[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Rules and Regulations]
[Pages 19887-19891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07897]



[[Page 19887]]

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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP09


Health Care for Certain Children of Vietnam Veterans and Certain 
Korea Veterans--Covered Birth Defects and Spina Bifida

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This rule adopts as final a proposed rule of the Department of 
Veterans Affairs (VA) to amend its regulations concerning the provision 
of health care to birth children of Vietnam veterans and veterans of 
covered service in Korea diagnosed with spina bifida, except for spina 
bifida occulta, and certain other birth defects. In the proposed rule 
published on May 15, 2015, VA proposed changes to more clearly define 
the types of health care VA provides, including day health care and 
health-related services, which we defined as homemaker or home health 
aide services that provide assistance with Activities of Daily Living 
or Instrumental Activities of Daily Living that have therapeutic value. 
We also proposed changes to the list of health care services that 
require preauthorization by VA. This final rule addresses comments 
received from the public and adopts as final the proposed rule, without 
change.

DATES: Effective Date: This rule is effective on May 6, 2016.

FOR FURTHER INFORMATION CONTACT: Karyn Barrett, Director, Program 
Administration Directorate, Chief Business Office Purchased Care 
(10NB3), Veterans Health Administration, Department of Veterans 
Affairs, 810 Vermont Ave. NW., Washington, DC 20420, (303) 331-7500. 
(This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: Chapter 18 of title 38, United States Code, 
provides for benefits for certain birth children of Vietnam veterans 
and veterans of covered service in Korea who have been diagnosed with 
spina bifida, except spina bifida occulta, and certain other birth 
defects. These benefits include: (1) Monthly monetary allowances for 
various disability levels; (2) health care; and (3) vocational training 
and rehabilitation. VA's regulations concerning health care for 
children authorized under this chapter are published at 38 CFR 17.900 
through 17.905.
    On May 15, 2015, VA published a proposed rule to more clearly 
define the types of healthcare VA provides, including day healthcare 
and health-related services, which VA would define as homemaker or home 
health aide services that provide assistance with Activities of Daily 
Living or Instrumental Activities of Daily Living that have therapeutic 
value; and to make changes to the list of health care services that 
require preauthorization by VA. (80 FR 27878). The comment period 
closed on June 14, 2015. We received ten comments, which were all 
generally supportive. However, the commenters raised several issues 
regarding beneficiaries covered by this rulemaking, specific services 
provided, definitions included in the proposed rule, and provision of 
health care through non-VA care (care in the community). We respond to 
these comments below and adopt as final the proposed rule, without 
change.

