[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Rules and Regulations]
[Pages 57415-57421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22635]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AO79
Payment or Reimbursement for Certain Medical Expenses for Camp
Lejeune Family Members
AGENCY: Department of Veterans Affairs.
ACTION: Interim final rule.
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SUMMARY: The Department of Veterans Affairs (VA) is promulgating
regulations to implement statutory authority to provide payment or
reimbursement for hospital care and medical services provided to
certain veterans' family members who resided at Camp Lejeune, North
Carolina, for at least 30 days during the period beginning on January
1, 1957, and ending on December 31, 1987. Under this rule, VA will
reimburse family members, or pay providers, for medical expenses
incurred as a result of certain illnesses and conditions that may be
attributed to exposure to contaminated drinking water at Camp Lejeune
during this time period. Payment or reimbursement will be made within
the limitations set forth in statute and Camp Lejeune family members
will receive hospital care and medical services that are consistent
with the manner in which we provide hospital care and medical services
to Camp Lejeune veterans.
DATES: Effective Date: This interim final rule is effective October 24,
2014.
Comment Date: Comments must be received on or before November 24,
2014.
ADDRESSES: Written comments may be submitted by email through http://www.regulations.gov; by mail or hand-delivery to Director, Regulation
Policy and Management (02REG), Department of Veterans Affairs, 810
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202)
273-9026. Comments should indicate that they are submitted in response
to ``RIN 2900-AO79, Payment or Reimbursement for Certain Medical
Expenses for Camp Lejeune Family Members.'' Copies of comments received
will be available for public inspection in the Office of Regulation
Policy and Management, Room 1068, between the hours of 8:00 a.m. and
4:30 p.m. Monday through Friday (except holidays). Please call (202)
461-4902 for an appointment. (This is not a toll-free number.) In
addition, comments may be viewed online through the Federal Docket
Management System (FDMS) at http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Terry Walters, Deputy Chief Consultant
Post-Deployment Health, Office of Public Health (10P3A), Veterans
Health Administration, 810 Vermont Avenue NW., Washington, DC 20420,
(202) 461-1017. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On August 6, 2012, the President signed into
law the Honoring America's Veterans and Caring for Camp Lejeune
Families Act of 2012, Public Law 112-154 (the Act). Among other things,
section 102 of the Act created 38 U.S.C. 1787, requiring VA to furnish
hospital care and medical services to certain family members of Camp
Lejeune veterans for certain specified illnesses and conditions. The
law requires the family members to have resided for at least 30 days at
Camp Lejeune, North Carolina (hereinafter referred to as Camp Lejeune),
while their veteran family member served on active duty in the Armed
Forces at Camp Lejeune for at least 30 days during the period beginning
on January 1, 1957, and ending on December 31, 1987. This interim final
rule implements this statutory requirement by amending existing VA
regulations and creating a new regulation, 38 CFR 17.410.
On September 11, 2013, VA published a notice of proposed rulemaking
concerning hospital care and medical services provided to Camp Lejeune
veterans. 78 FR 55671. In the supplementary information to that
rulemaking, we provided our interpretation of the purposes of the Act,
set forth criteria to identify a ``Camp Lejeune veteran,'' defined the
types of exposures experienced by veterans who served at Camp Lejeune
during the statutorily defined period, and defined several terms
relevant to this rulemaking. The final rule would apply equally and to
the same extent to family members who resided at Camp Lejeune during
the statutorily defined period. Under the law, family members, like
veterans, experienced the same risks of exposure if they resided at
Camp Lejeune during the statutorily prescribed period, and therefore
should be considered as needing identical hospital care and medical
services as those provided to Camp Lejeune veterans. This rulemaking
addresses only those regulatory provisions specific to family members,
which must be unique because VA has neither the authority nor the
resources to provide comprehensive medical care to veterans' family
members. In recognition of these limitations, we interpret the
statutory authority to ``furnish'' ``hospital care and medical
services'' as authorizing
[[Page 57416]]
VA to reimburse these family members, or pay providers, when they have
exhausted all claims and remedies against a third party for payment of
medical care for an illness or condition caused by Camp Lejeune
exposure. VA will not directly provide care to family members under any
circumstances outside VA's separate authorities to provide limited
emergency care to non-veterans. In paragraph (a) of 38 CFR 17.410 VA
states that it will pay providers or reimburse Camp Lejeune family
members for certain hospital care and medical services associated with
the specified conditions and furnished by non-VA health care providers.
We clarify the terms of the payment or reimbursement in paragraph (d),
which is discussed in detail below.
