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) * * * 

TABLE I 

Year 

Limit 

Auto. proj. 

cost limit 

(Col.1) 

Prior notice 

proj. cost limit 

(Col.2) 

1982 .......... $4,200,000 $12,000,000 

1983 .......... 4,500,000 12,800,000 

1984 .......... 4,700,000 13,300,000 

1985 .......... 4,900,000 13,800,000 

1986 .......... 5,100,000 14,300,000 

1987 .......... 5,200,000 14,700,000 

1988 .......... 5,400,000 15,100,000 

1989 .......... 5,600,000 15,600,000 

1990 .......... 5,800,000 16,000,000 

1991 .......... 6,000,000 16,700,000 

1992 .......... 6,200,000 17,300,000 

1993 .......... 6,400,000 17,700,000 

1994 .......... 6,600,000 18,100,000 

1995 .......... 6,700,000 18,400,000 

1996 .......... 6,900,000 18,800,000 

1997 .......... 7,000,000 19,200,000 

1998 .......... 7,100,000 19,600,000 

1999 .......... 7,200,000 19,800,000 

2000 .......... 7,300,000 20,200,000 

2001 .......... 7,400,000 20,600,000 

2002 .......... 7,500,000 21,000,000 

2003 .......... 7,600,000 21,200,000 

2004 .......... 7,800,000 21,600,000 

2005 .......... 8,000,000 22,000,000 

2006 .......... 9,600,000 27,400,000 

2007 .......... 9,900,000 28,200,000 

2008 .......... 10,200,000 29,000,000 

2009 .......... 10,400,000 29,600,000 

2010 .......... 10,500,000 29,900,000 

2011 .......... 10,600,000 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 

Year Limit 

1982 .................................. $2,700,000 

1983 .................................. 2,900,000 

1984 .................................. 3,000,000 

1985 .................................. 3,100,000 

1986 .................................. 3,200,000 

1987 .................................. 3,300,000 

1988 .................................. 3,400,000 

1989 .................................. 3,500,000 

1990 .................................. 3,600,000 

1991 .................................. 3,800,000 

1992 .................................. 3,900,000 

1993 .................................. 4,000,000 

1994 .................................. 4,100,000 

1995 .................................. 4,200,000 

1996 .................................. 4,300,000 

1997 .................................. 4,400,000 

1998 .................................. 4,500,000 

TABLE II—Continued 

Year Limit 

1999 .................................. 4,550,000 

2000 .................................. 4,650,000 

2001 .................................. 4,750,000 

2002 .................................. 4,850,000 

2003 .................................. 4,900,000 

2004 .................................. 5,000,000 

2005 .................................. 5,100,000 

2006 .................................. 5,250,000 

2007 .................................. 5,400,000 

2008 .................................. 5,550,000 

2009 .................................. 5,600,000 

2010 .................................. 5,700,000 

2011 .................................. 5,750,000 

* * * * * 

[FR Doc. 2011–3190 Filed 2–11–11; 8:45 am] 

BILLING CODE P 

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 

AGENCY: Customs and Border Protection, 

Department of Homeland Security. 

ACTION: Final rule; correction. 

SUMMARY: 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. 

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’’. 

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 

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 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. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 30 / Monday, February 14, 2011 / Rules and Regulations 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 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 

WReier-Aviles on DSKGBLS3C1PROD with RULES

8296 Federal Register / Vol. 76, No. 30 / Monday, February 14, 2011 / Rules and Regulations 

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 

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 

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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Federal Register / Vol. 76, No. 30 / Monday, February 14, 2011 / Rules and Regulations 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 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. 

* * * * * 

(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 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. 

* * * * * 

■ 3. Section 199.4 is amended by 

revising paragraphs (e)(15) and (g)(28) to 

read as follows: 

§ 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 § 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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8298 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 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: 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 

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. http://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 http:// 

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 http:// 

www.regulations.gov or e-mail. The 

http://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 http:// 

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. 

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 

http://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 http:// 

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 

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