TRICARE Program; Surgery for Morbid Obesity, 8294-8298 [2011-3207]
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8294
Federal Register / Vol. 76, No. 30 / Monday, February 14, 2011 / Rules and Regulations
§ 157.208 Construction, acquisition,
operation, replacement, and miscellaneous
rearrangement of facilities.
*
*
*
(d) * * *
*
Limit
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
Auto. proj.
cost limit
(Col.1)
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
$4,200,000
4,500,000
4,700,000
4,900,000
5,100,000
5,200,000
5,400,000
5,600,000
5,800,000
6,000,000
6,200,000
6,400,000
6,600,000
6,700,000
6,900,000
7,000,000
7,100,000
7,200,000
7,300,000
7,400,000
7,500,000
7,600,000
7,800,000
8,000,000
9,600,000
9,900,000
10,200,000
10,400,000
10,500,000
10,600,000
Prior notice
proj. cost limit
(Col.2)
$12,000,000
12,800,000
13,300,000
13,800,000
14,300,000
14,700,000
15,100,000
15,600,000
16,000,000
16,700,000
17,300,000
17,700,000
18,100,000
18,400,000
18,800,000
19,200,000
19,600,000
19,800,000
20,200,000
20,600,000
21,000,000
21,200,000
21,600,000
22,000,000
27,400,000
28,200,000
29,000,000
29,600,000
29,900,000
30,200,000
*
*
*
*
*
3. Table II in § 157.215(a)(5) is revised
to read as follows:
■
§ 157.215 Underground storage testing
and development.
(a) * * *
(5) * * *
TABLE II
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Year
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
VerDate Mar<15>2010
Year
Limit
*
TABLE I
Year
TABLE II—Continued
14:08 Feb 11, 2011
Limit
$2,700,000
2,900,000
3,000,000
3,100,000
3,200,000
3,300,000
3,400,000
3,500,000
3,600,000
3,800,000
3,900,000
4,000,000
4,100,000
4,200,000
4,300,000
4,400,000
4,500,000
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1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
*
*
*
*
4,550,000
4,650,000
4,750,000
4,850,000
4,900,000
5,000,000
5,100,000
5,250,000
5,400,000
5,550,000
5,600,000
5,700,000
5,750,000
*
[FR Doc. 2011–3190 Filed 2–11–11; 8:45 am]
BILLING CODE P
Dated: February 9, 2011.
Harold M. Singer,
Director, Regulations and Disclosure Law
Division, U.S. Customs and Border Protection.
[FR Doc. 2011–3265 Filed 2–11–11; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD–2008–HA–0057]
RIN 0720–AB24
TRICARE Program; Surgery for Morbid
Obesity
ACTION:
DEPARTMENT OF HOMELAND
SECURITY
U. S. Customs and Border Protection
19 CFR Part 141
[USCBP–2008–0062; CBP Dec. 10–34]
RIN 1515–AD61 (Formerly 1505–AB96)
Technical Correction: Completion of
Entry and Entry Summary—
Declaration of Value; Correction
Customs and Border Protection,
Department of Homeland Security.
ACTION: Final rule; correction.
AGENCY:
Customs and Border
Protection (CBP) published in the
Federal Register of December 30, 2010,
a document concerning technical
corrections to part 141 of title 19 of the
CBP Regulations (19 CFR part 141).
Inadvertently, an erroneous CBP
Decision Number was listed in the
heading of that document. This
document corrects the December 30,
2010 document to reflect that the correct
CBP Decision Number is 10–34 as set
forth above.
DATES: The final rule is effective
February 14, 2011.
FOR FURTHER INFORMATION CONTACT:
Michele J. Snavely, Regulations and
Rulings, Office of International Trade,
(202) 325–0354.
SUMMARY:
Correction
In rule document 2010–32912
beginning on page 82241 in the issue of
Thursday, December 30, 2010, make the
following correction in the third
column:
Remove in the heading of the
document ‘‘CBP Dec. 10–33’’ and add in
its place ‘‘CBP Dec. 10–34’’.
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Office of the Secretary, DoD.
Final rule.
AGENCY:
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This final rule adds a
definition of Bariatric Surgery, amends
the definition of Morbid Obesity, and
revises the language relating to the
treatment of morbid obesity to allow
benefit consideration for newer bariatric
surgical procedures that are considered
appropriate medical care. The final rule
removes language that specifically
limits the types of surgical procedures
to treat co-morbid conditions associated
with morbid obesity and retains the
TRICARE Program exclusion of nonsurgical interventions related to morbid
obesity, obesity and/or weight
reduction. This final rule is necessary to
allow coverage for other surgical
procedures that reduce or resolve comorbid conditions associated with
morbid obesity and the use of the Body
Mass Index (BMI), which is the more
accurate measure for excess weight to
estimate relative risk of disease. As new
technologies or procedures evolve from
investigational into generally accepted
norms for medical practice, the statutes
and regulations governing the TRICARE
Program allow the Department to offer
beneficiaries these new benefits. These
changes are required in order to allow
the Department to provide these newer
technologies and procedures for the
treatment of morbid obesity as they
evolve.
DATES: Effective Date: This rule is
effective March 16, 2011.
ADDRESSES: TRICARE Management
Activity, Medical Benefits and
Reimbursement Branch, 16401 East
Centretech Parkway, Aurora, CO 80011–
9066.
FOR FURTHER INFORMATION CONTACT: Gail
L. Jones, Medical Benefits and
Reimbursement Branch, TRICARE
Management Activity, telephone (303)
676–3401.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. Background
On December 27, 1982, the
Department of Defense (DoD) published
a final rule in the Federal Register (47
FR 57491–57493) that restricted surgical
intervention for morbid obesity to
gastric bypass, gastric stapling, or
gastroplasty method (excluding all other
types) when the primary purpose of
surgery is to treat a severe related
medical illness or medical condition.
