EXHIBIT_L-4_DoD_Benefit_Design_(Dec_17 _2013).pdf

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DoD Pharmacy Benefit

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

Attachment: L-4 - DoD Formulary Restrictions and Limitations

Benefit Area Pharmacy Benefit

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)

Non-Formulary Drugs

(Tier 3)

MTF(up to 90-day supply) $0 $0 Not Applicable

Home Delivery (up to 90-day supply) 4,7

$0 $13 $43

Retail Network

Pharmacy(up to 30-day supply) 4,6

$5 $17 $44

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 OTC smoking cessation drugs may be cost shared in mail order ($0 copay) when designated by the Assistant Secretary of Defense, Health Affairs

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Deductible See TRICARE Reimbursement Manual, Chapter 2.

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

Maximum Out-of-

Pocket

Maximum Out-of-Pocket / Cat Cap calculations will be maintained by the DOD, and Contractor will get information for each claim.

See TRICARE Reimbursement Manual, Chapter 2.

Days Supply Limit RETAIL:

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

Page - 3 - of 22 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.

Formulary Name TRICARE Uniform Formulary, which can be found at the www.tricare.mil/pharmacyformulary.

Mandatory Generic

Policy

32 CFR 199.21 (j)(2) Use of generic drugs under the pharmacy benefits program. The pharmacy benefits program generally requires mandatory substitution of generic drugs listed with an “A” rating in the current Approved Drug

Products with Therapeutic Equivalence Evaluations (Orange Book) published by the FDA and generic equivalents of grandfather or Drug Efficacy Study Implementation (DESI) category drugs for brand name drugs. In cases in which there is a clinical justification for a brand name drug in lieu of a generic equivalent, under the standards and procedures of paragraph (h)(3) of this section, the generic substitution policy is waived.

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.

Unit Dose Medications Covered

Refill too Soon

Overrides

Vacation supply or other extended fill are covered if requested for the following reasons:

Military deployment

Natural disaster

Patient lost their medications

Stolen medications

Medications discarded in error

Nursing Home or School Supply

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

Prior Authorization

Follows Group

Existing prior authorizations which are active will transfer as the member’s eligibility transfers to different groups within the TRICARE Pharmacy benefit.

Example: Active Duty Service Member moves to Retiree status

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Benefit Area Specific Covered

(Yes/No)

Prior Auth /

MN

Notes

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

Photo-aged skin products: (ex.

Renova, Avage)

No

Hair growth agents:

(ex. Propecia, Vaniqa)

No

Injectable cosmetics:

(ex. Botox cosmetic)

No

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Prior Auth /

MN

Notes 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.

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

Non-injectable monthly: (ex. oral, Ortho Evra, NuvaRing)

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

Non-injectable – 91 day supply only: (ex.

Seasonale)

Yes 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

Injectable-30 days supply

Yes

Implants (ex.

Implanon INJ)

No

Diaphragms Yes Retail only

IUDs No

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Prior Auth /

MN

Notes

Emergency – ALL

(ex. Plan B)

Yes Limited to females age

17 yrs of age or younger.

Plan-B One-Step OTC available at Retail and

MTF pharmacies for $0 cost-share.

QLL = 1 tablet per dispensing (OTC version not covered)

Fertility Agents ALL

Oral/Vaginal

(ex. Clomid, Crinone)

Yes

Injectable (ex.

Profasi, HCG)

Yes Only injectable gonadotropins require PA.

Others are cov without

Subject to quantity limits referenced in DoD

Formulary Limits and

Restrictions

(Attachment 10.1).

Approved PA’s only good for one year for gonadotropins

Erectile Dysfunction Non-Injectable

(ex. Viagra, Levitra, Yes PA req for Muse is covered wo/PA

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Prior Auth /

MN

Notes

TRICARE Policy Manual 6010.57-M Chapter 4 Section

15.1 and Chapter 8 Section 9.

Cialis, Muse) Viagra/Levitra/

Cialis/Staxyn for men under

PA req for

Viagra/Levitra/

Cialis/Staxyn for women of any age.

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

Agents used to suppress appetite and control fat absorption.

(ex. Xenical, Belviq, Qsymia)

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Prior Auth /

MN

Notes 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.

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.

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MN

Notes

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

ALL NO Not covered unless described below.

