EXHIBIT_L-4_DoD_Benefit_Design_(Aug_29 _2013).doc

DoD Pharmacy Benefit

Current as of 29 August 2013 ** Subject to change due to Legislative regulatory or formulary changes.**

Attachment: L-5 - DoD Formulary Restrictions and Limitations

Copayment(s) Tricare Reimbursement Manual, Chapter 2, Addendum A –Pharmacy Payment Matrix.

Tricare Reimbursement Manual, Chapter 4, Section 3, § 5 – Tricare Deductible in Double Coverage Type of Pharmacy

Formulary - Generic

(Tier 1) Formulary - Brand Name (Tier 2)5 Non-Formulary Drugs (Tier 3) 1 MTF(up to 90-day supply)

$0

$0

Not Applicable 2 Home Delivery (up to 90-day supply)4,7 $0

$13 $433 Retail Network Pharmacy(up to 30-day supply) 4,6 $5

$17 $443 Non-Network Pharmacy(up to 30-day supply)

TRICARE Prime options: 50% copayment applies after point-of-service (POS) deductible is met

All other beneficiaries: $12 or 20% of the total cost, whichever is greater, after annual deductible is met

TRICARE Prime options: 50% copayment applies after POS deductible is met

All other beneficiaries: $25 or 20% of the total cost, whichever is greater, after annual deductible is met

Non-Network Pharmacy(up to 30-day supply)

1. Approval is required for active duty service members (ADSMs). Non-formulary drugs may be obtained free of charge by ADSMs only if medical necessity has been established. All other beneficiaries will pay the copayments listed above. Medical necessity information should be submitted along with the prescriptions. The Department of Defense Pharmacy and Therapeutics Committee may set quantity limits on some medications. For more information, visit www.tricare.mil/pharmacy or www.tricare.mil/pharmacyformulary.

2. Non-formulary drugs are generally not available at MTFs.

3. The non-formulary copayment applies unless medical necessity is established.

4. Selected Vaccines in retail and OTC drugs in both retail and mail may be cost shared ($0 copay) when designated by the Assistant Secretary of Defense, Health Affairs

5. Compounded medications will have a cost share equal to or not less than the prevailing Formulary brand cost share

6. For member submitted claims for prescriptions filled at a network pharmacy, allowable charges, member cost shares and reimbursement will be based on network pharmacy rates.

7. Selected prescription and OTCsmoking cessation drugs may be cost shared in mail order ($0 copay) when designated by the Assistant Secretary of Defense, Health Affairs

In addition, Beneficiaries with OHI submitting Mail order claims are treated as in-network.

See TRICARE Reimbursement Manual, Chapter 2.

Up to 90 days supply (1 copay per 30 days)

Products packaged for greater than 30 day supply:

1. If the package contains a single dose (i.e., one injection) which has a duration of greater than 30 days, 1 copay will be applied.

2. If the package contains multiple dosings (i.e. 91 tablets) which together have a duration of greater than 30 days, then 1 copay applies for each 30 days of duration.

MAIL ORDER: Up to 90 days per copay Consolidation at Mail Order: YES

Member Reimbursement TRICARE Policy Manual 6010.56-M Chapter 8, Section 3 Claims filing deadline

Member payment services will be provided by the contractor.

Contractor will process in network and out of network member submitted claims.

Contractor will process claims from US and US territory pharmacies (Puerto Rico, Guam, American Samoa, Northern Mariana Islands & the Virgin Islands). Foreign claims are not processed by contractor Claims billed by a nursing home are not covered. (Claims billed by free-standing pharmacy for nursing home residents are covered.)

Member submitted claims for prescription fills may be paid if received by the contractor no later than (NLT) one year from the date of prescription fill. Exceptions to the filing deadline may be granted and payment made in accordance with the criteria in TOM Chapter 8, Section 3. Under no circumstances shall a payment be made for claims exceeding the filing exception time limitation of six years immediately preceding the receipt of request.

