CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Prescription Drug and Pharmacy Benefit Coverage Criteria

Governs coverage, preauthorization, quantity limits, pharmacy types, formulary exceptions, step therapy, and related pharmacy benefit rules for BCBSRI members and providers.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPrescription Drug and Pharmacy Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a preauthorization request form via BCBSRI or PBM contact when a drug requires prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 daysstandard written notice for preauthorization/coverage exception determinations

72 hrsresponse time for expedited preauthorization

24 hrsresponse time for expedited formulary/coverage exception

twice annualformulary updates

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Coverage Criteria

Pharmacy-dispensed drug coverage

Covered when ALL of the following are met

Standard pharmacy-dispensed prescriptions: The prescription is a legend drug or a compound containing at least one legend drug; the prescription is medically necessary and consistent with the prescriber's diagnosis; the drug is ordered by a licensed prescriber and filled at a pharmacy licensed to dispense the medication in accordance with state and federal law; the drug is dispensed at the place of service required by the formulary (e.g., retail, mail order, or specialty pharmacy when specified); and the quantity dispensed does not exceed the prescriber's authorization or the limits in the Subscriber Agreement Summary of Pharmacy Benefits.

Coverage subject to formulary placement, applicable quantity limits, and Subscriber Agreement benefit limits.

Provider-administered drugs

Covered when ALL of the following are met

Provider-administered injectable/infusible drugs: When a prescription drug is administered by injection or infusion by a licensed healthcare provider (other than a pharmacy), the drug is covered separately from the medical service when preauthorization is obtained if required; benefit limits and member cost sharing are subject to the Subscriber Agreement Summary of Medical Benefits; specialty drugs administered by a professional provider are not separately reimbursed unless purchased from a network pharmacy.

Coverage varies based on place of administration and applicable preauthorization requirements.

Formulary decision-making and implementation

Covered formulary governance actions and how they are decided:

P&T oversight: The Pharmacy & Therapeutics (P&T) Committee provides clinical oversight of plan-sponsored recommendations including formulary tiering, prior authorization requirements, suggested quantity limits for a 30-day supply, and specialty drug designation; committee evaluation is based on clinical information presented by BCBSRI clinical staff and PBM clinical representatives.

Pre-P&T review: A pre-P&T group (BCBSRI clinical pharmacy staff, Plan Medical Director, and PBM clinical representatives) reviews new drugs, generics, clinical studies, utilization data, and contracting/rebate implications to develop recommendations and model formulary tier changes prior to presentation to the full Committee.

Triggers for formulary action: Triggers for recommending formulary action include impending generic availability, release of new clinical studies for an important therapeutic class, PBM contracting/rebate opportunities for preferred status, utilization review findings suggesting need for prior authorization or quantity limits, marketplace pricing changes, and FDA approvals of new drugs.

The policy excludes a range of products from pharmacy coverage. Notable exclusions include biological products for allergen immunotherapy and vaccinations, blood fractions, and compound prescription drugs that do not contain at least one legend drug. Bulk powders and chemicals used in compound prescriptions that are not FDA approved are also excluded unless specifically listed on the formulary. Coverage is not provided for drugs that have not proven effective per the FDA, drugs purchased from a non-designated pharmacy when a Pharmacy Home Assignment applies, cosmetic uses, experimental drugs, or prescription-related supplies (except diabetic supplies). Additional exclusions include prescribed weight-loss drugs, replacement of lost/stolen medications, sexual dysfunction drugs, most therapeutic devices and appliances (except insulin administration supplies), vitamins unless listed, certain controlled substances and specialty drugs when purchased from mail order if restricted, and refills beyond authorized limits or over one year from the original prescription.

Coverage is denied for prescription drugs and specialty drugs when required preauthorization is not obtained. Prescriptions filled through internet pharmacies that are not a verified internet pharmacy practice site (per National Association of Boards of Pharmacy certification) are excluded. The policy also excludes certain products with OTC equivalents and illegal drugs (including medical marijuana dispensed in violation of law). These exclusions reinforce the importance of obtaining applicable preauthorization and using network-designated pharmacies to avoid claim denial or noncoverage.

No additional exclusions or coverage criteria are stated in this portion of the document.

The policy lists items considered not medically necessary or otherwise excluded from coverage, including off-label use of prescription drugs except as described in the Experimental or Investigational Services section. It also excludes most therapeutic devices and appliances (non-insulin) and certain supply items regardless of intended use or stated medical necessity. Providers should therefore ensure requests for off-label uses reference the appropriate experimental/ investigational policy language and supply clinical justification where applicable.

Provider Actions and Requirements

Prior Authorization

Prescription Drug Preauthorization

Prescription drug preauthorization is advance approval required before BCBSRI provides coverage for certain prescription drugs. Services that require preauthorization are marked in the published Prescription Preferred Drug List. Preauthorization is not a guarantee of payment and does not consider benefit limits.

To obtain preauthorization, the prescribing provider must submit a prescription drug preauthorization request form available on BCBSRI.com, by calling the Pharmacist number on the member's ID card, or by contacting the Physician & Provider Service Center.
Initial reviews are performed by pharmacists and authorized personnel against plan clinical criteria; requests that may be denied are reviewed by a physician reviewer who makes the final determination.
Written notification of approval or denial will be sent to members and practitioners within 14 calendar days of receipt (expedited reviews: 24 hours when delay poses significant risk).

Documentation Required

Formulary or Coverage Exception Process (Documentation Requirements)

When a drug is not on the formulary, the prescribing provider (or member) may submit a Coverage Exception form with all relevant clinical information to establish medical necessity.