The severe medical conditions or illness
associated with morbid obesity included
diabetes mellitus, hypertension,
cholecystitis, narcolepsy, Pickwickian
Syndrome (and other severe respiratory
disease), hypothalamic disorders, and
severe arthritis of the weight-bearing
joints. The DoD also limited program
payments to two categories of patients:
(1) Those who weighed 100 pounds over
their ideal weight with a specific severe
medical condition; and (2) those who
were 200 percent or more over their
ideal weight with no medical
complications required. Program
payment was made available as well in
cases in which a patient, who originally
met the criteria, received an intestinal
bypass, or other surgery for obesity and,
because of complications, required a
second surgery. Payment was allowed
even though the patient’s condition may
not have technically met the definition
of morbid obesity because of the weight
that was already lost following the
initial surgery. All other surgeries
including non-surgical treatment related
to morbid obesity, obesity, and/or
weight reduction were excluded.
The DoD used the definition of
morbid obesity, which was based on the
Metropolitan Life Table and used then
by other major health care plans, as well
as reflected the 1982 general opinion
regarding which cases justify surgical
intervention. The DoD decided, at the
time, that it was necessary to be very
specific in benefit parameters due to
fiscal responsibility and to ensure that
Program beneficiaries were not being
exposed to less than fully developed
medical technology or procedures.
At the time the current regulation was
written in 1982, gastric bypass, gastric
stapling, and gastroplasty methods were
the recognized surgeries for morbid
obesity. However, in recent years, other
bariatric surgical procedures have
evolved and some have a substantial
body of literature to support their safety
and efficacy. Unlike the original rule
that listed the specific surgical
procedures and the clinical conditions
for which coverage may be extended;
this final rule authorizes benefit
consideration for those bariatric surgical
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procedures that have moved from the
unproven status to the position of
nationally accepted medical practice, as
determined by the Program standard of
reliable evidence.
Also in 1982 during development of
the current regulation for morbid
obesity, overweight and obesity were
typically measured with height-weight
tables (such as the Metropolitan Life
Table). The 1982 regulation restricted
eligibility for bariatric surgery to
individuals who exceed their ideal
weight for height by 100 pounds with an
associated severe medical condition, or
200 percent or more over their ideal
body weight with no associated medical
condition required.
This final rule changes the Program
definition of morbid obesity to reflect
the current nationally accepted medical
use of the BMI, rather than the typical
assessed height-weight table (i.e., the
Metropolitan Life Table), to determine
an individual’s eligibility for bariatric
surgical treatment. The BMI is the more
accurate measure for excess weight to
estimate relative risk of disease. Since
there now are more than 30 major
diseases associated with obesity, the
final rule requires the Director, TMA, to
issue specific criteria for co-morbid
conditions exacerbated or caused by
(morbid) obesity, as determined by the
Program standard of reliable evidence.
This final rule does not expand the
TRICARE benefit for morbid obesity
surgery. However, it does make the
specific procedures that are covered, as
well as the clinical conditions for which
coverage may be extended, a matter of
policy. In other words, new bariatric
surgery procedures may be added to the
TRICARE benefit structure as such
procedures are proven safe and effective
and are established as nationally
accepted medical practice as
determined by the Program standard of
reliable evidence.
II. Public Comments
On October 29, 2009 (74 FR 55792–
55794), the Office of the Secretary of
Defense published a proposed rule and
provided the public the opportunity to
comment on implementing changes to
surgery for morbid obesity. The
comment period closed on December
28, 2009. As result of publication of the
proposed rule, DoD received 18
comments. Thirteen commenters
expressed support and approval. We
appreciate all expressions of support
and approval for the proposed
guidelines. We do not discuss the
majority these comments which were
favorable to the proposed rule and thus
with which the Agency generally agrees.
However, several people made
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comments with specific suggestions and
questions and we have responded to
each of these comments below.
Comment: One commenter objected to
the provisions of the proposed rule in
the belief the coverage is inappropriate
for the selected group of patients.
Response: We disagree. As discussed
in the proposed rule, TRICARE allows
coverage for surgical procedures that
may reduce or resolve co-morbid
conditions associated with morbid
obesity. This is because a component of
the effective treatment of the comorbidity condition for those who fit
the morbid obesity criteria set forth in
this rule is weight loss. Thus while the
Department does not pay for general
weight loss programs, it may pay for
these bariatric surgical procedures as a
component of the treatment of the comorbidity condition. Title 10, United
States Code Section 1079(a)(13) is
sometimes referred to as the
Department’s ‘‘medical necessity’’
provision. It prohibits the Department
from providing any service or supply,
which is not medically, or
psychologically necessary to prevent,
diagnose, or treat a mental or physical
illness, injury, or bodily malfunction as
assessed or diagnosed by a physician or
other authorized provider. Because the
Department has found this type of
treatment for the co-morbidity condition
to be medically necessary, the type of
health care services in the proposed rule
are the type of health care services
authorized by statute and may be
provided by the TRICARE program.
Comment: Another commenter asked
if there is anything being done to help
employees cope with their obesity, and
whether there are any preventative
programs in place to educate people and
help them to avoid obesity.
Response: There is a focus on health
and wellness for active duty members,
DoD civilians, retired members,
contractors, reservists, and beneficiaries
to help encourage healthy lifestyles.
Each of the armed services has
developed programs to promote fitness
and health. The Army has the MOVE
Program, which is a personalized online
weight management program that
comprises up to 13 one-hour sessions.
The Navy Shipshape Program is
designed to move military personnel
and their families toward healthier food
choices, fitness habits and lifestyles.
