Global prior authorization for medical drugs (Global PA)
Customize your policy alerts
Sign up for all medical mutual - ohio policy alerts
Know when medical mutual - ohio releases new policies or updates existing guidance.
Monitor payer policy activity
Defines Medical Mutual prior authorization requirements for new specialty drugs and drugs with significant safety/abuse concerns for Commercial and Medicare Advantage members, with submission/contact procedures and a drug-specific code list (partial).
No material clinical or coverage changes in this revision.
Coverage Criteria and General Policy
Global prior authorization
Covered when prior authorization is obtained as specified for each drug and plan:
Applies to Commercial and Medicare Advantage unless a line item specifically states otherwise.
Coverage depends on referenced criteria
Coverage and authorization references are guided by commercial criteria codes and Medicare LCD/NCD/Article references
Providers must consult the referenced criteria documents for the specific clinical requirements and documentation to support authorization.
Referenced commercial/Medicare criteria
Coverage is governed by referenced commercial and Medicare Advantage criteria codes:
Full clinical criteria are contained in the referenced IC/LCD/NCD/Article documents.
Prior Authorization for specific therapies
Coverage notes and PA requirements (as stated in this excerpt)
See each drug line for the PA status and whether inpatient and/or outpatient PA is required.
Medicare Part B step therapy references
Step therapy / Medicare Part B references
Examples and cross-references appear in multiple drug entries; consult Policy 201936 for step logic.
Coverage conditioned on referenced criteria identifiers
Listed medications are associated with commercial and Medicare Advantage criteria identifiers that define coverage requirements.
Providers must reference the specific criteria document identified by the criterion code when submitting prior authorization requests.
Medicare Advantage cross-referenced requirements
Medicare Advantage entries that reference external step therapy or LCD/Article guidance.
Include supporting documentation that demonstrates compliance with the referenced Medicare Advantage/LCD/NCD/Article requirements when submitting PA.
Drug-code to criteria mapping
Coverage and criteria are determined by referenced internal criteria documents (IC-#### or year codes) and Medicare LCD/NCD or Part B Step Therapy policy where noted.
This section is a mapping; consult the referenced IC/LCD/NCD/Article documents for the full clinical criteria required to support authorization.
Coverage governance for listed medications
Coverage and authorization references for listed drugs are governed by their commercial criteria identifiers and, where applicable, Medicare Advantage LCD/step therapy policies.
Examples in the list: J1412 Roctavian and J3402 Ryoncil note inpatient and outpatient PA requirements.
Multiple entries include 'See Medicare Part B Step Therapy Policy 201936' or LCD references.
Coverage distinctions (Part B vs Part D)
Coverage notes and distinctions present in this segment include:
Refer to Article A52527 and the drug line-item for Part B vs Part D guidance.
Avastin prior authorization condition
Authorization required for specific indications:
See individual bevacizumab line items (e.g., Q5129, Q5160, Q5118) for coding and PA instructions.
Drug-specific linkage to commercial/MA criteria
Coverage and authorization linkage by drug
Providers must submit documentation that cites the specific Commercial Criteria identifier (IC-####) or Medicare Advantage reference shown on the drug line when requesting authorization.
Coverage for medical-administered drugs listed in this document is conditioned on prior authorization. Prior authorization must be obtained as specified for each drug and plan; this requirement applies to Commercial and Medicare Advantage members unless an individual line item states otherwise. Providers should submit clinical documentation and the signed prescription to Medical Drug Management or the specialty pharmacy using the payer’s prior approval process when seeking authorization.
Bevacizumab (Avastin and biosimilars) entries note that prior authorization is required for non‑ophthalmic indications only. Medicare Advantage references and the document’s therapy/step-policy citations (see Medicare Part B Step Therapy Policy 201936 where indicated) mirror this PA requirement.
Several products in the list are identified as self‑administered. When an entry is labeled self‑administered the drug is typically subject to benefit (prescription/Part D) coverage rules rather than Medicare Part B. Providers must document route of administration and indicate whether the drug is being billed under the medical benefit or the pharmacy/Part D benefit when requesting authorization.
Medicare applicability: where a line item references Article A52527 or similar Medicare notes, the entry indicates that the drug is self‑administered and not covered under Medicare Part B; it may be covered under Part D. Providers should follow the Article/LCD guidance cited for Medicare Advantage members when determining Part B versus Part D applicability.
Effective-date note: certain self‑administered products have specific effective dates in the document. For example, Nemluvio has a new PA effective 3/1/2026 and a Part B exclusion effective 6/14/2026 when the product is listed as self‑administered and not covered under Part B. Check each line item for any effective PA or sourcing dates.
Examples mapping drugs between Part D and Part B in the document include growth hormones and biologics: J2941 (Norditropin / somatropin) is listed as self‑administered and references Article A52527 (may be covered under Part D, not Part B). Similarly, multiple J3590/C9399 entries for self‑administered biologics reference Article A52527 and note Part D applicability.
