[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Proposed Rules]
[Pages 13576-13582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06730]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ46
Veterans Community Care Program--Organ and Bone Marrow Transplant
Care
AGENCY: Department of Veterans Affairs.
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: On February 22, 2019, the Department of Veterans Affairs (VA)
published a proposed rulemaking to amend its regulations on the
provision of necessary hospital care, medical services, and extended
care services from non-VA entities or providers in the community. This
supplemental notice of proposed rulemaking (SNPRM) provides
clarification about the process to be used to make decisions regarding
organ and bone marrow transplant care.
DATES: Comments must be received by VA on or before April 22, 2019.
ADDRESSES: Written comments may be submitted by through http://www.Regulations.gov; by mail or hand-delivery to Director, Regulations
Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue
NW, Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026.
Comments should indicate that they are submitted in response to ``RIN
2900-AQ46, Veterans Community Care Program; Supplemental notice of
[[Page 13577]]
proposed rulemaking''. Copies of comments received will be available
for public inspection in the Office of Regulation Policy and
Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m.
Monday through Friday (except holidays). Please call (202) 461-4902 for
an appointment. (This is not a toll-free number.) In addition, during
the comment period, comments may be viewed online through the Federal
Docket Management System (FDMS) at http://www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Joseph Duran, Office of Community Care
(10D), Veterans Health Administration, Department of Veterans Affairs,
Ptarmigan at Cherry Creek, Denver, CO 80209; [email protected],
(303) 370-1637. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On February 22, 2019, VA published a
proposed rulemaking to amend its regulations on the provision of
necessary hospital care, medical services, and extended care services
from non-VA entities or providers in the community. Federal Register
(84 FR 5629). That rulemaking proposed to define and implement the new
Veterans Community Care Program authorized by section 1703 of title 38,
United States Code (U.S.C.), as that statute will be amended by section
101 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson
VA Maintaining Internal Systems and Strengthening Integrated Outside
Networks (MISSION) Act of 2018, effective upon VA's issuance of
implementing regulations. For the sake of convenience and
understanding, we will refer to provisions of section 1703, as section
101 of the MISSION Act will amend it, although we recognize that
section 1703 as so amended is not legally effective until VA has
published a final rule implementing the Veterans Community Care
Program. The Veterans Community Care Program will permit eligible
veterans to elect to receive hospital care, medical services, and
extended care services from eligible entities and providers. VA asked
for comments on the proposed rule on or before March 25, 2019. In that
proposed rule, we noted that we did not include language to address the
provisions in section 1703(l) regarding organ and bone marrow
transplants. We advised that we would address this through a subsequent
rulemaking. This rulemaking proposes to implement section 1703(l). We
propose to modify Sec. 17.4020, as proposed in VA's earlier proposed
rulemaking, by amending paragraph (a) and adding a paragraph (d) to
that section to govern decisions regarding organ and bone marrow
transplant care.
Background on VA Transplant Program
To help the public better understand the effect of this
supplemental notice of proposed rulemaking and this provision of law,
we offer some additional background on both VA's transplant program and
transplants in general. We believe this information would be helpful to
the public by providing context for how transplant care is furnished by
VA today and how the Organ and Procurement Transplantation Network
operates. Some of the following discussion is excerpted and edited from
an article by Dr. William Gunnar, ``The VA Transplant Program: A
Rebuttal to Criticism and a Look to the Future'', published online by
the American Journal of Transplantation on February 12, 2019, cited as
doi: 10.1111/ajt.15295.
The VA Transplant Program (VATP) was established decades ago during
initial development of solid organ transplantation in the United
States. It is well resourced, provides timely and high quality solid
organ transplant care and services to the nation's veterans, and
supports research and education missions of VA and affiliated academic
medical centers. Access and outcomes data for fiscal years (FY) 2014-
2018 show that the VATP received 12,801 solid organ and bone marrow
transplant referrals (10,494 solid organ and 2,307 bone marrow), added
3,972 veterans to the Organ Procurement and Transplantaton Network
(OPTN) waitlist, and performed 1,699 solid organ transplants (180
heart, 748 kidney, 694 liver, and 77 lung). Timeliness to transplant
evaluation within 30 days from referral was over 98 percent in FY 2018.
