[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Rules and Regulations]
[Pages 53202-53216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21556]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AN54


Diseases Associated With Exposure to Certain Herbicide Agents 
(Hairy Cell Leukemia and Other Chronic B-Cell Leukemias, Parkinson's 
Disease and Ischemic Heart Disease)

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA) 
adjudication regulations concerning presumptive service connection for 
certain diseases based upon the most recent National Academy of 
Sciences (NAS) Institute of Medicine committee report, Veterans and 
Agent Orange: Update 2008 (Update 2008). This amendment is necessary to 
implement the decision of the Secretary of Veterans Affairs that there 
is a positive association between exposure to certain herbicides and 
the subsequent development of hairy cell leukemia and other chronic B-
cell leukemias, Parkinson's disease, and ischemic heart disease. The 
effect of this amendment is to establish presumptive service connection 
for these diseases based on herbicide exposure.

DATES: Effective Date: This final rule is effective August 31, 2010. 
This final rule is a major rule and the implementation of this rule is 
subject to the provisions of the Congressional Review Act (CRA). The 
CRA provides for a 60-day waiting period before an agency may implement 
a major rule to allow Congress the opportunity to review the 
regulation. The impact of the CRA will require at least a 60-day delay 
between the issuance of the final regulation and when VA can begin 
paying benefits.
    Applicability Date: This final rule shall apply to claims received 
by VA on or after the date of publication of the final rule in the 
Federal Register and to claims pending before VA on that date. 
Additionally, VA will apply this rule in readjudicating certain 
previously denied claims as required by court orders in Nehmer v. 
Department of Veterans Affairs, No. CV-86-6161 TEH (N.D. Cal.) 
(Nehmer).

FOR FURTHER INFORMATION CONTACT: Thomas J. Kniffen, Regulations Staff 
(211D), Compensation and Pension Service, Veterans Benefits 
Administration, Department of Veterans Affairs, 810 Vermont Avenue, 
NW., Washington, DC 20420, (202) 461-9725 (This is not a toll-free 
number.)

SUPPLEMENTARY INFORMATION: On March 25, 2010, VA published in the 
Federal Register (75 FR 14391) a proposal to amend 38 CFR 3.309 to add 
hairy cell leukemia and other chronic B-cell leukemias, Parkinson's 
disease and ischemic heart disease to the list of diseases subject to 
presumptive service connection based on herbicide exposure. Interested 
persons were invited to submit written comments on or before April 26, 
2010. VA received 670 comments on the proposed rule. Overall, the 
comments VA received are

[[Page 53203]]

in favor of the Secretary's decision to establish the new presumption 
of service connection for hairy cell leukemia and other chronic B-cell 
leukemias, Parkinson's disease and ischemic heart disease.
    VA received comments from service organizations, including Vietnam 
Veterans of America, Inc. (VVA), The Blue Water Navy Vietnam Veterans 
Association (BWNVVA), and other organizations, which include The 
Parkinson's Action Network, National Parkinson's Foundation, U.S. 
Military Veterans with Parkinson's (USMVP), Team Parkinson, Parkinson's 
Focus Today, Middle Tennessee Chapter of the American Parkinson Disease 
Association, Froedtert & The Medical College of Wisconsin, and the 
National Organization of Veterans' Advocates, as well as from 
individuals. Those comments, which have been grouped by category, are 
addressed below.
    VA also received numerous comments from veterans and surviving 
spouses regarding their individual claims for veterans' benefits. We do 
not respond to these comments in this notice as they are beyond the 
scope of this rulemaking.

A. Comments Concerning the Effective Date

    VA received more than 20 comments concerning the effective date of 
the regulation. Comments included suggestions that this rule should be 
effective on the date the Secretary announced his decision to establish 
the new presumptives or on the date an eligible veteran incurred one of 
the presumptive diseases. Other commenters stated that the rule should 
be effective when an eligible veteran was diagnosed with a presumptive 
disease, rather than when the veteran submitted a claim for 
compensation.
    VA Response: The proposed rule did not state when this regulation 
will be effective. The final rule makes clear that the effective date 
of this rule is the date of publication in the Federal Register. This 
is consistent with the terms of section 1116, title 38, United States 
Code (U.S.C.), which provides detailed instructions as to promulgation 
of regulations relating to presumptions of service connection for 
diseases associated with herbicide agents, including the effective date 
for such rules. The statute prescribes that when the Secretary 
determines that such a presumption is warranted, the Secretary ``shall 
issue proposed regulations setting forth [the] determination.'' 38 
U.S.C. 1116(c)(1)(A). The Secretary must then ``issue final 
regulations'' which ``shall be effective on the date of issuance.'' 38 
U.S.C. 1116(c)(2). Many of the comments received about the effective 
date of the regulation encouraged VA to establish an effective date 
earlier than the date of issuance of the final rule for equitable 
reasons. These comments include statements that it would be more 
appropriate to compensate veterans back to when the newly established 
presumptive disease was diagnosed or when they became disabled. Other 
commenters stated that veterans who filed claims years ago that had 
little chance of being granted will now receive large retroactive 
awards but those who did not file such claims will be penalized for not 
filing such claims. As the governing statute mandates that the 
effective date of the new regulation be the date of issuance of the 
final rule the Secretary of Veterans Affairs has no discretion to set 
an effective date for the new presumptions earlier than the date the 
final regulation is issued.
    Significantly, however, VA may pay benefits for periods prior to 
the rule's effective date in certain circumstances which are set forth 
in detail in 38 CFR 3.816(c) and (d). These provisions, which implement 
a stipulation and various court orders in the Nehmer class action 
litigation, pertain to claims where VA previously denied benefits or VA 
received a claim for benefits for a newly added condition between 
September 25, 1985, and the date VA publishes the final regulation 
adding the new condition to the list of diseases presumptively 
associated with exposure to herbicides used in Vietnam.
    As set forth in 38 CFR 3.816(c) and (d), the effective date for 
such claims is the later of the date VA received the above described 
claim or the date the disability arose. As a result, effective dates 
for benefits earlier than the date the final regulation is issued may 
be assigned in cases governed by the Nehmer litigation. This means that 
in many cases veterans and their dependents who filed claims prior to 
the issuance of the final rule will be awarded retroactive benefits to 
the date the claim was filed. However, even in Nehmer cases there is no 
basis for a retroactive award of benefits based solely upon the date a 
condition was incurred or diagnosed, or when the veterans became 
disabled. Under 38 U.S.C. 5110(a), VA generally may not pay benefits 
for any period prior to the date it receives an application for those 
benefits.
    We recognize the concern stated by some commenters that the 
retroactive payments authorized under Nehmer do not extend to persons 
who refrained from filing prior claims that they reasonably believed 
would not have been granted at that time. As explained above, however, 
VA generally cannot pay benefits prior to the date of a claim for 
benefits. Ordinarily, when VA establishes a new presumption of service 
connection, it cannot pay retroactive benefits for any period before 
the new presumption takes effect, due to the operation of 38 U.S.C. 
5110(g). The Nehmer court orders create a limited exception to that 
statutory rule for cases where a Nehmer class member filed a claim 
before the new rule took effect. VA does not have authority to further 
expand that judicial exception in a manner that would conflict with the 
governing statutes.

B. Comments Regarding the Addition of Parkinson's Disease to VA's List 
of Presumptive Diseases

    VA received nearly 400 comments in favor of the proposed regulation 
from individuals and organizations that, for various reasons, support 
the addition of Parkinson's disease to VA's regulation listing diseases 
that are presumptively service connected based upon exposure to 
herbicides used in Vietnam. Many of these comments also suggest that VA 
clarify its definition of Parkinson's disease, to include diseases of 
Parkinsonism (primary, atypical, and secondary Parkinson's diseases) 
and secondary Parkinsonism syndromes, as well as other Parkinsonian 
disorders.
    VA Response: Update 2008 only evaluated the correlation between 
certain herbicide exposure and Parkinson's disease. Parkinsonism, and 
other similar diseases, is not the same disease as Parkinson's disease. 
According to Update 2008,

    PD [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 * * * 
Pathologic findings in other causes of parkinsonism show different 
patterns of brain injury [than with PD].

