Medical Drug Prior Authorization (Global PA) — Commercial & Medicare Advantage coverage criteria
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Defines Medical Mutual's prior authorization requirements and contact/process details for medical-administered drugs (Commercial and Medicare Advantage), including specialty drugs and medications with safety or diversion concerns.
New prior authorization requirements effective on various dates (examples: New PA requirement effective 1/1/26; 11/1/2025; 3/1/26; 5/1/26).
Coverage Criteria and Product-Level Rules
inv-01: General coverage criteria
Prior authorization is required for listed drugs when used under the medical benefit; individual drug entries reference specific commercial and Medicare Advantage criteria codes or articles.
See per‑drug criteria codes for clinical requirements (e.g., IC‑0598, IC‑0001, NCD references).
inv-02: Drug coverage metadata
Coverage and authorization are governed by the listed commercial criteria IDs and site-of-care indicators for each drug when present.
Providers must consult the referenced commercial criteria document for detailed medical necessity requirements.
inv-03: Prior Authorization (inpatient and outpatient)
Coverage and authorization notes by product
See individual product entries for commercial criteria codes and Medicare NCD references.
inv-04: Medicare Advantage step therapy / NCD notes
Medicare Advantage step therapy and NCD references
Follow the referenced Medicare Part B Step Therapy Policy 201936 or cited NCD when Medicare Advantage notes indicate it applies.
inv-05: Operational controls
Site-of-care and medication sourcing controls
When present, PA requests should identify and comply with the site‑of‑care designation.
Providers must follow medication sourcing instructions (white‑bagging/ship‑to) per the product entry when placing orders.
inv-06: Per-drug commercial criteria
Coverage and PA applicability are determined per listed Commercial Criteria identifiers for each drug entry.
Reference the exact Commercial Criteria identifier shown in the product entry when submitting PA documentation.
inv-07: Product-level coverage linkage
Coverage entries list product-level commercial criteria IDs and site-of-care flags; decisions depend on matching the applicable commercial criteria referenced.
Include the Commercial Criteria ID on PA requests and supply supporting clinical documentation per that criteria.
inv-08: Product-level coverage links
Listed products are associated with internal commercial or Medicare Advantage criteria and may have site-of-care or sourcing rules
For clinical medical‑necessity requirements, follow the referenced commercial or Medicare Advantage criteria document associated with the product.
inv-09: Code-specific coverage rules
Coverage/authorization stance is code-specific per listed commercial criteria identifiers or explicit notes
This section lists identifiers and operational flags; full clinical eligibility and required documentation are defined in the referenced criteria documents or Medicare references.
When a product listed in this document is identified as self‑administered in the Medicare Advantage notes (for example, entries where the notes state "Drug is self‑administered and is not covered under Part B. Drug may be covered under Part D."), coverage and prior authorization must follow the applicable prescription drug (Medicare Part D) pathway rather than the medical benefit. Providers should contact the member's pharmacy benefit manager using the number on the member ID card to confirm Part D prior approval requirements and routing. Prior authorization is still required for outpatient administration when the drug is billed under the medical benefit unless an individual drug entry specifies otherwise.
Bevacizumab products (Avastin and biosimilars) listed in this document require prior authorization when used for non‑ophthalmic indications only. Ophthalmic uses (e.g., intraocular/retinal injections) are explicitly excluded from the PA requirement — follow the per‑product entry and referenced Commercial or Medicare Advantage criteria for full details and applicable step therapy guidance.
Example: Several J3590/C9399 entries (and other listed products such as Praluent, Cosentyx, and somatropin) include Medicare Advantage notes indicating the drug is self‑administered and not covered under Part B; may be covered under Part D. In those cases, providers should bill and seek prior authorization under the pharmacy benefit (Part D) per the member's PBM requirements rather than the medical benefit.
Examples of self‑administered biologics and other products that are annotated as not covered under Part B and possibly covered under Part D include multiple brands shown under J3590 / C9399 mappings (e.g., Cosentyx SC, Kevzara, Skyrizi SC, and other J3590/C9399 entries). For such entries the Medicare Advantage note indicates the pharmacy benefit should be consulted for coverage and prior authorization.
