Federal Register/Vol. 84, No. 24/Tuesday, February 5, 2019/Proposed Rules

1678 Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Proposed Rules

and complete to the best of the DEPARTMENT OF VETERANS which pertains to chronic fatigue individual’s knowledge, information, AFFAIRS syndrome (CFS), and 38 CFR 4.88b, and belief, and is made in good faith. which pertains to the schedule of 38 CFR Part 4 (iii) Submission of an opt-out notice ratings for infectious diseases and immune disorders (we note that the does not constitute agreement by the RIN 2900–AQ43 proposed changes for § 4.88b exclude rights owner or the individual the schedule of ratings for nutritional submitting the opt-out notice that the Schedule for Rating Disabilities: Infectious Diseases, Immune deficiencies—diagnostic codes (DC) proposed use is in fact noncommercial. Disorders, and Nutritional Deficiencies 6313, 6314, and 6315). VA last updated The submitter may choose to comment the schedule of ratings in § 4.88b on July upon whether the rights owner agrees AGENCY: Department of Veterans Affairs. 31, 1996 (see 61 FR 39875) and updated that the proposed use is noncommercial ACTION: Proposed rule. § 4.88a on July 19, 1995 (see 60 FR use, but failure to do so does not 37012). constitute agreement that the proposed SUMMARY: The Department of Veterans VA proposes to: (1) Update the use is in fact noncommercial. Affairs (VA) proposes to amend the medical terminology and definition of section of the VA Schedule for Rating (3) Multiple rights owners. Where a certain infectious diseases and immune Disabilities (VASRD or Rating Schedule) disorders; (2) add medical conditions pre-1972 sound recording has multiple that addresses infectious diseases and rights owners, only one rights owner not currently in the Rating Schedule; (3) immune disorders. The purpose of these refine evaluation criteria based on needs to file an opt-out notice for changes is to incorporate medical medical advances that have occurred purposes of 17 U.S.C. 1401(c)(5). advances since the last revision, update since the last revision; and (4) (4) Effect of opting out. If a rights medical terminology, and clarify incorporate current understanding of owner files a timely opt-out notice evaluation criteria. The proposed rule functional changes associated with or under paragraph (e)(1) of this section, considers comments from experts and resulting from disease the user must wait one year before filing the public during a forum held from (pathophysiology). another notice of noncommercial use January 31 to February 1, 2011, on A panel of independent experts proposing the same or similar use of the revising this section of the VASRD. convened by the Institute of Medicine same pre-1972 sound recording(s). DATES: Comments must be received by (IOM) in February 2015 proposed an VA on or before April 8, 2019. updated set of diagnostic criteria for (5) Legal sufficiency. The Copyright ADDRESSES: Written comments may be infectious disease and immune Office does not review opt-out notices submitted through www.regulations.gov; disorders. This updated revision also submitted under paragraph (e)(1) of this by mail or hand-delivery to Director, included changing the name of CFS to section for legal sufficiency. The Regulation Policy and Management ‘‘Systemic Exertion Intolerance Disease Office’s review is limited to whether the (00REG), Department of Veterans (SEID)/Chronic fatigue Syndrome procedural requirements established by Affairs, 810 Vermont Ave. NW, Room (CFS).’’ the Office (including payment of the 1063B, Washington, DC 20420; or by fax VA has clear authority to make this proper filing fee) have been met. Rights to (202) 273–9026. (This is not a toll free regulatory change because of its broad owners are therefore cautioned to number.) Comments should indicate authority to ‘‘prescribe all rules and review and scrutinize opt-out notices to that they are submitted in response to regulations which are necessary or assure their legal sufficiency before ‘‘RIN 2900–AQ43—Schedule for Rating appropriate to carry out the laws submitting them to the Office. Disabilities: Infectious Diseases, administered by [VA] and are consistent with those laws.’’ 38 U.S.C. 501(a); see (6) Filing date. The date of filing of an Immune Disorders, and Nutritional also 38 U.S.C. 1155 (VA’s authority to opt-out notice is the date when a proper Deficiencies.’’ Copies of comments received will be available for public adopt and apply schedule for rating submission, including the prescribed disabilities). fee, is received in the Copyright Office. inspection in the Office of Regulation Policy and Management, Room 1063B, § 4.88a Chronic Fatigue Syndrome (7) Fee. The filing fee to submit an between the hours of 8 a.m. and 4:30 Currently, § 4.88a specifies older opt-out notice pursuant to this section is p.m., Monday through Friday (except diagnostic criteria for the diagnosis of prescribed in § 201.3(c). holidays). Please call (202) 461–4902 for CFS and uses outdated terminology to an appointment. (This is not a toll free (f) Fraudulent filings. If the Register refer to this complex disease. VA number.) In addition, during the becomes aware of abuse or fraudulent proposes to update the nomenclature for comment period, comments may be filings under this section by or from a this disease, which is also known as viewed online through the Federal certain filer or user, she shall have the systemic exertion intolerance disease Docket Management System (FDMS) at discretion to reject all submissions from (SEID) or myalgic encephalomyelitis www.Regulations.gov. that filer or user under this section for (ME), by changing the diagnostic code up to one year. FOR FURTHER INFORMATION CONTACT: name to ‘‘Systemic Exertion Intolerance Ioulia Vvedenskaya, M.D., M.B.A., Dated: January 30, 2019. Disease (SEID)/Chronic Fatigue Medical Officer, Part 4 VASRD Regan A. Smith, Syndrome (CFS).’’ This new name Regulations Staff (211C), Compensation captures a central characteristic of the General Counsel and Associate Register of Service, Veterans Benefits disease that reflects negative effects of Copyrights. Administration, Department of Veterans any exertion (physical, cognitive, or [FR Doc. 2019–00873 Filed 2–4–19; 8:45 am] Affairs, 810 Vermont Avenue NW, emotional) on patients’ many organ BILLING CODE 1410–30–P Washington, DC 20420, (202) 461–9700. systems. IOM (Institute of Medicine), (This is not a toll-free telephone Beyond Myalgic Encephalomyelitis/ number.) Chronic Fatigue Syndrome: Redefining SUPPLEMENTARY INFORMATION: As part of an Illness (2015), http://www.national its ongoing revision of the VASRD, VA academies.org/hmd/∼/media/Files/ proposes changes to 38 CFR 4.88a, Report%20Files/2015/

