Prior authorization required — submit PA form and medical records

Certain Part B drugs require prior authorization; providers must submit the appropriate Medicare Part B drug request form (Non‑Oncology) or the Oncology Drug Request form/Web Form and include supporting medical records demonstrating a medically accepted indication and prior therapies as applicable to the drug.

• Use the Medicare Part B (Non‑Oncology) drug request form for non‑oncology Part B drugs and the Medicare Part B Oncology Drug Request form for oncology drugs or the online Web Form to streamline review.
• Include dose, frequency, place of administration, and required medical records supporting diagnosis and prior therapy trials.

Step therapy may apply to Part B drugs (MAPD members)

Step therapy may apply to Part B drugs for MAPD members not currently receiving the Part B drug; providers must document trials of required preferred or generic comparators before coverage of the requested Part B product.

• Step therapy requires trial and documented failure (or intolerance/contraindication) of the specified preferred agent(s) per product.
• Biosimilars and generics are commonly designated as the required first‑line agents under step therapy.

Prior authorization form requirement — use Medicare Part B drug request or Oncology form

Providers must use the Medicare Part B (Non‑Oncology) drug request form, the Medicare Part B Oncology (Cancer Therapy) drug request form, or the Web Form as appropriate to submit prior authorization requests for Part B drugs; including these forms can streamline review.

• Provide dose, frequency, place of administration, and supporting medical records with the submission.
• Use the Oncology form/web form for oncology agents (e.g., Axtle, Beizray, Avastin).

Submit Medicare Part B drug request form or Web Form

Complete the Medicare Part B drug request form (Non‑Oncology) or the Medicare Part B Oncology form/Web Form to streamline review and avoid processing delays for Part B drug prior authorization submissions.

• Include required supporting medical records (diagnosis confirmation, prior therapy trials and responses, baseline measures where applicable).
• Omitting the appropriate form or required records may delay or result in denial.

Adakveo prior authorization and hydroxyurea trial

Adakveo requests require prior authorization using the Medicare Part B (Non‑Oncology) drug request form or Web Form; include medical records and documentation that the patient tried hydroxyurea for 6 months or has intolerance/contraindication.

• Coverage duration: 2 years; dosing per FDA labeling or accepted standards.
• Document hydroxyurea trial duration (6 months) or documented intolerance/contraindication.

Adzynma prior authorization — 12‑month approvals and diagnostic proof

Adzynma initial and reauthorization requests require prior authorization; initial and reauthorization approvals are for 12 months and providers must submit genetic testing confirming cTTP and ADAMTS13 activity < 10% plus medical records.

• Include patient's current weight for dosing on both initial and reauthorization requests.
• Prescriber must be, or document consultation with, an appropriate specialist.

Alhemo prior authorization — 12‑month approvals and required records

Alhemo requires prior authorization for initial and reauthorization approvals of 12 months; include medical records documenting diagnosis, prior therapies and (for hemophilia A) prior Hemlibra trial/failure where required.

• Patient must be ≥12 years of age for coverage.
• Prescriber must be, or document consultation with, a hematologist or appropriate specialist.

Avgemsi prior trial of generic gemcitabine required

Avgemsi requires step therapy — provider must document a prior trial of generic gemcitabine injection (Gemzar) before coverage of Avgemsi will be approved.

• Include medical records documenting the generic gemcitabine trial and response.
• Coverage duration: up to 1 year; dosing per FDA labeling.

Avtozma step therapy — trial Tyenne first

Avtozma requires step therapy — providers must document trial of Tyenne prior to approval; use the Medicare Part B (Non‑Oncology) drug request form or Web Form and provide medical records.

• Do not use Avtozma in combination with other biologic drugs, Otezla, or JAK inhibitors (combination use is excluded).
• Coverage duration: up to 2 years; dosing per FDA labeling.

Axtle step therapy and PA — trial generic pemetrexed required and submit Oncology form

Axtle requires a documented prior trial of generic pemetrexed before coverage; prior authorization must be submitted with the Medicare Part B Oncology drug request form or Web Form and supporting medical records.

• Coverage duration: 1 year; dosing per FDA labeling.
• Provide prior therapy records and treatment responses to avoid denial.

Axtle prior authorization — Oncology form and documentation required

Axtle prior authorization: submit the Medicare Part B Oncology drug request form or Web Form with supporting medical records documenting prior therapies and responses; coverage is typically for 1 year with dosing per FDA labeling.

• Failure to provide the required medical records may result in denial.
• Ensure the generic pemetrexed trial is documented in the submission.

