[Federal Register Volume 60, Number 23 (Friday, February 3, 1995)]
[Rules and Regulations]
[Pages 6660-6666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2764]



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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]
BILLING CODE 8320-01-P