FR Doc 04-22543

[Federal Register: October 7, 2004 (Volume 69, Number 194)]
[Rules and Regulations]
[Page 60083-60090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc04-5]

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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Parts 1 and 3

RIN 2900-AM09

Presumptions of Service Connection for Diseases Associated With
Service Involving Detention or Internment as a Prisoner of War

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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SUMMARY: The Department of Veterans Affairs (VA) is issuing this
interim final rule to establish guidelines for establishing
presumptions of service connection for diseases associated with service
involving detention or internment as a prisoner of war. In accordance
with those guidelines, this interim final rule also establishes
presumptions of service connection for atherosclerotic and hypertensive
heart disease and for stroke disease arising in former prisoners of
war. These rules are necessary because claims based on service
involving detention or internment as a prisoner of war present unique
medical issues and because factors including the lack of
contemporaneous medical records during periods of captivity and the
relatively small body of available medical information present
obstacles to substantiating claims for service-connected benefits based
on prisoner-of-war service. By establishing guidelines for identifying
diseases associated with service involving detention or internment as a
prisoner of war, these rules will help VA to ensure that claims for
service-connected benefits for disability or death of former prisoners
of war are decided fairly, consistently, and based on all available
medical information concerning the diseases associated with detention
or internment as a prisoner of war.

DATES: This interim final rule is effective October 7, 2004. Comments
must be received on or before November 8, 2004.

ADDRESSES: Written comments may be submitted by: mail or hand-delivery
to Director, Regulations Management (00REG1), Department of Veterans
Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; fax to
(202) 273-9026; e-mail to VAregulations@mail.va.gov; or, through http://www.Regulations.gov.
Comments should indicate that they are submitted

in response to ``RIN 2900-AM09.'' All comments received will be
available for public inspection in the Office of Regulation Policy and
Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m.,
Monday through Friday (except holidays). Please call (202) 273-9515 for
an appointment.

FOR FURTHER INFORMATION CONTACT: David Barrans, Deputy Assistant
General Counsel (022D), Office of General Counsel, Department of
Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202)
273-6332.

SUPPLEMENTARY INFORMATION: VA is revising its regulations to include a
new provision, codified at 38 CFR 1.18, establishing guidelines for
determining whether to establish new presumptions of service connection
for any disease associated with service involving detention or
internment as a prisoner of war. VA is also amending its adjudication
regulations at 38 CFR 3.309(c) to add atherosclerotic heart disease or
hypertensive vascular disease and stroke to the list of diseases VA
will presume to be associated with service involving detention or
internment as a prisoner of war (POW), and to reflect statutory
changes. These new presumptions of service connection reflect VA's
determination that presumptions for heart disease and stroke are
warranted by application of the guidelines set forth in Sec. 1.18.

Guidelines for Identifying POW Presumptive Conditions

Statutory and regulatory standards currently exist to guide VA in
identifying diseases associated with exposure to herbicide agents,
hazards of service in the Gulf War, and ionizing radiation. See 38
U.S.C. 1116 and 1118; 38 CFR 1.17. VA has determined that it would be
helpful to establish standards to guide VA in identifying diseases

[[Page 60084]]

