[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Rules and Regulations]
[Pages 41063-41065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17516]


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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.

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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

[[Page 41064]]

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-of-
pocket 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 co-payment 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 TRICARE-
covered 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

[[Page 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]

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. 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 Sec.  199.4 of this part, as well as such care 
authorized for Prime enrollees under the uniform HMO benefit of Sec.  
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.
    (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]
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