[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Pages 41696-41698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17814]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AN83
Presumptive Service Connection for Diseases Associated With
Service in the Southwest Asia Theater of Operations During the Persian
Gulf War: Functional Gastrointestinal Disorders
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: The Department of Veterans Affairs (VA) adopts as a final rule
the proposal to amend its adjudication regulations regarding
presumptive service connection for medically unexplained chronic
multisymptom illnesses associated with service in the Southwest Asia
theater of operations for which there is no record during service. This
amendment implements a decision by the Secretary that there is a
positive association between service in Southwest Asia during certain
periods and the subsequent development of functional gastrointestinal
disorders (FGIDs) and clarifies that FGIDs fall within the scope of the
existing presumptions of service connection for medically unexplained
chronic multisymptom illnesses.
DATES: This final rule is effective August 15, 2011.
Applicability Date: This final rule shall apply to claims pending
before, filed with or remanded to VA on or after August 15, 2011.
FOR FURTHER INFORMATION CONTACT: Nancy Copeland, Regulations Staff
(211D), Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue,
NW., Washington, DC 20420, (202) 461-9685. (This is not a toll-free
number.)
SUPPLEMENTARY INFORMATION: In a document published in the Federal
Register on November 17, 2010 (75 FR 70162-65), VA proposed to amend
its adjudication regulations regarding the presumption of service
connection for medically unexplained chronic multisymptom illnesses.
The amendment clarifies VA's interpretation that FGIDs fall within the
scope of the existing presumption of service connection for medically
unexplained chronic multisymptom illnesses. This clarification is based
on available scientific and medical evidence presented in the National
Academy of Sciences' (NAS) April 2010 report titled: Gulf War and
Health, Volume 8: Update on the Health Effects of Serving in the Gulf
War (NAS 2010 Report) and the Secretary's determination that there is a
positive association between service in Southwest Asia during certain
periods and the subsequent development of FGIDs.
In response to the proposed rule, VA received eight (8) public
comments. Of these comments, 5 expressed general support for the
rulemaking. The sixth commenter expressed belief that ``presumptive
service connection for gastrointestinal (GI) disorders and any
gastroesophageal reflux disease (GERD) or ``bowel inflammatory
conditions'' should be related to Gulf War service for the period 1990
through 1991 because of the ``hazardous chemical exposures known as a
toxic bowl of soup.'' VA appreciates this comment; however, based on
findings from the NAS 2010 report, the NAS Committee concluded that
there is sufficient evidence for an association between deployment to
the Southwest Asia theater of operations during the Gulf War and GI
symptoms consistent with FGIDs such as irritable bowel syndrome and
functional dyspepsia which involve ``recurrent or prolonged clusters of
symptoms that occur together.'' NAS 2010 Report, at 154. By contrast,
Inflammatory Bowel Disease (IBD), such as ulcerative colitis or Crohn's
disease, and GERD are considered to be ``organic'' or structural
diseases characterized by abnormalities seen on x-ray, endoscopy, or
through laboratory tests. The NAS Committee concluded that there is
inadequate/insufficient evidence to determine whether an association
exists between deployment to the Southwest Asia theater of operations
during the Gulf War and the development of structural gastrointestinal
diseases, and NAS defines both IBD and GERD as structural
gastrointestinal diseases. This rulemaking is limited to clarifying the
scope of the presumption for FGIDs as medically unexplained chronic
multisymptom illnesses. Therefore, we make no change based on this
comment.
The seventh commenter expressed belief that noise and vibration
exposure caused symptoms of various disorders, including intestinal
disorders, among the ``Gulf War Seabees'' and that some also have
neural damage as a result of vibration exposure. VA appreciates this
comment; however, we make no changes based on this comment. This rule
is intended to clarify the scope of the existing presumption of service
connection for medically unexplained chronic multisymptom illnesses,
which applies to all veterans who served in the Southwest Asia theater
of operations during the Persian Gulf War irrespective of whether their
illnesses can be shown to be linked to a specific cause in service,
such as noise and vibration exposure. To the extent the commenter
believes that noise and vibration exposure may cause FGIDs, no change
to this rule is necessary, because the rule already provides a
presumption of service connection for FGIDs in all Gulf War Veterans.
To the extent the commenter believes presumptive service connection
based on noise and vibration exposure is warranted for conditions other
than medically unexplained chronic multisymptom illnesses, that matter
is beyond the scope of this clarifying rule. We note that a Veteran who
believes his or her injury, disease, or illness may be related to noise
or vibration exposure in service may submit evidence of such effects in
support of his or her claim for benefits and VA will consider that
evidence in deciding the claim.
The eighth and final commenter advocated that VA broaden the scope
of
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the rule by adopting the same effective date standards established in
Nehmer v. United States Veterans' Administration, CV-86-6160 TEH (N.D.
Cal.). For the reasons explained below, we make no change based on this
comment.
In Nehmer, based on circumstances unique to that case, a district
court issued a series of orders requiring VA to readjudicate certain
previously and finally denied claims of Vietnam Veterans and their
survivors and, in some circumstances, to pay such claimants benefits
retroactive to the date of their previously denied claims. VA has
issued regulations at 38 CFR 3.816 to codify the requirements of the
Nehmer court orders.
