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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsFlorida Blue ValueScript Rx Coverage & Prior Auth …
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    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    CurrentFlorida BluePolicy N/A

    ValueScript Rx Medication Guide (Formulary) — Coverage Criteria

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    Defines the closed formulary, coverage tiers, specialty pharmacy rules, and member guidance for prescription drug coverage under Florida Blue's ValueScript Rx plan; applies to members and providers using the ValueScript formulary.

    Policy Summary
    PayerFlorida Blue
    PolicyValueScript Rx Medication Guide (Formulary) — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit a prior authorization form when a medication is marked 'PA' to avoid denial and member liability.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Closedformulary type
    6pharmacy tiers
    1‑monthspecialty dispensing
    ≤12moPA expiry rule
    24/7specialty support

    Coverage Criteria and General Policy Rules

    General coverage conditions

    Covered when meeting plan and formulary conditions:

    Formulary inclusion: Medication must be listed on the ValueScript medication list (closed formulary) to be covered.

    All non-listed medications are not covered.

    Generic substitution and brand requests: Generics are covered unless specifically excluded; if a prescriber requests a brand when a generic is available, the member is responsible for the cost difference unless clinical justification is provided and accepted.

    Providers may submit documentation to request a waiver of the brand–generic cost difference.

    Plan- and tier-specific rules: Coverage, cost sharing, and program applicability (including whether PA, Responsible Steps, or Medical Pharmacy Tier rules apply) depend on the member's specific plan documents and Schedule of Benefits.

    Medication tier assignments may change; the medication guide is updated quarterly and Florida Blue may add/remove drugs at any time.

    Policy Summary
    PayerFlorida Blue
    PolicyValueScript Rx Medication Guide (Formulary) — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit a prior authorization form when a medication is marked 'PA' to avoid denial and member liability.
    SourceLink
    On This Page
    Coverage Criteria and General Policy RulesCoding, Identifiers, and Administrative FlagsProvider Requirements, Prior Authorization, and DocumentationBackground and ScopeDefinitions and Key LegendResponsible Steps / Step-Therapy DetailsQuantity Limits and ExamplesSite of Care and Dispensing Channels
    Specialty medication dispensing (general): Specialty medications are covered only when dispensed through the channels required by the plan (participating specialty pharmacy for self-administered specialty drugs; in‑network provider/medical benefit for provider‑administered specialty drugs).one-month supply standard

    Specialty drugs generally limited to a one-month supply; some specialty products may have different supply rules per manufacturer or FDA dosing.

    Coverage Rules and Programs

    Coverage and access are governed by drug classification, network participation, and administrative programs:

    Self-Administered Specialty Drug Coverage: Self-administered specialty medications must be obtained from a participating specialty pharmacy to be covered at in-network cost share; out-of-network purchases are not covered.

    Self-administered injectables are identified in the medication list with 'inj' and will not be covered if administered in a physician's office unless noted otherwise.

    Provider-Administered Specialty Drug Coverage: Provider‑administered specialty medications are covered under the medical benefit when administered by an in‑network health care provider and may be processed outside the pharmacy benefit.

    Medications administered by a health professional may not appear on the pharmacy drug list and may be subject to the Medical Pharmacy Tier Program.

    Medical Pharmacy Tier Program: Provider-administered medications may be placed in Low or Standard tiers to reduce member cost share; medications in this program may also require prior authorization.

    Check the Medical Pharmacy Low Tier Drug List and plan documents for applicability.

    Prior Authorization Program: Medications indicated in the medication list as requiring Prior Authorization (PA) must have a submitted PA form and approved authorization for coverage; without approval the medication is not covered.PA duration ≤ 12 months

    Prior Authorizations expire on the earlier of the policy termination date or the period authorized by Florida Blue, not to exceed 12 months.

    Responsible Quantity Program: Certain medications have quantity limits (Responsible Quantity Program) based on FDA and manufacturer recommendations; providers may request an override if a larger quantity is medically required.

    Quantity limits are indicated in the medication list.

    Responsible Steps (Step Therapy) Program: Medications in the Responsible Steps Program require trial of one or more prerequisite covered medications before the listed medication is approved; providers may request PA to override for medical reasons.

    Responsible Steps may apply to both pharmacy and certain medical‑administered medications; check the Responsible Steps listings.

    General coverage stance for listed products

    Coverage listing with administrative constraints:

    Formulary inclusion and requirement flags: Products listed on the ValueScript formulary have an assigned Drug Tier and may include Requirement/Limits flags such as PA (Prior Authorization), LD (Limited Distribution), SP (Specialty), and QL (Quantity Limit). Coverage is conditional on meeting any listed Requirement/Limits.

    Examples: vaccines may have QL (e.g., PNEUMOVAX 23 and PREVNAR 20 QL = 1 vaccine/90 days; SHINGRIX QL = 2 vaccines/1 lifetime); many immune globulins and antineoplastics are SP and require PA and/or LD.

