[Federal Register Volume 78, Number 242 (Tuesday, December 17, 2013)]
[Rules and Regulations]
[Pages 76196-76209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29911]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AN89


Secondary Service Connection for Diagnosable Illnesses Associated 
With Traumatic Brain Injury

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) amends its 
adjudication regulations concerning service connection. This final rule 
acts upon a report of the National Academy of Sciences, Institute of 
Medicine (IOM), Gulf War and Health, Volume 7: Long-Term Consequences 
of Traumatic Brain Injury, regarding the association between traumatic 
brain injury (TBI) and five diagnosable illnesses. This amendment 
establishes that if a veteran who has a service-connected TBI also has 
one of these diagnosable illnesses, then that illness will be 
considered service connected as secondary to the TBI.

DATES: Effective Date: This rule is effective January 16, 2014.

FOR FURTHER INFORMATION CONTACT: Michael Ford, Regulatory Specialist, 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Avenue NW., Washington, DC 20420, (202) 461-6813. (This is not 
a toll-free number.)

SUPPLEMENTARY INFORMATION: On December 10, 2012, VA published in the 
Federal Register (77 FR 73366) a proposed rule to amend VA adjudication 
regulations (38 CFR Part 3) by revising 38 CFR 3.310 to add five 
diagnosable illnesses as secondary conditions which would be held to be 
the proximate result of service-connected TBI. The proposed rule 
identified those five illnesses as: (1) Parkinsonism, including 
Parkinson's disease, manifested following moderate or severe TBI; (2) 
Unprovoked seizures manifested following moderate or severe TBI; (3) 
Dementias (presenile dementia of the Alzheimer type and post-traumatic 
dementia) if manifest within 15 years following moderate or severe TBI; 
(4) Depression if manifest within 3 years of moderate or severe TBI, or 
within 12 months of mild TBI; and (5) Diseases of hormone deficiency 
that result from hypothalamo-pituitary changes if manifest within 12 
months of moderate or severe TBI. We provided a 60-day public-comment 
period, which ended on February 8, 2013, and received 201 public 
comments.

1. Executive Summary

A. Purpose

    This final rule amends VA's regulation concerning determinations of 
``secondary service connection'' by identifying circumstances under 
which certain illnesses will, absent clear evidence to the contrary, be 
found to be the secondary result of a service-connected TBI. The effect 
of the rule will be to eliminate the need for case-specific development 
and decision on that issue, thereby promoting efficiency and 
consistency in claim adjudications and making it easier for qualifying 
claimants to establish service connection for these conditions.
    VA provides disability compensation and other benefits for 
disability resulting from disease or injury that is ``service 
connected,'' meaning that it arose in service, was aggravated by 
service, or otherwise is causally related to service. See 38 CFR 3.303. 
``Secondary service connection'' refers to the situation in which a 
service-connected disease or injury causes or aggravates a distinct 
condition. In that situation, 38 CFR 3.310(a) provides that 
``disability which is proximately due to or the result of a service-
connected disease or injury shall be service connected'' and ``the 
secondary condition shall be considered a part of the original 
condition.''
    Regulations in VA's Schedule for Rating Disabilities currently 
recognize that TBIs potentially may produce a variety of cognitive, 
emotional/behavioral, or physical effects, including conditions that 
may be diagnosed as distinct mental or physical disorders. 38 CFR 
4.124a, Diagnostic Code 8045. However, when a Veteran has suffered a 
TBI in service and also has been diagnosed with a distinct mental or 
physical condition, such as depression or endocrine dysfunction, it may 
not be apparent whether the latter condition was caused by the TBI or 
resulted from some other cause. In such cases, VA ordinarily would seek 
to obtain a medical opinion on that question and would make a 
determination taking into account the medical opinion and all other 
relevant evidence of record.
    In a report titled ``Gulf War and Health, Volume 7: Long-Term 
Consequences of Traumatic Brain Injury,'' the IOM analyzed the 
available scientific and medical literature regarding the long-term 
consequences of TBI. In that report, IOM identified certain diagnosable 
conditions as to which there is relatively strong evidence that such 
conditions are associated with TBI because, for example, reliable 
studies show that those conditions occur more frequently in persons who 
have suffered a TBI than in other populations. After considering the 
IOM report and obtaining advice from medical experts and others within 
VA, the Secretary determined that there is a sufficient basis to 
establish a rule providing that certain diagnosable illnesses will be 
found to be the secondary result of TBI in certain circumstances, 
absent clear evidence to the contrary. Establishing such a rule will 
eliminate the need in individual cases to obtain a medical opinion or 
develop other evidence to determine whether the condition is associated 
with a TBI.

[[Page 76197]]

    This rule is necessary to implement the Secretary's determination. 
Under 38 U.S.C. 501(a)(1), the Secretary is authorized to issue 
regulations regarding ``the nature and extent of proof and evidence and 
the method of taking and furnishing them in order to establish the 
right to benefits.'' By eliminating the need to obtain medical opinions 
or other evidence in certain circumstances, this rule will enable VA to 
decide these claims more expeditiously and efficiently. Relatedly, this 
rule will make it easier for claimants to establish secondary service 
connection for the conditions covered by this rule. Further, this rule 
will ensure that claims involving the covered conditions are decided in 
accordance with available scientific knowledge and it will ensure 
consistency in the adjudication of claims.
    It is important to note that this rule is intended only to identify 
circumstances in which, absent clear evidence to the contrary, VA must 
find the identified conditions to be the secondary result of service-
connected TBI. It is not intended to limit or preclude a finding of 
secondary service connection for any other conditions or for any of the 
five specified conditions that are manifest outside the time periods 
set forth in this rule. Any claim that is not within the scope of this 
rule will be developed and decided under generally applicable 
procedures based on the evidence relating to that claim.

B. Summary of Major Provisions

    This final rule revises 38 CFR 3.310 to provide that, absent clear 
evidence to the contrary, five diagnosable illnesses ``shall be held to 
be'' secondary results of TBI in certain circumstances. The identified 
circumstances pertain to the severity of the TBI and the period of time 
between the TBI and the manifestation of the secondary condition. 
Specifically, paragraph (d)(1) of the rule provides for secondary 
service connection of the following illnesses: (1) Parkinsonism, 
including Parkinson's disease, manifested following moderate or severe 
TBI; (2) Unprovoked seizures manifested following moderate or severe 
TBI; (3) Dementias of the following types: presenile dementia of the 
Alzheimer type, frontotemporal dementia, and dementia with Lewy bodies, 
if manifest within 15 years following moderate or severe TBI; (4) 
Depression if manifest within 3 years of moderate or severe TBI, or 
within 12 months of mild TBI; and (5) Diseases of hormone deficiency 
that result from hypothalamo-pituitary changes if manifest within 12 
months of moderate or severe TBI. If those conditions are met, the 
secondary condition will be service connected and considered to be part 
of the service-connected TBI for purposes of providing VA disability 
benefits.
    The time periods set forth in this rule are based upon available 
scientific and medical evidence, as summarized by the IOM, and reflect 
the finding that, when the secondary condition manifests within such 
time period, it is reasonable to conclude, without the need for further 
evidentiary development, that the condition resulted from the TBI. 
Because no time period is specified for Parkinsonism or unprovoked 
seizures following moderate or severe TBI, secondary service connection 
will be established if those conditions are manifest at any time after 
the TBI.
    Paragraph (d)(3) of the final rule sets forth the criteria VA will 
use to determine whether a TBI in service was mild, moderate, or 
severe. Those criteria are the standard criteria that VA and the 
Department of Defense (DoD) both currently employ in evaluating the 
severity of a TBI. The criteria consist of five distinguishing factors, 
each pertaining to the effects of the injury at the time of the injury 
or shortly thereafter. The rule provides that a claimant need not meet 
all the criteria of a particular level of severity in order for VA to 
classify the TBI at that severity level. Rather, VA will rank the TBI 
at the highest level in which any criterion is met, except where the 
qualifying criterion is the same at both levels, in which case, VA 
would look to the other criterion to determine the highest level 
assignable.
    Paragraph (d)(2) of the rule would state that neither the severity 
levels nor the time limits set forth in the rule will preclude a 
finding of service connection for conditions shown by evidence to be 
proximately due to service-connected TBI. It further explains that, if 
a claim does not meet requirements of this rule for a mandatory finding 
of secondary service connection, VA will develop and decide the claim 
under generally applicable principles of service connection without 
regard to paragraph (d)(10) of this rule.

2. Responses to Comments

    We note that numerous commenters appeared to have slightly 
misunderstood the nature of the proposed rule in their comments. We are 
not establishing presumptions of service connection for these 
conditions. The proposed rule provides a legal framework for 
establishing the listed disabilities as service connected secondary to 
service-connected TBI. Presumptions, as VA generally uses them in 
establishing service connection, provide the nexus element between an 
event in service that is not itself disabling and the development of a 
disability. Secondary service connection, whether provided by 
regulation or shown by medical or lay evidence, links the secondary 
condition to an already established service-connected disability. 
However, the intent of the comments is clear, and we are responding to 
them as if the commenters had used ``secondary service connection'' 
instead of ``presumption.'' When noting the commenters' suggestions, we 
are using the commenters' term ``presumption'' so as to not change the 
commenters' meaning.

Favorable Comments

    VA received numerous comments generally supporting the proposed 
rule and noting that when the final rule is published, it will be 
beneficial to veterans who have suffered a TBI. We agree with these 
comments and thank the commenters for submitting their views.

