Medicare Part B Prior Authorization and Step Therapy Criteria (July 2026)
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Governs prior authorization and step therapy requirements for Medicare Part B drugs administered by providers under Priority Health Medicare; affects providers submitting PA/ST requests and billing for Part B drugs.
No material clinical or coverage changes in this revision.
Policy Header & Overview
Coverage Criteria (Product-level Initial & Continuation)
Actemra (tocilizumab) — Initial/General criteria
Covered when ALL of the following are met
Coverage duration 2 years; dose per FDA labeling or accepted standards.
Adakveo — Initial/General criteria
Covered when ALL of the following are met
Coverage duration 2 years; dose per FDA labeling or accepted standards.
Adakveo - Initial Authorization
Covered when ALL of the following are met:
Coverage duration 2 years.
Adzynma - Initial/Authorization and Reauthorization criteria
Covered when ALL of the following are met:
Initial coverage duration 12 months.
Reauthorization duration 12 months.
Alhemo - Initial Authorization and Reauthorization
Covered when ALL of the following are met:
Initial coverage duration 12 months.
Initial coverage duration 12 months.
Reauthorization duration 12 months.
Alyglo — Initial Coverage Criteria
Alyglo (immune globulin intravenous, human-stwk) — Covered when ALL of the following are met:
Coverage duration 2 years; dose per FDA labeling or accepted standards; refers to LCD L34771 for IVIG determinations.
Alymsys — Initial Coverage Criteria
Alymsys (bevacizumab biosimilar) — Covered when ALL of the following are met:
Coverage duration up to 1 year; dose per FDA labeling or accepted standards.
Amvuttra — Indication-specific Initial Coverage Criteria
Amvuttra (vutrisiran) — Covered when ALL of the following are met by indication:
Age ≥18 years; do not approve if primary (light‑chain) amyloidosis present; initial coverage duration 1 year; do not co‑administer with TTR stabilizers or TTR‑lowering agents.
Amvuttra - Initial/Authorization and Reauthorization criteria
Amvuttra — Reauthorization criteria
Reauthorization duration 1 year.
Amvuttra — Reauthorization criteria and requirement to demonstrate clinical benefit compared to baseline
Reauthorization covered when documentation demonstrates clinical benefit compared to baseline
Reauthorization duration 1 year.
Aralast NP — Initial Therapy
Covered when ALL of the following are met
Coverage duration 2 years; dose per FDA labeling.
Asceniv — Initial Therapy / Step Therapy
Covered when documentation supports medically accepted indication and step therapy met for Part B determinations
Coverage duration 2 years; dose per FDA labeling; refer to LCD L34771.
Aukelso — Step Therapy and Coverage Criteria
Covered when ALL of the following are met
Coverage duration up to 2 years; dose per FDA labeling.
Avastin (J9035) — Coverage Criteria (chemotherapy context)
Covered when ALL of the following are met:
Coverage duration up to 1 year; chemotherapy (J9035) only.
Aveed — Coverage Criteria with separate branches for hypogonadism and gender dysphoria
Covered when ALL of the following are met (separate branches for hypogonadism and gender dysphoria):
Coverage duration 2 years; dose per FDA labeling or accepted standards.
Avgemsi — Coverage Criteria
Covered when ALL of the following are met:
Coverage duration up to 1 year.
Avtozma/Other product-specific initial coverage criteria grouped here
Covered when ALL of the following are met for each listed product
Use Medicare Part B (Oncology or Non‑Oncology) drug request form or Web Form as applicable.
Exact prior agent depends on product.
Dose per FDA labeling or accepted standards.
Azmiro — Covered when ALL of the following are met
Covered for hypogonadism or gender dysphoria when required documentation is supplied and step therapy is met.
Coverage duration 2 years.
Beizray / Beizray-Albumin — Covered when ALL of the following are met
Covered for medically accepted indications when prior trial of generic docetaxel is documented.
Coverage duration 1 year; dose per FDA labeling.
Benlysta IV — SLE and Lupus Nephritis initial coverage and reauthorization criteria
Covered for SLE or lupus nephritis with required disease activity and serologic/biopsy confirmation.
Initial coverage duration 1 year.
Initial coverage duration 1 year; reauthorization requires improved or stable eGFR.
Reauthorization duration 2 years.
Bivigam (IVIG) — Part B Coverage
Covered when ALL of the following are met for Part B‑designated indications:
Coverage duration 2 years.
