TRICARE Program; Clarification of Benefit Coverage of Durable Equipment and Ordering or Prescribing Durable Equipment; Clarification of Benefit Coverage of Assistive Technology Devices Under the Extended Care Health Option Program, 78707-78714 [2014-30337]
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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations
adversely affect in a material way the
economy; a section of the economy;
productivity; competition; jobs; the
environment; public health or safety; or
State, local, or tribunal governments or
communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another Agency;
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs, or the rights and
obligations of recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in these Executive Orders.
Unfunded Mandates Reform Act (Sec.
202, Pub. L. 104–4)
It has been determined that this final
rule does not contain a Federal mandate
that may result in the expenditure by
State, local and tribal governments, in
aggregate, or by the private sector, of
$100 million or more in any one year.
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. 601)
It has been certified that this final rule
is not subject to the Regulatory
Flexibility Act (5 U.S.C. 601) because it
would not, if promulgated, have a
significant economic impact on a
substantial number of small entities. Set
forth in the final rule are minor
revisions to the existing regulation. The
DoD does not anticipate a significant
impact on the Program.
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
It has been determined that this final
rule does not impose reporting or
recordkeeping requirements under the
Paperwork Act of 1995.
Executive Order 13132, Federalism
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It has been determined that this final
rule does not have federalism
implications, as set forth in Executive
Order 13132. This rule does not have
substantial direct effects on:
(1) The States;
(2) The relationship between the
National Government and the States; or
(3) The distribution of power and
responsibilities among the various
levels of Government.
List of Subjects in 32 CFR Part 199
Claims, Dental health, Health care,
Health insurance, Individuals with
disabilities, and Military personnel.
Accordingly, 32 CFR part 199 is
amended to read as follows:
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PART 199—[AMENDED]
1. The authority citation for part 199
continues to read as follows:
■
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
2. Section 199.4 is amended by
revising paragraphs (e)(9) and (g)(63) to
read as follows:
■
§ 199.4
Basic program benefits.
*
*
*
*
*
(e) * * *
(9) Care related to non-covered initial
surgery or treatment. (i) Benefits are
available for otherwise covered services
and supplies required in the treatment
of complications resulting from a noncovered incident of treatment (such as
nonadjunctive dental care or cosmetic
surgery) but only if the later
complication represents a separate
medical condition such as a systemic
infection, cardiac arrest, and acute drug
reaction. Benefits may not be extended
for any later care or a procedure related
to the complication that essentially is
similar to the initial non-covered care.
Examples of complications similar to
the initial episode of care (and thus not
covered) would be repair of facial
scarring resulting from dermabrasion for
acne.
(ii) Benefits are available for
otherwise covered services and supplies
required in the treatment of
complications (unfortunate sequelae)
and any necessary follow-on care
resulting from a non-covered incident of
treatment provided in an MTF, when
the initial non-covered service has been
authorized by the MTF Commander and
the MTF is unable to provide the
necessary treatment of the
complications or required follow-on
care, according to the guidelines
adopted by the Director, DHA, or a
designee.
(iii) Benefits are available for
otherwise covered services and supplies
required in the treatment of
complications (unfortunate sequelae)
and any necessary follow-on care
resulting from a non-covered incident of
treatment provided in the private sector
pursuant to a properly granted waiver
under § 199.16(f). The Director, DHA, or
designee, shall issue guidelines for
implementing this provision.
*
*
*
*
*
(g) * * *
(63) Non-covered condition/
treatment, unauthorized provider. All
services and supplies (including
inpatient institutional costs) related to a
non-covered condition or treatment,
including any necessary follow-on care
or the treatment of complications, are
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78707
excluded from coverage except as
provided under paragraph (e)(9) of this
section. In addition, all services and
supplies provided by an unauthorized
provider are excluded.
*
*
*
*
*
Dated: December 22, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2014–30307 Filed 12–30–14; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD–2013–HA–0053]
RIN 0720–AB59
TRICARE Program; Clarification of
Benefit Coverage of Durable
Equipment and Ordering or
Prescribing Durable Equipment;
Clarification of Benefit Coverage of
Assistive Technology Devices Under
the Extended Care Health Option
Program
Office of the Secretary, DoD.
Final rule.
AGENCY:
ACTION:
This final rule modifies the
TRICARE regulation to add a definition
of assistive technology (AT) devices for
purposes of benefit coverage under the
TRICARE Extended Care Health Option
(ECHO) Program and to amend the
definitions of durable equipment (DE)
and durable medical equipment (DME)
to better conform the language in the
regulation to the statute. The final rule
amends the language that specifically
limits ordering or prescribing of DME to
only a physician under the Basic
Program, as this amendment will allow
certain other TRICARE authorized
individual professional providers,
acting within the scope of their
licensure, to order or prescribe DME.
This final rule also incorporates a policy
clarification relating to luxury, deluxe,
or immaterial features of equipment or
devices. That is, TRICARE cannot
reimburse for the luxury, deluxe, or
immaterial features of equipment or
devices, but can reimburse for the base
or basic equipment or device that meet
the beneficiary’s needs. Beneficiaries
may choose to pay the provider for the
luxury, deluxe, or immaterial features if
they desire their equipment or device to
have these ‘‘extra features.’’
DATES: This rule is effective January 30,
2015.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Gail
L. Jones, (303) 676–3401.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Final Rule
1. Coverage for DE, DME and AT
Devices.
The National Defense Authorization
Act for Fiscal Year 2002 revised the
coverage of DE under TRICARE. Those
revisions resulted in final amendments
to the TRICARE regulation regarding the
TRICARE Basic Program, effective
December 13, 2004, as published in the
Federal Register on October 12, 2004
(69 FR 60547), and regarding the
TRICARE Extended Health Care Option
(ECHO) Program, effective September
20, 2004, as published in the Federal
Register on August 20, 2004 (69 FR
51559). The original implementing
regulations made a potentially
confusing technical distinction between
‘‘DE’’ and ‘‘DME’’; that is, ‘‘DE’’ was
defined as an item that did not qualify
as ‘‘DME’’ that otherwise might be
available under the TRICARE ECHO
Program. This final rule provides
clarification by correcting the
definitions and adding a definition of
AT devices, which conforms to existing
policy covering devices not otherwise
qualifying as DE.
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2. Ordering and Prescribing DE and
DME
The current regulation in
§ 199.4(d)(3)(ii)(A)(1) does not allow
coverage of DME ordered by a
TRICARE-authorized individual
professional provider of care, with the
exception of a doctor of medicine (MD)
or a doctor of osteopathy (DO), even
though it is permitted by his or her
licensure. Paragraph (d)(3)(ii)(A)(1)
specifically states, ‘‘Subject to the
exceptions in paragraph (d)(3)(ii)(C) of
this same section, only DME which is
ordered by a physician for the specific
use of the beneficiary shall be covered.’’
Paragraph (d)(1) also states that only a
physician can order DME. This
restriction causes two problems:
• Certain other TRICARE authorized
individual professional providers such
as doctors of podiatric medicine
(DPMs), doctors of optometry (ODs),
doctors of dental surgery (DDSs),
doctors of dental medicine (DMDs),
certified nurse midwives (CNMs),
certified nurse practitioners (CNPs),
including certified clinical nurse
specialists (CCNSs), certified registered
nurse anesthetists (CRNAs), and
certified psychiatric nurse specialists
(CPNSs) cannot prescribe DME, even
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when acting within the scope of their
licensure.
• Beneficiaries cannot fill a
prescription for DME prescribed by
other non-physician professional
providers, even when they act as a
primary care provider, such as a CNP.
State governments generally regulate
the licensure and practice of specific
types of health care professionals, and
DoD limits TRICARE benefit coverage to
services and supplies furnished by
otherwise authorized TRICARE
individual professional providers
performing within the scope of their
state licenses or certifications. State
scope of practice laws vary about the
range of services and some include the
authority to prescribe DME. DoD
determines that it is unnecessarily
restrictive to not cover DE (including
DME) merely because it is ordered by an
otherwise authorized non-physician
allied health care professional and
certain other authorized individual
professional providers. Therefore, this
final rule amends the regulation to
allow TRICARE coverage of DE (except
for cardiorespiratory monitor) when
ordered by a physician, dentist, or any
other TRICARE authorized nonphysician allied health care
professional. This includes CNMs,
CNPs/CCNSs, CRNAs, CPNSs, and
certified physician assistants (CPAs),
and certain other TRICARE authorized
individual professional providers,
namely DPMs, ODs, DDSs, and DMDs,
when acting within the scope of their
state license or certificate.
Following further review of the
applicable regulation, in proposing to
expand the category of TRICARE
authorized providers allowed to
prescribe DE, the proposed amendment
was not specific enough to include only
physicians, dentists and other allied
health care professionals consistent
with the stated purpose of the proposed
rule. Therefore, this final rule amends
§ 199.4(d)(3)(ii)(A)(1) to limit those
individual professional providers
allowed to order DE to those listed in
§ 199.6(c)(3)(i), (ii), or (iii).
In addition, DoD must clarify that
when the proposed rule referred to
clinical nurse specialists (CNSs) as
being able to prescribe DE for TRICARE
beneficiaries, the reference should have
been to certified clinical nurse
specialists (CCNSs) and only those
CCNSs that are recognized by TRICARE
either as CNPs, CPNSs, or CNMs.
Further, the proposed rule did not
mention certified physician assistants
(CPAs) as allied health care
professionals authorized to prescribe
DE. The applicable regulation includes
CPAs as TRICARE authorized allied
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health care professionals at
§ 199.6(c)(3)(iii)(H), and this final rule
clarifies that CPAs are authorized to
order DE for TRICARE beneficiaries. See
the Public Comments section for
additional information on both CCNSs
and CPAs.
The legal authorities for this final rule
are 10 U.S.C. 1073, 1077(a)(12),
1077(f)(1) and (2), 1077, 1079, and 1086
respectively. Authority for the ECHO
Program: 10 U.S.C. 1079(d) through (f);
authority for TRICARE benefit coverage:
10 U.S.C. 1079(a)(13), 1079(o), and 32
CFR part 199; authority regarding
specific categories of TRICARE
authorized individual professional
providers: § 199.6(c)(1)(iii) and (2)(i);
authority for other allied health
professionals as TRICARE authorized
providers: § 199.6(c)(3)(iii).