Azmiro prior authorization — submit Non‑Oncology form and hypogonadism documentation

Azmiro prior authorization: providers must submit the Medicare Part B (Non‑Oncology) drug request form or Web Form with required medical documentation; include documentation of prior failure of generic testosterone cypionate and two pre‑treatment morning total testosterone measurements when applicable.

• Coverage duration: 2 years; dosing per FDA labeling or accepted standards.
• For hypogonadism, include two morning total testosterone values <300 ng/dL on separate days and clinical signs beyond erectile dysfunction/decreased libido.

Beizray prior authorization — Oncology form and generic docetaxel step

Beizray prior authorization: oncology requests must be submitted via the Medicare Part B Oncology drug request form or Web Form with supporting medical records; providers must document prior trial of generic docetaxel (Taxotere, J9171).

• Coverage duration: 1 year; dose approved per FDA labeling or accepted standards.
• Lack of supporting medical records may lead to denial.

Beizray‑Albumin prior authorization — Oncology form and documentation required

Beizray‑Albumin prior authorization: submit the Medicare Part B Oncology drug request form or Web Form with supporting records and document prior trial of generic docetaxel; coverage duration is typically 1 year.

• Dose will be approved per FDA labeling; absence of medical records may result in denial.
• Beizray products require documentation of prior therapies and responses.

Prior authorization required — document indication‑specific criteria and prior therapy failures

The policy lists many Part B drugs that require prior authorization; providers must document indication‑specific criteria, prior therapy failures, and prescriber requirements when submitting requests.

• Provide diagnosis confirmation, prior therapy trials and responses, and any specialist consultation or prescriber restriction documentation.
• Coverage durations and other product‑specific requirements vary by drug (see product entries).

Authorization durations — product‑specific time limits and lifetime limits

Prior authorization approvals have product‑specific durations and limits; examples include Casgevy (authorization 6 months; one lifetime dose), Cimzia (coverage duration 2 years), and others — confirm the product entry for the exact duration.

• Casgevy: 6‑month authorization; limit one dose per lifetime.
• Verify coverage duration listed in each product's criteria before submitting a request.

Prior authorization submission — include supporting medical records and specialist involvement when required

Prior authorization submissions must include supporting medical records documenting prior therapies and responses; for many products prescribers must be specialists or document specialist consultation.

• Where specified (e.g., NMOSD, myasthenia gravis), prescriptions must be by or in consultation with a neurologist.
• Omitting specialist prescriber documentation or prior therapy records may result in denial.

Prior authorization required for listed Part B drugs — use the appropriate Medicare Part B forms

A list of Part B drugs in this policy require prior authorization via the Medicare Part B (Non‑Oncology) drug request form or Oncology Web Form; submit the appropriate form and supporting records for the named products to streamline review.

• Oncology agents: use the Medicare Part B Oncology drug request form/Web Form.
• Non‑oncology Part B drugs: use the Medicare Part B (Non‑Oncology) drug request form or Web Form.

Medicare Part B drug request form — submit with product‑specific documentation

Submit the Medicare Part B (Non‑Oncology) drug request form or Web Form to streamline review for Part B drugs; include product‑level required documentation per the product's criteria.

• Using the correct form reduces processing time and clarifies required billing information (dose, frequency, place of administration).
• Product‑specific required records (diagnostics, prior therapy trials, specialist consults) must be attached.

Elevidys prior authorization and 1‑year approval — genetic and antibody documentation required

Elevidys initial and reauthorization approvals are for 1 year; prior authorization requires documentation per the Elevidys prescribing information (genetic confirmation, anti‑AAVrh74 titer <1:400, and absence of deletions in exon 8 or exon 9).

• Prescriber must be, or consult with, a neurologist experienced in DMD.
• Failure to document required genetic/antibody criteria may render the member ineligible.

Emblaveo prior authorization — 6‑month coverage and microbiology/susceptibility documentation

Emblaveo coverage is limited to 6 months; prior authorization requires culture and sensitivity results (or suspected organisms) and documentation that other appropriate generic/susceptible antibiotics were tried or are not appropriate.

• Prescriber must be an infectious disease specialist or document consultation with one.
• Include microbiology (culture/sensitivity) results or a statement of suspected organism(s) if cultures unavailable.

Encelto prior authorization — implant limit and required diagnostics

Encelto approvals are limited to 6 months and to one implant per affected eye per lifetime; prior authorization requires diagnostic testing supporting MacTel type 2 (e.g., FA, OCT), EZ (IS/OS) break measurement between 0.16 and 2.00 mm², and BCVA ETDRS score ≥54 letters.

