Prior authorization required for select Part B drugs

Submit a prior authorization (PA) request via the HAP Provider Portal for select Medicare Part B drugs and include supporting medical records to determine coverage under the medical benefit.

• PA may be required to determine whether the drug is covered under Medicare Part B or Part D.
• Include supporting medical records documenting diagnosis, prior therapies, and responses as specified by the drug-specific criteria.

Prior authorization required for J0225

Prior authorization is required for Amvuttra (vutrisiran) billed with J0225; requests must include the listed required medical information for the indication.

• J0225 (Amvuttra) is effective 1/1/2026 for PA requirements.
• Provide the specific required medical information enumerated in the Amvuttra criteria.

Prior authorization required

Prior authorization is required for Amvuttra (vutrisiran J0225) and must meet the medical information criteria for the indicated transthyretin amyloidosis conditions.

• PA applies to J0225 for transthyretin-related indications.
• Coverage requires submission of required documentation as specified in the policy.

Prior authorization for Amvuttra (J0225)

Prior authorization applies for Amvuttra (vutrisiran J0225) injection; include documentation supporting diagnosis and eligibility as specified (effective 1/1/2026).

• Provide medical records and required diagnostic documentation per the Amvuttra criteria.
• Policy effective date for these requirements is 1/1/2026.

Prior authorization required

Prior authorization is required for Amvuttra (J0225); coverage requires confirmation of diagnosis, and for cardiomyopathy the patient must have tried and failed Attruby per the criteria.

• Coverage duration and dosing are approved per FDA labeling or accepted standards.
• Patient must have documentation of prior trial and failure of Attruby for cardiomyopathy indication.

Docetaxel (J9171) prior authorization and step

Docetaxel requires prior authorization and a step: providers must first try the covered docetaxel drug identified by J9171 before coverage of alternative docetaxel products; coverage duration is up to 1 year.

• Must first try the covered docetaxel drug identified by J9171.
• Dose and duration approved per FDA labeling; typical coverage duration up to 1 year.

Epysqli (eculizumab-aagh) PA criteria

Epysqli (eculizumab-aagh) prior authorization must meet indication‑specific criteria (NMOSD, MG, aHUS, PNH) including required diagnostic tests, prior therapy trials, and reauthorization documentation of response.

• NMOSD: AQP4-antibody positive, failure of Uplizna and Enspryng, EDSS ≤7, and prohibition on combination with other NMOSD agents.
• MG: baseline MG-ADL ≥6, AChR-Ab positive, trial of a non-steroid immunosuppressant ≥6 months; reauthorization requires documented improvement.
• aHUS and PNH: diagnostic confirmations and reauthorization evidence as specified; avoid combination with other complement therapies.

Fulphila step therapy

Fulphila requires step therapy: prior trials of Neulasta, Udenyca, AND Nyvepria must be documented before approval; coverage duration up to 1 year.

• Provide medical records documenting trials and responses to preferred pegfilgrastim products.
• Duration and dosing will follow FDA labeling or accepted standards.

Herceptin biosimilar step requirements

Herceptin and related trastuzumab products require prior trials of the listed biosimilars (Trazimera AND Kanjinti) before coverage; include medical records documenting prior therapies and responses.

• Provide documentation that trials of Trazimera and Kanjinti were attempted and failed.
• Coverage duration typically up to 1 year; dosing per FDA labeling.

Trastuzumab biosimilars PA/ST

Prior authorization and step therapy apply to listed trastuzumab biosimilars and reference products; must try specified biosimilars (Trazimera AND Kanjinti) before coverage of Hercessi or Herzuma.

• Document trials and failures of the specified biosimilars in the medical records.
• Dosing and duration follow FDA labeling or accepted standards (typically 1 year).

Marstacimab (Hympavzi) PA/ST

Marstacimab (Hympavzi J7172) requires prior authorization; submit medical records documenting diagnosis, prior prophylaxis trials, and prescriber must be a hematologist; initial loading and maintenance dosing must be documented.

