................................. VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 E:\FR\FM\06AUP1.SGM 06AUP1 100 60 30 10 100 0 100 60 30 10 100 70 30 10 0 20 20 100 100 0 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules 46897 mstockstill on DSK4VPTVN1PROD with PROPOSALS Rating Note (1): Symptomatic myeloma requires, (i) an elevated serum or urine M (monoclonal) protein value (however no specific concentration is required for diagnosis), or (ii) presence of increased bone marrow clonal plasma cells ≥10%. There must be also evidence of related organ tissue impairment (ROTI) due to the plasma cell proliferation. This process is manifested by elevated serum calcium, renal failure, anemia, and bone lesions (CRAB). The corresponding laboratory values are: Serum calcium ≥11.5 mg/100 mL, renal insufficiency with creatinine clearance <40 cc/min or serum creatinine >1.73 mmol/L, normochromic, normocytic anemia with a hemoglobin value >2 g/100 mL below the lower limit of normal, or a hemoglobin value <10 g/100 mL, lytic lesions (one or more osteolytic lesions by radiographic or other imaging system) severe osteopenia, or pathologic bone fractures. A small percentage of patients with symptomatic myeloma have no detectable M-protein in serum or urine but do have myeloma-related organ impairment ROTI and increased bone marrow plasma cells. Any of the following validated biomarkers of malignancy are acceptable for the diagnosis of MM, including clonal bone marrow plasma cells ≥60%, serum free light chain ratio of ≥100, or free light chain of ≥100 mg/L, or more than one focal bone or bone marrow lesion on MRI >5 mm in size. Note (2): A nonsecretory myeloma (a variant form of symptomatic myeloma) shows absent M-protein in the serum and urine, bone marrow plasmacytosis, and ROTI. While this group of patients represents a minority of cases (1–2%), this uncommon presentation may lead to delay in diagnosis because of the scarcity of laboratory findings commonly in the face of an isolated bone process such as low back pain. Note (3): The diagnostic criteria for asymptomatic (smoldering or indolent) myeloma requires the following two criteria: (1) An elevated serum monoclonal protein (IgG or IgA) >30 g/L, urine monoclonal protein >500 mg/24 hrs., or clonal bone marrow plasma cells 10%–60%, and (2) absence of myeloma defining events of amyloidosis without any related organ or tissue impairment (ROTI) or end-organ damage. There is usually normal serum calcium, hemoglobin, and serum creatinine, and no bone lesions on full skeletal survey and no evidence of amyloidosis or light chain deposition disease. Note (4): The 100-percent evaluation shall continue for five years after the diagnosis of symptomatic multiple myeloma, at which time the appropriate disability evaluation shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) and § 3.344 (a) and (b) of this chapter. 7714 Sickle cell anemia: With at least 4 or more painful episodes per 12-month period, occurring in skin, joints, bones, or any major organs, caused by hemolysis and sickling of red blood cells, with anemia, thrombosis, and infarction, with residual symptoms precluding even light manual labor ....................................................................................................................................................................................... Averaging 3 or more painful episodes per 12-month period or with symptoms precluding other than light manual labor .................. Averaging 1 or 2 painful episodes per 12-month period ....................................................................................................................... Asymptomatic, established case in remission, but with identifiable organ impairment ......................................................................... Note: Sickle cell trait alone, without a history of directly attributable pathological findings, is not a ratable disability. Cases of symptomatic sickle cell trait will be forwarded to the Director, Compensation Service, for consideration under § 3.321(b)(1) of this chapter. 7715 Non-Hodgkin’s lymphoma: When there is active disease, during treatment phase or with indolent and non-contiguous phase of low grade NHL ...................... Note: A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures. Two years after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate on residuals under the appropriate diagnostic code(s). 7716 Aplastic anemia: Requiring peripheral blood or bone marrow stem cell transplant; or requiring transfusion of platelets or red cells, on average, at least once every six weeks per 12-month period; or infections recurring, on average, at least once every six weeks per 12month period ....................................................................................................................................................................................... Requiring transfusion of platelets or red cells, on average, at least once every three months per 12-month period; or infections recurring, on average, at least once every three months per 12-month period; or using continuous immunosuppressive therapy ... Requiring transfusion of platelets or red cells, on average, at least once per 12-month period, but less than once every three months per 12-month period; or infections recurring, on average, at least once per 12-month period, but less than once every three months per 12-month period ..................................................................................................................................................... Note: A 100-percent evaluation for peripheral blood or bone marrow stem cell transplant shall be assigned as of the date of hospital admission and shall continue with a mandatory VA examination six months following hospital discharge. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7718 Essential thrombocythemia and primary myelofibrosis Requiring either continuous myelosuppressive therapy or, for six months following hospital admission, peripheral blood or bone marrow stem cell transplant, or treatment with radioactive phosphorus or chemotherapy (including myelosuppressants) ............. Requiring continuous or intermittent myelosuppressive therapy to maintain platelet count <500 × 109/L ........................................... Requiring continuous or intermittent myelosuppressive therapy to maintain platelet count of 200,000–400,000, or white blood cell (WBC) count of 4,000–10,000 ............................................................................................................................................................ Asymptomatic ......................................................................................................................................................................................... Note (1): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703. Note (2): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant; or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). Six months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 7719 Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia): Requiring peripheral blood or bone marrow stem cell transplant, or continuous myelosuppressive or immunosuppressive therapy treatment ............................................................................................................................................................................................. Requiring intermittent myelosuppressive therapy, or targeted therapy with tyrosine kinase inhibitors, or interferon treatment .......... In apparent remission on continuous targeted therapy with tyrosine kinase inhibitors ......................................................................... Note (1): If the condition undergoes leukemic transformation, evaluate as leukemia under diagnostic code 7703. VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 E:\FR\FM\06AUP1.SGM 06AUP1 100 60 30 10 100 100 60 30 100 70 30 0 100 60 30 46898 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules Rating Note (2): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant; or during the period of treatment with radioactive phosphorus or chemotherapy (including myelosuppressants). Six months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105 of this chapter. 7720 Iron deficiency anemia: Requiring intravenous iron infusions on average 4 or more times per 12-month period ...................................................................... Requiring continuous treatment with high-dose oral supplementation .................................................................................................. Asymptomatic or requiring treatment only by dietary modification ........................................................................................................ Note: Do not evaluate iron deficiency anemia due to blood loss under this diagnostic code. Evaluate iron deficiency anemia due to blood loss under the criteria for the condition causing the blood loss. 7721 Folic acid deficiency: Requiring continuous treatment with high-dose oral supplementation .................................................................................................. Asymptomatic or requiring treatment only by dietary modification ........................................................................................................ 7722 Pernicious anemia and Vitamin B12 deficiency anemia: For initial diagnosis requiring transfusion due to severe anemia, or if there are signs or symptoms related to central nervous system impairment, such as encephalopathy, myelopathy, or severe peripheral neuropathy, requiring parenteral B12 therapy .......... Requiring continuous treatment with Vitamin B12 injections, Vitamin B12 sublingual or high-dose oral tablets, or Vitamin B12 nasal spray or gel ......................................................................................................................................................................................... Note: A 100-percent evaluation for pernicious anemia and Vitamin B12 deficiency shall be assigned as of the date of the initial diagnosis requiring transfusion due to severe anemia or parenteral B12 therapy and shall continue with a mandatory VA examination six months following hospital discharge or cessation of parenteral B12 therapy. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Thereafter, evaluate at 10-percent and separately evaluate any residual effects of pernicious anemia, such as neurologic involvement causing peripheral neuropathy, myelopathy, dementia, or related gastrointestinal residuals, under the most appropriate diagnostic code. 7723 Acquired hemolytic anemia: Requiring a bone marrow transplant or continuous intravenous or immunosuppressive therapy (e.g., prednisone, Cytoxan, azathioprine, or rituximab) .................................................................................................................................................................. Requiring immunosuppressive medication an average of 4 or more times per 12-month period ........................................................ Requiring an average of 2–3 courses of immunosuppressive therapy per 12-month period ............................................................... Requiring an average of one course of immunosuppressive therapy per 12-month period ................................................................. Asymptomatic ......................................................................................................................................................................................... Note (1): A 100-percent evaluation for bone marrow transplant shall be assigned as of the date of hospital admission and shall continue for six months after hospital discharge with a mandatory VA examination six months following hospital discharge. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Note (2): Separately evaluate splenectomy under diagnostic code 7706 and combine with an evaluation under diagnostic code 7723. 7724 Solitary plasmacytoma: Solitary plasmacytoma, when there is active disease or during a treatment phase ............................................................................. Note (1): A 100-percent evaluation shall continue beyond the cessation of any surgical therapy, radiation therapy, antineoplastic chemotherapy, or other therapeutic procedures (including autologous stem cell transplantation). Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, rate residuals under the appropriate diagnostic codes. Note (2): Rate a solitary plasmacytoma that has developed into multiple myeloma as symptomatic multiple myeloma. Note (3): Rate residuals of plasma cell dysplasia (e.g., thrombosis) and adverse effects of medical treatment (e.g., neuropathy) under the appropriate diagnostic codes. 7725 Myelodysplastic syndromes: Requiring peripheral blood or bone marrow stem cell transplant; or requiring chemotherapy ............................................................. Requiring, on average, 4 or more blood or platelet transfusions per 12-month period; or infections requiring hospitalization, on average, 3 or more times per 12-month period ..................................................................................................................................... Requiring, on average, 1 to 3 blood or platelet transfusions per 12-month period; infections requiring hospitalization, on average, 1 to 2 times per 12-month period; or requiring biologic therapy, either interferon alpha on an ongoing basis or erythropoiesis stimulating agent (ESA) for 12 weeks or less per 12-month period .................................................................................................. Note (1): If the condition progresses to leukemia, evaluate as leukemia under diagnostic code 7703. Note (2): A 100-percent evaluation shall be assigned as of the date of hospital admission for peripheral blood or bone marrow stem cell transplant, or during the period of treatment with chemotherapy and shall continue with a mandatory VA examination six months following hospital discharge or, in the case of radioactive phosphorus or chemotherapy treatment, six months after completion of treatment. Any reduction in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. If there has been no recurrence, residuals will be rated under the appropriate diagnostic codes. mstockstill on DSK4VPTVN1PROD with PROPOSALS (Authority: 38 U.S.C. 1155.) VerDate Sep<11>2014 16:37 Aug 05, 2015 ■ Jkt 235001 3. Amend appendix A to part 4 by: PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 30 10 0 0 10 0 100 10 100 60 30 10 0 100 100 60 30 a. Revising the entries for diagnostic codes 7700, 7702 through 7705, 7709, 7712, and 7714 through 7716; and ■ b. Adding entries for diagnostic codes 7718 through 7725. ■ E:\FR\FM\06AUP1.SGM 06AUP1 46899 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules The revisions and additions read as follows: APPENDIX A TO PART 4—TABLE OF AMENDMENTS AND EFFECTIVE DATES SINCE 1946 Diagnostic Code No. Sec. * 4.117 ... 7700 * 7702 7703 7704 7705 * * * Removed [effective date of final rule]. * * * * * * * * * * Evaluation October 23, 1995; title [effective date of final rule]; evaluation [effective date of final rule]. Evaluation August 23, 1948; criterion October 23, 1995; evaluation [effective date of final rule]; criterion [effective date of final rule]. Evaluation October 23, 1995; evaluation [effective date of final rule]. Evaluation October 23, 1995; title [insert effective date of final rule]; evaluation [effective date of final rule]; criterion [effective date of final rule]. 7709 * * * * * * Evaluation March 10, 1976; criterion October 23, 1995; title [effective date of final rule]; criterion [effective date of final rule]. 7712 * * Added [effective date of final rule]. * * * * * Added September 9, 1975; criterion October 23, 1995; criterion [effective date of final rule] Added October 26, 1990; criterion [effective date of final rule]. Added October 23, 1995; evaluation [effective date of final rule]; criterion [effective date of final rule]. * 7714 7715 7716 7718 7719 7720 7721 7722 7723 7724 7725 * Added Added Added Added Added Added Added Added * * * * [effective [effective [effective [effective [effective [effective [effective [effective date date date date date date date date * of final of final of final of final of final of final of final of final * * 4. Amend appendix B to part 4 by: a. Revising the undesignated center heading immediately preceding diagnostic code 7700; * * * * * * * * * * rule]. rule]. rule]. rule]. rule]. rule]. rule]. rule]. * ■ ■ * b. Removing the entry for diagnostic code 7700; ■ c. Revising the entries for diagnostic codes 7702, 7705 and 7709; and d. Adding entries for diagnostic codes 7712 and 7718 through 7725. The revisions and additions read as follows: ■ ■ APPENDIX B TO PART 4—NUMERICAL INDEX OF DISABILITIES Diagnostic Code No. * * * * * * * THE HEMATOLOGIC AND LYMPHATIC SYSTEMS Agranulocytosis, acquired. * * 7705 ......................................................... mstockstill on DSK4VPTVN1PROD with PROPOSALS 7702 ......................................................... * * Immune thrombocytopenia. * * * * * 7709 ......................................................... * Hodgkin’s lymphoma. * * * * * * 7712 ......................................................... * Multiple myeloma. * * * * * * 7718 ......................................................... * * * Essential thrombocythemia and primary myelofibrosis. * * * * 7719 ......................................................... * * * * * Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia). VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4702 Sfmt 4702 E:\FR\FM\06AUP1.SGM 06AUP1 46900 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Proposed Rules APPENDIX B TO PART 4—NUMERICAL INDEX OF DISABILITIES—Continued Diagnostic Code No. 7720 7721 7722 7723 7724 7725 ......................................................... ......................................................... ......................................................... ......................................................... ......................................................... ......................................................... * Iron deficiency anemia. Folic acid deficiency. Pernicious anemia and Vitamin B12 deficiency anemia. Acquired hemolytic anemia. Solitary plasmacytoma. Myelodysplastic syndromes. * * 5. Amend appendix C to part 4 by: a. Revising the entries for Agranulocytosis and Anemia; ■ c. Adding an entry for Hematologic in alphabetical order; ■ ■ * * d. Removing the entry for Hodgkin’s disease and adding in its place an entry for Hodgkin’s lymphoma; ■ e. Revising the entry for Leukemia; ■ * * The revisions and additions read as follows: APPENDIX C TO PART 4—ALPHABETICAL INDEX OF DISABILITIES Diagnostic Code No. * * * * * * Agranulocytosis, acquired .............................................................................................................................................................. * * * * * * * Anemia: Acquired hemolytic anemia .................................................................................................................................................... Folic acid deficiency ............................................................................................................................................................... Iron deficiency anemia ........................................................................................................................................................... Pernicious anemia and Vitamin B12 deficiency anemia ......................................................................................................... * * * * * * * Hematologic: Essential thrombocythemia and primary myelofibrosis .......................................................................................................... Immune thrombocytopenia ..................................................................................................................................................... Multiple myeloma .................................................................................................................................................................... Myelodysplastic syndromes .................................................................................................................................................... Solitary plasmacytoma ........................................................................................................................................................... * * * * * * * Hodgkin’s lymphoma ..................................................................................................................................................................... * * * * * * * Leukemia: Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or chronic granulocytic leukemia) ................................. Leukemia ................................................................................................................................................................................ * * * * * ACTION: [FR Doc. 2015–19197 Filed 8–5–15; 8:45 am] * Proposed rule. This document proposes updates to the rules that govern the evaluation and approval of RF devices. The Commission last comprehensively reviewed its equipment authorization procedures more than fifteen years ago. The RF equipment ecosystem has significantly expanded in that time, and the manner in which today’s RF equipment is now designed, manufactured, and marketed—as well as the sheer number of devices subject to authorization—warrant the proposed rule modifications. FEDERAL COMMUNICATIONS COMMISSION mstockstill on DSK4VPTVN1PROD with PROPOSALS 47 CFR Parts 0, 2, 15, and 18 [ET Docket No. 15–170; RM–11673; FCC 15– 92] Equipment Authorization and Electronic Labeling for Wireless Devices Federal Communications Commission. AGENCY: VerDate Sep<11>2014 16:37 Aug 05, 2015 Jkt 235001 PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 7723 7721 7720 7722 7718 7705 7712 7725 7724 7709 7719 7703 * Comments must be filed on or before September 8, 2015, and reply comments must be filed on or before September 21, 2015. FOR FURTHER INFORMATION CONTACT: Brian Butler, Office of Engineering and Technology, (202) 418–2702, email: Brian.Butler@fcc.gov., TTY (202) 418– 2989. ADDRESSES: You may submit comments, identified by ET Docket No. 15–170; RM–11673, by any of the following methods: • Federal Communications Commission’s Web site: https:// apps.fcc.gov/ecfs//. Follow the instructions for submitting comments. DATES: BILLING CODE 8320–01–P SUMMARY: * 7702 E:\FR\FM\06AUP1.SGM 06AUP1