    Institute of Medicine of the National Academies, Veterans and Agent 
Orange: Update 2008, The National Academies Press (Washington, DC, 
2009), pp. 515-16; available online at http://www.nap.edu/openbook.php?record_id=12662&page=515 (accessed May 19, 2010).
    VA greatly appreciates the outpouring of support of the proposed 
regulation by individuals affected by Parkinson's disease and 
organizations that advocate on behalf of the Parkinson's community. VA 
is not, however, able to revise the definition of Parkinson's disease 
to include Parkinsonism within this presumptive category. We understand 
that there are differing views in the

[[Page 53204]]

medical community concerning the clinical and pathological features of 
Parkinson's disease and other diseases that manifest similar symptoms. 
In VA's view, medical evidence, as described in Update 2008, simply 
does not support the expansion of the definition to include 
Parkinsonism and/or Parkinsonian syndromes and/or similar conditions at 
this time. If the Institute of Medicine (IOM) provides additional 
guidance regarding Parkinsonism, secondary Parkinsonian disorders, 
Parkinsonian syndromes or other similar conditions, and/or the 
synergistic effects of exposure to a combination of herbicides in 
future reports, VA will, of course, consider that guidance in assessing 
whether additional presumptive diseases should be added and/or whether 
its regulatory definitions should be revised. As acknowledged by the 
IOM in Update 2008, ``the preponderance of epidemiologic evidence now 
supports an association between herbicide exposure and PD.'' The IOM, 
however, also expressed concerns about the ``lack of data relating PD 
incidence to exposure in the Vietnam-Veteran population'' and 
``recommend[ed] strongly that studies to produce such data be 
performed.'' To that end, the IOM stated ``we are also concerned that a 
biologic mechanism by which the chemicals of interest may cause PD has 
not been demonstrated.''
    Institute of Medicine of the National Academies, Veterans and Agent 
Orange: Update 2008, The National Academies Press (Washington DC, 
2009), pp. 526-27; available online at http://www.nap.edu/openbook.php?record_id=12662&page=526 (accessed June 15, 2010).
    Expansion of VA's definition beyond Parkinson's disease is not 
warranted under such circumstances, particularly in light of the IOM's 
findings quoted above that ``PD must be distinguished from a variety of 
[P]arkinsonian syndromes.'' Accordingly, VA makes no change based on 
comments requesting a broader and/or more inclusive regulatory 
definition of Parkinson's disease.
    Included in the comments received concerning the addition of 
Parkinson's disease to VA's list of presumptive conditions were 
comments suggesting that VA make various improvements regarding 
procedures and services provided to veterans with Parkinson's disease 
and their caregivers. These suggestions, which range from conducting 
additional research and studies regarding Parkinson's disease and other 
similar conditions to revising the VA Schedule for Rating Disabilities, 
are beyond the scope of this rulemaking and will not be addressed.

C. Comments Concerning VA's Definition of Ischemic Heart Disease (IHD)

(1) Lack of Reference to ICD-9-CM Medical Terminology and Codes

    One commenter expressed concern that VA regulations do not include 
any references to The International Classification of Diseases, 9th 
Revision, Clinical Modification, Sixth Edition (ICD-9 CM) codes in 
addition to the cited definition of IHD from Harrison's Principles of 
Internal Medicine (Harrison's Online, Chapter 237, Ischemic Heart 
Disease, 2008). The commenter is concerned that a VA employee reviewing 
a claim for disability would be ``limited to the narrow and probably 
not extensive enough scope of representative criteria provided by the 
VA's definition.''
    VA Response: VA believes that the definition of IHD in the proposed 
rule and the clarifying description in the preamble to the proposed 
rule are actually more accommodating to appropriate ratings 
determinations than ICD-9-CM because the description of IHD contained 
in the proposed rule is not restricted to a finite list of diagnoses as 
would be the case if ICD-9-CM codes were employed. To this end, for 
purposes of establishing service connection VA interprets IHD, as 
referred to in the regulation, as encompassing any atherosclerotic 
heart disease resulting in clinically significant ischemia or requiring 
coronary revascularization.
    VA views ICD-9-CM as a reference tool ``used to code and classify 
morbidity data from the inpatient and outpatient records, physician 
offices, and most National Center for Health Statistics (NCHS) 
surveys.'' Centers for Disease Control and Prevention, ICD--
Classification of Diseases, Functioning, and Disability, available at 
http://www.cdc.gov/nchs/icd.htm (accessed May 13, 2010). It serves as a 
standardized listing of diseases designed to facilitate effective 
communication between medical personnel. It does not contain any 
descriptive definition of IHD; therefore, it does not provide any 
additional assistance to either VA employees or veterans in 
understanding what constitutes IHD or what criteria must be used in 
making a medical diagnosis of such.
    Consequently, VA chose to base its definition of Ischemic Heart 
disease upon the definition contained in a leading medical treatise, 
Harrison's Principles of Internal Medicine, and does not believe it is 
necessary to revise that definition to include ICD-9-CM references. VA 
makes no change based on this comment.

(2) Exclusion of Diseases That Do Not Result in Oxygen Deficiency in 
the Heart

    Three commenters expressed a desire for VA to expand the definition 
of IHD to include diseases (such as hypertension, peripheral arterial 
disease, and stroke) that are potentially secondarily connected to IHD.
    VA Response: In the preamble to the proposed rule, VA, citing 
Harrison's Principles of Internal Medicine--a respected and universally 
recognized reference in the medical community, clarified and explained 
the definition of IHD as ``an inadequate supply of blood and oxygen to 
a portion of the myocardium; it typically occurs when there is an 
imbalance between myocardial oxygen supply and demand.'' 75 FR 14393; 
See Harrison's Principles of Internal Medicine (Harrison's Online, 
Chapter 237, Ischemic Heart Disease, 2008). This definition is limited 
to conditions that directly affect the myocardium. ``Myocardium'' is 
defined as ``the middle muscular layer of the heart wall.'' Merriam-
Webster Dictionary Online, ``Myocardium'' available at http://www.merriam-webster.com/dictionary/myocardium (accessed May 13, 2010). 
Therefore, based on the definition found in Harrison's, IHD pertains 
only to conditions that directly affect the muscles of the heart. The 
accepted medical definition of IHD does not extend to other conditions, 
such as hypertension, peripheral artery disease, and stroke, that do 
not directly affect the muscles of the heart. As a result, VA will not 
include these conditions within the definition of IHD contained in this 
rulemaking.
    Additionally, this definition and limitation are consistent with 
the definition of IHD used by the IOM in Update 2008. IOM limited its 
consideration of IHD studies to ICD-9-CM codes 410-414. These codes 
explicitly exclude such disease as hypertension, which has its own 
unique code (402) in ICD-9-CM. The selection of these particular ICD-9-
CM codes shows that IOM chose to limit its consideration of IHD to only 
those diseases that affect the muscles of the heart. Hence, the 
definition of IHD used by IOM in Update 2008 confirms the medical 
soundness of VA's definition, and makes clear that the medical evidence 
on which VA based its decision relates only to those conditions 
directly affecting the oxygen supply in

[[Page 53205]]

the muscles of the heart and does not encompass such conditions as 
hypertension. Therefore, VA makes no change based on these comments.
    Two of these commenters would also have VA allow excluded 
conditions to be rated as secondarily caused by IHD.
    VA Response: The presumptive conditions addressed in this 
rulemaking only concern establishment of a primary service-connected 
condition. This rulemaking does not affect a claimant's ability to 
establish secondary conditions proximately caused by a service-
connected condition, including those conditions for which service 
connection is established presumptively. Section 3.310, title 38, Code 
of Federal Regulations, states that any disability which is proximately 
due to or the result of a service-connected disease or injury shall be 
service connected. This principle has not changed and there is no need 
to reiterate it in this rule. Therefore, VA makes no change based on 
these comments.

(3) Perceived Uncertainty Concerning the Definition of IHD

    One commenter queried ``what is ischemic heart disease''?
    VA Response: VA's definition of IHD in the proposed rule is based 
upon the accepted medical premise that, as stated in the preamble, IHD 
is ``an inadequate supply of blood and oxygen to a portion of the 
myocardium; it typically occurs when there is an imbalance between 
myocardial oxygen supply and demand.'' 75 FR 14393; See Harrison's 
Principles of Internal Medicine (Harrison's Online, Chapter 237, 
Ischemic Heart Disease, 2008). As previously stated, VA interprets IHD, 
for purposes of service connection, to encompass any atherosclerotic 
heart disease resulting in clinically significant ischemia or requiring 
coronary revascularization. In the notice of proposed rulemaking, we 
explained that the term ``ischemic heart disease'' does not encompass 
hypertension or peripheral manifestations of arteriosclerotic heart 
disease, such as peripheral vascular disease or stroke. To ensure that 
lay readers are aware of the distinction between these diseases, we are 
adding a Note 3 following 38 CFR 3.309(e) to include the information 
stated in the notice of proposed rulemaking.

(4) Inclusion of Angina as a Compensable Disability

    One commenter asked whether the rule will include Prinzmetal's 
Angina, and Stable and Unstable Angina in the list of compensable 
disabilities.
    VA Response: Prinzmetal's Angina, and Stable and Unstable Angina 
are explicitly included as forms of IHD in the list of illnesses that 
may be presumptively service connected due to exposure to certain 
herbicides. 75 FR 14393.