Bkemv, Bkemv-Albumin and related product-specific initial coverage criteria
Covered when ALL of the following are met (by indication):
Initial coverage 1 year; reauthorization 2 years with decreased relapse rate evidence required.
Reauthorization requires improvement in symptoms and hemoglobin/hemolysis measures.
Reauthorization requires decreased signs of TMA.
Reauthorization requires documented improvement in MG‑ADL from baseline.
Bomyntra — Initial Therapy
Bomyntra covered when ALL of the following are met:
Coverage duration up to 2 years; dose per FDA labeling.
Boruzu — Initial Therapy
Boruzu covered when ALL of the following are met:
Coverage duration up to 1 year; dose per FDA labeling.
Bosaya — Initial Therapy
Bosaya covered when ALL of the following are met:
Coverage duration up to 2 years; dose per FDA labeling.
Casgevy — Gene therapy initial criteria for SCD and Beta Thalassemia (including transfusion-dependence thresholds)
Casgevy (gene therapy) covered when ALL of the following are met depending on indication:
Age ≥12 years; prescriber hematologist; authorization 6 months; one lifetime dose limit; excluded if prior HSCT or prior gene therapy.
Age ≥12 years; prescriber hematologist; authorization 6 months; one lifetime dose limit; excluded if prior HSCT or prior gene therapy.
Cimzia — Initial Therapy
Covered when ALL of the following are met:
Coverage duration 2 years; dose per FDA labeling or accepted standards.
Cinqair and Severe eosinophilic asthma — initial and reauthorization criteria
Covered when ALL of the following are met:
Prescriber is a specialist or has consulted with a specialist; reauthorization requires documented clinical benefit (decreased exacerbations, improved symptoms, or reduced oral steroid use).
Cinryze — Initial Therapy/Step therapy
Covered when ALL of the following are met
Coverage duration 2 years; dose per FDA labeling or accepted standards.
Initial Therapy Criteria (Extracted per Product)
Step Therapy Requirements (Prior Trials Required)
| Product | Required prior agent(s) (step therapy) | Notes / trial duration / exceptions |
|---|---|---|
| Adakveo (crizanlizumab) | Hydroxyurea (trial 6 months) | Must document 6‑month hydroxyurea trial or intolerance/contraindication; coverage duration 2 years; submit Medicare Part B drug request form. |
| Alyglo (IVIG) | Two preferred IVIG products (examples: Gammagard Liquid, Gamunex‑C, Privigen) | Part B vs Part D determination required; must try two preferred IVIGs prior to Part B IVIG coverage; provide medical records. |
| Alymsys (bevacizumab biosimilar) | Mvasi AND Zirabev | Must try both biosimilars (Mvasi and Zirabev) prior to Avastin (J9035); criteria applied consistent with LCD L37205; coverage up to 1 year. |
| Avastin (bevacizumab) — J9035 chemotherapy | Mvasi AND Zirabev | Chemotherapy J9035 only; must document trials of Mvasi and Zirabev before Avastin; coverage duration up to 1 year; use Oncology drug request form. |
| Aveed (testosterone undecanoate) | Generic intramuscular testosterone (cypionate or enanthate) AND generic topical testosterone | For hypogonadism/gender dysphoria pathways: must document trials/failures of generic IM and topical testosterone, two morning total testosterone measurements on separate days <300 ng/dL (or below lab reference), and clinical signs; coverage 2 years. |
| Azmiro (testosterone formulation) | Generic testosterone cypionate trial | Prior trial and failure of generic testosterone cypionate required; must supply two morning total testosterone measurements <300 ng/dL and clinical signs; coverage 2 years. |
| Beizray / Beizray‑Albumin (docetaxel formulations) | Generic docetaxel (Taxotere, HCPCS J9171) | Must first try generic docetaxel (J9171) prior to Beizray/Beizray‑Albumin; provide medical records; coverage duration 1 year. |
| Boruzu (bortezomib) | Generic bortezomib injectable (e.g., HCPCS J9049 or J9041) | Step therapy requires trial of a generic bortezomib product prior to Boruzu; provide prior‑therapy documentation; coverage up to 1 year. |
| Aukelso (denosumab biosimilar) | Wyost, Xtrenbo, AND Bilprevda | Must try all three prior to Aukelso; biosimilar provisionally interchangeable with Xgeva; coverage up to 2 years. |
| Bomyntra (denosumab biosimilar) | Wyost, Xtrenbo, AND Bilprevda | Must first try Wyost, Xtrenbo, and Bilprevda before Bomyntra; provide medical records; coverage up to 2 years. |
| Bosaya (denosumab biosimilar) | Jubbonti, Enoby, AND Bildyos | Must first try listed preferred denosumab/alternatives prior to Bosaya; provide documentation; coverage per FDA labeling. |
| Cimzia (certolizumab) | Failure of TWO agents (e.g., preferred adalimumab product AND another listed agent such as Rinvoq, Skyrizi, Tyenne, Cosentyx, Otezla, Xeljanz/XR, Yesintek/Selaradi or Enbrel) | Step therapy requires failure/intolerance of two specified agents; prescriber specialist or consultation; coverage duration 2 years. |
