Step Therapy
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Defines Sanford Health Plan's step therapy program requiring trial and failure of specified lower-cost formulary medications before covering target medications; applies to providers requesting coverage for plan members. Non-formulary drugs are handled via formulary exception.
No material clinical or coverage changes in this revision.
Coverage and Step Therapy Criteria
Step therapy coverage requirement
Covered when ALL of the following are met
Applies only to formulary medications; non-formulary requires formulary exception.
Step-based coverage criteria (implicit)
Coverage is organized by step levels; agents are listed as Step Medication or Target Medication with step numbers (1–3).
Document lists many specific drugs under these labels but does not provide explicit logical tree in this excerpt.
Step Therapy Criteria (partial)
Covered when specific step therapy requirements are met (partial representation):
Document is repetitive and partial; exact required prior agents per target/step not fully legible in this segment.
Step sequence coverage criteria
Covered when ALL of the following are met for a target medication:
Document lists many antipsychotic agents repeatedly across steps; provider must show prior step failure before target coverage.
This step therapy policy applies only to medications that are included on the plan formulary. Medical records must document that the member has trialed and failed at least a 30-day supply of one or more listed step medications before the plan will cover the associated target medication. Requests for coverage of non‑formulary drugs are reviewed through a separate formulary exception process; to request a step therapy override or formulary exception submit the request via the Sanford Provider Portal at sanfordhealthplan.com.
The policy excerpt does not state any explicit exclusions beyond the formulary/non‑formulary distinction. The document separately identifies a distinct step therapy path for C. difficile (Dificid) within the listing, and otherwise lists numerous target and step medication groupings (for example, multiple atypical antipsychotics and their associated step medications) without providing additional exclusion language.
A separate step therapy pathway is called out for Clostridioides difficile (C. diff) treatment with Dificid; this indicates that C. diff therapies are managed on their own step sequence rather than within the general antipsychotic or other group listings.
Within the provided excerpt there are no other explicit exclusions stated. The step therapy lists repeatedly present target and step medications and step levels (1–3) but do not present exclusionary statements in these fragments.
Initial (Step 1) Therapy Requirements
inv-103: Initial (Step 1) therapy (implicit)
Covered when ALL of the following are met (partial excerpt):
Examples include propranolol, timolol, metoprolol, amitriptyline, nortriptyline, divalproex, topiramate, venlafaxine, duloxetine.
Quantity requirement repeated in document fragments.
inv-104: CGRP initial therapy (partial)
Initial step requirements for CGRP prophylactics (partial):
Specific agent examples listed in source (propranolol, amitriptyline, timolol, nortriptyline, metoprolol, atenolol, nadolol, divalproex, topiramate, venlafaxine, duloxetine).
inv-105: Initial therapy (migraine) - partial
Initial step therapy requirements (partial/fragments):
inv-106: Initial therapy (chronic idiopathic constipation) - partial
Initial step therapy requirements for chronic idiopathic constipation agents (partial):
Examples of step medications include Amitiza, Linzess, Lubiprostone, Motegrity, Trulance, Ibsrela as listed in the source.
inv-107: Initial therapy for chronic idiopathic constipation agents — Initial coverage for target GI agents requires prior failures
Initial coverage for target GI agents requires prior failures:
Phrase 'must fail two-step medications' appears repeatedly for constipation agents.
inv-108: Initial therapy requirements
Initial therapy prerequisites
Document repeatedly uses the phrase 'must fail two-step medications' to describe this requirement.
inv-109: Initial therapy (step requirements)
Initial therapy requirements as implied by step therapy lists:
inv-110: Initial step medication requirements (partial)
Examples of required initial (step) therapies before coverage of target medications as listed in this segment.