The document explicitly references Article A52527 for self‑administered products in Medicare Advantage entries. Where Article A52527 is cited, the payer indicates the drug is self‑administered and not covered under Part B; it may be covered under Part D. Providers should cite Article A52527 in Medicare Advantage authorization requests when applicable.
Code-mapping examples demonstrating benefit implications: J2941 (Saizen/Humatrope, somatropin) is listed as self‑administered and subject to benefit coverage with Medicare Advantage reference Article A52527. The document also shows Q9998/Q9996 ustekinumab entries paired with Article A52527 and sourcing notes indicating Part D vs Part B distinctions.
Tremfya (guselkumab) is documented as a self‑administered product; the SC formulation is noted as not covered under Medicare Part B and may instead be covered under Part D. The line item references Article A52527 to support the Part D/Part B determination.
Additional self‑administered examples include multiple adalimumab and other biologic listings where Commercial Notes state 'Self‑administered; subject to benefit coverage' and Medicare Advantage Criteria reference Article A52527. These entries indicate the payer treats the listed formulations as pharmacy/Part D benefit candidates rather than Part B medical benefit items.
Investigational/experimental definition excerpt: services, procedures, therapies, devices or supplies that are not approved by governing bodies or do not demonstrate outcomes comparable or superior to current practice standards (per peer‑reviewed evidence) are considered investigational and are subject to non‑coverage determinations.
The document is primarily an administrative mapping of codes, criteria identifiers and sourcing/site‑of‑care flags rather than an explicit clinical 'not medically necessary' determination list. No standalone clinical NMN statements are present; clinical NMN decisions would be governed by the referenced Commercial Criteria, LCD/NCD, or Article citations.
Where a product is identified as self‑administered, the entry routinely states it is not covered under Medicare Part B and may be covered under Part D (Article A52527). This constitutes an administrative exclusion from Part B for self‑administered formulations and indicates benefit‑based non‑coverage under the medical benefit.
The document includes multiple references to LCDs, NCDs, and Medicare Part B Step Therapy Policy 201936 as governing sources for Medicare Advantage coverage (examples shown alongside specific J‑ and Q‑codes). When an LCD/NCD or the Part B Step Therapy policy is cited, coverage decisions for Medicare Advantage follow those referenced policies.
Clinical coverage or 'not medically necessary' determinations are not stated directly in this file; instead, NMN outcomes would be governed by the referenced Commercial Criteria or Medicare policies (IC codes, LCD/NCD, Article A52527, and Medicare Part B Step Therapy Policy 201936) which contain the clinical logic.
The repeated Part B versus Part D references emphasize operational implications: when an entry references Article A52527 or explicitly states 'self‑administered; subject to benefit coverage', the product is treated as a pharmacy/Part D benefit candidate and the provider should confirm benefit routing before submitting a medical claim or PA under Part B.
This document functions as an administrative listing of codes, sourcing start dates, site‑of‑care flags and references to external criteria; it does not include standalone clinical NMN narratives. Providers must consult the referenced criteria documents (IC‑####), LCDs/NCDs and the Part B Step Therapy policy for clinical decision rules.
The listing maps each drug to its required prior authorization, site‑of‑care or sourcing flags and to the referenced Commercial Criteria or Medicare Advantage policy. For authorization requests, include the specific Commercial Criteria identifier or Medicare reference (IC‑####, NCD/LCD number or Article A52527) shown with the HCPCS/Q/J code on the line item.