D. Comments Concerning the Scope of Applicability of the Presumptions

(1) Expanding the Presumption of Herbicide Exposure Beyond Service in 
the Republic of Vietnam

    Approximately ten commenters advocated expanding coverage 
geographically, to include veterans who did not deploy within the land 
borders of the Republic of Vietnam, but may have been exposed to 
tactical herbicides in the course of their military service. For 
example, one commenter, the Vietnam Veterans of America (VVA), cited 
Update 2008 in support of its recommendation that VA adopt a 
presumption that veterans who served in the South China Sea during the 
Vietnam era were exposed to herbicides. Another commenter encouraged 
amending 38 CFR 3.307(a)(6)(iii), to include ``Blue Water Navy 
Veterans'' as qualifying for the presumptions listed in 38 CFR 
3.309(e).
    VA Response: These comments are beyond the scope of this 
rulemaking. We proposed to revise 38 CFR 3.309(e) to implement the 
requirements of 38 U.S.C. 1116(b) and (c) directing the Secretary of 
Veterans Affairs to determine whether there is a positive association 
between exposure to the herbicides used in Vietnam and the occurrence 
of specific diseases. The issue of which diseases are associated with 
herbicide exposure is distinct from the issue of which individuals are 
presumed to have been exposed to herbicides in service. The latter 
issue is governed by a separate regulation in 38 CFR 3.307(a)(6)(iii), 
which we did not propose to revise in this rulemaking. Accordingly, we 
make no change based on these comments.
    With respect to the issues raised by these comments, we note that, 
in a separate rulemaking (RIN 2900-AN27, Herbicide Exposure and 
Veterans With Covered Service in Korea), VA has proposed to provide a 
presumption of exposure to tactical herbicides for veterans who served 
with specific military units stationed at or near the Korean DMZ during 
the April 1968--July 1969 time frame. 74 FR 36640. We note further 
that, at VA's request, the NAS is undertaking a comprehensive study of 
the potential herbicide exposure among veterans who served in the 
offshore waters around Vietnam and VA will carefully evaluate the 
findings of the NAS resulting from that study. Finally, we wish to make 
clear that the presumptions of service connection provided by this rule 
will apply to any veteran who was exposed during service to the 
herbicides used in Vietnam, even if exposure occurred outside of 
Vietnam. A veteran who is not presumed to have been exposed to 
herbicides, but who is shown by evidence to have been exposed, is 
eligible for the presumption of service connection for the diseases 
listed in Sec.  3.309(e), including the three diseases added by this 
rule.

(2) Expanding the Presumptions To Include Other Herbicides

    Other commenters, including USMVP, seek to persuade VA to presume 
service connection for veterans exposed to trichloroethylene (TCE) (a 
substance found in organic solvents) and malathion (an insecticide). 
USMVP concedes that TCE and malathion are differently formulated 
chemical compounds used for pest control and equipment maintenance, 
respectively. Nevertheless, USMVP contends that VA's mandate is 
sufficiently broad to allow the Secretary to presume diseases to be 
service connected upon exposure to TCE and Malathion.
    VA Response: These comments are beyond the scope of this 
rulemaking. We proposed to revise 38 CFR 3.309(e) to implement the 
requirements of 38 U.S.C. 1116(b) and (c) directing the Secretary of 
Veterans Affairs to determine whether there is a positive association 
between exposure to the herbicides used in Vietnam and the occurrence 
of specific diseases. The comments concerning the health effects of 
other types of exposures are distinct from the scope and purpose of the 
proposed rule.
    USMVP notes that section 6 of the Agent Orange Act of 1991 directed 
VA to compile data that is likely to be scientifically useful in 
determining the association, if any, between disabilities and exposure 
to toxic substances including, but not limited to, dioxin. This 
rulemaking, however, is based on the distinct provisions in section 2 
of the Agent Orange Act, codified in pertinent part at 38 U.S.C. 1116, 
requiring VA to determine whether diseases are associated with an 
``herbicide agent,'' which is defined to refer to ``a chemical in an 
herbicide used in support of the United States and allied military 
operations in the Republic of Vietnam during the period beginning on 
January 9, 1962, and ending on May 7, 1975.'' 38 U.S.C. 1116(a)(3). 
Accordingly, VA's regulation

[[Page 53206]]

that implements 38 U.S.C. 1116(a)(3), 38 CFR 3.307(a)(6)(i), defines 
herbicide agents specifically: ``2,4-D; 2,4,5-T and its contaminant 
TCDD; cacodylic acid; and picloram.'' Therefore, VA makes no changes 
based on these comments.

(3) Secondary Service Connection Explicitly Listed in Regulation

    Some commenters suggest that the proposed regulation should include 
secondary conditions that result from disabilities presumptively 
service connected due to certain herbicide exposure. The commenters 
note that VA published a proposed rule establishing presumptive service 
connection for nine specific infectious diseases associated with 
military service in the Southwest Asia theater of operations and that 
the proposed rule listed secondary conditions potentially caused by 
those infectious diseases. 75 FR 13051-13058 (March 18, 2010). 
Furthermore, the commenters stated that when VA grants service 
connection for a primary disease, all secondary conditions proximately 
caused by that disease are also service connected. 38 CFR 3.310.
    VA Response: VA's proposed rule to establish presumptive service 
connection for nine specific infectious diseases associated with 
military service in the Southwest Asia theater of operations was based, 
in part, on the report issued by the National Academy of Sciences (NAS) 
entitled ``Gulf War and Health Volume 5: Infectious Diseases,'' which 
reported on the association between primary infectious disease and 
secondary health effects as a result of service in the Southwest Asia 
theater of operations. This report differed from previous NAS reports 
in that it implicated two tiers of possible association between a 
hazard and resulting health outcomes. In particular, NAS made 
comprehensive findings as to the conditions that may be secondarily 
caused by the primary infectious diseases, and VA determined that it 
would be helpful to include those findings in its rules. In contrast, 
the NAS reports on Agent Orange address only one tier of possible 
association between exposure to herbicides and the development of long-
term health effects. In view of the divergent structure of the two 
studies and the absence of findings in Update 2008 regarding secondary 
health effects, VA did not propose to list secondary health effects in 
this rule. Although it may be feasible to identify and list known 
secondary effects of the three diseases covered in this rule, doing so 
is beyond the scope of this rule and, moreover, is not necessary to 
ensure that veterans are properly compensated for such secondary 
effects.
    As the commenters correctly note, pursuant to 38 CFR 3.310, when VA 
grants service connection for a condition, all conditions proximately 
caused by that condition may also be service connected. This principle 
would apply to conditions where service connection is established by 
presumption or by other means, such as a direct link to incurrence 
during military service.
    Consequently, VA makes no change based on these comments.

E. Negative Comment

    Only one comment indicated clear opposition to the final rule. The 
commenter asserted that ``[t]he proposed rule for presumptive 
conditions to Agent Orange exposure * * * is ridiculous. Just because 
gen[e]tic and life style illness are now affecting those of an age that 
served in Vietnam, does not mean that their service in Vietnam caused 
this.'' The commenter went on to ask ``No medical expert links these 
diseases to Agent Orange exposure why should the VA?''
    VA Response: First we note that the comment only pertains to the 
addition of ischemic heart disease to VA's presumptive list. It does 
not express any opposition to the addition of Parkinson's disease or B-
cell Leukemias to VA's presumptive list.
    VA's decision to add ischemic heart disease to the list of diseases 
that are presumptively service connected based upon exposure to 
herbicides used in Vietnam was issued after the Secretary considered 
the IOM's Update 2008, concerning the health effects in Vietnam 
Veterans of exposure to herbicides. That report states as follows:

    After consideration of the relative strengths and weaknesses of 
the evidence regarding the chemicals of interest and ischemic heart 
disease (ICD 410-414), which includes a number of studies that 
showed a strong dose-response relationship and that had good 
toxicologic data demonstrating biologic plausibility, the committee 
judged that the evidence was adequately informative to advance this 
health outcome from the ``inadequate or insufficient'' category into 
the ``limited or suggestive'' category, again acknowledging that 
bias and confounding could not be ruled out. (Page 631 of Update 
2008) \1\
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    \1\ 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 May 25, 2010).

    The IOM report's discussion demonstrates that there are medical 
studies that show a correlation between exposure to herbicides and 
ischemic heart disease. As we explained in the notice of proposed 
rulemaking, the IOM committee found that, of the nine most informative 
studies on this issue, five showed strong statistically significant 
associations between herbicide exposure and IHD. The IOM committee 
noted that the evidence for an association was further strengthened by 
findings of a dose-response relationship, meaning that the risk of IHD 
was found to be highest in populations with the highest levels of 
herbicide exposure. As stated in the notice of proposed rulemaking, the 
Secretary has determined that this evidence meets the standard in 38 
U.S.C. 1116 for finding a ``positive association'' between herbicide 
exposure and IHD. The Secretary considers the analysis in the IOM 
report to provide sufficient scientific basis to conclude that ischemic 
heart disease merited inclusion on VA's list of presumptive diseases. 
It is important to note that 38 U.S.C. 1116 directs VA to establish a 
presumption if the credible evidence for an association between 
herbicide exposure and a disease is equal to or outweighs the credible 
evidence against the association. This evidentiary standard does not 
require the same level of proof that members of the scientific 
community might require before concluding that the disease is 
necessarily associated with herbicide exposure. The Secretary has 
determined that this decision is consistent with the standard of proof 
established by statute, and VA has no authority to change that 
statutory standard. Accordingly VA makes no changes based on this 
comment.

F. Comments Indicating General Support of the Rulemaking

    In addition to the nearly 400 comments received from the 
Parkinson's community expressing support for the addition of 
Parkinson's disease to VA's presumptive list, VA received just over 100 
additional comments that expressed support for the rulemaking in 
general. Many of these comments, which were received from individuals 
as well as public and private organizations, stated appreciation for 
VA's actions in adding one or more of the three diseases to its 
regulatory list of conditions that are presumptively service connected 
based upon herbicide exposure in Vietnam. VA appreciates the time and 
effort expended by these commenters in reviewing the proposed rule and 
in submitting comments, as well as their support for this rulemaking.

[[Page 53207]]

G. Additional Comments Outside the Scope of This Rulemaking

(1) Comments Related to VA's Cost Estimate and Assignment of Disability 
Ratings.

