TRICARE; Coverage of Care Related to Non-Covered Initial Surgery or Treatment, 78703-78707 [2014-30307]
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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations
monthly, except as otherwise provided
through administrative implementation,
pursuant to procedures established by
the Director, Healthcare Operations in
the Defense Health Agency. The
monthly rate for each month of a
calendar year is one-twelfth of the
annual rate for that calendar year.
(1) Annual establishment of rates.—(i)
TRICARE Retired Reserve monthly
premium rates shall be established and
updated annually on a calendar year
basis by the ASD(HA) for each of the
two types of coverage, member-only
coverage and member-and-family
coverage as described in paragraph
(d)(1) of this section.
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(d) Procedures. The Director,
Healthcare Operations in the Defense
Health Agency, may establish
procedures for the following.
(1) Purchasing Coverage. Procedures
may be established for a qualified
member to purchase one of two types of
coverage: Member-only coverage or
member and family coverage. Immediate
family members of the Retired Reserve
member as specified in paragraph (g)(2)
of this section may be included in such
family coverage. To purchase either type
of TRICARE Retired Reserve coverage
for effective dates of coverage described
below, Retired Reserve members and
survivors qualified under either
paragraph (b)(1) or (b)(2) of this section
must submit a request in the appropriate
format, along with an initial payment of
the applicable premium required by
paragraph (c) of this section in
accordance with established procedures.
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(3) Suspension and Termination.
Suspension/termination of coverage for
the TRR member/survivor will result in
suspension/termination of coverage for
the member’s/survivor’s family
members in TRICARE Retired Reserve,
except as described in paragraph
(d)(1)(iv) of this section. Procedures may
be established for coverage to be
suspended and/or terminated as
follows.
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(iii) Coverage may be suspended and
finally terminated for members/
survivors who fail to make premium
payments in accordance with
established procedures.
(iv) Coverage may be suspended and
finally terminated for members/
survivors upon request at any time by
submitting a completed request in the
appropriate format in accordance with
established procedures.
(v) Under paragraph (d)(3)(iii) or
(d)(3)(iv) of this section, TRICARE
Retired Reserve coverage may first be
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suspended for a period of up to one year
followed by final termination.
Procedures may be established for the
suspension to be lifted upon request
before final termination is applied.
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(f) Administration. The Director,
Healthcare Operations in the Defense
Health Agency may establish other rules
and procedures for the effective
administration of TRICARE Retired
Reserve, and may authorize exceptions
to requirements of this section, if
permitted by law.
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Dated: December 22, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2014–30282 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–0164]
RIN 0720–AB61
TRICARE; Coverage of Care Related to
Non-Covered Initial Surgery or
Treatment
Office of the Secretary,
Department of Defense.
ACTION: Final rule.
AGENCY:
This final rule revises the
limitations on certain TRICARE basic
program benefits. More specifically, it
allows coverage for otherwise covered
services and supplies required in the
treatment of complications (unfortunate
sequelae), as well as medically
necessary and appropriate follow-on
care, resulting from a non-covered
incident of treatment provided pursuant
to a properly granted Supplemental
Health Care Program waiver. This final
rule amends two provisions of the
TRICARE regulations which limits
coverage for the treatment of
complications resulting from a noncovered incident of treatment, and
which expressly excludes from coverage
in the Basic Program services and
supplies related to a non-covered
condition or treatment.
DATES: This final rule is effective
January 30, 2015.
FOR FURTHER INFORMATION CONTACT:
Thomas Doss (703) 681–7512.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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78703
Executive Summary
A. Purpose of Regulatory Action
Need for the Regulatory Action
This final rule is necessary for
consistency with existing regulatory
provisions and to protect TRICARE
beneficiaries from incurring
unnecessary financial hardships arising
from the current regulatory restrictions
that prohibit TRICARE coverage of the
treatment of complications resulting
from certain non-covered medical
procedures. On occasion, an authorized
official of a uniformed service may
request from the Director, Defense
Health Agency (DHA) a waiver of
TRICARE regulatory restrictions or
limitations, when the waiver is
necessary to assure adequate availability
of health care services to the active duty
member. In those cases when a waiver
has been properly granted under
§ 199.16(f), this rule grants benefits
coverage for otherwise covered services
and supplies required for treating
complications arising from the noncovered incident of treatment provided
in the private sector pursuant to the
waiver. Additionally, with respect to
care that is related to a non-covered
initial surgery or treatment, the final
rule seeks to eliminate any confusion
regarding what services and supplies
will be covered by TRICARE and under
what circumstances they will be
covered.
Legal Authority for the Regulatory
Action
This regulation is finalized under the
authorities of 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 Department is authorized to
provide medically necessary and
appropriate treatment for mental and
physical illnesses, injuries and bodily
malfunctions, including hospitalization,
outpatient care, drugs, treatment of
medical and surgical conditions and
other types of health care outlined in 10
U.S.C. 1077(a). Although section 1077
defines benefits to be provided in the
Military Treatment Facilities (MTFs),
these benefits are incorporated by
reference into the benefits provided in
the civilian health care sector to active
duty family members and retirees and
their dependents through sections 1079
and 1086 respectively.