Agencies

[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Proposed Rules]
[Pages 46888-46900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19197]


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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: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend the 
portion of the VA Schedule for Rating Disabilities (Rating Schedule) 
that addresses the hematologic and lymphatic systems. The intended 
effect of this change is to incorporate medical advances that have 
occurred since the last review, update medical terminology, add medical 
conditions not currently in the Rating Schedule, and refine criteria 
for further clarity and ease of rater application.

DATES: Comments must be received by VA on or before October 5, 2015.

ADDRESSES: Written comments may be submitted through 
www.Regulations.gov; by mail or hand-delivery to the Director, 
Regulation Policy and Management (02REG), Department of Veterans 
Affairs, 810 Vermont Ave. NW., Room 1068, Washington, DC 20420; or by 
fax to (202) 273-9026. Comments should indicate that they are submitted 
in response to RIN 2900-AO19--Schedule for Rating Disabilities: The 
Hematologic and Lymphatic Systems. Copies of comments received will be 
available for public inspection in the Office of Regulation Policy and 
Management, Room 1068, between the hours of 8:00 a.m. and 4:30 p.m., 
Monday through Friday (except holidays). Please call (202) 461-4902 for 
an appointment. (This is not a toll-free number.) In addition, during 
the comment period, comments may be viewed online through the Federal 
Docket Management System (FDMS) at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Nick Olmos-Lau, M.D., Medical Officer 
(211C), Compensation Service, Veterans Benefits Administration, 
Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 
20420, (202) 461-9695. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: As part of our ongoing revision of the VA 
Schedule for Rating Disabilities (Rating Schedule), we are proposing 
changes to 38 CFR 4.117, Schedule of ratings--hemic and lymphatic 
systems, and appendices A, B, and C of part 4 pertaining to this 
section. This section was last updated in 1995. By these revisions, we 
aim to update medical terminology; add medical conditions not currently 
in the Rating Schedule; and revise the rating criteria to reflect 
medical advances and to clarify them for ease of application.

Proposed Title Change: The Hematologic and Lymphatic Systems

    ``Hemic'' is an adjective previously used to describe diseases of 
or related to the blood. The current medical term for diseases of the 
blood or blood-forming organs is ``hematologic.'' In addition, the 2013 
National Library of Medicine-Medical Subject Headings (MESH) descriptor 
advisory discourages the use of the term ``hemic'' as too general, and 
recommends instead the use of the term ``hematologic'' as more specific 
(https://www.nlm.nih.gov/cgi/mesh/2013/MB_cgi?mode=&index=6154&field=all&HM=&II=&PA=&form=&input=).
    VA therefore proposes to edit the header of Sec.  4.117 to ``The 
Hematologic and Lymphatic Systems'' and the title of Sec.  4.117 to 
``Schedule of ratings--hematologic and lymphatic systems.''

Modification and Reorganization of Current Diagnostic Code (DC) 7700 
(Anemia, Hypochromic-Microcytic and Megaloblastic, Such as Iron-
Deficiency and Pernicious Anemia)

    Anemia is predominantly hereditary or secondary, a symptom of 
another condition. Secondary anemia is corrected by treatment of the 
underlying condition. Examples of conditions that cause secondary 
anemia include osteomyelitis (DC 5000) and hypothyroidism (DC 7903). 
Anemia is most appropriately evaluated as part of the underlying 
service-connected disability causing the anemia. VA proposes to address 
in proposed DCs 7720, 7721, 7722, and 7723 anemias that are neither 
hereditary nor addressed under DCs for the causative conditions.
    The title of current DC 7700 is ``Anemia, hypochromic-microcytic 
and megaloblastic, such as iron-deficiency and pernicious anemia.'' 
This title groups anemias based on red blood cell (RBC) morphology. VA 
proposes separate DCs and criteria for the major types of anemia. 
Separation would assist raters in distinguishing amongst and clarifying 
severity of anemias. Accordingly, VA proposes the removal of DC 7700 
from the Rating Schedule, and adding DC 7720 Iron deficiency anemia, 
7721 Folic acid deficiency, 7722 Pernicious anemia and Vitamin 
B12 deficiency anemia, and 7723 Acquired hemolytic anemia.
    Anemia is currently rated at levels of 100, 70, 30, 10, and 0-
percent, depending on the hemoglobin level and the associated signs and 
symptoms. It is evaluated at 100-percent for hemoglobin of 5gm/100ml or 
less, with findings such as high-output congestive heart failure or 
dyspnea at rest. It is evaluated at 70-percent for hemoglobin of 7gm/
100ml or less, with findings such as dyspnea on mild exertion, 
cardiomegaly, tachycardia (100 to 120 beats per minute) or syncope 
(three episodes in the last six months). It is evaluated at 30-percent 
for hemoglobin of 8gm/100ml or less, with findings such as weakness, 
easy fatigability, headaches, lightheadedness, or shortness of breath. 
It is evaluated at 10-percent for hemoglobin of 10gm/100ml or less, 
with findings such as weakness, easy fatigability, or headaches. It is 
evaluated at 0-percent for hemoglobin of 10gm/100ml or less and 
asymptomatic.
    While there is a high correlation between hemoglobin levels and 
signs or symptoms of anemia in acute anemia, the correlation is less 
accurate in chronic anemia. As the duration of the anemia lengthens, 
the individual becomes more tolerant of lower hemoglobin levels and 
symptom manifestation decreases. The functional impact of chronic 
anemia is more accurately measured by mode and frequency of treatment. 
VA proposes rating criteria based on the specific mode(s) and frequency 
of treatment.
    VA notes that the existing 100 and 70 percent categories for rating 
anemia are more descriptive of acute rather than

[[Page 46889]]

chronic anemia. Acute anemia is usually related to gastrointestinal or 
uterine bleeding or traumatic injuries with acute hemorrhage. The 
descriptors in the 100 and 70 percent categories reflect a clinical 
picture of rapid and extensive blood loss, and their symptoms include 
high output cardiac failure with hypoxemia due to inability to sustain 
proper tissue oxygenation, caused by low hemoglobin levels which can 
lead to shock or collapse. The laboratory values and symptoms described 
in the 100 and 70 percent categories of the current anemia DC reflect 
intolerable and life threatening symptoms that require emergency 
hospitalization and transfusion. See G. Limbruno, ``Recommendations for 
transfusion of red blood cells,'' 7 Blood Transfusion 49 (2009).
    Chronic anemia on the other hand, develops at a more gradual pace, 
and is usually related to serious medical conditions such as 
malignancies (cancer) on chemotherapy, infection (osteomyelitis), 
thyroid disease, hemoglobin disorders (such as sickle-cell disease or 
thalassemia), renal failure or chronic lower gastrointestinal bleeding. 
In such cases a slower decline in hemoglobin values allows gradual 
adjustment. However, even when an individual reaches such low levels as 
contemplated in the 100 and 70 percent evaluation, such a case reflects 
acute critical health emergencies that are unsustainable rather than 
having an ongoing chronic long term disability impairment as with 
chronic anemia. In those cases where chronic anemia results in urgent 
hospitalization, VA finds that compensation is more appropriately 
determined by evaluating the underlying primary medical problem that 
gave rise to the service-connected chronic anemia. As these more severe 
cases represent less than 2 percent of the total number of disability 
awards for anemia in the past years, VA does not anticipate a 
significant impact on future evaluations based on anemia.