    VA received 25 comments from organizations and members of the 
public concerning the assumptions stated in VA's budget estimates that: 
(1) The average disability rating for Parkinson's disease will be 100 
percent; (2) the average disability rating for IHD will be 60 percent; 
and (3) the average disability rating for leukemia will be 100 percent. 
Many of these comments construed these cost estimates as an expression 
of VA policy concerning the assignment of particular disability 
thresholds for each of the new presumptive conditions. Some of the 
comments urged VA to assign 100 percent evaluations for each of the 
three diseases.
    VA Response: The proposed rule contained cost estimate assumptions 
based on VA data which indicated that VA assumed the average disability 
evaluation for Parkinson's disease and leukemia to be 100 percent and 
for IHD to be 60 percent. VA would like to clarify that these 
assumptions are merely estimates and were made based on VA program 
experience. They are used for cost estimate purposes only, and they 
have no binding effect on any particular disability rating actually 
assigned. The fact that VA projects, for cost purposes, that particular 
disabilities will result in a particular average impairment, does not 
indicate the existence of a minimum level of disability compensation 
for any of the three new presumptive conditions. The disability rating 
assigned will be based on the individual factual situations and, in the 
case of Parkinson's disease and hairy cell leukemias, individual 
ratings may be less than 100 percent. Similarly, individual ratings for 
IHD may be greater, less, or equal to 60 percent. Indeed VA anticipates 
that some disabilities which are granted presumptive service connection 
will be assigned non-compensable ratings. This would occur, for 
example, if an individual was diagnosed with a disease, IHD for 
example, but manifested no current disabling symptoms.
    The disability ratings to be assigned for any disease or injury are 
based upon application of VA's Schedule for Rating Disabilities in 38 
CFR Part 4 to the facts of each case. VA did not propose in this 
rulemaking to revise any of the provisions in that schedule. As 
explained above, the assumptions stated for purposes of VA's cost 
estimate did not propose to adopt specific minimum ratings or to make 
any change to the rating schedule. To the extent these comments suggest 
adoption of minimum disability ratings they are outside the scope of 
this rulemaking. Accordingly, VA makes no changes based on these 
comments.

(2) Perceived Nehmer Contradiction

    One commenter expressed concern that the statement in the preamble 
of the proposed rule at 75 FR at 14394 that retroactive benefit costs 
are paid in the first year only conflicts with the decision in the 
Nehmer case. The stated concern appears to be that paying retroactive 
benefits in the first year only may limit retroactive payments 
authorized by the Nehmer court orders.
    VA Response: The commenter's reference pertains to the Preamble and 
cost estimate assumptions, which, as stated above, were used for cost 
estimating purposes only and will have no binding effect upon claims 
involving retroactive benefits under the proposed rule. Because this 
comment relates to a factual assumption in VA's cost analysis, which 
does not affect the scope of the final rule, the comment has no bearing 
on the final rule.
    We want to make clear, however, that nothing in this rule would 
contravene or limit the Nehmer court orders. When retroactive benefits 
are paid as a result of a claim that qualifies under the Nehmer 
litigation, the award is paid from current year appropriations and that 
VA's cost estimates for this regulation include first year, five year, 
and ten year costs. The statement in VA's cost estimate that 
retroactive benefits are paid in the first year only is intended merely 
to reflect that VA expects to process all claims involving retroactive 
payments for the new presumptions under Nehmer within the first year 
after this rule is issued. Accordingly, VA makes no changes based on 
these comments.

(3) Statements About Personal Situations and Hypothetical Benefit 
Questions

    Many commenters made general statements about their own personal 
difficulties battling one or more of the presumptive diseases. Another 
commenter inquired as to the possible implications of Bradley v. Peake, 
22 Vet. App. 280 (2008). The commenters who inquired about Bradley 
asked whether, hypothetically, an IHD disability rating in addition to 
another disability that meet the statutory criteria under 38 U.S.C. 
1114(s), could potentially establish eligibility for special monthly 
compensation.
    VA Response: Comments regarding hypothetical situations involving 
the possible outcome of benefit claims or the medical or claims history 
presented by individual veterans are beyond the scope of this 
rulemaking. Claimants should contact their VA regional office for 
assistance with their individual claims.

(4) Comments Unrelated to the Subject of the Rulemaking

    VA received approximately 40 comments dealing with issues not 
directly related to the addition of the three new presumptively 
service-connected diseases. Such comments covered a wide range of 
topics. Examples of such comments appear below.
    One commenter opined that spouses of veterans should be 
compensated. One commenter stated that more should be done for 
caregivers of veterans. Another commenter suggested that VA should 
guide the military services on presumptives related to Agent Orange. 
Some commenters complained that the rulemaking process is too lengthy. 
Two commenters disapproved of the fact that herbicides were allowed to 
be used during conflict. Several commenters criticized the benefit 
claims system, including the VA's Schedule for Rating Disabilities. One 
commenter stated that 38 CFR 3.816 (Nehmer Awards) should be revised to 
list the three new presumptions. A commenter recommended that a working 
group be created to define needed research and studies on diseases and 
Vietnam veterans. One commenter questioned whether there is a 
relationship between PTSD or stress and cardiovascular disease. Another 
commenter wanted VA to give greater weight to finding of total 
disability by the Social Security Administration. A commenter requested 
special guidance for compensation and pension examinations to ensure 
comprehensive evaluation of cognitive and dementia issues related to 
Parkinson's disease; another commenter similarly requested an update in 
rating templates for Parkinson's disease. A commenter wanted VA to 
provide guidance to the Department of Defense concerning the new 
presumptive conditions. Another commenter indicated disagreement with 
the findings and conclusion included in Update 2008. Some commenters 
expressed dissatisfaction with the note in the current regulation 
regarding requirements for peripheral neuropathy.
    VA Response: VA does not respond to these comments because they are 
either unrelated to this rulemaking or beyond its scope.

[[Page 53208]]

Paperwork Reduction Act

    The collection of information under the Paperwork Reduction Act (44 
U.S.C. 3501-3521) that is contained in this document is authorized 
under OMB Control No. 2900-0001.

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.
    VA has examined the economic, interagency, budgetary, legal, and 
policy implications of this rulemaking and determined that it is an 
economically significant rule under this Executive Order, because it 
will have an annual effect on the economy of $100 million or more.

Regulatory Impact Analysis

    VA followed OMB Circular A-4 to the extent feasible in this 
Regulatory Impact Analysis. The circular first calls for a discussion 
of the Statement of Need for the regulation. The Agent Orange Act of 
1991, as codified at 38 U.S.C. 1116 requires the Secretary of Veterans 
Affairs to publish regulations establishing a presumption of service 
connection for those diseases determined to have a positive association 
with herbicide exposure in humans.
    Statement of Need: On October 13th, 2009, the Secretary of Veterans 
Affairs, Eric K. Shinseki, announced his intent to establish 
presumptions of service connection for PD, IHD, and hairy cell/B cell 
leukemia for veterans who were exposed to herbicides used in the 
Republic of Vietnam during the Vietnam era.
    Summary of the Legal Basis: This rulemaking is necessary because 
the Agent Orange Act of 1991 requires the Secretary to promulgate 
regulations establishing a presumption of service connection once he 
finds a positive association between exposure to herbicides used in the 
Republic of Vietnam during the Vietnam era and the subsequent 
development of any particular disease. This final rulemaking is 
required by statute and the result of the Secretary's discharge of his 
statutory mandate pursuant to the statute.
    Alternatives: There are no feasible alternatives to this 
rulemaking, since the Agent Orange Act of 1991 requires the Secretary 
to initiate rulemaking once the Secretary finds a positive association 
between a disease and herbicide exposure in Vietnam during the Vietnam 
era. The rule implements statutorily required provisions to expand 
veteran benefits.
    Risks: The rule implements statutorily required provisions to 
expand veteran benefits. No risk to the public exists.
    Anticipated Costs and Benefits: In the proposed rule, we estimated 
the total cost for this rulemaking to be $13.6 billion during the first 
year (FY2010), $25.3 billion for 5 years, and $42.2 billion over 10 
years. These amounts included benefits costs and government operating 
expenses for both Veterans Benefits Administration (VBA) and Veterans 
Health Administration (VHA). A detailed cost analysis for each 
Administration is provided below.
    The proposed rule indicated costs beginning in FY2010. At the time 
the proposed rule impact analysis was developed, VA anticipated the 
final rulemaking would be published more than 60 days before the end of 
FY2010, including allowing time for the 60 day requirement under the 
CRA, and therefore payments would commence in FY2010. VA now knows that 
the timing of the final rulemaking will not allow payments to begin 
prior to FY2011. As a result, VA expects FY2010 and FY2011 costs, as 
shown in some of the tables below from the proposed rule, will both now 
occur in FY2011. We have not recalculated the tables to reflect this 
change.

Veterans Benefits Administration (VBA) Costs

    We estimated VBA's total cost to be $13.4 billion during the first 
year (FY2010), $24.3 billion for five years, and $39.7 billion over ten 
years.

