13236 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 

approved by the ALJ if the case is before 

the ALJ, or by the ARB if the ARB has 

accepted the case for review. A copy of 

the settlement will be filed with the ALJ 

or the ARB, as the case may be. 

(e) Any settlement approved by the 

Assistant Secretary, the ALJ, or the ARB 

will constitute the final order of the 

Secretary and may be enforced in 

United States district court pursuant to 

§ 1984.113. 

§ 1984.112 Judicial review. 

(a) Within 60 days after the issuance 

of a final order under §§ 1984.109 and 

1984.110, any person adversely affected 

or aggrieved by the order may file a 

petition for review of the order in the 

United States Court of Appeals for the 

circuit in which the violation allegedly 

occurred or the circuit in which the 

complainant resided on the date of the 

violation. 

(b) A final order is not subject to 

judicial review in any criminal or other 

civil proceeding. 

(c) If a timely petition for review is 

filed, the record of a case, including the 

record of proceedings before the ALJ, 

will be transmitted by the ARB or the 

ALJ, as the case may be, to the 

appropriate court pursuant to the 

Federal Rules of Appellate Procedure 

and the local rules of such court. 

§ 1984.113 Judicial enforcement. 

Whenever any person has failed to 

comply with a preliminary order of 

reinstatement, or a final order, including 

one approving a settlement agreement, 

issued under section 18C of the FLSA, 

the Secretary or a person on whose 

behalf the order was issued may file a 

civil action seeking enforcement of the 

order in the United States district court 

for the district in which the violation 

was found to have occurred. The 

Secretary also may file a civil action 

seeking enforcement of the order in the 

United States district court for the 

District of Columbia. 

§ 1984.114 District court jurisdiction of 

retaliation complaints. 

(a) The complainant may bring an 

action at law or equity for de novo 

review in the appropriate district court 

of the United States, which will have 

jurisdiction over such an action without 

regard to the amount in controversy, 

either: 

(1) Within 90 days after receiving a 

written determination under 

§ 1984.105(a) provided that there has 

been no final decision of the Secretary; 

or 

(2) If there has been no final decision 

of the Secretary within 210 days of the 

filing of the complaint. 

(3) At the request of either party, the 

action shall be tried by the court with 

a jury. 

(b) A proceeding under paragraph (a) 

of this section shall be governed by the 

same legal burdens of proof specified in 

section 1984.109. The court shall have 

jurisdiction to grant all relief necessary 

to make the employee whole, including 

injunctive relief and compensatory 

damages, including: 

(1) Reinstatement with the same 

seniority status that the employee 

would have had, but for the discharge 

or discrimination; 

(2) The amount of back pay, with 

interest; and 

(3) Compensation for any special 

damages sustained as a result of the 

discharge or discrimination, including 

litigation costs, expert witness fees, and 

reasonable attorney fees. 

(c) Within seven days after filing a 

complaint in federal court, a 

complainant must file with the 

Assistant Secretary, the ALJ, or the ARB, 

depending on where the proceeding is 

pending, a copy of the file-stamped 

complaint. A copy of the complaint also 

must be served on the OSHA official 

who issued the findings and/or 

preliminary order, the Assistant 

Secretary, and the Associate Solicitor, 

Division of Fair Labor Standards, U.S. 

Department of Labor. 

§ 1984.115 Special circumstances; waiver 

of rules. 

In special circumstances not 

contemplated by the provisions of these 

rules, or for good cause shown, the ALJ 

or the ARB on review may, upon 

application, after three- days notice to 

all parties, waive any rule or issue such 

orders that justice or the administration 

of section 18C of the FLSA requires. 

[FR Doc. 2013–04329 Filed 2–22–13; 11:15 am] 

BILLING CODE 4510–26–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2009–HA–0038] 

RIN 0720–AB50 

TRICARE: Smoking Cessation 

Program 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Final rule. 

SUMMARY: This final rule implements 

Section 713 of the Duncan Hunter 

National Defense Authorization Act 

(NDAA) for Fiscal Year 2009. Section 

713 states the Secretary shall establish 

a smoking cessation program under the 

TRICARE program. The smoking 

cessation program under TRICARE 

shall, at a minimum, include the 

following: The availability, at no cost to 

the beneficiary, of pharmaceuticals used 

for smoking cessation, with the 

limitation on the availability of such 

pharmaceuticals to the mail-order 

pharmacy program under the TRICARE 

program; smoking cessation counseling; 

access to a toll-free quit line 24 hours a 

day, 7 days a week; access to print and 

Internet web-based tobacco cessation 

material. Per the statute, Medicareeligible beneficiaries are excluded from 

the TRICARE smoking cessation 

program. 

