[Federal Register: November 29, 1994] DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 4 RIN 2900-AG86 Chronic Fatigue Syndrome AGENCY: Department of Veterans Affairs. ACTION: Interim rule with request for comments. ----------------------------------------------------------------------- SUMMARY: This document amends the Department of Veterans Affairs (VA) Schedule for Rating Disabilities by adding a diagnostic code and evaluation criteria for chronic fatigue syndrome. The intended effect of this amendment is to ensure that veterans diagnosed with this condition meet uniform criteria and receive consistent evaluations. DATES: Comments must be received on or before January 30, 1995. This amendment is effective November 29, 1994. ADDRESSES: Mail written comments to: Director, Office of Regulations Management (02D), Department of Veterans Affairs, 810 Vermont Ave., NW, Washington, DC 20420 or hand deliver written comments to: Office of Regulations Management, Room 1176, 801 Eye Street, NW, Washington, DC 20001. Comments should indicate that they are submitted in response to ``RIN 2900-AG86.'' All written comments received will be available for public inspection in the Office of Regulations Management, Room 1176, 801 Eye Street, NW, Washington, DC 20001 between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). FOR FURTHER INFORMATION CONTACT: Caroll McBrine, M.D., Consultant, Regulations Staff, Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington DC 20420, (202) 273-7210. SUPPLEMENTARY INFORMATION: Chronic fatigue syndrome (CFS), while similar to syndromes described in the last century, such as neurasthenia, is a syndrome in which there has been renewed interest in recent years. This document establishes a diagnostic code and criteria for its evaluation. While this condition is of unknown etiology, we have included it with systemic diseases, now designated Sec. 4.88b, because it often involves many body systems, and may be of infectious or immune origin, similar to other diseases in this section. CFS is a condition characterized by non-specific symptoms. Because it has been ill-defined and sometimes confused with other conditions, we have provided required diagnostic criteria for VA purposes in Sec. 4.88a. These criteria are based on diagnostic criteria for CFS provided in a pamphlet entitled ``Chronic Fatigue Syndrome--A Pamphlet for Physicians'' published in May, 1992 by the U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health (NIH Publication No. 92-484). The diagnosis of CFS, according to the NIH pamphlet, requires the presence of two major criteria: (1) The new onset of persistent or relapsing debilitating fatigue or easy fatigability in a person who has no previous history of similar symptoms, that does not resolve with bedrest, and that is severe enough to reduce or impair average daily activity below 50% of the patient's premorbid activity level for a period of at least six months, and (2) other clinical conditions that may produce similar symptoms must be excluded by thorough evaluation, based on history, physical examination, and appropriate laboratory findings. In addition to these major criteria, there must be either at least six of eleven specified symptoms plus at least two of three physical criteria, or at least eight of the specified eleven symptoms. These criteria are set forth in the final rule in a simplified form that is not intended to be materially different from that contained in the NIH pamphlet. We have established three criteria for diagnosis: (1) The new onset of debilitating fatigue that is severe enough to reduce daily activity below 50 percent of the usual level for at least six months, (2) the exclusion by history, examination and laboratory tests of other clinical conditions that may produce similar symptoms, and (3) the presence of six or more of the following: acute onset of the condition, low grade fever, nonexudative pharyngitis, palpable or tender cervical or axillary lymph nodes, generalized muscle aches or weakness, fatigue lasting 24 hours or longer after exercise, headaches (of a type, severity, or pattern that is different from headaches in the pre-morbid state), migratory joint pains, neuropsychologic symptoms, sleep disturbance. Following the initial six-month period of illness required to establish the diagnosis, some people function well at home and work, while others are partially or totally disabled by the debilitating fatigue and other symptoms, which often wax and wane. We will evaluate the condition based either on symptoms of the syndrome as they affect routine daily activities or on the periods of incapacitation which result. While a reduction in daily activities of 50 percent for six months is required to establish the diagnosis, thereafter CFS may be manifested at other levels of severity. We have thus provided evaluation