B. Summary of the Major Provisions of
the Final Rule
In this final rule, the regulatory
language more appropriately conforms
to that of the statutory language, which
identifies ‘‘DME’’ as a subset of ‘‘DE’’ for
purposes of the TRICARE Basic
Program. Therefore, the final rule
amends the TRICARE regulation on DE
and clarifies that the policies applicable
to DME (e.g., exclusion of luxury
features and pricing methods) have been
and are applicable to DE. DoD’s
interpretation of the statute and
regulation has been, and continues to
be, that all DE authorized under the
TRICARE Basic Program must be
determined to be medically necessary
for the treatment of an illness, injury or
bodily malfunction before the
equipment can be cost shared by
TRICARE. Consequently, this technical
revision does not change current
policies for coverage of DE.
This final rule clarifies that the
TRICARE ECHO Program includes
coverage of AT devices that do not
otherwise qualify as DE, and adds a
definition and specific criteria for
coverage of AT devices for individuals
qualified to receive benefits under the
ECHO Program.
This final rule also provides further
clarification that if a beneficiary wishes
to obtain an item of DE that has deluxe,
luxury, or immaterial features, the
beneficiary shall be responsible for the
difference between the price of the item
and the TRICARE allowable cost for an
otherwise authorized item of DE
without such features.
Finally, the final rule emphasizes that
certain other TRICARE authorized
individual professional providers who
are listed in the regulation as
physicians, dentists or allied health care
professionals, who are legally
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authorized to practice by the state, and
when they are practicing within the
scope of the license permitted by the
state licensing authorities, may
prescribe or order DE under the
TRICARE Program.
C. Summary of Costs and Benefits
This final rule is not anticipated to
have an annual effect on the economy
of $100 million or more, making it not
economically significant and non-major
under the Executive Order and the
Congressional Review Act.
The technical revisions for coverage
of DE do not change current policies.
DoD’s interpretation of the statute and
regulation has been, and will continue
to be, that all equipment authorized
under the TRICARE Basic Program must
be determined to be medically necessary
in the treatment of an illness, injury or
bodily malfunction before the
equipment can be cost shared by
TRICARE. The amendment to remove
the restriction that limits ordering or
prescribing of DME to only an MD or
DO is not expected to increase the
amount of DE and DME prescribed
because other providers are currently
writing prescriptions—it only changes
who prescribes it. However, DoD
anticipates that there may be a marginal
increase in administrative cost to
accommodate changes to definitions.
More importantly, this change will have
no impact on beneficiaries eligible for
DE.
II. Discussion of Final Rule
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A. Final Rule Authority
The legal authority for this final rule
is 10 U.S.C. 1073, which authorizes the
Secretary of Defense to administer the
medical and dental benefits provided in
10 U.S.C. chapter 55. The DoD is also
authorized to provide DE under 10
U.S.C. 1077(a)(12), which benefit is
further defined in 10 U.S.C. 1077(f)(1)
and (2). Although section 1077 defines
benefits to be provided in the military
treatment facilities (MTFs), these
benefits are incorporated by reference
for the benefits provided by healthcare
providers in the private sector to active
duty family members and retirees and
their dependents through sections 1079
and 1086 respectively. DoD is further
authorized to provide a program,
generally referred to as ECHO, for
dependents of active duty members,
who have a qualifying condition under
section 1079(d) through (f). The ECHO
Program may include DE not otherwise
available under the TRICARE Basic
Program and AT devices to assist in the
reduction of the disabling effects of a
qualifying condition.
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The DoD, in general, is only
authorized to cover as TRICARE
benefits, under section 1079(a)(13),
section 1079(o), and 32 CFR part 199,
any service or supply that is medically
or psychologically necessary to prevent,
diagnose or treat a mental or physical
illness, injury, or bodily malfunction.
Section 1079(a)(13) identifies specific
categories of individual professional
providers who may make the diagnosis
and recommend the treatment. Section
199.6(c)(1)(iii) requires TRICAREauthorized individual professional
providers to provide medical service
and care within the scope of their
licensure and training consistent with
the state practice act, or within the
scope of the test, which is the basis for
an individual’s certification by the state
where the individual renders the
service. Paragraph (2)(i) of this same
section specifies that an individual must
be currently licensed to render
professional health care services in each
state in which the individual renders
services to TRICARE beneficiaries. Such
license is required when a specific state
provides, but does not require, license
for a specific category of individual
professional providers. Under
§ 199.6(c)(3)(iii) of this part, certain
individual professional providers, other
than physicians and dentists, are
identified as allied health professionals
and authorized as TRICARE providers of
care for covered services or supplies
otherwise authorized by the regulation.
Section 199.4(a)(1)(i) specifies the
scope of benefits authorized for
TRICARE beneficiaries, including
requirements that the care be medically
necessary in the diagnosis and treatment
of illness or injury and that the care be
provided by either authorized
institutional providers or authorized
individual professional providers or
non-institutional providers. As defined
in § 199.2(b), ‘‘medically necessary’’
incorporates the concept of ‘‘appropriate
medical care,’’ which is further defined,
in part, as requiring that a TRICARE
authorized individual professional
provider rendering medical care be
qualified to perform such medical
services, by reason of his or her training
and education, and the provider is
licensed, or certified by the state where
the service is rendered or by an
appropriate national organization, or
otherwise meets TRICARE standards.
B. Provisions of the Final Rule
This final rule incorporates all the
provisions set forth in the proposed
rule, except that this final rule further
amends § 199.4.(d)(3)(ii)(A)(1) to clarify
that those individual professional
providers allowed to order DE are
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limited to physicians, dentists and
allied health care professionals listed in
§ 199.6(c)((3)(i), (ii), or (iii). In addition,
based on public comments received,
and after further review of the
applicable regulation, DoD clarifies that
certified clinical nurse specialists
(CCNSs) [when recognized by TRICARE
as a CNP, CNM, or CPNS] and certified
physician assistants (CPAs) are
TRICARE authorized allied health care
professionals who may order or
prescribe DE under TRICARE when
acting within the scope of their license
or certification. See the Public
Comments section for additional
information.
The provisions, which amend 32 CFR
part 199, are specified as follows:
§ 199.2 (Definitions)
• ‘‘Duplicate Equipment.’’ AT devices
are subject to the definition of duplicate
equipment.
• ‘‘Durable Equipment (DE).’’ To
clarify that DE may be a covered benefit
under the TRICARE Basic Program,
consistent with 10 U.S.C. 1079(a)(5) and
10 U.S.C. 1077(a)(12) and (f), DoD is
revising the definition of DE as ‘‘(1) a
medically necessary item, which can
withstand repeated use; (2) is primarily
and customarily used to serve a medical
purpose; and, (3) is generally not useful
to an individual in the absence of an
illness or injury.’’ It includes DME,
wheelchairs, iron lungs, and hospital
beds.
• ‘‘Durable Medical Equipment
(DME).’’ Consistent with 10 U.S.C.
1079(a)(5) and 10 U.S.C. 1077(a)(12) and
(f), DoD is revising the definition of
DME as ‘‘DE, which is medically
appropriate to (1) improve, restore, or
maintain the function of a malformed,
diseased, or injured body part, or can
otherwise minimize or prevent the
deterioration of the beneficiary’s
function or condition; or, (2) maximize
the beneficiary’s function consistent
with the beneficiary’s physiological or
medical needs.’’
• ‘‘Assistive Technology (AT)
Devices.’’ AT devices do not treat an
underlying injury, illness or disease, or
their symptoms. However, to clarify that
the TRICARE ECHO Program includes
coverage of AT devices, which do not
otherwise qualify as DE, DoD is adding
a definition of AT devices as
‘‘equipment that generally helps
overcome or remove a disability and is
used to increase, maintain, or improve
the functional capabilities of an
individual. AT devices may include
non-medical devices but do not include
any structural alterations (e.g.,
wheelchair ramps or alterations to street
curbs) or service animals (e.g., Seeing
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Eye dogs, hearing/handicapped
assistance animals, etc.). AT devices are
authorized only under coverage criteria
to assist in the reduction of the
disabling effects of a qualifying
condition for individuals eligible to
receive benefits under the ECHO
program as provided in § 199.5.’’
§ 199.4 (Basic Program Benefits)
DoD clarifies the following for
purposes of benefit coverage of DE
under the TRICARE Basic Program:
• DE is an authorized benefit when
medically necessary for the treatment of
a covered illness or injury.
• Authorized DE is a benefit when
ordered by certain authorized
individual professional providers listed
in § 199.6(c)(3)(i), (ii), or (iii) of this part
for the specific use of the beneficiary
and the equipment provides the
medically appropriate level of
performance and quality for the
beneficiary’s condition.
• Unless otherwise excluded under
the regulation, items authorized
coverage as DE include (1) DME
(including a cardiorespiratory monitor
under certain conditions), (2)
wheelchairs when medically
appropriate to provide basic mobility,
(3) iron lungs, and (4) hospital beds. An
electric wheelchair or a TRICAREapproved alternative to an electric
wheelchair may be used in lieu of a
manual wheelchair when it is medically
indicated and appropriate for the
individual patient.
• An item that provides a medically
appropriate level of performance or
quality for the beneficiary’s condition
does not include luxury, deluxe, or
immaterial items. Only the base or basic
model of equipment shall be covered,
unless any customization of the
equipment owned by the beneficiary, or
an accessory or item of supply for any
DE is essential for (1) achieving
therapeutic benefit for the beneficiary;
(2) making the equipment serviceable;
or (3) otherwise assuring the proper
functioning of the equipment. If a
beneficiary wishes to obtain an item of
DE that has deluxe, luxury, or
immaterial features, the beneficiary
shall be responsible for the difference
between the price of the item and the
TRICARE allowable cost for an
otherwise authorized item of DE
without such features.
• DE, which otherwise qualifies as a
benefit, is excluded from coverage if (1)
the beneficiary is a patient in a type of
facility that ordinarily provides the
same type of DE item to its patients at
no additional charge in the usual course
of providing its services; or (2) DE is
available to the beneficiary from a
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Uniformed Services Medical Treatment
Facility.
• DE may be provided on a rental or
purchase basis and coverage will be
based on the price most advantageous to
the government under established
procedures.
• Repairs of DE damaged while using
the equipment in a manner inconsistent
with its common use, and replacement
of lost or stolen DE are excluded from
Basic Program benefits.
• Repairs of deluxe, luxury or
immaterial features of DE are excluded
from Basic Program benefits.
§ 199.5 (TRICARE Extended Care Health
Option (ECHO))
DoD clarifies the following for
purposes of benefit coverage of DE and
AT devices under the ECHO Program:
• An AT device is authorized under
certain coverage criteria when necessary
to assist in the reduction of the
disabling effects of a qualifying
condition of the ECHO eligible
beneficiary. For beneficiaries eligible for
an individual education plan (IEP), AT
devices that are recommended as part of
the IEP may be covered.
