Blue Cross Blue Shield - Iowa Part B Prior Auth

Coverage and Step Therapy Criteria

Per-product step therapy/prior authorization conditions

Coverage depends on meeting specified step therapy or trial-and-failure requirements listed per product.

General per-product rule: For many listed drugs coverage is conditional on trial and failure of specified preferred drugs or biosimilars before the non-preferred product will be authorized (examples include botulinum toxins requiring prior trial of Botox and Xeomin; filgrastim products requiring use of preferred filgrastim biosimilars; and immune globulin products requiring trial and failure of Gammagard and Octagam where listed).documented prior trial and failure

See each J‑code/Q‑code entry for the precise required prior trials and preferred products.

Biologic/biosimilar required prior therapies

Coverage for certain biologics and infusion drugs is contingent on meeting ALL of the following step therapy requirements as stated per product.

Biologic/biosimilar step logic: Provider must document trial and failure of specified preferred infliximab biosimilars (e.g., Renflexis or Avsola) AND trial and failure of ustekinumab or its biosimilars when listed before coverage of the non‑preferred biologic is approved.documented prior trials and failure

Examples: infliximab, Ilumya (J3245), secukinumab and other listed biologics.

Hyaluronic acid/viscosupplementation

Hyaluronic acid intra-articular injections are covered only after ALL listed preferred hyaluronic acid products have been tried and failed.

Hyaluronic acid step logic: Trial and failure of Durolane, Euflexxa, Gelsyn‑30 and Supartz FXe (the payer‑designated preferred viscosupplements) is required prior to coverage of non‑preferred hyaluronic acid products or their J‑coded equivalents (examples: J7326 and other hyaluronic acid entries).documented trials of each preferred hyaluronic acid product

Effective date for these rules commonly 6/1/2023.

Ophthalmic agents

Anti-VEGF ophthalmology agents have specified step therapy.

Ophthalmic anti-VEGF logic: For J2777 (Vabysmo) and for ranibizumab/aflibercept biosimilars, providers must document trial and failure of bevacizumab (Avastin or a bevacizumab biosimilar) AND trial and failure of aflibercept, ranibizumab, or Beovu where indicated prior to coverage of the non‑preferred agent.prior trial and failure documented

Some bevacizumab biosimilars (e.g., Mvasie, Zirabev) are designated preferred and do not require prior authorization when used.

Preferred-agent and step therapy coverage groups

Covered when the following payer-designated preferred agents have been tried and failed where specified:

Pemetrexed preference: Pemetrexed (J9304): must try and fail one of the following preferred products — Alimta or generic pemetrexed; these preferred products do not require prior authorization.documented trial and failure of a preferred pemetrexed product

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Trastuzumab biosimilar first: For trastuzumab J‑ and Q‑codes (e.g., J9355, Q5114, Q5117, Q5146): use the preferred trastuzumab biosimilar Trazimera first; the preferred biosimilar does not require prior authorization.documented trial of preferred trastuzumab biosimilar when applicable

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Pegfilgrastim preference: For pegfilgrastim Q‑codes (e.g., Q5111, Q5120): use the payer‑designated preferred pegfilgrastim products (examples: Neulasta, Fulphila, Nyvepria); these preferred products do not require prior authorization.

Prior authorization is not required for bevacizumab (J9035) when used for retinal disorders. The policy also identifies payer-designated preferred bevacizumab biosimilars (for example, Mvasie and Zirabev) that will not require prior authorization when used as the preferred agent.

Certain infliximab-class and related biologic entries require providers to document trials of preferred infliximab biosimilars (for example, Renflexis or Avsola) before coverage of non-preferred products; however, the listing explicitly notes clinical exceptions in specific circumstances. For example, infliximab is not required for management of cytokine release syndrome or giant cell arteritis where tocilizumab step-therapy logic applies, and preferred biosimilar requirements (and their authorization exemptions) are documented per J-code/Q-code entries.

The revision history records multiple edits that add or remove prior authorization requirements with effective dates for specific products. Examples in the revision log include entries that removed authorization requirements effective 1/1/2024 for selected products (e.g., Nyvepria, Ogivri, Renflexis) and other lines that add or change authorization effective dates for various J- and Q-codes; providers must follow the listed effective dates in the revision history when determining whether an authorization is required.