These examples are presented in the step tables; durations/failure documentation also apply per policy.
inv-111: Initial step requirements (partial)
Partial list of initial/step therapy relationships present in this section
Partial/fragmented listing in source.
inv-112: Initial therapy — Initial step medications listed for non-hormonal VMS
Initial step medications listed for non-hormonal VMS
inv-113: Initial therapy examples — Initial step requirements for certain target drugs (examples)
Initial step requirements for certain target drugs (examples):
From source chunk listing insomnia step medications.
Step Levels and Tables
| Requirement | Details |
|---|---|
| Member must trial and fail one or more specified step medication(s) | Medical records must document trial and failure of at least a 30-day supply of the required step medication(s) prior to coverage of the target medication; applies to formulary medications (non‑formulary handled by formulary exception). |
| Failure documentation | Medical records demonstrating trial and failure of at least a 30‑day supply must be provided with prior authorization request. |
| Requirement | Details |
|---|---|
| Follow step sequencing | Prescribers must follow the step sequence (steps 1–3) as listed; requests for medications assigned to higher steps should include documentation of prior‑step trials, failures, or contraindications. |
| Documentation needed when skipping steps | Requests inconsistent with documented step relationships (e.g., skipping required step medications) should include evidence of failure or contraindication to prior step agents. |
| Step | Requirement |
|---|---|
| Step 2 | Medications assigned to step 2 require documented trial and inadequate response or intolerance to step 1 agents before approval of step 2/target medications. |
| Step | Requirement |
|---|---|
| Step 3 | Medications assigned to step 3 require documented failure or intolerance of step 2 agents (and prior lower steps as indicated) before target coverage. |
| Target medication | Prescriber must trial |
|---|---|
| Various target medications (e.g., antipsychotics, COPD inhalers, GI agents) | Prescriber must trial the specific step medication(s) listed for the target medication (document prior trials and failures per the step table). |
| Target medication | Step 2 step agents |
|---|---|
| Veozah (example target) | Paroxetine 7.5 mg; gabapentin; SSRIs/SNRIs as listed (citalopram, escitalopram, sertraline, desvenlafaxine ER, duloxetine) |
| Target medication | Step 3 step agents |
|---|---|
| Pulmicort HFA (example target) | Inhaled corticosteroid alternatives listed (Arnuity Ellipta, Asmanex, Flovent Diskus) per step table; higher‑step agents require prior trials of listed inhaled corticosteroids. |
| Requirement | Details |
|---|---|
| Document prior trials | Must document prior trials of lower‑step medications (medication names and step level) before authorization of the target medication. |
| Evidence to submit | Medical records or pharmacy claims documenting trials and failures of required step medications should be submitted with the prior authorization request. |
| Condition | Requirement |
|---|---|
| General (step progression) | Documented inadequate response or intolerance to step 1 agents is required before progressing to step 2 or target medications. |
| Condition | Requirement |
|---|---|
| General (step progression) | Documented inadequate response or intolerance to step 2 agents is required before progressing to step 3 or target medications. |
| CGRP requirement | Details |
|---|---|
| Prior trials from two classes required | Before CGRP prophylactic agents (e.g., Aimovig, Emgality, Ajovy, Nurtec, Qulipta) are approved, patient must trial at least one medication from two different classes (examples: beta‑blockers, tricyclic antidepressants, anti‑epileptics, SNRIs). |
| Quantity limit for some CGRP agents | For several CGRP agents the pharmacy claim must be for a quantity of 15 over a 30‑day span. |
| Step level | Antipsychotic agents (example) |
|---|---|
| Steps 1–3 | Atypical antipsychotics (e.g., Vraylar, Fanapt, Latuda, Rexulti, Saphris, Caplyta, Secuado, Lybalvi, aripiprazole, clozapine, olanzapine, paliperidone ER, quetiapine, risperidone, ziprasidone) are listed under step headings; specific step assignments and required trials are presented in the table. |
| Requirement | Constraint |
|---|---|