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MECFS/MECFScliniciansguide.pdf (last principles are generally consistent with evaluation. However, even though accessed August 30, 2018). the clinical presentation of infectious advancements in antimicrobial therapy VA is also proposing to revise the diseases. have significantly lessened the current diagnostic criteria for SEID/CFS VA proposes one General Rating occurrence of residuals of infectious to adhere to evidence-based criteria Formula for § 4.88b. This approach is diseases, they continue to occur. which were adopted by the Centers for based on the association between Therefore, VA generally proposes to Disease Control and Prevention (CDC). clinical resolution or stabilization of an append each diagnostic code with a IOM Report on ME/CFS (2015) (updated infectious disease and elimination or note describing the most common July 3, 2017), https://www.cdc.gov/me- complete suppression of the causative residuals associated with a given cfs/symptoms-diagnosis/diagnosis.html infectious agent. Regardless of whether infection. See below for additional (last accessed July 17, 2018). According resolution occurs spontaneously or details. As a list of every residual would to the 2015 IOM Report, up to 2.5 because of treatment, long-term be impractical, these notes would million Americans suffer from this disability in such situations results from clearly indicate that they are not disease which is characterized by residual functional impairment of the exhaustive. Where ascertainable profound fatigue, cognitive dysfunction, body systems affected by the infectious residuals exist, VA proposes to assign sleep abnormalities, pain, autoimmune disease, rather than the infection itself. evaluations for those residuals under manifestations, and a variety of other Sheila Davey, World Health the appropriate body system(s). symptoms that are made worse by Organization, World Health Certain infectious conditions are exertion of any sort. New diagnostic Organization Report on Infectious prone to relapse and require laboratory criteria will take into consideration Diseases: Removing Obstacles to evaluation for confirmation. L. Joseph whether this severe chronic fatigue Healthy Development (1999). Wheat et al., Clinical Practice significantly interferes with daily Therefore, VA’s proposal to use a Guidelines for the Management of activities and work, if the affected General Rating Formula does not Patients with Histoplasmosis: 2007 individual concurrently has four or substantively change the current Update by the Infectious Diseases more of the eight symptoms as outlined evaluation criteria so much as their Society of America, 45 Clinical in CDC evidence-based criteria and organization. This rulemaking proposes Infectious Diseases 807, 807–25 (2007). whether these symptoms first appeared to restructure rating criteria by creating Oftentimes, non-specific constitutional before the fatigue, have persisted or one General Rating Formula applicable symptoms (weakness, tiredness, recurred during six or more consecutive to multiple infectious diseases, insomnia, weight loss, etc.) occur months of illness, and were due to regardless of etiology. A General Rating following the active phase of an ongoing exertion or other medical Formula for infectious diseases would infectious disease. However, such conditions associated with fatigue. ensure consistency in rating these symptoms may be due to other causes The CDC mandates a thorough conditions and be similar to the use of than the infection. Therefore, to ensure medical history, physical examination, a General Rating Formula in other VA assigns the most appropriate mental status examination, and sections of the VASRD, such as in evaluations for relapsing infections, VA laboratory tests to identify underlying or §§ 4.97, 4.116, 4.130, and others. This proposes to include a note in the rule contributing conditions that require formula would be a familiar concept for requiring that relapses be confirmed by treatment. CDC recognizes and Veterans Benefits Administration (VBA) pathogen-specific testing using identifies several conditions that do not employees and minimize the risk for appropriate microbiologic, serologic, exclude a diagnosis of SEID/CFS. error by providing one criterion biochemical (e.g., nucleic acid Currently, § 4.88b lists 19 DCs applicable to multiple diagnostic codes. detection)histopathologic methods. encompassing infectious diseases and Although each specific infectious Finally, although VA proposes using immune disorders. VA proposes to disease has a different etiology and a General Rating Formula for most revise these codes to reflect current natural history, once the active disease infectious diseases, VA notes that each terminology, advances in medical phase is over, disability would be rated infectious disease has a different long- on residuals. VA would assign a 100 term impact. For those that have longer knowledge, recommendations from the percent disability rating during the active phases and/or are commonly 2015 IOM Report on ME/CFS and a variable length of each specific disease’s associated with relapse and residuals, 2007 IOM Report on evaluating veterans active phase. For most infectious VA proposes to require VA examination for disability benefits, IOM, A 21st diseases manifesting acutely, the length once the disease is no longer active so Century System For Evaluating Veterans of the active disease phase (i.e., the time that a medical professional can evaluate for Disability Benefits (2007), https:// between disease onset and resolution or the individual’s condition. In these www.nap.edu/read/11885/chapter/1 stabilization) is at most usually six to cases, VA also proposes to apply the (last accessed July 17, 2018). eight weeks. VA proposes to assign a provisions of § 3.105(e) that require VA Schedule of Ratings—Infectious 100 percent evaluation during the active to send beneficiaries notice of any Diseases, Immune Disorders, and disease phase. VA recognizes that some proposed reduction in evaluation and Nutritional Deficiencies infectious diseases, such as provide an opportunity to respond tuberculosis, may have a longer than before it becomes effective. Proposed General Rating Formula for average active disease phase. Therefore, § 4.88b VA proposes that the General Rating Proposed Changes to Existing Currently, each infectious disease Formula apply only in those cases Diagnostic Codes listed under § 4.88b has its own where specific rating criteria are not As discussed above, VA proposes to prescribed rating criteria. In most cases, otherwise provided. Diagnostic codes in apply a General Rating Formula for each specific infectious disease warrants § 4.88b that would not follow the infectious diseases unless otherwise a 100 percent evaluation during an General Rating Formula would be 6301, noted. Additionally, VA proposes to active period of the disease. Thereafter, 6302, 6310, 6311, 6312, 6313, 6314, provide notes identifying common any residual functional impairment 6315, 6325, 6326, 6351, and 6354. residuals associated with particular from the infectious disease determines After the disease becomes inactive, diseases and instructions to rating the level of disability. These evaluation VA proposes to assign a 0 percent personnel regarding the level of medical

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review necessary following cessation of otherwise without symptoms or Diagnostic Code 6304 treatment and infection. These specific disability that would warrant proposed changes are discussed below. evaluation. Robert Ferrer, VA proposes to evaluate DC 6304, Lymphadenopathy: Differential malaria, using the General Rating Diagnostic Code 6300 Diagnosis and Evaluation, 58 a.m. Fam. Formula because it is an acute, Currently, DC 6300 is titled ‘‘Cholera, Physician 1313, 1313–20 (Oct. 15, debilitating disease with predictable Asiatic’’ referring only to infection with 1998). In many cases, it may constitute clinical presentation. toxigenic strains of Vibrio cholerae; it a normal physical finding. Vikramjit S. VA proposes to amend an existing does not reflect infections due to other Kanwar, Lymphadenopathy, note and to add one new notes. Note 1 species within the genus Vibrio. Non- Medscape.com (Feb. 1, 2018), http:// would explicitly state that VA requires cholera Vibrio species cause diarrheal emedicine.medscape.com/article/ diagnostic confirmation for both the diseases, as well as wound infections 956340-overview. initial diagnosis and any relapse. To and septicemia. To reflect the total array As lymphadenopathy is often reflect advances in malarial testing, VA of diseases caused by Vibrio species, VA associated with other diseases and, also proposes to refer to other specific proposes to rename this DC ‘‘Vibriosis regardless of origin, commonly presents diagnostic tests such as antigen (cholera, non-cholera), to encompass without symptoms or disability detection, immunologic conditions caused by V. cholerae and by warranting evaluation, VA proposes to (immunochromatographic) tests, and non-cholera Vibrio organisms. remove it from the note in DC 6301. VA molecular testing, such as polymerase Cholera due to V. cholerae and notes that the list of possible residuals chain reaction tests. Malaria Diagnosis gastroenteritis due to other Vibrio in proposed DC 6301 would not be (United States), CDC (Nov. 19, 2015), species are associated with severe exhaustive. Thus, if a veteran presents https://www.cdc.gov/malaria/diagnosis_ diarrhea of relatively short duration. Hoi with lymphadenopathy as a residual of treatment/diagnosis.html. Ho et al., Vibrio Infections, visceral leishmaniasis that results in Medscape.com (July 24, 2018), http:// chronic, functional impairment, VA Note 2 would recognize potential emedicine.medscape.com/article/ would consider an evaluation under the nervous system residuals because severe 232038-overview. Including the appropriate system. forms of malaria affect the brain as an incubation period, cholera usually lasts In addition to the above revision, VA encephalopathy. Pralay Sarkar et al., 7 to 10 days and results in total proposes to amend the existing Note 1 ‘‘Critical care aspects of malaria,’’ 25 J. remission, or, in 5 to 10 percent of to inform that the residual effects of of Intensive Care Med. 93, 93–103 cases, death if left untreated. Therefore, infection include bone marrow diseases. (2010). In addition, this note would also the proposed General Rating Formula Parasites—Leishmaniasis, CDC (Jan. 10, refer to the residuals listed in § 3.317(d). would be appropriate for both cholera 2013), https://www.cdc.gov/parasites/ Diagnostic Code 6305 and non-cholera gastroenteritis due to leishmaniasis/index.html. This note other Vibrio species, and VA would would also refer to the residuals listed VA proposes to amend the title of this remove the existing provision for a in 38 CFR 3.317(d), ‘‘Long-term health DC, currently ‘‘Lymphatic filariasis,’’ to separate three-month convalescence effects potentially associated with include the term elephantiasis, which is period as it would no longer be infectious diseases.’’ another name commonly associated necessary. Finally, VA proposes to add a new with the chronic form of this condition. VA proposes to use a note to provide Note 2 to address the use of culture, Lymphatic Filariasis Fact Sheet No. 102, information about common residual histopathology, and other diagnostic World Health Organization (May 11, disability of cholera and non-cholera testing to confirm relapses. Clinicians 2018), http://www.who.int/mediacentre/ Vibrio infection, including renal failure, rely on such diagnostic testing, which factsheets/fs102/en/. skin, and musculoskeletal conditions, has increased steadily in accuracy and The new General Rating Formula such as necrotizing fasciitis. VA availability, to determine whether would provide 100 percent evaluation proposes no changes to the evaluation symptoms are due to leishmaniasis or for the acute phase of active infection criterion for this DC except eliminating some other disease. Shyam Sundar & M. for lymphatic filariasis. The proposed the three-month convalescence and Rai, ‘‘Laboratory Diagnosis of Visceral General Rating Formula would be adding a note to address rating of Leishmaniasis,’’ 9 Clinical and appropriate for use in this acute residual disability. Diagnostic Laboratory Immunology 951, infection. However, no actual changes 951–58 (2002). VA also proposes to Diagnostic Code 6301 in the evaluation criteria would result retitle the existing note as Note 1 to from this organizational change VA evaluates DC 6301, visceral account for the addition of this second intended to help rating personnel easily leishmaniasis, at 100 percent for six note. months following cessation of apply the VASRD. treatment, after which a VA Diagnostic Code 6302 VA proposes to add information to examination helps determine residual VA would not change the rating more adequately address the range of disability. VA proposes only minor criteria for leprosy (Hansen’s disease), potential residuals, which include changes to this rating criteria, but but proposes to amend the current Note lymphedema (permanent swelling) and proposes to change the note regarding under DC 6302 by adding amputations lymphatic obstruction. Parasites— rating residual disability. VA would as a residual in the proposed Note. The Lymphatic Filariasis, CDC (June 14, generally identify those residuals neurologic impairment in leprosy 2013), http://www.cdc.gov/parasites/ commonly associated with post- involves sensory and motor deficits/loss lymphaticfilariasis/disease.html. VA infection or post-treatment residuals in the extremities that may lead to auto- proposes a new Note to instruct rating that may warrant evaluation. Currently, amputation. Preenon Bagchi et al., personnel to evaluate under the DC 6301 lists lymphadenopathy as one Bacterio-Informatics: Identifying the appropriate body system residuals such such residual disability. However, Cause of Hansen’s Disease and as epididymitis, lymphangitis, lymphadenopathy follows numerous Establish [sic] a Remedy for the Same, lymphatic obstruction, or lymphedema diseases and is a frequent physical 2 Int’l J. of Bioinformatics Res. and affecting extremities, genitals, and/or finding which, even when permanent, is Applications 15, 15–19 (2010). breasts.

