Prior authorization required for listed Part B drugs

Prior authorization (PA) is required for Medicare Part B drugs listed in this document; complete the appropriate Medicare Part B PA form (Non‑Oncology or Oncology) or Web Form and submit clinical documentation including dose, frequency, place of administration, and supporting medical records demonstrating prior therapies and responses.

• Use Medical Drug List (MDL) to verify Part B vs Part D determination.
• Provide dose, frequency, place of administration for billing.

Complete Medicare Part B drug request form

To streamline review providers must complete the Medicare Part B (Non‑Oncology) drug request form or Web Form (or the Oncology drug request form when applicable) when requesting coverage for Part B drugs; include completed form with required clinical documentation.

• Use Oncology form for chemotherapeutic J9035/J9171 requests when indicated.
• Complete Web Form to improve timeliness of review.

Adakveo prior authorization — hydroxyurea trial required

Adakveo (crizanlizumab) requires prior authorization; requests must document a trial of hydroxyurea for 6 months or an intolerance/contraindication to hydroxyurea. Coverage is authorized for up to 2 years.

• Provide medical records supporting trial of hydroxyurea or reason for not using hydroxyurea.
• Include dose and administration details per FDA labeling.

Adzynma prior authorization — genetic and ADAMTS13 result required

Adzynma (rADAMTS13) requires prior authorization with genetic testing confirming congenital TTP (cTTP) and documentation of ADAMTS13 activity <10% for initial approval; include current weight for dosing. Initial and reauthorization approvals are 12 months.

• Submit genetic testing confirming cTTP.
• Include ADAMTS13 activity value (<10%) and current weight for dosing.

Alhemo prior authorization and reauthorization documentation

Alhemo requires prior authorization for routine prophylaxis in hemophilia A or B; initial requests for hemophilia A must include documentation of Hemlibra failure; reauthorization requires documentation of clinical benefit (fewer bleeds or reduced use of replacement/bypassing agents).

• Provide medical records documenting prior Hemlibra trial and reason for failure (hemophilia A).
• For reauthorization, include evidence of clinical benefit (e.g., reduced bleeding events).

Submit appropriate PA form (Alyglo/Alymsys examples)

Providers should complete the Medicare Part B drug request form or Web Form for products such as Alyglo (Non‑Oncology) or Alymsys (Oncology) and submit supporting medical records documenting prior therapies and responses to streamline review.

• Use the Oncology Drug Request form for Alymsys (bevacizumab biosimilar) when applicable.
• Attach medical records showing prior therapies and responses.

PA required — include medical records and prior therapy documentation

Prior authorization via the Medicare Part B (Non‑Oncology) drug request form or Web Form is required for the Part B drugs in this document; include required medical records and prior therapy documentation with the request.

• Ensure Part B vs Part D determination is clear on the form.
• Attach prior therapy history and response documentation.

PA required — dose per FDA labeling for IVIG and infusions

For IVIG and other infusion products, prior authorization is required and dose will be approved per FDA labeling or accepted standards of medical practice; submit the Medicare Part B drug request form or Web Form with supporting records.

• Include indication, dosing, and administration site for billing.
• For IVIG Part B requests include documentation of prior IVIG trials when applicable.

Prior authorization required — grouped products

This group of Part B biologics requires prior authorization; complete the Medicare Part B drug request form or Web Form and submit documentation of prior therapies and treatment responses with the request.

• For biosimilar groups, include evidence of trials of required biosimilars/generics per product-specific step therapy rules.
• Ensure prescriber specialty is documented when required.

Prior authorization plus step therapy designation — complete PA form

These Part B drugs are designated as Priority Health Part B Step Therapy Drugs and require prior authorization; complete the Medicare Part B drug request form or Web Form and show evidence of required prior trials per product-specific rules.

• Follow the product-specific step therapy requirements (e.g., Avtozma/Actemra biosimilar trials).
• Attach documentation showing failure/intolerance of required prior agents.

