Medicare Part B Step Therapy Criteria for Part B Drugs
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Defines step therapy, prior authorization, and the list of Medicare Part B drugs (by HCPCS/CPT) subject to step therapy protocols for Providence Medicare Advantage Plans; applies to providers prescribing or administering Part B medications for plan members.
No material clinical or coverage changes in this revision.
Step Therapy and Coverage Rules
Step therapy coverage rules
Covered when ALL of the following criteria are met:
Prior use of the non-preferred drug within 365 days waives step requirement
HCPCS/CPT Codes 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) |
Prior Authorization and Documentation Requirements
Prior authorization required for Step 2 and Step 3 (Step 1 usually)
Step 2 and Step 3 drugs always require prior authorization; Step 1 drugs usually require prior authorization but some Step 1 drugs may not—see individual drug entries. When requesting prior authorization for a Step 2 or Step 3 drug the provider must submit the information described for that step (clinical rationale, prior trials, or evidence of prior use).
- Step 1 drugs: usually require prior authorization; exceptions are noted in the drug list.
- Step 2 drugs: always require prior authorization plus documentation (see Step 2 documentation requirements).
- Step 3 drugs: always require prior authorization plus documentation (see Step 3 documentation requirements).
Step therapy mechanics — trial of preferred drug first; prior use exemption
Step therapy requires a documented trial of a preferred (Step 1) drug before a non-preferred (Step 2 or Step 3) drug is covered; prior use of the requested non-preferred drug within the past 365 days exempts the member from step requirements.
- Before coverage of a Step 3 drug, the member must have tried a Step 1 and a Step 2 drug unless an exemption applies.
- Prior use exemption: member use of the non-preferred drug within the past 365 days waives the step requirement.
Submit clinical rationale and treatment history with PA requests
When requesting prior authorization for Step 2 or Step 3 drugs the provider must submit clinical information documenting prior trials of required step drugs, reasons those drugs were ineffective or not tolerated, or evidence the member received the drug(s) within the past 365 days.
- Document attempts with Step 1 (and Step 2 when applicable) including duration, dose, and clinical outcome.
- If the prior step drug was not tried, provide a medical reason (e.g., intolerance, contraindication) explaining why it is not appropriate.
Denial risk if step therapy documentation is missing
Failure to document required trials of prior step drugs or a medically appropriate reason they were not used may result in non-coverage or denial of Step 2 and Step 3 drugs.
- If documentation does not show prior trials or acceptable medical justification, the authorization request may be denied.
- Provide evidence of prior use within 365 days when claiming a prior use exemption to avoid step requirements.
Policy Background
Medicare Part B covers many medically administered medications, including injectable drugs and biologics used across a range of conditions. This policy applies to Part B medications for Providence Medicare Advantage members and explains how step therapy is used to manage access to those therapies. Step therapy is a utilization management process that encourages use of a preferred agent first (labeled Step 1) before covering non-preferred agents (Step 2 or Step 3), and the list of affected HCPCS/CPT codes and products is provided in the document.
Under these Part B protocols, Step 1 drugs are the preferred/first-line agents and Step 2 and Step 3 drugs are non-preferred; Step 2 and Step 3 drugs always require prior authorization. Step 1 drugs usually require prior authorization, though the list indicates when a given Step 1 product does not. Prior authorization requests for later-step drugs must include clinical documentation explaining prior trials, intolerance, lack of efficacy, or other medical rationale.
A prior-use exemption is available when the member has received the requested non-preferred drug within the prior 365 days; in that case the step requirement is waived. The step therapy rules can apply across Part B and Part D agents (for example, a Part B drug may not be covered unless a Part D drug was tried first, or vice versa) depending on the clinical regimen described.
Step Definitions
Step Level Requirements
| Step | Description | Prior authorization required |
|---|---|---|
| Step 1 | Preferred drug — first-line; may still require prior authorization |
| Step | Description | Prior authorization & documentation required |
|---|---|---|
| Step 2 | Non-preferred drug; coverage requires documentation that Step 1 cannot be used or has failed (trial, intolerance, or clinical rationale) | Always required — provider must submit documentation why Step 1 was ineffective or not tolerated, or evidence of prior use within 365 days |
| Step | Description | Prior authorization & documentation required |
|---|---|---|
| Step 3 | Non-preferred drug; coverage requires documentation that Step 1 and Step 2 cannot be used or have failed (trial, intolerance, or clinical rationale) | Always required — provider must submit documentation why Step 1 and Step 2 were ineffective or not tolerated, or evidence of prior use within 365 days |
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