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Diagnostic Code 6306 VA proposes a new Note adding iritis To ensure that individuals are entitled Bartonellosis, currently evaluated and uveitis as residual disabilities and to any resumption or continuation of the under DC 6306, generally resolves retaining the remainder of the existing 100 percent evaluation after the initial within two months with appropriate information without substantive change. active disease, VA proposes to add a treatment. Kassem A. Hammoud et al., VA does not propose any changes to Note requiring confirmation of relapse by culture, histopathology, or other Bartonellosis, Medscape.com (Oct. 17, the evaluation criteria for this DC. diagnostic laboratory testing. 2012), http://emedicine.medscape.com/ Diagnostic Code 6309 VA also proposes Note 2 addressing article/213169-overview. Therefore, VA VA proposes to evaluate DC 6309, residuals which may be found under proposes to rate active bartonellosis § 4.88c. Infection residuals include, but under the General Rating Formula at rheumatic fever, which is an acute, febrile disease typically lasting less than are not limited to, chronic diagnosed 100 percent, and VA would remove the disabilities affecting such body systems existing provision for a separate three- a month, using the General Rating Formula. The existing note regarding as the skin and respiratory, central month convalescence period as it would nervous, musculoskeletal, ocular, no longer be necessary. residuals would remain substantively unchanged. gastrointestinal, and genitourinary VA also proposes to update the systems. VA would rate them under the residual disability to include Diagnostic Code 6310 appropriate body system. J.J. van der endocarditis, which occurs when the VA does not propose substantive Harst & G.J. Luijckx, Treatment of bloodstream may carry this bacterium to Central Nervous System Tuberculosis the heart valves. John L. Brusch et al., change to the criteria under diagnostic code 6310 for syphilis and other Infections and Neurological Infective Endocarditis— Complications of Tuberculosis Pathophysiology, Medscape.com (Dec. treponemal infections. However, for consistency with the remainder of this Treatment, 17 Current Pharmaceutical 17, 2013), http:// Design 2940, 2940–47 (2011). emedicine.medscape.com/article/ section, VA proposes to replace the term 216650-overview#a0104. ‘‘complications’’ with the term ‘‘residual Diagnostic Code 6316 disability,’’ which VA would rate under VA proposes to evaluate DC 6316, Diagnostic Code 6307 the appropriate body system. brucellosis, an acute, debilitating VA proposes to evaluate DC 6307, Additionally, VA proposes to remove disease of short duration usually lasting plague, which is an acute, debilitating specific references to the names several weeks or less, using the General disease of short duration, using the associated with each DC identified in Rating Formula. Brucellosis is easily General Rating Formula. this note because future revisions of the treated with antibiotics, but, if Use of modern antibiotics renders rating schedule would retitle several of untreated, brucellosis may become residual disability from the infection them. chronic and leave significant residuals. itself extremely rare. Therefore, VA Diagnostic Code 6311 VA proposes no changes to the proposes to delete the existing note evaluation criteria. regarding specific residuals and replace Currently, DC 6311, miliary As the correct diagnosis is essential in it with a note stating that VA would rate tuberculosis, provides a 100 percent determining if symptoms are due to any residual disability under the evaluation during active infection. brucellosis or some other disease entity, appropriate body system. Again, Under § 4.88c, the 100 percent is VA proposes to add a new Note 1 lymphadenopathy is a frequent physical continued for one year following the directing that culture, serologic testing, finding following numerous diseases, date of inactivity. Active infection may or both must confirm both the initial often permanent and without disabling last for months to years, and, if diagnosis and any relapse of active symptoms. Robert Ferrer, undiagnosed or untreated, may result in infection. Wafa Al-Nassir, Brucellosis, Lymphadenopathy: Differential death. The standard treatment for drug- Medscape.com (June 16, 2017), http:// Diagnosis and Evaluation, 58 Am.Fam. susceptible miliary tuberculosis is six to emedicine.medscape.com/article/ Physician at 1313–20. VA proposes nine months with a combination of anti- 213430-overview. removing lymphadenopathy as a tuberculosis drugs. If the meninges are VA proposes to amend the existing residual because it may be a normal involved, treatment will last for 9 to12 note as Note 2 and expand the list of physical finding. Vikramjit S. Kanwar, months, but may occasionally require residuals in light of advances in Lymphasdenopathy, Medscape.com longer a treatment duration. Nahid, P., medicine and early treatment. Note 2 (July 10, 2015), http:// et al., ‘‘Executive Summary: Official would reflect the residuals most emedicine.medscape.com/article/ American Thoracic Society/Centers for commonly associated with this 956340-overview); Plague, CDC (Nov. Disease Control and Prevention/ infection, including meningitis, and 28, 2012), http://www.cdc.gov/plague/. Infectious Diseases Society of America liver, spleen, or musculoskeletal Clinical Practice Guidelines: Treatment Diagnostic Code 6308 conditions. Brucellosis, CDC (Sept. 13, of Drug-Susceptible Tuberculosis,’’ 63 2017) http://www.cdc.gov/brucellosis/ VA proposes to evaluate DC 6308, Clinical Infectious Diseases 853, 853– index.html. As this condition is a relapsing fever, which is an acute, 867 (Oct. 2016), https:// presumptive disease related to Gulf War debilitating disease of short duration, www.nidcd.nih.gov/health/balance/ service, this note would also refer to the using the General Rating Formula. pages/meniere.aspx (last visited January many specific residuals of brucellosis Modern treatment helps most patients 22, 2019). Relapses are common when listed in § 3.317(d). recover from this disease within a few medication is not taken for the full time days, with little incidence of splenic prescribed and/or not taken in the Diagnostic Code 6317 damage. Long-term sequelae of relapsing appropriate combination. Generally, Currently, DC 6317 represents scrub fever are rare, but include iritis, uveitis, most relapses occur within the first 12 typhus, an acute debilitating rickettsial cranial nerve, and other neuropathies. months of treatment completion. disease lasting for several weeks or less. Tick-borne Relapsing Fever (TBRF), CDC Tuberculosis (TB) Guidelines. CDC (May If untreated, a high mortality rate (Jan. 8, 2016), http://www.cdc.gov/ 4, 2016), https://www.cdc.gov/tb/ results. Antibiotic treatment rapidly relapsing-fever/clinicians/. Therefore, publications/guidelines/treatment.htm. eradicates the disease and significantly