DATES: Effective Date: This final rule is 

effective March 29, 2013. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Ginnean Quisenberry, Population 

Health, Medical Management, and 

Patient Centered Medical Home 

Division, Office of the Chief Medical 

Officer, TRICARE Management Activity, 

telephone (703) 681–6717. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Purpose of the Final Rule 

The purpose of this final rule is to 

implement the provisions of the Duncan 

Hunter NDAA for FY 2009 (Pub. L. 110– 

417) that establishes a smoking 

cessation program under the TRICARE 

program. Establishment of the TRICARE 

smoking cessation program attempts to 

reduce the number of TRICARE 

beneficiaries who are nicotine 

dependent, thereby improving the 

health of the TRICARE beneficiary 

population and reducing Department of 

Defense costs, in particular those related 

to the adverse effects of smoking. The 

legal authority for the Final Rule is 

Section 713 of the Duncan Hunter 

NDAA FY09 (Pub. L. 110–417). 

B. Summary of the Major Provisions of 

the Final Rule 

Section 713 of the Duncan Hunter 

NDAA for FY 2009 stipulates the 

following key features for inclusion in 

the TRICARE smoking cessation 

program: 

1. The availability, at no cost to the 

beneficiary, of pharmaceuticals used for 

smoking cessation, with a limitation on 

the availability of such pharmaceuticals 

to the national mail-order pharmacy 

program under the TRICARE program if 

appropriate. 

Smoking cessation medications will 

be covered by TRICARE through the 

Mail Order Pharmacy program, as well 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 13237 

as at Military Treatment Facilities at no 

cost, including no co-pay. The type of 

smoking cessation medications 

available, which may include over-thecounter medications, will be determined 

by the TRICARE Pharmacy and 

Therapeutics Committee based on 

clinical and cost effectiveness 

considerations. 

2. Counseling. 

In person smoking cessation 

counseling from a TRICARE authorized 

provider as detailed in the TRICARE 

Policy Manual for is a covered TRICARE 

benefit for those beneficiaries that are 

not eligible for Medicare. 

3. Access to a toll-free quit line that 

is available 24 hours a day, 7 days a 

week. 

Beneficiaries will have access to a 

toll-free smoking cessation quit line that 

will be available 24 hours a day, 7 days 

a week. 

4. Access to print and Internet webbased tobacco cessation material. 

TRICARE will provide access to both 

print and web-based tobacco cessation 

materials for any beneficiary who is 

interested in quitting using tobacco 

products. 

5. Chain of command involvement by 

officers in the chain of command of 

participants in the program who are on 

active duty. 

All of those in the chain of command 

are expected to provide their support to 

the program and to any member who 

wishes to quit smoking. There is no 

intent for any reporting requirements to 

the chain of command related to any 

member’s participation. 

C. Costs and Benefits of this Regulatory 

Action 

The cost for these changes is 

estimated to be 24 million dollars for a 

one year period. The benefits are that 

TRICARE will be in compliance with its 

statutory provisions and health of 

beneficiaries who quit smoking will be 

improved. 

II. Background 

The Duncan Hunter NDAA for FY 

2009 (Pub. L. 110–417) provides 

authority for establishment of a smoking 

cessation program under the TRICARE 

program. Prior to enactment of Section 

713 of the Duncan Hunter NDAA FY09 

(Pub. L. 110–417), all supplies and 

services related to ‘‘stop smoking’’ 

programs were excluded from TRICARE 

coverage per the regulation, 32 CFR 

199.4(g)(65). 

Smoking is the number one cause of 

preventable illness and disease in the 

United States and yet, the prevalence of 

smoking among TRICARE beneficiaries 

exceeds that of the general population. 

According to the Centers for Disease 

Control and Prevention (CDC), adverse 

health effects from smoking account for 

an estimated 443,000 deaths in the 

United States each year. 

Smoking causes respiratory diseases 

such as emphysema, bronchitis, and 

chronic airway obstruction. It also 

causes several types of cancers 

including, but not limited to, 

esophageal, oral cavity, uterine, and 

lung cancer. In fact, the CDC estimates 

that 90 percent of lung cancer deaths in 

men and 80 percent in women are 

caused by smoking. 

Smoking also puts individuals at 

increased risk for several other types of 

diseases and adverse health outcomes 

such as coronary artery disease, chronic 

obstructive lung diseases, peripheral 

vascular disease, heart attack, and 

stroke. In addition, it increases the risk 

of infertility, preterm delivery, stillbirth, 

low birth weight, and sudden infant 

death syndrome. 

Smoking and its related adverse 

effects pose a significant challenge for 

many TRICARE beneficiaries. 

Establishment of the TRICARE smoking 

cessation program attempts to reduce 

the number of TRICARE beneficiaries 

who are nicotine dependent, thereby 

improving the health of the TRICARE 

beneficiary population and reducing 

Department of Defense costs, in 

particular those related to the adverse 

effects of smoking. For further 

information on TRICARE and the 

benefits provided under the TRICARE 

program, please visit www.tricare.mil. 