| Prior trials and quantity limits | Prior trials of the specified step medications must be documented; for certain agents (notably some CGRP products) claims must meet quantity limits (commonly 15 per 30 days). |
| Enforcement | Details |
|---|---|
| Prior failure required | Approval of listed target medications requires prior failure of the specified step medication(s); several entries explicitly require failure of two prior step medications for certain conditions (e.g., chronic idiopathic constipation). |
| Step level enumeration | Requirement |
|---|---|
| Steps 1–3 enumerated | Prior trials of the listed step medications for steps 1–3 must be completed and documented for the associated target medications as shown in the step tables. |
| Documentation requirement | Details |
|---|---|
| Proof of prior trials required | Documentation must support prior trials and failures (or intolerance) of the required step medications; medical records demonstrating trial and failure of at least a 30‑day supply are required with prior authorization. |
| Target medication (examples) | Mapped step medications |
|---|---|
| Qbrexza | Drysol; Xarac AC (hyperhidrosis step medications listed prior to Qbrexza) |
| Pulmicort HFA | Arnuity Ellipta; Asmanex; Flovent Diskus (inhaled corticosteroid step alternatives listed) |
| General mapping | Requirement |
|---|---|
| Prior trials indicated | Prior trial(s) of listed step medications are indicated before coverage of associated target medications across multiple therapeutic areas (COPD, fibromyalgia, GI, etc.). |
| Example target → step | Required prior trials |
|---|---|
| Qbrexza → Drysol / Xarac AC | Documented trial of Drysol or Xarac AC required prior to Qbrexza (hyperhidrosis mapping in table). |
| Pulmicort HFA → Arnuity Ellipta / Asmanex / Flovent Diskus | Listed inhaled corticosteroids are presented as step medications prior to some target inhaled agents; prior trials should be documented. |
| Target med category | Step medications required |
|---|---|
| Non‑hormonal VMS (example: Veozah) | Trial of listed agents such as gabapentin or an SSRI/SNRI (citalopram, escitalopram, paroxetine ER, sertraline, desvenlafaxine ER, duloxetine, fluoxetine, fluvoxamine, venlafaxine) is required before coverage of Veozah. |
| General rule | Provider action |
|---|---|
| Prior trials required | Prior trials of specified step medications are required before coverage of target medications; documented evidence must be submitted with the prior authorization request. |
| Submission requirement | Prescribers must include documentation of prior step medication trials and failures when requesting prior authorization or a step override via the provider portal. |
Prior Authorization, Documentation, and Denial Triggers
Submit override/exception via Sanford Provider Portal
To request a step therapy override or formulary exception, log into the Sanford Provider Portal at sanfordhealthplan.com.
- Contact pharmacy management for questions: (800) 752-5863.
Prior authorization implied if antipsychotic step requirements not met
When prescribing an atypical antipsychotic without documented completion of the listed prior step(s, prior authorization is implied and the provider must document step trials or an exception.
- Provide medical record evidence of prior step medication trials and failures or documented contraindication/intolerance.
Provide evidence of prior step trials for antipsychotic targets
Prior authorization is expected for target antipsychotic agents if the patient has not met the required step therapy trials; prescribers should submit evidence of prior step medication trials and failures.
- Document which step level was completed (1, 2, or 3) and the specific medications tried.
Obtain prior authorization when step requirements unmet
Prior authorization is required when a target medication is subject to step therapy and the patient has not met the indicated prior step(s); the request must show failure or intolerance to the required step medications.
- Include documentation of medication names, trial duration, and reason for discontinuation (failure or intolerance).
CGRP prior authorization: trials from listed classes and quantity compliance
For CGRP prophylactic target agents, prior authorization must include evidence of trials of step medications from the listed classes (e.g., beta-blockers, tricyclics, anti‑epileptics, SNRIs) and, for some CGRP agents, pharmacy claims must meet the quantity requirement of 15 over a 30-day span.
- Document trials from at least two different classes as indicated.