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reduces the chances of complications. when it is active. Lyme disease is an candidiasis for the criteria for a 30 Therefore, VA proposes to evaluate DC acute illness, usually lasting several percent evaluation. In the past, oral 6317 using the General Rating Formula. weeks or less. Therefore, VA proposes to candidiasis was strongly associated with VA proposes to rename this DC to rate Lyme disease under the General HIV infection. However, the increased encompass all forms of rickettsial and Rating Formula, without changes to the use of antiretroviral medications has similar erlichial and Anaplasma actual evaluation criteria. VA also greatly reduced the incidence of this infections. These infections are not proposes to amend the existing note condition in HIV-positive individuals. specific to the veteran population as associated with this DC to account for C. Frezzini et al., Current Trends of HIV they afflict travelers and field scientists residuals such as Bell’s palsy, Disease of the Mouth, 34 J. of Oral as well. Renaming this DC would mean radiculopathy, ocular, and cognitive Pathology & Med. 513, 513–31 (2005). rating personnel need not further clarify dysfunction, in addition to arthritis. For clarification, VA proposes to replace the phrase ‘‘definite medical the type of typhus infecting a veteran. Diagnostic Code 6320 VA is not proposing any changes to symptoms’’ in the criteria for a 10 the evaluation criteria except to use the Currently, DC 6320 represents percent evaluation with ‘‘HIV-related General Rating Formula. VA would also ‘‘Parasitic diseases otherwise not constitutional symptoms.’’ VA would remove the existing provision for a specified.’’ VA proposes no changes to not change the remainder of the criteria separate three-month convalescence the evaluation criteria except to use the for a 10 percent evaluation. The criteria period as it would no longer be General Rating Formula. VA also for a 0 percent evaluation would not necessary. proposes to amend the existing note change. VA proposes to update the existing associated with this DC with general Existing Note 1 would continue to note to include such residuals instructions to rate any residuals of this provide that ‘‘medications prescribed as frequently associated with DC 6317 as infection under the appropriate body part of a research protocol at an involvement of bone marrow and the system. accredited medical institution’’ are to be considered ‘‘approved medication’’ central nervous system, in addition to Diagnostic Code 6351 the current list of spleen damage or skin within the context of the evaluation conditions. VA proposes a number of changes to criteria. VA proposes to add a reference Rickettsial, ehrlichial, and Anaplasma DC 6351, which pertains to human to treatment regimens as part of a infections cause similar nonspecific immunodeficiency virus (HIV) related research protocol at an accredited influenza-like illness in humans, illness. Currently, VA provides a 100 medical institution because some including but not limited to, scrub percent evaluation for ‘‘AIDS with research protocols use not only new typhus, Rocky Mountain spotted fever, recurrent opportunistic infections or medications but also new regimens for African tick-borne fever, ehrlichiosis, with secondary diseases affecting already FDA approved medications. and anaplasmosis. Therefore, VA also multiple body systems; HIV-related Existing Note 2 would continue to proposes to add a second note to list illness with debility and progressive provide for separate evaluation of other rickettsial infections, including weight loss, without remission, or few various manifestations of HIV infection infections by Ehrlichia and Anaplasma or brief remissions.’’ VA proposes to under the appropriate diagnostic codes. species (members of the order remove the statement about remission VA proposes to retain the instruction to Rickettsiales) to account for its because the CDC considers AIDS a evaluate on the basis of psychiatric or occurrence in the U.S. veteran chronic condition, and the diagnosis central nervous system manifestations, population. Johan S. Bakken & J. continues once a person is properly opportunistic infections, and Stephen Dumler, Ehrlichiosis and diagnosed, regardless of improvements neoplasms, rather than based on this Anaplasmosis, Medscape.com (2004), in that person’s condition. diagnostic code, if a higher overall When VA last revised the evaluation https://www.medscape.com/viewarticle/ evaluation results. However, VA criteria, the medical community 490468_4. proposes to substitute the term considered oral hairy leukoplakia (OHL) ‘‘diagnosed psychiatric condition’’ for Diagnostic Code 6318 a distinctive clinical marker of HIV the phrase ‘‘psychiatric manifestations.’’ Currently, DC 6318 represents infection. Since then, measurement of VA recognizes that a veteran may melioidosis, an acute debilitating the peripheral CD4 cell count and HIV exhibit psychiatric symptoms, such as bacterial disease lasting several weeks viral load have become the standard depression, which do not rise to the or less, which, if left untreated, may method for evaluating a patient’s stage level of a diagnosed disability. Such result in mortality. VA proposes no of HIV infection. Sowmya Nanjappa, symptoms are more appropriately rated changes to the evaluation criteria, Anti-retroviral Therapy in Treatment- under DC 6351 as 10 percent disabling, except use of the General Rating Naı¨ve Patients, Medscape.com (June 3, provided there is evidence of activity Formula. 2016), https:// limitations. Note 2, however, would As accuracy is essential in diagnosing emedicine.medscape.com/article/ refer to diagnosed, disabling acquired melioidosis, VA proposes to add Note 1 2041458-overview. In addition, OHL by psychiatric illness. directing that culture or other specific itself rarely, if ever, requires specific VA also proposes the addition of a diagnostic laboratory tests must confirm treatment in patients receiving anti- new Note 3 to assist rating personnel in both the initial diagnosis and any retroviral therapy. James Cade, Hairy applying these revised evaluation relapse or chronic activity of infection. Leukoplakia Treatment and criteria. Note 3 would include a list of VA would retain the existing Management, Medscape.com (December current opportunistic infections, which information regarding common 19, 2018), https:// includes the following conditions: residuals and the instruction to rate emedicine.medscape.com/article/ Candidiasis of the bronchi, trachea, residuals under the appropriate body 279269-overview. VA proposes to esophagus, or lungs; invasive cervical system under Note 2. remove reference to OHL in the criteria cancer; coccidioidomycosis; for a 30 percent evaluation. cryptococcosis; cryptosporidiosis; Diagnostic Code 6319 Similarly, VA proposes to modify the cytomegalovirus (particularly CMV VA currently assigns a 100 percent reference of oral candidiasis to retinitis); HIV-related encephalopathy; evaluation for DC 6319, Lyme disease, esophageal and lower respiratory tract herpes simplex-chronic ulcers of greater