• Member must have documented hemophilia A without inhibitors or hemophilia B as applicable.
• For hemophilia A: trial of two prophylaxis drugs including Hemlibra; for hemophilia B: trial of two prophylaxis drugs such as Alprolix, BeneFIX, or Idelvion.
• Initial loading dose 300 mg (two 150 mg injections) and maintenance 150 mg weekly; dose escalation to 300 mg weekly requires documentation of medical necessity.

iDose TR (J7355) PA/ST

iDose TR (travoprost intracameral implant J7355) requires prior authorization and step therapy; requests must document diagnosis of open‑angle glaucoma or ocular hypertension and appropriate prior topical/Durysta trials per criteria.

• Provide medical records showing diagnosis and details of prior topical prostaglandin trials and Durysta use or contraindication.
• The requested eye must not have previously received IDOSE TR (prior same-device treatment is an exclusion).
• Approval is for one-time administration per FDA labeling when criteria are met.

PA/ST = Required Medical Information

PA/step therapy requests for iDose TR must include the required medical information: medical records supporting the request, diagnosis of open‑angle glaucoma or ocular hypertension, and documentation of required prior trials.

• Medical records must document prior use and failure (inadequate response, intolerance, or compliance issues) of specified topical prostaglandin drops and Durysta as applicable.
• If Durysta cannot be used, document trials and failures of two generic topical prostaglandin eye drops.

PA required for iDose TR (J7355)

Prior authorization is required for iDose TR (J7355); medical records must document open‑angle glaucoma or ocular hypertension and prior topical prostaglandin therapy trials per the policy criteria.

• Include documentation of the specific topical PGA trials and Durysta use or inability to use Durysta.
• Define and document reasons for 'failed' trials (inadequate response, intolerance, or compliance issues).

Prior authorization requirement

Prior authorization is required for iDose TR (J7355); submit medical records supporting the request and ensure the criteria below are met before coverage is considered.

• Medical records must document diagnosis, prior therapy trials and failures, and reasons for failure.
• Age restrictions are listed as N/A but required documentation remains mandatory.

Prior authorization required

Prior authorization is required for iDose TR (J7355) when the patient has open‑angle glaucoma or ocular hypertension and meets the specified prior therapy requirements; include supporting medical records.

• Provide documentation that the patient tried and failed one generic PGA plus Durysta, or is unable to use Durysta and tried and failed two generic PGAs.
• Define failure per policy (inadequate response, intolerance, or demonstrated compliance issues).

PA/ST required for iDose TR (J7355)

Prior authorization and step therapy apply for iDose TR (HCPCS J7355); ensure required medical information and prior therapy documentation are submitted with the PA request.

• PA/ST applies to J7355; include medical records documenting diagnosis and prior trials.
• Follow the alternate pathways (Durysta pathway or two-PGA pathway) as applicable.

PA required for iDose TR J7355

Prior authorization is required for iDose TR (travoprost intracameral implant J7355); submit medical records showing diagnosis of open‑angle glaucoma or ocular hypertension and prior topical prostaglandin trial documentation.

• Document failure reasons (inadequate response, intolerance, or compliance issues) for each prior trial.
• PA is required for one-time administration per FDA labeling when criteria are met.

PA required for J7355 (iDose TR)

Prior authorization is required for iDose TR (J7355) as a one-time administration per FDA-approved labeling; approval requires meeting the stated prior‑therapy criteria and providing supporting medical records.

• One-time administration coverage per FDA labeling contingent on meeting prior therapy pathways.
• Medical records must demonstrate prior topical PGA trials and Durysta use or inability to use Durysta.

PA required — iDose TR J7355

Prior authorization is required for iDose TR (HCPCS J7355); submit the required documentation demonstrating diagnosis and prior therapy failure per policy before implant will be approved.

• Include records of prior trial(s) of generic prostaglandin eye drops and Durysta pathway details where applicable.
• Confirm the requested eye has not previously received IDOSE TR.