The document contains no explicit statements designating items as not medically necessary (NMN). Instead, the coverage logic focuses on step therapy and payer-preferred products: providers must document trials and failures of preferred agents (for example, use of preferred trastuzumab biosimilar Trazimera first, or trial of preferred infliximab biosimilars) where specified in each J-code or Q-code entry.

HCPCS / J-code Listings

Sample J-code entriesHCPCS

J0129	Abatacept
J0174	Lecanemab-irmb (Leqembie)
J0175	Donanemab-azbt (Kisunla)
J0177	Aflibercept (Eylea HD)
J0178	Aflibercept (Eylea)
J0179	Brolucizumab-dbll (Beovuc)
J0180	Agalsidase beta (Fabrazyme)

Additional J-code examples from later chunksHCPCS

J1439	Ferric derisomaltose / IV iron product (Monoferric) — referenced as initial effective date placeholder
J1447	Tbo-filgrastim
J1449	Eflapegrastim-xnst (Rolvedon)

HCPCS J-codes (examples)HCPCS

J2267

OmvohTM IV

HCPCS J-codes listedHCPCS

J2326	Nusinersen (Spinraza)
J2507	Inj, pegloticase (Krystexxa)
J2508	Pegunigalsidase alfa-iwxj (Elfabrio)
J2777	Vabysmo
J7326	Gel-one
J7686	Tyvaso (nebulizer)
J9035	Bevacizumab (Avastin)

Drug J-codes and preferred product notesHCPCS

J9304

Pemetrexed (Pemfexy/Alimta)

Selected J-codesHCPCS

J9228	Ipilimumab (Yervoy)
J9271	Pembrolizumab (Keytruda)

Additional J-codes with step therapy notesHCPCS

J9289	Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig)
J9299	Nivolumab (Opdivo)
J9304	Pemetrexed (Pemfexy)

Misc J-codesHCPCS

J9355	Trastuzumab
J9361	Efbemalenograstim alfa-vuXW (Ryzneuta)
J9376	Pozelimab-bbfg (Veopoz)

Q-codes (CAR-T, biosimilars, CSFs, ophthalmics)HCPCS

Q2041	Axicabtagene ciloleucel (Yescarta)
Q2042	Tisagenlecleucel (Kymriah)
Q2053	Brexucabtagene autoleucel (Tecartus)
Q5111	Pegfilgrastim-cbqv (Udenyca)
Q5124	Ranibizumab-nuna (Byooviz)
Q5128	Ranibizumab-eqrn (Cimerli)
Q5129	Bevacizumab-adcd

Immunomodulators / complement inhibitorsHCPCS

Q5133	Tocilizumab-bavi (Tofidence)
Q5135	Tocilizumab-aazg (Tyennee/unbranded biosimilar)
Q5136	Denosumab-bbdz (Jubbontie/Wyoste)
Q5151	Eculizumab-aagh (Epysqli/e)

Ustekinumab IV variantsHCPCS

Q9997	Ustekinumab-ttwe (Pyzchiva IV)
Q9998	Ustekinumab-aekn (Selarsdi IV)
Q9999	Ustekinumab-aauz (Otulfi IV)

HCPCS/J-code entries mentionedHCPCS

J7172
J1299	Soliris
Q2057	Tecelra
09999	Otulfi
Q5152	Bkemv
J9038	Niktimvo
J2802	Nplate
Q5116	Trazimera
J3590	placeholder for many single‑source/novel agents (multiple specific products listed)
Q5151	Epysqli

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Initial effective dates for specific codes

J9334 initial effective date12/1/2023

J9355 initial effective date6/1/2023

J9361 initial effective date4/1/2024

J9376 initial effective date10/15/2023

J9380 initial effective date9/1/2023

What Providers Must Do

Note

Provider review recommended

Providers: Review step therapy and prior authorization rules before submitting requests. Prior authorization is not a guarantee of payment — benefits depend on member eligibility and contract terms at time of service.

Prior authorization may be required for certain J‑codes and HCPCS codes; failure to obtain required authorization may result in claim denial when effective.
Document prior trials/therapy failures clearly in the request (dates, drug names, duration, clinical response).

Step Therapy

Step therapy requirements (examples)

Step therapy applies to many products — providers must document trials and failures of the preferred agents listed before non‑preferred drugs will be considered. Examples below show the types of trials required; confirm specific brand/biosimilar names and effective dates on the drug list.