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than one month’s duration, or proposes a Note 1 to this effect and claims and can evaluate them only by bronchitis, pneumonia, or esophagitis; instructs that any change in evaluation analogy. histoplasmosis; isosporiasis (chronic based upon that or any subsequent Most people who contract intestinal); Kaposi’s sarcoma; examination shall be subject to the schistosomiasis are asymptomatic and lymphoma; Mycobacterium avium provisions of § 3.105(e). Furthermore, have subclinical disease during both complex; tuberculosis; Pneumocystis the note would instruct rating personnel acute and chronic stages of infection. jirovecii (carinii) pneumonia; to rate on residuals if there is no relapse. Persons with acute infection (also pneumonia, recurrent; progressive Establishing the correct diagnosis is known as Katayama syndrome) may multifocal leukoencephalopathy; essential in determining if symptoms present with mild symptoms such as Salmonella septicemia, recurrent; are due to NTM or some other disease rash, fever, headache, myalgia, and toxoplasmosis of the brain; and wasting entity. Diagnostic testing has become respiratory symptoms that are not syndrome due to HIV. AIDS and more accurate and readily available over disabling. Opportunistic Infections, CDC (July 23, the years. Therefore, VA proposes a Chronic disease results from host 2018), https://www.cdc.gov/hiv/basics/ Note 2, requiring diagnostic immune responses to schistosome eggs: livingwithhiv/ confirmation for subsequent relapses. S. mansoni and S. japonicum. These opportunisticinfections.html. VA proposes to include Note 3, which eggs most commonly lodge in the blood would identify common residuals to vessels of the liver or intestine with Diagnostic Code 6354 assist rating personnel in assigning chronic inflammation leading to bowel VA is proposing no change to the evaluations following cessation of the wall ulceration, hyperplasia, and rating criteria for this DC other than to 100 percent evaluation. Residuals of polyposis and, with heavy infections, to update the name from chronic fatigue infection identified in Note 3 would liver fibrosis and portal hypertension. syndrome (CFS) to systemic exertion include skin conditions and conditions S. haematobium eggs tend to lodge in intolerance disease/chronic fatigue of the respiratory, central nervous, the urinary tract and the female genital syndrome (CFS). VA would, however, musculoskeletal, ocular, tract. Female genital schistosomiasis can clarify the note to indicate that gastrointestinal, and genitourinary affect the cervix, fallopian tubes, and incapacitation requires that a licensed systems. vagina. Central nervous system lesions, such physician must prescribe both bed rest Proposed New Diagnostic Code 6325 and treatment, which would be as in the spinal cord or brain and consistent with current VA practice. VA proposes to add new DC 6325 inflammatory reactions, may cause the which applies to hyperinfection formation of granulomas that act as Proposed New Diagnostic Codes syndrome or disseminated space-occupying lesions. As discussed above, in addition to strongyloidiasis. Because VA proposes to evaluate DC 6326 by updating existing DCs, VA proposes to strongyloidiasis is not an acute, self- assigning a 0 percent evaluation for add medical conditions not currently limited disease, VA would not use the acute and asymptomatic chronic listed in the Rating Schedule: General Rating Formula. Similar to infections. Additionally, VA proposes to other severe infectious diseases, VA note common residuals of infection, Proposed New Diagnostic Code 6312 proposes to assign a 100 percent such as liver and genitourinary tract VA proposes to add a new DC 6312 evaluation during active disease conditions. VA would rate residual for ‘‘Nontuberculosis mycobacterial followed by a mandatory VA evaluation disability in the appropriate system. infection’’ (NTM). NTM lung infection to determine the appropriate evaluation occurs when a person inhales the based on any residuals. Systemic Proposed New Diagnostic Code 6329 organism from the environment. Most infection, which is the most severe form VA proposes new DC 6329 to people do not become ill but some of strongyloidiasis, with a mortality rate encompass hemorrhagic fevers, susceptible individuals require approaching 90 percent, is most often including dengue, yellow fever, and prolonged treatment of one to two years. seen in individuals with other others. While these fevers are Without treatment, many people, but underlying conditions, especially those uncommon in the United States, they not all, will develop a progressive lung with compromised immune function. are prevalent in tropical regions and, infection characterized by cough, Parasites—Strongyloides, Resources for therefore, associated with military fatigue, and often weight loss. However, Health Professionals, CDC (Jan. 6, 2012), deployments. David C. Pigott, CBRNE— death directly related to NTM lung http://www.cdc.gov/parasites/ Viral Hemorrhagic Fevers, disease is relatively rare in strongyloides/. VA is not proposing to Medscape.com (Mar. 16, 2017), https:// immunocompetent individuals. list the most common residuals because emedicine.medscape.com/article/ Systemic infection, which is the most their number is so vast. 830594-overview. VA may presume severe form, is most often seen in service connection for hemorrhagic individuals with other underlying Proposed New Diagnostic Code 6326 fever if records indicate service in conditions, especially those that inhibit VA proposes a new diagnostic code certain regions. See 38 CFR 3.309(b). VA immune function. Arry Dieudonne, for schistosomiasis, the second most is proposing to add a distinct DC for Atypical Mycobacterium Infection, common parasitic disease in the world. hemorrhagic fever because it otherwise Medscape.com (Feb. 7, 2018), http:// Parasites—Schistosomiasis, CDC (Apr. lacks a means to accurately track such emedicine.medscape.com/article/ 30, 2018), http://www.cdc.gov/parasites/ claims and can evaluate them only by 972708-overview. schistosomiasis/. While the parasite is analogy. Similar to other infectious diseases not found in the United States, it is VA proposes to apply the General found in the Rating Schedule, VA sufficiently prevalent in tropical regions Rating Formula and assign a 100 percent proposes to assign a 100 percent that VA may presume service evaluation for active disease because evaluation during active infection, after connection if records indicate service in hemorrhagic fever is associated with a which a mandatory VA evaluation such regions. See 38 CFR 3.309(b). VA debilitating, acute, febrile illness that would be conducted to determine the is proposing to add a distinct DC for often lasts for several weeks at most. VA appropriate evaluation based on schistosomiasis because it otherwise also proposes to include a note listing residuals, if any. Therefore, VA lacks a means to accurately track such common residual disabilities of central

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nervous system, liver, or kidney chronic fatigue syndrome, and vascular effects, and other advantages; conditions. infections. distributive impacts; and equity). Executive Order 13563 (Improving Proposed New Diagnostic Code 6330 Proposed New Diagnostic Code 6333 Regulation and Regulatory Review) VA proposes new DC 6330 for VA proposes a new diagnostic code to emphasizes the importance of infections caused by Campylobacter encompass infections caused by quantifying both costs and benefits, jejuni. In 2010, VA issued a regulation nontyphoidal Salmonella. In 2010, VA reducing costs, harmonizing rules, and establishing that Campylobacter jejuni issued a regulation establishing that promoting flexibility. Executive Order is subject to presumptive service nontyphoidal salmonellosis is subject to 12866 (Regulatory Planning and connection for certain veterans because presumptive service connection for Review) defines a ‘‘significant it is (1) prevalent in Southwest Asia, (2) certain veterans. See 75 FR 59968 and regulatory action,’’ which requires has been diagnosed among U.S. troops 38 CFR 3.317. To track claims decisions review by the Office of Management and serving in the Persian Gulf/Southwest regarding this infection and to more Budget (OMB), as ‘‘any regulatory action Asia Theater of operations, and (3) is consistently rate it, VA proposes a that is likely to result in a rule that may: known to cause long-term adverse diagnostic code specifically for (1) Have an annual effect on the health effects. See 75 FR 59968 and 38 nontyphoidal salmonellosis. economy of $100 million or more or CFR 3.317. To monitor claims for this VA proposes to assign a 100 percent adversely affect in a material way the infection, VA proposes a diagnostic evaluation during active infection economy, a sector of the economy, code specifically for Campylobacter according to the General Rating productivity, competition, jobs, the jejuni. Formula. Thereafter, VA would rate the environment, public health or safety, or VA proposes to rate Campylobacter condition based on residuals, including State, local, or tribal governments or jejuni infection under the General those listed in § 3.317(d), such as communities; (2) Create a serious Rating Formula, meaning that it would reactive arthritis. inconsistency or otherwise interfere receive a 100 percent evaluation during Proposed New Diagnostic Code 6334 with an action taken or planned by active infection. The symptoms of another agency; (3) Materially alter the Campylobacter jejuni infection consist VA proposes a new diagnostic code to budgetary impact of entitlements, of diarrhea, cramping, abdominal pain, encompass infections caused by grants, user fees, or loan programs or the and fever within two to five days after Shigella, which would be rated under rights and obligations of recipients exposure to the bacteria. The diarrhea the General Rating Formula. In 2010, thereof; or (4) Raise novel legal or policy may be bloody and can be accompanied VA issued a regulation presuming issues arising out of legal mandates, the by nausea and vomiting. The illness service connection for Shigella infection President’s priorities, or the principles typically lasts about one week. in certain veterans. See 75 FR 59968 and set forth in this Executive Order.’’ 38 CFR 3.317. To allow for better Campylobacter (Campylobacteriosis), The economic, interagency, tracking of decisions on claims for this CDC (Aug. 30, 2017), https:// budgetary, legal, and policy infection and to more consistently rate www.cdc.gov/campylobacter/ implications of this regulatory action it, VA proposes a diagnostic code index.html. have been examined, and it has been specifically for Shigella infection. determined not to be a significant Thereafter, VA would rate the VA would rate the condition based on regulatory action under E.O. 12866. condition based on residuals listed in residuals, including those listed in VA’s impact analysis can be found as a § 3.317(d), ‘‘Long-Term Health Effects § 3.317(d), such as hemolytic-uremic supporting document at http:// Potentially Associated With Infectious syndrome, and reactive arthritis. Diseases,’’ such as Guillain-Barre www.regulations.gov, usually within 48 syndrome, reactive arthritis, and uveitis. Proposed New Diagnostic Code 6335 hours after the rulemaking document is published. Additionally, a copy of this Proposed New Diagnostic Code 6331 VA proposes a new diagnostic code to encompass infections caused by West rulemaking and its impact analysis are VA proposes a new diagnostic code to Nile virus. In 2010, VA issued a available on VA’s website at http:// encompass infections caused by regulation presuming service www.va.gov/orpm/, by following the Coxiella burnetii. In 2010, VA issued a connection for West Nile virus in link for ‘‘VA Regulations Published regulation establishing that infection certain veterans. See 75 FR 59968. To From FY 2004 Through Fiscal Year to due to Coxiella burnetii (Q fever) is better track claims decisions regarding Date.’’ subject to presumptive service this infection, VA proposes a separate This rule is not an E.O. 13771 connection for certain veterans because diagnostic code for West Nile virus, regulatory action because this rule is not it is (1) prevalent in Southwest Asia, (2) which would be rated under the General significant under E.O. 12866. has been diagnosed among U.S. troops Rating Formula. Regulatory Flexibility Act serving in the Persian Gulf/Southwest VA would rate the condition based on Asia theater of operations, and (3) is residuals, including those listed in The Secretary hereby certifies that known to cause long-term adverse § 3.317(d), such as variable physical, this proposed rule would not have a health effects. See 75 FR 59968 and 38 functional, or cognitive disability. significant economic impact on a CFR 3.317. To track claims for this substantial number of small entities as infection, VA proposes a diagnostic Executive Orders 12866, 13563, and they are defined in the Regulatory code specifically for Coxiella burnetii 13771 Flexibility Act, 5 U.S.C. 601–612. This infection (Q fever). Executive Orders 12866 and 13563 proposed rule would not affect any VA proposes assigning a 100 percent direct agencies to assess the costs and small entities. Only certain VA evaluation during active infection benefits of available regulatory beneficiaries could be directly affected. according to the General Rating alternatives and, when regulation is Therefore, pursuant to 5 U.S.C. 605(b), Formula. Thereafter, VA would rate the necessary, to select regulatory this rulemaking is exempt from the condition based on residuals listed in approaches that maximize net benefits initial and final regulatory flexibility § 3.317(d), such as chronic hepatitis, (including potential economic, analysis requirements of sections 603 endocarditis, osteomyelitis, post Q-fever environmental, public health and safety and 604.

