Center for Innovation for Care and Payment, 57327-57331 [2019-23484]
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AQ56
Center for Innovation for Care and
Payment
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) adopts as final a proposed
rule amending its regulations that
govern VA health care. This final rule
establishes parameters and authority for
the new Center for Innovation for Care
and Payment in its conduct of pilot
programs designed to develop
innovative approaches to testing
payment and service delivery models to
reduce expenditures while preserving or
enhancing the quality of care furnished
by VA.
DATES: Effective Date: This rule is
effective November 25, 2019.
FOR FURTHER INFORMATION CONTACT:
Michael Akinyele, VA Chief Innovation
Officer and Executive Director (Acting),
VA Innovation Center (VIC) (008E), 810
Vermont Ave NW, Washington, DC
20420. Michael.Akinyele@va.gov. (202)
461–7271. (This is not a toll-free
number.)
SUMMARY:
On June 6,
2018, section 152 of Public Law 115–
182, the John S. McCain III, Daniel K.
Akaka, and Samuel R. Johnson VA
Maintaining Internal Systems and
Strengthening Integrated Outside
Networks Act of 2018, or the VA
MISSION Act of 2018, amended title 38
of the United States Code (U.S.C.) by
adding a new section 1703E, Center for
Innovation for Care and Payment. This
final rule implements this new authority
and establishes the parameters and
authority for the new Center for
Innovation for Care and Payment (the
Center) in its conduct of pilot programs
designed to develop innovative
approaches to testing payment and
service delivery models to reduce
expenditures while preserving or
enhancing the quality of care furnished
by VA.
VA published a proposed rule on the
Center on July 29, 2019. 84 FR 36507.
The public comment period closed on
August 28, 2019. In response to this
proposed rule, VA received multiple
comments. Several of the comments
expressed support for the rule in whole
or in part. One comment supported the
proposed ability to expand pilot
program duration for up to an additional
5 years. The comment suggested that an
SUPPLEMENTARY INFORMATION:
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extended pilot program duration would
afford clinicians greater opportunity to
improve care and obtain actionable data
beyond the initial pilot program
duration. One comment supported
many elements of the proposed rule:
VA’s definition of the term reduction in
expenditures; the ability to waive
applicable regulations along with
provisions of law; and VA’s ability to
extend and expand successful pilot
programs. We appreciate the comments’
support and make no changes to these
provisions.
Many of the comments addressed
issues related to implementation or
ideas for specific pilot programs;
because these are generally outside the
scope of the rulemaking, we make no
changes based on these comments.
However, we summarize these
comments below and address them as
appropriate.
Several comments made
recommendations on whom VA should
consult in developing pilot programs.
One comment supported VA’s intent to
consult with Federal agencies and
medical and health experts. The
comment encouraged VA to solicit input
from professional associations and
clinicians to ensure VA obtains a broad
swath of input, guidance, and
suggestions on innovations and
programmatic priorities. The comment
further encouraged VA to prioritize
health promotion and disease
prevention models that focus on
keeping people healthy. One comment
suggested that the inclusion of nurse
practitioners (NP) in VA’s consultation
with relevant Federal agencies and
clinical and analytical experts would be
important in developing effective care
models. One comment urged VA to
collaborate with veterans organizations
in local communities to ensure that
veterans receive proper notice and
information regarding pilot programs.
We appreciate these recommendations
and will take them into consideration
when developing specific pilot
proposals. We make no changes based
on these comments.
Other comments made
recommendations as to what types of
pilot programs VA should pursue. One
comment encouraged VA to consider
models that enhance community design
to promote safe physical activity and
active forms of transportation for
individuals and populations of all ages
and abilities. The comment also
recommended VA consider the
development of a model that directs
patients with musculoskeletal disorders
to physical therapists for primary
assessment in primary care. The
comment also recommended that VA
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57327
consider how it may integrate public
information and performance metrics to
assess the quality, timeliness, and
patient satisfaction of care and services
furnished. We appreciate these
recommendations and will take them
into consideration when developing
specific pilot proposals. We make no
changes based on this comment.
One comment supported the use of
evidence-based health care models as
necessary to make improvements to
VA’s health care system. The comment
stated that finding the right health care
model is essential in streamlining
veterans’ care. The comment
encouraged VA to be strategic in
creating pilot studies to provide
efficient, cost-effective care without
sacrificing quality of care. The comment
recommended VA health care delivery
models adhere to proper guideline
requirements for recommended
screenings and health promotion
initiatives. The comment also
encouraged the prioritization of care
models addressing common health
conditions unique to veterans, such as
mental health or substance abuse
disorders. The comment also
recommended addressing barriers to
care including better payment systems
with timely reimbursement to non-VA
health care providers and competency
training for providers to ensure
culturally competent care. We
appreciate these recommendations and
will take them into consideration when
developing specific pilot proposals;
however, because these comments make
no recommendations regarding the
specific provisions of this rule, which
lays out the parameters of the Center,
we make no changes based on these
comments.