Mandatory generic program but no ancillary charges apply.

DAW1, at mail order will reject: 70 NDC not covered, with message “DAW1-MANDATORY GENERICS” All other Multi Source brand product claims will reject: 70, NDC Not Covered.

· Military deployment

· Natural disaster

· Patient lost their medications

· Stolen medications

· Medications discarded in error

· Nursing Home or School Supply

· Delayed in transit (not reported by patient within 45 days of order ship date)

Example: Active Duty Service Member moves to Retiree status

Cosmetic Only Indications

TRICARE Policy Manual 6010.57-M Chapter 4 Section 2.1. Exclusions. Chemical Peeling (exfoliation) for the following: (a) Treatment or removal of facial wrinkles (b) Treatment of acne or acne scars. (c) Treatment of aging skin TRICARE Policy Manual 6010.57-M Chapter 4 Section 2.1 Exclusions. Any procedure performed for personal reasons to improve the appearance of an obvious feature or part of the body that would be considered by an average observer to be normal and acceptable for the patient’s age or ethnic or racial background.

TRICARE Policy Manual 6010.57-M Chapter 1 Section 1.2. Exclusions. Services and supplies in connection with cosmetic, reconstructive, or plastic surgery except as specifically provided in 32 CFR 199.4 (e)(8).

32 CFR 199.4 (g)(24) Exclusions. Cosmetic, reconstructive, or plastic surgery. Services and supplies in connection with cosmetic, reconstructive, or plastic surgery except as specifically provided in paragraph (e)(8) of this section.

Hair growth:

TRICARE Policy Manual 6010.57-M Chapter 8 Section 12.1 Exclusions. Any diagnostic or therapeutic method or supply intended to encourage hair re-growth.

32 CFR 199.4 (g)(41)(ii)(D) Exclusions. Any diagnostic or therapeutic method or supply intended to encourage hair re-growth.

Photo-aged skin products: (ex. Renova, Avage)

No

Hair growth agents:

(ex. Propecia, Vaniqa)

No

Injectable cosmetics:

(ex. Botox cosmetic)

No

Dermatology *Policy citations same as above for cosmetic.

Depigmentation products used for skin conditions requiring a bleaching agent

No

Contraception

When Non-Injectable Monthly products are dispensed at Mail Order and the days supply is 90, the maximum dispensed is 3 packages for one Mail Order copay.

When the following products are Not Covered implement the standard defaults to allow overrides to adjudicate correctly.

Non-injectable monthly:

1 package at Retail

3 packages at Mail Order

Participant may receive up to 3 packages at a time for 1 copayment per package.

At retail 3 copays charged for 1 pkg.

Injectable-90 day supply only: (ex. Depo-Provera, Depo-SubQ Provera)

Yes

1 copay charged for 1 90 day package

Implants (ex. Implanon INJ)

No

Retail only

IUDs

No

Emergency – ALL

(ex. Plan B) Yes

Limited to females age 17 yrs of age or younger (OTC version not covered)

Oral/Vaginal

(ex. Clomid, Crinone) Yes

Approved PA’s only good for one year for gonadotropins

Erectile Dysfunction

TRICARE Policy Manual 6010.57-M Chapter 4 Section 15.1 and Chapter 8 Section 9.

PA req for Viagra/Levitra/Cialis/Staxyn for men under 40

PA req for Viagra/Levitra/Cialis/Staxyn for women of any age.

Muse is covered wo/PA Qty/Days

*QLL= 6 tabs-pellets/30 ds and 18 tabs- pellets/90 ds

**QLL is collective across all oral products.

***QLL applies to Cialis 2.5mg as well

Injectable (ex. Caverject, Edex)

Yes

Qty/Days

*QLL= 6 inj/30 ds and 18 inj/90 ds

Medications not FDA approved for Erectile Dsyfunction (ex. Yoimbine)

No

Weight Management

TRICARE Policy Manual 6010.57-M

Chapter 1 Section 1.2 (1.1) Exclusions: In addition to any definitions, requirements, conditions, or limitations enumerated and described in other sections of this manual, the following are excluded: …(1.1.28) Services and supplies related to obesity or weight reduction whether surgical or non-surgical; wiring of the jaw or any procedure of similar purposes; 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 as provided in 32 CFR 199.4 (e)(15).