----------------------------------------------------------------------------------------------------------------
                  Benefits costs ($000's)                    1st year (FY10)       5-year            10-year
----------------------------------------------------------------------------------------------------------------
Retroactive benefits costs *..............................       $12,286,048    ** $12,286,048    ** $12,286,048
Recurring costs from retroactive processing...............                 0         4,388,773        10,300,132
Increased benefits costs for Veterans currently on the               415,927         2,188,784         4,864,755
 rolls....................................................
Accessions................................................           675,214         4,645,609        11,330,294
Administrative Costs......................................  ................  ................  ................
FTE costs.................................................         *** 4,554           797,473           894,614
New office space (minor construction).....................  ................            12,835            12,835
IT equipment..............................................  ................            30,232            32,805
                                                           -----------------------------------------------------
    Totals................................................        13,381,743        24,349,746        39,721,476
----------------------------------------------------------------------------------------------------------------
* Retroactive benefits costs are paid in the first year only.
** Inserted for cumulative totals.
*** FTE costs in FY 2010 represented a level of effort of current FTE that would be used to work claims received
  in FY2010. New hiring would begin in 2011.

    Of the total VBA benefits costs identified for FY 2010, $12.3 
billion accounted for retroactive benefit payments. Ten-year total 
costs for ischemic heart disease is $31.9 billion, Parkinson's disease 
accounts for $3.5 billion, and hairy cell and B-cell leukemia is the 
remaining $3.4 billion.

[[Page 53209]]



                                   Total Obligations by Presumptive Condition
----------------------------------------------------------------------------------------------------------------
                                             Retroactive
                ($000's)                      payments          1st year           5-year            10-year
----------------------------------------------------------------------------------------------------------------
Ischemic heart disease..................        $9,877,787          $900,470        $9,307,716       $21,978,301
Parkinson's.............................            692,20           166,300         1,189,143         2,796,852
Hairy cell/B-cell leukemia..............         1,716,057            24,372           726,306         1,720,028
Sub-total...............................        12,286,048         1,091,142        11,223,165        26,495,181
                                         -----------------------------------------------------------------------
    Total...............................        12,286,048      * 13,377,190      * 23,509,213      * 38,781,229
----------------------------------------------------------------------------------------------------------------
* Includes retroactive payments.

Methodology

    The cost estimate for the three presumptive conditions considers 
retroactive benefit payments for veterans and survivors, increases for 
veterans currently on the compensation rolls, and potential accessions 
for veterans and survivors. There are numerous assumptions made for the 
purposes of this cost estimate. At a minimum, four of those could vary 
considerably and the result could be dramatic increases or decreases to 
the mandatory benefit numbers provided. The estimate assumes:
    <bullet> A prevalence rate of 5.6% for IHD based upon information 
extracted from the CDC's Web site. Even slight variations to this 
number will result in significant changes.
    <bullet> An 80% application rate in most instances. We have prior 
experiences that have been as low as in the 70% range and as high as in 
the 90% range.
    <bullet> New enrollees will, on average, be determined to have 
about a 60% degree of disability for IHD. This would mirror the degree 
of disability for the current Vietnam Veteran population on VA's rolls. 
However, most of the individuals have had the benefit of VHA health 
care. We cannot be certain that the new population of Vietnam Veterans 
coming into the system will mirror that average.
    <bullet> Only the benefit costs of the presumptive conditions 
listed. Secondary conditions, particularly to IHD, may manifest 
themselves and result in even higher degrees of disability ultimately 
being granted.

Retroactive Veteran and Survivor Payments

Vietnam Veterans Previously Denied

    In 2010, approximately, 86,069 Vietnam beneficiaries (as of August 
2009 provided by PA&I) are eligible to receive retroactive payments for 
the new presumptive conditions under the provisions of 38 CFR 3.816 
(Nehmer). Of this total, 69,957 are living Vietnam Veterans, of which 
62,206 were denied for IHD, 5,441 were denied for hairy cell or B cell 
leukemia, and the remaining 2,310 for Parkinson's disease. Of those 
previously denied service connection for the three new presumptive 
conditions, 52,918, or nearly 76 percent, are currently on the rolls 
for other service-connected disabilities.
    Compensation and Pension (C&P) Service assumes the average degree 
of disability for both Parkinson's disease and hairy cell/B cell 
leukemia will be 100 percent, and IHD will be 60 percent. Based on the 
Combined Rating Table, we assume veterans currently not on the rolls 
would access at the percentages identified above. For those veterans 
currently on the rolls for other service-connected disabilities, we 
assume they would receive a retroactive award based on the higher 
combined disability rating. For example, a veteran who is on the rolls 
and rated 10 percent disabled who establishes presumptive service 
connection for Parkinson's disease will result in a higher combined 
rating of 100 percent and receive a retroactive award for the 
difference. For purposes of this cost estimate, we assumed that 
veterans previously denied service connection for one of the three new 
conditions who are currently receiving benefits were awarded benefits 
for another disability concurrently.
    Based on the Nehmer case review in conjunction with the August 2006 
Haas Court of Appeals for Veterans Claims (CAVC) decision, C&P Service 
identified an average retroactive payment of 11.38 years for veterans 
whose claims were previously denied. Obligations for retroactive 
payments for veterans not currently on the rolls were calculated by 
applying the caseload to the benefit payments by degree of disability, 
multiplied by the average number of years for veterans' claims. For 
those who are on the rolls, based on a distribution by degree of 
disability, obligations were calculated by applying the increased 
combined degree of disability for those currently rated zero to ninety 
percent. Of the total 52,918 currently on the rolls, 8,348 are 
currently rated 100 percent disabled and, therefore, would not likely 
receive a retroactive award payment.
    Of the total 86,069 Vietnam beneficiaries, a total of 69,957 are 
living Vietnam Veterans. Of this total, 52,918 are currently on the 
rolls for other service-connected disabilities and 17,039 are off the 
compensation rolls (52,918 + 17,039 = 69,957). Of the 52,918 Vietnam 
Veterans who are on the rolls, 8,348 are currently rated 100 percent 
disabled and would not likely receive a retroactive payment (17,039-
8,348 = 8,691 + 52,918 = 61,609).

        Veteran Caseload and Obligations for Retroactive Benefits
------------------------------------------------------------------------
                                                           Retroactive
       Presumptive conditions             Caseload          payments
                                                            ($000's)
------------------------------------------------------------------------
Ischemic Heart Disease..............            54,926        $7,837,369
Parkinson's Disease.................             2,042           568,920
Hairy Cell/B Cell Leukemia..........             4,641         1,209,586
                                     -----------------------------------
    Total...........................            61,609         9,615,875
------------------------------------------------------------------------


[[Page 53210]]

Vietnam Veteran Survivors Previously Denied

    Survivor caseload was determined based on veteran terminations. 
Based on data obtained from PA&I, of the 86,069 previous denials, 
16,112 of the Vietnam veterans are deceased. Of the deceased 
population, 13,420 were veterans previously denied claims for IHD, 
2,165 were denied for hairy cell or B cell leukemia, and 527 were 
denied for Parkinson's disease. We assumed that 90 percent of the 
survivor caseload will be new to the rolls and the remaining ten 
percent are currently in receipt of survivor benefits.
    The 2001 National Survey of Veterans found that approximately 75 
percent of veterans are married. With the marriage rate applied, we 
estimate there are 12,084 survivors in 2010. Based on the Nehmer case 
review in conjunction with the August 2006 Haas Court of Appeals for 
Veterans Claims (CAVC) decision, C&P Service identified an average 
retroactive payment of 9.62 years for veterans' survivors. Under 
Nehmer, in addition to survivor dependency and indemnity compensation 
(DIC) benefits, survivors are also entitled to the veteran's 
retroactive benefit payment to the date of the veteran's death. 
Obligations for survivors who were denied claims were determined by 
applying the survivor caseload for each presumptive condition to the 
average survivor compensation benefit payment from the 2010 President's 
Budget and the average number of years for the survivor's claim (9.62 
years). Veteran benefit payments to which survivors are entitled were 
calculated similarly with the exception of applying the survivor 
caseload for each presumptive condition to the difference between the 
average veteran claim of 11.38 years and the average survivor claim of 
9.62 years. The estimated remaining 4,028 deceased veterans who were 
not married would have their retroactive benefit payment applied to 
their estate.
    Of the 86,069 Vietnam beneficiaries, a total of 16,112 are Vietnam 
Veterans that are deceased. Of this total, an estimated 12,084 were 
married and an estimated 4,028 were not married (12,084 + 4,028 = 
16,112).

       Survivor Caseload and Obligations for Retroactive Benefits
------------------------------------------------------------------------
                                                    Retroactive payments
   Presumptive conditions           Caseload              ($000's)
------------------------------------------------------------------------
Ischemic Heart Disease......                13,420            $2,040,418
Parkinson's Disease.........                   527               123,284
Hairy Cell/B Cell Leukemia..                 2,165               506,470
                             -------------------------------------------
    Total...................                16,112             2,670,173
------------------------------------------------------------------------

Recurring Veteran and Survivor Payments

    Retroactive caseload obligations for both veterans and survivors 
become a recurring cost and are reflected in out-year estimates. 
Mortality rates are applied in the out years to determine caseload.