One comment supported the creation
of the Center and noted that it looked
forward to having NPs working with VA
on the development of new pilot
programs. The comment stated than an
overarching goal should be to support
and create models providing equal
opportunity for participation of
clinicians and their patients. The
comment suggested including NPs as
full participants in pilot programs as
one way to increase participation. The
comment noted that patient outcomes
are improved and cost savings are
realized when NPs are utilized to the
fullest extent of their educational and
clinical training. The comment noted
this has been demonstrated in a number
of models within the Center for
Medicare and Medicaid Innovation. The
comment suggested that including NPs
as full participants would help VA
enhance the quality of care provided to
veterans while also reducing
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expenditures. We appreciate these
recommendations and will take them
into consideration when developing
specific pilot proposals. We make no
changes based on this comment.
One comment was broadly supportive
of the proposed rule. The comment
recommended a specific focus on
modernizing drug pricing to allow for
greater adoption of more flexible pricing
arrangements, greater value for patients,
and an improved standard of care. The
comment encouraged a shift from
rebated and volume discount pricing
arrangements to an outcomes/valuebased flexible pricing arrangement. The
comment also encouraged VA to
continue to ensure that existing
arrangements for value-based health
care are not impacted by this
rulemaking. The comment
recommended VA assess the ability to
increase the amount of value-based
health care contracting opportunities
within VA systems and encouraged
further rulemaking in this area. We
appreciate these recommendations and
will take them into consideration when
developing specific pilot proposals. We
make no changes based on this
comment.
One comment recommended
leveraging existing partnerships to
design and test innovations in
telehealth, data exchange, care
transitions, and other areas. The
comment noted that comparative
effectiveness studies could identify cost
and quality outliers, leading to a
mutually beneficial exchange of best
practices between VA and communitybased providers. We appreciate this
input but make no changes based on
this comment, which makes no
recommendations regarding provisions
of the proposed rule.
One comment stated that it believed
this new Center has the potential to
facilitate additional opportunities to
more fully engage massage therapy
within veterans’ health care, such as
providing test cohorts of communitybased massage therapists, determining
how well massage therapists are
receiving provider referrals for massage
therapy, assessing outcomes following a
treatment cycle, and providing
important measurements to add to the
research base on massage efficacy and
cost-effectiveness for various
conditions. The comment also noted the
efficacy of massage therapy as a nonpharmacologic approach to pain
management, and its recognition in
guidelines for non-pharmacologic
opioid alternatives by the Attorney
General of West Virginia. We appreciate
the comment’s perspective regarding
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potential pilot programs but make no
changes based on this comment.
One comment recommended VA
consider, in developing pilot programs,
recommendations made by the
Commission on Care established by
section 202 of the Veterans Access,
Choice, and Accountability Act of 2014
(Pub. L. 113–146) that have not yet been
acted upon by Congress or VA. Other
possible pilot programs recommended
by the comment included VA
prioritizing treatment for serviceconnected conditions that are common
among veterans, including
posttraumatic stress disorder and
mental health concerns; modifying VA’s
personnel system to allow for improved
flexibility to respond to market
conditions related to compensation,
benefits, and recruitment; making VA
the secondary payer for all non-serviceconnected health care in the
community; and fully utilizing nurse
practitioners and physician assistants to
improve access to primary care, enhance
quality, and reduce expenditures. We
appreciate these recommendations
regarding specific pilot programs and
will take them under advisement.
However, because these deal with
specific pilot programs, and not with
VA’s general authority to operate the
Center addressed in this rulemaking, we
make no changes based on this
comment.
Some comments discussed issues
generally raised by other parts of the
rule. One comment generally supported
the use of patient health care experience
tools in determining patient satisfaction
but expressed concern that some of
these tools are outdated and do not
recognize NPs. The comment stated that
survey tools omitting NPs would fail to
provide accurate health care delivery
information. The comment encouraged
VA to accurately capture patient
satisfaction data by developing updated
patient satisfaction tools that include
NPs. We appreciate these
recommendations and will take them
into consideration when developing
specific pilot proposals. We make no
changes based on this comment.
One comment urged VA to actively
seek and fill as many of the new
leadership positions within the Center
as possible with outside candidates who
have experience with designing and
creating proven innovative health care
delivery solutions and can bring that
experience to the Center and to VA. The
comment also urged VA to select
internal candidates for the Center’s
leadership team who can best foster a
collaborative environment that inspires
effective innovation to enhance how VA
delivers health care services to veterans.
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We make no changes based on this
comment.
One comment recommended VA use
the same terminology and definitions
used by non-VA providers. The
comment did not identify any specific
terms it believed were inconsistent with
industry standards; indeed, it
recognized that many of the terms VA
proposed are well established and
consensus-based definitions. The
comment recognized that it may be
necessary to use a different definition
but urged VA to start with the
presumption of aligning terms and
definitions. As we explained in our
proposed rule, we believe the
definitions we proposed are consistent
with how these terms are used in the
industry, and to the extent there is any
variation, we believe our definitions are
broader to allow for maximal flexibility
in designing and operating pilot
programs. We make no changes based
on this comment.
One comment proposed VA allow
non-VA providers and other
stakeholders who are not affiliated with
VA to propose pilot ideas. The comment
recommended using the Center for
Medicare and Medicaid Innovation’s
process for soliciting ideas as a starting
point. The comment recognized that a
more open process may take more time
but could provide a greater breadth and
depth of innovative pilot program
concepts. We appreciate this
recommendation and anticipate
development of a system that would
permit this type of voluntary input. We
make no changes based on this
comment.
Two comments expressed differing
interpretations of provisions in the
proposed rule concerning the
operational independence of the Center.