• For those beneficiaries who cease to
meet the eligibility requirements for an
IEP, AT devices under TRICARE ECHO
Program must:
—Be preauthorized;
—Be prescribed by a TRICARE
authorized provider;
—Assist in the reduction of the
disabling effects of the qualifying
ECHO condition; and
—Be an item or educational learning
device normally included in an IEP.
Further, the item must not be
otherwise covered as a prosthetic,
augmentative communication device, or
a benefit under the TRICARE Basic
Program. The implementing instructions
for this provision will be outlined in the
TRICARE Policy Manual. As with all
aspects of this proposed rule, DoD
invites the public’s comments on our
approach regarding AT devices for those
beneficiaries who cease to be eligible for
an IEP.
• Repairs of DE or AT devices
damaged while using the equipment in
a manner inconsistent with its common
use, and replacement of lost or stolen
DE or AT devices are excluded from
ECHO coverage.
• Repairs of deluxe, luxury or
immaterial features of DE or AT devices
are excluded from ECHO coverage.
• Wheelchairs may exceed the basic
mobility limitation when needed to
mitigate the effects of the ECHO
qualifying condition of the beneficiary.
• DE may be provided on a rental or
purchase basis and coverage will be
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based on the price most advantageous to
the government under the same
procedures established for pricing DE
under the TRICARE Basic Program.
III. Public Comments
On August 8, 2013 (78 FR 48367–
48373), the Office of the Secretary of
Defense published a proposed rule and
provided the public an opportunity to
comment on implementing changes to
the coverage of DE, ordering or
prescribing DE and benefit coverage of
AT devices under the ECHO Program.
The comment period closed October 7,
2013.
As a result of publication of the
proposed rule, DoD received 57
comments. All of the commenters
supported the policies we proposed,
although there were concerns about
physician assistants, nurse practitioners,
and clinical nurse specialists not being
included on the list of providers
authorized to prescribe or order DE
under the TRICARE Program. We
appreciate all expressions of support
and approval for the proposed
guidelines.
Response Regarding Physician
Assistants
Generally, the Program policy has
been to recognize those authorized
individual professional providers
identified in 10 U.S.C. 1079(a)(13) when
acting within the scope of their licenses
and to allow direct reimbursement for
authorized services they provide.
However, § 199.14(j)(ix) allows an
otherwise authorized physician to bill
for the services of an authorized
‘‘certified’’ physician assistant (CPA)
under § 199.6(c)(3)(iii)(H), provided the
CPA is acting within the scope of his or
her license and is supervised by an
employing physician. Therefore, the
final rule will allow CPAs to prescribe
or order DE under the supervision of the
employing authorized physician who
must bill under his or her National
Provider Identifier (NPI) for services
that a CPA furnishes incident to his or
her professional services.
Response Regarding Nurse Practitioners
Nurse practitioners (NPs), by
TRICARE law and regulation, are only
recognized as individual professional
providers when they qualify as
‘‘certified’’ nurse practitioners (CNPs).
For that reason, DoD will authorize only
CNPs to prescribe or order DE when
acting within the scope of their state
license or certificate.
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Response Regarding Clinical Nurse
Specialists
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. 601)
‘‘Certified’’ clinical nurse specialists
(CCNSs) are recognized as advanced
practice nurses. They meet the same
state requirements and coursework as
any other advanced practice nurse (such
as a CPN) whose practice similarly
extends into the medical field, or for
that matter, into any other medical
professional area, and may use
advanced practice nurse practitioner
(APNP) or advanced practice nurse
(APN) title when practicing within a
CCNS’s scope of practice. Therefore,
CCNSs when recognized by TRICARE
under one of the existing categories of
authorized allied health care
professionals as found in
§ 199.6(c)(3)(iii) are authorized to
prescribe DE when acting within the
scope of their state license or certificate.
In this final rule, DoD considered all
comments received during the comment
period and responses to those comments
are included in the above section of this
final rule.
It has been certified that this final rule
is not subject to the Regulatory
Flexibility Act (5 U.S.C. 601) because it
would not, if promulgated, have a
significant economic impact on a
substantial number of small entities. Set
forth in the final rule are minor
revisions to the existing regulation. The
DoD does not anticipate a significant
impact on the Program.
IV. Regulatory Procedure
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’
tkelley on DSK3SPTVN1PROD with RULES
Unfunded Mandates Reform Act (Sec.
202, Pub. L. 104–4)
It has been determined that this final
rule does not contain a Federal mandate
that may result in the expenditure by
State, local and tribal governments, in
aggregate, or by the private sector, of
$100 million or more in any one year.
16:08 Dec 30, 2014
Jkt 235001
It has been determined that this final
rule does not impose reporting or
recordkeeping requirements under the
Paperwork Act of 1995.
Executive Order 13132, Federalism
It has been determined that this final
rule does not have federalism
implications, as set forth in Executive
Order 13132. This rule does not have
substantial direct effects on:
(1) The States;
(2) The relationship between the
National Government and the States; or
(3) The distribution of power and
responsibilities among the various
levels of Government.
List of Subjects in 32 CFR Part 199
It has been determined that this final
rule is not a significant regulatory
action. This rule does not:
(1) Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy; a section of the economy;
productivity; competition; jobs; the
environment; public health or safety; or
State, local, or tribunal governments or
communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another Agency;
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs, or the rights and
obligations of recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in these Executive Orders.
VerDate Sep<11>2014
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
Claims, Dental health, Health care,
Health insurance, Individuals with
disabilities, and Military personnel.
Accordingly, 32 CFR part 199 is
amended to read as follows:
PART 199—[AMENDED]
1. The authority citation for part 199
continues to read as follows:
■
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
2. Section 199.2, paragraph (b) is
amended by adding the definition of
‘‘Assistive technology devices’’ in
alphabetical order and revising the
definitions of ‘‘Duplicate equipment,’’
‘‘Durable equipment,’’ and ‘‘Durable
medical equipment’’ to read as follows:
■
§ 199.2
Definitions.
*
*
*
*
*
(b) * * *
Assistive technology devices.
Equipment that generally does not treat
an underlying injury, illness, disease or
their symptoms. Assistive technology
devices are authorized only under the
Extended Care Health Option (ECHO).
Assistive technology devices help an
ECHO beneficiary overcome or remove
a disability and are used to increase,
maintain, or improve the functional
capabilities of an individual. Assistive
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78711
technology devices may include nonmedical devices but do not include any
structural alterations (e.g., permanent
structure of wheelchair ramps or
alterations to street curbs) service
animals (e.g., Seeing Eye dogs, hearing/
handicapped assistance animals, etc.) or
specialized equipment and devices
whose primary purpose is to enable the
individual to engage in sports or
recreational events. Assistive
technology devices are authorized only
under coverage criteria determined by
the Director, TRICARE Management
Activity to assist in the reduction of the
disabling effects of a qualifying
condition for individuals eligible to
receive benefits under the ECHO
program, as provided in § 199.5.
*
*
*
*
*
Duplicate equipment. An item of
durable equipment, durable medical
equipment, or assistive technology
items, as defined in this section that
serves the same purpose that is served
by an item of durable equipment,
durable medical equipment, or assistive
technology item previously cost-shared
by TRICARE. For example, various
models of stationary oxygen
concentrators with no essential
functional differences are considered
duplicate equipment, whereas
stationary and portable oxygen
concentrators are not considered
duplicates of each other because the
latter is intended to provide the user
with mobility not afforded by the
former. Also, a manual wheelchair and
electric wheelchair, both of which
otherwise meet the definition of durable
equipment or durable medical
equipment, would not be considered
duplicates of each other if each is found
to provide an appropriate level of
mobility. For the purpose of this Part,
durable equipment, durable medical
equipment, or assistive technology
items that are essential in providing a
fail-safe in-home life support system or
that replace in-like-kind an item of
equipment that is not serviceable due to
normal wear, accidental damage, a
change in the beneficiary’s condition, or
has been declared adulterated by the
U.S. FDA, or is being or has been
recalled by the manufacturer is not
considered duplicate equipment.
Durable equipment. Equipment that—
(1) Is a medically necessary item,
which can withstand repeated use;
(2) Is primarily and customarily used
to serve a medical purpose; and
(3) Is generally not useful to an
individual in the absence of an illness
or injury. It includes durable medical
equipment as defined in § 199.2,
wheelchairs, iron lungs, and hospital
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beds. It does not include equipment
(including wheelchairs) used or
designed primarily for use in sports or
recreational activities.
Durable medical equipment. Durable
equipment that is medically appropriate
to—
(1) Improve, restore, or maintain the
function of a malformed, diseased, or
injured body part or can otherwise
minimize or prevent the deterioration of
the beneficiary’s function or condition;
or
(2) Maximize the beneficiary’s
function consistent with the
beneficiary’s physiological or medical
needs.
*
*
*
*
*
3. Section 199.4 is amended by
revising paragraphs (a)(1)(i), (d)(1),
(d)(3)(ii), and (g)(43) to read as follows:
■
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§ 199.4
Basic program benefits.
(a) * * *
(1)(i) Scope of benefits. Subject to all
applicable definitions, conditions,
limitations, or exclusions specified in
this part, the CHAMPUS Basic Program
will cost share medically necessary
services and supplies required in the
diagnosis and treatment of illness or
injury, including maternity care and
well-baby care. Benefits include
specified medical services and supplies
provided to eligible beneficiaries from
authorized civilian sources such as
hospitals, other authorized institutional
providers, physicians, other authorized
individual professional providers, and
professional ambulance services,
prescription drugs, authorized medical
supplies, and rental or purchase of
durable equipment.
*
*
*
*
*
(d) Other benefits—(1) General.
Benefits may be extended for the
allowable charge of those other covered
services and supplies described in
paragraph (d) of this section, which are
provided in accordance with good
medical practice and established
standards of quality by those other
authorized providers described in
§ 199.6. Such benefits are subject to all
applicable definitions, conditions,
limitations, or exclusions as otherwise
may be set forth in this or other chapters
of this Regulation. To be considered for
benefits under paragraph (d) of this
section, the described services or
supplies must be prescribed and
ordered by a physician. Other
authorized individual professional
providers acting within their scope of
licensure may also prescribe and order
these services and supplies unless
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16:08 Dec 30, 2014
Jkt 235001
otherwise specified in paragraph (d) of
this section.
*
*
*
*
*
(3) * * *
(ii) Durable equipment—(A) Scope of
benefit. (1) Durable equipment, which is
for the specific use of the beneficiary
and is ordered by an authorized
individual professional provider listed
in § 199.6(c)(3)(i), (ii) or (iii), acting
within his or her scope of licensure
shall be covered if the durable
equipment meets the definition in
§ 199.2 and—
(i) Provides the medically appropriate
level of performance and quality for the
medical condition present and
(ii) Is not otherwise excluded by this
part.
