Veterans Community Care Program-Organ and Bone Marrow Transplant Care, 13576-13582 [2019-06730]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[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 https://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 https://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 https://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 https://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