Medical Necessity Criteria and Dispensing Quantity Limits
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Rules for prior authorization, step therapy, and dispensing quantity limits that apply to the Individual/Small Group/Student ISHIP Metallic closed formulary (Rx plans M1, M2, M4) for Premera Bluecross members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Applicability
General medical necessity conditions
Coverage applies when drugs are on the closed formulary and meet prior authorization, step therapy, and quantity limit rules.
See drug-specific quantity limits listed in the policy and verify member's benefit for applicability to closed formulary plans.
Antiretroviral Quantity Limits
Antiretroviral-specific quantity rules
See table entries for product-specific limits (examples: Abacavir 60 mL or 60 tablets per 30 days; Biktarvy 30 tablets per 30 days; Atazanavir 30 or 60 capsules per 30 days depending on strength; Norvir 360 packets per 30 days; Reyataz 150 packets per 30 days).
This policy applies only to closed formulary pharmacy benefits sold on state and federal insurance exchanges. It does not govern coverage for open benefit designs in which non-formulary drugs may be covered (these may be provided at a different tier under the member contract). Providers should verify the member's formulary and plan-specific benefits when requesting authorization or determining coverage.
Quantity limits were removed in the 2026 update for numerous products either because the product was discontinued, moved to another policy, or is now managed under Policy 5.01.656 Drug Quantity Management. Examples of drugs with removed limits include abiraterone, anastrozole, bicalutamide, capecitabine, imatinib, letrozole, tamoxifen, and many others; a separate group of discontinued products (e.g., Alora, Axiron, Fortesta) were also cleared from the quantity limit tables.
This medical policy does not apply to Medicare Advantage benefits. Member contracts and benefit booklets should be consulted to determine coverage for Medicare Advantage enrollees.
Coverage for non-formulary drugs under open benefit designs is not governed by this policy. Requests for non-formulary products in open designs should be evaluated according to the member's contract and any applicable exception or medical-necessity review processes outside this closed-formulary policy.
Provider Responsibilities and Authorization Rules
Prior authorization and step therapy apply to closed formulary drugs
Prior authorization, step therapy, and quantity limits apply only when the drug is on the plan's closed formulary (Individual/Small Group/Student ISHIP Metallic formulary: Rx plans M1, M2, M4). Verify the member's plan booklet or ID card to confirm applicability before requesting authorization.
- Applies to closed formulary pharmacy benefits sold on state and federal exchanges (Metallic formulary).
- Policy does not apply to open benefit designs where non‑formulary drugs may be covered.
Pharmacy benefit prior authorization and step therapy
Drugs addressed in this policy are managed under the pharmacy benefit and may require prior authorization; many require step‑therapy that mandates trial and failure of specified first‑step formulary agents before coverage of second‑step agents.
- Use the pharmacy benefit/formulary when submitting prior authorization requests.
- Step‑therapy requirements are based on trial and failure of specified first‑step agents as listed in the policy.
Non‑formulary exception duration — up to 12 months
Non‑formulary exception review authorizations for drugs listed in this policy may be approved for a duration of up to 12 months.
- Clarification in 2025: non‑formulary exception review authorizations for all drugs listed may be approved up to 12 months.
- Initial authorization and re‑authorization guidance permits approvals up to 12 months for reviews.
Step therapy overview — trial of at least one formulary drug first
Step therapy requires that at least one drug on the plan's formulary be tried first (first‑use drugs are usually generic); follow the step‑therapy protocol in the policy when requesting coverage for subsequent agents.
- At least one formulary drug (usually a generic) should be tried first.
- Step therapy edits require trial of specified first‑step agents before second‑step agent coverage.
Step therapy requires trial/failure of specified first‑step agents (protocol changes noted)
When step therapy applies, providers must document trial and failure of the specified first‑step agents listed in the policy; note the 2020 update that some protocols were changed from one to two first‑step agent requirements unless specified otherwise.
- Follow the policy's first‑step agent lists; some protocols now require two first‑step agent trials as noted in the 2020 Update.
- Document clinical failure or intolerance to the first‑step agents per the policy requirements.
Step‑therapy rules present — multiple classes and first‑step lists
The policy includes multiple step‑therapy rules with specified first‑step agent lists across drug classes (examples include ophthalmic corticosteroids, overactive bladder agents, and inhaled asthma therapies); follow the class‑specific first‑step lists when applicable.
- Consult the policy step‑therapy tables for class‑specific first‑step agent lists.
- Some drugs have been removed from or added to step‑therapy over time; use the current tables in this policy.
