Provider-Based Requirements, 64235-64243 [2019-24880]
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Federal Register / Vol. 84, No. 225 / Thursday, November 21, 2019 / Proposed Rules
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on Monday, September 9, 2019 (84 FR
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[FR Doc. 2019–25161 Filed 11–20–19; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AQ68
Provider-Based Requirements
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) proposes to amend its
regulations concerning collection and
recovery by VA for medical care and
services provided to an individual at a
VA medical facility for treatment of a
nonservice-connected condition.
Specifically, this rulemaking would add
a regulation that establishes the
requirements VA will use to determine
whether a VA medical facility has
provider-based status. Such
determination affects the amount VA
can recover from a third party for the
cost of the nonservice-connected care.
Currently, VA uses the requirements
established by the Centers for Medicare
and Medicaid Services to determine
whether the facility has provider-based
status; however, it is necessary for VA
to establish its own requirements that
are tailored to VA’s unique operation
and structure.
DATES: Comments must be received by
VA on or before January 21, 2020.
ADDRESSES: Written comments may be
submitted through https://
www.Regulations.gov, by mail or handdelivery to Director, Office of Regulation
Policy and Management (00REG),
Department of Veterans Affairs, 810
Vermont Avenue NW, Room 1064,
Washington, DC 20420; or by fax to
(202) 273–9026. (This is not a toll-free
number.) Comments should indicate
that they are submitted in response to
RIN 2900–AQ68, Provider-Based
Requirements. Copies of comments
received will be available for public
inspection in the Office of Regulation
Policy and Management, Room 1064,
SUMMARY:
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64235
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, Director of Policy and
Planning, Office of Community Care
(10D), Ptarmigan at Cherry Creek
Denver, CO, 80209, Joseph.Duran2@
va.gov or (303) 372–4629. (This is not a
toll-free number.)
SUPPLEMENTARY INFORMATION: VA is
authorized under 38 U.S.C. 1729 to
recover or collect from a third party the
reasonable charges for medical care or
services VA furnishes to an individual
for a non-service connected disability,
to the extent that the individual, or the
provider of care or services, would be
eligible to receive payment from the
third party if the care or services had
not been furnished by VA. VA’s
collection or recovery under section
1729 is limited to care or services
furnished by VA for a nonserviceconnected disability: Incurred incident
to the individual’s employment and
covered under a worker’s compensation
law or plan that provides
reimbursement or indemnification for
such care and services; incurred as the
result of a crime of personal violence
that occurred in a State, or a political
subdivision of a State, in which a
person injured as the result of such a
crime is entitled to receive health care
and services at such State’s or
subdivision’s expense for personal
injuries suffered as the result of such
crime; incurred as a result of a motor
vehicle accident in a State that requires
automobile accident reparations (nofault) insurance; or for which the
individual is entitled to care (or the
payment of expenses of care) under a
health plan contract.
VA implements its authority under
section 1729 through regulations at title
38 Code of Federal Regulations (CFR)
17.101 through 17.106. More
specifically, the methodology that VA
uses to determine the amount of its
collection or recovery for is established
in 38 CFR 17.101. This rulemaking
would primarily seek to revise this
methodology with regards to calculating
the reasonable charges for care and
services VA provides on an outpatient
basis. Prior to explaining the proposed
regulatory changes for § 17.101, we
provide the following background on
how VA developed its current
methodology for charges for outpatient
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services. Historically, if VA had a
specific item of medical care or service
provided on an outpatient basis, VA
could charge a professional charge, an
outpatient facility charge, or both. These
charges were developed so as to be
mutually exclusive, with the
expectation that both charges could be
billed for the same occasion of service.
In April 2000, the Centers for
Medicare and Medicaid Services (CMS)
published a final rule with comment
period that, in pertinent part, codified
its long-standing use of provider-based
status in regulation at 42 CFR 413.65. 65
FR 18434 (April 7, 2000). In this final
rule, CMS explained that, since the
Medicare program started, some
providers, referred to as main providers,
had functioned as a single entity while
owning and operating additional
departments, locations, and facilities.
These departments, locations, and
facilities were referred to as providerbased and were treated as part of the
main provider for Medicare purposes. In
this regard, to the extent that overhead
costs of the main provider, such as
administrative and general costs, were
shared by the provider-based facility,
these costs were allowed to flow to the
provider-based facility through the cost
allocation process in the cost report.
This was considered appropriate
because these facilities were also
operationally integrated, and the
provider-based facility was sharing the
overhead costs and revenue producing
services controlled by the main
provider. In the April 2000 final
rulemaking, CMS defined the term
provider-based status as the relationship
between a main provider and a
provider-based entity or a department of
a provider, remote location of a hospital,
or satellite facility, that complies with
the provisions of this section. 42 CFR
413.65(a)(2). It also established specific
requirements that must be met in order
for CMS to recognize a facility as having
provider-based status. CMS explained
that specific criteria were necessary
because the designation of providerbased status could result in additional
Medicare payments for services
furnished at the provider-based facility
(outpatient facility charges), and could
also increase the coinsurance liability of
Medicare beneficiaries for those
services. The final rule clarified that 42
CFR 413.65 applied to providers and
facilities seeking Medicare payment. As
VA does not seek Medicare payment,
the requirements and criteria
established in 42 CFR 413.65 applies to
VA only if VA so establishes through its
own regulations.
In December 2003, VA amended 38
CFR 17.101 to establish that VA would
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use the CMS provider-based criteria in
42 CFR 413.65 to more closely
approximate industry standard charge
structures and billing practices. 68 FR
70714 (December 19, 2003). That VA
rulemaking further established two sets
of charges for outpatient care consistent
with Medicare: One for use by facilities
that had provider-based status and one
for facilities that did not have providerbased status. The facilities that had
provider-based status could bill both an
outpatient professional and facility
charge. The facilities that did not have
provider-based status could only bill a
professional charge. In consideration of
the fact that facilities that did not have
provider-based status could only bill a
professional charge, the professional
charge for those facilities would be
higher than the professional charge for
facilities that had provider-based status,
based on Medicare’s higher non-facility
practice expense relative value units
(RVUs).
Currently, VA defines the terms
provider-based and non-provider-based
in 38 CFR 17.101(a)(5). Section
17.101(a)(5) defines provider-based as
the outpatient department of a VA
hospital or any other VA health care
entity that meets CMS provider-based
criteria. Provider-based entities are
entitled to bill outpatient facility
charges. Under § 17.101(a)(5), nonprovider-based is defined as a VA health
care entity (such as a small VA
community-based outpatient clinic) that
functions as the equivalent of a doctor’s
office or for other reasons does not meet
CMS provider-based criteria, and,
therefore, is not entitled to bill
outpatient facility charges. VA
establishes the use of the CMS providerbased criteria in its third-party billing
through § 17.101(a)(6), which states in
pertinent part that each VA health care
entity are designated as either providerbased or non-provider based providerbased entities are entitled to bill
outpatient facility charges; nonprovider-based entities are not.
For the reasons below, VA proposes to
revise 38 CFR 17.101 to remove the
current regulatory requirement that VA
use the CMS provider-based criteria
with regards to VA billing of third
parties, and proposes to add a new
regulation at 38 CFR 17.100 that would
establish the criteria that VA would use
instead to determine whether a VA
facility has provider-based status. In so
doing, VA would model new proposed
38 CFR 17.100 on a majority of the
current CMS provider-based criteria in
42 CFR 413.65, but VA’s revisions
would address the unique structure of
VA’s health care system, versus the
CMS requirements that are more
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generally applicable to private health
care systems. Significantly, VA is an
integrated, national health care system
and, therefore, some of the CMS
requirements in 42 CFR 413.65,
especially as they pertain to proximity
limitations and licensure, are not
appropriate to use for VA facilities.
Those CMS requirements that are not
appropriate to use for VA facilities are
further identified and explained in more
detail in the discussions below.
Additionally, to provide a scope for
the proposed changes further explained
below, we note that as of June 2018, 93
percent out of the total number of VA’s
facilities from which recoverable costs
for care or services are provided (VA’s
billable facilities) already meet the
current CMS provider-based criteria
under 42 CFR 413.65(d) and (e) to
permit VA to bill both an outpatient
professional charge and an outpatient
facility charge. Therefore, the proposed
changes explained below would only
have a potential effect in practical
billing practices (to allow for the billing
of an outpatient facility charge, in
addition to the current billing of an
outpatient professional charge) for seven
percent of VA’s billable facilities. More
detail is provided in the section of this
rulemaking that discusses the
Regulatory Flexibility Act.
§ 17.100 Requirements for ProviderBased Status
We propose to add a new regulation
at 38 CFR 17.100. Section 17.100 would
be located under the undesignated
center heading Charges, Waivers, and
Collections and would be titled
Requirements for provider-based status.
In proposed § 17.100(a), we would
describe a clear scope for establishing
this section, which is to provide the
criteria we would use to determine
whether a VA medical facility has
provider-based status for purposes of
billing for nonservice-connected and
non-special treatment authority
conditions. We would also explain that
while these requirements are modeled
after the requirements established in the
CMS regulation, 42 CFR 413.65, there
are some differences that are designed to
address the unique operational activities
of the VA health care system.
Proposed § 17.100(b) would contain
the definitions that would apply to this
section. While some of these terms are
based on those definitions in the CMS
regulation, most are defined in the
context of VA’s unique structure and
organization as indicated within the
discussions of each proposed definition
below. This ensures that we use the
definitions and terminology that are
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most appropriate and applicable to VA’s
health care system.
Community Based Outpatient Clinic
(CBOC) would be defined as a VAoperated, VA-funded, or VA-reimbursed
site of care that is not located within a
VA Medical Center. We would further
explain that a CBOC can provide
primary, specialty, subspecialty, mental
health, or any combination of health
care delivery services that can be
appropriately provided in an outpatient
setting. A CBOC is unique to VA, and
would be consistent with other VA
definitions or uses of the term.
Community Living Center (CLC)
would be defined as a component of the
spectrum of long-term care that provides
a skilled nursing environment and
houses a variety of specialty programs,
such as respite care, dementia care, and
skilled nursing care, for persons needing
short and long stay services. We would
further explain that CLCs are typically
located on or near a VA medical facility
and are VA-owned and operated, but
may be free-standing in the community.
This definition of CLC would be
consistent with other VA definitions or
uses of the term.
Facility would be defined as a point
of care where individuals can seek
health care services, to include a VA
Medical Center, CBOC, Health Care
Center, CLC, and Other Outpatient
Services site. This definition would
specifically reference the facilities
within VA that currently provide health
care services.
Health Care Center (HCC) would be
defined as a VA-owned, VA-leased, VAcontracted, or shared clinic that is
operational at least five days per week
and provides primary care, mental
health care, on site specialty services,
and performs ambulatory surgery and/or
invasive procedures that may require
moderate sedation or general anesthesia.
This definition would be consistent
with other VA definitions or uses of the
term, and is defined to reflect VA’s
organization and structure.
Main Provider (or parent facility/
hospital or PBH) would be defined as a
provider that either creates, or acquires
ownership of, another facility to deliver
additional health care services under its
name, ownership, and financial and
administrative control. This is
consistent with the CMS definition of
main provider in 42 CFR 413.65(a)(2).