32 CFR 199.4 (g) (28). Exclusions and limitations: Obesity and weight reduction. Services and supplies related to obesity or weight reduction whether surgical or non-surgical; wiring of the jaw or any procedure of similar purposes; 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 as provided in paragraph (e)(15) of this section.

32 CFR 199.4 (e)(15) (ii) (A). Exclusions. CHAMPUS payment may not be made for non-surgical treatment of obesity or morbid obesity, for dietary control, or weight reduction.

Agents used to suppress appetite and control fat absorption.

(ex. Xenical, Belviq, Qsymia)

No

TRICARE Policy Manual 6010.57-M Chapter 7 Section 14.1 Allergy testing and treatment. Exclusions.

Allergy claims are not covered.

No

Examples of non-covered allergy treatments include:

· Sublingual antigen therapy.

· Sublingual neutralization therapy for food and inhalant allergy.

· Urine autoinjection (autogenous urine immunization).

· Intracutaneous (intradermal) and subcutaneous neutralization therapy for food allergies.

· Immunotherapy involving any injection of a food antigen.

· Chemical exposures avoidance, special diet therapy, drug therapy and neurealization therapy for environmental allergies.

· Total serum IgE concentration in cord blood.

Injectables

(Other than Insulin or if an Injectable is addressed in any other category within this document)

32 CFR 199.4 (d)(3)(vi)(A) Prescription Drugs and Medicines. Drugs administered by a physician or other authorized individual professional provider as an integral part of a procedure covered under paragraph (b) or (c) of this section (such as chemotherapy) are not covered under this subparagraph inasmuch as the benefit for the institutional services or the professional services in connection with the procedure itself also includes the drug used.

TRICARE Policy Manual 6010.57-M Chapter 8 Section 9.1 Other Pharmaceutical Delivery Venues. (1.4) Pharmaceutical agents provided by physicians and other appropriate clinicians, and pharmaceutical agents provided in support of home health care are processed by the Managed Care Support Contractor(s) (MCSC). Claims for pharmaceutical agents (e.g., injectables) not appropriate for self-administration are the responsibility of the MCSC. (1.5) When injectable and infusion drug therapy are medically necessary, and delivery and administration in the home is appropriate the MCSC shall provide prior authorization of injectable or infused drugs to a TRICARE authorized pharmacy in order for the pharmaceutical agent to be fulfilled under the pharmacy benefit pursuant to Section 20.1, “Infusion Drug Therapy Delivered in the home”

ALL

NO

Not covered unless described below.

The Self-administered Injectable Drug List is comprised of injectable medications deemed safe and appropriate by the manufacturer for self-administration. This list is developed and maintained by the contractor. The initial list and any changes are subject to approval by the government.

Injectable medications not considered self-administered are eligible for coverage if deemed medically necessary through a review process established by MCSC.

Allergens

No

Other

Attach list if applicable

Age 1 or older

Age 1 or older

Ages 11-26 (females and males)

Flu (Seasonal Flu)

· Influenza A flu shot (inactivated)

· Fluzone Yes

Age 1 or older

Age 1 or older

Age 1 or older

Age 1 or older

Age 2 or older

Age 1 or older

· Pneumonia (Pneumococcal)

· Pneumoxax-23 – PPSV23

· Prevnar-13 – PCV13 Yes

Age 2 or older

Birth to age 18

Birth to age 18

Age 60 or older

Age 7 or older

Tetanus, Diptheria & Pertussis (Whooping cough)

· Tdap/DTap Yes

No

Section must be addressed if Self Administered Drug List is Not Covered or PA Required.