Guselkumab (Tremfya IV): Trial and failure of preferred infliximab biosimilars (Renflexis or Avsola) AND trial and failure of ustekinumab or its biosimilars is required prior to coverage (effective 1/20/2025).
Hyaluronic acid injections (multiple products such as GenVisc, Gel‑one, Orthovisce, Synvisc): Must trial and fail all listed preferred viscosupplements first (Durolane, Euflexxa, Gelsyn‑30, Supartz FXe) — effective 6/1/2023.

Policy Background

This document is an administrative payer list linking specific HCPCS/J- and Q-codes to prior authorization and step therapy rules for Medicare Part B medical drugs. It identifies which products have required prior authorization, which agents are designated as preferred biosimilars (and therefore typically do not require prior authorization when used first), and notes effective dates where authorization requirements were added, removed, or revised. Providers should review the per-code entries and the revision history to confirm whether an authorization or documented prior trial of a preferred agent is required before submitting a claim.

Definitions and Benefit Notes

Prior Authorization — definition and limitation (not guarantee of payment)

DefinitionA payer administrative process that may be required before a drug is covered; listed per drug and does not guarantee payment.

ApplicabilityPrior authorization requirements are specified per drug entry in this document; providers should confirm requirements for each J/Q code before submitting requests.

LimitationApproval of prior authorization does not guarantee payment — benefits remain subject to member eligibility and contract terms at time of service.

Tyvaso DPI vs Tyvaso nebulizer — benefit distinction (pharmacy vs medical)

Tyvaso DPI (J3535)Pharmacy benefit (not covered under the medical benefit)

Tyvaso nebulizer (J7686)Medical benefit; prior authorization is required for nebulizer administration. Initial effective date = 1/1/2022.

Initial Therapy / Preferred-First Requirements

Initial therapy / preferred-first — required trials before non-preferred agents

Initial preferred-agent trials required prior to non-preferred agents in several therapeutic areas.

Nasopharyngeal cancer initial therapy: For nasopharyngeal cancer, pembrolizumab (J9271) and nivolumab variants (J9299/J9289) require trial and failure of Loqtorzi prior to coverage.documented trial and failure of Loqtorzi

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Pemetrexed initial therapy: For pemetrexed products, try Alimta or generic pemetrexed first; preferred pemetrexed products do not require prior authorization.documented trial of Alimta or generic pemetrexed

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Continuation and Revision Effective Dates

Follow revision effective dates — continuity depends on following effective dates in revisions

Revision history indicates ongoing updates to authorization and step therapy; continuity depends on following effective dates in revisions.

Follow revision effective dates: Providers must follow the effective dates shown in the revision history for when authorization requirements or step therapy updates take effect (examples include authorization requirements effective 11/1/2025 and step therapy updates effective 9/1/2025 and 5/1/2025).adhere to listed effective dates in the revision history

See revision history entries for specific codes and dates (chunks 53–54).

Step Therapy Tables

Product / Class	Step therapy requirement
Rimabotulinumtoxin B (J0587) / Botulinum toxins	Trial and failure of Botox and Xeomin required; note: step therapy with Xeomin not required for chronic migraines or urinary conditions.
Daxibotulinumtoxin A (J0589) / Botulinum toxins	Trial and failure of Botox and Xeomin required; note: step therapy with Xeomin not required for chronic migraines or urinary conditions.

Product / Class	Step therapy requirement
Filgrastim class (short‑acting CSFs)	Use both of the following preferred filgrastim biosimilars first: Nivestym and Zarxio; these preferred drugs do not require prior authorization.

Product / Class	Step therapy requirement
Immune globulin (IV and SC) products	Documented trial and failure of Gammagard and Octagam (and in some SC products Gammagard or Hizentra where specified) is required prior to authorization of other immune globulin products.

Product	Step therapy requirement
Guselkumab (Tremfya)	Trial and failure of a preferred infliximab biosimilar (Renflexis or Avsola) AND trial and failure of ustekinumab or its biosimilars are required prior to coverage.

Product / Code	Step therapy requirement
Vabysmo (J2777)	Trial and failure of bevacizumab (Avastin or a bevacizumab biosimilar) AND trial and failure of aflibercept, ranibizumab, or Beovu is required prior to coverage.

Product / Class	Step therapy requirement
Hyaluronic acid intra‑articular injections (multiple trade names, including J7326)	Trial and failure of all the following preferred hyaluronic acid products is required before coverage of non‑preferred viscosupplements: Durolane, Euflexxa, Gelsyn‑30, and Supartz FXe. These preferred drugs do not require authorization. (Effective date commonly 6/1/2023.)