We note that VA generally refers to its
main providers as provider-based
hospitals (PBHs). Although these
facilities operate as main providers
operate in the private sector and are not
subordinate facilities that would seek
provider-based status, VA has
historically referred to them as PBHs.
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For clarity, we will refer to these
facilities as main providers in the
preamble and regulation text. We would
further explain that VAMCs and HCCs
can be main providers. This definition
would reflect VA’s organization and
structure, and reference those facilities
within VA that are examples of main
providers.
Other Outpatient Services (OOS)
would be defined as a site that provides
outpatient services to veterans, but does
not meet the definition of a CBOC or
HCC. This definition would be
consistent with other VA definitions or
uses of the term, as well as VA’s
structure and organization. Examples of
OOS can include sleep centers, posttraumatic stress disorder clinics, and a
clinic without primary care or mental
health services.
Prospective Payment System (PPS)
would be defined as a method of
reimbursement in which Medicare
payment is made based on a
predetermined, fixed amount. The
payment amount for a particular service
is derived based on the classification
system of that service (for example,
Medicare Severity Diagnosis-Related
Groups for inpatient hospital services
furnished by most acute care hospitals).
This definition would be consistent
with the definition used by CMS.
Provider-Based Outpatient Facility
(PBO) would be defined as a provider of
health care services that is either created
by, or acquired by, a main provider for
the purpose of furnishing additional
health care services under the
ownership, administrative, and
financial control of the main provider
and meets the criteria outlined in this
section. CMS does not define the
general term of provider-based
outpatient facility and instead, CMS
separately defines the types of facilities
or entities that could obtain providerbased status, to include department of a
provider, provider-based entity, and
remote location of a hospital. However,
for the purposes of VA, it is not
necessary to distinguish between the
different types of facilities, and
therefore, VA will have one term to
broadly encompass all provider-based
outpatient facilities.
Remote Location of a Hospital would
be a CBOC, OOS site, or HCC that is
located offsite from the main facility.
This definition would differ from the
definition provided in 42 CFR 413.65 in
order to specifically define this term
within the context of VA’s facilities and
reflect VA’s unique organization and
structure.
VA Medical Center (VAMC) would be
defined as a VA facility that provides at
least two categories of care (inpatient,
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outpatient, residential, or institutional
extended care). This definition would
be consistent with other VA definitions
or uses of the term, as well as VA’s
structure and organization.
In proposed § 17.100(c), we would set
forth the criteria that would be used to
determine whether a facility has
provider-based status for purposes of
billing for nonservice-connected and
non-special treatment authority
conditions. Section 17.100(c) is largely
modeled after the requirements for all
facilities or organizations in 42 CFR
413.65(d), additional requirements
applicable to off-campus facilities or
organizations in 42 CFR 413.65(e), and
obligations of hospital outpatient
departments and hospital-based entities
in 42 CFR 413.65(g).
In proposed § 17.100(c)(1), we would
require that the facility seeking
provider-based status and the main
provider operate under the same
license. This requirement would be
consistent with the CMS provider-based
criteria located at 42 CFR 413.65(d)(1),
which generally requires a department
of a provider, the remote location of a
hospital, or the satellite facility and the
main provider operate under the same
license. As previously explained, VA is
not distinguishing between departments
of providers, remote locations of a
hospital, satellite facilities, and other
provider-based facilities. Therefore,
proposed paragraph (c)(1) would state
that the facility seeking provider-based
status and the main provider operate
under the same license. Because VA is
a Federal entity, VA facilities are not
licensed, and are not required to be
licensed, under any State laws or other
State authorities. Therefore, we would
also explain that VA facilities are not
licensed by States but are considered
licensed by VA for the purpose of
collection and recovery as part of VA’s
national organization structure and in
accordance with VA standards,
including those recognized by VA’s
Office of the Medical Inspector and
Inspector General, as well as standards
of major healthcare accreditation
organizations such as The Joint
Commission as applicable to specific
VA facilities.
In proposed § 17.100(c)(2), we would
require that the clinical services of the
facility seeking provider-based status
and the main provider be integrated. We
would further explain that integration is
demonstrated by several factors, which
would be listed in the regulation. These
factors would include (1) the
professional staff at the facility seeking
provider-based status has clinical
privileges at the main provider; (2) the
main provider maintains the same
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monitoring and oversight (i.e.
credentialing and privileging) of the
facility seeking provider-based status as
it does for any other department of the
provider; (3) the medical director of the
facility seeking provider-based status
maintains a reporting relationship with
the chief medical officer or other similar
official of the main provider that has the
same frequency, intensity, and level of
accountability that exists in the
relationship between the medical
director of a department of the main
provider and the chief medical officer or
other similar official of the main
provider, and is under the same type of
supervision and accountability as any
other director, medical or otherwise, of
the main provider; (4) the medical staff
committees or other professional
committees at the main provider are
responsible for medical activities in the
facility seeking provider-based status,
including quality assurance, utilization
review, and the coordination and
integration of services, to the extent
practicable, between the facility seeking
provider-based status and the main
provider; (5) the medical records for
patients treated in the facility are
integrated into a unified retrieval system
(or cross reference) of the main
provider; (6) inpatient and outpatient
services of the facility seeking providerbased status and the main provider are
integrated, and patients treated at the
facility who require further care have
full access to all services of the main
provider and are referred where
appropriate to the corresponding
inpatient or outpatient department or
service of the main provider; and (7)
inpatient and outpatient services of the
facility seeking provider-based status
and the main provider are recognized
under the main provider’s accreditation.
The first six factors would be consistent
with the CMS criteria located at 42 CFR
413.65(d)(2). However, the seventh
factor, regarding accreditation, would be
additional factor that demonstrates
integration for VA facilities. This would
reflect the unique structure and
organization of VA, in which inpatient
and outpatient services of VA facilities
are recognized under the main
provider’s accreditation.
In proposed § 17.100(c)(3), we would
propose to require financial integration
of the facility seeking provider-based
status and the main provider.
Specifically, we would require that the
financial operations of the facility
seeking provider-based status are fully
integrated within the financial system of
the main provider, as evidenced by
shared income and expenses between
the main provider and the facility. We
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would also require that the costs of a
facility that is a hospital department be
reported in a cost center of the provider,
costs of a provider-based facility other
than a hospital department be reported
in the appropriate cost center or cost
centers of the main provider. This
would be consistent with CMS
requirements in 42 CFR 413.65(d)(3).
However, we would also require that the
main provider’s integrated health care
system manpower and labor budget and
the financial status of any providerbased facility be incorporated and
readily identified in the main provider’s
integrated system reports. This
additional requirement would reflect
that the main provider has
administrative and financial control of
the provider-based facility, and would
be consistent with similar CMS
requirements in 42 CFR 413.65(d)(3).
This would reflect VA’s current
structure and organization in which a
main provider has such control,
particularly budgetary, over facilities.
Under proposed § 17.100(c)(4), we
would include a requirement for public
awareness. Specifically, we would
require that the facility seeking
provider-based status be held out to the
public (and other payers) as part of the
main provider. This would be exhibited
by the patients of the facility being
made aware that the facility is part of a
main provider and that they will be
billed accordingly. This would be
consistent with the CMS requirement
for public awareness in 42 CFR
413.65(d)(4). In addition, we would also
propose that all literature, brochures,
and public relations newsletters from
the facility seeking provider-based
status include the relationship between
the main provider and the facility. This
is current VA practice for facilities
associated or affiliated with a main
provider and reflects the relationship
between the facilities.
Proposed § 17.100(c)(5) would contain
obligations when the facility seeking
provider-based status is a hospital
outpatient department or hospital-based
entity, including (1) compliance with
the ‘‘antidumping’’ rules of 42 CFR
489.20(l), (m), (q), and (r) and 42 CFR
489.24; (2) physician services must be
billed with the correct site-of-service so
that appropriate physician and
practitioner amounts can be determined;
(3) physicians are obligated to comply
with the non-discrimination provisions
in 42 CFR 489.10; (4) the facility seeking
provider-based status must treat all
Medicare patients seen on an urgent/
emergent basis as hospital outpatients;
(5) in the case of a patient admitted to
the hospital as an inpatient after
receiving treatment in the hospital
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outpatient department or hospital-based
facility, payments for services in the
hospital outpatient department of
hospital-based facility are subject to the
payment window provisions applicable
to PPS hospitals and to hospitals and
units excluded from PPS set forth at 42
CFR 412.2(c)(5) and at 42 CFR
413.40(c)(2), respectively; (6) the
hospital outpatient department must
meet applicable VA policy pertaining to
hospital health and safety programs; and
(7) VA must treat any facility that is
located on the main hospital campus as
a department of the hospital. The
criteria described in (1)–(7) are largely
consistent with CMS regulations at
§ 413.65(d)(5) and (g).
We note that we would not propose
to include all of the criteria located at
§ 413.65(g), Obligations of hospital
outpatient departments and hospitalbased entities, because some of the
requirements are not applicable to VA.
For example, § 413.65(g)(3) (hospital
outpatient departments must comply
with all the terms of the hospital’s
provider agreement) and § 413.65(g)(7)
(when a Medicare beneficiary is treated
in a hospital outpatient department that
is not located on the main provider’s
campus, the treatment is not required to
be provided by the ‘‘antidumping’’ rules
in § 489.24 of this chapter, and the
beneficiary will incur a coinsurance
liability for an outpatient visit to the
hospital as well as for the physician
service, certain requirements must be
met) are not included because they are
not applicable.
In proposed § 17.100(c)(6), we would
include the requirement that the facility
seeking provider-based status is
operated under the control of the main
provider. Such control would require (1)
the main provider and the facility
seeking provider-based status have the
same governing body; (2) the facility
seeking provider-based status is
operated under the same organizational
documents as the main provider (e.g.
the facility is subject to common bylaws
and operating decisions of the main
provider’s governing body); (3) the main
provider has final responsibility for
administrative decisions, final approval
for contracts with outside parties, final
approval for personnel actions, final
responsibility for personnel policies
(such as code of conduct), and final
approval for medical staff appointments
in the facility seeking provider-based
status. This is modeled after the criteria
in § 413.65(e)(1) which requires
operation under the ownership and
control of the main provider as an
additional requirement applicable to offcampus facilities or organizations.
However, we propose to remove the
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ownership requirements because, in the
VA structure, main providers do not
own other facilities.
Proposed § 17.100(c)(7) would
establish the requirement for
administration and supervision of the
facility seeking provider-based status.
Significantly, the reporting relationship
between the facility seeking providerbased status and the main provider must
have the same frequency, intensity, and
level of accountability that exists in the
relationship between the main provider
and one of its existing departments, as
evidenced by compliance with further
identified requirements. These include
(1) the facility seeking provider-based
status must be under the direct
supervision of the main provider, (2) the
facility seeking provider-based status
must be operated under the same
monitoring and oversight by the main
provider as any other department of the
provider and is operated just as any
other department of the provider with
regard to supervision and
accountability; and (3) administrative
functions (i.e. billing services, records,
human resources, payroll, employee
benefit package, salary structure, and
purchasing services) of the facility
seeking provider-based status are
integrated with those of the main
provider.