(2) Items that may be provided to a
beneficiary as durable equipment
include:
(i) Durable medical equipment as
defined in § 199.2;
(ii) Wheelchairs. A wheelchair, which
is medically appropriate to provide
basic mobility, including reasonable
additional costs for medically
appropriate modifications to
accommodate a particular physiological
or medical need, may be covered as
durable equipment. An electric
wheelchair, or TRICARE approved
alternative to an electric wheelchair
(e.g., scooter) may be provided in lieu of
a manual wheelchair when it is
medically indicated and appropriate to
provide basic mobility. Luxury or
deluxe wheelchairs, as described in
paragraph (d)(3)(ii)(A)(3) of this section,
include features beyond those required
for basic mobility of a particular
beneficiary are not authorized.
(iii) Iron lungs.
(iv) Hospital beds.
(v) Cardiorespiratory monitors under
conditions specified in paragraph
(d)(3)(ii)(B) of this section.
(3) Whether a prescribed item of
durable equipment provides the
medically appropriate level of
performance and quality for the
beneficiary’s condition must be
supported by adequate documentation.
Luxury, deluxe, immaterial, or nonessential features, which increase the
cost of the item relative to a similar item
without those features, based on
industry standards for a particular item
at the time the equipment is prescribed
or replaced for a beneficiary, are not
authorized. Only the ‘‘base’’ or ‘‘basic’’
model of equipment (or more costeffective alternative equipment) shall be
covered, unless customization of the
equipment, or any accessory or item of
supply for any durable equipment, is
essential, as determined by the Director
(or designee), for—
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(i) Achieving therapeutic benefit for
the patient;
(ii) Making the equipment serviceable;
or
(iii) Otherwise assuring the proper
functioning of the equipment.
*
*
*
*
*
(B) * * *
(C) Exclusions. Durable equipment,
which is otherwise qualified as a benefit
is excluded from coverage under the
following circumstances:
(1) Durable equipment for a
beneficiary who is a patient in a type of
facility that ordinarily provides the
same type of durable equipment item to
its patients at no additional charge in
the usual course of providing its
services.
(2) Durable equipment, which is
available to the beneficiary from a
Uniformed Services Medical Treatment
Facility.
(D) Basis for reimbursement. (1)
Durable equipment may be provided on
a rental or purchase basis. Coverage of
durable equipment will be based on the
price most advantageous to the
government taking into consideration
the anticipated duration of the
medically necessary need for the
equipment and current price
information for the type of item. The
cost analysis must include a comparison
of the total price of the item as a
monthly rental charge, a lease-purchase
price, and a lump-sum purchase price
and a provision for the time value of
money at the rate determined by the
U.S. Department of Treasury. If a
beneficiary wishes to obtain an item of
durable equipment with deluxe, luxury,
immaterial or non-essential features, the
beneficiary may agree to accept
TRICARE coverage limited to the
allowable amount that would have
otherwise been authorized for a similar
item without those features. In that case,
the TRICARE coverage is based upon
the allowable amount for the kind of
durable equipment normally used to
meet the intended purpose (i.e., the
standard item least costly). The provider
shall not hold the beneficiary liable for
deluxe, luxury, immaterial, or nonessential features that cannot be
considered in determining the TRICARE
allowable costs. However, the
beneficiary shall be held liable if the
provider has a specific agreement in
writing from the beneficiary (or his or
her representative) accepting liability
for the itemized difference in costs of
the durable equipment with deluxe,
luxury, or immaterial features and the
TRICARE allowable costs for an
otherwise authorized item without such
features.
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(2) In general, repairs of beneficiary
owned durable equipment are covered
when necessary to make the equipment
serviceable and replacement of durable
equipment is allowed when the durable
equipment is not serviceable because of
normal wear, accidental damage or
when necessitated by a change in the
beneficiary’s condition. However,
repairs of durable equipment damaged
while using the equipment in a manner
inconsistent with its common use, and
replacement of lost or stolen durable
equipment are excluded from coverage.
In addition, repairs of deluxe, luxury, or
immaterial features of durable
equipment are excluded from coverage.
*
*
*
*
*
(g) * * *
(43) Exercise/relaxation/comfort/
sporting items or sporting devices.
Exercise equipment, to include items
primarily and customarily designed for
use in sports or recreational activities,
spas, whirlpools, hot tubs, swimming
pools health club memberships or other
such charges or items.
*
*
*
*
*
■ 4. Section 199.5 is amended by
revising paragraphs (c)(2), (c)(8)(ii), and
(c)(8)(iii), (d)(3), (d)(7) introductory text,
(d)(7)(i), (d)(7)(iv), and (d)(8), (g)(2), and
(h)(4), and adding new paragraph
(d)(7)(v) to read as follows:
§ 199.5 TRICARE extended care health
option (ECHO).
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*
*
*
*
*
(c) * * *
(2) Medical, habilitative, rehabilitative
services and supplies, durable
equipment and assistive technology
(AT) devices that assist in the reduction
of the disabling effects of a qualifying
condition. Benefits shall be provided in
the beneficiary’s home or another
environment, as appropriate. An AT
device may be covered only if it is
recommended in a beneficiary’s
Individual Educational Program (IEP)
or, if the beneficiary is not eligible for
an IEP, the AT device is an item or
educational learning device normally
included in an IEP and is preauthorized
under ECHO as an integral component
of the beneficiary’s individual
comprehensive health care services plan
(including rehabilitation) as prescribed
by a TRICARE authorized provider.
(i) An AT device may be covered
under ECHO only if it is not otherwise
covered by TRICARE as durable
equipment, a prosthetic, augmentation
communication device, or other benefits
under § 199.4.
(ii) An AT device may include an
educational learning device directly
related to the beneficiary’s qualifying
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16:08 Dec 30, 2014
Jkt 235001
condition when recommended by an
IEP and not otherwise provided by State
or local government programs. If an
individual is not eligible for an IEP, an
educational learning device normally
included in the IEP may be authorized
as if directly related to the beneficiary’s
qualifying condition and prescribed by
a TRICARE authorized provider as part
of the beneficiary’s individual
comprehensive health care services
plan.
(iii) Electronic learning devices may
include the hardware and software as
appropriate. The Director, DHA, shall
determine the types and (or) platforms
of electronic devices and the
replacement lifecycle of the hardware
and its supporting software. All
upgrades or replacements shall require
a recommendation from the individual’s
IEP or the individual’s comprehensive
health care services plan.
(iv) Duplicative or redundant
hardware platforms are not authorized.
Note to paragraph (c)(2)(iv): When one
or more electronic platforms such as a
desktop computer, laptop, notebook or
tablet can perform the same functions in
relation to the teaching or educational
objective directly related to the
qualifying condition, it is the intent of
this provision to allow only one
electronic platform that may be chosen
by the beneficiary. Duplicative or
redundant platforms are not allowed;
however, a second platform may be
obtained, if the individual’s IEP
recommends one platform such as a
computer for the majority of the
learning objectives, but there exists
another objective, which cannot be
performed on that platform. In these
limited circumstances, the beneficiary
may submit a request with the above
justification to the Director, TMA, who
may authorize a second device.
(v) AT devices damaged through
improper use of the device as well as
lost or stolen devices may not be
replaced until the device would next be
eligible for a lifecycle replacement.
(vi) AT devices do not include
equipment or devices whose primary
purpose is to assist the individual to
engage in sports or recreational
activities.
*
*
*
*
*
(8) * * *
(ii) Equipment adaptation. The
allowable equipment and an AT device
purchase shall include such services
and modifications to the equipment as
necessary to make the equipment usable
for a particular ECHO beneficiary.
(iii) Equipment maintenance.
Reasonable repairs and maintenance of
the beneficiary owned or rented DE or
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78713
AT devices provided by this section
shall be allowed while a beneficiary is
registered in the ECHO Program. Repairs
of DE and/or AT devices damaged while
using the item in a manner inconsistent
with its common use, and replacement
of lost or stolen DE and/or AT devices
are not authorized coverage as an ECHO
benefit. In addition, repairs and
maintenance of deluxe, luxury, or
immaterial features of DE or AT devices
are not authorized coverage as an ECHO
benefit.
(d) * * *
(3) Structural alterations. Alterations
to living space and permanent fixtures
attached thereto, including alterations
necessary to accommodate installation
of equipment or AT devices to facilitate
entrance or exit, are excluded.
*
*
*
*
*
(7) Equipment. Purchase or rental of
DE and AT devices otherwise allowed
by this section is excluded when:
(i) The beneficiary is a patient in an
institution or facility that ordinarily
provides the same type of equipment or
AT devices to its patients at no
additional charge in the usual course of
providing services; or
*
*
*
*
*
(iv) The item is a duplicate DE or an
AT device, as defined in § 199.2.
(v) The item (or charge for access to
such items through health club
membership or other activities) is
exercise equipment including an item
primarily and customarily designed for
use in sports or recreational activities,
spa, whirlpool, hot tub, swimming pool,
an electronic device used to locate or
monitor the location of the beneficiary,
or other similar items or charges.
(8) Maintenance agreements.
Maintenance agreements for beneficiary
owned or rented equipment or AT
device are excluded.
*
*
*
*
*
(g) * * *
(2) Equipment. (i) The TRICARE
allowable amount for DE or AT devices
shall be calculated in the same manner
as DME allowable through section 199.4
of this title, and accrues to the fiscal
year benefit limit specified in paragraph
(f)(3) of this section.
(ii) Cost-share. A cost-share, as
provided by paragraph (f)(2) of this
section, is required for each month in
which equipment or an AT device is
purchased under this section. However,
in no month shall a sponsor be required
to pay more than one cost-share
regardless of the number of benefits the
sponsor’s dependents received under
this section.
*
*
*
*
*
(h) * * *
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(4) Repair or maintenance of DE
owned by the beneficiary or an AT
device is exempt from the public
facility-use certification requirements.
*
*
*
*
*
Dated: December 22, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2014–30337 Filed 12–30–14; 8:45 am]
BILLING CODE 5001–06–P
POSTAL REGULATORY COMMISSION
39 CFR Part 3020
[Docket Nos. MC2010–21 and CP2010–36]
Update to Product Lists
Postal Regulatory Commission.
Final rule.
AGENCY:
ACTION:
The Commission is updating
the product lists. This action reflects a
publication policy adopted by
Commission order. The referenced
policy assumes periodic updates. The
updates are identified in the body of
this document. The product lists, which
is re-published in its entirety, includes
these updates.
DATES: Effective Date: December 31,
2014.