Paragraph (b) of Sec. 17.410 sets forth the definitions applicable
to 38 CFR 17.410. For the reasons explained above, we define Camp
Lejeune in this section by using the same definition established in 38
CFR 17.400(b). Under Sec. 17.400(b), ``Camp Lejeune'' means any area
within the borders of the U.S. Marine Corps Base Camp Lejeune or Marine
Corps Air Station New River, North Carolina. This area includes the
areas in which non-military personnel would have resided while their
active duty family member served at Camp Lejeune.
We define ``Camp Lejeune family member'' as an individual who meets
two requirements. First, the individual resided (or was in utero while
his or her mother either resided at Camp Lejeune or served at Camp
Lejeune under Sec. 17.400(b)) for at least 30 (consecutive or
nonconsecutive) days during the period beginning on January 1, 1957,
and ending on December 31, 1987. Second, the individual is either
related to a Camp Lejeune veteran by birth, was married to such a
veteran, or was a legal dependent of the veteran. Department of Defense
rules determined whether servicemembers and their families were
authorized to reside at Camp Lejeune during the relevant period; our
definition here aligns with those rules. Eligible individuals must meet
both the residency and relational requirements as set forth in 38
U.S.C. 1787(a). We note that the requirement that a family member be
related to the veteran by birth includes individuals who were in utero
while the mother of the individual resided at Camp Lejeune, as
identified under 38 U.S.C. 1787(a). The requirement of relation by
birth or marriage encompasses any relative of the Camp Lejeune veteran
who could have been authorized by a service department to reside on
Camp Lejeune and therefore may have been exposed to contaminated water.
We also clarify that family members include individuals who were legal
dependents of the Camp Lejeune veteran during their residency at Camp
Lejeune, such as adopted children, stepchildren, or individuals for
whom the veteran had custody as determined by a U.S. court.
When referring to Camp Lejeune veterans, we use the same definition
provided in 38 CFR 17.400(b). Under this definition, a ``Camp Lejeune
veteran'' is any veteran who served at Camp Lejeune on active duty, as
defined in 38 U.S.C. 101(21), in the Armed Forces for at least 30
(consecutive or nonconsecutive) days during the period beginning on
January 1, 1957, and ending on December 31, 1987. A veteran served at
Camp Lejeune if he or she was stationed at Camp Lejeune, or traveled to
Camp Lejeune as part of his or her professional duties.
We define a ``health-plan contract'' to carry the same definition
under this section as we define the term in Sec. 17.1001(a). The Sec.
17.1001(a) definition of health-plan contract implements the definition
set forth in 38 U.S.C. 1725(f). Under 38 U.S.C. 1787(b)(3), VA must use
that same definition for the purposes of this rulemaking. Under that
definition, health-plan contracts include insurance policies or
contracts, medical or hospital service agreements, membership or
subscription contracts, or similar arrangements under which health
services for individuals are provided or the expenses of such services
are paid, public insurance programs such as TRICARE, CHAMPVA, Medicare
or Medicaid, and worker's compensation law or plans. Similarly, as
directed by 38 U.S.C. 1787(b)(3), we define ``third party'' in
accordance with the definition set forth by Congress in section
1725(f), and as defined in 38 CFR 17.1001(b). Under Sec. 17.1001(b),
third parties include: A Federal entity, a State or political
subdivision of a State, an employer or an employer's insurance carrier,
an automobile accident reparations insurance carrier, and a person or
entity obligated to provide, or to pay the expenses of, health services
under a health-plan contract. VA has not changed those definitions in
this rulemaking because Congress specified in section 1787(b)(3) that
VA must define these terms to have the same meaning given to them under
section 1725(f).
In Sec. 17.410(c), we explain that individuals who seek to apply
for status as a Camp Lejeune family member must complete VA Form 10-
068, ``Camp Lejeune Family Member Heath Care Program Application.''
Once an individual submits a form, VA will confirm that the information
is accurate in order to confirm Camp Lejeune family member status. VA
has systems in place to verify that individuals meet the residence
requirements and that they have the appropriate relationship to the
Camp Lejeune veteran. VA will consider all supporting evidence
submitted to confirm that an individual resided at Camp Lejeune for at
least 30 days, including utility bills, pay stubs, tax forms, and
similar documentation. Additionally, VA will consider as evidence any
available internal housing records that show that the related Camp
Lejeune veteran resided in family housing on Camp Lejeune along with
all other residency-related evidence when confirming the accuracy of
the family member's application.
Under Sec. 17.410(d), we set out the process that providers of
care or family members must follow in order to receive payment or
reimbursement for hospital care and medical services provided by a non-
VA health care provider that occurred after March 26, 2013 in
connection with the 15 illnesses or conditions listed in 38 U.S.C.