Example product / code	Illustrative prior trial(s) required
Botulinum toxins (e.g., J0587, J0589)	Trial and failure of Botox and Xeomin prior to non‑preferred botulinum products (Xeomin exemption for chronic migraine/urinary indications noted).
Filgrastim biosimilars	Use preferred filgrastim biosimilars (Nivestym, Zarxio) first before non‑preferred filgrastim products.
Immune globulins	Trial and failure of Gammagard and Octagam (and Hizentra where specified) required before other IG products.
Guselkumab	Trial and failure of Renflexis or Avsola AND trial and failure of ustekinumab/biosimilars required.
Vabysmo (J2777)	Trial and failure of bevacizumab (or biosimilar) and aflibercept/ranibizumab/Beovu required.
Hyaluronic acids (e.g., J7326)	Must try and fail Durolane, Euflexxa, Gelsyn‑30, and Supartz FXe prior to non‑preferred viscosupplements.

Revision date / note	Affected products / summary of step therapy updates
5/15/2025	Fixed missing step therapy requirements for Rituxan Hycela (J9311) and related corrections noted in the revision history.
Update effective 5/1/2025	Step therapy updates recorded for multiple products including J2777 (Vabysmo), J3380 (Entyvio IV), J9332/J9334 (Vyvgart products), J9333 (Rystiggo), and J3111 (Evenity).
Authorization/step therapy effective dates (various 2024–2025)	Revision history records multiple authorization additions/removals and step therapy updates with specific effective dates (examples: authorization requirements and code updates effective 1/1/2025, 3/3/2025, 11/1/2025, etc.). Providers must follow the effective dates shown in the revision history.

Quantity Limits

J9334 (Efgartigimod alfa and hyaluronidase-qvfc) — quantity limits entry

DrugJ9334 — Efgartigimod alfa and hyaluronidase-qvfc (Vyvgarte Hytrulo)

Step therapy / preferred-firstTrial and failure of Ruxience or Riabni required prior to coverage; these preferred products do not require prior authorization.

Initial effective date12/1/2023

Biosimilar Preferences

Billing Rule

Infliximab biosimilars preferred first — Renflexise/Avsola

Preferred-first requirement for infliximab and certain TNF inhibitors: providers must use Renflexise or Avsola first; these preferred infliximab biosimilars do not require prior authorization when used.

Infliximab entries — “Use the following preferred medications first: Renflexise or Avsola. These preferred drugs don't require authorization.”

Billing Rule

Filgrastim biosimilars preferred first (Nivestym, Zarxio)

For filgrastim (short‑acting CSFs), providers must use the preferred filgrastim biosimilars (Nivestym and Zarxio) first; these preferred biosimilars do not require prior authorization.

Filgrastim group — “Use both of the following preferred filgrastim biosimilar drugs: Nivestym and Zarxio. These preferred drugs don't require prior authorization.”

Policy Revision Timeline

10/07/2025authorization_addedLatest

Authorization requirements added effective 11/01/2025 for multiple Q- and J-codes (examples: Q5156 Avtozma; Q5158 Conexxence/Denosumab-bnht; Q5154 Omlyclo/Omalizumab-igec; Q5159 Ospomyv/Denosumab-dssb; Q5155 Yesafili; 09997 Ustekinumab-ttwe; Q9998 Ustekinumab-aekn; J0714 Leqembi; J0897 Xgeva) and code updates effective 10/01/2025; preferred denosumab biosimilar and botulinum toxin preferences were added, and step therapy updates were made effective 11/01/2025.

9/01/2025authorization_removed_and_added

Authorization requirement removed for select codes effective 09/01/2025 (examples: G2082 & G2083 Spravato, J7601 Ohtuvayre) and authorization requirements added for multiple J3590 entries and other codes (examples: J3590 Qfitlia, J9024 Tecentriq Hybreza); step therapy updates for Opdivo (J9299) and Keytruda (J9271) were also applied effective 09/01/2025.

OpenPayer

Medicare Part B (Medical Drugs) Prior Authorization & Step Therapy List

Coverage and Step Therapy Criteria

HCPCS / J-code Listings

What Providers Must Do

Policy Background

Definitions and Benefit Notes

Initial Therapy / Preferred-First Requirements

Continuation and Revision Effective Dates

Step Therapy Tables

Quantity Limits

Biosimilar Preferences

Policy Revision Timeline