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					 Overview of the Department of
Defense (DoD) Pharmacy Program




                                 1
                     Outline – Part 1

•   Cost Drivers
•   Influence of technology
•   Electronic Prescribing
•   Centricity
•   Navy telepharmacy




                                        2
                 Objectives – Part 1

• Understand the many factors that
  influence the DoD pharmacy benefit
  design and implementation
• Understand how technology will influence
  the design and delivery of the DoD
  pharmacy benefit in the future




                                             3
                        Defense Health Budget

• 2001 --- $18 Billion

• 2006 --- $38 Billion
  (8% of DoD budget today)


• 2015 --- $64 Billion (estimate)
  (12% of DoD budget)



                                                4
                        Costs Drivers:

• Benefit Expansions, including TRICARE for Life
  and TRICARE Reserve Select
• No changes in TRICARE fees since inception of
  TRICARE Senior Program in 2001
• More beneficiaries attracted to low cost,
  expanded benefits, quality of the program
• High inflation in the health care industry
• Employers provided incentives for beneficiaries
  to use TRICARE


                                                    5
                      Scope of DoD Pharmacy
                              Benefit
• 9.2 M beneficiaries
   – 6.6M users of the pharmacy benefit
• 115M prescriptions dispensed in FY06
• 536 dispensing pharmacies across 3 military services in
  121 MTF’s
• 1 nationwide TRICARE Mail Order Pharmacy (TMOP)
• 58,650 retail pharmacies (TRRx) managed by one
  Pharmacy Benefit Manager (Express Scripts)




                                                            6
                                          Unique User Trends

   Point of Service           FY02        FY03         FY04        FY05        FY06
                 MTF only     3,454,419   3,574,200   3,319,477   3,031,537   2,833,312
                Retail only   1,033,576   1,264,787   1,500,504   1,820,899   1,992,616
           Mail Order only      79,124      83,654      64,605      61,343      55,076
        MTF & Retail only      814,048     927,717    1,104,689   1,253,612   1,297,796
   MTF & Mail Order only        54,885      37,777      42,791      45,569      45,752
  Retail & Mail Order only     181,881     206,748     256,927     288,287     331,587
 MTF, Mail Order & Retail       96,130     101,119     101,110     112,572     121,180

  Total Unique Users          5,714,063   6,187,185   6,390,103   6,612,378   6,685,709

     Eligible Beneficiaries   8,671,727   8,929,071   9,154,440   9,210,547   9,177,548
% of Eligible Beneficiaries
 Using Pharmacy Benefit
                                  66%         69%         70%         72%         73%




                                                                                Source: PDTS
                                                                                           7
                                        Unique Users
                          Total Unique Users Up 17%
7000000
6000000

5000000
                                                   MTF Only Users Down 18%
4000000
3000000
                               Retail Only Users Up 93%
2000000

1000000
     0
              FY02         FY03               FY04            FY05           FY06

   MTF Only      Retail Only        MTF & Retail          Total


                                                                                    8
                                                          MHS PHARMACY BENEFIT
                                                                 USERS
                    3.5
                                                                                   MTF
                    3.0
Millions of Users




                    2.5

                    2.0
                                                          Retail
                    1.5

                    1.0
                                                                                               Mail Order
                    0.5

                     0     4Q    1Q   2Q   3Q   4Q   1Q   2Q   3Q   4Q   1Q   2Q   3Q    4Q   1Q   2Q   3Q   4Q   1Q   2Q   3Q   4Q
                          FY01        FY02                FY03                FY04                 FY05                FY06




                                                                                                                       Source: PDTS
                                                                                                                                      9
                                               DoD Drug Expenditures thru
                                                       FY 2006
    Millions

    $7,000
                  Expenditures                 Workload (30 day equiv)
    $6,000
                  MTF     25%                  MTF     51%
                                                                                                                1536
                  Retail 63%                   Retail 35%
    $5,000
                  Mail    12%                  Mail    14%                                               1634

    $4,000                                                                                        1765


    $3,000                                                                                 1565
                                                                                                                3923
                                                                                 1388
                                                                                                         3097
    $2,000                                                                                        2423
                                                                        1170               1848
                                                          1034
    $1,000                                       878                             1278
                                 741    797
               617       662                                             681
                                                 342          455                                 546    629    721
               181       193     245    283                              191         347   429
         $0     0         0       0     35       83           106