1710(e)(1)(F) and 38 CFR 17.400(d)(1). These conditions are esophageal
cancer, lung cancer, breast cancer, bladder cancer, kidney cancer,
leukemia, multiple myeloma, myleodysplasic syndrome, renal toxicity,
hepatic steatosis, female infertility, miscarriage, scleroderma,
neurobehavioral effects, and non-Hodgkin's lymphoma. Pursuant to 38
U.S.C. 1787(b)(2), VA may not pay or reimburse for hospital care and
medical services ``for an illness or condition of a [Camp Lejeune]
family member that is found, in accordance with guidelines issued by
the Under Secretary for Health, to have resulted from a cause other
than the residence of the family member [at Camp Lejeune].'' We address
this clinical determination made with the support of VA clinical
practice guidelines in Sec. 17.410(d), and discuss in detail below.
First, pursuant to Sec. 17.410(d)(1), Camp Lejeune family members,
or providers of hospital care or medical services, must file a timely
claim for payment or reimbursement. The earliest that a Camp Lejeune
family member can submit a claim for reimbursement will be the date
that VA approves the application for Camp Lejeune family member status.
VA will begin to accept applications immediately upon publication of
this interim final rulemaking. We will apply a 2-year limit from the
time of approved Camp Lejeune family member status for a timely claim
filing. This 2-year limit is consistent with VA's review of
applications for retroactive copayment
[[Page 57417]]
waivers made by Camp Lejeune veterans. Given that a number of claims
may be for care received prior to the date of application, we set forth
separate standards for timely claims. We will also pay for or reimburse
certain claims for hospital care and medical services that took place
before VA receives the Camp Lejeune family member's application. If the
hospital care or medical services were provided prior to the date that
the family member application was received by VA, we explain in Sec.
17.410(d)(1)(i) that VA will accept claims for care dating as far back
as two years prior to the date that the Camp Lejeune family member's
application was received, but not earlier than March 26, 2013, the date
on which appropriations to pay such claims were received, provided that
claims for such care are received by VA no more than 60 days after VA
approves the application. We note that the 2-year limit may be
shortened if VA does not have the appropriation to provide payment or
reimbursement due to the limitation set forth in Sec. 17.410(d)(5). We
note further that the 2-year limit is contingent upon claims being
submitted within 60 days of the family member's application.
In Sec. 17.410(d)(1)(ii), we explain the claim deadline for
payment or reimbursement of hospital care and medical services that the
Camp Lejeune family member received after VA has already received the
Camp Lejeune family member's application. In that instance, the Camp
Lejeune family member must file such a claim within two years after the
date of discharge from hospital care or the date that the medical
services were rendered. We believe that two years strikes an
appropriate balance between allowing Camp Lejeune family members or
providers adequate time to acquire the appropriate information to
submit claims, and allowing VA to manage the claims process in an
efficient and expedient manner. Further, this two-year requirement
provides the family members and providers sufficient time to submit the
medical claims to other health insurers for payment and receipt of
their explanation of benefits.
We believe that VA can only effectively carry out its duty to
reimburse for care provided to family members in 38 U.S.C. 1787(a) if
both family members and providers can submit claims directly to VA. In
order to satisfy the exhaustion requirement set forth in Sec.
17.410(d)(4) (discussed in detail below), VA will ensure that third
party payers with liability for a claim, such as private health
insurers, have satisfied their respective liability before VA will
cover the remaining liability to the provider. VA will primarily rely
on the Camp Lejeune family member to self-report his or her insurance
information, and any future changes that might occur. VA will examine
claims for falsified information, and VA will follow up to verify
whether the individual is insured and filing accurate claims.
In Sec. 17.410(d)(2), we require that the Camp Lejeune family
member's treating physician certify that the claimed hospital care or
medical services were provided for an illness or condition listed in
Sec. 17.400(d)(1). We also require under Sec. 17.400(d)(2) that the
treating physician provide information about any co-morbidities, risk
factors, or other exposures that may have contributed to the illness or
condition. Because VA is not going to be conducting clinical
examinations, we must rely on the clinical determinations made by the
individual's treating physician who did conduct such clinical
examinations of the Camp Lejeune family member. VA will use this
information to reach the clinical determinations described in Sec.
17.410(d)(3). Because VA is not providing hospital care and medical
services to the Camp Lejeune family member directly, we require this
information from the treating physician in order to satisfy the
requirements that the treatment be for one of the 15 illnesses or
conditions set forth in 38 U.S.C. 1710(e)(1)(F). Pursuant to 38 U.S.C.
1787(b)(2), VA may not furnish hospital care and medical services to a
Camp Lejeune family member for illnesses or conditions that VA finds to
have resulted from a cause other than the individual's residence at
Camp Lejeune. VA will use clinical practice guidelines to make this
determination, which we discuss in greater detail in relation to Sec.
17.410(d)(3). VA will evaluate the clinical information provided by the
Camp Lejeune family member's treating physician in conjunction with
these clinical practice guidelines, and any other medical and
scientific evidence and research, to reach the clinical findings
described and discussed in Sec. 17.410(d)(3).