Coding: HCPCS / CPT / J / Q Codes
| Q2055 | Abecma (idecabtagene vicleucel) |
| J9264 | Abraxane (paclitaxel protein bound) |
| Q5145 | Abrilada (adalimumab-afzb) |
| J3262 | Actemra IV (tocilizumab) |
| J3590 | Actemra SC / multiple J3590 entries (tocilizumab and other SC biologics) |
| C9399 | Miscellaneous biologic codes used for several brand products |
| J0801 | Acthar Gel (corticotropin) |
| J0791 | Adakveo (crizanlizumab-tmca) |
| J9028 | listed with sourcing starting 1/1/2025; Medicare Advantage Criteria = IC-0753 |
| J2277 | Aphexda; motixafortide; Hematopoetic stem cell mobilizer; Commercial Subject to Site of Care = IC-0729 |
| J0256 | Aralast NP; alpha-1-proteinase inhibitor; Sourcing Starting 1/1/2025 = ✓; Medicare Advantage Criteria = IC-0052 |
| J0881 | Aranesp; darbepoetin alfa; Medicare Advantage Criteria = NCD: 110.21, LCD: L34356 |
| J2793 | Arcalyst; rilonacept; Medicare Advantage Criteria = L34356 CDP 210501 |
| Q5169 | Armlupeg; pegfilgrastim-unne; Classification = Colony stimulating factors; Commercial Criteria = 201827; New PA requirement effective 7/1/2026 |
| J9261 | Arranon Asceniv; nelarabine; Classification = Oncology; Commercial Criteria = IC-0280 |
| J1554 | Asceniv; globulin; Classification = Immune globulin; Commercial Criteria = IC-0071 |
| J9118 | Asparlas; calaspargase pegol-mknl; Classification = Oncology; Commercial Criteria = IC-0425, IC-0538-(E); Prior Authorization required |
| J3590 | Avlayah; tividenofusp alfa-eknm; Classification = Enzyme replacement therapy; Commercial Criteria = 231205; New PA requirement effective 5/1/26 |
| J1826 | Avonex; interferon beta-1a; Commercial Criteria = 201306; self-administered; may be covered under Part D |
| Q5121 | Avsola; infliximab-axxq; Classification = Inflammatory conditions; Commercial Criteria = IC-0104 |
| J9036 | Belrapzo; dilute; Classification = Oncology; Commercial Subject to Site of Care = IC-0130, MMO-0487-(E) |
| J9033 | Bendamustine; J9033; Classification = Oncology; Commercial Subject to Site of Care = IC-0130, MMO-0487-(E) |
| J0490 | Benlysta IV; belimumab; Classification = Inflammatory conditions; Commercial Subject to Site of Care = 201107; Sourcing Starting 1/1/2025 = ✓ (A,C,S) |
| J1556 | Bivigam; intravenous immune globulin; Commercial Subject to Site of Care = IC-0071; Sourcing Starting 1/1/2025 = ✓ (A,C,S) |
| J9999 | Avzivi / Blenrep entries shown under J9999/C9399; e.g., Avzivi bevacizumab-tnjn; Commercial Criteria = IC-0014; Avastin products require PA for non-ophthalmic indications |
| A9590 | Azedra; iobenguane I-131; Classification = Oncology 201828_MRx |
| J9023 | Bavencio; avelumab; Classification = Oncology; Commercial Subject to Site of Care = IC-0295, IC-0417-(E) |
| J9145 | Darzalex (daratumumab); Oncology; Commercial Subject to Site of Care = IC-0266, IC-0383-(E); Medicare Advantage Criteria = IC-0266; Note references Medicare Part B Step Therapy Policy 201936 |
| J9144 | Darzalex Faspro SC (daratumumab; hyaluronidase-fihj); Oncology; Commercial Subject to Site of Care = IC-0535, IC-0585-(E); Medicare Advantage Criteria = IC-0535 |
| J9011 | Datroway (datopotamab deruxtecan-dlnk); Oncology; Commercial Subject to Site of Care = IC-0785; Medicare Advantage Criteria = IC-0785 |
| J9348 | Danyelza (naxitamab-gqgk); Oncology; Commercial Subject to Site of Care = IC-0581; Medicare Advantage Criteria = IC-0581 |
| J3490/C9399 | Dawnzera (donidalorsen); Hereditary angioedema; Commercial Subject to Site of Care = 251202; Sourcing Starting 1/1/2025 = (C) |
| J0589 | Daxxify (daxibotulinumtoxinA-lanm); Botulinum toxins; Commercial Subject to Site of Care = IC-0728; Medicare Advantage Criteria = LCD: L39857 |
| J3121 | Delatestryl (testosterone enanthate); Testosterone; Commercial Subject to Site of Care = 201602; Medicare Advantage Criteria = NCD: 230.4 |
| J1071 | Depo-Testosterone (testosterone cypionate); Testosterone; Commercial Subject to Site of Care = 201602 |
| J3590/C9399 | Dupixent (dupilumab) and multiple other entries under J3590/C9399; Classification varies (Inflammatory conditions, Atopic Dermatitis, etc.); Commercial Subject to Site of Care and Medicare Advantage notes often indicate self-administered and Part D/Part B distinctions |
| J7318 | Durolane (hyaluronan or derivative); Viscosupplementation; Commercial Criteria = 99002; Medicare Advantage Criteria = No prior authorization required LCD: L39857 |
| J1551 | Cutaquig (subcutaneous immune globulin); Immune globulin; Commercial Subject to Site of Care = 201317-MRx; Sourcing Starting 1/1/2025 = (A,C,S); Medicare Advantage Criteria = LCD: L33794 |