Use correct PA form (Oncology vs Non‑Oncology)

Complete the appropriate Medicare Part B Oncology (Cancer Therapy) or Non‑Oncology drug request form or Web Form when requesting coverage to ensure all billing and clinical fields are provided; oncology drugs (e.g., J9035, J9171) should use the Oncology form when applicable.

• Provide HCPCS/HCPCS code (e.g., J9035 for Avastin, J9171 for docetaxel) and indication.
• Include prior therapy and response documentation.

PA required — include supporting records and evidence

Prior authorization is required for the listed Part B agents; requests must include supporting medical records and evidence of prior therapies and responses to treatment.

• Include diagnostic tests, lab values, and specialist consultation notes when relevant.
• Document prior treatments and their outcomes.

Prior authorization required — biosimilars and specialty agents

Prior authorization via the Medicare Part B drug request form or Web Form is required for Bomyntra, Boruzu, Bosaya, and Bkemv‑related requests; include medical records and documentation of prior therapy trials as specified.

• For Bkemv, include documentation of Epysqli/Vyvgart trials and baseline MG‑ADL when applicable.
• Provide prior therapy failure documentation per product.

Casgevy prior authorization — one lifetime dose, 6‑month auth

Casgevy requires completion of the Medicare Part B (Non‑Oncology) drug request form or Web Form and submission of supporting medical records; authorization is for 6 months and limited to a single lifetime treatment.

• Document genotype for SCD (βS/βS, βS/β0, or βS/β+), VOE history, current weight, and HSCT eligibility.
• For beta thalassemia, include transfusion history (≥100 mL/kg/year or ≥10 units/year) and donor availability assessment.

Cimzia prior authorization — step therapy and combination exclusion

Cimzia requires prior authorization via the Medicare Part B drug request form or Web Form with documentation that the patient tried and failed two listed alternative therapies and prescriber is a specialist or consulted one; do not combine with other biologics, Otezla, or JAK inhibitors.

• Submit documentation of trials/failures of two listed alternatives (e.g., preferred adalimumab, Rinvoq, Skyrizi).
• Do not submit requests supporting combination biologic/JAK/Otezla use.

Cinqair prior authorization — weight and eosinophil data required

Cinqair requires prior authorization; include the Medicare Part B drug request form or Web Form, medical records documenting prior controller therapy trials, current weight, and blood eosinophil counts meeting threshold criteria.

• Provide eosinophil count ≥150 cells/mcL at therapy start OR ≥300 cells/mcL in prior 12 months.
• Document trial/failure of ICS/LABA plus another controller within past 6 months.

Complete PA form and attach supporting records

Complete the Medicare Part B (Non‑Oncology) drug request form or Web Form for all Part B requests; fill required fields and attach supporting medical records to enable timely PA review.

• Ensure documentation of prior therapies, labs, and dosing is attached.
• Use Oncology form when the drug is a chemotherapy product.

Conexxence step therapy — document required prior trials

Conexxence (denosumab biosimilar) is subject to Part B step therapy; prior authorization must show trials of required agents before approval.

• Document trials of Jubbonti, Enoby, AND Bildyos as required before Conexxence.
• Include medical records and justification if step therapy cannot be met.

PA required — Cosentyx, Docivyx, Durysta examples

Prior authorization is required via the Medicare Part B (Non‑Oncology) drug request form or Web Form for Cosentyx, Docivyx, Durysta and similar agents; include supporting medical records and prior therapy documentation.

• For Cosentyx IV include prescriber specialty and prior biosimilar trial documentation.
• For Docivyx include trial of generic docetaxel (J9171).

PA required — Elevidys genetic and antibody prerequisites

Prior authorization is required and, for Elevidys, must document genetic confirmation of DMD that is not a deletion in exon 8 or exon 9 and an anti‑AAVrh74 titer <1:400 on the PA form or Web Form.