Step therapy requirement

Step therapy requires that providers document trials and failures of preferred or more cost‑effective drugs before prescribing non‑preferred agents; failure must be shown in medical records (inadequate response or intolerance).

• Step Therapy applies to MAPD members not currently receiving the Part B drug.
• Document inadequate response or intolerance in the medical record when requesting escalation.

Referenced numbered clinical criteria

Refer to the policy's numbered clinical criteria (1–4) when preparing PA requests; for transthyretin-related indications this includes documentation of a TTR mutation (e.g., V30M) and baseline PND/FAP staging.

• Include genetic documentation of a pathogenic TTR mutation where required.
• Provide baseline PND score (≤ IIIb) and/or FAP Stage 1 or 2 as applicable.

Step therapy — try Attruby first

For Amvuttra in transthyretin amyloid cardiomyopathy, the patient must first try and fail Attruby before Amvuttra (J0225) will be covered; document prior trial and failure in the medical records.

• Document trial of Attruby and evidence of inadequate response or intolerance.
• Include confirmation of diagnosis and other required Amvuttra medical information.

Evenity step therapy

Evenity requires prior trial and failure of Prolia before coverage; document failure (intolerance, decreased BMD vs prior DEXA, new fracture while on therapy, or contraindication) and include that an endocrinologist prescribed or was consulted.

• Evenity coverage is limited to 12 months per lifetime.
• Prescriber must be an endocrinologist.

Intravitreal agent step therapy

Intravitreal agents require step therapy: providers must document a trial of Avastin (bevacizumab) before aflibercept/Eylea family products and follow Eylea HD failure definitions where applicable.

• Document trial and failure of Avastin in the medical records.
• For Eylea HD, adhere to dose/failure criteria (e.g., maintenance dosing tried before deeming failure).

Exdensur step therapy

Exdensur requires prior controller therapy trials and an eosinophil count ≥150; include specialist prescribing/consultation documentation (allergist, immunologist, or pulmonologist) and prior therapy records.

• Document elevated eosinophils (≥150) and prior controller therapy trials or hospitalization history as applicable.
• Prescriber must be or consult an allergist, immunologist, or pulmonologist.

Biosimilar step therapy requirement

Biosimilar step therapy: for listed trastuzumab biosimilars, providers must document trials of the specified biosimilars (Trazimera AND Kanjinti) before requesting Hercessi or Herzuma.

• Medical records must show trials and reasons for failure of the biosimilars.
• Coverage duration typically 1 year; dosing per FDA labeling.

Step therapy requirement (topical prostaglandin)

For iDose TR, patient must have tried and failed topical prostaglandin therapy as specified: either one generic PGA plus Durysta, or if Durysta cannot be used, two generic PGAs; document trials and reasons for failure.

• Define 'failed' trials in the record (inadequate response, intolerance, or compliance issues).
• Include specifics of topical agents tried (e.g., latanoprost, bimatoprost, travoprost) and Durysta details.

Required prior topical therapy

Patients must try one generic prostaglandin eye drop and Durysta, or if Durysta is not usable, two generic prostaglandin eye drops, and document failure per policy before iDose TR will be approved.

• Provide medical records showing prior topical PGA trials and Durysta trial or documented inability to use Durysta.
• Failure is defined as inadequate response, intolerance, or demonstrated compliance issues.

Step therapy

Step therapy requires prior trials of generic topical prostaglandin eye drops as outlined in the coverage criteria; document the trials, outcomes, and reasons for failure in the medical records.

• List specific generic PGAs tried and dates/durations.
• Document reasons for failure (inadequate response, intolerance, or compliance issues).

Step therapy pathway for iDose TR

Step therapy requires documented prior use of generic topical prostaglandin(s) and, depending on Durysta availability, either one failed PGA plus Durysta or two failed PGAs if Durysta cannot be used.

• Document inability to use Durysta when claiming the two‑PGA pathway.
• Provide clinical justification and supporting records for each failed trial.