One comment supported the Center’s
operational independence from VA’s
three administrations because this
would grant it the appropriate access
and decision-making authority to work
across the entire VA system to reimagine care delivery, break and
eliminate internal systemic barriers,
create efficiencies, and improve care for
veterans. Another comment, however,
supported the Center being
operationally independent from VA
while also collaborating with VA. These
comments indicate this language was
unclear, so VA is revising paragraph (a)
to remove the reference to and
definition of operational independence.
VA will retain the language in the
proposed rule from paragraph (a)(3),
now redesignated as paragraph (a)(2),
that the Center will not operate within
any specific administration. This should
emphasize the Center’s role within VA,
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but as an organization that can break
and eliminate internal barriers, create
efficiencies, and improve care for
veterans. We further clarify that the
Center is part of VA and acts at the
direction of the Secretary, so it is not
‘‘independent’’ from VA; in the
proposed rule, we stated that the Center
will report through the Office of the
Secretary of Veterans Affairs and
ultimately the President of the United
States and does not have the unilateral
authority to execute pilot programs. (84
FR 36507, 36508.)
Effect of Rulemaking
The Code of Federal Regulations, as
revised by this rulemaking, represents
the exclusive legal authority on this
subject. No contrary rules or procedures
will be authorized. All VA guidance
will be read to conform with this
rulemaking if possible or, if not
possible, such guidance will be
superseded by this rulemaking.
Paperwork Reduction Act
This final rule contains no provisions
constituting a collection of information
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3521).
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
adopts regulations that are largely
procedural, and will not, without
Congressional approval of a pilot
program proposal from VA, result in any
change in benefits or services by
themselves. Thus, this final rule will not
have a significant economic impact on
qualifying non-VA entities or providers.
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, 13563 and
13771
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,
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reducing costs, harmonizing rules, and
promoting flexibility.
The Office of Information and
Regulatory Affairs has determined that
this rulemaking is a significant
regulatory action under Executive Order
12866. VA’s impact analysis can be
found as a supporting document at
https://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 website at
https://www.va.gov/orpm by following
the link for VA Regulations Published
from FY 2004 through FYTD. This final
rule is not subject to the requirements
of Executive Order 13771 because this
final rule is expected to result in no
more than de minimis costs.
facilities, Health professions, Health
records, Homeless, Medical and dental
schools, Medical devices, Medical
research, Mental health programs,
Nursing homes, Philippines, Reporting
and recordkeeping requirements,
Scholarships and fellowships, Travel
and transportation expenses, Veterans.
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.
Dated: October 23, 2019.
Michael P. Shores,
Director, Office of Regulation Policy &
Management, Office of the Secretary,
Department of Veterans Affairs.
Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a major rule,
as defined by 5 U.S.C. 804(2).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic
Assistance numbers and titles for the
programs affected by this document are
as follows: 64.007, Blind Rehabilitation
Centers; 64.008, Veterans Domiciliary
Care; 64.009, Veterans Medical Care
Benefits; 64.010, Veterans Nursing
Home Care; 64.011, Veterans Dental
Care; 64.012, Veterans Prescription
Service; 64.013, Veterans Prosthetic
Appliances; 64.014, Veterans State
Domiciliary Care; 64.015, Veterans State
Nursing Home Care; 64.016, Veterans
State Hospital Care; 64.018, Sharing
Specialized Medical Resources; 64.019,
Veterans Rehabilitation Alcohol and
Drug Dependence; and 64.022, Veterans
Home Based Primary Care.
List of Subjects in 38 CFR Part 17
Administrative practice and
procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug
abuse, Foreign relations, Government
contracts, Grant programs-health, Grant
programs-veterans, Health care, Health
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Signing Authority
The Secretary of Veterans Affairs
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. Pamela Powers,
Chief of Staff, Department of Veterans
Affairs, approved this document on
October 4, 2019, for publication.
For the reasons set forth in the
preamble, we amend 38 CFR part 17 as
follows:
PART 17—MEDICAL
1. The authority citation for part 17 is
amended by adding an entry for
§ 17.450 in numerical order to read in
part as follows:
■
Authority: 38 U.S.C. 501, and as noted in
specific sections.
*
*
*
*
*
Section 17.450 is also issued under 38
U.S.C. 1703E.
*
*
*
*
*
2. Add an undesignated center
heading and § 17.450 to read as follows.
■
Center for Innovation for Care and
Payment
§ 17.450 Center for Innovation for Care
and Payment.
(a) Purpose and organization. The
purpose of this section is to establish
procedures for the Center for Innovation
for Care and Payment.
(1) The Center for Innovation for Care
and Payment will be responsible for
working across VA to carry out pilot
programs to develop innovative
approaches to testing payment and
service delivery models to reduce
expenditures while preserving or
enhancing the quality of care furnished
by VA.
(2) The Center for Innovation for Care
and Payment will not operate within
any specific administration but will
operate in VA’s corporate portfolio to
ensure the limited number of concurrent
pilot programs under this section are
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not redundant of or conflicted by
ongoing innovation efforts within any
specific administration.
(b) Definitions. The following
definitions apply to this section.
Access refers to entry into or use of
VA services.
Patient satisfaction of care and
services refers to patients’ rating of their
experiences of care and services and as
further defined in a pilot program
proposal.
Payment models refer to the types of
payment, reimbursement, or incentives
that VA deems appropriate for
advancing the health and well-being of
beneficiaries.