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Unfunded Mandates Affairs proposes to amend 38 CFR part apnea, narcolepsy, and iatrogenic The Unfunded Mandates Reform Act 4 as set forth below: conditions such as side effects of medication. of 1995 requires, at 2 U.S.C. 1532, that PART 4—SCHEDULE FOR RATING agencies prepare an assessment of DISABILITIES (2) Some illnesses, including some anticipated costs and benefits before types of cancers and chronic cases of issuing any rule that may result in the Subpart B—Disability Ratings hepatitis B or C virus infection, which expenditure by State, local, and tribal could explain the presence of chronic governments, in the aggregate, or by the ■ 1. The authority citation for part 4 fatigue, and which have not clearly and private sector, of $100 million or more continues to read as follows: completely resolved. (adjusted annually for inflation) in any Authority: 38 U.S.C. 1155, unless (3) Any past or current diagnosis of: given year. This proposed rule would otherwise noted. have no such effect on State, local, and major depressive disorder with tribal governments, or on the private ■ 2. Revise § 4.88a to read as follows: psychotic or melancholic features, bipolar affective disorders, anorexia sector. § 4.88a Systemic exertion intolerance disease/chronic fatigue syndrome (CFS). nervosa, bulimia nervosa, or any Paperwork Reduction Act subtype of schizophrenia, delusional (a) For VA purposes, the diagnosis of This final rule contains no provisions disorders, or dementias. constituting a collection of information Systemic Exertion Intolerance Disease/ (4) Alcohol or other substance abuse, under the Paperwork Reduction Act of Chronic Fatigue Syndrome (CFS) must occurring within two years of the onset 1995 (44 U.S.C. 3501–3521). meet the following conditions: (1) A severe chronic fatigue that of chronic fatigue and any time Catalog of Federal Domestic Assistance significantly interferes with daily afterwards. Numbers and Titles activities and work. (5) Severe obesity, defined as having The Catalog of Federal Domestic (2) The individual concerned a body mass index equal to or greater Assistance program numbers and titles concurrently has four or more of the than 45. [Body mass index = weight in for this rule are 64.102, Compensation following eight symptoms: kilograms ÷ (height in meters)2]. for Service-Connected Deaths for (i) Post-exertion malaise lasting more Veterans’ Dependents; 64.105, Pension than 24 hours (6) Examination or testing detects any to Veterans, Surviving Spouses, and (ii) Unrefreshing sleep abnormality that strongly suggests an Children; 64.109, Veterans (iii) Significant impairment of short- exclusionary condition that needs to be Compensation for Service-Connected term memory or concentration treated or resolved before attempting Disability; and 64.110, Veterans (iv) Muscle pain further diagnosis. Once fully treated, Dependency and Indemnity (v) Pain in the joints without swelling diagnose accordingly if the individual Compensation for Service-Connected or redness still meets criteria for Systemic Exertion Death. (vi) Headaches of a new type, pattern, Intolerance Disease (SEID)/Chronic or severity Fatigue Syndrome (CFS). List of Subjects in 38 CFR Part 4 (vii) Tender lymph nodes in the neck ■ 3. Amend § 4.88b by: Disability benefits, Pensions, or armpit ■ Veterans. (viii) Sore throat that is frequent or a. Revising the entries for diagnostic codes 6300 through 6302 and 6304 Signing Authority recurring (3) These symptoms: through 6311; The Secretary of Veterans Affairs (i) Cannot have first appeared before ■ b. Adding in numerical order an entry approved this document and authorized the fatigue for diagnostic code 6312; the undersigned to sign and submit the (ii) Have persisted or recurred during document to the Office of the Federal ■ c. Revising the entries for diagnostic six or more consecutive months of codes 6316 through 6320; Register for publication electronically as illness, and ■ an official document of the Department (iii) Are not due to ongoing exertion d. Adding in numerical order entires of Veterans Affairs. Robert L. Wilkie, or other medical conditions associated for diagnostic codes 6325, 6326, 6329 Secretary, Department of Veterans with fatigue, as ruled out by a physician through 6331, and 6333 through 6335; Affairs, approved this document on who administered relevant diagnostic and January 29, 2019, for publication. tests. ■ e. Revising the entries for diagnostic Dated: January 29, 2019. (b) Several past or current medical codes 6351 and 6354. Jeffrey M. Martin, conditions exclude the diagnosis of The revisions and additions read as Assistant Director, Office of Regulation Policy systemic exertion intolerance disease/ follows: & Management, Office of the Secretary, CFS to include: Department of Veterans Affairs. (1) Any active condition that may § 4.88b Schedule of ratings-infectious For the reasons stated in the explain the presence of chronic fatigue, diseases, immune disorders, and nutritional preamble, the Department of Veterans such as untreated hypothyroidism, sleep deficiencies.

Rating

General Rating Formula for Infectious Diseases: For active disease ...... 100 After active disease has resolved, rate at 0 percent for infection. Rate any residual disability of infection within the appropriate body system. 6300 Vibriosis (Cholera, Non-cholera): Evaluate under the General Rating Formula. Note: Rate residuals of cholera and non-cholera Vibrio infections, such as renal failure, skin, and musculoskeletal conditions, within the appropriate body system.

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Rating

6301 Visceral leishmaniasis: As active disease ...... 100 Note 1: Continue a 100 percent evaluation beyond the cessation of treatment for active disease. Six months after discontinu- ance of such treatment, determine the appropriate disability rating 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. Thereafter, rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, liver damage, bone marrow disease, and those residuals listed in § 3.317(d) of this chapter. Note 2: Confirm the recurrence of active infection by culture, histopathology, or other diagnostic laboratory testing. 6302 Leprosy (Hansen’s disease): As active disease ...... 100 Note: Continue a 100 percent evaluation beyond the cessation of treatment for active disease. Six months after discontinu- ance of such treatment, determine the appropriate disability rating 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. Thereafter, rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, skin lesions, peripheral neuropathy, or amputations. 6304 Malaria: Evaluate under the General Rating Formula. Note 1: The diagnosis of malaria, both initially and during relapse, depends on the identification of the malarial parasites in blood smears or other specific diagnostic laboratory tests such as antigen detection, immunologic (immunochromatographic) tests, and molecular testing such as polymerase chain reaction tests. Note 2: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, liver or splenic damage, central nervous system conditions, and those residuals listed in § 3.317(d) of this chapter. 6305 Lymphatic filariasis, to include elephantiasis: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, epididymitis, lymphangitis, lymphatic obstruction, or lymphedema affecting extremities, genitals, and/or breasts. 6306 Bartonellosis: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, endocarditis or skin lesions. 6307 Plague: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection. 6308 Relapsing Fever: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, liver or spleen damage, iritis, uveitis, or central nervous system involvement. 6309 Rheumatic fever: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, heart damage. 6310 Syphilis, and other treponemal infections: Note : Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, diseases of the nervous system, vascular system, eyes, or ears (see DC 7004, DC 8013, DC 8014, DC 8015, and DC 9301). 6311 Tuberculosis, miliary: As active disease ...... 100 Inactive disease: See §§ 4.88c and 4.89. Note 1: Confirm the recurrence of active infection by culture, histopathology, or other diagnostic laboratory testing. Note 2: Rate under the appropriate body system any residual disability of infection which includes, but is not limited to, skin conditions and conditions of the respiratory, central nervous, musculoskeletal, ocular, gastrointestinal, and genitourinary systems and those residuals listed in § 4.88c of this chapter. 6312 Nontuberculosis mycobacterial infection: As active disease ...... 100 Note 1: Continue the rating of 100 percent for the duration of treatment for active disease followed by a mandatory VA exam. If there is no relapse, rate on residuals. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Note 2: Confirm the recurrence of active infection by culture, histopathology, or other diagnostic laboratory testing. Note 3: Rate under the appropriate body system any residual disability of infection which includes, but is not limited to, skin conditions and conditions of the respiratory, central nervous, musculoskeletal, ocular, gastrointestinal, and genitourinary systems and those residuals listed in § 4.88c of this chapter.