Somatropin products (example: J2941 entries such as Zomacton) are flagged in Medicare Advantage notes as self‑administered and not covered under Part B; may be covered under Part D. When somatropin is self‑administered, providers should confirm benefit routing and obtain any required Part D authorizations through the PBM; if administered and billed under the medical benefit, follow the listed Commercial Criteria (e.g., 95015) and PA requirements.
Billing note: when a drug is identified as self‑administered and may be covered under Part D, do not submit medical benefit claims under Medicare Part B for that product; instead, confirm Part D coverage with the member's PBM and follow the PBM's prior authorization process. If the drug is being provided under the medical benefit (e.g., administered in a facility and billed to the plan), obtain the medical PA per the Commercial/Medicare Advantage criteria listed in this document.
Reminder: Avastin (bevacizumab) and bevacizumab biosimilars require prior authorization for non‑ophthalmic indications only. Ophthalmic uses are excluded from the PA requirement; follow the specific commercial criteria and Medicare Advantage notes for step therapy references and any effective dates that may apply.
As noted elsewhere in the document, prior authorization is required for bevacizumab products (Avastin) when used for non‑ophthalmic indications only. Providers should reference the listed Commercial Criteria and Medicare Advantage guidance for any step therapy or site‑of‑care requirements associated with these codes.
Additional reference: bevacizumab entries across multiple code mappings repeat that Avastin and its biosimilars require PA for non‑ophthalmic indications only. Ensure PA requests reference the correct HCPCS/Q‑code and the associated commercial/MA criteria shown in the product entry.
Codes, Systems, and Medication Sourcing Dates
| Q2055 | Abecma (idecabtagene vicleucel) — Oncology; Commercial Criteria = IC-0598, IC-0654-(E); Medicare Advantage Criteria = NCD: 110.24 |
| J9264 | Abraxane (paclitaxel protein bound particles) — Oncology; Commercial Criteria = IC-0001, IC-0360-(E) |
| Q5145 | Abrilada (adalimumab-afzb) — Inflammatory conditions; Commercial Criteria = 200806 |
| J3262 | Actemra IV (tocilizumab) — Inflammatory conditions; Commercial Criteria = IC-0002 |
| J3590 | Actemra SC / multiple other products (tocilizumab and others) — various classifications; see individual entries for criteria codes |
| J0801 | Acthar Gel (corticotropin) — Adrenocorticotropin stimulating hormone; Commercial Criteria = 201010-MRx |
| J0791 | Adakveo (crizanlizumab-tmca) — Rare disease; Commercial Criteria = 202003 |
| J9029 | Adstiladrin (nadofaragene firadenovec-vncg) — Oncology; Commercial Criteria = IC-0691, IC-0745-(E) |
| J7171 | Adzynma (ADAMTS13, recombinant-krhn) — Rare disease; Commercial Criteria = IC-0736 |
| Q5150 | Ahzantive (aflibercept-mrbb) — Ophthalmic; Commercial Criteria = 201513-EY |
| J1554 | intravenous immune globulin (Asceniv) |
| J9118 | calaspargase pegol-mknl (Asparlas) |
| Q2058 | Obecabtagene autoleucel (Aucatzyl) |
| Q5161 | denosumab-kyqq (Aukelso) |
| J9035 | bevacizumab (Avastin) |
| J3590 | tividenofusp alfa-eknm (Avlayah) / other J3590 entries |
| J3145 | Testosterone undecanoate (Aveed) |
| J9184 | gemcitabine hydrochloride (Avgemsi) |
| J1826 | interferon beta-1a (Avonex) |
| Q5121 | infliximab-axxq (Avsola) |
| J1744 | Firazyr; icatibant; Hereditary angioedema |
| J9331 | Fyarro; sirolimus albumin-bound nanoparticles; Oncology |