Comment Suggesting That the Proposed Rule Should Include a Presumption 
That a TBI Occurred

    One commenter stated that the lack of a formal diagnosis of TBI 
should not be used to deny claims for conditions secondary to TBI. 
Instead, existence of the conditions should be used to presume the 
presence of TBI. Parkinsonism, Parkinson's disease, unprovoked 
seizures, dementia, depression, and diseases of hormone deficiency 
resulting from hypothalamo-pituitary changes are conditions that often 
occur in individuals who have no history of TBI; therefore, the mere 
presence of any of these conditions cannot be used to presume the 
presence of TBI. Further, each of these conditions manifest a distinct 
set of signs and symptoms that do not, by themselves, imply the 
preexistence of TBI. The purpose of this rulemaking is to address those 
situations in which a veteran has suffered a TBI during military 
service, later develops one of the five listed conditions, and the 
question arises as to whether the latter condition should be considered 
to be secondary to the former. Addressing situations where a veteran 
has one of the five listed conditions in the absence of TBI is outside 
the scope of this rulemaking.
    Another commenter suggested that, similar to the new PTSD 
regulation at 38 CFR 3.304(f), lay evidence alone be sufficient 
evidence to demonstrate that a TBI occurred in service. The commenter 
reasoned that there may be

[[Page 76198]]

no records available for these claims given the delay of identification 
and onset of many of these conditions and, therefore, lay evidence may 
be the only way that many of these claims could be granted. This 
comment relates to evidence necessary to prove service connection for 
TBI under 38 U.S.C. 1110. This rulemaking focuses on the secondary 
service-connected conditions that are a proximate result of TBI; 
therefore, this comment is outside the scope of this rulemaking.

Comments Regarding Effective Dates

    One commenter expressed the hope that the ``earliest effective 
date'' would provide veterans with retroactive benefits based on this 
rule. Another commenter asked whether this rule will be retroactive. In 
accordance with 5 U.S.C. 553(d), we are making this rule effective on 
the day 30 days after the date this notice is published in the Federal 
Register. We will apply this rule to all cases pending before VA on or 
after that date. If a claim that was previously and finally denied is 
later reopened and granted based on this rule, VA cannot pay benefits 
retroactive to the previously denied claim. Payments retroactive to a 
previously denied claim are authorized only in limited circumstances 
involving clear and unmistakable error or newly obtained service 
department records, but not where benefits are awarded based on a 
change in law. The U.S. Court of Appeals for the Federal Circuit has 
explained that, generally, ``[i]t is only by filing a [clear and 
unmistakable error] claim that a veteran can obtain benefits 
retroactive to the date of the original [VA] decision.'' Comer v. 
Peake, 552 F.3d 1362, 1370-71 (Fed. Cir. 2009). Further, 38 U.S.C. 
5110(g) states that the effective date of an award of benefits made 
``pursuant to any Act or administrative issue . . . shall not be 
earlier than the effective date of the Act or administrative issue.''
    Although payments would not be retroactive to a previously denied 
claim, we note that this rule change would constitute a liberalizing VA 
regulation under 38 U.S.C. 5110(g) and 38 CFR 3.114. Under those 
provisions, a claimant is eligible for certain retroactive benefits 
based on the liberalizing law or VA issue, if the claimant met all 
eligibility criteria for the liberalized benefit on the effective date 
of the liberalizing VA regulation and such eligibility existed 
continuously from that date to the date of the administrative 
determination of entitlement or of the claimant's request for review. 
In those circumstances, the effective date of an award will be ``fixed 
in accordance with the facts found'' except that it ``shall not be 
earlier than the effective date of the Act or administrative issue'' on 
which the award is based and, ``[i]n no event shall such award . . . be 
retroactive for more than one year from the date of application 
therefor.'' 38 U.S.C. 5110(g). Under this statute, if a qualifying 
application is received within one year of the date this final rule 
becomes effective, VA potentially may pay benefits retroactive to the 
effective date of this rule. If a qualifying application is filed more 
than one year after the effective date of this final rule, VA may pay 
benefits for a retroactive period of up to one year prior to the date 
of the application.

Comment Suggesting That Presumption Be Extended to Conditions With 
Limited/Suggestive Evidence of an Association With TBI

    As stated in the proposed rule, this rulemaking is based on a 
report of the National Academy of Sciences, IOM, Gulf War and Health, 
Volume 7: Long-Term Consequences of Traumatic Brain Injury, regarding 
the association between TBI and subsequent illness. The report ranked 
the illnesses it studied into five categories based on the IOM's degree 
of confidence in the association between TBI and the illness:
    1. Sufficient evidence of a causal relationship.
    2. Sufficient evidence of an association.
    3. Limited/suggestive evidence of an association.
    4. Inadequate/insufficient evidence to determine whether an 
association exists.
    5. Limited/suggestive evidence of no association.
    Upon review of the report, the Secretary determined that a 
rulemaking is warranted to establish five diagnosable illnesses, for 
which there is ``sufficient evidence of a causal relationship'' or 
``sufficient evidence of an association,'' as secondary conditions to 
TBI.
    One commenter noted that the proposed rule would only establish 
presumptions for conditions in the top two categories. The commenter 
urged VA to also establish presumptions for every condition that the 
IOM ranked in the category ``limited/suggestive evidence of an 
association.'' Without citing any authority, the commenter asserted, 
``The first three levels describe cases where the relationship is 
indicated by at least a preponderance of evidence.'' The commenter also 
described the third category as follows: ``For example, an evaluation 
of `limited/suggestive evidence of an association' may describe a 
condition very likely to follow TBI, but where the research has yet to 
satisfactorily describe the incidence, thresholds, or causal 
mechanism.'' The commenter noted that the presumptions in the proposed 
rule were all based on illnesses ranked in the top two categories and 
urged VA to include illnesses from the third category as well.
    We disagree that the category ``limited/suggestive evidence of an 
association'' describes conditions ``very likely to follow TBI, but 
where the research has yet to satisfactorily describe the incidence, 
thresholds, or causal mechanism.'' Nothing in the IOM report indicates 
that definition. In fact, the IOM report clearly states that this 
category means, ``Evidence is suggestive of an association between TBI 
and a specific health outcome in human studies but is limited because 
chance, bias, and confounding could not be ruled out with reasonable 
confidence.'' In contrast to the IOM's findings of ``sufficient 
evidence'' of a causal or statistical association, the ``limited/
suggestive'' classification reflects some uncertainty as to whether the 
condition ordinarily can be associated with TBI. Moreover, the 
``preponderance of evidence'' standard to which the commenter refers is 
not the basis for this final rule. This rule concerns the Secretary's 
decision to establish a special evidentiary rule applicable to specific 
conditions as to which there is particularly strong evidence of an 
association with TBI. Evidence in equipoise is the general standard of 
proof VA employs when weighing the evidence in an individual veteran's 
case in the absence of a special evidentiary rule. In exercising his 
rulemaking authority under 38 U.S.C. 501, the Secretary has decided to 
establish a special evidentiary rule for those conditions as to which 
there is strong evidence of an association with TBI, while retaining 
the generally applicable evidentiary rules, including evidence in 
equipoise standard, for all other conditions.
    The primary purpose of this final rule is to codify sound medical 
principles recognized in the IOM report. For example, in the absence of 
any rule establishing service connection secondary to TBI, a veteran 
who suffered a moderate or severe TBI in service and is diagnosed with 
a neuroendocrinological disorder (i.e., diseases of hormone deficiency 
that result from hypothalamo-pituitary changes) within 12 months 
thereafter could obtain service connection by submitting a physician's 
opinion that it is as likely as not that the TBI caused

[[Page 76199]]

the neuroendocrinological disorder. Such a physician's opinion would be 
consistent with the IOM's findings. Because illnesses listed in the top 
two IOM categories ordinarily would, upon proper development, be found 
to be secondary to TBI, VA has determined that it is appropriate to 
establish this rule to promote efficient and consistent decisions. 
Because the IOM's findings of ``limited/suggestive evidence'' reflect 
some uncertainty as to whether the condition ordinarily can be 
associated with TBI, VA believes that claims involving those conditions 
should continue to be decided based upon full development and 
evaluation of all evidence in each case, including the veteran's full 
medical history. In claims involving any disease not covered by this 
final rule, VA will apply the generally applicable standards governing 
service connection and secondary service connection to determine, based 
on the evidence in each case, whether the claimant's condition resulted 
from a service-connected TBI or is otherwise service connected. For 
these reasons, we make no change based on this comment.

Comment Suggesting Presumptions Should Be Adopted When Evidence Is 
Inconclusive

    The same commenter asserted that the proposed rule ``contradicts 
the VA's stated policy of adopting presumptions where the factual 
record or medical evidence is inconclusive.'' In support of this 
statement, the commenter quoted the preamble of the rulemaking that 
created 38 CFR 1.18, ``Guidelines for Establishing Presumptions of 
Service Connection for Former Prisoners of War'':

    Evidentiary presumptions of service connection serve a number of 
purposes. By codifying medical findings and principles that 
otherwise might 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.