We would further explain that as part
of the requirement for the same
monitoring and oversight located in
proposed § 17.100(c)(7)(ii), the facility
director or individual responsibility for
daily operations at the facility must
maintain a reporting relationship with a
manager at the main provider that has
the same frequency, intensity and level
of accountability that exists in the
relationship between the main provider
and its existing departments, and is
accountable to the governing body of the
main provider, in the same manner as
any department head of the provider. In
addition, we would explain that the
requirement of integrated administrative
functions, as set forth in proposed
§ 17.100(c)(7)(iii), includes that either
the same employees or group of
employees handle the identified
administrative functions for the facility
and main provider, or those functions
are contracted out under the same
contract agreement; or are handled
under different contract agreements,
with the contract of the facility or
organization being managed by the main
provider. The criteria under proposed
§ 17.100(c)(7) are consistent with those
under the CMS regulations at 42 CFR
413.65(e)(2).
Lastly, under proposed § 17.100(d),
we would illustrate how the criteria are
applied when VA does not own the
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facility, but operates under a contract,
and in the situation when the
employees at a VA facility are contract
employees. We would explain that, (1)
a VA facility that is seeking providerbased status that exists under contract
arrangements, where only VA patients
are seen, may be designated as providerbased as long as the provider-based
requirements in this section are met; (2)
A VA facility seeking provider-based
status that exists under contract
arrangements, where VA patients and
non-VA patients are seen at the same
non-VA owned facility, will have the
same provider-based status as the nonVA owned facility that is hosting the VA
facility; and (3) a VA owned and
operated facility seeking provider-based
status, where some or all of the staff are
contracted employees, may be
designated as provider-based as long as
the provider-based requirements in this
section are met. This is because the
facility is still considered VA owned
and operated, regardless of whether the
staff is contracted or not.
The CMS requirements include
numerous other provisions that are
applicable to private health care
systems, but are not applicable to the
VA health care system. For example, in
the proposed rulemaking we are not
including the information in 42 CFR
413.65(b) or (c) on what is required to
seek a determination of provider-based
status from CMS and what is required
for reporting material changes in
relationships to CMS, because VA and
not CMS will make the determination of
whether a VA facility has providerbased status.
In addition, this proposed rulemaking
does not include the CMS criteria at 42
CFR 413.65(e)(3) regarding location
requirements. These include, generally,
that the facility is located within a 35
mile radius of the campus of the
potential main provider or that the
facility is owned and operated by a
hospital that has a disproportionate
share adjustment greater than 11.75
percent and that the facility
demonstrates a high level of integration
with the main provider by showing that
it serves the same patient population as
the main provider. Although in the
private sector, mileage between the
main provider and the facility seeking
provider-based status demonstrates a
level of integration, we believe that the
same is not true for VA.
VA is a nationwide health care system
that is structured to require all facilities
that are not main providers be
controlled by and financially and
administratively integrated with the
main provider in its region, regardless of
mileage. In this regard, each designated
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region has one main provider and when
VA acquires or creates a new facility
(that is not a main provider), the new
facility is automatically paired with the
main provider that is in its region. The
new facility is assigned a shared station
number with the main provider that has
a unique suffix and is under the main
provider’s control. We emphasize that
the pairing is only based on location to
the extent that the new facility is within
the main provider’s region; it does not
depend upon a certain mileage
requirement. For example, in the State
of Maine, there is one main provider
and all other facilities, regardless of
distance from the main provider, are
administratively and financially
integrated with and controlled by the
main provider. It does not matter
whether the facility is 20 miles away or
200 miles away. Therefore, VA believes
that the location requirement is not a
relevant criterion to determine
integration within the VA system.
Moreover, the proposed rulemaking
does not include the requirements for
joint ventures under 42 CFR 413.65(f),
management contracts under 42 CFR
413.65(h), inappropriate treatment of a
facility or organization as providerbased under 42 CFR 413.65(j),
temporary treatment as provider-based
under 42 CFR 413.65(k), correction of
errors under 42 CFR 413.65(l), the status
of Indian Health Service and Tribal
facilities and organizations under 42
CFR 413.65(m), FQHCs and look alikes
under 42 CFR 413.65(n), and effective
date of provider-based status under 42
CFR 413.65(o). VA believes that these
provisions are not pertinent to VA’s
structure as a national health care
system for veterans, and therefore, we
will not include these or similarly not
relevant provisions into the proposed
rulemaking.
§ 17.101 Collection or Recovery by VA
for Medical Care or Services Provided
or Furnished to a Veteran for a
Nonservice-Connected Disability
We propose to revise § 17.101(a)(5) by
removing the definitions of providerbased and non-provider-based. The term
provider-based outpatient facility will
be defined in § 17.100(b)(2). Therefore,
we do not believe that it needs to be
defined in § 17.101. We also propose to
remove the definition of non-providerbased. CMS does not define that term in
§ 413.65 and we do not believe it is
necessary to define. If a facility does not
meet the criteria in § 17.100, the facility
will simply not have provider-based
status.
We propose to amend § 17.101(a) by
first stating that the paragraph will
cover charges related to provider-based
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status. We would explain that facilities
that have provider-based status by meet
the criteria in § 17.100 would be entitled
to bill outpatient facility charges and
professional charges. The professional
charges for these facilities would be
produced by the methodologies set forth
in this section based on facility expense
RVUs. Facilities that do not have
provider-based status because it did not
meet the criteria in § 17.100 would not
be permitted to bill outpatient facility
charges and could only bill a
professional charge. The professional
charges for these facilities would be
produced by the methodologies set forth
in this section based on non-facility
practice expense RVUs.
§ 17.106 VA Collection Rules; ThirdParty Payers
As previously discussed, under 38
U.S.C. 1729, VA has the right to recover
or collect reasonable charges for medical
care or services from a third party under
four circumstances. In addition, section
1729(f) provides that no law of any State
or of any political subdivision of a State,
and no provision of any contract or
other agreement, shall operate to
prevent recovery or collection by the
United States under this section or with
respect to care or services furnished
under section 1784 of this title. VA has
established rules for third party payers
in 38 CFR 17.106. Specifically,
§ 17.106(f) contains the general rules for
the administration of section 1729 and
this part, with clarifying examples of
when a third-party may not reduce,
offset, or request a refund for payments
made to VA. Section 17.106(f)(2)
explicitly provides that the list of
examples is not exclusive. We propose
to add another example to 38 CFR
17.106(f)(2) to clarify that third parties
cannot reduce or refuse payment based
on VA’s designation that a facility is
provider-based.
Effect of Rulemaking
The Code of Federal Regulations, as
proposed to be revised by this proposed
rulemaking, would represent the
exclusive legal authority on this subject.
No contrary rules or procedures would
be authorized. All VA guidance would
be read to conform with this proposed
rulemaking if possible or, if not
possible, such guidance would be
superseded by this rulemaking.
Paperwork Reduction Act
This rule contains no collections of
information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521).
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Regulatory Flexibility Act
The Secretary hereby certifies that
this proposed rule would not have a
significant economic impact on a
substantial number of small facilities as
they are defined in the Regulatory
Flexibility Act, 5 U.S.C. 601–612. Over
90 per cent of VA’s current billing
facilities presently engage in the
practices that would be enabled by this
rule for a remaining small percentage of
VA facilities. Additionally, while the
rule would allow for recognition of an
additional set of billable charges for the
small percentage of VA facilities that to
not already engage in such practices, the
rule would not guarantee such charges
would be paid by third parties or
collected by VA. The estimated average
annual potential impact of less than $4
million would otherwise not be
significant when considered to apply to
the aggregate of typical third-party
insurers or payers in the U.S. health
care industry at large. Therefore,
pursuant to 5 U.S.C. 605(b), this rule 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 Management and Budget
has examined the economic,
interagency, budgetary, legal, and policy
implications of this regulatory action
and determined that it is a significant
regulatory action under Executive Order
12866, because it raises novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in this Executive
Order. VA’s impact analysis can be
found as a supporting document at
https://www.regulations.gov, usually
within 48 hours after the rulemaking
document is published. Additionally, a
copy of the rulemaking and its impact
analysis are available on VA’s website at
https://www.va.gov/orpm by following
the link for VA Regulations Published
from FY 2004 through FYTD.
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This proposed rule is not subject to
the requirements of E.O. 13771 because
this proposed rule results 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 proposed rule is not
likely to have such effect on State, local,
and tribal governments, or on the
private sector.
Catalog of Federal Domestic Assistance
Numbers
The Catalog of Federal Domestic
Assistance numbers and titles for the
programs affected by this document are
64.008—Veterans Domiciliary 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; 64.026—Veterans State
Adult Day Health Care; 64.039—
CHAMPVA; 64.040—VHA Inpatient
Medicine; 64.041—VHA Outpatient
Specialty Care; 64.042—VHA Inpatient
Surgery; 64.043—VHA Mental Health
Residential; 64.044—VHA Home Care;
64.045—VHA Outpatient Ancillary
Services; 64.046—VHA Inpatient
Psychiatry; 64.047—VHA Primary Care;
64.048—VHA Mental Health clinics;
64.049—VHA Community Living
Center; 64.050—VHA Diagnostic Care.
List of Subjects in 38 CFR Part 17
Administrative practice and
procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug
abuse, Health care, Health facilities,
Health professions, Health records,
Medical devices, Medical research,
Mental health programs, Nursing
homes, Philippines, 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
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document on May 3, 2019, for
publication.
Consuela Benjamin,
Regulations Development Coordinator, Office
of Regulation Policy & Management, Office
of the Secretary, Department of Veterans
Affairs.
For the reasons set out in the
preamble, VA proposes to amend 38
CFR part 17 as set forth below:
PART 17—MEDICAL
1. The authority citation for part 17
continues to read in part as follows:
■
Authority: 38 U.S.C. 501, and as noted in
specific sections.
*
*
*
*
*
2. Add § 17.100 under the
undesignated center heading ‘‘Charges,
Waivers, and Collections’’ to read as
follows:
■
§ 17.100
status.
Requirements for provider-based
(a) Scope. This section establishes the
criteria that VA uses to determine
whether a VA medical facility is
designated as provider-based for
purposes of billing for non-serviceconnected and non-special treatment
authority conditions.
(b) Definitions. For purposes of this
section:
Community Based Outpatient Clinic
(CBOC). A CBOC is a VA-operated, VAfunded, or VA-reimbursed site of care
that is not located within a VA Medical
Center. A CBOC can provide primary,
specialty, subspecialty, mental health,
or any combination of health care
delivery services that can be
appropriately provided in an outpatient
setting.
Community Living Center (CLC). A
CLC is a component of the spectrum of
long-term care that provides a skilled
nursing environment and houses a
variety of specialty programs for persons
needing short and long stay services. VA
CLCs are typically located on, or near a
VA medical facility and are VA-owned
and operated, but may be free-standing
in the community.
Facility. A facility is a point of care
where individuals can seek VA health
care services, to include a VA Medical
Center, CBOC, Health Care Center, CLC,
and Other Outpatient Services site.
Health Care Center (HCC). An HCC is
a VA-owned, VA-leased, VA-contracted
or shared clinic that is operational at
least five days per week and provides
primary care, mental health care, on site
specialty services, and performs
ambulatory surgery and/or invasive
procedures that may require moderate
sedation or general anesthesia.