Pilot program refers to a pilot program
conducted under this section.
Quality enhancement refers to
improvement or improvements in such
factors as clinical quality, beneficiarylevel outcomes, and functional status as
documented through improvements in
measurement data from a reliable and
valid source, and as further defined in
a pilot program proposal.
Quality preservation refers to the
maintenance of such factors as clinical
quality, beneficiary-level outcomes, and
functional status as documented
through maintenance of measurement
data from an evidence-based source, and
as further defined in a pilot program
proposal.
Reduction in expenditure refers to,
but is not limited to, cost stabilization,
cost avoidance, or decreases in long- or
short-term spending, and as further
defined in a pilot program proposal.
NOTE: VA will also consider the
proposal’s potential impact on
expenditures for other related Federal
programs; however, this potential
impact will not count against the
limitation in paragraph (d)(2) of this
section.
Service delivery models refer to all
methods or programs for furnishing care
or services.
(c) Geographic locations. VA will
make decisions regarding the location of
each pilot program based upon the
appropriateness of testing a specific
model in a specific area while taking
efforts to ensure that pilot programs are
operated in geographically diverse areas
of the country. VA will include in its
proposal to Congress and publish a
document in the Federal Register
identifying the geographic locations
proposed for each pilot program, the
rationale for those selections, and how
VA believes the selected locations will
address deficits in care for a defined
population.
(d) Limitations. In carrying out pilot
programs under this section, VA will
not:
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(1) Actively operate more than 10
pilot programs at the same time; and
(2) Consistent with 38 U.S.C.
1703E(d), obligate more than $50
million in any fiscal year in the conduct
of the pilot programs (including all
administrative and overhead costs, such
as measurement, evaluation, and
expenses to implement the pilot
programs themselves) operated under
this section, unless VA determines it to
be necessary and submits a report to the
appropriate Committees of Congress that
sets forth the amount of, and
justification for, the additional
expenditure.
(e) Waiver of authorities. In carrying
out pilot programs under this section,
VA may waive statutory provisions by
adding to or removing from statutory
text in subchapters I, II, and III of
chapter 17, title 38, U.S.C., upon
Congressional approval, including
waiving any provisions of law in any
provision codified in or included as a
note to any section in subchapter I, II,
or III of chapter 17, title 38.
(1) Upon Congressional approval of
the waiver of a provision of law under
this section, VA will also deem waived
any applicable provision of regulation
implementing such law as identified in
VA’s pilot program proposal.
(2) VA will publish a document in the
Federal Register providing information
about, and seeking comment on, each
proposed pilot program upon its
submission of a proposal to Congress for
approval. VA will publish a document
in the Federal Register to inform the
public of any pilot programs that have
been approved by Congress.
(f) Notice of eligibility. VA will take
reasonable actions to provide direct
notice to veterans eligible to participate
in a pilot program operated under this
section and will provide general notice
to other individuals eligible to
participate in a pilot program. VA will
announce its methods of providing
notice to veterans, the public, and other
individuals eligible to participate
through the document it publishes in
the Federal Register for each proposed
and approved pilot program.
(g) Evaluation and reporting. VA will
evaluate each pilot program operated
under this section and report its
findings. Evaluations may be based on
quantitative data, qualitative data, or
both. Whenever appropriate,
evaluations will include a survey of
participants or beneficiaries to
determine their satisfaction with the
pilot program. VA will make the
evaluation results available to the public
on the VA Innovation Center website on
the schedule identified in VA’s proposal
for the pilot program.
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(h) Expansion of pilot programs. VA
may expand a pilot program consistent
with this paragraph (h).
(1) VA may expand the scope or
duration of a pilot program if, based on
an analysis of the data developed
pursuant to paragraph (g) of this section
for the pilot program, VA expects the
pilot program to reduce spending
without reducing the quality of care or
improve the quality of patient care
without increasing spending. Expansion
may only occur if VA determines that
expansion would not deny or limit the
coverage or provision of benefits for
individuals under 38 U.S.C. chapter 17.
Expansion of a pilot program may not
occur until 60 days after VA has
published a document in the Federal
Register and submitted an interim
report to Congress stating its intent to
expand a pilot program.
(2) VA may expand the scope of a
pilot program by modifying, among
other elements of a pilot program, the
range of services provided, the
qualifying conditions covered, the
geographic location of the pilot
program, or the population of eligible
participants in a manner that increases
participation in or benefits under a pilot
program.
(3) In general, pilot programs are
limited to 5 years of operation. VA may
extend the duration of a pilot program
by up to an additional 5 years of
operation. Any pilot program extended
beyond its initial 5-year period must
continue to comply with the provisions
of this section regarding evaluation and
reporting under paragraph (g) of this
section.
(i) Modification of pilot programs. The
Secretary may modify elements of a
pilot program in a manner that is
consistent with the parameters of the
Congressional approval of the waiver
described in paragraph (e) of this
section. Such modification does not
require a submission to Congress for
approval under paragraph (e) of this
section.
(j) Termination of pilot programs. If
VA determines that a pilot program is
not producing quality enhancement or
quality preservation, or is not resulting
in the reduction of expenditures, and
that it is not possible or advisable to
modify the pilot program either through
submission of a new waiver request
under paragraph (e) of this section or
through modification under paragraph
(i) of this section, VA will terminate the
pilot program within 30 days of
submitting an interim report to Congress
that states such determination. VA will
also publish a document in the Federal
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations
Register regarding the pilot program’s
termination.
