Step therapy criteria for Medicare Part B drugs
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Defines step therapy for Medicare Part B–covered drugs under Independent Health Medicare Advantage plans and describes provider requirements for coverage of specified Part B drugs (primarily applies to new therapy starts).
No material clinical or coverage changes in this revision.
Policy Overview
This policy implements step therapy for specified Medicare Part B–covered drugs under Independent Health Medicare Advantage plans. For listed products, approval for a new start generally requires documentation that the patient previously tried and had an inadequate response to the named preferred comparator(s) (or has a documented intolerance or contraindication where the policy allows). Providers should submit prior authorization requests with clear documentation of the prior agent trial(s) and the clinical outcome to demonstrate the requirement is met.
Step therapy is a utilization management approach that pairs a non-preferred Part B drug with one or more preferred comparator agents and requires a documented prior trial and inadequate response to the comparator before the non-preferred agent will be authorized. This document pairs Part B drugs with preferred comparators (for example, bevacizumab for many intravitreal anti‑VEGF agents, other IVIG products for Asceniv) and, in most cases, limits the requirement to patients initiating the listed drug (new starts). Clinical exceptions are recognized when documented intolerance or contraindication prevents use of the preferred agent.
Coverage Criteria by Drug / Product Group
Intravitreal anti-VEGF step therapy (example: Eylea/Pavblu)
For listed intravitreal products
Applies to the specified intravitreal products
IVIG step therapy for Asceniv
For Asceniv IVIG
Does not apply to indications not shared with preferred IVIG products
Oncology step therapy (Avgemsi)
For Avgemsi oncology use
Does not apply to indications not shared by intravenous gemcitabine
Bendamustine product step therapy
For Belrapzo / bendamustine alternatives
Does not apply to indications not shared with Treanda
HIV PrEP/related agent requirement (Apretude)
For Apretude
Intolerance/contraindication may be used in lieu of trial where specified
Oncology bevacizumab biosimilar step therapy
For oncology bevacizumab-class products
Does not apply to ophthalmic Avastin uses or indications not shared with Mvasi/Zirabev
Alymsys/Avastin/Jobevne/Vegzelma — Oncology
Covered when ALL of the following are met for oncology bevacizumab products (new starts only):
Does not apply to ophthalmic indications or to indications not shared by Mvasi or Zirabev
Myobloc — coverage when ALL of the following are met (new starts only)
Covered when ALL of the following are met (new starts only):
Kyxata — coverage when ALL of the following are met (new starts only)
Covered when ALL of the following are met (new starts only):
Does not apply to indications not shared by carboplatin
Docivyx and Beizray — coverage when ALL of the following are met (new starts only)
Covered when ALL of the following are met (new starts only):
Denosumab products and biosimilars
Covered when ALL of the following are met for denosumab products (new starts only):
Does not apply to indications not shared with Bildyos or Jubbonti
Does not apply to indications not shared with Bilprevda or Wyost
NMOSD and generalized myasthenia gravis biologic prior therapy
Covered when ALL of the following are met (new starts only):
Enjaymo prior rituximab requirement
Covered when ALL of the following are met (new starts only):
Briumvi — coverage when ALL of the following are met (new starts only)
Covered when ALL of the following are met (new starts only):
Ruxience / Riabni requirement
For approval (new starts)
applies only to new starts
Retacrit requirement
For approval (new starts)
applies only to new starts
Evkeeza requirement
For approval (new starts)
sourced from policy detail
Zarxio requirement
For approval (new starts)
Applies to listed G-CSF agents
Ilumya requirement
For approval (new starts)
sourced from policy detail
Imjudo requirement
For approval (non-small cell lung cancer)
sourced from policy detail
Avsola/Inflectra/Renflexis requirement
For approval (new starts)
Applies to Avsola, Inflectra, Renflexis
Inlexzo requirement
For approval (new starts)
Invega Hafyera requirement
For approval (new starts)
Applies to new starts only
Feiba requirement
For approval (new starts)
Invega Hafyera Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only