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Main provider. A main provider (or
parent facility/hospital or providerbased hospital (PBH)) is a provider that
either creates, or acquires ownership of,
another facility to deliver additional
health care services under its name,
ownership, and financial and
administrative control. For example, VA
Medical Centers and HCCs can be main
providers.
Other Outpatient Services (OOS). A
site that provides outpatient services to
veterans, but does not meet the
definition of a CBOC or HCC per this
section.
Prospective Payment System (PPS). A
Prospective Payment System (PPS) is a
method of reimbursement in which
Medicare payment is made based on a
predetermined, fixed amount. The
payment amount for a particular service
is derived based on the classification
system of that service (for example,
Medicare Severity Diagnosis-Related
Groups for inpatient hospital services
furnished by most acute care hospitals).
Provider-based outpatient facility
(PBO). A provider-based outpatient
facility is a provider of health care
services that is either created by, or
acquired by, a main provider for the
purpose of furnishing additional health
care services under the ownership,
administrative, and financial control of
the main provider, and meets the
criteria outlined in this section.
Remote location of a hospital. A
remote location of a hospital is a CBOC,
OOS Site, or HCC that is located offsite
from the main facility.
VA Medical Center (VAMC). A VAMC
is a VA facility that provides at least two
categories of care (inpatient, outpatient,
residential, or institutional extended
care).
(c) Criteria for provider-based status.
In order to be designated as a providerbased facility, the following criteria
must be met:
(1) Licensure. The facility seeking
provider-based status and the main
provider must operate under the same
license. VA facilities are not licensed by
States but all VA facilities are
considered licensed for the purpose of
collection and recovery by VA as part of
VA’s national organization structure and
in accordance with VA standards,
including standards established or
recognized by VA’s Offices of the
Medical Inspector and Inspector General
and major healthcare accreditation
organizations.
(2) Clinical services. The clinical
services of the facility seeking providerbased status and the main provider must
be integrated. Integration is
demonstrated by the following:
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(i) The professional staff of the facility
has clinical privileges at the main
provider.
(ii) The main provider maintains the
same monitoring and oversight (i.e.
credentialing and privileging) of the
facility seeking provider-based status as
it does for any other department of the
provider.
(iii) The medical director of the
facility seeking provider-based status
maintains a reporting relationship with
the chief medical officer or other similar
official of the main provider that has the
same frequency, intensity, and level of
accountability that exists in the
relationship between the medical
director of a department of the main
provider and the chief medical officer or
other similar official of the main
provider, and is under the same type of
supervision and accountability as any
other director, medical or otherwise, of
the main provider.
(iv) The medical staff committees or
other professional committees at the
main provider are responsible for
medical activities in the facility seeking
provider-based status, including quality
assurance, utilization review, and the
coordination and integration of services,
to the extent practicable, between the
facility seeking provider-based status
and the main provider.
(v) Medical records for patients
treated in the facility seeking providerbased status are integrated into a unified
retrieval system (or cross reference) of
the main provider.
(vi) Inpatient and outpatient services
of the facility seeking provider-based
status and the main provider are
integrated, and patients treated at the
facility who require further care have
full access to all services of the main
provider and are referred where
appropriate to the corresponding
inpatient or outpatient department or
service of the main provider.
(vii) Inpatient and outpatient services
of the facility seeking provider-based
status and the main provider are
recognized under the main provider’s
accreditation.
(3) Financial integration. The
financial operations of the facility
seeking provider-based status are fully
integrated within the financial system of
the main provider, as evidenced by
shared income and expenses between
the main provider and the facility. The
costs of a facility that is a hospital
department are reported in a cost center
of the provider, costs of a facility other
than a hospital department are reported
in the appropriate cost center or cost
centers of the main provider. The main
provider’s integrated health care system
manpower and labor budget and the
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financial status of any facility seeking
provider-based status is incorporated
and readily identified in the main
provider’s integrated system reports.
(4) Public awareness. The facility
seeking provider-based status must be
held out to the public (and other payers)
as part of the main provider. Patients of
the facility must be made aware that the
facility is part of a main provider and
that they will be billed accordingly. All
literature, brochures, and public
relations newsletters from the facility
seeking provider-based status must
provide the relationship between the
main provider and the facility.
(5) Obligations of hospital outpatient
departments and hospital-based
facilities. If the facility seeking providerbased status is a hospital outpatient
department or hospital-based facility,
the facility must fulfill the obligations
described in this paragraph:
(i) The hospital outpatient department
must comply with the antidumping
rules of 42 CFR 489.20(l), (m), (q), and
(r) and § 489.24.
(ii) Physician services furnished in
hospital outpatient departments or
hospital-based facilities must be billed
with the correct site-of-service so that
appropriate physician and practitioner
payment amounts can be determined
based on their geographical location.
(iii) Physicians who work in hospital
outpatient departments or hospitalbased facilities are obligated to comply
with the non-discrimination provisions
in 42 CFR 489.10(b).
(iv) Hospital outpatient departments
must treat all Medicare patients seen on
an urgent/emergent basis as hospital
outpatients.
(v) In the case of a patient admitted
to the hospital as an inpatient after
receiving treatment in the hospital
outpatient department or hospital-based
facility, payments for services in the
hospital outpatient department or
hospital-based facility are subject to the
payment window provisions applicable
to PPS hospitals and to hospitals and
units excluded from PPS set forth at 42
CFR 412.2(c)(5) and at 42 CFR
413.40(c)(2), respectively.
(vi) The hospital outpatient
department must meet applicable VA
policies pertaining to hospital health
and safety programs.
(vii) VA must treat any facility that is
located on the main hospital campus as
a department of the hospital.
(6) Operation under the control of the
main provider. The facility seeking
provider-based status is operated under
the control of the main provider.
Control of the main provider requires:
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(i) The main provider and the facility
seeking provider-based status have the
same governing body.
(ii) The facility seeking providerbased status is operated under the same
organizational documents as the main
provider. For example, the facility
seeking provider-based status must be
subject to common bylaws and
operating decisions of the governing
body of the main provider.
(iii) The main provider has final
responsibility for administrative
decisions, final approval for contracts
with outside parties, final approval for
personnel actions, final responsibility
for personnel policies (such as code of
conduct), and final approval for medical
staff appointments in the facility
seeking provider-based status.
(7) Administration and Supervision.
The reporting relationship between the
facility seeking provider-based status
and the main provider must have the
same frequency, intensity, and level of
accountability that exists in the
relationship between the main provider
and one of its existing departments, as
evidenced by compliance with all of the
following requirements:
(i) The facility seeking provider-based
status is under the direct supervision of
the main provider.
(ii) The facility seeking providerbased status is operated under the same
monitoring and oversight by the main
provider as any other department of the
provider, and is operated just as any
other department of the provider with
regard to supervision and
accountability. The facility director or
individual responsible for daily
operations at the facility:
(A) Maintains a reporting relationship
with a manager at the main provider
that has the same frequency, intensity,
and level of accountability that exists in
the relationship between the main
provider and its existing departments;
and
(B) Is accountable to the governing
body of the main provider, in the same
manner as any department head of the
provider.
(iii) The following administrative
functions of the facility seeking
provider-based status are integrated
with those of the main provider where
the facility is based: billing services,
records, human resources, payroll,
employee benefit package, salary
structure, and purchasing services.
Either the same employees or group of
employees handle these administrative
functions for the facility and the main
provider, or the administrative
functions for both the facility and the
main provider are contracted out under
the same contract agreement; or are
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handled under different contract
agreements, with the contract of the
facility or organization being managed
by the main provider.
(d) Illustrations of how the criteria are
applied. (1) A VA facility that is seeking
provider-based status that exists under
contract arrangements, where only VA
patients are seen, may be designated as
provider-based if the provider-based
requirements in this section are met.
(2) A VA facility seeking providerbased status that exists under contract
arrangements, where VA patients and
non-VA patients are seen at the same
non-VA owned facility, will have the
same provider-based status as the nonVA owned facility that is hosting the VA
facility.
(3) A VA owned and operated facility
seeking provider-based status, where
some or all of the staff are contracted
employees, may be designated as
provider-based if the provider-based
requirements in this section are met.
■ 2. Amend § 17.101 by:
■ a. Revising the section heading;
■ b. Removing the definitions ‘‘Nonprovider-based’’ and ‘‘Provider-based’’
from paragraph (a)(5); and
■ c. Revising paragraph (a)(6).
The revisions read as follows:
§ 17.101 Collection or recovery by VA for
medical care or services provided or
furnished to a veteran for a non-service
connected disability.
(a) * * *
(6) Provider-based status and charges.
Facilities that have provider-based
status by meeting the criteria in § 17.100
are entitled to bill outpatient facility
charges and professional charges. The
professional charges for these facilities
are produced by the methodologies set
forth in this section based on facility
expense RVUs. Facilities that do not
have provider-based status because they
do not meet the criteria in § 17.100 are
not permitted to bill outpatient facility
charges and can only bill a professional
charge. The professional charges for
these facilities are produced by the
methodologies set forth in this section
based on non-facility practice expense
RVUs.
*
*
*
*
*
■ 3. Amend § 17.106 by adding
paragraph (f)(2)(viii) to read as follows:
§ 17.106
payers.
VA collection rules; third-party
*
*
*
*
*
(f) * * *
(2) * * *
(viii) A third party may not reduce or
refuse payment if the facility where the
medical treatment was furnished is
designated by VA as provider-based, but
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the facility does not meet the providerbased status requirements under 42 CFR
413.65 Centers.
*
*
*
*
*
[FR Doc. 2019–24880 Filed 11–20–19; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2019–0553; FRL–10002–
39–Region 3]
Approval and Promulgation of Air
Quality Implementation Plans; West
Virginia; 2019 Amendments to West
Virginia’s Ambient Air Quality
Standards
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
state implementation plan (SIP) revision
submitted by the State of West Virginia.
This revision updates the effective date
of the national ambient air quality
standards (NAAQS) and the associated
monitoring reference and equivalent
methods for those NAAQS that West
Virginia incorporates by reference into
its state regulations. This action is being
taken under the Clean Air Act (CAA).
DATES: Written comments must be
received on or before December 23,
2019.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R03–
OAR–2019–0553, at https://
www.regulations.gov, or via email to
spielberger.susan@epa.gov. For
comments submitted at Regulations.gov,
follow the online instructions for
submitting comments. Once submitted,
comments cannot be edited or removed
from Regulations.gov. For either manner
of submission, EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
confidential business information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. EPA will generally not consider
comments or comment contents located
outside of the primary submission (i.e.
on the web, cloud, or other file sharing
system). For additional submission
methods, please contact the person
SUMMARY:
VerDate Sep<11>2014
16:09 Nov 20, 2019
Jkt 250001
identified in the FOR FURTHER
INFORMATION CONTACT section.
For the
full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Joseph Schulingkamp, Planning &
Implementation Branch (3AD30), Air &
Radiation Division, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103. The telephone number is (215)
814–2021. Mr. Schulingkamp can also
be reached via electronic mail at
schulingkamp.joseph@epa.gov.