               Recurring Veteran and Survivor Caseload and Obligations From Retroactive Processing
----------------------------------------------------------------------------------------------------------------
                      FY                          Veteran caseload      Survivor caseload   Obligations ($000's)
----------------------------------------------------------------------------------------------------------------
2010..........................................                   N/A                   N/A                   N/A
2011..........................................                61,365                10,672            $1,079,310
2012..........................................                61,243                10,570             1,084,209
2013..........................................                61,121                10,458             1,102,800
2014..........................................                61,000                10,336             1,122,454
2015..........................................                60,879                10,201             1,142,251
2016..........................................                60,758                10,052             1,162,167
2017..........................................                60,637                 9,891             1,182,189
2018..........................................                60,517                 9,716             1,202,298
2019..........................................                60,397                 9,526             1,222,453
                                               -----------------------------------------------------------------
    Total.....................................  ....................  ....................            10,300,132
----------------------------------------------------------------------------------------------------------------

Vietnam Veterans (Reopened Claims)

    We expected veterans who are currently on the compensation rolls 
and have any of the three presumptive conditions to file a claim and 
receive a higher combined disability rating beginning in 2010. We 
anticipate that veterans receiving compensation for other service-
connected conditions will continue to file claims over ten years. Total 
costs are expected to be $415.9 million the first year and 
approximately $4.9 billion over ten years.
    According to the Defense Manpower Data Center (DMDC), there are 2.6 
million in-country Vietnam Veterans. With mortality applied, an 
estimated 2.1 million will be alive in 2010. C&P Service assumes that 
34 percent of this population are service connected for other 
conditions and are already in receipt of compensation benefits. In 
2010, we anticipated that 725,547 Vietnam Veterans would be receiving 
compensation benefits. This number is further reduced by the number of 
veterans identified in the previous estimate for retroactive claims 
(52,918). C&P Service assumes an average age of 63 for all Vietnam 
Veterans. With prevalence and mortality rates applied, and an estimated 
80 percent application rate and 100 percent grant rate, we calculate 
that 32,606 veterans currently on the rolls would have a presumptive 
condition in 2010. Of this total, we anticipated 27,909 cases would 
result in increased obligations. Of the 27,909 veterans, 25,859 are 
associated with IHD, 1,693 are associated with Parkinson's disease, and 
the remaining 357 are associated with hairy cell/B cell leukemia. In 
future years, the estimated

[[Page 53211]]

number of veteran reopened claims decreases to almost one thousand 
cases and continues at a decreasing rate. The cumulative effect of 
additional cases with mortality rates applied is shown in the chart 
below.
    The Vietnam Era caseload distribution by degree of disability 
provided by C&P Service was used to further distribute the total 
Vietnam Veterans who will have a presumptive condition in 2010 by 
degree of disability for each of the three new presumptive conditions. 
We assume 100 percent for the average degree of disability for both 
Parkinson's disease and hairy cell/B cell leukemia and 60 percent for 
IHD. Based on the Combined Rating Table, veterans that are on the rolls 
for other service-connected conditions (with the exception of those 
that are currently receiving compensation benefits for 100 percent 
disability), would receive a higher combined disability rating if they 
have any of the three new presumptive conditions.
    September average payments from the 2010 President's Budget were 
used to calculate obligations. These average payments are higher than 
schedular rates due to adjustments for dependents, Special Monthly 
Compensation, and Individual Unemployability. The difference in average 
payments due to higher ratings was calculated, annualized, and applied 
to the on-rolls caseload to determine increased obligations. Because 
this particular veteran population is currently in receipt of 
compensation benefits, survivor caseload and obligations would not be 
impacted.

                    Reopened Caseload and Obligations
------------------------------------------------------------------------
                                           Veteran         Obligations
                 FY                       caseload          ($000's)
------------------------------------------------------------------------
2010................................            27,909          $415,927
2011................................            28,340           418,928
2012................................            29,051           431,726
2013................................            29,746           451,042
2014................................            30,425           471,161
2015................................            31,086           491,648
2016................................            31,746           512,767
2017................................            32,404           534,529
2018................................            33,061           556,958
2019................................            33,716           580,070
                                     -----------------------------------
    Total...........................  ................         4,864,755
------------------------------------------------------------------------

Vietnam Veteran and Survivor Accessions

    We anticipated accessions for both veterans and survivors beginning 
in 2010 and continuing over ten years. Total costs were expected to be 
$675.2 million in the first year and total just over $11.3 billion from 
the cumulative effect of cases accessing the rolls each year.
    To identify the number of veteran accessions in 2010, we applied 
prevalence rates to the anticipated living Vietnam Veteran population 
of 2,133,962, and reduced the population by those identified in the 
previous estimates for retroactive and reopened claims. Based on an 
expected application rate of 80 percent and a 100 percent grant rate, 
28,934 accessions are expected. Of the 28,934 veteran accessions, 
25,505 are associated with IHD, 3,074 are associated with Parkinson's 
disease, and the remaining 355 are associated with hairy cell/B cell 
leukemia. In the out years, anticipated veteran accessions drop to 
approximately 3,400 cases in 2011, and continue at a decreasing rate. 
The cumulative effect of additional cases coupled with applying 
mortality rates is shown in the chart below.
    To calculate obligations, the caseload was multiplied by the 
annualized average payment. We assumed those accessing the rolls due to 
IHD will be rated 60 percent disabled and those with either Parkinson's 
disease or hairy cell/B cell leukemia will be rated 100 percent 
disabled. Average payments were based on the 2010 President's Budget 
with the Cost of Living Adjustments factored into the out years.
    The caseload for survivor compensation is associated with the 
number of service-connected veterans' deaths. There are two groups to 
consider for survivor accessions: Those survivors associated with 
veterans who never filed a claim and died prior to 2010; and survivors 
associated with the mortality rate applied to the veteran accessions 
noted above.
    To calculate the survivor caseload associated with veterans who 
never filed a claim and died prior to 2010, general mortality rates 
were applied to the estimated total Vietnam Veteran population (2.6 
million). We estimate that almost 500,000 Vietnam Veterans were 
deceased by 2010. Prevalence rates for each condition were applied to 
the total veteran deaths to estimate the number of deaths due to each 
condition. With the marriage rate and survivor mortality applied, we 
anticipated 20,961 eligible spouses at the end of 2010. We assumed that 
half of this population would apply in 2010 and the remaining in 2011. 
Obligations were calculated by applying average survivor compensation 
payments to the caseload each year.
    The second group of survivors associated with veteran accessions 
was calculated by applying mortality rates for each of the presumptive 
conditions to the estimated eligible veteran population (28,934). In 
2010, 57 veteran deaths were anticipated as a result of one of the new 
presumptive conditions. With the marriage rate applied and aging the 
spouse population (and assuming spouses were the same age as veterans), 
we calculated 42 spouses at the end of 2010. Average survivor 
compensation payments were applied to the spouse caseload to determine 
total obligations.

[[Page 53212]]



                    Veteran and Survivor Accessions Cumulative Caseload and Total Obligations
----------------------------------------------------------------------------------------------------------------
                      FY                          Veteran caseload      Survivor caseload     Total obligations
----------------------------------------------------------------------------------------------------------------
2010..........................................                28,934                10,416              $675,214
2011..........................................                32,270                20,265               882,974
2012..........................................                35,541                20,693               955,525
2013..........................................                38,744                20,487             1,028,467
2014..........................................                41,874                20,283             1,103,429
2015..........................................                44,928                20,081             1,179,725
2016..........................................                47,900                19,881             1,257,259
2017..........................................                50,787                19,682             1,335,922
2018..........................................                53,583                19,485             1,415,601
2019..........................................                56,285                19,290             1,496,178
                                               -----------------------------------------------------------------
    Total.....................................  ....................  ....................            11,330,294
----------------------------------------------------------------------------------------------------------------

Estimated Claims From Veterans Not Eligible

    Based on program history, we anticipate that we will also receive 
claims from veterans who will not be eligible for presumptive service 
connection for the three new conditions.
    These claims will be received from two primary populations:
    <bullet> Veterans with a presumptive disease who did not serve in 
the Republic of Vietnam.
    <bullet> Claims from Vietnam Veterans with hypertension who claim 
``heart disease.''
    We applied the prevalence rate of IHD, Parkinson's disease and 
hairy cell/B cell leukemia to the estimated population of veterans who 
served in Southeast Asia during the Vietnam Era (45,304, 32, and 6 
respectively), and assumed that 10 percent of that population will 
apply for presumptive service connection.
    Review of data obtained from PA&I shows that 23 percent of Vietnam 
Veterans who have been denied entitlement to service connection for 
hypertension also have nonservice-connected heart disease. We applied 
the prevalence rate of hypertension to the living Vietnam Veteran 
population, and then subtracted 23 percent who are assumed to also have 
IHD. We assumed that 10 percent of the remaining population would apply 
for presumptive service connection to arrive at an estimated caseload 
of 111,256.
    We then assumed that 25 percent of the ineligible population would 
apply in 2010, 25 percent would apply in 2011, and the remaining 
population would apply over the next 8 years. For purposes of claims 
processing, anticipated claims are as follows. The chart below reflects 
workload, which is not directly comparable to the preceding caseload 
charts.