[FR Doc. 2019–23484 Filed 10–24–19; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0300; FRL–9999–58]
Fenbuconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
B. How can I get electronic access to
other related information?
This regulation establishes
tolerances for residues of fenbuconazole
in or on tea. Dow Agrosciences, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
October 25, 2019. Objections and
requests for hearings must be received
on or before December 24, 2019 and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0300, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
VerDate Sep<11>2014
15:53 Oct 24, 2019
Jkt 250001
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2018–0300 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
December 24, 2019. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2018–0300, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
57331
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of July 24,
2018 (83 FR 34968) (FRL–9980–31),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8E8678) by Dow
Agrosciences, LLC, 9330 Zionsville
Road, Indianapolis, IN 46268. The
petition requested that 40 CFR 180.480
be amended by establishing tolerances
for residues of the fungicide
fenbuconazole, in or on the raw
agricultural commodities tea, dried at 10
parts per million (ppm); and tea, instant
at 10 ppm. That document referenced a
summary of the petition prepared by
Dow Agrosciences, LLC, the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
After the publication of the notice of
filing in the Federal Register, Dow
Agrosciences, LLC requested that its
requested tolerance for residues on tea
be established at 30 ppm in/on tea,
dried and tea, instant based on
additional magnitude of the residue
studies conducted in 2016 and 2017.
Based upon the data reviewed by the
Food Safety Commission of Japan, EPA
is establishing tolerances for tea, dried
and tea, instant at 30 ppm. The reason
for these changes are explained in Unit
IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
E:\FR\FM\25OCR1.SGM
25OCR1
Agencies
[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57327-57331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23484]
[[Page 57327]]
=======================================================================
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ56
Center for Innovation for Care and Payment
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) adopts as final a
proposed rule amending its regulations that govern VA health care. This
final rule establishes parameters and authority for the new Center for
Innovation for Care and Payment in its conduct of pilot programs
designed to develop innovative approaches to testing payment and
service delivery models to reduce expenditures while preserving or
enhancing the quality of care furnished by VA.
DATES: Effective Date: This rule is effective November 25, 2019.
FOR FURTHER INFORMATION CONTACT: Michael Akinyele, VA Chief Innovation
Officer and Executive Director (Acting), VA Innovation Center (VIC)
(008E), 810 Vermont Ave NW, Washington, DC 20420.
[email protected]. (202) 461-7271. (This is not a toll-free
number.)
SUPPLEMENTARY INFORMATION: On June 6, 2018, section 152 of Public Law
115-182, the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson
VA Maintaining Internal Systems and Strengthening Integrated Outside
Networks Act of 2018, or the VA MISSION Act of 2018, amended title 38
of the United States Code (U.S.C.) by adding a new section 1703E,
Center for Innovation for Care and Payment. This final rule implements
this new authority and establishes the parameters and authority for the
new Center for Innovation for Care and Payment (the Center) in its
conduct of pilot programs designed to develop innovative approaches to
testing payment and service delivery models to reduce expenditures
while preserving or enhancing the quality of care furnished by VA.
VA published a proposed rule on the Center on July 29, 2019. 84 FR
36507. The public comment period closed on August 28, 2019. In response
to this proposed rule, VA received multiple comments. Several of the
comments expressed support for the rule in whole or in part. One
comment supported the proposed ability to expand pilot program duration
for up to an additional 5 years. The comment suggested that an extended
pilot program duration would afford clinicians greater opportunity to
improve care and obtain actionable data beyond the initial pilot
program duration. One comment supported many elements of the proposed
rule: VA's definition of the term reduction in expenditures; the
ability to waive applicable regulations along with provisions of law;
and VA's ability to extend and expand successful pilot programs. We
appreciate the comments' support and make no changes to these
provisions.
Many of the comments addressed issues related to implementation or
ideas for specific pilot programs; because these are generally outside
the scope of the rulemaking, we make no changes based on these
comments. However, we summarize these comments below and address them
as appropriate.
Several comments made recommendations on whom VA should consult in
developing pilot programs. One comment supported VA's intent to consult
with Federal agencies and medical and health experts. The comment
encouraged VA to solicit input from professional associations and
clinicians to ensure VA obtains a broad swath of input, guidance, and
suggestions on innovations and programmatic priorities. The comment
further encouraged VA to prioritize health promotion and disease
prevention models that focus on keeping people healthy. One comment
suggested that the inclusion of nurse practitioners (NP) in VA's
consultation with relevant Federal agencies and clinical and analytical
experts would be important in developing effective care models. One
comment urged VA to collaborate with veterans organizations in local
communities to ensure that veterans receive proper notice and
information regarding pilot programs. We appreciate these
recommendations and will take them into consideration when developing
specific pilot proposals. We make no changes based on these comments.
Other comments made recommendations as to what types of pilot
programs VA should pursue. One comment encouraged VA to consider models
that enhance community design to promote safe physical activity and
active forms of transportation for individuals and populations of all
ages and abilities. The comment also recommended VA consider the
development of a model that directs patients with musculoskeletal
disorders to physical therapists for primary assessment in primary
care. The comment also recommended that VA consider how it may
integrate public information and performance metrics to assess the
quality, timeliness, and patient satisfaction of care and services
furnished. We appreciate these recommendations and will take them into
consideration when developing specific pilot proposals. We make no
changes based on this comment.