SUPPLEMENTARY INFORMATION: On May 6,
2019, the West Virginia Department of
Environmental Protection (WVDEP)
submitted a formal revision to its SIP
pertaining to amendments of Legislative
Rule, 45CSR8—Ambient Air Quality
Standards. The SIP submittal updates
the version of the federal NAAQS and
the associated monitoring reference and
equivalent methods for those NAAQS
that West Virginia incorporates by
reference into West Virginia’s legislative
rules.
I. Summary of SIP Revision
WVDEP has historically chosen to
incorporate by reference the federal
NAAQS, found at 40 CFR part 50, and
the associated federal ambient air
monitoring reference methods and
equivalent methods for these NAAQS
found at 40 CFR part 53. When
incorporating by reference these federal
regulations, WVDEP has specified that it
is incorporating by reference these
regulations as they existed on a certain
date. The incorporation by reference of
the NAAQS that is currently SIPapproved by EPA incorporates by
reference 40 CFR parts 50 and 53 as they
existed on June 1, 2017. This SIP
revision updates the State’s
incorporation by reference of the
primary and secondary NAAQS and the
ambient air monitoring reference and
equivalent methods, found in 40 CFR
parts 50 and 53, respectively. Since the
last West Virginia incorporation by
reference of June 1, 2017, EPA reviewed
the primary standards for oxides of
nitrogen (NOX), as required by CAA
section 109(d), and retained the current
1-hour and annual nitrogen dioxide
(NO2) standards without revision. See
83 FR 17226. EPA has not made any
changes to the ambient air monitoring
reference methods or any ambient air
monitoring equivalent methods since
the last effective date of the West
Virginia rule.
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
64243
The amendments to the legislative
rule include the following changes: To
section 45–8–1 (General), the filing,
effective, and incorporation by reference
dates are changed to reflect the update
of the legislative rule, subsection 1.5
was renumbered to subsection 1.6, and
a new subsection 1.5 (Sunset Provision)
was added; to section 45–8–3 (Adoption
of Standards), the dates of the primary
and secondary NAAQS and the ambient
air monitoring reference and equivalent
methods that are to be incorporated by
reference are changed. The filing and
effective dates of the legislative rule
were updated to April 24, 2019 and June
1, 2019 respectively. The date of the
federal rules in 40 CFR parts 50 and 53
that are being incorporated by reference
into 45–8–3 are changed from June 1,
2017 to June 1, 2018.
II. Proposed Action
EPA is proposing to approve the West
Virginia SIP revision updating the date
of incorporation by reference, which
was submitted on May 6, 2019. EPA is
soliciting public comments on the
update to West Virginia’s incorporation
by reference. Please note that EPA is not
seeking public comment on the level of
the NAAQS being incorporated by
reference into the West Virginia
regulations. An opportunity for public
comment on the level of each individual
NAAQS was given when EPA proposed
each such NAAQS. Relevant comments
will be considered before taking final
action.
III. Incorporation by Reference
In this document, EPA is proposing to
include in a final EPA rule regulatory
text that includes incorporation by
reference. In accordance with
requirements of 1 CFR 51.5, EPA is
proposing to incorporate by reference
45CSR8, as effective on June 1, 2019.
EPA has made, and will continue to
make, these materials generally
available through https://
www.regulations.gov and at the EPA
Region III Office (please contact the
person identified in the FOR FURTHER
INFORMATION CONTACT section of this
preamble for more information).
IV. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
CAA and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions,
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely approves state law as meeting
E:\FR\FM\21NOP1.SGM
21NOP1
Agencies
[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Proposed Rules]
[Pages 64235-64243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24880]
=======================================================================
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ68
Provider-Based Requirements
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
regulations concerning collection and recovery by VA for medical care
and services provided to an individual at a VA medical facility for
treatment of a nonservice-connected condition. Specifically, this
rulemaking would add a regulation that establishes the requirements VA
will use to determine whether a VA medical facility has provider-based
status. Such determination affects the amount VA can recover from a
third party for the cost of the nonservice-connected care. Currently,
VA uses the requirements established by the Centers for Medicare and
Medicaid Services to determine whether the facility has provider-based
status; however, it is necessary for VA to establish its own
requirements that are tailored to VA's unique operation and structure.
DATES: Comments must be received by VA on or before January 21, 2020.
ADDRESSES: Written comments may be submitted through https://www.Regulations.gov, by mail or hand-delivery to Director, Office of
Regulation Policy and Management (00REG), Department of Veterans
Affairs, 810 Vermont Avenue NW, Room 1064, Washington, DC 20420; or by
fax to (202) 273-9026. (This is not a toll-free number.) Comments
should indicate that they are submitted in response to RIN 2900-AQ68,
Provider-Based Requirements. Copies of comments received will be
available for public inspection in the Office of Regulation Policy and
Management, Room 1064, 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, Director of Policy and
Planning, Office of Community Care (10D), Ptarmigan at Cherry Creek
Denver, CO, 80209, [email protected] or (303) 372-4629. (This is not
a toll-free number.)
SUPPLEMENTARY INFORMATION: VA is authorized under 38 U.S.C. 1729 to
recover or collect from a third party the reasonable charges for
medical care or services VA furnishes to an individual for a non-
service connected disability, to the extent that the individual, or the
provider of care or services, would be eligible to receive payment from
the third party if the care or services had not been furnished by VA.
VA's collection or recovery under section 1729 is limited to care or
services furnished by VA for a nonservice-connected disability:
Incurred incident to the individual's employment and covered under a
worker's compensation law or plan that provides reimbursement or
indemnification for such care and services; incurred as the result of a
crime of personal violence that occurred in a State, or a political
subdivision of a State, in which a person injured as the result of such
a crime is entitled to receive health care and services at such State's
or subdivision's expense for personal injuries suffered as the result
of such crime; incurred as a result of a motor vehicle accident in a
State that requires automobile accident reparations (no-fault)
insurance; or for which the individual is entitled to care (or the
payment of expenses of care) under a health plan contract.
VA implements its authority under section 1729 through regulations
at title 38 Code of Federal Regulations (CFR) 17.101 through 17.106.
More specifically, the methodology that VA uses to determine the amount
of its collection or recovery for is established in 38 CFR 17.101. This
rulemaking would primarily seek to revise this methodology with regards
to calculating the reasonable charges for care and services VA provides
on an outpatient basis. Prior to explaining the proposed regulatory
changes for Sec. 17.101, we provide the following background on how VA
developed its current methodology for charges for outpatient
[[Page 64236]]
services. Historically, if VA had a specific item of medical care or
service provided on an outpatient basis, VA could charge a professional
charge, an outpatient facility charge, or both. These charges were
developed so as to be mutually exclusive, with the expectation that
both charges could be billed for the same occasion of service.
In April 2000, the Centers for Medicare and Medicaid Services (CMS)
published a final rule with comment period that, in pertinent part,
codified its long-standing use of provider-based status in regulation
at 42 CFR 413.65. 65 FR 18434 (April 7, 2000). In this final rule, CMS
explained that, since the Medicare program started, some providers,
referred to as main providers, had functioned as a single entity while
owning and operating additional departments, locations, and facilities.
These departments, locations, and facilities were referred to as
provider-based and were treated as part of the main provider for
Medicare purposes. In this regard, to the extent that overhead costs of
the main provider, such as administrative and general costs, were
shared by the provider-based facility, these costs were allowed to flow
to the provider-based facility through the cost allocation process in
the cost report. This was considered appropriate because these
facilities were also operationally integrated, and the provider-based
facility was sharing the overhead costs and revenue producing services
controlled by the main provider. In the April 2000 final rulemaking,
CMS defined the term provider-based status as the relationship between
a main provider and a provider-based entity or a department of a
provider, remote location of a hospital, or satellite facility, that
complies with the provisions of this section. 42 CFR 413.65(a)(2). It
also established specific requirements that must be met in order for
CMS to recognize a facility as having provider-based status. CMS
explained that specific criteria were necessary because the designation
of provider-based status could result in additional Medicare payments
for services furnished at the provider-based facility (outpatient
facility charges), and could also increase the coinsurance liability of
Medicare beneficiaries for those services. The final rule clarified
that 42 CFR 413.65 applied to providers and facilities seeking Medicare
payment. As VA does not seek Medicare payment, the requirements and
criteria established in 42 CFR 413.65 applies to VA only if VA so
establishes through its own regulations.
In December 2003, VA amended 38 CFR 17.101 to establish that VA
would use the CMS provider-based criteria in 42 CFR 413.65 to more
closely approximate industry standard charge structures and billing
practices. 68 FR 70714 (December 19, 2003). That VA rulemaking further
established two sets of charges for outpatient care consistent with
Medicare: One for use by facilities that had provider-based status and
one for facilities that did not have provider-based status. The
facilities that had provider-based status could bill both an outpatient
professional and facility charge. The facilities that did not have
provider-based status could only bill a professional charge. In
consideration of the fact that facilities that did not have provider-
based status could only bill a professional charge, the professional
charge for those facilities would be higher than the professional
charge for facilities that had provider-based status, based on
Medicare's higher non-facility practice expense relative value units
(RVUs).
Currently, VA defines the terms provider-based and non-provider-
based in 38 CFR 17.101(a)(5). Section 17.101(a)(5) defines provider-
based as the outpatient department of a VA hospital or any other VA
health care entity that meets CMS provider-based criteria. Provider-
based entities are entitled to bill outpatient facility charges. Under
Sec. 17.101(a)(5), non-provider-based is defined as a VA health care
entity (such as a small VA community-based outpatient clinic) that
functions as the equivalent of a doctor's office or for other reasons
does not meet CMS provider-based criteria, and, therefore, is not
entitled to bill outpatient facility charges. VA establishes the use of
the CMS provider-based criteria in its third-party billing through
Sec. 17.101(a)(6), which states in pertinent part that each VA health
care entity are designated as either provider-based or non-provider
based provider-based entities are entitled to bill outpatient facility
charges; non-provider-based entities are not.
For the reasons below, VA proposes to revise 38 CFR 17.101 to
remove the current regulatory requirement that VA use the CMS provider-
based criteria with regards to VA billing of third parties, and
proposes to add a new regulation at 38 CFR 17.100 that would establish
the criteria that VA would use instead to determine whether a VA
facility has provider-based status. In so doing, VA would model new
proposed 38 CFR 17.100 on a majority of the current CMS provider-based
criteria in 42 CFR 413.65, but VA's revisions would address the unique
structure of VA's health care system, versus the CMS requirements that
are more generally applicable to private health care systems.
Significantly, VA is an integrated, national health care system and,
therefore, some of the CMS requirements in 42 CFR 413.65, especially as
they pertain to proximity limitations and licensure, are not
appropriate to use for VA facilities. Those CMS requirements that are
not appropriate to use for VA facilities are further identified and
explained in more detail in the discussions below.
Additionally, to provide a scope for the proposed changes further
explained below, we note that as of June 2018, 93 percent out of the
total number of VA's facilities from which recoverable costs for care
or services are provided (VA's billable facilities) already meet the
current CMS provider-based criteria under 42 CFR 413.65(d) and (e) to
permit VA to bill both an outpatient professional charge and an
outpatient facility charge. Therefore, the proposed changes explained
below would only have a potential effect in practical billing practices
(to allow for the billing of an outpatient facility charge, in addition
to the current billing of an outpatient professional charge) for seven
percent of VA's billable facilities. More detail is provided in the
section of this rulemaking that discusses the Regulatory Flexibility
Act.