                                                                      Total Claims
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Retroactive                                           Claims not
                              FY                                     claims        Reopened claims     Accessions         eligible        Total claims
--------------------------------------------------------------------------------------------------------------------------------------------------------
2010..........................................................            86,069            32,606            39,350            27,814           185,839
2011..........................................................  ................             1,069            13,806            27,814            42,689
2012..........................................................  ................             1,051             3,386             6,954            11,391
2013..........................................................  ................             1,032             3,329             6,954            11,314
2014..........................................................  ................             1,011             3,267             6,954            11,232
2015..........................................................  ................               989             3,201             6,954            11,143
2016..........................................................  ................               989             3,129             6,953            11,071
2017..........................................................  ................               989             3,053             6,953            10,995
2018..........................................................  ................               989             2,971             6,953            10,913
2019..........................................................  ................               989             2,885             6,953            10,827
--------------------------------------------------------------------------------------------------------------------------------------------------------

VBA Administrative Costs

    Administrative costs, including minor construction and information 
technology support were estimated to be $4.6 million during FY2010, 
$841 million for five years and $940 million over ten years.
    C&P Service, along with the Office of Field Operations, estimated 
the FTE that would be required to process the anticipated claims 
resulting from the new presumptive conditions using the following 
assumptions:
    1. 185,839 additional claims in addition to the projected 1,146,508 
receipts during FY2010. This includes:
    <bullet> 86,069 retroactive readjudications under Nehmer.
    <bullet> 89,354 new and reopened claims from veterans.
    <bullet> 10,416 new claims from survivors.
    2. The average number of days to complete all claims in FY2010 
would be 165.
    3. Priority will be given to those Agent Orange claims that fall in 
the Nehmer class action.
    In FY2010, we intended to leverage the existing C&P workforce to 
process as many of these new claims as possible, once the regulation 
was approved, but especially the Nehmer cases. However, to fully 
accommodate this additional claims volume with as little negative 
impact as possible on the processing of other claims, we plan to add 
1,772 claims processors to be brought on in the FY2011 budget and 
timeframe. This approximate level of effort will be sustained through 
2012 and into 2013 in order to process these claims without 
significantly degrading the processing of the non-presumptive workload.
    <bullet> Net administrative costs for payroll, training, additional 
office space, supplies and equipment were estimated to be $4.6 million 
in FY2010, $165 million in FY2011, $798 million over five years, and 
$895 million over 10 years. Additional support costs for minor 
construction are expected to be $12.8 million over the five and ten 
year period. Information Technology (computers and support) are assumed 
to

[[Page 53213]]

require $30.2 million over five years and $32.8 million over ten years.

Veterans Health Administration (VHA) Costs

    We estimated VHA's total cost to be $236 million during the first 
year (FY2010), $976 million for five years, and $2.5 billion over ten 
years.

FY2010 and FY2011 Summary

    <bullet> FY2010 new enrollee patients are expected to number 8,680.
    <bullet> FY2011 additional new enrollees are expected to number 
1,018.
    <bullet> FY2010 costs for C&P examinations are expected to be 
$114M.
    <bullet> FY2011 costs for C&P examinations are expected to be $23M.
    <bullet> FY2010 health care costs (inclusive of travel) are 
expected to be $236M (using cost per patient of 13,500).
    <bullet> FY2011 health care costs (inclusive of travel) are 
expected to be $165M (using cost per patient of 14,100).
    <bullet> Combined costs are as follows:
    [cir] FY2010: $236M.
    [cir] FY2011: $165M.

Assumptions

    <bullet> 30% of veterans newly determined to be service-connected 
will enroll and will use VA health care.
    <bullet> Newly enrolled veterans will be Priority Group 1 veterans.
    <bullet> The cost per patient is arrived at using the average cost 
per Priority Group 1 patient aged between 45-64.
    <bullet> Every VBA case will require a new exam.
    <bullet> It is assumed that 100% of newly enrolled veterans will 
request mileage reimbursement. The average amount of mileage 
reimbursement claims per veteran is $511 (this amount reflects to the 
FY2009 actual average amount).
    We note that many assumptions, which form the foundation for an 
agency's cost forecasts, seldom prove to be completely accurate due to 
variables over which VA has no control, such as application rates, 
veteran Priority Group designation, diagnostic examinations in the 
future, or changes in incidence rates. For example, we assumed that all 
newly enrolled veterans would be in Priority Group 1. If we were to 
assume that a substantial number of these new enrollees would be in 
Priority Group 2, the cost estimate could decrease significantly.

Distribution of Disability Claims

    VBA has established estimates for claims workload for veterans. 
Figure 1 provides breakdown of disability claims.
    Overall, VBA anticipates 69,957 claims. Of these, 17,039 will be 
for veterans whose previous claims for disability compensation were 
denied. Additionally, VBA anticipates reopened claim volume of 32,606 
claims in FY2010 with subsequent decreases to 1,069 per year in FY2011. 
VBA anticipates 28,934 accessions in FY2010. These are new disability 
compensation awards--for veterans who did not previously have an award 
for service connected disability compensation. Additionally, in FY2010 
VBA anticipates disability claim volume associated with the presumptive 
SC determination to be 159,311 and to exceed 270,000 through FY2019.

                                                                        Figure 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Retroactive
                                                                                       claims
                              FY                                   Retroactive    representing new   Reopened claims     Accessions     Total disability
                                                                     claims         SC disability                                         claim volume
                                                                                        award
--------------------------------------------------------------------------------------------------------------------------------------------------------
2010..........................................................            69,957            17,039            32,606            28,934           159,311
2011..........................................................  ................  ................             1,069             3,393            31,207
2012..........................................................  ................  ................             1,051             3,335            10,289
2013..........................................................  ................  ................             1,032             3,273            10,227
2014..........................................................  ................  ................             1,011             3,207            10,161
                                                               -----------------------------------------------------------------------------------------
    Subtotals.................................................  ................  ................            36,769            42,142           221,195
2015..........................................................  ................  ................               989             3,137            10,091
2016..........................................................  ................  ................               989             3,062            10,016
2017..........................................................  ................  ................               989             2,983             9,937
2018..........................................................  ................  ................               989             2,898             9,852
2019..........................................................  ................  ................               989             2,809             9,763
                                                               -----------------------------------------------------------------------------------------
    Totals....................................................            69,957  ................            41,714            57,031           270,854
--------------------------------------------------------------------------------------------------------------------------------------------------------

New Enrollments and Changed Enrollments

    The disability compensation workload, the resulting increases in 
service-connected patients, and the increased combined service 
connected percents will both add new patients to VA's health care 
system and will change the priority levels of veterans currently 
enrolled in VA's health care system.
    For purposes of estimation, it is assumed that 30% of veterans 
``Accessions'' will enroll in the system each year. For FY2010, this 
means that 8,680 of the 28,934 veteran ``Accessions''. Figure 2 
provides the estimate of new enrollments per year for the ten year 
period. In all, it is estimated that 17,109 new veterans will enroll in 
VA's health care system.

                                Figure 2
------------------------------------------------------------------------
                                                                 New
                   FY                       New enrollees     enrollees
                                              per year       cumulative
------------------------------------------------------------------------
2010....................................             8,680         8,680
2011....................................             1,018         9,698
2012....................................             1,001        10,699
2013....................................               982        11,681

[[Page 53214]]

 
2014....................................               962        12,643
                                         -------------------------------
    Subtotals...........................            12,643  ............
2015....................................               941        13,584
2016....................................               919        14,502
2017....................................               895        15,397
2018....................................               869        16,267
2019....................................               843        17,109
                                         -------------------------------
    Totals..............................            17,109        17,109
------------------------------------------------------------------------

    It is assumed that veterans enrolling will be Priority Group 1 
veterans and that they will use VA health care services.
    For purposes of estimation, it is assumed that 40% of the veterans 
whose claims are reopened will have been enrolled in VA's health care 
system and that their Priority Group will move from a copayment 
required status to a copayment exempt status. Additionally, it is 
assumed that their third party collections will be lost. It is assumed 
that 10% of the accessions will result in changes to veterans who are 
currently enrolled. These veterans would be enrolled in a copayment 
required status and would move to copayment exempt status. In FY2010 it 
is estimated that 43,919 veterans would have their enrollment status 
changed, and FY 2011 it is estimated that an additional 767 veterans 
would have their enrollment status changed. Figure 3 provides these 
estimated changes in enrollment status per year and cumulatively.

                                Figure 3
------------------------------------------------------------------------
                                          Upgraded          Upgraded
                 FY                     enrollees per       enrollees
                                            year           cumulative
------------------------------------------------------------------------
2010................................            43,919            43,919
2011................................               767            44,686
2012................................               754            45,439
2013................................               740            46,180
2014................................               725            46,905
                                     -----------------------------------
    Subtotals.......................            46,905            46,905
2015................................               709            47,614
2016................................               702            48,316
2017................................               694            49,010
2018................................               685            49,695
2019................................               677            50,372
                                     -----------------------------------
    Totals..........................            50,372            50,372
------------------------------------------------------------------------

Disability Exams Associated Costs

    It is assumed that each VBA case will result in disability 
examinations for the veteran. In all, it is estimated that 270,854 
disability examinations will need to be performed. An escalation factor 
of 4% is applied to cost of disability examinations.

                                                    Figure 4
----------------------------------------------------------------------------------------------------------------
                                                  Total disability    Cost per  disability     Annual cost per
                      FY                            claim volume             exam *           disability exams
----------------------------------------------------------------------------------------------------------------
2010..........................................               159,311                  $719          $114,544,609
2011..........................................                31,207                   748            23,335,346
2012..........................................                10,289                   778             8,001,451
2013..........................................                10,227                   809             8,271,365
2014..........................................                10,161                   841             8,546,705
                                               -----------------------------------------------------------------
    Subtotals.................................               221,195  ....................           162,699,475
2015..........................................                10,091                   875             8,827,339
2016..........................................                10,016                   910             9,112,200
2017..........................................                 9,937                   946             9,401,942
2018..........................................                 9,852                   984             9,694,379
2019..........................................                 9,763                 1,023             9,991,075
                                               -----------------------------------------------------------------
    Totals....................................               270,854  ....................           209,726,410
----------------------------------------------------------------------------------------------------------------
* Source: Allocation Resource Center.