• Prescriber must be, or consult with, an ophthalmologist; include required imaging and visual acuity data in the submission.
• One implant per affected eye lifetime limit must be documented in the request.

Enjaymo duration & reauthorization — initial 6 months, reauth requires clinical benefit

Enjaymo initial approval is 6 months; reauthorization requires documentation of clinical benefit (increase in hemoglobin and decreased transfusions) for a 12‑month reauthorization period.

• Provide baseline hemoglobin, documentation of at least one transfusion within 6 months prior to initiation, current weight, and details of prior rituximab‑containing regimen trial and failure.
• Prescriber should be, or consult with, a hematologist.

Prior authorization and step requirements — complete PA form and show required step trials

Prior authorization requires completion of the Medicare Part B drug request form and step therapy must be met where applicable (for example: Entyvio requires trial of Avsola OR Renflexis; Epogen requires trials of Procrit AND Retacrit).

• Document the specific prior agents tried and outcomes in the medical records.
• Failure to document required step therapy may result in denial.

Medicare Part B prior authorization — use Part B forms and attach required records

Medicare Part B prior authorization: for listed Part B drugs submit the Medicare Part B (Non‑Oncology) drug request form or Web Form and include required medical records and diagnostic proof as specified in the product criteria.

• Follow product‑specific instructions for diagnostics, specialist involvement, and prior therapy documentation.
• Use the Part B vs Part D Drug Request form when benefit determination is needed.

Denial risk — unmet prior authorization criteria may result in denial

Requests that do not meet prior authorization criteria may be denied; ensure the submission meets all listed clinical and documentation requirements.

• Common causes for denial include missing medical records, absent diagnostic tests, and failure to document required prior therapy trials.
• Use the specified PA form and attach all required supporting documentation to reduce denial risk.

Adakveo denial risk — missing 6‑month hydroxyurea trial

Adakveo denial trigger: failure to document a 6‑month hydroxyurea trial or documented intolerance/contraindication may result in denial of the request.

• If hydroxyurea was not used, provide documentation of medical rationale (intolerance or contraindication).
• Include hydroxyurea treatment dates and response in submitted records.

Evenity lifetime limit — requests >12 months per lifetime excluded

Evenity requests exceeding a cumulative use of more than 12 months per lifetime will be denied; include prior Evenity dosing history to confirm lifetime use does not exceed 12 months.

• Coverage duration is 12 months per lifetime; attest to prior Evenity exposure on requests.
• If prior bisphosphonate pathway requirements apply, document those trials or very high fracture‑risk criteria.

Infusion/administration site — document infusion center, office, or hospital outpatient

Part B drugs are typically administered by infusion or injection incident to a provider service; document place of administration (infusion center, office, or hospital outpatient) on the request for accurate billing and coverage.

• Provide place of administration and any site‑of‑care notes required for billing.
• No explicit site‑of‑care restrictions are stated in these product entries; follow FDA labeling and accepted standards.

Infusion center — submission guidance; no explicit site‑of‑care restrictions in excerpts

Submit Part B drug requests (Non‑Oncology or Oncology forms or Web Forms) as instructed; the excerpts do not impose explicit site‑of‑care restrictions, but providers must document place of administration when submitting the PA to support billing.

• Use the Oncology form for cancer therapies; include infusion site and relevant billing details.
• Provide medical records and dosing details to align with coverage and billing requirements.

Dose approvals — follow FDA labeling or accepted standards

When dosing approvals are requested, dose will be approved according to FDA labeling or accepted standards of medical practice; include dosing rationale and any weight‑based calculations in the submission.

• For oncology and specialty drugs, indicate the FDA‑approved regimen or accepted standard used for dosing decisions.
• Document current patient weight when dosing is weight‑based.

Infusion/administration — document site of care (infusion center/office/hospital outpatient)

Part B drugs are typically administered incident to a provider in an infusion center, office, or hospital outpatient setting; providers must document place of administration on the PA to support appropriate billing.

• Indicate infusion center, office, or hospital outpatient on the request form.
• No explicit site‑of‑care restrictions are specified in these excerpts; follow FDA labeling and accepted standards.

Biosimilar guidance — FDA supports biosimilars; biosimilar‑first trials may apply

Cosmetic or non‑medically accepted uses are not included; where biosimilars are appropriate, FDA supports their use and some policies require biosimilar‑first or biosimilar trial sequences (e.g., Avastin biosimilars Mvasi and Zirabev must be tried before Avastin).

• Biosimilar interchangeability or biosimilar‑first sequencing is enforced per product sections.
• Document trials of biosimilars and reasons for using the reference product if applicable.