In Sec. 17.410(d)(3), we incorporate a limitation similar to the
one in Sec. 17.400(c) by establishing that if a Camp Lejeune family
member is diagnosed with one of the 15 illnesses or conditions listed
in the Act, then the illness or condition is attributable to the
individual's residence at Camp Lejeune. However, if VA clinically
finds, after consideration of clinical practice guidelines and other
accepted forms of medical documentation, evidence, or research with
respect to the listed illness or condition, that the illness or
condition is not attributable to the individual's residence at Camp
Lejeune, then VA will not provide payment or reimbursement for care
under this rule. For many of the 15 conditions or illnesses specified
in the Act, scientific knowledge limits VA's ability to make a
determination regarding a specific cause. When the best scientific
evidence available at the time limits VA's ability to attribute the
family member's condition to a specific cause, VA will assume the
condition or illness was caused by exposures while at Camp Lejeune, and
thus will provide payment to providers or reimbursement to Camp Lejeune
family members provided they meet all other requirements under this
rule. For other conditions or illnesses, current medical knowledge
offers more guidance. As such, the clinical practice guidelines
represent best practices, providing factors for clinicians to consider
when making determination about whether an illness or condition is
attributable to a cause other than the individual's residence at Camp
Lejeune. The guidelines encourage clinicians to consider each patient's
full history in order to make the best possible clinical determination.
Best practices cannot be static. Consistent with standard VA practice,
the clinical guidelines used to make the determinations necessary to
implement this regulation will be subject to continuous improvement.
Specifically, over time we will update the clinical practice guidelines
to reflect evolution in the science underlying these conditions,
experience in implementing the guidelines, and other factors that
reflect our understanding of clinical indications and the potential for
more specific determinations. Camp Lejeune family members will have the
option to request reconsideration of clinical determinations, and at
that time will be able to submit additional evidence supporting the
claim as well. Appeals will be reviewed by VA clinicians with expertise
on Camp Lejeune matters, or experts on the specific illness or
condition in question. To the extent that there are issues about the
adequacy and sufficiency of VA's review of evidence presented by the
Camp Lejeune family member, the individual can appeal to the Board of
Veterans Appeals.
Under 38 CFR 17.410(d)(3), the claim must be for hospital care or
medical services provided in connection with one of the 15 illnesses or
conditions listed in Sec. 17.400(d)(1). As explained in the proposed
rule for ``Hospital Care and Medical Services for Camp Lejeune
Veterans,'' VA is in the process of
[[Page 57418]]
developing clinical practice guidelines in order to determine whether
an individual has been diagnosed with one of the illnesses or
conditions listed in the Act and to determine the clinical relationship
of a specific illness or condition to possible exposure to contaminated
drinking water at Camp Lejeune. 78 FR 55673, Sept. 11, 2013. We will
utilize those same non-determinative clinical practice guidelines in
concluding whether the similar requirement under 38 U.S.C. 1787(b)(2),
that VA may not furnish hospital care and medical services for Camp
Lejeune family members if the illness or condition is determined ``to
have resulted from a cause other than the residence of the family
member [at Camp Lejeune],'' is satisfied.
The VA health care system is designed to provide comprehensive
health care to veterans. Section 1787(a) authorizes VA to furnish
hospital care and medical services to veterans' family members only for
the 15 listed illnesses and conditions listed in 38 U.S.C.
1710(e)(1)(F). We believe that family members will receive continuity
of health care for these 15 illnesses or conditions and any other
health needs by receiving hospital care and medical services from their
private providers. More importantly, because our authority to provide
care to family members is limited to care specifically for one of the
listed illnesses or conditions, there could be significant medical and
ethical issues presented if VA were to attempt to provide direct care
to family members. Our medical providers treat the ``whole patient,''
and it could be unethical (and bad for the patient) in many cases to
treat a specific illness or condition while disregarding other medical
issues. Therefore, as a matter of policy, VA has determined that it is
in the best interests of Camp Lejeune family members to receive
hospital care and medical services from private providers chosen by the
family. In contrast, VA provides direct care to Camp Lejeune veterans
by enrolling them in the VHA health care system because VA has separate
authority to provide hospital care and medical services to eligible
veterans. This is explained further in ``Hospital Care and Medical
Services for Camp Lejeune Veterans,'' 78 FR 55671, September 11, 2013.