69 FR 60084, Oct. 7, 2004.
    The commenter noted that in that rulemaking, VA established new 
presumptions for former prisoners of war (POW) based partly on the 
proposition that relevant medical research was poorly-developed because 
of the unusual nature of the POW experience, because few subjects were 
available for study, and because there are few comparable civilian 
populations. Based on the preamble language of this proposed rule, the 
commenter asserted, ``A presumption's purpose is to produce easier and 
more consistent outcomes for claimants in cases where the factual 
record is unavailable or where the medical science is undeveloped.'' 
The commenter further stated that the purpose of a presumption of 
service connection is ``not to codify scientific certainty, but rather 
to avoid denying claims simply because methodological research 
challenges have prevented the publication of high-quality medical 
science.''
    In applying this analysis to the proposed rule, the commenter noted 
that the IOM report recognized that the research on the long-term 
health effects of TBI is limited and that the studies that have been 
done were limited by the difficulty of performing controlled primary 
studies on these effects. The commenter went on to assert that the 
proposed rule ``merely codifies existing scientific certainties; it 
provides no aid for cases where persistent scientific uncertainty may 
prevent adjudicators from correctly deciding meritorious claims.'' 
Based on these assertions, the commenter again stated that VA should 
extend the TBI presumptions to include all conditions for which the IOM 
found ``limited/suggestive evidence'' of an association.
    As a preliminary matter, we agree with the commenter that the 
proposed rule essentially codifies established scientific principles, 
as this was VA's intention in proposing the rulemaking. However, we 
disagree that the state of medical knowledge on the health effects of 
POW service is the same or similar to the state of medical knowledge on 
the health effects of TBI. First, there are many more TBI subjects 
available for study than former POWs. According to the Defense and 
Veterans Brain Injury Center, there are over 266,000 veterans who 
suffered a TBI sometime between 2000 and 2012. Defense and Veterans 
Brain Injury Center, ``DoD Worldwide Numbers for TBI,'' http://www.dvbic.org/dod-worldwide-numbers-tbi (last visited April 15, 2013). 
In contrast, there were only 29,350 living former POWs in 2005 (when 
the final rule of the cited rulemaking was published). U.S. Dept. of 
Veterans Affairs, Office of the Assistant Secretary for Policy and 
Planning, ``American Prisoners of War (POWs) and Missing in Action 
(MIAs)'' (2006). According to data from VA's Office of Performance 
Analysis & Integrity, there are now only 10,059 living former POWs.
    Second, there are many more comparable civilian population studies 
for TBI than for former POWs, including those who suffered TBIs from 
motor vehicle accidents, sports injuries, and workplace injuries. There 
is, therefore, considerably more medical research available on TBI than 
on former POWs. IOM was not limited to reviewing scientific studies of 
veterans, and according to its report, it did an initial assessment of 
30,000 titles and abstracts and out of those further reviewed 
approximately 1,900 peer-reviewed scientific studies. There have been 
far fewer studies of former POWs. There are fewer than 200 peer-
reviewed scientific studies on POWs. The rulemaking cited by the 
commenter established rules applicable only to former POWs precisely 
because VA determined that the challenges facing former POWs were very 
different from those facing veterans alleging injury due to most other 
types of in-service experiences.
    We disagree that it would be appropriate to establish a rule 
directing a finding of service connection secondary to TBI on a matter 
for which there has been no ``publication of high-quality medical 
science.'' As stated in the preamble to the POW rulemaking cited above, 
``presumptions [of service connection] 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.'' We believe that the scope of the proposed rule 
is properly limited to conditions for which sound scientific research 
permits confidence that an association with TBI exists in virtually 
every case. Where existing scientific evidence is less conclusive, we 
believe it is more appropriate to decide claims based on development 
and analysis of the facts of each case, including medical examinations 
and opinions taking account of the veteran's medical condition and 
history. This approach is consistent with the recognition by the U.S. 
Court of Appeals for Veterans Claims that medical studies and treatises 
alone often are insufficient to establish that a particular veteran's 
medical condition was caused by his or her service, but that there may 
be instances where medical treatises provide a sufficient ``degree of 
certainty'' that they may provide a basis for finding service 
connection in an individual case. Sacks v. West, 11 Vet. App. 314, 317 
(1998).
    Further, we note that the rankings in the IOM report, particularly 
in the

[[Page 76200]]

broadly defined ``limited/suggestive evidence'' category, do not 
precisely correspond to or control the statutory standards governing 
service connection, which VA is responsible for implementing through 
rulemaking and adjudication. There may be significant differences in 
the strength of the evidence for different conditions in the same 
category. The IOM also acknowledges that its ``limited/suggestive 
evidence'' classifications are ``limited because chance, bias, and 
confounding could not be ruled out with reasonable confidence.''
    Finally, we note that VA's rating schedule indicates that TBI may 
cause a variety of cognitive, emotional/behavioral, and physical 
effects and instructs VA raters to appropriately consider and rate all 
such effects. 38 CFR 4.124a, Diagnostic Code 8045. These provisions 
properly notify VA raters to fully consider all potential health 
effects of TBI, including distinctly diagnosed conditions that may be 
due to a TBI. This final rule is intended to promote efficiency and 
uniformity by codifying certain well established medical principles, 
but is not intended to imply any finding by VA that veterans who 
incurred TBIs in service presently face unusual difficulties in 
establishing the right to compensation for the effects of their 
injuries, due to scientific uncertainty or other causes. In instances 
where there is some scientific uncertainty, or where TBI is one of 
several potential causes of a particular health effect, we believe that 
case-by-case evaluation of the facts of the veteran's disability 
picture is appropriate and that current procedures provide an adequate 
basis for ensuring the full and fair evaluation of disability due to 
TBI.
    For these reasons, we make no change based on this comment.

Comment Suggesting the Proposed Rule Applies a Higher Evidentiary 
Standard for Service Connection Secondary to TBI

    As part of the commenter's suggestion to create presumptions for 
every condition in the ``limited/suggestive evidence'' category, the 
same commenter asserted that the proposed rule applied a higher 
evidentiary standard than called for by statute. In support of this 
assertion, the commenter cited to the ``benefit of the doubt rule'' in 
38 U.S.C. 5107(b). The commenter repeated the argument that conditions 
in the top three categories ``describe cases where the relationship is 
indicated by at least a preponderance of evidence.'' The commenter also 
asserted that VA should establish TBI presumptions for conditions in 
the fourth category, ``Inadequate/insufficient evidence to determine 
whether an association exists,'' because this ``describes conditions 
where doubt exists, due to insufficient or conflicting evidence'' and, 
therefore, the ``benefit of the doubt'' standard is satisfied. The 
commenter acknowledged that the ``benefit of the doubt rule'' applies 
to adjudicatory facts rather than legislative facts.
    The ``benefit of the doubt rule'' states:

    (b) Benefit of the Doubt.--The Secretary shall consider all 
information and lay and medical evidence of record in a case before 
the Secretary with respect to benefits under laws administered by 
the Secretary. When there is an approximate balance of positive and 
negative evidence regarding any issue material to the determination 
of a matter, the Secretary shall give the benefit of the doubt to 
the claimant.

38 U.S.C. 5107(b). There is no indication that Congress intended VA to 
use the benefit of the doubt principle when developing regulations, and 
this rulemaking is not based on the benefit of the doubt rule. Under 38 
U.S.C. 501, VA has authority to issue regulations that are ``necessary 
or appropriate'' to carry out the laws VA administers. The evidentiary 
factors involved in adjudicating one claim are entirely different than 
the factors VA considers in drafting regulations of general 
applicability, and it ordinarily would not be logical to use the 
standard in section 5107(b) in the latter context. As previously 
explained, this rule establishes a special evidentiary rule for certain 
conditions as to which there is particularly strong evidence of an 
association with TBI; it does not purport to define all circumstances 
in which the evidence in a particular case may meet the benefit of the 
doubt standard. Furthermore, we note that Sec.  3.310(d) is not an 
exclusive list of all of the conditions that may be secondarily service 
connected based on service-connected TBI; it merely establishes 
secondary service connection for a certain condition for which there is 
sound evidence of a strong association with TBI. Claimants may still 
file claims for secondary service connection for conditions not listed 
in Sec.  3.310(d) under Sec.  3.310(a). We make no change based on this 
comment.
    In addition to 38 U.S.C. 5107(b), the commenter asserted that 
another statute, 38 U.S.C. 5103A, ``Duty to assist claimants,'' should 
guide VA's establishment of TBI presumptions. In support of this 
assertion, the commenter stated that VA's duty to assist a claimant in 
obtaining necessary evidence ``surely encompasses a duty not to require 
claimants to provide unnecessary evidence.'' The commenter concluded 
that, ``If the VA already has information sufficient to satisfy the 
`benefit of the doubt rule' for a given question, then additional 
supporting evidence is unnecessary and the VA should not require it.'' 
The commenter pointed out that in some cases, VA has adopted 
presumptions for illnesses ranked in the limited/suggestive category, 
``for conditions related to prisoner of war status, herbicide exposure, 
and general military service, among others.''
    This comment appears to rest on the premise that the IOM's finding 
of ``limited/suggestive evidence'' of an association between TBI and a 
particular health effect is sufficient evidence to establish secondary 
service connection for that health effect in every case, such that any 
further evidentiary development would be unnecessary. VA does not agree 
with that premise. The IOM's own definition of ``limited/suggestive 
evidence'' indicates that there may be significant limitations on the 
conclusions and inferences that may be drawn from the available medical 
evidence regarding health effects in that category. Further, as the 
U.S. Court of Appeals for Veterans Claims has noted, evidence from 
medical studies and treatises of a general nature often is 
insufficient, standing alone, to resolve questions of causation and 
service connection in individual cases. Even if medical studies 
indicate that TBI is one possible risk factor for the development of a 
particular condition, it may be necessary to develop and consider each 
veteran's medical history regarding the onset, nature, and course of 
the veteran's condition and any other risk factors applicable to the 
veteran's case in order to determine the likelihood that the condition 
is related to TBI. It is VA's policy to avoid unnecessary development 
of evidence, and VA applies this policy on a case-by-case basis. 38 CFR 
3.304(c). However, we do not believe that the IOM's findings of 
``limited/suggestive evidence'' that certain conditions may be 
associated with TBI will obviate the need to develop and consider other 
medical evidence in all or most cases involving those conditions.
    As noted above, VA proposed in this rulemaking to codify sound 
medical principles recognized in the IOM report, not to create 
presumptions. VA has created presumptions for certain diseases for 
which the IOM or VA has found ``limited/suggestive evidence of an 
association'' with herbicide exposure or other circumstances of 
service. In some instances, VA has determined that presumptions were 
not warranted for diseases in IOM's ``limited/suggestive

[[Page 76201]]

evidence'' category. Many of those determinations were made under a 
specific statutory formula for making such determinations in the 
context of the use of Agent Orange during the Vietnam War. Moreover, 
those prior determinations were based on the evidence and circumstances 
applicable to the particular condition at issue and do not establish 
any binding precedent for future rulemaking concerning other 
circumstances. Consequently, we make no change based on this comment.

