Medicare Part B Step Therapy Program for Providers
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Describes Alacura's Medicare Part B step therapy process for certain Part B prescription drugs, explaining preferred vs nonpreferred medications, required prior-use or continuation exceptions, and when prior authorization is needed; intended for providers serving Blue Cross Medicare Advantage markets.
No material clinical or coverage changes in this revision.
Coverage Criteria and Drug-Specific Requirements
Step therapy coverage logic
Covered when the step therapy process is satisfied or exception criteria are met.
Preferred and nonpreferred medications are listed in the step therapy chart
Provider must document reason for exception
Antiemetic (Sustol/Posfrea) - Nonpreferred criteria
Sustol/Posfrea (nonpreferred antiemetic injectable) coverage
Applicable MAC regions listed in source
NK1 receptor antagonist injectables - Nonpreferred criteria
Akynzeo/Cinvanti/Focinvez (nonpreferred NK1 injectables) coverage
Applicable MAC regions listed in source
Bevacizumab - Nonpreferred criteria
Nonpreferred bevacizumab products coverage (Avastin, Avzivi, Jobevne, Vegzelma)
Applicable MAC regions listed in source
Botulinum toxin (Myobloc) - Nonpreferred criteria
Myobloc (nonpreferred botulinum toxin) coverage
Region-specific variations noted for MACs
Colony-stimulating factors - Nonpreferred criteria
Colony-stimulating factors (long and short acting) - Nonpreferred coverage
Applicable MAC regions listed
Applicable MAC regions listed
Denosumab and similar agents - Nonpreferred criteria
Denosumab/Prolia and biosimilars - Nonpreferred coverage
Applicable MAC regions listed
Denosumab-class nonpreferred coverage — Boncresa, Bosaya, Conexxence, Enoby, Ospomyv, Osvyrti, Prolia or Stoboclo coverage conditions
Boncresa, Bosaya, Conexxence, Enoby, Ospomyv, Osvyrti, Prolia or Stoboclo may be covered when ALL of the following are met
The policy presents the three clauses with an AND/OR structure: first clause requires history of one preferred med; the second and third are alternative pathways allowing coverage.
Denosumab/Xgeva-class nonpreferred coverage — Aukelso, Bomyntra, Jubereq, Osenvelt, Oziltus, Xbryk, Xgeva or Xtrenbo coverage conditions
Aukelso, Bomyntra, Jubereq, Osenvelt, Oziltus, Xbryk, Xgeva or Xtrenbo may be covered when ALL of the following are met
Same logical structure as other denosumab group.
Eculizumab nonpreferred coverage — Bkemv or Soliris coverage conditions
Bkemv or Soliris may be covered when ALL of the following are met
Eculizumab nonpreferred products follow same step rules.
IVIG nonpreferred coverage — Nonpreferred IVIG products (Alyglo, Asceniv, Bivigam, Panzyga, Qivigy, Yimmugo, etc.) coverage when ALL criteria met
Nonpreferred IVIG products (Alyglo, Asceniv, Bivigam, Panzyga, Qivigy, Yimmugo, etc.) may be covered when ALL of the following are met
The document lists many indications and repeats that history of two preferred products or continuation within 365 days also qualifies.