Proposed DC 7720 (Iron Deficiency Anemia)

    Iron deficiency anemia is defined as a decrease in total body iron 
content. Total body iron content is regulated through the balance of 
iron absorption and loss. Iron deficiency anemia is most commonly due 
to blood loss, post- hemorrhagic anemia. Iron deficiency anemia due to 
blood loss would be evaluated under criteria for the causative 
condition, e.g., duodenal ulcer (DC 7305) or hemorrhoids (DC 7336), 
rather than under DC 7720. VA proposes to clarify the rating of anemia 
due to blood loss by adding the following note: ``Do not evaluate iron 
deficiency anemia due to blood loss under this diagnostic code. 
Evaluate iron deficiency anemia due to blood loss under the criteria 
for the condition causing the blood loss.''
    Iron deficiency anemia can be readily treated by diet or dietary 
supplements. It is ordinarily short term with mild symptoms and 
responds to treatment. However, fatigue due to chronic, severe iron 
deficiency anemia can decrease the ability to perform physical labor. 
VA proposes rating levels of 30, 10, and 0-percent for iron deficiency 
anemia not due to blood loss. VA proposes a 30-percent evaluation for 
iron deficiency anemia requiring intravenous (IV) iron infusions on 
average 4 or more times per 12-month period; a 10-percent evaluation if 
requiring continuous treatment with high-dose oral supplementation; and 
a 0-percent evaluation if asymptomatic or requiring treatment only by 
dietary modification.

Proposed DC 7721 (Folic Acid Deficiency)

    The prevalence of folic acid deficiency has decreased in the United 
States due to dietary fortification. This form of anemia is amenable to 
dietary modification and oral supplementation. VA proposes a 10-percent 
evaluation for folic acid deficiency requiring continuous treatment 
with high-dose oral supplementation. VA proposes a 0-percent evaluation 
when asymptomatic or requiring treatment only by dietary modification.

Proposed DC 7722 (Pernicious Anemia and Vitamin B12 Deficiency Anemia)

    Pernicious anemia is the most common form of severe Vitamin 
B12 deficiency. S. Stabler, ``Vitamin B12 deficiency,'' 
368(2) New Eng. J. Med. 149 (2013). Other causes of Vitamin 
B12 deficiency that could lead to anemia include: Dietary 
avoidance (vegetarianism), malabsorption, gastrectomy or gastric 
bypass, inflammatory bowel disease (IBD), pancreatic insufficiency, use 
of histamine 2-blockers and proton pump inhibitors. Pernicious anemia 
is associated with gastric atrophy, due to autoimmune destruction, and 
a lack of intrinsic factor, a glycoprotein necessary for the absorption 
of Vitamin B12, in the gastric mucosa. Pernicious anemia 
requires lifelong treatment with Vitamin B12 injections, 
sublingual or high-dose oral Vitamin B12 tablets, or Vitamin 
B12 nasal spray or gel. Since disabilities from nutritional 
B12 deficiency are consistent with pernicious anemia, 
nutritional B12 deficiency would be rated under the same 
diagnostic code as pernicious anemia.
    In accordance with the above discussion, VA proposes to evaluate 
pernicious anemia and other forms of severe B12 deficiency 
at 100 percent for initial diagnosis requiring transfusion due to 
severe anemia, or if there are signs or symptoms related to central 
nervous system impairment, such as encephalopathy, myelopathy, or 
severe peripheral neuropathy, requiring parenteral B12 
therapy. Since certitude of neurologic reversibility cannot be 
initially determined, and B12 absorption issues may require 
lifelong supplementation with B12 injections every 1-3 
months, VA proposes to re-evaluate at 6 months and rate according to 
presence of neurologic or gastrointestinal residuals.
    If absorption is adequate, lifelong oral or intranasal 
B12 treatment may be used. VA proposes to evaluate 
pernicious anemia and other forms of severe Vitamin B12 
deficiency at 10 percent if it requires continuous treatment with 
Vitamin B12 injections, Vitamin B12 sublingual or 
high-dose oral tablets, or Vitamin B12 nasal spray or gel.
    VA proposes to add a note regarding evaluation which states that 
the 100-percent evaluation for pernicious anemia and Vitamin 
B12 deficiency shall be assigned as of the date of initial 
diagnosis requiring transfusion due to severe anemia or parenteral 
B12 therapy and shall continue with a mandatory VA 
examination six months following hospital discharge or cessation of 
continuous parenteral B12 therapy. The note would also state 
that any reduction in evaluation based upon that or any subsequent 
examination shall be subject to the provisions of 38 CFR 3.105(e) and 
that, thereafter, evaluation would be at 10-percent and any residual 
effects of pernicious anemia, such as neurologic involvement causing 
peripheral neuropathy, myelopathy, dementia, or related 
gastrointestinal residuals, would be separately evaluated under the 
most appropriate diagnostic code.

Proposed 7723 (Acquired Hemolytic Anemia)

    There are over 200 causes of hemolytic anemia, including both 
acquired and hereditary types. The causes of acquired hemolytic anemia 
include immune disorders, toxic chemicals, medications, physical damage 
(such as may occur with prosthetic heart valves), and infections. 
Treatment may include intermittent corticosteroids; other 
immunosuppressive drugs; immune globulin; monoclonal antibody therapy, 
such as rituximab; splenectomy; erythropoiesis stimulating agent (ESA) 
to boost production of RBC;

[[Page 46890]]

plasmapheresis (a process similar to dialysis that can remove certain 
components, such as harmful antibodies, from the blood); blood 
transfusions; and peripheral blood or bone marrow stem cell 
transplantation (www.nhlbi.nih.gov/health).
    VA proposes to list the evaluation criteria for acquired hemolytic 
anemia under DC 7723.
    VA proposes to rate acquired hemolytic anemia at 100 percent, if 
requiring a bone marrow transplant or continuous intravenous or 
immunosuppressive therapy (e.g., prednisone, Cytoxan 
(cyclophosphamide), azathioprine, or rituximab). VA proposes to rate 
acquired hemolytic anemia at 60 percent, if requiring immunosuppressive 
medication an average of 4 or more times per 12-month period. VA 
proposes to rate acquired hemolytic anemia at 30 percent, if requiring 
an average of 2-3 courses of immunosuppressive therapy per 12-month 
period. VA proposes to rate acquired hemolytic anemia at 10 percent, if 
requiring an average of 1 course of immunosuppressive therapy per 12-
month period. VA proposes to evaluate acquired hemolytic anemia at 0 
percent if asymptomatic.
    VA also proposes to add a Note (1) in relation to this DC, stating 
that a 100-percent evaluation for bone marrow transplant shall be 
assigned as of the date of hospital admission and shall continue for 
six months after hospital discharge with a mandatory VA examination six 
months following hospital discharge. The note would also state that any 
reduction in evaluation based upon that or any subsequent examination 
shall be subject to the provisions of 38 CFR 3.105(e).
    To remind rating specialists that there is a separate DC for 
splenectomy, VA proposes to add a Note (2), which would state that VA 
will separately evaluate splenectomy under DC 7706 and combine with an 
evaluation under DC 7723.

DC 7702 (Agranulocytosis, Acute); Proposed DC 7702 (Agranulocytosis, 
Acquired)

    Agranulocytosis, by definition, is an acute condition. Therefore, 
this disease is better categorized as agranulocytosis, acquired, than 
as agranulocytosis, acute. VA proposes to list updated evaluation 
criteria for this condition under DC 7702 with the title 
``Agranulocytosis, acquired'' to reflect current medical terminology.
    Acute agranulocytosis is currently evaluated at levels of 100, 60, 
30, and 10 percent based on type of treatment or frequency of episodes 
of recurring infections. A 100-percent evaluation is currently assigned 
if requiring bone marrow transplant or transfusion of platelets or red 
cells at least once every six weeks or if infections recur at least 
once every six weeks. A 60-percent evaluation is assigned if requiring 
transfusion of platelets or red cells at least once every three months 
or if infections recur at least once every three months. A 30-percent 
evaluation is assigned if requiring transfusion of platelets or red 
cells at least once per year but less than once every three months or 
if infections recur at least once per year but less than once every 
three months. A 10-percent evaluation is assigned if requiring 
continuous medication for control.
    Due to advances in the pharmacological treatment of agranulocytosis 
and a shift in standard of care, VA proposes the deletion of the number 
of transfusions as a criterion for rating agranulocytosis. 
``Granulocyte transfusions have undergone a cycle of popularity 
followed by disfavor,'' although they may be useful in patients with 
life-threatening infections whose conditions are not responding to 
antibiotics. A. Distenfeld, M.D., N.Y. Univ. Sch. of Med., 
``Agranulocytosis,'' eMedicine (Updated Jan 9, 2015, by C. Braden). 
These transfusions are accompanied by many complications, including 
severe febrile reactions. The use of granulocyte transfusions remains 
controversial. VA proposes to evaluate agranulocytosis based on type 
and frequency of treatment or the average number of infections per 12-
month period. VA proposes to evaluate agranulocytosis at 100 percent if 
requiring bone marrow transplant or if infections recur, on average, at 
least once every six weeks per 12-month period. VA proposes to evaluate 
agranulocytosis at 60 percent if requiring intermittent myeloid growth 
factors (granulocyte colony-stimulating factor (G-CSF) or granulocyte-
macrophage colony-stimulating factor (GM-CSF)) or continuous 
immunosuppressive therapy such as cyclosporine to maintain absolute 
neutrophil count (ANC) greater than 500/[mu]l but less than 1000/[mu]l, 
or if infections recur, on average, at least once every three months 
per 12-month period. VA proposes to evaluate agranulocytosis at 30 
percent if requiring intermittent myeloid growth factors to maintain 
ANC greater than 1000/[mu]l or if infections recur, on average, at 
least once per 12-month period but less than once every three months 
per 12-month period. VA proposes to evaluate agranulocytosis at 10 
percent if requiring continuous medication (e.g., antibiotics) for 
control or if requiring intermittent use of a myeloid growth factor to 
maintain ANC greater than or equal to 1500/[mu]l.
    VA proposes to preserve the existing note under current DC 7702.