Invega Trinza Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only
Khapzory Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only; does not apply when patient uses levoleucovorin for an indication not shared with leucovorin
Factor VIII Products Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only
Tysabri Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only; does not apply to indications not shared with Tyruko
Opdualag Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only
Abraxane Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only; does not apply for indications not shared with generic paclitaxel
Pegfilgrastim Biosimilars Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only; does not apply for indications not shared with preferred pegfilgrastim products
Pemetrexed Products Initial Therapy
Covered when ALL of the following are met for new starts
Applies to new starts only
Intravitreal anti-VEGF — Cimerli/ranibizumab-eqrn
Covered when ALL of the following are met (intravitreal products):
Applies to new starts only
Byooviz / Lucentis / Susvimo step-therapy
Covered when ALL of the following are met (Byooviz, Lucentis, Susvimo for shared indications):
Step 1
Step 2
Rituximab products
Covered when ALL of the following are met (rituximab agents):
Does not apply when indication is not shared with Riabni or Ruxience
Rystiggo
Covered when ALL of the following are met (Rystiggo):
Applies to new starts only
Rytelo
Covered when ALL of the following are met (Rytelo):
Detailed MDS subcriteria present in source
Spinraza
Covered when ALL of the following are met (Spinraza):
Applies to new starts only
Tezspire
Covered when ANY of the following are met (Tezspire):
Option 1
Option 2
Actemra / Tocilizumab biosimilars
Covered when ALL of the following are met (Actemra / non-preferred tocilizumab biosimilars):
Does not apply when indication is not shared with the preferred agents
Herceptin / Trastuzumab biosimilars
Covered when ALL of the following are met (Herceptin / trastuzumab biosimilars):
Does not apply when indication is not shared with the preferred agents
Herceptin / trastuzumab biosimilars — new-start specifics
Herceptin and trastuzumab biosimilars (new starts)
Does not apply when indication is not shared by Kanjinti or Trazimera
Ultomiris GMG requirement
Ultomiris (generalized myasthenia gravis, new starts)
Uplizna indications-specific requirements
Uplizna (NMOSD and gMG, new starts)
Stelara / ustekinumab biosimilabls
Stelara / ustekinumab biosimilars (new starts)
Does not apply when indication is not shared by Selarsdi or Yesintek
Vabysmo requirement
Vabysmo (new starts)
Viscosupplement step therapy
Viscosupplements (non-preferred, new starts)
All viscosupplements require medical prior authorization and are billed through Medicare Part B as devices
Vyepti requirement
Vyepti (new starts)
Vyvgart Hytrulo requirement
Vyvgart Hytrulo (new starts)
Zilretta requirement
Zilretta (new starts)
Initial Therapy (new starts)
Covered when ALL of the following are met (for new starts):
See individual product-specific entries for exact comparators and exceptions
Step therapy requirements do not apply when the patient is using the requested product for an indication that is not shared with the preferred comparator(s). In those cases the prior‑trial requirement is waived and the clinician should document the indication to support coverage.
The requirement to trial Mvasi or Zirabev does not apply when bevacizumab (Avastin) is being used for ophthalmic (intravitreal) indications. For intravitreal uses, the intravitreal anti‑VEGF step rules (which start with bevacizumab) govern authorization instead.
The carboplatin prior‑trial requirement for Kyxata is limited to indications shared by carboplatin; if Kyxata is requested for an indication not shared with carboplatin the prior‑trial requirement does not apply. Providers should indicate the specific diagnosis when requesting authorization.
Prior‑trial requirements for denosumab biosimilars (Prolia/Xgeva and non‑preferred biosimilars) do not apply when the denosumab agent is used for an indication not shared with the named comparators (Bildyos/Jubbonti for Prolia; Bilprevda/Wyost for Xgeva). Document the indication to support an exception.
The requirement to trial Retacrit before initiating listed erythropoiesis‑stimulating agents applies to new starts only and is waived when the patient is using Epogen or Procrit for an indication not shared with Retacrit. Prior‑trial documentation or reason for exemption must be included in the request.