| J1555 | Cuvitru (subcutaneous immune globulin); Immune globulin; Commercial Subject to Site of Care = 201317-MRx; Sourcing Starting 1/1/2025 = (A,C,S); Medicare Advantage Criteria = LCD: L33794 |
| C9309 | Listed with J9207; related PA requirements and commercial/Medicare criteria |
| J9207 | Ixempra / onasemnogene abeparvovec-brve ixabepilone (document lists both brand/generic associations) |
| J2782 | Listed alongside J9207 and J9281; multiple classifications including oncology and ophthalmic injections |
| J9281 | Listed with J2782; associated classifications |
| J2506 | Neulasta / pegfilgrastim; Colony stimulating factors; Commercial Criteria = 201827 |
| J1442 | Neupogen / filgrastim; Colony stimulating factors; Commercial Criteria = 201424 |
| Q5110 | Nivestym / filgrastim-aafi; Colony stimulating factors; Commercial Criteria = 201424 |
| Q5148 | Nypozi / filgrastim-txid; Colony stimulating factors; Commercial Criteria = 201424 |
| Q5122 | Nyvepria / pegfilgrastim-apgf; Colony stimulating factors; Commercial Criteria = 201827 |
| J9205 | Onivyde / irinotecan liposome; Oncology; Commercial Criteria = IC-0256, IC-0428-(E) |
| J9264 | Paclitaxel Albumin-Bound / paclitaxel albumin-bound particles; Oncology; Commercial Criteria = IC-0001, IC-0360-(E) |
| J9177 | Padcev / enfortumab vedotin-ejfv; Oncology; Commercial Criteria = IC-0521, IC-0542-(E) |
| J9304 | Pemfexy / pemetrexed; Oncology; Commercial Criteria = IC-0007, MMO-0489-(E) |
| Q5137 | Wezlana SC (ustekinumab-auub) |
| J3590 | General J3590 entries (e.g., Winrevair sotatercept; Xtrenbo denosumab-qbde; Yartemlea narsoplimab-wuug) |
| Q5136 | Wyost (denosumab-bbdz) |
| Q5159 | Xbryk (denosumab-dssb) |
| J1558 | Xembify (subcutaneous immune globulin) |
| J0218 | Olipudase alfa / incobotulinumtoxinA listing |
| J9228 | Yervoy (ipilimumab) |
| Q2041 | Yescarta (axicabtagene ciloleucel) |
| Q5100 | Yesintek IV (ustekinumab-kfce) |
| Q5101 | Zarxio (filgrastim-sndz) |
Provider Actions, Submission & Prior Authorization
Prior authorization required
Request prior authorization for listed specialty drugs before inpatient or outpatient administration; prior authorization applies to Commercial and Medicare Advantage members unless a specific entry states otherwise. Failure to obtain required PA may result in denial of coverage for outpatient drug administration.
- PA requirement applies to all new specialty drugs and new drugs with significant safety/abuse concerns.
- For Medicare Advantage, Medical Mutual follows CMS guidance; include Medicare-specific criteria or LCD/NCD references when applicable.
Prior Authorization required for J9118 (Asparlas)
Asparlas (J9118) requires prior authorization per the commercial criteria listed for this agent.
- Commercial Criteria: IC-0425, IC-0538-(E).
No PA required (commercial) for Q5158
No prior authorization is required under the commercial criteria for Bomyntra/denosumab-bnht (Q5158); note Medicare Advantage references may differ.
- Commercial Criteria: No PA required.
- Medicare Advantage: see Part B Step Therapy Policy 201936; PA may be required except when used for osteoporosis treatment/prevention.
Breyanzi PA requirement (Q2054)
Breyanzi (Q2054) requires prior authorization for both inpatient and outpatient administration; submit PA referencing the listed commercial and Medicare criteria.
- Commercial Criteria: IC-0590, IC-0617-(E).
- Medicare Advantage Criteria: NCD: 110.24 — PA required for inpatient and outpatient.
Casgevy PA requirement (J3392)
Casgevy (J3392) requires prior authorization for inpatient and outpatient use; include the referenced commercial criteria when submitting.
- Commercial Criteria: IC-0744.
- Commercial Subject to Site of Care and Sourcing flags are noted in the entry.
Medicare Advantage / LCD-related prior authorization
Some J3590/C9399-coded self‑administered drugs and immune globulin products reference Medicare Advantage criteria and LCDs; providers must follow the referenced Medicare Advantage/LCD guidance when obtaining PA or submitting documentation.
- Examples: immune globulin entries reference LCDs (e.g., L33794, L38268) and Therapy Policy 201936.
- Include Medicare Advantage criteria identifiers in PA requests when applicable.
New PA requirement example (J7322 Hymovis One) effective 4/1/26
Hymovis One (J7322) has a new prior authorization requirement effective 4/1/2026; verify PA applicability and submit authorization accordingly for Commercial and Medicare Advantage members.
- Commercial Criteria: 99002 (viscosupplementation).
- Medicare Advantage notes reference Part B Step Therapy Policy 201936.