| J2941 | Genotropin / Humatrope; somatropin; Growth hormone |
| J0599 | Haegarda; c-1 esterase inhibitor (human); Hereditary angioedema |
| C9309 | listed with Commercial Criteria = 231205; Classification = CNS: Rare Disease |
| J9207 | Ixempra / ixabepilone — Oncology |
| J2782 | Izervay / avacincaptad pegol — Ophthalmic injections |
| J9281 | Jelmyto / mitomycin — Oncology |
| J9272 | Jemperli / dostarlimab-gxly — Oncology |
| J9043 | Jevtana / cabazitaxel — Oncology |
| Q5160 | Jobevne / bevacizumab-nwgd — Inflammatory conditions |
| J3590 | Used for multiple brands (e.g., denosumab-desu, Kesimpta, Kevzara, anakinra, and many C9399 cross-listings) |
| C9399 | Used with J3590 for multiple gene/rare-disease products (e.g., Kebilidi, Kresladi) |
| J2840 | Kanuma / sebelipase alfa — Enzyme replacement therapy |
| J9203 | Mylotarg (gemtuzumab ozogamicin) — Oncology; Commercial Criteria = IC-0320, IC-0491-(E) |
| J2941 | Norditropin / Omnitrope / Nutropin AQ (somatropin) — Growth hormone; Commercial Criteria 95015 |
| J1568 | Octagam (intravenous immune globulin) — IC-0071 |
| J9299 | Opdivo IV (nivolumab) — Oncology; Commercial Criteria IC-0226, IC-0541-(E) |
| J2326 | Spinraza; nusinersen; CNS: Rare diseases; Commercial Criteria = 201705 |
| J0013 | Spravato; esketamine; Psychotherapeutic; Commercial Criteria = 201911 - MRx |
| J3590 C9399 | Starjemza; ustekinumab-hmny; Inflammatory conditions; Commercial Criteria = 201012-2 / 201012 |
| J3358 | Stelara IV; ustekinumab; Inflammatory conditions; Commercial Criteria = 201012-2 |
| J3357 | Stelara SC; ustekinumab; Inflammatory conditions; Commercial Criteria = 201012 |
| Q5099 | Steqeyma IV/SC; ustekinumab-stba; Inflammatory conditions; Commercial Criteria = 201012-2 / 201012 |
| Q5127 | Stimufend; pegfilgrastim-fpgk; Colony stimulating factors; Commercial Criteria = 201827 |
| J7321 | Supartz; hyaluronan derivative; Viscosupplementation; Commercial Criteria = 99002 |
| J2779 | Susvimo; ranibizumab; Ophthalmic injections; Commercial Criteria = IC-0634 |
| J2781 | Syfovre; pegcetacoplan; Ophthalmic injections; Commercial Criteria = IC-0697 |
| J1823 | Uplizna (inebilizumab-cdon) — Hematology: NMOSD; Commercial Criteria = CDP-0549 |
| J9217 | Vabrinty (leuprolide acetate depot) — Oncology; Commercial Criteria = 221201 |
| J2777 | Vabysmo (faricimab-svoa) — Ophthalmic injections; Criteria = IC-0659 |
| J9303 | Vectibix (panitumumab) — Oncology; Criteria = IC-0136, IC-0389-(E) |
| Q5129 | Vegzelma (bevacizumab-adcd) — Oncology; Criteria = IC-0014, MMO-0450-(E) |
| J1325 | Veletri (epoprostenol) — Pulmonary arterial; Criteria = 201806; Subject to Site of Care = ✓ |
| Q4074 | Ventavis (iloprost) — Pulmonary arterial hypertension; Criteria = 201807; Subject to Site of Care = ✓ |
| J9376 | Veopoz (pozelimab-bbfg) — Rare disease; Criteria = IC-0727 |
| J1427 | Viltepso (viltolarsen) — Rare disease; Criteria = IC-0562; Subject to Site of Care = ✓ |
| J1322 | Vimizim (elosulfase alfa) — Enzyme replacement therapy; Criteria = IC-0190; Subject to Site of Care = ✓ |
| J7321 | Visco-3 (hyaluronan or derivative) — Viscosupplementation; Criteria = 99002 |
| J3396 | Visudyne (verteporfin) — Ophthalmic injections; Criteria = IC-0181 |
Prior Authorization Process, Submission, and Operational Guidance
Prior Authorization Required
Prior Authorization Required. Medical Mutual requires prior authorization (PA) for the listed medical drugs for Commercial and Medicare Advantage members. Failure to obtain PA prior to administration may result in denial of coverage.