Thirty-day and one-year survival rates for veterans receiving a
transplant during the 10-year period from October 1, 2008, to September
30, 2018, were 98.0 percent and 93.5 percent respectively for heart,
99.9 percent and 97.5 percent respectively for kidney; 97.7 percent and
90.5 percent respectively for liver; and 98.8 percent and 88.4 percent
respectively for lung. Outcomes were on par or better than national
data made publicly available by the Scientific Registry of Transplant
Recipients. VATCs have leveraged VA specialty programs for veteran-
prevalent diseases, such as posttraumatic stress disorder, to better
ensure transplant candidacy for high-risk patients and to provide
support to optimize post-transplantation outcomes.
The VATP is comprised of the following VA Transplant Centers
(VATC): Five heart (Madison, Wisconsin; Nashville, Tennessee; Palo
Alto, California; Richmond, Virginia; and Salt Lake City, Utah); seven
kidney (Birmingham, Alabama; Bronx, New York; Houston, Texas; Iowa
City, Iowa; Nashville, Tennessee; Pittsburgh, Pennsylvania; and
Portland, Oregon); six liver (Houston, Texas; Madison, Wisconsin;
Nashville, Tennessee; Pittsburgh, Pennsylvania; Portland, Oregon; and
Richmond, Virginia); and two lung (Madison, Wisconsin; and Seattle,
Washington). Three additional VATCs are planned for activation in FY
2019: One kidney transplantation program; one heart transplantation
program; and one program for heart and lung transplants.
All VATCs are members of the OPTN and abide by OPTN policy. Some
VATCs perform all transplantation care within VA as ``in-house''
programs and are independent OPTN members. Others are integrated with
an academic medical center which is an OPTN member. These integrated
VATCs have established infrastructure to provide pre- and post-
transplant care at the VA medical facility, but transplant procedures
are performed at the affiliate. Each VATC also supports veterans who
transition transplantation care to VA after having received transplant
procedures in the community.
VA policy establishes a standardized process for veteran referral
to the VATP in order to facilitate timely and high-quality care. The
referring VA medical facility submits veteran health information into a
secure intranet-based application called Transplant Referral and Cost
Evaluation/Reimbursement (TRACER, developed and implemented in 2013),
the referring medical facility selects a VATC with patient concurrence,
and TRACER then notifies the VATC. The VATC reviews the information and
submits an initial review decision as to whether the clinical
information supports further evaluation. Emergency referrals are
decided within 48 hours and stable referrals within 5 business days.
When referrals are accepted, the VATC completes an evaluation within 30
calendar days of the referral submission date for stable patients;
emergency referrals may require transfer to the VATC for inpatient
management and listing. Following evaluation and determination that the
veteran is a transplant candidate, the VATC directs transplant-related
care, orders additional testing as needed, and waitlists the veteran
with OPTN when
[[Page 13578]]
the candidate's clinical status is deemed appropriate. Each VATC is
responsible for veteran transplant care and compliance with OPTN policy
including maintenance of program-specific eligibility criteria. VA
program offices do not dictate VATC clinical decisions. TRACER
facilitates the referral process and tracks dates for VATC initial
review decision, evaluation, OPTN waitlisting, and transplantation.
Referring medical facilities may request a second opinion in TRACER if
the primary VATC deems the veteran not-eligible for transplantation at
its program. The referring medical facility may also submit an appeal
to VA in TRACER if both primary and second VATC determinations are that
the patient is not-eligible for transplantation. Appeals are reviewed
by a national Transplant Surgical Advisory Board, and veterans deemed
not eligible through the appeal process may be resubmitted to TRACER
when clinical conditions change. TRACER also supports dual-OPTN listing
at two transplant centers in response to requests by patients via
referring facilities or VATCs.
Each veteran and her or his caregiver, as well as a living donor
and living donor caregiver, if applicable, are supported with travel
and lodging to and from home and the VATC for pre-operative evaluation,
pre-operative testing or in-hospital care, the transplant procedure,
the immediate post-transplant recovery, and necessary post-operative
care and treatment. Evaluations for candidacy, wait-list management,
and post-transplantation care may be completed using telehealth,
thereby keeping the veteran close to home (or providing certain care in
home). In fiscal year 2018, 12.7 percent of cardiac evaluations, 22.1
percent of kidney evaluations, 25.8 percent of liver evaluations, and
78.7 percent of lung evaluations were completed through telehealth.