DC 7703 (Leukemia)

    One type of leukemia, chronic myelogenous leukemia (CML), is 
evaluated as a myeloproliferative disorder. CML is a heterogeneous 
disease with three clinical phases: Chronic, transitional 
(accelerated), and acute (blast). Most individuals with CML are 
diagnosed in the chronic phase and with adequate treatment can remain 
in this phase for several years. However, patients with CML are never 
``cured'' with current therapy, but often have no evidence of the 
disease at a molecular level. The term used for this state is 
``complete molecular remission'' (CMR). These patients require 
continuous treatment because otherwise they would relapse. Patients 
with CML need to be considered as having active disease even when they 
would otherwise appear to be in remission. Therefore, VA proposes to 
evaluate CML under separate DC 7719.
    Leukemia is currently evaluated at 100 percent for active disease 
or during a treatment phase. There is also a directive to otherwise 
rate as anemia (current DC 7700) or aplastic anemia (DC 7716), 
whichever would result in the greater benefit.
    VA proposes to evaluate all forms of active leukemia other than 
chronic myelogenous leukemia under DC 7703.
    VA proposes to retain the 100-percent evaluation ``[w]hen there is 
active disease or during a treatment phase.'' For rating purposes, VA 
considers any diagnosed cancer as ``active disease'' if medical 
evidence does not demonstrate the eradication of cancerous cells, if 
the cancer is not in remission, or when the condition requires 
continuous treatment since otherwise there would invariably be a 
relapse.
    Since there are numerous residual effects of leukemia and its 
treatment, which may involve any body system, VA proposes to remove the 
current directive, which addresses only certain hematologic residuals: 
``Otherwise rate as anemia (code 7700) or aplastic anemia (code 7716), 
whichever would result in the greater benefit.'' VA proposes another 
directive, which would read: ``Otherwise rate residuals under the 
appropriate diagnostic code(s).''
    One of the four main types of leukemia, chronic lymphocytic

[[Page 46891]]

leukemia (CLL), is now often diagnosed at a very early stage when the 
blood lymphocyte count is high, but the patient does not have 
enlargement of the lymph nodes, spleen, or liver, and the red blood 
cells and platelets are normal or nearly so. The average age of 
patients with this type of leukemia is 70. In the staging system 
commonly used to assess the severity of CLL, this early stage is known 
as Rai Stage 0. Occasionally patients are diagnosed instead as having 
monoclonal B-cell lymphocytosis (MBL). The diagnosis is in a similar 
category as Rai Stage 0 CLL. Unlike the course of the other major types 
of leukemia, this early stage of CLL may not progress for many years. 
The median survival time for this stage of disease is over 12 years. No 
treatment is required, and it is considered a low risk stage. For 
individuals with CLL at Rai Stage 0, assigning a 100-percent evaluation 
would be inappropriate, since antineoplastic treatment is not 
warranted, and at this early stage, there is little or no effect on a 
patient's well-being, according to the Leukemia and Lymphoma Society 
(www.leukemia-lymphoma.org/). Therefore, VA proposes to add a 0-percent 
evaluation level for asymptomatic low risk level patients with CLL at 
Rai Stage 0.
    Patients with lymphocytosis, enlarged lymph nodes and splenomegaly 
or hepatomegaly are defined as having an intermediate risk for disease 
progression (Rai Stages I or II). Patients with hepatomegaly (enlarged 
liver), anemia (Hemoglobin <11 g/dL), or thrombocytopenia (platelet 
counts lower than 100,000) are considered to be in the higher risk 
categories for disease progression (Rai Stages III and IV). Oncologists 
have developed criteria to determine when to initiate treatment based 
on the presence of genetic mutation, micro-globulins, lymphocyte 
doubling times and other markers to help boost the accuracy criteria of 
the CLL tumor burden along with staging provided by the Rai scale. 
Patients with newly diagnosed asymptomatic early-stage disease are 
generally monitored without therapy unless they show signs of disease 
progression or symptoms. Patients with intermediate risk (Rai Stages I 
and II) and those with high risk (Rai Stages III or IV) are usually 
started on treatment.
    VA proposes editorial changes to the currently existing note, which 
would be numbered as Note (1).
    Rai Stages I-IV (intermediate and high risk) usually require 
progressively aggressive therapy, consistent with leukemias and other 
malignancies. VA proposes addition of notes to clarify evaluation of 
CLL that progresses beyond Rai Stage 0.
    The proposed Note (2) would read: ``Evaluate symptomatic chronic 
lymphocytic leukemia that is at Rai Stage I, II, III, or IV the same as 
any other leukemia evaluated under this diagnostic code.''
    The proposed Note (3) would read: ``Evaluate residuals of leukemia 
or leukemia therapy under the appropriate diagnostic code(s). 
Myeloproliferative Disorders: (Diagnostic Codes 7704, 7718, 7719).''

Myeloproliferative Disorders

    This section includes: DC 7704 (Polycythemia vera); Proposed DC 
7718 (Essential thrombocythemia and primary myelofibrosis); Proposed DC 
7719 (Chronic myelogenous leukemia (CML) (chronic myeloid leukemia or 
chronic granulocytic leukemia)).
    Myeloproliferative disorders are a group of slow-growing blood 
neoplasms in which the bone marrow produces excess numbers of red blood 
cells, white blood cells, or platelets. Polycythemia vera is one type 
of myeloproliferative disorder. Other conditions included in this 
category are essential thrombocythemia, primary idiopathic 
myelofibrosis, and chronic myelogenous leukemia (CML) (also called 
chronic myeloid leukemia or chronic granulocytic leukemia) 
(www.cancer.gov/cancertopics/types/myeloproliferative and www.leukemia-lymphoma.org). These conditions may evolve into acute leukemia.
    According to the National Cancer Institute of the U.S. National 
Institutes of Health, a variety of treatments are used for 
myeloproliferative disorders. For example, polycythemia vera is 
commonly treated by phlebotomy (removal of blood, as needed, to 
decrease the number of red blood cells and platelets). However, other 
treatments used to achieve appropriate levels of cells and to reduce 
complications, such as thrombosis, include radioactive phosphorous 
(which suppresses the overproduction of blood cells), interferon alpha 
(which boosts the immune system), chemotherapeutic agents (including 
myelosuppressants, which decrease bone marrow production), and low dose 
aspirin. Some of these treatments are also used for other 
myeloproliferative disorders.
    Other treatments used for myeloproliferative disorders include: 
stem cell transplant; platelet apheresis (removal of platelets from the 
blood in a process similar to dialysis); blood or platelet transfusions 
(when the bone marrow production is insufficient); periods of 
hospitalizations to treat infections (since patients with these 
conditions are at high risk for serious infections); erythropoiesis-
stimulating agents (ESA) to boost production of red blood cells; 
tyrosine kinase inhibitors such as imatinib (Gleevec) (commonly used to 
treat chronic myelogenous leukemia) or ruxolitinib (new kinase 
inhibitor); and androgen-like drugs (which also may stimulate the bone 
marrow).
    Polycythemia vera is the only myeloproliferative disorder, of the 
above-mentioned disorders, currently evaluated in the Rating Schedule. 
Therefore, VA proposes the addition of DCs to provide rating criteria 
for other diseases under the category of myeloproliferative disorders: 
7718 Essential thrombocythemia/primary myelofibrosis, and 7719 Chronic 
myelogenous leukemia (CML) (chronic myeloid leukemia or chronic 
granulocytic leukemia).
    VA proposes to add a note applicable to all myeloproliferative 
disorders, which would state that if the condition undergoes leukemic 
transformation, it should be evaluated as leukemia under DC 7703. This 
note is intended to remind rating specialists that a myeloproliferative 
disorder may undergo leukemic transformation and warrant evaluation 
under DC 7703.
    VA also proposes to add another note applicable to all 
myeloproliferative disorders, which would state that a 100-percent 
evaluation shall be assigned as of the date of hospital admission for 
peripheral blood or bone marrow stem cell transplant, or during the 
period of treatment with radioactive phosphorus or chemotherapy 
(including myelosuppressants), and that six months following hospital 
discharge or, in the case of radioactive phosphorus or chemotherapy 
treatment, six months after completion of treatment, the appropriate 
disability rating shall be determined by mandatory VA examination. The 
note would also state that any reduction in evaluation based upon that 
or any subsequent examination shall be subject to the provisions of 38 
CFR 3.105(e).

DC 7704 (Polycythemia Vera)

    VA proposes a 100-percent evaluation if requiring peripheral blood 
or bone marrow stem-cell transplant or treatment with radioactive 
phosphorus or chemotherapy (including myelosuppressants).
    VA proposes a 60-percent evaluation if requiring phlebotomy 6 or 
more times per 12-month period to control RBC count or if requiring 
radioactive phosphorous treatment, chemotherapy, or targeted agents 
like ruxolitinib or

[[Page 46892]]

imatinib. VA proposes a 30-percent evaluation if requiring phlebotomy 
4-5 times per 12-month period or if requiring continuous biologic 
therapy or myelosuppressive agents to maintain platelet count in the 
less than 200,000 range or white blood cells (WBC) in the less than 
12,000 range. VA proposes a 10-percent evaluation if requiring, on an 
intermittent basis, phlebotomy, biologic therapy, or interferon, as 
needed, but less than 4 times per 12-month period.
    VA proposes to number the current note for DC 7704 as Note (1). VA 
proposes the addition of the two notes described above for all 
myeloproliferative disorders to be added as Notes (2) and (3) after the 
current note for DC 7704.

Proposed DC 7718 (Essential Thrombocythemia and Primary Myelofibrosis)

    VA proposes a 100-percent evaluation if requiring either continuous 
myelosuppressive therapy or, for six months following hospital 
admission, any of the following treatments: Peripheral blood or bone 
marrow stem cell transplant, or treatment with radioactive phosphorus 
or chemotherapy (including myelosuppressants); a 70 percent evaluation 
if requiring either continuous or intermittent myelosuppressive therapy 
to maintain platelet count less than 500 x 10 \9\/L; a 30-percent 
evaluation if requiring continuous or intermittent myelosuppressive 
therapy to maintain platelet count of 200,000-400,000 or white blood 
cell (WBC) count of 4,000-10,000; and a 0-percent evaluation if 
asymptomatic.
    VA proposes the addition of the two notes described above for all 
myeloproliferative disorders.

Proposed DC 7719 (Chronic Myelogenous Leukemia (CML) (Chronic Myeloid 
Leukemia or Chronic Granulocytic Leukemia))

    VA proposes a 100-percent evaluation if requiring peripheral blood 
or bone marrow stem cell transplant or requiring continuous 
myelosuppressive or immunosuppressive therapy. VA proposes a 60-percent 
evaluation if requiring intermittent myelosuppressive therapy, or 
targeted therapy with tyrosine kinase inhibitors, or interferon 
treatment. VA proposes a 30-percent evaluation if in apparent remission 
on continuous targeted therapy with tyrosine kinase inhibitors.
    VA proposes the addition of the two notes described above for all 
myeloproliferative disorders.