[[Page 53215]]

Health Care and Total Costs

    Figure 5 provides extended health care costs per year and includes 
costs for C&P disability examinations and travel associated with C&P 
examinations. The cost per patient is arrived at using the average cost 
per Priority Group 1 patient, ages 45-64. It is assumed that 100% of 
newly enrolled veterans will request mileage reimbursement. The average 
amount of mileage reimbursement claims per veteran is $511 (this amount 
reflects to the FY2009 actual average amount). Total costs over the 10-
year period are estimated to be in excess of $2.4B.

                                                                        Figure 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Beneficiary
                                               Annual cost per     Cost per BT      travel costs                         Health care     Extended annual
                     FY                       disability exams    mileage claim     (41.5 cents/    Cost per patient      costs per           costs
                                                                                        mile)                              patient
--------------------------------------------------------------------------------------------------------------------------------------------------------
2010........................................      $114,544,609              $511        $4,435,582           $13,500      $117,182,700      $236,162,891
2011........................................        23,335,346               511         4,955,729            14,100       136,743,210       165,034,285
2012........................................         8,001,451               511         5,466,985            14,700       157,269,420       170,737,855
2013........................................         8,271,365               511         5,968,736            15,100       176,375,550       190,615,650
2014........................................         8,546,705               511         6,460,369            15,700       198,488,820       213,495,893
                                             -----------------------------------------------------------------------------------------------------------
    Subtotals...............................       162,699,475  ................        27,287,400  ................       786,059,700       976,046,575
2015........................................         8,827,339               511         6,941,271            16,300       221,414,310       237,182,919
2016........................................         9,112,200               511         7,410,675            17,100       247,989,330       264,512,205
2017........................................         9,401,942               511         7,867,969            17,900       275,609,880       292,879,791
2018........................................         9,694,379               511         8,312,233            18,800       305,812,080       323,818,692
2019........................................         9,991,075               511         8,742,852            19,800       338,764,140       357,498,068
                                             -----------------------------------------------------------------------------------------------------------
    Totals..................................       209,726,410  ................        66,562,400  ................     2,175,649,440     2,451,938,251
--------------------------------------------------------------------------------------------------------------------------------------------------------

Summary

    Combined estimated increases in health care costs are presented in 
Figure 6.

                                Figure 6
------------------------------------------------------------------------
                                                         Extended annual
                          FY                                  costs
------------------------------------------------------------------------
2010..................................................      $236,162,891
2011..................................................       165,034,285
2012..................................................       170,737,855
2013..................................................       190,615,650
2014..................................................       213,495,893
                                                       -----------------
    Subtotals.........................................       976,046,575
2015..................................................       237,182,919
2016..................................................       264,512,205
2017..................................................       292,879,791
2018..................................................       323,818,692
2019..................................................       357,498,068
                                                       -----------------
    Totals............................................     2,451,938,251
------------------------------------------------------------------------

    Uncertainties: After the comment period had expired, VA received 
correspondence from the Chairman of the Senate Committee on Veterans 
Affairs which questioned VA's use of the prevalence rate of 5.6 percent 
for IHD in the proposed rule. The Chairman mentioned that the 5.6 
percent prevalence rate was for the general U.S. population, instead of 
a rate more representative of the Vietnam Veteran population, which is 
older. He also asked why the prevalence rate for IHD among Vietnam 
Veterans was not assumed to increase on a yearly basis as they age over 
the next ten years, citing Centers for Disease Control (CDC) findings 
that the prevalence rate for IHD increases as an individual ages.
    For purposes of costing the three new presumptive conditions in the 
proposed rule, VA's assumptions for the prevalence and mortality rates 
were identified based on information obtained from the CDC, the 
National Institutes of Health (NIH), and the Census Bureau. In FY2000, 
15,800,000 people were identified with coronary heart disease. The 
total U.S. population according to the Census Population Survey in the 
same year was 281,421,906, reflecting the 5.6 percent prevalence rate. 
Since veteran-specific prevalence and mortality rates are not commonly 
reported, it is standard practice to use general population prevalence 
and mortality rates for cost estimating purposes.
    After publishing a proposed rule, agencies often receive additional 
information, which in turn improves the analysis of agency action. It 
is not unusual for an agency to receive new data during or after the 
comment period, either submitted by the public with comments or 
collected by the agency in a continuing effort to give the agency's 
regulations a more complete foundation. An agency may use such data to 
address potential deficiencies in the proposed rule's data, so long as 
no prejudice is shown.
    We have, therefore, conducted a separate analysis based on the 
CDC's age-adjusted prevalence rates for coronary heart disease. We 
found that CDC's data uses the age categories of 45-54, 55-64, 65-74, 
75-84, and 85 and older, for both males and females. These age-adjusted 
prevalence rates were applied in a separate analysis, which resulted in 
much higher potential costs.
    Using age-adjusted prevalence rates, shifting initial costs data 
from FY2010 to FY2011, adjusting the assumed degree of disability, and 
updating the assumed caseload, the estimated VBA costs in the first 
year would decrease by nearly $1.5 billion compared to VA's proposed 
rule estimate and the overall ten-year costs would increase by nearly 
$19.8 billion. Similarly, VHA developed a methodology based on the data 
provided by VBA to evaluate VBA projected claims data from a health 
care cost analysis perspective. Making adjustments for priority group 
distributions and shifting the FY2010 cost data to FY2011, the 
associated VHA costs in the first year would increase by nearly $100 
million compared to VA's proposed rule estimate and the overall ten-
year costs would increase by nearly $5.0 billion. The details of this 
analysis are available on VA's Web site at: http://vaww1.va.gov/ORPM/FY_2010_Published_VA_Regulations.asp, and also may be viewed online 
through the Federal Docket Management System at http://www.regulations.gov.
    We note that many assumptions, which form the foundation for an 
agency's cost forecasts, seldom prove to be completely accurate due to 
variables over which VA has no control, such as application rates, 
better diagnostic techniques in the future, or changes in incidence 
rates. As documented in the Department's analysis, there are various

[[Page 53216]]

assumptions applied in the cost estimate that, if altered, could result 
in dramatic increases (e.g. age adjustment of prevalence rates) or 
decreases (e.g., lower application rates) in the range of costs 
attributed to the rule. We further note that, in addition to being 
subject to various sources of uncertainty, the model applied by the 
Department for estimating the range of prospective impacts is further 
subject to the relative sensitivity of variation in the respective 
inputs to the model; for example, the model is highly sensitive to 
variation in the prevalence rates, such as that resulting from age 
adjustment.
    While all three presumptive conditions covered by this rule are 
subject to these variations and the resulting impacts on projected 
obligations, VA considers the proposed rule's cost estimate to remain a 
reasonable baseline projection of the costs associated with this final 
rule. However, cost estimates provided and the assumptions used to 
develop them have no binding effect, and veterans who qualify for 
benefits on the basis of these presumptions will receive their benefits 
regardless of cost estimates used at this time. VA's discretionary and 
mandatory funding require explicit appropriations on an annual basis. 
Mandatory out-year estimates are evaluated for relevant current data as 
they become available and budget estimates are adjusted accordingly.

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 would have no such effect on 
State, local, and Tribal governments, or on the private sector.

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 not affect any 
small entities. Only individuals will be directly affected. Therefore, 
pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial 
and final regulatory flexibility analysis requirements of sections 603 
and 604.

Catalog of Federal Domestic Assistance Numbers and Titles

    The Catalog of Federal Domestic Assistance program numbers and 
titles for this 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. John R. 
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this 
document on July 7, 2010, for publication.

List of Subjects in 38 CFR Part 3

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

    Dated: August 25, 2010.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General 
Counsel, Department of Veterans Affairs.

0
For the reasons set out in the preamble, VA is amending 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. Section 3.309 is amended as follows:
0
a. In paragraph (e), by removing ``Chronic lymphocytic leukemia'' and 
adding, in its place, ``All chronic B-cell leukemias (including, but 
not limited to, hairy-cell leukemia and chronic lymphocytic 
leukemia).''
0
b. In paragraph (e), by adding ``Parkinson's disease'' immediately 
preceding ``Acute and subacute peripheral neuropathy''.
0
c. In paragraph (e), by adding ``Ischemic heart disease (including, but 
not limited to, acute, subacute, and old myocardial infarction; 
atherosclerotic cardiovascular disease including coronary artery 
disease (including coronary spasm) and coronary bypass surgery; and 
stable, unstable and Prinzmetal's angina)'' immediately following 
``Hodgkin's disease''.
0
d. At the end of Sec.  3.309, immediately following Note 2, adding a 
new Note 3 to reads as follows:


Sec.  3.309  Disease subject to presumptive service connection.

* * * * *

    Note 3: For purposes of this section, the term ischemic heart 
disease does not include hypertension or peripheral manifestations 
of arteriosclerosis such as peripheral vascular disease or stroke, 
or any other condition that does not qualify within the generally 
accepted medical definition of Ischemic heart disease.

[FR Doc. 2010-21556 Filed 8-30-10; 8:45 am]
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