associated with service involving detention or internment as a POW and
establishing new presumptions of service connection for such diseases.
We are establishing a new provision at 38 CFR 1.18 setting forth
guidelines for such determinations. The guidelines are substantially
similar to the above-referenced existing guidelines, with minor
differences necessary to reflect considerations unique to former POWs.
VA is authorized to provide compensation and other benefits for
disability or death due to disease or injury incurred in or aggravated
by service. To establish service connection for a disease or injury, a
claimant ordinarily must provide evidence, with VA's assistance,
establishing that the claimed disease or injury was incurred in or
aggravated by service. Statutory and regulatory presumptions of service
connection relieve claimants of this evidentiary burden in certain
circumstances by directing VA adjudicators to presume that certain
diseases were incurred in or aggravated by service unless evidence
shows otherwise. These presumptions are generally based on scientific
and medical data that provide a basis for inferring a connection
between a particular disease and some circumstance regarding the
veteran's service.
Evidentiary presumptions of service connection serve a number of
purposes. By codifying medical findings and principles that otherwise
may not be familiar to VA adjudicators, they promote the efficient
resolution of issues of service connection without the need for case-
by-case investigation and interpretation of the available medical
literature. They promote fair and consistent decision making by
establishing simple adjudicatory rules to govern the claims of
similarly situated veterans. They also may assist claimants who would
otherwise face substantial difficulties in obtaining direct proof of
service connection due to the complexity of the factual issues, the
lack of contemporaneous medical records during service, or other
circumstances.
Currently, 38 U.S.C. 1112(b) establishes presumptions of service
connection for sixteen categories of disease that are deemed to be
associated with detention or internment as a POW. Eleven of those
conditions are presumed to be service connected only if the veteran was
detained or interned for a period of at least thirty days, and the
remaining five are presumed to be service connected if the veteran was
detained or interned for any period.
The Secretary of Veterans Affairs is authorized by 38 U.S.C. 501(a)
to prescribe all rules and regulations that are necessary or
appropriate to carry out the laws administered by VA, including
regulations with respect to the nature and extent of proof necessary to
establish entitlement to benefits under such laws. Pursuant to that
authority, the Secretary may establish reasonable evidentiary
presumptions of service connection for diseases. The Secretary has
determined that presumptions of service connection are particularly
appropriate for former POWs.
Veterans who were detained or interned as POWs generally were
subjected to unique hardships including malnutrition, torture, physical
and psychological abuse, and a lack of adequate medical care. Although
POW experiences have varied with time, place, and other factors,
certain hardships are so prevalent across the spectrum of POW
experience as to support the presumption that POWs as a group have
incurred similar health risks. The lack of contemporaneous personnel
and health records to document events, injuries, or diseases during
periods of captivity also provides a strong justification for relying
on evidentiary presumptions rather than requiring direct proof of
service connection. Further, presumptions may simplify and expedite the
claims adjudication process, a particularly significant consideration
for former POWs, more than ninety percent of whom served in World War
II and are now, on average, over eighty years old.
Additionally, although several health effects associated with
prisoner-of-war experiences are well known and reflected in existing
presumptions of service connection, determining whether other health
effects may be associated with prisoner-of-war experience is not a
simple task. This is due in part to the discrete nature of the POW
experience. The effects of certain other service-related risk factors
such as exposure to ionizing radiation or herbicide agents have been
extensively studied in relation to exposures occurring in occupational
and other civilian settings in addition to studies of veteran
populations. In contrast, the effects of the POW experience have been
less extensively studied, because there generally are not comparable
civilian populations and the number of former POWs available for study
is comparatively small. Although studies of former POWs do exist, the
limited amount of information available complicates the task of
identifying diseases associated with the POW experience. In view of
these circumstances, VA has determined that it is appropriate to
establish guidelines for VA's review of the medical evidence concerning
the association between the POW experience and particular diseases and
to establish presumptions of service connection when the evidence
reasonably establishes an association.
We are setting forth the guidelines VA will apply in a new
regulation at 38 CFR 1.18. Paragraph (a) of Sec. 1.18 states VA's
policy to establish presumptions of service connection for former POWs
when necessary to prevent denials of benefits in significant numbers of
meritorious claims.
Paragraph (b) of Sec. 1.18 states the standard VA will apply in
determining whether a presumption of service connection is warranted.
That paragraph states that the Secretary may establish a presumption of
service connection for a disease when there is ``at least limited/
suggestive evidence that an increased risk of such disease is
associated with service involving detention or internment as a prisoner
of war and an association between such detention or internment and the
disease is biologically plausible.'' We define the term ``limited/
suggestive evidence'' in paragraph (b)(1) to refer to ``evidence of a
sound scientific or medical nature that is reasonably suggestive of an
association between prisoner-of-war experience and the disease, even
though the evidence may be limited because matters such as chance,
bias, and confounding could not be ruled out with confidence or because
the relatively small size of the affected population restricts the data
available for study.'' Paragraph (b)(2) states, for purposes of
illustration, that ``limited/suggestive evidence'' may be found where
one high-quality study detects a statistically significant association
or where several smaller studies detect an association that is
consistent in magnitude and direction.
The ``limited/suggestive evidence'' standard is essentially the
same standard that the Institute of Medicine (IOM) of the National
Academy of Sciences employs in reports it prepares for VA analyzing the
health effects of exposure to herbicide agents. In those reports, which
are mandated by statute, the IOM classifies the association between a
particular disease and the hazard in question as belonging to one of
the following four categories: ``Sufficient evidence of an
association,'' ``limited/suggestive evidence of an association,''
``inadequate or insufficient evidence to determine whether an
association exists,'' and ``sufficient evidence of no association.'' VA
has established presumptions of service connection for each of the
diseases the IOM has classified as having at least

[[Page 60085]]