The Zarxio (filgrastim biosimilar) trial requirement for listed G‑CSF agents does not apply when the non‑preferred agent is being used for an indication not shared with Zarxio. Include the indication in the prior authorization documentation when seeking an exception.
Infliximab biosimilar step requirements (Avsola/Inflectra/Renflexis) are limited to shared indications: the prior trial of generic infliximab or Remicade is not required when the requested infliximab‑class agent is being used for an indication not shared with those comparators. State the indication on the authorization request to support the exception.
The Inlexzo prior‑trial requirement (intravesical gemcitabine) does not apply when Inlexzo is used for an indication not shared with intravesical gemcitabine. Providers should document the indication to establish applicability.
The Feiba requirement (prior trial of Hemlibra) applies to new starts only and explicitly does not apply to treatment of hemophilia B. When requesting Feiba for hemophilia B, indicate the diagnosis to avoid unnecessary step‑therapy denial.
Patients using levoleucovorin are exempt from the Khapzory (leucovorin) prior‑trial requirement when the indication for levoleucovorin is not shared with generic leucovorin. Document the indication to support the exemption.
The Tysabri prior‑trial requirement (trial and inadequate response to Tyruko) does not apply when Tysabri is used for an indication not shared with Tyruko. Providers should document the diagnosis on the prior authorization request.
The rituximab step requirement (prior trial and inadequate response to Riabni or Ruxience) is waived when a rituximab agent is being used for an indication not shared with Riabni or Ruxience. Include indication details in the authorization to demonstrate applicability.
Step requirements for tocilizumab (Actemra or non‑preferred biosimilars) and trastuzumab (Herceptin/other trastuzumab biosimilars) do not apply when the non‑preferred agent is used for an indication not shared with the preferred comparator biosimilars. Document the indication to support exemption.
Prior Authorization, Documentation, and Denial Risk
Document prior trial and inadequate response (or intolerance/contraindication)
For approval of the specified Part B drugs at new start, document that the patient tried and failed to have an adequate response to the named preferred alternative drug(s), or document intolerance/contraindication where the policy allows.
- Applies to new starts only; many product-specific rules reference this general step-therapy requirement.
- Intolerance or contraindication can substitute for a trial where explicitly permitted.
Document prior bevacizumab trial for intravitreal agents
For approval of listed intravitreal agents, document that the patient tried and failed to have an adequate response to bevacizumab (Avastin).
- Requirement applies to new starts only.
- For Byooviz/Lucentis/Susvimo shared indications, also document failure of one additional anti‑VEGF as specified (Step 2).
Document prior IVIG trial for Asceniv
For new starts of Asceniv, document a prior trial and inadequate response to another IVIG product (or show the indication is not shared with preferred IVIGs).
- Requirement applies to new starts only.
- Exemption when Asceniv is used for an indication not shared with preferred IVIG products.
Document prior carboplatin trial for Kyxata
For Kyxata new starts, document a prior trial and inadequate response to carboplatin (unless the requested indication is not shared with carboplatin).
- Requirement applies to new starts only.
- Does not apply when Kyxata is used for an indication not shared by carboplatin.
Document prior Ruxience or Riabni trial for rituximab products
For new starts of rituximab products (e.g., Rituxan, Rituxan Hycela, Truxima, Enjaymo), document prior trial and inadequate response to Ruxience or Riabni (or another rituximab biosimilar).
- Requirement applies to new starts only.
- Exemption when the patient is using a rituximab agent for an indication not shared with Riabni/Ruxience.
Document Retacrit trial for ESA approvals
For listed erythropoiesis‑stimulating agents, new starts require documentation of trial and inadequate response to Retacrit (unless the member uses Epogen/Procrit for an indication not shared with Retacrit).
- Requirement applies to new starts only.
- Exemption when indication is not shared with Retacrit.
Document statin + PCSK9 trial or contraindication for Evkeeza
For Evkeeza new starts, document trial and inadequate response to, or contraindication to, both a maximally‑tolerated statin and a PCSK9 inhibitor.
- Requirement applies to new starts only.
- Contraindication may be documented instead of trial where specified.