    Medications must be listed on the ValueScript medication list (closed formulary) to be covered. Medications not on the formulary are not covered. Reasons a drug may be excluded include documented safety or effectiveness concerns, availability of a preferred formulary or OTC alternative, discontinuation from market, availability of an AB-rated generic, repackaging by another manufacturer, or that the drug is indicated for weight loss. To confirm applicable exclusions, review the member's plan documents or the online member portal.

    Self‑administered specialty medications must be dispensed from a participating specialty pharmacy to be covered at in‑network benefit levels. If obtained from a non‑participating specialty pharmacy, out‑of‑network coverage may be unavailable and the member may be responsible for full cost. Self‑administered injectables are only covered when identified as Specialty Drugs in the Medication List and will follow the member's Brand/Generic cost‑share rules.

    No additional exclusion conditions are explicitly stated in this excerpt beyond those identified in the medication exclusions and formulary rules shown elsewhere in the guide.

    The policy excludes medications that are unsafe or not effective; examples called out include drugs with excessive adverse effects or those for which safer alternatives exist. In addition, medications prescribed for weight loss indications are not covered under the formulary exclusions described.

    Drugs that require Prior Authorization (PA) must have an approved PA before coverage is provided. If the required prior authorization is not obtained or the prescriber fails to submit the PA form, the medication will not be covered and the member may be liable for the full cost.

    This excerpt does not contain explicit statements using the phrase 'not medically necessary.' Coverage determinations for medications lacking required approvals are treated as authorization deficiencies (see PA rules) rather than being labeled in this text as "not medically necessary."

    Coding, Identifiers, and Administrative Flags

    Identifiersmixed
    NCPDP: 6013914Advocate+ Pharmacy Match NCPDP identifier
    NPI: 1366292880Advocate+ Prescriber NPI
    Document header/identifiermixed
    87768 0625Rheader code present on many lines in this excerpt
    Quantity-limited vaccine entriesmixedCovered
    QL (1 vaccine/90 days)Quantity limit applied to PNEUMOVAX 23, PREVNAR 20, VAXNEUVANCE
    QL (2 vaccines/1 lifetime)Quantity limit applied to SHINGRIX (zoster recombinant adjuvanted)
    Administrative requirement flags for specialty/antineoplastic agentsmixed
    PAPrior Authorization flag
    LDLimited Distribution flag
    SPSpecialty designation
    Formulary drug entries (sample)NDC | internal
    COMETRIQ - cabozantinib s-malate cap 3 x 20 mg (60 mg dose) kitDrug Tier = 5; Specialty = SP; Requirements/Limits = PA, LD, QL (1 kit/28 days)
    COPIKTRA - duvelisib cap 15 mg, 25 mgDrug Tier = 5; Specialty = SP; Requirements/Limits = PA, LD, QL (60 capsules/30 days)
    COTELLIC - cobimetinib fumarate tab 20 mg (base equivalent)Drug Tier = 5; Specialty = SP; Requirements/Limits = PA, LD, QL (63 tablets/28 days)
    Formulary drug entries (additional)NDC | internal
    IMBRUVICA - ibrutinib tab 140 mg, 280 mg, 420 mgDrug Tier = 5; Specialty = SP; Requirements/Limits = PA, LD, QL (30 tablets/30 days)
    JAKAFI - ruxolitinib phosphate tab 5 mg ... 25 mgDrug Tier = 5; Specialty = SP; Requirements/Limits = PA, LD, QL (60 tablets/30 days)
    LENVIMA 10 MG DAILY DOSE - lenvatinib cap therapy pack 10 mgDrug Tier = 5; Specialty = SP; Requirements/Limits = PA, LD, QL (30 capsules/30 days)
    Formulary requirement codesmixed
    PAPrior Authorization
    LDLimited Distribution
    SPSpecialty
    STResponsible Steps (Step Therapy)
    QLQuantity Limit (Max Quantity/Time)
    Prior Authorization Expiry
    Prior Authorization ExpiryPrior authorizations expire on the earlier of the policy termination date or the period authorized by Florida Blue, not to exceed 12 months.
    Maximum DurationAuthorization duration will not exceed 12 months for most medications.
    Termination RuleIf the policy terminates earlier than the authorized period, the PA expires on the policy termination date.
    Quantity limits examples
    Example QL — 4/28dQuantity limit example: 4 units per 28 days.
    Example QL — 8/28dQuantity limit example: 8 units per 28 days.
    Example QL — 24/28dQuantity limit example: 24 units per 28 days.
    Example QL — 32/28dQuantity limit example: 32 units per 28 days.
    Example QL — 120/30dQuantity limit example: 120 units per 30 days.
    Example QL — 240/30dQuantity limit example: 240 units per 30 days.
    Repatha limit
    REPATHA (prefilled syringe)Quantity Limit: 6 syringes per 28 days.
    Requirement FlagsListed with PA and QL indicators (prior authorization and quantity limit may apply).
    Coverage NoteCoverage subject to meeting listed Requirements/Limits in the medication list.
    Repatha SureClick limit
    REPATHA SURECLICK (auto-injector)Quantity Limit: 6 pens per 28 days.
    Requirement FlagsListed with PA and QL indicators (prior authorization and quantity limit may apply).
    Coverage NoteCoverage subject to meeting listed Requirements/Limits in the medication list.
    Vyndamax limit
    VYNDAMAX (tafamidis)Quantity Limit: 30 capsules per 30 days.
    Requirement FlagsMarked with PA and QL in the medication list; prior authorization and quantity limits may apply.
    Coverage NoteCovered under specified requirements; refer to medication line for medical necessity criteria.