Therapy Policy / Medicare Part B Step references
Several entries reference the Medicare Part B Step Therapy Policy 201936; when a drug line references that policy, follow its step therapy rules and include step therapy documentation with the PA for Medicare Advantage members.
- Examples referencing Policy 201936 include bevacizumab, daratumumab, pegfilgrastim/filgrastim products and many oncology agents.
- Medicare Advantage entries may note new step therapy requirements with effective dates — follow those dates.
PA requirement and effective dates
Multiple drugs have PA requirements with specific effective dates; providers must check each line item for the PA effective date and submit PA for dates on or after the listed effective date.
- Examples: new PA requirements effective 1/1/2026, 3/1/26, 4/1/26, 7/1/26 are noted in various entries.
- Include the referenced Commercial or Medicare criteria code when submitting PA.
Nemluvio (J3590, C9399) PA (new effective 3/1/26)
Nemluvio (nemolizumab-ilto) reported under J3590/C9399 requires a new prior authorization effective 3/1/2026; note that effective 6/14/2026 the product is noted as self‑administered and may not be covered under Medicare Part B.
- Commercial Criteria: 250101.
- Medicare Advantage notes: New PA effective 3/1/26; effective 6/14/26 drug is self‑administered and not covered under Part B (may be Part D).
Norditropin (J2941) PA/coverage and documentation notes
Norditropin / somatropin (J2941) is listed as self‑administered and subject to benefit coverage; include documentation of route and benefit applicability and reference Commercial Criteria 95015 or Medicare Article A52527 when submitting PA or coverage inquiries.
- Commercial Criteria: 95015.
- Medicare Advantage: Article A52527 — drug is self‑administered and not covered under Part B; may be covered under Part D.
Oncology/inflammatory agents PA references
Multiple oncology and inflammatory agents reference commercial criteria and Medicare Advantage criteria and may require prior authorization consistent with those references; providers must submit PA citing the listed criteria.
Roctavian prior authorization (J1412)
Roctavian (J1412) requires prior authorization for both inpatient and outpatient administration; include the Commercial Criteria IC-0718 in the request.
- Commercial Criteria: IC-0718.
- Submit documentation supporting inpatient or outpatient use per the listed criteria.
Rituximab / related PA references
Rituximab products (e.g., J9312, Q5123, J9311) reference Medicare LCDs and the Medicare Part B Step Therapy Policy 201936; include the LCD/IC references and step therapy documentation when requesting authorization.
- Medicare Advantage Criteria: LCD: L38920, LCD: L38268 (varies by product).
- PA requests should reference the applicable LCD/IC code and Part B Step Therapy Policy 201936 when noted.
Prior Authorization required for specified drugs (examples)
Certain high‑cost therapies and specified drugs require prior authorization for inpatient and outpatient administration; providers must submit PA referencing the listed Commercial and Medicare Advantage criteria for each drug.
Prior Authorization / New PA effective dates (examples)
Multiple listed drugs have new prior authorization effective dates (for example olezarsen effective 1/1/2026 and other agents with 2026 effective dates); verify the effective date in the drug entry and obtain PA on or after that date.
- Examples: entries note new PA or sourcing effective dates of 1/1/2026, 2/1/26, 3/1/26, 4/1/26, 5/1/26, 7/1/26.
- Ensure PA submission cites the effective date and applicable criteria.
Drugs subject to commercial criteria and site-of-care sourcing
Some drugs (e.g., Tysabri J2323, Ultomiris J1303) reference commercial criteria and site‑of‑care or medication sourcing requirements; when site‑of‑care or sourcing flags are present include those program requirements in the authorization submission.
- Check Medication Sourcing Program effective 1/1/2025 and any later sourcing effective dates.
- Include site‑of‑care IC identifiers when arranging administration.
Prior Authorization required for high-cost therapies and gene therapies
Prior authorization is required for several high-cost therapies and gene/cell therapies (examples include Q2041 Yescarta; J3399 Zolgensma; J3389 Zevaskyn); obtain PA for inpatient and outpatient use where indicated.
Step therapy references (general)
Step therapy requirements from the Medicare Part B Step Therapy Program may apply to certain drugs; when a line item references Part B Step Therapy Policy 201936 include documentation demonstrating compliance with that policy for Medicare Advantage members.
- Many ophthalmic, oncology, colony stimulating factor and immune globulin entries reference Policy 201936.
- Follow the referenced policy for step sequencing and prior therapy requirements.
Medicare Part B Step Therapy references (examples)
Medicare Part B Step Therapy Policy 201936 is cited for multiple agents (examples: Avtozma, Avgemsi, bevacizumab products); providers must follow that policy for Medicare Advantage PA submissions and include step therapy documentation where required.
- Entries that state 'See Medicare Part B Step Therapy Policy 201936' require compliance with that policy.
- New Medicare Advantage step therapy requirements and effective dates (e.g., 5/1/2026) are noted in several entries.