******* 6316 Brucellosis: Evaluate under the General Rating Formula. Note 1: Culture, serologic testing, or both must confirm the initial diagnosis and recurrence of active infection. Note 2: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, meningitis, liver, spleen and musculoskeletal conditions, and those residuals listed in § 3.317(d) of this chapter. 6317 Rickettsial, erlichial, and Anaplasma infections: Evaluate under the General Rating Formula. Note 1: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, bone marrow, spleen, central nervous system, and skin conditions. Note 2: This diagnostic code includes, but is not limited to, scrub typhus, Rickettsial pox, African tick-borne fever, Rocky Mountain spotted fever, ehrlichiosis, or anaplasmosis. 6318 Melioidosis:

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Rating

Evaluate under the General Rating Formula. Note 1: Confirm by culture or other specific diagnostic laboratory tests the initial diagnosis and any relapse or chronic activity of infection. Note 2: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, arthritis, lung lesions, or meningitis. 6319 Lyme disease: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, arthritis, Bell’s palsy, radiculopathy, ocular, or cognitive dysfunction. 6320 Parasitic diseases otherwise not specified: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection.

******* 6325 Hyperinfection syndrome or disseminated strongyloidiasis: As active disease ...... 100 Note: Continue the rating of 100 percent through active disease followed by a mandatory VA exam. If there is no relapse, rate on residual disability. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. 6326 Schistosomiasis: As acute or asymptomatic chronic disease ...... 0 Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, conditions of the liver, intestinal system, female genital tract, genitourinary tract, or central nervous system. 6329 Hemorrhagic fevers, including dengue, yellow fever, and others: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, conditions of the central nervous system, liver, or kidney. 6330 Campylobacter jejuni infection: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, Guillain- Barre syndrome, reactive arthritis, or uveitis as specified in § 3.317(d) of this chapter. 6331 Coxiella burnetii infection (Q fever): Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, chronic hepatitis, endocarditis, osteomyelitis, post Q-fever chronic fatigue syndrome, or vascular infections as specified in § 3.317(d) of this chapter. 6333 Nontyphoid Salmonella infections: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, reactive arthritis as specified in § 3.317(d) of this chapter. 6334 Shigella infections: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, hemolytic-uremic syndrome or reactive arthritis as specified in § 3.317(d) of this chapter. 6335 West Nile virus infection: Evaluate under the General Rating Formula. Note: Rate under the appropriate body system any residual disability of infection, which includes, but is not limited to, variable physical, functional, or cognitive disabilities as specified in § 3.317(d) of this chapter.

******* 6351 HIV-related illness: AIDS with recurrent opportunistic infections (see Note 3) or with secondary diseases afflicting multiple body systems; HIV-related illness with debility and progressive weight loss ...... 100 Refractory constitutional symptoms, diarrhea, and pathological weight loss; or minimum rating following development of AIDS- related opportunistic infection or neoplasm ...... 60 Recurrent constitutional symptoms, intermittent diarrhea, and use of approved medication(s); or minimum rating with T4 cell count less than 200 ...... 30 Following development of HIV-related constitutional symptoms; T4 cell count between 200 and 500, and use of approved medication(s); or with evidence of depression or memory loss with employment limitations ...... 10 Asymptomatic, following initial diagnosis of HIV infection, with or without lymphadenopathy or decreased T4 cell count ...... 0 Note 1: In addition to standard therapies and regimens, the term ‘‘approved medication(s)’’ includes treatment regimens and medications prescribed as part of a research protocol at an accredited medical institution. Note 2: Diagnosed psychiatric illness, central nervous system manifestations, opportunistic infections, and neoplasms may be rated separately under the appropriate diagnostic codes if a higher overall evaluation results, provided the disability symptoms do not overlap with evaluations otherwise assignable above. Note 3: The following list of opportunistic infections are considered AIDS-defining conditions, that is, a diagnosis of AIDS follows if a person has HIV and one more of these infections, regardless of the CD4 count—candidiasis of the bronchi, trachea, esophagus, or lungs; invasive cervical cancer; coccidioidomycosis; cryptococcosis; cryptosporidiosis; cytomegalovirus (particularly CMV retinitis); HIV-related encephalopathy; herpes simplex-chronic ulcers for greater than one month, or bronchitis, pneumonia, or esophagitis; histoplasmosis; isosporiasis (chronic intestinal); Kaposi’s sarcoma; lymphoma; Mycobacterium avium complex; tuberculosis; Pneumocystis jirovecii (carinii) pneumonia; pneumonia, recurrent; progressive multifocal leukoencephalopathy; Salmonella septicemia, recurrent; toxoplasmosis of the brain; and wasting syndrome due to HIV. 6354 Systemic exertional intolerance disease/chronic fatigue syndrome (CFS):

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Rating

Debilitating fatigue, cognitive impairments (such as inability to concentrate, forgetfulness, or confusion), or a combination of other signs and symptoms: Which are nearly constant and so severe as to restrict routine daily activities almost completely and which may occasionally preclude self-care ...... 100 Which are nearly constant and restrict routine daily activities to less than 50 percent of the pre-illness level; or which wax and wane, resulting in periods of incapacitation totaling at least six weeks per year ...... 60 Which are nearly constant and restrict routine daily activities from 50 to 75 percent of the pre-illness level; or which wax and wane, resulting in periods of incapacitation totaling at least four but less than six weeks per year ...... 40 Which are nearly constant and restrict routine daily activities by less than 25 percent of the pre-illness level; or which wax and wane, resulting in periods of incapacitation totaling at least two but less than four weeks per year ...... 20 Which wax and wane but result in periods of incapacitation totaling at least one but less than two weeks per year; or symptoms controlled by continuous medication ...... 10 Note: For the purpose of evaluating this disability, incapacitation exists only when a licensed physician prescribes bed rest and treatment.

■ 4. In appendix A to part 4 by: ■ c. Revising the entries for diagnostic ■ e. Revising the entries for diagnostic ■ a. Revising the entries for diagnostic codes 6316–6320; codes 6351 and 6354. ■ codes 6300–6302, 6304–6311; d. Adding in numerical order entries The revisions and additions read as for diagnostic codes 6325, 6326, 6329 follows: ■ b. Adding in numerical order an entry through 6331, and 6333 through 6335; for diagnostic code 6312; and

APPENDIX A TO PART 4—TABLE OF AMENDMENTS AND EFFECTIVE DATES SINCE 1946

Diagnostic Sec. code No.

******* 4.88a ...... March 11, 1969; re-designated § 4.88b November 29, 1994; § 4.88a added to read ‘‘Chronic fatigue syndrome’’; criterion November 29, 1994; title, criterion [insert effective date of final rule]. 4.88b ...... Added March 11, 1969; re-designated § 4.88c November 29, 1994; § 4.88a re-designated to § 4.88b Novem- ber 29, 1994; General Rating Formula for Infectious Diseases added [insert effective date of final rule]. 6300 Criterion August 30, 1996; title, criterion, and note [insert effective date of final rule]. 6301 Criterion, note [insert effective date of final rule]. 6302 Criterion September 22, 1978; criterion August 30, 1996; criterion, note [insert effective date of final rule]. 6304 Evaluation August 30, 1996; criterion, note [insert effective date of final rule]. 6305 Criterion March 1, 1989; evaluation August 30, 1996; title, criterion, note [insert effective date of final rule]. 6306 Evaluation August 30, 1996; criterion, note [insert effective date of final rule]. 6307 Criterion May 13, 2018; criterion, note [insert effective date of final rule]. 6308 Criterion August 30, 1996; criterion, note [insert effective date of final rule]. 6309 Added March 1, 1963; criterion March 1, 1989; criterion August 30, 1996; criterion, note [insert effective date of final rule]. 6310 Criterion, note [insert effective date of final rule]. 6311 Criterion, note [insert effective date of final rule]. 6312 Added [insert effective date of final rule].