- Applies to all new specialty drugs and new drugs with significant safety, clinical, or diversion concerns.
- PA requirement applies to both inpatient and outpatient settings where noted in the drug listing.
- For Medicare Advantage, Medical Mutual follows CMS guidance and applicable NCDs/LCDs; Medicare coverage is limited to clinically proven items and services.
How to Submit Prior Authorization
How to submit prior authorization requests. Providers should submit PA requests to Medical Drug Management using the contact channels below; use the Prior Approval Form when available.
- Medicare Part B / Medicare Advantage requests: Phone 1-800-424-7698; Fax 1-888-656-1948; Web: www.gatewaypa.com
- Commercial and Exchange requests: Phone 1-800-424-7698; Fax 1-888-656-1948; Web: www.gatewaypa.com (handled by Prime Therapeutics for Commercial)
Icatibant (Firazyr) PA and Sourcing
Icatibant (Firazyr) (J1744) requires prior authorization and is subject to medication sourcing and site-of-care flags for Commercial plans. Note Medicare Advantage: this product is typically self-administered and may be Part D rather than Part B.
- Code: J1744 — Commercial Criteria: 201509-MRx
- Commercial Subject to Site of Care: ✓; Medication Sourcing Starting 1/1/2025 = (A,C)
- New medication sourcing requirement effective 7/1/2026
- Medicare Advantage Criteria: Article A52527 — Medicare notes: drug is self-administered and not covered under Part B; may be covered under Part D
Fyarro (J9331) PA
Fyarro (J9331) requires prior authorization per the listed commercial criteria (IC-0647) and Medicare Advantage criteria. Confirm PA prior to administration.
- Code: J9331 — sirolimus albumin-bound nanoparticles
- Commercial Criteria: IC-0647, IC-0681-(E); Medicare Advantage Criteria: IC-0647
- Medication sourcing and site-of-care flags as listed in the drug-specific row should be followed
Somatropin (J2941) PA and Sourcing
Somatropin (Zomacton, J2941) requires prior authorization under Commercial Criteria 95015 and has site-of-care and medication sourcing flags; for Medicare Advantage the product is typically self-administered and may be covered under Part D.
- Code: J2941 — Commercial Criteria: 95015
- Commercial Subject to Site of Care: ✓; Medication Sourcing Starting 1/1/2025 = (A,C)
- New medication sourcing requirement effective 7/1/26
- Medicare Advantage Criteria: Article A52527 — Medicare notes: drug is self-administered and not covered under Part B; may be covered under Part D
Medication Sourcing and PA Timing
Medication sourcing and PA timing. Providers ordering drugs that are subject to the Medication Sourcing Program should follow the processing recommendations to avoid shipment delays when white-bagging to hospital outpatient infusion departments.
- Medication Sourcing Program effective 1/1/2025 — follow specialty pharmacy submission guidance (clinical documentation, signed prescription, member demographics).
- On referral forms, specify medical benefit billing, indicate 'Drug is to be sourced/white bagged', include ship-to location and required delivery date.
- Members should be informed the specialty pharmacy will contact them; timely member response prevents shipment delays.
- Some products have future sourcing effective dates (examples in drug rows: new sourcing requirements effective 4/1/26, 7/1/26, etc.).
Vyvgart Hytrulo Sourcing
Vyvgart Hytrulo (J9334) medication sourcing change. Vyvgart Hytrulo is subject to a new medication sourcing requirement — providers must account for the sourcing requirement when submitting PA and scheduling therapy.