Step therapy pathway

Step therapy requires trial and failure of specified generic topical prostaglandin eye drops (latanoprost, bimatoprost, or travoprost) and, depending on pathway, Durysta; document trials and outcomes in the medical record.

• Ensure records include dates, dosages, and documented reason the trial is considered failed.
• Attach Durysta trial documentation or documented contraindication/inability to use Durysta if applicable.

Required supporting medical records

Provide medical records supporting the PA request for all drugs requiring documentation; include prior therapy trials, diagnostic test results, specialist consultations, and objective measures as specified by the drug criteria.

• Include prior therapies and responses, genetic testing (e.g., TTR mutation V30M) when required, baseline scores (PND, MG-ADL, EDSS) where applicable.
• For specialist-restricted drugs, include consultation notes or prescriber specialty documentation.

Required medical information (TTR conditions)

For Amvuttra and other transthyretin-targeted therapies, include documentation of a pathogenic TTR mutation (example V30M), baseline PND score ≤ IIIb and/or FAP Stage 1 or 2, and clinical signs/symptoms in the PA submission.

• Attach genetic testing results showing the TTR mutation.
• Provide baseline neurologic assessments (PND score) and clinical notes describing motor/autonomic neuropathy symptoms.

Diagnosis confirmation

Confirm and document the diagnosis with appropriate testing for transthyretin amyloid cardiomyopathy (wild-type or hereditary) when submitting PA for Amvuttra; include diagnostic test results in the medical records.

• Include imaging, biopsy, or other confirmatory testing results as applicable.
• Document that the patient is ≥18 years of age when applicable.

Age documentation

Document the patient’s age in the PA request; for transthyretin‑related indications the patient must be at least 18 years of age.

• Include date of birth and age in the medical record extract submitted with the PA.
• Age requirement: ≥18 years for the specified Amvuttra indications.

Required documentation

Provide required medical records documenting diagnosis confirmation, prior therapies, baseline assessments, and clinical signs/symptoms as specified in the drug criteria when submitting a PA.

• For TTR therapies: TTR mutation, baseline PND/FAP staging, clinical symptoms.
• For iDose TR: prior topical PGA trials, Durysta trial or inability to use Durysta, and evidence the requested eye has not received prior IDOSE TR.

Required clinical documentation

Provide clinical documentation that confirms diagnosis and, where applicable, genetic testing and baseline disability measures (e.g., PND score ≤ IIIb, FAP Stage 1–2) for transthyretin-related indications.

• Attach genetic test reports and baseline neurologic assessments.
• Document clinical signs such as motor disability or autonomic neuropathy.

Required medical information (prior therapies)

Medical records supporting the PA request must include prior therapies and documented responses to treatment for drugs with step‑therapy or prior‑therapy requirements.

• Include dates, dosages, duration, and the clinical rationale for failure or intolerance.
• For biosimilar sequencing, document trials of the specified biosimilars.

Required medical records and prior therapy documentation

Include documentation of prior therapies and responses when requesting PA for agents with prior‑therapy requirements; this includes specialist consultation notes where required.

• For Epysqli and similar agents, include neurologist consultation notes and prior biologic therapy history.
• Document objective measures of response for reauthorization (e.g., decreased relapse rate, improved MG‑ADL).

Evkeeza LDL-C documentation

For Evkeeza (evinacumab J1305), submit the most recent LDL‑C level with the PA request and document specialist prescriber or consultation (cardiologist, endocrinologist, or lipidologist).

• Include the latest LDL‑C laboratory result in the medical record submission.
• Document that the prescriber is, or consulted with, an appropriate specialist.

Required medical records (hemophilia/marstacimab)

Provide medical records supporting requests for hemophilia prophylaxis agents and marstacimab, including hemophilia diagnosis documentation and prior prophylaxis trials; prescriptions must be written by a hematologist.

• Document hemophilia type and absence of inhibitors where required.
• Provide records of trials of prior prophylaxis agents and rationale for progression to marstacimab.

