Medical Necessity Criteria and Dispensing Quantity Limits
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Defines prior authorization, step therapy, and dispensing quantity limits for drugs on the Premera Metallic closed formulary (Rx plans M1, M2, M4) and applies to providers submitting pharmacy requests for those members.
Updated quantity limit for Atazanavir 200 mg capsules from 30 to 60 capsules per 30 days.
Updated quantity limit for Norvir packets from 30 to 360 packets per 30 days.
Updated quantity limit of Reyataz 50 mg packets from 30 to 150 packets per 30 days.
Removed criteria for Entresto (sacubitril-valsartan), Entresto Sprinkle, and oxycodone ER.
Removed quantity limits for a list of oncology, endocrine, and other agents (abiraterone, anastrozole, bicalutamide, capecitabine, carbinoxamine, desloratadine, Duetact, exemestane, flutamide, imatinib, letrozole, megestrol, mercaptopurine, Nitro-Dur, Qvar HFA, Sivextro, tamoxifen).
Coverage Criteria and Scope
General Coverage
Applies to drugs on the closed Metallic formulary; non-formulary drugs require exception review.
Refer to Definitions for 'closed formulary' and to provider actions for the exception review process.
Dispensing Quantity Limits
Dispensing quantity limits are specified per product and strength and are based on FDA-approved labeling.
Quantity limits for antiretrovirals are listed as per-30-day limits in the antiretroviral table.
Step Therapy / Prior Authorization
Utilization management edits
Specific first‑ and second‑step agent lists and any multi‑step requirements are maintained in the policy's step‑therapy tables and history; see history for prior changes (e.g., added requirement to try generic sacubitril‑valsartan prior to Entresto noted in history).
Failure to follow required step‑therapy or to comply with dispensing quantity limits may result in denial of coverage.
Recent updates and removals
Recent coverage actions effective 07/01/26
Applies to the antiretroviral quantity limits table entries.
Refer to the policy history for the complete list of removed items and the effective dates.
This policy applies only to drugs covered under Premera's closed formulary pharmacy benefits designed for sale on state and federal insurance exchanges (Metallic formulary, Rx plans M1, M2, M4). It does not apply to open benefit designs in which non-formulary drugs are covered, even if those drugs may be available at a higher tier; providers should confirm a member's benefit design via the member's plan booklet or ID card.
Effective 07/01/26, a number of dispensing quantity limits and step edits were removed because those products are either discontinued or are now managed under other specific policies (for example, 5.01.656 Drug Quantity Management). The 2026 update documents removals of quantity limits for numerous agents and relocates management of certain drugs to the referenced policy where appropriate.
This medical policy does not apply to Medicare Advantage. Member contracts differ in benefits; always consult the member benefit booklet or customer service to determine coverage for Medicare Advantage members.
Coverage of non-formulary drugs is not routine under this closed formulary policy. Non-formulary drugs will only be considered after an individual medical necessity determination; requests for non-formulary drugs may be denied unless the medical necessity review supports coverage for the specific member.
Coding and Basis for Limits
| No codes listed |
Provider Actions, Prior Authorization, and Exceptions
Prior authorization and applicability
This policy describes prior authorization and step therapy requirements for drugs on the closed Metallic formulary (Individual/Small Group/Student ISHIP Rx plans M1, M2, M4). Providers should verify whether the member’s plan is subject to this policy by referring to the member’s plan booklet or member ID card.
- Applies only to closed formulary pharmacy benefits (Metallic formulary).
- Confirm applicability using the member’s plan booklet or member ID card.
Non‑formulary exception duration — up to 12 months
Non‑formulary exception review authorizations for drugs listed in this policy may be approved for up to 12 months for initial authorizations and reauthorizations.
Prior authorization required for many listed drugs
Many drugs listed in this policy are subject to step‑therapy and/or dispensing quantity limits and require prior authorization per the policy tables and criteria; follow the product‑specific tables when submitting authorization requests.
- Refer to the policy’s step‑therapy and quantity‑limit tables for drug‑specific prior authorization criteria.
Step therapy overview — document trial and failure
Step therapy requires documented trial and failure of one or more specified first‑step agents (typically formulary or generic agents) before coverage will be provided for a second‑step agent; requirements are evidence‑based.
- Document the trial and clinical reason for failure of required first‑step agent(s) when requesting coverage for a second‑step agent.
Step therapy requirement — follow table for one vs two trials
Step therapy requires trial and failure of the specified first‑step agent(s); in some cases the policy updated in 2020 changed from one to two required first‑step agent trials for many edits — follow the step‑therapy table for the number and identity of required first‑step agents.
- Follow the step‑therapy table to confirm whether one or two first‑step trials are required for a specific drug.
- If two first‑step agents are required, document trials and failures of both agents per the table.
Step‑therapy requirement summary — verify product‑specific agents
The policy maintains step‑therapy requirements for numerous products; for each drug, confirm the specific first‑step agents and any historical changes recorded in the policy history before submitting an authorization request.
- Check the policy history and step‑therapy table for product‑specific first‑step agents and recent changes (e.g., updates to first‑step agents for select drugs).
When larger quantities may be approved — individual case review
Dispensing of quantities larger than the listed quantity limits may be approved on individual case review when member‑specific circumstances justify a larger supply (for example, travel, supply disruption, or remote location).
