Compensation for Certain Undiagnosed Illnesses

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AH35

Compensation for Certain Undiagnosed Illnesses

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA)

adjudication regulations to authorize compensation for disabilities

resulting from the undiagnosed illnesses of Persian Gulf veterans. This

amendment provides the necessary regulatory framework to allow the

Secretary to pay compensation under the authority granted by the

Persian Gulf War Veterans' Benefits Act.

EFFECTIVE DATE: November 2, 1994, the effective date of Title I of

Public Law 103-446.

FOR FURTHER INFORMATION CONTACT: Steven Thornberry, Consultant,

Regulations Staff, Compensation and Pension Service, Veterans Benefits

Administration, 810 Vermont Avenue, NW, Washington, DC 20420, telephone

(202) 273-7210.

SUPPLEMENTARY INFORMATION: ``The Persian Gulf War Veterans' Benefits

Act,'' Title I of Public Law 103-446, authorizes the Secretary of

Veterans Affairs to compensate any Persian Gulf veteran suffering from

a chronic disability resulting from an undiagnosed illness or

combination of undiagnosed illnesses that became manifest either during

active duty in the Southwest Asia theater of operations during the

Persian Gulf War or to a degree of 10 percent or more within a

presumptive period following such service, as determined by the

Secretary. On December 8, 1994, VA published a proposed rule to

implement the statute (59 FR 63283-85). We requested that comments to

the proposed rule be submitted on or before January 9, 1995. We

received 10 comments.

We had proposed that, for the purposes of Sec. 3.317, a disability

resulting from an undiagnosed illness would be considered chronic if it

had existed for 6 months or more. One commenter recommended that VA

consider disabilities subject to [[Page 6661]] intermittent periods of

improvement and worsening over a 6-month period as chronic.

VA agrees that including this concept in the rule will promote

clarity and ensure that the criteria for chronicity are consistently

applied. Therefore, we have revised Sec. 3.317(a) as the commenter

suggested.

Another commenter recommended that the rule specify the point from

which VA would measure chronicity, i.e., forward from the date symptoms

were first reported or backward from date of claim.

The 6-month period of chronicity will be measured from the earliest

date the symptoms of the disability became manifest, whether as

reported and documented during the course of a medical examination or

as established by other, non-medical evidence. In order to ensure

proper understanding, we have revised Sec. 3.317(a) to clarify this

issue.

Another commenter objected to defining a chronic disease as one

which has existed for at least 6 months and suggested that chronicity

be determined on the basis of clinical and laboratory findings and

application of the criteria for a showing of chronic diseases in 38 CFR

3.303(b).

VA does not agree. The criteria of Sec. 3.303(b) require a

combination of manifestations sufficient to identify the disease entity

and sufficient observation to establish chronicity at the time. So long

as we are dealing with a known disease whose clinical course is

familiar, those criteria are appropriate. In our judgment, however,

they are not appropriate for dealing with an undiagnosed illness, which

cannot be associated with a known disease process and the clinical

course of which cannot be predicted. In these cases, it is essential to

establish an objective indicator of chronicity to ensure that the same

standard will be applied in every case. Therefore, we have adopted 6

months, a period commonly accepted within the medical community for

that purpose, as the standard for determining chronicity.

One commenter recommended that the regulation include a statement

that objective indications of disability mean both ``signs'' in the

medical sense and non-medical indicators capable of independent

verification, as VA stated in the preamble to the proposed rule.

We agree with the commenter's recommendation and have amended

Sec. 3.317(a) accordingly.

Another commenter suggested that the regulation explicitly state

how many ``signs or symptoms'' of undiagnosed illness must be present

for a veteran to be eligible for compensation under Sec. 3.317. The

commenter stated that it appears that VA would accept even a single

symptom as sufficient to qualify.

The commenter is correct in assuming that a single symptom or sign

may be sufficient to establish entitlement under Sec. 3.317, provided

it is determined to be the result of an undiagnosed illness. This was

intended by our proposed Sec. 3.317(a)(1): ``* * * objective

indications of chronic disability * * * manifested by one or more signs

and symptoms * * *'' (emphasis added). However, as further

clarification, we have amended the words ``signs and symptoms'' to read

``signs or symptoms.''

