[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Proposed Rules]
[Pages 73366-73369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29709]


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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: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is amending its 
adjudication regulations concerning service-connection. This amendment 
is necessary to act 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. 
The intended effect of this amendment is to establish that if a veteran 
who has a service-connected TBI also has one of these diagnosable 
illnesses, then that

[[Page 73367]]

illness will be considered service connected as secondary to the TBI.

DATES: Effective Date: Comments must be received by VA on or before 
February 8, 2013.

ADDRESSES: Written comments may be submitted through 
www.Regulations.gov; by mail or hand-delivery to Director, Regulations 
Management (02REG), Department of Veterans Affairs, 810 Vermont Ave. 
NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. 
(This is not a toll free number.) Comments should indicate that they 
are submitted in response to ``RIN 2900-AN89--Secondary Service 
Connection for Diagnosable Illnesses Associated with Traumatic Brain 
Injury.'' Copies of comments received will be available for public 
inspection in the Office of Regulation Policy and Management, Room 
1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through 
Friday (except holidays). Please call (202) 461-4902 for an 
appointment. (This is not a toll free number.) In addition, during the 
comment period, comments may be viewed online through the Federal 
Docket Management System (FDMS) at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Thomas J. Kniffen, Chief, Regulations 
Staff (211D), Compensation and Pension Service, Veterans Benefits 
Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., 
Washington, DC 20420, (202) 461-9739. (This is not a toll free number.)

SUPPLEMENTARY INFORMATION: This document proposes to amend VA 
adjudication regulations (38 CFR Part 3) by revising 38 CFR 3.310 to 
add five diagnosable illnesses as secondary conditions which shall be 
held to be the proximate result of service-connected TBI.