******* 6316 Evaluation March 1, 1989; evaluation August 30, 1996; criterion, note [insert effective date of final rule]. 6317 Criterion August 30, 1996; title, criterion, note [insert effective date of final rule]. 6318 Added March 1, 1989; criterion August 30, 1996; criterion, note [insert effective date of final rule]. 6319 Added August 30, 1996; criterion, note [insert effective date of final rule]. 6320 Added August 30, 1996; criterion, note [insert effective date of final rule]. 6325 Added [insert effective date of final rule]. 6326 Added [insert effective date of final rule]. 6329 Added [insert effective date of final rule]. 6330 Added [insert effective date of final rule]. 6331 Added [insert effective date of final rule]. 6333 Added [insert effective date of final rule]. 6334 Added [insert effective date of final rule]. 6335 Added [insert effective date of final rule].

******* 6351 Added March 1, 1989; evaluation March 24, 1992; criterion August 30, 1996; criterion, note [insert effective date of final rule]. 6354 Added November 29, 1994; criterion August 30, 1996; title, criterion, note [insert effective date of final rule].

*******

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■ 5. Amend appendix B to part 4 by: ■ c. Revising the entry for diagnostic The revisions and additions read as ■ a. Revising the entries for diagnostic code 6317; and, follows: codes 6300 and 6305; ■ d. Adding in numerical order entries ■ b. Adding in numerical order an entry for diagnostic codes 6325, 6326, 6329 for diagnostic code 6312; through 6331, and 6333 through 6335.

APPENDIX B TO PART 4—NUMERICAL INDEX OF DISABILITIES

Diagnostic code No.

*******

INFECTIOUS DISEASES, IMMUNE DISORDERS AND NUTRITIONAL DEFICIENCIES

******* 6300 ...... Vibriosis (Cholera, Non-cholera).

******* 6305 ...... Lymphatic filariasis, to include elephantiasis.

******* 6312 ...... Nontuberculosis mycobacterial infection.

******* 6317 ...... Rickettsial, erlichial, and Anaplasma infections.

******* 6325 ...... Hyperinfection syndrome or disseminated strongyloidiasis. 6326 ...... Schistosomiasis. 6329 ...... Hemorrhagic fevers, including dengue, yellow fever, and others. 6330 ...... Campylobacter jejuni infection. 6331 ...... Coxiella burnetii infection (Q Fever). 6333 ...... Nontyphoid salmonella infections. 6334 ...... Shigella infections. 6335 ...... West Nile virus infection.

******* 6351 ...... HIV-related infection. 6356 ...... Systemic exertional intolerance disease/chronic fatigue syndrome (CFS).

■ 6. Amend appendix C to part 4 by: dengue, yellow fever, and others’’, and Anaplasma infections’’, Shigella ■ a. Adding in alphabetical order an ‘‘Hyperinfection syndrome or infections, and ‘‘Schistosomiasis’’; entry for ‘‘Campylobacter jejuni disseminated strongyloidiasis’’; ■ f. Removing the entry for ‘‘Typhus, infection’’; ■ d. Revise the entry for ‘‘Lymphatic scrub’’; and ■ b. Removing the entry for ‘‘Cholera, filariasis’’; ■ g. Adding in alphabetical order entries Asiatic’’; ■ e. Adding in alphabetical order entries for ‘‘Vibriosis (Cholera, Non-cholera)’’ ■ c. Adding in alphabetical order entries for ‘‘Nontuberculosis mycobacterial and ‘‘West Nile virus infection’’ for ‘‘Coxiella burnetii infection (Q infection’’, ‘‘Nontyphoid salmonella The additions and revisions read as Fever)’’, ‘‘Hemorrhagic fevers, including infection’’, ‘‘Rickettsial, erlichial, and follows:

APPENDIX C TO PART 4—ALPHABETICAL INDEX OF DISABILITIES

Diagnostic code No.

******* Campylobacter jejuni infection ...... 6330

******* Coxiella burnetii infection (Q Fever) ...... 6331

******* Hemorrhagic fevers, including dengue, yellow fever, and others) ...... 6329

******* Hyperinfection syndrome or disseminated strongyloidiasis ...... 6325

******* Lymphatic filariasis, to include elephantiasis ...... 6305

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APPENDIX C TO PART 4—ALPHABETICAL INDEX OF DISABILITIES—Continued

Diagnostic code No.

******* Nontyphoid salmonella infection ...... 6333

******* Nontuberculosis mycobacterial infection ...... 6312

******* Rickettsial, erlichial, and Anaplasma Infections ...... 6317

******* Schistosomiasis ...... 6326

******* Shigella infections ...... 6334

******* Vibriosis (Cholera, Non-cholera) ...... 6300

******* West Nile virus infection ...... 6335

*******

[FR Doc. 2019–00636 Filed 2–4–19; 8:45 am] program and revise the Federal additional submission methods, the full BILLING CODE 8320–01–P Implementation Plan for the Kalispel EPA public comment policy, Reservation and State Implementation information about CBI or multimedia Plan for the State of Washington submissions, and general guidance on ENVIRONMENTAL PROTECTION accordingly. A commenter requested making effective comments, please visit AGENCY additional time to review the proposal https://www.epa.gov/dockets/ and prepare comments. In response to commenting-epa-dockets. 40 CFR Parts 49 and 52 this request, the EPA is reopening the comment period. FOR FURTHER INFORMATION CONTACT: [EPA–R10–OAR–2017–0347; FRL–9988–88– Sandra Brozusky at (206) 553–5317, or DATES: Region 10] The comment period for the [email protected]. proposed rule published October 31, Indian Country: Air Quality Planning 2018 (83 FR 54691), is reopened, and SUPPLEMENTARY INFORMATION: On and Management; Federal written comments must be received on October 31, 2018, the EPA published a Implementation Plan for the Kalispel or before February 20, 2019. proposed rulemaking to approve the Indian Community of the Kalispel ADDRESSES: Submit your comments, Kalispel Indian Community of the Reservation, Washington; identified by Docket ID No. EPA–R10– Kalispel Reservation’s request to Redesignation to a PSD Class I Area OAR–2017–0347 at https:// redesignate certain lands within its AGENCY: Environmental Protection www.regulations.gov. Follow the online reservation to a Class I area under the Agency (EPA). instructions for submitting comments. Prevention of Significant Deterioration ACTION: Notice of proposed rulemaking; Once submitted, comments cannot be program and revise the Federal reopening of comment period. edited or removed from Regulations.gov. Implementation Plan for the Kalispel The EPA may publish any comment Reservation (40 CFR part 49, subpart M) SUMMARY: The Environmental Protection received to its public docket. Do not and State Implementation Plan for the Agency (EPA) is reopening the public submit electronically any information State of Washington (40 CFR part 52, comment period for the proposed rule you consider to be Confidential subpart WW) accordingly. (83 FR ‘‘Indian Country: Air Quality Planning Business Information (CBI) or other 54691). A commenter requested and Management; Federal information, the disclosure of which is additional time to review the proposal Implementation Plan for the Kalispel restricted by statute. Multimedia and prepare comments. In response to Indian Community of the Kalispel submissions (audio, video, etc.) must be this request, the EPA is reopening the Reservation, Washington; Redesignation accompanied by a written comment. comment period. to a PSD Class I Area’’ published on The written comment is considered the October 31, 2018. In the October 31, official comment and should include Dated: December 20, 2018. 2018, publication, the EPA proposed to discussion of all points you wish to Michelle L. Pirzadeh, approve the Kalispel Indian Community make. The EPA will generally not Acting Regional Administrator, Region 10. of the Kalispel Reservation’s request to consider comments or comment [FR Doc. 2019–00935 Filed 2–4–19; 8:45 am] redesignate certain lands within its contents located outside of the primary BILLING CODE 6560–50–P reservation to a Class I area under the submission (i.e., on the web, cloud, or Prevention of Significant Deterioration other file sharing system). For

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