The proposed regulation, as required by the statute, contained a

list of 13 categories of signs and symptoms which might be

manifestations of undiagnosed illnesses. One commenter said that it was

not clear why VA considered some of the 13 signs and symptoms listed at

Sec. 3.317(b) undiagnosable. As an example, the commenter referred to

fatigue lasting longer than 6 months as having a known diagnosis,

already recognized by VA, of chronic fatigue syndrome (CFS).

The signs and symptoms listed at Sec. 3.317(b) represent possible

manifestations of undiagnosed illnesses. However, the commenter's

implication that a medically verifiable sign of an illness constitutes

a diagnosis of a specific disease is not correct. A ``disease'' is

manifested by a characteristic set of symptoms and signs (Dorland's

Illustrated Medical Dictionary, 27th ed.). A single sign or symptom may

be among the characteristic signs and symptoms of more than one

disease, depending on any other signs and symptoms with which it

appears. Many Persian Gulf veterans, however, have come forward with

signs and symptoms which are not characteristic of any known disease.

The commenter's assertion that fatigue lasting longer than 6 months

by itself equates to CFS is also incorrect. VA has adopted criteria for

CFS similar to those contained in guidelines published by the U.S.

Department of Health and Human Services (HHS), which require a

combination of several major and minor criteria to establish a

diagnosis of CFS (see the Federal Register of November 29, 1994, 59 FR

60901). The major criteria include fatigue so severe as to reduce daily

activities below 50 percent of the usual, pre-illness level for at

least 6 months. Fatigue of a lesser severity, which does not last for 6

months, or which is not accompanied by the major or minor criteria

recognized by VA, would not support a diagnosis of CFS. If that fatigue

does not fall among the characteristic signs and symptoms of another

disease, it certainly might indicate the presence of an undiagnosed

illness.

This same commenter stated that VA has a working definition of

``Persian Gulf Syndrome'' that lists many of the 13 signs and symptoms

listed at Sec. 3.317(b) and wondered why this ``syndrome'' is not cited

in that paragraph.

``Persian Gulf Syndrome'' is not a disease entity currently

recognized by VA or commonly accepted within the medical community. VA

has, in fact, been unable to establish a single ``working definition,''

and any working definition, by its very nature, would not find a firm

basis in the current scientific and medical evidence and, in our

judgment, should not be used to establish entitlement under the

provisions of this rule. The purpose of this rule making is not to

define by regulation what the medical community has yet to identify or

define, but rather to establish criteria for paying compensation to

Persian Gulf veterans suffering from chronic disabilities resulting

from undiagnosed illnesses.

One commenter recommended that Sec. 3.317(b) specify that other

signs and symptoms might qualify as possible manifestations of

undiagnosed illness.

The list at Sec. 3.317(b) is simply a guideline presenting the

symptoms and signs which have been encountered in over 17,000 completed

and analyzed examinations of participants in VA's Persian Gulf Health

Registry. The categories are broad and encompass a wide range of

conditions and complaints. Section 3.317(b) itself clearly indicates

that this list is not exclusive, and we do not believe that revising

the language would make the point any clearer.

Another commenter stated that many Persian Gulf veterans also

complained of hair loss and memory loss and requested that VA clarify

whether these conditions are encompassed by the 13 listed categories.

Hair loss is included within the category ``signs and symptoms

involving skin'' (Sec. 3.317(b)(2)), and memory loss is included within

the category ``neuropsychological signs or symptoms''

(Sec. 3.317(b)(7)). This is consistent with current VA rating

procedures, and we see no need to make the list more specific, since

any attempts to expand the list and make it exclusive might

inadvertently omit conditions that could be manifestations of

undiagnosed illnesses.

[[Page 6662]]

One commenter recommended that VA alter the wording of proposed

Sec. 3.317(a)(3) (Sec. 3.317(a)(4) in the final rule), which provides

that VA will evaluate chronic disabilities of undiagnosed illnesses

using the criteria of VA's Rating Schedule for a disease or injury in

which ``the functions affected, anatomical localization, and

symptomatology are similar,'' to read ``the functions affected,

anatomical localization, or symptomatology.''

Since we intend to allow rating specialists enough flexibility to

rate as accurately and fairly as possible, we have amended the language

as the commenter suggested.