B. Summary of the Final Rule
The final rule amends the existing
special benefit provision regarding
complications (unfortunate sequelae)
resulting from non-covered initial
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surgery or treatment, to more clearly
address what services and supplies will
be covered by TRICARE and under what
circumstances they will be covered. The
provision itself is relabeled ‘‘Care
related to non-covered initial surgery or
treatment’’ to eliminate any confusion
regarding what constitutes a
complication or unfortunate sequelae
and how broadly or narrowly the
exclusion and exceptions to the
exclusion should be applied. As
amended, the regulatory section will
specifically address coverage of
otherwise covered medically necessary
treatment, to include coverage of (i)
treatment of complications that
represent a separate medical condition;
(ii) treatment of complications and
necessary follow-on care resulting from
a non-covered incident of treatment
provided in an MTF; and (iii) treatment
of complications and necessary followon care resulting from a non-covered
incident of treatment provided pursuant
to an approved Supplemental Health
Care Program (SHCP) waiver.
Additionally, the regulatory exclusion at
§ 199.4(g)(63) is amended to state clearly
that all services and supplies related to
a non-covered condition or treatment,
including any necessary follow-on care
and treatment of complications, are
excluded from coverage except as
provided in § 199.4(e)(9).
C. Costs and Benefits
This final rule is not anticipated to
have an annual effect on the economy
of $100 million or more, making it a
non-economically significant rule under
Executive Order 12866 and non-major
rule under the Congressional Review
Act. All services and supplies
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 care can be cost shared by
TRICARE. For this reason, DoD
anticipates that TRICARE will incur
only a marginal increase in cost
associated with the inclusion of
coverage for treatment of complications
and necessary follow-on care for
TRICARE beneficiaries who received
previously authorized non-covered
treatment pursuant to a SHCP waiver
while on active duty.
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I. Background
A. Statutory and Regulatory Background
Members of the uniformed services on
active duty are entitled to medical and
dental care pursuant to 10 U.S.C. 1074,
including the provision of such care in
private facilities. With respect to the
purchase of private sector health care
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services for Active Duty Service
Members (ADSMs) under the SHCP,
§ 199.16 implements the statutory
provision at 10 U.S.C. 1074(c).
Generally, the same rules that govern
payment and administration of private
sector health care claims under
TRICARE apply to the SHCP and the
care that members receive in private
facilities is comparable to coverage for
medical care under the TRICARE Prime
program. Section 199.16(f) provides the
Director of DHA discretionary authority
to waive requirements of TRICARE
regulations, including any restrictions
or limitations under the TRICARE Basic
Program benefits, except those
specifically set forth in statute, based on
‘‘a determination that such waiver is
necessary to assure adequate availability
of health care to Active Duty members.’’
ADSMs have access to non-covered care
including experimental or unproven
medical care and treatments in the
purchased care sector on a case-by-case
basis using the SHCP waiver process.
The Director, DHA, or designee
specifically approves these case-by-case
treatment decisions, resulting in a
number of ADSMs receiving otherwise
non-covered private sector care while
serving.
If an ADSM is granted a waiver under
the SHCP to receive an otherwise noncovered incident of treatment by a
private sector provider, rather than in an
MTF, and suffers complications from
the care, SHCP funds can be used to
cover necessary follow-on care and
treatment of complications in the
purchased care system as long as the
member remains on active duty. Once
the member retires, however, SHCP
coverage no longer exists and TRICARE
does not cover unfortunate sequelae of
non-covered care provided in the
purchased care sector, except in limited
circumstances (e.g. later complications
that represent a separate medical
condition separate from the condition
that the non-covered treatment or
surgery was directed toward, and the
treatment of the complication is not
essentially similar to the covered
procedures. This may include a
systemic infection, cardiac arrest, or
acute drug reaction). Additionally, once
the service member has retired, existing
regulations would not allow the
continuation of any needed follow-on
care such as rehabilitative care or drug
therapy. When these beneficiaries
require such treatment, they are
responsible for the payment for this
necessary treatment, which may result
in significant financial hardship.
This rule resolves that unfortunate
situation by allowing coverage of
treatment for necessary follow-on care,
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including complications, resulting from
non-covered treatment provided to
beneficiaries pursuant to a SHCP
waiver. The specific procedures for
approval of this treatment will be
addressed in the TRICARE Policy
Manual to ensure that this information
is current and easily accessible.
TRICARE manuals may be accessed at
https://www.tricare.mil.
B. Summary of the Proposed Rule
We proposed to amend the existing
special benefit provision regarding
complications (unfortunate sequelae)
resulting from non-covered initial
surgery, to more clearly address what
services and supplies will be covered by
TRICARE and under what
circumstances they will be covered. We
also proposed to re-label the regulatory
provision to read: ‘‘Care related to noncovered initial surgery or treatment’’ to
eliminate any confusion regarding what
constitutes a complication or
unfortunate sequelae and how broadly
or narrowly the exclusion and
exceptions to the exclusion would be
applied. As amended, the regulatory
section would specifically address
coverage of otherwise covered medically
necessary treatment, to include (i)
coverage of complications that represent
a separate medical condition; (ii)
treatment of complications and
necessary follow-on care resulting from
a non-covered incident of treatment
provided in an MTF; and (iii) treatment
of complications and necessary followon care resulting from a non-covered
incident of treatment provided pursuant
to an approved SHCP waiver. Inclusion
of the third prong would support the
provision of care necessary to allow
members to return to full duty and/or
reach their maximum rehabilitative
potential without requiring the member
to bear the sole financial risk for
unfortunate sequelae once they are no
longer on active duty. This amendment
would also provide consistent treatment
of unfortunate sequelae and necessary
follow-on care when an original episode
of non-covered care is provided for a
valid governmental purpose, whether to
support Graduate Medical Education
(GME) and maintain provider skill
levels within an MTF or an ADSM’s
fitness for duty through authorization of
the purchase of otherwise non-covered
care via an SHCP waiver. Additionally,
we proposed to amend the regulatory
exclusion at § 199.4(g)(63) to clearly
state that all services and supplies
related to a non-covered condition or
treatment, including any necessary
follow-on care and treatment of
complications, would be excluded from
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coverage except as provided in
§ 199.4(e)(9).