- Code: J9334 — Commercial Criteria: CDP-0712; Commercial Subject to Site of Care: ✓
- Commercial Subject to Medication Sourcing Starting 1/1/2025 = (A,C,S)
- New medication sourcing requirement effective 4/1/2026 — ensure PA requests include sourcing details and ship-to location
Oncology / Avastin Prior Authorization
Oncology agents and Avastin (bevacizumab) PA. Avastin and bevacizumab biosimilars require prior authorization for non-ophthalmic indications only. Many oncology agents also require PA for inpatient and outpatient use — verify drug-specific rows for PA, criteria, and step-therapy cross-references.
- Avastin (bevacizumab) and bevacizumab products (J9035, Q5126, Q5107, Q5160, J9999, Q5118, Q5129, Q5118, etc.): PA required for non-ophthalmic indications only; ophthalmic injections are treated separately.
- Oncology CAR-T and other cell/gene therapies (e.g., Abecma Q2055, Carvykti Q2056, Kymriah Q2042, Yescarta Q2041, Tecartus Q2053, etc.): Prior Authorization required for both inpatient and outpatient and may reference NCD 110.24 for Medicare Advantage.
- Refer to each drug's Commercial Criteria ID and Medicare Advantage Criteria entry for specific coverage rules and site-of-care or sourcing notes.
Reference Commercial Criteria & Medicare Part B Step Therapy
Reference commercial criteria and Medicare Part B Step Therapy. PA requests should reference the applicable Commercial Criteria ID listed for each HCPCS/CPT/J-code product. Where the Medicare Advantage Notes reference Medicare Part B Step Therapy Policy 201936, follow the step therapy requirements for Medicare Advantage members.
- Always include the Commercial Criteria identifier (e.g., IC-0598, IC-0647, CDP-0649, 95015, etc.) on PA requests to expedite review.
- Medicare Part B Step Therapy Policy 201936 is cross-referenced for multiple agents — when noted in the Medicare Advantage Notes, follow that Step Therapy policy for MA members.
- New Medicare Advantage step therapy requirements are effective for certain agents on 5/1/2026 (see drug-specific entries).
- If a drug is noted as self-administered in Medicare notes (Article A52527), it may not be a Part B benefit and could instead be Part D — confirm benefit pathway to avoid billing denials.
Site-of-Care Flags and Administration Location Guidance
Medicare Part B Step Therapy Cross-References
| Reference | Summary |
|---|---|
| Medicare Part B Step Therapy Policy 201936 | Some drug entries in this document reference Medicare Part B Step Therapy Policy 201936; providers must follow the step therapy requirements in that policy where indicated in per‑product Medicare Advantage notes. |
| See per‑product Medicare Advantage notes | Multiple entries include a Medicare Advantage note directing: 'See Medicare Part B Step Therapy Policy 201936.' When present, Step Therapy Policy 201936 governs step therapy requirements for Medicare Advantage members. |
| Reference | Applicability |
|---|---|
| Medicare Part B Step Therapy Policy 201936 | Referenced repeatedly in Medicare Advantage criteria notes; follow Policy 201936 for step therapy requirements affecting Medicare Advantage enrollees. |
| Examples of affected agents | Examples in the document referencing Policy 201936 include bevacizumab products (Avastin and biosimilars), selected colony stimulating factors, immune globulins, and multiple oncology agents; see individual code entries for specifics. |
| Reference | Effective date / Note |
|---|---|
| Medicare Part B Step Therapy Policy 201936 | Some Medicare Advantage notes state a new Step Therapy requirement becomes effective 5/1/2026; when that date is shown in an entry, Step Therapy Policy 201936 requirements apply beginning 5/1/2026 for those agents. |
| Document examples | Multiple oncology and biologic entries include the note: 'New Medicare Advantage Step Therapy requirement effective 5/1/2026.' Providers should observe those effective dates in Medicare Advantage cases. |
| Reference | Example products |
|---|---|
| J9272 (Jemperli); bevacizumab products (Avastin and biosimilars); colony stimulating factors | Medicare Advantage notes on these products reference See Medicare Part B Step Therapy Policy 201936; follow that policy for step therapy requirements for these products as indicated. |