    Provider Requirements, Prior Authorization, and Documentation

    Prior Authorization

    Prior authorization may be required

    Certain specialty and provider‑administered medications listed in the medication guide may be subject to prior authorization under the plan. Providers should verify the medication's Requirements/Limits field and submit a PA when the PA indicator is present to avoid coverage denial.

    Prior Authorization

    Submit Prior Authorization when PA shown

    When a medication line shows a prior authorization indicator, the prescribing physician is required to complete and submit a Prior Authorization form so the prescription can be considered for coverage; approvals may be limited to the earlier of the policy termination date or up to 12 months.

    Prior Authorization

    PA enforces appropriate use before coverage

    Prior authorization is used to encourage appropriate, safe, and cost‑effective use of medications; if the PA indicator is present the PA program may apply to the member's benefit and coverage may be approved only after listed criteria are met.

    Prior Authorization

    PA required for select high‑tier/specialty drugs

    Select high‑tier and specialty agents (examples in the formulary include NUZYRA and SIRTURO) are designated with Requirements/Limits = PA and require prior authorization before they will be covered.

    • NUZYRA (omadacycline) listed among anti‑infectives with PA flags
    • SIRTURO (bedaquiline) indicated Specialty = SP and Requirements/Limits = PA, LD, QL
    Prior Authorization

    PA required for specialty antivirals/hepatitis C regimens

    Certain high‑cost antivirals and hepatitis C regimens are marked PA (examples include EPCLUSA, HARVONI, MAVYRET, SOVALDI, VOSEVI) and require prior authorization before coverage.

    • EPCLUSA — Requirements/Limits = PA, QL (28 tablets/28 days)
    • MAVYRET — Requirements/Limits = PA, QL (84 tablets/28 days)
    • VOSEVI — Requirements/Limits = PA, QL (28 tablets/28 days)
    Prior Authorization

    PA required for listed agents (examples)

    Listed agents such as VOSEVI, COARTEM, IMPAVIDO, SIVEXTRO, and selected strengths of XIFAXAN carry a PA requirement and must have prior authorization before dispensing.

    • VOSEVI — PA, QL (28 tablets/28 days)
    • COARTEM — Requirements/Limits = PA
    • IMPAVIDO — Requirements/Limits = PA
    • SIVEXTRO — Requirements/Limits = PA, QL (6 tablets/30 days)
    • XIFAXAN — Requirements/Limits = PA, QL (strength‑dependent)
    Prior Authorization

    PA required for many specialty agents

    Many specialty products including immune globulins, antineoplastics, and oral oncology agents are designated 'PA' (and often 'SP'/'LD') and require prior authorization prior to coverage.

    • Immune globulins (e.g., GAMMAGARD, GAMUNEX‑C, HIZENTRA) — Requirements/Limits = PA (and LD where noted)
    • Numerous antineoplastic agents list PA in Requirements/Limits
    Documentation Required

    PA, LD, and QL may apply per product

    Several drugs in the formulary are shown with multiple administrative flags; when PA, LD, and QL appear on a product line, providers must meet prior authorization requirements and adhere to limited distribution and quantity limits as indicated.

    Prior Authorization

    Obtain PA for listed specialty/oncology agents

    This segment of the formulary contains many specialty and oncology agents that are flagged PA; providers must obtain authorization for these products before coverage will be processed.

    Prior Authorization

    PA required for select oncology agents

    Multiple oncology products (e.g., XPOVIO, XTANDI, ZEJULA, YONSA) list Prior Authorization in their Requirements/Limits and require PA before coverage.

    • XPOVIO — Requirements/Limits = PA, LD, QL
    • XTANDI — Requirements/Limits = PA, LD, QL
    • ZEJULA / YONSA — Requirements/Limits = PA, LD, QL
    Prior Authorization

    PA required for selected antidiabetic/GLP‑1 agents

    Selected antidiabetic and GLP‑1 agents are marked with PA in the formulary (examples include MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY, and TRIJARDY XR) and require prior authorization prior to coverage.

    • MOUNJARO — Requirements/Limits = PA, QL (4 pens/28 or 180 days depending on listing)
    • OZEMPIC — Requirements/Limits = PA, QL (1 pen/28 days)
    • RYBELSUS — Requirements/Limits = PA, QL (varies by strength)
    Prior Authorization

    PA required for additional listed drugs

    Numerous other branded therapies (examples include ORILISSA, OSPHENA and others) are shown with a PA requirement on the drug line and must have prior authorization before benefits apply.

    • ORILISSA — Requirements/Limits = PA, QL
    • OSPHENA — Requirements/Limits = PA
    Prior Authorization

    Prior authorization required where indicated

    Certain listed products require prior authorization before coverage; providers must check the Requirements/Limits field and submit PA documentation when 'PA' is indicated.

