Medicare Part B Step Therapy Criteria for Part B Drugs
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Defines step therapy requirements, prior authorization expectations, and the list of Part B-administered drugs subject to step therapy for Providence Medicare Advantage Plans members. Affects providers prescribing or administering Medicare Part B drugs to Providence Medicare Advantage enrollees.
No material clinical or coverage changes in this revision.
Coverage Criteria
General Step Therapy Criteria
Covered when step therapy rules are satisfied.
Members who received the non-preferred drug in the prior 365 days are exempt; Step 1 drugs may require prior authorization; Step 2 and Step 3 always require prior authorization and clinical justification or documentation of prior use.
Members who have received the non-preferred Part B drug within the prior 365 days are exempt from step therapy requirements. In other words, if the member has documentation of treatment with the same non-preferred drug during the last 365 days, the member does not need to first trial a preferred (Step 1) agent before receiving the non-preferred (Step 2 or Step 3) drug.
Coding and Lookback
| J3262 | Actemra (Tocilizumab) |
| J0791 | Adakveo (Crizanlizumab-tmca) |
| J7173 | Alhemo (Concizumab-mtci) |
| J1552 | Alyglo (Immune globulin, gamma(IGG)-stwk) |
| Q5126 | Alymsys (Bevacizumab-maly) |
| J1554 | Asceniv (Immune globulin) |
| Q5161 | Aukelso/Bosaya (denosumab-kyqq) |
| J9035 | Avastin (Bevacizumab) |
| J3145 | Aveed (Testosterone undecanoate) |
| Q5121 | Avsola (Infliximab-axxq) |
Provider Actions and Authorization
Prior Authorization Required
Prior authorization is required for all Step 2 and Step 3 drugs. Some Step 1 (preferred) drugs may also require prior authorization — check the drug list for exceptions. Your patient’s prescriber must submit a completed prior authorization request before the drug is covered.
- Step 2 and Step 3 drugs always require prior authorization.
- Some Step 1 drugs may require prior authorization — see drug-specific list.
Step Therapy Requirement
Step therapy requires a trial of a Step 1 (preferred) drug before a non-preferred Step 2 or Step 3 drug will be approved. For Step 3 drugs, the member generally must have tried and failed (or have a contraindication/intolerance to) both a Step 1 and a Step 2 drug prior to approval.
- To obtain a Step 3 drug, the member must first have trialed a Step 1 and a Step 2 drug unless an exemption is documented.
- Exemptions include documented contraindication or intolerance to required prior steps.
Required Documentation for Prior Authorization
When requesting prior authorization, the prescriber must document why earlier step(s) were ineffective or not tolerated, or provide evidence of prior use within the last 365 days. Documentation should clearly state the clinical rationale for moving to the requested (non-preferred) drug.
- For Step 2 requests: document why the Step 1 drug failed or cannot be used, OR why the Step 2 drug is clinically preferred, OR provide evidence of Step 2 use within the past 365 days.
- For Step 3 requests: document why Step 1 and Step 2 drugs failed or cannot be used, OR why the Step 3 drug is clinically preferred, OR provide evidence of Step 1/Step 2 use within the past 365 days.
Denial Risk for Unmet Step Therapy or PA Requirements
If step therapy requirements or prior authorization criteria are not met or documentation is incomplete, the request may be denied. Denials typically occur when required trials are not documented, clinical rationale is missing, or supporting records (including recent medication history) are not provided.
- Incomplete prior authorization forms or missing clinical notes may result in denial.
- Lack of documentation showing prior trials within the past 365 days risks denial.
- Requests that do not justify medical necessity relative to required step therapy may be denied.
Background
Medicare Part B covers certain physician‑administered injectable and infused drugs and biologics, and some of these medications are subject to step therapy. Step therapy requires a trial of a preferred agent (Step 1) before a non‑preferred agent (Step 2 or Step 3) will be covered, although both preferred and non‑preferred drugs may still require prior authorization or quantity limits. The policy also allows cross‑plan sequences (Part B vs Part D) where coverage of a Part B drug may depend on prior use of a Part D drug or vice versa, depending on the therapy described for the medical condition.
Definitions
Initial Therapy Criteria
Initial Therapy — general initial step therapy rules
General initial step therapy rules.
Specific drug-level criteria are linked from the list. For Step 2 and Step 3 drugs providers must submit prior authorization documenting why prior steps were ineffective or not tolerated, or documentation of prior use within the past 365 days. Step 1 drugs usually require prior authorization as indicated in the drug list.
Step Therapy Table
| Step | Requirement | Prior Authorization | Documentation to Support Exception |
|---|---|---|---|
| Step 3 (Non-Preferred drug) | |||
| Requires prior trials of Step 1 and Step 2 (where applicable) before coverage unless exempted by prior use within 365 days or clinical justification. | |||
| Always requires prior authorization. | |||
| Provider must document why Step 1 and Step 2 were ineffective or not tolerated, why Step 3 is clinically necessary, or provide records showing prior use of Step 1 and/or Step 2 drugs within the past 365 days. |
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