One comment supported the use of evidence-based health care models
as necessary to make improvements to VA's health care system. The
comment stated that finding the right health care model is essential in
streamlining veterans' care. The comment encouraged VA to be strategic
in creating pilot studies to provide efficient, cost-effective care
without sacrificing quality of care. The comment recommended VA health
care delivery models adhere to proper guideline requirements for
recommended screenings and health promotion initiatives. The comment
also encouraged the prioritization of care models addressing common
health conditions unique to veterans, such as mental health or
substance abuse disorders. The comment also recommended addressing
barriers to care including better payment systems with timely
reimbursement to non-VA health care providers and competency training
for providers to ensure culturally competent care. We appreciate these
recommendations and will take them into consideration when developing
specific pilot proposals; however, because these comments make no
recommendations regarding the specific provisions of this rule, which
lays out the parameters of the Center, we make no changes based on
these comments.
One comment supported the creation of the Center and noted that it
looked forward to having NPs working with VA on the development of new
pilot programs. The comment stated than an overarching goal should be
to support and create models providing equal opportunity for
participation of clinicians and their patients. The comment suggested
including NPs as full participants in pilot programs as one way to
increase participation. The comment noted that patient outcomes are
improved and cost savings are realized when NPs are utilized to the
fullest extent of their educational and clinical training. The comment
noted this has been demonstrated in a number of models within the
Center for Medicare and Medicaid Innovation. The comment suggested that
including NPs as full participants would help VA enhance the quality of
care provided to veterans while also reducing
[[Page 57328]]
expenditures. We appreciate these recommendations and will take them
into consideration when developing specific pilot proposals. We make no
changes based on this comment.
One comment was broadly supportive of the proposed rule. The
comment recommended a specific focus on modernizing drug pricing to
allow for greater adoption of more flexible pricing arrangements,
greater value for patients, and an improved standard of care. The
comment encouraged a shift from rebated and volume discount pricing
arrangements to an outcomes/value-based flexible pricing arrangement.
The comment also encouraged VA to continue to ensure that existing
arrangements for value-based health care are not impacted by this
rulemaking. The comment recommended VA assess the ability to increase
the amount of value-based health care contracting opportunities within
VA systems and encouraged further rulemaking in this area. We
appreciate these recommendations and will take them into consideration
when developing specific pilot proposals. We make no changes based on
this comment.
One comment recommended leveraging existing partnerships to design
and test innovations in telehealth, data exchange, care transitions,
and other areas. The comment noted that comparative effectiveness
studies could identify cost and quality outliers, leading to a mutually
beneficial exchange of best practices between VA and community-based
providers. We appreciate this input but make no changes based on this
comment, which makes no recommendations regarding provisions of the
proposed rule.
One comment stated that it believed this new Center has the
potential to facilitate additional opportunities to more fully engage
massage therapy within veterans' health care, such as providing test
cohorts of community-based massage therapists, determining how well
massage therapists are receiving provider referrals for massage
therapy, assessing outcomes following a treatment cycle, and providing
important measurements to add to the research base on massage efficacy
and cost-effectiveness for various conditions. The comment also noted
the efficacy of massage therapy as a non-pharmacologic approach to pain
management, and its recognition in guidelines for non-pharmacologic
opioid alternatives by the Attorney General of West Virginia. We
appreciate the comment's perspective regarding potential pilot programs
but make no changes based on this comment.
One comment recommended VA consider, in developing pilot programs,
recommendations made by the Commission on Care established by section
202 of the Veterans Access, Choice, and Accountability Act of 2014
(Pub. L. 113-146) that have not yet been acted upon by Congress or VA.
Other possible pilot programs recommended by the comment included VA
prioritizing treatment for service-connected conditions that are common
among veterans, including posttraumatic stress disorder and mental
health concerns; modifying VA's personnel system to allow for improved
flexibility to respond to market conditions related to compensation,
benefits, and recruitment; making VA the secondary payer for all non-
service-connected health care in the community; and fully utilizing
nurse practitioners and physician assistants to improve access to
primary care, enhance quality, and reduce expenditures. We appreciate
these recommendations regarding specific pilot programs and will take
them under advisement. However, because these deal with specific pilot
programs, and not with VA's general authority to operate the Center
addressed in this rulemaking, we make no changes based on this comment.
Some comments discussed issues generally raised by other parts of
the rule. One comment generally supported the use of patient health
care experience tools in determining patient satisfaction but expressed
concern that some of these tools are outdated and do not recognize NPs.
The comment stated that survey tools omitting NPs would fail to provide
accurate health care delivery information. The comment encouraged VA to
accurately capture patient satisfaction data by developing updated
patient satisfaction tools that include NPs. We appreciate these
recommendations and will take them into consideration when developing
specific pilot proposals. We make no changes based on this comment.
One comment urged VA to actively seek and fill as many of the new
leadership positions within the Center as possible with outside
candidates who have experience with designing and creating proven
innovative health care delivery solutions and can bring that experience
to the Center and to VA. The comment also urged VA to select internal
candidates for the Center's leadership team who can best foster a
collaborative environment that inspires effective innovation to enhance
how VA delivers health care services to veterans. We make no changes
based on this comment.