Sec. 17.100 Requirements for Provider-Based Status
We propose to add a new regulation at 38 CFR 17.100. Section 17.100
would be located under the undesignated center heading Charges,
Waivers, and Collections and would be titled Requirements for provider-
based status.
In proposed Sec. 17.100(a), we would describe a clear scope for
establishing this section, which is to provide the criteria we would
use to determine whether a VA medical facility has provider-based
status for purposes of billing for nonservice-connected and non-special
treatment authority conditions. We would also explain that while these
requirements are modeled after the requirements established in the CMS
regulation, 42 CFR 413.65, there are some differences that are designed
to address the unique operational activities of the VA health care
system.
Proposed Sec. 17.100(b) would contain the definitions that would
apply to this section. While some of these terms are based on those
definitions in the CMS regulation, most are defined in the context of
VA's unique structure and organization as indicated within the
discussions of each proposed definition below. This ensures that we use
the definitions and terminology that are
[[Page 64237]]
most appropriate and applicable to VA's health care system.
Community Based Outpatient Clinic (CBOC) would be defined as a VA-
operated, VA-funded, or VA-reimbursed site of care that is not located
within a VA Medical Center. We would further explain that a CBOC can
provide primary, specialty, subspecialty, mental health, or any
combination of health care delivery services that can be appropriately
provided in an outpatient setting. A CBOC is unique to VA, and would be
consistent with other VA definitions or uses of the term.
Community Living Center (CLC) would be defined as a component of
the spectrum of long-term care that provides a skilled nursing
environment and houses a variety of specialty programs, such as respite
care, dementia care, and skilled nursing care, for persons needing
short and long stay services. We would further explain that CLCs are
typically located on or near a VA medical facility and are VA-owned and
operated, but may be free-standing in the community. This definition of
CLC would be consistent with other VA definitions or uses of the term.
Facility would be defined as a point of care where individuals can
seek health care services, to include a VA Medical Center, CBOC, Health
Care Center, CLC, and Other Outpatient Services site. This definition
would specifically reference the facilities within VA that currently
provide health care services.
Health Care Center (HCC) would be defined as a VA-owned, VA-leased,
VA-contracted, or shared clinic that is operational at least five days
per week and provides primary care, mental health care, on site
specialty services, and performs ambulatory surgery and/or invasive
procedures that may require moderate sedation or general anesthesia.
This definition would be consistent with other VA definitions or uses
of the term, and is defined to reflect VA's organization and structure.
Main Provider (or parent facility/hospital or PBH) would be defined
as a provider that either creates, or acquires ownership of, another
facility to deliver additional health care services under its name,
ownership, and financial and administrative control. This is consistent
with the CMS definition of main provider in 42 CFR 413.65(a)(2). We
note that VA generally refers to its main providers as provider-based
hospitals (PBHs). Although these facilities operate as main providers
operate in the private sector and are not subordinate facilities that
would seek provider-based status, VA has historically referred to them
as PBHs. For clarity, we will refer to these facilities as main
providers in the preamble and regulation text. We would further explain
that VAMCs and HCCs can be main providers. This definition would
reflect VA's organization and structure, and reference those facilities
within VA that are examples of main providers.
Other Outpatient Services (OOS) would be defined as a site that
provides outpatient services to veterans, but does not meet the
definition of a CBOC or HCC. This definition would be consistent with
other VA definitions or uses of the term, as well as VA's structure and
organization. Examples of OOS can include sleep centers, post-traumatic
stress disorder clinics, and a clinic without primary care or mental
health services.
Prospective Payment System (PPS) would be defined as a method of
reimbursement in which Medicare payment is made based on a
predetermined, fixed amount. The payment amount for a particular
service is derived based on the classification system of that service
(for example, Medicare Severity Diagnosis-Related Groups for inpatient
hospital services furnished by most acute care hospitals). This
definition would be consistent with the definition used by CMS.
Provider-Based Outpatient Facility (PBO) would be defined as a
provider of health care services that is either created by, or acquired
by, a main provider for the purpose of furnishing additional health
care services under the ownership, administrative, and financial
control of the main provider and meets the criteria outlined in this
section. CMS does not define the general term of provider-based
outpatient facility and instead, CMS separately defines the types of
facilities or entities that could obtain provider-based status, to
include department of a provider, provider-based entity, and remote
location of a hospital. However, for the purposes of VA, it is not
necessary to distinguish between the different types of facilities, and
therefore, VA will have one term to broadly encompass all provider-
based outpatient facilities.
Remote Location of a Hospital would be a CBOC, OOS site, or HCC
that is located offsite from the main facility. This definition would
differ from the definition provided in 42 CFR 413.65 in order to
specifically define this term within the context of VA's facilities and
reflect VA's unique organization and structure.
VA Medical Center (VAMC) would be defined as a VA facility that
provides at least two categories of care (inpatient, outpatient,
residential, or institutional extended care). This definition would be
consistent with other VA definitions or uses of the term, as well as
VA's structure and organization.
In proposed Sec. 17.100(c), we would set forth the criteria that
would be used to determine whether a facility has provider-based status
for purposes of billing for nonservice-connected and non-special
treatment authority conditions. Section 17.100(c) is largely modeled
after the requirements for all facilities or organizations in 42 CFR
413.65(d), additional requirements applicable to off-campus facilities
or organizations in 42 CFR 413.65(e), and obligations of hospital
outpatient departments and hospital-based entities in 42 CFR 413.65(g).
In proposed Sec. 17.100(c)(1), we would require that the facility
seeking provider-based status and the main provider operate under the
same license. This requirement would be consistent with the CMS
provider-based criteria located at 42 CFR 413.65(d)(1), which generally
requires a department of a provider, the remote location of a hospital,
or the satellite facility and the main provider operate under the same
license. As previously explained, VA is not distinguishing between
departments of providers, remote locations of a hospital, satellite
facilities, and other provider-based facilities. Therefore, proposed
paragraph (c)(1) would state that the facility seeking provider-based
status and the main provider operate under the same license. Because VA
is a Federal entity, VA facilities are not licensed, and are not
required to be licensed, under any State laws or other State
authorities. Therefore, we would also explain that VA facilities are
not licensed by States but are considered licensed by VA for the
purpose of collection and recovery as part of VA's national
organization structure and in accordance with VA standards, including
those recognized by VA's Office of the Medical Inspector and Inspector
General, as well as standards of major healthcare accreditation
organizations such as The Joint Commission as applicable to specific VA
facilities.
In proposed Sec. 17.100(c)(2), we would require that the clinical
services of the facility seeking provider-based status and the main
provider be integrated. We would further explain that integration is
demonstrated by several factors, which would be listed in the
regulation. These factors would include (1) the professional staff at
the facility seeking provider-based status has clinical privileges at
the main provider; (2) the main provider maintains the same
[[Page 64238]]
monitoring and oversight (i.e. credentialing and privileging) of the
facility seeking provider-based status as it does for any other
department of the provider; (3) the medical director of the facility
seeking provider-based status maintains a reporting relationship with
the chief medical officer or other similar official of the main
provider that has the same frequency, intensity, and level of
accountability that exists in the relationship between the medical
director of a department of the main provider and the chief medical
officer or other similar official of the main provider, and is under
the same type of supervision and accountability as any other director,
medical or otherwise, of the main provider; (4) the medical staff
committees or other professional committees at the main provider are
responsible for medical activities in the facility seeking provider-
based status, including quality assurance, utilization review, and the
coordination and integration of services, to the extent practicable,
between the facility seeking provider-based status and the main
provider; (5) the medical records for patients treated in the facility
are integrated into a unified retrieval system (or cross reference) of
the main provider; (6) inpatient and outpatient services of the
facility seeking provider-based status and the main provider are
integrated, and patients treated at the facility who require further
care have full access to all services of the main provider and are
referred where appropriate to the corresponding inpatient or outpatient
department or service of the main provider; and (7) inpatient and
outpatient services of the facility seeking provider-based status and
the main provider are recognized under the main provider's
accreditation. The first six factors would be consistent with the CMS
criteria located at 42 CFR 413.65(d)(2). However, the seventh factor,
regarding accreditation, would be additional factor that demonstrates
integration for VA facilities. This would reflect the unique structure
and organization of VA, in which inpatient and outpatient services of
VA facilities are recognized under the main provider's accreditation.
In proposed Sec. 17.100(c)(3), we would propose to require
financial integration of the facility seeking provider-based status and
the main provider. Specifically, we would require that the financial
operations of the facility seeking provider-based status are fully
integrated within the financial system of the main provider, as
evidenced by shared income and expenses between the main provider and
the facility. We would also require that the costs of a facility that
is a hospital department be reported in a cost center of the provider,
costs of a provider-based facility other than a hospital department be
reported in the appropriate cost center or cost centers of the main
provider. This would be consistent with CMS requirements in 42 CFR
413.65(d)(3). However, we would also require that the main provider's
integrated health care system manpower and labor budget and the
financial status of any provider-based facility be incorporated and
readily identified in the main provider's integrated system reports.
This additional requirement would reflect that the main provider has
administrative and financial control of the provider-based facility,
and would be consistent with similar CMS requirements in 42 CFR
413.65(d)(3). This would reflect VA's current structure and
organization in which a main provider has such control, particularly
budgetary, over facilities.
Under proposed Sec. 17.100(c)(4), we would include a requirement
for public awareness. Specifically, we would require that the facility
seeking provider-based status be held out to the public (and other
payers) as part of the main provider. This would be exhibited by the
patients of the facility being made aware that the facility is part of
a main provider and that they will be billed accordingly. This would be
consistent with the CMS requirement for public awareness in 42 CFR
413.65(d)(4). In addition, we would also propose that all literature,
brochures, and public relations newsletters from the facility seeking
provider-based status include the relationship between the main
provider and the facility. This is current VA practice for facilities
associated or affiliated with a main provider and reflects the
relationship between the facilities.
Proposed Sec. 17.100(c)(5) would contain obligations when the
facility seeking provider-based status is a hospital outpatient
department or hospital-based entity, including (1) compliance with the
``antidumping'' rules of 42 CFR 489.20(l), (m), (q), and (r) and 42 CFR
489.24; (2) physician services must be billed with the correct site-of-
service so that appropriate physician and practitioner amounts can be
determined; (3) physicians are obligated to comply with the non-
discrimination provisions in 42 CFR 489.10; (4) the facility seeking
provider-based status must treat all Medicare patients seen on an
urgent/emergent basis as hospital outpatients; (5) in the case of a
patient admitted to the hospital as an inpatient after receiving
treatment in the hospital outpatient department or hospital-based
facility, payments for services in the hospital outpatient department
of hospital-based facility are subject to the payment window provisions
applicable to PPS hospitals and to hospitals and units excluded from
PPS set forth at 42 CFR 412.2(c)(5) and at 42 CFR 413.40(c)(2),
respectively; (6) the hospital outpatient department must meet
applicable VA policy pertaining to hospital health and safety programs;
and (7) VA must treat any facility that is located on the main hospital
campus as a department of the hospital. The criteria described in (1)-
(7) are largely consistent with CMS regulations at Sec. 413.65(d)(5)
and (g).