Applicability Dates: See the
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT:
David A. Trissell, General Counsel, at
202–789–6800.
SUPPLEMENTARY INFORMATION: This
document identifies updates to the
product lists, which appear as
Appendix A to Subpart A of 39 CFR part
3020—Mail Classification Schedule.
Publication of the updated product lists
in the Federal Register is addressed in
the Postal Accountability and
Enhancement Act (PAEA) of 2006.
Applicability Dates: August 29, 2014,
Priority Mail Contract 89 (MC2014–39
and CP2014–72); September 10, 2014,
Priority Mail Express Contract 19
(MC2014–41 and CP2014–74);
September 10, 2014, First-Class Package
Service Contract 37 (MC2014–42 and
CP2014–75); September 15, 2014,
Priority Mail Express, Priority Mail &
First-Class Package Service Contract 4
(MC2014–43 and CP2014–76); October
1, 2014, Priority Mail Contract 92
(MC2014–46 and CP2014–82); October
1, 2014, Priority Mail Contract 93
(MC2014–47 and CP2014–83); October
3, 2014, Priority Mail Contract 91
(MC2014–45 and CP2014–81); October
8, 2014, Priority Mail Contract 94
(MC2014–48 and CP2014–84); October
tkelley on DSK3SPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:08 Dec 30, 2014
Jkt 235001
8, 2014, Priority Mail Contract 95
(MC2014–49 and CP2014–85); October
23, 2014, Market Test Customized
Delivery (MT2014–1); October 24, 2014,
Outbound Competitive International
Merchandise Return Service Agreement
with Royal Mail Group, Ltd. (CP2015–
1); October 30, 2014, Priority Mail
Express & Priority Mail Contract 16
(MC2015–2 and CP2015–4); November
5, 2014, Priority Mail Contract 97
(MC2015–5 and CP2015–6); November
5, 2014, Priority Mail Contract 98
(MC2015–6 and CP2015–7); November
5, 2014, Parcel Select Contract 8
(MC2015–1 and CP2015–3); November
10, 2014, Priority Mail Contract 96
(MC2015–4 and CP2015–5); December
5, 2014, Priority Mail Contract 101
(MC2015–11 and CP2015–14);
December 5, 2014, Priority Mail Express
Contract 20 (MC2015–12 and CP2015–
15); December 5, 2014, Priority Mail
Contract 100 (MC2015–10 and CP2015–
13); December 5, 2014, Priority Mail
Contract 99 (MC2015–9 and CP2015–2);
December 11, 2014, Priority Mail
Express Contract 21 (MC2015–14 and
CP2015–17); December 12, 2014,
Priority Mail Contract 102 (MC2015–13
and CP2015–16); December 19, 2014,
Priority Mail Express Contract 23
(MC2015–16 and CP2015–20).
Authorization. The Commission
process for periodic publication of
updates was established in Docket Nos.
MC2010–21 and CP2010–36, Order No.
445, April 22, 2010, at 8.
Changes. The product lists are being
updated by publishing a replacement in
its entirety of Appendix A to Subpart A
of 39 CFR part 3020—Mail
Classification Schedule. The following
products are being added, removed, or
moved within the product lists:
1. Priority Mail Contract 89 (MC2014–
39 and CP2014–72) (Order No. 2175),
added August 29, 2014.
2. Priority Mail Express Contact 19
(MC2014–41 and CP2014–74) (Order
No. 2178), added September 10, 2014.
3. First-Class Package Service
Contract 37 (MC2014–42 and CP2014–
75) (Order No. 2179), added September
10, 2014.
4. Priority Mail Express, Priority Mail
& First-Class Package Service Contract 4
(MC2014–43 and CP2014–76), added
September 15, 2014.
5. Priority Mail Contract 92 (MC2014–
46 and CP2014–82), added October 1,
2014.
6. Priority Mail Contract 93 (MC2014–
47 and CP2014–83), added October 1,
2014.
7. Priority Mail Contract 91 (MC2014–
45 and CP2014–81), added October 3,
2014.
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8. Priority Mail Contract 94 (MC2014–
48 and CP2014–84), added October 8,
2014.
9. Priority Mail Contact 95 (MC2014–
49 and CP2014–85), added October 8,
2014.
10. Market Test Customized Delivery
(MT2014–1), authorizing test October
23, 2014.
11. Outbound Competitive
International Merchandise Return
Service Agreement with Royal Mail
Group, Ltd. (CP2015–1), added October
24, 2014.
12. Priority Mail Express & Priority
Mail Contract 16 (MC2015–2 and
CP2015–4), added October 30, 2014.
13. Priority Mail Contract 97
(MC2015–5 and CP2015–6), added
November 5, 2014.
14. Priority Mail Contract 98
(MC2015–6 and CP2015–7), added
November 5, 2014.
15. Parcel Select Contract 8 (MC2015–
1 and CP2015–3), added November 5,
2014.
16. Priority Mail Contract 96
(MC2015–4 and CP2015–5), added
November 10, 2014.
17. Priority Mail Contract 101
(MC2015–11 and CP2015–14), added
December 5, 2014.
18. Priority Mail Express Contract 20
(MC2015–12 and CP2015–15), added
December 5, 2014.
19. Priority Mail Contract 100
(MC2015–10 and CP2015–13), added
December 5, 2014.
20. Priority Mail Contract 99
(MC2015–9 and CP2015–12), added
December 5, 2014.
21. Priority Mail Express Contract 21
(MC2015–14 and CP2015–17), added
December 11, 2014.
22. Priority Mail Contract 102
(MC2015–13 and CP2015–16), added
December 12, 2014.
23. Priority Mail Express Contract 23
(MC2015–16 and CP2015–20), added
December 19, 2014.
Updated product lists. The referenced
changes to the product lists are
incorporated into Appendix A to
Subpart A of 39 CFR part 3020—Mail
Classification Schedule.
List of Subjects in 39 CFR Part 3020
Administrative practice and
procedure, Postal Service.
For the reasons discussed in the
preamble, the Postal Regulatory
Commission amends chapter III of title
39 of the Code of Federal Regulations as
follows:
PART 3020—PRODUCT LISTS
1. The authority citation for part 3020
continues to read as follows:
■
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Agencies
[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Rules and Regulations]
[Pages 78707-78714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30337]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD-2013-HA-0053]
RIN 0720-AB59
TRICARE Program; Clarification of Benefit Coverage of Durable
Equipment and Ordering or Prescribing Durable Equipment; Clarification
of Benefit Coverage of Assistive Technology Devices Under the Extended
Care Health Option Program
AGENCY: Office of the Secretary, DoD.
ACTION: Final rule.
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SUMMARY: This final rule modifies the TRICARE regulation to add a
definition of assistive technology (AT) devices for purposes of benefit
coverage under the TRICARE Extended Care Health Option (ECHO) Program
and to amend the definitions of durable equipment (DE) and durable
medical equipment (DME) to better conform the language in the
regulation to the statute. The final rule amends the language that
specifically limits ordering or prescribing of DME to only a physician
under the Basic Program, as this amendment will allow certain other
TRICARE authorized individual professional providers, acting within the
scope of their licensure, to order or prescribe DME. This final rule
also incorporates a policy clarification relating to luxury, deluxe, or
immaterial features of equipment or devices. That is, TRICARE cannot
reimburse for the luxury, deluxe, or immaterial features of equipment
or devices, but can reimburse for the base or basic equipment or device
that meet the beneficiary's needs. Beneficiaries may choose to pay the
provider for the luxury, deluxe, or immaterial features if they desire
their equipment or device to have these ``extra features.''
DATES: This rule is effective January 30, 2015.
[[Page 78708]]
FOR FURTHER INFORMATION CONTACT: Gail L. Jones, (303) 676-3401.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Final Rule
1. Coverage for DE, DME and AT Devices.
The National Defense Authorization Act for Fiscal Year 2002 revised
the coverage of DE under TRICARE. Those revisions resulted in final
amendments to the TRICARE regulation regarding the TRICARE Basic
Program, effective December 13, 2004, as published in the Federal
Register on October 12, 2004 (69 FR 60547), and regarding the TRICARE
Extended Health Care Option (ECHO) Program, effective September 20,
2004, as published in the Federal Register on August 20, 2004 (69 FR
51559). The original implementing regulations made a potentially
confusing technical distinction between ``DE'' and ``DME''; that is,
``DE'' was defined as an item that did not qualify as ``DME'' that
otherwise might be available under the TRICARE ECHO Program. This final
rule provides clarification by correcting the definitions and adding a
definition of AT devices, which conforms to existing policy covering
devices not otherwise qualifying as DE.
2. Ordering and Prescribing DE and DME
The current regulation in Sec. 199.4(d)(3)(ii)(A)(1) does not
allow coverage of DME ordered by a TRICARE-authorized individual
professional provider of care, with the exception of a doctor of
medicine (MD) or a doctor of osteopathy (DO), even though it is
permitted by his or her licensure. Paragraph (d)(3)(ii)(A)(1)
specifically states, ``Subject to the exceptions in paragraph
(d)(3)(ii)(C) of this same section, only DME which is ordered by a
physician for the specific use of the beneficiary shall be covered.''
Paragraph (d)(1) also states that only a physician can order DME. This
restriction causes two problems:
Certain other TRICARE authorized individual professional
providers such as doctors of podiatric medicine (DPMs), doctors of
optometry (ODs), doctors of dental surgery (DDSs), doctors of dental
medicine (DMDs), certified nurse midwives (CNMs), certified nurse
practitioners (CNPs), including certified clinical nurse specialists
(CCNSs), certified registered nurse anesthetists (CRNAs), and certified
psychiatric nurse specialists (CPNSs) cannot prescribe DME, even when
acting within the scope of their licensure.
Beneficiaries cannot fill a prescription for DME
prescribed by other non-physician professional providers, even when
they act as a primary care provider, such as a CNP.
State governments generally regulate the licensure and practice of
specific types of health care professionals, and DoD limits TRICARE
benefit coverage to services and supplies furnished by otherwise
authorized TRICARE individual professional providers performing within
the scope of their state licenses or certifications. State scope of
practice laws vary about the range of services and some include the
authority to prescribe DME. DoD determines that it is unnecessarily
restrictive to not cover DE (including DME) merely because it is
ordered by an otherwise authorized non-physician allied health care
professional and certain other authorized individual professional
providers. Therefore, this final rule amends the regulation to allow
TRICARE coverage of DE (except for cardiorespiratory monitor) when
ordered by a physician, dentist, or any other TRICARE authorized non-
physician allied health care professional. This includes CNMs, CNPs/
CCNSs, CRNAs, CPNSs, and certified physician assistants (CPAs), and
certain other TRICARE authorized individual professional providers,
namely DPMs, ODs, DDSs, and DMDs, when acting within the scope of their
state license or certificate.
