Chronic Fatigue Syndrome

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.

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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.

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Rating

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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.

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[FR Doc. 94-29274 Filed 11-28-94; 8:45 am]

BILLING CODE 8320-01-P