III. Section 713 of the Duncan Hunter 

NDAA for FY 2009 

This final rule implements Section 

713 of the Duncan Hunter NDAA for FY 

2009. Section 713 stipulates the 

following key features for inclusion in 

the TRICARE smoking cessation 

program: 

(1) The availability, at no cost to the 

beneficiary, of pharmaceuticals used for 

smoking cessation, with a limitation on 

the availability of such pharmaceuticals 

to the national mail-order pharmacy 

program under the TRICARE program if 

appropriate. 

(2) Counseling. 

(3) Access to a toll-free quit line that 

is available 24 hours a day, 7 days a 

week. 

(4) Access to print and Internet webbased tobacco cessation material. 

(5) Chain of command involvement by 

officers in the chain of command of 

participants in the program who are on 

active duty. 

Additionally, Section 713 of NDAA 

FY 2009 stated the TRICARE smoking 

cessation program shall not be made 

available to Medicare-eligible 

beneficiaries. The statutory language 

further stated that refunds of 

copayments paid by Medicare-eligible 

beneficiaries are available during fiscal 

year 2009, subject to the specific 

availability of appropriations for this 

purpose. However, this authority was 

not extended beyond FY 2009; 

consequently, no action is required by 

TRICARE regarding this provision. 

IV. Final Rule 

This final rule establishes a smoking 

cessation program under the TRICARE 

program. The TRICARE smoking 

cessation program will be available to 

all TRICARE beneficiaries who reside in 

one of the 50 United States or the 

District of Columbia who are not eligible 

for Medicare benefits authorized under 

Title XVIII of the Social Security Act. In 

general, the TRICARE smoking cessation 

program will not be available to 

TRICARE beneficiaries who reside 

overseas except that under authority of 

32 CFR 199.17, active duty service 

members and active duty dependents 

residing overseas including the U.S. 

territories of Guam, Puerto Rico, and the 

Virgin Islands who are enrolled in 

TRICARE Prime at a military treatment 

facility may have access to those 

services that the ASD(HA) has 

determined may be reasonably provided 

overseas. 

It is the intent of the Department to 

provide access to smoking cessation 

pharmaceuticals and web based 

smoking cessation materials overseas 

where feasible. However, beneficiaries 

residing in certain areas overseas may 

not have easy access to the mail 

services, equipment or technology 

needed to receive these smoking 

cessation benefits and in those areas 

there is no requirement to make them 

available. For example, there is no 

intent by the Department to make the 

web based services available in areas 

where there are no web based carriers to 

provide such a service. Additionally, 

the laws and our treaties with various 

countries restrict the mailing of 

pharmaceuticals into the country. If 

such laws or treaties do not allow the 

delivery of the pharmaceuticals through 

the TRICARE Mail Order Pharmacy 

(TMOP), it is not the intent of the 

Secretary to provide the pharmaceutical 

benefit in those areas through this 

mechanism. 

At this time, it is not the intent of the 

Department to provide access to the toll 

free quit line overseas due to the 

technological barriers and cost involved 

in providing this service. In addition, it 

is not the intent of the Department at 

this time to make face-to-face smoking 


erowe on DSK2VPTVN1PROD with RULES
13238 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 

cessation counseling available overseas 

through the local economy. However, in 

accordance with 32 CFR 199.17 should 

the ASD(HA) determine that it is 

technologically, economically, or 

otherwise feasible to provide additional 

benefits or it becomes impractical to 

continue the benefits and services 

overseas, the ASD(HA) may use this 

authority to add or modify any benefit 

or service. Notice of the use of this 

authority shall be published in the 

Federal Register. 

There will be no requirement for an 

eligible beneficiary to be diagnosed with 

a smoking related illness in order to 

access benefits under the TRICARE 

smoking cessation program. Benefits 

under this program will include, at no 

cost to the beneficiary, pharmaceuticals 

used for smoking cessation available 

through the TRICARE mail-order 

pharmacy program and at Military 

Treatment Facilities. The program will 

include smoking cessation counseling; 

access to a toll-free quit line 24 hours a 

day, 7 days a week; and access to 

printed and Internet web-based tobacco 

cessation material. Like other 

pharmaceuticals, smoking cessation 

pharmaceuticals may also be available 

at no cost to the beneficiary at an MTF; 

however, smoking cessation 

pharmaceuticals are not a covered 

benefit under the TRICARE Retail 

Pharmacy program. 

V. Public Comments 

The proposed rule was published in 

the Federal Register (76 FR 58199) 

dated September 20, 2011, for a 60-day 

public comment period. We received 

sixteen comments from different 

respondents on the proposed rule. 