``limited/suggestive evidence'' of an association. The ``limited/
suggestive evidence'' standard employed by the IOM is familiar to VA
and has proven to be a useful analytical framework for assessing
scientific evidence and determining whether a presumption of service
connection may be warranted. Accordingly, we will use that standard for
determining when a presumption may be warranted for former POWs.
The IOM defines the ``limited/suggestive evidence'' standard to
refer to circumstances in which evidence is suggestive of an
association but is limited because matters of chance, bias, and
confounding cannot be ruled out with confidence. Our definition adds
that the evidence may be limited because the relatively small size of
the affected population may restrict the data available for study. We
believe this additional consideration is significant with respect to
former POWs. As noted above, the lack of a comparable civilian
population for study may limit the amount of data available for
discerning the health effects of the POW experience. The data available
for study are also severely restricted by the fact that there is often
little or no information about veterans' health status or adverse
exposures during captivity. Moreover, opportunities for future studies
are increasingly limited because the population of surviving former
POWs, most of whom served in World War II, is declining rapidly.
Although we intend that any presumptions VA establishes will be based
on sound scientific and medical evidence, we believe that VA's analysis
of the evidence should take account of the unique circumstances and
evidentiary hurdles affecting this deserving group of veterans. It may
be unrealistic to expect the same degree of data or the same number of
corroborative studies that may exist with respect to the health effects
of herbicide exposure or other areas of investigation. We believe that
fairness to former POWs requires that VA fully evaluate the available
data and not accord undue significance to the fact that such data are
comparatively limited by the small size of the affected population.
The requirement that the association be biologically ``plausible''
does not require proof of a casual relationship. This is further
clarified by Sec. 1.18(d), discussed below. Rather, it requires only a
determination that there is a possible biological mechanism, consistent
with sound scientific evidence, by which the suspected precipitating
event (POW experience) could lead to the health outcome. The IOM
routinely applies the concept of biologic plausibility in its reviews
of the literature concerning the health effects of herbicide exposure
and hazards of Gulf War service and is required by statute to consider
biologic plausibility. See Pub. L. 102-4, Sec. 3(d)(1)(C), and Pub. L.
105-277, Sec. 1603(e)(1)(C).
Paragraph (c) of Sec. 1.18 states that, in establishing a
presumption of service connection for a disease, the Secretary may
specify a minimum period of detention or internment necessary to
qualify for the presumption. As noted above, some of the current
statutory presumptions apply only to former POWs who were detained or
interned for a period of at least thirty days. That requirement
apparently reflects the determination that certain conditions, such as
certain diseases associated with vitamin deficiency, ordinarily may
arise only after a prolonged period of food deprivation during
confinement. Our rule is intended to allow the Secretary to establish a
similar requirement concerning the length of detention or internment
for new presumptions established in the future, if warranted by sound
scientific or medical evidence.
Paragraph (d) of Sec. 1.18 explains that the requirement in
paragraph (b) that a disease be ``associated'' with the POW experience
may be satisfied by evidence demonstrating either a statistical or a
causal association. Paragraph (e) of the rule specifies the types of
evidence the Secretary will consider in deciding whether a presumption
is warranted. This paragraph makes clear that the Secretary need not
rely exclusively on studies of former POWs, but may consider studies
concerning the health effects of circumstances or hardships similar to
those experienced by POWs, if available, as well as any other sound
scientific or medical evidence the Secretary considers relevant.
Paragraph (f) of Sec. 1.18 states several factors that VA will
consider in evaluating any scientific study concerning diseases
possibly associated with the POW experience. The specified factors are
similar to the factors VA considers in assessing studies relating to
herbicide exposure and other hazards. See 38 U.S.C. 1116(b)(2) and
1118(b)(2)(B); 38 CFR 1.17(b).
Paragraph (g) of Sec. 1.18 states that the Secretary may contract
with an appropriate expert body, such as the IOM, to review and
summarize the scientific evidence or for any other purpose relevant to
the Secretary's determinations under this rule.

Evidence of Association Between POW Experience and Stroke

There are very few studies investigating the possible relationship
between POW experience and stroke. In September 2000, the VA Advisory
Committee on Former Prisoners of War received the report of an Expert
Panel on Stroke in Former Prisoners of War, which, based on review of
the existing scientific literature, found only one relevant study. That
1996 study examined records of 475 former World War II POWs and a
control group of 81 non-POW World War II veterans who had been followed
as part of a long-term study by the Medical Follow-up Agency of the
National Academy of Sciences' IOM. The study found a seven-fold
increase in the incidence of stroke among the POWs as compared to the
control group (relative risk = 7.03), and a statistically significant
nearly ten-fold increase in stroke incidence among POWs who had
suffered extreme malnutrition during captivity (relative risk = 9.76).
(Brass LM, Page WF. Stroke in Former Prisoners of War. J Stroke and
Cerebrovascular Diseases 1996; 6:72-78.) The study also found that the
risk of stroke was higher among former POWs suffering from post-
traumatic stress disorder (PTSD) than among former POWs without PTSD
(relative risk = 1.67). The strength of those findings is limited by
the small size of the study population.
Two more recent studies have also addressed the relationship
between POW experience and stroke. A 2001 study used Federal death
records to obtain death data through 1996 for a study population of
9,457 former POWs and 7,178 controls. The study found that former POWs
aged 75 years and older had an increased risk of stroke mortality
(hazard ratio = 1.13), although the risk was not statistically
significant. (Page WF, Brass LM. Long-Term Heart Disease and Stroke
Mortality Among Former American Prisoners of War of World War II and
the Korean Conflict: Results of a 50-Year Follow-Up. Military Medicine
2001; 166:803-08.) A subsample of the overall study population had
completed a questionnaire in 1967 indicating the presence or absence of
certain symptoms during their captivity. The study authors found a
statistically significant increase in death due to stroke among
veterans who had experienced visual symptoms, such as night blindness,
during their captivity (hazard ratio = 3.10). Because the presence of
visual symptoms during captivity may be associated with vitamin A
deficiency (Page WF. The

[[Page 60086]]