Required clinical documentation (iDose TR)

Medical records supporting PA for ophthalmic implants must include prior topical prostaglandin trials, Durysta trial or documented inability to use Durysta, and evidence of open‑angle glaucoma or ocular hypertension.

• Document specific topical agents tried, durations, and reasons for failure.
• If claiming inability to use Durysta, include clinical rationale and supporting notes.

Exclusion and documentation-related denial risk

Use of certain drugs in combination with other prophylactic agents for hemophilia A or B is an exclusion and lack of required documentation may result in denial; ensure combination therapy is not used and submit complete records.

• Do not request concurrent use of marstacimab with other hemophilia prophylaxis agents.
• Provide full prior therapy documentation to avoid exclusion‑based denials.

Insufficient documentation

Requests lacking medical records, genetic confirmation (TTR mutation), baseline PND ≤ IIIb and/or FAP Stage 1–2, or clinical signs/symptoms for transthyretin conditions may be denied; include complete supporting documentation with the PA.

• Attach genetic test results and baseline neurologic assessments where required.
• Document clinical signs such as motor disability or autonomic neuropathy in submitted records.

Documentation-based denial risk

Lack of required medical records documenting TTR mutation, baseline PND score ≤ IIIb or FAP Stage 1–2, and clinical signs/symptoms may trigger denial for transthyretin therapies; ensure these items are provided.

• Provide clear documentation of mutation and staging in the medical records.
• Include baseline functional assessments and clinician notes describing symptoms.

Diagnosis confirmation required

Failure to confirm diagnosis with appropriate testing for transthyretin amyloid cardiomyopathy (wild‑type or hereditary) may result in denial; include diagnostic test results with the PA.

• Attach confirmatory test results (e.g., imaging, biopsy) when submitting the PA.
• Document that the patient meets age and other specified criteria.

Documentation and diagnosis confirmation required

Lack of documentation confirming diagnosis or prior therapies and responses may trigger denial for therapies requiring such evidence; provide complete medical records with PA requests.

• Include prior therapy timelines, objective measures of response, and clinician notes.
• For reauthorization, include documentation of clinical improvement where required.

Evenity cumulative use cap

Evenity use beyond 12 months per lifetime is not covered; do not request reauthorization for cumulative use exceeding the 12‑month lifetime limit.

• Document prior Evenity exposure and cumulative duration when requesting coverage.
• If prior therapy exceeds 12 months, requests will be considered not medically necessary.

Hympavzi combination and prescriber restrictions

Marstacimab must not be used in combination with other prophylaxis drugs for hemophilia A or B and the prescription must be written by a hematologist; combination use or lack of prescriber documentation may trigger denial.

• Include hematology prescriber information on the PA submission.
• Do not request concurrent use with other hemophilia prophylaxis agents.

iDose TR prior-treatment exclusion

Requests for iDose TR (J7355) will be denied if the requested eye has previously received IDOSE TR (prior same-device treatment); confirm and document prior eye‑specific treatments before submission.

• Document the treatment history for the requested eye and confirm no prior IDOSE TR implantation.
• If prior IDOSE TR is present for the requested eye, do not submit for coverage.

Failure to provide required prior therapy documentation

Failure to provide medical records or to document required prior topical prostaglandin trials and/or Durysta use (or inability to use Durysta) for iDose TR requests may result in denial; include complete trial documentation.

• Provide dates, agents, duration, and reasons for failure for each topical PGA trial.
• If Durysta was tried, include documentation of trial and outcome; if not usable, document clinical rationale.

Denial triggers (iDose TR)

Lack of supporting medical records, absence of diagnosis of open‑angle glaucoma or ocular hypertension, or failure to document required prior topical prostaglandin trials may trigger denial for iDose TR requests.

• Ensure the PA includes clinical diagnosis notes and evidence of prior trial failures per policy.
• Document reasons and objective findings supporting each claim of failure.

Denial triggers (documentation)

Failure to provide supporting medical records or to meet the required prior therapy criteria for iDose TR may trigger denial; submit complete records demonstrating diagnosis and prior trial failures.

