Federal Register, Volume 75 Issue 57 (Thursday, March 25, 2010)

[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Proposed Rules]
[Pages 14391-14401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6549]

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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: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend
its 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 proposed amendment is
necessary to implement a decision of the Secretary of Veterans Affairs
that there is a positive association between exposure to herbicides and
the subsequent development of hairy cell leukemia and other chronic B-
cell leukemias, Parkinson's disease, and ischemic heart disease. The
intended effect of this proposed amendment is to establish presumptive
service connection for these diseases based on herbicide exposure.

DATES: Comments must be received by VA on or before April 26, 2010.

ADDRESSES: Written comments may be submitted through http://www.Regulations.gov; by mail or hand-delivery to Director, Regulations
Management (02REG), Department of Veterans Affairs, 810 Vermont Ave.,
NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026.
(This is not a toll free number.) Comments should indicate that they
are submitted in response to ``RIN 2900-
AN54[m x dash]Diseases Associated With Exposure to Certain
Herbicide Agents (Hairy Cell Leukemia and other Chronic B Cell
Leukemias, Parkinson's Disease and Ischemic Heart Disease).'' Copies of
comments received will be available for public inspection in the Office
of Regulation Policy and Management, Room 1063B, between the hours of 8
a.m. and 4:30 p.m., Monday through Friday (except holidays). Please
call (202) 461-4902 for an appointment. (This is not a toll free
number.) In addition, during the comment period, comments may be viewed
online through the Federal Docket Management System at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Gerald Johnson, Regulations Staff
(211D), Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue,
NW., Washington, DC 20420, (202) 461-9727 (This is not a toll-free
number.)

SUPPLEMENTARY INFORMATION: Section 3 of the Agent Orange Act of 1991,
Public Law 102-4, 105 Stat. 11, directed the Secretary to seek to enter
into an agreement with NAS to review and summarize the scientific
evidence concerning the association between exposure to herbicides used
in support of military operations in the Republic of Vietnam during the
Vietnam era and each disease suspected to be associated with such
exposure. Congress mandated that NAS determine, to the extent possible:
(1) Whether there is a statistical association between the suspect
diseases and herbicide exposure, taking into account the strength of
the scientific evidence and the appropriateness of the methods used to
detect the association; (2) the increased risk of disease among
individuals exposed to herbicides during service in the Republic of
Vietnam during the Vietnam era; and (3) whether there is a plausible
biological mechanism or other evidence of a causal relationship between
herbicide exposure and the suspect disease. Section 3 of Public Law
102-4 also required that NAS submit reports on its activities every 2
years (as measured from the date of the first report) for a 10-year
period. The Veterans Education and Benefits Expansion Act of 2001
(Benefits Expansion Act), Public Law 107-103, Sec. 201(d), extended
through October 1, 2014, the period for submission of NAS reports.
Section 1116(b) of title 38, United States Code, as enacted by the
Agent Orange Act of 1991, Public Law 102-4, provides that whenever the
Secretary determines, based on sound medical and scientific evidence,
that a positive association (i.e., the credible evidence for the
association is equal to or outweighs the credible evidence against the
association) exists between exposure of humans to an herbicide agent
(i.e., a chemical in an herbicide used in support of the United States
and allied military operations in the Republic of Vietnam during the
Vietnam era) and a disease, the Secretary will publish regulations
establishing presumptive service connection for that disease.
Section 2 of the Agent Orange Act of 1991, Public Law 102-4,
provided that the congressional mandate that the Secretary establish
presumptions of service connection under 38 U.S.C. 1116(b) would expire
10 years after the first day of the fiscal year in which the NAS
transmitted its first report to VA. The first NAS report was
transmitted to VA in July 1993, during the fiscal year that began on
October 1, 1992. Accordingly, under the Agent Orange Act of 1991,
Public Law 102-4, the mandate for VA to issue regulatory presumptions
as specified in section 1116(b) expired on September 30, 2002. In
December 2001, however, Congress enacted the Benefits Expansion Act,
section 201(d) of which extended the mandate under section 1116(b)
through September 30, 2015. Pursuant to the Benefits Expansion Act,
Public Law 107-103, VA must issue new regulations between October 1,
2002, and September 30, 2015, establishing additional presumptions of
service connection for diseases that the Secretary finds to be
associated with exposure to an herbicide agent.
The Secretary of Veterans Affairs has determined that the available
scientific and medical evidence discussed in the ``Veterans and Agent
Orange Update 2008,'' authored by the Committee to Review the Health
Effects in Vietnam Veterans of Exposure to Herbicides, Institute of
Medicine (IOM) of the NAS, and other information available to the
Secretary, are sufficient to establish that