Current DC 7705 (Thrombocytopenia, Primary, Idiopathic or Immune); 
Proposed DC 7705 (Immune Thrombocytopenia)

    Thrombocytopenia is currently evaluated at levels of 100, 70, 30, 
and 0 percent based on the platelet count, the presence or absence of 
bleeding episodes, and whether treatment is required. VA proposes to 
change the title from ``Thrombocytopenia, primary, idiopathic or 
immune'' to ``Immune thrombocytopenia.''
    VA proposes to use the same bases for evaluation of disability, 
while updating criteria to reflect advances in medical knowledge. A 
100-percent evaluation is currently assigned if the platelet count is 
less than 20,000, with active bleeding, requiring treatment with 
medication and transfusions. A 70-percent evaluation is currently 
assigned for a platelet count between 20,000 and 70,000, not requiring 
treatment, without bleeding. A 30-percent evaluation is currently 
assigned for a stable platelet count between 70,000 and 100,000, 
without bleeding. A 0-percent evaluation is currently assigned for a 
stable platelet count of 100,000 or more, without bleeding. VA proposes 
to provide evaluation levels of 100, 70, 30, 10 and 0 percent, with 
criteria based in part on the recommendations of the American Society 
of Hematology for diagnosis and treatment of idiopathic 
thrombocytopenic purpura, updated in 2010.
    VA proposes to assign a 100-percent evaluation for immune 
thrombocytopenia requiring chemotherapy for chronic refractory 
thrombocytopenia or a platelet count from 20,000 to 30,000 despite 
treatment. VA proposes to assign a 70-percent evaluation if requiring 
immunosuppressive therapy or for a platelet count higher than 30,000 
but not higher than 50,000, with history of hospitalization because of 
severe bleeding requiring intravenous immune globulin, high-dose 
parenteral corticosteroids, and platelet transfusions. VA proposes to 
assign a 30-percent evaluation for a platelet count higher than 30,000 
but not higher than 50,000, with either immune thrombocytopenia or mild 
mucous membrane bleeding which requires oral corticosteroid therapy or 
intravenous immune globulin. VA proposes to assign a 10-percent 
evaluation for a platelet count higher than 30,000 but not higher than 
50,000, not requiring treatment. VA proposes to assign a 0-percent 
evaluation for platelet count above 50,000 and asymptomatic, or for 
immune thrombocytopenia in remission.
    VA also proposes to add a note instructing raters to separately 
evaluate splenectomy under DC 7706 and combine with an evaluation under 
this DC. VA proposes to add a second note clarifying re-evaluation 
following chemotherapy as follows: ``A 100-percent evaluation shall 
continue beyond the cessation of chemotherapy. Six months after 
discontinuance of such treatment, the appropriate disability rating 
shall be determined by mandatory VA examination. Any reduction in 
evaluation based upon that or any subsequent examination shall be 
subject to the provisions of [38 CFR 3.105(e)].''

DC 7706 (Splenectomy); DC 7707 (Spleen, Injury of, Healed)

    VA proposes no change to these DCs except to move the word 
``separately'' in the note following DC 7706 to clarify the meaning.

Current DC 7709 (Hodgkin's Disease); Proposed DC 7709 (Hodgkin's 
Lymphoma)

    VA proposes to change the title associated with current DC 7709 
from ``Hodgkin's disease'' to ``Hodgkin's lymphoma'' to be consistent 
with current medical terminology and knowledge. VA proposes minor 
editorial changes to the existing note. The following sentence was 
modified to read as follows at the end of the existing note: ``If there 
has been no local recurrence or metastasis, rate on residuals under the 
appropriate diagnostic code(s).''

DC 7710 (Adenitis, Tuberculous, Active or Inactive)

    VA proposes no changes for this diagnostic code except for the 
deletion of a section symbol (Sec.  ).

Proposed DC 7712 (Multiple Myeloma)

    VA proposes to add a new DC 7712 for multiple myeloma (MM). MM is a 
type of systemic, incurable malignancy resulting from the proliferation 
of abnormal plasma cells in the bone marrow. The overgrowth of these 
plasma cells results in tumors that are deposited primarily in the 
bones, but also in the kidneys and other organs. The median age at 
diagnosis is 65 years, and the average 5-year survival rate is about 30 
percent. Survival time depends on many factors, such as age, gender, 
race, stage of disease at time of diagnosis, and treatment. Recent 
therapeutic advances have improved the quality of life and length of 
survival time, but MM remains incurable. Some patients go into 
remission for various

[[Page 46893]]

periods but require maintenance therapy even while in remission.
    MM has a wide variety of clinical presentations that can vary 
between asymptomatic to severely symptomatic.
    Asymptomatic (smoldering or indolent) myeloma is a slow-growing, 
asymptomatic precursor or pre-malignant phase of MM. It is usually not 
treated until evidence of end organ damage develops. It has a high risk 
of developing into MM. However, since it is not malignant, is 
asymptomatic, and does not require treatment, it would not warrant a 
compensable evaluation under this diagnostic code, and VA proposes to 
rate it at 0 percent.
    Even if smoldering MM is currently regarded as a pre-malignant 
state, there are subsets of patients with different rates of 
progression towards MM. No single pathological or molecular feature can 
be used to distinguish between smoldering and pre-malignant MM with 
clonal plasma cells from those with clonal malignant plasma cells. A 
biomarker-based definition that can predict this transformation is 
needed but is not yet currently available.
    Symptomatic multiple myeloma, as further defined in the below 
proposed notes to new DC 7712, would therefore be rated at 100 percent. 
VA proposes the following notes to new DC 7712 based on the most 
recently updated diagnostic criteria staging system of the 
International Diagnostic Working Group of 2014. See S. Rajkumar, M.D., 
``International Myeloma Working Group updated criteria for the 
diagnosis of multiple myeloma,'' 15(12) Lancet Oncol. e538 (2014).
    The first note would state the following: ``Symptomatic myeloma 
requires an elevated serum or urine M (monoclonal) protein value 
(however no specific concentration is required for diagnosis) or 
presence of increased bone marrow clonal plasma cells >=10%. There must 
be also evidence of related organ tissue impairment (ROTI) due to the 
plasma cell proliferation. This process is manifested by elevated serum 
calcium, renal failure, anemia, and bone lesions (CRAB). The 
corresponding laboratory values are: Serum calcium >=11.5 mg/100 mL, 
renal insufficiency with creatinine clearance <40 cc/min or serum 
creatinine >1.73 mmol/L, normochromic, normocytic anemia with a 
hemoglobin value >2 g/100 mL below the lower limit of normal, or a 
hemoglobin value <10 g/100 mL, lytic lesions (one or more osteolytic 
lesions by radiographic or other imaging system), severe osteopenia, or 
pathologic bone fractures. A small percentage of patients with 
symptomatic myeloma have no detectable M-protein in serum or urine but 
do have myeloma-related organ impairment ROTI and increased bone marrow 
plasma cells. Any of the following validated biomarkers of malignancy 
are acceptable for the diagnosis of MM, including clonal bone marrow 
plasma cells >=60%, serum free light chain ratio >=100, or free light 
chain >=100 mg/L, or more than one focal bone or bone marrow lesion on 
MRI >5 mm in size.''
    The second note would state the following: ``A nonsecretory myeloma 
(a variant form of symptomatic myeloma) shows absent M-protein in the 
serum and urine, bone marrow plasmacytosis, and ROTI. While this group 
of patients represents a minority of cases (1-2%), this uncommon 
presentation may lead to delay in diagnosis because of the scarcity of 
laboratory findings commonly in the face of an isolated bone process 
such as low back pain.''
    The third note would state the following: ``The diagnostic criteria 
for asymptomatic (smoldering or indolent) myeloma requires the 
following two criteria: (1) An elevated serum monoclonal protein (IgG 
or IgA) >30 g/L, urine monoclonal protein >500 mg/24 hrs. or clonal 
bone marrow plasmal cells 10%-60%, and (2) absence of myeloma defining 
events or amyloidosis without any related organ or tissue impairment 
(ROTI) or end-organ damage. There is usually normal serum calcium, 
hemoglobin, and serum creatinine, and no bone lesions on full skeletal 
survey and no evidence of amyloidosis or light chain deposition 
disease.''
    Multiple myeloma is incurable, and carries a poor prognosis. 
Therefore, VA proposes Note (4), which would state that the 100-percent 
evaluation shall continue for five years after the diagnosis of 
symptomatic multiple myeloma, at which time the appropriate disability 
evaluation shall be determined by mandatory VA examination. It would 
also state that any reduction in evaluation based upon that or any 
subsequent examination shall be subject to the provisions of 38 CFR 
3.105(e) and 3.344 (a) and (b).

DC 7714 (Sickle Cell Anemia)

    Sickle cell anemia is currently evaluated at levels of 100, 60, 30, 
and 10 percent. The current 100-percent evaluation criteria are: ``With 
repeated painful crises, occurring in skin, joints, bones or any major 
organs caused by hemolysis and sickling of red blood cells, with 
anemia, thrombosis and infarction, with symptoms precluding even light 
manual labor.'' VA proposes at the 100-percent level to change the term 
``painful crises'' to ``painful episodes'' in keeping with current 
medical terminology, to insert the word ``residual'' before the word 
``symptoms,'' and to change punctuation to clarify meaning. The 100 
percent category would also require at least 4 or more painful episodes 
in the past 12 months for clarification purposes.
    The current 60-percent evaluation criteria are: ``With painful 
crises several times a year or with symptoms precluding other than 
light manual labor.'' As in the 100-percent evaluation criteria, VA 
proposes to change the term ``painful crises'' to ``painful episodes.'' 
To remove ambiguity, we also propose replacement of the phrase ``With 
painful crises several times a year'' with ``Averaging 3 or more 
painful episodes per 12-month period.''
    The current 30-percent evaluation criterion is: ``Following 
repeated hemolytic sickling crises with continuing impairment of 
health.'' VA proposes to replace ``Following repeated hemolytic 
sickling crises with continuing impairment of health'' with ``Averaging 
1 or 2 painful episodes per 12-month period'' in order to make the 
criterion less ambiguous and promote consistent evaluations. VA 
proposes no change in the current 10-percent evaluation criteria of 
``Asymptomatic, established case in remission, but with identifiable 
organ impairment,'' and only an editorial change in the note under this 
DC to reflect the fact that the former Compensation and Pension Service 
has been reorganized as the Compensation Service and the Pension and 
Fiduciary Service.

DC 7715 (Non-Hodgkin's Lymphoma)

    Currently, non-Hodgkin's lymphoma (NHL), DC 7715, is evaluated at 
100 percent for active disease or during a treatment phase. VA proposes 
to modify the current note under DC 7715 with some non-substantive 
changes and by extending the allowable time required for mandatory 
examination from six months to 2 years, as provided in the proposed 
note to DC 7715. This is based upon current medical information 
suggesting that recurrences in non-Hodgkin's lymphoma are very high, 
with common tumor recurrences within or after the period that mandates 
lowering of disability rating for treatment completion or apparent 
remission of 6 months. Data on relapsed aggressive NHL: https://www.texasoncology.com/types-of-cancer/non-hodgkins-lymphoma/intermediate-grade-aggressive-grade-nhl/relapsed-aggressive-nhl/). VA 
also proposes to modify the criteria as, ``When there is active 
disease, during treatment phase or with indolent and

[[Page 46894]]

non-contiguous phase of low grade NHL.'' See National Cancer Institute 
Adult NHL PDQ treatment Update (https://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins/HealthProfessional/page9#_195_toc (Dec. 
2014).