Following further review of the applicable regulation, in proposing
to expand the category of TRICARE authorized providers allowed to
prescribe DE, the proposed amendment was not specific enough to include
only physicians, dentists and other allied health care professionals
consistent with the stated purpose of the proposed rule. Therefore,
this final rule amends Sec. 199.4(d)(3)(ii)(A)(1) to limit those
individual professional providers allowed to order DE to those listed
in Sec. 199.6(c)(3)(i), (ii), or (iii).
In addition, DoD must clarify that when the proposed rule referred
to clinical nurse specialists (CNSs) as being able to prescribe DE for
TRICARE beneficiaries, the reference should have been to certified
clinical nurse specialists (CCNSs) and only those CCNSs that are
recognized by TRICARE either as CNPs, CPNSs, or CNMs. Further, the
proposed rule did not mention certified physician assistants (CPAs) as
allied health care professionals authorized to prescribe DE. The
applicable regulation includes CPAs as TRICARE authorized allied health
care professionals at Sec. 199.6(c)(3)(iii)(H), and this final rule
clarifies that CPAs are authorized to order DE for TRICARE
beneficiaries. See the Public Comments section for additional
information on both CCNSs and CPAs.
The legal authorities for this final rule are 10 U.S.C. 1073,
1077(a)(12), 1077(f)(1) and (2), 1077, 1079, and 1086 respectively.
Authority for the ECHO Program: 10 U.S.C. 1079(d) through (f);
authority for TRICARE benefit coverage: 10 U.S.C. 1079(a)(13), 1079(o),
and 32 CFR part 199; authority regarding specific categories of TRICARE
authorized individual professional providers: Sec. 199.6(c)(1)(iii)
and (2)(i); authority for other allied health professionals as TRICARE
authorized providers: Sec. 199.6(c)(3)(iii).
B. Summary of the Major Provisions of the Final Rule
In this final rule, the regulatory language more appropriately
conforms to that of the statutory language, which identifies ``DME'' as
a subset of ``DE'' for purposes of the TRICARE Basic Program.
Therefore, the final rule amends the TRICARE regulation on DE and
clarifies that the policies applicable to DME (e.g., exclusion of
luxury features and pricing methods) have been and are applicable to
DE. DoD's interpretation of the statute and regulation has been, and
continues to be, that all DE authorized under the TRICARE Basic Program
must be determined to be medically necessary for the treatment of an
illness, injury or bodily malfunction before the equipment can be cost
shared by TRICARE. Consequently, this technical revision does not
change current policies for coverage of DE.
This final rule clarifies that the TRICARE ECHO Program includes
coverage of AT devices that do not otherwise qualify as DE, and adds a
definition and specific criteria for coverage of AT devices for
individuals qualified to receive benefits under the ECHO Program.
This final rule also provides further clarification that if a
beneficiary wishes to obtain an item of DE that has deluxe, luxury, or
immaterial features, the beneficiary shall be responsible for the
difference between the price of the item and the TRICARE allowable cost
for an otherwise authorized item of DE without such features.
Finally, the final rule emphasizes that certain other TRICARE
authorized individual professional providers who are listed in the
regulation as physicians, dentists or allied health care professionals,
who are legally
[[Page 78709]]
authorized to practice by the state, and when they are practicing
within the scope of the license permitted by the state licensing
authorities, may prescribe or order DE under the TRICARE Program.
C. Summary of Costs and Benefits
This final rule is not anticipated to have an annual effect on the
economy of $100 million or more, making it not economically significant
and non-major under the Executive Order and the Congressional Review
Act.
The technical revisions for coverage of DE do not change current
policies. DoD's interpretation of the statute and regulation has been,
and will continue to be, that all equipment authorized under the
TRICARE Basic Program must be determined to be medically necessary in
the treatment of an illness, injury or bodily malfunction before the
equipment can be cost shared by TRICARE. The amendment to remove the
restriction that limits ordering or prescribing of DME to only an MD or
DO is not expected to increase the amount of DE and DME prescribed
because other providers are currently writing prescriptions--it only
changes who prescribes it. However, DoD anticipates that there may be a
marginal increase in administrative cost to accommodate changes to
definitions. More importantly, this change will have no impact on
beneficiaries eligible for DE.
II. Discussion of Final Rule
A. Final Rule Authority
The legal authority for this final rule is 10 U.S.C. 1073, which
authorizes the Secretary of Defense to administer the medical and
dental benefits provided in 10 U.S.C. chapter 55. The DoD is also
authorized to provide DE under 10 U.S.C. 1077(a)(12), which benefit is
further defined in 10 U.S.C. 1077(f)(1) and (2). Although section 1077
defines benefits to be provided in the military treatment facilities
(MTFs), these benefits are incorporated by reference for the benefits
provided by healthcare providers in the private sector to active duty
family members and retirees and their dependents through sections 1079
and 1086 respectively. DoD is further authorized to provide a program,
generally referred to as ECHO, for dependents of active duty members,
who have a qualifying condition under section 1079(d) through (f). The
ECHO Program may include DE not otherwise available under the TRICARE
Basic Program and AT devices to assist in the reduction of the
disabling effects of a qualifying condition.
The DoD, in general, is only authorized to cover as TRICARE
benefits, under section 1079(a)(13), section 1079(o), and 32 CFR part
199, any service or supply that is medically or psychologically
necessary to prevent, diagnose or treat a mental or physical illness,
injury, or bodily malfunction. Section 1079(a)(13) identifies specific
categories of individual professional providers who may make the
diagnosis and recommend the treatment. Section 199.6(c)(1)(iii)
requires TRICARE-authorized individual professional providers to
provide medical service and care within the scope of their licensure
and training consistent with the state practice act, or within the
scope of the test, which is the basis for an individual's certification
by the state where the individual renders the service. Paragraph (2)(i)
of this same section specifies that an individual must be currently
licensed to render professional health care services in each state in
which the individual renders services to TRICARE beneficiaries. Such
license is required when a specific state provides, but does not
require, license for a specific category of individual professional
providers. Under Sec. 199.6(c)(3)(iii) of this part, certain
individual professional providers, other than physicians and dentists,
are identified as allied health professionals and authorized as TRICARE
providers of care for covered services or supplies otherwise authorized
by the regulation.
Section 199.4(a)(1)(i) specifies the scope of benefits authorized
for TRICARE beneficiaries, including requirements that the care be
medically necessary in the diagnosis and treatment of illness or injury
and that the care be provided by either authorized institutional
providers or authorized individual professional providers or non-
institutional providers. As defined in Sec. 199.2(b), ``medically
necessary'' incorporates the concept of ``appropriate medical care,''
which is further defined, in part, as requiring that a TRICARE
authorized individual professional provider rendering medical care be
qualified to perform such medical services, by reason of his or her
training and education, and the provider is licensed, or certified by
the state where the service is rendered or by an appropriate national
organization, or otherwise meets TRICARE standards.
B. Provisions of the Final Rule
This final rule incorporates all the provisions set forth in the
proposed rule, except that this final rule further amends Sec.
199.4.(d)(3)(ii)(A)(1) to clarify that those individual professional
providers allowed to order DE are limited to physicians, dentists and
allied health care professionals listed in Sec. 199.6(c)((3)(i), (ii),
or (iii). In addition, based on public comments received, and after
further review of the applicable regulation, DoD clarifies that
certified clinical nurse specialists (CCNSs) [when recognized by
TRICARE as a CNP, CNM, or CPNS] and certified physician assistants
(CPAs) are TRICARE authorized allied health care professionals who may
order or prescribe DE under TRICARE when acting within the scope of
their license or certification. See the Public Comments section for
additional information.
The provisions, which amend 32 CFR part 199, are specified as
follows:
Sec. 199.2 (Definitions)
``Duplicate Equipment.'' AT devices are subject to the
definition of duplicate equipment.
``Durable Equipment (DE).'' To clarify that DE may be a
covered benefit under the TRICARE Basic Program, consistent with 10
U.S.C. 1079(a)(5) and 10 U.S.C. 1077(a)(12) and (f), DoD is revising
the definition of DE as ``(1) a medically necessary item, which can
withstand repeated use; (2) is primarily and customarily used to serve
a medical purpose; and, (3) is generally not useful to an individual in
the absence of an illness or injury.'' It includes DME, wheelchairs,
iron lungs, and hospital beds.
``Durable Medical Equipment (DME).'' Consistent with 10
U.S.C. 1079(a)(5) and 10 U.S.C. 1077(a)(12) and (f), DoD is revising
the definition of DME as ``DE, which is medically appropriate to (1)
improve, restore, or maintain the function of a malformed, diseased, or
injured body part, or can otherwise minimize or prevent the
deterioration of the beneficiary's function or condition; or, (2)
maximize the beneficiary's function consistent with the beneficiary's
physiological or medical needs.''
``Assistive Technology (AT) Devices.'' AT devices do not
treat an underlying injury, illness or disease, or their symptoms.
However, to clarify that the TRICARE ECHO Program includes coverage of
AT devices, which do not otherwise qualify as DE, DoD is adding a
definition of AT devices as ``equipment that generally helps overcome
or remove a disability and is used to increase, maintain, or improve
the functional capabilities of an individual. AT devices may include
non-medical devices but do not include any structural alterations
(e.g., wheelchair ramps or alterations to street curbs) or service
animals (e.g., Seeing
[[Page 78710]]
Eye dogs, hearing/handicapped assistance animals, etc.). AT devices are
authorized only under coverage criteria to assist in the reduction of
the disabling effects of a qualifying condition for individuals
eligible to receive benefits under the ECHO program as provided in
Sec. 199.5.''
Sec. 199.4 (Basic Program Benefits)
DoD clarifies the following for purposes of benefit coverage of DE
under the TRICARE Basic Program:
DE is an authorized benefit when medically necessary for
the treatment of a covered illness or injury.
Authorized DE is a benefit when ordered by certain
authorized individual professional providers listed in Sec.
199.6(c)(3)(i), (ii), or (iii) of this part for the specific use of the
beneficiary and the equipment provides the medically appropriate level
of performance and quality for the beneficiary's condition.
Unless otherwise excluded under the regulation, items
authorized coverage as DE include (1) DME (including a
cardiorespiratory monitor under certain conditions), (2) wheelchairs
when medically appropriate to provide basic mobility, (3) iron lungs,
and (4) hospital beds. An electric wheelchair or a TRICARE-approved
alternative to an electric wheelchair may be used in lieu of a manual
wheelchair when it is medically indicated and appropriate for the
individual patient.