| Cinqair (reslizumab) | ICS/LABA plus 1 other controller (prior controller therapy) — and biomarker criteria | For severe eosinophilic asthma: eosinophils ≥150 cells/µL at start OR ≥300 cells/µL in prior 12 months; must have tried appropriate inhaled controller regimen; provide weight and records. |
| Cinryze (C1‑esterase inhibitor) | Haegarda | Must first try Haegarda before Cinryze; provide medical records documenting prior therapies and responses; coverage duration 2 years. |
| Conexxence (C1‑esterase reference biosimilar) | Jubbonti, Enoby, AND Bildyos | Must first try Jubbonti, Enoby, and Bildyos prior to Conexxence; provide prior‑therapy documentation; coverage up to 2 years. |
| Cosentyx IV (secukinumab IV) | Avsola OR Renflexis OR Simponi Aria | Must first try Avsola, Renflexis, or Simponi Aria prior to Cosentyx IV; not to be used in combination with other biologics, Otezla, or JAK inhibitors; prescriber specialist; coverage 2 years. |
| Docivyx (docetaxel) | Generic docetaxel (Taxotere, J9171) | Must first try generic docetaxel (J9171) prior to Docivyx; submit Medicare Part B (Non‑Oncology) drug request form; coverage duration 1 year. |
| Durysta (bimatoprost implant) | Two topical prostaglandin analogs (latanoprost, bimatoprost, travoprost) | Must try TWO topical prostaglandin analogs prior to Durysta implant; provide documentation of trials and responses; dosing per FDA labeling. |
| Emblaveo (aztreonam‑avibactam) | All other generic susceptible antibiotics per culture/sensitivity (or empiric guidance) | Designated Part B Step Therapy drug; must try other appropriate antibiotics per culture/sensitivity; prescriber infectious disease specialist or consult; approval limited to 6 months. |
| Enjaymo (sutimlimab) | Rituximab‑containing regimen (documented trial and failure) | Document trial and failure of a rituximab‑containing regimen prior to Enjaymo; provide transfusion history, baseline labs, weight; initial 6 months, reauth 12 months with documented benefit. |
| Entyvio (vedolizumab) | Avsola OR Renflexis | Must first try Avsola or Renflexis prior to Entyvio; provide medical records documenting prior therapies and responses; not used with other biologics/Otezla/JAK inhibitors; initial 1 year, reauth 2 years. |
| Epogen (epoetin alfa) — non‑ESRD Part B requests | Procrit AND Retacrit | Non‑ESRD Part B requests must first try Procrit and Retacrit per LCD L34633; provide documentation; coverage up to 2 years. |
| Erzofri (paliperidone long‑acting) | Invega Sustenna OR Invega Trinza OR Invega Hayfera | Must first try one of the specified Invega products prior to Erzofri; step therapy applied per guidance. |
| Evenity (romosozumab) | Oral bisphosphonate (alendronate, risedronate, ibandronate) AND either zoledronic acid or Jubbonti — OR meet very high fracture risk criteria | Must meet one pathway: prior bisphosphonate plus zoledronic acid/Jubbonti failure or very high fracture risk (T‑score thresholds); cumulative use limited to 12 months lifetime; prescriber endocrinologist; coverage 12 months per lifetime. |
| Evkeeza (evinacumab) | Repatha (prior trial) — except children 5–9 years where trial not required | Must first try Repatha prior to Evkeeza (trial not required in children 5–9 yrs); provide medical records documenting prior therapies and responses; coverage 2 years. |
| Casgevy (gene therapy) | N/A (one‑time gene therapy) — must document prior standard therapies such as hydroxyurea or alternatives for SCD; transfusion history for beta thalassemia | Requires comprehensive documentation (genotype confirmation for SCD or transfusion dependence for beta thalassemia), prior therapy history, organ function and HSCT eligibility; limited to one lifetime dose; authorization 6 months; prior HSCT or prior gene therapy excludes coverage. |
Submit Medicare Part B PA form with complete supporting records
Submit prior authorization using the Medicare Part B (Non‑Oncology) drug request form or the applicable Web Form (Oncology form for chemotherapeutics). Include completed request form fields (drug, dose, frequency, place of administration) and attach supporting medical records documenting diagnosis, prior therapies and responses, required labs/diagnostic tests, prescriber specialty/consultation when specified, and any weight or transfusion history requested by the product-specific criteria. Coverage durations and product-specific prior‑therapy/step requirements are determined from the PA review; follow product nodes for exact duration and step edits (examples: Adakveo — 6‑month hydroxyurea trial; Aukelso — trials of Wyost, Xtrenbo, AND Bilprevda; Avastin J9035 — must first try Mvasi AND Zirabev).