• Attach genetic testing confirming DMD without exon 8/9 deletions.
• Provide anti‑AAVrh74 total binding antibody titer (<1:400).

Complete PA form for Enjaymo/Entyvio — attach labs

Complete the Medicare Part B (Non‑Oncology) drug request form or Web Form to streamline review for Enjaymo, Entyvio, and other Part B agents; attach required clinical documentation and labs.

• Use the Web Form and include clinical labs (e.g., baseline hemoglobin for Enjaymo).
• Provide prior therapy history and specialist consult notes as required.

Enjaymo PA — CAD diagnosis, transfusion, rituximab trial required

Enjaymo prior authorization requires documentation of confirmed cold agglutinin disease (CAD), at least one blood transfusion within 6 months prior to initiation, a documented trial and failure of a rituximab‑containing regimen, presence of CAD‑related symptoms, age ≥18, and that the prescriber is or consulted a hematologist.

• Provide transfusion record within prior 6 months.
• Attach documentation of rituximab‑containing regimen trial and failure and baseline hemoglobin.

Entyvio step therapy — Avsola or Renflexis trial required

Entyvio requires prior trial of Avsola OR Renflexis before approval (Part B step therapy); the prescriber must be a specialist or have consulted with one and documentation of prior trial must be included with the PA request.

• Document trial and failure/intolerance of Avsola OR Renflexis.
• Include specialist consultation note from gastroenterology when applicable.

Step therapy — Actemra IV requires trial of Tyenne first

Priority Health applies Part B step therapy per CMS guidance; Actemra IV is a Part B step therapy drug and requires trial of the preferred agent Tyenne before approval.

• Document trial and failure or intolerance of Tyenne.
• Attach medical records demonstrating trial period and outcome.

Adakveo step therapy — hydroxyurea trial required

Adakveo step therapy: prior authorization will require documentation that the member tried hydroxyurea for 6 months or has an intolerance/contraindication to hydroxyurea prior to approval of Adakveo.

• Provide clinical notes showing 6 months of hydroxyurea use or documentation of intolerance/contraindication.
• If hydroxyurea was not tried, include rationale and supporting records.

Alyglo Part B step therapy — try two preferred IVIGs first

For Alyglo determined to be a Part B benefit, the patient must first try two preferred IVIG products (examples: Gammagard Liquid, Gamunex‑C, Privigen) before Alyglo will be approved.

• Document trials of two preferred IVIG products and outcomes.
• Attach IVIG administration records and response documentation.

Alymsys step therapy — Mvasi and Zirabev required first

Alymsys (bevacizumab‑maly) requires trying Mvasi AND Zirabev prior to approval; include documentation of those biosimilar trials with the PA request.

• Provide records showing trials of Mvasi and Zirabev and treatment outcomes.
• If trials cannot be completed, include justification.

General Part B step therapy policy — document trials/failures

Priority Health applies Part B step therapy consistent with CMS guidance to certain drugs/biologics; when step therapy applies, providers must document trials and failures (or intolerance) of required preferred or biosimilar agents on the PA form.

• Attach documentation of trial duration and clinical response for required agents.
• For exceptions, submit supporting medical evidence with the PA request.

Part B step therapy status — Amvuttra not subject to ST

This policy notes that Amvuttra is not subject to Part B step therapy per Priority Health; however providers must still submit required medical records and meet other coverage criteria.

• Provide required diagnostic documentation per Amvuttra criteria.
• Ensure exclusions (primary amyloidosis; combination with TTR stabilizers) are considered.

Step therapy examples — IVIG, Aukelso, Avastin

Step therapy applies to products such as Asceniv (IVIG) — for Part B determinations the patient must first try two preferred IVIGs; Aukelso requires trials of Wyost, Xtrenbo, and Bilprevda; Avastin (J9035) requires Mvasi and Zirabev first.

• Document prior use of the specified preferred products before PA submission.
• Refer to LCD L34771 or L37205 as applicable.