               1995      1996    1997   1998    1999      2000          2001     2002      2003   2004   2005   2006


                                                       Mail         Retail     MTF

.
                                                                                                                       10
                         Influence of Technology


• Standardization of business processes across the
  enterprise
• Adoption and incorporation of industry “best practices,”
  standards
• Enhanced data aggregation, mining, sharing
• Enhanced communications
• Scalable systems
• Interoperability of disparate systems




                                                             11
                   Influence of Technology,
                             Con’t

• Medical
  – improved quality of care
  – improved patient safety
  – more accurate and complete documentation
  – more accurate capture of codes and charges
  – improved timeliness in processing claims
  – increased staff productivity
  – improved customer satisfaction


                                                 12
                                         GE Centricity Pharmacy

•   COTS Solution to replace CHCS pharmacy functionality.
•   Rated #1 for the last 4 years by an independent healthcare technology company (KLAS)
•   Currently installed in over 100 hospital systems in North America
•   Standardization of Pharmacy business practices within DoD
•   Standardization - One Enterprise Drug File
          • Centrally managed updates to drug file
          • Uniformity across the Military Health System
•   Integrated Inventory Package (POS Tracking, Ordering, Reporting and Auditing)
          • 3rd Party Collections – Increased claims integrity
•   Industry Standard Interfaces
          • In-patient / Out-patient
          • Robotics
          • Refill System
•   Complete Inpatient Functionality
•   Alpha site licenses have been purchased




                                                                                           13
                        ePharmacy Initiative


• Electronic prescribing from all points of order
  entry (Civilian Network and Military providers) to
  all points of dispensing (military treatment
  facility, mail order, and retail)
• Develop an ePharmacy portal for patients
  (influence Point of Service decisions)
• Still in conceptual stage




                                                       14
                          What is
                      telepharmacy?
Telepharmacy: Pharmacists using
telecommunications technology to systematically
provide personalized, electronically documented
real-time professional services to patients at a
remote location, including prescription dispensing
and counseling, and to oversee and supervise
remote pharmacy operations.




                                                     15
                         Why Telepharmacy?
• Problem:
  - While a pharmacist on site is optimal in all MTF
  pharmacies, it is clear that this is not feasible due to the
  insufficient number of MTF pharmacists to meet the
  needs of our patients

   – JCAHO MM 4.1 requires prospective pharmacists
     review of orders

• Prognosis:
  - Private sector studies show 6,000 unfilled positions
  today, projected to 157,000+ by 2020



                                                                 16
                  Telepharmacy (cont.)

• Currently telepharmacy deployed at 3
  sites: Bremerton (Scriptpro), Portsmouth
  and Bethesda (Parata)

• Pensacola is scheduled for deployment
  with Scriptpro. This will be first hub/spoke
  deployment


                                                 17
           Overview of
DoD Pharmacy & Therapeutics Cmte
    and the Uniform Formulary
                      Overview

•   DoD P&T Committee
•   DoD Formulary Management
•   Uniform Formulary Processes
•   Beneficiary Impact
•   Current Status
•   Challenges
•   The Road Ahead

                                  19
                             Objectives
1.   Name the two circumstances in which the DoD
     Pharmacy and Therapeutics Committee may
     recommend a drug for non-formulary status.
2.   Describe, in general terms, the roles of the DoD
     Pharmacy and Therapeutics Committee, the
     Beneficiary Advisory Panel, and the Director,
     TMA, in the Uniform Formulary process.
3.   Discuss tools that might potentially be used in
     the future to better manage pharmacy
     utilization.


                                                        20
                        P&T Committee Activities
                                     The Basics

• Conduct therapeutic drug class reviews
   – Uniform Formulary
   – Basic and Extended Core Formulary
• Review newly approved drugs
• Manage the pharmacy benefit
   – Prior authorizations
   – Quantity limits
• Monitor MHS pharmacy utilization and cost data
• Review other issues related to pharmacy:
   – Patient safety issues
   – Incentive agreements
   – Pending legislation

                                                   21
                       Uniform Formulary
                     Part of the Pharmacy Benefits Program

• DoD’s Pharmacy Benefits Program is:
  –   Clinically effective
  –   Fiscally efficient
  –   Equitable to beneficiaries
  –   Integrated across the MHS
• “… and includes a Uniform Formulary of
  pharmaceutical agents based upon relative
  clinical and cost effectiveness.”