Nonpreferred immune globulins and related products — Asceniv and certain nonpreferred immune globulins coverage when ANY criteria met
Asceniv and certain nonpreferred immune globulins may be covered when ANY of the following are met:
supported by chunk 126
supported by chunks 126-129
supported by chunks 126, 134
recurrent criterion across multiple products
Alyglo — coverage rules
Alyglo coverage rules:
supported by chunk 128
SC immune globulins (Cuvitru, HyQvia) — coverage rules
Cuvitru and HyQvia coverage rules:
supported by chunk 132
supported by chunk 132
Remicade / infliximab — coverage rules vary by MAC region; core requirements
Remicade (infliximab) coverage rules vary by MAC region but share core requirements:
supported by chunks 134-135
Intravenous iron agents — coverage criteria for Feraheme, Monoferric, Injectafer
Intravenous iron (Feraheme, Monoferric, Injectafer):
supported by chunk 137
supported by chunk 137
Ophthalmic VEGF inhibitors — intravitreal VEGF inhibitors coverage criteria
Intravitreal VEGF inhibitors (multiple agents):
supported by chunk 139
supported by chunks 139-141
supported by chunk 140
Paclitaxel nonpreferred formulations coverage
Paclitaxel formulations (Abraxane, paclitaxel protein-bound):
supported by chunk 143
supported by chunk 143
PD-L1 inhibitors (nasopharyngeal carcinoma) — nonpreferred criteria
PD-L1 agents for nasopharyngeal carcinoma:
supported by chunk 145
supported by chunk 145
PD-L1 - Nasopharyngeal Carcinoma / Head & Neck
Keytruda / Opdivo (intravenous and Qlex/Qvantig) coverage when ANY of the following are met:
Applies to IV and Qlex/Qvantig formulations with Qlex/Qvantig additional allowance for inability to obtain/maintain IV access
Rituximab (Rituxan IV / Rituxan Hycela) coverage — nonpreferred coverage when ALL/ANY as specified
Rituxan IV / Rituxan Hycela nonpreferred coverage when ALL/ANY as specified below:
Typically required across MAC regions
Many specific diagnoses enumerated in chunks 147-149
Somatostatin analogs, long acting — Sandostatin LAR coverage when ANY of the following
Sandostatin LAR (nonpreferred) coverage for somatostatin indications when ANY of the following:
Applies across listed indications
SLE drugs (Saphnelo) — nonpreferred coverage when ANY of the following
Saphnelo (nonpreferred for SLE) coverage when ANY of the following:
Applies to SLE patients as an exception to step therapy
Testosterone, injectable — nonpreferred coverage when ANY of the following
Testosterone injectables (Aveed, Azmiro, Testopel, Xyosted) nonpreferred coverage when ANY of the following:
Applies across listed MAC regions
Tocilizumab (Actemra / Avtozma) — nonpreferred coverage when ALL/ANY as specified
Tocilizumab nonpreferred coverage when ALL/ANY as specified:
And one of the exception conditions below
Applies to listed MAC regions
Trastuzumab — Herceptin and Herceptin Hylecta nonpreferred coverage when ANY of the following
Herceptin and Herceptin Hylecta (trastuzumab products) nonpreferred coverage when ANY of the following:
Herceptin Hylecta allowance noted
Ustekinumab — nonpreferred coverage when ALL/ANY as specified
Ustekinumab nonpreferred coverage when ALL/ANY as specified:
Applies to multiple listed formulations and MAC regions
Viscosupplements — nonpreferred coverage when ANY of the following
Viscosupplements nonpreferred coverage when ANY of the following:
Applies only to listed MAC regions and does not apply to MAC regions not listed
Viscosupplement nonpreferred coverage — may be covered when ONE of the following is met
Nonpreferred viscosupplements may be covered when ONE of the following is met:
Examples of preferred agents listed separately in document
Applies to the listed viscosupplement agents
Vyepti coverage — may be covered when ONE of the following is met
Vyepti (CGRP infusion) step therapy criteria
Preferred Part D agents referenced to Part D Drug List
Applies to Vyepti
Leqvio coverage — All of the following must be met or continuation applies
Leqvio (PCSK9 agent) step therapy criteria
Prescriber attestation required for inadequate efficacy/intolerance
Alternative path to coverage
This step therapy policy applies to Part B drugs across Blue Cross Medicare Advantage markets. The step therapy chart is stated to apply to all Blue Cross Medicare Advantage ℠ markets, and no state-specific exclusions are listed in this portion of the document.
Some therapeutic classes noted in the step therapy chart reference preferred agents that are managed under the Part D (pharmacy) benefit rather than Part B. For example, CGRP inhibitors and certain PCSK9 agents (inclisiran/Leqvio) are noted as Preferred Part D medications with the corresponding nonpreferred Part B product (e.g., Vyepti, Leqvio) listed under Step 2; providers should consult the Part D Drug List and Part D utilization management requirements when evaluating these agents.
