Attachment J-1 Definitions.DOCX

SECTION J

ATTACHMENTS

Attachment J-1 – Definitions

703 (or 703b): Refers to FY08 NDAA, section 703 that expanded Federal Ceiling Prices to the retail network. See “Federal Ceiling Prices.”

Accurate: Containing all information and void of omitted information; note that clinical and financial records may not always match and may need to be adjusted independently Accurate Clinical Record: Contains all prescriptions dispensed to patients and the actual quantities dispensed; includes medication shipped, even if reported missing by patient

Accurate Financial Record: Correct accounting of the costs paid by patients and by the Government; accounts for reversals of fees and copays and other financial adjustments

Agent: Pharmaceuticals and supplies covered by the TRICARE Pharmacy benefit, as determined by the DoD P&T Committee.

Administrative Review/Override: Any non-clinical review. Includes automated reviews conducted in the adjudication process, profile reviews conducted prior to issuing an override code in response to certain types of edits, and system-generated prior authorizations and medical necessity determinations resulting from an MTF dispensing.

Authorized Generic: Any drug approved by the FDA under a NDA that is marketed, sold or distributed under different labeling, packaging, product code, labeler code, trade name or trade mark than the listed (i.e., brand name) drug (21 USC §355). Authorized Generics as defined and maintained by the FDA will be treated as brand name drugs, unless specified by the DoD P&T Committee.

Base Period of Performance: Runs from the intial start date of transition in until the start of pharmacy services. Can be found in Section F. Also referred to as “Initial Period of Performance”, “Transition-In”, “Start of transition” and “Start-up”.

Basic Core Formulary: The Basic Core Formulary (BCF) is a list of medications required to be on formulary at all full-service military treatment facilities (MTFs). BCF medications are intended to meet the majority of the primary care needs of DoD beneficiaries. BCF status has no impact on cost-sharing at other points of service

Brand Name Drugs: A brand name drug is a drug marketed under a proprietary, trademark-protected name. Brand name drugs are usually approved by the FDA under a NDA or a BLA. Also see “Authorized Generics.”

Branded Generic: A generic drug, as approved by the FDA under an ANDA, which has a proprietary name. Branded Generics as maintained by the FDA (i.e., Orange Book) and will be treated as generic drugs, unless specified by the DoD P&T Committee.

Business day: Any day in which the contractor’s relevant operations are staffed.

Clarification: Any out-reach to the provider to verify prescription information for completeness, accuracy, legibility and appropriate dosing or other clinical/safety aspects. Examples of necessary information include: prescription information such as drug name and strength, package size, directions, refills, quantity, prescription date, provider's name and provider's signature or beneficiary information such as address, DOB or patient name.

Contract award: Block 28 on SF-33

Clinical Review: Review conducted in response to a request for prior authorization or medical necessity, prompted by submission of the appropriate form (to include electronic methods) from the prescriber or beneficiary or a telephonic inquiry from the prescriber. Appropriateness is determined relative to criteria established by P&T or contractor-developed criteria approved by the government.

Day: Unless otherwise specified, a calendar day, as defined in FAR 2.101.

Direct Member Reimbursement (DMR):Beneficiary request for reimbursement of an agent. See TOM Chapter 23, Section 3 for additional information.

DoD Benefit Number (DBN): A unique identifier assigned to a beneficiary based on association with a DoD sponsor and used to determine benefits. DoD beneficiaries who have multiple sponsors will be assigned unique DBNs for each relationship (DoDI 6040.45). It is typically 11 digits.

DoD Identification Number (DOD ID): A unique 10-digit identifier assigned to each person who has a record in the DEERS database, including all military personnel, family members, employees, most contractors. The DoD identification number identifies the individual in all interactions with DoD. Also known as the EDI-PI (DoDI 6040.45).

Dual eligible beneficiaries: TRICARE beneficaries who also have Medicare Parts A and B.

Dynamic linking: A process to connect various patient idenfication numbers (e.g., patient/sponsor SSN, DBN, DoD ID) to a single patient profile, including claims history and clinical reviews, in instances when patients are detached from one sponsor and reestablished under another separate sponsor. Examples include, but are not limited do, a beneficiary divorcing one TRICARE sponsor and marrying a different TRICARE sponsor, retirement of an active duty member who becomes the dependent of the active duty member spouse, or a dependent of a TRICARE sponsor who becomes his/her own sponsor.