Step therapy/diagnostic requirements — Aveed and testosterone products

For Aveed and other testosterone products, prior authorization requires trials of generic injectable testosterone and a generic topical testosterone and two pre‑treatment morning serum total testosterone measurements <300 ng/dL on separate days; include these data on the PA form.

• Attach records of trials of generic testosterone cypionate/enanthate and topical testosterone.
• Provide two morning serum total testosterone values <300 ng/dL on separate days and clinical signs/symptoms.

Beizray step therapy — try generic docetaxel (J9171) first

Beizray and Beizray kit require trial of generic docetaxel (Taxotere, HCPCS J9171) before approval; include documentation of the generic docetaxel trial with the PA request.

• Provide administration records for generic docetaxel (J9171) and treatment response.
• If generic trial not feasible, submit justification and supporting evidence.

IVIG Part B step therapy — try two preferred IVIGs first

For IVIG Part B determinations (e.g., Bivigam, Asceniv), prior authorization requires documentation that the patient tried two preferred IVIG products before approval; include those trial records on the PA form.

• List the two preferred IVIG products tried and dates administered.
• Provide clinical response and reason for switching to the requested IVIG.

Step therapy — oncology and complement/biosimilar products

Step therapy applies to several oncology and specialty agents (e.g., Bomyntra, Bosaya, Boruzu, Bkemv) — providers must document required prior trials (examples: Wyost/Xtrenbo/Bilprevda; generic bortezomib J9049 or J9041; Epysqli/Vyvgart for Bkemv) with the PA request.

• For Bkemv include baseline MG‑ADL and documentation of Epysqli and Vyvgart trials/failures.
• For Boruzu include trial of a generic bortezomib injectable (J9049 or J9041).

Cimzia step therapy — two alternative agents required

Cimzia step therapy: prior authorization must document failure of two listed alternative therapies (preferred adalimumab product, Rinvoq, Skyrizi, Tyenne, Cosentyx, Otezla, Xeljanz, Yesintek/Selarsdi, or Enbrel) before approval unless contraindicated or not tolerated.

• Attach records showing trials and reason for discontinuation/intolerance.
• Include specialist consultation notes.

Cinqair step therapy — controller trial and eosinophil threshold

Cinqair requires prior trial and failure of 1 ICS/LABA plus one other asthma controller in the past 6 months before approval; include documentation of that trial and the eosinophil counts on the PA request.

• Document controller medications tried (dates/doses) and outcome after ≥4 weeks.
• Provide eosinophil counts meeting ≥150 cells/mcL at start OR ≥300 cells/mcL in prior 12 months.

Cosentyx IV step therapy and combination exclusion

Cosentyx IV requires prior trial of Avsola, Renflexis OR Simponi Aria before approval; do not use Cosentyx in combination with other biologic drugs, Otezla, or JAK inhibitors — include prior biosimilar trial documentation and prescriber specialty on the PA form.

• Attach records of trial of Avsola OR Renflexis OR Simponi Aria and failure/intolerance documentation.
• Provide specialist consultation note per prescriber restriction.

Enjaymo/Entyvio — Part B step therapy designation and trials

Priority Health Part B Step Therapy Drugs include Enjaymo and Entyvio; Enjaymo is designated a Part B step therapy drug and Entyvio requires prior trial of Avsola OR Renflexis before approval.

• For Enjaymo, include transfusion and rituximab trial documentation.
• For Entyvio, include documentation of Avsola or Renflexis trial.

Required submission documents — complete PA form and provide clinical records

Providers must submit required documents with PA requests: the Medicare Part B (Non‑Oncology) drug request form or Web Form, dose/frequency/place of administration, and supporting medical records documenting diagnoses, prior therapies, and responses.

• Include lab values, imaging, genetic test results, and specialist notes as applicable.
• Ensure billing fields are completed to avoid processing delays.