    Note

    Condition Care Rx Program — check Schedule of Benefits

    The Condition Care Rx Program promotes use of specified, lower‑cost medications for chronic conditions; providers should check the member's Schedule of Benefits to determine program applicability and preferred alternatives.

    Step Therapy

    Responsible Steps: try prerequisites before coverage

    Under the Responsible Steps step‑therapy program, members must try one or more covered alternative medications before the Responsible Steps medication will be covered; providers may request a PA override for medical reasons if prerequisites cannot be used.

    • Provider may submit prior authorization to request an override for medical reasons
    • Responsible Steps lists and forms available at Responsible Steps Program Information
    Step Therapy

    Responsible Steps applies to medical‑administered drugs

    For physician‑administered (medical pharmacy) Responsible Steps drugs, members must trial the prerequisite drug(s) before coverage of the higher‑cost medication; the provider can request a prior authorization override for medical reasons.

    Step Therapy

    Responsible Steps (ST) applies to select antidiabetics

    Step therapy applies to various antidiabetic agents and combinations (Responsible Steps/ST indicated); examples include FARXIGA, GLYXAMBI, JANUMET, JANUMET XR, JANUVIA and related products which are marked ST and have QL where noted.

    • FARXIGA — Requirements/Limits = ST, QL (30 tablets/30 days)
    • JANUMET / JANUMET XR — Requirements/Limits = ST, QL
    • JANUVIA — Requirements/Limits = ST, QL (30 tablets/30 days)
    Note

    ST = Responsible Steps (step therapy indicator)

    The 'ST' label in the Requirements/Limits key denotes Responsible Steps (step therapy); when 'ST' appears on a product line the step‑therapy program may apply and prerequisite requirements must be met.

    Step Therapy

    Follow ST program when applicable; request PA for overrides

    Prescribers must follow the Responsible Steps (ST) program when a product is marked 'ST' on the medication list; if prerequisites cannot be used, submit prior authorization for an override.

    • Check Responsible Steps list for required prerequisite agents
    • Submit PA to request override for medical reasons
    Documentation Required

    Provide documentation when brand required over generic

    If a prescriber requires a brand‑name product when an AB‑rated generic is available, the prescriber must provide supporting documentation to justify the brand to avoid the member being responsible for the cost difference.

    • Supporting documentation required to request exception to the cost difference
    Prior Authorization

    Complete and submit the Prior Authorization form

    Providers are required to complete and submit the Prior Authorization form for coverage determinations when a drug's Requirements/Limits field indicates PA; the decision will be communicated to the member and provider.

    • If PA is denied, the member may purchase the medication but will pay full cost and is not entitled to reimbursement
    Documentation Required

    Submit Coverage Exception Request; note decision timelines

    Coverage exceptions (standard or expedited) must be submitted using the Coverage Exception Request Form by the prescriber, member, or designee; standard requests are decided within 72 hours and expedited requests within 24 hours.

    • Standard exception decision: within 72 hours
    • Expedited exception decision: within 24 hours
    Documentation Required

    Documentation and limits for antimycobacterial agents

    Specialty antimycobacterial agents (e.g., SIRTURO, pretomanid) are listed with PA and LD flags and have specified QL values that must be adhered to when requesting coverage.

    • SIRTURO (bedaquiline) — Requirements/Limits = PA, LD, QL (940 tablets/365 days or 188 tablets/365 days depending on strength)
    • PRETOMANID — Requirements/Limits = LD, QL (182 tablets/365 days)
    Prior Authorization

    Obtain PA for specialty antiviral agents

    Prescribers must obtain prior authorization for the specialty antiviral agents flagged PA in the medication list before dispensing; PA documentation should be submitted per the Prior Authorization Program instructions.

    Documentation Required

    PA/LD indicate authorization or distribution controls

    The formulary key indicates 'PA' and 'LD' denote payer authorization and limited distribution controls; products so marked require submission of authorization documentation and adherence to the specified distribution channel.

    Documentation Required

    Submit authorization docs and use LD channels for PA/LD products

    Products labeled 'PA' require prior authorization documentation and products labeled 'LD' must be sourced through the limited distribution network listed; providers must supply authorization and follow distribution procedures when applicable.

    Note

    Key: PA, LD, QL definitions

    The policy key explains the requirement codes: PA = Prior Authorization; LD = Limited Distribution; QL = Quantity Limit (maximum quantity per time period).

    Documentation Required

    Supply authorization info for PA/LD/QL drugs

    The medication list shows which products carry PA, LD, and QL requirements; providers must meet these requirements and include authorization details when submitting claims for PA‑designated drugs.

    Documentation Required

    Provide PA documentation and use LD channels as required

    Prescribers must provide documentation to satisfy prior authorization when requesting drugs marked 'PA' and must use the specialty or limited distribution channels indicated for drugs marked 'LD'.

    Documentation Required

    Adhere to formulary requirement tags on drug lines

    Formulary entries include requirement tags (PA, ST, QL); when these tags appear the provider must follow the associated program rules or supply required documentation as part of the authorization or claims process.