• Include provider notes, medication histories, and objective measures documenting inadequate response or intolerance.
• If claiming inability to use Durysta, include documented clinical barriers.

Requests may be denied if patient does not meet glaucoma criteria

Requests may be denied if the patient does not have a diagnosis of open‑angle glaucoma or ocular hypertension or has not met the required prior topical prostaglandin trial criteria; confirm diagnosis and prior trials in the PA submission.

• Provide clear diagnostic documentation and prior treatment history.
• Denials will be issued when required criteria are not met or documented.

Denial triggers (prior trial unmet)

A PA request may be denied for iDose TR if the patient lacks open‑angle glaucoma or ocular hypertension or has not met the required prior trial criteria (one PGA + Durysta or two PGAs if Durysta unusable); include detailed trial documentation to avoid denial.

• Document specific PGA trials, Durysta trial or inability to use Durysta, and outcomes.
• Attach clinical notes demonstrating inadequate response, intolerance, or compliance issues as the reason for failure.

Missing prior therapy documentation

Lack of documentation showing prior trial failures with required topical prostaglandin drops and/or Durysta will trigger denial for iDose TR; ensure all prior trial records and the reason each trial failed are submitted.

• Include dates, agents, dosing, adherence information, and clinician assessment of response for each prior trial.
• Provide Durysta trial documentation or clinical justification if Durysta is not usable.

Documentation of indication and prior therapy required

Documentation must show the patient has open‑angle glaucoma or ocular hypertension and has met the required prior topical/Durysta trial criteria before iDose TR will be approved; submit complete clinical records with the PA.

• Medical records should clearly state the diagnosis and describe prior therapy attempts and outcomes.
• Failure reasons must align with policy definitions (inadequate response, intolerance, or compliance issues).

Evenity cumulative use cap — not covered >12 months

Evenity is limited to 12 months per lifetime; do not request reauthorization beyond the 12‑month cumulative cap.

Document site of care for infusion/office administration

Part B drugs are typically administered by infusion or injection furnished incident to a physician or provider service (infusion center or office); document site of care and administration details in the claim/PA.

Infusion center dosing approved per FDA labeling

Dose approvals for infusion‑administered Part B drugs will follow FDA‑approved labeling or accepted standards of medical practice; include dosing rationale if outside standard labeling.

Hospital outpatient — document one‑time intracameral implant administration

For hospital outpatient administration, document that the one‑time intracameral implant is being administered per FDA labeling and include supporting PA documentation.

Office/outpatient one‑time administration — include PA and docs

For office/outpatient one‑time administrations (e.g., iDose TR) ensure PA and documentation support the one‑time administration per FDA labeling.

If site not specified, provide rationale with PA

If site of care is not specified in the request, include rationale and documentation for the chosen site when submitting PA to avoid processing delays.

Alymsys — must try Mvasi AND Zirabev first

Alymsys (bevacizumab‑maly) coverage requires trying Mvasi AND Zirabev first for all medically‑accepted indications; document trials of those biosimilars in the PA.

Trastuzumab preference — try Trazimera AND Kanjinti first

Trastuzumab (Herceptin) products require that providers document trials of Trazimera AND Kanjinti before Herceptin family products will be covered.

Trazimera AND Kanjinti required before Hercessi

Trastuzumab biosimilar preference: providers must document trials of Trazimera AND Kanjinti before coverage of Hercessi is authorized.

Entyvio — must try Inflectra or Renflexis and Hadlima first

Entyvio coverage requires trying Inflectra OR Renflexis and Hadlima first; document those prior biosimilar trials in the PA submission.

Must try Trazimera AND Kanjinti before Hercessi

Providers must document trials of Trazimera AND Kanjinti before Hercessi will be covered; include records of those biosimilar trials in the PA.

Must try Trazimera AND Kanjinti before Herzuma

Providers must document trials of Trazimera AND Kanjinti before Herzuma will be covered; include trial documentation in the PA submission.