LEGEND VITAMINS (Applies to oral only if Injectables are Not Covered or require Prior Authorization)

**Section must be addressed if Self Administered Drug List is Not Covered or PA Required.

TRICARE Policy Manual 6010.57-M Chapter 8 Section 9.1. Vitamins may be cost-shared only when used as a specific treatment of a medical condition.

TRICARE Policy Manual 6010.57-M Chapter 8 Section 7.1 Exclusions. Vitamins or mineral preparations, except as provided in POLICY above or by Chapter 8 Section 9.1.

TRICARE Policy Manual 6010.57-M Chapter 1 Section 1.2 Exclusions. Food, food substitutes, vitamins, or other nutritional supplements, including those related to prenatal care, except as specifically covered (see chapter 8, Sections 7.1 and 7.2)

32 CFR 199.4 (g)(57) Exclusions. Food, food substitutes, vitamins, or other nutritional supplements, including those related to prenatal care.

ALL

Legend Multivitamins (usually have OTC counterparts)

(ex. Nephrocaps, Vitacon Forte, Berocca) Yes

Legend products only

Supplemental agents (usually have OTC counterparts)

(ex. Biotin) Yes

Legend products only

Legend products only

Legend Fluoride Products TRICARE Policy Manual 6010.57-M Chapter 8 Section 13.1 (III)(A) Policy Considerations. Dental care which is routine, preventative, restorative, prosthodontic (adding or modifying of bridge work and dentures), periodontic or emergency does not qualify as adjunctive dental care except when performed in preparation for, or as a result of, dental trauma caused by medically necessary treatment of an injury or disease.

32 CFR 199.4 (E)(10)(i) Adjunctive dental care: Limited. Adjunctive dental care is limited to those services and supplies provided under the following conditions: (A) Dental care which is medically necessary in the treatment of an otherwise covered medical (not dental) condition, is an integral part of the treatment of such medical condition, and is essential to the control of the primary medical condition.

Dental (ex. Paste, gel, mouthwash)

No

Pediatric (ex. Luride, Poly-Vi-Flor)

No

Legend and OTC Smoking Cessation Products 32 CFR 199.4 (e) (30). The TRICARE smoking cessation program is a behavioral modification program to assist eligible beneficiaries who desire to quit smoking. The program consists of a pharmaceutical benefit; smoking cessation counseling; access to a toll-free quit line for non-medical assistance; and, access to print and internet web-based tobacco cessation materials.

32 CFR 199.21 (a) (2) (ii). The pharmaceutical benefit under the TRICARE smoking cessation program under § 199.4(e)(30) is available to TRICARE beneficiaries who are not entitled to Medicare benefits authorized under Title XVIII of the Social Security Act.

Compounded Products

Yes

Compounds will process as a formulary brand drug with the applicable copay.

Legend products covered but OTC’s not covered

Non-Legend Medications (OTC)

TRICARE Policy Manual 6010.57-M Chapter 8 Section 9.1. Exclusions. Drugs, including compounded preparations, that are available over the counter.

TRICARE Policy Manual 6010.57-M chapter 8 Section 9.1 (II)(A) Paragraph 2. The prescription drug benefit under TRICARE provides cost sharing for drugs and medicines that (1) are approved for marketing by the U.S. Food and Drug Administration (FDA), and (2) by United States law require a physician’s or other authorized individual professional provider prescription (acting within the scope of their license), and (3) are actually ordered or prescribed by an authorized provider in accordance with state and federal law. The benefit does not include prescription drugs for medical conditions that are expressly excluded form the TRICARE benefit by statute or regulation. The Pharmacy Benefits Program will include a Uniform Formulary of pharmaceutical agents that will assure the availability of pharmaceutical agents in the complete range of therapeutic classes authorized under the TRICARE prescription drug benefit.