    Documentation Required

    LD and PA products require distribution documentation and PA

    When a product is designated LD and/or PA, providers must document limited distribution sourcing and submit prior authorization as required; examples in the guide include medications such as Kuvan and SOMAVERT.

    • KUVAN — Requirements/Limits = PA, LD
    • SOMAVERT — Requirements/Limits = LD
    Billing Rule

    Adhere to quantity limits; exceedances require documentation/PA

    Many specialty drugs include quantity limits (QL) specified per drug and time period; prescriptions that exceed the stated QL may require supporting documentation or prior authorization for coverage.

    • Repatha — QL (6 syringes/28 days)
    • Examples show QL values for numerous products across the formulary
    Denial Risk

    Non‑formulary medications are not covered

    Medications not listed on the ValueScript formulary are not covered; prescribing a non‑formulary medication without an approved exception may result in denial and full member financial responsibility.

    Denial Risk

    No PA submitted/received → no coverage

    If a prior authorization is not requested or received for a PA‑flagged drug, the medication will not be covered and the member will be responsible for the full cost without entitlement to reimbursement.

    Denial Risk

    PA noncompliance may trigger denial

    Failure to meet the prior authorization criteria for drugs that display a PA indicator may result in coverage denial; providers should ensure PA criteria are met before dispensing.

    Denial Risk

    PA/LD/SP/QL flags may trigger denial if unmet

    Drugs marked with PA, LD, SP, or QL indicate utilization management or distribution controls; if those requirements are not met (for example, sourcing via LD or obtaining PA), coverage may be denied.

    Denial Risk

    PA required for select hepatitis C/antiviral agents

    Certain hepatitis C and other specialty antiviral agents (EPCLUSA, HARVONI, MAVYRET, SOVALDI, VOSEVI) are subject to prior authorization and may be denied if PA is not obtained.

    Documentation Required

    Follow PA/LD markers on drug lines

    Authorization markers (PA, LD) are present next to many drug lines (e.g., COARTEM, VOSEVI, BENZNIDAZOLE) and indicate that payer authorization or limited distribution procedures must be followed to obtain coverage.

    Denial Risk

    Obtain PA and follow LD channels to avoid denial

    Requests for products flagged 'PA' or 'LD' may be denied if prior authorization is not obtained or if distribution constraints are not followed; providers must obtain approval and route orders through the correct channels.

    Denial Risk

    Claims may be denied without PA

    Claims for products with 'PA' in the Requirements/Limits field may be denied without an approved prior authorization; ensure PA is in place before claim submission.

    Denial Risk

    PA and LD noncompliance risks denial

    Drugs listed with PA and/or LD require an approved prior authorization and, for LD products, sourcing through the specified limited distribution channel; failure to comply may result in denial or claim processing failure.

    Denial Risk

    PA, LD, or QL violations may prompt denial

    Requests for medications listed with PA, LD, or exceeding specified QL values may be denied or require prior authorization review; check each product's Requirements/Limits prior to prescribing or dispensing.

    Documentation Required

    PA/ST/QL on line items require documentation or PA

    When a prescription is marked with PA, ST, or QL, prior authorization or evidence of prerequisite therapy and adherence to quantity limits may be required for approval; providers should submit necessary documentation to support the request.

    Denial Risk

    Exceeding QL or missing PA may cause denial

    Requests that exceed quantity limits (e.g., tolvaptan Jynarque 56 tablets/28 days or Samsca listings) or lack required prior authorization may be denied; obtain PA or provide justification when exceeding QL.

    • Jynarque (tolvaptan) — QL 56 tablets/28 days
    • Samsca (tolvaptan) — QL examples include 30 tablets/365 days or 60 tablets/30 days
    Prior Authorization

    Verify PA applicability and obtain authorization

    Prior authorization is required for many of the drugs flagged 'PA' in the medication list; providers should verify PA applicability for the patient’s plan and obtain authorization to avoid claim denials.

    Background and Scope

    This medication guide lists covered drugs by formulary inclusion and encourages generic substitution where appropriate to reduce member cost. Specialty drugs are identified as high‑cost agents that frequently require special handling—many are managed through designated specialty pharmacy channels or covered under the medical benefit when provider‑administered. Specialty products are commonly subject to utilization controls such as Prior Authorization (PA), Limited Distribution (LD), and Quantity Limits (QL), and specialty dispensing is typically limited to a one‑month supply unless otherwise indicated.