Comment Suggesting That There Are Practical Reasons To Establish More 
Categories as Service Connected Secondary to TBI Than Proposed

    In addition to the above legal arguments, the same commenter 
asserted that there are practical reasons for VA to expand the list of 
conditions beyond the five in the proposed rule. The commenter stated:

    When evaluating whether to adopt this presumption, the VA should 
take into consideration the very real costs that will arise if it 
requires claimants to jump through the hoop of re-proving facts that 
the VA already knows to be true. First, some claimants will fail to 
provide the results of the IOM Study and therefore fail to prove 
this element. Second, some adjudicators may incorrectly infer from 
the VA's decision not to adopt a presumption that the IOM Study's 
evidence is insufficient to satisfy the veteran's burden of proof. 
Third, the adjudication system is already far too burdened for the 
VA to saddle it with pro forma responsibilities. We recognize that 
the VA may be reluctant to disturb the veteran's statutory burden of 
proof, but these costs are too high a price to pay in cases where 
the burden of proof has become a mere formality.

    The commenter's first point, that ``some claimants will fail to 
provide the results of the IOM Study and therefore fail to prove the 
[nexus] element,'' implies that the results of a scientific study or 
report are the only way a veteran can satisfy the nexus element in a 
service-connection claim. This assumption is incorrect because in most 
cases, the nexus element is proven via a medical opinion from an 
appropriate professional. The medical opinion would contain any 
necessary citation to medical authorities. Further, as noted above, the 
U.S. Court of Appeals for Veterans Claims has noted that, except where 
medical treatises speak with a sufficient ``degree of certainty,'' such 
treatises alone generally cannot establish that a particular claimant's 
disability is service connected and it is ordinarily necessary to 
obtain a medical opinion concerning the specific veteran's condition. 
Sacks v. West, 11 Vet. App. 314, 317 (1998). We, therefore, make no 
change based on this comment.
    Regarding the commenter's concern that VA adjudicators may 
incorrectly infer from VA's decision not to issue rules directing a 
finding of secondary service connection for certain diseases that the 
IOM Study's evidence is insufficient to satisfy the veteran's burden of 
proof, we do not believe this is valid basis to change the proposed 
rule. That is because the proposed rule expressly precludes such 
inferences with regard to the severity of levels of the illnesses or 
the time limits with the following provision:

    (2) Neither the severity levels nor the time limits in paragraph 
(d)(1) of this section preclude a finding of service connection for 
conditions shown by evidence to be proximately due to service-
connected TBI. If a claim does not meet the requirements of 
paragraph (d)(1) with respect to the time of manifestation or the 
severity of the TBI, or both, VA will develop and decide the claim 
under generally applicable principles of service connection without 
regard to paragraph (d)(1).

Furthermore, such inferences would also not be logical with regard to 
other conditions because the establishment of this rulemaking would not 
preclude a veteran from filing a claim for compensation with VA for a 
service-connected disability secondary to TBI for a condition other 
than the ones listed in the proposed rule. We note also that VA's 
rating schedule reflects that TBI may result in a variety of cognitive, 
emotional/behavioral, and physical effects, and directs VA raters to 
assign ratings applicable to all such conditions found in an 
individual's case to be the result of a TBI. 38 CFR 4.124a, Diagnostic 
Code 8045. That provision, which properly notifies VA raters to 
consider all health effects potentially associated with TBI, further 
makes clear that the beneficial provisions of this rule must not be 
construed to preclude compensation for other health effects associated 
with TBI.
    The third comment, that ``the adjudication system is already far 
too burdened for the VA to saddle it with pro forma responsibilities,'' 
is based upon a false premise: That providing evidence of nexus by 
obtaining a medical opinion is inherently ``pro forma'' whenever a 
veteran's claim falls outside the conditions that are listed in the 
proposed rule. In many cases, VA is required to obtain a medical 
opinion under 38 U.S.C. 5103A, ``Duty to assist claimants.'' As noted 
above, this statute requires VA to obtain a medical examination or a 
medical opinion ``when such an examination or opinion is necessary to 
make a decision on the claim.''
    As stated above, the limitations in the scope of the proposed rule 
are based on sound medical and scientific principles regarding the 
health effects of TBI. In our judgment, there is no basis to expand 
these provisions as suggested by the commenter. In some cases, doing so 
would actually be contrary to current medical and scientific research. 
VA will monitor ongoing TBI research and can modify or expand the 
secondary service connections of TBI if medical research leads to that 
conclusion. For these reasons, we make no change based on this comment.
    Another commenter also suggested that VA expand the diagnosable 
illnesses as secondary to service connection to TBI, to include post-
traumatic headache, chronic post-traumatic stress disorder, 
exacerbation or precipitation of a psychiatric disorder (e.g., a stable 
bipolar patient whose bipolar illness becomes unstable following TBI), 
attentional disorders, sleep and wake disorders, and anxiety. The IOM 
report on which this rule is based did not expressly address all of 
those conditions and, to the extent it did address them, did not find 
sufficient evidence of an association between such conditions and TBI. 
We recognize that the health effects the commenter identifies may be 
found to be related to TBI in a particular case and, as noted above, 
VA's rating schedule for TBI instructs raters to provide appropriate 
evaluations for all health effects found to be related to a veteran's 
TBI. As to the conditions listed by the commenter, we find no basis for 
changing the current practice of relying upon case-by-case 
determinations as to whether those conditions are related to a 
veteran's TBI.
    Another commenter suggested that the language of the proposed 
rulemaking be strengthened so that certain behavioral and social 
problems, while not diagnosable, including diminished social 
relationships, aggressive behaviors, long-term unemployment, be 
included in evaluating the severity of the claim for compensation 
purposes. For the reasons stated above, we believe that these types of 
effects are most properly evaluated on a case-by-case basis under VA's 
rating schedule, which provides that, in assigning a disability 
evaluation for TBI, due consideration will be given to emotional/
behavioral dysfunction, whether or not such function is diagnosed as a 
mental disorder. 38 CFR 4.124a, Diagnostic Code 8045.

[[Page 76202]]

Comment Suggesting Language Stating That Claims That Are Not Included 
in This Rulemaking Will Be Given Equal Consideration

    One commenter suggested that VA should use explicit language 
stating that cases/claims that fall outside of the established time 
frames of Sec.  3.310(d) will be given equal consideration to determine 
whether a condition is secondarily service connected to the original 
TBI condition. The commenter states that many veterans do not report 
TBIs, which skews the entire timeframe, and inadequate screening and 
coping skills may delay diagnosis and screening of secondary 
conditions. Similarly, another commenter suggested that we remove all 
time limits because, in her experience, certain conditions relating to 
TBI do not manifest until many months after the TBI occurred.
    The conditions and time limits specified in this rule reflect the 
IOM's findings and the Secretary's determination that IOM's findings 
provide a sufficient basis for concluding that, absent clear evidence 
to the contrary, the identified conditions will be deemed to be a 
secondary result of service-connected TBI in each case where they are 
manifest within the specified time periods. We decline to remove the 
time limits, because doing so would result in a broad rule going well 
beyond the scope of the IOM's findings. However, we emphasize that this 
rule is intended only to assist claimants and simplify adjudications in 
cases falling within the scope of this rule. It is not intended to have 
any adverse effect on claims involving other conditions or involving 
conditions manifest outside the times frames in this rule. In all 
claims for service connected benefits, VA evaluates all evidence of 
record on a case-by-case basis and applies generally applicable 
principles of service connection set forth in statute and regulation to 
determine whether the condition is service connected. This case-by-case 
analysis ensure that VA gives due consideration to unique circumstances 
in individual claims, such as delays in reporting an injury or delays 
in diagnosis.
    Language to this effect is already included in the proposed rule at 
Sec.  3.310(d)(2), which states that ``If a claim does not meet the 
requirements of paragraph (d)(1) with respect to the time of 
manifestation or the severity of the TBI, or both, VA will develop and 
decide the claim under generally applicable principles of service 
connection without regard to paragraph (d)(1).'' (Emphasis added.) We 
interpret generally applicable principles of service connection to 
include secondary service connection. Thus, we believe that the 
language that specifically refers to secondary service connection is 
unnecessary.

Comments Suggesting the Inclusion of Mild TBIs and Multiple Mild TBIs

    At least two commenters urged VA to include mild TBI within the 
scope of this rulemaking. One commenter stated that the effects of mild 
TBI may not be apparent immediately following injury and that limiting 
the presumptions reflected in paragraph (d) to moderate or severe TBI, 
and placing time limitations for onset of symptoms, is not appropriate. 
Another commenter suggested that mild TBIs can swell the connections 
between neurons in the brain and this swelling, in turn, can cause 
types of dementia of the Alzheimer's type.
    The primary and secondary studies cited by the IOM support its 
finding that there is sufficient evidence of an association between TBI 
(including mild TBI) and depression, as well as limited/suggestive 
evidence of an association between mild TBI and dementia of the 
Alzheimer type and parkinsonism, but only in the case of mild TBI with 
loss of consciousness. We did not include mild TBI in the rulemaking 
regarding dementia. A finding by the IOM of ``limited/suggestive 
evidence'' indicates that the evidence is suggestive of an association 
between TBI and the specific health outcome in human studies but is 
limited because chance, bias, and confounding factors could not be 
ruled out with reasonable confidence. There were no findings of a 
causal relationship or association between mild TBI and the other 
conditions that are the subject of this rulemaking. Given the findings 
of the IOM, and research since the IOM report was issued, VA does not 
believe that the rule should be amended as suggested by the commenter. 
We, therefore, make no changes based on this comment.
    One commenter stated that multiple mild TBIs should be considered 
equivalent to moderate TBI for the purposes of this rulemaking. Citing 
the discussion by the IOM of the dose-response relationship, the 
commenter argued that the IOM treats multiple mild TBIs as a high-
exposure cohort similar to severe TBI. In its report, the IOM described 
the types of evidence that were evaluated by the committee. This 
included data from observational studies that may infer a causal 
relationship between an event and possible outcome. The IOM noted that 
the dose-response relationship could be one element considered when 
inferring causality. The dose-response relationship is studied in 
various scientific disciplines, most notably toxicology. It describes 
the change in effect on an organism caused by differing levels of 
exposure to a stressor after a certain exposure time. On pages 107-08 
of its report, the IOM observed that ``if studies of presumably low-
exposure cohorts (for example, mild TBIs or a single injury) show only 
mild increases in risk whereas studies of presumably high-exposure 
cohorts (for example, moderate to severe TBIs or repeated injuries) 
show larger increases in risk, the pattern would be consistent with a 
dose-response relationship.'' VA views this as a restatement of the 
definition of dose-response relationship using TBI and physical injury 
as examples of stressors, not a finding by the IOM equating multiple 
mild TBIs with severe TBI. Our conclusion is consistent with a reading 
of the IOM report as a whole.
    We note that because there is very little research on the chronic 
effects of mild TBI, VA and the DoD recently invested $62.2 million, to 
be spent over the next 5 years on a research consortium, ``Chronic 
Effects of Neurotrauma Consortium--CENC'' to study the chronic effects 
of mild TBI and common comorbidities in order to improve diagnostic and 
treatment options. See http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2473.
    In addition, the commenter argued that failure to include multiple 
mild TBIs in the proposed rule is inconsistent with VA's purpose of 
adopting presumptions where persistent scientific uncertainty 
interferes with correct adjudication. As this commenter correctly 
noted, in a previous rulemaking, we stated that evidentiary 
presumptions ``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.'' 69 FR 60084, October 7, 2004. We wrote this in 
relation to the use of presumptions in the case of prisoners of war who 
may have incurred injury in circumstances in which contemporaneous 
medical records were not created or are not available, and in which 
direct confirmatory proof of an incident is difficult to obtain. 
Presumptions are sometimes acceptable where factual uncertainty exists. 
However, the primary purpose of this final rule is to codify the sound 
medical principles recognized in the IOM report, and thus, addressing 
situations where there is scientific uncertainty relating to