Health of Former Prisoners of War: Results from the Medical Examination
Survey of Former Prisoners of World War II and the Korean Conflict, p.
75. Washington DC, National Academies Press, 1992.), this finding is
consistent with the 1996 Brass and Page study in suggesting an
association between malnutrition during POW captivity and subsequent
stroke.
On the recommendation of the Expert Panel on Strokes in Former
Prisoners of War, VA's Environmental Epidemiology Service in 2003
conducted a study using medical and death data from records of VA and
the Health Care Financing Administration (HCFA) of the Department of
Health and Human Services for the period from 1991 to 2002. This study,
which has not yet been published, included 16,641 World War II POWs and
1,051 Korean War POWs, as well as 8,406 World War II controls and 3,816
Korean War controls. This study found that POWs had a significantly
higher incidence of PTSD than the controls and that POWs with PTSD had
a higher incidence of stroke than POWs without PTSD (odds ratio = 1.12
for World War II and 1.25 for Korean War). (Kang HK, Bullman TA. Ten
Year Mortality and Morbidity Follow-up of Former World War II and
Korean War Prisoners of War (unpublished VA Study 2003).) Although the
study did not find a significantly increased risk of stroke among POWs
as compared to non-POWs, the evidence for an association between PTSD
and stroke among POWs is consistent with findings stated in the 1996
study by Brass and Page.
The 1996 Brass and Page study noted that several studies have
provided evidence suggesting an association between stress and stroke,
although the evidence overall is not conclusive. The authors also noted
that the effects of stress on stroke may vary depending upon individual
reactions to stress. As stated in paragraph (e)(2) of Sec. 1.18, the
Secretary will consider evidence concerning the effects of
circumstances or hardships similar to those experienced by POWs,
including stress, in assessing the evidence for establishing
presumptions of service connection.
Based on the evidence discussed above, the Secretary has determined
that a presumption of service connection is warranted for stroke among
former prisoners of war. The 1996 and 2001 POW studies both found an
increased risk of stroke among former POWs. Although there is an
absence of other directly corroborating studies, the lack of additional
data is due in part to the small size of the POW population available
for study and the limited number of studies generally undertaken in
this field. Accordingly, the lack of corroborating data does not imply
the absence of an association under these circumstances.
The evidence that the risk of stroke is increased among POWs who
suffered extreme malnutrition or visual symptoms during captivity or
who have been diagnosed with PTSD also lends support to the finding of
an association between POW experience and stroke. As indicated in Sec.
1.18, VA considers stress and malnutrition to be among the hardships
ordinarily associated with POW experience. Evidence suggesting that the
risk of stroke increases with the severity of those hardships supports
the conclusion that stroke is associated with POW experience.
Under the standards set forth in Sec. 1.18, the Secretary finds
that the available evidence is suggestive of an association between POW
experience and stroke because sound scientific studies provide evidence
of an association that is consistent in magnitude and direction, even
though it is limited in some respects by the small size of the affected
population and the correspondingly limited data available for study.
The Secretary further finds that an association between stroke and POW
experience is biologically plausible, as discussed below. Accordingly,
the Secretary is establishing a presumption of service connection for
stroke in former POWs.
The interim final rule establishing this presumption refers
generally to ``stroke and its complications'' and thus will apply to
any type of stroke. The associations detected in the 1996 and 2001 POW
studies were based on diagnoses of all types of stroke, and the studies
did not state separate findings for specific types of stroke. Although
there are known differences in the three major categories of stroke
(ischemic, hemorrhagic, and embolic) that may suggest etiological
differences in some circumstances, the existing data do not provide a
basis for excluding any category of stroke from the presumption, and we
believe that any uncertainty regarding the strength of the association
for these closely related diseases should be resolved in favor of the
former POWs. Further, VA believes that the requirements of biologic
plausibility are satisfied for each of the major categories of stroke.
Presumptions of service connection for former POWs can be rebutted as
provided in 38 U.S.C. 1113(a) and 38 CFR 3.307(d). Accordingly, if
evidence in a case supports a finding that a particular presumptive
condition was not actually caused by a veteran's POW experience, VA may
consider the presumption to be rebutted.

Evidence of Association Between POW Experience and Heart Disease

As with stroke, there are relatively few studies addressing the
association between POW experience and heart disease. A series of older
studies did not find consistent evidence of an association, as
summarized in Page WF, Ostfeld AM. Malnutrition and Subsequent Ischemic
Heart Disease in Former Prisoners of War of World War II and the Korean
Conflict. (J Clin Epidemiol 1994; 47:1437-41.) A 1954 study found an
excess of cardiovascular deaths among World War II POWs (Cohen BM,
Cooper MZ. A Follow-up Study of World War II Prisoners of War. Veterans
Administration Medical Monograph, Washington DC: Government Printing
Office; 1954.), although subsequent mortality studies in 1970 and 1980
found no excess deaths due to cardiovascular diseases (Nefzger, MD.
Follow-up Studies of World War II and Korean War Prisoners. I. Study
Plan and Mortality Findings. Am J Epidemiol 1970; 91:123-38; Keehn RJ.
Follow-up Studies of World War II and Korean War Prisoners III.
Mortality to January 1, 1976. Am J Epidemiol 1980; 111:194-211.) A 1975
morbidity study found a significantly higher rate of hospitalization
for heart disease among World War II Pacific Theater POWs as compared
to controls. (Beebe GW. Follow-up Studies of World War II and Korean
War Prisoners: II. Morbidity, Disability, and Maladjustments. Am J
Epidemiol 1975; 101:400-22.) Studies of POWs from other countries also
yielded inconsistent results.
More recent studies have yielded intriguing findings concerning the
association between heart disease and POW experience. The 1994 study by
Page and Ostfeld found a statistically significant increase in deaths
due to ischemic heart disease among former POWs who experienced edema
(swelling) in their lower limbs during captivity (odds ratio = 2.83).
Because localized edema is a symptom of thiamine deficiency, the
authors theorized that the findings may suggest an association between
malnutrition during captivity and subsequent ischemic heart disease.
Current VA regulations provide for presumptive service connection of
ischemic heart disease in former POWs who experienced localized edema
during captivity. 38 CFR 3.309(c).
The 2001 study by Page and Brass analyzed the increased risk of
heart disease among former POWs by age