Document Zarxio trial for G‑CSF agents
For Filkri/Granix/Neupogen/Nivestym/Nypozi/Releuko new starts, document prior trial and inadequate response to Zarxio.
- Requirement applies to new starts only.
- Does not apply when the member is using a non‑preferred agent for an indication not shared with Zarxio.
Document trial/failure of preferred IL‑17 inhibitor and one biologic for Ilumya
For Ilumya new starts, document trial and failure or intolerance to the formulary‑preferred IL‑17 inhibitor (Cosentyx) and one of the listed on‑formulary biologics as specified.
- Requirement applies to new starts only.
Document prior cemiplimab (Libtayo) response/intolerance for Imjudo
For Imjudo in NSCLC, document prior adequate response to or intolerance/contraindication to cemiplimab (Libtayo).
- Requirement applies to new starts only.
- Intolerance or contraindication to cemiplimab may be used in lieu of prior response when specified.
Document intravesical gemcitabine trial for Inlexzo
For Inlexzo new starts, document prior trial and inadequate response to intravesical gemcitabine (or show the indication is not shared).
- Requirement applies to new starts only.
- Does not apply when Inlexzo is used for an indication not shared by intravesical gemcitabine.
Document paliperidone palmitate prior treatment for Invega Hafyera
For Invega Hafyera new starts, provide documentation of prior paliperidone palmitate treatment: at least 4 months of 1‑month dosing or at least one 3‑month paliperidone palmitate injection.
- This documentation requirement applies to new starts only.
Document 4 months' 1‑month paliperidone palmitate prior treatment for Trinza
For Invega Trinza new starts, document at least 4 months' prior treatment with 1‑month paliperidone palmitate.
- Requirement applies to new starts only.
Document generic leucovorin trial for Khapzory
For Khapzory new starts, document trial and inadequate response to generic leucovorin (unless the member uses levoleucovorin for an indication not shared).
- Requirement applies to new starts only.
- Exemption when indication is not shared with leucovorin.
Document Jivi trial for hemophilia products
For Adynovate, Eloctate, or Esperoct new starts, document trial and inadequate response to Jivi.
- Requirement applies to new starts only.
- Does not apply to treatment of hemophilia B per policy exception.
Document Tyruko trial for Tysabri
For Tysabri new starts, document trial and inadequate response to Tyruko (natalizumab‑sztn) or show the indication is not shared with Tyruko.
- Requirement applies to new starts only.
- Exemption when indication is not shared with Tyruko.
Document Opdivo+Yervoy trial or Yervoy contraindication for Opdualag
For Opdualag new starts, document trial and inadequate response to Opdivo plus Yervoy or document a contraindication to Yervoy.
- Requirement applies to new starts only.
- Absence of Yervoy due to contraindication must be documented.
Document generic paclitaxel trial for Abraxane
For Abraxane new starts (except pancreatic cancer or small bowel carcinoma), document prior trial and inadequate response to generic paclitaxel.
- Requirement applies to new starts only.
- Does not apply for indications not shared with generic paclitaxel.
Document Udenyca trial for pegfilgrastim approvals
For non‑preferred pegfilgrastim biosimilars or Ryzneuta new starts, document trial and inadequate response to Udenyca.
- Requirement applies to new starts only.
- Does not apply for indications not shared with preferred pegfilgrastim products.
Document trial of preferred pemetrexed (listed J‑codes)
For Axtle, Pemfexy, or Pemrydi new starts, document trial and inadequate response to a preferred pemetrexed agent (listed J‑codes) unless contraindicated or not tolerated.
- Requirement applies to new starts only.
- Preferred comparator J‑codes are listed in the policy's coding section.
Document bevacizumab trial (and additional anti‑VEGF where required) for intravitreal agents
For intravitreal anti‑VEGF products (Cimerli, ranibizumab‑eqrn) new starts, document prior trial and inadequate response to bevacizumab (Avastin); for Byooviz/Lucentis/Susvimo shared indications, also document failure of an additional anti‑VEGF per the two‑step rule.
- All intravitreal anti‑VEGF step requirements apply to new starts only.