Scientific Bases for This Rulemaking

    In the National Academy of Science IOM Report, Gulf War and Health 
Volume 7: Long-Term Consequences of Traumatic Brain Injury, the IOM 
concluded there was ``sufficient evidence of a causal relationship'' 
(the IOM's highest evidentiary standard) between moderate or severe 
levels of TBI and diagnosed unprovoked seizures. The IOM found 
``sufficient evidence of an association'' between moderate or severe 
levels of TBI and parkinsonism; dementias (which VA understands to 
include presenile dementia of the Alzheimer type and post-traumatic 
dementia); depression (which also was associated with mild TBI); and 
diseases of hormone deficiency that may result from hypothalamo-
pituitary changes.
    The medical literature that IOM reviewed included two primary 
studies and one secondary study on TBI and parkinsonism. One primary 
study involved 196 Parkinson's patients living in Olmstead County, 
Minnesota, and the second involved 93 pairs of male twins who were 
veterans from World War II. The secondary study involved 140 civilian 
Parkinson's patients in Boston, Massachusetts, who had suffered a TBI 
severe enough to cause loss of consciousness, blurred or double vision, 
dizziness, seizures, or memory loss. These three studies support a link 
between moderate or severe TBI and parkinsonism.
    Medical literature supports a link between TBI and the two types of 
dementias listed above (presenile dementia of the Alzheimer type and 
post-traumatic dementia). Reported cases show that individuals with TBI 
often are diagnosed with dementia at ages younger than their early 50s 
and within 15 years of their injuries. As classic Alzheimer's disease 
strikes sufferers much later in life, the dementias suffered by TBI 
victims are unlikely to be classic Alzheimer's dementias. Classic 
Alzheimer's disease is the most common of many types of dementia that 
occur in older adults. It is difficult to conclude that Alzheimer's 
occurring at ages in the 60s or 70s is related to a distant TBI.
    The IOM reviewed 4 primary studies of civilians and of troops 
serving in World War II and the current conflict in Iraq and five 
secondary studies of mood disorders including major depression. The 
primary studies generally supported an association between mild, 
moderate, or severe TBI and major depression within the first twelve 
months after the injury. Current research does not provide significant 
evidence to support association more than 12 months following mild TBI. 
Moderate or severe TBI appears to cause an elevated risk for depression 
(up to 50% in some research) for at least the first 3 years.
    The IOM reviewed five studies on TBI and hypopituitarism, and five 
studies on TBI and growth hormone insufficiency. The studies generally 
showed increased risk of those conditions developing within months 
after a moderate or severe TBI and, although the effects in many cases 
were acute and eventually resolved, some long-term effects were 
observed. The medical literature reviewed by IOM supports a link 
between TBI and diseases of hormone deficiency resulting from 
hypothalamo-pituitary changes, when the disease manifests within 12 
months of a moderate or severe TBI. The presence of other peripherally-
mediated endocrinologic disorders (including, but not limited to 
diabetes mellitus) has no association with TBI.
    After careful review of the findings of the NAS Report, Gulf War 
and Health Volume 7, the Secretary of Veterans Affairs has determined 
that the scientific evidence present in the NAS Report, Gulf War and 
Health Volume 7 and other information available to the Secretary 
indicates that a revision to VA regulations to add the five diagnosable 
illnesses as secondary conditions is warranted. The five diagnosable 
illnesses to be added are the following: (1) Parkinsonism following 
moderate or severe TBI; (2) unprovoked seizures following moderate or 
severe TBI; (3) dementias (to include presenile dementia of the 
Alzheimer type and post-traumatic dementia) within 15 years of 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 
manifest within 12 months of moderate or severe TBI.
    Section 501(a) of title 38, U.S. Code, establishes the Secretary of 
Veterans Affairs' general rulemaking authority to prescribe all rules 
and regulations which are necessary or appropriate to carry out the 
laws administered by VA. Based on VA's analysis of the scientific 
evidence discussed in the IOM report as well as the IOM's finding of 
sufficient evidence of relationships between specific levels of TBI and 
certain diagnosable illnesses, and all other information available to 
the Secretary, we propose to amend 38 CFR 3.310 in order to incorporate 
five diagnosable illnesses as secondary conditions that are the 
proximate result of service-connected TBI.
    The IOM also found associations between TBI and certain behavioral 
and social problems. These include diminished social relationships, 
aggressive behaviors, long-term unemployment, and premature death. 
Under 38 U.S.C. 1110, VA may only grant service connection ``[f]or 
disability resulting from personal injury suffered or disease 
contracted in line of duty * * *''. Similarly, Sec.  1310(a) states, 
``When any veteran dies * * * from a service-connected or compensable 
disability, the Secretary shall pay dependency and indemnity 
compensation to such veteran's surviving spouse, children, and 
parents.'' VA does not believe it is

[[Page 73368]]

necessary to establish new presumptions of service connection for these 
effects because they are not distinct physical or mental 
``disabilities'' for VA compensation purposes. However, the behavioral, 
social, and occupational effects of TBI and related service-connected 
conditions may be considered in evaluating the severity of those 
conditions for compensation purposes as provided in provisions of VA's 
rating schedule.
    In relevant part, Sec.  3.310(a) states: ``[A] disability which is 
proximately due to or the result of a service-connected disease or 
injury shall be service connected. When service connection is thus 
established for a secondary condition, the secondary condition shall be 
considered a part of the original condition.'' We propose to revise 
Sec.  3.310 by adding a new subsection (d)(1) that lists five 
diagnosable illnesses as secondary conditions that shall be held to be 
proximate results of service-connected TBI.
    VA recognizes that not all those who suffer a TBI during military 
service seek immediate medical assistance and receive a medical 
assessment of the severity of the TBI. Therefore, proposed paragraph 
(d)(2) will clarify that neither severity levels nor time limits for 
manifesting secondary conditions as proximate causes of service-
connected TBI shall preclude a veteran from establishing direct service 
connection under the generally applicable principles of service 
connection in 38 CFR 3.303 and 3.304.