Required medical records — include diagnosis, prior therapies, weight

Medical records supporting PA requests must be provided for initial and reauthorization requests; include diagnosis confirmation, prior therapies and responses, current weight (for dosing), and any required diagnostic testing.

• For drug‑specific requirements include genetic tests (Adzynma), transfusion history (Enjaymo), or antibody titers (Elevidys).
• Attach documentation of prior therapy failures or intolerances.

Attach prior therapy response documentation with PA

For many products providers must include documentation of prior therapies and responses with the PA request; this includes trials of specific generics/biosimilars where step therapy applies.

• Examples: Mvasi and Zirabev trials before Alymsys; two preferred IVIGs before Alyglo.
• If prior trials not performed, include medical justification and supporting evidence.

Alhemo reauthorization — require documentation of clinical benefit

For Alhemo reauthorization, providers must submit documentation demonstrating clinical benefit (e.g., fewer bleeding episodes or reduced use of factor replacement or bypassing agents) to support continued coverage.

• Provide bleed frequency data and replacement therapy utilization pre‑ and post‑Alhemo.
• Include hematology specialist notes supporting continued use.

Initial hATTR‑PN documentation required

Initial hATTR‑PN requests must include medical records confirming a pathogenic TTR mutation, baseline PND score ≤ IIIb, and clinical signs/symptoms of polyneuropathy; include these documents on the PA form.

• Attach genetic testing showing pathogenic TTR mutation.
• Provide baseline PND score and clinical exam notes describing neuropathy.

Initial ATTR‑CM documentation and tafamidis trial required

Initial ATTR‑CM requests must include NYHA class I–III heart failure documentation, ECHO or CMR evidence of increased LV wall thickness, confirmatory diagnostic testing (biopsy, genetic testing, or radionuclide imaging), and if radionuclide imaging used include Grade 2 or 3 uptake; also document prior trial and failure of tafamidis.

• Attach ECHO/CMR reports, biopsy or genetic results, and radionuclide imaging reports if used.
• Provide documentation of tafamidis trial and reason for failure.

Reauthorization documentation — show clinical benefit vs baseline

For reauthorization of hATTR‑PN and ATTR‑CM, submit documentation demonstrating positive clinical response compared to baseline (e.g., improved neuropathy symptoms, motor function, QoL, or reduced CV hospitalizations); reauthorization duration is 1 year.

• Compare baseline and current clinical measures (PND, functional tests, hospitalizations).
• Include specialist notes documenting improvement.

Submit the Medicare Part B drug request form with documentation

To streamline review, complete the Medicare Part B (Non‑Oncology) drug request form or Web Form and include the submission form with the clinical documentation.

• Completing the form helps ensure required billing and clinical fields are provided.
• Attach the form to all supporting medical records.

Aveed/Azmiro required information — testosterone trials and labs

Required medical information for hypogonadism (Aveed/Azmiro) includes trials of specified generic testosterone products, two pre‑treatment morning serum total testosterone values on separate days <300 ng/dL, and clinical signs/symptoms consistent with testosterone deficiency; include these on the PA request.

• Provide dates and outcomes of trials of generic injectable and topical testosterone.
• Attach two morning testosterone lab results and clinical notes describing symptoms.

Benlysta — attach disease‑specific diagnostics and prior therapy data

Providers must attach medical records and disease‑specific documentation (e.g., SELENA‑SLEDAI, anti‑dsDNA, ANA titer, kidney biopsy for lupus nephritis) when requesting Benlysta; include these diagnostic results on the PA form.

• For SLE include SELENA‑SLEDAI ≥6 and antibody evidence (anti‑dsDNA >30 IU/ml or ANA >1:80) and documentation of prior standard‑of‑care therapies for ≥12 weeks.
• For lupus nephritis attach kidney biopsy showing class 3, 4, and/or 5 disease and eGFR data.

