Medicare Part B Step Therapy Criteria for Part B Drugs
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Defines step therapy protocols, prior authorization expectations, and the list of Part B medications (by HCPCS/J-codes and others) subject to step requirements for Providence Medicare Advantage members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Step therapy sequence and authorization
Covered when following step therapy rules are satisfied
Step 1 drugs usually require prior authorization; Step 2 and Step 3 always require prior authorization. For Step 2 and Step 3 the prescriber must document why prior steps failed or are contraindicated, or provide evidence of prior administration within the past 365 days.
Recent use exemption
Evidence of administration within 365 days should be provided.
The step therapy requirement does not apply to members who have already received the non-preferred drug within the past 365 days. Evidence of administration within this 365-day look-back should be provided to support exemption from the step sequence.
Coding and Procedure Codes
| J3262 | Actemra (Tocilizumab) |
| J0791 | Adakveo (Crizanlizumab-tmca) |
| J7173 | Alhemo (Concizumab-mtci) |
| J1552 | Alyglo (Immune globulin, gamma) |
| Q5126 | Alymsys (Bevacizumab-maly) |
| J1554 | Asceniv (Immune globulin) |
| J9035 | Avastin (Bevacizumab) |
| J3145 | Aveed (Testosterone undecanoate) |
| Q5121 | Avsola (Infliximab-axxq) |
| Q5156 | Avtozma (Tocilizumab-anoh) |
| Q5152 | Bkemv (Eculizumab-aeeb) |
| Q5158 | Bomyntra/Conexxence (Denosumab-bnht) |
| J9054 | Boruzu (Bortezomib) |
| J2329 | Briumvi (Ublituximab) |
| J3392 | Casgevy (Exagemglogene autotemcel) |
| J3490 | Miscellaneous HCPCS (multiple drugs listed) |
| J0717 | Cimzia IV (Certolizumab) |
| J2786 | Cinqair (Reslizumab) |
| J0598 | Cinryze (C1 esterase inhibitor) |
| J3247 | Cosentyx IV (Secukinumab) |
| J1299 | Soliris (Eculizumab) |
| J2350 | Ocrevus (Ocrelizumab) |
| J0889 | Jesduvroq (Daprodustat) |
| J0888 | Mircera (Epoetin beta) non-ESRD use |
| J0219 | Nexviazyme (Avalglucosidase alfa) |
| J2802 | Nplate (Romiplostim) |
| J2182 | Nucala (Mepolizumab) |
| Q5122 | Nyvepria (Pegfilgrastim-apgf) |
| J9312 | Rituxan (Rituximab) |
| Q5119 | Ruxience (Rituximab-pvvr) |
| J9334 | Vyvgart Hytrulo (Efgartigimod alfa/hyaluronidase) |
| Q5138 | Wezlana (Ustekinumab-auub) |
| J3490/C9399 | Winrevair (Sotatercept-csrk) / miscellaneous codes |
| J1558 | Xembify (Immune globulin) |
| J2357 | Xolair (Omalizumab) |
| Q5100 | Yesintek (Ustekinumab-kfce) |
| J1553 | Yimmugo (Immune globulin (IgG)-dira human) |
| Q5120 | Ziextenzo (Pegfilgrastim-bmez) |
Provider Actions & Authorization
Prior authorization required for Step 2/3 (Step 1 usually)
Step 2 and Step 3 drugs always require prior authorization; Step 1 drugs usually require prior authorization unless the drug-specific list indicates otherwise.
- Provider must submit a prior authorization request for any Step 2 or Step 3 agent.
- If a Step 1 drug requires prior authorization, the list will note that — follow the drug-specific instruction.
Follow the step therapy sequence
Prescribers must follow the step therapy sequence: a trial of a preferred (Step 1) drug is required before coverage of a Step 2 agent, and a trial of Step 1 and Step 2 drugs is required before a Step 3 agent.
- Step 2 always follows Step 1; Step 3 requires prior trial of both Step 1 and Step 2.
- Confirm member eligibility and applicable step levels on the drug-specific list before requesting coverage.
Document prior therapy failure, contraindication, or prior use
For Step 2 and Step 3 drugs, the prescriber must document one of the acceptable reasons for bypassing prior steps or provide evidence of prior use within the look-back period.
- Document why the Step 1 (for Step 2) or Step 1 and Step 2 (for Step 3) drugs were ineffective or not tolerated, or why they are contraindicated.
- Alternatively, provide clinical details showing the member received the required prior step drug(s) within the past 365 days.
Risk of non-coverage if prior authorization is not provided
Failure to obtain and submit required prior authorization documentation for Step 1 (when required), Step 2, or Step 3 drugs may result in denial of coverage.
- Submit complete prior authorization with the required clinical justification or evidence of prior administration within 365 days to avoid non-coverage.
- Check the drug-specific list for any Step 1 exceptions and for the required supporting details for Step 2/3 requests.
Background
Medicare Part B covers many physician‑administered and infusion drugs and biologics that may be subject to step therapy to promote the use of preferred therapies first. Step therapy requires a trial of a preferred (Step 1) drug before covering a non‑preferred (Step 2 or Step 3) drug. Both preferred and non‑preferred drugs may still require prior authorization or quantity limits. Step therapy protocols in this document may coordinate treatment expectations across Part B and Part D when clinically appropriate.
Definitions
Initial Therapy Criteria
Initial therapy and Step 1 expectations
General initial therapy expectations for step therapy
Step 2 and Step 3 always require prior authorization and require documentation that Step 1 (and Step 2 when required) were ineffective or contraindicated, or evidence of prior administration within 365 days.
Step Therapy Details
| Step | Requirement | Prior authorization | Provider documentation needed |
|---|---|---|---|
| Step 1 (Preferred) | |||
| Member should be initiated on a preferred (Step 1) agent before progressing to Step 2. | |||
| Usually required unless the drug-specific list indicates otherwise. | |||
| If prior authorization is required, prescriber must submit clinical rationale for use; if the Step 1 drug does not require prior authorization this will be noted in the drug list. |
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