DC 7716 (Aplastic Anemia)

    Aplastic anemia, DC 7716, is currently evaluated at levels of 100, 
60, 30, and 10 percent. The current 100-percent evaluation criteria 
are: ``Requiring bone marrow transplant, or; requiring transfusion of 
platelets or red cells at least once every six weeks, or; infections 
recurring at least once every six weeks.'' VA proposes to expand ``bone 
marrow transplant'' to ``peripheral blood or bone marrow stem cell 
transplant,'' as either may be used for treatment. In addition, VA 
proposes to add the phrase ``on average'' to the specific numbers of 
platelet or red cell transfusions required and to the frequency of 
recurring infections, and to add ``per 12-month period'' to promote 
consistent evaluations at the 100-, 60-, and 30-percent levels.
    The current 60-percent criteria are: ``Requiring transfusion of 
platelets or red cells at least once every three months, or; infections 
recurring at least once every three months.'' Continuous 
immunosuppressive therapy is currently a standard treatment option for 
aplastic anemia. A. Bacigalupo, ``Diagnosis and treatment of acquired 
aplastic anemia,'' 23(2) Hematol Oncol. Clinical N. Am. 159 (2009). We 
therefore propose to add, ``using continuous immunosuppressive 
therapy'' as an alternative criterion for the 60-percent level. VA also 
proposes the changes described above for the 100-percent criteria 
concerning adding ``on average'' and ``per 12-month period.'' The 
current 30-percent evaluation criteria are: ``Requiring transfusion of 
platelets or red cells at least once per year but less than once every 
three months, or; infections recurring at least once per year but less 
than once every three months.'' VA proposes only the changes described 
above for the 100-percent criteria concerning adding ``on average'' and 
``per 12-month period.'' The current 10-percent criterion is 
``Requiring continuous medication for control.'' VA proposes to delete 
this evaluation level as the medications used to treat aplastic anemia 
warrant higher levels of evaluation.
    VA proposes a change in the note following this DC stating that a 
100-percent evaluation will be provided for either peripheral blood or 
bone marrow stem cell transplant. The reminder of the note is otherwise 
unchanged.

Proposed DC 7724 (Solitary Plasmacytoma)

    Solitary bone or extramedullary (occurring in soft tissue outside 
of the bone marrow) plasmacytomas are malignant plasma cell neoplasms 
that are closely related to multiple myeloma. A solitary bone 
plasmacytoma develops into multiple myeloma in 50 to 60 percent of 
cases, and into an extramedullary plasmacytoma in 10 to 30 percent of 
cases. A solitary plasmacytoma that remains solitary has a better 
prognosis than multiple myeloma and may be curable. VA proposes to rate 
solitary plasmacytomas similarly to other malignant neoplasms that are 
potentially curable. VA proposes to rate solitary plasmacytoma at 100 
percent when there is active disease or during a treatment phase and to 
add Note (1) to state that a 100-percent evaluation shall continue 
beyond the cessation of any surgical therapy, radiation therapy, 
antineoplastic chemotherapy, or other therapeutic procedures (including 
autologous stem cell transplantation), and that six months after 
discontinuance of such treatment, the appropriate disability rating 
shall be determined by mandatory VA examination. The note would also 
state that any change in evaluation based upon that or any subsequent 
examination shall be subject to the provisions of 38 CFR 3.105(e) and 
that, if there has been no recurrence, to rate residuals under the 
appropriate diagnostic codes.
    VA proposes to add Note (2) to remind rating specialists of the 
potential for the transformation of solitary plasmacytomas into 
multiple myeloma. VA also proposes to add Note (3) to remind rating 
specialists of the residual effects of a solitary plasmacytoma and the 
adverse effects of medical treatment.

Proposed DC 7725 (Myelodysplastic Syndromes)

    VA proposes to add a new DC 7725 for myelodysplastic syndromes 
because these conditions are relatively common in veterans and do not 
have a diagnostic code under which they can be appropriately evaluated. 
These syndromes, sometimes called ``pre-leukemia'' in the past, are a 
group of disorders associated with bone marrow dysfunction, in which 
healthy and mature red blood cells, white blood cells, and platelets 
are not produced. Therefore, there may be a deficiency of any type of 
blood cell. About one-third of those with myelodysplastic syndromes 
progress to acute myelogenous leukemia in months or years. Some types 
of myelodysplastic syndromes are primary, in which there is no known 
cause for the syndromes, and others are secondary types, which develop 
after treatment with chemotherapy or radiation therapy for other 
diseases. The classification of these disorders is complex and differs 
among different medical organizations. Treatment depends in part on the 
specific disorder but also on many other factors. The mean overall 
survival time for these conditions is 6 months to 6 years.
    VA proposes to evaluate myelodysplastic syndromes based on type and 
frequency of treatment and number of infections per 12-month period. VA 
also proposes to include in the evaluation criteria treatment with 
biologic therapy, either interferon alpha on an ongoing basis or 
erythropoiesis-stimulating agent (ESA) to boost red blood cell 
production. These treatments are used in some types of myelodysplastic 
disorders. VA proposes to provide evaluation levels of 100, 60, and 30 
percent. VA proposes to assign 100 percent for either of the following: 
Requiring peripheral blood or bone marrow stem cell transplant, or 
requiring chemotherapy (including hypomethylating agents and 
immunmodulators, e.g., lenalidomide). VA proposes to assign 60 percent 
for either of the following: Requiring, on average, 4 or more blood or 
platelet transfusions per 12-month period, or infections requiring 
hospitalization, on average, 3 or more times per 12-month period. VA 
proposes to assign 30 percent for any of the following: Requiring, on 
average, 1 to 3 blood or platelet transfusions per 12-month period, 
infections requiring hospitalization, on average, 1 to 2 times per 12-
month period; or requiring biologic therapy, either interferon alpha on 
an ongoing basis or erythropoiesis stimulating agent (ESA) for up to 12 
weeks per 12-month period.
    VA also proposes to add Note (1) stating that if this condition 
progresses to leukemia, to evaluate it as leukemia under DC 7703 and 
Note (2) stating that a 100-percent evaluation shall be assigned as of 
the date of hospital admission for peripheral blood or bone marrow stem 
cell transplant, or during the period of treatment with chemotherapy 
and shall continue with a mandatory VA examination six months following 
hospital discharge or, in the case of radioactive phosphorus or 
chemotherapy treatment, six months after completion of treatment. Note 
(2) would also state that any reduction in evaluation based upon that 
or any subsequent examination shall be subject

[[Page 46895]]

to the provisions of 38 CFR 3.105(e) and that, if there has been no 
recurrence, residuals will be rated under the appropriate diagnostic 
codes.

Proposed Changes to Appendices A, B, and C to Part 4

    VA proposes to amend appendices A, B, and C to reflect the above-
noted proposed changes. In appendix A to part 4, Sec.  4.117, remove 
diagnostic code 7700, revise diagnostic codes 7702-7705, 7709, and 
7714-7716, and add diagnostic codes 7718-7725.
    In appendix B to part 4, revise the title from ``The Hemic and 
Lymphatic Systems'' to ``The Hematologic and Lymphatic Systems'', 
remove diagnostic code 7700 and its disability entry, revise the 
section heading and the disability entry for diagnostic codes 7702, 
7705 and 7709, and add disability codes and disability entries for 7712 
and 7718-7725.
    In appendix C to part 4, convert the existing entry for ``Anemia'' 
into a new section titled ``Anemia'', remove diagnostic code 7700 and 
its disability entry and insert diagnostic codes 7720-7723 and their 
disability entries in that section; revise the disability entry for 
diagnostic codes 7702, 7705 and 7709; create a new section titled 
``Hematologic'' and insert diagnostic codes 7705, 7712, 7718, 7724 and 
7725 and their disability entries in that section; and convert the 
existing entry for leukemia into a new section titled ``Leukemia'' and 
insert diagnostic codes 7703 and 7719 into that section.

Paperwork Reduction Act

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

Regulatory Flexibility Act

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

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' which requires review by the Office 
of Management and Budget, as ``any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) Create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) Materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action has been examined, and it has 
been determined not to be a significant regulatory action under 
Executive Order 12866. VA's impact analysis can be found as a 
supporting document at https://www.regulations.gov, usually within 48 
hours after the rulemaking document is published. Additionally, a copy 
of this rulemaking and its impact analysis are available on VA's Web 
site at https://www1.va.gov/orpm/, by following the link for ``VA 
Regulations Published.''

Unfunded Mandates

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

Catalog of Federal Domestic Assistance Numbers and Titles

    The Catalog of Federal Domestic Assistance program numbers and 
titles for this proposal are 64.104, Pension for Non-Service-Connected 
Disability for Veterans, and 64.109, Veterans Compensation for Service-
Connected Disability.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Robert L. 
Nabors II, Chief of Staff, Department of Veterans Affairs, approved 
this document on July 30, 2015, for publication.

List of Subjects in 38 CFR Part 4

    Disability benefits, Pensions, Veterans.

    Dated: July 31, 2015.
Jeffrey M. Martin,
Office Program Manager, Office of Regulation Policy & Management, 
Office of the General Counsel, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA proposes to amend 38 
CFR part 4, subpart B, to read as follows:

PART 4--SCHEDULE FOR RATING DISABILITIES

Subpart B--Disability Ratings

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

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

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

The Hematologic and Lymphatic Systems

0
3. Revise Sec.  4.117 to read as follows:


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

[[Page 46896]]



