Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations 41063 

§ 240.19b–4 Filings with respect to 

proposed rule changes by self-regulatory 

organizations. 

* * * * * 

(f) * * * 

(4) * * * 

(ii)(A) Primarily affects the futures 

clearing operations of the clearing 

agency with respect to futures that are 

not security futures; and 

(B) Does not significantly affect any 

securities clearing operations of the 

clearing agency or any related rights or 

obligations of the clearing agency or 

persons using such service; 

* * * * * 

PART 249—FORMS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 4. The general authority citation for 

part 249 continues to read in part as 

follows: 

Authority: 15 U.S.C. 78a et seq. and 7201 

et seq.; and 18 U.S.C. 1350, unless otherwise 

noted. 

* * * * * 

■ 5. Amend Form 19b–4 (referenced in 

§ 249.819) by: 

■ a. Amending paragraph (b)(iv) in Item 

7 of the General Instructions 

(Information to be Included in the 

Completed Form (‘‘Form 19b–4 

Information’’)) as follows: 

Note: The text of Form 19b–4 does not, and 

the amendments will not, appear in the Code 

of Federal Regulations. 

Form 19b–4 

* * * * * 

GENERAL INSTRUCTIONS FOR 

FORM 19b–4 

* * * * * 

Information to be Included in the 

Completed Form (‘‘Form 19b–4 

Information’’) 

* * * * * 

7. Basis for Summary Effectiveness 

Pursuant to Section 19(b)(3) or for 

Accelerated Effectiveness Pursuant to 

Section 19(b)(2) or Section 19(b)(7)(D) 

* * * * * 

(b) * * * 

(iv) effects a change in an existing 

service of a registered clearing agency 

that either (A)(1) does not adversely 

affect the safeguarding of securities or 

funds in the custody or control of the 

clearing agency or for which it is 

responsible and (2) does not 

significantly affect the respective rights 

or obligations of the clearing agency or 

persons using the service or (B)(1) 

primarily affects the futures clearing 

operations of the clearing agency with 

respect to futures that are not security 

futures and (2) does not significantly 

affect any securities clearing operations 

of the clearing agency or any related 

rights or obligations of the clearing 

agency or persons using such service, 

and set forth the basis on which such 

designation is made, 

* * * * * 

Dated: July 7, 2011. 

By the Commission. 

Cathy H. Ahn, 

Deputy Secretary. 

[FR Doc. 2011–17524 Filed 7–12–11; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DoD–2009–HA–0151; 0720–AB37] 

Civilian Health and Medical Program of 

the Uniformed Services (CHAMPUS)/ 

TRICARE: Inclusion of Retail Network 

Pharmacies as Authorized TRICARE 

Providers for the Administration of 

TRICARE Covered Vaccines 

AGENCY: Office of the Secretary, 

Department of Defense (DoD). 

ACTION: Final rule. 

SUMMARY: This final rule allows a 

TRICARE retail network pharmacy to be 

an authorized provider for the 

administration of TRICARE-covered 

vaccines in the retail pharmacy setting. 

The value of vaccines lies in the 

prevention of disease and reduced 

healthcare costs in the long term. When 

vaccines are made more readily 

accessible, a broader section of the 

population will receive them. 

DATES: Effective Date: This final rule is 

effective August 12, 2011. 

FOR FURTHER INFORMATION CONTACT: 

RADM Thomas McGinnis, TRICARE 

Management Activity, telephone (703) 

681–2890. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The value of vaccines lies in the 

prevention of disease and reduced 

healthcare costs in the long term. 

Vaccines are highly effective in 

preventing death and disability, and 

save billions of dollars in health costs 

annually. When vaccines are made more 

readily accessible, a broader section of 

the population will receive them. In the 

last 5 years, registered pharmacists have 

played an increasing role in providing 

clinical services through the retail 

pharmacy venue. In 50 states, registered 

pharmacists are authorized to 

administer vaccines in a retail pharmacy 

setting, vastly increasing the 

accessibility of many vaccines. State 

Boards of Pharmacy are responsible for 

the training, oversight, and stipulating 

the conditions under which a 

pharmacist may administer a vaccine. 

The Department of Defense (DoD) 

regulation implementing the TRICARE 

Pharmacy Benefit Program was written 

prior to this recent development. 