Veteran candidates can communicate with the VATC team through video
connected care and secure messaging. Additional information regarding
the VATP referral process can be found on the following website:
https://www.va.gov/health/services/transplant/.
VATCs typically require veterans to travel for transplant
procedures or for care when telehealth is not appropriate or desired by
the veteran. Inequalities in geographic access to solid organ
transplantation exist in the United States, are not limited to veterans
enrolled in VA, and require many non-veterans to travel. Transplant
care is complicated, and every transplant center requires significant
resources that are simply unavailable in certain parts of the country.
Four States are without an established transplant center (VA or non-
VA); 14 States do not have a liver transplant center; 15 States do not
have a cardiac transplant center; and 22 States do not have a lung
transplant center. Prior studies suggest that distance to a transplant
center may adversely impact access to transplant service, mortality on
the OPTN waitlist, and transplant outcomes. Non-veteran patients living
in small towns and isolated rural regions are 8-15 percent less likely
to be placed on a waitlist and 10-20 percent less likely to undergo
heart, kidney, and liver transplantation than patients in urban
environments. For perspective, approximately 2.8 million VA enrolled
veterans (approximately 31 percent) reside in a rural or highly rural
location.
TRACER data identifies that referrals from VA medical facilities
located less than 100 miles from the selected VATC experienced shorter
average times for initial decision review, evaluation, and placement on
the OPTN waitlist. A majority of these patients receive other care at
the VATC and are ``self-referred'' by the facility through TRACER to
the VATC. No statistically significant differences were identified in
heart, kidney, liver, or lung referral timeliness to initial decision
review, evaluation, or placement on the OPTN waitlist for distances of
100-300 miles, 301-500 miles, and greater than 500 miles. Distance
between the referring VA medical facility and the VATC, including
distances less than 100 miles and greater than 500 miles, was not found
to impact the rate of mortality on the OPTN waitlist, time to
transplantation, or post-transplant survival. While travel distance may
impact veteran or caregiver satisfaction, there is no demonstrated
impact on key clinical outcomes.
In addition to the clinical transplantion care provided to
veterans, VATCs have significant impacts on the academic missions of VA
and affiliated medical centers. Nearly all VATC physicians hold faculty
appointments at affiliated academic centers; most are involved in
graduate medical education; and several participate in basic science or
clinical research related to transplantation. Trainees at VATCs, both
students and residents, benefit from participation in transplantation
care of veterans and include surgery, general medicine, medical
subspecialties, behavioral health, nursing, and pharmacy. Numerous
research studies and publications from VATCs have addressed
transplantation-related care, disease mechanisms, and clinical outcomes
for veterans.
Proposed Changes to Sec. 17.4020 for Organ and Bone Marrow Transplants
First, we would amend Sec. 17.4020(a), as proposed in VA's earlier
proposed rulemaking. As initially proposed Sec. 17.4020(a) would
incorporate a provision from the Veterans Choice Program at Sec.
17.1515(a) related to a covered veteran's election to receive care in
the community. This provision would be carried over to the Veterans
Community Care Program to confirm a veteran's ability to elect to
receive community care under appropriate circumstances, consistent with
section 1703(d)(3). The change proposed in this supplemental notice of
proposed rulemaking (SNPRM) would amend Sec. 17.4020(a), as it was
proposed in VA's earlier proposed rulemaking, to create an exception to
the ability to elect to receive non-VA care for organ and bone marrow
transplants in paragraph (d), as further described below.