| Selected oncology agents (e.g., J9022 Tecentriq, J9299 Opdivo, J9380 Tecvayli) | These entries include Medicare Advantage references to Policy 201936 and some indicate new Step Therapy effective dates; follow Policy 201936 per the product note. |
| Reference | Instruction |
|---|---|
| See Medicare Part B Step Therapy Policy 201936 | Where a product's Medicare Advantage notes state 'See Medicare Part B Step Therapy Policy 201936,' providers must follow that step therapy policy for Medicare Advantage members; consult the referenced policy for detailed step requirements. |
| Per‑product cross‑reference | Several immune globulin and biologic entries include this cross‑reference; the plan's Medicare Advantage step therapy handling is governed by Policy 201936 for those products. |
| Reference | Occurrences |
|---|---|
| Multiple product entries | The document contains multiple instances where product Medicare Advantage notes state 'See Medicare Part B Step Therapy Policy 201936.' These references appear across oncology, biologic, and immune globulin entries—follow Policy 201936 where cited. |
| Examples include: | Entries for J9321 (Epkinly), J9145 (Darzalex), J9272 (Jemperli), J9022 (Tecentriq), and various bevacizumab biosimilars include the Step Therapy 201936 reference. |
| Reference | Notes on effective dates and products |
|---|---|
| Medicare Part B Step Therapy Policy 201936 references | Document entries note new Medicare Advantage Step Therapy requirements becoming effective on various dates (notably 5/1/2026 for many entries); providers should check the per‑product Medicare Advantage note for the effective date and follow Policy 201936 accordingly. |
| Product examples with effective dates | Examples include multiple oncology agents and select biologics where the Medicare Advantage note includes 'New Medicare Advantage Step Therapy requirement effective 5/1/2026.' |
| Reference | Guidance |
|---|---|
| Follow Medicare Part B Step Therapy Policy 201936 when cited | Across the document, Medicare Advantage criteria or notes that reference Policy 201936 indicate that step therapy requirements in that policy govern Medicare Advantage members for the named products; providers must follow those step therapy requirements and the specified effective dates where present. |
| Provider action | When a product entry includes a Medicare Advantage note citing Step Therapy Policy 201936 (and any effective date), include adherence to that policy in the prior authorization submission for Medicare Advantage members. |
Policy Background and Scope
Background: This document enumerates medical‑administered drugs that require prior authorization to ensure safe and effective use. It applies to drugs administered under the medical benefit for both Commercial and Medicare Advantage members and includes per‑product Commercial Criteria references, site‑of‑care flags, and medication sourcing start dates (many effective 1/1/2025 or later). Where Medicare Advantage notes indicate a product is self‑administered and not covered under Part B, the document also directs providers to the member's PBM for Part D prior authorization requirements.
Key Definitions and Operational Terms
Policy Updates and Material Changes
Policy effective date published as 2026-05-15; document lists multiple new PA and medication sourcing effective dates across 2025–2026.
New Medicare Advantage step therapy requirement referenced (see Medicare Part B Step Therapy Policy 201936) effective 2026-05-01 for select agents.
New medication sourcing requirement effective 2026-04-01 for selected products (example: Q5138 shows new sourcing requirement effective 4/1/26).
New prior authorization requirement effective 2026-02-01 for select J3490/C9399 entries (example: Yartemlea noted with new PA requirement effective 2/1/26).
New prior authorization requirement effective 2025-11-01 for specified J3490/C9399 product(s) referenced elsewhere in the document.
New medication sourcing requirements effective 2025-07-01 for certain products (examples: multiple entries note sourcing effective 7/1/26 in the broader series; document lists 7/1/26 as a sourcing date category).
Medication sourcing program start date for many products (Commercial Subject to Medication Sourcing starting 1/1/2025).
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