Medical Necessity Criteria and Dispensing Quantity Limits
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Defines prior authorization, step therapy, and dispensing quantity limits for drugs under the Individual/Small Group/Student ISHIP Metallic closed formulary (Rx plans M1, M2, M4) and explains applicability to members and providers.
No material clinical or coverage changes in this revision.
Coverage Criteria and Application
Dispensing Quantity Limits and Exceptions
Dispensing quantity limits and related coverage rules
Information available from manufacturer or www.fda.gov
Refer to the antiretroviral table for limits reported per 30 days.
See antiretroviral quantity limits tables for product-level values (e.g., Biktarvy 30 tablets/30 days; Norvir packets 360/30 days).
Circumstances that may justify larger dispensing quantities include member travel, disruption of normal prescription supply chains (disasters), or residence in remote areas.
Policy-wide coverage principles
General coverage rules and prior edits history
Consult member plan booklet or ID card to confirm benefit applicability.
Exceptions considered for travel, supply disruptions, remote residence, or evidence-based higher dosing.
Specific step-therapy tables and drug-level requirements are documented elsewhere in the policy history and step-therapy sections.
Recent 2026 changes adjusted antiretroviral limits and removed criteria/limits for several drugs as documented in the history entries.
General application and scope
Policy contains step-therapy and quantity limit criteria for many drugs; specific covered conditions and step rules are documented elsewhere in the full policy.
Member contracts determine actual benefits; consult member materials to confirm coverage.
Policy changes over time have moved some products to other policies or removed quantity limits when products discontinued or managed elsewhere.
Historic updates show additions and removals of drugs from step-therapy tables across review cycles.
This policy applies only to closed formulary pharmacy benefits sold on state and federal exchanges. It does not apply to open benefit designs where non‑formulary drugs are routinely covered (even if at a higher tier). Providers should confirm a member's benefit design using the member ID card or benefit booklet before relying on these criteria.
Dispensing quantity limits listed in this policy are not intended to be inflexible in situations where logistics reasonably require larger supplies. A larger quantity may be approved on individual case review when member‑specific circumstances exist (for example, vacation or business travel, disruption of supply chains due to weather or disaster, or when a member resides in a remote area where pharmacy access is limited). Requests for quantities above the published limits must be supported by documentation of the circumstance or other clinical justification.
This medical policy is not applicable to Medicare Advantage membership. Member contracts determine actual benefits; providers and members should consult the member benefit booklet or contact customer service to confirm coverage under Medicare Advantage plans.
Coding
| No codes listed |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization and non‑formulary exception approvals up to 12 months
Non-formulary exception reviews and initial authorizations for drugs listed in this policy may be approved for up to 12 months for initial authorization and re-authorization.
Pharmacy‑benefit drugs subject to PA and exceptions (up to 12 months)
Drugs addressed in this policy are managed through the pharmacy benefit and are subject to prior authorization and non‑formulary exception review; non‑formulary exception authorizations for drugs listed in this policy may be approved up to 12 months.
Prior authorization, step‑therapy and authorization durations
Certain drugs in this policy are subject to step‑therapy, prior authorization, and dispensing quantity limits; prior authorization and non‑formulary exception reviews may be approved for up to 12 months.
Try a formulary first‑step agent before second‑step coverage
Step therapy requires that at least one formulary first‑step agent (usually a generic) be tried and failed before coverage will be provided for a second‑step agent.
2020 change: trial of two first‑step agents unless specified
In the 2020 update the policy changed to require trial of two first‑step agents unless specified otherwise; this requirement is applied where noted in the step‑therapy protocol.
Follow the step‑therapy table for drug‑specific first‑step requirements
The policy maintains a step‑therapy table listing specific drugs and their required first‑step agents; these requirements have been added, revised, or removed in the policy history and must be followed as listed.
- Follow the current step‑therapy table in this policy for drug‑specific first‑step requirements.
- Refer to the policy history for changes that added or removed drugs from step‑therapy.
Verify member plan and submit supporting documentation for exceptions
Verify whether this policy applies to the member by checking the member plan booklet or ID card (policy applies to closed formulary Metallic plans M1, M2, M4); provide documentation that supports medical necessity for non‑formulary exception requests.
- Confirm the member's formulary/plan (closed formulary M1, M2, M4) before submitting a request.
- Include clinical documentation demonstrating medical necessity when requesting non‑formulary coverage.
Submit exception request with rationale for quantities above limits
When requesting quantities larger than the policy’s specified limits, submit an exception request including individual‑specific circumstances or published clinical evidence that justifies the larger dispensing quantity.
- State the individual‑specific rationale (e.g., travel, remote residence, supply disruption) or provide published evidence for higher dosing.
- Request will be reviewed on an individual case basis.
Follow FDA prescribing information and verify member benefits
Prescribing must follow the product's FDA dosage and administration prescribing information; confirm member benefits via the member benefit booklet or customer service to determine coverage limits.
- Ensure prescribed dose and administration align with FDA‑approved labeling.
- Verify coverage and quantity limits with member benefit documents or customer service.
Risk of denial for non‑formulary drug requests under closed formulary
Because this policy applies only to closed formulary benefits, requests for non‑formulary drugs may be denied unless a medical necessity exception is approved.
Potential denial without approved quantity‑limit exception
Requests for quantities that exceed the policy’s specified quantity limits may be denied unless an exception request with individual clinical justification is approved.
Denial risk when drug no longer meets current coverage criteria
Coverage criteria for specific drugs have changed over time (examples in history include Entresto coverage adjustments and later removal); failure to meet the current policy criteria for a listed drug may result in denial.
- Refer to the current policy criteria—historical requirements (e.g., Entresto generic trial) may have been modified or removed.
Background and Rationale
Step therapy, prior authorization, and dispensing quantity limits are utilization management tools used to promote safe, effective, and evidence‑based use of pharmacy products. Step therapy requires trial and documented failure (or intolerance) of specified first‑line formulary agents before a second‑line agent is covered. Prior authorization and non‑formulary exception reviews ensure that use of non‑formulary or restricted drugs is medically necessary; such approvals may be granted for up to 12 months when supported. Quantity limits define the maximum amount that may be dispensed per fill or time period (often based on FDA labeling); larger quantities can be approved on a case‑by‑case basis when clinically justified or when member circumstances (for example, travel or supply disruptions) warrant an exception.
Definitions
Authorization Duration and Continuation Criteria
Authorization duration
Authorization lengths for continuation
Applies to prior authorizations and non-formulary exception approvals as documented in policy updates.
Step Therapy Rules and Tables
| Requirement | Details |
|---|---|
| Step therapy requirement | |
| At least one formulary first-step agent (usually generic) must be tried before coverage of second-step agents will be allowed under step therapy edits. |
| Change (year) | Summary |
|---|---|
| 2020 policy change | |
| Policy was changed in 2020 from requiring trial of one first-step agent to requiring trial of two first-step agents unless specified otherwise; documented updates also added and removed specific first-step agents in the step therapy protocol. |
| Example drug / topic | Step-therapy detail / history |
|---|---|
| Ventolin HFA (albuterol) | |
| Step-therapy requirement updated to require trial and failure of generic albuterol HFA prior to coverage of Ventolin HFA (noted in 2020 history entries). |
Dispensing Quantity Limits (by product)
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