                                                             22
                    Uniform Formulary
                             Legal Authority

• The process to be used in establishing
  the Uniform Formulary is mandated in
  law, and implemented in regulation and
  policy.
 – Title 10 U.S. Code, Section 1074g
 – 32 Code of Federal Regulations, Part 199.21
 – TRICARE Policy Manual, Chapter 8, Section 9.1




                                                   23
                             Uniform Formulary
                             Identifying a Competitive Class

• Assessing general competitiveness of a class
 – Degree of clinical interchangeability between drugs
   • The higher the better
 – Number of agents with moderate to high
   interchangeability
   • At least two required
 – Size of the target market
   • Patient count &/or total $$
 – Application to DoD population and demographics
   • e.g., Ramipril



                                                               24
                            Uniform Formulary
                              Identifying a Competitive Class

• Assessing DoD priority for review
  – DoD fiscal impact (MHS class spend)
  – Market analysis
    • Impending new drugs, new generics, or new significant clinical
      information (outcomes, indications, etc.)
  – Current DoD use analysis
    • Opportunity to increase efficiency (e.g., Norvasc)
    • Address emerging threat to current efficiency (e.g., Lyrica)
  – Resources to complete review (PEC & Committee)
  – Resources to implement review
  – Disruption of change (MHS, patients)

                                                                       25
                      Uniform Formulary
                              Decision Process

• P&T Committee: drug class reviews and
  recommendations
 – Determines relative clinical effectiveness
 – Determines relative cost effectiveness
 – Recommends agent(s) for non-formulary status, as
   appropriate
 – Recommends implementation period
 – Establishes medical necessity criteria, if needed




                                                       26
                      Uniform Formulary
                              Decision Process

• Beneficiary Advisory Panel: beneficiary
  comment
  – BAP, a committee subject to FACA, meets 4-6 weeks
    after P&T Cmte meeting
  – Offers beneficiary perspective on proposed UF changes
• Director, TMA: final decision
  – Considers both P&T Committee recommendations and
    BAP input
  – Makes final decisions on UF




                                                            27
                         Uniform Formulary
                              Implementation Process

• Notification of MTFs
  – On decision date, PEC notifies MTFs of UF, and
    provides criteria for establishing medical necessity
• Notification of Express Scripts, Inc. (ESI)
  – 30 days prior to implementation date, PEC notifies ESI,
    the TRRx and TMOP contractor, and provides medical
    necessity criteria forms




                                                              28
                      Uniform Formulary
                           Implementation Process

• Communications Plan
 – “Push-out” documents to all MTFs and pharmacy
   consultants (PEC)
 – TRICARE news release (C&CS)
 – TRICARE Formulary Search Tool updates (PEC)
 – Regional MCSC provider and Prime newsletter notices
   (C&CS)




                                                         29
                       Uniform Formulary
                            Implementation Process

• Blanket Purchase Agreements (BPAs)
 – After P&T UF review, no locally-negotiated BPAs for
   formulary or non-formulary drugs in that class
 – After UF decision, central BPAs for formulary and generic
   agents
 – 120 day “out” clause for DoD or company




                                                               30
                         Uniform Formulary
                              Implementation Process

• Voluntary Retail Rebates (VRRs)
  – First opportunity to receive discounts on retail utilization
  – Based on a discount per retail dispensed unit (tablet,
    inhaler, etc.)
  – Accrual of dispensed units for accepted proposals begins
    on the UF class implementation date set by Director, TMA
  – Quarterly invoicing/billing cycle thereafter
  – 120 day “out” clause for DoD or company




                                                                   31
                                       Uniform Formulary
                                    Beneficiary Impact by Point of Service

TRRx and TMOP:                                  MTF:
• Beneficiaries may fill scripts                • Beneficiaries may fill scripts
  for non-formulary drugs:                        for non-formulary drugs:
      − If MN is established:                     − If MN is established, but only
         $9 cost-share ($0 for AD)                  for scripts written in MTF, or by
      − If MN is not established:                   network providers to whom
         $22 for non-AD Prime bene1                 patient was referred by MTF
        $22 for non-AD Standard bene2           • Beneficiaries may NOT fill
        100% cost-share for AD                    scripts for non-formulary
1At
                                                  drugs if MN is not established
   a network pharmacy. At a non-network
pharmacy, 50 percent cost-share after           • Non-formulary drugs may no
point-of-service deductible.                      longer be on MTF formularies
2At a network pharmacy. At a non-network
pharmacy, cost-share is greater of $22 or 20%
after deductible is met .