In 38 CFR 17.410(d)(4), we explain that any hospital care and
medical services must be authorized under VA's medical benefits package
in Sec. 17.38. In 38 CFR 17.38, VA sets forth the broad scope of the
medical benefits package that it furnishes to veterans, based on our
authority to provide ``hospital care'' and ``medical services'' under
38 U.S.C. 1710. Because the authorizing statutes for both family
members under 38 U.S.C. 1787 and veterans under 38 U.S.C. 1710 use the
terms ``hospital care'' and ``medical services,'' we will pay only for
care and services that meet the statutory definitions under section
1701, i.e., those that we would otherwise be authorized to provide to
veterans. In short, through the payment and reimbursement system
described in this rulemaking, we will ``furnish'' the same hospital
care and medical services to family members that we would furnish to
veterans for the 15 illnesses and conditions specified in Act.
Under Sec. 17.410(d)(5), Camp Lejeune family members or hospital
care or medical service providers must exhaust all claims and remedies
reasonably available to the family member or provider against a third
party, including health-plan contracts. We have repeated in Sec.
17.410(d)(5) a statutory requirement under 38 U.S.C. 1787(b)(3).
Section 1787(b)(3) specifically cites health-plan contracts, which we
defined in Sec. 17.1001(a) to include private health insurance.
Generally, this requirement will be interpreted to be satisfied when
the Camp Lejeune family member submits claims for all hospital care and
medical services to the all relevant third party insurers, including
Medicare and Medicaid, before submitting the claim to VA. We recognize
that in some cases the only option available to the family member may
have been to obtain out-of-network care, and in such cases we will find
that the exhaustion requirement has been met and will cover the claimed
amount so long as it is otherwise in compliance with all relevant
third-party coverage.
Under paragraph Sec. 17.410(d)(6), we note that payment or
reimbursement will only be made if adequate funds have been
appropriated to implement 38 U.S.C. 1787. Medical Services account
funds will be available each fiscal year for Camp Lejeune care received
by qualifying family members on or after the date that an
appropriations act is signed into law. Under 38 U.S.C. 1787(b)(1), VA
is authorized to furnish hospital care and medical services to Camp
Lejeune family members ``to the extent and in the amount provided in
advance in appropriations Acts for such purpose.'' VA is not authorized
to provide payments or reimbursements before the date that an
appropriation Act provides funds for the purpose of furnishing hospital
care and medical service to Camp Lejeune family members. The
Consolidated and Further Continuing Appropriations Act, 2013, Public
Law 113-6, 127 Stat. 396, appropriated funds to the Medical Services
account for fiscal year 2014 for, among other things, ``hospital care
and medical services authorized by section 1787 of title 38, United
States Code.'' These funds became available on October 1, 2013, and
will expire on September 30, 2014.
In 38 CFR 17.410(e), we establish the amounts that VA will pay or
reimburse for hospital care and medical services furnished to family
members. Under paragraph (e)(1), if a third party is liable for partial
payment for hospital care or medical services provided to a Camp
Lejeune family member consistent with the other requirements of Sec.
17.410, then VA will pay or reimburse the lesser of two rates. The
first possible rate is the amount for which the Camp Lejeune family
member remains personally liable. For example, if a Camp Lejeune family
member receives medical services consistent with paragraph (d) and is
insured under a health-plan contract, then VA will pay or reimburse any
cost share or copayment amounts for which the Camp Lejeune family
member is personally liable under that health-plan contract.
The second rate calculation is based on VA's existing mechanisms
for paying for hospital care and medical services provided by non-VA
providers to veterans under 38 CFR 17.55 and 17.56. Section 17.55 sets
VA's payment methodology for authorized public or private hospital care
to veterans. Section 17.56 sets VA's payment methodology for authorized
medical services provided to veterans. Both 38 U.S.C. 1710(e)(1)(F) and
1787 require VA to ``furnish hospital care and medical services'' for
the same set of 15 illnesses or conditions. Given the identical
language, VA intends, to the extent possible, to furnish hospital care
and medical services to Camp Lejeune family members in the same manner
that it does for veterans receiving non-VA care, including calculating
payments at the same rate. Under Sec. Sec. 17.55(g) and 17.56(c),
payments made by VA under those authorities ``shall be considered
payment in full.'' Likewise, by cross-referencing Sec. Sec. 17.55 and
17.56 in Sec. 17.410(e)(1) and (2), any payments or reimbursements
made will be payment in full, which in turn extinguishes all personal
liability for the Camp Lejeune family member for the hospital care and
medical services related to one of the 15 illnesses or conditions
listed in the Act.
VA will pay the lesser of those two calculations because by
extinguishing the Camp Lejeune family member's individual liability, VA
will satisfy the requirement under 38 U.S.C. 1787 to
[[Page 57419]]
furnish hospital care and medical services. By paying the lesser of the
two rates listed in Sec. 17.410(e)(1), VA will ensure that its
resources are being managed in the most efficient way possible. Under
paragraph (e)(2), if VA is the sole payer, meaning that no other party
is liable for the provided hospital care and medical services, then VA
will calculate payment amounts by using the methodologies in Sec. Sec.