Proposed Sec. 17.4020(d) would implement section 1703(l), related
to organ and bone marrow transplants. Section 1703(l) states that VA
must determine whether to authorize an organ or bone marrow transplant
for a covered veteran at a non-VA facility in the case of a covered
veteran in need of an organ or bone marrow transplant who has, in the
opinion of the primary care provider of the veteran, a medically
compelling reason to travel outside of the region of the Organ
Procurement and Transplantation Network (OPTN) in which the veteran
resides. (OPTN matches organs with transplant candidates on waiting
lists in need of transplantation, but does not regulate bone marrow
transplantation. Regions have been used to facilitate transplantation
and communication among OPTN member organizations.) While section
1703(d)(3) generally provides that a covered veteran who is determined
by VA to meet eligibility criteria in 1703(d)(1) has the ability to
decide whether to receive care in the community, section 1703(l)
expressly provides to the Secretary the authority to decide whether to
authorize organ or bone marrow transplant care in the community for
certain veterans, specifically those who require an organ or bone
marrow transplant and who have, in the opinion of the primary care
provider of the veteran, a medically compelling reason to travel
outside of the OPTN region in which the veteran resides.
Section 1703(l) qualifies determinations under section 1703(d) and
(e) for these veterans. It is a well-
[[Page 13579]]
accepted principle of statutory construction that a more specific
provision is read to qualify a more general provision in a law.
Congress often states general principles that are further qualified or
revised in other provisions of law. Sections 1703(d) and 1703(l) fit
this model. Section 1703(d) establishes a general rule that covered
veterans who satisfy one of the conditions for eligibility are able to
elect to have VA authorize their care in the community or to schedule
an appointment with a VA provider. Section 1703(l) inverts this
decision making and states unequivocally that the Secretary makes the
determination of whether to authorize community care for covered
veterans requiring an organ or bone marrow transplant and who have a
medically compelling reason to travel outside of the OPTN region in
which they reside to receive the transplant. For any other type of
health care, section 1703(d) controls, and the covered veteran's
election is binding on VA. For those veterans described in section
1703(l), however, this provision of law controls. If section 1703(d)
applied to covered veterans described in section 1703(l), then section
1703(l) would have no meaning or effect. There is a strong presumption
against reading a provision of law that would render other provisions
of the statute superfluous or unnecessary. Reading section 1703(d) to
authorize covered veterans described in section 1703(l)(2) to determine
where to receive their care would render section 1703(l)(1)
meaningless, and therefore such a reading should be rejected.
We wish to be clear on the effect of section 1703(l). The
Secretary's discretion is limited to covered veterans who: (1) Meet one
or more of the eligibility criteria under proposed Sec. 17.4010; (2)
require an organ or bone marrow transplant; and (3) have a medically
compelling reason to travel outside the OPTN region in which the
veteran resides to receive such a transplant. The first condition has
already been described in VA's earlier proposed rule. The second
condition, requiring an organ or bone marrow transplant (as required by
section 1703(l)(2)(A)), would be satisfied when VA has determined that
a transplant is clinically necessary and appropriate. For the third
condition, we propose to regulate the factors that would be considered
when a medically compelling reason to travel outside the OPTN region in
which the veteran resides exists. However, before describing these
factors, we wish to provide some examples to illustrate the scope of
this authority.
We note initially that this section only applies for a covered
veteran (as defined in Sec. 17.4005) who meets one or more of the
eligibility criteria under Sec. 17.4010. If, for example, a covered
veteran resided near a VATC that could furnish the care within the
designated access standards proposed under Sec. 17.4040 and no other
eligibility criterion applied, the veteran would not be eligible to
elect to have VA authorize their care in the community. If the veteran
was eligible for care in the community under one or more of the
eligibility criteria, and if the veteran did not have a medically
compelling reason to travel outside the OPTN region in which the
veteran resided, the veteran's election would control because the
Secretary would not have the discretion conferred by section 1703(l).
Take, as an example, a veteran who lived more than a 60 minute average
driving time from a VATC within the OPTN region in which the veteran
resides. If a VATC were within the veteran's OPTN region, and assuming
this was a typical case, it is very likely that the VATC could furnish
the transplant care safely, timely, and effectively, with relatively
little travel burden. Given these facts, there would likely be no
medically compelling reason to travel outside the OPTN region for the
transplant care due to the availability of the VATC. Therefore, it
would be up the veteran to decide whether to receive care from a
community transplant center or through a VATC.