- Ensure pharmacy claim quantity equals 15 per 30 days for listed agents (Aimovig, Emgality, Ajovy, Nurtec, Qulipta).
Document trial and failure of specified step medications
Prior authorization for many target medications requires documentation that the patient trialed and failed the specified step medications; for Chronic Idiopathic Constipation agents this commonly requires failure of two prior step medications.
- Include records showing trials and failures of the named step agents (examples: Amitiza, Linzess, lubiprostone, Motegrity, Trulance, Ibsrela).
Show failure of required prior step medications on PA
When requesting coverage for a target medication listed under step therapy, the prior authorization request must show failure of the required prior step medication(s) before the target medication will be approved.
- If the policy lists a two‑step failure requirement, provide documentation showing two prior step medications were tried and failed.
Two‑step failure evidence required for certain targets
For target medications that specify 'must fail two‑step medications,' prior authorization requires evidence that the patient failed the two listed step medications prior to approving the target agent.
- Supply clinical notes or pharmacy claims demonstrating trials and outcomes for both required step agents.
Demonstrate failure of listed step meds for CIC targets
Prior authorization for Chronic Idiopathic Constipation target medications requires demonstration of failure of the listed step medications (the policy repeatedly states 'must fail two‑step medications' for these agents).
- Document trials of the named constipation step agents and show inadequate response or intolerance before approval of target agents.
Medication lists present; explicit PA codes not included in excerpt
This excerpt lists many target and step medications (medication name mappings are provided) but does not include an explicit prior authorization form number or billing code in this fragment.
- Use the Sanford Provider Portal prior authorization workflows (per policy) since no specific codes are listed here.
Step-listing implies PA but no specific PA codes provided
The step therapy listings imply that prior authorization is required for the named target medications when step requirements are not met, but this segment does not present specific prior authorization form or codes.
- Follow the plan's prior authorization process via the provider portal for requests tied to step therapy entries.
Document step trials for target medications (examples included)
Target medications identified in the step tables (examples: Qbrexza, Pulmicort HFA, Veozah) require documented trials of the listed step medications in the prior authorization request to be approved.
- Include evidence of trial/failure or intolerance to the step medications named alongside each target drug.
PA requires documented trial and failure (or intolerance) of step meds
Prior authorization decisions are based on evidence of trial and failure (or intolerance) of the listed step medications; the PA should include documentation of those trials before a target medication is approved.
- Provide dates, durations, and outcomes of step medication trials in the medical record or pharmacy claims.
PA requires documented step failures; lack of documentation risks denial
Prescribers must document failure of required step medications when requesting prior authorization for target medications listed in the step therapy tables; failure to provide this documentation may result in denial.
- Medical records must show trial and failure of at least a 30‑day supply of one or more step medications prior to PA submission.
- If medications are non‑formulary, submit a formulary exception via the Sanford Provider Portal.
Follow listed target→step medication mappings in PA requests
The document lists target medications with their associated required step medications (e.g., Qbrexza → Drysol/Xarac AC; Pulmicort HFA → inhaled corticosteroids), and prescribers must follow these mappings when preparing PA requests.
- When requesting PA, reference the specific step medication(s) named for the target medication and include trial/failure details.
Adhere to antipsychotic step sequencing or document exception
Step therapy groupings for many atypical antipsychotics are defined across step levels 1–3; prescribing outside the specified step order may require an exception and implied prior authorization.
- Document contraindication or intolerance if skipping lower‑step agents; include which step level was completed in the PA request.
Documentation Requirements and Denial Triggers
Quantity Limits and Key Values
Background and Definitions
Step therapy is a utilization management strategy that requires that a member trial and fail lower‑cost, therapeutically equivalent step medications before the plan will cover a higher‑cost target medication. Per the policy text, medical records must document that the member has tried and failed at least a 30‑day supply of one or more step medications prior to coverage of the target medication.
Quantity Limits for Specific Agents
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