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C. Summary of the Final Rulemaking
Modifications to the TRICARE Basic
Program Benefits
Under the TRICARE private sector
health care program, certain conditions
and treatments are excluded from
coverage. For example, any drug,
device, medical treatment, or procedure
whose safety and efficacy has not been
established by reliable evidence is
considered unproven and excluded
from coverage. This exclusion includes
all services directly related to the
unproven drug, device, medical
treatment or procedure. Specifically,
benefits for otherwise covered services
and supplies that are required in the
treatment of complications (unfortunate
sequelae) resulting from a non-covered
incident of treatment, are generally
excluded from TRICARE coverage
pursuant to § 199.4(e)(9), unless the
complication represents a separate
medical condition such as a systemic
infection, cardiac arrest, and acute drug
reaction. TRICARE also excludes any
needed follow-on care resulting from a
non-covered condition or initial surgery
or treatment pursuant to § 199.4(g)(63).
There is currently one exception to
this general exclusion, found at
§ 199.4(e)(9)(ii), which allows coverage
of otherwise covered services and
supplies required in the treatment of
complications (unfortunate sequelae)
resulting from a non-covered incident of
treatment provided in a 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. This current exception
recognizes that in order to support GME
and maintain provider skill levels, MTF
providers are required to perform
medical procedures that may be
excluded from coverage under the
TRICARE private sector program. This
coverage provision was viewed as
necessary to protect TRICARE
beneficiaries from incurring financial
hardships in such cases.
Currently, Active Duty Service
Members (ADSMs) may receive noncovered TRICARE private sector health
care services under the SHCP if a waiver
is submitted through the Service and
approved by the Director, DHA, or
designee, in accordance with § 199.6(f).
While the Department wants to ensure
that Service members have access to the
latest, promising medical technologies
and procedures, there must be assurance
that the care is safe and effective, and
that members are not subjected to undue
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risk, or rendered unfit for continued
service, due to complications suffered
because of unproven medical care.
Consequently, requests for non-covered
procedures and treatments, including
unproven care, are carefully reviewed in
conjunction with other available,
proven treatments, if any exist, to
determine whether approval of the
requested care is necessary to assure the
adequate availability of health care to
the member. Currently, Service
members are counseled that the
treatment remains a non-covered
TRICARE benefit, and that any followon care, including care for
complications, will not be covered by
TRICARE once the member separates or
retires. Members are left to make a
difficult choice between pursuing a
SHCP waiver in an effort to remain fit
for full duty while assuming the
financial risk of any necessary follow-on
care after discharge, or, electing not to
receive the care and risk separation from
the Service.
Like the existing exception at
§ 199.4(e)(9)(ii) for non-covered care
provided in a MTF, this exception is
narrowly tailored to serve a similar
government interest; namely, protecting
former active duty members who have
received private sector care pursuant to
a SHCP waiver in an effort to ensure
their fitness for duty and continued
service.
Additionally, some confusion has
arisen regarding the terms
‘‘complication’’ and ‘‘unfortunate
sequelae’’ as these terms are not
currently defined in regulation.
Questions have arisen with respect to
whether necessary follow-on care
resulting from a non-covered procedure
or treatment in an MTF is covered in
situations where the MTF is unable to
provide the necessary treatment. The
intent of the prior September 16, 2011,
final rule, as well as this final rule, is
to protect TRICARE beneficiaries from
incurring financial hardships in limited
circumstances, which serve valid
governmental purposes. Absent an
exception to the general exclusion from
coverage, treatment of adverse
outcomes, both expected and
unexpected, as well as any necessary
follow-on care that is a direct result of
the initial non-covered treatment, are
excluded and could result in less than
optimal care (e.g., not receiving
necessary physical therapy following
surgery) and/or a significant financial
hardship for the beneficiary. The
Agency did not intend to prevent
coverage of necessary follow-on private
sector care in situations where an MTF
is unable to provide that care but the
current regulatory language is subject to
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such a narrow interpretation absent
additional clarification. This final rule
permits coverage of necessary continued
treatment, such as physical therapy
following a non-covered surgical
procedure in an MTF. It also covers
medically necessary follow-on care,
including, for example, anti-rejection
medications for former members who
have received face and hand
transplants. This rule eliminates the
need to try to determine whether the
medically necessary and appropriate
care the patient is seeking from the
private sector is considered treatment of
an expected complication, an
unexpected complication or routine
follow-on care, because it will be clearly
covered.
II. Summary of and Responses to Public
Comments
The proposed rule was published in
the Federal Register (78 FR 62506)
October 22, 2013, for a 60-day comment
period. We received comments on the
proposed rule from three commenters.
Comments: Two commenters
expressed general support for TRICARE
expressly covering otherwise medically
necessary treatment resulting from a
non-covered incident of treatment
provided pursuant to an approved SHCP
waiver. They supported the policy
objective of reducing financial risk for
unfortunate sequelae once service
members are no longer on active duty.
One commenter stated further that
TRICARE should cover all of the
medical procedures that beneficiaries
need. The second commenter, in
addition to expressing support for the
proposed change, emphasized the need
for a properly approved SHCP waiver.