An item that provides a medically appropriate level of
performance or quality for the beneficiary's condition does not include
luxury, deluxe, or immaterial items. Only the base or basic model of
equipment shall be covered, unless any customization of the equipment
owned by the beneficiary, or an accessory or item of supply for any DE
is essential for (1) achieving therapeutic benefit for the beneficiary;
(2) making the equipment serviceable; or (3) otherwise assuring the
proper functioning of the equipment. If a beneficiary wishes to obtain
an item of DE that has deluxe, luxury, or immaterial features, the
beneficiary shall be responsible for the difference between the price
of the item and the TRICARE allowable cost for an otherwise authorized
item of DE without such features.
DE, which otherwise qualifies as a benefit, is excluded
from coverage if (1) the beneficiary is a patient in a type of facility
that ordinarily provides the same type of DE item to its patients at no
additional charge in the usual course of providing its services; or (2)
DE is available to the beneficiary from a Uniformed Services Medical
Treatment Facility.
DE may be provided on a rental or purchase basis and
coverage will be based on the price most advantageous to the government
under established procedures.
Repairs of DE damaged while using the equipment in a
manner inconsistent with its common use, and replacement of lost or
stolen DE are excluded from Basic Program benefits.
Repairs of deluxe, luxury or immaterial features of DE are
excluded from Basic Program benefits.
Sec. 199.5 (TRICARE Extended Care Health Option (ECHO))
DoD clarifies the following for purposes of benefit coverage of DE
and AT devices under the ECHO Program:
An AT device is authorized under certain coverage criteria
when necessary to assist in the reduction of the disabling effects of a
qualifying condition of the ECHO eligible beneficiary. For
beneficiaries eligible for an individual education plan (IEP), AT
devices that are recommended as part of the IEP may be covered.
For those beneficiaries who cease to meet the eligibility
requirements for an IEP, AT devices under TRICARE ECHO Program must:
--Be preauthorized;
--Be prescribed by a TRICARE authorized provider;
--Assist in the reduction of the disabling effects of the qualifying
ECHO condition; and
--Be an item or educational learning device normally included in an
IEP.
Further, the item must not be otherwise covered as a prosthetic,
augmentative communication device, or a benefit under the TRICARE Basic
Program. The implementing instructions for this provision will be
outlined in the TRICARE Policy Manual. As with all aspects of this
proposed rule, DoD invites the public's comments on our approach
regarding AT devices for those beneficiaries who cease to be eligible
for an IEP.
Repairs of DE or AT devices damaged while using the
equipment in a manner inconsistent with its common use, and replacement
of lost or stolen DE or AT devices are excluded from ECHO coverage.
Repairs of deluxe, luxury or immaterial features of DE or
AT devices are excluded from ECHO coverage.
Wheelchairs may exceed the basic mobility limitation when
needed to mitigate the effects of the ECHO qualifying condition of the
beneficiary.
DE may be provided on a rental or purchase basis and
coverage will be based on the price most advantageous to the government
under the same procedures established for pricing DE under the TRICARE
Basic Program.
III. Public Comments
On August 8, 2013 (78 FR 48367-48373), the Office of the Secretary
of Defense published a proposed rule and provided the public an
opportunity to comment on implementing changes to the coverage of DE,
ordering or prescribing DE and benefit coverage of AT devices under the
ECHO Program. The comment period closed October 7, 2013.
As a result of publication of the proposed rule, DoD received 57
comments. All of the commenters supported the policies we proposed,
although there were concerns about physician assistants, nurse
practitioners, and clinical nurse specialists not being included on the
list of providers authorized to prescribe or order DE under the TRICARE
Program. We appreciate all expressions of support and approval for the
proposed guidelines.
Response Regarding Physician Assistants
Generally, the Program policy has been to recognize those
authorized individual professional providers identified in 10 U.S.C.
1079(a)(13) when acting within the scope of their licenses and to allow
direct reimbursement for authorized services they provide. However,
Sec. 199.14(j)(ix) allows an otherwise authorized physician to bill
for the services of an authorized ``certified'' physician assistant
(CPA) under Sec. 199.6(c)(3)(iii)(H), provided the CPA is acting
within the scope of his or her license and is supervised by an
employing physician. Therefore, the final rule will allow CPAs to
prescribe or order DE under the supervision of the employing authorized
physician who must bill under his or her National Provider Identifier
(NPI) for services that a CPA furnishes incident to his or her
professional services.
Response Regarding Nurse Practitioners
Nurse practitioners (NPs), by TRICARE law and regulation, are only
recognized as individual professional providers when they qualify as
``certified'' nurse practitioners (CNPs). For that reason, DoD will
authorize only CNPs to prescribe or order DE when acting within the
scope of their state license or certificate.
[[Page 78711]]
Response Regarding Clinical Nurse Specialists
``Certified'' clinical nurse specialists (CCNSs) are recognized as
advanced practice nurses. They meet the same state requirements and
coursework as any other advanced practice nurse (such as a CPN) whose
practice similarly extends into the medical field, or for that matter,
into any other medical professional area, and may use advanced practice
nurse practitioner (APNP) or advanced practice nurse (APN) title when
practicing within a CCNS's scope of practice. Therefore, CCNSs when
recognized by TRICARE under one of the existing categories of
authorized allied health care professionals as found in Sec.
199.6(c)(3)(iii) are authorized to prescribe DE when acting within the
scope of their state license or certificate.
In this final rule, DoD considered all comments received during the
comment period and responses to those comments are included in the
above section of this final rule.
IV. Regulatory Procedure
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
It has been determined that this final rule is not a significant
regulatory action. This rule does not:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy; a section of the
economy; productivity; competition; jobs; the environment; public
health or safety; or State, local, or tribunal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another Agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
these Executive Orders.
Unfunded Mandates Reform Act (Sec. 202, Pub. L. 104-4)
It has been determined that this final rule does not contain a
Federal mandate that may result in the expenditure by State, local and
tribal governments, in aggregate, or by the private sector, of $100
million or more in any one year.
Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)
It has been certified that this final rule is not subject to the
Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if
promulgated, have a significant economic impact on a substantial number
of small entities. Set forth in the final rule are minor revisions to
the existing regulation. The DoD does not anticipate a significant
impact on the Program.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
It has been determined that this final rule does not impose
reporting or recordkeeping requirements under the Paperwork Act of
1995.
Executive Order 13132, Federalism
It has been determined that this final rule does not have
federalism implications, as set forth in Executive Order 13132. This
rule does not have substantial direct effects on:
(1) The States;
(2) The relationship between the National Government and the
States; or
(3) The distribution of power and responsibilities among the
various levels of Government.
List of Subjects in 32 CFR Part 199
Claims, Dental health, Health care, Health insurance, Individuals
with disabilities, and Military personnel.
Accordingly, 32 CFR part 199 is amended to read as follows:
PART 199--[AMENDED]
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Section 199.2, paragraph (b) is amended by adding the definition of
``Assistive technology devices'' in alphabetical order and revising the
definitions of ``Duplicate equipment,'' ``Durable equipment,'' and
``Durable medical equipment'' to read as follows:
Sec. 199.2 Definitions.
* * * * *
(b) * * *
Assistive technology devices. Equipment that generally does not
treat an underlying injury, illness, disease or their symptoms.
Assistive technology devices are authorized only under the Extended
Care Health Option (ECHO). Assistive technology devices help an ECHO
beneficiary overcome or remove a disability and are used to increase,
maintain, or improve the functional capabilities of an individual.
Assistive technology devices may include non-medical devices but do not
include any structural alterations (e.g., permanent structure of
wheelchair ramps or alterations to street curbs) service animals (e.g.,
Seeing Eye dogs, hearing/handicapped assistance animals, etc.) or
specialized equipment and devices whose primary purpose is to enable
the individual to engage in sports or recreational events. Assistive
technology devices are authorized only under coverage criteria
determined by the Director, TRICARE Management Activity to assist in
the reduction of the disabling effects of a qualifying condition for
individuals eligible to receive benefits under the ECHO program, as
provided in Sec. 199.5.
* * * * *
Duplicate equipment. An item of durable equipment, durable medical
equipment, or assistive technology items, as defined in this section
that serves the same purpose that is served by an item of durable
equipment, durable medical equipment, or assistive technology item
previously cost-shared by TRICARE. For example, various models of
stationary oxygen concentrators with no essential functional
differences are considered duplicate equipment, whereas stationary and
portable oxygen concentrators are not considered duplicates of each
other because the latter is intended to provide the user with mobility
not afforded by the former. Also, a manual wheelchair and electric
wheelchair, both of which otherwise meet the definition of durable
equipment or durable medical equipment, would not be considered
duplicates of each other if each is found to provide an appropriate
level of mobility. For the purpose of this Part, durable equipment,
durable medical equipment, or assistive technology items that are
essential in providing a fail-safe in-home life support system or that
replace in-like-kind an item of equipment that is not serviceable due
to normal wear, accidental damage, a change in the beneficiary's
condition, or has been declared adulterated by the U.S. FDA, or is
being or has been recalled by the manufacturer is not considered
duplicate equipment.
Durable equipment. Equipment that--
(1) Is a medically necessary item, which can withstand repeated
use;
(2) Is primarily and customarily used to serve a medical purpose;
and
(3) Is generally not useful to an individual in the absence of an
illness or injury. It includes durable medical equipment as defined in
Sec. 199.2, wheelchairs, iron lungs, and hospital
[[Page 78712]]
beds. It does not include equipment (including wheelchairs) used or
designed primarily for use in sports or recreational activities.
Durable medical equipment. Durable equipment that is medically
appropriate to--
(1) Improve, restore, or maintain the function of a malformed,
diseased, or injured body part or can otherwise minimize or prevent the
deterioration of the beneficiary's function or condition; or
(2) Maximize the beneficiary's function consistent with the
beneficiary's physiological or medical needs.
* * * * *
0
3. Section 199.4 is amended by revising paragraphs (a)(1)(i), (d)(1),
(d)(3)(ii), and (g)(43) to read as follows:
Sec. 199.4 Basic program benefits.
(a) * * *
(1)(i) Scope of benefits. Subject to all applicable definitions,
conditions, limitations, or exclusions specified in this part, the
CHAMPUS Basic Program will cost share medically necessary services and
supplies required in the diagnosis and treatment of illness or injury,
including maternity care and well-baby care. Benefits include specified
medical services and supplies provided to eligible beneficiaries from
authorized civilian sources such as hospitals, other authorized
institutional providers, physicians, other authorized individual
professional providers, and professional ambulance services,
prescription drugs, authorized medical supplies, and rental or purchase
of durable equipment.