Avastin biosimilar step therapy — try Mvasi and Zirabev first

For Avastin and related products, providers must document trials of Mvasi and Zirabev prior to approval of Avastin; per NCCN, FDA‑approved biosimilars are appropriate substitutes.

• Use the Oncology Drug Request form and include documentation of Mvasi and Zirabev trials.
• Coverage up to 1 year; dosing per FDA labeling.

Avtozma biosimilar — FDA supports use

Avtozma is a biosimilar to Actemra and FDA supports use of approved biosimilars; follow product‑specific step therapy and documentation requirements.

• Document prior therapy trials and prescriber specialty when requesting Avtozma.
• Do not use in combination with other biologics, Otezla, or JAK inhibitors.

Interchangeable biosimilars — follow product criteria and boxed warnings

FDA has determined that certain biosimilars (e.g., Bkemv/Epysqil) are interchangeable with their reference products; providers should follow the product‑specific criteria and boxed warnings (e.g., meningococcal infection risk with complement inhibitors).

• Ensure meningococcal vaccine/risk mitigation per labeling when applicable for complement inhibitors.
• Provide documentation of prior therapies and indication‑specific tests.

Actemra and biosimilars — FDA supports biosimilar use

FDA supports biosimilars as highly similar to reference biologics (e.g., Actemra biosimilars); where biosimilars are appropriate substitutes, providers should follow product‑specific step therapy and substitution guidance.

• Document prior biosimilar trials or reasons for selecting the reference product.
• Biosimilar interchangeability designations (when present) permit substitution consistent with FDA guidance.

Denial risk — requests not meeting prior authorization criteria may be denied

If prior authorization criteria are not met, the request may be denied; ensure step therapy trials, diagnostic test results, specialist prescriber requirements, and all required medical records are included with the submission.

• Denial reasons include missing documentation, unmet step therapy, and failure to meet product‑specific clinical criteria.
• Review the product section for exact documentation and test requirements to avoid denial.

Denial risk — IVIG step therapy not met may trigger denial

For IVIG requests, failing to document trials of two preferred IVIG products (when determined a Part B benefit) may result in denial of the requested IVIG product.

• Include dates, doses, and reasons for inadequate response or intolerance for the two preferred IVIG trials.
• Refer to LCD L34771 for additional documentation requirements.

Denial risk — missing Amvuttra diagnostic or prior therapy requirements

For Amvuttra, missing required diagnostic confirmation (TTR mutation for hATTR‑PN or specified imaging/biopsy for ATTR‑CM) or lack of documented prior tafamidis failure for ATTR‑CM may result in denial.

• Provide TTR genetic testing for hATTR‑PN and radionuclide imaging grade when used for ATTR‑CM.
• Document prior tafamidis trial and outcome for ATTR‑CM requests.

Amvuttra reauthorization risk — document positive clinical response

At reauthorization for Amvuttra, lack of documentation demonstrating positive clinical response compared to baseline (e.g., improved neuropathy, motor function, QoL, or reduced CV hospitalizations) may lead to denial.

• Submit measurable clinical outcomes compared to baseline to support continued coverage.
• Reauthorization duration: 1 year.

Denial risk — Aveed hypogonadism documentation missing may cause denial

For Aveed, requests lacking documentation of prior failures of generic intramuscular testosterone (cypionate or enanthate), a generic topical testosterone, and two pre‑treatment morning total testosterone measurements <300 ng/dL (plus required clinical signs and birth assignment where applicable) may be denied.

• Provide two separate morning total testosterone measurements and documentation of prior generic testosterone trials and outcomes.
• Include clinical signs consistent with testosterone deficiency (beyond ED or decreased libido) when applicable.

Denial risk — missing step therapy trials may lead to denial

If required step therapy trials are not completed (e.g., required prior therapies for Entyvio, Epogen, or Epysqli), the request may be denied; include documentation of trials and failures or documented contraindications.

• Entyvio requires prior trial of Avsola OR Renflexis.
• Epogen requires trials of Procrit AND Retacrit for non‑ESRD Part B requests.

Denial risk — Elevidys eligibility requirements must be met or request may be denied

For Elevidys, failure to meet genetic, age/ambulatory, or anti‑AAVrh74 antibody titer criteria may trigger denial; document the required genetic testing, ambulatory status, and anti‑AAVrh74 titer <1:400.

• Elevidys is contraindicated in patients with deletions in exon 8 or exon 9 of the DMD gene.
• Provide anti‑AAVrh74 total binding antibody titer results (<1:400) on the PA submission.