    Definitions and Key Legend

    Specialty Pharmacy Medications
    DefinitionSpecialty Pharmacy Medications are high-cost injectable, infused, oral or inhaled medications that generally require close supervision and monitoring of the patient's therapy.
    DispensingSpecialty drugs are only covered when dispensed from a Specialty Pharmacy (self-administered specialty drugs) or when administered by a provider (provider-administered) under the medical benefit.
    Standard SupplySpecialty Drugs are generally dispensed up to a one-month supply unless otherwise specified by manufacturer packaging or FDA dosing requirements.
    Pharmacy Tiers
    Tier StructureSix tiers: Tier 1 preventive; Tier 2 condition care generic; Tier 3 low-cost generic; Tier 4 condition care brand; Tier 5 high-cost generic/preferred brand; Tier 6 specialty/non-preferred (some specialty drugs may be listed in lower tiers).
    Cost-share ImplicationTier assignment determines member cost share as described in the member's Schedule of Benefits.
    Tier ChangesMedications may be reassigned between tiers and are reviewed quarterly.
    Self-Administered Specialty Medications
    DefinitionSelf-Administered Specialty Medications are specialty pharmacy medications intended for patient self-administration (often designated with 'inj' for injectables in the medication list).
    Coverage CaveatThese medications may not be covered if administered in a physician's office and must be obtained from a participating specialty pharmacy for in-network coverage; out-of-network coverage is not available if not obtained from a participating specialty pharmacy.
    Cost-shareSelf-administered injectables are subject to the Brand or Generic cost share as described in the member's Schedule of Benefits.
    Provider-Administered Specialty Medications
    DefinitionProvider-Administered Specialty Medications require administration by a physician and are covered under the member's medical benefit.
    SourcingThese medications can be obtained from any in‑network health care provider and may be billed to the medical benefit rather than pharmacy benefit.
    Program InclusionSome provider‑administered specialty drugs may be included in Medical Pharmacy tier programs and may be subject to prior authorization.
    Responsible Steps Program
    Program PurposeResponsible Steps is a step‑therapy program for certain physician‑administered drugs that requires trial of one or more prerequisite covered medications before coverage of the Responsible Steps medication.
    OverrideProviders may request a prior authorization override for medical reasons if the prerequisite cannot be used.
    ApplicabilityApplies to select drugs and may include medications administered in a physician's office (medical pharmacy).
    Coverage Exception
    PurposeCoverage Exception process allows requests for non‑formulary medications or deviations from step‑therapy protocols via standard or expedited exception requests.
    SubmissionException requests may be submitted by the prescriber, member, or designee using the Coverage Exception Request Form.
    TimelinesDecision timelines: standard requests — notified within 72 hours; expedited requests — notified within 24 hours for exigent circumstances.
    KEY legend — Abbreviations
    PAPrior Authorization — coverage requires pre‑approval before the drug will be covered.
    LDLimited Distribution — product distribution is limited to specific channels designated by the manufacturer.
    SPSpecialty — product designated and managed as a specialty medication (often requiring specialty pharmacy).
    STST = Responsible Steps (step therapy) — prerequisite drug(s) may be required before coverage of the listed medication.
    QLQuantity Limit (QL) — maximum quantity allowed per specified time period.
    PA — Prior Authorization
    Prior Authorization (PA)Prior Authorization — coverage requires pre‑approval from Florida Blue before the drug will be covered.
    UseIf the PA indicator is present on the medication list, providers must submit a PA request; claims may be denied without an approved PA.
    DocumentationProviders must supply supporting documentation when requesting PA; specific clinical criteria are provided with the PA decision letter.
    QL — Quantity Limit
    Quantity Limit (QL)Quantity Limit — the maximum quantity that can be dispensed over a given period (e.g., vaccines commonly 1 vaccine/90 days; Shingrix 2 vaccines/1 lifetime).
    ApplicationMedications with a QL indicator in the medication list are subject to the specified maximum quantity and time period.
    OverridesProviders can request an override when a larger quantity is medically required via the Responsible Quantity/exception process.
    SP — Specialty
    Specialty (SP)Specialty — product managed as a specialty medication, often high‑cost and requiring special handling, storage, distribution, or monitoring.
    ChannelSpecialty products are typically dispensed through a Specialty Pharmacy and may require use of preferred specialty channels for in‑network coverage.
    BenefitSome specialty medications administered by a provider are covered under the medical benefit rather than the pharmacy benefit.
    LD — Limited Distribution
    Limited Distribution (LD)Limited Distribution — certain drugs are distributed through one or a limited number of specialty pharmacies chosen by the manufacturer.
    ImplicationLD drugs may require channel‑specific sourcing and adherence to manufacturer distribution networks for coverage.
    Prior AuthorizationLD products commonly also have PA and QL requirements; claims may be denied if distribution constraints are not met.
    PA — Prior Authorization (coverage requires pre-approval)
    PA — DefinitionPrior Authorization: when a PA indicator is present, the prescriber must submit a prior authorization request; coverage is contingent on approval.
    ConsequencesIf PA is not requested/received or criteria are not met, the medication will not be covered and the member may be financially responsible.
    Duration NoteApproved PAs expire on the earlier of the policy termination date or the period authorized by Florida Blue (not to exceed 12 months).
    SP — Specialty (medication designation)
    SP — Specialty (legend)Specialty: product managed as a specialty medication and typically handled through specialty pharmacy channels.
    ExamplesMany high‑cost agents (immune globulins, antineoplastics, oral oncology agents) are designated SP in the medication list.
    Coverage PathwaySpecialty designation may trigger PA, LD, and QL utilization controls.
    LD — Limited Distribution (distribution channels)
    LD — Limited DistributionLimited Distribution: product distribution is limited to specific channels or specialty pharmacies designated by the manufacturer.
    Coverage RequirementLD products may require sourcing from specified pharmacies and often have PA and QL requirements listed.
    Denial RiskClaims may be denied if LD distribution constraints are not met.
    QL — Quantity Limit examples
    QL — ExamplesQuantity limits include examples such as 1 vaccine/90 days for many pneumococcal vaccines and 2 vaccines/1 lifetime for Shingrix.
    Vaccine QLsPNEUMOVAX 23, PREVNAR 20, and VAXNEUVANCE: QL = 1 vaccine/90 days; SHINGRIX: QL = 2 vaccines/1 lifetime.
    ApplicationQLs are specified in the medication list next to each product and govern dispensing frequency.
    PA / LD / QL — Legend reiteration
    Legend — PA / LD / QLPA = Prior Authorization; LD = Limited Distribution; QL = Quantity Limit (Max Quantity/Time).
    UsageThese codes appear in the Requirements/Limits column of the medication list to indicate utilization controls that may apply to coverage.
    InterplayProducts may carry multiple flags (e.g., PA + LD + QL) requiring compliance with all noted controls for coverage.
    ST — Responsible Steps (legend entry)
    ST — Responsible StepsST indicates Responsible Steps (step therapy); no detailed step sequence is provided in this excerpt but it signals prerequisite drug requirements may apply.
    Provider ActionProviders may request PA overrides for medical reasons when prerequisites cannot be used.
    ApplicabilityST appears in the legend and may apply to select products elsewhere in the formulary.
    Key abbreviations summary
    PAPrior Authorization — pre‑approval is required for coverage when indicated.
    LDLimited Distribution — restricted dispensing channels may apply.
    SPSpecialty — product designated as specialty medication requiring specialty management.
    QLQuantity Limit — maximum quantity allowed per specified time period.
    STResponsible Steps — step therapy indicator requiring trial of prerequisite medications when applicable.