32 CFR 199.4 (d)(3)(vi)(A). Other covered services and supplies: Prescription Drugs and Medicines. Prescription drugs and medicines that by United States Law require a physician’s or other authorized individual professional provider’s prescription (acting within the scope of their license) and that are ordered or prescribed by a physician or other authorized individual professional provider (except that insulin is covered for a known diabetic, even though a prescription may not be required for its purchase) in connection with an otherwise covered condition or treatment, including Rh immune globulin.

No

Drugs covered under The OTC Demonstration Project:

Cetirizine tablets

Loratadine tablets

Prilosec OTC

Omeprazole (generic of Prilosec OTC)

*QLL applies to syringes/needles

Insulin Pump

No

Non pre-filled insulin injection devices (ex. Insulin pen devices)

No

Swabs

No

Blood Monitors and Kits

No

*QLL applies

Blood Glucose Calibration Solutions

No

*QLL applies

Lancet Devices

No

Other

Attach list if applicable

Peak Flow Meters

No

Respiratory supplies such as nebulizers and respiratory mask

No

*QLL applies

Ostomy Supplies

No

No

Legend Homeopathic Drugs (all dosage forms including Injectable)

TRICARE Policy Manual 6010.57-M Chapter 8 Section 9.1. General Prescription Coverage. Labeled Indications. Drugs may be cost shared when: The drug is approved for marketing by the U.S. Food and Drug Administration;

TRICARE Policy Manual 6010.57-M chapter 1 Section 2.1. Any drug, device, medical treatment, or procedure whose safety and efficacy has not been established is unproven and excluded from coverage.

32 CFR 199.4 (d)(3)(vi)(B). CHAMPUS benefits may not be extended for drugs not approved by the U.S. Food and Drug Administration for commercial marketing. Drugs grandfathered by the Federal Food, Drug and Cosmetic Act of 1938 may be covered under CHAMPUS as if FDA approved.

32 CFR 199.4 (e)(15). Unproven drugs, devices and medical treatments or procedures. By law, CHAMPUS can only cost share medically necessary supplies and services. Any drug, device, or medical treatment or procedure, the safety and efficacy of which have not been established, as described in this paragraph (g)(15), is unproved and cannot be cost shared by CHAMPUS.

32 CFR 199.4 (e)(15)(i)(A). A drug, device, or medical treatment or procedure is unproven: if the drug or device cannot be lawfully marketed without the approval or clearance of the United States Food and Drug Administration (FDA) and approval or clearance for marketing has not been given at the time the drug or device is furnished to the patient.

No

Legend Medical Food TRICARE Policy Manual 6010.57-M Chapter 1 Section 1.1 (I)(57) Exclusions. Food, food substitutes, vitamins, or other nutritional supplements, including those related to prenatal care, except as specifically covered (see chapter 8, Sections 7.1 and 7.2)

32 CFR 199.4 (g)(57) Exclusions. Food, food substitutes, vitamins, or other nutritional supplements, including those related to prenatal care.

Example: Neophe Tablet , Deplin Tablet Zycose Tablet

No

No

Medical benefit

Prolasatin/Aralast inj.

No

Medical benefit

Myobloc inj.

No

Medical benefit

Remicade inj.

No

Xolair inj.

No

Rituxan Inj

No

Boniva IV, Reclast inj.

No

Cerezyme Inj.

No

Fabrazyme inj.

No

Hyaluronic Acid Derivatives (inj.)

No

Immune Globulin Intravenous (inj.)

No

Novantrone inj.

No

Synagis inj.

No

Tysabri inj.

No

Vivaglobin inj.

No

*Retail only

Medications Requiring Specialty Services

Yes

See attached list, prior authorizations and quantity limits may apply

Medications Requiring Prior Authorization Determination

Medications Requiring Medical Necessity Determination

Medications With Specified Quantity Limitations

Yes

See attached list: DoD Formulary Restrictions and Limitations

Medications With Age/Gender Limitations

Medications Covered under TRICARE Home Infusion Therapy Program

Drugs Subject to Exclusion Under Section 703 of the 2010 NDAA

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