Step Therapy Prior Authorization Medical Necessity Guidelines
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Defines step therapy requirements and prior authorization conditions for specified formulary drugs (antidepressants, atypical antipsychotics, inhaled corticosteroids, interferons) for Harvard Pilgrim members. Affects prescribers and pharmacy benefit administrators processing prior authorizations and claims.
No material clinical or coverage changes in this revision.
Coverage Criteria by Therapeutic Category
Antidepressants - Coverage Criteria
Covered when the following step-therapy conditions are met for antidepressant products listed:
Evidence may be a paid pharmacy claim or physician documentation.
Atypical Antipsychotics - Coverage Criteria
Covered when the following step-therapy conditions are met for atypical antipsychotic products listed:
Evidence may be a paid pharmacy claim or physician documentation.
Inhaled Corticosteroids - Coverage Criteria
Covered when the following step-therapy conditions are met for inhaled corticosteroid products listed:
Evidence may be a paid pharmacy claim or physician documentation.
Interferons - Coverage Criteria
Covered when the following step-therapy conditions are met for interferon products listed:
Evidence may be a paid pharmacy claim or physician documentation.
Definitions
Product-Specific Step Therapy Requirements
| Drug | Step | Coverage requirement |
|---|---|---|
| Emsam | ||
| Step-2 | ||
| Will be covered if the member has filled for a Step-1 or Step-2 medication within the previous 180 days as evidenced by a paid claim or physician documentation. |
| Drug | Step | Coverage requirement |
|---|---|---|
| Fetzima | ||
| Step-2 | ||
| Will be covered if the member has filled for a Step-1 or Step-2 medication within the previous 180 days as evidenced by a paid claim or physician documentation. | ||
| Exxua | ||
| Step-2 | ||
| Will be covered if the member has filled for a Step-1 or Step-2 medication within the previous 180 days as evidenced by a paid claim or physician documentation. |
| Drug | Step | Coverage requirement |
|---|---|---|
| Asenapine | ||
| Step-2 | ||
| Will be covered if the member has filled for one or more Step-1 or Step-2 medications within the previous 180 days as evidenced by a paid claim or physician documentation. | ||
| Fanapt | ||
| Step-2 | ||
| Will be covered if the member has filled for one or more Step-1 or Step-2 medications within the previous 180 days as evidenced by a paid claim or physician documentation. |
| Drug | Step | Coverage requirement |
|---|---|---|
| Fluticasone (Diskus/HFA) | ||
| Step-2 | ||
| Will be covered if the member has filled for one or more Step-1 medications within the previous 180 days as evidenced by a paid claim or physician documentation. |
Coding and Lookback Period
Provider Actions and Prior Authorization Requirements
Step-2 drugs require prior authorization with 180‑day fill evidence
Certain Step-2 products require prior authorization and will only be approved when the member has evidence of prior fills as specified for the drug class (lookback: 180 days). Approval is contingent on a paid pharmacy claim or physician documentation showing the required Step-1/Step-2 medication fills within the prior 180 days.
- Applies to Step-2 antidepressants (Emsam, Fetzima, Exxua): member must have filled a Step-1 or Step-2 medication within previous 180 days. [[do not include chunk refs in body]]
- Applies to Step-2 atypical antipsychotics (Asenapine, Fanapt): member must have filled one or more Step-1 or Step-2 medications within previous 180 days.
- Applies to Step-2 inhaled corticosteroids (Fluticasone): member must have filled one or more Step-1 medications within previous 180 days.
- Applies to Step-2 interferons (Rebif, Rebif Rebidose): member must have filled two or more Step-1 interferon medications within previous 180 days.
General step therapy rule: try Step-1 first or document recent use
Step therapy requires that Step-1 agents (covered without prior authorization) be tried before Step-2 products are covered unless documentation shows the member has used the specified Step-1/Step-2 medication(s) within the prior 180 days as allowed by the policy.
- Step-1 agents are covered without prior authorization (examples listed per drug class).
- If paid claim or physician documentation demonstrates prior use within 180 days, Step-2 may be covered without additional trial.
Required evidence for Step-2 coverage: paid claim or physician documentation
To support Step-2 coverage, the provider must submit evidence of prior medication fills: a paid pharmacy claim or physician documentation demonstrating the member filled the required Step-1 (or Step-2 where specified) medication(s) within the previous 180 days.
- Acceptable evidence: paid pharmacy claim showing fill within 180 days.
- Or: physician documentation confirming the member filled the required medication(s) within 180 days.
Denial risk if no prior step therapy evidence within 180 days
Coverage will be denied if there is no evidence — either a paid pharmacy claim or physician documentation — that the member filled the required Step-1 (or specified number of Step-1) or Step-2 medication(s) within the previous 180 days as required for the drug.
- Example denials: antidepressant Step-2 (Emsam/Fetzima/Exxua) without a paid claim or documentation of a Step-1/Step-2 fill in past 180 days.
- Interferon Step-2 (Rebif/Rebif Rebidose) requires documentation of two or more Step-1 fills in prior 180 days; absence of this evidence leads to denial.
Step-1 Initial Therapy
Step-1 initial therapy
Step-1 drugs are covered without prior authorization as first-line agents.
Background
This policy groups select formulary drugs into four therapeutic categories — Antidepressants, Atypical Antipsychotics, Inhaled Corticosteroids, and Interferons — and assigns each drug to either Step-1 or Step-2 within its category. Step-1 agents are the preferred initial therapies and are covered without prior authorization. Step-2 agents require evidence of prior use of Step-1 (or the number of Step-1 fills specified) within a 180-day lookback before coverage is approved, and certain Step-2 products require prior authorization.
The step-therapy structure is an administrative utilization management tool: for Step-2 coverage the provider must document that the member filled the required Step-1 (or Step-2 where specified) medication(s) within the previous 180 days by supplying a paid pharmacy claim or physician documentation. If that evidence is not provided as specified for the category, coverage for the Step-2 product will be denied.
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