levels of 10, 20, 40, 60 and 100 percent; the 10% evaluation will be assigned for the condition when symptoms are controlled by continuous medication. We have also included a note defining incapacitation, a term used in the criteria, as a requirement for bed rest and treatment by a physician. According to the Centers for Disease Control (CDC) , approximately 50 percent of individuals suspected of having CFS show signs of psychiatric illness before the onset of CFS symptoms (``Chronic Fatigue Syndrome'', Disease Directory Document #362100, CDC FAX Information Service, November 18, 1993). It is also possible that there may be a secondary mental disorder in some cases that encompasses some or all of the neuropsychologic symptoms used to establish the diagnosis of CFS. This would not, however, negate the diagnosis of CFS. It is necessary to make this rule effective upon publication. Unlisted conditions are rated under the schedules for closely related conditions. However, because of the variety of analogous conditions to be considered with chronic fatigue syndrome, it is necessary to establish a final rule immediately in order to avoid inconsistency in evaluations. Comments have been solicited for 60 days after publication of this document. VA may modify the rule in response to comments, if appropriate. Because no notice of proposed rulemaking was required in connection with the adoption of this interim final rule, no regulatory flexibility analysis is required under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Further, this amendment would not directly affect any small entities since it would affect only individuals. This rule has been reviewed as a ``significant regulatory action'' under E.O. 12866 by the Office of Management and Budget. The Catalog of Federal Domestic Assistance program numbers are 64.104 and 64.109. List of Subjects in 38 CFR Part 4 Individuals with disability, Pensions, Veterans. Approved: August 1, 1994. Jesse Brown, Secretary of Department of Veterans Affairs. For the reasons set out in the preamble, 38 CFR part 4, subpart B, is amended as set forth below: PART 4--SCHEDULE FOR RATING DISABILITIES Subpart B--Disability Ratings 1. The authority citation for part 4 is revised to read as follows: Authority: 38 U.S.C. 1155. Sec. 4.88a [Redesignated as Sec. 4.88b] Sec. 4.88b [Redesignated as Sec. 4.88c] 2. Sections 4.88a and 4.88b are redesignated 4.88b and 4.88c respectively. 3. Section 4.88a is added to read as follows: Sec. 4.88a Chronic fatigue syndrome. (a) For VA purposes, the diagnosis of chronic fatigue syndrome requires: (1) new onset of debilitating fatigue severe enough to reduce daily activity to less than 50 percent of the usual level for at least six months; and (2) the exclusion, by history, physical examination, and laboratory tests, of all other clinical conditions that may produce similar symptoms; and (3) six or more of the following: (i) acute onset of the condition, (ii) low grade fever, (iii) nonexudative pharyngitis, (iv) palpable or tender cervical or axillary lymph nodes, (v) generalized muscle aches or weakness, (vi) fatigue lasting 24 hours or longer after exercise, (vii) headaches (of a type, severity, or pattern that is different from headaches in the pre-morbid state), (viii) migratory joint pains, (ix) neuropsychologic symptoms, (x) sleep disturbance. (b) [Reserved] 4. Newly redesignated section 4.88b is amended by adding diagnostic code 6354 following diagnostic code 6351, to read as follows: Sec. 4.88b Schedule of ratings--systemic diseases. ------------------------------------------------------------------------ Rating ------------------------------------------------------------------------ ***** 6354Chronic Fatigue Syndrome (CFS): Debilitating fatigue, cognitive impairments (such as inability to concentrate, forgetfulness, 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 of at least six weeks total duration per year...................................................... 60 Which are nearly constant and restrict routine daily activities to 50 to 75 percent of the pre-illness level; or which wax and wane, resulting in periods of incapacitation of at least four but less than six weeks total duration 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 of at least two but less than four weeks total duration per year................................... 20 Which wax and wane but result in periods of incapacitation of at least one but less than two weeks total duration per year; or symptoms controlled by continuous medication..... 10 Note: For the purpose of evaluating this disability, the condition will be considered incapacitating only while it requires bed rest and treatment by a physician. ***** ------------------------------------------------------------------------ [FR Doc. 94-29274 Filed 11-28-94; 8:45 am] BILLING CODE 8320-01-P