Response: We appreciate the
commenters’ support of this regulatory
proposal. We would note that the
comment pertaining to coverage of all
medical procedures that beneficiaries
need exceeds the scope of this Final
Rule. Moreover, current TRICARE
regulations already address those
circumstances under which TRICARE is
statutorily authorized to provide
coverage. We also point out that the
Defense Health Agency issues waivers
infrequently and with careful
consideration to ensure that the member
has access to medically necessary
treatment. In these circumstances, SHCP
waivers are only issued when necessary
to ensure that health care services are
adequately available to active duty
service members.
Comment: One commenter observed
that the Proposed Rule deleted the
reference to ‘‘transsexual surgery’’ and
‘‘repair of a prolapsed vagina in a
biological male who had undergone
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transsexual surgery’’ in the regulation
text for § 199.4(e)(9)(i). The commenter
queried whether we were proposing a
change in policy regarding transsexual
procedures.
Response: The proposed deletions in
the regulation text of the proposed rule
were intended to be strictly stylistic and
not intended to reflect any change in
policy regarding transsexual procedures.
TRICARE continues not to cover
transsexual surgery and consequently
would not cover complications similar
to the initial episode of non-covered
care, such as the repair of a prolapsed
vagina in a biological male who had
undergone transsexual surgery. The
statutory prohibition at 10 U.S.C.
1079(a)(12) continue to apply. The one,
very limited exception to this general
exclusion is that TRICARE may cover
surgery and related medically necessary
services performed to correct sex gender
confusion (that is, ambiguous genitalia)
which has been documented to be
present at birth.
In the proposed rule, we
acknowledged that some confusion had
arisen in the industry regarding the
terms ‘‘complication’’ and ‘‘unfortunate
sequelae’’ because the terms were not
defined in regulation. While not
defining the terms in the regulation text,
we did further explain and clarify the
intended scope of excluded treatment of
complications and unfortunate sequelae
resulting from non-covered initial
surgery or treatment, to include
expected and unexpected
complications, as well as any necessary
follow-on care that is a direct result of
the initial non-covered treatment, absent
an exception to the exclusion. We
explained that in § 199.4(e)(9)(ii), for
instance, the Agency did not intend to
prevent coverage of necessary follow-on
private sector care in situations where
an MTF was unable to provide that care
but the MTF Commander had
authorized the initial noncovered
service. To clarify the intended scope of
the excluded treatment of complications
or unfortunate sequelae, this rule adds
‘‘including any necessary follow-on care
or the treatment of complications’’ in
§ 199.4(g)(63), and ‘‘and any necessary
follow-on care’’ in § 199.4(e)(9)(ii).
Comment: We received one comment
supporting our amendments to the
regulations which clarify that the
treatment of complications or
unfortunate sequelae includes necessary
follow-on care. The commenter felt that
the Agency should withhold coverage of
treatment for secondary complications
when the initial procedure was purely
elective and did not serve a legitimate
national defense purpose. The
commenter also recommended the
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adoption of a regulatory definition of
‘‘complication,’’ relying perhaps on a
definition of the term used by private
health insurers.
Response: We appreciate the
commenter’s support of our clarifying
amendments to the two regulatory
provisions. While we will take under
advisement proposing a regulatory
definition of ‘‘complication’’ in the
future, at this time we believe that the
amendments in this rule will be
adequate to clarify our intended
meaning of the term and allow us to
retain the necessary flexibility when
implementing these regulations. The
Agency is also reluctant to classify
levels of ‘‘complications’’ as primary or
secondary, or consider the purpose for
which non-covered treatment was
provided. These proposals would add
an unnecessary degree of complexity to
this regulatory structure, or
alternatively, would require the Agency
to exceed the bounds of its statutory
authority.
Comment: A commenter
recommended that the Agency
specifically exclude certain initial
procedures from TRICARE coverage.
Response: This comment exceeds the
scope of this final rule, and we will
therefore not exclude from TRICARE
coverage any initial procedures
specified in the comment.
As a final matter, we are finalizing
corrections in the regulatory text for
§ 199.4(e)(9)(ii) and (iii), including
substituting references to the Director,
DHA, in lieu of the Director, TMA, and
the change from ‘‘§ 199.6(f) of this
chapter’’ to ‘‘§ 199.16(f)’’ in
§ 199.4(e)(9)(iii). We are making the first
non-substantive change for consistency
with recent changes to the structure of
the DoD. Section 731 of the National
Defense Authorization Act for FY 2013
directed the Secretary of Defense to
develop a plan carry out the reforms of
the governance of the military health
system, previously outlined in a March
2, 2012, Deputy Secretary of Defense
memorandum. As described in a March
11, 2013, Deputy Secretary of Defense
memorandum, the centerpiece of the
governance reform was the
establishment of a Defense Health
Agency (DHA) which would, among
other responsibilities, assume the
designated functions of the TMA, which
was being disestablished. Subsequently,
the Department of Defense published
Directive 5136.13 (published September
30, 2013), which provided that any
reference in law, rule, regulation, or
issuance to TMA will be deemed to be
a reference to DHA, unless otherwise
specified by the Secretary of Defense,
and further, that the Director, DHA, will
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serve as the program manager for
TRICARE health and medical resources,
as directed by the ASD(HA) and within
the established MHS governance
process. The reference to Director, DHA,
in these two regulatory sections will
clarify the provisions and ensure
consistency with the current meaning of
the existing regulations. The second
non-substantive change clarifies a cross
reference to ‘‘§ 199.16(f).’’ The proposed
rule inaccurately referred to ‘‘§ 199.16(f)
of this chapter.’’ In our view, these
textual corrections do not constitute a
rulemaking that would be subject to the
APA notice and comment or delayed
effective date requirements.