                                                                                        32
                                 Uniform Formulary
                                 Drug Classes Reviewed in CY 2005

 Meeting            Drug Class              Impl. Date   $ M – FY05
           ARBs                             17 JUL 05      $ 136
Feb 2005   PPIs                             17 JUL 05      $ 418
           Topical Antifungals              17 AUG 05       $ 12
May 2005   PDE-5s                           12 OCT 05       $ 35
           MS-DMDs                             N/A          $ 48
           Alpha Blockers for BPH           15 FEB 06       $ 55
Aug 2005   ACE Inhibitors                   15 FEB 06       $ 74
           CCBs                             15 MAR 06      $ 125
           Macrolide/Ketolide Antibiotics   22 MAR 06       $ 46
           Nasal Corticosteroids            19 APR 06       $ 66
Nov 2005
           Alzheimer’s Disease Agents       19 APR 06        $69
           Antidepressants (Part 1)         19 JUL 06      $ 282

                                                                      33
                                Uniform Formulary
                                Drug Classes Reviewed in CY 2006

 Meeting              Drug Class            Impl. Date   $ M – FY05
           GABA Analogs                    28 JUN 2006      $ 63
Feb 2006   Misc Antihypertensives          26 JUL 2006      $ 37
           OABs                            26 JUL 2006      $ 52
           Contraceptives                  24 JAN 2007      $ 72
May 2006   Antiemetics                     27 SEP 2006      $ 34
           Thiazolidinediones                  N/A         $ 110
Aug 2006   H2 Antagonists & Other GI
           Protectants                         N/A          $ 11
           Antilipidemics (Part 1)         1 FEB 2007      $ 595
           ADHD & Narcolepsy Agents        18 APR 2007      $ 35
Nov 2006   Sedative Hypnotics (Part 2)         N/A           $3




                                                                      34
                                                                                                   100,000
                                                                                                                             120,000




                              20,000
                                                 40,000
                                                                                 60,000
                                                                                          80,000




                 0
     31-Oct-04

     30-Nov-04

     31-Dec-04

     31-Jan-05

     28-Feb-05

     31-Mar-05

     30-Apr-05

     31-May-05




                                                 AD1s
     30-Jun-05

     31-Jul-05

     31-Aug-05

     30-Sep-05
                                                          ACEs
                                                                                                               CCBs




     31-Oct-05
                                       BPH-ABs


     30-Nov-05       PDE-5s

     31-Dec-05

     31-Jan-06
                                                                                                             Decision date




     28-Feb-06

     31-Mar-06

     30-Apr-06

     31-May-06

     30-Jun-06

     31-Jul-06

     31-Aug-06
                                                           Implementation date
                                                                                                                                       MTFs, All Implemented UF Classes




     30-Sep-06
                                                                                                                                                                          Non-formulary 30-day Rxs




     31-Oct-06
35
                                                                                                      % Non-formulary
                                                                                                     by Point of Service
                                                                               30-day Rxs, All Implemented UF Classes

30%
                                                                                                                                                                                       MAIL

25%
                                                                                                                                                                                                         RETAIL


20%
                                                                                                                                                                                                              - 30%
                                                                                                                                                                         OVERALL
                                                                                                  MTF
15%

               All implemented UF classes:                                                                                                                                                                    - 40%
10%            MTFs: -89% Mail: +6% Retail: -11%

5%
               NF drugs implemented ≥ 6 months
               MTFs: -93% Mail: +1% Retail: -21%
0%
                                                             Apr-05




                                                                                                 Aug-05




                                                                                                                                                                          Apr-06




                                                                                                                                                                                                              Aug-06
                                                                      May-05




                                                                                                                                                                                   May-06
                Nov-04




                                                                                                                            Nov-05
      Oct-04



                         Dec-04

                                  Jan-05

                                           Feb-05

                                                    Mar-05




                                                                               Jun-05

                                                                                        Jul-05



                                                                                                          Sep-05

                                                                                                                   Oct-05



                                                                                                                                     Dec-05

                                                                                                                                              Jan-06

                                                                                                                                                       Feb-06

                                                                                                                                                                Mar-06




                                                                                                                                                                                            Jun-06

                                                                                                                                                                                                     Jul-06



                                                                                                                                                                                                                       Sep-06

                                                                                                                                                                                                                                Oct-06
                                                                                                                                                                                                                                         36
                                                                                                          Cost Per Day
                                                                                                       by Point of Service
                                                                                                     All Implemented UF Classes
$2.50