This same commenter also recommended that VA develop full rating

criteria specific to the undiagnosed illnesses of Persian Gulf

veterans, and covering the full range of physiological and

psychological disabilities being reported.

Although Persian Gulf veterans have reported that they are

suffering from a variety of signs and symptoms, the scientific and

medical communities have been unable to identify a single disease

process and, in fact, have suggested that more than one disease

category may be involved. Our purpose in this rule making is to

authorize compensation for the disabilities resulting from the

undiagnosed illnesses, and, in our judgment, the criteria in the Rating

Schedule are adequate to evaluate any disabilities which may arise.

One commenter recommended that VA revise Sec. 3.317 to specify that

service connection may be recognized for aggravation of a preexisting

undiagnosed illness during service in the Southwest Asia theater of

operations or during the presumptive period.

VA does not agree. In enacting Public Law 103-446, Congress

authorized VA to compensate Persian Gulf veterans who suffer chronic

disabilities resulting from undiagnosed illnesses that became manifest

during active service in the Southwest Asia theater of operations or

within a presumptive period thereafter, as determined by the Secretary.

It would exceed the Secretary's statutory authority to compensate for

aggravation of disabilities resulting from preexisting undiagnosed

illnesses. Furthermore, since the course of an undiagnosed illness

cannot be predicted, it would be impossible to determine whether an

increase in disability was due to the natural progress of the illness

or to aggravation during service.

The proposed regulation contained provisions prohibiting payment of

compensation where affirmative evidence establishes that an undiagnosed

illness was not incurred during active service in the Persian Gulf

(Sec. 3.317(c)(1)), and where affirmative evidence establishes that an

undiagnosed illness is the result of a supervening condition or event

that occurred following the veteran's most recent departure from the

Southwest Asia theater of operations and the onset of the illness

(Sec. 3.317(c)(2)). One commenter stated that Sec. 3.317(c)(1) was

redundant and unnecessary in light of Sec. 3.317(c)(2).

VA does not agree. The prohibition contained in Sec. 3.317(c)(2)

applies whether the illness was alleged to have occurred during service

in the Southwest Asia theater of operations or during the presumptive

period thereafter. However, since Public Law 103-446 did not

contemplate eligibility by reason of aggravation of a pre-existing

undiagnosed illness, the provisions of Sec. 3.317(c)(1) are necessary

to ensure that entitlement to compensation is properly established.

One commenter stated that the ``affirmative evidence'' standard for

determining that an undiagnosed illness was the result of a supervening

condition or event does not equate to any standard known in law but is

rather an arbitrary standard established by VA. The commenter suggested

substituting the recognized legal standard of ``clear and convincing

evidence.''

VA does not agree. In fact, the standard of ``affirmative

evidence'' is long established in the statutes and regulations

governing VA benefits. It is used in 38 U.S.C. 1113 to define the type

of evidence sufficient to rebut a presumption of service connection.

Congress again adopted the term at 38 U.S.C. 1116(a)(3), which provides

that a veteran who served in the Republic of Vietnam during the Vietnam

era and has one of the presumptive diseases related to herbicide

exposure will be presumed to have been exposed to herbicides ``unless

there is affirmative evidence'' to the contrary. Under 38 CFR 3.307(d),

affirmative evidence accepted to rebut a presumption of service

connection, although not requiring a conclusive showing, must,

nonetheless, be competent to indicate the time of existence or

inception of a disease and must support a conclusion that a disease was

not incurred in service. We believe that this standard is both

reasonable for determining whether a claimed undiagnosed illness is the

result of a supervening condition and consistent with standards that VA

applies to presumption for diagnosed conditions.

One commenter recommended that the regulation define the term

``known clinical diagnosis'' in order to specify the criteria to be

applied in determining whether a condition qualifies as an undiagnosed

illness.

VA does not agree. The concept of what constitutes a ``known

clinical diagnosis'' is not such a matter of uncertainty within the

medical community as the commenter has implied. Examining physicians

routinely determine whether or not an illness is part of a disease

process that follows a particular clinical course which can be

generally predicted. If the physician is unable to attribute a

disability to such a known clinical diagnosis, he or she would

routinely include a statement to that effect on the examination report.