Provisions of the Final Rule
Because all comments that were
within the scope of this rulemaking
supported the proposed regulation
changes, we are finalizing the proposed
rule, with the exception of the nonsubstantive text corrections discussed
above. The final rule amends the
existing special benefit provision
regarding complications (unfortunate
sequelae) resulting from non-covered
initial surgery. It re-labels the regulatory
provision to read: ‘‘Care related to noncovered initial surgery or treatment.’’ It
amends § 199.4(e)(9) to provide
coverage for otherwise covered services
and supplies required in the treatment
of complications resulting from a
noncovered incident of treatment: (i)
But only if the later complication
represented a separate medical
condition; or (ii) if the noncovered
incident of treatment was provided in
an MTF, had been authorized by the
MTF Commander, and the MTF was
unable to provide the necessary
treatment of the complications; or (iii) if
the noncovered incident of treatment
was provided in the private sector
pursuant to a properly granted waiver
under § 199.16(f). This final rule also
amends the regulatory exclusion at
§ 199.4(g)(63) to state that all services
and supplies related to a non-covered
condition or treatment, including any
necessary follow-on care and treatment
of complications, will be excluded from
coverage except as provided in
§ 199.4(e)(9).
III. 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
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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
tkelley on DSK3SPTVN1PROD with RULES
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:
VerDate Sep<11>2014
16:08 Dec 30, 2014
Jkt 235001
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
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
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:
E:\FR\FM\31DER1.SGM
31DER1
Agencies
[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Rules and Regulations]
[Pages 78703-78707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30307]
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD-2013-HA-0164]
RIN 0720-AB61
TRICARE; Coverage of Care Related to Non-Covered Initial Surgery
or Treatment
AGENCY: Office of the Secretary, Department of Defense.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule revises the limitations on certain TRICARE
basic program benefits. More specifically, it allows coverage for
otherwise covered services and supplies required in the treatment of
complications (unfortunate sequelae), as well as medically necessary
and appropriate follow-on care, resulting from a non-covered incident
of treatment provided pursuant to a properly granted Supplemental
Health Care Program waiver. This final rule amends two provisions of
the TRICARE regulations which limits coverage for the treatment of
complications resulting from a non-covered incident of treatment, and
which expressly excludes from coverage in the Basic Program services
and supplies related to a non-covered condition or treatment.
DATES: This final rule is effective January 30, 2015.
FOR FURTHER INFORMATION CONTACT: Thomas Doss (703) 681-7512.
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Purpose of Regulatory Action
Need for the Regulatory Action
This final rule is necessary for consistency with existing
regulatory provisions and to protect TRICARE beneficiaries from
incurring unnecessary financial hardships arising from the current
regulatory restrictions that prohibit TRICARE coverage of the treatment
of complications resulting from certain non-covered medical procedures.
On occasion, an authorized official of a uniformed service may request
from the Director, Defense Health Agency (DHA) a waiver of TRICARE
regulatory restrictions or limitations, when the waiver is necessary to
assure adequate availability of health care services to the active duty
member. In those cases when a waiver has been properly granted under
Sec. 199.16(f), this rule grants benefits coverage for otherwise
covered services and supplies required for treating complications
arising from the non-covered incident of treatment provided in the
private sector pursuant to the waiver. Additionally, with respect to
care that is related to a non-covered initial surgery or treatment, the
final rule seeks to eliminate any confusion regarding what services and
supplies will be covered by TRICARE and under what circumstances they
will be covered.
Legal Authority for the Regulatory Action
This regulation is finalized under the authorities of 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
Department is authorized to provide medically necessary and appropriate
treatment for mental and physical illnesses, injuries and bodily
malfunctions, including hospitalization, outpatient care, drugs,
treatment of medical and surgical conditions and other types of health
care outlined in 10 U.S.C. 1077(a). Although section 1077 defines
benefits to be provided in the Military Treatment Facilities (MTFs),
these benefits are incorporated by reference into the benefits provided
in the civilian health care sector to active duty family members and
retirees and their dependents through sections 1079 and 1086
respectively.
B. Summary of the Final Rule
The final rule amends the existing special benefit provision
regarding complications (unfortunate sequelae) resulting from non-
covered initial
[[Page 78704]]
surgery or treatment, to more clearly address what services and
supplies will be covered by TRICARE and under what circumstances they
will be covered. The provision itself is relabeled ``Care related to
non-covered initial surgery or treatment'' to eliminate any confusion
regarding what constitutes a complication or unfortunate sequelae and
how broadly or narrowly the exclusion and exceptions to the exclusion
should be applied. As amended, the regulatory section will specifically
address coverage of otherwise covered medically necessary treatment, to
include coverage of (i) treatment of complications that represent a
separate medical condition; (ii) treatment of complications and
necessary follow-on care resulting from a non-covered incident of
treatment provided in an MTF; and (iii) treatment of complications and
necessary follow-on care resulting from a non-covered incident of
treatment provided pursuant to an approved Supplemental Health Care
Program (SHCP) waiver. Additionally, the regulatory exclusion at Sec.
199.4(g)(63) is amended to state clearly that all services and supplies
related to a non-covered condition or treatment, including any
necessary follow-on care and treatment of complications, are excluded
from coverage except as provided in Sec. 199.4(e)(9).