Self –administered

Injectable Drugs

YES 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

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Prior Auth /

MN

Notes 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” 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

Other Attach list if applicable

Vaccines Chickenpox

(Varicella)

Yes Age 1 or older

Diptheria & Tetanus

(DT/TD)

Yes

Haemophilus

Influenzae – (Hib)

Yes

Hepatitis A Virus –

HAV

Yes Age 1 or older

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Prior Auth /

MN

Notes

Hepatitis B Virus –

HBV

Yes

Human

Papillomavirus HPV

Yes Ages 11-26 (females and males)

Flu (Seasonal Flu)

Influenza A flu shot (inactivated)

Fluzone

Yes

German Measles

(Rubella)

Yes Age 1 or older

Measles Yes Age 1 or older

Measles, Mumps &

Rubella (MMR)

Yes Age 1 or older

Measles, Mumps, Rubella & Varicella

(MMRV)

Yes Age 1 or older

Meningitis Yes Age 2 or older or 2 months and older who are at increased risk for meningococcal disease

Mumps Yes Age 1 or older

Pneumonia

(Pneumococcal)

Pneumoxax-23 –

PPSV23

Prevnar-13 –

PCV13

Yes Age 2 or older

Birth to age 18

Polio Yes Birth to age 18

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Prior Auth /

MN

Notes

Shingles (Zoster –

Zostavax)

Yes Age 60 or older

Tetanus Booster Yes Age 7 or older

Tetanus, Diptheria &

Pertussis (Whooping cough)

Tdap/DTap

Yes

Serums, Toxoids, (all dosage forms including Injectable) ALL 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.

7.1 Exclusions. Vitamins or mineral preparations, except as

ALL

Prenatal agents used in pregnancy

Yes X Age Limit PA for women over 45. All other ages covered.

Therapeutic agents used for specific deficiencies and conditions (ex.

Rocaltrol, Calcitriol, Niacin, Potaba)

Legend Multivitamins

(usually have OTC counterparts)

(ex. Nephrocaps, Vitacon Forte, Legend products only

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Prior Auth /

MN

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.

Berocca)

Supplemental agents

(usually have OTC counterparts)

(ex. Biotin)

Hemopoetic agents used to treat anemia

(ex. Folic Acid, Niferex Forte)

Legend Fluoride Products

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

Dental (ex. Paste, gel, mouthwash)

No

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

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Prior Auth /

MN

Notes 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.

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.

(ex. Zyban, Nicotrol

Inhaler)

Yes X Specific smoking cessation products are covered at mail order with $0 copay for non-

Medicare eligible patients over age 17.

Limited to two 120 day quit attempts per 365 calendar days; 3 rd attempt allowed with

Prior Authorization.

QLL applies.

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

OTC Equivalents – Prescription drugs with equivalent products also available OTC. These products are identical in active chemical ingredient, dosage form, strength and

(ex. Hydrocortisone

1% cream, Ibuprofen

200mg, Yes Legend products covered but OTC’s not

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Prior Auth /

MN

Notes route of administration. Diphenhydramine

25mg, Niacin 125mg

& 250mg) covered

Non-Legend Medications (OTC)

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.

No Drugs covered under

The OTC

Demonstration Project:

Cetirizine tablets

Loratadine tablets

Prilosec OTC

Omeprazole (generic of

Prilosec OTC)

Plan-B One-Step OTC

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Prior Auth /

MN

Notes

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.

Diabetic Supplies ALL

Syringes, Needles, Insulin Pump Tubing and Insulin Pump

Reservoir or

Cartridges.

*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

Blood Test Strips

(Glucose or Ketone)

Yes *QLL applies

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MN

Notes

Blood Glucose

Calibration Solutions

No

Urine Tests Yes

Lancets Yes *QLL applies

Lancet Devices No

Other Attach list if applicable

Durable Medical Equipment ALL

Respiratory Spacers for oral inhalers.

Yes

Peak Flow Meters No

Respiratory supplies such as nebulizers and respiratory mask

No

Non-Insulin Syringes Yes *QLL applies

Ostomy Supplies No

Legend Diagnositic, Testing, & Imaging Supplies (all dosage forms including Injectable)

ALL (ex. Tubersol used for TB skin test, Radiopaque dye for outpatient testing)

No

Legend Homeopathic Drugs (all dosage forms including

Injectable)

9.1. General Prescription Coverage. Labeled Indications.

Drugs may be cost shared when: The drug is approved for

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MN

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

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MN

Notes 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.

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

Other Drugs Botox inj. 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 No

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MN

Notes inj.

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

Zyvox tablets, susp, inj

Yes *Retail only

Medications Requiring Specialty Services Yes See attached list, prior authorizations and quantity limits may apply

Medications Requiring Prior Authorization Determination X See attached list: DoD

Formulary Restrictions and Limitations, quantity limits may also apply

Medications Requiring Medical Necessity Determination X See attached list: DoD

Formulary Restrictions and Limitations, PA and quantity limits may also

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MN

Notes apply

Medications With Specified Quantity Limitations Yes See attached list: DoD

Formulary Restrictions and Limitations

Medications With Age/Gender Limitations X See attached list: DoD

Formulary Restrictions and Limitations

Medications Covered under TRICARE Home Infusion

Therapy Program

X See TPM, Section 20.1, Chapter 8

Drugs Subject to Exclusion Under Section 703 of the 2010

NDAA

X See attached list: DoD

Formulary Restrictions and Limitations, PA also applies