In the event of conflicting findings, it would be incumbent upon VA to

resolve the issue on the basis of all medical evidence of record.

Another commenter believed that the requirement for a finding of

undiagnosed illness is outside currently accepted standards of medical

practice and that physicians should not be required to make a diagnosis

of an ``undefined non-disease.''

The regulation does not require that physicians make such a

diagnosis. Physicians should simply record all noted signs and reported

symptoms, document all clinical findings, and provide a diagnosis where

possible. If the signs and symptoms are not characteristic of a known

clinical diagnosis, the physician should so indicate. This conforms

with the usual standards of medical practice.

The proposed regulation provided that VA shall pay compensation to

a Persian Gulf veteran who exhibits objective indications of chronic

disability resulting from an undiagnosed illness or combination of

illnesses as manifested by one of the 13 signs and symptoms listed at

Sec. 3.317(b). One commenter stated that objective verification of

symptoms by an examining physician would be impossible, since most of

the 13 signs and symptoms are subjective. He predicted that many

veterans would not present with objective signs perceptible to

examining physicians and that, therefore, examinations would be judged

inadequate or claims would be denied for a lack of objective evidence.

Another commenter recommended that VA omit the word ``objective.''

VA does not agree. Some veterans may present with purely subjective

symptoms, which, nonetheless, establish the basis for a valid claim

under the provisions of this rule. We believe, however, that it is not

only fair but also in keeping with Congressional intent to require some

objective [[Page 6663]] indication of the presence of a chronic

disability attributable to an undiagnosed illness before awarding

compensation. In the House of Representatives report on H.R. 4386, an

earlier version of Persian Gulf legislation, the Committee on Veterans'

Affairs stated its intention ``that there must be some objective

indication or showing of the disability which is observable by a person

other than the veteran, or for which medical treatment has been

sought.'' (House Report # 103-669, p. 7.) Similarly, at a September 14,

1994, hearing on the Senate Committee on Veterans' Affairs, Senator

Rockefeller, then Chairman of the Committee, stated that in introducing

S. 2330, an earlier Senate version of the legislation, it was his

intention that compensation be paid in situations where a veteran ``has

symptoms that can be verified by objective tests that show that the

[veteran] is not well.'' (S. Hrg. 103-829, p. 3.)

Ordinarily, an objective indication is established through medical

findings, i.e., ``signs'' in the medical sense of evidence perceptible

to an examining physician. However, we also will consider non-medical

indications which can be independently observed or verified, such as

time lost from work, evidence that a veteran has sought medical

treatment for his or her symptoms, evidence affirming changes in the

veteran's appearance, physical abilities, and mental or emotional

attitude, etc. Lay statements from individuals who establish that they

are able from personal experience to make their observations or

statements will be considered as evidence when VA determines whether

the veteran is suffering from an undiagnosed illness.

Two commenters suggested that where the previously undiagnosed

illness of a veteran is subsequently diagnosed, compensation under

Sec. 3.317 should continue until a decision on eligibility under other

statutory or regulatory provisions has been reached.

Once the illness in a particular case has been diagnosed and a

veteran is no longer entitled to compensation under the provisions of

Sec. 3.317, the provisions of Sec. 3.500(y) require termination of

compensation as of the last day of the month in which 60 days following

the final rating decision expires. However, VA will simultaneously

begin consideration of potential entitlement under other statutory and

regulatory provisions and will initiate any required development for

additional evidence. Although the 60-day period of Sec. 3.500(y) is

fixed in accordance with the requirements of 38 CFR 3.105(d) and (e),

those sections of the regulations also provide for a 60-day

predetermination period prior to final rating action in order to

safeguard a veteran's due process rights. We believe that a decision on

entitlement under other provisions can be made prior to termination or

reduction under Sec. 3.500(y).

While the possibility remains that some awards under Sec. 3.317

might be terminated prior to a final determination of entitlement under

other provisions, we have no authority to pay compensation in the

absence of an actual determination of entitlement. However, if payment

is terminated but entitlement is subsequently established on another

basis, payments may be made retroactive to the date compensation under

the provisions of Sec. 3.317 was terminated.

