[Federal Register Volume 76, Number 30 (Monday, February 14, 2011)]
[Rules and Regulations]
[Pages 8294-8298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3207]


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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.

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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