The Air Force Fit to Fight Program
encourages unit fitness programs,
encourages units to exercise together,
and offers nutrition and fitness
counseling to those with borderline
fitness test scores. These wellness
programs are designed to provide
individuals with tools to improve their
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overall health and lifestyles and address
everything from smoking to obesity.
Comment: One professional
organization affirmed the purpose and
scope of the rule acknowledging the
need to use body mass index (BMI)
criteria instead of the Metropolitan Life
Tables accurately to classify the degree
of morbid obesity. The commenter
recommends that DoD provide coverage
for other standard accepted bariatric
surgical procedures as recognized by the
American College of Surgeons (ACS),
Bariatric Surgery Center Network
(BSCN) and American Society for
Metabolic and Bariatric Surgery
(ASMBS). Another professional
commenter points out that gastric sleeve
resection has been established and
recognized by the ASMBS as having an
important role, as an intermediate
intervention regarding both risk and
efficacy of weight loss between bypass
and adjustable gastric banding.
Response: Before the Department may
offer any treatment or procedure to its
beneficiaries, the regulations in this part
require that the treatment or procedure
must be ‘‘proven care’’. This is done as
outlined in § 199.4(g)(15) of this part
using the hierarchy of established
reliable evidence as defined in § 199.2
of this part. A procedure must meet this
standard in order for the Department to
ensure safe, quality health care for its
beneficiaries and to avoid arbitrary
administration of TRICARE benefit
decisions.
Comment: Another commenter agrees
with the changes as well but
recommends that the list of obesityassociated co-morbidities be a complete,
inclusive list to prevent inappropriate
denial of service. The commenter goes
on to state that covered procedures
should include the laparoscopic vertical
sleeve gastrectomy and duodenal switch
procedures.
Response: We appreciate the
suggestion that morbid obesity multiple
co-morbidities be a complete, inclusive
list and will consider it as one of many
recommendations in revising the benefit
policy. We disagree with the
commenter’s suggestion that vertical
sleeve gastrectomy (VSG) and
biliopancreatic diversion with duodenal
switch (BPD/DS) should be covered
under the TRICARE Program. The
evidence evaluating the safety and
efficacy of BPD/DS and VSG do not
meet the program specific standards of
reliable evidence. Existing data does
suggest the use of these procedures is a
possible benefit to some patients but
there is incomplete information to
predict the effect of long-term outcomes.
This lack of information relating to the
long-term outcomes is a matter of
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concern to the Department. Medical
literature indicates as well that wellcontrolled trials are needed to
determine both short-term and longterm safety and efficacy of BPD/DS and
long-term (> 5 years) weight loss and comorbidity resolution data for VSG. The
Agency will continue to monitor the
development of the literature and the
status of ongoing well-controlled
clinical trials regarding the effectiveness
of the laparoscopic VSG and BPD/DS
procedures. At such time when the
reliable evidence demonstrates that
these bariatric surgical procedures have
proven medical effectiveness, the
Director, TMA will initiate action to
cover these procedures.
Comment: This same commenter asks
that DoD consider improving
reimbursement for bariatric surgical
procedure to a level that increases
access for patients. The commenter goes
on to state that current reimbursement
levels are so low that many surgeons
will not accept these patients because
TRICARE rates are tied to Medicare fee
schedule, and rates have declined over
10% in the last two years despite
increasing practice overhead expenses.
Response: In section 707 the National
Defense Authorization Act of Fiscal
Year 2002, Congress amended the
statutory authorization (in 10 U.S.C.
1079(j)(2)) to a mandate that TRICARE
payment methods shall be determined
in accordance with Medicare payment
rules to the extent practicable. In the
same way under 10 U.S.C. 1079(h), the
amount to be paid to health care
professional and other non-institutional
health care providers ‘‘shall be equal to
an amount determined to be
appropriate, to the extent practicable, in
accordance with the same
reimbursement rules used by Medicare’’
Comment: One commenter asked if
the proposed guidelines apply to active
duty service members as well.
Response: TRICARE covers most
health care deemed medically necessary
for active and retired military and their
dependent family. However, bariatric
surgery primarily represents a major and
permanent change to the digestive
system and requires a strict adherence
to a dietary regimen, which interferes
with operational deployment of active
duty service members (ADSMs).
Because of this, ADSMs are not
permitted to have bariatric surgery.
ADSMs have an obligation to maintain
themselves in a state of high physical
readiness and the Services have weight
and fitness screening programs to assure
compliance with Service standards, and
each Service offers evidence-based,
multidisciplinary weight and fitness
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programs for individuals who are
unable to meet those standards.
Comment: Another commenter
expresses his company’s support for the
proposal rule to add new bariatric
surgical procedures to the TRICARE
benefit structure when such procedures
are proven safe, effective, and
established as nationally accepted
medical practice, as determined by the
TRICARE definition of reliable
evidence. The commenter also noted
that the proposed rule did not clearly
state that the definition of reliable
evidence applies to the determination
that a procedure is established as
nationally accepted medical practice;
and therefore, recommend paragraph
(e)(15) of this section be modify.
Response: We appreciate the
commenter’s support and concerns
regarding the application of TRICARE
definition of reliable evidence and have
modified paragraph (e)(15) of this
section to include a reference to § 199.2
of this part for the procedures used in
determining if a medical treatment or
procedure is unproven.
Comment: This same commenter
recommends coverage for laparoscopic
adjustable gastric band (LAGB) and
medically necessary adjustment of
LAGB systems. The commenter also
recommends that DoD revise the
proposed rule to add coverage for postsurgical follow-up and band
adjustments. The commenter also
recommends that DoD not specify any
minimum duration of weight loss
management as a precondition for the
bariatric surgery and that type 2
diabetes mellitus be specified as a highrisk co-morbidity exacerbated or caused
by morbid obesity.