One commenter recommended that this regulation state that if

scientific research eventually establishes that the signs and symptoms

of Persian Gulf veterans with undiagnosed illnesses constitute a

syndrome which can be attributed to service in the Persian Gulf, the

provisions of 38 CFR 3.303(d) will provide a basis for establishing

service connection for this syndrome.

VA does not agree. Section 3.303(d) provides that, notwithstanding

statutory presumptive periods, service connection may be granted for a

disease first diagnosed after discharge from service when all pertinent

evidence establishes that the disease was incurred in service. However,

so long as medical and scientific research has not established that

some or all Persian Gulf veterans with undiagnosed illnesses are in

fact suffering from a recognizable disease process attributable to

service in the Gulf, any regulatory assumption that research will, in

fact, eventually support such a finding would be conjectural and

premature.

One commenter remarked that VA, in establishing a presumptive

period, seems not to have taken into account either credible scientific

and medical evidence or pertinent circumstances regarding the

experiences of Persian Gulf veterans and, thus, failed to meet

statutory requirements of Public Law 103-446.

VA does not agree. Public Law 103-446 required VA to determine an

appropriate presumptive period following a review of the credible

scientific and medical evidence and the historical treatment afforded

disabilities for which manifestation periods have been established, and

taking into account other pertinent circumstances regarding the

experiences of veterans of the Persian Gulf War. Although many veterans

began to develop unexplained signs and symptoms of illness shortly

after their return from the Persian Gulf, there is as yet little or no

medical or scientific evidence definitively linking the illnesses with

service in the Gulf, and the credible evidence available supports no

conclusions regarding etiology or definition of these illnesses. The

National Institutes of Health (NIH)-sponsored Technology Assessment

Workshop on the Persian Gulf Experience and Health, held in April 1994,

concluded that it was not possible to establish a single case

definition for the illnesses of Persian Gulf veterans and that, in

fact, more than one disease category might be present, with overlapping

symptoms and causes. More recently, a report of the Medical Follow-up

Agency of the Institute of Medicine (IOM), published in January of this

year, endorsed the report of the NIH panel comprized of non-government

experts and stated that ``[t]he Gulf War illness phenomenon may prove

to be a mixture of several illnesses, or may prove not to be associated

with a specific exposure or disease.'' The IOM report further concluded

that establishment of a case definition was ``handicapped by the lack

of any generally recognized pathognomonic physical signs or laboratory

findings, and by uncertainty about whether a specific syndrome exists

and, if it does exist, its prevalence among Gulf War veterans. The

subjectivity of many of the complaints associated with the Gulf War

illness creates serious problems for those seeking to investigate the

validity and origins of the illness.'' (Health Consequences of Service

During the Persian Gulf War: Initial Findings and Recommendations for

Immediate Action, National Academy Press, 1995, p. 26.) Given this

uncertainty of available scientific and medical evidence, we felt that

a presumptive period could not be established on this basis, and we

looked to the other 2 factors, historical treatment and pertinent

circumstances, to determine an appropriate period.

For many years Congress has authorized a one-year presumptive

period for various chronic diseases, many of which present signs and

symptoms similar to those of the undiagnosed illnesses of Persian Gulf

veterans (see 38 U.S.C. 1101(3) and 1112(a)). This historical treatment

of chronic diseases might indicate that a one-year presumptive period

would be warranted for the undiagnosed illnesses of Persian Gulf

veterans. We felt, however, that a one-year presumptive period would

not meet the particular needs of these veterans, because it was

[[Page 6664]] not immediately apparent when most of them left the

Southwest Asia theater of operations that their signs and symptoms,

which some believed resulted from exposure to environmental hazards,

would present the problems of diagnosis and etiology that remain

unresolved today. We believe that two years following service in the

Gulf provides an adequate period of time in which all veterans of the

hostilities would have become aware of the potential significance of

their symptoms and have had an opportunity to present and document

health concerns that arose soon after their departure from the Gulf.

Certainly by the end of the first 2 years following their return, there

were great public awareness of and concern for Persian Gulf veterans

with unexplained illnesses that defied diagnosis but seemed to be in

some way linked to service in the Persian Gulf.

An additional reason for establishing a 2-year presumptive period

rather than a one-year period is that VA did not begin full-scale

operation of its Persian Gulf Health Registry until November 1992.