[[Page 60087]]

group and found a trend of increased excess risk with advanced age,
with a statistically significant increased risk for former POWs aged 75
years or over (hazard ratio = 1.25). The authors stated that the
findings may indicate that the sequelae of serious, acute malnutrition
may not appear until after many decades.
The 2003 VA study analyzed records of inpatient and outpatient
treatment from VA and HCFA records to determine whether POWs had an
increased incidence of certain diseases in comparison to the non-POW
controls. The study detected small increases in the incidence of
hypertension and myocardial infarction among some, but not all of the
subpopulations examined, and not all of the findings were statistically
significant. However, the study did find a statistically significant
increased incidence of hypertension and chronic heart disease among
World War II veterans with PTSD (odds ratio = 1.25 for hypertension and
1.19 for chronic heart disease).
The conclusion that PTSD may be associated with cardiovascular
disorders is also supported by a 1997 study finding that Vietnam
veterans diagnosed with PTSD had a significantly increased risk of
circulatory disease many years after service. (Boscarino JA. Diseases
Among Men 20 Years After Exposure to Severe Stress: Implications for
Clinical Research and Medical Care. Psychosom Med 1997; 59:605-14.)
Based on the evidence discussed above, the Secretary has determined
that a presumption of service connection is warranted for
atherosclerotic heart disease and hypertensive vascular disease among
former POWs. The 2001 study by Page and Brass found a statistically
significant increased risk of mortality due to heart disease in former
POWs aged 75 and older, based on a relatively large population of
former POWs and controls, many of whom had been followed for as many as
fifty years by the Medical Follow-up Agency of the National Academy of
Sciences' IOM. The 1994 Page and Ostfeld study also found a
statistically significant increased risk of heart disease in former
POWs who experienced edema, a consequence of malnutrition, and the 2003
VA study found a statistically significant increased risk of heart
disease among former POWs with PTSD. As noted above with respect to
stroke, the Secretary concludes that the evidence suggesting an
association between heart disease and specific hardships of POW
experience--malnutrition and stress--is significant. Although the
available data concerning the health effects of POW experience are
limited, the link to specific aspects of POW experience strengthens the
evidence for an association between heart disease and POW service.
Accordingly, the Secretary concludes that sound scientific studies
provide limited/suggestive evidence of an association between POW
experience and heart disease. As discussed below, the Secretary has
also determined that the association between POW experience and heart
disease is biologically plausible. Accordingly, the Secretary is
establishing a presumption of service connection for heart disease in
former POWs.
The studies discussed above did not all investigate the same range
of heart diseases and thus do not clearly resolve the question of which
types of heart disease may be associated with POW experience. For
purposes of this presumption, we will include all cardiovascular
diseases that are consistent, in terms of biologic plausibility, with
the findings in the relevant studies in that the diseases are
potentially capable of being caused by the circumstances or hardships
of POW service such as extreme stress or malnutrition. We describe
these diseases as atherosclerotic heart disease or hypertensive
vascular disease (to include hypertensive heart disease).
Atherosclerotic heart disease is a term used to refer to a heart
disease involving progressive narrowing and hardening of the arteries
over time and encompasses ischemic heart disease, coronary artery
disease, and other diseases that may be described by a more specific
diagnosis. Hypertensive vascular disease refers to disease associated
with elevated blood pressure. The presumption would not extend to
diseases that arise from viral or bacterial causes, because we conclude
that the relevant studies, and the evidence concerning biologic
plausibility, do not support a finding at this time that such heart
diseases are associated with POW experience.
With respect to certain types of atherosclerotic heart disease or
hypertensive vascular disease that are to be covered by these
presumptions, there is little available evidence upon which to rule in
or rule out the possibility that the condition is capable of being
caused by the hardships of POW service. In those cases, we have chosen
to resolve the doubt in favor of veterans and include the condition
within the scope of the presumption. Although the necessity of
inclusion of some conditions may be uncertain from a purely scientific
perspective, VA has decided as a policy matter to resolve this issue in
favor of veterans because there is a reasonable basis for doing so.
Presumptions of service connection for former POWs can be rebutted as
provided in 38 U.S.C. 1113(a) and 38 CFR 3.307(d). Accordingly, if
evidence in a case supports a finding that a particular presumptive
condition was not actually caused by a veteran's POW experience, VA may
consider the presumption to be rebutted.
The interim final rule also states that the presumption of service
connection applies to the complications of atherosclerotic heart
disease and hypertensive vascular disease, to make clear that
congestive heart failure, myocardial infarction, arrhythmias, and
similar complications may be service connected if they result from
atherosclerotic heart disease or hypertensive vascular disease.

