[Federal Register Volume 69, Number 194 (Thursday, October 7, 2004)]
[Rules and Regulations]
[Pages 60083-60090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22543]


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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 [email protected]; 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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