Formulary Medical Necessity Program
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Defines medical necessity requirements and prior authorization criteria for multiple outpatient prescription drugs subject to the payer's formulary medical necessity program; applies to providers submitting coverage requests to Blue Cross Blue Shield - Iowa (Wellmark).
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Approval — Inhaled corticosteroids
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Combination ICS/LABA
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Umeclidinium-vilanterol
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Rapid/Short-acting insulins
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Basal insulins
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Long-acting insulins
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — SGLT2 and related agents
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Dapagliflozin-metformin combinations
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — DPP-4 inhibitors
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Combination DPP-4/metformin agents
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Qtern/Steglujan
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Oral anticoagulants
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Rivaroxaban oral suspension
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — GI motility agents
Covered when ALL of the following are met
Approval duration 12 months
Initial Approval — Ophthalmic agents
Covered when ALL of the following are met
Approval duration 12 months
Requests for the drugs enumerated in this policy are covered only when the specific medical necessity criteria described in each group are met. If the patient does not meet those trial, failure, or documented contraindication requirements, the request is considered not medically necessary and will be denied.
Specifically, requests are considered not medically necessary when the required evidence of prior trial and inadequate response to specified formulary alternatives, or a documented clinical reason preventing those trials (e.g., intolerance or contraindication), has not been provided.
Procedures, Billing and Quantity Limits
| Code(s), if applicable. | Placeholder indicating CPT, HCPCS, Revenue, and/or ICD codes should be used where appropriate. |
Prior Authorization, Step Therapy, and Documentation Requirements
Prior authorization: show FDA or compendia‑supported indication and prior trials
Prior authorization requires evidence that the requested drug is being used for an FDA‑approved indication or an indication supported in compendia (examples: AHFS, Micromedex, current accepted guidelines) and that the patient tried and had an inadequate treatment response or intolerance to the specified formulary alternatives, or has a documented clinical reason preventing trials of those alternatives.
- Authorization typically aligned to the group-specific criteria: requested drug used for FDA‑approved or compendia‑supported indication; AND prior trial and inadequate response/intolerance to listed formulary alternatives at optimal dosages; OR documented contraindication/adverse reaction preventing those trials.
- Approval durations noted as 12 months for listed groups.
No prior‑auth rules in references section
This section contains only reference citations and does not define prior authorization rules for those referenced prescribing information entries.
- References list prescribing information for many drugs; the references themselves do not establish authorization criteria in this section.
Step therapy: trial required of listed formulary alternatives
Step therapy is enforced: before approving the requested drug, the patient must have trialed the specified formulary alternatives (one, two, or three alternatives depending on the drug group) and had inadequate response or intolerance, unless there is a documented clinical reason preventing those trials.
- Examples by group: inhaled corticosteroids require trials of Asmanex AND QVar; combination ICS/LABA require trials of Breo Ellipta, budesonide‑formoterol, AND fluticasone‑salmeterol; other groups list one or two named alternatives as shown in the criteria.
- If contraindication or expected adverse reaction prevents trials, document the clinical reason.
No step therapy rules in references section
This portion of the document includes only reference listings and does not impose any step therapy requirements itself.
- Prescribing information references are provided for background and support but do not replace the documented step therapy criteria in the criteria sections.
Documentation required: prior trials or clinical reason preventing trials
Required clinical documentation must include evidence of prior trial and inadequate treatment response or intolerance to the specified formulary alternatives, or a documented clinical reason (expected adverse reaction or contraindication) preventing trials of those alternatives.
- Document the specific alternative(s) tried, dose(s), duration, and clinical outcome (inadequate response or intolerance).
- If no trial was possible, provide a clear clinical rationale (e.g., contraindication or expected adverse reaction) preventing the trial.
Prescribing information references support decisions but do not set rules
Prescribing information references are provided for many listed drugs and may support authorization decisions, but the references themselves do not set or replace the authorization rules in the criteria sections.
- Providers may cite relevant prescribing information from the references to support indications or safety considerations when submitting prior authorization requests.
Denial risk: requests without required trials or documentation are not medically necessary
Requests will be considered not medically necessary (denied) if the patient does not meet the specified criteria — i.e., lacks evidence of trial/failure or intolerance to the required formulary alternatives and has no documented contraindication.
- The policy explicitly states listed drugs are considered not medically necessary for patients who do not meet the criteria set forth (trial/failure or documented contraindication).
- Ensure submitted documentation directly addresses the group‑specific trial/failure or contraindication requirements to avoid denial.
References‑only sections: no authorization or denial criteria specified
Some sections list only references and do not specify authorization or denial criteria; where only references are listed, no explicit authorization rules or denial criteria are provided in that portion of the document.
- When relying on referenced prescribing information, also ensure submission meets the explicit criteria found in the criteria sections of this policy.
Program Background
The purpose of this Formulary Medical Necessity Program is to ensure appropriate utilization of select outpatient prescription drugs by confirming adherence to selection elements found in product labeling and accepted clinical guidelines. The program requires documented evidence of treatment with preferred formulary alternatives (or a clinical reason why such trials cannot be completed) before approving non‑preferred medications, with the intent of reducing inappropriate utilization and aligning coverage with established standards of care.
Key Definitions
Explicit Quantity Limits
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