[[Page 76203]]

TBI is outside the scope of this rulemaking.
    Another group also urged VA to include multiple mild TBIs within 
the scope of this rulemaking, citing studies performed on football 
players as well as a study on patients diagnosed with Chronic Traumatic 
Encephalopathy. VA believes that there is currently an inadequate body 
of reliable research equating multiple mild TBI and moderate TBI. 
Concussion, or mild TBI, is a condition medically distinct from 
moderate or severe TBI. While the cited studies are suggestive, there 
are significant limitations in the applicability of the findings and 
conclusions. VA does not believe that multiple mild TBIs should be 
included within the scope of this rulemaking given the current state of 
research.
    Two commenters urged VA to revise the rule to address the health 
effects of multiple mild brain injuries incurred over time. One of 
these commenters noted that some veterans may sustain multiple traumas 
to the brain over time resulting in brain injury that initially might 
be perceived as mild to moderate but cumulatively are moderate to 
severe.
    The IOM recognized the cumulative effect of multiple incidents of 
head trauma in its discussion of sports-related TBIs and Dementia 
Pugilistica. Studies have shown that there is a period following brain 
injury when the brain remains particularly vulnerable to damage from a 
subsequent injury. See, e.g., Prins ML et. al., ``Repeated Mild 
Traumatic Brain Injury: Mechanisms of Cerebral Vulnerability,'' Journal 
of Neurotrauma, 30(1):30-8) (2013).
    The IOM also noted that in determining TBI severity, different 
methods have been used in the last three decades to measure the 
magnitude of brain damage and to predict its outcome. The most widely 
used tool for measuring severity is the Glasgow Coma Scale. Other 
methods specifically mentioned by the IOM are the Abbreviated Injury 
Scale and the International Classification of Diseases. In addition, 
clinical criteria have also been used to determine the severity of head 
injuries, including alteration of consciousness, loss of consciousness, 
CT scans, and the duration of post-traumatic amnesia. Each of these 
tools has its own limitations. However, the cumulative effect of 
multiple head trauma over a period of time is taken into account during 
the clinical evaluation process through a review of the patient's 
history, comparison to baseline readings, and diagnostic examination. 
This would be a case-by-case evaluation, not suitable for prescriptive 
application as a secondary service connection. We believe that existing 
rating procedures, which include consideration of the veteran's full 
medical history in rendering medical opinions and assigning disability 
ratings, ensures that due consideration will be given to the potential 
effects of multiple mild TBIs based on their number, proximity in time, 
and any other relevant factors.

Comment Suggesting Assessment of TBI Severity

    In the proposed rule, we recognized that some veterans may not meet 
all of the criteria within a particular severity level (as described 
above) or may not have been examined for all the severity factors at or 
shortly after the time of the incurrence of the TBI. We went on to note 
that the simplest, most efficient, and fairest way to rank such 
veterans was to apply two rules: (1) VA will not require that a TBI 
meet all the criteria listed under a certain severity level to classify 
the TBI under that severity level; and (2) If a TBI meets the criteria 
relating to loss of consciousness, post-traumatic amnesia, or Glasgow 
Coma Scale in more than one severity level, then VA will rank the TBI 
at the highest of those levels. We included these rules in proposed 
paragraph (d)(3)(ii).
    One commenter asserted that ``the rating criteria [in the proposed 
rule] differ from those of established medical practice.'' The 
commenter noted that the joint DoD/VA guidelines on the evaluation of 
severity of TBI state that when the diagnostic criteria indicate 
different levels of severity, the highest level of any one criterion 
will be assigned. In the proposed regulation, however, raters will not 
apply a higher level when the higher level is indicated by the 
``alteration of consciousness'' or ``structural imaging of the brain'' 
criterion.
    We note that the joint VA/DoD guidelines cited above state, ``The 
patient is classified as mild/moderate/severe if he or she meets any of 
the criteria below within a particular severity level. If a patient 
meets criteria in more than one category of severity, the higher 
severity level is assigned.'' These principles are not limited to 
certain factors. We agree with the principle of applying the higher of 
two potentially applicable severity levels. However, literal 
application of the above-quoted statements would yield illogical and 
unintended results. The ``structural imaging of the brain'' criterion 
identifies ``Normal structural imaging'' as a feature of mild TBI and 
``Normal or abnormal structuring'' as a feature of both moderate and 
severe TBI. If a claimant need only meet any single criterion of the 
``severe TBI'' classification, then all TBIs would be evaluated as 
severe, because all TBIs would involve ``Normal or abnormal structural 
imaging.'' Similarly, the ``alteration of consciousness'' criterion 
indicates that both moderate and severe TBI involve alteration of 
consciousness for a period exceeding 24 hours and that differentiation 
between moderate and severe TBI should, therefore, be ``based on other 
criteria.'' It would be inconsistent with that stated direction to 
conclude that a patient's TBI was severe solely because it met the 
criterion of alteration of consciousness exceeding 24 hours. 
Accordingly, we decline to adopt the unqualified principle that meeting 
any single criterion for a specific severity level will result in 
assignment of that severity level. In considering this comment, 
however, we recognized that the criteria for alteration of 
consciousness and structural imaging of the brain do provide meaningful 
distinctions between mild and moderate TBI. We believe that a TBI that 
meets the criterion for moderate TBI under either of those categories 
should be evaluated as moderate, even if it meets none of the other 
criteria for moderate TBI. Accordingly, we have revised (d)(3)(ii) of 
the proposed regulation to read, in pertinent part, ``If a TBI meets 
the criteria in more than one category of severity, then VA will rank 
the TBI at the highest level in which a criterion is met, except where 
the qualifying criterion is the same at both levels.'' This language is 
intended to clarify that VA generally will assign the highest 
applicable level of severity, but will not treat ``Normal or abnormal 
structural imaging'' or alteration of consciousness exceeding 24 hours, 
standing alone, as establishing that the TBI is severe rather than 
moderate.
    The commenter also noted that because medical science on TBI is 
evolving ``it is likely that medical practice will change and that it 
will diverge from whatever criteria are published in this regulation.'' 
The commenter, therefore, suggested that VA insert the following 
language in Sec.  3.310(d): ``(i) For diagnoses of the severity of TBI, 
this regulation adopts the nomenclature of the Department of Defense 
Assistant Secretary for Health Affairs, `Traumatic Brain Injury: 
Definition and Reporting,' October 1, 2007. Medical diagnoses of the 
severity of TBI must be made in accordance with those standards, or 
with updated versions of the same standards.''
    For two reasons, we decline to adopt this suggestion. First, it 
would make the regulation difficult to use. It would require anyone 
using this regulation to

[[Page 76204]]

find and read the DoD document referenced. It would cause confusion 
because the reader would not know whether DoD has published an 
``updated version'' or where to find it. Second, it would bind VA to 
apply unknown future standards that may not be usable in the 
adjudication of veterans' disability claims.
    Another commenter suggested that we clarify paragraph (3)(ii) to 
state that the severity of TBI is based on contemporaneous 
documentation not subsequent testimony or witness statements. Proposed 
paragraph (3)(ii) stated that ``[t]he determination of the severity 
level under this paragraph is based on the TBI symptoms at the time of 
injury or shortly thereafter, rather than the current level of 
functioning.'' Although contemporaneous evidence ordinarily will be the 
most probative evidence of the TBI symptoms at the time of injury or 
shortly thereafter, we cannot rule out the possibility that subsequent 
statements may also be probative evidence that VA must consider. We, 
therefore, make no change based on this comment.