    Responsible Steps / Step-Therapy Details

    ProgramDescription
    Condition Care Rx ProgramThe Condition Care Rx Program encourages use of specified lower‑cost medications for certain chronic conditions and offers reduced‑cost options; members should check their Schedule of Benefits to determine applicability and cost share.
    Where to confirm applicabilityCheck the member's Schedule of Benefits or the member section of www.floridablue.com for program details and applicable cost share.
    RequirementDetails
    Prerequisite medication trialResponsible Steps requires members to try one or more covered alternative (prerequisite) medications before the Responsible Steps medication is covered.
    Provider exemption processIf a patient cannot use the prerequisite drug for medical reasons, the provider may request an override via prior authorization; if approved, coverage for the Responsible Steps medication will be provided.
    Who is affectedAction required
    Members prescribed Responsible Steps medicationsMembers must have tried the specified prerequisite drug(s) prior to approval unless a prior authorization override is granted for medical reasons.
    ProvidersProviders may submit a prior authorization request to request an exemption/override when a prerequisite medication is medically inappropriate.
    DrugDesignation / Requirements
    NUZYRA (omadacycline) 150 mg tabletsDesignated Specialty (SP); Requirements/Limits: Prior Authorization (PA), Limited Distribution (LD), Quantity Limit QL (30 tablets/180 days).
    Drug groupDesignation / Requirements
    Selected hepatitis C regimens (examples: EPCLUSA, MAVYRET, VOSEVI)Designated Specialty (SP) where noted; Prior Authorization (PA) is required and quantity limits (QL) apply per listing.
    IssueNotes
    Limited‑distribution products (LD)Some products are identified as Limited Distribution (LD) requiring sourcing through specified channels; no explicit step sequence is provided in the excerpt.
    Step Therapy detailsSummary
    Explicit step sequencesNo explicit step therapy steps are listed in this segment; the key defines 'ST' as 'Responsible Steps' but detailed sequences are not provided in the excerpt.
    Presence of ST flagImplication
    ST indicated on some specialty/high‑tier agentsThe 'ST = Responsible Steps' indicator appears for select agents, signaling that step therapy may apply where listed.
    Therapeutic examplesResponsible Steps note
    Antidiabetic combination products (examples)Multiple antidiabetic agents and combinations (e.g., FARXIGA, GLYXAMBI, JANUMET / JANUMET XR, JANUVIA, JARDIANCE, SYNJARDY, TRIJARDY XR, XIGDUO XR) are marked with ST indicating Responsible Steps may apply.
    Legend indicatorMeaning
    ST in document legendThe legend includes 'ST = Responsible Steps', indicating that step therapy requirements may apply to products noted elsewhere in the formulary.
    ApplicabilityProvider responsibility
    Where Responsible Steps appliesWhen a product is noted with 'ST', prescribers must follow the Responsible Steps program requirements when applicable; providers can seek PA overrides for medical reasons.