Include contraindications, allergies, adverse reactions to alternatives, and documentation of medications previously tried and failed.
Pharmacists perform initial reviews against medical necessity criteria; physician reviewers adjudicate requests that may be denied.
If an exception is granted, copayment will be at the highest non‑specialty formulary tier and other benefit requirements (such as step therapy) still apply.
Expedited formulary/coverage exception requests should be marked 'urgent' or communicated to Customer Service; determinations are provided within 24 hours for urgent requests.

Step Therapy

Step Therapy Process

Step therapy requires that a member try a preferred agent(s) prior to coverage of an alternative drug. The intent is to document trial and treatment failure or adverse reaction to the preferred agent before covering the requested drug.

Pharmacy claim history may be used to demonstrate prior use of required step agents (look‑back).
Step therapy is a form of utilization management and may be applied even when an exception is requested unless specifically waived.
Providers should supply clinical records documenting trials, failures, or adverse events to support exception requests to bypass step therapy.

Note

Step Therapy Determination and Formulary‑Driven Management

Decisions about implementing step therapy or other management strategies are informed by Pre‑P&T and PBM reviews that compare new drugs to existing products and model formulary tiering and rebate impacts.

Pre‑P&T analyses consider clinical study advantages, class redundancy, generic pipeline, and potential member impact.
PBM modeling of formulary tier changes, rebates, and member out‑of‑pocket effects contributes to recommendations that can trigger prior authorization, quantity limits, specialty designation, or step therapy requirements.
Formulary actions made between full P&T meetings follow Formulary Guiding Principles authorized by the Committee and may result in timely claim‑processing updates.

Denial Risk

Triggers for Denial

Coverage may be denied when required preauthorization is not obtained, when drugs are not on the formulary and no exception is granted, or when the service falls under policy exclusions.

Examples of denial triggers include: missing or incomplete preauthorization, failure to demonstrate medical necessity for a formulary exception, drugs falling within stated exclusions (e.g., experimental drugs, off‑label uses not covered, non‑designated pharmacy purchases).
Providers should submit complete clinical documentation (records, prior medication trials, adverse reactions) with exception or preauthorization requests to reduce denial risk.
If a request is potentially deniable after pharmacist review, it will be escalated to a physician reviewer for final determination; written notice will be provided within the required timeframe.

Definitions

inv-18: Specialty pharmacy / specialty prescription drugs — Specialty pharmacies dispense drugs designated as specialty on the formulary; specialty drugs may have different place-of-service coverage

DefinitionSpecialty pharmacies dispense drugs designated as specialty on the formulary.

Place-of-service differencesSpecialty drugs may have different place‑of‑service coverage and reimbursement compared with retail or mail order dispensing.

Coverage determinationCoverage and whether a drug must be obtained from a specialty pharmacy is determined by formulary placement and P&T decisions.

inv-19: Formulary Guiding Principles — A set of guidelines authorized by the P&T Committee that allow clinical staff to implement formulary actions outside of scheduled Committee meetings

AuthorityFormulary Guiding Principles are guidelines authorized by the P&T Committee to allow clinical staff to implement formulary actions outside scheduled Committee meetings.

PurposeThey provide direction to update the claims system based upon a standard set of principles to respond timely to marketplace and claim processing needs.

Review cadenceAll actions taken under these principles are reviewed by the full P&T Committee as part of the twice‑annual formulary update process.

Step	Requirement	How prior trial is demonstrated
1	Must try a preferred agent first before coverage of an alternative agent is granted	Pharmacy claims history may be used to demonstrate prior use or documented treatment failure/adverse reaction

Decision group	Basis for step therapy requirement	Resulting action
Pre‑P&T review (BCBSRI clinical pharmacy staff, Plan Medical Director, PBM clinical representatives)	Assessment of new drugs versus existing products, clinical study review, utilization data, and contracting/rebate implications	Develops recommendations and models formulary placement; may propose step therapy requirements for presentation to full P&T Committee
P&T Committee	Evaluation of pre‑P&T recommendations, therapeutic class reviews, utilization findings, generic availability, PBM contracting opportunities, and FDA approvals	Adoption, modification, or disapproval of proposed step therapy requirements and other formulary management actions

Quantity Limits

inv-22: various (listed on formulary) — per formulary (may restrict number of prescriptions in time period, pills per 30-day, or 90-day supply)

Formulary-listed limitsQuantity limits vary by drug and are listed on the formulary; they may restrict number of prescriptions in a timeframe, pills per 30‑day, or 90‑day supply.

Where to find detailsDrug‑specific quantity limit information is available on the BCBSRI formulary on the website or via Customer Service.

Periodic reviewQuantity limit criteria are subject to periodic review and modification based on clinical policy updates.

inv-23: unspecified — amount allowed for a 30 day supply as determined by Committee/PBM

Determination of 30‑day amountThe amount allowed for a 30‑day supply is determined by the P&T Committee in conjunction with PBM recommendations.

Committee/PBM roleSuggested quantity limits for a 30‑day supply are part of plan‑sponsored recommendations reviewed by the P&T Committee.

ImplementationCommittee decisions on 30‑day quantity limits are implemented in the claims system following Formulary Guiding Principles as needed.

OpenPayer

Prescription Drug and Pharmacy Benefit Coverage Criteria

Coverage Criteria

Coding and Limits

Provider Actions and Requirements

Definitions

Step Therapy Rules

Quantity Limits

Place of Service and Site-of-Care Rules

Background