Therefore, although vaccines are 

covered under the TRICARE medical 

benefit, if administered by a pharmacist 

in a pharmacy the service is not 

currently covered by TRICARE except as 

provided for by the interim final rule 

published December 10, 2009 at 74 FR 

65436. Inclusion of vaccines under the 

pharmacy benefit when provided by a 

TRICARE retail network pharmacy in 

accordance with state law, including 

when administered by a registered 

pharmacist, is the purpose of this 

regulation. 

TRICARE recognizes that registered 

pharmacists are increasingly providing 

vaccine administration services in retail 

pharmacies. Although vaccines are a 

covered TRICARE medical benefit, 

when administered by a pharmacist 

claims cannot be adjudicated because 

vaccines are not covered under the 

pharmacy benefit and pharmacies are 

not recognized by regulation as 

authorized providers for the 

administration of vaccines except as 

provided for by the interim final rule. 

Currently, TRICARE beneficiaries who 

receive a vaccine administered by a 

pharmacist cannot be reimbursed for 

any out-of-pocket expenses except as 

provided for by the interim final rule. 

TRICARE would like to include 

vaccines under the pharmacy benefit 

when provided by a TRICARE retail 

network pharmacy when functioning 

within the scope of their state laws, 

including when administered by a 

registered pharmacist, to enable claims 

processing and reimbursement for 

services. 

Adding immunizations to the 

pharmacy benefits program is an 

important public health initiative for 

TRICARE, making immunizations more 

readily available to beneficiaries. It is 

especially important as part of the 

Nation’s public health preparations for 

a potential pandemic, such as was 

threatened last fall and winter by a 

novel H1N1 virus strain. Ensuring that 

TRICARE beneficiaries have ready 

access to vaccine supplies allocated to 

private sector pharmacies will facilitate 

making vaccines appropriately available 

to high risk groups of TRICARE 

mstockstill on DSK4VPTVN1PROD with RULES

41064 Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations 

beneficiaries. The vaccines to be made 

available at network pharmacies under 

this final rule are those authorized as 

preventive care under the TRICARE 

basic program benefits at 32 CFR 199.4 

and those authorized for Prime enrollees 

at 32 CFR 199.18, i.e., immunizations 

for individuals age six and older, as 

recommended by the Centers for Disease 

Control and Prevention (CDC), and 

immunizations provided when required 

in the case of dependents of active duty 

military personnel who are traveling 

outside the United States as a result of 

an active duty member’s assignment and 

such travel is being performed under 

orders issued by a Uniformed Service. 

Immunizations included will be those 

recommended by the CDC and 

published in the Morbidity and 

Mortality Weekly Report (MMWR). To 

find information on recommended 

vaccinations, TRICARE will refer 

beneficiaries to http://www.cdc.gov/ 

vaccines or http://www.tricare.mil/ 

pharmacy. TRICARE will also 

encourage beneficiaries to speak with 

their doctor or pharmacist about which 

vaccinations may be appropriate for 

them. 

An Independent Government Cost 

Estimate (IGCE) shows an additional 

cost to the Defense Health Program 

(DHP) of approximately $4M annually. 

This cost is primarily driven from 

beneficiaries who were not receiving the 

vaccines previously, or from 

beneficiaries who were paying out-ofpocket to get the vaccines. For the first 

six months following publication of the 

interim final rule, 18,361 vaccines were 

administered under the pharmacy 

benefits program at a cost of 

$298,513.19. Had those vaccines been 

administered under the medical benefit, 

the cost to TRICARE would have been 

$1.8M. These savings come both from 

the lower cost of the vaccines procured 

under the pharmacy benefits program 

rather than under the medical benefit 

which uses the Medicare payment 

allowance and a shift from the overall 

higher costs of obtaining a vaccine 

through a physician office visit. 

Expanding the number of vaccines 

available under the pharmacy benefits 

program from the three listed in the 

original interim final rule (seasonal 

influenza, H1N1 vaccine and 

pneumococcal vaccine) to all of those 

covered under the DoD’s preventive care 

program, will result in increased savings 

over the cost of administering those 

vaccines under the medical benefit. In 

addition to the lower vaccine costs and 

costs of administration through the 

pharmacy benefits program, there is an 

anticipated cost savings which will 

result from not having to treat 

beneficiaries who, due to a higher 

expected vaccination rate, will not 

develop the illnesses for which the 

vaccines were administered. For 

example an IGCE showed DHP savings 

of over $600,000 annually in medical 

costs that would have been incurred in 

treating beneficiaries for influenza but 

were not because increased availability 

of the flu vaccine led to more 

beneficiaries being vaccinated. 