Medicare Part B Step Therapy references (multiple entries)
Multiple entries reference Medicare Part B Step Therapy Policy 201936 or list Medicare Advantage step therapy changes effective in 2026; when applicable, follow that policy and include related documentation with the PA request.
Refer to Part B Step Therapy Policy
See the Medicare Part B Step Therapy Policy 201936 for products that explicitly reference it (for example bevacizumab and other oncology agents); include the step therapy policy citation in the PA submission for Medicare Advantage members.
- Examples: bevacizumab (Avastin products) reference IC-0014 and Policy 201936.
- Providers must consult the referenced policy for step logic.
Medicare Part B Step Therapy cross-reference
Medicare Advantage entries frequently state 'See Medicare Part B Step Therapy Policy 201936' — when present, providers must comply with that policy and supply step therapy documentation with prior authorization requests.
- Applicable to multiple oncology, ophthalmic and biologic agents.
- Check for MA-specific effective dates noted in individual entries.
Submission requirements
When submitting prior authorization requests, include clinical notes, a signed prescription, and member demographics; follow the Medical Drug Management contact methods (phone, fax, web) or the specialty pharmacy referral instructions.
- Medical Drug Management phone: 1-800-424-7698; fax: 1-888-656-1948; web: www.gatewaypa.com.
- Specialty pharmacy submissions should indicate medical benefit billing, sourcing/white-bag instructions, ship-to location and required delivery date to avoid delays.
Avonex coverage note (J1826, Q3027)
Avonex (J1826, Q3027) is noted as self‑administered and subject to benefit coverage; for Medicare Advantage, the entry references Article A52527 and indicates the drug is not covered under Part B and may be covered under Part D.
- Commercial Criteria: 201306.
- Document route of administration and benefit applicability on the PA submission.
Supporting documentation for referenced criteria
Include the cited Commercial Criteria or Medicare Advantage Criteria identifiers (IC-####, LCD/NCD, Article) in the PA submission as supporting references; PA decisions depend on meeting those referenced criteria.
- Examples: IC-0071, IC-0266, LCD: L33794, Article: A52527, Medicare Part B Step Therapy Policy 201936.
- Cite the exact criteria identifier shown in the drug line item when submitting documentation.
Self-administered drug documentation (Norditropin example)
Norditropin (J2941) and other self‑administered products should have documentation that reflects route of administration and whether the drug is a pharmacy/Part D benefit or a medical/Part B benefit; include Article A52527 references for Medicare Advantage submissions.
- Commercial Criteria for J2941: 95015.
- Medicare Advantage: Article A52527 — self‑administered drugs may not be covered under Part B.
Medicare Part B Step Therapy references (submission guidance)
When a drug entry references Medicare Part B Step Therapy Policy 201936, include relevant step therapy documentation with PA submissions for Medicare Advantage members and follow any MA-specific step therapy effective dates.
- Many oncology and biologic agents reference Policy 201936 — providers must follow that policy's step sequencing and documentation requirements.
- Note MA-specific effective dates (e.g., 5/1/2026) listed in entries.
Avastin coverage note and PA condition
Avastin/bevacizumab products require prior authorization for non‑ophthalmic indications only; failure to obtain PA for non‑ophthalmic use may result in denial.
- Commercial Criteria: IC-0014 (Avastin non‑ophthalmic PA requirement).
- Medicare Advantage entries reference Part B Step Therapy Policy 201936.
Blenrep PA requirement (effective 11/7/25)
Blenrep (listed under J9999/C9399) has a new prior authorization requirement effective 11/7/2025; obtain PA per the listed commercial criteria and include the ICD/criteria references.
- Commercial Subject to Site of Care: IC-0561.
- New PA requirement effective 11/7/25 as noted in the entry.
Asparlas PA requirement (J9118)
Asparlas (J9118) is identified as requiring prior authorization; include the commercial criteria cited for the drug when submitting PA.
- Commercial Criteria: IC-0425, IC-0538-(E).
LCD/Step Therapy denial risk for immune globulin products
Some immune globulin products (e.g., J1569, various Gammagard entries) are subject to Medicare LCDs and Part B step therapy references; failing to meet LCD/step therapy requirements may trigger coverage limitations or denials.
- Medicare Advantage Criteria include multiple LCDs (L38268, L35891, L33610) and Therapy Policy 201936.
- Commercial Criteria: IC-0071 for many IVIG products — include IC reference in PA.
Avastin PA requirement (non-ophthalmic) — denial risk
Avastin (bevacizumab products) require prior authorization for non‑ophthalmic indications only; absence of PA for non‑ophthalmic administration may result in denial.
- Commercial Criteria: IC-0014.
- Medicare Advantage references Part B Step Therapy Policy 201936 for related rules.