- Failure to document these prior trials may result in denial.
Document Riabni or Ruxience trial for Rituxan/Truxima requests
For Rituxan, Rituxan Hycela, or Truxima new starts, document prior failure of Riabni or Ruxience (preferred rituximab biosimilars) before requesting the non‑preferred product.
- Requirement applies to new starts only.
- Document indication‑specific exemptions where the indication is not shared with Riabni/Ruxience.
Obtain medical PA and bill viscosupplements via Medicare Part B
All viscosupplements require medical prior authorization; because they are considered medical devices, bill them through Medicare Part B.
- Non‑preferred viscosupplements require prior failure or intolerance to both Euflexxa and Synvisc‑One before approval.
- This billing rule applies to new starts only where step criteria are specified.
Submit PA with product‑specific step/failure documentation
Products listed in the Part B section require prior authorization and are subject to the product‑specific step/failure criteria described in the policy details; providers must submit documentation of prior trials and outcomes when requesting authorization.
- This statement covers the multiple Part B products enumerated in the policy.
- Failure to include required prior‑trial documentation may cause denial.
Document prior injectable corticosteroid trial for new starts
For new starts of injectable corticosteroid therapies, document trial and inadequate response to at least one other injectable corticosteroid.
- This requirement applies to new starts only.
- Failure to document a prior injectable corticosteroid trial may trigger denial.
Denial risk if prior trial and outcome not documented
Requests for new‑start coverage may be denied if the provider does not document the required prior trial(s) and the clinical outcome (inadequate response or intolerance/contraindication) for the named comparator(s).
- Denial risk highlighted for intravitreal anti‑VEGF agents (no prior bevacizumab documented).
- Denial risk also cited for multiple product groups when required prior trials are not shown.
Document prior trial details: agent, dates, and outcome
Always include documentation showing the prior agent tried, the dates of therapy, and the outcome (inadequate response, intolerance, or contraindication) when requesting prior authorization for a new start.
- This documentation requirement applies to new starts and to continuation where specified by product rules.
- Insufficient documentation of dates or outcomes may delay or cause denial.
Step Therapy Tables and Operational Rules
| Coverage requirement | Notes / scope |
|---|---|
| Prior trial and inadequate response to the named preferred comparator (e.g., bevacizumab for intravitreal agents; Treanda for bendamustine products; gemcitabine for Avgemsi; other specified comparators) | Applies to new therapy starts only; documentation must show prior trial and inadequate response (or documented intolerance/contraindication where allowed). Exclusions apply when the indication is not shared with the preferred comparator. |
| Drug / Step | Required prior trial (new starts) |
|---|---|
| Asceniv (intravenous immunoglobulin) | Trial and inadequate response to another IVIG product; does not apply when Asceniv is used for an indication not shared with preferred IVIG products. |
| Drugs (oncology bevacizumab group) | Required prior trial (new starts) |
|---|---|
| Alymsys / Avastin / Jobevne / Vegzelma (oncology indications) | Trial and inadequate response to Mvasi or Zirabev. Does not apply to Avastin when used for ophthalmic (eye) indications or to indications not shared with Mvasi/Zirabev. |
| Product group | Required prior trial (new starts) |
|---|---|
| Prolia and non-preferred Prolia denosumab biosimilars | Trial and inadequate response to Bildyos or Jubbonti (applies to new starts; exemption if indication not shared with comparators). |
| Xgeva and non-preferred Xgeva denosumab biosimilars | Trial and inadequate response to Bilprevda or Wyost (applies to new starts; exemption if indication not shared with comparators). |
| Requested agent | Required prior trial (new starts) |
|---|---|
| Docivyx (J9172) / Beizray (J9174) | Trial and inadequate response to docetaxel (J9171) is required for new starts. |