There are no additional program-level exclusions stated in the excerpt beyond the standard step-therapy rules. Coverage of nonpreferred Part B medications is contingent on meeting the listed step-therapy criteria (for example, prior trial of preferred agent(s), documented inability to use a preferred agent, or continuation of prior therapy within the lookback period). Requests that do not satisfy those criteria may be denied.
The policy distinguishes preferred and nonpreferred Part B agents. Preferred medications listed for each drug class are expected to be tried first; nonpreferred agents require meeting the step-therapy exceptions (prior use of preferred agent(s), documented intolerance/ineffectiveness, or continuation/ prior use). Biosimilar Q‑codes are commonly listed as preferred while reference J‑codes (non‑biosimilar) are often nonpreferred for several classes.
The viscosupplement step-therapy requirements described apply only to the MAC regions specifically listed. Nonpreferred viscosupplements may be covered when the patient has trialed two different preferred medication therapy courses or is continuing prior therapy; the document explicitly notes the rule does not apply to MAC regions not listed.
HCPCS/CPT/Q-Code Groups
| J2506 | Injection, pegfilgrastim, excludes biosimilar, 0.5 mg |
| Q5108 | Injection, pegfilgrastim-jmdb (Fulphila), 0.5 mg |
| Q5111 | Injection, pegfilgrastim-cbqv (Udenyca), 0.5 mg |
| J1449 | Injection, eflapegrastim-xnst, 0.1 mg |
| J9361 | Injection, efbemalenograstim alfa-vuxw (Ryzneuta), 0.5 mg |
| Q5120 | Injection, pegfilgrastim-bmez (Ziextenzo), 0.5 mg |
| Q5122 | Injection, pegfilgrastim-apgf (Nyvepria), 0.5 mg |
| Q5127 | Injection, pegfilgrastim-fpgk (Stimufend), 0.5 mg |
| Q5130 | Injection, pegfilgrastim-pbbk (Fylnetra), 0.5 mg |
| Q5169 | Injection, pegfiligrastim-unne (Armlupeg), 0.5 mg |
| J1572 | Injection, immune globulin (Flebogamma), 500 mg |
| J1569 | Injection, immune globulin (Gammagard liquid), 500 mg |
| J1566 | Injection, immune globulin (powder), 500 mg |
| J1561 | Injection, immune globulin (Gamunex-C/Gammaked), 500 mg |
| J1557 | Injection, immune globulin (Gammaplex), 500 mg |
| J1568 | Injection, immune globulin (Octagam), 500 mg |
| J1459 | Injection, immune globulin (Privigen), 500 mg |
| J1551 | Injection, immune globulin (Cutaquig), 100 mg |
| J1559 | Injection, immune globulin (Hizentra), 100 mg |
| J1558 | Injection, immune globulin (Xembify), 100 mg |
| J1572 | Injection, immune globulin (Flebogamma), 500 mg. |
| J1569 | Injection, immune globulin (Gammagard liquid/Gammagard liquid ERC), 500 mg. |
| J1566 | Injection, immune globulin (powder), 500 mg. |
| J1561 | Injection, immune globulin (Gamunex-C/Gammaked), 500 mg. |
| J1557 | Injection, immune globulin (Gammaplex), 500 mg. |
| J1568 | Injection, immune globulin (Octagam), 500 mg. |
| J1459 | Injection, immune globulin (Privigen), 500 mg. |
| J1552 | Injection, immune globulin, Alyglo, 500 mg. |
| J1554 | Injection, immune globulin (Asceniv), 500 mg. |
| J1556 | Injection, immune globulin (Bivigam), 500 mg. |
| J1551 | Injection, immune globulin (Cutaquig), 100 mg. |
| J1569 | Injection, immune globulin (Gammagard liquid/Gammagard liquid ERC), 500 mg. |
| J1561 | Injection, immune globulin (Gamunex-C/Gammaked), 500 mg. |
| J1559 | Injection, immune globulin (Hizentra), 100 mg. |
| J1558 | Injection, immune globulin (Xembify), 100 mg. |
| J1555 | Injection, immune globulin (Cuvitru), 100 mg. |