C. Costs and Benefits
This final rule is not anticipated to have an annual effect on the
economy of $100 million or more, making it a non-economically
significant rule under Executive Order 12866 and non-major rule under
the Congressional Review Act. All services and supplies 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 care can be cost shared by TRICARE. For this reason, DoD
anticipates that TRICARE will incur only a marginal increase in cost
associated with the inclusion of coverage for treatment of
complications and necessary follow-on care for TRICARE beneficiaries
who received previously authorized non-covered treatment pursuant to a
SHCP waiver while on active duty.
I. Background
A. Statutory and Regulatory Background
Members of the uniformed services on active duty are entitled to
medical and dental care pursuant to 10 U.S.C. 1074, including the
provision of such care in private facilities. With respect to the
purchase of private sector health care services for Active Duty Service
Members (ADSMs) under the SHCP, Sec. 199.16 implements the statutory
provision at 10 U.S.C. 1074(c). Generally, the same rules that govern
payment and administration of private sector health care claims under
TRICARE apply to the SHCP and the care that members receive in private
facilities is comparable to coverage for medical care under the TRICARE
Prime program. Section 199.16(f) provides the Director of DHA
discretionary authority to waive requirements of TRICARE regulations,
including any restrictions or limitations under the TRICARE Basic
Program benefits, except those specifically set forth in statute, based
on ``a determination that such waiver is necessary to assure adequate
availability of health care to Active Duty members.'' ADSMs have access
to non-covered care including experimental or unproven medical care and
treatments in the purchased care sector on a case-by-case basis using
the SHCP waiver process. The Director, DHA, or designee specifically
approves these case-by-case treatment decisions, resulting in a number
of ADSMs receiving otherwise non-covered private sector care while
serving.
If an ADSM is granted a waiver under the SHCP to receive an
otherwise non-covered incident of treatment by a private sector
provider, rather than in an MTF, and suffers complications from the
care, SHCP funds can be used to cover necessary follow-on care and
treatment of complications in the purchased care system as long as the
member remains on active duty. Once the member retires, however, SHCP
coverage no longer exists and TRICARE does not cover unfortunate
sequelae of non-covered care provided in the purchased care sector,
except in limited circumstances (e.g. later complications that
represent a separate medical condition separate from the condition that
the non-covered treatment or surgery was directed toward, and the
treatment of the complication is not essentially similar to the covered
procedures. This may include a systemic infection, cardiac arrest, or
acute drug reaction). Additionally, once the service member has
retired, existing regulations would not allow the continuation of any
needed follow-on care such as rehabilitative care or drug therapy. When
these beneficiaries require such treatment, they are responsible for
the payment for this necessary treatment, which may result in
significant financial hardship.
This rule resolves that unfortunate situation by allowing coverage
of treatment for necessary follow-on care, including complications,
resulting from non-covered treatment provided to beneficiaries pursuant
to a SHCP waiver. The specific procedures for approval of this
treatment will be addressed in the TRICARE Policy Manual to ensure that
this information is current and easily accessible. TRICARE manuals may
be accessed at https://www.tricare.mil.
B. Summary of the Proposed Rule
We proposed to amend the existing special benefit provision
regarding complications (unfortunate sequelae) resulting from non-
covered initial surgery, to more clearly address what services and
supplies will be covered by TRICARE and under what circumstances they
will be covered. We also proposed to re-label the regulatory provision
to read: ``Care related to non-covered initial surgery or treatment''
to eliminate any confusion regarding what constitutes a complication or
unfortunate sequelae and how broadly or narrowly the exclusion and
exceptions to the exclusion would be applied. As amended, the
regulatory section would specifically address coverage of otherwise
covered medically necessary treatment, to include (i) coverage of
complications that represent a separate medical condition; (ii)
treatment of complications and necessary follow-on care resulting from
a non-covered incident of treatment provided in an MTF; and (iii)
treatment of complications and necessary follow-on care resulting from
a non-covered incident of treatment provided pursuant to an approved
SHCP waiver. Inclusion of the third prong would support the provision
of care necessary to allow members to return to full duty and/or reach
their maximum rehabilitative potential without requiring the member to
bear the sole financial risk for unfortunate sequelae once they are no
longer on active duty. This amendment would also provide consistent
treatment of unfortunate sequelae and necessary follow-on care when an
original episode of non-covered care is provided for a valid
governmental purpose, whether to support Graduate Medical Education
(GME) and maintain provider skill levels within an MTF or an ADSM's
fitness for duty through authorization of the purchase of otherwise
non-covered care via an SHCP waiver. Additionally, we proposed to amend
the regulatory exclusion at Sec. 199.4(g)(63) to clearly state that
all services and supplies related to a non-covered condition or
treatment, including any necessary follow-on care and treatment of
complications, would be excluded from
[[Page 78705]]
coverage except as provided in Sec. 199.4(e)(9).
C. Summary of the Final Rulemaking
Modifications to the TRICARE Basic Program Benefits
Under the TRICARE private sector health care program, certain
conditions and treatments are excluded from coverage. For example, any
drug, device, medical treatment, or procedure whose safety and efficacy
has not been established by reliable evidence is considered unproven
and excluded from coverage. This exclusion includes all services
directly related to the unproven drug, device, medical treatment or
procedure. Specifically, benefits for otherwise covered services and
supplies that are required in the treatment of complications
(unfortunate sequelae) resulting from a non-covered incident of
treatment, are generally excluded from TRICARE coverage pursuant to
Sec. 199.4(e)(9), unless the complication represents a separate
medical condition such as a systemic infection, cardiac arrest, and
acute drug reaction. TRICARE also excludes any needed follow-on care
resulting from a non-covered condition or initial surgery or treatment
pursuant to Sec. 199.4(g)(63).
