Prescription Drug and Pharmacy Benefit Coverage Criteria
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Governs coverage, preauthorization, quantity limits, pharmacy types, formulary exceptions, step therapy, and related pharmacy benefit rules for BCBSRI members and providers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Pharmacy-dispensed drug coverage
Covered when ALL of the following are met
Coverage subject to formulary placement, applicable quantity limits, and Subscriber Agreement benefit limits.
Provider-administered drugs
Covered when ALL of the following are met
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:
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.
Coding and Limits
Provider Actions and Requirements
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).
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 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.
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.
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
Step Therapy Rules
| 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
Place of Service and Site-of-Care Rules
Site-of-care requirements — retail, mail order, specialty, or provider
Coverage depends on the place of service: drugs may be covered only when dispensed at a retail, mail order, or designated specialty pharmacy; specialty drugs dispensed by providers are not separately reimbursed unless purchased from a network pharmacy.
- Confirm the required site of service (retail, mail order, specialty) as indicated on the formulary before dispensing.
- Provider-dispensed specialty drugs will not be separately reimbursed unless bought from a network pharmacy.
Background
The formulary is maintained by BCBSRI in conjunction with the pharmacy benefit manager and overseen by a Pharmacy & Therapeutics (P&T) Committee. The P&T Committee provides clinical oversight of formulary recommendations from BCBSRI clinical staff and PBM clinical representatives, including formulary tiering, prior authorization requirements, suggested quantity limits for a 30-day supply, and specialty drug designations. Because of marketplace volatility and the need to update claim systems between scheduled meetings, the Committee has authorized Formulary Guiding Principles that permit clinical staff to implement formulary actions outside the regular meeting schedule. The Committee reviews all decisions and actions on a twice annual basis.
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