All but one of the public comments 

was positive and supported the 

provisions of the proposed rule. Fifteen 

of the respondents approved of the new 

coverage of smoking cessation 

medications with no copay, however 

there were two comments questioning 

the limitation of availability to the Mail 

Order Pharmacy Program. There was 

concern that TRICARE had not 

explained the reasoning for this 

decision and some were concerned that 

this limitation would be a barrier to 

those seeking treatment. We appreciate 

the comments and acknowledge the 

concern. However, we do not believe 

that limiting availability of smoking 

cessation pharmaceuticals to the mail 

order pharmacy will be a barrier to 

seeking care by the majority of 

beneficiaries. Mail order is a more cost 

effective venue than retail pharmacy 

and this limitation is a way of 

controlling the cost of providing these 

pharmaceuticals at no cost to the 

beneficiary. We believe that providing 

these pharmaceuticals at no cost has a 

greater influence on a beneficiary’s 

decision to seek care than the fact that 

the care is limited to a specific venue. 

We believe this to be a prudent, fair, and 

reasonable approach to providing the 

pharmaceutical component of the 

benefit. 

Additionally, one respondent, 

representing the National Community 

Pharmacists Association felt that since 

some retail pharmacists provide 

smoking cessation counseling, it would 

be more convenient for beneficiaries to 

be able to get their medications at the 

retail pharmacy where they might 

possibly be going for smoking cessation 

counseling, so that both activities could 

occur in one location. We appreciate the 

respondent’s comment and the 

suggestion that would seemingly offer 

greater convenience to TRICARE 

beneficiaries; however, consistent with 

Center for Medicare and Medicaid 

Services (CMS), pharmacists are not 

recognized as authorized TRICARE 

independent providers. Although 

TRICARE currently recognizes 

pharmacies as providers for purposes of 

the pharmacy benefits program under 32 

CFR 199.21, which includes providing 

immunizations to our beneficiaries, the 

individual pharmacist is not recognized 

as an independent provider. Therefore, 

pharmacist counseling services are not 

currently a covered benefit under 

TRICARE and pharmacists cannot be 

reimbursed for this service. Therefore, 

beneficiaries who obtain smoking 

cessation products in a retail pharmacy 

may not receive counseling from the 

pharmacist as a covered benefit. In 

addition, as mentioned above, providing 

these products in the retail venue would 

significantly increase the cost of this 

program. The respondents were also 

concerned that if medications for 

smoking cessation are mailed to a 

patient’s home, they will not have the 

opportunity to ask questions of a 

pharmacist before taking them. Unlike 

the majority of retail pharmacies, the 

mail order pharmacy program provides 

access to pharmacists 24/7 via a toll free 

number. Consistent with most pharmacy 

services, the mail order program 

provides complete written information 

including instructions for use, side 

effects, adverse effects, doses, warnings, 

and telephone numbers for questions. 

Five respondents expressed concern 

that these new benefits were only 

available CONUS and not OCONUS. 

One respondent suggested a change to 

the language that deals with OCONUS 

availability. The commentor would 

prefer that it say that TRICARE is 

required to make the smoking cessation 

program available overseas unless the 

ASD(HA) determines it is not possible 

to provide the program in specific 

overseas locations or situations, instead 

of stating that the benefits are not 

available overseas unless the Assistant 

Secretary of Defense for Health Affairs 

[ASD(HA)] determines they can be 

reasonably provided. We appreciate the 

respondent’s comments and 

acknowledge the respondent’s 

suggestion, however during the 

implementation of this benefit the 

ability to provide the benefit overseas 

was extensively explored. The 

Department found significant barriers 

and elected not to implement at this 

time. The language gives the Assistant 

Secretary the ability to expand the 

benefit as technology and other 

innovations make the delivery of these 

benefits feasible. Additionally the 

current federal regulations relating to 

the implementation of TRICARE 

overseas states that the program is not 

implemented overseas without 

affirmative action by the Department, 

thus the language used is consistent 

with our current regulatory framework. 

One person commented that the 

smoking cessation program should 

include provisions to assist with 

tobacco cessation as well. We appreciate 

the comment; however, the language in 

section 713 of the NDAA 2009 limits us 

to providing a smoking cessation 

program with one exception. That 

exception allows the Department to 

provide printed and Internet web-based 

tobacco cessation materials. 

One respondent was concerned that 

the language in the summary statement 

that says that there is a ‘‘limitation on 

the availability of such pharmaceuticals 

to the mail-order pharmacy’’ will cause 

the beneficiaries to believe that they 

cannot get these medications at the MTF 

pharmacies. We appreciate the 

respondent’s comment and concern, and 

would like to assure the respondent that 

this was unintentional. To correct this 

and assure clarity, the language in 

Section III, the Summary, concerning 

the availability of smoking cessation 

pharmaceuticals has been revised to 

include a reference to the availability of 

pharmaceuticals at the MTFs. The 

language in the regulation itself reflects 

the correct availability of these 

pharmaceutical agents. 