Because many Persian Gulf veterans first presented their health

concerns in connection with VA's Persian Gulf Health Registry

examination, veterans of the actual hostilities, who began to return

from the Gulf by mid-1991, did not have this resource available to them

within their first year after leaving the Gulf. Within 2 years,

however, all veterans of the hostilities would have had this

opportunity to document their illnesses. Therefore, we established a 2-

year presumptive period running from the date of a veteran's last

service in the Southwest Asia theater of operations.

Two commenters recommended that in establishing a presumptive

period VA take into account the bases for the longer presumptive

periods established for certain diseases associated with radiation and

herbicide exposure. One of these same commenters specifically

recommended establishing a presumptive period based on the onset of

symptoms of ``slow viruses,'' which may take up to 8 years to become

manifest.

VA does not agree. Where scientific and medical evidence has

concluded that manifestation of a disease may be delayed following

exposure to specific substances, such as herbicides or radiation, that

evidence might justify establishment of an appropriate presumptive

period. However, medical and scientific evidence addressing the latency

periods of known diseases cannot form a basis for determining a latency

period for undiagnosed illnesses. Longer or open-ended presumptive

periods for certain diseases, such as those associated with exposure to

radiation or herbicides, were established only following many years of

extensive research. For example, to assist in determining what diseases

may be associated with exposure to herbicides used in the Republic of

Vietnam during the Vietnam era, VA contracted with the National Academy

of Sciences (NAS) to do a review of the available scientific and

medical literature. The NAS subsequently reviewed 6,420 abstracts of

scientific or medical studies and approximately 230 epidemiological

studies prior to submitting recommendations. A similar body of medical

and scientific evidence addressing the undiagnosed illnesses of Persian

Gulf veterans simply does not exist at this time, and what evidence is

available supports no conclusions regarding etiology or identification.

There is no basis, other than conjecture, for comparing the undiagnosed

illnesses of Persian Gulf veterans to the symptoms of slow viruses or

to diseases associated with exposure to radiation or herbicides.

Several commenters believed that a 2-year presumptive period was

either arbitrary, premature, or too restrictive and, citing the current

uncertainty of medical and scientific evidence, recommended presumptive

periods ranging from 5 years to open-ended.

Although medical and scientific evidence is accumulating about the

various signs and symptoms of Persian Gulf veterans with undiagnosed

illnesses, there is little or no evidence definitively linking the

illnesses with service in the Gulf, and the credible evidence available

supports no conclusions regarding etiology, definition of the

undiagnosed illnesses, or latency period, which would justify adopting

a longer presumptive period. The commenters offered no other reasonable

basis to justify a presumptive period longer than 2 years, and we have

not adopted their recommendations.

Six commenters believe that the 2-year presumptive period is

inadequate because Persian Gulf veterans were unaware that they would

need to document their undiagnosed illnesses. They stated that

associating the presumptive period with establishment of the Persian

Gulf Health Registry did not give all veterans of the hostilities an

adequate opportunity to document their illnesses because availability

of the Registry examination was not widely known until mid-1993, nearly

2 years after the first U.S. servicemembers began returning from the

Persian Gulf.

The Persian Gulf Registry examination is not the only acceptable

means of documenting the presence of an undiagnosed illness. Other

types of medical evidence may be used, such as routine VA medical

reports, military medical records, and reports from private physicians.

We believe that where the illness of a veteran manifested itself to a

compensable degree (10 percent or greater), it is very likely either

that the veteran would have sought medical treatment or that other,

non-medical evidence is available which would document the veteran's

signs or symptoms. For example, lay statements from individuals who

establish that they are able from personal experience to make their

observations or statements concerning the appearance of the signs or

symptoms of a veteran's illness may be used to establish entitlement.

In fact, many veterans did file claims for compensation within 2 years

of leaving the Gulf based on disabilities that they felt may have

resulted from exposure to environmental hazards. VA examinations and

other medical evidence reflecting complaints of or treatment for these

disabilities should provide adequate documentation for the purposes of

this regulation. The 2-year presumptive period is not intended to limit

the presumption of service connection under Sec. 3.317 to illnesses

documented within that time frame. Documentation of the signs and

symptoms first made shortly after the presumptive period might

establish entitlement if it reasonably supports a conclusion that the

illness existed during the 2-year period following a veteran's last

service in the Persian Gulf region.