Although the DoD is normally 

required to follow the same 

reimbursement methodologies as 

Medicare, there is an exception allowed 

when it is not practicable to do so. In 

calculating the administration fee for 

injecting these vaccines, the Department 

has determined that it is not practicable 

to follow Medicare. Medicare Part B 

preventive services vaccinations are 

limited to invasive pneumococcal 

disease, hepatitis B, and influenza. 

Medicare’s administration fee schedules 

are adjusted for each Medicare payment 

locality. Therefore, there is a variation 

in the Medicare administration payment 

amount nationwide. The TRICARE 

pharmacy benefits program will provide 

many more vaccines than those 

available under Medicare Part B, and 

the Medicare rates vary by its various 

regions and the contractors who 

administer the programs in those 

regions. However, TRICARE has only 

one network retail pharmacy manager 

and to require the one network 

administrator to have various rates for 

the small number of drugs covered by 

Medicare is neither administratively 

feasible nor cost effective. To analyze 

administrative costs of the program, an 

IGCE compared the Medicare 

administration fee for the vaccines 

covered under Medicare Part B to the 

nationwide administration fees 

negotiated by the TRICARE pharmacy 

benefits manager. The results of the 

IGCE show the rates available to 

TRICARE will be lower than the rates 

reimbursed by Medicare. 

B. Provisions of the Interim Final Rule 

The interim final rule amended 

sections 199.6 and 199.21 of the 

TRICARE regulation to authorize retail 

network pharmacies when functioning 

under the scope of their state laws to 

provide vaccines and immunizations to 

eligible beneficiaries as covered 

TRICARE pharmacy benefits. Under the 

interim final rule, this authorization 

applied immediately to three 

immunizations. The three 

immunizations are H1N1 vaccine, 

seasonal influenza vaccine, and 

pneumococcal vaccine. In addition, the 

interim final rule solicited public 

comment on also including other 

TRICARE-covered immunizations in the 

future for which retail network 

pharmacies will be authorized 

providers. 

C. Public Comments 

The interim final rule, published in 

the Federal Register December 10, 2009, 

provided for a 60-day comment period. 

DoD received seven public comments: 

four comments from DoD beneficiaries; 

two comments from professional 

pharmacy associations; and, one 

comment from a retail pharmacy chain. 

Comments are discussed below. 

1. DoD Beneficiary Comments (4 Total) 

a. Co-Payments 

Comments: Two beneficiary 

comments were in favor of making 

vaccines available in retail pharmacies 

and asked if there would be a co-pay. 

Response: The final rule makes no 

change to the interim final rule 

provision that there will be $0.00 copayment for vaccines/immunizations 

authorized as preventive care for 

eligible beneficiaries. 

b. Expand To Include Other Vaccines 

Comments: Two beneficiary 

comments were in favor of making 

vaccine available in retail pharmacies 

and suggested expanding the program to 

include other vaccines. 

Response: The final rule authorizes 

retail network pharmacies when 

functioning under the scope of their 

state laws to provide all TRICAREcovered vaccines and immunizations. 

2. Professional Pharmacy Associations 

(2) 

Comments: Both associations highly 

support and applaud DoD in 

recognizing that services provided by 

pharmacists are essential in meeting the 

healthcare needs of all communities, 

especially those of TRICARE 

beneficiaries. Both associations were 

favorable to expanding the role of 

pharmacists, including as a community 

point of service for vaccine 

administration. Both agree that this rule 

brings the DoD pharmacy program in 

line with other insurers that have 

covered pharmacy/pharmacist 

administered vaccinations for years. 

Response: DoD agrees. 

3. Retail Pharmacy Chain (1) 

Comment: A retail chain with 211 

pharmacies in the state of Texas stated 

that over 70% of its pharmacists are 

active immunizers and have been 

actively providing this service for over 

10 years. The chain strongly supports 

the expansion of the program to include 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations 41065 

other vaccines and commends the 

Department for waiving cost shares. 

Response: DoD agrees. 

D. Provisions of Final Rule 

The final rule amends sections 199.6 

and 199.21 of the TRICARE regulation 

to authorize retail network pharmacies 

when functioning under the scope of 

their state laws to provide TRICARE 

authorized vaccines and immunizations 

to eligible beneficiaries as covered 

TRICARE pharmacy benefits. 

E. Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ and Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review’’ 

Executive Order 12866 and 13563 

requires that a comprehensive 

regulatory impact analysis be performed 

on any economically 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. The DoD has 

examined the economic and policy 

implications of this final rule and has 

concluded that it is not a significant 

regulatory action. 