- Use the Medicare Part B drug request form or Web Form to streamline review and determine Part B vs Part D responsibility [[chunk 121],[chunk 122],[chunk 145]].
- Attach supporting medical records: diagnosis, prior therapies and responses, baseline and follow‑up data, required labs/diagnostics, patient weight or transfusion history when requested [[chunk 122],[chunk 173],[chunk 179]].
- Follow product‑specific PA rules: Adakveo requires documentation of a 6‑month hydroxyurea trial or intolerance/contraindication; Aukelso requires prior trials of Wyost, Xtrenbo, AND Bilprevda; Avastin (J9035) requires trials of Mvasi AND Zirabev per LCD L37205 [[chunk 19],[chunk 123],[chunk 124],[chunk 45]].
- Observe PA coverage durations and prescriber restrictions indicated per product (typical initial durations: 1 year for many agents; some 2 years; some gene therapies/implants have unique limits) and include specialist attestation when required [[chunk 127],[chunk 131],[chunk 133],[chunk 136],[chunk 140]].
Coding & Billing (HCPCS/CPT/NDC references)
| J9035 | Bevacizumab, chemotherapy drug code (Avastin) — chemotherapy (J9035) only |
| Bivigam | Affected product name listed (Bivigam) |
| Bkemv | Affected product name listed (Bkemv) |
| Benlysta | Belimumab product referenced for SLE and Lupus Nephritis (no explicit CPT/HCPCS code listed) |
| CIMZIA 2X200 MG/ML SYRINGE KIT 2X200MG SYR/BOX | Product affected (text listing) |
| Cimzia Powder for Reconst | Product affected (text listing) |
| Cimzia Starter Kit | Product affected (text listing) |
| Cinqair | Product affected (text listing) |
| J9171 | Docetaxel (Taxotere) — generic comparator HCPCS referenced as required prior agent (J9171) |
| J9171 | Docetaxel (Taxotere) — referenced as required prior agent before Beizray / Beizray kit (J9171) |
| No codes listed |
Provider Actions, Prior Authorization Process & Denial Triggers
Submit Medicare Part B drug request form with complete documentation
Complete and submit the appropriate Medicare Part B drug prior authorization request form (Oncology or Non‑Oncology) or the web form and include dose, frequency, place of administration, and supporting medical records to support the request.
- Use the Medicare Part B (Oncology or Non‑Oncology) drug request form or Web Form to streamline review.
- Include dose, frequency, place of administration, and supporting medical records documenting prior therapies and clinical response.
Include product‑specific documentation with PA submissions (Azmiro, Beizray, Benlysta, Cimzia, Cinqair)
Provide the product‑specific supporting documentation requested in the policy when submitting the prior authorization for Azmiro, Beizray, Benlysta, Cimzia, and Cinqair — failure to include these items will delay or risk denial.
- Azmiro: medical records showing trial and failure of generic testosterone cypionate and two separate morning total testosterone measurements <300 ng/dL, plus clinical signs of testosterone deficiency and birth‑sex documentation.
- Beizray/Beizray‑Albumin: documentation that generic docetaxel (Taxotere, J9171) was tried prior to Beizray.
- Benlysta IV: SELENA‑SLEDAI ≥6 and either anti‑dsDNA >30 IU/mL or ANA >1:80 for SLE; kidney biopsy class 3,4, or 5 for lupus nephritis; specialist prescriber or consultation.
- Cimzia: medical records documenting failure of two listed prior agents and specialist prescriber/consultation.