| J1575 | Injection, immune globulin (Hyqvia), 100 mg. |
| C9257 | Injection, bevacizumab (Avastin), 0.25 mg. |
| J7999 | Compounded drug, not otherwise classified. |
| J9035 | Injection, bevacizumab (Avastin), 10 mg. |
| J0178 | Injection, aflibercept, 1 mg. |
| J0179 | Injection, brolucizumab-dbll, 1 mg. |
| J0177 | Injection, aflibercept hd, 1 mg. |
| J2777 | Injection, faricimab-svoa, 0.1 mg. |
| J2778 | Injection, ranibizumab, 0.1 mg. |
| Q5147 | Injection, afilbercept-ayyh (Pavblu), 1 mg. |
| Q5124 | Injection, ranibizumab-nuna, biosimilar (Byooviz), 0.1 mg. |
| Q5114 | Injection, trastuzumab-dkst, biosimilar (Ogivri), 10 mg. |
| Q5116 | Injection, trastuzumab-qyyp, biosimilar (Trazimera), 10 mg. |
| Q5117 | Injection, trastuzumab-anns, biosimilar (Kanjinti), 10 mg. |
| J9355 | Injection, trastuzumab, excludes biosimilar, 10 mg. |
| J9356 | Injection, trastuzumab, 10 mg and hyaluronidase-oysk. |
| Q5112 | Injection, trastuzumab-dttb, biosimilar (Ontruzant), 10 mg. |
| Q5113 | Injection, trastuzumab-pkrb, biosimilar (Herzuma), 10 mg. |
| Q5146 | Injection, trastuzumab-strf, biosimilar (Hercessi), 10 mg. |
| Q9998 | Injection, ustekinumab-aekn, biosimilar (Selarsdi IV), 1 mg. |
| J3358 | |
| Q5098 | Injection, ustekinumab-srlf, biosimilar (Imuldosa IV), 1 mg. |
| Q5099 | Injection, ustekinumab-stba, biosimilar (Steqeyma IV), 1 mg. |
| Q5100 | Injection, ustekinumab-kfce, biosimilar (Yesintek IV), 1 mg. |
| Q5138 | Injection, ustekinumab-aaub, biosimilar (Wezlana IV), 1 mg. |
| Q9997 | Injection, ustekinumab-ttwe, iv biosimilar (Pyzchiva IV), 1 mg. |
| Q9999 | Injection, ustekinumab-aauz, biosimilar, (Otulfi IV), 1 mg. |
| Q5164 | Injection, ustekinumab-hmny, biosimilar (Starjemza IV), 1 mg. |
| J7324 | Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose. |
| J7325 | Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg. |
| J7327 | Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose. |
| J7318 | Hyaluronan or derivative, Durolane, for intra-articular injection, 1 mg. |
| J7320 | Hyaluronan or derivative, GenVisc 850, for intra-articular injection, 1 mg. |
| J7321 | Hyaluronan or derivative, Hyalgan, Supartz or Visco-3, per dose. |
| J7322 | Hyaluronan or derivative, Hymovis or Hymovis One, for intra-articular injection, 1 mg. |
| J7323 | Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose. |
| J7326 | Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose. |
| J7328 | Hyaluronan or derivative, Gel-Syn, for intra-articular injection, 0.1 mg. |
| J1306 | Injection, inclisiran, 1 mg. |
Provider Steps, Prior Authorization and Documentation
Part B step therapy applies to listed Part B drugs
Step therapy applies to certain Medicare Part B prescription drugs listed in the payer's Part B step therapy chart for Blue Cross Medicare Advantage markets; providers should consult that chart to determine whether a medication is subject to step therapy prior to prescribing.
Drugs enumerated as requiring Part B step therapy
The document lists numerous specific Part B products and product families that are subject to Part B step therapy; this segment provides drug names but does not itself give step mechanics.
Part B drugs in step therapy may require prior authorization
Many Part B drugs included in the step therapy chart (for example colony‑stimulating factors, denosumab products, immune globulins, and other biologics/biosimilars) may require prior authorization or must satisfy step edits before coverage is allowed.