[[Page 14392]]

a positive association exists between exposure of humans to a herbicide
agent and the occurrence in humans of Hairy Cell Leukemia (HCL) and
other Chronic B-Cell Leukemias, Parkinson's disease (PD) and Ischemic
Heart Disease (IHD). Consistent with that determination and as required
by 38 U.S.C. 1116(b) and the Agent Orange Act of 1991, we propose to
amend VA's adjudication regulations (38 CFR part 3) by revising section
3.309(e) to add these diseases to the diseases subject to presumptive
service connection on the basis of herbicide exposure.

Hairy Cell Leukemia and Other Chronic B-Cell Leukemias

In delivering the charge to the IOM Committee, the Secretary
specifically asked the IOM Committee, whether the occurrence of HCL
should be regarded as associated with exposure to the chemical
compounds in the herbicides used by the military in Vietnam. HCL is a
chronic B-cell lymphoproliferative disorder. Because it is so rare, the
Committee reported that HCL would never be studied epidemiologically on
its own, and there are no studies of animals that describe HCL in
animals exposed to the compounds of interest. The IOM Committee stated
that HCL has been classified as a rare form of CLL and that both derive
from B-cell neoplasms. Based on its biology, the Committee saw no
reason to exclude HCL or any other chronic lymphoproliferative disease
of B-cell origin from the overarching broader groupings for which
positive epidemiologic evidence is available. Because HCL is related to
chronic lymphocytic leukemia (CLL) (a disease that is already included
on VA's regulatory list of diseases that qualify for presumptive
service connection based upon herbicide exposure), the Committee
explicitly included HCL and other chronic B-cell leukemias in its
discussions and conclusions regarding CLL. The Committee explicitly re-
categorized HCL and other chronic B-cell leukemias along with CLL in
Update 2008, which the Committee lists as a category clarification
since Update 2006. Based on its review of the available scientific and
medical literature, the Committee concluded that there is sufficient
evidence of an association between exposure to herbicide agents and
CLL, including HCL and all other chronic B-cell hematoproliferative
leukemias.
The Secretary has determined that the available scientific and
medical evidence presented in Update 2008 and other information
available to the Secretary are sufficient to establish a new
presumption of service connection for HCL and other chronic B-cell
leukemias in veterans who were exposed to herbicides used in the
Republic of Vietnam. The Secretary concludes that the credible evidence
for an association between exposure to an herbicide agent and the
occurrence of HCL and other chronic B-cell leukemias in humans
outweighs the credible evidence against such an association.
Accordingly, the Secretary has determined that a presumption of service
connection for HCL and other chronic B-cell leukemias is warranted
pursuant to 38 U.S.C. 1116(b). Because these leukemias are related to
CLL and the evidence supporting an association is the same for these
leukemias, we propose to refer to them as a group in VA's regulatory
list in 38 CFR 3.309(e) of diseases associated with herbicide exposure.
Specifically, we propose to establish a presumption of service
connection for ``All chronic B-cell leukemias (including, but not
limited to, hairy-cell leukemia and chronic lymphocytic leukemia).''