We note that we would not propose to include all of the criteria
located at Sec. 413.65(g), Obligations of hospital outpatient
departments and hospital-based entities, because some of the
requirements are not applicable to VA. For example, Sec. 413.65(g)(3)
(hospital outpatient departments must comply with all the terms of the
hospital's provider agreement) and Sec. 413.65(g)(7) (when a Medicare
beneficiary is treated in a hospital outpatient department that is not
located on the main provider's campus, the treatment is not required to
be provided by the ``antidumping'' rules in Sec. 489.24 of this
chapter, and the beneficiary will incur a coinsurance liability for an
outpatient visit to the hospital as well as for the physician service,
certain requirements must be met) are not included because they are not
applicable.
In proposed Sec. 17.100(c)(6), we would include the requirement
that the facility seeking provider-based status is operated under the
control of the main provider. Such control would require (1) the main
provider and the facility seeking provider-based status have the same
governing body; (2) the facility seeking provider-based status is
operated under the same organizational documents as the main provider
(e.g. the facility is subject to common bylaws and operating decisions
of the main provider's governing body); (3) the main provider has final
responsibility for administrative decisions, final approval for
contracts with outside parties, final approval for personnel actions,
final responsibility for personnel policies (such as code of conduct),
and final approval for medical staff appointments in the facility
seeking provider-based status. This is modeled after the criteria in
Sec. 413.65(e)(1) which requires operation under the ownership and
control of the main provider as an additional requirement applicable to
off-campus facilities or organizations. However, we propose to remove
the
[[Page 64239]]
ownership requirements because, in the VA structure, main providers do
not own other facilities.
Proposed Sec. 17.100(c)(7) would establish the requirement for
administration and supervision of the facility seeking provider-based
status. Significantly, the reporting relationship between the facility
seeking provider-based status and the main provider must have the same
frequency, intensity, and level of accountability that exists in the
relationship between the main provider and one of its existing
departments, as evidenced by compliance with further identified
requirements. These include (1) the facility seeking provider-based
status must be under the direct supervision of the main provider, (2)
the facility seeking provider-based status must be operated under the
same monitoring and oversight by the main provider as any other
department of the provider and is operated just as any other department
of the provider with regard to supervision and accountability; and (3)
administrative functions (i.e. billing services, records, human
resources, payroll, employee benefit package, salary structure, and
purchasing services) of the facility seeking provider-based status are
integrated with those of the main provider.
We would further explain that as part of the requirement for the
same monitoring and oversight located in proposed Sec.
17.100(c)(7)(ii), the facility director or individual responsibility
for daily operations at the facility must maintain a reporting
relationship with a manager at the main provider that has the same
frequency, intensity and level of accountability that exists in the
relationship between the main provider and its existing departments,
and is accountable to the governing body of the main provider, in the
same manner as any department head of the provider. In addition, we
would explain that the requirement of integrated administrative
functions, as set forth in proposed Sec. 17.100(c)(7)(iii), includes
that either the same employees or group of employees handle the
identified administrative functions for the facility and main provider,
or those functions are contracted out under the same contract
agreement; or are handled under different contract agreements, with the
contract of the facility or organization being managed by the main
provider. The criteria under proposed Sec. 17.100(c)(7) are consistent
with those under the CMS regulations at 42 CFR 413.65(e)(2).
Lastly, under proposed Sec. 17.100(d), we would illustrate how the
criteria are applied when VA does not own the facility, but operates
under a contract, and in the situation when the employees at a VA
facility are contract employees. We would explain that, (1) a VA
facility that is seeking provider-based status that exists under
contract arrangements, where only VA patients are seen, may be
designated as provider-based as long as the provider-based requirements
in this section are met; (2) A VA facility seeking provider-based
status that exists under contract arrangements, where VA patients and
non-VA patients are seen at the same non-VA owned facility, will have
the same provider-based status as the non-VA owned facility that is
hosting the VA facility; and (3) a VA owned and operated facility
seeking provider-based status, where some or all of the staff are
contracted employees, may be designated as provider-based as long as
the provider-based requirements in this section are met. This is
because the facility is still considered VA owned and operated,
regardless of whether the staff is contracted or not.
The CMS requirements include numerous other provisions that are
applicable to private health care systems, but are not applicable to
the VA health care system. For example, in the proposed rulemaking we
are not including the information in 42 CFR 413.65(b) or (c) on what is
required to seek a determination of provider-based status from CMS and
what is required for reporting material changes in relationships to
CMS, because VA and not CMS will make the determination of whether a VA
facility has provider-based status.
In addition, this proposed rulemaking does not include the CMS
criteria at 42 CFR 413.65(e)(3) regarding location requirements. These
include, generally, that the facility is located within a 35 mile
radius of the campus of the potential main provider or that the
facility is owned and operated by a hospital that has a
disproportionate share adjustment greater than 11.75 percent and that
the facility demonstrates a high level of integration with the main
provider by showing that it serves the same patient population as the
main provider. Although in the private sector, mileage between the main
provider and the facility seeking provider-based status demonstrates a
level of integration, we believe that the same is not true for VA.
VA is a nationwide health care system that is structured to require
all facilities that are not main providers be controlled by and
financially and administratively integrated with the main provider in
its region, regardless of mileage. In this regard, each designated
region has one main provider and when VA acquires or creates a new
facility (that is not a main provider), the new facility is
automatically paired with the main provider that is in its region. The
new facility is assigned a shared station number with the main provider
that has a unique suffix and is under the main provider's control. We
emphasize that the pairing is only based on location to the extent that
the new facility is within the main provider's region; it does not
depend upon a certain mileage requirement. For example, in the State of
Maine, there is one main provider and all other facilities, regardless
of distance from the main provider, are administratively and
financially integrated with and controlled by the main provider. It
does not matter whether the facility is 20 miles away or 200 miles
away. Therefore, VA believes that the location requirement is not a
relevant criterion to determine integration within the VA system.
Moreover, the proposed rulemaking does not include the requirements
for joint ventures under 42 CFR 413.65(f), management contracts under
42 CFR 413.65(h), inappropriate treatment of a facility or organization
as provider-based under 42 CFR 413.65(j), temporary treatment as
provider-based under 42 CFR 413.65(k), correction of errors under 42
CFR 413.65(l), the status of Indian Health Service and Tribal
facilities and organizations under 42 CFR 413.65(m), FQHCs and look
alikes under 42 CFR 413.65(n), and effective date of provider-based
status under 42 CFR 413.65(o). VA believes that these provisions are
not pertinent to VA's structure as a national health care system for
veterans, and therefore, we will not include these or similarly not
relevant provisions into the proposed rulemaking.
Sec. 17.101 Collection or Recovery by VA for Medical Care or Services
Provided or Furnished to a Veteran for a Nonservice-Connected
Disability
We propose to revise Sec. 17.101(a)(5) by removing the definitions
of provider-based and non-provider-based. The term provider-based
outpatient facility will be defined in Sec. 17.100(b)(2). Therefore,
we do not believe that it needs to be defined in Sec. 17.101. We also
propose to remove the definition of non-provider-based. CMS does not
define that term in Sec. 413.65 and we do not believe it is necessary
to define. If a facility does not meet the criteria in Sec. 17.100,
the facility will simply not have provider-based status.
We propose to amend Sec. 17.101(a) by first stating that the
paragraph will cover charges related to provider-based
[[Page 64240]]
status. We would explain that facilities that have provider-based
status by meet the criteria in Sec. 17.100 would be entitled to bill
outpatient facility charges and professional charges. The professional
charges for these facilities would be produced by the methodologies set
forth in this section based on facility expense RVUs. Facilities that
do not have provider-based status because it did not meet the criteria
in Sec. 17.100 would not be permitted to bill outpatient facility
charges and could only bill a professional charge. The professional
charges for these facilities would be produced by the methodologies set
forth in this section based on non-facility practice expense RVUs.
Sec. 17.106 VA Collection Rules; Third-Party Payers
As previously discussed, under 38 U.S.C. 1729, VA has the right to
recover or collect reasonable charges for medical care or services from
a third party under four circumstances. In addition, section 1729(f)
provides that no law of any State or of any political subdivision of a
State, and no provision of any contract or other agreement, shall
operate to prevent recovery or collection by the United States under
this section or with respect to care or services furnished under
section 1784 of this title. VA has established rules for third party
payers in 38 CFR 17.106. Specifically, Sec. 17.106(f) contains the
general rules for the administration of section 1729 and this part,
with clarifying examples of when a third-party may not reduce, offset,
or request a refund for payments made to VA. Section 17.106(f)(2)
explicitly provides that the list of examples is not exclusive. We
propose to add another example to 38 CFR 17.106(f)(2) to clarify that
third parties cannot reduce or refuse payment based on VA's designation
that a facility is provider-based.
Effect of Rulemaking
The Code of Federal Regulations, as proposed to be revised by this
proposed rulemaking, would represent the exclusive legal authority on
this subject. No contrary rules or procedures would be authorized. All
VA guidance would be read to conform with this proposed rulemaking if
possible or, if not possible, such guidance would be superseded by this
rulemaking.
Paperwork Reduction Act
This rule contains no collections of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
facilities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. Over 90 per cent of VA's current billing facilities
presently engage in the practices that would be enabled by this rule
for a remaining small percentage of VA facilities. Additionally, while
the rule would allow for recognition of an additional set of billable
charges for the small percentage of VA facilities that to not already
engage in such practices, the rule would not guarantee such charges
would be paid by third parties or collected by VA. The estimated
average annual potential impact of less than $4 million would otherwise
not be significant when considered to apply to the aggregate of typical
third-party insurers or payers in the U.S. health care industry at
large. Therefore, pursuant to 5 U.S.C. 605(b), this rule 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 Management and Budget has examined the economic,
interagency, budgetary, legal, and policy implications of this
regulatory action and determined that it is a significant regulatory
action under Executive Order 12866, because it raises novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order. VA's
impact analysis can be found as a supporting document at https://
www.regulations.gov, usually within 48 hours after the rulemaking
document is published. Additionally, a copy of the rulemaking and its
impact analysis are available on VA's website at https://www.va.gov/orpm
by following the link for VA Regulations Published from FY 2004 through
FYTD.
This proposed rule is not subject to the requirements of E.O. 13771
because this proposed rule results 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 proposed rule is not likely to have
such effect on State, local, and tribal governments, or on the private
sector.
Catalog of Federal Domestic Assistance Numbers
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are 64.008--Veterans Domiciliary
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; 64.026--
Veterans State Adult Day Health Care; 64.039--CHAMPVA; 64.040--VHA
Inpatient Medicine; 64.041--VHA Outpatient Specialty Care; 64.042--VHA
Inpatient Surgery; 64.043--VHA Mental Health Residential; 64.044--VHA
Home Care; 64.045--VHA Outpatient Ancillary Services; 64.046--VHA
Inpatient Psychiatry; 64.047--VHA Primary Care; 64.048--VHA Mental
Health clinics; 64.049--VHA Community Living Center; 64.050--VHA
Diagnostic Care.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Health care, Health
facilities, Health professions, Health records, Medical devices,
Medical research, Mental health programs, Nursing homes, Philippines,
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
[[Page 64241]]
document on May 3, 2019, for publication.
Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy &
Management, Office of the Secretary, Department of Veterans Affairs.
For the reasons set out in the preamble, VA proposes to amend 38
CFR part 17 as set forth below:
PART 17--MEDICAL
0
1. The authority citation for part 17 continues to read in part as
follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
0
2. Add Sec. 17.100 under the undesignated center heading ``Charges,
Waivers, and Collections'' to read as follows:
Sec. 17.100 Requirements for provider-based status.
(a) Scope. This section establishes the criteria that VA uses to
determine whether a VA medical facility is designated as provider-based
for purposes of billing for non-service-connected and non-special
treatment authority conditions.
(b) Definitions. For purposes of this section:
Community Based Outpatient Clinic (CBOC). A CBOC is a VA-operated,
VA-funded, or VA-reimbursed site of care that is not located within a
VA Medical Center. A CBOC can provide primary, specialty, subspecialty,
mental health, or any combination of health care delivery services that
can be appropriately provided in an outpatient setting.
Community Living Center (CLC). A CLC is a component of the spectrum
of long-term care that provides a skilled nursing environment and
houses a variety of specialty programs for persons needing short and
long stay services. VA CLCs are typically located on, or near a VA
medical facility and are VA-owned and operated, but may be free-
standing in the community.
Facility. A facility is a point of care where individuals can seek
VA health care services, to include a VA Medical Center, CBOC, Health
Care Center, CLC, and Other Outpatient Services site.
Health Care Center (HCC). An HCC is a VA-owned, VA-leased, VA-
contracted or shared clinic that is operational at least five days per
week and provides primary care, mental health care, on site specialty
services, and performs ambulatory surgery and/or invasive procedures
that may require moderate sedation or general anesthesia.
Main provider. A main provider (or parent facility/hospital or
provider-based hospital (PBH)) is a provider that either creates, or
acquires ownership of, another facility to deliver additional health
care services under its name, ownership, and financial and
administrative control. For example, VA Medical Centers and HCCs can be
main providers.
Other Outpatient Services (OOS). A site that provides outpatient
services to veterans, but does not meet the definition of a CBOC or HCC
per this section.
Prospective Payment System (PPS). A Prospective Payment System
(PPS) is a method of reimbursement in which Medicare payment is made
based on a predetermined, fixed amount. The payment amount for a
particular service is derived based on the classification system of
that service (for example, Medicare Severity Diagnosis-Related Groups
for inpatient hospital services furnished by most acute care
hospitals).
Provider-based outpatient facility (PBO). A provider-based
outpatient facility is a provider of health care services that is
either created by, or acquired by, a main provider for the purpose of
furnishing additional health care services under the ownership,
administrative, and financial control of the main provider, and meets
the criteria outlined in this section.
Remote location of a hospital. A remote location of a hospital is a
CBOC, OOS Site, or HCC that is located offsite from the main facility.
VA Medical Center (VAMC). A VAMC is a VA facility that provides at
least two categories of care (inpatient, outpatient, residential, or
institutional extended care).
(c) Criteria for provider-based status. In order to be designated
as a provider-based facility, the following criteria must be met:
(1) Licensure. The facility seeking provider-based status and the
main provider must operate under the same license. VA facilities are
not licensed by States but all VA facilities are considered licensed
for the purpose of collection and recovery by VA as part of VA's
national organization structure and in accordance with VA standards,
including standards established or recognized by VA's Offices of the
Medical Inspector and Inspector General and major healthcare
accreditation organizations.
(2) Clinical services. The clinical services of the facility
seeking provider-based status and the main provider must be integrated.
Integration is demonstrated by the following:
(i) The professional staff of the facility has clinical privileges
at the main provider.
(ii) The main provider maintains the same monitoring and oversight
(i.e. credentialing and privileging) of the facility seeking provider-
based status as it does for any other department of the provider.
(iii) The medical director of the facility seeking provider-based
status maintains a reporting relationship with the chief medical
officer or other similar official of the main provider that has the
same frequency, intensity, and level of accountability that exists in
the relationship between the medical director of a department of the
main provider and the chief medical officer or other similar official
of the main provider, and is under the same type of supervision and
accountability as any other director, medical or otherwise, of the main
provider.
(iv) The medical staff committees or other professional committees
at the main provider are responsible for medical activities in the
facility seeking provider-based status, including quality assurance,
utilization review, and the coordination and integration of services,
to the extent practicable, between the facility seeking provider-based
status and the main provider.
(v) Medical records for patients treated in the facility seeking
provider-based status are integrated into a unified retrieval system
(or cross reference) of the main provider.
(vi) Inpatient and outpatient services of the facility seeking
provider-based status and the main provider are integrated, and
patients treated at the facility who require further care have full
access to all services of the main provider and are referred where
appropriate to the corresponding inpatient or outpatient department or
service of the main provider.
(vii) Inpatient and outpatient services of the facility seeking
provider-based status and the main provider are recognized under the
main provider's accreditation.
(3) Financial integration. The financial operations of the facility
seeking provider-based status are fully integrated within the financial
system of the main provider, as evidenced by shared income and expenses
between the main provider and the facility. The costs of a facility
that is a hospital department are reported in a cost center of the
provider, costs of a facility other than a hospital department are
reported in the appropriate cost center or cost centers of the main
provider. The main provider's integrated health care system manpower
and labor budget and the
[[Page 64242]]
financial status of any facility seeking provider-based status is
incorporated and readily identified in the main provider's integrated
system reports.
(4) Public awareness. The facility seeking provider-based status
must be held out to the public (and other payers) as part of the main
provider. Patients of the facility must be made aware that the facility
is part of a main provider and that they will be billed accordingly.
All literature, brochures, and public relations newsletters from the
facility seeking provider-based status must provide the relationship
between the main provider and the facility.
(5) Obligations of hospital outpatient departments and hospital-
based facilities. If the facility seeking provider-based status is a
hospital outpatient department or hospital-based facility, the facility
must fulfill the obligations described in this paragraph:
(i) The hospital outpatient department must comply with the
antidumping rules of 42 CFR 489.20(l), (m), (q), and (r) and Sec.
489.24.
(ii) Physician services furnished in hospital outpatient
departments or hospital-based facilities must be billed with the
correct site-of-service so that appropriate physician and practitioner
payment amounts can be determined based on their geographical location.
(iii) Physicians who work in hospital outpatient departments or
hospital-based facilities are obligated to comply with the non-
discrimination provisions in 42 CFR 489.10(b).
(iv) Hospital outpatient departments must treat all Medicare
patients seen on an urgent/emergent basis as hospital outpatients.
(v) In the case of a patient admitted to the hospital as an
inpatient after receiving treatment in the hospital outpatient
department or hospital-based facility, payments for services in the
hospital outpatient department or hospital-based facility are subject
to the payment window provisions applicable to PPS hospitals and to
hospitals and units excluded from PPS set forth at 42 CFR 412.2(c)(5)
and at 42 CFR 413.40(c)(2), respectively.
(vi) The hospital outpatient department must meet applicable VA
policies pertaining to hospital health and safety programs.
(vii) VA must treat any facility that is located on the main
hospital campus as a department of the hospital.
(6) Operation under the control of the main provider. The facility
seeking provider-based status is operated under the control of the main
provider. Control of the main provider requires:
(i) The main provider and the facility seeking provider-based
status have the same governing body.
(ii) The facility seeking provider-based status is operated under
the same organizational documents as the main provider. For example,
the facility seeking provider-based status must be subject to common
bylaws and operating decisions of the governing body of the main
provider.
(iii) The main provider has final responsibility for administrative
decisions, final approval for contracts with outside parties, final
approval for personnel actions, final responsibility for personnel
policies (such as code of conduct), and final approval for medical
staff appointments in the facility seeking provider-based status.
(7) Administration and Supervision. The reporting relationship
between the facility seeking provider-based status and the main
provider must have the same frequency, intensity, and level of
accountability that exists in the relationship between the main
provider and one of its existing departments, as evidenced by
compliance with all of the following requirements:
(i) The facility seeking provider-based status is under the direct
supervision of the main provider.
(ii) The facility seeking provider-based status is operated under
the same monitoring and oversight by the main provider as any other
department of the provider, and is operated just as any other
department of the provider with regard to supervision and
accountability. The facility director or individual responsible for
daily operations at the facility:
(A) Maintains a reporting relationship with a manager at the main
provider that has the same frequency, intensity, and level of
accountability that exists in the relationship between the main
provider and its existing departments; and
(B) Is accountable to the governing body of the main provider, in
the same manner as any department head of the provider.
(iii) The following administrative functions of the facility
seeking provider-based status are integrated with those of the main
provider where the facility is based: billing services, records, human
resources, payroll, employee benefit package, salary structure, and
purchasing services. Either the same employees or group of employees
handle these administrative functions for the facility and the main
provider, or the administrative functions for both the facility and the
main provider are contracted out under the same contract agreement; or
are handled under different contract agreements, with the contract of
the facility or organization being managed by the main provider.
(d) Illustrations of how the criteria are applied. (1) A VA
facility that is seeking provider-based status that exists under
contract arrangements, where only VA patients are seen, may be
designated as provider-based if the provider-based requirements in this
section are met.
(2) A VA facility seeking provider-based status that exists under
contract arrangements, where VA patients and non-VA patients are seen
at the same non-VA owned facility, will have the same provider-based
status as the non-VA owned facility that is hosting the VA facility.
(3) A VA owned and operated facility seeking provider-based status,
where some or all of the staff are contracted employees, may be
designated as provider-based if the provider-based requirements in this
section are met.
0
2. Amend Sec. 17.101 by:
0
a. Revising the section heading;
0
b. Removing the definitions ``Non-provider-based'' and ``Provider-
based'' from paragraph (a)(5); and
0
c. Revising paragraph (a)(6).
The revisions read as follows:
Sec. 17.101 Collection or recovery by VA for medical care or services
provided or furnished to a veteran for a non-service connected
disability.
(a) * * *
(6) Provider-based status and charges. Facilities that have
provider-based status by meeting the criteria in Sec. 17.100 are
entitled to bill outpatient facility charges and professional charges.
The professional charges for these facilities are produced by the
methodologies set forth in this section based on facility expense RVUs.
Facilities that do not have provider-based status because they do not
meet the criteria in Sec. 17.100 are not permitted to bill outpatient
facility charges and can only bill a professional charge. The
professional charges for these facilities are produced by the
methodologies set forth in this section based on non-facility practice
expense RVUs.
* * * * *
0
3. Amend Sec. 17.106 by adding paragraph (f)(2)(viii) to read as
follows:
Sec. 17.106 VA collection rules; third-party payers.
* * * * *
(f) * * *
(2) * * *
(viii) A third party may not reduce or refuse payment if the
facility where the medical treatment was furnished is designated by VA
as provider-based, but
[[Page 64243]]
the facility does not meet the provider-based status requirements under
42 CFR 413.65 Centers.
* * * * *
[FR Doc. 2019-24880 Filed 11-20-19; 8:45 am]
BILLING CODE 8320-01-P