There is currently one exception to this general exclusion, found
at Sec. 199.4(e)(9)(ii), which allows coverage of otherwise covered
services and supplies required in the treatment of complications
(unfortunate sequelae) resulting from a non-covered incident of
treatment provided in a 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. This current exception
recognizes that in order to support GME and maintain provider skill
levels, MTF providers are required to perform medical procedures that
may be excluded from coverage under the TRICARE private sector program.
This coverage provision was viewed as necessary to protect TRICARE
beneficiaries from incurring financial hardships in such cases.
Currently, Active Duty Service Members (ADSMs) may receive non-
covered TRICARE private sector health care services under the SHCP if a
waiver is submitted through the Service and approved by the Director,
DHA, or designee, in accordance with Sec. 199.6(f). While the
Department wants to ensure that Service members have access to the
latest, promising medical technologies and procedures, there must be
assurance that the care is safe and effective, and that members are not
subjected to undue risk, or rendered unfit for continued service, due
to complications suffered because of unproven medical care.
Consequently, requests for non-covered procedures and treatments,
including unproven care, are carefully reviewed in conjunction with
other available, proven treatments, if any exist, to determine whether
approval of the requested care is necessary to assure the adequate
availability of health care to the member. Currently, Service members
are counseled that the treatment remains a non-covered TRICARE benefit,
and that any follow-on care, including care for complications, will not
be covered by TRICARE once the member separates or retires. Members are
left to make a difficult choice between pursuing a SHCP waiver in an
effort to remain fit for full duty while assuming the financial risk of
any necessary follow-on care after discharge, or, electing not to
receive the care and risk separation from the Service.
Like the existing exception at Sec. 199.4(e)(9)(ii) for non-
covered care provided in a MTF, this exception is narrowly tailored to
serve a similar government interest; namely, protecting former active
duty members who have received private sector care pursuant to a SHCP
waiver in an effort to ensure their fitness for duty and continued
service.
Additionally, some confusion has arisen regarding the terms
``complication'' and ``unfortunate sequelae'' as these terms are not
currently defined in regulation. Questions have arisen with respect to
whether necessary follow-on care resulting from a non-covered procedure
or treatment in an MTF is covered in situations where the MTF is unable
to provide the necessary treatment. The intent of the prior September
16, 2011, final rule, as well as this final rule, is to protect TRICARE
beneficiaries from incurring financial hardships in limited
circumstances, which serve valid governmental purposes. Absent an
exception to the general exclusion from coverage, treatment of adverse
outcomes, both expected and unexpected, as well as any necessary
follow-on care that is a direct result of the initial non-covered
treatment, are excluded and could result in less than optimal care
(e.g., not receiving necessary physical therapy following surgery) and/
or a significant financial hardship for the beneficiary. The Agency did
not intend to prevent coverage of necessary follow-on private sector
care in situations where an MTF is unable to provide that care but the
current regulatory language is subject to such a narrow interpretation
absent additional clarification. This final rule permits coverage of
necessary continued treatment, such as physical therapy following a
non-covered surgical procedure in an MTF. It also covers medically
necessary follow-on care, including, for example, anti-rejection
medications for former members who have received face and hand
transplants. This rule eliminates the need to try to determine whether
the medically necessary and appropriate care the patient is seeking
from the private sector is considered treatment of an expected
complication, an unexpected complication or routine follow-on care,
because it will be clearly covered.
II. Summary of and Responses to Public Comments
The proposed rule was published in the Federal Register (78 FR
62506) October 22, 2013, for a 60-day comment period. We received
comments on the proposed rule from three commenters.
Comments: Two commenters expressed general support for TRICARE
expressly covering otherwise medically necessary treatment resulting
from a non-covered incident of treatment provided pursuant to an
approved SHCP waiver. They supported the policy objective of reducing
financial risk for unfortunate sequelae once service members are no
longer on active duty. One commenter stated further that TRICARE should
cover all of the medical procedures that beneficiaries need. The second
commenter, in addition to expressing support for the proposed change,
emphasized the need for a properly approved SHCP waiver.
Response: We appreciate the commenters' support of this regulatory
proposal. We would note that the comment pertaining to coverage of all
medical procedures that beneficiaries need exceeds the scope of this
Final Rule. Moreover, current TRICARE regulations already address those
circumstances under which TRICARE is statutorily authorized to provide
coverage. We also point out that the Defense Health Agency issues
waivers infrequently and with careful consideration to ensure that the
member has access to medically necessary treatment. In these
circumstances, SHCP waivers are only issued when necessary to ensure
that health care services are adequately available to active duty
service members.
Comment: One commenter observed that the Proposed Rule deleted the
reference to ``transsexual surgery'' and ``repair of a prolapsed vagina
in a biological male who had undergone
[[Page 78706]]
transsexual surgery'' in the regulation text for Sec. 199.4(e)(9)(i).
The commenter queried whether we were proposing a change in policy
regarding transsexual procedures.
Response: The proposed deletions in the regulation text of the
proposed rule were intended to be strictly stylistic and not intended
to reflect any change in policy regarding transsexual procedures.
TRICARE continues not to cover transsexual surgery and consequently
would not cover complications similar to the initial episode of non-
covered care, such as the repair of a prolapsed vagina in a biological
male who had undergone transsexual surgery. The statutory prohibition
at 10 U.S.C. 1079(a)(12) continue to apply. The one, very limited
exception to this general exclusion is that TRICARE may cover surgery
and related medically necessary services performed to correct sex
gender confusion (that is, ambiguous genitalia) which has been
documented to be present at birth.