Drug names shown as subject to Part B step therapy (no codes here)
This section of the chart lists drug names that are subject to Part B step therapy but does not list specific HCPCS/CPT codes or step‑edit mechanics within the listing fragments.
Listed Part B drugs subject to step therapy
The payer's step therapy lists specific products (brand and biosimilar names) grouped by drug family; providers must use those lists to identify which agents require step‑first trials.
Denosumab‑class nonpreferred: prior use or exception required
When prescribing a nonpreferred denosumab‑class product, coverage requires meeting step criteria: history of use of one preferred denosumab agent, or documented inability to use the preferred agent due to a formulation (inactive‑ingredient) allergy/serious adverse reaction per the prescriber, or continuation/prior use within the past 365 days.
IVIG: prior use or indication documentation required
Nonpreferred IVIG products commonly require meeting step‑therapy documentation: either disease‑specific indication criteria, history of use of two preferred IVIG products (as specified), or continuation/prior use within the past 365 days for coverage to be allowed.
Prior authorization required for nonpreferred/step agents
Prior authorization is required when prescribing nonpreferred or step‑therapy medications unless an allowed continuation or other listed exception applies; providers must follow the payer's medical prior authorization process.
Step therapy prior‑use requirements for nonpreferred IV/SC agents
Nonpreferred intravenous or subcutaneous Part B agents require meeting the step therapy criteria (history of preferred agent use, clinical indication exceptions, or continuation within 365 days) before Step‑2 agents will be covered.
Viscosupplement step requirement: two preferred trials or continuation
Nonpreferred viscosupplements are subject to step criteria in listed MAC regions: coverage requires documentation of a history of two different preferred viscosupplement medication courses or continuation/use within the past 365 days.
Vyepti: preferred Part D CGRP trial or continuation required
Vyepti coverage requires a history of use of one preferred Part D subcutaneous CGRP inhibitor for migraine prophylaxis, or documentation of continuation/prior use within the past 365 days.
Leqvio: Part D PCSK9 trial plus inadequate efficacy/intolerance or continuation
Leqvio coverage requires prior use of one preferred Part D PCSK9 inhibitor plus documented inadequate efficacy or significant intolerance per the prescriber, or continuation/prior use within the past 365 days.
Use medical prior authorization process for coverage reviews
Medical prior authorization reviews are the pathway for coverage determinations for Part B step‑therapy and nonpreferred agents; providers must submit PA requests per Alacura/Blue Cross procedures.
Submit PA/step therapy requests via payer Provider Manuals/PA code list
Prior authorization or step therapy review requests must be submitted through the Provider Manuals/prior authorization code list URLs provided by the payer (see Provider Manuals and prior authorization code list links).
Reference prescribing information and guidelines for PA support
The step therapy reference materials include prescribing information and clinical guideline citations for immune globulins and immunomodulators; providers should reference these PIs and guidelines when preparing PA requests.
Drug and PI listings included for reference (no PA mechanics provided here)
The document enumerates covered drugs and cites prescribing information for many injectable specialty drugs relevant to step therapy; however these listings do not themselves provide PA forms, codes, or the step mechanics—use them as references only.
Consult cited prescribing information when preparing PA documentation
Product‑specific prescribing information references (e.g., denosumab, eculizumab, IVIG, trastuzumab, viscosupplements) are listed in the policy and should be consulted for dosing, indications, and administration details when completing PA documentation.
Providers must document Step‑1 (preferred) trial before Step‑2 agents
Members must first try preferred medications (Step 1) for specified Part B drug classes; if a preferred medication was tried within the past 365 days or was proven ineffective or intolerable, a nonpreferred agent may be covered under the step therapy rules.
- Preferred agent trial or documented ineffectiveness/intolerance supports escalation to nonpreferred
- Prior trial within 365 days qualifies as recent use
Multiple drug classes/products are included in Part B step therapy
The policy lists many Part B drug classes and specific products as subject to Part B step therapy (for example colony‑stimulating factors, denosumab, IVIGs, rituximab, viscosupplements, among others); providers should review the chart to identify the applicable preferred agents for each class.