| Requested agent | Required prior trial (new starts) |
|---|---|
| Kyxata | Trial and inadequate response to carboplatin is required for new starts; does not apply to indications not shared with carboplatin. |
| Indication group | Required prior agents (new starts) |
|---|---|
| Neuromyelitis optica spectrum disorder (NMOSD) | Trial and inadequate response to or intolerance/contraindication to Enspryng AND either Uplizna or rituximab (applies to new starts). |
| Generalized myasthenia gravis (gMG) | Trial and inadequate response to or intolerance/contraindication to Vyvgart or Vyvgart Hytrulo (applies to new starts). |
| Rituximab product group | Required prior trial (new starts) |
|---|---|
| Rituxan / Rituxan Hycela / Truxima (and other rituximab products) | Patient must have tried and failed to have an adequate response to preferred rituximab biosimilars Riabni or Ruxience (or another rituximab product) prior to approval for new starts. |
| ESA agents | Required prior trial (new starts) |
|---|---|
| Listed ESAs (e.g., Epogen / Procrit presentations referenced) | Trial and inadequate response to Retacrit is required for new starts; does not apply when patient is using Epogen or Procrit for an indication not shared with Retacrit. |
| G-CSF agents | Required prior trial (new starts) |
|---|---|
| Filkri / Granix / Neupogen / Nivestym / Nypozi / Releuko (listed G-CSF agents) | Trial and inadequate response to Zarxio is required for new starts; does not apply to indications not shared with Zarxio. |
| Infliximab biosimilars | Required prior trial (new starts) |
|---|---|
| Avsola / Inflectra / Renflexis | Trial and inadequate response to generic infliximab or Remicade is required for new starts; does not apply to indications not shared with those agents. |
| Product | Required prior treatment (new starts) |
|---|---|
| Invega Hafyera | Documentation of at least 4 months' treatment with 1‑month paliperidone palmitate OR at least one 3‑month paliperidone palmitate injection is required for new starts. |
| Product | Required prior treatment (new starts) |
|---|---|
| Invega Trinza | Documentation of at least 4 months' treatment with 1‑month paliperidone palmitate is required for new starts. |
| Product | Required prior trial (new starts) |
|---|---|
| Khapzory | Trial and inadequate response to generic leucovorin is required for new starts; does not apply when indication is not shared with leucovorin (e.g., levoleucovorin users). |
| Hemophilia products | Required prior trial (new starts) |
|---|---|
| Adynovate / Eloctate / Esperoct | Trial and inadequate response to Jivi is required for new starts. |
| Product | Required prior trial (new starts) |
|---|---|
| Tysabri (natalizumab) | Trial and inadequate response to Tyruko (natalizumab‑sztn) is required for new starts; does not apply to indications not shared with Tyruko. |
| Product group | Required prior trial (new starts) |
|---|---|
| Non‑preferred pegfilgrastim biosimilars or Ryzneuta | Trial and inadequate response to Udenyca is required for new starts; does not apply to indications not shared with preferred pegfilgrastim products. |
| Requested pemetrexed products | Required prior trial (new starts) |
|---|---|
| Axtle (J9292) / Pemfexy (J9304) / Pemrydi RTU (J9324) | Trial and inadequate response to a preferred pemetrexed agent (one of the listed J‑codes: J9294, J9296, J9297, J9305, J9314, J9322, J9323) is required for new starts unless contraindicated or not tolerated. |
| Intravitreal agents | Step therapy requirement (new starts) |
|---|---|
| Cimerli / ranibizumab‑eqrn | Step 1: trial and inadequate response to bevacizumab (Avastin) is required for new starts. |
| Byooviz / Lucentis / Susvimo (shared indications) | Step 1: trial and inadequate response to bevacizumab (Avastin); Step 2: trial and inadequate response to one additional anti‑VEGF (Cimerli/ranibizumab‑eqrn, aflibercept/Eylea, brolucizumab/Beovu, or faricimab/Vabysmo) — both steps apply to new starts. |
| Intravitreal shared‑indication agents | Second‑step requirement (new starts) |
|---|---|
| Byooviz / Lucentis / Susvimo (for shared indications) | After Step 1 failure of bevacizumab (Avastin), a second‑step trial and inadequate response to one additional anti‑VEGF (Cimerli/ranibizumab‑eqrn, aflibercept/Eylea, brolucizumab/Beovu, or faricimab/Vabysmo) is required for new starts. |