The statement in the proposed rule 

that says, ‘‘the Secretary of Defense shall 

provide for involvement by officers in 

the chain of command of participants in 

the program who are on active duty’’ 

caused concern for one responder. This 

commentor took this statement to mean 

that those active duty members who 

took advantage of the program would 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 13239 

have to report on their progress to their 

supervisor, which they felt would be 

very intimidating for those trying to 

quit, especially if they were having 

difficulties. We appreciate the comment, 

and want to clarify that the intent is not 

to have supervising officers be directly 

involved in individual active duty 

service members quit attempts, but to 

have them provide their support to the 

program. That is, it is the intent of the 

Department for all parts of the chain of 

command to support any member who 

wishes to quit smoking. There is no 

intent for any reporting requirements by 

a member to his or her command or for 

any member within the chain of 

command to report to their superiors 

relating to any member’s participation 

in a smoking cessation program. 

There were several comments related 

to the number of quit attempts available 

to participants in the program. One 

respondent did not think that a 

beneficiary should get more than three 

attempts total. The commenter was 

opposed to having three possible 

attempts per year and felt it would be 

a waste of TRICARE resources to 

continue to pay for additional attempts 

for someone who was not successful 

within a year of trying. We acknowledge 

the respondent’s comments and 

appreciate the concerns. TRICARE is 

dedicated to the appropriate and 

judicious use of taxpayers’ money and 

the decision to allow more than three 

quit attempts in total was the result of 

extensive research concerning smoking 

cessation. This research revealed that, 

on average, it takes smokers seven 

attempts to quit. Allowing more than 

three total attempts will give TRICARE 

beneficiaries who want to quit smoking 

the best opportunity to do so. This will 

result in a healthier beneficiary 

population; and as this population 

becomes healthier and more individuals 

choose to quit, TRICARE health care 

costs associated with treating diseases 

that are either caused by or exacerbated 

by smoking will be reduced. 

Another respondent had the opposite 

view, believing that since ‘‘tobacco 

dependence is a chronic disease that 

often requires repeated intervention and 

multiple attempts to quit’’, patients 

should not be limited in their attempts 

and should have access to tobacco 

cessation services throughout the year. 

We acknowledge and respect this 

respondent’s point of view; however, 

believe it would be fiscally irresponsible 

not to impose a limit on quit attempts. 

Furthermore, while our research 

revealed that the average person 

requires multiple attempts at quitting 

before they are successful, our research 

did not support a conclusion that 

allowing unlimited quit attempts results 

in improved success rates. 

This respondent also requested that 

the DoD Pharmacy and Therapeutics 

Committee, when deciding which 

specific smoking cessation medications 

TRICARE will cover, will choose to 

include all FDA-approved tobacco 

cessation medications. We appreciate 

this respondent’s comment and 

suggestion. The Pharmacy and 

Therapeutics Committee has a mandate 

to review and recommend drugs based 

on their clinical and cost effectiveness. 

After this formal process, these 

recommendations will then go to the 

TMA Director, who will make the final 

decision. At this point, we do not know 

which of the smoking cessation 

medications will, or will not be on the 

formulary. 

Another comment requested that 

TRICARE providers be made aware of 

the available cessation benefits and be 

trained in smoking cessation 

counseling. We appreciate the 

respondent’s comments and suggestions 

and want to assure this respondent that 

once the final rule is published and this 

becomes a TRICARE benefit, 

information concerning it will be well 

publicized. This publicity will include 

information for TRICARE providers and 

our beneficiaries. Information 

concerning this new benefit will also be 

available on the TRICARE Web site 

(www.TRICARE.mil), which is 

accessible to beneficiaries, providers 

and the general public. In addition, the 

Managed Care Support Contractors are 

required to disseminate information to 

providers affected by implementation of 

new TRICARE benefits. 

Another comment recommended an 

expansion of the TRICARE smoking 

cessation program to include a 

reduction of tobacco advertising in 

military literature and increasing the 

cost of tobacco products on military 

bases. We appreciate this respondent’s 

comment and suggestions; however, the 

authority to take the actions suggested is 

beyond the scope of the requirements of 

the law that TRICARE was tasked to 

implement. 

Unrelated to the Proposed Rule on 

Smoking Cessation, one comment was 

received from a retiree who was upset 

that he might be forced to pay more for 

TRICARE Prime as a part of DoD 

cutbacks. We appreciate this 

respondent’s comments; however, we 

cannot address these here as they are 

outside the scope of the law that 

implements the TRICARE smoking 

cessation benefits. 