Scope of the Rulemaking

    One commenter stated that children of Vietnam veterans who have 
spina bifida may have children of their own, and VA should also provide 
care to grandchildren of Vietnam veterans who have spina bifida. The 
commenter stated that according to the US National Library of Medicine, 
spina bifida is likely caused by the interaction of multiple genetic 
and environmental factors, and that genetic changes in individuals with 
spina bifida may increase the risk of neural tube defects in the 
subsequent generation. The commenter stated that if a child with spina 
bifida can establish that the grandfather was exposed to herbicides 
during the Vietnam War, that child should also be covered.
    Another commenter stated that children of Air Force active duty 
servicemembers and reservists who were exposed to Agent Orange while 
flying C-123 aircraft both during the Vietnam War and the post-war 
period should also be covered. The commenter noted that these 
servicemembers flew out of air bases in Thailand and Clark Air Base in 
the Philippine Islands, and some of the airplanes potentially 
contaminated by Agent Orange remained in service after the war.
    In response to the first comment, VA does not have statutory 
authority to provide health care to grandchildren of Vietnam veterans 
who may have spina bifida. VA's authority to provide health care to 
children with spina bifida or other covered birth defects is limited by 
statute. A ``child'' covered under this statute is defined at 38 U.S.C. 
1831(1) as an individual, regardless of age or marital status, who is 
the natural child of a Vietnam veteran, and was conceived after the 
date on which that veteran first entered the Republic of Vietnam during 
the Vietnam era; or, is the natural child of a veteran of covered 
service in Korea (as determined for purposes of 38 U.S.C. 1821), and 
was conceived after the date on which that veteran first entered 
service described in 38 U.S.C. 1821(c).
    With respect to the second comment, VA also does not have the 
authority to extend benefits under 38 U.S.C. Chapter 18 to children of 
veterans who did not serve in the Republic of Vietnam during the 
Vietnam era or who did not have certain service in Korea. ``Vietnam 
veteran'' is defined at 38 U.S.C. 1831(2) to mean an individual who 
performed active military, naval, or air service in the Republic of 
Vietnam during the Vietnam era, without regard to the characterization 
of that individual's service. The ``Vietnam era'' is defined at 38 
U.S.C. 1831(3) as ending on May 7, 1975. A veteran of covered service 
in Korea is any individual, without regard to the characterization of 
that individual's service, who served in the active military, naval, or 
air service in or near the Korean demilitarized zone (DMZ), as 
determined by the Secretary in consultation with the Secretary of 
Defense, during the period beginning on September 1, 1967, and ending 
on August 31, 1971; and is determined by VA, in consultation with the 
Department of Defense, to have been exposed to an herbicide agent 
during such service in or near the Korean demilitarized zone. 38 U.S.C. 
1821(c). To the extent a veteran who flew in a C-123 is also a veteran 
with covered service defined in 38 U.S.C. 1831(2) and has a child 
covered by 38 U.S.C. 1831(1), however, the child would be eligible for 
benefits under Chapter 18.
    In further response to the comment regarding reservists and 
servicemembers who flew in C-123 aircraft, we note that VA does have 
authority in certain other circumstances to extend benefits to veterans 
who did not serve in those defined areas or time periods, but may have 
been exposed to Agent Orange. This authority is unrelated to benefits 
furnished to eligible children under 38 U.S.C. Chapter 18 but we 
briefly discuss it here because a recent VA rulemaking is relevant to 
the second public comment. On June 19, 2015, VA published an interim 
final rule (80 FR 35248) extending the presumption of herbicide 
exposure and presumption of service connection to individuals who 
performed service in the Air Force or Air Force Reserve under 
circumstances in which the individual concerned regularly and 
repeatedly operated, maintained, or served onboard C-123

[[Page 19888]]

aircraft known to have been used to spray an herbicide agent during the 
Vietnam era. The June 2015 interim final rule thus covers 
servicemembers who were potentially exposed to Agent Orange during 
periods after the end of the Vietnam War, and in regions outside of 
Vietnam. VA determined that the presumption of service connection 
should be extended to these servicemembers based on a January 2015 
report from the National Academies of Sciences, Engineering, and 
Medicine's Institute of Medicine (IOM) titled ``Post-Vietnam Dioxin 
Exposure in Agent Orange-Contaminated C-123 Aircraft.'' In that report 
the IOM noted that between 1972 and 1982, approximately 1,500 to 2,100 
U.S. Air Force Reserve personnel trained and worked on C-123 aircraft 
that previously had been used to spray herbicides, including Agent 
Orange, during Operation Ranch Hand. Based on a review of the evidence, 
IOM concluded that it was plausible that Air Force reservists flying C-
123 aircraft used in Operation Ranch Hand were exposed to Agent Orange.
    We make no changes based on these comments.