Parkinson's Disease

In Update 2008, the Committee placed Parkinson's disease (PD) in
the category ``limited or suggestive evidence of an association.'' This
was a category change from IOM's prior report, Veterans and Agent
Orange: Update 2006 (Update 2006). For Update 2008, the Committee
selectively reevaluated all past epidemiologic studies that
specifically assessed herbicide exposures and reviewed in detail those
studies published since Update 2006. The older studies, taken as a
group, suggest that there is a relationship between pesticide exposure
and risk of PD, but generally did not contain sufficient exposure data
to show an association specifically to the herbicides of interest.
However, several studies published since Update 2006 now suggest a
specific relationship between exposure to the herbicides of interest
and PD. Three of the four studies published since Update 2006 showed a
statistically significant odds ratio for development of PD and exposure
to herbicides, most notably to 2, 4-D and 2, 4, 5-T and other
chlorophenoxy herbicides. Accordingly, the recent studies are
consistent with the body of epidemiologic and toxicologic data
suggesting a relationship between exposure to pesticides and PD, but
provide more specific evidence of an association between PD and the
herbicides used in the Republic of Vietnam. The Committee noted that,
to date, no studies have been done on Vietnam veterans to determine if
an increased relative risk of developing PD exists for this cohort, and
the Committee recommended that such studies be done. Based upon the
available scientific and medical evidence, the Committee placed PD in
the category of ``limited or suggestive evidence of an association.''
The Secretary requested expert opinion from the Parkinson's and
Associated Diseases Research and Education Clinical Center (PADRECC)
network, a network of VA medical professionals designed to focus on
care, research, and education relating to PD. These experts believe
that there is an increasing body of evidence indicating exposure to
herbicides increases the risk of developing PD and developing it at an
earlier age. These experts also identified a September 2008 report by
Tanner, et al., in Arch Neurol, 2008; 66(9):1106-1113, which found that
the risk of Parkinsonism was increased by exposure to a variety of
chemicals, including dioxin-like chemicals of interest in Update 2008.
The Tanner study was published after Update 2008 was completed but
provides additional support for an association between herbicide
exposure and PD.
The Secretary has determined that the available scientific and
medical evidence presented in Update 2008 and other information
available to the Secretary are sufficient to establish a new
presumption of service connection for PD in veterans exposed to
herbicides, as the credible evidence for an association between
exposure to an herbicide agent and the occurrence of PD in humans
outweighs the credible evidence against such an association.

Ischemic Heart Disease

The previous Committee responsible for Update 2006 was divided as
to whether the evidence related to IHD and exposure to the compounds of
interest was sufficient to advance IHD from the category of
``inadequate or insufficient evidence to determine whether an
association exists'' to the category of ``limited or suggestive
evidence of an association.'' Due to the lack of consensus, the 2006
Committee left IHD in the ``inadequate or insufficient evidence''
category.
For Update 2008, the Committee revisited the entire body of
evidence relating herbicide exposure to heart disease risk and placed
more emphasis on studies that had been rigorously conducted. These
studies focused specifically on the chemicals of concern, compared
Vietnam veterans to non-deployed Vietnam-era veterans, and had
individual and reliable measures of exposure that permitted the
evaluation of dose-response, to promote the

[[Page 14393]]

interpretation of epidemiologic data. The Committee identified nine
studies (including two new studies) that were deemed most informative.
Of these nine studies, five showed strong statistically significant
associations between herbicide exposure and ischemic heart disease. The
studies considered by the Committee also included data from Agent
Orange sprayers, occupationally exposed populations, and
environmentally exposed populations that were either prevalence surveys
or mortality follow-up studies. In situations where several alternative
analyses were presented, the results with the greatest specificity in
the dose-response relationship were given more weight.
The Committee stated that evidence of a dose-response relationship
is especially helpful in interpretation of the epidemiological data,
and the Committee was impressed by the fact that those studies with the
best dose information all showed evidence for risk elevations in the
highest exposure categories. The Committee noted that some of the study
findings could be limited by the effect of selection bias or possible
confounding factors. However, the Committee noted that one of the new
studies showed an association that persisted after statistical
adjustments for a large number of potential confounding risk factors,
which is not generally available in studies of other dioxin exposed
populations. The Committee also indicated that the major potential
confounders were likely inadequate to explain away the high relative
risks and dose-response relationships seen in the data for IHD.
Further, the Committee noted that toxicologic data supports the
biologic plausibility of an association between exposure to the
compounds of interest and IHD.
After considering the relative strengths and weaknesses of the
evidence, and emphasizing in particular the numerous studies showing a
strong dose-response relationship and good toxicology data regarding
IHD, the Committee concluded that there was adequate information to
advance IHD from the ``inadequate or insufficient evidence'' category
to the ``limited or suggestive evidence'' category.
The Secretary has determined that the available scientific and
medical evidence presented in Update 2008 and other information
available to the Secretary are sufficient to establish a new
presumption of service connection for IHD in veterans exposed to
herbicides. After considering all of the evidence, the Secretary has
concluded that the credible evidence for an association between
exposure to an herbicide agent and the occurrence of IHD in humans
outweighs the credible evidence against such an association.
Accordingly, the Secretary has determined that a presumption of service
connection for IHD is warranted pursuant to 38 U.S.C. 1116(b).
According to Harrison's Principles of Internal Medicine (Harrison's
Online, Chapter 237, Ischemic Heart Disease, 2008), IHD is a condition
in which there 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. Therefore, for purposes of
this regulation, the term ``IHD'' includes, but is 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. Since the term refers only to heart disease, it
does not include hypertension or peripheral manifestations of
arteriosclerosis such as peripheral vascular disease or stroke.