------------------------------------------------------------------------
                                                                 Rating
------------------------------------------------------------------------
7702 Agranulocytosis, acquired:
    Requiring bone marrow transplant or infections recurring,        100
     on average, at least once every six weeks per 12-month
     period...................................................
    Requiring intermittent myeloid growth factors (granulocyte        60
     colony-stimulating factor (G-CSF) or granulocyte-
     macrophage colony-stimulating factor (GM-CSF)) or
     continuous immunosuppressive therapy such as cyclosporine
     to maintain absolute neutrophil count (ANC) greater than
     500/[mu]l but less than 1,000/[mu]l; or infections
     recurring, on average, at least once every three months
     per 12-month period......................................
    Requiring intermittent myeloid growth factors to maintain         30
     ANC greater than 1,000/[micro]l; or infections recurring,
     on average, at least once per 12-month period but less
     than once every three months per 12-month period.........
    Requiring continuous medication (e.g., antibiotics) for           10
     control; or requiring intermittent use of a myeloid
     growth factor to maintain ANC greater than or equal to
     1,500/[mu]l..............................................
Note: A 100-percent evaluation for bone marrow transplant
 shall be assigned as of the date of hospital admission and
 shall continue with a mandatory VA examination six months
 following hospital discharge. Any change in evaluation based
 upon that or any subsequent examination shall be subject to
 the provisions of Sec.   3.105(e) of this chapter.
7703 Leukemia (except for chronic myelogenous leukemia):
    When there is active disease or during a treatment phase..       100
    Otherwise rate residuals under the appropriate diagnostic
     code(s).
    Chronic lymphocytic leukemia or monoclonal B-cell                  0
     lymphocytosis (MBL), asymptomatic, Rai Stage 0...........
Note (1): A 100-percent evaluation shall continue beyond the
 cessation of any surgical therapy, radiation therapy,
 antineoplastic chemotherapy, or other therapeutic procedures.
 Six months after discontinuance of such treatment, the
 appropriate disability rating shall be determined by
 mandatory VA examination. Any change in evaluation based upon
 that or any subsequent examination shall be subject to the
 provisions of Sec.   3.105(e) of this chapter. If there has
 been no recurrence, rate on residuals.
Note (2): Evaluate symptomatic chronic lymphocytic leukemia
 that is at Rai Stage I, II, III, or IV the same as any other
 leukemia evaluated under this diagnostic code.
Note (3): Evaluate residuals of leukemia or leukemia therapy
 under the appropriate diagnostic code(s). Myeloproliferative
 Disorders: (Diagnostic Codes 7704, 7718, 7719).
7704 Polycythemia vera:
    Requiring peripheral blood or bone marrow stem-cell              100
     transplant or treatment with radioactive phosphorus or
     chemotherapy (including myelosuppressants)...............
    Requiring phlebotomy 6 or more times per 12-month period          60
     to control RBC count or if requiring radioactive
     phosphorous treatment, chemotherapy, or targeted agents
     such as imatinib or ruxolitinib..........................
    Requiring phlebotomy 4-5 times per 12-month period or if          30
     requiring continuous biologic therapy or myelosuppresive
     agents to maintain platelets <200,000 or white blood
     cells (WBC) <12,000......................................
    Requiring phlebotomy, biologic therapy, or interferon on          10
     an intermittent basis, as needed, 3 or fewer times per 12-
     month period.............................................
Note (1): Rate complications such as hypertension, gout,        ........
 stroke, or thrombotic disease separately.
Note (2): If the condition undergoes leukemic transformation,
 evaluate as leukemia under diagnostic code 7703.
Note (3): A 100-percent evaluation shall be assigned as of the
 date of hospital admission for peripheral blood or bone
 marrow stem cell transplant; or during the period of
 treatment with radioactive phosphorus or chemotherapy
 (including myelosuppressants). Six months following hospital
 discharge or, in the case of radioactive phosphorus or
 chemotherapy treatment, six months after completion of
 treatment, the appropriate disability rating shall be
 determined by mandatory VA examination. Any reduction in
 evaluation based upon that or any subsequent examination
 shall be subject to the provisions of Sec.   3.105(e) of this
 chapter.
7705 Immune thrombocytopenia:
    Requiring chemotherapy for chronic refractory                    100
     thrombocytopenia or a platelet count from 20,000 to
     30,000 despite treatment.................................
    Requiring immunosuppressive therapy or for a platelet             70
     count higher than 30,000 but not higher than 50,000, with
     history of hospitalization because of severe bleeding
     requiring intravenous immune globulin, high-dose
     parenteral corticosteroids, and platelet transfusions....
    Platelet count higher than 30,000 but not higher than             30
     50,000, with either immune thrombocytopenia or mild
     mucous membrane bleeding which requires oral
     corticosteroid therapy or intravenous immune globulin....
    Platelet count higher than 30,000 but not higher than             10
     50,000, not requiring treatment..........................
    Platelet count above 50,000 and asymptomatic, or for               0
     immune thrombocytopenia in remission.....................
Note (1): Separately evaluate splenectomy under diagnostic
 code 7706 and combine with an evaluation under this
 diagnostic code.
Note (2): A 100-percent evaluation shall continue beyond the
 cessation of chemotherapy. Six months after discontinuance of
 such treatment, the appropriate disability rating shall be
 determined by mandatory VA examination. Any reduction in
 evaluation based upon that or any subsequent examination
 shall be subject to the provisions of Sec.   3.105(e) of this
 chapter.
7706 Splenectomy..............................................        20
Note: Separately rate complications such as systemic                  20
 infections with encapsulated bacteria.
7707 Spleen, injury of, healed.
    Rate for any residuals.
7709 Hodgkin's lymphoma:
    With active disease or during a treatment phase...........       100
Note: A 100-percent evaluation shall continue beyond the
 cessation of any surgical therapy, radiation therapy,
 antineoplastic chemotherapy, or other therapeutic procedures.
 Six months after discontinuance of such treatment, the
 appropriate disability rating shall be determined by
 mandatory VA examination. Any reduction in evaluation based
 upon that or any subsequent examination shall be subject to
 the provisions of Sec.   3.105(e) of this chapter. If there
 has been no local recurrence or metastasis, rate on residuals
 under the appropriate diagnostic code(s).
7710 Adenitis, tuberculous, active or inactive.
    Rate under Sec.   4.88c or 4.89 of this part, whichever is
     appropriate.
7712 Multiple myeloma:
    Symptomatic multiple myeloma..............................       100
    Asymptomatic (smoldering or indolent).....................         0

[[Page 46897]]

 
Note (1): Symptomatic myeloma requires, (i) an elevated serum
 or urine M (monoclonal) protein value (however no specific
 concentration is required for diagnosis), or (ii) presence of
 increased bone marrow clonal plasma cells >=10%. There must
 be also evidence of related organ tissue impairment (ROTI)
 due to the plasma cell proliferation. This process is
 manifested by elevated serum calcium, renal failure, anemia,
 and bone lesions (CRAB). The corresponding laboratory values
 are: Serum calcium >=11.5 mg/100 mL, renal insufficiency with
 creatinine clearance <40 cc/min or serum creatinine >1.73
 mmol/L, normochromic, normocytic anemia with a hemoglobin
 value >2 g/100 mL below the lower limit of normal, or a
 hemoglobin value <10 g/100 mL, lytic lesions (one or more
 osteolytic lesions by radiographic or other imaging system)
 severe osteopenia, or pathologic bone fractures. A small
 percentage of patients with symptomatic myeloma have no
 detectable M-protein in serum or urine but do have myeloma-
 related organ impairment ROTI and increased bone marrow
 plasma cells. Any of the following validated biomarkers of
 malignancy are acceptable for the diagnosis of MM, including
 clonal bone marrow plasma cells >=60%, serum free light chain
 ratio of >=100, or free light chain of >=100 mg/L, or more
 than one focal bone or bone marrow lesion on MRI >5 mm in
 size.
Note (2): A nonsecretory myeloma (a variant form of
 symptomatic myeloma) shows absent M-protein in the serum and
 urine, bone marrow plasmacytosis, and ROTI. While this group
 of patients represents a minority of cases (1-2%), this
 uncommon presentation may lead to delay in diagnosis because
 of the scarcity of laboratory findings commonly in the face
 of an isolated bone process such as low back pain.
Note (3): The diagnostic criteria for asymptomatic (smoldering
 or indolent) myeloma requires the following two criteria: (1)
 An elevated serum monoclonal protein (IgG or IgA) >30 g/L,
 urine monoclonal protein >500 mg/24 hrs., or clonal bone
 marrow plasma cells 10%-60%, and (2) absence of myeloma
 defining events of amyloidosis without any related organ or
 tissue impairment (ROTI) or end-organ damage. There is
 usually normal serum calcium, hemoglobin, and serum
 creatinine, and no bone lesions on full skeletal survey and
 no evidence of amyloidosis or light chain deposition disease.
Note (4): The 100-percent evaluation shall continue for five
 years after the diagnosis of symptomatic multiple myeloma, at
 which time the appropriate disability evaluation shall be
 determined by mandatory VA examination. Any reduction in
 evaluation based upon that or any subsequent examination
 shall be subject to the provisions of Sec.   3.105(e) and
 Sec.   3.344 (a) and (b) of this chapter.
7714 Sickle cell anemia:
    With at least 4 or more painful episodes per 12-month            100
     period, occurring in skin, joints, bones, or any major
     organs, caused by hemolysis and sickling of red blood
     cells, with anemia, thrombosis, and infarction, with
     residual symptoms precluding even light manual labor.....
    Averaging 3 or more painful episodes per 12-month period          60
     or with symptoms precluding other than light manual labor
    Averaging 1 or 2 painful episodes per 12-month period.....        30
    Asymptomatic, established case in remission, but with             10
     identifiable organ impairment............................
Note: Sickle cell trait alone, without a history of directly
 attributable pathological findings, is not a ratable
 disability. Cases of symptomatic sickle cell trait will be
 forwarded to the Director, Compensation Service, for
 consideration under Sec.   3.321(b)(1) of this chapter.
7715 Non-Hodgkin's lymphoma:
    When there is active disease, during treatment phase or          100
     with indolent and non-contiguous phase of low grade NHL..
Note: A 100-percent evaluation shall continue beyond the
 cessation of any surgical therapy, radiation therapy,
 antineoplastic chemotherapy, or other therapeutic procedures.
 Two years after discontinuance of such treatment, the
 appropriate disability rating shall be determined by
 mandatory VA examination. Any reduction in evaluation based
 upon that or any subsequent examination shall be subject to
 the provisions of Sec.   3.105(e) of this chapter. If there
 has been no recurrence, rate on residuals under the
 appropriate diagnostic code(s).
7716 Aplastic anemia:
    Requiring peripheral blood or bone marrow stem cell              100
     transplant; or requiring transfusion of platelets or red
     cells, on average, at least once every six weeks per 12-
     month period; or infections recurring, on average, at
     least once every six weeks per 12-month period...........
    Requiring transfusion of platelets or red cells, on               60
     average, at least once every three months per 12-month
     period; or infections recurring, on average, at least
     once every three months per 12-month period; or using
     continuous immunosuppressive therapy.....................
    Requiring transfusion of platelets or red cells, on               30
     average, at least once per 12-month period, but less than
     once every three months per 12-month period; or
     infections recurring, on average, at least once per 12-
     month period, but less than once every three months per
     12-month period..........................................
Note: A 100-percent evaluation for peripheral blood or bone
 marrow stem cell transplant shall be assigned as of the date
 of hospital admission and shall continue with a mandatory VA
 examination six months following hospital discharge. Any
 change in evaluation based upon that or any subsequent
 examination shall be subject to the provisions of Sec.
 3.105(e) of this chapter.
7718 Essential thrombocythemia and primary myelofibrosis
    Requiring either continuous myelosuppressive therapy or,         100
     for six months following hospital admission, peripheral
     blood or bone marrow stem cell transplant, or treatment
     with radioactive phosphorus or chemotherapy (including
     myelosuppressants).......................................
    Requiring continuous or intermittent myelosuppressive             70
     therapy to maintain platelet count <500 x 10\9\/L........
    Requiring continuous or intermittent myelosuppressive             30
     therapy to maintain platelet count of 200,000-400,000, or
     white blood cell (WBC) count of 4,000-10,000.............
    Asymptomatic..............................................         0
Note (1): If the condition undergoes leukemic transformation,
 evaluate as leukemia under diagnostic code 7703.
Note (2): A 100-percent evaluation shall be assigned as of the
 date of hospital admission for peripheral blood or bone
 marrow stem cell transplant; or during the period of
 treatment with radioactive phosphorus or chemotherapy
 (including myelosuppressants). Six months following hospital
 discharge or, in the case of radioactive phosphorus or
 chemotherapy treatment, six months after completion of
 treatment, the appropriate disability rating shall be
 determined by mandatory VA examination. Any reduction in
 evaluation based upon that or any subsequent examination
 shall be subject to the provisions of Sec.   3.105(e) of this
 chapter.
7719 Chronic myelogenous leukemia (CML) (chronic myeloid
 leukemia or chronic granulocytic leukemia):
    Requiring peripheral blood or bone marrow stem cell              100
     transplant, or continuous myelosuppressive or
     immunosuppressive therapy treatment......................
    Requiring intermittent myelosuppressive therapy, or               60
     targeted therapy with tyrosine kinase inhibitors, or
     interferon treatment.....................................
    In apparent remission on continuous targeted therapy with         30
     tyrosine kinase inhibitors...............................
Note (1): If the condition undergoes leukemic transformation,
 evaluate as leukemia under diagnostic code 7703.