Comment Alleging That Medical Determinations Will Be Made by VA 
Adjudication Staff

    Under the proposed rule, VA would determine eligibility for 
secondary service connection based in part on the severity of the 
initial TBI. VA would rate the severity of the TBI in one of three 
categories (mild, moderate, and severe) in conformity with joint VA/DoD 
guidance on the assessment of TBI severity. Department of Defense 
Assistant Secretary for Health Affairs, ``Traumatic Brain Injury: 
Definition and Reporting'' 2, October 1, 2007. This guidance considers 
the following factors: structural imaging of the brain, the Glasgow 
Coma Scale, and the durations of any loss of consciousness, alteration 
of consciousness/mental state, or post-traumatic amnesia.
    One commenter asserted that this provision in the proposed rule 
would improperly ``permit raters to make medical diagnoses.'' The 
commenter cites the seminal case Colvin v. Derwinski, 1 Vet. App. 171, 
174 (1991), for the principle that VA adjudication staff ``are 
prohibited from relying on their own lay judgment to decide medical 
questions.'' The commenter goes on to assert that, ``[b]ecause the 
criteria that define the levels of severity are individual 
physiological responses rather than external factual circumstances, 
determining the severity of a TBI is a medical diagnosis.'' The 
commenter concluded that, ``[t]he fact that the protocol for 
determining the severity of TBI appears to be relatively mechanical 
does not mean that laypersons are competent to make that 
determination.''
    As a preliminary matter, we note that the commenter misstates the 
concept of diagnosis. As stated in Dorland's Illustrated Medical 
Dictionary, diagnosis means, ``1. the determination of the nature of a 
case of disease'' or ``2. the art of distinguishing one disease from 
another.'' Dorland's Illustrated Medical Dictionary 507 (30th ed. 
2003). Assessment of the severity of an injury is not a diagnosis.
    Furthermore, it is well within the authority of a VA adjudicator to 
determine the nature and severity of an injury based on the available 
medical and lay evidence. For example, in 38 CFR 4.56, ``Evaluation of 
muscle disabilities,'' VA regulations refer to various types of 
``[t]hrough and through'' gunshot wounds. In such cases, the VA 
adjudicator reviews the relevant medical evidence and then makes a 
determination whether the gunshot passed through the veteran's body. He 
or she can make this determination even if the medical records do not 
explicitly address this point. The adjudicator is merely overlaying the 
medical and lay evidence onto the regulatory criteria to reach a 
factual determination. There is no medical judgment required to do 
this. Similarly, a VA adjudicator is empowered under 38 CFR 4.120, 
``Evaluations by comparison'' to determine the ``site and character of 
the injury. Likewise, in 38 CFR 4.41, ``History of injury,'' VA 
instructs its adjudicators, ``In considering the residuals of injury, 
it is essential to trace the medical-industrial history of the disabled 
person from the original injury, considering the nature of the injury 
and the attendant circumstances . . .''
    The table in proposed Sec.  3.310(d)(3) simply requires a VA 
adjudicator to apply certain objective criteria to the medical and lay 
evidence of record regarding the TBI symptoms at the time of the injury 
or shortly thereafter. Nothing in the proposed rule would prohibit a VA 
adjudicator from obtaining a medical opinion if he or she requires more 
precise medical information to properly determine in which of the three 
severity levels the veteran's TBI belongs. In fact, under VA's duty to 
assist (38 U.S.C. 5103A(d)), VA is required to obtain a medical 
examination or a medical opinion ``when such an examination or opinion 
is necessary to make a decision on the claim.''
    If VA were to adopt the commenter's implied suggestion that we 
obtain a medical opinion regarding severity of the TBI in every case, 
we would be needlessly delaying many veterans' claims which could 
otherwise be granted without such an opinion. This would not only delay 
the claims of veterans seeking service connection for the secondary 
effects of their TBI, but the claims of other veterans who would be 
forced to wait longer for their medical exam or opinion. For these 
reasons, we make no change based on this comment.

Comment Suggesting Clarification on the Rating of the Secondary 
Condition

    One commenter expressed concern that the proposed rule did not 
address cases in which ``a veteran with an existing rating for a 
secondary illness is higher than the [TBI] rating they would receive 
under the new rule, which could result in a reduction in the veteran's 
compensation and schedular rating from the application of this rule.'' 
The commenter further stated, ``This could also result in situations 
where a veteran is not adequately compensated for the severity of the 
secondary illness and its impact on quality of life/functioning.'' This 
same commenter also alleges that the proposed rule does not address the 
rule's applicability to prior determinations made by VA regarding 
service connection for TBI and the severity of the secondary condition 
in relation to the TBI rating. This commenter states that ``the rule 
only provides for a service connection for [TBI] that do not have the 
necessary medical documentation to be assessed under the new section 
proposed if there are also secondary illnesses that may warrant a 
rating greater than under the new rule.'' He further asserts that 
``[T]his could result in veterans receiving a lower schedular rating 
and subsequent reduction in category grouping for treatment of their 
illness than previously received.''
    VA does not believe that this rulemaking could result in a lower 
disability rating for any veteran. This rule does not govern how VA 
determines the degree of disability caused by any service-connected 
illness, but only provides a mechanism for establishing service 
connection for certain illnesses. If a veteran were already service 
connected for one of the five illnesses listed in the rule, then this 
rule would have no impact on his or her status or rating. Regarding 
prior claims for service connection of a TBI, this rule would have no 
impact on those either. This rule does not alter the requirement to 
first prove that a TBI is service connected in order for VA to consider

[[Page 76205]]

what conditions may be service connected as secondary to that TBI.

Comment Suggesting Inclusion of Acquired Brain Injuries

    One commenter urged VA to include all acquired brain injuries in 
the coverage of this rule, such as damage caused by anoxia or hypoxia 
when the body is subjected to blast or pressure waves following an 
explosion. The IOM noted at page 14 of its report that TBI can be 
caused not only by a blow or by jolt to the head or penetrating head 
injury, but also by exposure to an external energy source. VA agrees 
with that observation, and we did not limit the scope of this 
rulemaking to only TBI incurred as a result of a blow to the head. 
Acquired brain injuries that meet the criteria for service-connected 
TBI would be covered by this rule. Acquired brain injuries that are not 
categorized as TBI were not studied in the IOM report and are outside 
of the scope of this rulemaking. We make no change based on this 
comment.

Comments Regarding Specific Conditions Secondarily Service-Connected to 
TBI

1. Parkinsonism and Parkinson's Disease
    We received two comments urging VA to amend proposed paragraph 
(d)(1)(i), that states that parkinsonism shall be held to be the 
proximate result of service-connected moderate or severe TBI, in the 
absence of clear evidence to the contrary. One commenter urged VA to 
clearly indicate that Parkinson's disease is included in the definition 
of parkinsonism. In support, the commenter cites the definition of 
parkinsonism found on VA's Parkinson's Disease Research, Education, and 
Clinical Centers (PADRECC) Web site, which can be interpreted to 
exclude Parkinson's disease from that definition. In addition, the 
commenter cited definitions of parkinsonism found on the Web sites of 
the Michael J. Fox Foundation and the National Parkinson's Foundation.
    Another commenter referred to an earlier IOM report, Veterans and 
Agent Orange: Update 2008. Institute of Medicine of the National 
Academies, Veterans and Agent Orange: Update 2008, The National 
Academies Press (Washington, DC, 2009); available online at http://www.nap.edu/openbook.php?record-id=12662&page=515 (accessed June 24, 
2013) (hereinafter ``Veterans and Agent Orange: Update 2008''). The 
commenter asserts that parkinsonism and other similar diseases are not 
the same disease as Parkinson's disease, citing the IOM's statement in 
that earlier report that ``[Parkinson's disease] must be distinguished 
from a variety of parkinsonian syndromes, including drug-induced 
parkinsonism and neurodegenerative diseases, such as multiple systems 
atrophy, which have parkinsonian features combined with other 
abnormalities.'' Veterans and Agent Orange: Update 2008, 515-16.
    The commenter is correct in the assertion that Parkinson's disease 
is not the same as parkinsonism. The earlier report that the commenter 
is referring to--Veterans and Agent Orange: Update 2008--evaluated the 
correlation between Parkinson's disease and certain herbicide 
exposures. In Veterans and Agent Orange: Update 2008, the IOM 
specifically limited its study to the relationship between herbicide 
exposure and Parkinson's disease and cautioned readers, as the 
commenter correctly noted, that Parkinson's disease ``must be 
distinguished from a variety of parkinsonian syndromes, including drug-
induced parkinsonism and neurodegenerative diseases.'' Agent Orange: 
Update 2008 at 515-16. The IOM included this caution because it wanted 
to be clear that it was not evaluating the correlation between 
parkinsonism and certain herbicide exposure; rather, its evaluation was 
explicitly limited to correlations between certain herbicide exposure 
and Parkinson's disease. Veterans and Agent Orange: Update 2008 was the 
subject of an earlier VA rulemaking in which VA amended 38 CFR 3.309(e) 
to establish presumptive service connection for Parkinson's disease 
based on exposure to certain herbicide agents. 38 CFR 3.309(e); see 
Diseases Associated with Exposure to Certain Herbicide Agents (Hairy 
Cell Leukemia and Other Chronic B-Cell Leukemias, Parkinson's Disease 
and Ischemic Heart Disease), 75 FR 53202-53204 (Aug. 31, 2010); see 
also Diseases Associated with Exposure to Certain Herbicide Agents 
(Hairy Cell Leukemia and Other Chronic B-Cell Leukemias, Parkinson's 
Disease and Ischemic Heart Disease), 75 FR 14391-14392 (Mar. 25, 2010). 
Based on the limited scope of the IOM report, VA amended Sec.  3.309(e) 
to only include Parkinson's disease while clarifying in its Final Rule 
that ``Parkinson's disease'' does not include parkinsonism because the 
IOM report specifically did not opine regarding parkinsonism. In the 
Final Rule, VA stated, ``Update 2008 only evaluated the correlation 
between certain herbicide exposures and Parkinson's disease. 
Parkinsonism, and other similar diseases, is not the same disease as 
Parkinson's disease''.
    On page 246 of the IOM report at issue in this rulemaking--Gulf War 
and Health, Volume 7: Long-Term Consequences of Traumatic Brain 
Injury--the IOM clearly affirms the commenter's assertion that 
parkinsonism is not the same as Parkinson's disease. The IOM notes that 
although Parkinson's disease is the primary underlying cause of 
parkinsonism ``other factors have been associated with 
[parkinsonism].'' The IOM committee clearly considered Parkinson's 
disease to be the primary underlying cause of parkinsonism, and 
symptoms of Parkinson's disease to be within the constellation of 
symptoms that comprise parkinsonism and we agree with that assessment. 
In essence, Parkinson's disease is a form of parkinsonism; therefore, 
all Parkinson's disease is parkinsonism. However, the reverse 
relationship is not true: not all parkinsonism is Parkinson's disease. 
Therefore, it is not contradictory for VA to include Parkinson's 
disease as a part of parkinsonism in this rulemaking while maintaining 
that Parkinson's disease does not include parkinsonism with regard to 
38 CFR 3.309(e). Furthermore, in the present report, the IOM evaluated 
parkinsonism while in Veterans and Agent Orange: Update 2008 referred 
to by the commenter the IOM limited its evaluation only to Parkinson's 
disease; therefore, VA is justified in using the broader term 
``parkinsonism'' in Sec.  3.310(d)(i) while maintaining the use of the 
more limited term ``Parkinson's disease'' in Sec.  3.309(e). However, 
VA understands that, due to the limited scope of the term ``Parkinson's 
disease'' in 38 CFR 3.309(e), there exists the potential for confusion 
concerning the scope of the term ``parkinsonism'' as used in 38 CFR 
3.310(d)(i). Therefore, we are adding ``, including Parkinson's 
disease,'' following Parkinsonism in paragraph (d)(1)(i) to provide 
clarity.
    Numerous commenters urged ``VA to continue to review research to 
assess whether it supports extending eligibility for these benefits to 
veterans who experience any TBI, not just those classified as moderate 
or severe.'' One commenter specifically urged VA to amend paragraph 
(d)(1)(i) to include veterans with parkinsonism following mild TBI with 
loss of consciousness (LOC). The commenter relied on the two primary 
studies considered by the IOM. In one of the cited studies, the authors 
examined a history of TBI as a risk factor for Parkinson's Disease (PD) 
in a case-control study. Bower JH, et. al., ``Head trauma preceding PD: 
A case-