Bkemv documentation — prior trials and reauth improvement required

For Bkemv requests, include medical records documenting prior therapies and, for reauthorization, objective evidence of clinical improvement (e.g., improvement in MG‑ADL for myasthenia gravis); do not use Bkemv in combination with similar MG therapies.

• Provide baseline MG‑ADL and follow‑up MG‑ADL demonstrating improvement for reauthorization.
• Attach documentation of prior Epysqli and Vyvgart/Vyvgart Hytrulo trials and outcomes.

Casgevy required medical records — genotype, weight, HSCT eligibility

Required Medical Records for Casgevy: submit diagnosis confirmation, prior therapies, organ function status, current weight, and HSCT eligibility assessment; Casgevy is not covered for patients with prior HSCT or prior gene therapy.

• Attach genetic confirmation of SCD genotype or transfusion history for beta thalassemia.
• Provide HSCT eligibility attestation and organ function labs.

Cinqair required records — weight, eosinophils, prior controller trial

For Cinqair, provide medical records documenting prior controller therapy trials and responses, current weight, and blood eosinophil counts meeting thresholds; for reauthorization include documentation of clinical benefit (fewer exacerbations, reduced steroid use).

• Attach eosinophil counts (≥150 cells/mcL at start OR ≥300 in prior 12 months).
• Provide documentation of prior ICS/LABA plus another controller trial and outcome.

Reauthorization documentation — demonstrate clinical benefit vs baseline

For reauthorization requests generally, providers must submit documentation of clinical benefit compared to baseline (e.g., decreased exacerbations, improved function, reduced hospitalizations) to support continued coverage.

• Compare baseline and on‑therapy measures relevant to the indication.
• Include objective measures where available (lab tests, hospitalizations, functional scores).

Cosentyx IV — prescriber restriction and prior biosimilar trial required

Cosentyx IV prescriber must be a specialist or have consulted a specialist; include the specialist’s documentation and prior biosimilar trial evidence (Avsola, Renflexis, or Simponi Aria) on the PA form and do not combine Cosentyx with other biologics, Otezla, or JAK inhibitors.

• Attach specialist consultation note.
• Provide records of prior Avsola/ Renflexis/ Simponi Aria trial and failure/intolerance.

Elevidys coverage prerequisites — genetic test and anti‑AAVrh74 titer

Documentation for Elevidys must include genetic confirmation of DMD that is not a deletion in exon 8 or exon 9 and an anti‑AAVrh74 titer <1:400; include these results with the PA request to avoid denial.

• Attach genetic testing report confirming DMD and absence of exon 8/9 deletions.
• Include anti‑AAVrh74 total binding antibody titer (<1:400) result.

Enjaymo reauthorization and initial lab/weight requirements

Enjaymo reauthorization requires documentation of clinical benefit (increase in hemoglobin and decrease in transfusions compared to baseline); initial PA must include current weight and baseline hemoglobin.

• Provide transfusion history and Hgb trends pre‑ and post‑therapy.
• Attach baseline labs and weight for dosing.

Submission form — include dose, frequency, place of administration

Complete the Medicare Part B (Non‑Oncology) drug request form or Web Form and include required submission documents (dose, frequency, place of administration) with the PA to streamline review and reduce denial risk.

• Ensure required billing fields are completed and clinical documents attached.
• Use the Web Form when available to expedite processing.

Denial risk — unsupported exceptions or missing documentation

Requests that do not meet coverage criteria or lack supporting medical records or medical literature evidence risk denial; submit complete documentation or an exception rationale with supporting evidence to avoid denial.

• If requesting an exception include peer‑reviewed literature or specialist rationale.
• Incomplete documentation commonly triggers denial.

Adakveo denial risk — lack of hydroxyurea trial

Failure to document a 6‑month trial of hydroxyurea (or an intolerance/contraindication) will likely result in denial for Adakveo requests.

• Include clinical notes documenting hydroxyurea use and response for 6 months or rationale for not using it.