[[Page 46898]]

 
Note (2): A 100-percent evaluation shall be assigned as of the
 date of hospital admission for peripheral blood or bone
 marrow stem cell transplant; or during the period of
 treatment with radioactive phosphorus or chemotherapy
 (including myelosuppressants). Six months following hospital
 discharge or, in the case of radioactive phosphorus or
 chemotherapy treatment, six months after completion of
 treatment, the appropriate disability rating shall be
 determined by mandatory VA examination. Any reduction in
 evaluation based upon that or any subsequent examination
 shall be subject to the provisions of Sec.   3.105 of this
 chapter.
7720 Iron deficiency anemia:
    Requiring intravenous iron infusions on average 4 or more         30
     times per 12-month period................................
    Requiring continuous treatment with high-dose oral                10
     supplementation..........................................
    Asymptomatic or requiring treatment only by dietary                0
     modification.............................................
Note: Do not evaluate iron deficiency anemia due to blood loss         0
 under this diagnostic code. Evaluate iron deficiency anemia
 due to blood loss under the criteria for the condition
 causing the blood loss.
7721 Folic acid deficiency:
    Requiring continuous treatment with high-dose oral                10
     supplementation..........................................
    Asymptomatic or requiring treatment only by dietary                0
     modification.............................................
7722 Pernicious anemia and Vitamin B12 deficiency anemia:
    For initial diagnosis requiring transfusion due to severe        100
     anemia, or if there are signs or symptoms related to
     central nervous system impairment, such as
     encephalopathy, myelopathy, or severe peripheral
     neuropathy, requiring parenteral B12 therapy.............
    Requiring continuous treatment with Vitamin B12                   10
     injections, Vitamin B12 sublingual or high-dose oral
     tablets, or Vitamin B12 nasal spray or gel...............
Note: A 100-percent evaluation for pernicious anemia and
 Vitamin B12 deficiency shall be assigned as of the date of
 the initial diagnosis requiring transfusion due to severe
 anemia or parenteral B12 therapy and shall continue with a
 mandatory VA examination six months following hospital
 discharge or cessation of parenteral B12 therapy. Any
 reduction in evaluation based upon that or any subsequent
 examination shall be subject to the provisions of Sec.
 3.105(e) of this chapter. Thereafter, evaluate at 10-percent
 and separately evaluate any residual effects of pernicious
 anemia, such as neurologic involvement causing peripheral
 neuropathy, myelopathy, dementia, or related gastrointestinal
 residuals, under the most appropriate diagnostic code.
7723 Acquired hemolytic anemia:
    Requiring a bone marrow transplant or continuous                 100
     intravenous or immunosuppressive therapy (e.g.,
     prednisone, Cytoxan, azathioprine, or rituximab).........
    Requiring immunosuppressive medication an average of 4 or         60
     more times per 12-month period...........................
    Requiring an average of 2-3 courses of immunosuppressive          30
     therapy per 12-month period..............................
    Requiring an average of one course of immunosuppressive           10
     therapy per 12-month period..............................
    Asymptomatic..............................................         0
Note (1): A 100-percent evaluation for bone marrow transplant
 shall be assigned as of the date of hospital admission and
 shall continue for six months after hospital discharge with a
 mandatory VA examination six months following hospital
 discharge. Any reduction in evaluation based upon that or any
 subsequent examination shall be subject to the provisions of
 Sec.   3.105(e) of this chapter.
Note (2): Separately evaluate splenectomy under diagnostic
 code 7706 and combine with an evaluation under diagnostic
 code 7723.
7724 Solitary plasmacytoma:
    Solitary plasmacytoma, when there is active disease or           100
     during a treatment phase.................................
Note (1): A 100-percent evaluation shall continue beyond the
 cessation of any surgical therapy, radiation therapy,
 antineoplastic chemotherapy, or other therapeutic procedures
 (including autologous stem cell transplantation). Six months
 after discontinuance of such treatment, the appropriate
 disability rating shall be determined by mandatory VA
 examination. Any change in evaluation based upon that or any
 subsequent examination shall be subject to the provisions of
 Sec.   3.105(e) of this chapter. If there has been no
 recurrence, rate residuals under the appropriate diagnostic
 codes.
Note (2): Rate a solitary plasmacytoma that has developed into
 multiple myeloma as symptomatic multiple myeloma.
Note (3): Rate residuals of plasma cell dysplasia (e.g.,
 thrombosis) and adverse effects of medical treatment (e.g.,
 neuropathy) under the appropriate diagnostic codes.
7725 Myelodysplastic syndromes:
    Requiring peripheral blood or bone marrow stem cell              100
     transplant; or requiring chemotherapy....................
    Requiring, on average, 4 or more blood or platelet                60
     transfusions per 12-month period; or infections requiring
     hospitalization, on average, 3 or more times per 12-month
     period...................................................
    Requiring, on average, 1 to 3 blood or platelet                   30
     transfusions per 12-month period; infections requiring
     hospitalization, on average, 1 to 2 times per 12-month
     period; or requiring biologic therapy, either interferon
     alpha on an ongoing basis or erythropoiesis stimulating
     agent (ESA) for 12 weeks or less per 12-month period.....
Note (1): If the condition progresses to leukemia, evaluate as
 leukemia under diagnostic code 7703.
Note (2): A 100-percent evaluation shall be assigned as of the
 date of hospital admission for peripheral blood or bone
 marrow stem cell transplant, or during the period of
 treatment with chemotherapy and shall continue with a
 mandatory VA examination six months following hospital
 discharge or, in the case of radioactive phosphorus or
 chemotherapy treatment, six months after completion of
 treatment. Any reduction in evaluation based upon that or any
 subsequent examination shall be subject to the provisions of
 Sec.   3.105(e) of this chapter. If there has been no
 recurrence, residuals will be rated under the appropriate
 diagnostic codes.
------------------------------------------------------------------------


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

0
3. Amend appendix A to part 4 by:
0
a. Revising the entries for diagnostic codes 7700, 7702 through 7705, 
7709, 7712, and 7714 through 7716; and
0
b. Adding entries for diagnostic codes 7718 through 7725.

[[Page 46899]]

    The revisions and additions read as follows:

Appendix A to Part 4--Table of Amendments and Effective Dates Since 1946
------------------------------------------------------------------------
                          Diagnostic
         Sec.              Code No.
------------------------------------------------------------------------
 
                              * * * * * * *
4.117.................            7700  Removed [effective date of final
                                         rule].
 
                              * * * * * * *
                                  7702  Evaluation October 23, 1995;
                                         title [effective date of final
                                         rule]; evaluation [effective
                                         date of final rule].
                                  7703  Evaluation August 23, 1948;
                                         criterion October 23, 1995;
                                         evaluation [effective date of
                                         final rule]; criterion
                                         [effective date of final rule].
                                  7704  Evaluation October 23, 1995;
                                         evaluation [effective date of
                                         final rule].
                                  7705  Evaluation October 23, 1995;
                                         title [insert effective date of
                                         final rule]; evaluation
                                         [effective date of final rule];
                                         criterion [effective date of
                                         final rule].
 
                              * * * * * * *
                                  7709  Evaluation March 10, 1976;
                                         criterion October 23, 1995;
                                         title [effective date of final
                                         rule]; criterion [effective
                                         date of final rule].
 
                              * * * * * * *
                                  7712  Added [effective date of final
                                         rule].
 
                              * * * * * * *
                                  7714  Added September 9, 1975;
                                         criterion October 23, 1995;
                                         criterion [effective date of
                                         final rule]
                                  7715  Added October 26, 1990;
                                         criterion [effective date of
                                         final rule].
                                  7716  Added October 23, 1995;
                                         evaluation [effective date of
                                         final rule]; criterion
                                         [effective date of final rule].
 
                              * * * * * * *
                                  7718  Added [effective date of final
                                         rule].
                                  7719  Added [effective date of final
                                         rule].
                                  7720  Added [effective date of final
                                         rule].
                                  7721  Added [effective date of final
                                         rule].
                                  7722  Added [effective date of final
                                         rule].
                                  7723  Added [effective date of final
                                         rule].
                                  7724  Added [effective date of final
                                         rule].
                                  7725  Added [effective date of final
                                         rule].
 
                              * * * * * * *
------------------------------------------------------------------------

0
4. Amend appendix B to part 4 by:
0
a. Revising the undesignated center heading immediately preceding 
diagnostic code 7700;
0
b. Removing the entry for diagnostic code 7700;
0
c. Revising the entries for diagnostic codes 7702, 7705 and 7709; and
0
d. Adding entries for diagnostic codes 7712 and 7718 through 7725.
    The revisions and additions read as follows:

          Appendix B to Part 4--Numerical Index of Disabilities
------------------------------------------------------------------------
         Diagnostic Code No.
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
                  THE HEMATOLOGIC AND LYMPHATIC SYSTEMS
------------------------------------------------------------------------
7702.................................  Agranulocytosis, acquired.
 
                              * * * * * * *
7705.................................  Immune thrombocytopenia.
 
                              * * * * * * *
7709.................................  Hodgkin's lymphoma.
 
                              * * * * * * *
7712.................................  Multiple myeloma.
 
                              * * * * * * *
7718.................................  Essential thrombocythemia and
                                        primary myelofibrosis.
 
                              * * * * * * *
7719.................................  Chronic myelogenous leukemia
                                        (CML) (chronic myeloid leukemia
                                        or chronic granulocytic
                                        leukemia).

[[Page 46900]]

 
7720.................................  Iron deficiency anemia.
7721.................................  Folic acid deficiency.
7722.................................  Pernicious anemia and Vitamin B12
                                        deficiency anemia.
7723.................................  Acquired hemolytic anemia.
7724.................................  Solitary plasmacytoma.
7725.................................  Myelodysplastic syndromes.
 
                              * * * * * * *
------------------------------------------------------------------------

0
5. Amend appendix C to part 4 by:
0
a. Revising the entries for Agranulocytosis and Anemia;
0
c. Adding an entry for Hematologic in alphabetical order;
0
d. Removing the entry for Hodgkin's disease and adding in its place an 
entry for Hodgkin's lymphoma;
0
e. Revising the entry for Leukemia;
    The revisions and additions read as follows:

        Appendix C to Part 4--Alphabetical Index of Disabilities
------------------------------------------------------------------------
                                                        Diagnostic Code
                                                              No.
------------------------------------------------------------------------
 
                              * * * * * * *
Agranulocytosis, acquired............................               7702
 
                              * * * * * * *
Anemia:
    Acquired hemolytic anemia........................               7723
    Folic acid deficiency............................               7721
    Iron deficiency anemia...........................               7720
    Pernicious anemia and Vitamin B12 deficiency                    7722
     anemia..........................................
 
                              * * * * * * *
Hematologic:
    Essential thrombocythemia and primary                           7718
     myelofibrosis...................................
    Immune thrombocytopenia..........................               7705
    Multiple myeloma.................................               7712
    Myelodysplastic syndromes........................               7725
    Solitary plasmacytoma............................               7724
 
                              * * * * * * *
Hodgkin's lymphoma...................................               7709
 
                              * * * * * * *
Leukemia:
    Chronic myelogenous leukemia (CML) (chronic                     7719
     myeloid leukemia or chronic granulocytic
     leukemia).......................................
    Leukemia.........................................               7703
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-19197 Filed 8-5-15; 8:45 am]
 BILLING CODE 8320-01-P
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