                                                                                                                                                                     Retail          (-2%) (-4%)

$2.00




$1.50
                                                                                                                                                                                        OVERALL               (-5%) (-7%)

                                                                                                                                                                 Mail       (-5%) (-5%)
$1.00

                                                                                                                                                         MTF                (-23%) (-30%)

$0.50
           All implemented UF classes
           NF drugs implemented ≥ 6 months
$0.00
                                                              Apr-05




                                                                                                  Aug-05




                                                                                                                                                                          Apr-06




                                                                                                                                                                                                              Aug-06
                                                                       May-05




                                                                                                                                                                                   May-06
                 Nov-04




                                                                                                                             Nov-05
        Oct-04



                          Dec-04
                                   Jan-05

                                            Feb-05
                                                     Mar-05




                                                                                Jun-05

                                                                                         Jul-05



                                                                                                           Sep-05

                                                                                                                    Oct-05



                                                                                                                                      Dec-05
                                                                                                                                               Jan-06

                                                                                                                                                        Feb-06

                                                                                                                                                                 Mar-06




                                                                                                                                                                                            Jun-06

                                                                                                                                                                                                     Jul-06


                                                                                                                                                                                                                       Sep-06

                                                                                                                                                                                                                                Oct-06
                                                                                                                                                                                                                                         37
                      Improving the UF Process
                        Additional PEC and Cmte Activities

• Education of MTF medical staffs on UF and required
  implementation processes
  – CE/CME opportunity in conjunction with each P&T Cmte meeting
  – Push-out documents
• Improving compliance within MTFs re use of
  non-formulary drugs
  – PACER performance and benchmarking data for MTF leadership
• Sharing of best practices
  – Combined Forces Pharmacy Seminar
  – PEC Conference



                                                                   38
                    Improving the UF Process
                     Additional PEC and Cmte Activities

• BAP improvements
 – Briefs tailored to BAP feedback
 – Physician rep from DoD P&T Cmte at every BAP
   meeting
• Service support for the DoD P&T Committee
 – TMA now funds travel for P&T Cmte members
 – Services encouraged to fill Committee vacancies
   promptly




                                                          39
                                     Challenges
• Deployed active duty who need non-formulary drugs
  for chronic conditions
  – If MN exists for a non-formulary drug, use TMOP
  – If no MN on file, establish MN or switch to Joint Deployment
    Formulary agent
• Active duty who present scripts for non-formulary
  drugs to TRRx, and prescribing provider cannot be
  reached
  – Standing waiver to permit fills in TRRx under consideration
  – Use of POC (or TMA medical directors) to resolve under
    consideration



                                                                   40
                                       Challenges
• Establishing MN in direct care system
  – At present, no consistent process
  – Establishing MN centrally is under consideration
• Compliance within MTFs
  – Medical necessity, quantity limits, prior authorization
• Informing beneficiaries of UF changes
  – Preferably before they’re asked to pay $22 at the retail pharmacy
    window
• Informing prescribers of UF changes
  – Use of formulary tools (e.g., Epocrates) under consideration



                                                                        41
                                     Challenges
• Generic drugs
  – No detailers for omeprazole, fluoxetine, gabapentin, and other
    generics
• Off-label use of drugs
  – Difficult to control off-label use outside the TRICARE benefit, except
    through prior authorization process
• Patient safety issues
  – Roles of PEC, DoD P&T Cmte, Patient Safety Center
• The “ENTER” button
  – The most expensive tool used by privileged providers




                                                                             42
                            The Road Ahead
                        Tools to Manage Pharmacy Utilization

• Available at present:
  – Joint VA – DoD contracting
  – Automated PA processes (step-therapy)
• With contract modifications:
  – Incentivize network providers to use generic drugs
  – Step-therapy (provider telephone contact)
• Under demonstration authority
  – Over-the-Counter Drug demonstration (FY 2007 NDAA)
  – Other demonstration programs to influence drug utilization
• Other ideas

                                                                 43
Additional Information




                         44
                      Uniform Formulary
                                Legal Authority

• Per 10 USC 1074g:
  – “The pharmacy benefits program shall include a
    uniform formulary of pharmaceutical agents…in the
    complete range of therapeutic classes.”
• Per 32 CFR 199.4:
  – “…pharmaceutical agents in each therapeutic class
    are selected for inclusion on the uniform formulary
    based upon the relative clinical effectiveness and cost
    effectiveness of the agents in such class.”