17.55 and 17.56.
Effect of Rulemaking
Title 38 of the Code of Federal Regulations, as revised by this
interim final rulemaking, represents VA's implementation of its legal
authority on this subject. Other than future amendments to this
regulation or governing statutes, no contrary guidance or procedures
are authorized. All existing or subsequent VA guidance must be read to
conform with this rulemaking if possible or, if not possible, such
guidance is superseded by this rulemaking.
Administrative Procedure Act
Under 5 U.S.C. 553(b)(B), the general requirements for notice of
proposed rulemaking do not apply when the agency finds that notice and
public procedure are impracticable, unnecessary, or contrary to the
public interest. In accordance with that section, the Secretary of
Veterans Affairs finds good cause to issue this interim final rule
without prior notice and comment. Accordingly, it is not necessary to
obtain public comment prior to implementation. Moreover, although
public comments prior to implementation are not necessary to fulfill
the mandate of the law in a timely manner, comments received after
publication and a brief period of implementation may assist in
understanding whether this interim final rule requires minor
adjustments or refinement of attendant procedures.
First, VA believes that prior notice and comment would be contrary
to the public interest. This interim final rule implements VA's duty to
furnish hospital care and medical services to family members of
veterans, pursuant to 38 U.S.C. 1787, who may have been exposed to
toxic substances due to their residence at Camp Lejeune. Many of the 15
listed conditions or illnesses are life-threatening and require
immediate medical care that is often quite costly to patients,
regardless of whether they have health-plan contracts. For example,
several of the 15 illnesses or conditions are serious cancers, and
medical research indicates that the probability of survival increases
with early diagnosis and treatment. The cost of care for one of the 15
illnesses or conditions is frequently prohibitive, leading individuals
to delay or forego obtaining vital hospital care and medical services.
In addition to increased mortality, delays in pursuing care can
unnecessarily complicate treatment when the individual eventually does
seek care because, by that time, the illness or condition can progress
and may directly lead to secondary conditions. VA is capable of
reimbursing Camp Lejeune family members for such illnesses or
conditions, and there are critical health care reasons to ensure that
these family members can obtain care as soon as possible.
In addition, we believe that prior notice and comment are
unnecessary. This interim final rule enforces the Congressional mandate
of 38 U.S.C. 1787 very broadly. We do not believe that we would receive
any comments suggesting that the proposed coverage is too broad and
should be more restrictive than is provided in this rule. For these
reasons, the Secretary has concluded that ordinary notice and comment
procedures would be unnecessary, and contrary to the public interest
and is accordingly issuing this rule as an interim final rule.
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 1 year. This interim final rule has no such effect on
State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3507) requires
that VA consider the impact of paperwork and other information
collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an
agency may not collect or sponsor the collection of information, nor
may it impose an information collection requirement unless it displays
a currently valid Office of Management and Budget (OMB) control number.
See also 5 CFR 1320.8(b)(3)(vi).
This interim final rule will impose the following new information
collections requirements. Section 17.410(c) of title 38, CFR, requires
an individual applying for benefits associated with hospital care and
medical services for Camp Lejeune family members to submit an
application to VA on VA Form 10068, ``Camp Lejeune Family Member
Program Application.'' Section 17.410(d)(1) requires a Camp Lejeune
family member or provider of care or services to submit a timely claim
for payment or reimbursement. Section 17.410(d)(2) requires the
provider of a Camp Lejeune family member to certify that a Camp Lejeune
family member has been diagnosed with one of the 15 required illnesses
or conditions. Section 17.410 requires VA to maintain timely
information about the Camp Lejeune family member in order to correctly
identify the individual in VA's system, and to submit any information
or reimbursements. As required by the Paperwork Reduction Act of 1995
(at 44 U.S.C. 3507(d)), VA has submitted these information collections
to OMB for its review. OMB assigns a control number for each collection
of information it approves. Except for emergency approvals under 44
U.S.C. 3507(j), VA may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. We have requested that OMB
approve the collections of information on an emergency basis. If OMB
does not approve the collections of information as requested, we will
immediately remove Sec. Sec. 17.410(c), 17.410(d)(1), 17.410(d)(2), or
take such other action as is directed by OMB.
Comments on the collection of information should be submitted to
the Office of Management and Budget, Attention: Desk Officer for the
Department of Veterans Affairs, Office of Information and Regulatory
Affairs, Washington, DC 20503, with copies mailed or hand-delivered to:
Director, Office of Regulation Policy and Management (02REG),
Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1068,
Washington, DC 20420; fax to (202) 273-9026; or through
www.regulations.gov. Comments should indicate that they are submitted
in response to ``RIN 2900-AO79, Payment or Reimbursement for Certain
Medical Expenses for Camp Lejeune Family Members.''