| Requested rituximab products | Required prior trial (new starts) |
|---|---|
| Rituxan / Rituxan Hycela / Truxima | Patient must have tried and failed to have an adequate response to Riabni or Ruxience for new starts; does not apply when indication is not shared with these biosimilars. |
| Viscosupplement status | Required prior trial (new starts) |
|---|---|
| Non‑preferred viscosupplements (e.g., any listed other than Euflexxa or Synvisc‑One) | Patient must have tried and failed to have an adequate response to BOTH preferred viscosupplements (Euflexxa and Synvisc‑One) before approval; all viscosupplements require medical prior authorization and are billed through Medicare Part B. |
| Injectable corticosteroid products | Required prior trial (new starts) |
|---|---|
| Non‑preferred injectable corticosteroids (new starts) | Patient must have tried and failed to have an adequate response to at least one other injectable corticosteroid for approval of a new start. |
Biosimilar Preferences and Exceptions
Document Mvasi or Zirabev trial for oncology bevacizumab biosimilars
For oncology bevacizumab presentations (Alymsys, Avastin, Jobevne, Vegzelma) used for cancer indications, document prior trial and inadequate response to Mvasi or Zirabev before approval of the requested bevacizumab agent.
- Requirement applies to new starts only.
- Does not apply to ophthalmic Avastin or indications not shared with Mvasi/Zirabev.
Document Bildyos or Jubbonti trial for Prolia requests
For Prolia biosimilar or non‑preferred Prolia agent new starts, document prior trial and inadequate response to Bildyos or Jubbonti.
- Requirement applies to new starts only.
- Does not apply when indication is not shared with Bildyos or Jubbonti.
Document Bilprevda or Wyost trial for Xgeva requests
For Xgeva biosimilar or non‑preferred Xgeva agent new starts, document prior trial and inadequate response to Bilprevda or Wyost.
- Requirement applies to new starts only.
- Does not apply when indication is not shared with Bilprevda or Wyost.
Require Ruxience or Riabni trial before other rituximab products
For other rituximab product new starts, document trial and inadequate response to Ruxience or Riabni (preferred rituximab biosimilars) before approval of non‑preferred rituximab agents.
- Requirement applies to new starts only.
- Exemption when indication is not shared with the preferred biosimilars.
Require Retacrit trial for Epogen/Procrit new starts
For Epogen or Procrit new starts, document trial and inadequate response to Retacrit before requesting the non‑preferred ESA.
- Requirement applies to new starts only.
- Does not apply when the patient's indication is not shared with Retacrit.
Require Zarxio trial for listed G‑CSF agents
For Filkri, Granix, Neupogen, Nivestym, Nypozi, or Releuko new starts, document trial and inadequate response to Zarxio before requesting the non‑preferred G‑CSF agent.
- Requirement applies to new starts only.
- Does not apply when indication is not shared with Zarxio.
Require generic infliximab/Remicade trial for infliximab biosimilars
For Avsola, Inflectra, or Renflexis new starts, document trial and inadequate response to generic infliximab or Remicade before requesting the non‑preferred infliximab biosimilar.
- Requirement applies to new starts only.
- Does not apply when indication is not shared with generic infliximab or Remicade.
Require Tyruko trial for Tysabri new starts
For natalizumab (Tysabri) new starts, document trial and inadequate response to Tyruko; the step does not apply when the indication is not shared with Tyruko.
- Requirement applies to new starts only.
- Document indication differences to support exemption.
Require Udenyca trial for non‑preferred pegfilgrastim products
For non‑preferred pegfilgrastim biosimilar or Ryzneuta new starts, document trial and inadequate response to Udenyca prior to approval.
- Requirement applies to new starts only.
- Does not apply when indication is not shared with preferred pegfilgrastim products.
Require Riabni/Ruxience before Rituxan/Truxima
For Rituxan, Rituxan Hycela, or Truxima new starts, require trial and inadequate response to Riabni or Ruxience before approving the non‑preferred rituximab product.
- Requirement applies to new starts only.