Response: The laparoscopic
adjustable gastric banding surgical
procedure (including post-surgical
follow-up and band adjustments)
became a TRICARE benefit effective
February 1, 2007. TRICARE also
provides coverage for follow-up care to
include band adjustments and any
unfortunate sequelae resulting from the
adjustment for those patients who
underwent the LAP-Band surgery before
the effective date of coverage. Coverage,
however, is contingent upon the patient
meeting TRICARE morbid obesity policy
criteria at the time of his or her surgery.
We appreciate the suggestion that DoD
not specify any minimum duration of
weight loss management as a
precondition for the bariatric surgery
and that type 2 diabetes mellitus be
specified as a high-risk co-morbidity
and will consider these as one of many
recommendations in future revisions
regarding the benefit policy.
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Comment: This same commenter
noted that the proposed rule did not
require physicians or facilities
performing bariatric surgical procedures
to fulfill any specific qualification
requirements for coverage. The
commenter states that it is the
understanding that DoD intends to leave
the issue of facility and surgeon
qualification to the discretion of TMA or
its Managed Care Support Contractors.
Response: All TRICARE authorized
providers are subject to the
requirements as outlined in 32 CFR
199.6. Otherwise covered services are
cost shared only if the individual
professional provider holds a current,
valid license or certification to practice
his or her profession in the jurisdiction
where the service is rendered.
This final rule considered all
comments received during the comment
period and has responded to those
comments in this final rule. Since the
proposed rule was published, DoD has
revised paragraph (e)(15) of this section.
Regulatory Procedures
Executive Order 12866, ‘‘Regulatory
Planning and Review’’
It has been determined that this 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 tribal governments or
communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another Agency;
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs, or the rights and
obligations of recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in this Executive Order.
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Unfunded Mandates Reform Act (Sec.
202, Pub. L. 104–4)
It has been certified that this 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 rule is
not subject to the Regulatory Flexibility
Act (5 U.S.C. 601) because it would not,
if promulgated, have a significant
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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. The change from heightweight tables to the BMI should have a
minimal impact on the number of
beneficiaries eligible for surgery.
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
It has been certified that this rule does
not impose reporting or recordkeeping
requirements under the Paperwork
Reduction Act of 1995.
Executive Order 13132, Federalism
It has been certified that this 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.
The final rule is consistent with the
proposed rule.
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 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
‘‘Bariatric Surgery’’ and revising the
definition of ‘‘Morbid Obesity’’ to read as
follows:
■
§ 199.2
Definitions.
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(b) * * *
Bariatric Surgery. Surgical procedures
performed to treat co-morbid conditions
associated with morbid obesity.
Bariatric surgery is based on two
principles: (1) Divert food from the
stomach to a lower part of the digestive
tract where the normal mixing of
digestive fluids and absorption of
nutrients cannot occur (i.e.,
Malabsorptive surgical procedures); or
(2) Restrict the size of the stomach and
decrease intake (i.e., Restrictive surgical
procedures).
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8297
Morbid obesity. A body mass index
(BMI) equal to or greater than 40
kilograms per meter squared (kg/m2), or
a BMI equal to or greater than 35 kg/m2
in conjunction with high-risk comorbidities, which is based on the
guidelines established by the National
Heart, Lung and Blood Institute on the
Identification and Management of
Patients with Obesity.
Note: Body mass index is equal to weight
in kilograms divided by height in meters
squared.
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3. Section 199.4 is amended by
revising paragraphs (e)(15) and (g)(28) to
read as follows:
■
§ 199.4
Basic program benefits.
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(e) * * *
(15) Morbid obesity. The TRICARE
morbid obesity benefit is limited to
those bariatric surgical procedures for
which the safety and efficacy has been
proven comparable or superior to
conventional therapies and is consistent
with the generally accepted norms for
medical practice in the United States
medical community. (See the definition
of reliable evidence in § 199.2 of this
part for the procedures used in
determining if a medical treatment or
procedure is unproven.)
(i) Conditions for coverage.
(A) Payment for bariatric surgical
procedures is determined by the
requirements specified in paragraph
(g)(15) of this section, and as defined in
§ 199.2(b) of this part.
(B) Covered bariatric surgical
procedures are payable only when the
patient has completed growth (18 years
of age or documentation of completion
of bone growth) and has met one of the
following selection criteria:
(1) The patient has a BMI that is equal
to or exceeds 40 kg/m2 and has
previously been unsuccessful with
medical treatment for obesity.
(2) The patient has a BMI of 35 to 39.9
kg/m2, has at least one high-risk comorbid condition associated with
morbid obesity, and has previously been
unsuccessful with medical treatment for
obesity.
Note: The Director, TMA, shall issue
guidelines for review of the specific high-risk
co-morbid conditions, exacerbated or caused
by obesity based on the Reliable Evidence
Standard as defined in § 199.2 of this part.
(ii) Treatment of complications.
(A) Payment may be extended for
repeat bariatric surgery when medically
necessary to correct or treat
complications from the initial covered
bariatric surgery (a takedown). For
instance, the surgeon in many cases will
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Federal Register / Vol. 76, No. 30 / Monday, February 14, 2011 / Rules and Regulations
do a gastric bypass or gastroplasty to
help the patient avoid regaining the
weight that was lost. In this situation,
payment is authorized even though the
patient’s condition technically may not
meet the definition of morbid obesity
because of the weight that was already
lost following the initial surgery.
(B) Payment is authorized for
otherwise covered medical services and
supplies directly related to
complications of obesity when such
services and supplies are an integral and
necessary part of the course of treatment
that was aggravated by the obesity.
