[Federal Register Volume 74, Number 236 (Thursday, December 10, 2009)]
[Rules and Regulations]
[Pages 65436-65438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29432]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[DoD-2009-HA-0151; 0720-AB37]

32 CFR Part 199


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: Interim final rule.

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SUMMARY: This interim final rule allows a TRICARE retail network 
pharmacy to be an authorized provider for the administration of three 
TRICARE-covered vaccines in the retail pharmacy setting. The three 
immunizations are H1N1 vaccine, seasonal influenza vaccine, and 
pneumococcal vaccine. In addition, this interim final rule solicits 
public comment on also including other TRICARE-covered immunizations in 
the future for which retail network pharmacies will be authorized 
providers. As part of DoD preparations for a possible public health 
emergency involving H1N1 influenza this fall and winter, this is being 
issued as an interim final rule.

DATES: This interim final rule is effective December 10, 2009. Written

[[Page 65437]]

comments received at the address indicated below by February 8, 2010 
will be considered and addressed in the final rule.

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

FOR FURTHER INFORMATION CONTACT: LtCol Thomas Bacon, TRICARE Management 
Activity, telephone (703) 681-2890.

SUPPLEMENTARY INFORMATION:

A. Background

    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. State Boards of 
Pharmacy are responsible for the training, oversight, and stipulating 
the conditions under which a pharmacist may administer a vaccine.
    The 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. 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. Currently, TRICARE beneficiaries who 
receive a vaccine administered by a pharmacist cannot be reimbursed for 
any out-of-pocket expenses. 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 influenza, such as is threatened this fall and winter by a 
novel H1N1 virus strain. In view of potential shortages of H1N1 flu 
vaccine, military treatment facilities may not have sufficient vaccine 
for all high risk categories of beneficiaries, necessitating reliance 
on non-DoD sources of vaccine. Ensuring that TRICARE beneficiaries have 
ready access to vaccine supplies allocated to private sector pharmacies 
will facilitate making vaccine appropriately available to high risk 
groups of TRICARE beneficiaries.

B. Provisions of Rule

    The 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 vaccines and immunizations to eligible 
beneficiaries as covered TRICARE pharmacy benefits. Under this interim 
final rule, this authorization applies immediately to three 
immunizations. The three immunizations are H1N1 vaccine, seasonal 
influenza vaccine, and pneumococcal vaccine. In addition, this interim 
final rule solicits public comment on the option of expanding this 
authorization in a final rule to also include all other TRICARE-covered 
immunizations.

C. Regulatory Procedures

Interim Final Rule

    This is being issued as an interim final rule as part of DoD 
preparations for a potential public health emergency this fall and 
winter involving the H1N1 influenza virus. The normal practice of 
soliciting public comment before making a change to the regulation 
would in this case be contrary to the public interest because there is 
insufficient time to do so in anticipation for a potential public 
health emergency this fall and winter associated with a possible 
reemergence of a more virulent strain of H1N1 influenza virus. Thus, 
this rule will be effective from the date of publication. However, 
public comments are still invited and all such comments will be 
considered in the issuance of a final rule, expected later this year or 
early next.

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

    Executive Order 12866 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 interim 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.

Sec. 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 rule has no new information collection requirements.

[[Page 65438]]

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.

0
Accordingly, 32 CFR part 199 is amended as follows:

PART 199--[AMENDED]

0
1. The authority citation for part 199 continues to read as follows:

    Authority: 5 U.S.C. 301; 10 U.S.C., Chapter 55.


0
2. Section 199.6 is amended by revising paragraph (d)(3) to read as 
follows:


Sec.  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 Sec.  199.21 of this Part 
implementing the Pharmacy Benefits Program.
* * * * *

0
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:


Sec.  199.21  Pharmacy benefits program.

* * * * *
    (h) Obtaining pharmacy services under the retail network pharmacy 
benefits program. * * *
    (4) Availability of vaccines/immunizations. This paragraph (h)(4) 
applies to the following three immunizations: H1N1 vaccine, seasonal 
influenza vaccine, and pneumococcal vaccine. 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 vaccines/
immunizations authorized as preventive care under the basic program 
benefits of Sec.  199.4 of this Part, as well as such care authorized 
for Prime enrollees under the uniform HMO benefit of section 199.18. 
For Prime enrollees under the uniform HMO benefit, a referral is not 
required under paragraph (n)(2) of Sec.  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, or designee.
    (i) * * *
    (2) * * *
    (ii) * * *
    (D) $0.00 co-payment for vaccines/immunizations authorized as 
preventive care for eligible beneficiaries.
* * * * *

    Dated: December 3, 2009.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. E9-29432 Filed 12-9-09; 8:45 am]
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