Prior Authorization required — failure to obtain may lead to denial
Prior authorization is required for multiple listed drugs; providers should obtain PA before administration to avoid denials.
- This global PA requirement applies to Commercial and Medicare Advantage unless specifically exempted in a line item.
- Failure to obtain PA may lead to denial of coverage for outpatient administrations.
Nemluvio PA requirement (denial risk if not obtained)
Nemluvio (nemolizumab-ilto) has a new PA requirement effective 3/1/2026; obtain PA for dates on or after that effective date to avoid denial. The entry also notes that effective 6/14/2026 the drug is self‑administered and may not be covered under Part B.
- Commercial Criteria: 250101.
- Medicare Advantage: note MA PA effective date and Part B/Part D distinction on 6/14/26.
Q5168 and related PA (effective 7/1/2026) — denial risk
New PA requirements effective 7/1/2026 apply to certain ophthalmic agents (for example Q5168); providers must obtain PA on or after the effective date to avoid denial.
- Q5168 (ranibizumab-leyk) lists a new PA requirement effective 7/1/2026.
- Check the drug line for the exact effective date and PA instructions.
Prior Authorization required for Roctavian (denial risk)
Roctavian (J1412) requires prior authorization for inpatient and outpatient administration; lack of PA may result in denial.
- Commercial Criteria: IC-0718 — include this identifier in PA submissions.
- Medicare Advantage notes also require PA for inpatient and outpatient.
PA required for Tecvayli (teclistamab-cqyv)
Tecvayli (teclistamab-cqyv) (J9380) requires prior authorization for both inpatient and outpatient use; include the commercial criteria identifiers (IC-0682, IC-0706-(E)) in PA requests.
- Commercial Criteria: IC-0682, IC-0706-(E).
- Medicare Advantage: PA required for inpatient and outpatient per the entry.
Prior Authorization required for Q2041 (Yescarta)
Yescarta (Q2041) requires prior authorization for inpatient and outpatient use; include the listed commercial criteria and any Medicare NCD references when submitting PA.
- Q2041 Commercial Subject to Site of Care: 201733; include IC/NCD references in documentation.
- Medicare Advantage notes reference NCD: 110.24.
Site-of-Care and Medication Sourcing
Provide site-of-care and sourcing details when entries flag Medication Sourcing or Site-of-Care
Some PA requirements are tied to site-of-care or Medication Sourcing Program flags (Medication Sourcing starting 1/1/2025); when a drug is flagged as Commercial Subject to Site of Care or Sourcing Starting 1/1/2025, include site and sourcing details in the PA and follow the Medication Sourcing Program guidance.
- Specify 'drug to be billed under the medical benefit' and whether the drug is to be sourced/white‑bagged and the ship‑to location on referral forms.
Follow the specified site‑of‑care designation in the drug entry
When a drug line is marked 'Commercial Subject to Site of Care' providers must follow the listed site-of-care policy (examples: infusion center, office, home) for arranging administration and include that site information in the PA submission.
- Check the specific drug row for the site-of-care designation (e.g., 201317-MRx) and follow the referenced IC/site policy.
Include home‑administration/site notes for subcutaneous immune globulins
For subcutaneous immune globulins (e.g., J1551 Cutaquig, J1555 Cuvitru) which are marked 'Commercial Subject to Site of Care = 201317-MRx ✓' include the site-of-care designation and sourcing flags in the submission since home administration or pharmacy benefit applicability may affect coverage.
Confirm and document permitted administration location when site‑of‑care flag is present
Many infusion and specialty products are flagged Commercial Subject to Site of Care (examples annotated across the list); when present, providers should confirm permitted administration locations (infusion center, outpatient hospital, office, home) and note that location on the PA.
Initial Therapy References & Criteria Identifiers
Initial therapy references (drug-specific IC numbers / Medicare articles)
Drug-specific criteria references are listed in the drug table (IC numbers or Medicare articles/LCDs).
This initial therapy reference list points to external criteria documents for full clinical detail.
Initial therapy references (continued)
Drug-specific criteria references are listed in the drug table (IC numbers or Medicare articles/LCDs). (continued)
Providers should cite the exact IC/LCD/NCD/Article identifier from the drug line when submitting PA.