One comment recommended VA use the same terminology and definitions
used by non-VA providers. The comment did not identify any specific
terms it believed were inconsistent with industry standards; indeed, it
recognized that many of the terms VA proposed are well established and
consensus-based definitions. The comment recognized that it may be
necessary to use a different definition but urged VA to start with the
presumption of aligning terms and definitions. As we explained in our
proposed rule, we believe the definitions we proposed are consistent
with how these terms are used in the industry, and to the extent there
is any variation, we believe our definitions are broader to allow for
maximal flexibility in designing and operating pilot programs. We make
no changes based on this comment.
One comment proposed VA allow non-VA providers and other
stakeholders who are not affiliated with VA to propose pilot ideas. The
comment recommended using the Center for Medicare and Medicaid
Innovation's process for soliciting ideas as a starting point. The
comment recognized that a more open process may take more time but
could provide a greater breadth and depth of innovative pilot program
concepts. We appreciate this recommendation and anticipate development
of a system that would permit this type of voluntary input. We make no
changes based on this comment.
Two comments expressed differing interpretations of provisions in
the proposed rule concerning the operational independence of the
Center. One comment supported the Center's operational independence
from VA's three administrations because this would grant it the
appropriate access and decision-making authority to work across the
entire VA system to re-imagine care delivery, break and eliminate
internal systemic barriers, create efficiencies, and improve care for
veterans. Another comment, however, supported the Center being
operationally independent from VA while also collaborating with VA.
These comments indicate this language was unclear, so VA is revising
paragraph (a) to remove the reference to and definition of operational
independence. VA will retain the language in the proposed rule from
paragraph (a)(3), now redesignated as paragraph (a)(2), that the Center
will not operate within any specific administration. This should
emphasize the Center's role within VA,
[[Page 57329]]
but as an organization that can break and eliminate internal barriers,
create efficiencies, and improve care for veterans. We further clarify
that the Center is part of VA and acts at the direction of the
Secretary, so it is not ``independent'' from VA; in the proposed rule,
we stated that the Center will report through the Office of the
Secretary of Veterans Affairs and ultimately the President of the
United States and does not have the unilateral authority to execute
pilot programs. (84 FR 36507, 36508.)
Effect of Rulemaking
The Code of Federal Regulations, as revised by this rulemaking,
represents the exclusive legal authority on this subject. No contrary
rules or procedures will be authorized. All VA guidance will be read to
conform with this rulemaking if possible or, if not possible, such
guidance will be superseded by this rulemaking.
Paperwork Reduction Act
This final rule contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
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 adopts regulations that are largely procedural,
and will not, without Congressional approval of a pilot program
proposal from VA, result in any change in benefits or services by
themselves. Thus, this final rule will not have a significant economic
impact on qualifying non-VA entities or providers. 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, 13563 and 13771
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.
The Office of Information and Regulatory Affairs has determined
that this rulemaking is a significant regulatory action under Executive
Order 12866. VA's impact analysis can be found as a supporting document
at https://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 website at
https://www.va.gov/orpm by following the link for VA Regulations
Published from FY 2004 through FYTD. This final rule is not subject to
the requirements of Executive Order 13771 because this final rule is
expected to result in no more than de minimis costs.
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.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are as follows: 64.007, Blind
Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009,
Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care;
64.011, Veterans Dental Care; 64.012, Veterans Prescription Service;
64.013, Veterans Prosthetic Appliances; 64.014, Veterans State
Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016,
Veterans State Hospital Care; 64.018, Sharing Specialized Medical
Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence;
and 64.022, Veterans Home Based Primary Care.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Foreign relations,
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, Philippines, Reporting
and recordkeeping requirements, Scholarships and fellowships, Travel
and transportation expenses, Veterans.
Signing Authority
The Secretary of Veterans Affairs 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. Pamela Powers,
Chief of Staff, Department of Veterans Affairs, approved this document
on October 4, 2019, for publication.
Dated: October 23, 2019.
Michael P. Shores,
Director, Office of Regulation Policy & Management, Office of the
Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, we amend 38 CFR part 17
as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 is amended by adding an entry for
Sec. 17.450 in numerical order to read in part as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
Section 17.450 is also issued under 38 U.S.C. 1703E.
* * * * *
0
2. Add an undesignated center heading and Sec. 17.450 to read as
follows.
Center for Innovation for Care and Payment
Sec. 17.450 Center for Innovation for Care and Payment.
(a) Purpose and organization. The purpose of this section is to
establish procedures for the Center for Innovation for Care and
Payment.
(1) The Center for Innovation for Care and Payment will be
responsible for working across VA to carry out pilot programs to
develop innovative approaches to testing payment and service delivery
models to reduce expenditures while preserving or enhancing the quality
of care furnished by VA.
(2) The Center for Innovation for Care and Payment will not operate
within any specific administration but will operate in VA's corporate
portfolio to ensure the limited number of concurrent pilot programs
under this section are
[[Page 57330]]
not redundant of or conflicted by ongoing innovation efforts within any
specific administration.
(b) Definitions. The following definitions apply to this section.
Access refers to entry into or use of VA services.
Patient satisfaction of care and services refers to patients'
rating of their experiences of care and services and as further defined
in a pilot program proposal.
Payment models refer to the types of payment, reimbursement, or
incentives that VA deems appropriate for advancing the health and well-
being of beneficiaries.
Pilot program refers to a pilot program conducted under this
section.