Definitions

    One commenter asked whether the proposed addition of day health 
care to the list of health care services would require the beneficiary 
to transfer to a group home. In the proposed rule we defined day health 
care to mean a therapeutic program prescribed by an approved health 
care provider that provides necessary medical services, rehabilitation, 
therapeutic activities, socialization, nutrition, and transportation 
services in a congregate setting. Day health care services contemplated 
under this proposal are non-residential and equivalent to adult day 
health care provided to disabled veterans under 38 CFR 17.111(c)(1). 
These would not require the beneficiary to relocate to a group home. 
The essential features are the therapeutic focus of the day health care 
services and provision of these services in a congregate setting. The 
addition of day health care to the list of covered health care services 
augments rather than contracts the options available. Day health care 
is an alternative care setting that can allow some beneficiaries who 
require long term care services to remain in their homes rather than be 
institutionalized in a nursing home. Such beneficiaries typically 
require support for some, but not all, Activities of Daily Living 
(ADLs), such as bathing, dressing or feeding. In many cases, a family 
member may provide the beneficiary with much of their care, but require 
additional support for some ADLs. By filling these gaps, day health 
care can allow these beneficiaries to remain in their homes and 
communities for additional months or even years. Day health care 
programs can help caregivers to meet their other professional and 
family obligations, or provide a well-deserved respite, while their 
loved ones are participating in the program.
    Two commenters urged VA to allow payment for homemakers and home 
health aides to shop for groceries outside of the home. Homemaker and 
home health aide (H/HHA) services are health-related services. VA 
provides health-related services, including H/HHA services, to veterans 
under 38 U.S.C. 1720C. We proposed to provide H/HHA services to spina 
bifida beneficiaries similar to that provided to veterans, to the 
extent allowed by law. Under 38 U.S.C. 1720C, VA may provide H/HHA to 
veterans in ``noninstitutional settings.'' This includes services 
performed outside the home, such as grocery shopping and escorting the 
veteran to necessary appointments. VA may not provide such services to 
beneficiaries under the Spina Bifida Health Care Benefits Program, 
health-related services for spina bifida beneficiaries are included as 
a component of home care. Home care is defined at 38 U.S.C. 1803(c)(3) 
as outpatient care, habilitative and rehabilitative care, preventive 
health services, and health-related services furnished to an individual 
in the individual's home or other place of residence. This definition 
specifically limits the provision of health-related services under 38 
U.S.C. 1803 to those services furnished within the home or other place 
of residence. Grocery shopping, which is an H/HHA type of health-
related service performed outside the home or other place of residence, 
cannot be provided due to this statutory restriction that applies to 
the Spina Bifida Health Care Benefits Program, but not to VA's 
authorities to provide care to veterans.
    One commenter supported the proposed rule, but urged us to amend 
the definition of ``other place of residence.'' As noted above, home 
care, including health-related services such as H/HHA services, is 
provided in the individual's home or other place of residence. We 
proposed to define other place of residence to include an assisted 
living facility or residential group home. Assisted living facilities 
and residential group homes are appropriate for individuals who do not 
require the level of care provided in a nursing home, and VA believes 
that providing home care in assisted living facilities and residential 
group homes will allow individuals to retain a greater level of 
independence and quality of life, and delay or prevent any need for 
nursing home care. While VA may provide services to an individual 
residing in an assisted living facility or residential group home, we 
do not have the statutory authority to pay for placement in such 
facility. The types of alternatives to home care that VA may provide 
under 38 U.S.C. 1803 are nursing home care, hospital care, and respite 
care. The commenter suggested amending the definition of ``other place 
of residence'' to state that ``placement in such facility or home is 
covered to the extent that the facility or home provides covered care 
or services.'' The commenter stated that this would clarify that VA can 
provide for placement in an assisted living facility or residential 
group home to the extent that such location provides aspects of care or 
services covered under 38 U.S.C. 1803. We do not agree. Payment for 
placement in an assisted living facility or residential group home is 
distinctly different than providing for care and services rendered in 
such facility. While VA cannot do the former, we may do the latter to 
the extent allowed by law. VA believes that the suggested language 
would lead to confusion as it implies that VA can cover, to some 
extent, placement in an assisted living facility or residential group 
home.
    One commenter asked for clarification of what long-term care means 
as that term applies to H/HHA services. Specifically, the commenter 
asked whether a spina bifida beneficiary would be entitled to receive 
H/HHA services around the clock and indefinitely. One commenter asked 
whether there would be a limit on the number of hours of H/HHA services 
that a beneficiary may receive. As noted above, H/HHA services provided 
to spina bifida beneficiaries are similar to that provided to veterans, 
to the extent allowed by law. Under 38 U.S.C. 1720C, VA is authorized 
to provide veterans with health-related services in a non-institutional 
setting. The total cost of providing such services or in-kind 
assistance to any veteran in any fiscal year may not exceed 65 percent 
of the cost that would have been incurred by VA during that fiscal year 
if the veteran had been furnished, instead, nursing home care under 38 
U.S.C. 1710. See 38 U.S.C. 1720C(d). The same limitation is applied 
currently to H/HHA services provided to spina bifida beneficiaries and 
will continue to apply under this

[[Page 19889]]

rule. Consistent with this limitation, H/HHA services will be provided 
to spina bifida beneficiaries if medically necessary.
    The commenter also requested clarification on what type of health 
care provider must prescribe H/HHA services. These services must be 
prescribed by an approved health care provider. Under Sec.  17.900, 
``approved health care provider'' means a health care provider 
currently approved by the Center for Medicare and Medicaid Services 
(CMS), Department of Defense TRICARE Program, Civilian Health and 
Medical Program of the Department of Veterans Affairs (CHAMPVA), Joint 
Commission, or currently approved for providing health care under a 
license or certificate issued by a governmental entity with 
jurisdiction.
    The commenter also raised several procedural issues that are beyond 
the scope of this rulemaking.
    We make no changes based on these comments.