Biologic Plausibility

The Secretary has concluded that an association between POW
experience and both heart disease and stroke is biologically plausible.
The concept of biologic plausibility refers to knowledge of the
biological mechanism by which a particular event can lead to a health
outcome. It does not require conclusive proof of a causal relationship
between the event and the health outcome, but requires a determination
as to whether there is a possible biological mechanism that is
consistent with sound scientific evidence by which the event could lead
to the health outcome. Accordingly, to be biologically plausible, an
association must be consistent with existing scientific and medical
knowledge, even if current evidence does not conclusively identify a
specific known mechanism by which the circumstances in question cause
the diseases associated with such circumstances. Current medical
literature suggests plausible, though not established, biological
mechanisms by which stress and/or malnutrition during POW captivity
could contribute to heart disease or stroke.
A number of authorities have postulated that stress may contribute
to cardiovascular disease through a concept referred to as ``allostatic
load,'' which is described as the long-term effect of the physiological
response to stress. Through the process of allostasis, the autonomic
nervous system, the hypothalamic-pituitary-adrenal (HPA) axis, and the
cardiovascular, metabolic, and immune systems protect the body by
responding to stress with adaptive changes. Those adaptations can cause
wear and tear on the systems involved in this response and may produce
a variety of cardiovascular changes associated with atherosclerosis,
hypertension, cardiac arrhythmias,

[[Page 60088]]

compromised coronary function, and increased risk of myocardial
infarction and stroke. (McEwen BS. Protective and Damaging Effects of
Stress Mediators. N Engl J Med 1998; 338:171-79; Brunner E. Stress
Mechanisms in Coronary Artery Disease. In: Stansfeld S, Marmot M
(eds.). Stress and the Heart: Psychosocial Pathways to Coronary Heart
Disease. London. BMJ Books 2002.)
Support for the biologic plausibility of an association between
malnutrition and heart disease and stroke comes from evidence that
vitamin deficiencies may cause elevated plasma levels of homocysteine,
a naturally occurring amino acid. A number of studies suggest that
elevated homocysteine levels may produce effects on the cardiovascular
system that can lead to heart disease or stroke. (Stein, JH, McBride
PE. Hyperhomocysteinemia and Atherosclerotic Vascular Disease:
Pathophysiology, Screening, and Treatment. Arch Int Med 1998; 158:1301-
06; Tsai J, Perrella MA, Yoshizumi M, Hseih C, Haber E, Schlegel R, Lee
M. Promotion of Vascular Smooth Muscle Cell Growth by Homocysteine: A
Link to Atherosclerosis. 91 Proc Natl Acad Sci 1994; 91:6369-73.)
Although the available evidence is not conclusive, it satisfies the
requirement of biologic plausibility for purposes of the Secretary's
determination.

Presumptions of Service Connection

VA's regulation at 38 CFR 3.309(c) identifies the diseases VA
presumes to be service connected for former POWs. We are amending this
list of diseases by adding atherosclerotic heart disease, hypertensive
vascular disease (including hypertensive heart disease), stroke, and
their complications.
We are removing the note in current Sec. 3.309(c) specifying that
the term ``beriberi heart disease'' includes ischemic heart disease in
a former POW who experienced localized edema during captivity. This
note was added based on the 1994 Page and Ostfeld study finding an
association between the presence of lower-limb edema during POW
captivity and subsequent ischemic heart disease. This interim final
rule establishes a presumption of service connection for heart disease,
including ischemic heart disease, without regard to whether localized
edema was present in service. Accordingly, we are removing the current
note to make clear that the presence of edema is no longer required in
order to establish service connection for ischemic heart disease.

Other Changes to Sec. 3.309(c)