    Quantity Limits and Examples

    Specialty medications (general)
    Standard SupplySpecialty medications are generally dispensed as a one‑month supply (standard).
    ExceptionsSome specialty products may vary from the one‑month supply due to manufacturer package size or FDA‑approved dosing for a course of therapy.
    Check PlanCoverage details and any plan‑specific variations are provided in the member's plan documents and Schedule of Benefits.
    Responsible Quantity Drugs
    Responsible Quantity DrugsMaximum quantity per month is specified for Responsible Quantity Drugs as indicated in the medication list.
    BasisQuantity limits are based on FDA guidance and manufacturer dosing recommendations.
    Override ProcessProviders can request an override when a larger quantity is medically required via the Responsible Quantity authorization process.
    fidaxomicin susp 40 mg/ml (DIFICID)
    DIFICID (fidaxomicin) suspension 40 mg/mlQuantity Limit: 272 mls (QL 272 mls/180 days).
    Tier/FlagsListed with Drug Tier = 5 and QL specified in the medication list.
    OverrideOverrides available if larger quantity is medically necessary as per Responsible Quantity Program.
    fidaxomicin tab 200 mg (DIFICID)
    DIFICID (fidaxomicin) tablets 200 mgQuantity Limit: 40 tablets (QL 40 tablets/180 days).
    Tier/FlagsListed with Drug Tier = 5 and QL specified in the medication list.
    Coverage NoteCoverage subject to meeting listed QL and any PA if applicable.
    itraconazole (Sporanox) — capsules & oral solution
    Itraconazole capsules 100 mg (Sporanox)Quantity Limit: 120 capsules (QL 120 capsules/30 days).
    Itraconazole oral solution 10 mg/ml (Sporanox)Quantity Limit: 1200 mls (QL 1200 mls/30 days).
    Tier/FlagsEntries listed with Drug Tier = 5 and QL (and PA where indicated) in the medication list.
    terbinafine hcl tab 250 mg
    Terbinafine HCl 250 mg tabletsQuantity Limit: 30 tablets per 30 days.
    TierListed in medication list with specified QL.
    Coverage NoteCoverage subject to listed Requirements/Limits; overrides possible if medically necessary.
    Selected antiviral/HIV product quantity limits
    Ziagen — abacavir sulfate solution 20 mg/mlQuantity Limit: 960 mls per 30 days.
    BARACLUDE — entecavir oral solution 0.05 mg/mlQuantity Limit: 630 mls per 30 days.
    HIV combination productsVarious HIV combination products listed with QL commonly 30 tablets per 30 days.
    SIRTURO / PRETOMANID examples
    SIRTURO (bedaquiline) tabletsQuantity Limits: examples include 940 tablets/365 days and 188 tablets/365 days (strength‑dependent).
    PRETOMANID (pretomanid) 200 mg tabletsQuantity Limit: 182 tablets/365 days.
    LD/PA FlagsThese antimycobacterial agents commonly carry PA, LD, and QL flags in the medication list.
    darunavir 600 mg
    Darunavir 600 mgQuantity Limit: 60 tablets per 30 days (QL 60/30d).
    Darunavir 800 mgQuantity Limit: 30 tablets per 30 days (QL 30/30d).
    Tier/FlagsListed with Drug Tier = 5 and QL in the medication list.
    darunavir 800 mg
    Darunavir 800 mgQuantity Limit: 30 tablets per 30 days (QL 30/30d).
    Tier/FlagsListed with Drug Tier = 5 and QL in the medication list.
    Coverage NoteCoverage subject to meeting the specified QL and any PA if indicated.
    EPCLUSA / MAVYRET
    EPCLUSA (sofosbuvir-velpatasvir)PA and QL apply: 28 tablets per 28 days.
    MAVYRET (glecaprevir-pibrentasvir)PA and QL apply: 84 tablets per 28 days or pellet pack QL 140 packets per 28 days.
    Coverage NoteBoth products are specialty antiviral agents with PA and QL controls listed in the medication guide.
    SUNLENCA, PAXLOVID, and selected antiviral QLs
    SUNLENCA (lenacapavir)Limited Distribution and QL: 4 tablets per 365 days (or therapy pack limits).
    PAXLOVID packagingPAXLOVID packaging variations have QL ranging from 11 to 30 tablets per 30 days depending on pack size.
    TRIUMEQ / TRUVADA / VEMLIDYExamples of QLs for antiviral agents (e.g., TRIUMEQ 180 tablets/30 days; TRUVADA 30 tablets/30 days; VEMLIDY 30 tablets/30 days).
    Selected quantity limit highlights (REPATHA, VYNDAMAX, etc.)
    REPATHA (prefilled syringe)Quantity Limit: 6 syringes per 28 days.
    REPATHA SURECLICK (auto-injector)Quantity Limit: 6 pens per 28 days.
    VYNDAMAXQuantity Limit: 30 capsules per 30 days.

    Site of Care and Dispensing Channels

    Billing Rule

    Dispense self‑administered specialty drugs via participating specialty pharmacies

    Self‑administered specialty medications must be dispensed from participating specialty pharmacies for in‑network coverage; provider‑administered specialty medications are covered under the medical benefit and administered in an office or outpatient setting.

    • Self‑administered specialty drugs: dispense from participating specialty pharmacies (one‑month supply standard)
    • Provider‑administered specialty drugs: bill under medical benefit and administer in‑office/outpatient
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