Miscellaneous

    One commenter stated that health care should be provided directly 
by VA health care providers rather than through care in the community. 
However, children with covered birth defects or spina bifida require 
specialty care that may not be available in a VA medical center, and 
requiring the beneficiary to commute to a VA medical facility could 
impose an undue burden on the caregiver. Here, care in the community 
ensures that the beneficiary receives necessary specialty medical care 
in a timely manner, and eliminates the need to travel to the nearest VA 
medical center to obtain that care.
    Based on the rationale set forth in the preamble to the proposed 
rule and in this preamble, VA is adopting the proposed rule as a final 
rule, with no changes.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
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.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 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)(2)(vi).
    This final rule will impose the following amended information 
collection requirements. Preauthorization from VA under 38 CFR 
17.902(a) is required for certain services or benefits under Sec. Sec.  
17.900 through 17.905. Information collection under this rule is 
approved under OMB control number 2900-0219. VA is making a minor 
modification to this information collection by requiring 
preauthorization for mental health services only for outpatient mental 
health services, and only when those services are provided in excess of 
23 visits in a calendar year. VA also adds day health care provided as 
outpatient care and homemaker services to the list of services or 
benefits that must receive preauthorization. VA anticipates that the 
decrease in the number of beneficiaries that must request 
preauthorization for mental health services will be offset by the 
number of beneficiaries that will request preauthorization for day 
health care. Therefore, we believe that there will be little, if any, 
change in the total burden hours as a result of this modification. As 
required by the 44 U.S.C. 3507(d), VA submitted these information 
collection amendments to OMB for its review, and the information 
collection is pending OMB approval. Notice of OMB approval for this 
information collection will be published in a future Federal Register 
document.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This final rule will directly affect only individuals and will not 
directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), 
this rulemaking is exempt from the initial and final regulatory 
flexibility analysis requirements of 5 U.S.C. 603 and 604.

Executive Orders 12866 and 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), unless OMB waives such review, 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 final rule have been examined, and it has been 
determined not 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://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published From FY 2004 Through Fiscal Year to Date.''

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 one year. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

[[Page 19890]]

Catalog of Federal Domestic Assistance

    There are no Catalog of Federal Domestic Assistance numbers and 
titles for the programs affected by this document.

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. Robert D. 
Snyder, Chief of Staff, Department of Veterans Affairs, approved this 
document on March 31, 2016, for publication.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Government contracts, 
Grant programs-health, Grant programs-veterans, Health care, Health 
facilities, Health professions, Health records, Homeless, Medical and 
dental schools, Medical devices, Medical research, Mental health 
programs, Nursing homes, Reporting and recordkeeping requirements, 
Travel and transportation expenses, Veterans.

    Dated: April 1, 2016.
William F. Russo,
Director, Office of Regulation Policy & Management, Office of the 
General Counsel, Department of Veterans Affairs.
    For the reasons set out in the preamble, the Department of Veterans 
Affairs 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. Amend Sec.  17.900 by:
0
a. In the definition of ``Approved health care provider'' removing 
``Joint Commission on Accreditation of Health Care Organizations 
(JCAHO)'' from the first sentence and adding, in its place, ``The Joint 
Commission''.
0
b. Adding in alphabetical order a definition of ``Day health care'';.
0
c. In the definition of ``Health care'' adding ``long-term care,'' to 
the first sentence immediately after ``hospital care,''.
0
d. Adding in alphabetical order definitions of ``Health-related 
services'', ``Home health aide services'', ``Homemaker services'', 
``Long-term care'', and ``Other place of residence'';
0
e. In the definition of ``Outpatient care'' adding ``day health care 
and'' immediately after the word ``including''; and
0
f. Revising the definition of ``Respite care''.
    The additions and revision read as follows:


Sec.  17.900  Definitions.

