CurrentProvidence Health PlanPolicy N/A

Medicare Part B Step Therapy Criteria for Part B Drugs

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.

Policy Summary

PayerProvidence Health Plan

PolicyMedicare Part B Step Therapy Criteria for Part B Drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 1, 2026

Key ActionObtain prior authorization and document why prior steps were ineffective, not tolerated, or prior use within 365 days for Step 2/3 drugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~250+Part B medication entries listed

365Lookback period (days)

SomeSome Step 1 require PA

Step 2/3Non-preferred require PA

Coverage Criteria

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General Step Therapy Criteria

Covered when step therapy rules are satisfied.

General Step Therapy Logic: Member must trial preferred Step 1 drug(s) before Step 2 or Step 3 drugs unless an exemption applies.

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.

Coding and Lookback

Listed Part B HCPCS/Codesmixed

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)

1–10 of 138

1/14

Prior use lookback period (inv-04)

Lookback period365 days — members who received the non-preferred drug within the prior 365 days are exempt from step therapy.

ScopeApplies to Medicare Part B step therapy for medically administered drugs (injectables, biologics).

Effect on prior authorizationPrior authorization requirements may still apply to preferred and non-preferred drugs despite the exemption.

Provider Actions and Authorization

Prior 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

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.

Documentation Required

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

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

Step 1 definition (inv-10)

DefinitionStep 1 = Preferred drug (preferred agent).

Prior authorizationStep 1 drugs usually require prior authorization; if a specific Step 1 drug does not require prior authorization this will be indicated in the drug list.

Role in step therapyTrial of a Step 1 agent is required before covering Step 2 or Step 3 drugs unless an exemption applies (e.g., prior use within 365 days or clinical justification).

Step 2 definition (inv-11)

DefinitionStep 2 = Non-preferred drug.

Prior authorizationStep 2 drugs always require prior authorization.

Documentation requiredProvider must document why the Step 1 drug was ineffective or not tolerated, why the Step 2 drug is clinically necessary, or that the member received the Step 2 drug in the past 365 days.

Step 3 definition (inv-12)

DefinitionStep 3 = Non-preferred drug.

Prior authorizationStep 3 drugs always require prior authorization.

Documentation requiredProvider must document why Step 1 and Step 2 drugs were ineffective or not tolerated, why the Step 3 drug is clinically necessary, or that the member received the Step 1 and/or Step 2 drug(s) in the past 365 days.

Initial Therapy Criteria

Initial Therapy — general initial step therapy rules

General initial step therapy rules.

Initial step therapy: Before covering Step 2 or Step 3 drugs, member must have trial of Step 1 preferred drug(s) unless exempted by prior use within 365 days or clinical justification.365 days

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	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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