- Provide documentation of the member‑specific circumstance that justifies the larger quantity.
- Approval of larger quantities is determined by individual case review, not automatically granted.
Supporting documentation required for quantity exceptions
When requesting an exception to a quantity limit, submit supporting documentation such as individual‑specific circumstances (e.g., travel, supply disruption, remote location) or published clinical evidence that justifies a larger dispensing quantity.
- Include clinical rationale or published evidence supporting higher‑dose protocols when applicable.
- Document logistics reasons (e.g., extended travel) if applicable to the request.
Non‑formulary exception duration — up to 12 months (authorization length)
Authorizations for non‑formulary exceptions for drugs listed in this policy may be approved for up to 12 months for initial authorization and renewal; submit the non‑formulary exception review request with clinical justification for medical necessity.
- Non‑formulary exception approvals are subject to individual medical necessity review.
- Authorization length may be up to 12 months for approved exceptions.
Denial risk for non‑formulary drug requests
Requests for non‑formulary drugs may be denied unless an individual medical necessity review determines the non‑formulary drug is medically necessary for the member’s clinical circumstances.
- Submit a medical necessity justification when requesting coverage for a non‑formulary drug under the closed formulary benefit.
Quantity limit exceptions — risk of denial without approved exception
Dispensing of a quantity greater than the quantity limit may be denied unless an exception request is approved after individual case review and adequate supporting documentation is provided.
- Ensure exception requests include the specific member circumstances or clinical evidence to avoid denial.
- Without an approved exception, claims exceeding quantity limits are subject to denial.
Denial triggers — step‑therapy failures or quantity exceedances
Failure to follow required step‑therapy (for example, not trialing a required first‑step agent such as generic sacubitril‑valsartan before Entresto where that requirement applied) or exceeding dispensing quantity limits may trigger denial of coverage.
- Confirm required first‑step agent trials per the step‑therapy table prior to requesting coverage for a second‑step agent.
- Do not submit requests exceeding quantity limits without an approved exception to avoid denial.
Background and Rationale
Step therapy and prior authorization are used to promote safe, effective medication use by encouraging trials of formulary-preferred agents first. Step therapy requires documentation of trial and failure of one or more specified first-step agents (typically formulary or generic) before a second-step agent will be approved. Utilization management edits, including step-therapy and dispensing quantity limits, are evidence-based and explained in the policy tables and criteria.
Dispensing quantity limits are set based on maximum dose recommendations in FDA-approved labeling and define the maximum amount that may be dispensed per fill or time period. Exceptions to quantity limits or step therapy may be granted after individual case review when supporting documentation demonstrates medical necessity (examples: travel, supply disruptions, or other member-specific circumstances).
Definitions
Continuation and Authorization Length
Continuation / Approval Length
Authorization durations
See provider actions/documentation for requirements when requesting longer dispensing quantities or exception reviews.
Step Therapy Tables and Requirements
| Requirement | Detail |
|---|---|
| Must document trial and failure of first-step agent(s) | |
| Step therapy requires that one or more specified first-step agents (typically formulary/generic) be tried and documented as ineffective or not tolerated before coverage for a second‑step agent is approved. |
| Aspect | Policy note |
|---|---|
| Step-therapy tables maintained | |
| Policy includes step-therapy tables that list required first‑step agents and step progression; providers must follow the table-listed trials before approval of second‑step agents. | |
| 2020 change | |
| In 2020 the policy was changed from one to two required first‑step agent trials for many step‑therapy edits unless specified otherwise (i.e., two first‑step agent trials became the default). |
| History item | Summary |
|---|---|
| Interim review Aug 25, 2025 | |
| History records an interim review on August 25, 2025 that added a requirement to try generic sacubitril‑valsartan prior to Entresto (sacubitril‑valsartan). | |
| 2025 clarifications | |
| The 2025 update clarified that non‑formulary exception review authorizations may be approved up to 12 months and updated Entresto criteria to require trial of generic sacubitril‑valsartan first (later removed in 2026). | |
| 2026 actions | |
| Annual review effective 07/01/26 updated quantity limits for several antiretroviral products and removed criteria for Entresto, Entresto Sprinkle, and oxycodone ER (removal of the earlier Entresto step requirement). |
Drug-Specific Dispensing Quantity Limits
Policy Revision History
Updated quantity limits effective 07/01/26: Atazanavir 200 mg capsules changed from 30 to 60 capsules per 30 days; Norvir packets changed from 30 to 360 packets per 30 days; Reyataz 50 mg packets changed from 30 to 150 packets per 30 days.
Removed coverage criteria effective 07/01/26 for Entresto (sacubitril-valsartan), Entresto Sprinkle, and oxycodone ER; removed quantity limits for a list of oncology, endocrine, and other agents and for multiple discontinued products.
Interim review approved 08/25/25 added requirement to try generic sacubitril-valsartan prior to Entresto (noted later as removed on 07/01/26).
09/01/25 updated Entresto Sprinkle coverage criteria to include a requirement to try generic sacubitril-valsartan first.
01/01/26 added coverage criteria for oxycodone ER and updated various antiretroviral and inhaled product quantity limits (e.g., Emtriva solution and Prezista suspension), prior to later removals on 07/01/26.
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