Step Therapy and Part B Step Program
| Reference | Summary / Instruction |
|---|---|
| Medicare Part B Step Therapy Program (general) | Medicare Part B Step Therapy Program may apply to certain drugs; providers must follow the referenced Part B step therapy policies where indicated in individual drug entries. |
| See Medicare Part B Step Therapy Policy 201936 | Multiple drug entries reference Policy 201936 — follow that policy for step therapy sequencing and requirements for Medicare Advantage and Part B claims where noted. |
| Reference | Summary / Instruction |
|---|---|
| Policy 201936 (explicit reference) | Numerous oncology and biologic agents list 'See Medicare Part B Step Therapy Policy 201936' — include the Part B Step Therapy requirements when submitting authorizations for Medicare Advantage members. |
| Examples citing 201936 (daratumumab, pemfexy, others) | Entries such as J9145 (daratumumab), J9304 (pemetrexed) and others explicitly reference therapy policy 201936; check that policy for required step edits and documentation. |
| Reference | Summary / Instruction |
|---|---|
| MA step therapy effective dates | Several Medicare Advantage entries note new step therapy requirements effective 5/1/2026 (e.g., daratumumab J9145, Danyelza J9348); follow the MA effective dates when processing MA prior authorizations. |
| MA cross-references to Part B Step Therapy Policy 201936 | Medicare Advantage criteria fields often instruct 'See Medicare Part B Step Therapy Policy 201936' — MA determinations should include compliance with that policy in addition to listed IC/LCD references. |
| Reference | Summary / Instruction |
|---|---|
| Medicare Advantage entries referencing 201936 | Multiple MA entries (e.g., J9321 Epkinly, J9145 Darzalex, other oncology agents) reference Policy 201936 and note MA-specific step therapy requirements; include step therapy documentation for MA PA submissions. |
| MA new step therapy requirements (various effective dates) | Some MA entries indicate new MA step therapy requirements effective in 2026 (see individual drug lines for exact effective date and guidance). |
| Reference | Summary / Instruction |
|---|---|
| Bevacizumab / Avastin family references | Bevacizumab products (Avastin biosimilars and branded bevacizumab entries) uniformly note: prior authorization required for non‑ophthalmic indications only; MA notes reference Medicare Part B Step Therapy Policy 201936. |
| Other oncology agents referencing step therapy | Multiple oncology agents listed alongside bevacizumab references (e.g., Q5107 Mvasi, Q5160 bevacizumab-nwgd) instruct providers to follow Part B Step Therapy Policy 201936 for applicable step edits and MA requirements. |
| Reference | Summary / Instruction |
|---|---|
| Frequent 'See Medicare Part B Step Therapy Policy 201936' | Many drug entries include the phrase 'See Medicare Part B Step Therapy Policy 201936' — treat that cross-reference as indicating step therapy applies per that policy for Medicare Advantage and as directed in the MA notes. |
| Implication for PA submissions | When an entry references Policy 201936, submitters must include documentation demonstrating compliance with the Part B step therapy rules when requesting authorization for MA members or when the MA field references step therapy. |
| Reference | Summary / Instruction |
|---|---|
| Multiple entries reference 201936 | Rituximab and several other biologics and oncology agents reference Medicare Part B Step Therapy Policy 201936 in their Medicare Advantage Criteria fields (e.g., rituximab-related entries, daratumumab, epcoritamab); follow policy 201936 for step therapy requirements. |
| Provider action note | Include relevant step therapy evidence or prior step trial documentation per Policy 201936 when submitting PAs for these agents under Medicare Advantage. |
| Reference | Summary / Instruction |
|---|---|
| LCDs and Part B Step Therapy Policy 201936 applied to MA | Several entries pair LCD/LCD citations with 'See Medicare Part B Step Therapy Policy 201936' (examples include entries citing LCDs such as L38268/L35891); for MA claims, adjudication should follow both the LCD guidance and the Part B Step Therapy policy where indicated. |
| Example guidance | Entries such as J9311 and immune globulin listings show LCD references plus instruction to see Policy 201936 — include LCD-required documentation and step therapy compliance documentation for MA PA reviews. |
| Reference | Summary / Instruction |
|---|---|
| MA step therapy effective 5/1/2026 noted | Multiple Medicare Advantage entries note new step therapy requirements effective 5/1/2026 (see J9145, J9348 and other oncology entries) — apply the MA effective date when determining step therapy applicability for MA members. |
| Cross-reference to 201936 | These MA entries frequently cross‑reference Medicare Part B Step Therapy Policy 201936; providers must consult that policy for the step sequence and required prior trials or exceptions. |
| Reference | Summary / Instruction |
|---|---|
| Multiple agents reference 201936 | Across the drug list many agents (oncology, biologics, colony stimulating factors, immune globulins) include 'See Medicare Part B Step Therapy Policy 201936' in MA fields — treat Policy 201936 as the controlling step therapy guidance when indicated. |
| Practical note for reviewers | When Policy 201936 is referenced, reviewers should verify prior-step treatments and any MA-specific effective dates (e.g., 5/1/2026) before approving or denying MA prior authorization requests. |
Definitions and Background
Background summary: the plan defines investigational/experimental services as those lacking regulatory approval or robust evidence of outcomes comparable or superior to standard care. Medical Mutual aligns Medicare Advantage determinations with CMS guidance and limits Medicare coverage to clinically proven items and services; investigational services are considered non‑covered.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.