We are making one other change to Sec. 3.309(c). Section 3.309(c)
states that the presumptions of service connection apply only to
veterans who were interned or detained for not less than 30 days. The
30-day requirement was formerly mandated by the governing statutory
provisions at 38 U.S.C. 1112(b). Effective December 16, 2003, however,
section 201 of the Veterans Benefits Act of 2003, Pub. L. No. 108-183,
117 Stat. 2651, amended 38 U.S.C. 1112(b) to eliminate the 30-day
requirement for psychosis, any anxiety states, dysthymic disorders,
organic residuals of frostbite and post-traumatic osteoarthritis. We
are revising Sec. 3.309(c) to conform to the current provisions of
section 1112(b). We are including heart disease and stroke among the
conditions that will be presumed to be service connected following any
period of POW captivity. The diseases that remain subject to a 30-day
detention or internment requirement generally are those that would be
expected to be incurred only over a prolonged period of detention or
internment, such as diseases associated with malnutrition. Because the
evidence indicates that heart disease and stroke potentially may be
associated either with malnutrition during prolonged captivity or with
stress due to circumstances such as torture or abuse, which may occur
during even brief periods of captivity, we do not believe a minimum
period of detention or internment is warranted for these presumptions.
As part of a VA project to rewrite all of its adjudication
regulations in part 3 of title 38, Code of Federal Regulations, we
published a notice of proposed rule making in the Federal Register of
July 27, 2004 (69 FR 44614), proposing a new regulation that would
implement the provisions of section 201 of the Veterans Benefits Act of
2003 removing the 30-day detention or internment requirement for
certain POW diseases. Because we are now issuing this interim final
rule to amend the list of diseases in Sec. 3.309(c) effective
immediately, we believe it is desirable to make these additional
changes at this time to bring the regulation into conformity with the
current statute.

Administrative Procedure Act

VA has determined that it is appropriate to issue this rule as an
interim final rule without providing an opportunity for prior public
comment. The provisions of this rule to be codified at 38 CFR 1.18
specify the procedures VA intends to follow in exercising its
discretionary authority under 38 U.S.C. 501(a) to establish new
presumptions of service connection for former POWs. These portions of
the rule constitute a general statement of VA policy or, alternatively,
rules of VA procedure and practice. Accordingly, they are exempt under
5 U.S.C. 553(b)(3)(A) from the notice and comment requirements of the
Administrative Procedure Act. The portions of this rule revising 38 CFR
3.309(c) to conform to the provisions of 38 U.S.C. 1112(b), as amended
by the Veterans Benefits Act of 2003, do not involve any change in law,
but merely restate the statutory provisions of 38 U.S.C. 1112(b).
Accordingly, these portions of the rule are, at most, interpretative
rules that are also exempt under 5 U.S.C. 553(b)(3)(A) from the notice
and comment requirements of the Administrative Procedure Act.
Alternatively, pursuant to 5 U.S.C. 553(b)(3)(B), the Secretary for
good cause finds that notice and an opportunity for prior public
comment is unnecessary with respect to this portion of the rule because
it merely tracks a statutory provision that VA is required to follow.
In accordance with 5 U.S.C. 553(b)(3)(B), the Secretary finds that
there is good cause for dispensing with the opportunity for prior
comment with respect to the portions of this rule establishing new
presumptions of service connection for atherosclerotic heart disease,
hypertensive vascular disease, and stroke among former POWs. The
Secretary concludes that providing an opportunity for prior comment is
unnecessary because this portion of the rule is unlikely to generate
any adverse public comment, inasmuch as it confers a benefit on a
deserving class of veterans based on sound scientific evidence. The
Secretary further finds that it is impracticable to delay this
regulation for the purpose of soliciting prior public comment because
the class of veterans affected by this rule is elderly and rapidly
dwindling. More than 90% of all POWs served in World War II and are
now, on average, over eighty years old. As of January 1, 2003, this
population of World War II veterans had an annual mortality rate of
nine percent. Delay in implementing these rules would have a
significant adverse effect and frustrate the beneficial purpose of this
rule in view of the high mortality rate among the POW population and
the fact that the majority of former POWs are at an age where their
medical and financial needs are likely to be at their greatest.
For the foregoing reasons, the Secretary is issuing this rule as an
interim final rule. The Secretary will

[[Page 60089]]

consider and address comments that are received within 30 days of the
date this interim final rule is published in the Federal Register.

Unfunded Mandates

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of anticipated costs and benefits before
developing any rule that may result in an expenditure by State, local,
or tribal governments, in the aggregate, or by the private sector, of
$100 million or more in any given year. This rule will have no such
effect on State, local, or tribal governments, or the private sector.

Executive Order 12866

The Office of Management and Budget has reviewed this document
under Executive Order 12866.

Paperwork Reduction Act

This document contains no provisions constituting a collection of
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

The Secretary hereby certifies that this regulatory amendment will
not have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act (RFA), 5
U.S.C. 601-612. The reason for this certification is that these
amendments will not directly affect any small entities. Only VA
beneficiaries and their survivors will be directly affected. Therefore,
pursuant to 5 U.S.C. 605(b), these amendments are exempt from the
initial and final regulatory flexibility analysis requirements of
sections 603 and 604.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance program numbers are
64.109, and 64.110.

List of Subjects

38 CFR Part 1

Administrative practice and procedure, Claims.

38 CFR Part 3

Administrative practice and procedure, Claims, Disability benefits,
Health care, Veterans, Vietnam.

Approved: September 8, 2004.
Anthony J. Principi,
Secretary of Veterans Affairs.

0
For the reasons set forth in the preamble, the Department of Veterans
Affairs amends 38 CFR parts 1 and 3 as follows:

PART 1--GENERAL PROVISIONS

0
1. The authority citation for part 1 continues to read as follows:

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

0
2. Section 1.18 is added to read as follows:

Sec. 1.18 Guidelines for establishing presumptions of service
connection for former prisoners of war.