VI. Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ and Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review’’ 

Section 801 of title 5, United States 

Code, and Executive Orders 12866 and 

13563 require certain regulatory 

assessments and procedures for any 

major rule or significant regulatory 

action, defined as one that would result 

in an annual effect of $100 million or 

more on the national economy or which 

would have other substantial impacts. 

This final rule is not a significant 

regulatory action. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (RFA) (5 U.S.C. 601) 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (RFA) (5 U.S.C. 601), 

requires that each Federal agency 

prepare a regulatory flexibility analysis 

when the agency issues a regulation 

which would have a significant impact 

on a substantial number of small 

entities. This final rule will not have a 

significant impact on a substantial 

number of small entities. Therefore, this 

final rule is not subject to the 

requirements of the RFA. 

Public Law 96–511, ‘‘Paperwork 

Reduction Act’’ (44 U.S.C. Chapter 35) 

This rule does not contain a 

‘‘collection of information’’ 

requirement, and will not impose 

additional information collection 

requirements on the public under Public 

Law 96–511, ‘‘Paperwork Reduction 

Act’’ (44 U.S.C. Chapter 35). 

Public Law 104–4, Section 202, 

‘‘Unfunded Mandates Reform Act’’ 

Section 202 of Public Law 104–4, 

‘‘Unfunded Mandates Reform Act,’’ 

requires that an analysis be performed 

to determine whether any federal 

mandate may result in the expenditure 

by State, local and tribal governments, 

in the aggregate, or by the private sector 

of $100 million in any one year. This 

final rule does not contain a Federal 

mandate that may result in the 

expenditure by State, local and tribal 

governments, in aggregate, or by the 

private sector, of $100 million or more 

in any one year, and thus this final rule 

is not subject to this requirement. 

Executive Order 13132, ‘‘Federalism’’ 

Executive Order 13132, ‘‘Federalism,’’ 

requires that an impact analysis be 

performed to determine whether the 

rule has federalism implications that 

would have substantial direct effects on 

the States, on the relationship between 

the national government and the States, 


erowe on DSK2VPTVN1PROD with RULES
13240 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 

or on the distribution of power and 

responsibilities among the various 

levels of government. This final rule 

does not have federalism implications, 

as set forth in Executive Order 13132. 

List of Subjects in 32 CFR Part 199 

Claims, Dental health, Health care, 

Health insurance, Individuals with 

disabilities, 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 199.4 is amended by: 

■ a. Revising paragraph (d)(3)(vi) 

introductory text. 

■ b. Adding new paragraph (d)(3)(vi)(C). 

■ c. Adding new paragraph (e)(30). 

■ d. Revising paragraph (g)(39). 

■ e. Removing and reserving paragraph 

(g)(65). 

The revisions and additions read as 

follows: 

§ 199.4 Basic program benefits. 

* * * * * 

(d) * * * 

(3) * * * 

(vi) Drugs and medicines. Drugs and 

medicines that by United States law 

require a prescription are also referred 

to as ‘‘legend drugs.’’ Legend drugs are 

covered when prescribed by a physician 

or other authorized individual 

professional provider acting within the 

scope of the provider’s license and 

ordered or prescribed in connection 

with an otherwise covered condition or 

treatment, and not otherwise excluded 

by TRICARE. This includes Rh immune 

globulin. 

* * * * * 

(C) Over-the-counter (OTC) drugs 

(drugs that by United States law do not 

require a prescription), in general, are 

not covered. However, insulin is 

covered for a known diabetic even in 

states that do not require a prescription 

for its purchase. In addition, OTC drugs 

used for smoking cessation are covered 

when all requirements under the 

TRICARE smoking cessation program 

are met as provided in paragraph (e)(30) 

of this section. 

* * * * * 

(e) * * * 

(30) Smoking cessation program. The 

TRICARE smoking cessation program is 

a behavioral modification program to 

assist eligible beneficiaries who desire 

to quit smoking. The program consists 

of a pharmaceutical benefit; smoking 

cessation counseling; access to a tollfree quit line for non-medical assistance; 

and, access to print and internet webbased tobacco cessation materials. 

(i) Availability. The TRICARE 

smoking cessation program is available 

to all TRICARE beneficiaries who reside 

in one of the 50 United States or the 

District of Columbia who are not eligible 

for Medicare benefits authorized under 

Title XVIII of the Social Security Act. In 

addition, pursuant to § 199.17, if 

authorized by the Assistant Secretary of 

Defense (Health Affairs), the TRICARE 

smoking cessation program may be 

implemented in whole or in part in 

areas outside the 50 states and the 

District of Columbia for active duty 

members and their dependents who are 

enrolled in TRICARE Prime (overseas 

Prime beneficiaries). In such cases, the 

Assistant Secretary of Defense (Health 

Affairs) may also authorize 

modifications to the TRICARE smoking 

cessation program rules and procedures 

as may be appropriate to the overseas 

area involved. Notice of the use of this 

authority, not otherwise mentioned in 

this paragraph (e)(30), shall be 

published in the Federal Register. 