(iii) Exclusions. CHAMPUS payment
may not be extended for weight control
services, weight control/loss programs,
dietary regimens and supplements,
appetite suppressants and other
medications; food or food supplements,
exercise and exercise programs, or other
programs and equipment that are
primarily intended to control weight or
for the purpose of weight reduction,
regardless of the existence of co-morbid
conditions.
*
*
*
*
*
(g) * * *
(28) Obesity, weight reduction.
Service and supplies related ‘‘solely’’ to
obesity or weight reduction or weight
control whether surgical or nonsurgical;
wiring of the jaw or any procedure of
similar purpose, regardless of the
circumstances under which performed
(except as provided in paragraph (e)(15)
of this section).
*
*
*
*
*
Dated: February 1, 2011.
Morgan F. Park,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2011–3207 Filed 2–11–11; 8:45 am]
BILLING CODE 5001–06–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2010–0902; FRL–9265–6]
Approval and Promulgation of Air
Quality Implementation Plans; Virginia;
Revision to the Definition of Volatile
Organic Compound
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
WReier-Aviles on DSKGBLS3C1PROD with RULES
AGENCY:
EPA is taking direct final
action to approve a revision to the
Virginia State Implementation Plan
(SIP). The revision amends the
definition of Volatile Organic
Compound (VOC). EPA is approving
SUMMARY:
VerDate Mar<15>2010
14:08 Feb 11, 2011
Jkt 223001
these revisions to Virginia’s definitions
in accordance with the requirements of
the Clean Air Act (CAA).
DATES: This rule is effective on April 15,
2011 without further notice, unless EPA
receives adverse written comment by
March 16, 2011. If EPA receives such
comments, it will publish a timely
withdrawal of the direct final rule in the
Federal Register and inform the public
that the rule will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID Number EPA–
R03–OAR–2010–0902 by one of the
following methods:
A. https://www.regulations.gov. Follow
the on-line instructions for submitting
comments.
B. E-mail: frankford.harold@epa.gov.
C. Mail: EPA–R03–OAR–2010–0902,
Harold A. Frankford, Air Protection
Division, Mailcode 3AP00, U.S.
Environmental Protection Agency,
Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
D. Hand Delivery: At the previouslylisted EPA Region III address. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–R03–OAR–2010–
0902. EPA’s policy is that all comments
received will be included in the public
docket without change, and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: All documents in the
electronic docket are listed in the
https://www.regulations.gov index.
Although listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in https://
www.regulations.gov or in hard copy
during normal business hours at the Air
Protection Division, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103. Copies of the State submittal are
available at the Virginia Department of
Environmental Quality, 629 East Main
Street, Richmond, Virginia 23219.
FOR FURTHER INFORMATION CONTACT:
Harold A. Frankford, (215) 814–2108, or
by e-mail at frankford.harold@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Throughout this document, whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA. On September 27, 2010, the
Commonwealth of Virginia submitted a
formal revision to its State
Implementation Plan (SIP). The SIP
revision consists of the revised
definition of ‘‘Volatile organic
compound’’ (VOC) listed in 9VAC5
Chapter 10 (General Definitions),
Regulation 5–10–20 (Terms defined).
II. Summary of SIP Revision
Virginia amended the definition of
‘‘Volatile organic compound’’ to add the
organic compounds propylene
carbonate and dimethyl carbonate to the
list of excluded compounds. The
exclusion of these compounds is
consistent with the list of excluded
compounds found in EPA’s definition of
‘‘Volatile organic compounds (VOC)’’ at
40 CFR 51.100(s)(1).
III. General Information Pertaining to
SIP Submittals From the
Commonwealth of Virginia
In 1995, Virginia adopted legislation
that provides, subject to certain
conditions, for an environmental
assessment (audit) ‘‘privilege’’ for
voluntary compliance evaluations
performed by a regulated entity. The
legislation further addresses the relative
burden of proof for parties either
asserting the privilege or seeking
disclosure of documents for which the
E:\FR\FM\14FER1.SGM
14FER1
]]>Agencies
[Federal Register Volume 76, Number 30 (Monday, February 14, 2011)]
[Rules and Regulations]
[Pages 8294-8298]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3207]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD-2008-HA-0057]
RIN 0720-AB24
TRICARE Program; Surgery for Morbid Obesity
AGENCY: Office of the Secretary, DoD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule adds a definition of Bariatric Surgery, amends
the definition of Morbid Obesity, and revises the language relating to
the treatment of morbid obesity to allow benefit consideration for
newer bariatric surgical procedures that are considered appropriate
medical care. The final rule removes language that specifically limits
the types of surgical procedures to treat co-morbid conditions
associated with morbid obesity and retains the TRICARE Program
exclusion of non-surgical interventions related to morbid obesity,
obesity and/or weight reduction. This final rule is necessary to allow
coverage for other surgical procedures that reduce or resolve co-morbid
conditions associated with morbid obesity and the use of the Body Mass
Index (BMI), which is the more accurate measure for excess weight to
estimate relative risk of disease. As new technologies or procedures
evolve from investigational into generally accepted norms for medical
practice, the statutes and regulations governing the TRICARE Program
allow the Department to offer beneficiaries these new benefits. These
changes are required in order to allow the Department to provide these
newer technologies and procedures for the treatment of morbid obesity
as they evolve.
DATES: Effective Date: This rule is effective March 16, 2011.
ADDRESSES: TRICARE Management Activity, Medical Benefits and
Reimbursement Branch, 16401 East Centretech Parkway, Aurora, CO 80011-
9066.
FOR FURTHER INFORMATION CONTACT: Gail L. Jones, Medical Benefits and
Reimbursement Branch, TRICARE Management Activity, telephone (303) 676-
3401.