Congressional Review Act, 5 U.S.C. 801, 

et seq. 

Under the Congressional Review Act, 

a major rule may not take effect until at 

least 60 days after submission to 

Congress of a report regarding the rule. 

A major rule is one that would have an 

annual effect on the economy of $100 

million or more or have certain other 

impacts. This rule is not a major rule 

under the Congressional Review Act. 

Section 202, Public Law 104–4, 

‘‘Unfunded Mandates Reform Act’’ 

This rule does not contain a Federal 

mandate that may result in the 

expenditure by State, local and tribunal 

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) 

The Regulatory Flexibility Act (RFA) 

requires that each Federal agency 

prepare and make available for public 

comment, a regulatory flexibility 

analysis when the agency issues a 

regulation which would have a 

significant impact on a substantial 

number of small entities. This rule does 

not have a significant impact on a 

substantial number of small entities. 

Public Law 96–511, ‘‘Paperwork 

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

This final rule does include 

information collection requirements that 

are subject to the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3511). The 

information collection has been 

approved with the Office of 

Management and Budget control 

number 0720–0032. 

Executive Order 13132, ‘‘Federalism’’ 

This rule does not have federalism 

implications, as set forth in Executive 

Order 13132. This rule does not have 

substantial direct effects on the States; 

the relationship between the National 

Government and the States; or the 

distribution of power and 

responsibilities among the various 

levels of Government. 

List of Subjects in 32 CFR Part 199 

Claims, Health care, Health insurance, 

Military personnel, Pharmacy benefits. 

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 199.6 is amended by 

revising paragraph (d)(3) to read as 

follows: 

§ 199.6 TRICARE—authorized providers. 

* * * * * 

(d) * * * 

(3) Pharmacies. Pharmacies must 

meet the applicable requirements of 

state law in the state in which the 

pharmacy is located. In addition to 

being subject to the policies and 

procedures for authorized providers 

established by this section, additional 

policies and procedures may be 

established for authorized pharmacies 

under § 199.21 of this part 

implementing the Pharmacy Benefits 

Program. 

* * * * * 

■ 3. Section 199.21 is amended by 

revising the heading of paragraph (h), 

and adding new paragraphs (h)(4) and 

(i)(2)(ii)(D) to read as follows: 

§ 199.21 Pharmacy benefits program. 

* * * * * 

(h) Obtaining pharmacy services 

under the retail network pharmacy 

benefits program. * * * 

(4) Availability of vaccines/ 

immunizations. A retail network 

pharmacy may be an authorized 

provider under the Pharmacy Benefits 

Program when functioning within the 

scope of its state laws to provide 

authorized vaccines/immunizations to 

an eligible beneficiary. The Pharmacy 

Benefits Program will cover the vaccine 

and its administration by the retail 

network pharmacy, including 

administration by pharmacists who 

meet the applicable requirements of 

state law to administer the vaccine. A 

TRICARE authorized vaccine/ 

immunization includes only vaccines/ 

immunizations authorized as preventive 

care under the basic program benefits of 

§ 199.4 of this part, as well as such care 

authorized for Prime enrollees under the 

uniform HMO benefit of § 199.18. For 

Prime enrollees under the uniform HMO 

benefit, a referral is not required under 

paragraph (n)(2) of § 199.18 for 

preventive care vaccines/immunizations 

received from a retail network pharmacy 

that is a TRICARE authorized provider. 

Any additional policies, instructions, 

procedures, and guidelines appropriate 

for implementation of this benefit may 

be issued by the TMA Director. 

(i) * * * 

(2) * * * 

(ii) * * * 

(D) $0.00 co-payment for vaccines/ 

immunizations authorized as preventive 

care for eligible beneficiaries. 

* * * * * 

Dated: July 5, 2011. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2011–17516 Filed 7–12–11; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

Docket No. USCG–2011–0264 

RIN 1625–AA00 

Safety Zones; Annual Events 

Requiring Safety Zones in the Captain 

of the Port Lake Michigan Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

33 CFR 165.929 Safety Zones; Annual 

Events requiring safety zones in the 

Captain of the Port Lake Michigan zone. 

This rule will amend, establish, or 

delete the rules that restrict vessels from 

portions of water areas during events 

that pose a hazard to public safety. The 

safety zones amended or established by 

mstockstill on DSK4VPTVN1PROD with RULES