(ii) Benefits. There is no requirement 

for an eligible beneficiary to be 

diagnosed with a smoking related 

illness to access benefits under this 

program. The specific benefits available 

under the TRICARE smoking cessation 

program are: 

(A) Pharmaceutical agents. Products 

available under this program are 

identified through the DoD Pharmacy 

and Therapeutics Committee, consistent 

with the DoD Uniform Formulary in 

§ 199.21. Smoking cessation 

pharmaceutical agents, including FDAapproved over-the-counter (OTC) 

pharmaceutical agents, are available 

through the TRICARE Mail Order 

Pharmacy (TMOP) or the MTF at no cost 

to the beneficiary. Smoking cessation 

pharmaceuticals through the TRICARE 

program will not be available at any 

retail pharmacies. A prescription from a 

TRICARE-authorized provider is 

required to obtain any pharmaceutical 

agent used for smoking cessation, 

including OTC agents. For overseas 

Prime beneficiaries, pharmaceutical 

agents may be provided either in the 

MTF or through the TMOP where such 

facility or service is available. 

(B) Face-to-face smoking cessation 

counseling. Both individual and group 

smoking cessation counseling are 

covered. The number and mix of faceto-face counseling sessions covered 

under this program shall be determined 

by the Director, TMA; however, shall 

not exceed the limits established in 

paragraph (e)(30)(iii) of this section. A 

TRICARE-authorized provider listed in 

§ 199.6 must render all counseling 

sessions. 

(C) Toll-free quit line. Access to a nonmedical toll-free quit line 7 days a week, 

24 hours a day will be available. The 

quit line will be staffed with smoking 

cessation counselors trained to assess a 

beneficiary’s readiness to quit, identify 

barriers to quitting, and provide specific 

suggested actions and motivational 

counseling to enhance the chances of a 

successful quit attempt. When 

appropriate, quit line counselors will 

refer beneficiaries to a TRICAREauthorized provider for medical 

intervention. The quit line may, at the 

discretion of the Director, TMA, include 

the opportunity for the beneficiary to 

request individual follow-up contact 

initiated by quit line personnel; 

however, the beneficiary is not required 

to participate in the quit line initiated 

follow-up. Printed educational materials 

on the effects of tobacco use will be 

provided to the beneficiary upon 

request. This benefit may be made 

available to overseas Prime beneficiaries 

should the ASD(HA) exercise his 

authority to do so and provide 

appropriate notice in the Federal 

Register. 

(D) Web-based resources. 

Downloadable educational materials on 

the effects of tobacco use will be 

available through the internet or other 

electronic media. This service may be 

made available to overseas Prime 

beneficiaries in all locations where web 

based resources are available. There 

shall be no requirement to create web 

based resources in any geographic area 

in order to make this service available. 

(iii) Limitations of smoking cessation 

program. Eligible beneficiaries are 

entitled to two quit attempts per year 

(consecutive 12 month period). A third 

quit attempt may be covered per year 

with physician justification and preauthorization. A quit attempt is defined 

as up to eighteen face-to-face counseling 

sessions over a 120 consecutive day 

period and/or 120 days of 

pharmacologic intervention for the 

purpose of smoking cessation. 

Counseling and pharmacological 

treatment periods that overlap by at 

least 60-days are considered a single 

quit attempt. 

* * * * * 

(g) * * * 

(39) Counseling. Educational, 

vocational, and nutritional counseling 

and counseling for socioeconomic 

purposes, stress management, and/or 

lifestyle modification purposes, except 

that the following are not excluded: 

(i) Services provided by a certified 

marriage and family therapist, pastoral 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 13241 

or mental health counselor in the 

treatment of a mental disorder as 

specifically provided in paragraph 

(c)(3)(ix) of this section and in § 199.6. 

(ii) Diabetes self-management training 

(DSMT) as specifically provided in 

paragraph (d)(3)(ix) of this section. 

(iii) Smoking cessation counseling 

and education as specifically provided 

in paragraph (e)(30) of this section. 

(iv) Services provided by alcoholism 

rehabilitation counselors only when 

rendered in a CHAMPUS-authorized 

treatment setting and only when the 

cost of those services is included in the 

facility’s CHAMPUS-determined 

allowable cost rate. 

* * * * * 

(65) [Reserved] 

* * * * * 

■ 3. Section 199.21 is amended by: 

■ a. Revising paragraph (a)(2); 

■ b. Revising paragraph (h)(2)(i); 

■ c. Adding a new paragraph (h)(2)(iii); 

and 

■ d. Adding a new (i)(2)(v)(D). 