Trigger for denial: failure to meet step therapy criteria
Coverage of a nonpreferred medication will be denied if the step therapy criteria are not satisfied (for example, no documented trial of the preferred medication, no documented intolerability/inefficacy, and no continuation within the past 365 days), unless an allowed exception applies.
Sustol/Posfrea may be denied without preferred antiemetic trial
Claims for nonpreferred antiemetic injectables (for example Sustol or Posfrea) may be denied unless the prescriber documents history of use of one preferred injectable antiemetic or documents continuation/prior use within the past 365 days.
Bevacizumab (Avastin/others) denial risk without preferred trial or exception
Nonpreferred bevacizumab reference products may be denied unless the provider documents history of use of a preferred agent, inability to use the preferred agent due to formulation‑related inactive‑ingredient allergy/serious adverse reaction per prescriber, or continuation/prior use within the past 365 days.
Denosumab nonpreferred requests risk denial without step criteria
Requests for nonpreferred denosumab‑class products may be denied unless step‑therapy criteria are met: documented history of one preferred denosumab agent, documented formulation‑based inability to use the preferred agent per prescriber, or continuation/prior use within the past 365 days.
Denosumab/Xgeva nonpreferred requests may be denied without documentation
Requests for nonpreferred denosumab/Xgeva‑group products follow the same denial risk: coverage may be denied unless prior use of a preferred agent, formulation‑based exception, or continuation within 365 days is documented.
Eculizumab nonpreferred requests risk denial without prior‑use documentation
Requests for nonpreferred eculizumab products (e.g., Bkemv, Soliris) may be denied unless the provider documents prior use of the preferred medication, a formulation‑based inability to use the preferred drug, or continuation/prior use within the past 365 days.
IVIG nonpreferred requests may be denied without indications or prior‑use evidence
Nonpreferred IVIG product requests (Alyglo, Asceniv, Bivigam, Panzyga, Qivigy, Yimmugo, etc.) may be denied unless the request meets product‑specific indication criteria, documents history of appropriate preferred IVIG trials (commonly two preferred agents where specified), or documents continuation/prior use within the past 365 days.
Nonpreferred immune globulins risk denial without indication/prior‑use documentation
Nonpreferred immune globulins without meeting listed clinical indications, prior‑use requirements, or continuation criteria may be denied; providers must document indication and prior therapy as specified in the policy.
General denial risk for not meeting step therapy
General step‑therapy denial trigger: coverage may be denied when step therapy conditions are not satisfied for nonpreferred medications (no history of preferred use, no continuation within 365 days, or absence of listed clinical exceptions).
Viscosupplement denials possible without two preferred trials or recent use
Requests for listed nonpreferred viscosupplements may be denied unless the patient has trialed two different preferred viscosupplements or is continuing prior therapy/used the agent within the past 365 days (applies in the MAC regions listed).
Vyepti/Leqvio requests may be denied without Part D preferred‑agent history or continuation
Vyepti or Leqvio requests may be denied if the required Part D preferred‑agent history (Vyepti: one preferred Part D SC CGRP trial; Leqvio: one preferred Part D PCSK9 with inadequate efficacy or intolerance) or continuation criteria (use within past 365 days) are not documented.
Submit PA per payer process or risk non‑compliance
Providers must submit prior authorization requests using the payer's medical prior authorization process; failure to submit PA/step therapy review through the Provider Manuals/PA code list links may result in non‑compliance with PA requirements.
Document prior preferred trial, ineffectiveness/intolerance, or formulation‑based exception
Providers should document prior trial of the preferred medication within the past 365 days, or document ineffectiveness/adverse effects to the preferred agent, or provide a prescriber attestation that the preferred formulation cannot be used due to an inactive‑ingredient allergy/serious adverse reaction to support exceptions.