[[Page 8295]]
SUPPLEMENTARY INFORMATION:
I. Background
On December 27, 1982, the Department of Defense (DoD) published a
final rule in the Federal Register (47 FR 57491-57493) that restricted
surgical intervention for morbid obesity to gastric bypass, gastric
stapling, or gastroplasty method (excluding all other types) when the
primary purpose of surgery is to treat a severe related medical illness
or medical condition. The severe medical conditions or illness
associated with morbid obesity included diabetes mellitus,
hypertension, cholecystitis, narcolepsy, Pickwickian Syndrome (and
other severe respiratory disease), hypothalamic disorders, and severe
arthritis of the weight-bearing joints. The DoD also limited program
payments to two categories of patients: (1) Those who weighed 100
pounds over their ideal weight with a specific severe medical
condition; and (2) those who were 200 percent or more over their ideal
weight with no medical complications required. Program payment was made
available as well in cases in which a patient, who originally met the
criteria, received an intestinal bypass, or other surgery for obesity
and, because of complications, required a second surgery. Payment was
allowed even though the patient's condition may not have technically
met the definition of morbid obesity because of the weight that was
already lost following the initial surgery. All other surgeries
including non-surgical treatment related to morbid obesity, obesity,
and/or weight reduction were excluded.
The DoD used the definition of morbid obesity, which was based on
the Metropolitan Life Table and used then by other major health care
plans, as well as reflected the 1982 general opinion regarding which
cases justify surgical intervention. The DoD decided, at the time, that
it was necessary to be very specific in benefit parameters due to
fiscal responsibility and to ensure that Program beneficiaries were not
being exposed to less than fully developed medical technology or
procedures.
At the time the current regulation was written in 1982, gastric
bypass, gastric stapling, and gastroplasty methods were the recognized
surgeries for morbid obesity. However, in recent years, other bariatric
surgical procedures have evolved and some have a substantial body of
literature to support their safety and efficacy. Unlike the original
rule that listed the specific surgical procedures and the clinical
conditions for which coverage may be extended; this final rule
authorizes benefit consideration for those bariatric surgical
procedures that have moved from the unproven status to the position of
nationally accepted medical practice, as determined by the Program
standard of reliable evidence.
Also in 1982 during development of the current regulation for
morbid obesity, overweight and obesity were typically measured with
height-weight tables (such as the Metropolitan Life Table). The 1982
regulation restricted eligibility for bariatric surgery to individuals
who exceed their ideal weight for height by 100 pounds with an
associated severe medical condition, or 200 percent or more over their
ideal body weight with no associated medical condition required.
This final rule changes the Program definition of morbid obesity to
reflect the current nationally accepted medical use of the BMI, rather
than the typical assessed height-weight table (i.e., the Metropolitan
Life Table), to determine an individual's eligibility for bariatric
surgical treatment. The BMI is the more accurate measure for excess
weight to estimate relative risk of disease. Since there now are more
than 30 major diseases associated with obesity, the final rule requires
the Director, TMA, to issue specific criteria for co-morbid conditions
exacerbated or caused by (morbid) obesity, as determined by the Program
standard of reliable evidence.
This final rule does not expand the TRICARE benefit for morbid
obesity surgery. However, it does make the specific procedures that are
covered, as well as the clinical conditions for which coverage may be
extended, a matter of policy. In other words, new bariatric surgery
procedures may be added to the TRICARE benefit structure as such
procedures are proven safe and effective and are established as
nationally accepted medical practice as determined by the Program
standard of reliable evidence.
II. Public Comments
On October 29, 2009 (74 FR 55792-55794), the Office of the
Secretary of Defense published a proposed rule and provided the public
the opportunity to comment on implementing changes to surgery for
morbid obesity. The comment period closed on December 28, 2009. As
result of publication of the proposed rule, DoD received 18 comments.
Thirteen commenters expressed support and approval. We appreciate all
expressions of support and approval for the proposed guidelines. We do
not discuss the majority these comments which were favorable to the
proposed rule and thus with which the Agency generally agrees. However,
several people made comments with specific suggestions and questions
and we have responded to each of these comments below.
Comment: One commenter objected to the provisions of the proposed
rule in the belief the coverage is inappropriate for the selected group
of patients.
Response: We disagree. As discussed in the proposed rule, TRICARE
allows coverage for surgical procedures that may reduce or resolve co-
morbid conditions associated with morbid obesity. This is because a
component of the effective treatment of the co-morbidity condition for
those who fit the morbid obesity criteria set forth in this rule is
weight loss. Thus while the Department does not pay for general weight
loss programs, it may pay for these bariatric surgical procedures as a
component of the treatment of the co-morbidity condition. Title 10,
United States Code Section 1079(a)(13) is sometimes referred to as the
Department's ``medical necessity'' provision. It prohibits the
Department from providing any service or supply, which is not
medically, or psychologically necessary to prevent, diagnose, or treat
a mental or physical illness, injury, or bodily malfunction as assessed
or diagnosed by a physician or other authorized provider. Because the
Department has found this type of treatment for the co-morbidity
condition to be medically necessary, the type of health care services
in the proposed rule are the type of health care services authorized by
statute and may be provided by the TRICARE program.
Comment: Another commenter asked if there is anything being done to
help employees cope with their obesity, and whether there are any
preventative programs in place to educate people and help them to avoid
obesity.
Response: There is a focus on health and wellness for active duty
members, DoD civilians, retired members, contractors, reservists, and
beneficiaries to help encourage healthy lifestyles. Each of the armed
services has developed programs to promote fitness and health. The Army
has the MOVE Program, which is a personalized online weight management
program that comprises up to 13 one-hour sessions. The Navy Shipshape
Program is designed to move military personnel and their families
toward healthier food choices, fitness habits and lifestyles. The Air
Force Fit to Fight Program encourages unit fitness programs, encourages
units to exercise together, and offers nutrition and fitness counseling
to those with borderline fitness test scores. These wellness programs
are designed to provide individuals with tools to improve their
[[Page 8296]]
overall health and lifestyles and address everything from smoking to
obesity.