These commenters also stated that many who remained on active duty

after service in the Persian Gulf were hesitant to report their

ailments for fear of jeopardizing their military careers.

In our judgment, remaining on active duty following service in the

Persian Gulf does not necessarily preclude the likelihood that

alternative documentation acceptable to VA can be obtained. Although

many of these individuals might have been unwilling to seek treatment

for their illnesses from military physicians, documentation of

treatment from civilian physicians might exist for some. In the event

that others chose not to obtain medical treatment of any kind, lay

statements, such as those mentioned earlier, may be used to establish

entitlement.

These commenters also stated that since many VA and Department of

Defense (DOD) physicians have been unwilling to acknowledge that their

[[Page 6665]] illnesses could be related to Persian Gulf service, it is

possible that complaints that have been made have gone unreported to VA

regional offices in connection with claims for compensation.

When a veteran files a claim for compensation, the regional office

of jurisdiction obtains all pertinent VA, military, and private medical

records. Whether or not an examining physician agreed with the

veteran's belief that his or her illness was the result of service in

the Persian Gulf, it is likely that documentation of the complaint

exists, since the physician would have been obligated to record it. If

the complaint was made within the 2-year presumptive period, that

record will serve as documentation to establish potential entitlement

to compensation.

Three commenters recommended that VA measure the presumptive period

from a date other than the date of a veteran's last service in the

Southwest Asia theater of operations. They separately recommended that

the presumptive period run from the effective date of Public Law 103-

446, the date VA's Persian Gulf Health registry was established, or the

date of a veteran's separation from service.

VA does not agree. Since the statute presumes that these health

concerns are related to Persian Gulf service, it is reasonable that the

presumptive period be measured from the date service in the Gulf ended,

and the statute itself specifically indicates that the presumptive

period will be so measured. Furthermore, measuring the presumptive

period from the last date of Gulf service is consistent with other

presumptive periods, such as those for diseases related to radiation or

herbicide exposure, which are measured from the last date on which

exposure could have occurred. Finally, if the presumptive period were

to be measured from the date a veteran was separated from service,

veterans who remained on active duty for several years after they left

the Persian Gulf would be unfairly advantaged.

Another commenter felt that, where the undiagnosed illnesses of

Persian Gulf veterans are eventually diagnosed, the regulation should

also allow a 2-year presumptive period for the diagnosed conditions.

VA does not agree. The undiagnosed illness provisions of Public Law

103-446, as implemented by Sec. 3.317, were specifically intended to

relieve the unique situation in which certain Persian Gulf War veterans

found themselves unable to establish entitlement to VA compensation

because their illnesses currently cannot be diagnosed. There is already

a well-established statutory and regulatory framework for compensating

disabilities resulting from diagnosed diseases, which Congress could

have revised if it had chosen to do so. Compensation may be awarded

when the evidence establishes that a disease was incurred directly

during active duty or that a preexisting disease was aggravated by

active duty, so long as any increase in severity was not due to the

natural progress of the disease. Compensation may also be paid on a

presumptive basis for certain chronic diseases that appear within a

statutory presumptive period, generally one year. If the undiagnosed

illnesses of Persian Gulf veterans are eventually identified and this

current legal framework for compensation proves to be inadequate, that

will be an issue for VA and the Congress to consider at that time.

VA wishes to thank the commenters for their thoughtful remarks. The

rule is hereby adopted as proposed with the revisions to Sec. 3.317(a)

mentioned in the preamble.

The Secretary hereby certifies that this final rule will not have a

significant economic impact on a substantial number of small entities

as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-

612. This final rule would not directly affect small entities. Only VA

beneficiaries could be directly affected. Therefore, pursuant to 5

U.S.C. 605(b), this final rule is exempt from the initial and final

regulatory flexibility analysis requirements of Secs. 603 and 604.

This final rule has been reviewed by the Office of Management and

Budget under the provisions of Executive Order 12866, Regulatory

Planning and Review, dated September 30, 1993.

(The Catalog of Federal Domestic Assistance program numbers are

64.109 and 64.110.)

List of Subjects in 38 CFR Part 3

Administrative practice and procedure, Claims, Health care,

Individuals with disabilities, Pensions, Veterans.