- Exemption when indication is not shared with Riabni/Ruxience.
Require Kanjinti or Trazimera trial for trastuzumab products
For Herceptin and trastuzumab biosimilar new starts, document trial and inadequate response to Kanjinti or Trazimera before approving Herceptin or a non‑preferred trastuzumab biosimilar.
- Requirement applies to new starts only.
- Does not apply when indication is not shared with the preferred agents.
Referenced HCPCS / J-Codes
| J9292 | Axtle (listed as J9292 in context) |
| J9304 | Pemfexy (listed as J9304 in context) |
| J9324 | Pemrydi RTU (listed as J9324 in context) |
| J9294 | pemetrexed (preferred agent listed) |
| J9296 | pemetrexed (preferred agent listed) |
| J9297 | pemetrexed (preferred agent listed) |
| J9305 | pemetrexed (preferred agent listed) |
| J9314 | pemetrexed (preferred agent listed) |
| J9322 | pemetrexed (preferred agent listed) |
| J9323 | pemetrexed (preferred agent listed) |
Billing, Site of Care, and Medicare Part B Notes
Bill viscosupplements through Medicare Part B (medical device)
Viscosupplements are billed through Medicare Part B as medical devices and require medical prior authorization; providers must bill these products via Part B.
- All viscosupplements require medical PA.
- Non‑preferred viscosupplements require prior failure/intolerance to both Euflexxa and Synvisc‑One.
Require medical PA and prior‑failure proof for non‑preferred viscosupplements
Medical prior authorization is required for all viscosupplements; submit prior‑failure documentation for Euflexxa and Synvisc‑One when requesting a non‑preferred viscosupplement.
- Because viscosupplements are considered medical devices, they are billed through Medicare Part B.
- Failure to document prior preferred‑agent trials may result in denial.
For new starts of Vabysmo, prior authorization requires documentation of a trial and inadequate response to bevacizumab (Avastin). Because bevacizumab is commonly used off‑label intravitreally, clinicians should document prior intravitreal bevacizumab treatment when requesting Vabysmo for a Medicare Part B–billed ophthalmic injection.
Initial (New-Start) Therapy Criteria
inv cu-188: New-start step therapy — initial therapy requirements aggregated
Initial therapy (new starts) requirements
See individual product entries for specifics
inv cu-189: Bevacizumab initial therapy requirement
Excludes ophthalmic and indications not shared with comparators
inv cu-190: Evkeeza initial therapy
Evkeeza initial therapy — new starts
inv cu-191: Invega Hafyera
Invega Hafyera initial therapy requirements
Applies to new starts only
inv cu-192: Invega Trinza
Invega Trinza initial therapy requirements
Applies to new starts only
inv cu-193: Initial therapy requirements (collection)
Initial therapy (new starts) requirements:
See intravitreal-specific entries
See rituximab-specific entry
inv cu-194: Initial therapy requirement
Requirement for new starts
Applies to new starts only
Continuation of Therapy
Include agent, dates, and outcome when documenting prior trials
Documentation of prior trial and outcome (agent tried, dates, and whether response was inadequate or patient had intolerance/contraindication) is required for new starts and where product rules specify continuation documentation.
- Applies broadly to product‑specific prior‑trial requirements.
- Insufficient documentation may delay or cause denial.
Policy Background and Scope
Step therapy pairs a non‑preferred Part B drug with one or more preferred comparators; for many intravitreal products the specified preferred comparator is bevacizumab (Avastin). For approval of certain intravitreal agents as new starts, the policy requires documentation that the member tried and had an inadequate response to bevacizumab before higher‑cost alternatives will be authorized.
Scope: This policy applies to Independent Health Medicare Advantage members and governs coverage and prior authorization requirements for specified Medicare Part B drugs. Clinicians requesting coverage must meet the documented prior‑trial and outcome requirements described in the product‑specific rules, and must indicate when an exception applies (for example, a non‑shared indication or documented contraindication).
Policy Revision History
Policy content and step-therapy list effective as of 2026-06-01 (document current as of 6/1/2026).
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