Pursuant to statute, when VA issues a final decision denying
disability compensation for a condition, VA is, with one exception
described below, prohibited from later awarding benefits retroactive to
the date of the finally denied claim. 38 U.S.C. 5110. Claimants may
seek to reopen their claims with new evidence or may seek a new
decision based on an intervening change in law, but the effective date
of awards in those circumstances generally may be no earlier than the
date of the new claim or the effective date of the intervening change
in law. Id.; 38 CFR 3.114, 3.400. Congress has authorized payment
retroactive to the date of a previously and finally denied claim only
in the limited circumstance where the prior final decision is shown to
have been based on ``clear and unmistakable error'' of fact or law. See
38 U.S.C. 5109A and 7111.
The Nehmer court orders require VA in certain cases to pay benefits
retroactive to the date of a previously denied claim, even if VA's
prior decision did not involve clear and unmistakable error. The Nehmer
court orders apply only to claims by certain Vietnam Veterans and their
survivors based on disability due to herbicide exposure. Although VA is
required to comply with the Nehmer court orders, VA has no independent
authority to expand the court's orders or otherwise to pay retroactive
benefits not authorized by statute. Accordingly, VA cannot in this rule
authorize retroactive payments without regard to the effect of prior
final decisions and without regard to the requirement for a showing of
clear and unmistakable error in order to support such a retroactive
award. Because existing statutes and regulations provide clear guidance
concerning the effective dates of awards under this rule, we make no
change to the rule based on this comment.
In this final rule we are making a change to subparagraph (3) to
improve clarity and revising the note to subparagraph (3) to clarify
concepts involving medically unexplained chronic multisymptom illnesses
that comprise FGIDs and facilitate understanding of information
relating to diagnosis of such disorders. Subparagraph (3) of the
proposed rule stated that the disorders entitled to presumptive service
connection are ``Functional gastrointestinal disorders, including, but
not limited to irritable bowel syndrome and functional dyspepsia
(excluding structural gastrointestinal diseases).'' 75 FR at 70165. We
believe this language, in conjunction with information in the note to
paragraph (a)(2)(i)(B)(3), which lists irritable bowel syndrome and
functional dyspepsia as specific functional gastrointestinal disorders,
is repetitive and unnecessary. We have therefore revised subparagraph
(3) to remove the language regarding irritable bowel syndrome and
functional dyspepsia. Secondly, the proposed rule included the
following language in a note to paragraph (a)(2)(i)(B)(3): ``Functional
gastrointestinal disorders are a group of conditions characterized by
chronic or recurrent symptoms that were present for at least 6 months
prior to diagnosis and have been currently active for 3 months, that
are unexplained by any structural, endoscopic, laboratory, or other
objective signs of disease or injury and that may be related to any
part of the gastrointestinal tract. * * *'' We believe this language
might be unclear as to when the 3-month period starts and what the
difference is between the 6-month and 3-month periods. Established
medical principles regarding these disorders generally require symptom
onset at least 6 months prior to diagnosis and the presence of symptoms
sufficient to diagnose the specific disorder at least 3 months prior to
diagnosis. We have therefore revised the note to explain how a
diagnosis of FGID is made.
Therefore, based on the rationale set forth in the proposed rule
and this document, we are adopting the provisions of the proposed rule
as a final rule with the changes discussed above.
Paperwork Reduction Act
This document contains no provisions constituting a collection of
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this 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 Order 12866
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation 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). The Executive
Order classifies a ``significant regulatory action,'' requiring 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 final rule have been examined and it has been
determined not to be a significant regulatory action under 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 final rule are 64.109, Veterans
[[Page 41698]]
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. John R.
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this
document on July 6, 2011, for publication.
List of Subjects in 38 CFR Part 3
Administrative practice and procedure, Claims, Disability benefits,
Health care, Veterans, Vietnam.
Dated: July 12, 2011.
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 amends 38 CFR part 3 as
follows:
PART 3--ADJUDICATION
Subpart A--Pension, Compensation, and Dependency and Indemnity
Compensation
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. 3.317 by revising paragraph (a)(2)(i)(B)(3) and adding a
note to paragraph (a)(2)(i)(B)(3) to read as follows:
Sec. 3.317 Compensation for certain disabilities due to undiagnosed
illnesses.
(a) * * *
(2) * * *
(i) * * *
(B) * * *
(3) Functional gastrointestinal disorders (excluding structural
gastrointestinal diseases).
Note to paragraph (a)(2)(i)(B)(3):
Functional gastrointestinal disorders are a group of conditions
characterized by chronic or recurrent symptoms that are unexplained
by any structural, endoscopic, laboratory, or other objective signs
of injury or disease and may be related to any part of the
gastrointestinal tract. Specific functional gastrointestinal
disorders include, but are not limited to, irritable bowel syndrome,
functional dyspepsia, functional vomiting, functional constipation,
functional bloating, functional abdominal pain syndrome, and
functional dysphagia. These disorders are commonly characterized by
symptoms including abdominal pain, substernal burning or pain,
nausea, vomiting, altered bowel habits (including diarrhea,
constipation), indigestion, bloating, postprandial fullness, and
painful or difficult swallowing. Diagnosis of specific functional
gastrointestinal disorders is made in accordance with established
medical principles, which generally require symptom onset at least 6
months prior to diagnosis and the presence of symptoms sufficient to
diagnose the specific disorder at least 3 months prior to diagnosis.
* * * * *
[FR Doc. 2011-17814 Filed 7-14-11; 8:45 am]
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