* * * * *
(d) Other benefits--(1) General. Benefits may be extended for the
allowable charge of those other covered services and supplies described
in paragraph (d) of this section, which are provided in accordance with
good medical practice and established standards of quality by those
other authorized providers described in Sec. 199.6. Such benefits are
subject to all applicable definitions, conditions, limitations, or
exclusions as otherwise may be set forth in this or other chapters of
this Regulation. To be considered for benefits under paragraph (d) of
this section, the described services or supplies must be prescribed and
ordered by a physician. Other authorized individual professional
providers acting within their scope of licensure may also prescribe and
order these services and supplies unless otherwise specified in
paragraph (d) of this section.
* * * * *
(3) * * *
(ii) Durable equipment--(A) Scope of benefit. (1) Durable
equipment, which is for the specific use of the beneficiary and is
ordered by an authorized individual professional provider listed in
Sec. 199.6(c)(3)(i), (ii) or (iii), acting within his or her scope of
licensure shall be covered if the durable equipment meets the
definition in Sec. 199.2 and--
(i) Provides the medically appropriate level of performance and
quality for the medical condition present and
(ii) Is not otherwise excluded by this part.
(2) Items that may be provided to a beneficiary as durable
equipment include:
(i) Durable medical equipment as defined in Sec. 199.2;
(ii) Wheelchairs. A wheelchair, which is medically appropriate to
provide basic mobility, including reasonable additional costs for
medically appropriate modifications to accommodate a particular
physiological or medical need, may be covered as durable equipment. An
electric wheelchair, or TRICARE approved alternative to an electric
wheelchair (e.g., scooter) may be provided in lieu of a manual
wheelchair when it is medically indicated and appropriate to provide
basic mobility. Luxury or deluxe wheelchairs, as described in paragraph
(d)(3)(ii)(A)(3) of this section, include features beyond those
required for basic mobility of a particular beneficiary are not
authorized.
(iii) Iron lungs.
(iv) Hospital beds.
(v) Cardiorespiratory monitors under conditions specified in
paragraph (d)(3)(ii)(B) of this section.
(3) Whether a prescribed item of durable equipment provides the
medically appropriate level of performance and quality for the
beneficiary's condition must be supported by adequate documentation.
Luxury, deluxe, immaterial, or non-essential features, which increase
the cost of the item relative to a similar item without those features,
based on industry standards for a particular item at the time the
equipment is prescribed or replaced for a beneficiary, are not
authorized. Only the ``base'' or ``basic'' model of equipment (or more
cost-effective alternative equipment) shall be covered, unless
customization of the equipment, or any accessory or item of supply for
any durable equipment, is essential, as determined by the Director (or
designee), for--
(i) Achieving therapeutic benefit for the patient;
(ii) Making the equipment serviceable; or
(iii) Otherwise assuring the proper functioning of the equipment.
* * * * *
(B) * * *
(C) Exclusions. Durable equipment, which is otherwise qualified as
a benefit is excluded from coverage under the following circumstances:
(1) Durable equipment for a beneficiary who is a patient in a type
of facility that ordinarily provides the same type of durable equipment
item to its patients at no additional charge in the usual course of
providing its services.
(2) Durable equipment, which is available to the beneficiary from a
Uniformed Services Medical Treatment Facility.
(D) Basis for reimbursement. (1) Durable equipment may be provided
on a rental or purchase basis. Coverage of durable equipment will be
based on the price most advantageous to the government taking into
consideration the anticipated duration of the medically necessary need
for the equipment and current price information for the type of item.
The cost analysis must include a comparison of the total price of the
item as a monthly rental charge, a lease-purchase price, and a lump-sum
purchase price and a provision for the time value of money at the rate
determined by the U.S. Department of Treasury. If a beneficiary wishes
to obtain an item of durable equipment with deluxe, luxury, immaterial
or non-essential features, the beneficiary may agree to accept TRICARE
coverage limited to the allowable amount that would have otherwise been
authorized for a similar item without those features. In that case, the
TRICARE coverage is based upon the allowable amount for the kind of
durable equipment normally used to meet the intended purpose (i.e., the
standard item least costly). The provider shall not hold the
beneficiary liable for deluxe, luxury, immaterial, or non-essential
features that cannot be considered in determining the TRICARE allowable
costs. However, the beneficiary shall be held liable if the provider
has a specific agreement in writing from the beneficiary (or his or her
representative) accepting liability for the itemized difference in
costs of the durable equipment with deluxe, luxury, or immaterial
features and the TRICARE allowable costs for an otherwise authorized
item without such features.
[[Page 78713]]
(2) In general, repairs of beneficiary owned durable equipment are
covered when necessary to make the equipment serviceable and
replacement of durable equipment is allowed when the durable equipment
is not serviceable because of normal wear, accidental damage or when
necessitated by a change in the beneficiary's condition. However,
repairs of durable equipment damaged while using the equipment in a
manner inconsistent with its common use, and replacement of lost or
stolen durable equipment are excluded from coverage. In addition,
repairs of deluxe, luxury, or immaterial features of durable equipment
are excluded from coverage.
* * * * *
(g) * * *
(43) Exercise/relaxation/comfort/sporting items or sporting
devices. Exercise equipment, to include items primarily and customarily
designed for use in sports or recreational activities, spas,
whirlpools, hot tubs, swimming pools health club memberships or other
such charges or items.
* * * * *
0
4. Section 199.5 is amended by revising paragraphs (c)(2), (c)(8)(ii),
and (c)(8)(iii), (d)(3), (d)(7) introductory text, (d)(7)(i),
(d)(7)(iv), and (d)(8), (g)(2), and (h)(4), and adding new paragraph
(d)(7)(v) to read as follows:
Sec. 199.5 TRICARE extended care health option (ECHO).
* * * * *
(c) * * *
(2) Medical, habilitative, rehabilitative services and supplies,
durable equipment and assistive technology (AT) devices that assist in
the reduction of the disabling effects of a qualifying condition.
Benefits shall be provided in the beneficiary's home or another
environment, as appropriate. An AT device may be covered only if it is
recommended in a beneficiary's Individual Educational Program (IEP) or,
if the beneficiary is not eligible for an IEP, the AT device is an item
or educational learning device normally included in an IEP and is
preauthorized under ECHO as an integral component of the beneficiary's
individual comprehensive health care services plan (including
rehabilitation) as prescribed by a TRICARE authorized provider.
(i) An AT device may be covered under ECHO only if it is not
otherwise covered by TRICARE as durable equipment, a prosthetic,
augmentation communication device, or other benefits under Sec. 199.4.
(ii) An AT device may include an educational learning device
directly related to the beneficiary's qualifying condition when
recommended by an IEP and not otherwise provided by State or local
government programs. If an individual is not eligible for an IEP, an
educational learning device normally included in the IEP may be
authorized as if directly related to the beneficiary's qualifying
condition and prescribed by a TRICARE authorized provider as part of
the beneficiary's individual comprehensive health care services plan.
(iii) Electronic learning devices may include the hardware and
software as appropriate. The Director, DHA, shall determine the types
and (or) platforms of electronic devices and the replacement lifecycle
of the hardware and its supporting software. All upgrades or
replacements shall require a recommendation from the individual's IEP
or the individual's comprehensive health care services plan.
(iv) Duplicative or redundant hardware platforms are not
authorized.
Note to paragraph (c)(2)(iv): When one or more electronic platforms
such as a desktop computer, laptop, notebook or tablet can perform the
same functions in relation to the teaching or educational objective
directly related to the qualifying condition, it is the intent of this
provision to allow only one electronic platform that may be chosen by
the beneficiary. Duplicative or redundant platforms are not allowed;
however, a second platform may be obtained, if the individual's IEP
recommends one platform such as a computer for the majority of the
learning objectives, but there exists another objective, which cannot
be performed on that platform. In these limited circumstances, the
beneficiary may submit a request with the above justification to the
Director, TMA, who may authorize a second device.
(v) AT devices damaged through improper use of the device as well
as lost or stolen devices may not be replaced until the device would
next be eligible for a lifecycle replacement.
(vi) AT devices do not include equipment or devices whose primary
purpose is to assist the individual to engage in sports or recreational
activities.
* * * * *
(8) * * *
(ii) Equipment adaptation. The allowable equipment and an AT device
purchase shall include such services and modifications to the equipment
as necessary to make the equipment usable for a particular ECHO
beneficiary.
(iii) Equipment maintenance. Reasonable repairs and maintenance of
the beneficiary owned or rented DE or AT devices provided by this
section shall be allowed while a beneficiary is registered in the ECHO
Program. Repairs of DE and/or AT devices damaged while using the item
in a manner inconsistent with its common use, and replacement of lost
or stolen DE and/or AT devices are not authorized coverage as an ECHO
benefit. In addition, repairs and maintenance of deluxe, luxury, or
immaterial features of DE or AT devices are not authorized coverage as
an ECHO benefit.
(d) * * *
(3) Structural alterations. Alterations to living space and
permanent fixtures attached thereto, including alterations necessary to
accommodate installation of equipment or AT devices to facilitate
entrance or exit, are excluded.
* * * * *
(7) Equipment. Purchase or rental of DE and AT devices otherwise
allowed by this section is excluded when:
(i) The beneficiary is a patient in an institution or facility that
ordinarily provides the same type of equipment or AT devices to its
patients at no additional charge in the usual course of providing
services; or
* * * * *
(iv) The item is a duplicate DE or an AT device, as defined in
Sec. 199.2.
(v) The item (or charge for access to such items through health
club membership or other activities) is exercise equipment including an
item primarily and customarily designed for use in sports or
recreational activities, spa, whirlpool, hot tub, swimming pool, an
electronic device used to locate or monitor the location of the
beneficiary, or other similar items or charges.
(8) Maintenance agreements. Maintenance agreements for beneficiary
owned or rented equipment or AT device are excluded.
* * * * *
(g) * * *
(2) Equipment. (i) The TRICARE allowable amount for DE or AT
devices shall be calculated in the same manner as DME allowable through
section 199.4 of this title, and accrues to the fiscal year benefit
limit specified in paragraph (f)(3) of this section.
(ii) Cost-share. A cost-share, as provided by paragraph (f)(2) of
this section, is required for each month in which equipment or an AT
device is purchased under this section. However, in no month shall a
sponsor be required to pay more than one cost-share regardless of the
number of benefits the sponsor's dependents received under this
section.
* * * * *
(h) * * *
[[Page 78714]]
(4) Repair or maintenance of DE owned by the beneficiary or an AT
device is exempt from the public facility-use certification
requirements.
* * * * *
Dated: December 22, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2014-30337 Filed 12-30-14; 8:45 am]
BILLING CODE 5001-06-P