Comment: One professional organization affirmed the purpose and
scope of the rule acknowledging the need to use body mass index (BMI)
criteria instead of the Metropolitan Life Tables accurately to classify
the degree of morbid obesity. The commenter recommends that DoD provide
coverage for other standard accepted bariatric surgical procedures as
recognized by the American College of Surgeons (ACS), Bariatric Surgery
Center Network (BSCN) and American Society for Metabolic and Bariatric
Surgery (ASMBS). Another professional commenter points out that gastric
sleeve resection has been established and recognized by the ASMBS as
having an important role, as an intermediate intervention regarding
both risk and efficacy of weight loss between bypass and adjustable
gastric banding.
Response: Before the Department may offer any treatment or
procedure to its beneficiaries, the regulations in this part require
that the treatment or procedure must be ``proven care''. This is done
as outlined in Sec. 199.4(g)(15) of this part using the hierarchy of
established reliable evidence as defined in Sec. 199.2 of this part. A
procedure must meet this standard in order for the Department to ensure
safe, quality health care for its beneficiaries and to avoid arbitrary
administration of TRICARE benefit decisions.
Comment: Another commenter agrees with the changes as well but
recommends that the list of obesity-associated co-morbidities be a
complete, inclusive list to prevent inappropriate denial of service.
The commenter goes on to state that covered procedures should include
the laparoscopic vertical sleeve gastrectomy and duodenal switch
procedures.
Response: We appreciate the suggestion that morbid obesity multiple
co-morbidities be a complete, inclusive list and will consider it as
one of many recommendations in revising the benefit policy. We disagree
with the commenter's suggestion that vertical sleeve gastrectomy (VSG)
and biliopancreatic diversion with duodenal switch (BPD/DS) should be
covered under the TRICARE Program. The evidence evaluating the safety
and efficacy of BPD/DS and VSG do not meet the program specific
standards of reliable evidence. Existing data does suggest the use of
these procedures is a possible benefit to some patients but there is
incomplete information to predict the effect of long-term outcomes.
This lack of information relating to the long-term outcomes is a matter
of concern to the Department. Medical literature indicates as well that
well-controlled trials are needed to determine both short-term and
long-term safety and efficacy of BPD/DS and long-term (> 5 years)
weight loss and co-morbidity resolution data for VSG. The Agency will
continue to monitor the development of the literature and the status of
ongoing well-controlled clinical trials regarding the effectiveness of
the laparoscopic VSG and BPD/DS procedures. At such time when the
reliable evidence demonstrates that these bariatric surgical procedures
have proven medical effectiveness, the Director, TMA will initiate
action to cover these procedures.
Comment: This same commenter asks that DoD consider improving
reimbursement for bariatric surgical procedure to a level that
increases access for patients. The commenter goes on to state that
current reimbursement levels are so low that many surgeons will not
accept these patients because TRICARE rates are tied to Medicare fee
schedule, and rates have declined over 10% in the last two years
despite increasing practice overhead expenses.
Response: In section 707 the National Defense Authorization Act of
Fiscal Year 2002, Congress amended the statutory authorization (in 10
U.S.C. 1079(j)(2)) to a mandate that TRICARE payment methods shall be
determined in accordance with Medicare payment rules to the extent
practicable. In the same way under 10 U.S.C. 1079(h), the amount to be
paid to health care professional and other non-institutional health
care providers ``shall be equal to an amount determined to be
appropriate, to the extent practicable, in accordance with the same
reimbursement rules used by Medicare''
Comment: One commenter asked if the proposed guidelines apply to
active duty service members as well.
Response: TRICARE covers most health care deemed medically
necessary for active and retired military and their dependent family.
However, bariatric surgery primarily represents a major and permanent
change to the digestive system and requires a strict adherence to a
dietary regimen, which interferes with operational deployment of active
duty service members (ADSMs). Because of this, ADSMs are not permitted
to have bariatric surgery. ADSMs have an obligation to maintain
themselves in a state of high physical readiness and the Services have
weight and fitness screening programs to assure compliance with Service
standards, and each Service offers evidence-based, multidisciplinary
weight and fitness programs for individuals who are unable to meet
those standards.
Comment: Another commenter expresses his company's support for the
proposal rule to add new bariatric surgical procedures to the TRICARE
benefit structure when such procedures are proven safe, effective, and
established as nationally accepted medical practice, as determined by
the TRICARE definition of reliable evidence. The commenter also noted
that the proposed rule did not clearly state that the definition of
reliable evidence applies to the determination that a procedure is
established as nationally accepted medical practice; and therefore,
recommend paragraph (e)(15) of this section be modify.
Response: We appreciate the commenter's support and concerns
regarding the application of TRICARE definition of reliable evidence
and have modified paragraph (e)(15) of this section to include a
reference to Sec. 199.2 of this part for the procedures used in
determining if a medical treatment or procedure is unproven.
Comment: This same commenter recommends coverage for laparoscopic
adjustable gastric band (LAGB) and medically necessary adjustment of
LAGB systems. The commenter also recommends that DoD revise the
proposed rule to add coverage for post-surgical follow-up and band
adjustments. The commenter also recommends that DoD not specify any
minimum duration of weight loss management as a precondition for the
bariatric surgery and that type 2 diabetes mellitus be specified as a
high-risk co-morbidity exacerbated or caused by morbid obesity.