Impact of the Nehmer Class Action Litigation

Nehmer v. U.S. Department of Veterans Affairs, Civ. Action No. 86-
6160 (N.D. Cal.) (TEH) (Nehmer) is a long-standing class action
(originated in 1986) on behalf of all veterans and survivors of
veterans eligible to claim VA disability compensation benefits based on
exposure to herbicides in the Republic of Vietnam during the Vietnam
era. In 1989, the U.S. District Court for the Northern District of
California invalidated a 1985 VA regulation governing claims based on
herbicide exposure. In 1991, the parties entered into a stipulation to
provide for re-adjudication of class members' claims and payment of
retroactive benefits, if warranted. Since that time, the district court
has issued a series of orders interpreting the 1991 stipulation to
impose ongoing duties on VA. Consistent with those orders, whenever VA
identifies a new disease that is associated with herbicide exposure and
adds a new disease to its regulatory list, it must identify and
readjudicate any previously-filed claims by the class members involving
that disease and, if warranted under VA regulations governing Nehmer
awards, must pay benefits retroactive to the date the prior claim was
received by VA to the veteran or, if the veteran is deceased, to the
veteran's surviving spouse, child, or parents. In July 2007, the U.S.
Court of Appeals for the Ninth Circuit rejected VA's position that its
duties under the Nehmer stipulation have ended and held that VA's
duties extend through at least 2015. Nehmer v. U.S. Dept. of Veterans
Affairs, 494 F.3d 846, 862-63 (9th Cir. 2007). Accordingly, the
requirements of the Nehmer court orders for review of previously denied
claims and for retroactive payment will apply to the proposed new
presumptions, to the extent consistent with the court orders and 38 CFR
3.816, the VA regulation implementing those orders. The impact of these
procedures is discussed in the Regulatory Impact Analysis below.

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 regulatory action as a ``significant regulatory
action,'' requiring review by the Office of Management and Budget
(OMB), unless OMB waives such review, if it is a 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. A
Regulatory Impact Analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).

[[Page 14394]]

Comment Period

Although under the rulemaking guidelines in Executive Order 12866
VA ordinarily provides a 60 day comment period, the Secretary has
determined that there is good cause to limit the public comment period
on this proposed rule to 30 days. This proposed rule is necessary to
implement section 1116(c) of title 38 as enacted by the Agent Orange
Act of 1991, Public Law 102-4, which sets forth time limits for
rulemaking when the Secretary determines that a new presumption of
service connection for veterans exposed to herbicides used in the
Republic of Vietnam is warranted. Those time limits include the
requirement for issuance of final regulations ``[n]ot later than 90
days after the date on which the Secretary issues proposed
regulations.'' 38 U.S.C. 1116(c)(2). The statute thus requires VA to
act expeditiously to issue final rules, which will allow VA to begin
providing benefits to veterans and their families based on this rule. A
30-day notice and comment period is necessary both to facilitate
expeditious issuance of final regulations and to promote rapid action
on affected benefits claims.

Regulatory Impact Analysis

VA followed OMB Circular A-4 to the extent feasible in this
regulatory analysis. The circular first calls for a discussion of the
Statement of Need for the regulation. As discussed in the preamble, 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.
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.
Risks: The rule implements statutorily required provisions to
expand veteran benefits. No risk to the public exists.
Anticipated Costs and Benefits: We estimate 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
include 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.

Veterans Benefits Administration (VBA) Costs

We estimate 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 ($000s) 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 rolls. 415,927 2,188,784 4,864,755
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 represent a level of effort of current FTE that will be used to work claims received in
FY2010. New hiring will begin in 2011.

Of the total VBA benefits costs identified for FY 2010, $12.3
billion accounts 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.