Adzynma denial risk — missing genetic/ADAMTS13 data

For Adzynma, absence of genetic testing confirming cTTP or ADAMTS13 activity <10% may result in denial; include the genetic test report and ADAMTS13 activity result with the PA.

• Attach genetic testing confirming cTTP.
• Provide ADAMTS13 activity value (<10%).

Alhemo denial risks — prior Hemlibra and reauth benefit documentation

For Alhemo initial requests in hemophilia A, lack of documentation that the patient tried and failed Hemlibra may lead to denial; for reauthorization, absence of documented clinical benefit may trigger denial.

• Provide Hemlibra trial records or justification for not using Hemlibra.
• For reauth include bleed reduction or reduced factor use evidence.

Alyglo denial risk — missing two preferred IVIG trials

Failure to try two preferred IVIG products for Part B‑determined Alyglo requests may trigger denial; include records of the two preferred IVIG trials when submitting the PA.

• List products and dates of prior IVIG trials (e.g., Gammagard Liquid, Gamunex‑C).
• Document response or intolerance to those products.

Alymsys denial risk — missing Mvasi and Zirabev trials

For Alymsys, failure to document trials of Mvasi AND Zirabev prior to requesting Alymsys may lead to denial; include these biosimilar trial records with the PA.

• Attach administration records for Mvasi and Zirabev and clinical response documentation.
• If unavailable, include justification and evidence supporting exception.

Amvuttra exclusion — primary amyloidosis not approved

Use of Amvuttra in patients with primary (light‑chain) amyloidosis will not be approved; requesting Amvuttra for primary amyloidosis risks denial.

• Confirm diagnosis is hereditary or wild‑type ATTR (not primary light‑chain amyloidosis).
• Do not submit requests for primary amyloidosis.

Amvuttra denial risk — combination therapy with TTR agents

Requests for Amvuttra that seek combined use with TTR stabilizers (e.g., tafamidis) or TTR‑lowering agents (e.g., Onpattro) may be denied; do not request combination therapy without strong supporting evidence.

• Document prior tafamidis trial and reason for failure when requesting Amvuttra as monotherapy.
• Avoid combination therapy requests unless supported by peer‑reviewed evidence.

Documentation deficiency — common denial trigger

Lack of medical records supporting the request — including prior therapies and responses — is a common denial trigger; always attach complete clinical documentation to the PA form.

• Include diagnostic test results, specialist notes, and treatment timelines.
• Incomplete submissions will delay or result in denial.

Aveed denial triggers — missing testosterone trials or labs

For Aveed (testosterone) denial triggers: failure to document trials of generic injectable and topical testosterone, absence of two pre‑treatment morning total testosterone values <300 ng/dL on separate days, or lack of required clinical signs/symptoms may lead to denial.

• Attach records of trials of injectable and topical generic testosterone and two morning testosterone labs.
• Document clinical signs/symptoms consistent with testosterone deficiency beyond erectile dysfunction/decreased libido.

Avgemsi denial trigger — missing generic gemcitabine trial

For Avgemsi/Avgemsi, lack of documentation showing a prior trial of generic gemcitabine injection may result in denial; include those records with the PA.

• Provide generic gemcitabine administration records and outcomes.
• If generic not used, include rationale and supporting documentation.

Avopef denial trigger — missing generic etoposide trial

For Avopef, failure to document prior therapy and response (including trial of generic etoposide) may result in denial; attach those trial records to the PA.

• Include dates, doses, and response to generic etoposide.
• Provide justification if generic trial not possible.

Avtozma combination exclusion — do not combine with biologics/Otezla/JAKis

For Avtozma, use in combination with other biologic drugs, Otezla, or JAK inhibitors is an exclusion and may trigger denial; ensure PA requests do not propose concurrent use of these agents.

• Do not request approval for Avtozma in combination with other biologics, Otezla, or JAKis.
• If combination is clinically necessary, submit peer‑reviewed evidence and rationale for exception.