Response: The laparoscopic adjustable gastric banding surgical
procedure (including post-surgical follow-up and band adjustments)
became a TRICARE benefit effective February 1, 2007. TRICARE also
provides coverage for follow-up care to include band adjustments and
any unfortunate sequelae resulting from the adjustment for those
patients who underwent the LAP-Band surgery before the effective date
of coverage. Coverage, however, is contingent upon the patient meeting
TRICARE morbid obesity policy criteria at the time of his or her
surgery. We appreciate the suggestion that DoD not specify any minimum
duration of weight loss management as a precondition for the bariatric
surgery and that type 2 diabetes mellitus be specified as a high-risk
co-morbidity and will consider these as one of many recommendations in
future revisions regarding the benefit policy.
[[Page 8297]]
Comment: This same commenter noted that the proposed rule did not
require physicians or facilities performing bariatric surgical
procedures to fulfill any specific qualification requirements for
coverage. The commenter states that it is the understanding that DoD
intends to leave the issue of facility and surgeon qualification to the
discretion of TMA or its Managed Care Support Contractors.
Response: All TRICARE authorized providers are subject to the
requirements as outlined in 32 CFR 199.6. Otherwise covered services
are cost shared only if the individual professional provider holds a
current, valid license or certification to practice his or her
profession in the jurisdiction where the service is rendered.
This final rule considered all comments received during the comment
period and has responded to those comments in this final rule. Since
the proposed rule was published, DoD has revised paragraph (e)(15) of
this section.
Regulatory Procedures
Executive Order 12866, ``Regulatory Planning and Review''
It has been determined that this 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 tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another Agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.
Unfunded Mandates Reform Act (Sec. 202, Pub. L. 104-4)
It has been certified that this 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 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. The change from height-weight tables to the BMI
should have a minimal impact on the number of beneficiaries eligible
for surgery.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
It has been certified that this rule does not impose reporting or
recordkeeping requirements under the Paperwork Reduction Act of 1995.
Executive Order 13132, Federalism
It has been certified that this 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.
The final rule is consistent with the proposed rule.
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 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
``Bariatric Surgery'' and revising the definition of ``Morbid Obesity''
to read as follows:
Sec. 199.2 Definitions.
* * * * *
(b) * * *
Bariatric Surgery. Surgical procedures performed to treat co-morbid
conditions associated with morbid obesity. Bariatric surgery is based
on two principles: (1) Divert food from the stomach to a lower part of
the digestive tract where the normal mixing of digestive fluids and
absorption of nutrients cannot occur (i.e., Malabsorptive surgical
procedures); or (2) Restrict the size of the stomach and decrease
intake (i.e., Restrictive surgical procedures).
* * * * *
Morbid obesity. A body mass index (BMI) equal to or greater than 40
kilograms per meter squared (kg/m2), or a BMI equal to or
greater than 35 kg/m2 in conjunction with high-risk co-
morbidities, which is based on the guidelines established by the
National Heart, Lung and Blood Institute on the Identification and
Management of Patients with Obesity.
Note: Body mass index is equal to weight in kilograms divided
by height in meters squared.
* * * * *
0
3. Section 199.4 is amended by revising paragraphs (e)(15) and (g)(28)
to read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(e) * * *
(15) Morbid obesity. The TRICARE morbid obesity benefit is limited
to those bariatric surgical procedures for which the safety and
efficacy has been proven comparable or superior to conventional
therapies and is consistent with the generally accepted norms for
medical practice in the United States medical community. (See the
definition of reliable evidence in Sec. 199.2 of this part for the
procedures used in determining if a medical treatment or procedure is
unproven.)
(i) Conditions for coverage.
(A) Payment for bariatric surgical procedures is determined by the
requirements specified in paragraph (g)(15) of this section, and as
defined in Sec. 199.2(b) of this part.
(B) Covered bariatric surgical procedures are payable only when the
patient has completed growth (18 years of age or documentation of
completion of bone growth) and has met one of the following selection
criteria:
(1) The patient has a BMI that is equal to or exceeds 40 kg/
m2 and has previously been unsuccessful with medical
treatment for obesity.
(2) The patient has a BMI of 35 to 39.9 kg/m\2\, has at least one
high-risk co-morbid condition associated with morbid obesity, and has
previously been unsuccessful with medical treatment for obesity.
Note: The Director, TMA, shall issue guidelines for review of
the specific high-risk co-morbid conditions, exacerbated or caused
by obesity based on the Reliable Evidence Standard as defined in
Sec. 199.2 of this part.
(ii) Treatment of complications.
(A) Payment may be extended for repeat bariatric surgery when
medically necessary to correct or treat complications from the initial
covered bariatric surgery (a takedown). For instance, the surgeon in
many cases will
[[Page 8298]]
do a gastric bypass or gastroplasty to help the patient avoid regaining
the weight that was lost. In this situation, payment is authorized even
though the patient's condition technically may not meet the definition
of morbid obesity because of the weight that was already lost following
the initial surgery.
(B) Payment is authorized for otherwise covered medical services
and supplies directly related to complications of obesity when such
services and supplies are an integral and necessary part of the course
of treatment that was aggravated by the obesity.
(iii) Exclusions. CHAMPUS payment may not be extended for weight
control services, weight control/loss programs, dietary regimens and
supplements, appetite suppressants and other medications; food or food
supplements, exercise and exercise programs, or other programs and
equipment that are primarily intended to control weight or for the
purpose of weight reduction, regardless of the existence of co-morbid
conditions.
* * * * *
(g) * * *
(28) Obesity, weight reduction. Service and supplies related
``solely'' to obesity or weight reduction or weight control whether
surgical or nonsurgical; wiring of the jaw or any procedure of similar
purpose, regardless of the circumstances under which performed (except
as provided in paragraph (e)(15) of this section).
* * * * *
Dated: February 1, 2011.
Morgan F. Park,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-3207 Filed 2-11-11; 8:45 am]
BILLING CODE 5001-06-P