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................................. 692,204 166,300 1,189,143 2,796,852
Hairy Cell/B cell Leukemia.................. 1,716,057 24,372 726,306 1,720,028
-------------------------------------------------------------------
Subtotal................................ 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.

[[Page 14395]]

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:
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.
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.
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.
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) will be 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
------------------------------------------------------------------------

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).

[[Page 14396]]

Survivor Caseload and Obligations for Retroactive Benefits
------------------------------------------------------------------------
Retroactive
Presumptive conditions Caseload payments
($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
------------------------------------------------------------------------
Veteran Survivor Obligations
FY caseload caseload ($000s)
------------------------------------------------------------------------
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 expect 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 anticipate that 725,547 Vietnam Veterans will 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 will have a presumptive
condition in 2010. Of this total, we anticipate 27,909 cases will
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 number of Veteran reopened claims decreases
to almost one thousand cases and continue 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 ($000s)
------------------------------------------------------------------------
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 anticipate accessions for both Veterans and survivors beginning
in 2010 and continuing over ten years. Total costs are 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.

[[Page 14397]]

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
anticipate 20,961 eligible spouses at the end of 2010. We assume that
half of this population will 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 are 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.

Veteran and Survivor Accessions Cumulative Caseload and Total
Obligations
------------------------------------------------------------------------
Veteran Survivor Total
FY caseload caseload 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:
Veterans with a presumptive disease who did not serve in
the Republic of Vietnam.
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 Reopened Claims not
FY claims 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

[[Page 14398]]

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 are 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:
86,069 retroactive readjudications under Nehmer.
89,354 new and reopened claims from veterans.
10,416 new claims from survivors.
2. The average number of days to complete all claims in FY2010 will
be 165.
3. Priority will be given to those Agent Orange claims that fall in
the Nehmer class action.
In FY2010, we will leverage the existing C&P workforce to process
as many of these new claims as possible, once the regulation is
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.
Net administrative costs for payroll, training, additional
office space, supplies and equipment are 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 require $30.2 million over five years and $32.8 million over ten
years.

Veterans Health Administration (VHA) Costs

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

Assumptions

30% of Veterans newly determined to be service-connected
will enroll and will use VA health care.
Newly enrolled Veterans will be Priority Group 1 Veterans.
The cost per patient is arrived at using the average cost
per Priority Group 1 patient aged between 45-64.
Every VBA case will require a new exam.
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).

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
Retroactive representing Reopened Total
FY claims new SC claims Accessions disability
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

[[Page 14399]]

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 enrollees New enrollees
FY per year cumulative
------------------------------------------------------------------------
2010.................................... 8,680 8,680
2011.................................... 1,018 9,698
2012.................................... 1,001 10,699
2013.................................... 982 11,681
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 copay required
status to a copay 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 copay required status
and would move to copay 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 Annual cost per
FY claim volume disability 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
--------------------------------------------------------

[[Page 14400]]

Totals............................................. 270,854 ................. 209,726,410
----------------------------------------------------------------------------------------------------------------
* Source: Allocation Resource Center.

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 aged between 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
FY Annual cost per Cost per BT travel costs Cost per Health care costs Extended annual
disability exams mileage claim (41.5 cents/mile) patient per patient costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 and lost revenues
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
------------------------------------------------------------------------

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 an 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 given year. This rulemaking would have no such effect
on State, local, and Tribal governments, or on the private sector.

Regulatory Flexibility Act

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

Congressional Review Act

Under the Congressional Review Act, a major rule may not take
effect until at least 60 days after submission to Congress of a report
regarding the rule. A major rule is one that would have an annual
effect on the economy of $100 million or more or have certain other
impacts. We have determined this rulemaking to be a major rule under
the Congressional Review Act.

Catalog of Federal Domestic Assistance Numbers and Titles

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

List of Subjects in 38 CFR Part 3

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

Approved: December 23, 2009.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.

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

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity
Compensation

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

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

[[Page 14401]]

Sec. 3.309 [Amended]

2. In Sec. 3.309(e) the listing of diseases is amended as follows:
a. 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)''.
b. By adding ``Parkinson's disease'' immediately preceding ``Acute
and subacute peripheral neuropathy''.
c. 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''.

[FR Doc. 2010-6549 Filed 3-24-10; 8:45 am]
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