[[Page 76206]]

control study,'' Neurology, 60(10):1610-1615 (2012). Mild head trauma 
was defined in this study as the absence of skull fracture and an LOC 
or post-traumatic amnesia lasting less than 30 minutes. The authors 
considered the association between PD and a history of mild TBI with 
LOC, moderate TBI, or severe TBI and found a significant association. 
The reported data did not further differentiate between mild TBI with 
LOC, moderate TBI, or severe TBI, so it is unclear how many of the 
identified patients had mild TBI with LOC. The authors noted that the 
``results suggest an association between head trauma and the later 
development of [Parkinson's disease] that varies with severity.'' The 
IOM noted several possible study limitations.
    In the second study, the authors conducted a case-control study of 
93 male twin pairs discordant for Parkinson's disease, identified 
through the National Academy of Science's World War II veteran twins 
cohort. Goldman SM, et al, ``Head Injury and Parkinson's Disease Risk 
in Twins,'' Annals of Neurology, 60(1):65-72 (2006). The authors 
concluded that there was an association between TBI and parkinsonism, 
and an increased risk of Parkinson's disease in patients that had TBI 
with LOC or post-traumatic amnesia. They found no significant 
association between duration of LOC and Parkinson's disease.
    The IOM concluded that there is ``limited/suggestive evidence of an 
association'' between mild TBI with LOC and parkinsonism, which means 
that ``[e]vidence is suggestive of an association between TBI and a 
specific health outcome in human studies but is limited because chance, 
bias, and confounding could not be ruled out with reasonable 
confidence.'' Based on our independent review and analysis of these two 
research studies, we agree with the IOM's conclusion. In the Bower 
study, there was insufficient differentiation of data to determine how 
many subjects had mild TBI with LOC, and the study has limited utility 
for our purposes because of broad confidence intervals and the 
possibility that mild TBI could not be identified based solely on a 
review of the medical records. The Goldman study concluded solely that 
there was an increased risk of Parkinson's disease in patients that had 
TBI with LOC or post-traumatic amnesia and no association between 
duration of LOC and Parkinson's disease. VA does not believe that the 
available scientific evidence warrants expanding the list of conditions 
in paragraph (d)(1)(i) to include mild TBI with LOC, and so we make no 
changes based on this comment.
2. Seizures
    One commenter asserted that we misquoted study results regarding 
when seizures occur following a TBI. The commenter asserted that the 
study stated that seizures may occur at any time following a TBI. In 
the proposed rule at paragraph (d)(1)(ii), we stated that unprovoked 
seizures following moderate or severe TBI shall be held to be the 
proximate result of the service-connected TBI, in the absence of clear 
evidence to the contrary. We placed no limitation on when the 
unprovoked seizure must manifest during the veteran's life, and so we 
make no change based on this comment.
3. Dementias
    Two commenters recommended amending paragraph (d)(1)(iii) to remove 
any time limit on when dementias must manifest in order for the 
establishment of service connection secondary to TBI to apply. 
Dementias are very common, with many patients without a history of TBI 
over the age of 60 being diagnosed annually with dementia. Given the 
prevalence of the condition in the general population, VA believes it 
appropriate to require development of dementia within a certain time 
period following a TBI for this rulemaking to apply. The available 
medical research indicates that TBI increases the risk of dementia and 
accelerates the timeline for developing that condition. In cases where 
dementia develops more than 15 years after a TBI, the link between the 
two conditions becomes less clear as the intervening time period 
becomes more attenuated. We make no changes to the rulemaking as a 
result of these comments.
    One commenter recommended that the definition of dementia in 
paragraph (d)(1)(iii) be amended to include frontotemporal dementia and 
dementia with Lewy bodies. VA agrees. The research studies cited in 
support of this recommendation are persuasive and consistent with the 
body of research considered by the IOM. In addition, VA has continued 
to review the definition of dementia in this rulemaking and has 
determined that post-traumatic dementia should be removed from the 
definition. Post-traumatic dementia is not a recognized ICD-9 
diagnosis, and including the condition in this rulemaking could result 
in confusion, uncertainty, and inconsistent application of the 
establishment of service connection secondary to TBI. We are, 
therefore, revising the regulation at (d)(1)(iii) to read, ``Dementias 
of the following types: Presenile dementia of the Alzheimer type, 
frontotemporal dementia, and dementia with Lewy bodies, if manifest 
within 15 years following moderate or severe TBI.'' This change is not 
intended to suggest that dementia noted by a physician as being ``post-
traumatic'' or otherwise related to a TBI would be outside the scope of 
this rule. Rather, it reflects that clinicians generally do not use 
that term as a diagnostic classification and are not required to do so 
for purposes of this rule. The purpose of this change is to ensure that 
the text of the rule accurately reflects recognized diagnostic 
categories and will, therefore, be easier to apply.
    One commenter urged VA to continue to review research on the 
relationship between Alzheimer's disease and TBI and to emphasize the 
importance of early diagnosis of Alzheimer's disease. While matters of 
medical research and treatment are outside the scope of this 
rulemaking, we will continue to review the emerging research literature 
on TBI and dementia. In addition, we will continue our efforts to 
improve dementia recognition, diagnosis, and care.
4. Depression
    The proposed rule suggested that VA establish service connection 
secondary to TBI for depression if manifest within 3 years of the 
incurrence of a moderate or severe TBI or within 12 months of the 
incurrence of a mild TBI. One commenter stated that we misquoted study 
results and that there was no limitation on when the depression 
manifests following a TBI. It is unclear whether the commenter meant 
that VA had misquoted the IOM report itself or the research studies 
referenced in that report.
    As a preliminary matter, we note that the proposed rule concerning 
secondary service connection for depression does not preclude a claim 
for direct service connection of depression, or a claim for service 
connection of depression secondary to TBI under Sec.  3.310(a) for a 
condition that manifests outside the prescribed time periods. Paragraph 
(d)(2) provides that if a claim does not meet either the time of 
manifestation or severity of TBI, or both, VA will develop and decide 
the claim under generally applicable principles of service connection 
without regard to these rules concerning secondary service connection.
    Moreover, we believe that the scientific literature supports the 
proposed rule's time and severity limitations for depression. The IOM

[[Page 76207]]