(a) Purpose. The Secretary of Veterans Affairs will establish
presumptions of service connection for former prisoners of war when
necessary to prevent denials of benefits in significant numbers of
meritorious claims.
(b) Standard. The Secretary may establish a presumption of service
connection for a disease when the Secretary finds that there is at
least limited/suggestive evidence that an increased risk of such
disease is associated with service involving detention or internment as
a prisoner of war and an association between such detention or
internment and the disease is biologically plausible.
(1) Definition. The phrase ``limited/suggestive evidence'' refers
to evidence of a sound scientific or medical nature that is reasonably
suggestive of an association between prisoner-of-war experience and the
disease, even though the evidence may be limited because matters such
as chance, bias, and confounding could not be ruled out with confidence
or because the relatively small size of the affected population
restricts the data available for study.
(2) Examples. ``Limited/suggestive evidence'' may be found where
one high-quality study detects a statistically significant association
between the prisoner-of-war experience and disease, even though other
studies may be inconclusive. It also may be satisfied where several
smaller studies detect an association that is consistent in magnitude
and direction. These examples are not exhaustive.
(c) Duration of detention or internment. In establishing a
presumption of service connection under paragraph (b) of this section,
the Secretary may, based on sound scientific or medical evidence,
specify a minimum duration of detention or internment necessary for
application of the presumption.
(d) Association. The requirement in paragraph (b) of this section
that an increased risk of disease be ``associated'' with prisoner-of-
war service may be satisfied by evidence that demonstrates either a
statistical association or a causal association.
(e) Evidence. In making determinations under paragraph (b) of this
section, the Secretary will consider, to the extent feasible:
(1) Evidence regarding the increased incidence of disease in former
prisoners of war;
(2) Evidence regarding the health effects of circumstances or
hardships similar to those experienced by prisoners of war (such as
malnutrition, torture, physical abuse, or psychological stress);
(3) Evidence regarding the duration of exposure to circumstances or
hardships experienced by prisoners of war that is associated with
particular health effects; and
(4) Any other sound scientific or medical evidence the Secretary
considers relevant.
(f) Evaluation of studies. In evaluating any study for the purposes
of this section, the Secretary will consider:
(1) The degree to which the study's findings are statistically
significant;
(2) The degree to which any conclusions drawn from the study data
have withstood peer review;
(3) Whether the methodology used to obtain the data can be
replicated;
(4) The degree to which the data may be affected by chance, bias,
or confounding factors; and
(5) The degree to which the data may be relevant to the experience
of prisoners of war in view of similarities or differences in the
circumstances of the study population.
(g) Contracts for Scientific Review and Analysis. To assist in
making determinations under this section, the Secretary may contract
with an appropriate expert body to review and summarize the scientific
evidence, and assess the strength thereof, concerning the association
between detention or internment as a prisoner of war and the occurrence
of any disease, or for any other purpose relevant to the Secretary's
determinations.

Authority: 38 U.S.C. 501(a), 1110.

PART 3--ADJUDICATION

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

0
3. The authority citation for part 3, subpart A continues to read as
follows:

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

0
4. Section 3.309 (c) is amended by removing the ``Note'' immediately
following the list of diseases and by revising the paragraph and its
authority citation to read as follows:

[[Page 60090]]

Sec. 3.309 Disease subject to presumptive service connection.

* * * * *
(c) Diseases specific as to former prisoners of war. (1) If a
veteran is a former prisoner of war, the following diseases shall be
service connected if manifest to a degree of disability of 10 percent
or more at any time after discharge or release from active military,
naval, or air service even though there is no record of such disease
during service, provided the rebuttable presumption provisions of Sec.
3.307 are also satisfied.
Psychosis.
Any of the anxiety states.
Dysthymic disorder (or depressive neurosis).
Organic residuals of frostbite, if it is determined that the
veteran was interned in climatic conditions consistent with the
occurrence of frostbite.
Post-traumatic osteoarthritis.
Atherosclerotic heart disease or hypertensive vascular disease
(including hypertensive heart disease) and their complications
(including myocardial infarction, congestive heart failure,
arrhythmia).
Stroke and its complications.
(2) If the veteran:
(i) Is a former prisoner of war and;
(ii) Was interned or detained for not less than 30 days, the
following diseases shall be service connected if manifest to a degree
of 10 percent or more at any time after discharge or release from
active military, naval, or air service even though there is no record
of such disease during service, provided the rebuttable presumption
provisions of Sec. 3.307 are also satisfied.
Avitaminosis.
Beriberi (including beriberi heart disease).
Chronic dysentery.
Helminthiasis.
Malnutrition (including optic atrophy associated with
malnutrition).
Pellagra.
Any other nutritional deficiency.
Irritable bowel syndrome.
Peptic ulcer disease.
Peripheral neuropathy except where directly related to infectious
causes.
Cirrhosis of the liver.

Authority: 38 U.S.C. 1112(b).
* * * * *
[FR Doc. 04-22543 Filed 10-6-04; 8:45 am]

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