* * * * *
    Day health care means a therapeutic program prescribed by an 
approved health care provider that provides necessary medical services, 
rehabilitation, therapeutic activities, socialization, nutrition, and 
transportation services in a congregate setting. Day health care may be 
provided as a component of outpatient care or respite care.
* * * * *
    Health-related services means homemaker or home health aide 
services furnished in the individual's home or other place of residence 
to the extent that those services provide assistance with Activities of 
Daily Living and Instrumental Activities of Daily Living that have 
therapeutic value.
* * * * *
    Home health aide services is a component of health-related services 
providing personal care and related support services to an individual 
in the home or other place of residence. Home health aide services may 
include assistance with Activities of Daily Living such as: Bathing; 
toileting; eating; dressing; aid in ambulating or transfers; active and 
passive exercises; assistance with medical equipment; and routine 
health monitoring. Home health aide services must be provided according 
to the individual's written plan of care and must be prescribed by an 
approved health care provider.
    Homemaker services is a component of health-related services 
encompassing certain activities that help to maintain a safe, healthy 
environment for an individual in the home or other place of residence. 
Such services contribute to the prevention, delay, or reduction of risk 
of harm or hospital, nursing home, or other institutional care. 
Homemaker services include assistance with personal care; home 
management; completion of simple household tasks; nutrition, including 
menu planning and meal preparation; consumer education; and hygiene 
education. Homemaker services may include assistance with Instrumental 
Activities of Daily Living, such as: Light housekeeping; laundering; 
meal preparation; necessary services to maintain a safe and sanitary 
environment in the areas of the home used by the individual; and 
services essential to the comfort and cleanliness of the individual and 
ensuring individual safety. Homemaker services must be provided 
according to the individual's written plan of care and must be 
prescribed by an approved health care provider.
* * * * *
    Long-term care means home care, nursing home care, and respite 
care.
* * * * *
    Other place of residence includes an assisted living facility or 
residential group home.
* * * * *
    Respite care means care, including day health care, furnished by an 
approved health care provider on an intermittent basis for a limited 
period to an individual who resides primarily in a private residence 
when such care will help the individual continue residing in such 
private residence.
* * * * *

0
3. Amend Sec.  17.902 by:
0
a. Revising the first three sentences of paragraph (a) introductory 
text; and
0
b. At the end of the section, removing ``2900-0578'' from the notice of 
the Office of Management and Budget control number and adding, in its 
place, ``2900-0219''.
    The revisions read as follows:


Sec.  17.902  Preauthorization.

    (a) Preauthorization from VA is required for the following services 
or benefits under Sec. Sec.  17.900 through 17.905: Rental or purchase 
of durable medical equipment with a total rental or purchase price in 
excess of $300, respectively; day health care provided as outpatient 
care; dental services; homemaker services; outpatient mental health 
services in excess of 23 visits in a calendar year; substance abuse 
treatment; training; transplantation services; and travel (other than 
mileage at the General Services Administration rate for privately owned 
automobiles). Authorization will only be given in spina bifida cases 
where it is demonstrated that the care is medically necessary. In cases 
of other covered birth defects, authorization will only be given where 
it is demonstrated that the care is medically necessary and related to 
the covered birth defects. * * *
* * * * *

0
4. Amend Sec.  17.903 by:
0
a. In paragraph (a)(1), adding a second sentence; and
0
b. At the end of the section, removing ``2900-0578'' from the notice of 
the Office of Management and Budget

[[Page 19891]]

control number and adding, in its place, ``2900-0219''.
    The addition reads as follows:


Sec.  17.903  Payme.

    (a)(1) * * * For those services or benefits covered by Sec. Sec.  
17.900 through 17.905 but not covered by CHAMPVA we will use payment 
methodologies the same or similar to those used for equivalent services 
or benefits provided to veterans.
* * * * *


Sec.  17.904  [Amended]

0
5. Amend Sec.  17.904 by, at the end of the section, removing ``2900-
0578'' from the notice of the Office of Management and Budget control 
number and adding, in its place, ``2900-0219''.
[FR Doc. 2016-07897 Filed 4-5-16; 8:45 am]
BILLING CODE 8320-01-P