- Cinqair: medical records including prior therapies, current weight, and eosinophil count ≥150 cells/mcL at start or ≥300 cells/mcL in prior 12 months.
PA duration and reauthorization expectations — typical 1 year initial; many reauth to 2 years
Initial prior authorizations are typically granted for approximately 1 year (many reauthorizations up to 2 years); some products have shorter or lifetime limits — submit reauthorization documentation showing clinical benefit per product rules.
- Initial approvals commonly 1 year; many reauthorizations are for 2 years (verify product‑specific duration).
- Some agents have unique limits (e.g., Emblaveo approvals limited to 6 months; Casgevy authorization 6 months with one lifetime dose).
- Ensure reauthorization requests include documentation of clinical benefit compared to baseline as required by the product (e.g., Amvuttra, Enjaymo, Elevidys).
Denial risk — missing prior trials, diagnostic/genetic/antibody tests, or prohibited combinations
Prior authorization requests lacking required prior‑trial evidence, diagnostic/antibody/genetic test results, or showing use with excluded combination therapies may be denied.
- Missing documentation of required prior trials (e.g., hydroxyurea for Adakveo; Mvasi and Zirabev for Avastin; generic docetaxel for Docivyx) risks denial.
- Absent diagnostic or lab criteria (e.g., SELENA‑SLEDAI and autoantibodies for Benlysta; anti‑AAVrh74 titer and DMD genotype for Elevidys) can trigger denial.
- Requests for drugs used in prohibited combinations (e.g., Benlysta with another biologic or Lupkynis) may be denied as exclusions apply.
Noncoverage triggers — Evenity and prohibited combinations
Do not request coverage for products with explicit noncoverage triggers (example: Evenity cumulative use >12 months per lifetime) or for uses excluded by policy — such requests will be denied.
- Evenity: cumulative use beyond 12 months per lifetime is not covered.
- Products that must not be used in combination with excluded agents (e.g., Cosentyx IV, Entyvio) will be denied if combination use is documented.
Required supporting records/tests — Emblaveo, Elevidys, Enjaymo, Encelto
Attach the required medical records and test results listed per product: cultures and sensitivities or suspected organisms for Emblaveo; genotype confirmation and anti‑AAVrh74 titer for Elevidys; anti‑AAVrh74 <1:400; weight, baseline hemoglobin and transfusion history for Enjaymo; IS/OS PR (EZ) break and BCVA for Encelto.
- Emblaveo: culture and sensitivity results or specified suspected organism(s); prescriber must be or consult an infectious disease specialist.
- Elevidys: genetic confirmation of DMD excluding deletions in exon 8 or 9 and anti‑AAVrh74 total binding antibody titer <1:400; specialist prescriber or consultation required.
- Enjaymo: current weight, baseline hemoglobin, confirmed CAD diagnosis, and documentation of at least one transfusion within 6 months prior to therapy.
- Encelto: fluorescein angiography or OCT supporting MacTel type 2 diagnosis, IS/OS (EZ) break between 0.16 and 2.00 mm2, and BCVA ≥54 ETDRS letters; one implant per eye lifetime; approval limited to 6 months.
Quantity Limits, Dose & Site-of-Care Notes
Site‑of‑care and Part B administration — no explicit restrictions; follow Part B rules
Follow Part B administration rules for site of care — there are no explicit site‑of‑care restrictions in the policy; drugs may be administered in infusion center, hospital outpatient, or office settings as applicable and billing should follow Part B processes.
- No explicit site‑of‑care restrictions stated; administer per Part B rules.
- Use the Medicare Part B drug request form/Web Form to document place of administration for billing and Part B vs Part D determinations.
Biosimilar & Interchangeable Product Guidance
Biosimilar substitution and biosimilar-first step edits — trials of biosimilars/generics required where specified
Where the FDA has approved biosimilars, Priority Health expects providers to document trials of biosimilars or generics per product‑specific step edits (examples: Avtozma/Actemra biosimilars; Mvasi and Zirabev tried before Avastin; Avsola or Renflexis prior to Entyvio).
- Avtozma (tocilizumab biosimilar) and other tocilizumab biosimilars are supported as substitutes for Actemra per FDA guidance.
- Avastin (J9035) chemotherapy requires prior trials of Mvasi AND Zirabev before Avastin.
- Entyvio requires trial of Avsola OR Renflexis prior to approval.
Key Clinical Thresholds & Eligibility Values
Policy Revision History
Policy effective date set to 2026-07-01.
Policy last reviewed on 2026-07-01.
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