Approved: January 25, 1995.

Jesse Brown,

Secretary of Veterans Affairs.

For the reasons set forth in the preamble, 38 CFR Part 3 is amended

as follows:

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity

Compensation

1. The authority citation for part 3, subpart A continues to read

as follows:

Authority: 38 U.S.C. 501(a), unless otherwise noted.

2. Section 3.317 is added to read as follows:

Sec. 3.317 Compensation for certain disabilities due to undiagnosed

illnesses.

(a)(1) Except as provided in paragraph (c) of this section, VA

shall pay compensation in accordance with chapter 11 of title 38,

United States Code, to a Persian Gulf veteran who exhibits objective

indications of chronic disability resulting from an illness or

combination of illnesses manifested by one or more signs or symptoms

such as those listed in paragraph (b) of this section, provided that

such disability:

(i) became manifest either during active military, naval, or air

service in the Southwest Asia theater of operations during the Persian

Gulf War, or to a degree of 10 percent or more not later than two years

after the date on which the veteran last performed active military,

naval, or air service in the Southwest Asia theater of operations

during the Persian Gulf War; and

(ii) by history, physical examination, and laboratory tests cannot

be attributed to any known clinical diagnosis.

(2) For purposes of this section, ``objective indications of

chronic disability'' include both ``signs,'' in the medical sense of

objective evidence perceptible to an examining physician, and other,

non-medical indicators that are capable of independent verification.

(3) For purposes of this section, disabilities that have existed

for 6 months or more and disabilities that exhibit intermittent

episodes of improvement and worsening over a 6-month period will be

considered chronic. The 6-month period of chronicity will be measured

from the earliest date on which the pertinent evidence establishes that

the signs or symptoms of the disability first became manifest.

(4) A chronic disability resulting from an undiagnosed illness

referred to in this section shall be rated using evaluation criteria

from part 4 of this chapter for a disease or injury in which the

functions affected, anatomical localization, or symptomatology are

similar.

(5) A disability referred to in this section shall be considered

service connected for purposes of all laws of the United States.

(b) For the purposes of paragraph (a)(1) of this section, signs or

symptoms which may be manifestations of undiagnosed illness include,

but are not limited to:

(1) fatigue

(2) signs or symptoms involving skin [[Page 6666]]

(3) headache

(4) muscle pain

(5) joint pain

(6) neurologic signs or symptoms

(7) neuropsychological signs or symptoms

(8) signs or symptoms involving the respiratory system (upper or lower)

(9) sleep disturbances

(10) gastrointestinal signs or symptoms

(11) cardiovascular signs or symptoms

(12) abnormal weight loss

(13) menstrual disorders.

(c) Compensation shall not be paid under this section:

(1) if there is affirmative evidence that an undiagnosed illness

was not incurred during active military, naval, or air service in the

Southwest Asia theater of operations during the Persian Gulf War; or

(2) if there is affirmative evidence that an undiagnosed illness

was caused by a supervening condition or event that occurred between

the veteran's most recent departure from active duty in the Southwest

Asia theater of operations during the Persian Gulf War and the onset of

the illness; or

(3) if there is affirmative evidence that the illness is the result

of the veteran's own willful misconduct or the abuse of alcohol or

drugs.

(d) For purposes of this section:

(1) the term ``Persian Gulf veteran'' means a veteran who served on

active military, naval, or air service in the Southwest Asia theater of

operations during the Persian Gulf War.

(2) the Southwest Asia theater of operations includes Iraq, Kuwait,

Saudi Arabia, the neutral zone between Iraq and Saudi Arabia, Bahrain,

Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of

Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace

above these locations.

(Authority: Title I, Pub. L. 103-446; 38 U.S.C. 501(a))

3. Section 3.500 is amended by adding paragraph (y) to read as

follows:

Sec. 3.500 General.

* * * * *

(y) Compensation for certain disabilities due to undiagnosed

illnesses (Secs. 3.105; 3.317). Last day of the month in which the 60-

day period following notice to the payee of the final rating action

expires. This applies to both reduced evaluations and severance of

service connection. (Authority: Pub. L. 103-446; 38 U.S.C. 501(a))

[FR Doc. 95-2764 Filed 2-1-95; 9:07 am]

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