In the proposed rule, we acknowledged that some confusion had
arisen in the industry regarding the terms ``complication'' and
``unfortunate sequelae'' because the terms were not defined in
regulation. While not defining the terms in the regulation text, we did
further explain and clarify the intended scope of excluded treatment of
complications and unfortunate sequelae resulting from non-covered
initial surgery or treatment, to include expected and unexpected
complications, as well as any necessary follow-on care that is a direct
result of the initial non-covered treatment, absent an exception to the
exclusion. We explained that in Sec. 199.4(e)(9)(ii), for instance,
the Agency did not intend to prevent coverage of necessary follow-on
private sector care in situations where an MTF was unable to provide
that care but the MTF Commander had authorized the initial noncovered
service. To clarify the intended scope of the excluded treatment of
complications or unfortunate sequelae, this rule adds ``including any
necessary follow-on care or the treatment of complications'' in Sec.
199.4(g)(63), and ``and any necessary follow-on care'' in Sec.
199.4(e)(9)(ii).
Comment: We received one comment supporting our amendments to the
regulations which clarify that the treatment of complications or
unfortunate sequelae includes necessary follow-on care. The commenter
felt that the Agency should withhold coverage of treatment for
secondary complications when the initial procedure was purely elective
and did not serve a legitimate national defense purpose. The commenter
also recommended the adoption of a regulatory definition of
``complication,'' relying perhaps on a definition of the term used by
private health insurers.
Response: We appreciate the commenter's support of our clarifying
amendments to the two regulatory provisions. While we will take under
advisement proposing a regulatory definition of ``complication'' in the
future, at this time we believe that the amendments in this rule will
be adequate to clarify our intended meaning of the term and allow us to
retain the necessary flexibility when implementing these regulations.
The Agency is also reluctant to classify levels of ``complications'' as
primary or secondary, or consider the purpose for which non-covered
treatment was provided. These proposals would add an unnecessary degree
of complexity to this regulatory structure, or alternatively, would
require the Agency to exceed the bounds of its statutory authority.
Comment: A commenter recommended that the Agency specifically
exclude certain initial procedures from TRICARE coverage.
Response: This comment exceeds the scope of this final rule, and we
will therefore not exclude from TRICARE coverage any initial procedures
specified in the comment.
As a final matter, we are finalizing corrections in the regulatory
text for Sec. 199.4(e)(9)(ii) and (iii), including substituting
references to the Director, DHA, in lieu of the Director, TMA, and the
change from ``Sec. 199.6(f) of this chapter'' to ``Sec. 199.16(f)''
in Sec. 199.4(e)(9)(iii). We are making the first non-substantive
change for consistency with recent changes to the structure of the DoD.
Section 731 of the National Defense Authorization Act for FY 2013
directed the Secretary of Defense to develop a plan carry out the
reforms of the governance of the military health system, previously
outlined in a March 2, 2012, Deputy Secretary of Defense memorandum. As
described in a March 11, 2013, Deputy Secretary of Defense memorandum,
the centerpiece of the governance reform was the establishment of a
Defense Health Agency (DHA) which would, among other responsibilities,
assume the designated functions of the TMA, which was being
disestablished. Subsequently, the Department of Defense published
Directive 5136.13 (published September 30, 2013), which provided that
any reference in law, rule, regulation, or issuance to TMA will be
deemed to be a reference to DHA, unless otherwise specified by the
Secretary of Defense, and further, that the Director, DHA, will serve
as the program manager for TRICARE health and medical resources, as
directed by the ASD(HA) and within the established MHS governance
process. The reference to Director, DHA, in these two regulatory
sections will clarify the provisions and ensure consistency with the
current meaning of the existing regulations. The second non-substantive
change clarifies a cross reference to ``Sec. 199.16(f).'' The proposed
rule inaccurately referred to ``Sec. 199.16(f) of this chapter.'' In
our view, these textual corrections do not constitute a rulemaking that
would be subject to the APA notice and comment or delayed effective
date requirements.
Provisions of the Final Rule
Because all comments that were within the scope of this rulemaking
supported the proposed regulation changes, we are finalizing the
proposed rule, with the exception of the non-substantive text
corrections discussed above. The final rule amends the existing special
benefit provision regarding complications (unfortunate sequelae)
resulting from non-covered initial surgery. It re-labels the regulatory
provision to read: ``Care related to non-covered initial surgery or
treatment.'' It amends Sec. 199.4(e)(9) to provide coverage for
otherwise covered services and supplies required in the treatment of
complications resulting from a noncovered incident of treatment: (i)
But only if the later complication represented a separate medical
condition; or (ii) if the noncovered incident of treatment was provided
in an MTF, had been authorized by the MTF Commander, and the MTF was
unable to provide the necessary treatment of the complications; or
(iii) if the noncovered incident of treatment was provided in the
private sector pursuant to a properly granted waiver under Sec.
199.16(f). This final rule also amends the regulatory exclusion at
Sec. 199.4(g)(63) to state that all services and supplies related to a
non-covered condition or treatment, including any necessary follow-on
care and treatment of complications, will be excluded from coverage
except as provided in Sec. 199.4(e)(9).
III. 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
[[Page 78707]]
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]
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1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
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2. Section 199.4 is amended by revising paragraphs (e)(9) and (g)(63)
to read as follows:
Sec. 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 non-covered
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 Sec. 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 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