- Document preferred agent trial within past 365 days when applicable
- Document ineffectiveness or significant adverse reaction to preferred agent
- Prescriber attestation required for formulation‑based exceptions
Use the Part B step therapy list and Provider Manuals when submitting PA
This segment provides lists of drugs subject to Part B step therapy but does not itself specify how to submit documentation; providers must reference the payer's Part B step therapy list and Provider Manuals when preparing coverage or PA requests.
Initial (Step 1) Therapy Requirements
Initial therapy (step 1)
Initial preferred medication requirement
See class-specific lists in the chart
Preferred medication trial
Preferred-first step required for many nonpreferred biologics
Document prior use to satisfy step requirement.
Preferred-first expectation
Preferred medications are listed and initial therapy is expected to use preferred agents before nonpreferred options.
supported by chunk 131 and 134
Rituximab initial therapy exceptions
Initial coverage exceptions for Rituxan IV
Region-specific lists apply
Initial therapy requirements
Initial coverage requires prior trials of preferred agents unless continuation criteria are met
Applies in listed MAC regions
Preferred Part D medications per Part D Drug List
Prescriber attestation of inadequate efficacy/intolerance
Continuation of Prior Therapy
Continuation of prior therapy
Continuation of prior therapy is an allowed pathway for covering nonpreferred products.
Appears across multiple product groups.
Continuation exceptions
Continuation of prior therapy is a recurring exception across multiple agents.
supported by multiple chunks
Continuation of prior therapy
Continuation allowance
Repeated across multiple drug sections
Continuation therapy provision
Continuation/prior-use paths included for nonpreferred agents
Applies across multiple nonpreferred agents (viscosupplements, Vyepti, Leqvio)
Step Therapy Tables and Summaries
| Requirement | Notes / Evidence |
|---|---|
| Providers must document a trial of the designated preferred medication(s) for the applicable Part B drug class before a nonpreferred (Step 2) agent will be covered. | |
| Documentation should show either: (a) prior trial of the preferred medication(s), or (b) documented ineffectiveness or adverse reaction to preferred medication(s), or (c) continuation/prior use of the nonpreferred agent within the past 365 days. |
| Drugs / Classes Subject to Part B Step Therapy (examples) | Notes |
|---|---|
| Colony-stimulating factors (long‑ and short‑acting) — e.g., Fulphila, Neulasta, Armlupeg, Rolvedon, Nivestym, Zarxio, Granix, Neupogen, Releuko | |
| Denosumab products and biosimilars — e.g., Prolia, Boncresa, Bosaya, Conexxence, Enoby, Ospomyv, Osvyrti, Xgeva, Aukelso | |
| Immune globulins (IV and SC) — e.g., Flebogamma DIF, Gammagard Liquid/ERC, Gamunex‑C, Octagam, Privigen, Alyglo, Asceniv, Bivigam, Panzyga, Qivigy, Yimmugo, Cutaquig, Cuvitru, HyQvia | |
| Botulinum toxins — e.g., Botox, Daxxify, Dysport, Xeomin, Myobloc | |
| Eculizumab and complement inhibitors — e.g., Soliris, Bkemv/Epzyňi |
| Provider Action | Supporting detail / citation |
|---|---|
| Follow the payer's Part B step therapy program for listed agents before requesting coverage for nonpreferred products. | |
| Identify the drug class and confirm whether the prescribed agent is listed as preferred (Step 1) or nonpreferred (Step 2) in the step therapy chart. | |
| If prescribing a nonpreferred agent, include documentation of prior preferred-agent trial(s), a prescriber attestation of intolerance/adverse reaction, or evidence of continuation/use within 365 days. |
| Immune globulin / related brand | Step therapy requirement |
|---|---|
| Alyglo | |
| Asceniv | |
| Bivigam | |
| Panzyga | |
| Qivigy | |
| Yimmugo | |
| Cutaquig, Cuvitru, HyQvia |
| Named immunoglobulin product | Coverage pathway / criteria |
|---|---|
| Flebogamma DIF — listed among immune globulins subject to step therapy | |
| Gammagard Liquid / Gammagard Liquid ERC — listed among immune globulins subject to step therapy | |
| Gamunex‑C, Octagam, Privigen — listed among immune globulins subject to step therapy |
| Product | Step therapy note |
|---|---|
| Alyglo | |
| Asceniv | |
| Bivigam | |
| Panzyga | |
| Qivigy |
| Step 1 (Preferred agents) | Step 2 (Nonpreferred agents) — implication |
|---|---|