The additions and revisions read as 

follows: 

§ 199.21 Pharmacy benefits program. 

(a) * * * 

(2) Pharmacy benefits program. (i) 

Applicability. The pharmacy benefits 

program, which includes the uniform 

formulary and its associated tiered copayment structure, is applicable to all of 

the uniformed services. Geographically, 

except as specifically provided in 

paragraph (a)(2)(ii) of this section, this 

program is applicable to all 50 states 

and the District of Columbia, Guam, 

Puerto Rico, and the Virgin Islands. In 

addition, if authorized by the Assistant 

Secretary of Defense (Health Affairs) 

(ASD(HA)), the TRICARE pharmacy 

benefits program may be implemented 

in areas outside the 50 states and the 

District of Columbia, Guam, Puerto 

Rico, and the Virgin Islands. In such 

case, the ASD (HA) may also authorize 

modifications to the pharmacy benefits 

program rules and procedures as may be 

appropriate to the area involved. 

(ii) Applicability exception. The 

pharmaceutical benefit under the 

TRICARE smoking cessation program 

under § 199.4(e)(30) is available to 

TRICARE beneficiaries who are not 

entitled to Medicare benefits authorized 

under Title XVIII of the Social Security 

Act. Except as noted in § 199.4(e)(30), 

the smoking cessation program, 

including the pharmaceutical benefit, is 

not applicable or available to 

beneficiaries who reside overseas, 

including the U. S. territories of Guam, 

Puerto Rico, and the Virgin Islands, 

except that under the authority of 

§ 199.17 active duty service members 

and active duty dependents enrolled in 

TRICARE Prime residing overseas, 

including the U. S. territories of Guam, 

Puerto Rico, and the Virgin Islands, 

shall have access to smoking cessation 

pharmaceuticals through either an MTF 

or the TMOP program where available. 

* * * * * 

(h) * * * 

(2) Availability of formulary 

pharmaceutical agents. (i) General. 

Subject to paragraphs (h)(2)(ii) and 

(h)(2)(iii) of this section, formulary 

pharmaceutical agents are available 

under the Pharmacy Benefits Program 

from all points of service identified in 

paragraph (h)(1) of this section. 

* * * * * 

(iii) Pharmaceutical agents prescribed 

for smoking cessation are not available 

for coverage when obtained through a 

retail pharmacy. This includes network 

and non-network retail pharmacies. 

* * * * * 

(i) * * * 

(2) * * * 

(v) * * * 

(D) $0.00 co-payment for smoking 

cessation pharmaceutical agents covered 

under the smoking cessation program. 

* * * * * 

Dated: February 1, 2013. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2013–03417 Filed 2–26–13; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2012–1065] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Sabine River, Near Ruliff, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is removing 

the existing drawbridge operation 

regulation for the Kansas City Southern 

(KCS) Railroad drawbridge across 

Sabine River, mile 36.2, between 

Newton County, TX and Calcasieu 

Parish, LA. The drawbridge was 

converted to a fixed bridge in 2012 and 

the operating regulation is no longer 

applicable or necessary. 

DATES: This rule is effective February 

27, 2013. 

ADDRESSES: Documents mentioned in 

this preamble are part of docket USCG– 

2012–1065. To view documents 

mentioned in this preamble as being 

available in the docket, go to http:// 

www.regulations.gov, type the docket 

number in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rulemaking. You may also visit the 

Docket Management Facility in Room 

W12–140 on the ground floor of the 

Department of Transportation West 

Building, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Mr. Jim Wetherington, Bridge 

Administration Branch, Coast Guard; 

telephone 504–671–2128, email 

james.r.wetherington@uscg.mil. If you 

have questions on viewing the docket, 

call Barbara Hairston, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

A. Regulatory History and Information 

The Coast Guard is issuing this final 

rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

Kansas City Southern Railroad Bridge 

over the Sabine River, mile 36.2, that 

once required draw operations in 33 

CFR 117.493(b), was converted to a 

fixed bridge in 2012. Therefore, the 

regulation is no longer applicable and 

shall be removed from publication. It is 

unnecessary to publish an NPRM 

because this regulatory action does not 

purport to place any restrictions on 

mariners but rather removes a 

restriction that has no further use or 

value. 

Under 5 U.S.C. 553(d)(1), a rule that 

relieves a restriction is not required to 

provide the 30 day notice period before 

its effective date. This rule removes the 

Kansas City Southern (KCS) Railroad 

Bridge over the Sabine River, mile 36.2, 

draw operation requirements under 33 

CFR 117. 493(b), thus removing a 

regulatory restriction on the public. 


erowe on DSK2VPTVN1PROD with RULES