Electronic Claim: Any claim received through electronic submission or other digital media, including batch claims.

Extended Core Formulary: The Extended Core Formulary (ECF) includes medications in therapeutic classes that are used to support more specialized scopes of practice than those on the Basic Core Formulary (BCF). ECF status has no impact on cost-sharing at other points of service.

Federal Ceiling Price (FCP): Pricing provisions of pharmaceuticals dispensed at retail pharmacies as outlined in 38 USC §8126 and 10 USC §1074g(f) and applied as described in 32 CFR 199.21(q). Manufacturers that do not sign the Retail Refund Pricing Agreement for specific pharmaceuticals are considered non-compliant with FCP (Non-FCP compliant).

Non -FCP compliant; Retail Exclusion: Specific drugs of manufacturers that do not sign the Retail Refund Pricing Agreement.

Generic Drugs: A drug containing the identical amounts of active ingredient(s) as the reference brand drug and has been evaluated as “therapeutically equivalent” and expected to have equal effects and no difference when substituted for the brand product. Generic drugs are approved by the FDA under an Abbreviated New Drug Application (ANDA) and are proven to be bioequivalent to an innovator drug. Also see “Branded Generics”.

In writing: Any means of notification as authorized by the beneficiary, including but not limited to, email, secure messaging, a letter delivered via a common carrier.

Initial Period of Performance: A time frame in which the incoming contractor completes the phase-in transition activities during the outgoing contractor’s last Option Period. Also referred to as “Base Period of Performance”, “Start of transition” and “Start-up”.

Intervention: Any out-reach to the provider to request initial or additional information regarding prior authorization, medical necessity or quantity restrictions to confirm clinical and/or safety criteria.

Medical Necessity (MN): A request to demonstrate medical need for a Non-Formulary medication. If approved at retail or mail order, the beneficiary will receive a non-formulary medication at the appropriate tier formulary copay. At the MTF, an approval will allow access to the medication. MNs are categorized as a type of Clinical Review under this contract.

Non-formulary (NF) agent: A higher cost-share tier of agents based on reduced relative clinical effectiveness and cost effectiveness compared to other agents. Cost-share may be reduced with an approved Medical Necessity. These agents are general not available at MTFs without a Medical Necessity.

Non-preferred agent: Generally agents that require an approved prior authorization or prior history of a preferred agent. Non-formulary agents are usually considered non-preferred.

Non-replenishable (non-replenished): Medications or supplies that are not available from the NPV to replace contractor’s stock dispensed for a TRICARE prescription, due to limited distribution or NPV contract limitations This is not the same as “Unreplenishable.”

Not covered: Agent in a therapeutic class determined by the DoD P&T Committee as not to have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome over other pharmaceutical agents (32 CFR 199.21(a)(3)(ii)). Also includes items not covered under the pharmacy benefit (eg, cosmetic). Not covered agents are not available for cost-share.

Paper Claim: A non-electronic claim request for reimbursement, usually by the beneficiary (also known as a direct member reimbursement (DMR) claim), but can also be by the pharmacy. See TOM Chapter 23, Section 3 for additional information.

Preauthorization: Specific type of clinical review relating to the availability of certain medications through the retail pharmacy network under Federal Ceiling Price restrictions described under 32 C.F.R. 199.21(q)(2).

Preferred agent: Agents which generally do not require a prior authorization or prior history of use.

Prior Authorization (PA): See TOM, Appendix A.

Replenished (replenishment): Process by which the Contractor orders agents from the National Prime Vendor to replace stock dispensed by prescription to an eligible TRICARE beneficiary.

Run-off Claims: Claims received at the outgoing contractor's facility prior to the start of pharmacy services of the incoming contractor. The outgoing contractor should process all run-off claims and forward all claims received on or after the new contract's service delivery start date to the new contractor.

Start of pharmacy services: The beginning of Option Period 1, which occurs after the base period of performance, or transition-in, is complete. Also referred to as “Start Date.”

Utilization Management: Efficient management of access to care or drug therapies utilizing available benefit design tools. These may include quantity limits, prior authorizations, step therapy, and other activities to ensure appropriate care while minimizing costs.

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