[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.
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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
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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/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,
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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, 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 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 website at
http://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
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Register regarding the pilot program's termination.
[FR Doc. 2019-23484 Filed 10-24-19; 8:45 am]
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