Quality enhancement refers to improvement or improvements in such
factors as clinical quality, beneficiary-level outcomes, and functional
status as documented through improvements in measurement data from a
reliable and valid source, and as further defined in a pilot program
proposal.
Quality preservation refers to the maintenance of such factors as
clinical quality, beneficiary-level outcomes, and functional status as
documented through maintenance of measurement data from an evidence-
based source, and as further defined in a pilot program proposal.
Reduction in expenditure refers to, but is not limited to, cost
stabilization, cost avoidance, or decreases in long- or short-term
spending, and as further defined in a pilot program proposal. NOTE: VA
will also consider the proposal's potential impact on expenditures for
other related Federal programs; however, this potential impact will not
count against the limitation in paragraph (d)(2) of this section.
Service delivery models refer to all methods or programs for
furnishing care or services.
(c) Geographic locations. VA will make decisions regarding the
location of each pilot program based upon the appropriateness of
testing a specific model in a specific area while taking efforts to
ensure that pilot programs are operated in geographically diverse areas
of the country. VA will include in its proposal to Congress and publish
a document in the Federal Register identifying the geographic locations
proposed for each pilot program, the rationale for those selections,
and how VA believes the selected locations will address deficits in
care for a defined population.
(d) Limitations. In carrying out pilot programs under this section,
VA will not:
(1) Actively operate more than 10 pilot programs at the same time;
and
(2) Consistent with 38 U.S.C. 1703E(d), obligate more than $50
million in any fiscal year in the conduct of the pilot programs
(including all administrative and overhead costs, such as measurement,
evaluation, and expenses to implement the pilot programs themselves)
operated under this section, unless VA determines it to be necessary
and submits a report to the appropriate Committees of Congress that
sets forth the amount of, and justification for, the additional
expenditure.
(e) Waiver of authorities. In carrying out pilot programs under
this section, VA may waive statutory provisions by adding to or
removing from statutory text in subchapters I, II, and III of chapter
17, title 38, U.S.C., upon Congressional approval, including waiving
any provisions of law in any provision codified in or included as a
note to any section in subchapter I, II, or III of chapter 17, title
38.
(1) Upon Congressional approval of the waiver of a provision of law
under this section, VA will also deem waived any applicable provision
of regulation implementing such law as identified in VA's pilot program
proposal.
(2) VA will publish a document in the Federal Register providing
information about, and seeking comment on, each proposed pilot program
upon its submission of a proposal to Congress for approval. VA will
publish a document in the Federal Register to inform the public of any
pilot programs that have been approved by Congress.
(f) Notice of eligibility. VA will take reasonable actions to
provide direct notice to veterans eligible to participate in a pilot
program operated under this section and will provide general notice to
other individuals eligible to participate in a pilot program. VA will
announce its methods of providing notice to veterans, the public, and
other individuals eligible to participate through the document it
publishes in the Federal Register for each proposed and approved pilot
program.
(g) Evaluation and reporting. VA will evaluate each pilot program
operated under this section and report its findings. Evaluations may be
based on quantitative data, qualitative data, or both. Whenever
appropriate, evaluations will include a survey of participants or
beneficiaries to determine their satisfaction with the pilot program.
VA will make the evaluation results available to the public on the VA
Innovation Center website on the schedule identified in VA's proposal
for the pilot program.
(h) Expansion of pilot programs. VA may expand a pilot program
consistent with this paragraph (h).
(1) VA may expand the scope or duration of a pilot program if,
based on an analysis of the data developed pursuant to paragraph (g) of
this section for the pilot program, VA expects the pilot program to
reduce spending without reducing the quality of care or improve the
quality of patient care without increasing spending. Expansion may only
occur if VA determines that expansion would not deny or limit the
coverage or provision of benefits for individuals under 38 U.S.C.
chapter 17. Expansion of a pilot program may not occur until 60 days
after VA has published a document in the Federal Register and submitted
an interim report to Congress stating its intent to expand a pilot
program.
(2) VA may expand the scope of a pilot program by modifying, among
other elements of a pilot program, the range of services provided, the
qualifying conditions covered, the geographic location of the pilot
program, or the population of eligible participants in a manner that
increases participation in or benefits under a pilot program.
(3) In general, pilot programs are limited to 5 years of operation.
VA may extend the duration of a pilot program by up to an additional 5
years of operation. Any pilot program extended beyond its initial 5-
year period must continue to comply with the provisions of this section
regarding evaluation and reporting under paragraph (g) of this section.
(i) Modification of pilot programs. The Secretary may modify
elements of a pilot program in a manner that is consistent with the
parameters of the Congressional approval of the waiver described in
paragraph (e) of this section. Such modification does not require a
submission to Congress for approval under paragraph (e) of this
section.
(j) Termination of pilot programs. If VA determines that a pilot
program is not producing quality enhancement or quality preservation,
or is not resulting in the reduction of expenditures, and that it is
not possible or advisable to modify the pilot program either through
submission of a new waiver request under paragraph (e) of this section
or through modification under paragraph (i) of this section, VA will
terminate the pilot program within 30 days of submitting an interim
report to Congress that states such determination. VA will also publish
a document in the Federal
[[Page 57331]]
Register regarding the pilot program's termination.
[FR Doc. 2019-23484 Filed 10-24-19; 8:45 am]
BILLING CODE 8320-01-P