Proposed section 17.4020(d)(1) would state that, in the case of a
covered veteran described in paragraph (d)(3), VA would determine
whether to authorize an organ or bone marrow transplant for the covered
veteran through an eligible entity or provider. This language is
entirely consistent with section 1703(l)(1). Proposed section
17.4020(d)(3) would restate the language in 1703(l)(2) to provide that
this paragraph would only apply to a covered veteran who met one or
more conditions of eligibility under section 17.4010(a) and (1)
required an organ or bone marrow transplant, and (2) has, in the
opinion of the primary care provider of the veteran, a medically
compelling reason to travel outside the region of the Organ Procurement
and Transplantation Network in which the veteran resides, to receive
such transplant.
VA would, in section 17.4020(d)(3)(i), clarify that VA would
determine, based upon generally-accepted medical criteria, whether an
organ or bone marrow transplant is likely to be indicated. These
generally-accepted medical criteria include the exercise of some
clinical discretion, which we do not purport or intend to regulate, but
which are generally known by recognized medical experts and accredited
transplant centers. Such criteria are those commonly accepted across
the country as related to general suitability and qualification for a
transplant from any provider. These criteria would support decision
making for comprehensive transplantation evaluation. VA understands
that each OPTN member organ transplant center and each bone marrow
transplant center determines transplant suitabilty of each patient for
its program in consideration of patient and program factors. Each
transplant center must define and apply its own eligibility criteria in
consideration of individual patients. Current VA process supports
veterans having a formal evaluation by at least two transplant centers,
and published policy also defines an appeal process with review by a
multidisciplinary Transplantation Surgery Advisory Board to ensure that
patients receive due consideration for transplantation.
Proposed section 17.4020(d)(2) would provide a non-exhaustive list
of factors for consideration in making determinations as to whether:
(1) There is a medically compelling reason to travel outside the OPTN
region, and (2) organ or bone marrow transplant care would be provided
in the community. We emphasize that decisions should be personalized in
consideration of the veteran's preference and health care needs but
balanced with efforts to ensure high-quality care. There would be four
factors to consider in both determinations. First, specific patient
factors would be considered. We would not expressly describe specific
factors in the interest of avoiding the regulation of medical practice,
but we offer a few examples here for understanding and reference. For
example, it may be relevant to consider the characteristics of disease
processes which might warrant care in specific transplantation
programs. Certain disease indications for transplant warrant referral
to sub-specialty centers with particular expertise for that disease
process. Another factor could be patient preferences regarding waitlist
time and organ availability. Characteristics of waitlists including
mortality rate and time to transplant will be considered for shared
decision making with veterans. Yet another factor may be access to
specialty support programs for the unique needs of the individual
veteran; and comprehensive care coordination. Many veterans requiring
transplants
[[Page 13580]]
also face other health issues, including substance use disorder,
posttraumatic stress disorder, and other mental health disorders. The
ability to address the totality of these conditions in an integrated,
supportive, and patient-centered manner is often critical for the
patient's health, candidacy for transplantation, and successful post-
transplantation outcomes.
Second, VA and the primary care provider would consider which
facilities meet VA's standards for quality, including quality metrics
and outcomes, for the required transplant. This reflects VA's
responsibility to ensure veterans receive high quality care. We note
that VA is required by section 1703C to establish standards for
quality, and these standards and their respective quality metrics
(which are consistent with industry standard metrics) would be used to
help inform VA's determination. Additionally, VA would assess the
effectiveness of transplantation care using publicly-reported risk-
adjusted outcomes of patient and graft survival, such as Scientific
Registry of Transplantation Recipients data for solid organ
transplantation programs.
Third, VA and the primary care provider would consider the travel
burden on covered veterans based upon their medical conditions and the
geographical location of eligible transplant centers. This would allow
consideration of the realities of long travel distances for veterans
who have advanced disease processes, who reside in locations without
any qualified transplant centers, or whose caregivers are unduly
burdened by travel. As noted in the section of this SNPRM providing
background information on the VATP, many Americans face considerable
travel distances or driving times when seeking transplant care.
Finally, VA and the primary care provider would consider the
timeliness of transplant center evaluations and management. In some
transplant cases, time for evaluation and waitlisting is a critical
factor affecting patient outcomes and health and well-being.
Cumulatively, these factors would allow VA to make determinations
on whether to provide transplantation care in the community and primary
care providers to determine whether there is a medically compelling
reason to travel outside the OPTN region of the veteran's residence.