Establish Part B vs Part D determination for infusion center billing

Determine Part B vs Part D benefit for infusion center claims and document the benefit decision on the PA form; Part B vs Part D determinations affect site‑of‑care billing and payment.

Infusion dosing must follow FDA labeling or accepted standards

Doses for infusion center administration will be approved according to FDA‑approved labeling or accepted standards of medical practice; include dosing details on the PA form.

Document Part B benefit determination for infusion claims

Make a Part B benefit determination (Part B vs Part D) for each infusion request; document this determination and include it with the PA submission to ensure correct benefit and payment processing.

Site of care and administration setting must be specified

Administration settings (infusion center, office, hospital outpatient) are subject to Part B coverage rules; include place of administration on the PA form and follow FDA labeling or accepted standards for dosing and administration.

Part B infusion products: site‑of‑care determination required

For Part B infusion products (e.g., IVIG, Bkemv), site‑of‑care determinations (Part B vs Part D) are required and may affect management and payment; document site and benefit decision on the PA form.

Actemra/biosimilar support — FDA‑determined biosimilars supported

FDA‑determined biosimilars are supported for use and may be used in place of the reference biologic when indicated; reference the policy's biosimilar guidance when selecting products.

Avastin: must try Mvasi and Zirabev first (J9035)

Avastin biosimilars (Mvasi, Zirabev) must be tried before alternative bevacizumab products; document trials of Mvasi and Zirabev prior to requesting Avastin (J9035) per policy.

Aukelso biosimilar: interchangeable; required prior trials per policy

Aukelso (denosumab biosimilar to Xgeva) is FDA‑approved for the reference product indications and provisionally interchangeable; policy requires trials of specified alternatives before Aukelso.

Avastin biosimilar trial requirement (Mvasi/Zirabev)

Avastin biosimilars Mvasi and Zirabev are preferred biosimilars and must be tried before Avastin (J9035) per step therapy; document prior biosimilar trials on the PA form.

Actemra/Avtozma biosimilar: Avsola/Renflexis trial required

Actemra/Avtozma biosimilar guidance: Avtozma is FDA‑determined highly similar to Actemra; covered for medically accepted indications but step therapy requires trial of Avsola OR Renflexis for most indications.

Avtozma biosimilar — step therapy and documentation note

Avtozma (tocilizumab‑anoh) is covered as a biosimilar to Actemra; follow the policy's step therapy requirement (Avsola or Renflexis trial) and document prior biosimilar trials on the PA.

Bkemv interchangeability with Soliris — document and follow safety guidance

Bkemv is FDA‑designated interchangeable with Soliris (eculizumab) and may be used in place of the reference product; document interchangeability and follow related safety guidance (boxed warning for meningococcal infection).

Bkemv: interchangeable biosimilar — include safety/risk mitigation documentation

Bkemv interchangeability and biosimilar designation is noted in policy; ensure required vaccination/risk mitigation and supporting documentation are included with PA requests.

Bomyntra biosimilar to Xgeva — trial requirements apply

Bomyntra is a biosimilar to Xgeva and is provisionally determined interchangeable; follow the policy's step therapy requirements and document prior biosimilar trials.

Bosaya biosimilar to Prolia — follow prior trial requirements

Bosaya is a biosimilar to Prolia and is provisionally determined interchangeable; document required prior trials per policy before requesting the reference or biosimilar product.

Conexxence biosimilar: interchangeable — document prior trials

Conexxence (Prolia biosimilar) is FDA‑approved for the reference product indications and provisionally interchangeable; follow the policy's step therapy and trial requirements and document prior agent trials on the PA form.

Entyvio: document Avsola or Renflexis trial before Entyvio PA

Entyvio requires a prior trial of Avsola OR Renflexis per Part B step therapy; document the prior biosimilar trial when submitting the PA request for Entyvio.