                                                              45
                     TRICARE Pharmacy Benefit
                                         The Details

• Most FDA-approved prescription medications are
  covered by TRICARE.
  – Some are excluded from the TRICARE pharmacy benefit
  – It is not the DoD Pharmacy and Therapeutics Committee that
    determines which drugs are part of the pharmacy benefit and
    which are excluded.
• The TRICARE pharmacy benefit includes:
  – FDA-approved drugs that by U.S. law require a physician’s or
    other authorized provider’s prescription
     • FDA-labeled indications
     • Off-label use when there is reliable evidence the drug is safe
       and effective


                                                                        46
                    TRICARE Pharmacy Benefit
                                       The Details

• The TRICARE pharmacy benefit excludes:
  – Medications that are not medically or psychologically necessary
    for the diagnosis or treatment of a covered illness.
  – Prescription drugs used in medical treatments or procedures
    which are expressly excluded from the TRICARE benefit by
    statute or regulation.
  – OTC drugs
     • except insulin and related supplies for diabetic patients
  – Vitamins
     • except when used as a specific treatment of a medical
       condition



                                                                      47
                             Uniform Formulary
                                Details of Interest to Clinicians

• Non-formulary drugs remain available to beneficiaries
  – At non-formulary cost-share
  – At formulary cost-share when medical necessity is established
     • 100% cost-share for active duty when MN is not established
• New drugs that are part of the TRICARE benefit are
  initially categorized as “formulary” under the UF
  – A drug cannot be placed in the non-formulary tier until it has been
    selected for non-formulary status through the UF process.
• Excluded drugs are not part of the UF
  – These drugs “shall not be available as non-formulary agents, nor
    will they be cost-shared under the TRICARE pharmacy benefits
    program.


                                                                          48
                                        Uniform Formulary
                                                        Obesity Drugs

• Obesity drugs are excluded from the TRICARE benefit
  – 10 USC 1079(a)(11): “Treatment of obesity may not be provided if
    obesity is the sole or major condition treated.”
  – 32 CFR 199.4(g), which lists services excluded under TRICARE,
    specifically excludes: “… Services and supplies related to obesity or
    weight reduction whether surgical or nonsurgical; wiring of the jaw or
    any procedure of similar purpose, regardless of the circumstances
    under which performed; except that benefits may be provided for the
    gastric bypass, gastric stapling, or gastroplasty procedures in
    connection with morbid obesity…”
  – TRICARE Policy Manual excludes “nonsurgical treatment of obesity,
    morbid obesity, dietary control, or weight reduction.”

 TRICARE Policy Manual (Chapter 4, Section 13.2, August 2002 edition)

                                                                             49
                                        Uniform Formulary
                                                       Infertility Drugs

• Infertility drugs are excluded from the TRICARE benefit
  when used in conjunction with non-coital reproductive
  technologies:
  – Under 10 U.S.C. 1079(a)(13), TRICARE may only cost share medical
    services and supplies that are medically and psychologically necessary.
  – 32 C.F.R. 199.4 (g)(34) specifically excludes coverage for “services and
    supplies related to non-coital reproduction technologies, including but not
    limited to artificial insemination (including any costs related to donors or
    semen banks), in-vitro fertilization and gamete intrafallopian transfer.”
  – TRICARE does cover the diagnostic evaluation of infertility and the
    treatment of infertility, including infertility drugs, but only when assisted
    reproductive technology is not part of the course of therapy.


 TRICARE Policy Manual (Chapter 4, Section 17.1, August 2002 edition)

                                                                                    50
                                       TRICARE Coverage
                                                      Off-Label Usage

• “Drugs may be cost-shared for off-label uses when
  determined, by the contractor with responsibility for the
  venue distributing the drugs, that reliable evidence
  demonstrates such usage is safe and effective. As
  presented in order of relative weight in 32 CFR 199.2,
  reliable evidence means:
  – Well-controlled studies of clinically meaningful endpoints, published in
    refereed medical literature
  – Published formal technology assessments
  – Published reports of national professional medical associations
  – Published national medical policy organization positions
  – Published reports of national expert opinion organizations.”
 TRICARE Policy Manual (Chapter 9, Section 9.1, August 2002 edition)
                                                                               51

				
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