This list of factors is not intended to be exhaustive, as each
transplant case is unique and VA needs to maintain flexibility to
ensure that covered veterans receive the best and most appropriate
care. We note that any covered veteran who disagreed with VA's
determination could appeal this determination through VA's clinical
appeals process.
As a general matter, a veteran's primary care provider may not, and
often will not, be the health care provider who is actively managing
the patient's transplant care needs, nor will the primary care provider
necessarily have an understanding of the unique needs faced by veterans
requiring a transplant. While section 1703(l) establishes that the
determination of a medically compelling reason to travel outside the
OPTN region in which the veteran resides is made by the primary care
provider, we believe in practice, this will be made in consultation
with the appropriate specialists that are evaluating the covered
veteran and managing the patient's transplant needs.
We note that section 153 of the MISSION Act added a new section
1788 to title 38, United States Code, specifically authorizing VA to
provide for an operation on a live donor to carry out a transplant
procedure for an eligible veteran, notwithstanding that the live donor
may not be eligible for VA health care. VA will issue separate
regulations concerning this new authority, and the preceding discussion
is not dependent upon the promulgation of such regulations. Any
comments on care for living donors will be considered outside the scope
of this rulemaking.
Effect of Rulemaking
The Code of Federal Regulations, as proposed to be revised by the
proposed rulemaking at 84 FR 5629 and this SNPRM, would represent the
exclusive legal authority on this subject. No contrary guidance or
procedures would be authorized. All VA guidance would be read to
conform with the proposed rulemaking at 84 FR 5629 and this SNPRM if
possible or, if not possible, such guidance would be superseded by this
SNPRM and the proposed rulemaking at 84 FR 5629.
Paperwork Reduction Act
This SNPRM 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 SNPRM would not have a
significant economic impact on a substantial number of small entities
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. Although some eligible entities or providers that would furnish
care and services to veterans under this rule might be considered small
entities, there would be no significant adverse economic impact. To the
extent there is any impact on small entities, it would be a potential
increase in business due to proposed expanded eligibility for non-VA
care. Therefore, pursuant to 5 U.S.C. 605(b), these amendments would be
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.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' requiring review by the Office of
Management and Budget (OMB) as ``any regulatory action that is likely
to result in a rule that may: (1) Have an annual effect on the economy
of $100 million or more or adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) Create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.''
VA has examined the economic, interagency, budgetary, legal, and
policy implications of this regulatory action and determined that the
action would be an economically significant regulatory action under
Executive Order 12866, because it will have an annual effect on the
economy of $100 million or more. 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 regulatory impact analysis are available on
VA's website at http://www.va.gov/
[[Page 13581]]
orpm/, by following the link for ``VA Regulations Published.'' This
SNPRM is expected to be an E.O. 13771 regulatory action. Details on the
estimated costs of this rule can be found in the rule's regulatory
impact analysis.
Executive Order 12866 also directs agencies to ``in most cases . .
. include a comment period of not less than 60 days.'' This SNPRM would
address one provision for the new Veterans Community Care Program.
Providing a comment period of 15 days would allow the Secretary to
ensure the provisions of this SNPRM can be finalized with the
regulations for the rest of the new Veterans Community Care Program at
the same time. This would ensure a smooth transition from the current
Veterans Choice Program that will expire on June 6, 2019, and prevent
lapses in regulatory authority for VA's national community care
program. Delays in implementation of the Veterans Community Care
Program and provisions related to organ and bone marrow transplants
arising because the regulatory standards and guidelines were not in
place by June 6, 2019, would result in inconsistent decision making
that could harm veterans' health outcomes. Having clear, consistent
criteria is essential to ensuring that veterans receive the right care
in the right place at the right time. Moreover, we believe that VA
community care is now a familiar benefit to the public and that
providing 15 days would still be a sufficient period of time for the
public to comment on this single aspect of the new Veterans Community
Care Program. In sum, providing a 60-day public comment period would be
against public interest and contrary to the health and safety of
eligible veterans. For the above reasons, the Secretary issues this
rule with a public comment period of 15 days.
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 SNPRM would have no such effect on
State, local, and tribal governments, or on the private sector.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are as follows: 64.009, Veterans
Medical Care Benefits; and 64.018, Sharing Specialized Medical
Resources.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Government contracts, Health
care, Health facilities, Health professions, Health records, Reporting
and recordkeeping requirements, Veterans.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Robert L.