Title: Camp Lejeune Family Member Program Application.
Summary of collection of information: Section 17.410(c) requires
individuals to complete an application in order to be considered for
designation by VA as Camp Lejeune Family Members.
Description of the need for information and proposed use of
information: This information is needed to determine eligibility for
benefits as a Camp Lejeune family member.
[[Page 57420]]
Description of likely respondents: Veterans' family members.
Estimated number of respondents per year: 3,000.
Estimated frequency of responses per year: 1.
Estimated total annual reporting and recordkeeping burden: 1,500
hours.
Estimated average burden per collection: 30 minutes.
Title: Camp Lejeune Family Members Claim Form.
Summary of collection of information: Claims for payment or
reimbursement of hospital care or medical services will be submitted to
VA by the Camp Lejeune family member.
Description of the need for information and proposed use of
information: This information is needed to determine the amount that VA
will pay or reimburse the Camp Lejeune family member.
Description of likely respondents: Veterans' family members.
Estimated number of respondents per year: 3,000.
Estimated frequency of responses per year: 11.
Estimated total annual reporting and recordkeeping burden: 16,500
hours.
Estimated average burden per collection: 30 minutes. VA estimates
that there will be some claims that will be completed by filling out
the information and attaching a recently-received bill, which may take
as little as 15 minutes. Other complicated instances may require an
hour or more of time. VA has decided to use an estimate of 30 minutes
to represent the average time required to complete the form and submit
the supporting documentation.
Title: Camp Lejeune Family Members Treating Physician Report.
Summary of collection of information: The physician providing
hospital care or medical services will certify whether the Camp Lejeune
family member has been diagnosed with one or more of the illnesses or
conditions listed in 38 CFR 17.400(d)(1). The physician must also list
any other co-morbidities, risk factors, or other exposures that may
have contributed to the patient's development of the diagnoses illness
or condition.
Description of the need for information and proposed use of
information: VA will utilize the diagnosis information to determine
whether the Camp Lejeune family member has been diagnosed with one of
the illnesses or conditions identified in 38 CFR 17.400(d)(1). VA will
also use this information to determine whether the condition or illness
resulted from a cause other than the Camp Lejeune family member's
residence at Camp Lejeune.
Description of likely respondents: Camp Lejeune family members'
treating physicians.
Estimated number of respondents per year: 3,000.
Estimated frequency of responses per year: 1.
Estimated total annual reporting and recordkeeping burden: 750
hours.
Estimated average burden per collection: 15 minutes.
Title: Camp Lejeune Family Members Information Update Form.
Summary of collection of information: The Camp Lejeune family
member will complete this form if he or she changes his or her address
or health plan contract.
Description of the need for information and proposed use of
information: VA will use the information provided to update the Camp
Lejeune family member's information as initially provided on the Camp
Lejeune Family Member Program Application.
Description of likely respondents: Veterans' family members.
Estimated number of respondents per year: 1,000.
Estimated frequency of responses per year: 1.
Estimated total annual reporting and recordkeeping burden: 250
hours.
Estimated average burden per collection: 15 minutes.
A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication. This does not affect the
deadline for the public to comment on the interim final rule. VA
considers comments by the public on collections of information in:
Evaluating whether the collections of information are
necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility;
Evaluating the accuracy of the Department's estimate of
the burden of the collections of information, including the validity of
the methodology and assumptions used;
Enhancing the quality, usefulness, and clarity of the
information to be collected; and
Minimizing the burden of the collections of information on
those who are to respond, including responses through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses.
Regulatory Flexibility Act
The Secretary hereby certifies that this interim 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. 601-12. This rule will not require any medical providers to
provide care, does not specify that care be provided by any particular
medical providers, and does not supersede any existing insurance or
other payment mechanism. Rather, this rule simply authorizes VA to
serve as a payer of last resort for care obtained privately by Camp
Lejeune family members. Therefore, pursuant to 5 U.S.C. 605(b), this
rulemaking is exempt from the initial and final flexibility analysis
requirements of 5 U.S.C. 603 and 604.
Executive Order 12866 and Executive Order 13563
Executive Orders 12866 and 13563 direct agencies to assess the
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 effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' requiring review by the Office of
Management and Budget (OMB) 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
this Executive Order.
The economic, interagency, budgetary, legal, and policy
implications of this regulatory action have been examined, and it has
been
[[Page 57421]]
determined to be a significant regulatory action under Executive Order
12866. VA's impact analysis can be found as a supporting document at
http://www.regulations.gov, usually within 48 hours after the
rulemaking document is published. Additionally, a copy of the
rulemaking and its impact analysis are available on VA's Web site at
http://www1.va.gov/orpm/, by following the link for ``VA Regulations
Published.''
