[Federal Register Volume 74, Number 208 (Thursday, October 29, 2009)]
[Proposed Rules]
[Pages 55792-55794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26042]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DOD-2008-HA-0057]
RIN 0720-AB24


TRICARE Program; Morbid Obesity

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

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SUMMARY: The Department of Defense (DoD) proposes to amend the TRICARE 
regulation on surgery for morbid obesity to allow benefit consideration 
for the newest bariatric surgical procedures that are considered 
appropriate medical care. The amendment also removes language that 
limits the types of surgical procedures to treat co-morbid conditions 
associated with morbid obesity, revises the TRICARE Program definition 
of morbid obesity, and retains the TRICARE Program exclusion of non-
surgical interventions related to morbid obesity, obesity and/or weight 
reduction. These changes are 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. Additionally, as new technologies or 
procedures evolve from investigational into generally accepted norms 
for medical practice, beneficiaries are entitled to TRICARE coverage of 
the new technology or procedures.

DATES: Comments must be received on or before December 28, 2009. Do not 
submit comments directly to the point of contact or mail your comments 
to any address other than what is shown below. Doing so will delay the 
posting of the submission.

ADDRESSES: You may submit comments, identified by docket number and/or 
RIN number and title, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 1160 
Defense Pentagon, OSD Mailroom 3C843, Washington, DC 20301-1160.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
Federal Register document. The general policy for comments and other 
submissions from members of the public is to make these submissions 
available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any 
personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT: Gail L. Jones (303) 676-3401.

SUPPLEMENTARY INFORMATION: 

I. Background

    This document contains proposed regulation amending the 
requirements and procedures in 32 CFR, part 199 relating to surgery for 
morbid obesity, under section 2 (Definitions) and section 4 (Basic 
Program Benefits) of the regulation. On December 27, 1982, the 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 that weigh 100 pound 
over their ideal weight with a specific severe medical condition; and 
(2) those who are 200 percent or more over their ideal weight with no 
medical complications required. Program payment was made available as 
well for special consideration of those unique cases in which the 
patient received an intestinal bypass, or other surgery for obesity 
and, because of complications, required a

[[Page 55793]]

second surgery. Payment is allowed even though the patient's condition 
may not technically meet 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 are excluded.
    The DoD did not revise the definition of morbid obesity, which is 
based on the Metropolitan Life Table and used then by other major 
health care plan, 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.

II. Explanation for Proposed Provisions

Overview

    At the time the current regulation was written, gastric bypass, 
gastric stapling, and gastroplasty methods were the recognized 
surgeries for morbid obesity. In recent years, other bariatric surgical 
procedures have been used more and more frequently, and some have a 
substantial body of literature to support their safety and efficacy. 
Rather than list the specific surgical procedures that may be covered 
under the TRICARE Program and the clinical conditions for which 
coverage may be extended, this proposed 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 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 regulation (as 
currently written) restricts 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 proposed amendment changes the Program definition of morbid 
obesity to reflect the 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 Director, TMA, 
or a designee, will issue specific criteria for co-morbid conditions 
exacerbated or caused by (morbid) obesity.
    This proposed 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.
    This amendment is being published for proposed rulemaking at the 
same time as it is being coordinated within the DoD, with the 
Department of Health and Human Services, and with other interested 
agencies, in order that consideration of both internal and external 
comments and publication of the final rulemaking document can be 
expedited.

III. Response to Comments

    Because of the large number of public comments generally received 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
major comments in the preamble to that document. We will make all 
submissions from organizations or businesses, and from individuals 
identifying themselves as representatives or officials of organizations 
or businesses, available for public inspection in their entirety.

IV. Regulatory Procedures

Executive Order 12866, ``Regulatory Planning and Review''

    It has been determined that this proposed rule is not a significant 
regulatory action. This rule does not:
    1. Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy; a section of the 
economy; productivity; competition; jobs; the environment; public 
health or safety; or State, local, or tribunal governments or 
communities;
    2. Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another Agency;
    3. Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs, or the rights and obligations of 
recipients thereof; or
    4. Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive Order.

Unfunded Mandates Reform Act (Sec. 202, Pub. L. 104-4)

    It has been certified that this proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed to be amended to read as 
follows:

PART 199--[AMENDED]

    1. The authority citation for part 199 continues to read as 
follows:

    Authority:  5 U.S.C. 301; 10 U.S.C. chapter 55.

    2. Section 199.2, paragraph (b) is amended by adding the definition 
of

[[Page 55794]]

``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 adsorption 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 Federal 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.

* * * * *
    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.
    (i) Conditions for coverage. (A) Payment for bariatric surgical 
procedures are 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/m2, 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, or a designee, shall issue guidelines 
for review or the specific high-risk co-morbid conditions, 
exacerbated or, caused by obesity.

    (ii) Treatment of complications. (A) Payment may be extended for 
repeat bariatric surgery when medically necessary to correct or treat 
complications from the initial bariatric surgery (a takedown). For 
instance, the surgeon in many cases will 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 program 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: October 23, 2009.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. E9-26042 Filed 10-28-09; 8:45 am]
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