Wilkie, Secretary, Department of Veterans Affairs, approved this
document on February 28, 2019, for publication.
Dated: April 2, 2019.
Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy &
Management, Office of the Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, we propose to amend 38
CFR part 17 as follows:
PART 17--MEDICAL
0
1. The general authority citation for part 17 continues to read as
follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
0
2. Add Sec. 17.4020 to read as follows:
Sec. 17.4020 Authorized non-VA care.
(a) Electing non-VA care. Except as provided for in paragraph (d)
of this section, a covered veteran eligible for the Veterans Community
Care Program under Sec. 17.4010 may choose to schedule an appointment
with a VA health care provider, or have VA authorize the veteran to
receive an episode of care for hospital care, medical services, or
extended care services from an eligible entity or provider when VA
determines such care or services are clinically necessary.
(b) Selecting an eligible entity or provider. A covered veteran may
specify a particular eligible entity or provider. If a covered veteran
does not specify a particular eligible entity or provider, VA will
refer the veteran to a specific eligible entity or provider.
(c) Authorizing emergency treatment. This paragraph (c) applies
only to emergency treatment furnished to a covered veteran by an
eligible entity or provider when such treatment was not the subject of
an election by a veteran under paragraph (a) of this section. This
paragraph (c) does not affect eligibility for, or create any new rules
or conditions affecting, reimbursement for emergency treatment under
section 1725 or 1728 of title 38, United States Code.
(1) Under the conditions set forth in this paragraph (c), VA may
authorize emergency treatment after it has been furnished to a covered
veteran. For purposes of this paragraph (c), ``emergency treatment''
has the meaning defined in section 1725(f)(1) of title 38, United
States Code.
(2) VA may only authorize emergency treatment under this paragraph
(c) if the covered veteran, someone acting on the covered veteran's
behalf, or the eligible entity or provider notifies VA within 72-hours
of such care or services being furnished and VA approves the furnishing
of such care or services under paragraph (c)(3) of this section.
(3) VA may approve emergency treatment of a covered veteran under
this paragraph (c) only if:
(i) The veteran is receiving emergency treatment from an eligible
entity or provider.
(ii) The notice to VA complies with the provisions of paragraph
(c)(4) of this section and is submitted within 72 hours of the
beginning of such treatment.
(iii) The emergency treatment only includes services covered by
VA's medical benefits package in Sec. 17.38 of this part.
(4) Notice to VA must:
(i) Be made to the appropriate VA official at the nearest VA
facility;
(ii) Identify the covered veteran; and
(iii) Identify the eligible entity or provider.
(d) Organ and bone marrow transplant care. (1) In the case of a
covered veteran described in paragraph (d)(3) of this section, the
Secretary will determine whether to authorize an organ or bone marrow
transplant for the covered veteran through an eligible entity or
provider.
(2) The Secretary will make determinations under paragraph (d)(1)
of this section, and the primary care provider of the veteran will make
determinations concerning whether there is a medically compelling
reason to travel outside the region of the Organ Procurement and
Transplantation Network in which the veteran resides to receive a
transplant, in consideration of, but not limited to, the following
factors:
(i) Specific patient factors.
(ii) Which facilities meet VA's standards for quality, including
quality metrics and outcomes, for the required transplant.
[[Page 13582]]
(iii) The travel burden on covered veterans based upon their
medical conditions and the geographic location of eligible transplant
centers.
(iv) The timeliness of transplant center evaluations and
management.
(3) This paragraph (d) applies to covered veterans who meet one or
more conditions of eligibility under Sec. 17.4010(a) and:
(i) Require an organ or bone marrow transplant as determined by VA
based upon generally-accepted medical criteria; and
(ii) Have, in the opinion of the primary care provider of the
veteran, a medically compelling reason, as determined in consideration
of the factors described in paragraph (d)(2) of this section, to travel
outside the region of the Organ Procurement and Transplantation Network
in which the veteran resides, to receive such transplant.
[FR Doc. 2019-06730 Filed 4-4-19; 8:45 am]
BILLING CODE 8320-01-P