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this rule are 64.007, Blind Rehabilitation
Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical
Care Benefits; 64.010, Veterans Nursing Home Care; 64.012, Veterans
Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014,
Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home
Care; 64.022, Veterans Home Based Primary Care.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Jose D.
Riojas, Chief of Staff, Department of Veterans Affairs, approved this
document on March 5, 2014, for publication.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Health care, Health
facilities, Health professions, Health records, Homeless, Medical
devices, Medical research, Mental health programs, Nursing homes,
Veterans.
Dated: September 18, 2014.
William F. Russo,
Acting Director, Office of Regulation Policy & Management, Office of
the General Counsel, U.S. Department of Veterans Affairs.
For the reasons set out in the preamble, VA amends 38 CFR part 17
as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 continues to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
0
2. Add Sec. 17.410 under undesignated center heading ``Hospital Care
and Medical Services for Camp Lejeune Veterans and Families'' to read
as follows:
Sec. 17.410 Hospital care and medical services for Camp Lejeune
family members.
(a) General. In accordance with this section and subject to the
availability of funds appropriated for such purpose, VA will provide
payment or reimbursement for certain hospital care and medical services
furnished to Camp Lejeune family members by non-VA health care
providers.
(b) Definitions. For the purposes of this section:
Camp Lejeune has the meaning set forth in Sec. 17.400(b).
Camp Lejeune family member means an individual who:
(i) Resided at Camp Lejeune (or was in utero while his or her
mother either resided at Camp Lejeune or served at Camp Lejeune under
Sec. 17.400(b)) for at least 30 (consecutive or nonconsecutive) days
during the period beginning on January 1, 1957, and ending on December
31, 1987; and
(ii) Meets one of the following criteria:
(A) Is related to a Camp Lejeune veteran by birth;
(B) Was married to a Camp Lejeune veteran; or
(C) Was a legal dependent of a Camp Lejeune veteran.
Camp Lejeune veteran has the meaning set forth in Sec. 17.400(b).
Health-plan contract has the meaning set forth in Sec. 17.1001(a).
Third party has the meaning set forth in Sec. 17.1001(b).
(c) Application. An individual may apply for benefits under this
section by completing and submitting an application form.
(d) Payment or reimbursement of certain medical care and hospital
services. VA will provide payment or reimbursement for hospital care
and medical services provided to a Camp Lejeune family member by a non-
VA provider if all of the following are true:
(1) The Camp Lejeune family member or provider of care or services
has submitted a timely claim for payment or reimbursement, which means:
(i) For hospital care and medical services provided before the date
that the application discussed in paragraph (c) of this section was
received by VA, the hospital care and medical services must have been
provided no more than 2 years prior to the date that VA receives the
application but not prior to March 26, 2013, and the claim for payment
or reimbursement must be received by VA no more than 60 days after VA
approves the application;
(ii) For hospital care and medical services provided on or after
the date that the application discussed in paragraph (c) of this
section was received by VA, the claim for payment or reimbursement must
be received by VA no more than 2 years after the later of either the
date of discharge from a hospital or the date that medical services
were rendered;
(2) The Camp Lejeune family member's treating physician certifies
that the claimed hospital care or medical services were provided for an
illness or condition listed in Sec. 17.400(d)(1), and provides
information about any co-morbidities, risk factors, or other exposures
that may have contributed to the illness or condition;
(3) VA makes the clinical finding, under VA clinical practice
guidelines, that the illness or condition did not result from a cause
other than the residence of the family member at Camp Lejeune;
(4) VA would be authorized to provide the claimed hospital care or
medical services to a veteran under VA's medical benefits package in
Sec. 17.38;
(5) The Camp Lejeune family member or hospital care or medical
service provider has exhausted without success all claims and remedies
reasonably available to the family member or provider against a third
party, including health-plan contracts; and
(6) Funds were appropriated to implement 38 U.S.C. 1787 in a
sufficient amount to permit payment or reimbursement.
(e) Payment or reimbursement amounts. Payments or reimbursements
under this section will be in amounts determined in accordance with
this paragraph (e).
(1) If a third party is partially liable for the claimed hospital
care or medical services, then VA will pay or reimburse the lesser of
the amount for which the Camp Lejeune family member remains personally
liable or the amount for which VA would pay for such care under
Sec. Sec. 17.55 and 17.56.
(2) If VA is the sole payer for hospital care and medical services,
then VA will pay or reimburse in accordance with Sec. Sec. 17.55 and
17.56, as applicable.
(Authority: 38 U.S.C. 1787)
(The information collection requirements have been submitted to OMB
and are pending OMB approval.)
[FR Doc. 2014-22635 Filed 9-23-14; 8:45 am]
BILLING CODE 8320-01-P