| Preferred agents listed per class (Step 1) — providers should initiate therapy with these agents where indicated. | |
| Nonpreferred (Step 2) agents are covered only after Step 1 requirements are met unless an exception applies. |
| Supporting evidence for prior-use or inability to use preferred | Policy implication |
|---|---|
| Prior history of use of one preferred medication (for many biologic classes) or two preferred IVIGs where specified. | |
| Documented inability to use preferred due to formulation inactive‑ingredient allergy/serious adverse reaction per prescriber. | |
| Continuation/prior use within the past 365 days qualifies as an alternative pathway to coverage. |
| Failure / exception | Example / citation |
|---|---|
| Trial and inadequate efficacy of preferred agent(s) supports coverage of nonpreferred agents. | |
| Prescriber attestation of hypersensitivity or formulation‑related contraindication permits bypassing preferred trial in some cases. | |
| Continuation of prior therapy or use within 365 days is accepted as an alternative pathway. |
| General rule | Specifics / citation |
|---|---|
| Most nonpreferred products require prior history of one preferred medication before coverage; viscosupplements commonly require two preferred trials. | |
| Documented inability to use preferred medication (formulation differences causing allergy/adverse reaction) qualifies as exception. | |
| Use within the past 365 days (continuation) is an accepted alternative pathway for coverage of nonpreferred agents. |
| Requirement | Example from policy |
|---|---|
| Some classes (CGRP inhibitors, PCSK9/inclisiran) are preferred under Part D — providers should reference the Part D Drug List and Part D UM requirements. | |
| Vyepti and Leqvio are listed as nonpreferred Part B agents with Part D preferred alternatives referenced; prior Part D use may be required per policy. |
| Immunomodulator | Step therapy context |
|---|---|
| Infliximab and biosimilars (Remicade and biosimilars e.g., Inflectra, Renflexis) are included in the step therapy discussion. | |
| Policy describes preferred biosimilars vs reference products and requires prior preferred‑agent history or allowable exceptions for nonpreferred infliximab. |
| Step 1 | Detail / source |
|---|---|
| Step 1 = preferred medications per drug class (providers should initiate with these agents where indicated). | |
| The document lists preferred biosimilars and preferred agents for many classes; nonpreferred agents require meeting step therapy criteria to be covered. |
| Condition allowing coverage of nonpreferred agent | Policy language / citation |
|---|---|
| Prior use of the preferred medication(s) (one preferred for denosumab-class; generally two preferred IVIGs when specified) supports coverage of nonpreferred agents. | |
| Prescriber documentation of inability to use preferred due to formulation-related serious allergy/adverse reaction is an allowed exception. | |
| Continuation/prior use within the past 365 days also permits coverage of the nonpreferred agent. |
Biosimilar and Formulary Preference Notes
Background and Scope
Step therapy is a utilization management process that requires members to initiate treatment with designated preferred medications (Step 1) before coverage of nonpreferred alternatives (Step 2). The purpose is to ensure use of clinically appropriate, preferred therapies first while permitting exceptions when a preferred agent is ineffective, not tolerated, or when the member is continuing prior therapy. Providers must document prior trials, clinical rationale for exceptions, or evidence of continuation within the specified lookback period to support coverage of nonpreferred Part B drugs.
Definitions and Key Terms
Revision History
Document reflects Part D vs Part B distinctions: certain classes (CGRP and PCSK9 inhibitors) may be managed under Part D rather than Part B; providers should reference the Part D Drug List and Part D UM requirements.
Updated bibliographic references for immunomodulators and biosimilars, including prescribing information and recent guideline citations for infliximab and related agents.
Prescribing information and literature citations for immune globulins and supportive agents were consolidated to support prior authorization documentation.
Document date listed on the source document.
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