Determination of the Severity of a TBI

    VA and the Department of Defense have established a joint set of 
factors and criteria for classifying a TBI as mild, moderate, or 
severe. The factors and criteria were created by a team of physicians 
from VA and the Department of Defense who are experts on diagnosing and 
treating TBI. The factors are structural imaging (such as functional 
magnetic resonance imaging, diffusion tensor imaging, positron emission 
tomography (PET) scanning), duration of alteration of consciousness/
mental state, duration of loss of consciousness, duration of post-
traumatic amnesia, and score on the Glasgow Coma Scale. See Memorandum 
by Asst. Secretary of Defense for Health Affairs, ``Traumatic Brain 
Injury: Definition and Reporting,'' October 1, 2007. See also 
Compensation & Pension Service Training Letter 09-01, January 21, 2009.
    We propose to include these severity criteria as a table in Sec.  
3.310(d)(3)(i). We also propose to explain in paragraph (d)(3)(ii) that 
the determination of the severity level is based on the TBI symptoms at 
the time of injury or shortly thereafter, rather than the current level 
of functioning. This provision is consistent with established medical 
principles for assessing the severity of TBI. See Memorandum by Asst. 
Secretary of Defense for Health Affairs, ``Traumatic Brain Injury: 
Definition and Reporting,'' October 1, 2007. See also Compensation & 
Pension Service Training Letter 09-01, January 21, 2009.
    Some veterans may not meet all of the criteria within a particular 
severity level or may not have been examined for all the factors. We 
believe the simplest, most efficient, and fairest way to rank such 
veterans is 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 propose to include these rules in 
paragraph (d)(3)(ii).
    In some cases, it may not be clinically possible to determine the 
severity of a TBI (e.g., because of a lack of medical records 
contemporaneous with the injury or medical complications (e.g., 
medically induced coma)). In such cases, Sec.  3.310(d) would not apply 
and the veteran's claim would be processed under Sec.  3.310(a) which 
states that ``disability which is proximately due to or the result of a 
service-connected disease or injury shall be service connected.''

Paperwork Reduction Act

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

Regulatory Flexibility Act

    The Secretary of Veterans Affairs hereby certifies that this 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 rule would not affect any small entities. Only VA 
beneficiaries could be directly affected. Therefore, pursuant to 5 
U.S.C. 605(b), this rule 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,'' which requires review by the Office 
of Management and Budget (OMB), 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 proposed rule have been examined and it has been 
determined to be a significant regulatory action under the Executive 
Order 12866.

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 rule would 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 proposed rule are 64.109, Veterans Compensation for 
Service-Connected Disability, and 64.110, Veterans Dependency and 
Indemnity Compensation for Service-Connected Death.

[[Page 73369]]

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 John R. Gingrich, Chief of 
Staff, Department of Veterans Affairs, approved this document on 
December 4, 2012, for publication.

List of Subjects in 38 CFR Part 3

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

    Dated: December 5, 2012.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General 
Counsel, Department of Veterans Affairs.

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

PART 3--ADJUDICATION

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

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

    2. Revise 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 following moderate or severe TBI;
    (ii) Unprovoked seizures following moderate or severe TBI;
    (iii) Dementias (presenile dementia of the Alzheimer type and post-
traumatic dementia) 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:

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                Mild                                          Moderate                                                   Severe
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Normal structural imaging...........  Normal or abnormal structural imaging...................  Normal or abnormal structural imaging.
LOC = 0-30 min......................  LOC >30 min and <24 hours...............................  LOC >24 hrs.
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AOC = a moment up to 24 hrs.........                                   AOC >24 hours. Severity based on other criteria.
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PTA = 0-1 day.......................  PTA >1 and <7 days......................................  PTA > 7 days.
GCS = 13-15.........................  GCS = 9-12..............................................  GCS = 3-8.
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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 relating to LOC, PTA, or GCS in more than one 
severity level, then VA will rank the TBI at the highest of those 
levels.

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

[FR Doc. 2012-29709 Filed 12-7-12; 8:45 am]
BILLING CODE 8320-01-P