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, 65436-65438 [E9-29432]

Download as PDF 65436 Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Rules and Regulations the performance of a radiochemical identity/purity test or prevents the determination of the product’s specific activity. (3) You may not release another batch of the PET drug product until you have corrected the problem concerning the malfunction of analytical equipment and completed the omitted finishedproduct test. § 212.71 What actions must I take if a batch of PET drug product does not conform to specifications? (a) Rejection of nonconforming product. You must reject a batch of a PET drug product that does not conform to specifications. You must have and follow procedures to identify and segregate the product to avoid mix-ups. You must have and follow procedures to investigate the cause(s) of the nonconforming product. The investigation must include, but is not limited to, examination of processes, operations, records, complaints, and any other relevant sources of information concerning the nonconforming product. (b) Investigation. You must document the investigation of a PET drug product that does not meet specifications, including the results of the investigation and what happened to the rejected PET drug product. (c) Correction of problems. You must take action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem. (d) Reprocessing. If appropriate, you may reprocess a batch of a PET drug product that does not conform to specifications. If material that does not meet acceptance criteria is reprocessed, you must follow procedures stated in the product’s approved application and the finished product must conform to specifications, except for sterility, before final release. Subpart I—Packaging and Labeling mstockstill on DSKH9S0YB1PROD with RULES § 212.80 What are the requirements associated with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and packaged to protect the product from alteration, contamination, and damage during the established conditions of shipping, distribution, handling, and use. (b) Labels must be legible and applied so as to remain legible and affixed during the established conditions of processing, storage, handling, distribution, and use. (c) All information stated on each label must also be contained in each batch production record. VerDate Nov<24>2008 16:49 Dec 09, 2009 Jkt 220001 (d) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups. Subpart J—Distribution § 212.90 What actions must I take to control the distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET drug production facility to ensure that the method of shipping chosen will not adversely affect the identity, purity, or quality of the PET drug product. (b) Distribution records. You must maintain distribution records for each PET drug product that include or refer to the following: (1) The name, address, and telephone number of the receiving facility that received each batch of a PET drug product; (2) The name and quantity of the PET drug product shipped; (3) The lot number, control number, or batch number for the PET drug product shipped; and (4) The date and time you shipped the PET drug product. Subpart K—Complaint Handling § 212.100 What do I do if I receive a complaint about a PET drug product produced at my facility? (a) Written complaint procedures. You must develop and follow written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product. (b) Complaint review. The procedures must include review by a designated person of any complaint involving the possible failure of a PET drug product to meet any of its specifications and an investigation to determine the cause of the failure. (c) Complaint records. A written record of each complaint must be maintained in a file designated for PET drug product complaints. The record must include the name and strength of the PET drug product, the batch number, the name of the complainant, the date the complaint was received, the nature of the complaint, and the response to the complaint. It must also include the findings of any investigation and followup. (d) Returned products. A PET drug product that is returned because of a complaint or for any other reason may not be reprocessed and must be destroyed in accordance with applicable Federal and State law. PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 Subpart L—Records § 212.110 How must I maintain records of my production of PET drugs? (a) Record availability. Records must be maintained at the PET drug production facility or another location that is reasonably accessible to responsible officials of the production facility and to employees of FDA designated to perform inspections. (b) Record quality. All records, including those not stored at the inspected establishment, must be legible, stored to prevent deterioration or loss, and readily available for review and copying by FDA employees. (c) Record retention period. You must maintain all records and documentation referenced in this part for a period of at least 1 year from the date of final release, including conditional final release, of a PET drug product. Dated: December 3, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–29285 Filed 12–9–09; 8:45 am] BILLING CODE 4160–01–S 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. SUMMARY: This interim final rule allows a TRICARE retail network pharmacy to be an authorized provider for the administration of three TRICAREcovered 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 E:\FR\FM\10DER1.SGM 10DER1 Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Rules and Regulations mstockstill on DSKH9S0YB1PROD with RULES 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 VerDate Nov<24>2008 16:49 Dec 09, 2009 Jkt 220001 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-ofpocket 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 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 65437 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. E:\FR\FM\10DER1.SGM 10DER1 65438 Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Rules and Regulations 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. * 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 § 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 § 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. * * * * * * * * * (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: 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] § 199.21 Coast Guard, DHS. Notice of enforcement of regulation. DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2009–1014] RIN 1625–AA00 Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, IL Pharmacy benefits program. * mstockstill on DSKH9S0YB1PROD with RULES BILLING CODE 5001–06–P * * * * (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 VerDate Nov<24>2008 16:58 Dec 09, 2009 Jkt 220001 AGENCY: ACTION: SUMMARY: The Coast Guard will enforce the Navy Pier Southeast Safety Zone in Chicago Harbor from December 4, 2009, through January 1, 2010. This action is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after fireworks events. This rule will establish restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after fireworks events. During the enforcement period, no person or vessel may enter the safety zones without permission of the Captain of the Port Lake Michigan. PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 DATES: The regulations in 33 CFR 165.931 will be enforced on December 4, 2009, from 7 p.m. through 7:30 p.m.; on December 31, 2009, from 8 p.m. through 8:30 p.m.; on December 31, 2009, from 11:45 p.m. through 12:30 a.m. on January 1, 2010. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call or email BM1 Adam Kraft, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at 414–747– 7154, e-mail Adam.D.Kraft@uscg.mil. The Coast Guard will enforce the Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, IL, in 33 CFR 165.931, for the following events: (1) Navy Pier Fireworks: on December 4, 2009, from 7 p.m. through 7:30 p.m.; on December 31, 2009, from 8 p.m. through 8:30 p.m.; on December 31, 2009, from 11:45 p.m. through 12:30 a.m. on January 1, 2010. All vessels must obtain permission from the Captain of the Port or a designated representative to enter, move within, or exit the safety zone. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port or a designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course. This notice is issued under authority of 33 CFR 165.931, Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, IL and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of these enforcement periods via broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port will issue a Broadcast Notice to Mariners notifying the public when enforcement of the safety zone established by this section is suspended. If the Captain of the Port determines that the safety zone need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the safety zone. The Captain of the Port or their on-scene representative may be contacted via VHF–FM Channel 16. SUPPLEMENTARY INFORMATION: Dated: November 30, 2009. L. Barndt, Captain, U.S. Coast Guard, Captain of the Port Lake Michigan. [FR Doc. E9–29416 Filed 12–9–09; 8:45 am] BILLING CODE 9110–04–P E:\FR\FM\10DER1.SGM 10DER1

Agencies

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


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 5001-06-P