Documentation and applicability — use policy sections and member plan verification
Use the Policy Criteria, Documentation Requirements, and Coding Related Information sections plus the member's plan booklet or ID card to determine applicability and what documentation is required for authorization reviews.
- Verify member benefit applicability (closed formulary vs open plan) via member materials.
- Provide documentation as specified in the policy when submitting prior authorization or exception requests.
Coverage and dispensing larger quantities require individual case review documentation
Requesting coverage or dispensing quantities larger than the specified quantity limits requires submission of individual case review documentation explaining the member‑specific reason (e.g., travel, remote location, disaster‑related supply disruption) and clinical rationale to support an exception.
- Dispensing of a larger quantity may be approved based on individual case review with supporting documentation.
- Examples of acceptable circumstances include member vacation/travel, supply chain disruption, or clinical evidence supporting higher dosing.
Documentation and benefit verification — follow FDA dosing and check member benefit booklet
Medications are subject to the product's FDA dosing and administration prescribing information; always verify benefit limitations and whether the policy applies by checking the member benefit booklet or contacting customer service.
- Follow the FDA‑approved label for dosing and administration when justifying requests.
- Check the member benefit booklet to confirm coverage rules; this policy does not apply to Medicare Advantage.
Applicability restriction — applies only to closed formulary pharmacy benefits
This policy is limited to closed formulary pharmacy benefits sold on state and federal exchanges and does not govern open benefit designs or Medicare Advantage; verify the member's plan before submitting authorizations.
- Applies to closed formulary Metallic plans (Rx M1, M2, M4) only.
- Policy does not apply to Medicare Advantage or open benefit designs where non‑formulary drugs may be covered.
Dispensing larger quantities may be denied without approved exception
Dispensing quantities in excess of the policy's specified limits may be denied unless an approved exception exists; providers should submit an exception request with clinical justification to avoid denial.
- Quantity limits are the maximum amount dispensed without an exception request; larger amounts require approval via individual case review.
- Without an approved exception, dispensing larger quantities may be denied.
Coverage absence may trigger denial — missing/discontinued products removed from tables
If a drug or product is not listed (for example because it was removed from formulary or discontinued by the manufacturer), coverage may be denied if no alternative coverage criteria are met; check the current policy tables for removed or discontinued products.
- Products removed from step‑therapy and quantity limit tables (e.g., discontinued products) are no longer covered under those entries.
- Absence from the policy tables may trigger denial unless medical necessity is established through an exception review.
Coding Information
| No codes listed |
| N/A | Coding |
Authorization Length and Renewal
Approval length — authorization length guidance
Authorization length guidance
This applies to non-formulary exception reviews and all other reviews for drugs listed in this policy.
Step Therapy Requirements
| Step therapy requirement | Description / provider action |
|---|---|
| Try at least one formulary drug (usually a generic) first | |
| Step therapy requires that at least one drug on the health plan's formulary be tried before coverage of a subsequent agent; the first-use drugs are usually generic. Providers must refer to the formulary and this policy when requesting authorization. |
| Step therapy requirement | Specified first-step agents / notes |
|---|---|
| Trial of specified formulary first-step agent(s) required | |
| Policy requires trial and failure of one or more specified first‑step agents before coverage of second‑step agents; some protocols were changed in 2020 from one required first‑step trial to two unless otherwise specified. |
| Class / area | Step-therapy details |
|---|---|
| Ophthalmic corticosteroids | |
| Step‑therapy tables include specific first‑step agent lists for classes such as ophthalmic corticosteroids (e.g., additions and updates over time such as Alrex added in 2024); multiple class‑level requirements are maintained and updated in history entries. | |
| Overactive bladder and other classes | |
| Policy contains multiple step‑therapy requirements and first‑step agent lists across therapeutic classes (examples noted include overactive bladder agents and various inhalers); products have been added or removed from protocols over time per the history updates. |
Product-Specific Quantity Limits
Definitions and Key Terms
Background and Rationale
Prior authorization, step therapy, and quantity limits are utilization-management tools used to promote safe and effective medication use and to align dispensing with FDA-approved dosing. Step therapy requires trial and failure of one or more specified first-step formulary agents (typically at least one formulary drug, often a generic) before coverage of subsequent agents is authorized. Quantity limits set the maximum amount dispensed per defined time period; larger quantities may be approved through individual case review when clinically justified. These controls apply when the drug is on the plan's closed formulary and the member's benefit design is subject to this policy.
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