reviewed four primary and five secondary studies of major depression 
manifesting following TBI. The studies showed a higher rate of major 
depression 6 months or more after TBI when compared to appropriate 
comparison groups. For example, one 2004 study showed that in the first 
year after a moderate to severe TBI, 49% of the patients had evidence 
of psychiatric illnesses compared with 34% in the mild-TBI group and 
18% in the comparison group. Fann JR, et. al., ``Psychiatric illness 
following traumatic brain injury in an adult health maintenance 
organization population,'' Archives of General Psychiatry, 61(1):53-61 
(2004). The authors found the risk of psychiatric illness to be 
greatest in the period 6 to 12 months after the TBI and the risk was 
higher for moderate or severe TBI than for mild TBI. For depression 
that is first manifest after this identified period of significant 
increased risk, the available studies provide no reliable basis for 
concluding as a general matter that the depression is linked to the TBI 
rather than other causes. In such cases, we believe it is necessary to 
evaluate the medical evidence concerning the particular veteran's 
illness, under ordinary procedures, to determine whether the depression 
is related to TBI or is otherwise service connected. We, therefore, 
make no change based on this comment.
    One commenter stated that paragraph (d)(1)(iv) should be amended to 
either exclude depression if manifested within 12 months of mild TBI, 
or to include only those veterans with mild TBI diagnosed on the basis 
of LOC, not on the basis of altered mental state. The commenter 
believes that there is not sufficient evidence to assume that mild TBI 
diagnosed on the basis of altered mental status is the proximate cause 
of depression that develops within 12 months post-injury. The IOM 
concluded that there was sufficient evidence of an association between 
TBI (mild, moderate, and severe) and depression based on its review of 
four primary and five secondary studies. In making a distinction 
between mild TBI with LOC and mild TBI diagnosed based on altered 
mental status, the commenter relies on a recent study of mild TBI in US 
soldiers that saw a high level of combat during a year-long deployment 
in Iraq. Hoge CW, et. al., ``Mild traumatic brain injury in U.S. 
soldiers returning from Iraq,'' New England Journal of Medicine, 
358(5):453-463) (2008). This research was also considered by the IOM. 
In this study, soldiers were given a questionnaire which included 
questions regarding TBI. Soldiers were deemed to have mild TBI if they 
answered yes to any of three questions about losing consciousness, 
being dazed or confused, or not recalling the injury. Answers to these 
questions were used to form two subgroups within the mild-TBI group to 
determine whether LOC or altered mental status was a strong predictor 
of various conditions, including depression. A total of 124 soldiers 
were identified with mild TBI with LOC, and 260 soldiers were 
identified with mild TBI and altered mental status. This is the only 
study identified by the IOM that distinguished between how mild TBI was 
diagnosed, whether because of LOC or altered mental state. Limitations 
of this study include the fact that the researchers relied on 
information self-reported by study participants, and the study included 
only a small number of soldiers who were identified as having mild TBI.
    In contrast, the greater preponderance of studies upon which the 
IOM based its findings showed that groups with TBI (mild, moderate, or 
severe) had higher rates of major depression 6 months or longer after 
TBI than did appropriate comparison and control groups. As noted by the 
commenter, these studies (as with Hoge and colleagues) also had 
limitations. The limitations identified in these studies include a lack 
of differentiation in severity of TBI in one study, and another study 
being conducted on the general population rather than solely veterans. 
However, the results of these research studies viewed as a whole 
support the IOM's conclusion that led to the conclusion that there is 
sufficient evidence of an association between TBI and depression. VA 
has reviewed the supporting research, as well as the IOM's analysis, 
and accepts the committee's conclusion. VA has determined that the 
proper course of action is to include all levels of severity of TBI in 
the rulemaking regarding depression. While the research relied on by 
the commenter is intriguing and suggestive, given the limitations in 
the study and the absence of any follow up studies confirming the 
results, we do not believe the data at this time is strong enough to 
justify a decision to limit the scope of this rulemaking.
5. Diseases of Hormone Deficiency
    The proposed rule suggested that VA establish procedures for 
establishing secondary service connection for ``Diseases of hormone 
deficiency that result from hypothalamo-pituitary changes if manifest 
within 12 months of moderate or severe TBI.'' VA received one comment 
asking us to clarify which hormone deficiencies or disorders will be 
presumed to be the proximate result of service-connected TBI in the 
absence of clear evidence to the contrary. The IOM noted at page 227 of 
its report that clinical data suggest that TBI can lead to acute and 
chronic hypopituitarism as a result of hypothalamo-pituitary changes. 
(Hypopituitarism is the decreased secretion of one or more of the eight 
hormones normally produced by the pituitary gland).
    The IOM identified eight primary studies and four secondary studies 
that assessed the relationship between various endocrine disorders and 
TBI. The studies, viewed together, evaluate the possible relationship 
between TBI and deficiencies in hormones produced in both the anterior 
and posterior pituitary gland. Based on these studies, the IOM 
concluded that there is sufficient evidence of an association between 
moderate or severe TBI and endocrine dysfunction, particularly 
hypopituitarism. VA agrees with that conclusion. The scientific 
evidence supports a finding that moderate or severe TBI can produce 
changes in the pituitary gland and hypothalamus that can lead to 
pituitary hormone deficiencies, i.e., hypopituitarism. We believe it is 
unnecessary to list in the regulation the various diseases of hormone 
deficiency that result from hypothalamo-pituitary changes. There are 
various mechanisms by which a TBI may cause the hypothalamus and/or the 
pituitary gland to malfunction. Describing them individually would not 
add any clarity for the reader and would make the regulation more 
technical and difficult to read, understand, and apply. Further, 
although current research supports a finding that some diseases of 
hormone deficiency are associated with TBI, this does not preclude the 
possibility that future research could find an association between TBI 
and other diseases of hormone deficiency that result from hypothalamo-
pituitary changes. Listing specific diseases here would limit VA's 
ability to make determinations based on the most current peer reviewed 
research, and would require VA to continually update this rule based on 
that research. We, therefore, decline to make any changes based on this 
comment.

Other Comments

    Other commenters asked for VA to include additional focuses in this 
rulemaking, such as extending eligibility to veterans overexposed to 
radiation and suffering from Parkinson's disease, extending benefits to 
veterans with sealed service records, providing

[[Page 76208]]

name-brand prescription medication to veterans with Parkinson's 
disease, supporting funding for Parkinson's research, and improving 
rural veterans' access to hospitals. As previously stated, this 
rulemaking focuses on the secondary service-connected conditions that 
are a proximate result of TBI; therefore, these comments are outside 
the scope of this rulemaking.
    Numerous comments requested additional research. VA agrees that 
further research on the health effects of TBI is warranted and we note 
that VA/DoD have recently invested $62.2 million to begin a research 
consortium ``Chronic Effects of Neurotrauma Consortium--CENC'' to study 
the chronic effects of TBI.

Paperwork Reduction Act

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

Regulatory Flexibility Act

    The Secretary of Veterans Affairs hereby certifies that this final 
rule will not have a significant economic impact on a substantial 
number of small entities as they are defined in the Regulatory 
Flexibility Act (5 U.S.C. 601-612). This final rule will directly 
affect only individuals and will not affect any small entities. Only VA 
beneficiaries could be directly affected. Therefore, pursuant to 5 
U.S.C. 605(b), this rulemaking is exempt from the initial and final 
regulatory flexibility analysis requirements of sections 603 and 604.

Executive Orders 13563 and 12866

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulatory action is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
Create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) Materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) Raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this final rule have been examined, and it has been 
determined to be a significant regulatory action under the Executive 
Order 12866. VA's impact analysis can be found as a supporting document 
at http://www.regulations.gov, usually within 48 hours after the 
rulemaking document is published. Additionally, a copy of the 
rulemaking and its impact analysis are available on VA's Web site at 
http://www1.va.gov/orpm/, by following the link for ``VA Regulations 
Published.''

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any year. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance Numbers and Titles

    The Catalog of Federal Domestic Assistance program numbers and 
titles for this final rule are 64.109, Veterans Compensation for 
Service-Connected Disability, and 64.110, Veterans Dependency and 
Indemnity Compensation for Service-Connected Death.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Jose D. 
Riojas, Chief of Staff, Department of Veterans Affairs, approved this 
document on August 23, 2013, for publication.

List of Subjects in 38 CFR Part 3

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

    Dated: December 12, 2013.
William F. Russo,
Deputy Director, Regulation Policy and Management, Office of the 
General Counsel, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA amends 38 CFR part 3 as 
follows:

PART 3--ADJUDICATION

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

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


0
2. Amend Sec.  3.310 by adding paragraph (d), to read as follows:


Sec.  3.310  Disabilities that are proximately due to, or aggravated 
by, service-connected disease or injury.

* * * * *
    (d) Traumatic brain injury. (1) In a veteran who has a service-
connected traumatic brain injury, the following shall be held to be the 
proximate result of the service-connected traumatic brain injury (TBI), 
in the absence of clear evidence to the contrary:
    (i) Parkinsonism, including Parkinson's disease, following moderate 
or severe TBI;
    (ii) Unprovoked seizures following moderate or severe TBI;
    (iii) Dementias of the following types: presenile dementia of the 
Alzheimer type, frontotemporal dementia, and dementia with Lewy bodies, 
if manifest within 15 years following moderate or severe TBI;
    (iv) Depression if manifest within 3 years of moderate or severe 
TBI, or within 12 months of mild TBI; or
    (v) Diseases of hormone deficiency that result from hypothalamo-
pituitary changes if manifest within 12 months of moderate or severe 
TBI.
    (2) Neither the severity levels nor the time limits in paragraph 
(d)(1) of this section preclude a finding of service connection for 
conditions shown by evidence to be proximately due to service-connected 
TBI. If a claim does not meet the requirements of paragraph (d)(1) with 
respect to the time of manifestation or the severity of the TBI, or 
both, VA will develop and decide the claim under generally applicable 
principles of service connection without regard to paragraph (d)(1).
    (3)(i) For purposes of this section VA will use the following table 
for determining the severity of a TBI:

[[Page 76209]]



------------------------------------------------------------------------
            Mild                    Moderate               Severe
------------------------------------------------------------------------
Normal structural imaging...  Normal or abnormal    Normal or abnormal
                               structural imaging.   structural imaging.
LOC = 0-30 min..............  LOC > 30 min and <    LOC > 24 hrs.
                               24 hours.
                             -------------------------------------------
AOC = a moment up to 24 hrs.    AOC > 24 hours. Severity based on other
                                               criteria.
                             -------------------------------------------
PTA = 0-1 day...............  PTA > 1 and < 7 days  PTA > 7 days.
GCS = 13-15.................  GCS = 9-12..........  GCS = 3-8.
------------------------------------------------------------------------


    Note: The factors considered are:

    Structural imaging of the brain.
    LOC--Loss of consciousness.
    AOC--Alteration of consciousness/mental state.
    PTA--Post-traumatic amnesia.
    GCS--Glasgow Coma Scale. (For purposes of injury stratification, 
the Glasgow Coma Scale is measured at or after 24 hours.)

    (ii) The determination of the severity level under this paragraph 
is based on the TBI symptoms at the time of injury or shortly 
thereafter, rather than the current level of functioning. VA will not 
require that the TBI meet all the criteria listed under a certain 
severity level in order to classify the TBI at that severity level. If 
a TBI meets the criteria in more than one category of severity, then VA 
will rank the TBI at the highest level in which a criterion is met, 
except where the qualifying criterion is the same at both levels.

(Authority: 38 U.S.C. 501, 1110 and 1131)


[FR Doc. 2013-29911 Filed 12-16-13; 8:45 am]
BILLING CODE 8320-01-P